WorldWideScience

Sample records for randomly combined shapes

  1. Combined Shape and Topology Optimization

    DEFF Research Database (Denmark)

    Christiansen, Asger Nyman

    Shape and topology optimization seeks to compute the optimal shape and topology of a structure such that one or more properties, for example stiffness, balance or volume, are improved. The goal of the thesis is to develop a method for shape and topology optimization which uses the Deformable...... Simplicial Complex (DSC) method. Consequently, we present a novel method which combines current shape and topology optimization methods. This method represents the surface of the structure explicitly and discretizes the structure into non-overlapping elements, i.e. a simplicial complex. An explicit surface...... representation usually limits the optimization to minor shape changes. However, the DSC method uses a single explicit representation and still allows for large shape and topology changes. It does so by constantly applying a set of mesh operations during deformations of the structure. Using an explicit instead...

  2. Rethinking Robot Vision - Combining Shape and Appearance

    Directory of Open Access Journals (Sweden)

    Matthias J. Schlemmer

    2008-11-01

    Full Text Available Equipping autonomous robots with vision sensors provides a multitude of advantages by simultaneously bringing up difficulties with regard to different illumination conditions. Furthermore, especially with service robots, the objects to be handled must somehow be learned for a later manipulation. In this paper we summarise work on combining two different vision sensors, namely a laser range scanner and a monocular colour camera, for shape-capturing, detecting and tracking of objects in cluttered scenes without the need of intermediate user interaction. The use of different sensor types provides the advantage of separating the shape and the appearance of the object and therefore overcome the problem with changing illumination conditions. We describe the framework and its components of visual shape-capturing, fast 3D object detection and robust tracking as well as examples that show the feasibility of this approach.

  3. Cochlea Segmentation using Iterated Random Walks with Shape Prior

    DEFF Research Database (Denmark)

    Ruiz Pujadas, Esmeralda; Kjer, Hans Martin; Vera, Sergio

    2016-01-01

    Cochlear implants can restore hearing to deaf or partially deaf patients. In order to plan the intervention, a model from high resolution μCT images is to be built from accurate cochlea segmentations and then, adapted to a patient-specific model. Thus, a precise segmentation is required to build...... such a model. We propose a new framework for segmentation of μCT cochlear images using random walks where a region term is combined with a distance shape prior weighted by a confidence map to adjust its influence according to the strength of the image contour. Then, the region term can take advantage...

  4. Shape modelling using Markov random field restoration of point correspondences.

    Science.gov (United States)

    Paulsen, Rasmus R; Hilger, Klaus B

    2003-07-01

    A method for building statistical point distribution models is proposed. The novelty in this paper is the adaption of Markov random field regularization of the correspondence field over the set of shapes. The new approach leads to a generative model that produces highly homogeneous polygonized shapes and improves the capability of reconstruction of the training data. Furthermore, the method leads to an overall reduction in the total variance of the point distribution model. Thus, it finds correspondence between semi-landmarks that are highly correlated in the shape tangent space. The method is demonstrated on a set of human ear canals extracted from 3D-laser scans.

  5. Shape Modelling Using Markov Random Field Restoration of Point Correspondences

    DEFF Research Database (Denmark)

    Paulsen, Rasmus Reinhold; Hilger, Klaus Baggesen

    2003-01-01

    A method for building statistical point distribution models is proposed. The novelty in this paper is the adaption of Markov random field regularization of the correspondence field over the set of shapes. The new approach leads to a generative model that produces highly homogeneous polygonized...... shapes and improves the capability of reconstruction of the training data. Furthermore, the method leads to an overall reduction in the total variance of the point distribution model. Thus, it finds correspondence between semilandmarks that are highly correlated in the shape tangent space. The method...

  6. Mode shape expansions for the dynamic testing of cable domes considering random pretension deviations

    Science.gov (United States)

    Wu, Xiaoshun; Deng, Hua; Zhu, Dexi

    2017-04-01

    Cable domes maintain their structural stability and deformation resistance substantially depending on the geometrical stiffness contributed by pretension. Dynamic testing can be employed to monitor the possible stiffness degeneration caused by pretension deviations in existing cable domes. The measured incomplete mode shapes should be expanded for effectively evaluating the actual structural stiffness. However, conventional methods lose effectiveness for expanding mode shapes of cable domes whose modes are sensitive to the pretension deviations. A novel method is developed in this paper to expand the incomplete mode shapes of existing cable domes with random pretension deviations. For a monitored target mode of the existing structure, its mode shape can be approximately expressed as a linear combination of a few mode shapes of the ideal structure. Once their combinational coefficients are determined based on the measured incomplete mode shape, the expansion of this target mode is achieved. Two key steps are included: the determination of these so-called contribution modes and the estimation of their combinational coefficients. For the prescribed limit values of equivalent member length errors adopted to simulate random pretension deviations, contribution modes can be determined by considering the mode shape variations and mode jumpings. A proposed contribution mode effective independence (CMEI) method is further put forward to obtain the best estimate of combinational coefficients and the optimal layout of sensors. The numerical example of a cable dome illustrates the invalidation of the conventional expansion methods when random pretension deviations are considered. In contrast, the method proposed in this paper is validated to be effective and reliable even in the cases of severe modal variations and high noise levels.

  7. Rethinking Robot Vision – Combining Shape and Appearance

    Directory of Open Access Journals (Sweden)

    Matthias J. Schlemmer

    2007-09-01

    Full Text Available Equipping autonomous robots with vision sensors provides a multitude of advantages by simultaneously bringing up difficulties with regard to different illumination conditions. Furthermore, especially with service robots, the objects to be handled must somehow be learned for a later manipulation. In this paper we summarise work on combining two different vision sensors, namely a laser range scanner and a monocular colour camera, for shape-capturing, detecting and tracking of objects in cluttered scenes without the need of intermediate user interaction. The use of different sensor types provides the advantage of separating the shape and the appearance of the object and therefore overcome the problem with changing illumination conditions. We describe the framework and its components of visual shape-capturing, fast 3D object detection and robust tracking as well as examples that show the feasibility of this approach.

  8. Combined Digital Holography and Speckle Correlation for Rapid Shape Evaluation

    OpenAIRE

    Khodadad, Davood

    2014-01-01

    In manufacturing industry there is a high demand for on line quality control to minimize the risk of incorrectly produced objects. Conventional contact measurement methods are usually slow and invasive, meaning that they cannot be used for soft materials and for complex shapes without influencing thecontrolled parts. In contrast, interferometry and digital holography in combination with computers become faster, more reliable and highly accurate as an alternative non-contact technique for indu...

  9. Fourier based methodology for simulating 2D-random shapes in heterogeneous materials

    Science.gov (United States)

    Mattrand, C.; Béakou, A.; Charlet, K.

    2015-08-01

    Gaining insights into the effects of microstructural details on materials behavior may be achieved by incorporating their attributes into numerical modeling. This requires us to make considerable efforts to feature heterogeneity morphology distributions and their spatial arrangement. This paper focuses on modeling the scatter observed in materials heterogeneity geometry. The proposed strategy is based on the development of a 1D-shape signature function representing the 2D-section of a given shape, on Fourier basis functions. The Fourier coefficients are then considered as random variables. This methodology has been applied to flax fibers which are gradually introduced into composite materials as a potential alternative to synthetic reinforcements. In this contribution, the influence of some underlying assumptions regarding the choice of one 1D-shape signature function, its discretization scheme and truncation level, and the best way of modeling the associated random variables is also investigated. Some configurations coming from the combination of these tuning parameters are found to be sufficiently relevant to render efficiently the morphometric factors of the observed fibers statistically speaking.

  10. Limit Shapes and Fluctuations of Bounded Random Partitions

    DEFF Research Database (Denmark)

    Beltoft, Dan

    Young diagrams confined to a rectangle. When the rectangle grows, and diagrams are rescaled, the probability measure degenerates to a delta measure on a continuous curve, the limit shape. In the intermediate scaling, the fluctuations around the limit shape turn out to be governed by an Ornstein...

  11. Shaping the spectrum of random-phase radar waveforms

    Science.gov (United States)

    Doerry, Armin W.; Marquette, Brandeis

    2017-05-09

    The various technologies presented herein relate to generation of a desired waveform profile in the form of a spectrum of apparently random noise (e.g., white noise or colored noise), but with precise spectral characteristics. Hence, a waveform profile that could be readily determined (e.g., by a spoofing system) is effectively obscured. Obscuration is achieved by dividing the waveform into a series of chips, each with an assigned frequency, wherein the sequence of chips are subsequently randomized. Randomization can be a function of the application of a key to the chip sequence. During processing of the echo pulse, a copy of the randomized transmitted pulse is recovered or regenerated against which the received echo is correlated. Hence, with the echo energy range-compressed in this manner, it is possible to generate a radar image with precise impulse response.

  12. Combined shape and topology optimization of 3D structures

    DEFF Research Database (Denmark)

    Christiansen, Asger Nyman; Bærentzen, Jakob Andreas; Nobel-Jørgensen, Morten

    2015-01-01

    We present a method for automatic generation of 3D models based on shape and topology optimization. The optimization procedure, or model generation process, is initialized by a set of boundary conditions, an objective function, constraints and an initial structure. Using this input, the method...... will automatically deform and change the topology of the initial structure such that the objective function is optimized subject to the specified constraints and boundary conditions. For example, this tool can be used to improve the stiffness of a structure before printing, reduce the amount of material needed...

  13. Effect of particle shape on the random packing density of amorphous solids

    NARCIS (Netherlands)

    Kyrylyuk, A.V.|info:eu-repo/dai/nl/269067590; Philipse, A.P.|info:eu-repo/dai/nl/073532894

    2011-01-01

    The packing density of a particulate solid strongly depends on the shape of the particles that are jammed at random close packing (RCP). To investigate the effect of particle shape on the RCP density of an amorphous solid, we studied jammed packings of binary mixtures of a-thermal or granular

  14. [Randomized controlled study on chronic functional constipation treated with grain-shaped moxibustion and acupuncture].

    Science.gov (United States)

    Wang, Li-juan; Wang, Ling-ling

    2011-04-01

    To compare the therapeutic effect differences of chronic functional constipation treated with the combined therapy of grain-shaped moxibustion and acupuncture and simple acupuncture therapy. One hundred cases of constipation were randomly divided into an acupuncture and moxibustion group and an acupuncture group by fifty-fifty. Both groups were treated by acupuncture therapy with acupoints of two groups alternatively. Group 1: Tianshu (ST 25), Daheng (SP 15), Qihai (CV 6), Guanyuan (CV 4), Zusanli (ST 36), Shangjuxu (ST 37) and Sanyinjiao (SP 6). Group 2: Zhongliao (BL 33), Xialiao (BL 34), Dachangshu (BL 25), Shenshu (BL 23) and Pishu (BL 20). In acupuncture group, all the acupoints, were punctured; in acupuncture and moxibustion group, grain-shaped moxibustion was given at Qihai (CV 6), Susanli (ST 36), Dachangshu (BL 25) and Pishu (BL 20), and others were treated by puncture. The clinical therapeutic effect, and the changes of clinical score of constipation, quality of life and psychological symptoms score were observed before and after treatment. The total effective rate in acupuncture and moxibustion group was 74.0% (37/50), superior to that (52.0%, 26/50) in acupuncture group (P life and psychological symptoms score in both groups improved after treatment; in clinical score of constipation, the improvement of difficulty of defecation, defecation time, abdominal pain, exsufflation difficulty, endless sensation of defecation, obstruction sense of anus, purgative prescription dependence, quality of life score and psychological symptoms score in acupuncture and moxibustion group were superior to those in acupuncture group (P < 0.05, P < 0.01). For treating chronic functional constipation, the combined therapy of both grain-shaped moxibustion and acupuncture is safe and effective, superior to the simple acupuncture therapy.

  15. New beam shaping: Matched filtering combined with GPC

    DEFF Research Database (Denmark)

    Glückstad, Jesper

    2010-01-01

    We adapt concepts frolll matched filtering 10 propose a method for generating rcconligurablc multiple beams. Combined with the Generalized Phase Contrast (GPC) technique, the proposed method coined mGPC can yield dynamically rcconfigurablc optical beam 31rdYS wilh high light efficiency for optical...

  16. Combination of optical shape measurement and augmented reality for task support: II. Real-time feedback of shape measurement results

    Science.gov (United States)

    Yamauchi, Makoto; Iwamoto, Kazuyo

    2010-05-01

    Line heating is a skilled task in shipbuilding to shape the outer plates of ship hulls. Real-time information on the deformation of the plates during the task would be helpful to workers performing this process. Therefore, we herein propose an interactive scheme for supporting workers performing line heating; the system provides such information through an optical shape measurement instrument combined with an augmented reality (AR) system. The instrument was designed and fabricated so that the measured data were represented using coordinates based on fiducial markers. Since the markers were simultaneously used in the AR system for the purpose of positioning, the data could then be displayed to the workers through a head-mounted display as a virtual image overlaid on the plates. Feedback of the shape measurement results was thus performed in real time using the proposed system.

  17. Combined shape and topology optimization for minimization of maximal von Mises stress

    DEFF Research Database (Denmark)

    Lian, Haojie; Christiansen, Asger Nyman; Tortorelli, Daniel A.

    2017-01-01

    This work shows that a combined shape and topology optimization method can produce optimal 2D designs with minimal stress subject to a volume constraint. The method represents the surface explicitly and discretizes the domain into a simplicial complex which adapts both structural shape and topology...

  18. Combining Shape-Changing Interfaces and Spatial Augmented Reality Enables Extended Object Appearance

    DEFF Research Database (Denmark)

    Lindlbauer, David; Grønbæk, Jens Emil; Birk, Morten

    2016-01-01

    for increasing the realism of 3D objects such as bump mapping. This extensible framework helps us identify challenges of the two techniques and benefits of their combination. We utilize our prototype shape-changing device enriched with spatial augmented reality through projection mapping to demonstrate...... the concept. We present a novel mechanical distance-fields algorithm for real-time fitting of mechanically constrained shape-changing devices to arbitrary 3D graphics. Furthermore, we present a technique for increasing effective screen real estate for spatial augmented reality through view-dependent shape......We propose combining shape-changing interfaces and spatial augmented reality for extending the space of appearances and interactions of actuated interfaces. While shape-changing interfaces can dynamically alter the physical appearance of objects, the integration of spatial augmented reality...

  19. Spectral shaping of a randomized PWM DC-DC converter using maximum entropy probability distributions

    CSIR Research Space (South Africa)

    Dove, Albert

    2017-01-01

    Full Text Available stream_source_info Dove_2018.pdf.txt stream_content_type text/plain stream_size 26566 Content-Encoding UTF-8 stream_name Dove_2018.pdf.txt Content-Type text/plain; charset=UTF-8 SPECTRAL SHAPING OF A RANDOMIZED PWM DC... behind spectral shaping is to select a randomization technique with its associated PDF to analytically obtain a specified spectral profile [21]. The benefits of this idea comes in being able to achieve some level of controllability on the spectral content...

  20. Statistical Shape Modelling and Markov Random Field Restoration (invited tutorial and exercise)

    DEFF Research Database (Denmark)

    Hilger, Klaus Baggesen

    This tutorial focuses on statistical shape analysis using point distribution models (PDM) which is widely used in modelling biological shape variability over a set of annotated training data. Furthermore, Active Shape Models (ASM) and Active Appearance Models (AAM) are based on PDMs and have proven...... themselves a generic holistic tool in various segmentation and simulation studies. Finding a basis of homologous points is a fundamental issue in PDMs which effects both alignment and decomposition of the training data, and may be aided by Markov Random Field Restoration (MRF) of the correspondence...... deformation field between shapes. The tutorial demonstrates both generative active shape and appearance models, and MRF restoration on 3D polygonized surfaces. ''Exercise: Spectral-Spatial classification of multivariate images'' From annotated training data this exercise applies spatial image restoration...

  1. Investigating preferences for color-shape combinations with gaze driven optimization method based on evolutionary algorithms.

    Science.gov (United States)

    Holmes, Tim; Zanker, Johannes M

    2013-01-01

    Studying aesthetic preference is notoriously difficult because it targets individual experience. Eye movements provide a rich source of behavioral measures that directly reflect subjective choice. To determine individual preferences for simple composition rules we here use fixation duration as the fitness measure in a Gaze Driven Evolutionary Algorithm (GDEA), which has been demonstrated as a tool to identify aesthetic preferences (Holmes and Zanker, 2012). In the present study, the GDEA was used to investigate the preferred combination of color and shape which have been promoted in the Bauhaus arts school. We used the same three shapes (square, circle, triangle) used by Kandinsky (1923), with the three color palette from the original experiment (A), an extended seven color palette (B), and eight different shape orientation (C). Participants were instructed to look for their preferred circle, triangle or square in displays with eight stimuli of different shapes, colors and rotations, in an attempt to test for a strong preference for red squares, yellow triangles and blue circles in such an unbiased experimental design and with an extended set of possible combinations. We Tested six participants extensively on the different conditions and found consistent preferences for color-shape combinations for individuals, but little evidence at the group level for clear color/shape preference consistent with Kandinsky's claims, apart from some weak link between yellow and triangles. Our findings suggest substantial inter-individual differences in the presence of stable individual associations of color and shapes, but also that these associations are robust within a single individual. These individual differences go some way toward challenging the claims of the universal preference for color/shape combinations proposed by Kandinsky, but also indicate that a much larger sample size would be needed to confidently reject that hypothesis. Moreover, these experiments highlight the

  2. Nonlinear spatial focusing in random layered media by spectral pulse shaping

    Science.gov (United States)

    Han, Alex C.; Milner, Valery

    2016-02-01

    We demonstrate numerically a method of focusing two-photon fields inside one-dimensional random media. The approach is based on coherent control of backscattering achieved by adaptive spectral pulse shaping. The spectral phases of a femtosecond laser pulse are adjusted for the constructive interference of its backward-traveling components, resulting in an enhanced reflection from within the random system. A delayed forward-propagating second pulse overlaps with the controlled reflection, increasing the interpulse multiphoton field at a location determined by the delay between the two pulses. The technique is shown to be robust against the variations of the disorder and to work with realistic pulse-shaping parameters, hence enabling applications in controlling random lasing and multiphoton imaging in scattering materials.

  3. Formation of Combined Surface Features of Protrusion Array and Wrinkles atop Shape-Memory Polymer

    Science.gov (United States)

    Sun, L.; Zhao, Y.; Huang, W. M.; Tong, T. H.

    We demonstrate a simple and cost-effective approach to realize two combined surface features of different scales together, namely submillimeter-sized protrusion array and microwrinkles, atop a polystyrene shape-memory polymer. Two different types of protrusions, namely flat-top protrusion and crown-shaped protrusion, were studied. The array of protrusions was produced by the Indentation-Polishing-Heating (IPH) process. Compactly packed steel balls were used for making array of indents. A thin gold layer was sputter deposited atop the polymer surface right after polishing. After heating for shape recovery, array of protrusions with wrinkles on the top due to the buckling of gold layer was produced.

  4. Markov Random Field Restoration of Point Correspondences for Active Shape Modelling

    DEFF Research Database (Denmark)

    Hilger, Klaus Baggesen; Paulsen, Rasmus Reinhold; Larsen, Rasmus

    2004-01-01

    In this paper it is described how to build a statistical shape model using a training set with a sparse of landmarks. A well defined model mesh is selected and fitted to all shapes in the training set using thin plate spline warping. This is followed by a projection of the points of the warped...... model mesh to the target shapes. When this is done by a nearest neighbour projection it can result in folds and inhomogeneities in the correspondence vector field. The novelty in this paper is the use and extension of a Markov random field regularisation of the correspondence field. The correspondence...... model that produces highly homogeneous polygonised shapes with improved reconstruction capabilities of the training data. Furthermore, the method leads to an overall reduction in the total variance of the resulting point distribution model. The method is demonstrated on a set of human ear canals...

  5. Mode shape combination in a two-dimensional vibration energy harvester through mass loading structural modification

    Energy Technology Data Exchange (ETDEWEB)

    Sharpes, Nathan; Kumar, Prashant [Center for Energy Harvesting Materials and Systems (CEHMS), Virginia Tech, Blacksburg, Virginia 24061 (United States); Abdelkefi, Abdessattar; Abdelmoula, Hichem [Department of Mechanical and Aerospace Engineering, New Mexico State University, Las Cruces, New Mexico 88003 (United States); Adler, Jan [Center for Energy Harvesting Materials and Systems (CEHMS), Virginia Tech, Blacksburg, Virginia 24061 (United States); Institute of Dynamics and Vibration Research (IDS), Leibniz Universität, Hannover 30167 (Germany); Priya, Shashank [Center for Energy Harvesting Materials and Systems (CEHMS), Virginia Tech, Blacksburg, Virginia 24061 (United States); Bio-Inspired Materials and Devices Laboratory (BMDL), Virginia Tech, Blacksburg, Virginia 24061 (United States)

    2016-07-18

    Mode shapes in the design of mechanical energy harvesters, as a means of performance increase, have been largely overlooked. Currently, the vast majority of energy harvester designs employ some variation of a single-degree-of-freedom cantilever, and the mode shapes of such beams are well known. This is especially true for the first bending mode, which is almost exclusively the chosen vibration mode for energy harvesting. Two-dimensional beam shapes (those which curve, meander, spiral, etc., in a plane) have recently gained research interest, as they offer freedom to modify the vibration characteristics of the harvester beam for achieving higher power density. In this study, the second bending mode shape of the “Elephant” two-dimensional beam shape is examined, and its interaction with the first bending mode is evaluated. A combinatory mode shape created by using mass loading structural modification to lower the second bending modal frequency was found to interact with the first bending mode. This is possible since the first two bending modes do not share common areas of displacement. The combined mode shape is shown to produce the most power of any of the considered mode shapes.

  6. Influence of crystal shapes on radiative fluxes in visible wavelength: ice crystals randomly oriented in space

    Directory of Open Access Journals (Sweden)

    P. Chervet

    1996-08-01

    Full Text Available Radiative properties of cirrus clouds are one of the major unsolved problems in climate studies and global radiation budget. These clouds are generally composed of various ice-crystal shapes, so we tried to evaluate effects of the ice-crystal shape on radiative fluxes. We calculated radiative fluxes of cirrus clouds with a constant geometrical depth, composed of ice crystals with different shapes (hexagonal columns, bullets, bullet-rosettes, sizes and various concentrations. We considered ice particles randomly oriented in space (3D case and their scattering phase functions were calculated by a ray-tracing method. We calculated radiative fluxes for cirrus layers for different microphysical characteristics by using a discrete-ordinate radiative code. Results showed that the foremost effect of the ice-crystal shape on radiative properties of cirrus clouds was that on the optical thickness, while the variation of the scattering phase function with the ice shape remained less than 3% for our computations. The ice-water content may be a better choice to parameterize the optical properties of cirrus, but the shape effect must be included.

  7. Combined SPHARM-PDM and entropy-based particle systems shape analysis framework.

    Science.gov (United States)

    Paniagua, Beatriz; Bompard, Lucile; Cates, Josh; Whitaker, Ross; Datar, Manasi; Vachet, Clement; Styner, Martin

    2012-03-23

    The NA-MIC SPHARM-PDM Toolbox represents an automated set of tools for the computation of 3D structural statistical shape analysis. SPHARM-PDM solves the correspondence problem by defining a first order ellipsoid aligned, uniform spherical parameterization for each object with correspondence established at equivalently parameterized points. However, SPHARM correspondence has shown to be inadequate for some biological shapes that are not well described by a uniform spherical parameterization. Entropy-based particle systems compute correspondence by representing surfaces as discrete point sets that does not rely on any inherent parameterization. However, they are sensitive to initialization and have little ability to recover from initial errors. By combining both methodologies we compute reliable correspondences in topologically challenging biological shapes. Diverse subcortical structures cohorts were used, obtained from MR brain images. The SPHARM-PDM shape analysis toolbox was used to compute point based correspondent models that were then used as initializing particles for the entropy-based particle systems. The combined framework was implemented as a stand-alone Slicer3 module, which works as an end-to-end shape analysis module. The combined SPHARM-PDM-Particle framework has demonstrated to improve correspondence in the example dataset over the conventional SPHARM-PDM toolbox. The work presented in this paper demonstrates a two-sided improvement for the scientific community, being able to 1) find good correspondences among spherically topological shapes, that can be used in many morphometry studies 2) offer an end-to-end solution that will facilitate the access to shape analysis framework to users without computer expertise.

  8. Efficiency Enhancement of an Envelope Tracking Power Amplifier Combining Supply Shaping and Dynamic Biasing

    DEFF Research Database (Denmark)

    Tafuri, Felice Francesco; Sira, Daniel; Jensen, Ole Kiel

    2013-01-01

    This paper presents a new method to improve the performance of envelope tracking (ET) power amplifiers (PAs). The method consists of combining the supply modulation that characterizes the envelope tracking architecture with supply shaping and dynamic biasing. The inclusion of dynamic biasing allows...

  9. A comparative study of combined small-incision cataract surgery with sutureless trabeculectomy versus trabeculectomy using W-shaped incision.

    Science.gov (United States)

    Khurana, A K; Chawla, U; Passi, N; Jyoti; Archana; Yogesh

    2011-01-01

    Manual small-incision cataract surgery with trabeculectomy is now an acceptable option in the surgical management of combined cataract and glaucoma uncontrolled with maximum tolerated medical therapy. To compare the results and complications of combined manual small-incision cataract surgery (SICS) and posterior chamber intraocular lens (PCIOL) implantation with trabeculectomy by sutureless versus W-shaped incision technique. The study included 30 eyes of 28 patients with senile cataract and primary open-angle glaucoma (POAG) who were randomly divided into two groups. The patients in Group A (n = 15) underwent SICS with sutureless trabeculectomy and those in Group B (n =15) underwent SICS with trabeculectomy using W-shaped incision with one suture. Post-operative evaluation was done at the first post-operative day and thereafter on follow-ups at 1 week, 2 weeks, 4 weeks and 8 weeks. The mean preoperative and postoperative intraocular pressure (IOP) in Group A was 27.33 ± 3.35 mmHg and 16.13 ± 4.30 mmHg respectively and in Group B it was 29.46 ± 6.06 mmHg and 14.66 ± 2.69 mmHg respectively. The mean reduction in IOP after 8 weeks of follow-up in Group A was 12.52 ± 3.59 mmHg and that in Group B was 16.47 ± 3.79 mmHg (p less than 0.001). Besides this, the uncorrected visual acuity (UCVA) was better in Group B postoperatively with less surgically-induced against-the-rule (ATR) astigmatism. Combined SICS with trabeculectomy using W-shaped incision offers better prospective in terms of glaucoma control and visual performance than sutureless combined surgery. © NEPjOPH.

  10. Investigating preferences for colour-shape combinations with gaze driven optimization method based on evolutionary algorithms.

    Directory of Open Access Journals (Sweden)

    Tim eHolmes

    2013-12-01

    Full Text Available Studying aesthetic preference is notoriously difficult because it targets individual experience. Eye movements provide a rich source of behavioural measures that directly reflect subjective choice. To determine individual preferences for simple composition rules we here use fixation duration as the fitness measure in a Gaze Driven Evolutionary Algorithm (GDEA, which has been used as a tool to identify aesthetic preferences (Holmes & Zanker, 2012. In the present study, the GDEA was used to investigate the preferred combination of colour and shape which have been promoted in the Bauhaus arts school. We used the same 3 shapes (square, circle, triangle used by Kandinsky (1923, with the 3 colour palette from the original experiment (A, an extended 7 colour palette (B, and 8 different shape orientation (C. Participants were instructed to look for their preferred circle, triangle or square in displays with 8 stimuli of different shapes, colours and rotations, in an attempt to test for a strong preference for red squares, yellow triangles and blue circles in such an unbiased experimental design and with an extended set of possible combinations. We Tested 6 participants extensively on the different conditions and found consistent preferences for individuals, but little evidence at the group level for preference consistent with Kandinsky’s claims, apart from some weak link between yellow and triangles. Our findings suggest substantial inter-individual differences in the presence of stable individual associations of colour and shapes, but also that these associations are robust within a single individual. These individual differences go some way towards challenging the claims of the universal preference for colour/shape combinations proposed by Kandinsky, but also indicate that a much larger sample size would be needed to confidently reject that hypothesis. Moreover, these experiments highlight the vast potential of the GDEA in experimental aesthetics

  11. Robust mechanisms of ventral furrow invagination require the combination of cellular shape changes

    Science.gov (United States)

    Conte, Vito; Muñoz, José J.; Baum, Buzz; Miodownik, Mark

    2009-03-01

    Ventral furrow formation in Drosophila is the first large-scale morphogenetic movement during the life of the embryo, and is driven by co-ordinated changes in the shape of individual epithelial cells within the cellular blastoderm. Although many of the genes involved have been identified, the details of the mechanical processes that convert local changes in gene expression into whole-scale changes in embryonic form remain to be fully understood. Biologists have identified two main cell deformation modes responsible for ventral furrow invagination: constriction of the apical ends of the cells (apical wedging) and deformation along their apical-basal axes (radial lengthening/shortening). In this work, we used a computer 2D finite element model of ventral furrow formation to investigate the ability of different combinations of three plausible elementary active cell shape changes to bring about epithelial invagination: ectodermal apical-basal shortening, mesodermal apical-basal lengthening/shortening and mesodermal apical constriction. We undertook a systems analysis of the biomechanical system, which revealed many different combinations of active forces (invagination mechanisms) were able to generate a ventral furrow. Two important general features were revealed. First that combinations of shape changes are the most robust to environmental and mutational perturbation, in particular those combining ectodermal pushing and mesodermal wedging. Second, that ectodermal pushing plays a big part in all of the robust mechanisms (mesodermal forces alone do not close the furrow), and this provides evidence that it may be an important element in the mechanics of invagination in Drosophila.

  12. Fully Automatic Myocardial Segmentation of Contrast Echocardiography Sequence Using Random Forests Guided by Shape Model.

    Science.gov (United States)

    Li, Yuanwei; Ho, Chin Pang; Toulemonde, Matthieu; Chahal, Navtej; Senior, Roxy; Tang, Meng-Xing

    2017-09-26

    Myocardial contrast echocardiography (MCE) is an imaging technique that assesses left ventricle function and myocardial perfusion for the detection of coronary artery diseases. Automatic MCE perfusion quantification is challenging and requires accurate segmentation of the myocardium from noisy and time-varying images. Random forests (RF) have been successfully applied to many medical image segmentation tasks. However, the pixel-wise RF classifier ignores contextual relationships between label outputs of individual pixels. RF which only utilizes local appearance features is also susceptible to data suffering from large intensity variations. In this paper, we demonstrate how to overcome the above limitations of classic RF by presenting a fully automatic segmentation pipeline for myocardial segmentation in full-cycle 2D MCE data. Specifically, a statistical shape model is used to provide shape prior information that guide the RF segmentation in two ways. First, a novel shape model (SM) feature is incorporated into the RF framework to generate a more accurate RF probability map. Second, the shape model is fitted to the RF probability map to refine and constrain the final segmentation to plausible myocardial shapes. We further improve the performance by introducing a bounding box detection algorithm as a preprocessing step in the segmentation pipeline. Our approach on 2D image is further extended to 2D+t sequences which ensures temporal consistency in the final sequence segmentations. When evaluated on clinical MCE datasets, our proposed method achieves notable improvement in segmentation accuracy and outperforms other state-of-the-art methods including the classic RF and its variants, active shape model and image registration.

  13. Phenotype Recognition with Combined Features and Random Subspace Classifier Ensemble

    Directory of Open Access Journals (Sweden)

    Pham Tuan D

    2011-04-01

    Full Text Available Abstract Background Automated, image based high-content screening is a fundamental tool for discovery in biological science. Modern robotic fluorescence microscopes are able to capture thousands of images from massively parallel experiments such as RNA interference (RNAi or small-molecule screens. As such, efficient computational methods are required for automatic cellular phenotype identification capable of dealing with large image data sets. In this paper we investigated an efficient method for the extraction of quantitative features from images by combining second order statistics, or Haralick features, with curvelet transform. A random subspace based classifier ensemble with multiple layer perceptron (MLP as the base classifier was then exploited for classification. Haralick features estimate image properties related to second-order statistics based on the grey level co-occurrence matrix (GLCM, which has been extensively used for various image processing applications. The curvelet transform has a more sparse representation of the image than wavelet, thus offering a description with higher time frequency resolution and high degree of directionality and anisotropy, which is particularly appropriate for many images rich with edges and curves. A combined feature description from Haralick feature and curvelet transform can further increase the accuracy of classification by taking their complementary information. We then investigate the applicability of the random subspace (RS ensemble method for phenotype classification based on microscopy images. A base classifier is trained with a RS sampled subset of the original feature set and the ensemble assigns a class label by majority voting. Results Experimental results on the phenotype recognition from three benchmarking image sets including HeLa, CHO and RNAi show the effectiveness of the proposed approach. The combined feature is better than any individual one in the classification accuracy. The

  14. Shape Universality Classes in the Random Sequential Adsorption of Nonspherical Particles

    Science.gov (United States)

    Baule, Adrian

    2017-07-01

    Random sequential adsorption (RSA) of particles of a particular shape is used in a large variety of contexts to model particle aggregation and jamming. A key feature of these models is the observed algebraic time dependence of the asymptotic jamming coverage ˜t-ν as t →∞ . However, the exact value of the exponent ν is not known apart from the simplest case of the RSA of monodisperse spheres adsorbed on a line (Renyi's seminal "car parking problem"), where ν =1 can be derived analytically. Empirical simulation studies have conjectured on a case-by-case basis that for general nonspherical particles, ν =1 /(d +d ˜ ), where d denotes the dimension of the domain, and d ˜ the number of orientational degrees of freedom of a particle. Here, we solve this long-standing problem analytically for the d =1 case—the "Paris car parking problem." We prove, in particular, that the scaling exponent depends on the particle shape, contrary to the original conjecture and, remarkably, falls into two universality classes: (i) ν =1 /(1 +d ˜ /2 ) for shapes with a smooth contact distance, e.g., ellipsoids, and (ii) ν =1 /(1 +d ˜ ) for shapes with a singular contact distance, e.g., spherocylinders and polyhedra. The exact solution explains, in particular, why many empirically observed scalings fall in between these two limits.

  15. Aeroelastic flutter enhancement by exploiting the combined use of shape memory alloys and nonlinear piezoelectric circuits

    Science.gov (United States)

    Sousa, Vagner Candido de; Silva, Tarcísio Marinelli Pereira; De Marqui Junior, Carlos

    2017-10-01

    In this paper, the combined effects of semi-passive control using shunted piezoelectric material and passive pseudoelastic hysteresis of shape memory springs on the aerolastic behavior of a typical section is investigated. An aeroelastic model that accounts for the presence of both smart materials employed as mechanical energy dissipation devices is presented. The Brinson model is used to simulate the shape memory material. New expressions for the modeling of the synchronized switch damping on inductor technique (developed for enhanced piezoelectric damping) are presented, resulting in better agreement with experimental data. The individual effects of each nonlinear mechanism on the aeroelastic behavior of the typical section are first verified. Later, the combined effects of semi-passive piezoelectric control and passive shape memory alloy springs on the post-critical behavior of the system are discussed in details. The range of post-flutter airflow speeds with stable limit cycle oscillations is significantly increased due to the combined effects of both sources of energy dissipation, providing an effective and autonomous way to modify the behavior of aeroelastic systems using smart materials.

  16. Support vector machine-based facial-expression recognition method combining shape and appearance

    Science.gov (United States)

    Han, Eun Jung; Kang, Byung Jun; Park, Kang Ryoung; Lee, Sangyoun

    2010-11-01

    Facial expression recognition can be widely used for various applications, such as emotion-based human-machine interaction, intelligent robot interfaces, face recognition robust to expression variation, etc. Previous studies have been classified as either shape- or appearance-based recognition. The shape-based method has the disadvantage that the individual variance of facial feature points exists irrespective of similar expressions, which can cause a reduction of the recognition accuracy. The appearance-based method has a limitation in that the textural information of the face is very sensitive to variations in illumination. To overcome these problems, a new facial-expression recognition method is proposed, which combines both shape and appearance information, based on the support vector machine (SVM). This research is novel in the following three ways as compared to previous works. First, the facial feature points are automatically detected by using an active appearance model. From these, the shape-based recognition is performed by using the ratios between the facial feature points based on the facial-action coding system. Second, the SVM, which is trained to recognize the same and different expression classes, is proposed to combine two matching scores obtained from the shape- and appearance-based recognitions. Finally, a single SVM is trained to discriminate four different expressions, such as neutral, a smile, anger, and a scream. By determining the expression of the input facial image whose SVM output is at a minimum, the accuracy of the expression recognition is much enhanced. The experimental results showed that the recognition accuracy of the proposed method was better than previous researches and other fusion methods.

  17. Random walks with shape prior for cochlea segmentation in ex vivo μCT

    DEFF Research Database (Denmark)

    Ruiz Pujadas, Esmeralda; Kjer, Hans Martin; Piella, Gemma

    2016-01-01

    previously proposed the use of a high-resolution model built from μCT images and then adapted to patient-specific clinical CT scans. As the accuracy of the model is dependent on the precision of the original segmentation, it is extremely important to have accurate μCT segmentation algorithms. Methods We......(2):236–253, 2013) and constrained random walks (Li et al. in Advances in image and video technology. Springer, Berlin, pp 215–226, 2012). Our approach demonstrated higher accuracy results due to the probability density model constituted by the region term and shape prior information weighed by a confidence map...

  18. Non-convex shape effects on the dense random packing properties of assembled rods

    Science.gov (United States)

    Meng, Lingyi; Wang, Chao; Yao, Xiaohu

    2018-01-01

    The packing of rod-like particles, which is common in physical and mathematical studies, has arisen in a variety of industrial applications. Elongation effect on the packing properties of rod-like particle has been well investigated. Besides that, rod-like particles can be easily deformed into a large amount of non-convex shapes by simply bending or assembling several particles, in which effects of non-convex deformations should also be concerned. In this work, the packing behaviors of particulate systems composed of various non-convex deformations of rod-like particles are numerically simulated via the analytical model and the relaxation algorithm. The packing configurations are further optimized using the Monte Carlo method to eliminate the local ordered structures. 8 shapes of non-convex particles including 2-dimensional and 3-dimensional particles are employed in the packing systems. Independent of aspect ratio, the dense random packing densities of identical assembled rods are up to 20% higher than those of spherocylinders and are less dependent from the specific particle shape. However, the coordination numbers of various non-convex particle packings are quite different. With a parameter of convex ratio defined, a packing composed of more non-convex particles will have a higher coordination number. This indicates that for more non-convex particle packings, there are more constraints and entanglements among neighboring particles, resulting in a more stable configuration. The nearest-neighbor contact to a centered particle in 3DX-shaped particle packings is quite different from those of other shapes, which can be identified from the location of the first peak in the radial distribution function. It is also the cause to the distinct disparities of estimated excluded volumes of non-convex particles simulated in this work.

  19. Efficiency Enhancement of an Envelope Tracking Power Amplifier Combining Supply Shaping and Dynamic Biasing

    DEFF Research Database (Denmark)

    Tafuri, Felice Francesco; Sira, Daniel; Jensen, Ole Kiel

    2013-01-01

    This paper presents a new method to improve the performance of envelope tracking (ET) power amplifiers (PAs). The method consists of combining the supply modulation that characterizes the envelope tracking architecture with supply shaping and dynamic biasing. The inclusion of dynamic biasing allo...... magnitude (EVM) of 1.2% and an adjacent channel power ratio (ACPR) of -39.4/-43.5 dBc. The presented transmitter architecture allowed an improvement of 12% PAE compared to a classical ET transmitter where the measured PA was biased in class-AB, maintaining the linearity indicators.......This paper presents a new method to improve the performance of envelope tracking (ET) power amplifiers (PAs). The method consists of combining the supply modulation that characterizes the envelope tracking architecture with supply shaping and dynamic biasing. The inclusion of dynamic biasing allows...... of the input envelope by means of two shaping functions jointly designed on the basis of a single-tone characterization. The presented technique is demonstrated by means of measurements on a commercial GaAs HBT power amplifier. Measured results showed a PA power added efficiency (PAE) of 51.9%, an error vector...

  20. Combined Randomized-Local Hough Transform versus UpWrite Transform in stamp detection

    Directory of Open Access Journals (Sweden)

    Daniela Tondini

    2003-10-01

    Full Text Available The conventional Hough Transform used for detection of objects with known shape and size has proved its robustness. One typical task for this transform can be the detection of stamp(s on an envelope. Unfortunately, the Hough Transform has an important drawback: the heavy computational effort and, as consequence, a big execution time. This paper introduces a variant of Hough Transform that speeds up the process. One important aid is given by a filtering step based on a fast analysis of a rough deformation model. This method is a combination of Randomized and Local Hough Transform. Experiments were made comparing the modified Hough Transform approach with the UpWrite Transform and they proved that the first approach preserves the quality of the Hough Transform results at a higher speed.

  1. Detection of Corn and Weed Species by the Combination of Spectral, Shape and Textural Features

    Directory of Open Access Journals (Sweden)

    Fenfang Lin

    2017-08-01

    Full Text Available Accurate detection of weeds in farmland can help reduce pesticide use and protect the agricultural environment. To develop intelligent equipment for weed detection, this study used an imaging spectrometer system, which supports micro-scale plant feature analysis by acquiring high-resolution hyper spectral images of corn and a number of weed species in the laboratory. For the analysis, the object-oriented classification system with segmentation and decision tree algorithms was utilized on the hyper spectral images to extract shape and texture features of eight species of plant leaves, and then, the spectral identification characteristics of different species were determined through sensitive waveband selection and using vegetation indices calculated from the sensitive band data of the images. On the basis of the comparison and analysis of the combined characteristics of spectra, shape, and texture, it was determined that the spectral characteristics of the ratio vegetation index of R677/R710 and the normalized difference vegetation index, shape features of shape index, area, and length, as well as the texture feature of the entropy index could be used to build a discrimination model for corn and weed species. Results of the model evaluation showed that the Global Accuracy and the Kappa coefficient of the model were both over 95%. In addition, spectral and shape features can be regarded as the preferred characteristics to develop a device of weed identification from the view of accessibility to crop/weeds discriminant features, according to different roles of various features in classifying plants. Therefore, the results of this study provide valuable information for the portable device development of intelligent weed detection.

  2. Iterative deblending using shaping regularization with a combined PNMO-MF-FK coherency filter

    Science.gov (United States)

    Chen, Yangkang; Jin, Zhaoyu; Gan, Shuwei; Yang, Wencheng; Xiang, Kui; Bai, Min; Huang, Weilin

    2015-11-01

    Simultaneous shooting achieves a much faster acquisition but poses a challenging problem for subsequent processing because of the interference from the neighbor crews. Separation of different sources, also called deblending, becomes important for the overall success of the new acquisition technology. In this paper, we propose a novel deblending approach following the shaping regularization framework. The shaping operator is chosen as an effective filter, combining pseudo normal-moveout, median filtering, and frequency wavenumber filtering (PNMO-MF-FK). We combine the median-filter based deblending approaches and the FK filter based deblending approach within the proposed framework. Instead of simply using the median filter to remove blending noise, we apply a pseudo NMO (PNMO) to prepare a relatively flatter profile in advance, which can make the median filter more effective. It is the first time that the PNMO, median filtering, and FK filtering are combined to form a powerful coherency filter in order to improve the performance of iterative deblending. The proposed deblending approach with the PNMO-MF-FK filter can obtain successful performance within small number of iterations. Compared with the alternative MF-FK filter and FK filter, the PNMO-MF-FK filter can obtain obviously better deblending results. We use both simulated synthetic and field data examples to demonstrate the performance of the proposed approach.

  3. Three-dimensional shape measurement using color random binary encoding pattern projection

    Science.gov (United States)

    Zhou, Pei; Zhu, Jiangping; Su, Xianyu; Jing, Hailong; Zhang, Xing

    2017-10-01

    Acquiring the three-dimensional (3-D) surface geometry of objects with a full-frame resolution is of great concern in many applications. This paper reports a 3-D measurement scheme based on single-frame pattern projection in the combination of random binary encoding and color encoding. Three random binary encoding patterns generated by a computer embedded in three channels of a color pattern lead to a color binary encoding pattern. Two color cameras with a stereo-vision arrangement simultaneously capture the measured scene under the proposed encoding structured illumination. From captured images, three encoding images are extracted and analyzed using the extended spatial-temporal correlation algorithm for 3-D reconstruction. Theoretical explanation and analysis concerning the encoding principle and reconstruction algorithm, followed by experiments for reconstructing 3-D geometry of stationary and dynamic scenes show the feasibility and practicality of the proposed method.

  4. Combining the ensemble and Franck-Condon approaches for calculating spectral shapes of molecules in solution.

    Science.gov (United States)

    Zuehlsdorff, T J; Isborn, C M

    2018-01-14

    The correct treatment of vibronic effects is vital for the modeling of absorption spectra of many solvated dyes. Vibronic spectra for small dyes in solution can be easily computed within the Franck-Condon approximation using an implicit solvent model. However, implicit solvent models neglect specific solute-solvent interactions on the electronic excited state. On the other hand, a straightforward way to account for solute-solvent interactions and temperature-dependent broadening is by computing vertical excitation energies obtained from an ensemble of solute-solvent conformations. Ensemble approaches usually do not account for vibronic transitions and thus often produce spectral shapes in poor agreement with experiment. We address these shortcomings by combining zero-temperature vibronic fine structure with vertical excitations computed for a room-temperature ensemble of solute-solvent configurations. In this combined approach, all temperature-dependent broadening is treated classically through the sampling of configurations and quantum mechanical vibronic contributions are included as a zero-temperature correction to each vertical transition. In our calculation of the vertical excitations, significant regions of the solvent environment are treated fully quantum mechanically to account for solute-solvent polarization and charge-transfer. For the Franck-Condon calculations, a small amount of frozen explicit solvent is considered in order to capture solvent effects on the vibronic shape function. We test the proposed method by comparing calculated and experimental absorption spectra of Nile red and the green fluorescent protein chromophore in polar and non-polar solvents. For systems with strong solute-solvent interactions, the combined approach yields significant improvements over the ensemble approach. For systems with weak to moderate solute-solvent interactions, both the high-energy vibronic tail and the width of the spectra are in excellent agreement with

  5. Wave pressure acting on V-shaped floating breakwater in random seas

    Science.gov (United States)

    Yu, Yang; Ding, Ning; Lin, Jie; Hou, Jiajia

    2015-12-01

    Wave pressure on the wet surface of a V-shaped floating breakwater in random seas is investigated. Considering the diffraction effect, the unit velocity potential caused by the single regular waves around the breakwater is solved using the finite-depth Green function and boundary element method, in which the Green function is solved by integral method. The Response-Amplitude Operator (RAO) of wave pressure is acquired according to the Longuet-Higgins' wave model and the linear Bernoulli equation. Furthermore, the wave pressure's response spectrum is calculated according to the wave spectrum by discretizing the frequency domain. The wave pressure's characteristic value corresponding to certain cumulative probability is determined according to the Rayleigh distribution of wave heights. The numerical results and field test results are compared, which indicates that the wave pressure calculated in random seas agrees with that of field measurements. It is found that the bigger angle between legs will cause the bigger pressure response, while the increase in leg length does not influence the pressure significantly. The pressure at the side of head sea is larger than that of back waves. When the incident wave angle changes from 0° to 90°, the pressure at the side of back waves decreases clearly, while at the side of head sea, the situation is more complicated and there seems no obvious tendency. The concentration of wave energy around low frequency (long wavelength) will induce bigger wave pressure, and more attention should be paid to this situation for the structure safety.

  6. Aerodynamic Shape Optimization Using A Combined Distributed/Shared Memory Paradigm

    Science.gov (United States)

    Cheung, Samson; Holst, Terry

    1999-01-01

    Current parallel computational approaches involve distributed and shared memory paradigms. In the distributed memory paradigm, each processor has its own independent memory. Message passing typically uses a function library such as MPI or PVM. In the shared memory paradigm, such as that used on the SGI Origin 2000 machine, compiler directives are used to instruct the compiler to schedule multiple threads to perform calculations. In this paradigm, it must be assured that processors (threads) do not simultaneously access regions of memory in such away that errors would occur. This paper utilizes the latest version of the SGI MPI function library to combine the two parallelization paradigms to perform aerodynamic shape optimization of a generic wing/body.

  7. Utilization of random process spectral properties for the calculation of fatigue life under combined loading

    Directory of Open Access Journals (Sweden)

    Svoboda J.

    2009-12-01

    Full Text Available The contribution includes the results of experimental works aiming to find a new methodology for the calculation of fatigue life of structures subjected to operational loading from a combination of forces and moments of random character. Considering the fracture mechanics theory, then the damaging of material is both in the micro- and macro-plastic area connected with the rise of plastic deformation and hence with the plastic transformation rate which depends on the amount of supplied energy. The power spectral density (PSD indicating the power at individual frequencies in the monitored frequency band yields information about the supplied amount of energy. Therefore, it can be assumed that there is a dependence between the PSD shape and the size of damage and that the supplied power which is proportional to the value of dispersion s^2 under the PSD curve could be a new criterion for the calculation of fatigue life under combined loading. The searching for links between the spectral properties of the loading process and the fatigue life of structure under load is dealt with by new Grant GA No. 101/09/0904 of the Czech Technical University in Prague and the Institute of Thermomechanics of the Academy of Sciences of the Czech Republic, v.v.i.

  8. Shape dependency of the extinction and absorption cross sections of dust aerosols modeled as randomly oriented spheroids

    Directory of Open Access Journals (Sweden)

    R. Wagner

    2011-09-01

    Full Text Available We present computational results on the shape dependency of the extinction and absorption cross sections of dustlike aerosol particles that were modeled as randomly oriented spheroids. Shape dependent variations in the extinction cross sections are largest in the size regime that is governed by the interference structure. Elongated spheroids best fitted measured extinction spectra of re-dispersed Saharan dust samples. For dust particles smaller than 1.5 μm in diameter and low absorption potential, shape effects on the absorption cross sections are very small.

  9. Combined emulsifying capacity of polysaccharide particles of different size and shape.

    Science.gov (United States)

    Matos, María; Marefati, Ali; Bordes, Romain; Gutiérrez, Gemma; Rayner, Marilyn

    2017-08-01

    The aim of this study is to understand mixed systems of two types of particles with different size and shape, quinoa starch granules (NQ) and cellulose nanocrystals (CNC), to stabilize oil-in-water (O/W) emulsions. This study considers the extent of Pickering stabilization with respect to which particle type dominates at droplet interfaces and how stability is affected by the addition of one particle type to already formed emulsions, or combining both, simultaneously. Results demonstrate that the order of addition has an influence allowing to predominantly have NQ particles at the interface when both types are added simultaneously. However when CNC is added first, both types are responsible for emulsion stabilization leading to a system with an intermediate droplet size yet with a higher stability compared to single particle formulations. A dual stabilization mechanism is observed, large particles prevent coalescence and small particles regulate the curvature of the interface and govern the droplet size. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. An accurate online calibration system based on combined clamp-shape coil for high voltage electronic current transformers.

    Science.gov (United States)

    Li, Zhen-hua; Li, Hong-bin; Zhang, Zhi

    2013-07-01

    Electronic transformers are widely used in power systems because of their wide bandwidth and good transient performance. However, as an emerging technology, the failure rate of electronic transformers is higher than that of traditional transformers. As a result, the calibration period needs to be shortened. Traditional calibration methods require the power of transmission line be cut off, which results in complicated operation and power off loss. This paper proposes an online calibration system which can calibrate electronic current transformers without power off. In this work, the high accuracy standard current transformer and online operation method are the key techniques. Based on the clamp-shape iron-core coil and clamp-shape air-core coil, a combined clamp-shape coil is designed as the standard current transformer. By analyzing the output characteristics of the two coils, the combined clamp-shape coil can achieve verification of the accuracy. So the accuracy of the online calibration system can be guaranteed. Moreover, by employing the earth potential working method and using two insulating rods to connect the combined clamp-shape coil to the high voltage bus, the operation becomes simple and safe. Tests in China National Center for High Voltage Measurement and field experiments show that the proposed system has a high accuracy of up to 0.05 class.

  11. [Research on cleaning rate of the C-shaped canal treated by manual or rotary endodontic file combined with ultrasonic rinsing].

    Science.gov (United States)

    Wang, Jing; Gao, Yan; Wang, Qing-shan; Zhang, Yan; Rong, Li; Wang, Jiu

    2014-08-01

    To evaluate the cleaning effect of the C-shaped canal treated by manual K file and ProTaper rotary endodontic file combined with ultrasonic cleaning, and find a better cleaning program for the C-shaped root canal. Fifty mandibular second molars were randomly divided into 5 groups: K file group, K file+ultrasonic rinsing group, ProTaper group, ProTaper+ultrasonic rinsing group and the control group. After initial shaping and cleaning, the mandibular second molars were soaked in formalin and stained. Under microscopy, the cleaning rate of necrotic tissue and cutting area were observed and analyzed. The data was processed with SPSS 17.0 software package. The cleaning rates of the treated groups were significantly higher than that of the control group (Pultrasonic cleaning group was lower than that of the other treatment groups; The cutting score of the K file+ultrasonic rinsing group was significantly lower than that of the K file group (Pendodontic file should be chosen to clean the top of the taproot pipe and combined with ultrasonic rinsing to achieve better results.

  12. Simultaneous acquisition of 3D shape and deformation by combination of interferometric and correlation-based laser speckle metrology.

    Science.gov (United States)

    Dekiff, Markus; Berssenbrügge, Philipp; Kemper, Björn; Denz, Cornelia; Dirksen, Dieter

    2015-12-01

    A metrology system combining three laser speckle measurement techniques for simultaneous determination of 3D shape and micro- and macroscopic deformations is presented. While microscopic deformations are determined by a combination of Digital Holographic Interferometry (DHI) and Digital Speckle Photography (DSP), macroscopic 3D shape, position and deformation are retrieved by photogrammetry based on digital image correlation of a projected laser speckle pattern. The photogrammetrically obtained data extend the measurement range of the DHI-DSP system and also increase the accuracy of the calculation of the sensitivity vector. Furthermore, a precise assignment of microscopic displacements to the object's macroscopic shape for enhanced visualization is achieved. The approach allows for fast measurements with a simple setup. Key parameters of the system are optimized, and its precision and measurement range are demonstrated. As application examples, the deformation of a mandible model and the shrinkage of dental impression material are measured.

  13. Dumbbell-shaped spinal solitary fibrous tumor: Combined approach and a review of the literature.

    Science.gov (United States)

    Lavrador, J P; Oliveira, E; Neto, L; Pimentel, J; Francisco, A F; Livraghi, S

    2015-08-01

    Spinal solitary fibrous tumors are rare entities, particularly when considered in a dumbbell-shaped form. The authors report on a 23-year-old female patient with dorsalgia and a D11-D12 dumbbell-shaped lesion on MRI, and highly vascularized on angiography. After a biopsy-based diagnosis, an integrated approach was performed with a preoperative embolization of the feeding intercostal arteries and an en bloc resection. At 3 months postoperatively, the patient had no pain or other neurologic symptoms and a complete resection was performed and documented on MRI. To our knowledge, only 3 previous reports of dumbbell-shaped spinal solitary fibrous tumors were carried-out and this is the first case, to our knowledge, treated by pre-operatory embolization. Nevertheless, this tumor should be considered among other spinal dumbbell-shaped lesions with a differential diagnosis, i.e. meningioma and schwannoma. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  14. Laplacian drop shapes and effect of random perturbations on accuracy of surface tension measurement for different drop constellations.

    Science.gov (United States)

    Saad, Sameh M I; Neumann, A Wilhelm

    2015-08-01

    Theoretical drop shapes are calculated for three drop constellations: pendant drops, constrained sessile drops, and unconstrained sessile drops. Based on total Gaussian curvature, shape parameter and critical shape parameter are discussed as a function of different drop sizes and surface tensions. The shape parameter is linked to physical parameters for every drop constellation. The as yet unavailable detailed dimensional analysis for the unconstrained sessile drop is presented. Results show that the unconstrained sessile drop shape depends on a dimensionless volume term and the contact angle. Random perturbations are introduced and the accuracy of surface tension measurement is assessed for precise and perturbed profiles of the three drop constellations. It is concluded that pendant drops are the best method for accurate surface tension measurement, followed by constrained sessile drops. The unconstrained sessile drops come last because they tend to be more spherical at low and moderate contact angles. Of course, unconstrained sessile drops are the only option if contact angles are to be measured. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Combined Optical and Electrical Spectrum Shaping for High-Baud-Rate Nyquist-WDM Transceivers

    DEFF Research Database (Denmark)

    Porto da Silva, Edson; Borkowski, Robert; Preussler, Stefan

    2016-01-01

    . To investigate the benefits of the proposed approach, we demonstrate 32 the first WDM Nyquist-OTDM signal generation based on the periodic train of sinc pulses 33 and electrical spectrum shaping. Straight line transmission of five 112.5-Gbd Nyquist- 34 OTDM dual-polarization quadrature phase-shift keying (QPSK...... bandwidth is related to the optical comb parameters 25 and the pulse shaping of the modulating waveforms in the electrical domain. Such de- 26 pendence may result in broadening of the modulated spectra, which can degrade the 27 performance of Nyquist-WDM systems due to interchannel crosstalk penalties...

  16. Research on the reliability of friction system under combined additive and multiplicative random excitations

    Science.gov (United States)

    Sun, Jiaojiao; Xu, Wei; Lin, Zifei

    2018-01-01

    In this paper, the reliability of a non-linearly damped friction oscillator under combined additive and multiplicative Gaussian white noise excitations is investigated. The stochastic averaging method, which is usually applied to the research of smooth system, has been extended to the study of the reliability of non-smooth friction system. The results indicate that the reliability of friction system can be improved by Coulomb friction and reduced by random excitations. In particular, the effect of the external random excitation on the reliability is larger than the effect of the parametric random excitation. The validity of the analytical results is verified by the numerical results.

  17. Combining interscalene brachial plexus block with intravenous-inhalation combined anesthesia for upper extremity fractures surgery: a randomized controlled trial.

    Science.gov (United States)

    Yuan, Lan; Tang, Wei; Fu, Guo-qiang; Wang, Jian; Guo, Jun; Chen, Wen-ting

    2014-12-01

    A parallel-group randomized controlled trial (RCT) was conducted to evaluate the effect of combining the interscalene brachial plexus block (IBPB) with Intravenous-inhalation combined anesthesia to isolated Intravenous-inhalation anesthesia in the upper extremity fractures surgery of elderly patients. One hundred elderly patients who underwent upper extremity surgery were randomly assigned to received isolated Intravenous-inhalation combined anesthesia (group CI, n = 50) and IBPB associated with Intravenous-inhalation combined anesthesia (group NB, n = 50). Associated side effects, recovery time after operation, as well as the dose of intraoperative vasoactive agents and auxiliary drugs were noted. The two groups were not significantly different in gender (P = 0.539), ages (P = 0.683) and weight (P = 0.212). Five patients (10%) in the group NB and 17 patients (34%) in the group CI suffered from preoperative hypotension (P = 0.004). Besides, lower incidence of other adverse effects such as mental stress, incision pain and hypertension were also found in the group NB; however, the differences were not statistically significant (P > 0.05). The consumption of general anesthetics in the group NB was significantly less than that of the group CI (propofol, P = 0.004; lsoflurane, P < 0.001), and the recovery time of the group NB was significantly shorter than that of the group CI (P = 0.020). Combining IBPB with Intravenous-inhalation combined anesthesia in elderly patients hold a greater potential for upper extremity fractures surgery due to its improved clinical effectiveness and fewer side effects. Copyright © 2014. Published by Elsevier Ltd.

  18. Posterior Laminoplastic Laminotomy Combined with a Paraspinal Transmuscular Approach for Removing a Lumbar Dumbbell-shaped Schwannoma: A Technical Note.

    Science.gov (United States)

    Ngerageza, Japhet Gideon; Ito, Kiyoshi; Aoyama, Tatsuro; Murata, Takahiro; Horiuchi, Tetsuyoshi; Hongo, Kazuhiro

    2015-01-01

    The surgical strategies and methods used to treat dumbbell-shaped tumors located in the lumbar-foraminal region are controversial. Although a total facetectomy and combined intra- and extraspinal canal approach provide a wide operative field, facet fusion is required, which can be rather invasive. Here, we report a successful removal of a lumbar dumbbell-shaped schwannoma using a combined laminoplastic laminotomy with Wiltse's paraspinal surgical approach. This was performed under an operating microscope without a complete facetectomy, fusion, and posterior fixation. Briefly, we treated two patients with lumbar foraminal tumors, both dumbbell-shaped schwannomas located in the intra- and extradural portion. After a laminoplastic laminotomy, the intradural tumor was removed. The tumor located at the extracanalicular site was removed after drilling the pars interarticularis of the lamina, which was performed to enlarge the intervertebral foramen via Wiltse's paraspinal surgical approach. During surgery, facetectomy with posterior fixation was not needed to remove the intraforaminal component. There was no lumbar instability or complication after surgery. Our results suggest that a combined posterior laminoplastic laminotomy and Wiltse's paraspinal surgical approach is useful and less invasive for treating patients with lumbar foraminal tumors.

  19. Imipramine and Pregabalin Combination for Painful Polyneuropathy. A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B

    2015-01-01

    Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more...... effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo-controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy...... randomized, and 69 patients were included in the data analysis. The effect on average pain in comparison with placebo was: combination (-1.67 NRS points, P pregabalin (-0.48 NRS points, P = 0.03). The combination therapy had significantly lower pain...

  20. Combined shape-material sensitivity approach for elastic-wave identification of penetrable obstacles

    Energy Technology Data Exchange (ETDEWEB)

    Bonnet, Marc [Laboratoire de Mecanique des Solides (UMR CNRS 7649), Ecole Poly technique, F-91128 Palaiseau Cedex (France); Guzina, Bojan B [Department of Civil Engineering, University of Minnesota, Minneapolis, MN 55455 (United States)], E-mail: bonnet@lms.polytechnique.fr, E-mail: guzina@wave.ce.umn.edu

    2008-11-01

    This study deals with elastic-wave identification of heterogeneities (inclusions) in an otherwise homogeneous 'reference' solid from limited-aperture measurements taken on its surface. On adopting the boundary integral equation (BIE) framework for elastodynamic scattering, the inverse query is cast as a minimization problem involving experimental observations and their simulations for a trial inclusion defined through its boundary, elastic moduli, and mass density. Expressions for the shape and material sensitivities of the misfit functional are obtained via the adjoint field approach and direct differentiation of the governing BIE's, respectively. A constrained nonlinear optimization framework based on the direct BIE method and an augmented Lagrangian is implemented. Numerical results for the reconstruction of an ellipsoidal defect in a semi-infinite solid show the effectiveness of the proposed shape-material sensitivity formulation, which constitutes an essential computational component.

  1. A Combination of Shape and Texture Features for Classification of Pulmonary Nodules in Lung CT Images

    OpenAIRE

    Dhara, Ashis Kumar; Mukhopadhyay, Sudipta; Dutta, Anirvan; Garg, Mandeep; Khandelwal,Niranjan

    2016-01-01

    Classification of malignant and benign pulmonary nodules is important for further treatment plan. The present work focuses on the classification of benign and malignant pulmonary nodules using support vector machine. The pulmonary nodules are segmented using a semi-automated technique, which requires only a seed point from the end user. Several shape-based, margin-based, and texture-based features are computed to represent the pulmonary nodules. A set of relevant features is determined for th...

  2. On-line measurement of ski-jumper trajectory: combining stereo vision and shape description

    Science.gov (United States)

    Nunner, T.; Sidla, O.; Paar, G.; Nauschnegg, B.

    2010-01-01

    Ski jumping has continuously raised major public interest since the early 70s of the last century, mainly in Europe and Japan. The sport undergoes high-level analysis and development, among others, based on biodynamic measurements during the take-off and flight phase of the jumper. We report on a vision-based solution for such measurements that provides a full 3D trajectory of unique points on the jumper's shape. During the jump synchronized stereo images are taken by a calibrated camera system in video rate. Using methods stemming from video surveillance, the jumper is detected and localized in the individual stereo images, and learning-based deformable shape analysis identifies the jumper's silhouette. The 3D reconstruction of the trajectory takes place on standard stereo forward intersection of distinct shape points, such as helmet top or heel. In the reported study, the measurements are being verified by an independent GPS measurement mounted on top of the Jumper's helmet, synchronized to the timing of camera exposures. Preliminary estimations report an accuracy of +/-20 cm in 30 Hz imaging frequency within 40m trajectory. The system is ready for fully-automatic on-line application on ski-jumping sites that allow stereo camera views with an approximate base-distance ratio of 1:3 within the entire area of investigation.

  3. Empirical forward scattering phase functions from 0.08 to 16 deg. for randomly shaped terrigenous 1-21 microm sediment grains.

    Science.gov (United States)

    Agrawal, Y C; Mikkelsen, Ole A

    2009-05-25

    We present in-water forward scattering phase functions covering the angle range 0.08 to 16 degrees for 19 narrow-sized dispersions of randomly shaped sediment grains. These dispersions cover particle size range from 1 to 20 microns. These phase functions offer a realistic alternative to Mie theory. Qualitatively, (i) the magnitude of phase functions at the smallest angles for equal size spheres and randomly shaped particles are nearly equal; (ii) the oscillations predicted by Mie theory for spheres disappear for random shaped grains, and (iii) the tendency of phase functions of large spheres to merge at large angles is also seen with randomly shaped grains. The data are also provided in tabulated form.

  4. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial

    NARCIS (Netherlands)

    van Tubergen, A.; Landewé, R.; van der Heijde, D.; Hidding, A.; Wolter, N.; Asscher, M.; Falkenbach, A.; Genth, E.; Thè, H. G.; van der Linden, S.

    2001-01-01

    To determine the efficacy of combined spa-exercise therapy in addition to standard treatment with drugs and weekly group physical therapy in patients with ankylosing spondylitis (AS). A total of 120 Dutch outpatients with AS were randomly allocated into 3 groups of 40 patients each. Group 1 (mean

  5. T3, a Combinator-based Random Testing Tool for Java: Benchmarking

    NARCIS (Netherlands)

    Prasetya, I.S.W.B.

    2014-01-01

    T3 is the next generation of the light weight automated testing tool T2 for Java. In the heart T3 is still a random testing tool; but it now comes with some new features: pair-wise testing, concurrent generators, and a combinator-based approach ala QuickCheck. This paper presents the result of

  6. 3D statistical shape models incorporating 3D random forest regression voting for robust CT liver segmentation

    Science.gov (United States)

    Norajitra, Tobias; Meinzer, Hans-Peter; Maier-Hein, Klaus H.

    2015-03-01

    During image segmentation, 3D Statistical Shape Models (SSM) usually conduct a limited search for target landmarks within one-dimensional search profiles perpendicular to the model surface. In addition, landmark appearance is modeled only locally based on linear profiles and weak learners, altogether leading to segmentation errors from landmark ambiguities and limited search coverage. We present a new method for 3D SSM segmentation based on 3D Random Forest Regression Voting. For each surface landmark, a Random Regression Forest is trained that learns a 3D spatial displacement function between the according reference landmark and a set of surrounding sample points, based on an infinite set of non-local randomized 3D Haar-like features. Landmark search is then conducted omni-directionally within 3D search spaces, where voxelwise forest predictions on landmark position contribute to a common voting map which reflects the overall position estimate. Segmentation experiments were conducted on a set of 45 CT volumes of the human liver, of which 40 images were randomly chosen for training and 5 for testing. Without parameter optimization, using a simple candidate selection and a single resolution approach, excellent results were achieved, while faster convergence and better concavity segmentation were observed, altogether underlining the potential of our approach in terms of increased robustness from distinct landmark detection and from better search coverage.

  7. Objective definition of rosette shape variation using a combined computer vision and data mining approach.

    Science.gov (United States)

    Camargo, Anyela; Papadopoulou, Dimitra; Spyropoulou, Zoi; Vlachonasios, Konstantinos; Doonan, John H; Gay, Alan P

    2014-01-01

    Computer-vision based measurements of phenotypic variation have implications for crop improvement and food security because they are intrinsically objective. It should be possible therefore to use such approaches to select robust genotypes. However, plants are morphologically complex and identification of meaningful traits from automatically acquired image data is not straightforward. Bespoke algorithms can be designed to capture and/or quantitate specific features but this approach is inflexible and is not generally applicable to a wide range of traits. In this paper, we have used industry-standard computer vision techniques to extract a wide range of features from images of genetically diverse Arabidopsis rosettes growing under non-stimulated conditions, and then used statistical analysis to identify those features that provide good discrimination between ecotypes. This analysis indicates that almost all the observed shape variation can be described by 5 principal components. We describe an easily implemented pipeline including image segmentation, feature extraction and statistical analysis. This pipeline provides a cost-effective and inherently scalable method to parameterise and analyse variation in rosette shape. The acquisition of images does not require any specialised equipment and the computer routines for image processing and data analysis have been implemented using open source software. Source code for data analysis is written using the R package. The equations to calculate image descriptors have been also provided.

  8. Objective definition of rosette shape variation using a combined computer vision and data mining approach.

    Directory of Open Access Journals (Sweden)

    Anyela Camargo

    Full Text Available Computer-vision based measurements of phenotypic variation have implications for crop improvement and food security because they are intrinsically objective. It should be possible therefore to use such approaches to select robust genotypes. However, plants are morphologically complex and identification of meaningful traits from automatically acquired image data is not straightforward. Bespoke algorithms can be designed to capture and/or quantitate specific features but this approach is inflexible and is not generally applicable to a wide range of traits. In this paper, we have used industry-standard computer vision techniques to extract a wide range of features from images of genetically diverse Arabidopsis rosettes growing under non-stimulated conditions, and then used statistical analysis to identify those features that provide good discrimination between ecotypes. This analysis indicates that almost all the observed shape variation can be described by 5 principal components. We describe an easily implemented pipeline including image segmentation, feature extraction and statistical analysis. This pipeline provides a cost-effective and inherently scalable method to parameterise and analyse variation in rosette shape. The acquisition of images does not require any specialised equipment and the computer routines for image processing and data analysis have been implemented using open source software. Source code for data analysis is written using the R package. The equations to calculate image descriptors have been also provided.

  9. A Combined Random Forests and Active Contour Model Approach for Fully Automatic Segmentation of the Left Atrium in Volumetric MRI

    Directory of Open Access Journals (Sweden)

    Chao Ma

    2017-01-01

    Full Text Available Segmentation of the left atrium (LA from cardiac magnetic resonance imaging (MRI datasets is of great importance for image guided atrial fibrillation ablation, LA fibrosis quantification, and cardiac biophysical modelling. However, automated LA segmentation from cardiac MRI is challenging due to limited image resolution, considerable variability in anatomical structures across subjects, and dynamic motion of the heart. In this work, we propose a combined random forests (RFs and active contour model (ACM approach for fully automatic segmentation of the LA from cardiac volumetric MRI. Specifically, we employ the RFs within an autocontext scheme to effectively integrate contextual and appearance information from multisource images together for LA shape inferring. The inferred shape is then incorporated into a volume-scalable ACM for further improving the segmentation accuracy. We validated the proposed method on the cardiac volumetric MRI datasets from the STACOM 2013 and HVSMR 2016 databases and showed that it outperforms other latest automated LA segmentation methods. Validation metrics, average Dice coefficient (DC and average surface-to-surface distance (S2S, were computed as 0.9227±0.0598 and 1.14±1.205 mm, versus those of 0.6222–0.878 and 1.34–8.72 mm, obtained by other methods, respectively.

  10. Automatic Detection of Tuberculosis in Chest Radiographs Using a Combination of Textural, Focal, and Shape Abnormality Analysis.

    Science.gov (United States)

    Hogeweg, Laurens; Sánchez, Clara I; Maduskar, Pragnya; Philipsen, Rick; Story, Alistair; Dawson, Rodney; Theron, Grant; Dheda, Keertan; Peters-Bax, Liesbeth; van Ginneken, Bram

    2015-12-01

    Tuberculosis (TB) is a common disease with high mortality and morbidity rates worldwide. Automatic systems to detect TB on chest radiographs (CXRs) can improve the efficiency of diagnostic algorithms for pulmonary TB. The diverse manifestation of TB on CXRs from different populations requires a system that can be adapted to deal with different types of abnormalities. A computer aided detection (CAD) system was developed which combines several subscores of supervised subsystems detecting textural, shape, and focal abnormalities into one TB score. A general framework was developed to combine an arbitrary number of subscores: subscores were normalized, collected in a feature vector and then combined using a supervised classifier into one combined score. The method was evaluated on two databases, both consisting of 200 digital CXRs, from: (A) Western high-risk group screening, (B) TB suspect screening in Africa. The subscores and combined score were compared to (1) an external, non-radiological, reference and (2) a radiological reference determined by a human expert. Performance was measured using Receiver Operator Characteristic (ROC) analysis. Different subscores performed best in the two databases. The combined TB score performed better than the individual subscores, except for the external reference in database B. The performances of the independent observer were slightly higher than the combined TB score. Compared to the external reference, differences in performance between the combined TB score and the independent observer were not significant in both databases. Supervised combination to compute an overall TB score allows for a necessary adaptation of the CAD system to different settings or different operational requirements.

  11. Radar Shape Modeling Of 1996 HW1 Combined With Thermal Observations

    NARCIS (Netherlands)

    Howell, Ellen S.; Magri, C.; Nolan, M. C.; Taylor, P. A.; Vervack, R. J., Jr.; Fernandez, Y. R.; Mueller, M.; Benner, L. A. M.; Giorgini, J. D.; Scheeres, D. J.; Hicks, M. D.; Rhoades, H.; Somers, J. M.; Gaftonyuk, N. M.; Krugly, Y. N.; Kouprianov, V. V.; Molotov, I. E.; Benishek, V.; Protitch-Benishek, V.; Galad, A.; Higgins, D.; Kusnirak, P.; Pray, D.

    2010-01-01

    We observed near-Earth asteroid (8567) 1996 HW1 at the Arecibo Observatory on six dates in September 2008, obtaining radar images and spectra. By combining these data with an extensive set of new lightcurves taken during 2008-2009 and with previously published lightcurves from 2005, we were able to

  12. Combining generalized phase contrast with matched filtering into a versatile beam shaping system

    DEFF Research Database (Denmark)

    Glückstad, Jesper

    2009-01-01

    We adapt concepts from matched filtering to propose a method for generating reconfigurable multiple beams. Combined with the Generalized Phase Contrast (GPC) technique, the proposed method coined mGPC can yield dynamically reconfigurable optical beam arrays with high light efficiency for optical...

  13. Deformation scenarios of combined stretching and bending in complex shaped deep drawing parts

    NARCIS (Netherlands)

    Kitting, D.; Ofenheimer, A.; van den Boogaard, Antonius H.; Dietmaier, P.

    2013-01-01

    Bending effects, especially for Advanced High Strength Steels (AHSS), are known to influence the material formability when stretching and bending is combined in sheet forming. Traditional formability measures (e.g. the conventional forming limit curve (FLC)) fail to reliably predict formability when

  14. Multiple trait model combining random regressions for daily feed intake with single measured performance traits of growing pigs

    Directory of Open Access Journals (Sweden)

    Künzi Niklaus

    2002-01-01

    Full Text Available Abstract A random regression model for daily feed intake and a conventional multiple trait animal model for the four traits average daily gain on test (ADG, feed conversion ratio (FCR, carcass lean content and meat quality index were combined to analyse data from 1 449 castrated male Large White pigs performance tested in two French central testing stations in 1997. Group housed pigs fed ad libitum with electronic feed dispensers were tested from 35 to 100 kg live body weight. A quadratic polynomial in days on test was used as a regression function for weekly means of daily feed intake and to escribe its residual variance. The same fixed (batch and random (additive genetic, pen and individual permanent environmental effects were used for regression coefficients of feed intake and single measured traits. Variance components were estimated by means of a Bayesian analysis using Gibbs sampling. Four Gibbs chains were run for 550 000 rounds each, from which 50 000 rounds were discarded from the burn-in period. Estimates of posterior means of covariance matrices were calculated from the remaining two million samples. Low heritabilities of linear and quadratic regression coefficients and their unfavourable genetic correlations with other performance traits reveal that altering the shape of the feed intake curve by direct or indirect selection is difficult.

  15. Calendering as a direct shaping tool for the continuous production of fixed-dose combination products via co-extrusion.

    Science.gov (United States)

    Vynckier, A-K; Lin, H; Zeitler, J A; Willart, J-F; Bongaers, E; Voorspoels, J; Remon, J P; Vervaet, C

    2015-10-01

    In this study calendering is used as a downstream technique to shape monolithic co-extruded fixed-dose combination products in a continuous way. Co-extrudates with a metoprolol tartrate-loaded sustained-release core and a hydrochlorothiazide-loaded immediate-release coat were produced and immediately shaped into a monolithic drug delivery system via calendering, using chilled rolls with tablet-shaped cavities. In vitro metoprolol tartrate release from the ethylcellulose core of the calendered tablets was prolonged in comparison with the sustained release of a multiparticulate dosage form, prepared manually by cutting co-extrudates into mini-matrices. Analysis of the dosage forms using X-ray micro-computed tomography only detected small differences between the pore structure of the core of the calendered tablet and the mini-matrices. Diffusion path length was shown to be the main mechanism behind the release kinetics. Terahertz pulsed imaging visualized that adhesion between the core and coat of the calendered tablet was not complete and a gradient in coat thickness (varying from 200 to 600μm) was observed. Modulated differential scanning calorimetry and X-ray diffraction indicated that the solid-state properties of both drugs were not affected by the calendering procedure. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Polarimetric SAR Image Classification Using Multifeatures Combination and Extremely Randomized Clustering Forests

    Directory of Open Access Journals (Sweden)

    Zou Tongyuan

    2010-01-01

    Full Text Available Abstract Terrain classification using polarimetric SAR imagery has been a very active research field over recent years. Although lots of features have been proposed and many classifiers have been employed, there are few works on comparing these features and their combination with different classifiers. In this paper, we firstly evaluate and compare different features for classifying polarimetric SAR imagery. Then, we propose two strategies for feature combination: manual selection according to heuristic rules and automatic combination based on a simple but efficient criterion. Finally, we introduce extremely randomized clustering forests (ERCFs to polarimetric SAR image classification and compare it with other competitive classifiers. Experiments on ALOS PALSAR image validate the effectiveness of the feature combination strategies and also show that ERCFs achieves competitive performance with other widely used classifiers while costing much less training and testing time.

  17. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    OBJECTIVES: To compare the efficacy and safety of indinavir 800 mg three times a day, ritonavir 600 mg twice a day, and a combination of ritonavir 400 mg twice a day and saquinavir 400 mg twice a day, when administered with two nucleoside analogues. DESIGN: A randomized, open-labelled, controlled...... is generally safe, and has superior short-term antiviral efficacy compared with indinavir and ritonavir also combined with two nucleoside analogues in antiretroviral drug-naive patients. Further follow-up is needed to determine the durability of the viral response....

  18. Single-blind, randomized, pilot study combining shiatsu and amitriptyline in refractory primary headaches.

    Science.gov (United States)

    Villani, Veronica; Prosperini, Luca; Palombini, Fulvio; Orzi, Francesco; Sette, Giuliano

    2017-06-01

    Complementary alternative medicine, such as shiatsu, can represent a suitable treatment for primary headaches. However, evidence-based data about the effect of combining shiatsu and pharmacological treatments are still not available. Therefore, we tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive shiatsu plus amitriptyline, shiatsu alone, or amitriptyline alone for 3 months. Primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month. After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline. Although all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers (p < 0.05), there was no between-group difference in primary endpoint (p = ns). Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month (p < 0.05). Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment. Shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study. Trial registration 81/2010 (Ethical Committee, S. Andrea Hospital

  19. Phase transition analysis of V-shaped liquid crystal: Combined temperature-dependent FTIR and density functional theory approach.

    Science.gov (United States)

    Singh, Swapnil; Singh, Harshita; Karthick, T; Tandon, Poonam; Prasad, Veena

    2018-01-05

    Temperature-dependent Fourier transform infrared spectroscopy (FTIR) combined with density functional theory (DFT) is employed to study the mechanism of phase transitions of V-shaped bent-core liquid crystal. Since it has a large number of flexible bonds, one-dimensional potential energy scan (PES) was performed on the flexible bonds and predicted the most stable conformer I. A detailed analysis of vibrational normal modes of conformer I have been done on the basis of potential energy distribution. The good agreement between the calculated spectrum of conformer I and observed FTIR spectrum at room temperature validates our theoretical structure model. Furthermore, the prominent changes observed in the stretching vibrational bands of CH3/CH2, CO, ring CC, ring CO, ring CH in-plane bending, and ring CH out-of-plane bending at Iso→nematic phase transition (at 155°C) have been illustrated. However, the minor changes in the spectral features observed for the other phase transitions might be due to the shape or bulkiness of molecules. Combined FTIR and PES study beautifully explained the dynamics of the molecules, molecular realignment, H-bonding, and conformational changes at the phase transitions. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Phase transition analysis of V-shaped liquid crystal: Combined temperature-dependent FTIR and density functional theory approach

    Science.gov (United States)

    Singh, Swapnil; Singh, Harshita; Karthick, T.; Tandon, Poonam; Prasad, Veena

    2018-01-01

    Temperature-dependent Fourier transform infrared spectroscopy (FTIR) combined with density functional theory (DFT) is employed to study the mechanism of phase transitions of V-shaped bent-core liquid crystal. Since it has a large number of flexible bonds, one-dimensional potential energy scan (PES) was performed on the flexible bonds and predicted the most stable conformer I. A detailed analysis of vibrational normal modes of conformer I have been done on the basis of potential energy distribution. The good agreement between the calculated spectrum of conformer I and observed FTIR spectrum at room temperature validates our theoretical structure model. Furthermore, the prominent changes observed in the stretching vibrational bands of CH3/CH2, Cdbnd O, ring CC, ring CO, ring CH in-plane bending, and ring CH out-of-plane bending at Iso → nematic phase transition (at 155 °C) have been illustrated. However, the minor changes in the spectral features observed for the other phase transitions might be due to the shape or bulkiness of molecules. Combined FTIR and PES study beautifully explained the dynamics of the molecules, molecular realignment, H-bonding, and conformational changes at the phase transitions.

  1. Combining microsatellite, otolith shape and parasites community analyses as a holistic approach to assess population structure of Dentex dentex

    Science.gov (United States)

    Marengo, M.; Baudouin, M.; Viret, A.; Laporte, M.; Berrebi, P.; Vignon, M.; Marchand, B.; Durieux, E. D. H.

    2017-10-01

    The common dentex, Dentex dentex, is an iconic marine coastal fish of the Mediterranean Sea. Despite its economic and ecological importance, data on the population structure of this species are still very limited. The aim of this study was to identify the stock structure of the common dentex at relatively fine spatial scale around Corsica Island, using a combination of markers that have different spatial and temporal scales of integration: microsatellite DNA markers, otolith shape analysis and parasites communities. Microsatellite analysis indicated that there was no significant genetic differentiation in D. dentex between the four sampling sites around Corsica. Otolith shape analysis suggests one potential distinct population unit of D. dentex centered in one site (Cap Corse) varying in their degree of differentiation from those in the other zones. Multivariate analysis on parasite abundance data highlights to a lower extent two sites (Bonifacio and Galeria) with some connectivity between adjacent zones. The combination of these three markers together highlights the resulting three sites while giving complementary insights and an opportunity to compare their utility and potential to understand population interactions. A complex population structure around Corsican coasts is then proposed, providing a new perspective on common dentex fishery stock conservation and management strategies.

  2. Pregabalin and Speech Pathology Combination Therapy for Refractory Chronic Cough: A Randomized Controlled Trial.

    Science.gov (United States)

    Vertigan, Anne E; Kapela, Sarah L; Ryan, Nicole M; Birring, Surinder S; McElduff, Patrick; Gibson, Peter G

    2016-03-01

    Chronic refractory cough (CRC) is a difficult problem to treat. Speech pathology treatment (SPT) improves symptoms but resolution is incomplete. Centrally acting neuromodulators also improve cough symptoms, but not cough reflex sensitivity, and the effect is short-lived. We hypothesized that combined SPT and centrally acting neuromodulators would have a superior outcome than SPT alone. Our goal was to determine whether combined pregabalin and SPT is more effective than SPT alone. Randomized placebo controlled trial. Forty patients with CRC were randomly assigned to receive either combined SPT and pregabalin 300 mg daily or combined SPT and placebo. Outcome measures were collected at baseline, end of treatment, and 4 weeks after the end of treatment. Primary outcome measures were cough frequency using the Leicester Cough Monitor, cough severity using a visual analog scale (coughVAS), and cough-related quality of life (QOL) using the Leicester Cough Questionnaire (LCQ). Cough severity, cough frequency, and cough QOL improved in both groups. The degree of improvement in LCQ and coughVAS was greater with combined SPT and pregabalin than SPT alone; the mean difference in LCQ was 3.5, 95%CI of difference 1.1 to 5.8; the mean difference in coughVAS was 25.1, 95% CI of difference 10.6 to 39.6. There was no significant difference in improvement in cough frequency between groups. There was no deterioration in symptoms once pregabalin was withdrawn. Median capsaicin cough sensitivity improved from 15.7 to 47.5 μM with combined SPT and pregabalin and from 3.92 to 15.7 μM with SPT alone. Combined SPT and pregabalin reduces symptoms and improves QOL compared with SPT alone in patients with CRC. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  3. Transcranial Random Noise Stimulation (tRNS Shapes the Processing of Rapidly Changing Auditory Information

    Directory of Open Access Journals (Sweden)

    Katharina S. Rufener

    2017-06-01

    Full Text Available Neural oscillations in the gamma range are the dominant rhythmic activation pattern in the human auditory cortex. These gamma oscillations are functionally relevant for the processing of rapidly changing acoustic information in both speech and non-speech sounds. Accordingly, there is a tight link between the temporal resolution ability of the auditory system and inherent neural gamma oscillations. Transcranial random noise stimulation (tRNS has been demonstrated to specifically increase gamma oscillation in the human auditory cortex. However, neither the physiological mechanisms of tRNS nor the behavioral consequences of this intervention are completely understood. In the present study we stimulated the human auditory cortex bilaterally with tRNS while EEG was continuously measured. Modulations in the participants’ temporal and spectral resolution ability were investigated by means of a gap detection task and a pitch discrimination task. Compared to sham, auditory tRNS increased the detection rate for near-threshold stimuli in the temporal domain only, while no such effect was present for the discrimination of spectral features. Behavioral findings were paralleled by reduced peak latencies of the P50 and N1 component of the auditory event-related potentials (ERP indicating an impact on early sensory processing. The facilitating effect of tRNS was limited to the processing of near-threshold stimuli while stimuli clearly below and above the individual perception threshold were not affected by tRNS. This non-linear relationship between the signal-to-noise level of the presented stimuli and the effect of stimulation further qualifies stochastic resonance (SR as the underlying mechanism of tRNS on auditory processing. Our results demonstrate a tRNS related improvement in acoustic perception of time critical auditory information and, thus, provide further indices that auditory tRNS can amplify the resonance frequency of the auditory system.

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

    Science.gov (United States)

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

    2011-08-01

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

  5. A combined Lattice Boltzmann and Immersed Boundary approach for predicting the vascular transport of differently shaped particles

    CERN Document Server

    Coclite, Alessandro; Pascazio, Giuseppe; Decuzzi, Paolo

    2016-01-01

    Modelling the vascular transport and adhesion of man-made particles is crucial for optimizing their efficacy in the detection and treatment of diseases. Here, a Lattice Boltzmann and Immersed Boundary methods are combined together for predicting the near wall dynamics of particles with different shapes in a laminar flow. For the lattice Boltzmann modelling, a Gauss-Hermite projection is used to derive the lattice equation, wall boundary conditions are imposed through the Zou-He framework, and a moving least squares algorithm accurately reconstructs the forcing term accounting for the immersed boundary. First, the computational code is validated against two well-known test cases: the sedimentation of circular and elliptical cylinders in a quiescent fluid. A very good agreement is observed between the present results and those available in the literature. Then, the transport of circular, elliptical, rectangular, square and triangular particles is analyzed in a Couette flow, at Re=20. All particles drifted later...

  6. A Combined Polling and Random Access Technique for Enhanced Anti-Collision Performance in RFID Systems

    Science.gov (United States)

    Kim, Jeong Geun

    In this paper we propose a novel RFID anti-collision technique that intelligently combines polling and random access schemes. These two fundamentally different medium access control protocols are coherently integrated in our design while functionally complementing each other. The polling mode is designed to enable fast collision-free identification for the tags that exist within reader's coverage across the sessions. In contrast, the random access mode attempts to read the tags uncovered by the polling mode. Our proposed technique is particularly suited for a class of RFID applications in which a stationary reader periodically attempts to identify the tags with slow mobility. Numerical results show that our proposed technique yields much faster identification time against the existing approaches under various operating conditions.

  7. Comparative Efficacy of Newer Antidepressants in Combination with Pregabalin for Fibromyalgia Syndrome: A Controlled, Randomized Study.

    Science.gov (United States)

    Ramzy, Eiad A

    2017-01-01

    This controlled, randomized study investigated the hypothesis that the combined use of pregabalin plus paroxetine for fibromyalgia management would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and Center for Epidemiological Studies Depression Scale (CESDS) scores, but higher tolerability than the combined use of pregabalin plus either amitriptyline or venlafaxine. After institutional ethics committee approval, 75 female subjects diagnosed with fibromyalgia and in receipt of pregabalin (75 mg/day) were randomly allocated to concurrently receive amitriptyline (25 mg/day; n = 24), venlafaxine (75 mg/day; n = 25), or paroxetine (25 mg/day; n = 26). All patients were assessed bimonthly for 6 consecutive months for changes in SSS-8 and CESDS scores, life satisfaction, mood, sleep quality, fatigue, medication tolerability, and adverse events. Compared with pregabalin plus amitriptyline or venlafaxine, the combined use of pregabalin plus paroxetine in fibromyalgia patients resulted in significantly lower SSS-8 and CESDS scores from 18 (P fibromyalgia and to enhance the quality of life in affected individuals. © 2016 World Institute of Pain.

  8. A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students.

    Science.gov (United States)

    Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi

    2009-07-01

    The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.

  9. Pseudo-random Aloha for inter-frame soft combining in RFID systems

    DEFF Research Database (Denmark)

    Castiglione, Paolo; Ricciato, Fabio; Popovski, Petar

    2013-01-01

    In this work we consider a recently proposed variant of the classical Framed Slotted-ALOHA where slot selection is based on a pseudo-random function of the message to be transmitted and of the frame index. We couple this feature with convolutional encoding, that allows to perform Inter-frame Soft...... cancellation (instead of combining). Numerical simulation results show that the ISoC scheme brings a noticeable throughput gain over traditional schemes in a dense RFID scenario with multiple concurrent Tag transmissions....

  10. Chinese massage combined with core stability exercises for nonspecific low back pain: a randomized controlled trial.

    Science.gov (United States)

    Zhang, Yingjie; Tang, Shujie; Chen, Guangmin; Liu, Yuanmei

    2015-02-01

    To determine the effect of Chinese massage combined with core stability exercises on nonspecific low back pain. In the prospective study, ninety-two participants with nonspecific low back pain were divided into experimental and control group at random, and 46 in each. The experimental group were treated using Chinese massage combined with core stability exercises, while the control group were treated using Chinese massage alone. The two groups were evaluated using visual analog scale and Oswestry disability index at baseline, immediately after two and eight weeks. In addition, the recurrence rate of nonspecific low back pain was evaluated one year after the last intervention. Two weeks after treatment, both VAS and ODI scores decreased significantly in two groups (p0.05). Eight weeks later, the VAS and ODI scores decreased significantly in both groups (pCore stability exercises can improve the therapeutic effect of Chinese massage in treating nonspecific low back pain. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Combined treatment with headgear and the Frog appliance for maxillary molar distalization: a randomized controlled trial.

    Science.gov (United States)

    Burhan, Ahmad Sharafeddin

    2013-04-01

    To evaluate the efficiency of the Frog appliance (FA) alone or in combination with headgear for distalizing the maxillary molars. Fifty patients (25 males and 25 females) aged 12.6 - 16.7 years who received treatment for Class II malocclusion at the Orthodontic Clinic of Al-Baath University were selected for this study and randomly divided into 2 equal groups. Maxillary molar distalization was achieved using the FA alone (group 1) or a combination of the FA with high-pull headgear worn at night (group 2). Lateral cephalograms were obtained before and after treatment. The maxillary molars moved distally by 5.51 and 5.93 mm in groups 1 and 2, respectively. Distal movements were associated with axial tipping by 4.96° and 1.25°, and with loss of anchorage by mesial movement of the second maxillary premolars by 2.70 and 0.90 mm in groups 1 and 2, respectively. The combined use of the FA and nighttime high-pull headgear decreased the distalization time and improved the ratio of maxillary molar distalization movement relative to the overall opening space between the first maxillary molars and second premolars. The FA can effectively distalize the maxillary molars, this distalization associates with some unfavorable changes. Nighttime use of high-pull headgear combined with the FA can reduce these unfavorable changes and improve treatment outcomes.

  12. Effectiveness of combined exercise training to improve functional fitness in older adults: A randomized controlled trial.

    Science.gov (United States)

    Sousa, Nelson; Mendes, Romeu; Abrantes, Catarina; Sampaio, Jaime; Oliveira, José

    2014-10-01

    The present randomized controlled trial evaluated the impact of different exercise training modalities on functional fitness responses in apparently healthy older men. A total of 59 community-dwelling older men were randomly assigned to an aerobic training group (ATG, n=19), a combined aerobic and resistance training group (CTG, n=20) or a control group (n=20). Both exercise training programs were moderate-to-vigorous intensity, 3 days/week for 9 months. Six independent functional fitness tests (back scratch, chair sit-and-reach, 30-s chair stand, arm curl, 8-ft up-and-go, 6-min walk) were measured on five different occasions. The data were analyzed using a mixed-model ANOVA. ANOVA showed a significant main effect of group (Pfunctional fitness tests, with significant differences between both training groups and controls. However, the ATG only improved the chair sit-and-reach and the 30-s chair stand performance, whereas CTG improved in all functional fitness tests. ANOVA also identified a significant main effect of time for 8-ft up-and-go (P=0.031) in the CTG. Only the combined exercise program was effective in improving all functional fitness components related to daily living activities. © 2014 Japan Geriatrics Society.

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

    National Research Council Canada - National Science Library

    Seo, Byung-Kwan; Lee, Jun-Hwan; Kim, Pil-Kun; Baek, Yong-Hyeon; Jo, Dae-Jean; Lee, Sanghun

    2014-01-01

    ... in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA...

  14. [Acupuncture combined with auricle cutting method for blood stasis-type psoriasis: a randomized controlled trial].

    Science.gov (United States)

    Li, Ting; Liu, Zhi-Yan; Yang, Huan; Ma, Zhong; Qu, Hong-Yan; Li, Yu; Huang, Hai-Bin; Liu, Juan; Li, Jie; Wu, Ji-Xin

    2014-05-01

    To verify the clinical efficacy of acupuncture combined with auricle cutting method for treatment of blood stasis-type psoriasis. Fifty-six cases of blood stasis-type psoriasis were randomly divided into a combined therapy group, a auricle cutting group, an acupuncture group and a control group, 14 cases in each one. Based on regular treatment of TCM decoction in four groups, the combined therapy group was treated with acupuncture and auricle cutting method, and the auricle cutting group was treated with sham-acupuncture and auricle cutting, and the acupuncture group was treated with acupuncture and sham auricle cutting, and the control group was treated with sham-acupuncture and sham auricle cutting. The acupuncture was applied at Dazhui (GV 14), Feishu (BL 13), Ganshu (BL 18) and Geshu (BL 17), etc., and manipulated with routine technique; in the sham acupuncture, the needle was inserted into dermis layer so that the needles could be swung without being dropped out. In the auricle cutting, erbeixin (P1) of unilateral auricle was selected and cut by Chan needle to perform bloodletting; in the sham auricle cutting, the neighborhood approximately 0.5 cm next to erbeixin (P) of auricle was selected as cutting area. The treatment was given once a day, seven days as a treatment session for totally two sessions. Psoriasis area and severity index (PASI) before and after treatment was observed and efficacy of each group was compared. The effective rate was 57.1% (8/14) in the combined therapy group, which was superior to 14.3% (2/14) in the auricle cutting group, 7.1% (1/14) in the acupuncture group and 0.0% (0/14) in the control group (all P cutting, P cutting method and TCM decoction, among which the interaction effect of auricle cutting and acupuncture combined with TCM decoction is the most significant.

  15. Increased statistical power with combined independent randomization tests used with multiple-baseline design.

    Science.gov (United States)

    Tyrrell, Pascal N; Corey, Paul N; Feldman, Brian M; Silverman, Earl D

    2013-06-01

    Physicians often assess the effectiveness of treatments on a small number of patients. Multiple-baseline designs (MBDs), based on the Wampold-Worsham (WW) method of randomization and applied to four subjects, have relatively low power. Our objective was to propose another approach with greater power that does not suffer from the time requirements of the WW method applied to a greater number of subjects. The power of a design that involves the combination of two four-subject MBDs was estimated using computer simulation and compared with the four- and eight-subject designs. The effect of a delayed linear response to treatment on the power of the test was also investigated. Power was found to be adequate (>80%) for a standardized mean difference (SMD) greater than 0.8. The effect size associated with 80% power from combined tests was smaller than that of the single four-subject MBD (SMD=1.3) and comparable with the eight-subject MBD (SMD=0.6). A delayed linear response to the treatment resulted in important reductions in power (20-35%). By combining two four-subject MBD tests, an investigator can detect better effect sizes (SMD=0.8) and be able to complete a comparatively timelier and feasible study. Copyright © 2013 Elsevier Inc. All rights reserved.

  16. Aerobic training alone or combined with strength training affects fitness in elderly: Randomized trial.

    Science.gov (United States)

    Burich, Rasmus; Teljigović, Sanel; Boyle, Eleanor; Sjøgaard, Gisela

    2015-01-01

    To investigate if combined strength and aerobic training can enhance aerobic capacity in the elderly to a similar extent as aerobic training alone when training duration is matched. Elderly men and women (age 63.2 ± 4.7) were randomized into two intervention groups: an aerobic group (AG, n = 17) and a combined group (CG, n = 16). Subjects trained 40 minutes three times a week for 12 weeks. Both groups trained 20 minutes at 65% of heart rate reserve on ergometer cycles followed by another 20 minutes on the ergometer cycles for AG and 20-minute strength training for the lower body for CG. The primary outcome was VO2max. Secondary outcomes were maximal voluntary contraction (MVC) in isometric knee extension, 1 repetition maximum in three leg exercises, body fat, waist-to-hip ratio, blood pressure and score on the Health Survey Short Form 36 (SF-36). Both groups improved VO2max (p Elderly can substitute a part of their aerobic training with strength training and still improve VO2max to a clinically significant degree when strength training is performed with large muscle groups subsequently to the aerobic training. Combined training additionally improves strength and self-assessed general health more than aerobic training alone.

  17. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    trial. Two hundred and eighty-four patients started randomized treatment. The primary end-point was the proportion of patients with HIV RNA of 200 copies/ml or less (Roche Amplicor) and HIV RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent......-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 patients should have completed 24 weeks of treatment. The proportion of patients with HIV RNA of 200 copies/ml or less was 71% (indinavir), 67% (ritonavir), and 82% (ritonavir + saquinavir), P = 0.07. In antiretroviral drug...... is generally safe, and has superior short-term antiviral efficacy compared with indinavir and ritonavir also combined with two nucleoside analogues in antiretroviral drug-naive patients. Further follow-up is needed to determine the durability of the viral response....

  18. Effects of combined harmonic and random excitations on a Brusselator model

    Science.gov (United States)

    Xu, Yong; Ma, Jinzhong; Wang, Haiyan; Li, Yongge; Kurths, Jürgen

    2017-10-01

    We discuss the constructive role of combined harmonic and random excitation on stochastic resonance (SR) in a Brusselator model. We first numerically investigate SR determined by the Signal-to-Noise Ratio (SNR) in this model. Effects of different parameters on SR are described in detail. Our simulation results show that the intensity of the Gaussian colored noise and the amplitude of the periodic force can enhance SR. Moreover, an analytical framework is presented for the SNR of the Brusselator model, leading to a theoretical expression of SNR. We observe a good agreement between the theoretical and numerical results, and the effectiveness of the proposed theoretical method is verified. This theoretical analysis provides a global view on how the dynamics of a periodically forced system with noise changes in the vicinity of a Hopf bifurcation.

  19. Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial.

    Science.gov (United States)

    Kang, Si-Hyuck; Han, Donghoon; Kim, Sehun; Yoon, Chang-Hwan; Park, Jin-Joo; Suh, Jung-Won; Cho, Young-Seok; Youn, Tae-Jin; Chae, In-Ho

    2017-01-01

    Arterial access and hemostasis are important processes during percutaneous coronary procedures. In this study, we tested if the use of chitosan-based pads on top of compression devices could improve hemostasis efficacy compared with compression devices alone after transradial coronary angiography or interventions. This study was a single-center open-label randomized controlled trial. Patients who underwent coronary angiography or intervention with the transradial approach were randomly assigned to the study (compression device and a chitosan-based pad) or control (compression devices alone) group in a 2:1 fashion. The primary endpoint was time to hemostasis, categorized into ≤5, 6-10, 11-20, and >20 minutes. Between April and July 2016, 95 patients were enrolled (59 were assigned to the study arm and 36 to the control arm). Time to hemostasis, the primary endpoint, was significantly lower in the study group than in the control group (phemostasis pad in combination with rotatory compression devices is a safe and effective hemostasis strategy after radial artery access. ClinicalTrials.gov NCT02954029.

  20. A Combined Weighting Method Based on Hybrid of Interval Evidence Fusion and Random Sampling

    Directory of Open Access Journals (Sweden)

    Ying Yan

    2017-01-01

    Full Text Available Due to the complexity of system and lack of expertise, epistemic uncertainties may present in the experts’ judgment on the importance of certain indices during group decision-making. A novel combination weighting method is proposed to solve the index weighting problem when various uncertainties are present in expert comments. Based on the idea of evidence theory, various types of uncertain evaluation information are uniformly expressed through interval evidence structures. Similarity matrix between interval evidences is constructed, and expert’s information is fused. Comment grades are quantified using the interval number, and cumulative probability function for evaluating the importance of indices is constructed based on the fused information. Finally, index weights are obtained by Monte Carlo random sampling. The method can process expert’s information with varying degrees of uncertainties, which possesses good compatibility. Difficulty in effectively fusing high-conflict group decision-making information and large information loss after fusion is avertible. Original expert judgments are retained rather objectively throughout the processing procedure. Cumulative probability function constructing and random sampling processes do not require any human intervention or judgment. It can be implemented by computer programs easily, thus having an apparent advantage in evaluation practices of fairly huge index systems.

  1. Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Si-Hyuck Kang

    Full Text Available Arterial access and hemostasis are important processes during percutaneous coronary procedures. In this study, we tested if the use of chitosan-based pads on top of compression devices could improve hemostasis efficacy compared with compression devices alone after transradial coronary angiography or interventions.This study was a single-center open-label randomized controlled trial. Patients who underwent coronary angiography or intervention with the transradial approach were randomly assigned to the study (compression device and a chitosan-based pad or control (compression devices alone group in a 2:1 fashion. The primary endpoint was time to hemostasis, categorized into ≤5, 6-10, 11-20, and >20 minutes.Between April and July 2016, 95 patients were enrolled (59 were assigned to the study arm and 36 to the control arm. Time to hemostasis, the primary endpoint, was significantly lower in the study group than in the control group (p<0.001. Both groups showed low rates of vascular complications.This study suggests that the use of a hemostasis pad in combination with rotatory compression devices is a safe and effective hemostasis strategy after radial artery access.ClinicalTrials.gov NCT02954029.

  2. 3D Statistical Shape Models Incorporating Landmark-Wise Random Regression Forests for Omni-Directional Landmark Detection.

    Science.gov (United States)

    Norajitra, Tobias; Maier-Hein, Klaus H

    2017-01-01

    3D Statistical Shape Models (3D-SSM) are widely used for medical image segmentation. However, during segmentation, they typically perform a very limited unidirectional search for suitable landmark positions in the image, relying on weak learners or use-case specific appearance models that solely take local image information into account. As a consequence, segmentation errors arise, and results in general depend on the accuracy of a previous model initialization. Furthermore, these methods become subject to a tedious and use-case dependent parameter tuning in order to obtain optimized results. To overcome these limitations, we propose an extension of 3D-SSM by landmark-wise random regression forests that perform an enhanced omni-directional search for landmark positions, thereby taking rich non-local image information into account. In addition, we provide a long distance model fitting based on a multi-scale approach, that allows an accurate and reproducible segmentation even from distant image positions, thus enabling an application without model initialization. Finally, translation of the proposed method to different organs is straightforward and requires no adaptation of the training process. In segmentation experiments on 45 clinical CT volumes, the proposed omni-directional search significantly increased accuracy and displayed great precision regardless of model initialization. Furthermore, for liver, spleen and kidney segmentation in a competitive multi-organ labeling challenge on publicly available data, the proposed method achieved similar or better results than the state of the art. Finally, liver segmentation results were obtained that successfully compete with specialized state-of-the-art methods from the well-known liver segmentation challenge SLIVER.

  3. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation

    Science.gov (United States)

    Danaher, Brian G.; Severson, Herbert H.; Zhu, Shu-Hong; Andrews, Judy A.; Cummins, Sharon E.; Lichtenstein, Edward; Tedeschi, Gary J.; Hudkins, Coleen; Widdop, Chris; Crowley, Ryann; Seeley, John R.

    2015-01-01

    Background Use of smokeless tobacco (moist snuff and chewing tobacco) is a significant public health problem but smokeless tobacco users have few resources to help them quit. Web programs and telephone-based programs (Quitlines) have been shown to be effective for smoking cessation. We evaluate the effectiveness of a Web program, a Quitline, and the combination of the two for smokeless users recruited via the Web. Objectives To test whether offering both a Web and Quitline intervention for smokeless tobacco users results in significantly better long-term tobacco abstinence outcomes than offering either intervention alone; to test whether the offer of Web or Quitline results in better outcome than a self-help manual only Control condition; and to report the usage and satisfaction of the interventions when offered alone or combined. Methods Smokeless tobacco users (N= 1,683) wanting to quit were recruited online and randomly offered one of four treatment conditions in a 2×2 design: Web Only, Quitline Only, Web + Quitline, and Control (printed self-help guide). Point-prevalence all tobacco abstinence was assessed at 3- and 6-months post enrollment. Results 69% of participants completed both the 3- and 6-month assessments. There was no significant additive or synergistic effect of combining the two interventions for Complete Case or the more rigorous Intent To Treat (ITT) analyses. Significant simple effects were detected, individually the interventions were more efficacious than the control in achieving repeated 7-day point prevalence all tobacco abstinence: Web (ITT, OR = 1.41, 95% CI = 1.03, 1.94, p = .033) and Quitline (ITT: OR = 1.54, 95% CI = 1.13, 2.11, p = .007). Participants were more likely to complete a Quitline call when offered only the Quitline intervention (OR = 0.71, 95% CI = .054, .093, p = .013), the number of website visits and duration did not differ when offered alone or in combination with Quitline. Rates of program helpfulness (p Web and

  4. Combinations of Stressors in Midlife: Examining Role and Domain Stressors Using Regression Trees and Random Forests

    Science.gov (United States)

    2013-01-01

    Objectives. Global perceptions of stress (GPS) have major implications for mental and physical health, and stress in midlife may influence adaptation in later life. Thus, it is important to determine the unique and interactive effects of diverse influences of role stress (at work or in personal relationships), loneliness, life events, time pressure, caregiving, finances, discrimination, and neighborhood circumstances on these GPS. Method. Exploratory regression trees and random forests were used to examine complex interactions among myriad events and chronic stressors in middle-aged participants’ (N = 410; mean age = 52.12) GPS. Results. Different role and domain stressors were influential at high and low levels of loneliness. Varied combinations of these stressors resulting in similar levels of perceived stress are also outlined as examples of equifinality. Loneliness emerged as an important predictor across trees. Discussion. Exploring multiple stressors simultaneously provides insights into the diversity of stressor combinations across individuals—even those with similar levels of global perceived stress—and answers theoretical mandates to better understand the influence of stress by sampling from many domain and role stressors. Further, the unique influences of each predictor relative to the others inform theory and applied work. Finally, examples of equifinality and multifinality call for targeted interventions. PMID:23341437

  5. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Peña, Javier; Ibarretxe-Bilbao, Naroa; Sánchez, Pedro; Iriarte, Maria B; Elizagarate, Edorta; Garay, Maria A; Gutiérrez, Miguel; Iribarren, Aránzazu; Ojeda, Natalia

    2016-01-01

    This study examined the efficacy of an integrative cognitive remediation program (REHACOP) in improving cognition and functional outcome in patients with schizophrenia. The program combines cognitive remediation, social cognitive intervention, and functional skills training. Few studies have attempted this approach. One hundred and eleven patients diagnosed with schizophrenia were randomly assigned to either the cognitive remediation group (REHACOP) or an active control group (occupational activities) for 4 months (three sessions per week, 90 min). Primary outcomes were change on general neurocognitive performance and social cognition, including theory of mind (ToM), emotion perception (EP), attributional style, and social perception (SP). Secondary outcomes included changes on clinical symptoms (Positive and Negative Syndrome Scale) and functional outcome (UCSD Performance-Based Skills Assessment and the Global Assessment of Functioning). The trial was registered with clinicaltrials.gov (NCT02796417). No baseline group differences were found. Significant differences were found in the mean change between the REHACOP group and control group in neurocognition ([Formula: see text]), SP ([Formula: see text]), ToM ([Formula: see text]), EP ([Formula: see text]), negative symptoms ([Formula: see text]), emotional distress ([Formula: see text]), Global Assessment of Functioning ([Formula: see text]), and UCSD Performance-Based Skills Assessment ([Formula: see text]). The combination of cognitive remediation, social cognitive intervention, and functional skills training demonstrated statistically significant and clinically meaningful changes in neurocognition, social cognition, negative, and functional disability.

  6. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Luiz Eduardo Imbelloni

    Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

  7. Successful white hair removal with combined coloring and intense pulsed Light (IPL): a randomized clinical trial.

    Science.gov (United States)

    Alijanpoor, Robabeh; Poorsattar BejehMir, Arash; Mokmeli, Soheila

    2011-11-01

    The purpose of this study was to introduce adjunct therapy to intense pulsed light (IPL) and to assess it in terms of safety, expense, feasibility, and efficacy. Currently there is no satisfactory, efficient method for long-term white hair removal. We conducted a randomized clinical trial of hirsute patients with excessive white hair on the chin and cheeks. In addition to IPL, the patients were randomly assigned to have their white hair colored with either black eyeliner or black hair dye as an adjunct to IPL aided for of six sessions (with a 4-week interval between sessions). The primary efficacy outcome, which was defined as the outcome after six sessions of therapy, was scored as poor (60%) response to white hair removal in predefined areas. The secondary outcome was recurrence 6 months after the final therapy session. In the eyeliner group (n=31), 15 (48.4%) individuals showed a fair response, and 16 (51.6%) individuals showed a good response. In the color-dye group (n=31), 1 (3.2%), 17 (54.8%) and 13 (41.9%) participants scored poor, fair, and good, respectively. There were no differences in clinician judgment of the treatment success between the eyeliner and color-dye groups after the six therapy sessions (p=0.895). Thirty-one patients had 6 months of visits (11 in the hair dye and 20 in the eyeliner group). Three participants in the color-dye group and five participants in the eyeliner group failed to show improvement 6 months after the laser surgery. There was no distinguishable pattern of failure between the two study groups (p=1). This study supports that hair coloring is an efficient and feasible technique that can be combined with IPL to eliminate white facial hair.

  8. Combined use of dexmedetomidine and propofol in monitored anesthesia care: a randomized controlled study.

    Science.gov (United States)

    Kim, Kyu Nam; Lee, Hee Jong; Kim, Soo Yeon; Kim, Ji Yoon

    2017-03-01

    Although propofol and dexmedetomidine have been widely used for monitored anesthesia care, their adverse effects necessitate the search for better methods. Therefore, we performed this randomized controlled trial to evaluate the combined use of propofol and dexmedetomidine. Eighty-seven adult patients undergoing hand surgery under brachial plexus block were randomly allocated to receive 1.6 μg/ml of the target effect site concentration of propofol (P group) and infusion of 0.4 μg/kg/h dexmedetomidine following a loading dose of 1.0 μg/kg for 10 min (D group). The M group received a half-dose of both drugs simultaneously. The maintenance dose was adjusted to maintain an Observer Assessment of Alertness/Sedation score of 3. Cardiorespiratory variables, adverse effects, and drug efficacy were observed. The significantly higher mean arterial pressure (mmHg) in the D group [P group 86.9 (12.6), D group 96.0 (12.2), M group 85.6 (10.6), p = 0.004)] and a significantly higher heart rate (beat/min) in the P group were observed [P group 67.3 (9.0), D group 57.8 (6.9), M group 59.2 (7.4), p propofol and dexmedetomidine provided cardiovascular stability with decreased adverse effects. Additionally, it led to a similar onset time of propofol and achieved higher satisfaction scores. KCT0001284 . Retrospectively registered 25 November 2014.

  9. Combined fuzzy logic and random walker algorithm for PET image tumor delineation.

    Science.gov (United States)

    Soufi, Motahare; Kamali-Asl, Alireza; Geramifar, Parham; Abdoli, Mehrsima; Rahmim, Arman

    2016-02-01

    The random walk (RW) technique serves as a powerful tool for PET tumor delineation, which typically involves significant noise and/or blurring. One challenging step is hard decision-making in pixel labeling. Fuzzy logic techniques have achieved increasing application in edge detection. We aimed to combine the advantages of fuzzy edge detection with the RW technique to improve PET tumor delineation. A fuzzy inference system was designed for tumor edge detection from RW probabilities. Three clinical PET/computed tomography datasets containing 12 liver, 13 lung, and 18 abdomen tumors were analyzed, with manual expert tumor contouring as ground truth. The standard RW and proposed combined method were compared quantitatively using the dice similarity coefficient, the Hausdorff distance, and the mean standard uptake value. The dice similarity coefficient of the proposed method versus standard RW showed significant mean improvements of 21.0±7.2, 12.3±5.8, and 18.4%±6.1% for liver, lung, and abdominal tumors, respectively, whereas the mean improvements in the Hausdorff distance were 3.6±1.4, 1.3±0.4, 1.8±0.8 mm, and the mean improvements in SUVmean error were 15.5±6.3, 11.7±8.6, and 14.1±6.8% (all P's<0.001). For all tumor sizes, the proposed method outperformed the RW algorithm. Furthermore, tumor edge analysis demonstrated further enhancement of the performance of the algorithm, relative to the RW method, with decreasing edge gradients. The proposed technique improves PET lesion delineation at different tumor sites. It depicts greater effectiveness in tumors with smaller size and/or low edge gradients, wherein most PET segmentation algorithms encounter serious challenges. Favorable execution time and accurate performance of the algorithm make it a great tool for clinical applications.

  10. A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

    Science.gov (United States)

    Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z

    2016-01-19

    Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in

  11. Laminaria japonica combined with probiotics improves intestinal microbiota: a randomized clinical trial.

    Science.gov (United States)

    Ko, Seok-Jae; Kim, Jinsung; Han, Gajin; Kim, Seul-Ki; Kim, Hong-Geol; Yeo, Inkwon; Ryu, Bongha; Park, Jae-Woo

    2014-01-01

    Laminaria japonica--a widely used ingredient in seaweed kimchi--and lactic acid bacteria (LAB)--a main component of traditional fermented Korean food--may alter human intestinal microbiota composition and have a positive effect on various digestive problems. However, few clinical trials have investigated the potential benefits of L. japonica when combined with LAB for human intestinal microbiota. Therefore, this study was designed to evaluate the effects of L. japonica and representative LAB on the human intestine. Forty participants with no known digestive diseases were randomly assigned to one of the two combination groups: (1) L. japonica with LAB and (2) L. japonica with placebo LAB. The study agents were administered for 4 weeks with a 2-week follow-up period. The primary outcome measure was the number of each of the seven LAB species in the human intestine, and the secondary outcome measures included the Korean version of the Gastrointestinal Symptom Rating Scale, the World Health Organization Quality of Life, and bowel functions. The primary outcome was evaluated before and after administration of the study agents (0 and 4 weeks), and the secondary outcomes were evaluated at 0, 4, and 6 weeks. Four of the seven LAB species were found to be significantly increased in the L. japonica with the LAB group and five species were significantly different from those of the placebo group. The secondary outcome measures did not change significantly. In conclusion, L. japonica with LAB facilitated the proliferation of beneficial human intestinal microbiota. ( ClinicalTrials.gov NCT01651741).

  12. Effects of combined training vs aerobic training on cognitive functions in COPD: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Aquino G

    2016-04-01

    Full Text Available Giovanna Aquino,1 Enzo Iuliano,1 Alessandra di Cagno,2 Angela Vardaro,3 Giovanni Fiorilli,1 Stefano Moffa,1 Alfonso Di Costanzo,1 Giuseppe De Simone,3 Giuseppe Calcagno1 1Department of Medicine and Health Sciences “Vincenzo Tiberio”, University of Molise, Campobasso, 2Department of Health Science, University ForoItalico, Rome, 3“Villa Margherita”, Benevento, Italy Aim: The aim of this study was to investigate the effects of high-intensity aerobic training (AT and high-intensity aerobic training combined with resistance training (ie, combined training [CT] on cognitive function in patients with COPD. Methods: Twenty-eight Caucasian male patients (68.35±9.64 years; mean ± SD with COPD were recruited and randomized into two groups, AT and CT. Both groups performed physical reconditioning for 4 weeks, with a frequency of five training sessions per week. The CT group completed two daily sessions of 30 minutes: one aerobic session and one strength session, respectively; The AT group performed two 30-minute aerobic endurance exercise sessions on treadmill. Physical and cognitive function tests were performed before and after the training intervention performances. Results: Exercise training improved the following cognitive functions: long-term memory, verbal fluency, attentional capacity, apraxia, and reasoning skills (P<0.01. Moreover, the improvements in the CT group were significantly greater than those in the AT group in long-term memory, apraxia, and reasoning skills (P<0.05. Conclusion: CT may be a possible strategy to prevent cognitive decline and associated comorbidities in male patients with COPD. Keywords: physical training, cognition, resistance training, rehabilitation, respiratory disease

  13. The combination of digital surface scanners and cone beam computed tomography technology for guided implant surgery using 3Shape implant studio software: a case history report.

    Science.gov (United States)

    Lanis, Alejandro; Álvarez Del Canto, Orlando

    2015-01-01

    The incorporation of virtual engineering into dentistry and the digitization of information are providing new perspectives and innovative alternatives for dental treatment modalities. The use of digital surface scanners with surgical planning software allows for the combination of the radiographic, prosthetic, surgical, and laboratory fields under a common virtual scenario, permitting complete digital treatment planning. In this article, the authors present a clinical case in which a guided implant surgery was performed based on a complete digital surgical plan combining the information from a cone beam computed tomography scan and the virtual simulation obtained from the 3Shape TRIOS intraoral surface scanner. The information was imported to and combined in the 3Shape Implant Studio software for guided implant surgery planning. A surgical guide was obtained by a 3D printer, and the surgical procedure was done using the Biohorizons Guided Surgery Kit and its protocol.

  14. [Efficacy comparison of different points combination in the treatment of menopausal insomnia: a randomized controlled trial].

    Science.gov (United States)

    Yang, Song-Bai; Mei, Zhi-Gang; Cai, San-Jin; Lei, Hua-Ping; Sun, Cheng-Hong; Chen, Ling; Zhou, Chuang

    2014-01-01

    To compare the efficacy of different points combination in the treatment of menopausal insomnia. Ninety-six cases of menopausal insomnia were randomized into 3 groups, Xinshu (BL 15), Shenshu (BL 23), Sishencong (EX-HN 1), Shenmen (HT 7), Sanyinjiao (SP 6) were chosen in the restore interaction between the heart and the kidney group (group A, 32 cases); Zhaohai (KI 6), Jiaoxin (KI 8), Shenmai (BL 62), Pucan (BL 61) were chosen in the acupuncturing qiao mai group (group B, 32 cases); auricular Shenmen (TF4) and sensitive spot at the distribution area of auricular vagus nervus were chosen in the ear acupuncture group (group C, 32 cases). Six days made one session and the treatments were finished after 4 courses. The polysomnography (PSG) and Pittsburgh sleep quality index (PSQI) were employed before and after treatment to evaluate the alleviation of insomnia. The parameters of the sleep latency (SL), rapid wave sleep latency (RL) and sleep efficiency (SE) were significantly improved in the three groups, and the differences were statistically significant (P acupuncture has a better curative effect than the restore interaction between the heart and the kidney group and acupuncturing qiao mai group, it is worth of being promoted.

  15. SUMOhunt: Combining Spatial Staging between Lysine and SUMO with Random Forests to Predict SUMOylation

    Science.gov (United States)

    2013-01-01

    Modification with SUMO protein has many key roles in eukaryotic systems which renders the identification of its target proteins and sites of considerable importance. Information regarding the SUMOylation of a protein may tell us about its subcellular localization, function, and spatial orientation. This modification occurs at particular and not all lysine residues in a given protein. In competition with biochemical means of modified-site recognition, computational methods are strong contenders in the prediction of SUMOylation-undergoing sites on proteins. In this research, physicochemical properties of amino acids retrieved from AAIndex, especially those involved in docking of modifier and target proteins and optimal presentation of target lysine, in combination with sequence information and random forest-based classifier presented in WEKA have been used to develop a prediction model, SUMOhunt, with statistics significantly better than all previous predictors. In this model 97.56% accuracy, 100% sensitivity, 94% specificity, and 0.95 MCC have been achieved which shows that proposed amino acid properties have a significant role in SUMO attachment. SUMOhunt will hence bring great reliability and efficiency in SUMOylation prediction. PMID:25937950

  16. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others

    2017-05-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  17. Disease named entity recognition by combining conditional random fields and bidirectional recurrent neural networks

    Science.gov (United States)

    Wei, Qikang; Chen, Tao; Xu, Ruifeng; He, Yulan; Gui, Lin

    2016-01-01

    The recognition of disease and chemical named entities in scientific articles is a very important subtask in information extraction in the biomedical domain. Due to the diversity and complexity of disease names, the recognition of named entities of diseases is rather tougher than those of chemical names. Although there are some remarkable chemical named entity recognition systems available online such as ChemSpot and tmChem, the publicly available recognition systems of disease named entities are rare. This article presents a system for disease named entity recognition (DNER) and normalization. First, two separate DNER models are developed. One is based on conditional random fields model with a rule-based post-processing module. The other one is based on the bidirectional recurrent neural networks. Then the named entities recognized by each of the DNER model are fed into a support vector machine classifier for combining results. Finally, each recognized disease named entity is normalized to a medical subject heading disease name by using a vector space model based method. Experimental results show that using 1000 PubMed abstracts for training, our proposed system achieves an F1-measure of 0.8428 at the mention level and 0.7804 at the concept level, respectively, on the testing data of the chemical-disease relation task in BioCreative V. Database URL: http://219.223.252.210:8080/SS/cdr.html PMID:27777244

  18. Mollusk communities of the central Congo River shaped by combined effects of barriers, environmental gradients, and species dispersal

    Directory of Open Access Journals (Sweden)

    Oscar Wembo Ndeo

    2017-05-01

    Full Text Available Rapids, falls, and cascades might act as barriers for freshwater species, determining the species community up- and downstream of barriers. However, they affect community composition not only by acting as barriers but also by their influence on environmental gradients. Moreover, the directional dispersal of species along the watercourse might determine community composition. A suitable system to study these differential effects is the Congo River, the world’s second largest river by discharge. The small ‘Upper Congo Rapids’ ecoregion features several rapids known as barrier for fishes. The Wagenia Cataracts at the town of Kisangani constitute the strongest drop of the Congo River and several studies have emphasized its role as barrier for fish distribution. Alternative explanations for this pattern, however, are rarely evaluated. Though mollusks represent a vital component of the macrozoobenthos, with distribution patterns and underlying drivers often distinct from that of fishes, virtually no field surveys of the Congo River have been reported for decades. We collected and determined mollusks of 51 stations, recorded environmental conditions, and generated proxies for directional species dispersal and an indirect barrier effect. Those variables were subjected to distance-based redundancy analyses and variation partitioning in order to test whether the mollusk community compositions are better explained by an individual or combined influence of the direct and indirect effect of the cataract barrier, environmental conditions, and downstream-directed dispersal. Our survey showed an exclusive upstream/downstream distribution for just four out of the 19 species, suggesting a limited barrier effect. We revealed no direct influence of the barrier itself on community composition but of substrate type. However, we found an indirect effect of the barrier through replacing spatially structured communities upstream of the cataract with more uniform

  19. [Acupuncture combined with western medicine for CP/CPPS:a randomized controlled trial].

    Science.gov (United States)

    Chen, Guo; Xiang, Juan; Ouyang, Lizhi; Wang, Xuzhe; Zhang, Sainan; Chen, Haijiao; Chen, Junjun; Li, Tielang

    2016-12-12

    To compare the clinical efficacy differences among acupuncture combined with western medicine, acupuncture alone and western medicine alone for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Ninety patients were randomly assigned into a needle-medicine group, an acupuncture group and a western medicine group, 30 patients in each group. The patients in the needle-medicine group were treated with acupuncture combined with western medicine; the scalp points included Shenting (GV 24), Xinhui (GV 22), Qianding (GV 21), Baihui (GV 20), Chengguang (BL 6), Tongtian (BL 7), etc. The body points were Zhongji (CV 3), Guanyuan (CV 4), Pangguangshu (BL 28), Ciliao (BL 32), etc. The acupuncture was given 30 min per treatment, once a day. Besides, oral administration of 0.2g levofloxacin (twice per day) and 0.2 mg tamsulosin (once a day) was applied. The patients in the acupuncture group and western medicine group were treated by acupuncture and western medicine respectively. 12-d treatment was taken as one session, and totally 2 sessions were given. The clinical efficacy of the three groups after treatment was compared as well as the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total score and pain score, self-rating anxiety scale (SAS) and self-rating depression scale (SDS) before and after treatment. During the trial two patients dropped out, as a result, 30 patients in the needle-medicine group, 29 patients in the acupuncture group and 29 patients in the western medicine group were included in the analysis. After treatment, 21 patients were cured, 6 patients were markedly effective, 2 patients were effective and 1 patient failed in the needle-medicine group;12 patients were cured, 10 patients were markedly effective, 5 patients were effective and 2 patients failed in the acupuncture group; 11 patients were cured, 12 patients were markedly effective, 4 patients were effective and 2 patients failed in the medicine group; the efficacy

  20. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    OpenAIRE

    Falgun Indravadan Vyas; Devang Ashwinkumar Rana; Patel, Piyush M.; Varsha Jitendra Patel; Bhavsar, Rekha H.

    2014-01-01

    Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, al...

  1. Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

    2017-03-21

    A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically

  2. A Randomized Controlled Trial of Cognitive-Behavioral Therapy, Light Therapy, and Their Combination for Seasonal Affective Disorder

    Science.gov (United States)

    Rohan, Kelly J.; Roecklein, Kathryn A.; Tierney Lindsey, Kathryn; Johnson, Leigh G.; Lippy, Robert D.; Lacy, Timothy J.; Barton, Franca B.

    2007-01-01

    This first controlled psychotherapy trial for seasonal affective disorder (SAD) compared SAD-tailored cognitive-behavioral therapy (CBT), light therapy (LT), and their combination to a concurrent wait-list control. Adults (N = 61) with major depression, recurrent with seasonal pattern, were randomized to one of four 6-week conditions: CBT (1.5-hr…

  3. Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

    Science.gov (United States)

    Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

    2016-01-01

    Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

  4. Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial

    NARCIS (Netherlands)

    van Dam, D.; Ehring, T.; Vedel, E.; Emmelkamp, P.M.G.

    2013-01-01

    Background: This randomized controlled trial (RCT) investigated the effectiveness of a combined treatment for co-morbid Posttraumatic Stress Disorder (PTSD) and severe Substance Use Disorder (SUD). Methods: Structured Writing Therapy for PTSD (SWT), an evidence-based traumafocused intervention, was

  5. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial.

    Directory of Open Access Journals (Sweden)

    Franciele R Figueira

    Full Text Available To evaluate the effects of aerobic (AER or aerobic plus resistance exercise (COMB sessions on glucose levels and glucose variability in patients with type 2 diabetes. Additionally, we assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS.Fourteen patients with type 2 diabetes (56±2 years wore a CGMS during 3 days. Participants randomly performed AER and COMB sessions, both in the morning (24 h after CGMS placement, and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE, and glucose coefficient of variation (conventional methods as well as by spectral and symbolic analysis (non-conventional methods.Baseline fasting glycemia was 139±05 mg/dL and HbA1c 7.9±0.7%. Glucose levels decreased immediately after AER and COMB protocols by ∼16%, which was sustained for approximately 3 hours. Comparing the two exercise modalities, responses over a 24-h period after the sessions were similar for glucose levels, glucose variance and glucose coefficient of variation. In the symbolic analysis, increases in 0 V pattern (COMB, 67.0±7.1 vs. 76.0±6.3, P = 0.003 and decreases in 1 V pattern (COMB, 29.1±5.3 vs. 21.5±5.1, P = 0.004 were observed only after the COMB session.Both AER and COMB exercise modalities reduce glucose levels similarly for a short period of time. The use of non-conventional analysis indicates reduction of glucose variability after a single session of combined exercises.Aerobic training, aerobic-resistance training and glucose profile (CGMS in type 2 diabetes (CGMS exercise. ClinicalTrials.gov ID: NCT00887094.

  6. Automatic gallbladder segmentation using combined 2D and 3D shape features to perform volumetric analysis in native and secretin-enhanced MRCP sequences.

    Science.gov (United States)

    Gloger, Oliver; Bülow, Robin; Tönnies, Klaus; Völzke, Henry

    2017-11-24

    We aimed to develop the first fully automated 3D gallbladder segmentation approach to perform volumetric analysis in volume data of magnetic resonance (MR) cholangiopancreatography (MRCP) sequences. Volumetric gallbladder analysis is performed for non-contrast-enhanced and secretin-enhanced MRCP sequences. Native and secretin-enhanced MRCP volume data were produced with a 1.5-T MR system. Images of coronal maximum intensity projections (MIP) are used to automatically compute 2D characteristic shape features of the gallbladder in the MIP images. A gallbladder shape space is generated to derive 3D gallbladder shape features, which are then combined with 2D gallbladder shape features in a support vector machine approach to detect gallbladder regions in MRCP volume data. A region-based level set approach is used for fine segmentation. Volumetric analysis is performed for both sequences to calculate gallbladder volume differences between both sequences. The approach presented achieves segmentation results with mean Dice coefficients of 0.917 in non-contrast-enhanced sequences and 0.904 in secretin-enhanced sequences. This is the first approach developed to detect and segment gallbladders in MR-based volume data automatically in both sequences. It can be used to perform gallbladder volume determination in epidemiological studies and to detect abnormal gallbladder volumes or shapes. The positive volume differences between both sequences may indicate the quantity of the pancreatobiliary reflux.

  7. Object detection approach using generative sparse, hierarchical networks with top-down and lateral connections for combining texture/color detection and shape/contour detection

    Science.gov (United States)

    Paiton, Dylan M.; Kenyon, Garrett T.; Brumby, Steven P.; Schultz, Peter F.; George, John S.

    2015-07-28

    An approach to detecting objects in an image dataset may combine texture/color detection, shape/contour detection, and/or motion detection using sparse, generative, hierarchical models with lateral and top-down connections. A first independent representation of objects in an image dataset may be produced using a color/texture detection algorithm. A second independent representation of objects in the image dataset may be produced using a shape/contour detection algorithm. A third independent representation of objects in the image dataset may be produced using a motion detection algorithm. The first, second, and third independent representations may then be combined into a single coherent output using a combinatorial algorithm.

  8. Object detection approach using generative sparse, hierarchical networks with top-down and lateral connections for combining texture/color detection and shape/contour detection

    Science.gov (United States)

    Paiton, Dylan M.; Kenyon, Garrett T.; Brumby, Steven P.; Schultz, Peter F.; George, John S.

    2016-10-25

    An approach to detecting objects in an image dataset may combine texture/color detection, shape/contour detection, and/or motion detection using sparse, generative, hierarchical models with lateral and top-down connections. A first independent representation of objects in an image dataset may be produced using a color/texture detection algorithm. A second independent representation of objects in the image dataset may be produced using a shape/contour detection algorithm. A third independent representation of objects in the image dataset may be produced using a motion detection algorithm. The first, second, and third independent representations may then be combined into a single coherent output using a combinatorial algorithm.

  9. Shape Reconstruction of Thin Electromagnetic Inclusions via Boundary Measurements: Level-Set Method Combined with the Topological Derivative

    Directory of Open Access Journals (Sweden)

    Won-Kwang Park

    2013-01-01

    Full Text Available An inverse problem for reconstructing arbitrary-shaped thin penetrable electromagnetic inclusions concealed in a homogeneous material is considered in this paper. For this purpose, the level-set evolution method is adopted. The topological derivative concept is incorporated in order to evaluate the evolution speed of the level-set functions. The results of the corresponding numerical simulations with and without noise are presented in this paper.

  10. Advanced Ring-Shaped Microelectrode Assay Combined with Small Rectangular Electrode for Quasi-In vivo Measurement of Cell-to-Cell Conductance in Cardiomyocyte Network

    Science.gov (United States)

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

    2013-06-01

    To predict the risk of fatal arrhythmia induced by cardiotoxicity in the highly complex human heart system, we have developed a novel quasi-in vivo electrophysiological measurement assay, which combines a ring-shaped human cardiomyocyte network and a set of two electrodes that form a large single ring-shaped electrode for the direct measurement of irregular cell-to-cell conductance occurrence in a cardiomyocyte network, and a small rectangular microelectrode for forced pacing of cardiomyocyte beating and for acquiring the field potential waveforms of cardiomyocytes. The advantages of this assay are as follows. The electrophysiological signals of cardiomyocytes in the ring-shaped network are superimposed directly on a single loop-shaped electrode, in which the information of asynchronous behavior of cell-to-cell conductance are included, without requiring a set of huge numbers of microelectrode arrays, a set of fast data conversion circuits, or a complex analysis in a computer. Another advantage is that the small rectangular electrode can control the position and timing of forced beating in a ring-shaped human induced pluripotent stem cell (hiPS)-derived cardiomyocyte network and can also acquire the field potentials of cardiomyocytes. First, we constructed the human iPS-derived cardiomyocyte ring-shaped network on the set of two electrodes, and acquired the field potential signals of particular cardiomyocytes in the ring-shaped cardiomyocyte network during simultaneous acquisition of the superimposed signals of whole-cardiomyocyte networks representing cell-to-cell conduction. Using the small rectangular electrode, we have also evaluated the response of the cell network to electrical stimulation. The mean and SD of the minimum stimulation voltage required for pacing (VMin) at the small rectangular electrode was 166+/-74 mV, which is the same as the magnitude of amplitude for the pacing using the ring-shaped electrode (179+/-33 mV). The results showed that the

  11. Combination Therapy Showed Limited Superiority Over Monotherapy for Alzheimer Disease: A Meta-analysis of 14 Randomized Trials.

    Science.gov (United States)

    Tsoi, Kelvin K F; Chan, Joyce Y C; Leung, Nelson W Y; Hirai, Hoyee W; Wong, Samuel Y S; Kwok, Timothy C Y

    2016-09-01

    Acetylcholinesterase inhibitor (AChEI) and memantine are recognized drug treatments with limited clinical efficacy. Combination therapy for patients with Alzheimer disease (AD) was suggested, but the additional benefit of combination therapy is still controversial. To evaluate the additional benefit of combination therapy over monotherapy with either AChEI or memantine. Prospective randomized controlled trials were searched from the OVID databases. The trials were eligible if study subjects were diagnosed with AD, and were randomized to compare combination therapy with monotherapy. Any clinical assessment measured using validated scales on cognitive function, activities of daily living, behavioral problems, and global changes were the primary outcomes, and any reported adverse events were the secondary outcomes. Quality of studies and risk of bias were evaluated. Fourteen randomized trials were identified between 2004 and 2015 from the United States, Canada, Germany, Japan, China, and Korea. A total of 5019 patients with AD were randomly assigned to receive combination therapy of AChEI and memantine or monotherapy with AChEI or memantine. Combination therapy showed no significant benefit on cognitive function (mean difference [MD] of MMSE = 0.06, 95% CI -0.52 to 0.65), activities of daily living (MD of ADCS-ADL = -0.15, 95% CI -1.08 to 0.78), neuropsychiatric symptoms and behavioral problems (MD of NPI = -1.85, 95% CI -4.83 to 1.13), and global changes (MD of CIBIC-plus = 0.01, 95% CI -0.25 to 0.28). In subgroup analyses, combination therapy can improve cognitive function more than memantine alone; and it can significantly relieve neuropsychiatric symptoms and behavioral problems when concomitantly used with donepezil. No additional adverse event was reported in the combination therapy. Combination therapy only showed the benefit on neuropsychiatric symptoms and behavioral problems in moderate-to-severe AD, but no other superiority in terms of cognitive

  12. Utilization of random process spectral properties for the calculation of fatigue life under combined loading

    National Research Council Canada - National Science Library

    Svoboda J; Balda M; Fröhlich V

    2009-01-01

    ... of forces and moments of random character. Considering the fracture mechanics theory, then the damaging of material is both in the micro- and macro-plastic area connected with the rise of plastic deformation and hence with the plastic...

  13. Combined Effect of Random Transmit Power Control and Inter-Path Interference Cancellation on DS-CDMA Packet Mobile Communications

    Science.gov (United States)

    Kudoh, Eisuke; Ito, Haruki; Wang, Zhisen; Adachi, Fumiyuki

    In mobile communication systems, high speed packet data services are demanded. In the high speed data transmission, throughput degrades severely due to severe inter-path interference (IPI). Recently, we proposed a random transmit power control (TPC) to increase the uplink throughput of DS-CDMA packet mobile communications. In this paper, we apply IPI cancellation in addition to the random TPC. We derive the numerical expression of the received signal-to-interference plus noise power ratio (SINR) and introduce IPI cancellation factor. We also derive the numerical expression of system throughput when IPI is cancelled ideally to compare with the Monte Carlo numerically evaluated system throughput. Then we evaluate, by Monte-Carlo numerical computation method, the combined effect of random TPC and IPI cancellation on the uplink throughput of DS-CDMA packet mobile communications.

  14. Combined cognitive and parent training interventions for adolescents with ADHD and their mothers: A randomized controlled trial.

    Science.gov (United States)

    Steeger, Christine M; Gondoli, Dawn M; Gibson, Bradley S; Morrissey, Rebecca A

    2016-01-01

    This study examined the individual and combined effects of two nonpharmacological treatments for attention deficit/hyperactivity disorder (ADHD): Cogmed working memory training (CWMT) for adolescents and behavioral parent training (BPT) for mothers. Ninety-one adolescents (ages 11-15) and their mothers were randomized to one of four CWMT and BPT treatment and active control (placebo) group combinations of 5-week interventions. At pre- and posttest, mothers and teachers completed rating forms, and adolescents completed neuropsychological measures of working memory (WM). Individual intervention effects showed that treatment CWMT significantly improved WM spans, whereas there were no significant differences for treatment or control BPT on reports of parent-related outcomes. Combined treatment effects indicated an overall pattern of greatest improvements for the control CWMT/treatment BPT group, as compared to the other three groups, on adolescent WM deficit, behavioral regulation problems, and global executive deficit. Most significant effects for outcomes were main effects of improvements over time. A combination of CWMT and BPT did not result in increased treatment gains. However, potential effects of combined treatment may have been masked by greater perceived benefits arising from lack of struggle in the nonadaptive, CWMT active control condition. Future combined intervention research should focus on specific, theoretically driven WM deficits among individuals with ADHD, should include possible adaptations to the standard CWMT program, should examine effectiveness of cognitive treatments combined with contextual interventions and should utilize appropriate control groups to fully understand the unique and combined effects of interventions.

  15. Multivariate high-dimensional cortical folding analysis, combining complexity and shape, in neonates with congenital heart disease.

    Science.gov (United States)

    Awate, Suyash P; Yushkevich, Paul; Song, Zhuang; Licht, Daniel; Gee, James C

    2009-01-01

    The paper presents a novel statistical framework for cortical folding pattern analysis that relies on a rich multivariate descriptor of folding patterns in a region of interest (ROI). The ROI-based approach avoids problems faced by spatial-normalization-based approaches stemming from the severe deficiency of homologous features between typical human cerebral cortices. Unlike typical ROI-based methods that summarize folding complexity or shape by a single number, the proposed descriptor unifies complexity and shape of the surface in a high-dimensional space. In this way, the proposed framework couples the reliability of ROI-based analysis with the richness of the novel cortical folding pattern descriptor. Furthermore, the descriptor can easily incorporate additional variables, e.g. cortical thickness. The paper proposes a novel application of a nonparametric permutation-based approach for statistical hypothesis testing for any multivariate high-dimensional descriptor. While the proposed framework has a rigorous theoretical underpinning, it is straightforward to implement. The framework is validated via simulated and clinical data. The paper is the first to quantitatively evaluate cortical folding in neonates with complex congenital heart disease.

  16. Design of the Park-in-Shape study: a phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson's disease.

    Science.gov (United States)

    van der Kolk, Nicolien M; Overeem, Sebastiaan; de Vries, Nienke M; Kessels, Roy P C; Donders, Rogier; Brouwer, Marc; Berg, Daniela; Post, Bart; Bloem, Bas R

    2015-04-16

    Parkinson's disease (PD) is a neurodegenerative disorder with a wide range of motor and non-motor symptoms. Despite optimal medical management, PD still results in a high disability rate and secondary complications and many patients lead a sedentary lifestyle, which in turn is also associated with a higher co-morbidity and mortality. Exercise has been explored as a strategy to reduce secondary complications and results suggests that it not only provides general health benefits, but may also provide symptomatic relief. If this holds true exercise would be a very attractive addition to the therapeutic arsenal in PD. The supportive evidence remains incomplete. Here, we describe the design of the Park-in-Shape study, which primarily aims to evaluate whether aerobic exercise affords clinically relevant improvements in motor symptoms in sedentary PD patients. A specific new element is the introduction of gaming to optimize compliance to the exercise intervention. The Park-in-Shape study is a randomized controlled, assessor- and patient-blinded single center study. Two parallel groups will include a total of 130 patients, receiving either aerobic exercise on a home trainer equipped with gaming elements ("exergaming"), or a non-aerobic intervention (stretching, flexibility and relaxation exercises). Both groups are supported by a specifically designed motivational app that uses gaming elements to stimulate patients to exercise and rewards them after having completed the exercise. Both interventions are delivered at home at least 3 times a week for 30-45 minutes during 6 months. Eligible patients are community-dwelling, sedentary patients diagnosed with mild-moderate PD. The primary outcome is the MDS-UPDRS motor score (tested in the off state) after 6 months. Secondary outcomes include various motor and non-motor symptoms, quality of life, physical fitness, and adherence. This Park-in-Shape study is anticipated to answer the question whether high intensity aerobic

  17. The Opioid-Sparing Effect of Perioperative Dexmedetomidine Combined with Oxycodone Infusion during Open Hepatectomy: A Randomized Controlled Trial

    OpenAIRE

    Benhou Zhang; Benhou Zhang; Guifang Wang; Xiaopeng Liu; Tian-Long Wang; Ping Chi

    2018-01-01

    Background: A large right subcostal incision performed by open hepatectomy is associated with significant post-operative pain and distress. However, post-operative analgesia solutions still need to be devised. We investigated the effects of intra- and post-operative infusion of dexmedetomidine (Dex) combined with oxycodone during open hepatectomy.Methods: In this prospective, randomized and double-blind investigation, 52 patients undergoing selective open hepatectomy were divided into Dex gro...

  18. The effect of lidocaine jelly on a taper-shaped cuff of an endotracheal tube on the postoperative sore throat: a prospective randomized study: A CONSORT compliant article.

    Science.gov (United States)

    Lee, Jiwon; Lee, Yong-Cheol; Son, Je-Do; Lee, Jae-Yoon; Kim, Hyun-Chang

    2017-09-01

    Postoperative sore throat (POST) following general anesthesia with endotracheal intubation is a common complication. We hypothesized that lidocaine jelly applied to the tapered cuff of the endotracheal tube (ETT) might decrease the incidence of POST most commonly arising from endotracheal intubation. A total of 208 patients under general anesthesia were randomly assigned into 1 of 2 groups. In the lidocaine group (n = 104), the distal part of ETTs with tapered-shaped cuff was lubricated with lidocaine jelly. In the control group (n = 104), the distal part of ETTs with tapered-shaped cuff was lubricated with normal saline. The incidence of POST, hoarseness, and cough in the postanesthesia patients was compared. The overall incidence of POST was higher in the lidocaine group than in the normal saline group [60 (58%) vs 40 (39%), P = .006]. The incidence of POST at 1 hour postoperatively was higher in the lidocaine group than in the normal saline group [53 (51%) vs 32 (31%), P = .003]. The overall incidence of hoarseness for 24 hours postoperatively was comparable (P = .487). The overall incidence of cough for 24 hours postoperatively is higher in the lidocaine group (P = .045). The lidocaine jelly applied at the distal part of ETT with tapered-shaped cuff increased the overall incidence of POST in patients undergoing general anesthesia.

  19. Noninvasive bipolar double-pulsed-field-gradient NMR reveals signatures for pore size and shape in polydisperse, randomly oriented, inhomogeneous porous media.

    Science.gov (United States)

    Shemesh, Noam; Ozarslan, Evren; Adiri, Tal; Basser, Peter J; Cohen, Yoram

    2010-07-28

    Noninvasive characterization of pore size and shape in opaque porous media is a formidable challenge. NMR diffusion-diffraction patterns were found to be exceptionally useful for obtaining such morphological features, but only when pores are monodisperse and coherently placed. When locally anisotropic pores are randomly oriented, conventional diffusion NMR methods fail. Here, we present a simple, direct, and general approach to obtain both compartment size and shape even in such settings and even when pores are characterized by internal field gradients. Using controlled porous media, we show that the bipolar-double-pulsed-field-gradient (bp-d-PFG) methodology yields diffusion-diffraction patterns from which pore size can be directly obtained. Moreover, we show that pore shape, which cannot be obtained by conventional methods, can be directly inferred from the modulation of the signal in angular bp-d-PFG experiments. This new methodology significantly broadens the types of porous media that can be studied using noninvasive diffusion-diffraction NMR.

  20. A randomized study of combining maze surgery for atrial fibrillation with mitral valve surgery

    NARCIS (Netherlands)

    Jessurun, ER; Van Hemel, NM; Defauw, JJ; De La Riviere, AB; Stofmeel, MAM; Kingma, JH; Ernst, JMPG

    Aim Mitral valve surgery seldom suppresses atrial fibrillation (AF), present prior to surgery. Maze III surgery eliminates AF in >80% of cases, the reason why combining this procedure with mitral valve surgery in patients with AF seems worthwhile. We prospectively studied the outcome of combining

  1. Combined functional pelvic floor muscle exercises with Swiss ball and urotherapy for management of dysfunctional voiding in children: a randomized clinical trial.

    Science.gov (United States)

    Ladi Seyedian, Seyedeh Sanam; Sharifi-Rad, Lida; Ebadi, Maryam; Kajbafzadeh, Abdol-Mohammad

    2014-10-01

    We report the clinical results of two types of urotherapy programs in children with dysfunctional voiding (DV). Sixty children with a median age of 8 (range, 5-14) diagnosed with DV were randomly allocated to one of two groups, each made up of 30 patients. Patients in group A underwent behavioral urotherapy (hydration, scheduled voiding, toilet training, and high-fiber diet) combined with pelvic floor muscle (PFM) exercises, whereas group B only received behavioral urotherapy. All parents completed a voiding and bowel habit diary chart. Uroflowmetry with pelvic floor surface electromyography (EMG) and bladder ultrasound were performed on all patients at the beginning and the end of the 1-year study. Abnormal voiding pattern normalized to a bell shape in 21/30 of patients in group A and 8/30 of patients in group B (P Swiss ball combined with behavioral urotherapy proved as a safe and effective therapeutic modality, reducing the frequency of urinary incontinence, PVR, and the severity of constipation in children with DV.

  2. Randomized controlled trial of the combined monoaminergic and opioid investigational compound GRT9906 in painful polyneuropathy

    DEFF Research Database (Denmark)

    Sindrup, Søren Hein; Konder, R; Lehmann, R

    2012-01-01

    GRT9906 is an investigational novel compound with μ-opioid receptor agonism and inhibition of noradrenalin/serotonin re-uptake. In this randomized, double-blind, placebo-controlled, three-way cross-over trial in painful polyneuropathy, the efficacy and safety of GRT9906 was assessed and compared...

  3. Normalizing Social Media Texts by Combining Word Embeddings and Edit Distances in a Random Forest Regressor

    NARCIS (Netherlands)

    van der Goot, Rob

    2016-01-01

    In this work, we adapt the traditional framework for spelling correction to the more novel task of normalization of social media content. To generate possible normalization candidates, we complement the traditional approach with a word embeddings model. To rank the candidates we will use a random

  4. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children.

    Science.gov (United States)

    Vyas, Falgun Indravadan; Rana, Devang Ashwinkumar; Patel, Piyush M; Patel, Varsha Jitendra; Bhavsar, Rekha H

    2014-01-01

    Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1(st) h (P = 0.04). Highest fall of temperature was noted in the 1(st) h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.

  5. Combining walking and relaxation for stress reduction-A randomized cross-over trial in healthy adults.

    Science.gov (United States)

    Matzer, Franziska; Nagele, Eva; Lerch, Nikolaus; Vajda, Christian; Fazekas, Christian

    2017-08-25

    Both physical activity and relaxation have stress-relieving potential. This study investigates their combined impact on the relaxation response while considering participants' initial stress level. In a randomized cross-over trial, 81 healthy adults completed 4 types of short-term interventions for stress reduction, each lasting for 1 hr: (1) physical activity (walking) combined with resting, (2) walking combined with balneotherapy, (3) combined resting and balneotherapy, and (4) resting only. Saliva cortisol, blood pressure, state of mood, and relaxation were measured preintervention and postintervention. Stress levels were determined by validated questionnaires. All interventions were associated with relaxation responses in the variables saliva cortisol, blood pressure, state of mood, and subjective relaxation. No significant differences were found regarding the reduction of salivary cortisol (F = 1.30; p = .281). The systolic blood pressure was reduced best when walking was combined with balneotherapy or resting (F = 7.34; p < .001). Participants with high stress levels (n = 25) felt more alert after interventions including balneotherapy, whereas they reported an increase of tiredness when walking was combined with resting (F = 3.20; p = .044). Results suggest that combining physical activity and relaxation (resting or balneotherapy) is an advantageous short-term strategy for stress reduction as systolic blood pressure is reduced best while similar levels of relaxation can be obtained. Copyright © 2017 John Wiley & Sons, Ltd.

  6. Oncoplastic breast surgery combining periareolar mammoplasty with volume displacement using a crescent-shaped cutaneous flap for early breast cancer in the upper quadrant.

    Science.gov (United States)

    Kijima, Yuko; Yoshinaka, Heiji; Hirata, Munetsugu; Nakajo, Akihiro; Arima, Hideo; Ishigami, Sumiya; Ueno, Shinichi; Natsugoe, Shoji

    2013-08-01

    Oncoplastic breast surgery (OBS), which combines the concepts of oncological and plastic surgery, is becoming more common, especially in Western countries; however, only a few reports have been published in Japan. We herein report the results of OBS for Japanese patients with early breast cancer in the upper quadrant. We performed oncoplastic surgery combining partial mastectomy using a periareolar incision with immediate breast reshaping using a crescent-shaped cutaneous flap in three patients with a past history of breast-feeding, ptotic breasts and lesions that were suitable for breast conserving surgery. The lesions were located in the upper quadrant and were 5, 6 and 10 cm from the nipple, respectively. The total length of the operations ranged between 86 and 192 min, with the mean being 164 min. Two patients underwent contralateral surgery to produce symmetrical breasts and one did not. The plastic period after receiving pathological results intraoperatively ranged between 47 and 120 min, with the mean period being 82 min. The observation period ranged between 6 and 12 months, and the cosmetic results were excellent in all three cases. OBS combining partial mastectomy using a periareolar incision with immediate breast reshaping using a crescent-shaped cutaneous flap was successfully performed in patients with early cancer in the upper quadrant.

  7. Oral Tranexamic Acid with Fluocinolone-Based Triple Combination Cream Versus Fluocinolone-Based Triple Combination Cream Alone in Melasma: An Open Labeled Randomized Comparative Trial.

    Science.gov (United States)

    Padhi, Tanmay; Pradhan, Swetalina

    2015-01-01

    Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy. Tranexamic acid, a plasmin inhibitor, has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results. To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients. 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study. Participants were randomly divided into two groups with 20 patients in each group. Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05%, and hydroquinone 2% once daily for 8 weeks. Response was evaluated using melasma area severity index (MASI) at baseline, 4 weeks, and 8 weeks. 40 patients completed the study. The MASI scores at baseline, 4 weeks and 8 weeks in group A were 15.425 + 1.09, 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05, 6.135 + 4.94 and 2.19 + 3.38. Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks (P value 0.014) and 8 weeks (P value 0.000). The efficacy was maintained throughout the 6-month follow-up period. Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma.

  8. Oral tranexamic acid with fluocinolone-based triple combination cream versus fluocinolone-based triple combination cream alone in melasma: An open labeled randomized comparative trial

    Directory of Open Access Journals (Sweden)

    Tanmay Padhi

    2015-01-01

    Full Text Available Background : Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy. Tranexamic acid, a plasmin inhibitor, has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results. Objectives : To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients. Materials and Methods : 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study. Participants were randomly divided into two groups with 20 patients in each group. Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05%, and hydroquinone 2% once daily for 8 weeks. Response was evaluated using melasma area severity index (MASI at baseline, 4 weeks, and 8 weeks. Results : 40 patients completed the study. The MASI scores at baseline, 4 weeks and 8 weeks in group A were 15.425 + 1.09, 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05, 6.135 + 4.94 and 2.19 + 3.38. Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks (P value 0.014 and 8 weeks (P value 0.000. The efficacy was maintained throughout the 6-month follow-up period. Conclusion: Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma.

  9. Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Arruda Viani, Gustavo, E-mail: gusviani@gmail.com [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Carrara Fonseca, Ellen [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); De Fendi, Ligia Issa [Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Melani Rocha, Eduardo [Department of Ophthalmology, School of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto (Brazil)

    2012-03-01

    Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.

  10. The SKE-DOCK server and human teams based on a combined method of shape complementarity and free energy estimation.

    Science.gov (United States)

    Terashi, Genki; Takeda-Shitaka, Mayuko; Kanou, Kazuhiko; Iwadate, Mitsuo; Takaya, Daisuke; Umeyama, Hideaki

    2007-12-01

    We participated in rounds 6-12 of the critical assessment of predicted interaction (CAPRI) contest as the SKE-DOCK server and human teams. The SKE-DOCK server is based on simple geometry docking and a knowledge base scoring function. The procedure is summarized in the following three steps: (1) protein docking according to shape complementarity, (2) evaluating complex models, and (3) repacking side-chain of models. The SKE-DOCK server did not make use of biological information. On the other hand, the human team tried various intervention approaches. In this article, we describe in detail the processes of the SKE-DOCK server, together with results and reasons for success and failure. Good predicted models were obtained for target 25 by both the SKE-DOCK server and human teams. When the modeled receptor proteins were superimposed on the experimental structures, the smallest Ligand-rmsd values corresponding to the rmsd between the model and experimental structures were 3.307 and 3.324 A, respectively. Moreover, the two teams obtained 4 and 2 acceptable models for target 25. The overall result for both the SKE-DOCK server and human teams was medium accuracy for one (Target 25) out of nine targets. (c) 2007 Wiley-Liss, Inc.

  11. [Combination of acupuncture, cupping and medicine for treatment of fibromyalgia syndrome: a multi-central randomized controlled trial].

    Science.gov (United States)

    Jang, Zhen-Ya; Li, Chang-Du; Qiu, Ling; Guo, Jun-Hua; He, Ling-Na; Yue, Yang; Li, Fang-Ze; Qin, Wen-Yi

    2010-04-01

    To evaluate the clinical effect of combination of acupuncture, cupping and medicine for treatment of fibromyalgia syndrome. By using multi-central randomized controlled method, 186 cases were randomly divided into an acupuncture combined with cupping and western medicine group (group A), an acupuncture combined with cupping group (group B) and a western medicine group (group C) and treated continuously for 4 weeks. The treatment of acupuncture combined with cupping was produced by acupuncture at five mental points and moving cupping on the Hechelu of the back, once evrey other day, thrice each week, and the western medicine therapy by oral administration of Amitriptyline, once each day. The scores of McGill Pain Questionnaire (MPQ), the amount of tenderness point and the time of producing effect were compared and the therapeutic effects were assessed with the Hamilton Depression Scale (HAMD). The cured and markedly effective rate was 65.0% (39/60) in the group A, which was superior to 15.9% (10/63) in the group B and 16.1% (9/56) in the group C (both P treatment, the scores of MPQ and HAMD and the amount of tenderness point all decreased in the three groups, group A being significantly better than group B and group C, and the time of producing effect in the group A was more earlier than those in the group B and the group C. The therapeutic effect of combination of acupuncture, cupping and medicine on fibromyalgia syndrome is superior to that of the simple acupuncture combined with cupping or the simple medicine.

  12. Effect of upper extremity proprioceptive neuromuscular facilitation combined with elastic resistance bands on respiratory muscle strength: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Guilherme P. T. Areas

    2013-12-01

    Full Text Available BACKGROUND: Elastic resistance bands (ERB combined with proprioceptive neuromuscular facilitation (PNF are often used in resistance muscle training programs, which have potential effects on peripheral muscle strength. However, the effects of the combination of ERB and PNF on respiratory muscle strength warrant further investigation. OBJECTIVES: The assessment of the effects of PNF combined with ERB on respiratory muscle strength. METHOD: Twenty healthy, right-handed females were included. Subjects were randomized to either the resistance training program group (TG, n=10 or the control group (CG, n=10. Maximal expiratory pressure (MEP and inspiratory pressure (MIP were measured before and after four weeks of an upper extremity resistance training program. The training protocol consisted of upper extremity PNF combined with ERB, with resistance selected from 1 repetition maximum protocol. RESULTS: PNF combined with ERB showed significant increases in MIP and MEP (p<0.05. In addition, there were significant differences between the TG and CG regarding ∆MIP (p=0.01 and ∆MEP (p=0.04. CONCLUSIONS: PNF combined with ERB can have a positive impact on respiratory muscle strength. These results may be useful with respect to cardiopulmonary chronic diseases that are associated with reduced respiratory muscle strength.

  13. Computational and experimental research of explosive meteorial devices with combined cumulative liners of the semi-sphere-cylinder shape

    Science.gov (United States)

    Fedorov, S. V.; Ladov, S. V.; Nikolskaya, Ya M.

    2017-10-01

    On the basis of numerical modeling within the two-dimensional axisymmetric problem of continuum mechanics and experimental studies, the features of the formation of high-speed compact elements using cumulative charges with liners of the combined form have been analysed.Such liners may have a jet-forming part in the form of a hemisphere, a slightly stretched semi-ellipsoid or a truncated sphere and an ellipsoid, as well as a cutting part in the form of a cylinder.The constructive solutions promoting increase in mass and high-speed parametrs of the compact element formed by explosion are proposed.The variants of steel combined cumulative liners as a part of an explosive device provided the formation of non-gradient elements with a mass from15 to a fraction of a gram moving at speeds from 7.5 to 10 km / s respectively are defined.Such fairly simple explosive devices can be used to simulate, in terrestrial conditions, single and group effects of micrometeorites and fragments of space debris on rocket and space equipment.

  14. Combining hydrodynamic modelling with genetics: can passive larval drift shape the genetic structure of Baltic Mytilus populations?

    Science.gov (United States)

    Stuckas, Heiko; Knöbel, Loreen; Schade, Hanna; Breusing, Corinna; Hinrichsen, Hans-Harald; Bartel, Manuela; Langguth, Klaudia; Melzner, Frank

    2017-05-01

    While secondary contact between Mytilus edulis and Mytilus trossulus in North America results in mosaic hybrid zone formation, both species form a hybrid swarm in the Baltic. Despite pervasive gene flow, Baltic Mytilus species maintain substantial genetic and phenotypic differentiation. Exploring mechanisms underlying the contrasting genetic composition in Baltic Mytilus species will allow insights into processes such as speciation or adaptation to extremely low salinity. Previous studies in the Baltic indicated that only weak interspecific reproductive barriers exist and discussed the putative role of adaptation to environmental conditions. Using a combination of hydrodynamic modelling and multilocus genotyping, we investigate how oceanographic conditions influence passive larval dispersal and hybrid swarm formation in the Baltic. By combining our analyses with previous knowledge, we show a genetic transition of Baltic Mytilus species along longitude 12°-13°E, that is a virtual line between Malmö (Sweden) and Stralsund (Germany). Although larval transport only occurs over short distances (10-30 km), limited larval dispersal could not explain the position of this genetic transition zone. Instead, the genetic transition zone is located at the area of maximum salinity change (15-10 psu). Thus, we argue that selection results in weak reproductive barriers and local adaptation. This scenario could maintain genetic and phenotypic differences between Baltic Mytilus species despite pervasive introgressive hybridization. © 2017 John Wiley & Sons Ltd.

  15. A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

    Science.gov (United States)

    Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

    2011-01-01

    A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

  16. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    Directory of Open Access Journals (Sweden)

    Falgun Indravadan Vyas

    2014-01-01

    Full Text Available Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Results: Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P < 0.05; however, the difference was not clinically significant (<1΀C. The rate of fall of temperature was highest in the combination group. Number of afebrile children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1 st h (P = 0.04. Highest fall of temperature was noted in the 1 st h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Conclusion: Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.

  17. Chinese Massage Combined with Herbal Ointment for Athletes with Nonspecific Low Back Pain: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ling Jun Kong

    2012-01-01

    Full Text Available Non-specific low back pain (NLBP is an increasing health problem for athletes. This randomized controlled trial was designed to investigate the effects of Chinese massage combined with herbal ointment for NLBP. 110 athletes with NLBP were randomly assigned to experimental group with Chinese massage combined with herbal ointment or control group with simple massage therapy. The primary outcome was pain by Chinese Short Form McGill Pain Questionnaire (C-SFMPQ. The secondary outcome was local muscle stiffness by Myotonometer. After 4 weeks, the experimental group experienced significant improvements in C-SFMPQ and in local muscle stiffness compared with control group (between-group difference in mean change from baseline, −1.24 points, P=0.005 in sensory scores; −3.14 points, P<0.001 in affective scores; −4.39 points, P<0.001 in total scores; −0.64 points, P=0.002 in VAS; −1.04 points, P=0.005 in local muscle stiffness during relaxation state. The difference remained at one month followup, but it was only significant in affective scores (−2.83 points, P<0.001 at three months followup. No adverse events were observed. These findings suggest that Chinese massage combined with herbal ointment may be a beneficial complementary and alternative therapy for athletes with NLBP.

  18. Effect of Combined Use of Calcium and Vitamin B6 on Premenstrual Syndrome Symptoms: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Seyedeh Zahra Masoumi

    2016-03-01

    Full Text Available Introduction: Premenstrual syndrome is one of the most common disorders in women, which includes a group of psychological and physical symptoms. The aim of this study was to examine the impact of combined use of calcium and vitamin B6 on premenstrual syndrome symptoms. Methods: This double blind randomized controlled was carried out on 76 students of Hamadan University of Medical Sciences. Students were randomly allocated to two groups. (38 people in each group. Student in intervention groups received calcium tablet (500mg and vitamin B6 (40 mg and student in intervention groups received only vitamin B6 twice a day for two consecutive months. The symptoms were assessed by Beck depression inventory (BDI and daily symptom records (DSR questionnaires. Analyses were carried out by test-retest method, Chi-square, Mann-Whitney, Independent t-test, and paired t-test using SPSS software ver.13. Results: The result showed that although the severity of symptoms decreased in both groups, but this reduction was more significant in the combined calcium and vitamin B6 group. Conclusion: According to the result, using of combination of calcium and vitamin B6 leads to better controlling of the premenstrual syndrome symptoms. Therefore it is recommended for women who suffer from these syndromes.

  19. Antipsychotic Medication Alone versus Combined with Psychosocial Intervention on Outcomes of Early Stage Schizophrenia: A Randomized, One-year Study

    Science.gov (United States)

    Guo, Xiaofeng; Zhai, Jinguo; Liu, Zhening; Fang, Maosheng; Wang, Bo; Wang, Chuanyue; Hu, Bin; Sun, Xueli; Lv, Luxian; Lu, Zheng; Ma, Cui; He, Xiaolin; Guo, Tiansheng; Xie, Shiping; Wu, Renrong; Xue, Zhimin; Chen, Jindong; Twamley, Elizabeth W.; Jin, Hua; Zhao, Jingping

    2013-01-01

    Context Antipsychotic drugs are limited in their ability to improve the overall outcome of schizophrenia. Adding psychosocial treatment may produce greater improvement in functional outcome than does medication treatment alone. Objective To evaluate the effectiveness of antipsychotic medication alone versus combined with psychosocial intervention on outcomes of early stage schizophrenia. Design, Setting, and Participants Randomized controlled trial of a clinical sample of 1268 patients with early stage schizophrenia, conducted at 10 clinical sites in China from 2005–2007. Intervention Patients were randomly assigned to antipsychotic medication treatment only or antipsychotic medication plus 12 months of psychosocial intervention, consisting of psycho-education, family intervention, skills training and cognitive-behavioral therapy, administered over 48 group sessions. Main Outcome Measures The rate of treatment discontinuation or change due to any cause, relapse or remission, and assessments of insight, treatment adherence, quality of life and social functioning. Results The rates of treatment discontinuation or change due to any cause were 32.8% in the combined treatment group and 46.8% in the medication alone group. Comparisons with medication treatment alone showed lower risk for any cause discontinuation with combined treatment (hazard ratios [HR], 0.62; 95% confidence interval [CI], 0.52–0.74; ppsychosocial intervention had a lower rate of treatment discontinuation or change, lower risk of relapse, and improved insight, quality of life and social functioning. PMID:20819983

  20. Randomized Controlled Trial of Fish Oil and Montelukast and Their Combination on Airway Inflammation and Hyperpnea-Induced Bronchoconstriction

    Science.gov (United States)

    Tecklenburg-Lund, Sandra; Mickleborough, Timothy D.; Turner, Louise A.; Fly, Alyce D.; Stager, Joel M.; Montgomery, Gregory S.

    2010-01-01

    Background Both fish oil and montelukast have been shown to reduce the severity of exercise-induced bronchoconstriction (EIB). The purpose of this study was to compare the effects of fish oil and montelukast, alone and in combination, on airway inflammation and bronchoconstriction induced by eucapnic voluntary hyperpnea (EVH) in asthmatics. Methods In this model of EIB, twenty asthmatic subjects with documented hyperpnea-induced bronchoconstriction (HIB) entered a randomized double-blind trial. All subjects entered on their usual diet (pre-treatment, n = 20) and then were randomly assigned to receive either one active 10 mg montelukast tablet and 10 placebo fish oil capsules (n = 10) or one placebo montelukast tablet and 10 active fish oil capsules totaling 3.2 g EPA and 2.0 g DHA (n = 10) taken daily for 3-wk. Thereafter, all subjects (combination treatment; n = 20) underwent another 3-wk treatment period consisting of a 10 mg active montelukast tablet or 10 active fish oil capsules taken daily. Results While HIB was significantly inhibited (pmontelukast, fish oil and combination treatment compared to pre-treatment, there was no significant difference (p>0.017) between treatment groups; percent fall in forced expiratory volume in 1-sec was −18.4±2.1%, −9.3±2.8%, −11.6±2.8% and −10.8±1.7% on usual diet (pre-treatment), fish oil, montelukast and combination treatment respectively. All three treatments were associated with a significant reduction (p0.017) in these biomarkers between treatments. Conclusion While fish oil and montelukast are both effective in attenuating airway inflammation and HIB, combining fish oil with montelukast did not confer a greater protective effect than either intervention alone. Fish oil supplementation should be considered as an alternative treatment for EIB. Trial Registration ClinicalTrials.gov NCT00676468 PMID:20976161

  1. Effect of Kangaroo Care Combined with Music on the Mother-premature Neonate Attachment: A Randomized Controlled Trial.

    Science.gov (United States)

    Vahdati, Maryam; Mohammadizadeh, Majid; Talakoub, Sedigheh

    2017-01-01

    Premature birth may complicate the development and quality of the mother-infant attachment relationship. Music and kangaroo care are two common complementary cares performed in the neonatal intensive care unit (NICU). The present study investigated the effect of kangaroo care combined with music on the mother-premature neonate attachment. In this clinical trial, 64 mothers with premature neonates were selected and assigned to the control and study groups through random allocation. In the control group, kangaroo care, and in the study group, kangaroo care combined with music was adopted. The level of mother-premature neonate attachment was measured and compared before and after the intervention in both the groups using Avant's Maternal Attachment Assessment Scale. There was a significant increase in the mean overall score of attachment in the kangaroo care combined with music group (70.72 (11.46)) after the intervention compared to the kangaroo care without music group (53.61 (9.76)). The mean overall score of mother-neonate attachment in the kangaroo care combined with music group was higher than the kangaroo care group. This difference can be related to the effectiveness of music combined with kangaroo care.

  2. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial.

    Science.gov (United States)

    Komasawa, Nobuyasu; Mihara, Ryosuke; Imagawa, Kentaro; Hattori, Kazuo; Minami, Toshiaki

    2015-01-01

    The present study compared changes in cuff pressure by head and neck position between high-volume low-pressure (HVLP) and taper-shaped (taper) cuffs in a prospective randomized clinical trial. Methods. Forty patients were intubated using tracheal tubes with either HVLP (n = 20; HVLP group) or taper-shaped (n = 20; Taper group) cuffs. Initial cuff pressure was adjusted to 15, 20, or 25 cmH2O in the neutral position. Cuff pressure was evaluated after changing the head and neck positions to flexion, extension, and rotation. Results. Cuff pressure significantly increased with flexion in both HVLP and Taper groups at all initial cuff pressures. It significantly increased with extension in the HVLP group, but not in the Taper group. Cuff pressure did not significantly differ with rotation in either group and was significantly smaller in the Taper group during flexion and extension than in the HVLP group, regardless of initial cuff pressure. Conclusion. Cuff pressure changes with head and neck flexion and extension were smaller in the Taper group than in the HVLP group. Our results highlight the potential for taper cuffs to prevent excessive cuff pressure increases with positional changes in the head and neck. This trial is registered with UMIN000016119.

  3. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Nobuyasu Komasawa

    2015-01-01

    Full Text Available The present study compared changes in cuff pressure by head and neck position between high-volume low-pressure (HVLP and taper-shaped (taper cuffs in a prospective randomized clinical trial. Methods. Forty patients were intubated using tracheal tubes with either HVLP (n=20; HVLP group or taper-shaped (n=20; Taper group cuffs. Initial cuff pressure was adjusted to 15, 20, or 25 cmH2O in the neutral position. Cuff pressure was evaluated after changing the head and neck positions to flexion, extension, and rotation. Results. Cuff pressure significantly increased with flexion in both HVLP and Taper groups at all initial cuff pressures. It significantly increased with extension in the HVLP group, but not in the Taper group. Cuff pressure did not significantly differ with rotation in either group and was significantly smaller in the Taper group during flexion and extension than in the HVLP group, regardless of initial cuff pressure. Conclusion. Cuff pressure changes with head and neck flexion and extension were smaller in the Taper group than in the HVLP group. Our results highlight the potential for taper cuffs to prevent excessive cuff pressure increases with positional changes in the head and neck. This trial is registered with UMIN000016119.

  4. OPTIMAL LINEAR COMBINED FILTERING OF RANDOM SEQUENCES BASED ON THE RECURSIVE LEAST SQUARES METHOD

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    V. M. Artemiev

    2015-01-01

    Full Text Available The problem of the synthesis of linear combined filter for the criterion of minimizing current losses on the basis of the recursive least squares method is being solved. This approach does not requirea priori knowledge of the statistical characteristics of impacts that is an advantage compared with the Kalman filter. A comparative evaluation of the filters’ accuracy is provided using the values of variances of the filtering errors.

  5. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    trial. Two hundred and eighty-four patients started randomized treatment. The primary end-point was the proportion of patients with HIV RNA of 200 copies/ml or less (Roche Amplicor) and HIV RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent......-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 patients should have completed 24 weeks of treatment. The proportion of patients with HIV RNA of 200 copies/ml or less was 71% (indinavir), 67% (ritonavir), and 82% (ritonavir + saquinavir), P = 0.07. In antiretroviral drug......-naive patients (n = 119), the corresponding figures were 63, 57, and 89% (P RNA of 200 copies/ml or less (P = 0.90). The same pattern was observed in the ultradirect analysis. All three regimens were generally safe...

  6. Controllable microwave and ultrasonic wave combined synthesis of ZnO micro-/nanostructures in HEPES solution and their shape-dependent photocatalytic activities

    Energy Technology Data Exchange (ETDEWEB)

    Li, Qin; Li, Hui; Wang, Runming; Li, Guangfang; Yang, Hao [Key Laboratory for Green Chemical Process of Ministry of Education and Hubei Novel Reactor and Green Chemical Technology Key Laboratory, Wuhan Institute of Technology, Xiongchu Street, Wuhan 430073 (China); Chen, Rong, E-mail: rchenhku@hotmail.com [Key Laboratory for Green Chemical Process of Ministry of Education and Hubei Novel Reactor and Green Chemical Technology Key Laboratory, Wuhan Institute of Technology, Xiongchu Street, Wuhan 430073 (China); Engineering Research Center of Nano-Geomaterials of Ministry of Education, China University of Geosciences, Lumo Road, Wuhan 430074 (China)

    2013-08-05

    Grahpical abstract: ZnO micro-/nanostructures with controllable size and morphology were successfully synthesized by microwave and ultrasonic wave combined method in HEPES solution, and exhibit shape-dependent photocatalytic activity for MB degradation under UV light irradiation. Highlights: •ZnO micro-/nanostructures were synthesized by combined microwave-ultrasonic wave method. •Morphologies of ZnO micro-/nanostructures could be modulated by varying reaction conditions. •HEPES plays a crucial role in the controllable synthesis of ZnO micro-/nanostructures. •ZnO micro-/nanostructures exhibit shape-dependent photocatalytic activity. •Spindle-like ZnO microstructures show superior photocatalytic activity. -- Abstract: Size- and morphology-controlled zinc oxide (ZnO) micro-/nanostructures have been successfully synthesized via a facile and rapid microwave and ultrasonic wave combined method in HEPES solution (HEPES = 2-[4-(2-hydroxyethyl)-1-piperazinyl]ethanesulfonic acid). The as-prepared ZnO products are characterized by powder X-ray diffraction (XRD), scanning electron microscopy (SEM), transmission electron microscopy (TEM), selected area electron diffraction (SAED) and UV–vis diffuse reflection spectroscopy (DRS). Various morphologies of ZnO products, including grenade-like, column-like, spindle-like, rod-like, shuttle-like and flower-like micro-/nanostructures are obtained, which are strongly dependent on Zn/HEPES moral ratio, pH value and Zn precursor. It is found that HEPES plays a crucial role in the formation of ZnO micro-/nanostructures with controllable size and morphology. The photocatalytic activities of the prepared ZnO micro-/nanostructures are evaluated by degradation of methylene blue (MB) under UV light irradiation, among which spindle-like ZnO microstructures exhibit superior photocatalytic activity compared with other ZnO products.

  7. Effect of Combined versus Monotherapy with Deferoxamine and Deferiprone in Iron Overloaded Thalassemia Patients: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Sasan Hejazi

    2016-06-01

    Full Text Available Background: Patients with transfusional iron overload have depended on iron chelation therapy and improving chelation regimens have been of the highest priority. The aim of this study was to compare effect of combined versus monotherapy with Deferoxamine (DFO and Deferiprone (DFP in iron overloaded beta thalassemia (BT major patients Materials and Methods We studied 36 BT major patients (mean age 7.6±4.6; range 3–16 years attending the Ormieh Motahari hospital for regular transfusional support. Patients were randomly allocated to receive one of the following two treatments: DFO in combination with DFP (n=12, DFO alone (n=12 and DFP alone (n=12. Serum ferritin level, liver enzymes, blood urea nitrogen, and creatinine and side effects were monitored over a 12 months period. Results: After one year, serum ferritin decreased more significantly in patients on DFO+DFP therapy compared to patients who only received DFO or DFP alone (P

  8. Randomized controlled trial of fish oil and montelukast and their combination on airway inflammation and hyperpnea-induced bronchoconstriction.

    Directory of Open Access Journals (Sweden)

    Sandra Tecklenburg-Lund

    2010-10-01

    Full Text Available Both fish oil and montelukast have been shown to reduce the severity of exercise-induced bronchoconstriction (EIB. The purpose of this study was to compare the effects of fish oil and montelukast, alone and in combination, on airway inflammation and bronchoconstriction induced by eucapnic voluntary hyperpnea (EVH in asthmatics.In this model of EIB, twenty asthmatic subjects with documented hyperpnea-induced bronchoconstriction (HIB entered a randomized double-blind trial. All subjects entered on their usual diet (pre-treatment, n = 20 and then were randomly assigned to receive either one active 10 mg montelukast tablet and 10 placebo fish oil capsules (n = 10 or one placebo montelukast tablet and 10 active fish oil capsules totaling 3.2 g EPA and 2.0 g DHA (n = 10 taken daily for 3-wk. Thereafter, all subjects (combination treatment; n = 20 underwent another 3-wk treatment period consisting of a 10 mg active montelukast tablet or 10 active fish oil capsules taken daily.While HIB was significantly inhibited (p0.017 between treatment groups; percent fall in forced expiratory volume in 1-sec was -18.4 ± 2.1%, -9.3±2.8%, -11.6 ± 2.8% and -10.8 ± 1.7% on usual diet (pre-treatment, fish oil, montelukast and combination treatment respectively. All three treatments were associated with a significant reduction (p0.017 in these biomarkers between treatments.While fish oil and montelukast are both effective in attenuating airway inflammation and HIB, combining fish oil with montelukast did not confer a greater protective effect than either intervention alone. Fish oil supplementation should be considered as an alternative treatment for EIB.ClinicalTrials.gov NCT00676468.

  9. Preoperative Pain Neuroscience Education Combined With Knee Joint Mobilization for Knee Osteoarthritis: A Randomized Controlled Trial.

    Science.gov (United States)

    Lluch, Enrique; Dueñas, Lirios; Falla, Deborah; Baert, Isabel; Meeus, Mira; Sánchez-Frutos, José; Nijs, Jo

    2018-01-01

    This study aimed to first compare the effects of a preoperative treatment combining pain neuroscience education (PNE) with knee joint mobilization versus biomedical education with knee joint mobilization on central sensitization (CS) in patients with knee osteoarthritis, both before and after surgery. Second, we wanted to compare the effects of both interventions on knee pain, disability, and psychosocial variables. Forty-four patients with knee osteoarthritis were allocated to receive 4 sessions of either PNE combined with knee joint mobilization or biomedical education with knee joint mobilization before surgery. All participants completed self-administered questionnaires and quantitative sensory testing was performed at baseline, after treatment and at a 1 month follow-up (all before surgery), and at 3 months after surgery. Significant and clinically relevant differences before and after surgery were found after treatments for both knee pain and disability, and some measures of CS (ie, widespread hyperalgesia, CS inventory), with no significant between-group differences. Other indicators of CS (ie, conditioned pain modulation, temporal summation) did not change over time following either treatment, and in some occasions the observed changes were not in the expected direction. Patients receiving PNE with knee joint mobilization achieved greater improvements in psychosocial variables (pain catastrophizing, kinesiophobia) both before and after surgery. Preoperative PNE combined with knee joint mobilization did not produce any additional benefits over time for knee pain and disability, and CS measures compared with biomedical education with knee joint mobilization. Superior effects in the PNE with knee joint mobilization group were only observed for psychosocial variables related to pain catastrophizing and kinesiophobia.

  10. Randomized comparison between the combination of acetaminophen and ibuprofen and each constituent alone for analgesia following tonsillectomy in children.

    Science.gov (United States)

    Merry, Alan F; Edwards, Kylie-Ellen; Ahmad, Zahoor; Barber, Colin; Mahadevan, Murali; Frampton, Chris

    2013-12-01

    Combined acetaminophen and ibuprofen may be more effective than either constituent alone for pain in adults. The combination was compared with the individual constituents for analgesia following tonsillectomy in children. One hundred and fifty-two children (6-14 yr) undergoing tonsillectomy were randomized to receive either combination acetaminophen (48 mg·kg(-1)·day(-1)) and ibuprofen (24 mg·kg(-1)·day(-1)) or the same doses of acetaminophen alone or ibuprofen alone, every six hours for 48 hr. The primary outcome measure was a time-corrected area under the curve (AUCt) calculated from assessments on a 100-mm visual analogue scale (with Wong Baker FACES(®) as anchors). At each assessment the children rated pain while at rest and on swallowing at multiple time points over the study duration. Secondary outcome measures were a global pain rating, requirement for rescue analgesia, sleep disturbance, and frequency of adverse events. The mean [standard error of the mean (SEM)] AUCt values at rest were; combination 29.6 (1.9), acetaminophen 30.4 (2.0), ibuprofen 34 (1.9). The mean (SEM) AUCt values on swallowing were; combination 39.1 (2.0), acetaminophen 39.9 (2.0), ibuprofen 43.7 (1.9). The mean (95% confidence interval) differences in AUCt values between groups on swallowing were: combination vs acetaminophen -0.9 (-6.2 to 4.5); combination vs ibuprofen -4.6 (-9.9 to 0.67) and at rest were: combination vs acetaminophen -0.81 (-6.11 to 4.48); combination vs ibuprofen -4.37 (-9.62 to 0.88). Differences between groups were not clinically important for the pain scores, similarly for the secondary outcomes. The combination of ibuprofen and acetaminophen was not superior to its individual components in the regimen studied in this pediatric population undergoing tonsillectomy. The study was registered with the Australia New Zealand Clinical Trial Registry (ACTRN12607000005459) on January 4, 2007.

  11. Intrathecal Fentanyl Lidocaine combination for cesarean section: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Raji B

    2007-09-01

    Full Text Available Background: Spinal anesthesia can be associated with hemodynamic changes and some other complications. The aim of this study was to evaluate the effect of adding fentanyl to lidocaine on the spinal anesthesia time and its complications for cesarean section.Methods: Sixty pregnant women with gestational age of 37- 42 weeks and ASA physical status I and II undergoing elective cesarean section under spinal anesthesia were enrolled in a randomized double blinded clinical trial. They were randomly allocated to receive spinal anesthesia with lidocaine-normal saline (LS: 75 mg lidocaine 5% with 0.3 ml normal saline lidocaine-fentanyl (LF group (75 mg lidocaine 5% with 50 μg fentanyl. The duration of initiation of sensory block to achieve T4 level, time to return of sensory level to T12, time to first analgesic request, ephedrine requirement, nausea and vomiting during and after the surgery, pruritus, respirator depression, headache and apgar score of the new born  at 1st and 5th minutes were assessed. Results: There was no significant difference between time to achieve T4 level, ephedrine dose, post operative nausea and vomiting (PONV, pruritus and headache in study groups. Time to return of sensory level to T12 was significantly longer in LF group (152.6±14.7 vs. 66.2±11.2 min, P=0.0009. Time to first analgesic request was also longer in LF group (164.2±20.8 vs. 68.1±11.3 min, P=0.0009. The incidence of nausea and vomiting during surgery was significantly more in LF group (20% vs. 0%, P=0.023. No case of respiratory depression was observed in groups. The 1st and 5th minute's apgar score were comparable between groups and were between 7 and 10.Conclusions: Addition of fentanyl to intrathecal lidocaine in patients undergoing elective cesarean section results in increasing of the block duration and time to first analgesic request without significant maternal or neonatal side-effects, without effect on 1st and 5th minutes apgar score

  12. Combining rational and random strategies in β-glucosidase Zm-p60.1 protein library construction.

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    Dušan Turek

    Full Text Available Saturation mutagenesis is a cornerstone technique in protein engineering because of its utility (in conjunction with appropriate analytical techniques for assessing effects of varying residues at selected positions on proteins' structures and functions. Site-directed mutagenesis with degenerate primers is the simplest and most rapid saturation mutagenesis technique. Thus, it is highly appropriate for assessing whether or not variation at certain sites is permissible, but not necessarily the most time- and cost-effective technique for detailed assessment of variations' effects. Thus, in the presented study we applied the technique to randomize position W373 in β-glucosidase Zm-p60.1, which is highly conserved among β-glucosidases. Unexpectedly, β-glucosidase activity screening of the generated variants showed that most variants were active, although they generally had significantly lower activity than the wild type enzyme. Further characterization of the library led us to conclude that a carefully selected combination of randomized codon-based saturation mutagenesis and site-directed mutagenesis may be most efficient, particularly when constructing and investigating randomized libraries with high fractions of positive hits.

  13. Stimulus-response mappings shape inhibition processes: a combined EEG-fMRI study of contextual stopping.

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    Christina F Lavallee

    Full Text Available Humans are rarely faced with one simple task, but are typically confronted with complex stimulus constellations and varying stimulus-relevance in a given situation. Through modifying the prototypical stop-signal task and by combined recording and analysis of electroencephalography (EEG and functional magnetic resonance imaging (fMRI, we studied the effects of stimulus relevance for the generation of a response or its inhibition. Stimulus response mappings were modified by contextual cues, indicating which of two different stimuli following a go stimulus was relevant for stopping. Overall, response inhibition, that is comparing successful stopping to a stop-signal against go-signal related processes, was associated with increased activity in right inferior and left midfrontal regions, as well as increased EEG delta and theta power; however, stimulus-response conditions in which the most infrequent stop-signal was relevant for inhibition, were associated with decreased activity in regions typically involved in response inhibition, as well as decreased activity in the delta and theta bands as compared to conditions wherein the relevant stop-signal frequency was higher. Behaviorally, this (aforementioned condition, which demanded inhibition only from the most infrequent stimulus, was also associated with reduced reaction times and lower error rates. This pattern of results does not align with typical stimulus frequency-driven findings and suggests interplay between task relevance and stimulus frequency of the stop-signal. Moreover, with a multimodal EEG-fMRI analysis, we demonstrated significant parameterization for response inhibition with delta, theta and beta time-frequency values, which may be interpreted as reflecting conflict monitoring, evaluative and/or motor processes as suggested by previous work (Huster et al., 2013; Aron, 2011. Further multimodal results suggest a possible neurophysiological and behavioral benefit under conditions

  14. Prevention of post-spinal hypotension using crystalloid, colloid and ephedrine with three different combinations: A double blind randomized study

    Directory of Open Access Journals (Sweden)

    Mitra Jabalameli

    2012-01-01

    Full Text Available Background: The benefit of prophylactic combination therapy using crystalloid and colloid preload with ephedrine has not been cleared to prevent maternal hypotension after spinal anesthesia at cesarean delivery. This study evaluated the efficacy of three combinational methods to prevent hypotension following spinal anesthesia. Materials and Methods: In this prospective double blind trial, 150 candidates of elective cesarean delivery under spinal anesthesia were randomly allocated to three treatment groups; 1---Ringer′s Lactate (RL solution (15 ml/kg plus Hemaxel (7 ml/kg preload, 2---RL solution (15 ml/kg preload plus ephedrine (15 mg, IV, bolus, 3---Hemaxel (7 ml/kg preload plus ephedrine (15 mg, IV, bolus. Maternal hemodynamic changes during 60 min after spinal injection, nausea/vomiting, and neonatal condition were compared among the groups. Results: The cumulative incidence of hypotension was 44%, 40%, and 46% in groups 1 to 3, respectively. There were not significant differences in supplementary ephedrine requirement among groups which received or among groups which did not receive prophylactic ephedrine. Groups were not different in the incidence of hypertension and nausea or vomiting. There were no significant differences among groups in Apgar scores at 1 or 5 min and umbilical artery PH. Conclusion: Combination of preventive methods decreased the occurrence of hypotension following spinal anesthesia to an acceptable level. Overall, the most effective method was a combination of crystalloid preload with ephedrine.

  15. A Randomized Controlled Trial to Evaluate a Potential Hepatitis B Booster Vaccination Strategy Using Combined Hepatitis A and B Vaccine.

    Science.gov (United States)

    Li, Fangjun; Hu, Yuansheng; Zhou, Youming; Chen, Lixin; Xia, Wei; Song, Yufei; Tan, Zhengliang; Gao, Lidong; Yang, Zhong; Zeng, Gang; Han, Xing; Li, Junhua; Li, Jing

    2017-05-01

    Booster doses could play a major role in no responders or low responders to primary hepatitis B (HB) vaccine. Planed time point for hepatitis A vaccination in China provides a good opportunity to carry out HB booster dose by using combined hepatitis A and B vaccine. A randomized, double-blinded clinical trial was conducted to compare the immunogenicity and safety of toddlers 18-24 months of age receiving 3 different vaccination regimens: 2 doses of inactivated hepatitis A vaccine (group 1), 1 dose of inactivated hepatitis A vaccine plus 1 dose of combined hepatitis A and B vaccine (group 2) or 2 doses of combined hepatitis A and B vaccine (group 3). All 3 groups showed 100% seroprotection for antihepatitis A virus antibody after vaccination. Seroprotection rate for anti-HB antibody before vaccination ranged from 79.5% to 92.9% in the 3 groups. After second inoculation, anti-HBs seroprotection increased from 92.9% to 100% in group 2 with postvaccination geometric mean concentration (GMC) of 2258.3 mIU/mL and from 79.5% to 98.9% in group 3 with postvaccination GMC of 2055.3 mIU/mL. The adverse events were not statistically different among groups (P = 0.345). Combined hepatitis A and B vaccine could stimulate high level of both antihepatitis A virus and anti-HBs antibodies and not increase adverse events, providing a new choice for HB booster.

  16. Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients.

    Science.gov (United States)

    Hu, Ruiming; Xu, Feng; Sheng, Youyu; Qi, Sisi; Han, Yumei; Miao, Ying; Rui, Wenlong; Yang, Qinping

    2015-01-01

    Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy. © 2015 Wiley Periodicals, Inc.

  17. Randomized clinical trial of artemisinin versus non-artemisinin combination therapy for uncomplicated falciparum malaria in Madagascar

    Directory of Open Access Journals (Sweden)

    Ratsimbasoa Arsène

    2007-05-01

    Full Text Available Abstract Background Data concerning antimalarial combination treatment for uncomplicated malaria in Madagascar are largely lacking. Randomized clinical trial was designed to assess therapeutic efficacies of chloroquine (CQ, amodiaquine (AQ, sulphadoxine-pyrimethamine (SP, amodiaquine plus sulphadoxine-pyrimethamine combination (AQ+SP and artesunate plus amodiaquine combination (AQ+AS. Methods 287 children between 6 months and 15 years of age, with uncomplicated falciparum malaria, were enrolled in the study. Primary endpoints were the day-14 and day-28 risks of parasitological failure, either unadjusted or adjusted by genotyping. Results All treatment regimens, except for CQ treatment, gave clinical cure rates above 97% by day-14 and 92% by day-28 (PCR-corrected. AQ+SP was as effective as AQ+AS. The risk of new infection within the month after therapy was generally higher for AQ+AS than AQ+SP. Conclusion These findings show that the inexpensive and widely available combination AQ+SP may be valuable in for the treatment of uncomplicated malaria in Madagascar and could have an important role in this country, where much of the drugs administered go to patients who do not have malaria.

  18. Triple combination as adjuvant to cryotherapy in the treatment of solar lentigines: investigator-blinded, randomized clinical trial.

    Science.gov (United States)

    Hexsel, D; Hexsel, C; Porto, M D; Siega, C

    2015-01-01

    Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines. To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01%, hydroquinone 4% and tretinoin 0.05% as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum, and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. This prospective, randomized, controlled, investigator-blinded, single-centre study enrolled 50 patients. Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone. After that, cryotherapy was performed in all patients followed by a 3-week recovery period. After this period, patients received the same initial treatment and were followed up for 8 weeks. Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer. Lentigines count, colour homogeneity and global improvement were also assessed. The number of solar lentigines reduced in the first 2 weeks only in patients who used the triple combination 25 ± 7 vs. 22 ± 8 (P cryotherapy were the reported adverse reactions. Triple combination cream can be used to enhance the resolution of solar lentigines, and to significantly reduce melanin levels and lentigines count, improving treatment results. It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy. © 2014 European Academy of Dermatology and Venereology.

  19. Predictors of remission in depression to individual and combined treatments (PReDICT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dunlop Boadie W

    2012-07-01

    -week course of treatment, during which they receive a combination of CBT and antidepressant medication. Predictors of the primary outcome, remission, will be identified for overall and treatment-specific effects, and a statistical model incorporating multiple predictors will be developed to predict outcomes. Discussion The PReDICT study’s evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness. Trial registration Clinicaltrials.gov Identifier: NCT00360399. Registered 02 AUG 2006. First patient randomized 09 FEB 2007.

  20. Effect of health education combining diet and exercise supervision in Chinese women with perimenopausal symptoms: a randomized controlled trial.

    Science.gov (United States)

    Xi, S; Mao, L; Chen, X; Bai, W

    2017-04-01

    This study aimed to evaluate the effect of health education combining diet and exercise supervision on menopausal symptoms and diet/exercise habits. The randomized controlled study enrolled 60 patients with perimenopausal syndrome (Kupperman Menopause Index (KMI) score ≥15). The participants were randomized into either an intervention group (n = 30) or a control group (n = 30). Women were interviewed with questionnaires about perimenopausal symptoms, diet pattern and exercise habit. Their height and weight were measured. Women in the intervention group received health education, diet supervision and exercise supervision twice a week while those in the control group continued as normal. The total KMI score, scores of individual symptoms, diet pattern and exercise habit were measured after intervention. The total KMI score, the individual KMI scores for paresthesia, irritability, depression/suspicious, fatigue, arthralgia/myalgia, and palpitations of the intervention group were significantly lower compared with the control group after intervention. The intake of cereal, meat, fats and oils of the intervention group were significantly lower at week 12 compared with baseline. The percentage of women with a regular exercise habit was significantly higher in the intervention group than in the control group after intervention. Twelve weeks intervention of health education combining diet and exercise supervision could improve perimenopausal symptoms and help the patients establish good living habits.

  1. A randomized controlled trial of combined 5-fluorouracil and low-molecular-weight heparin in management of established proliferative vitreoretinopathy.

    Science.gov (United States)

    Charteris, David G; Aylward, G William; Wong, David; Groenewald, Carl; Asaria, Riaz H Y; Bunce, Catey

    2004-12-01

    To determine the efficacy of a combination of 5-fluorouracil and low-molecular-weight heparin (LMWH) to improve the outcome of surgery for established proliferative vitreoretinopathy (PVR). Double-masked, prospective, randomized, placebo-controlled clinical trial. Three tertiary-referral teaching hospital vitreoretinal surgical units. One hundred fifty-seven patients with established PVR (grade C, anterior or posterior) undergoing vitrectomy surgery. All patients underwent vitreoretinal surgery and silicone oil exchange with or without membrane peeling and/or retinectomy. Patients were randomly allocated to perioperative infusion with or without 5-fluorouracil (200 microg/ml) and LMWH (5 IU/ml) in Hartmann's solution for 1 hour. The primary outcome measure was defined as posterior retinal reattachment after removal of silicone oil without any reoperations at 6 months. Secondary outcome measures recorded were posterior retinal reattachment, localized/tractional retinal detachment, visual acuity, macular pucker, hypotony, glaucoma, keratopathy, and cataract. Removal of silicone oil and reoperations were also recorded. Overall, at 6 months 84% of patients had full retinal reattachment and 94% had stable posterior retinal reattachment. There was no significant difference in success in the primary outcome measure (56%, treatment group; 51%, placebo group; P = 0.59) or in secondary outcome measures or rates of complications. Secondary macular pucker occurred less often in the treatment group (6% vs. 17% at 6 months, P = 0.068). A perioperative infusion of combined 5-fluorouracil and LMWH does not significantly increase the success rate of vitreoretinal surgery for established PVR.

  2. Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Zheng, Kai; Shen, Hong; Jia, Jia; Lu, Yuelin; Zhu, Lei; Zhang, Lu; Shen, Zhaofeng

    2017-01-10

    Approximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. This is a parallel, multicenter, randomized controlled trial. One hundred and twenty eligible patients will be randomly assigned to a traditional Chinese medicine group or azathioprine group. All patients will be given basic treatment, which includes steroids and 5-aminosalicylic acid. Patients allocated to the traditional Chinese medicine group will receive basic treatment plus Chinese herbal medicine granules, while patients in the azathioprine group will receive basic treatment plus azathioprine. The whole study will last 24 weeks. The primary outcome measure is the steroid-free remission rate. Secondary outcome measures are health-related quality of life, efficacy of endoscopic response, degree of mucosal healing, and inflammation indicators. Results from this study may provide evidence for the effectiveness of traditional Chinese medicine combined with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. The findings will provide a basis for further confirmatory studies. Chinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.

  3. Effects of Duhuojisheng Tang and combined therapies on prolapse of lumbar intervertebral disc: a systematic review of randomized control trails.

    Science.gov (United States)

    Ma, Yanxu; Cui, Jingyan; Huang, Minghua; Meng, Kai; Zhao, Yuhao

    2013-04-01

    A systematic review of the literature was conducted to evaluate the curative effect and safety of Duhuojisheng Tang on prolapse of the lumbar intervertebral disc. The databases of PubMed, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), Chinese Biomedical Literature Database (CBM) and Chinese Medical Citation Index (CMCI) were searched up to January 30, 2012. Randomized controlled trials were selected to compare Duhuojisheng Tang with one or more of the following treatments: traction, acupuncture, massage, cupping and Western medical treatment. The quality-evaluating standard and the software RevMan 5.1 in Cochrane coordinative net were used to analyze the data. The effective indexes of the results were clinical curative rate, effectiveness of alleviating clinical symptoms and adverse reaction. Thirty-one randomized controlled trials of low quality, involving 3915 patients were systematically evaluated. Statistical analyses showed that good curative effect was achieved in both the group using Duhuojisheng Tang alone and with combined therapies. Using Duhuojisheng Tang alone or combined with other therapies can effectively improve pain, leg-raising height and other clinical symptoms of patients with prolapse of lumbar intervertebral disc. Due to low methodological quality of the articles, no exact recommendations can be made.

  4. Randomized Phase II trial of nintedanib, afatinib and sequential combination in castration-resistant prostate cancer.

    Science.gov (United States)

    Molife, L Rhoda; Omlin, Aurelius; Jones, Rob J; Karavasilis, Vasilios; Bloomfield, David; Lumsden, Graeme; Fong, Peter C; Olmos, David; O'Sullivan, Joe M; Pedley, Ian; Hickish, Tamas; Jenkins, Peter; Thompson, Emilda; Oommen, Nikhil; Wheatley, Duncan; Heath, Catherine; Temple, Graham; Pelling, Katy; de Bono, Johann S

    2014-02-01

    The aim of this article was to evaluate afatinib (BIBW 2992), an ErbB family blocker, and nintedanib (BIBF 1120), a triple angiokinase inhibitor, in castration-resistant prostate cancer patients. Patients were randomized to receive nintedanib (250 mg twice daily), afatinib (40 mg once daily [q.d.]), or alternating sequential 7-day nintedanib (250 mg twice daily) and afatinib (70 mg q.d. [Combi70]), which was reduced to 40 mg q.d. (Combi40) due to adverse events. The primary end point was progression-free rate at 12 weeks. Of the 85 patients treated 46, 20, 16 and three received nintedanib, afatinib, Combi40 and Combi70, respectively. At 12 weeks, the progression-free rate was 26% (seven out of 27 patients) for nintedanib, and 0% for afatinib and Combi40 groups. Two patients had a ≥50% decline in PSA (nintedanib and the Combi40 groups). The most common drug-related adverse events were diarrhea, nausea, vomiting and lethargy. Nintedanib and/or afatinib demonstrated limited anti-tumor activity in unselected advanced castration-resistant prostate cancer patients.

  5. Citicoline Combination Therapy for Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Roohi-Azizi, Mahtab; Arabzadeh, Somaye; Amidfar, Meysam; Salimi, Samrand; Zarindast, Mohammad Reza; Talaei, Ali; Akhondzadeh, Shahin

    Residual symptoms of major depressive disorder are a source of long-term morbidity. New therapeutic strategies are required to alleviate this morbidity and enhance patient quality of life. Citicoline has been used for vascular accidents and has been effective in cognitive rehabilitation. It has been used successfully to reduce craving in patients with substance abuse disorder and for mood management of bipolar disorder. Here, we test citicoline effectiveness as an adjuvant therapy in major depression. A double-blind randomized trial was designed on 50 patients with major depressive disorder who were under treatment with citalopram. Patients were allocated to 2 groups and received citicoline (100 mg twice a day) or placebo as an adjuvant treatment for 6 weeks. Depressive symptoms were assessed by the Hamilton Depression Rating Scale (HDRS) at baseline and at weeks 2, 4, and 6. Significantly greater improvement was observed in the HDRS scores of the citicoline group compared with the placebo group from baseline to weeks 2, 4, and 6 (Ps = 0.030, 0.032, and 0.021, respectively). Repeated-measures general linear model demonstrated a significant effect for time × treatment interaction on the HDRS score (F2.10,101.22 = 3.12, P = 0.04). Remission rate was significantly higher in the citicoline group compared with the placebo group (P = 0.045). Citicoline was an effective adjuvant to citalopram in the therapy of major depressive disorder.

  6. Combining double random phase encoding for color image watermarking in quaternion gyrator domain

    Science.gov (United States)

    Shao, Zhuhong; Duan, Yuping; Coatrieux, Gouenou; Wu, Jiasong; Meng, Jinyu; Shu, Huazhong

    2015-05-01

    Quaternion representation of color image has attracted great attention due to its capability to treat holistically the three color channels. In a more general way, it has successfully been used in multi-channel signal processing applications over the past few decades. In this study, a joint encryption/watermarking system with more security based on double random phase encoding (DRPE) in quaternion gyrator transform domain is addressed. In the proposed scheme, an RGB-scale watermark image together with a grayscale watermark image or not is encoded into a quaternion matrix and encrypted through the DRPE, the encrypted data is then fused into the middle coefficients of the quaternion gyrator-transformed host image. In the process of extracting watermarks, it is impossible to retrieve them without authorized keys. Compared with the three channels independently processing approach implemented in fractional Fourier domain, the proposed algorithm achieves lower complexity by reason of avoiding repetitive operations. Experimental results have demonstrated the feasibility of the proposed algorithm and its superior performance in terms of noise robustness.

  7. Combined olmesartan, amlodipine, and hydrochlorothiazide therapy in randomized patients with hypertension: a subgroup analysis of the TRINITY study by age.

    Science.gov (United States)

    Lewin, Andrew J; Izzo, Joseph L; Melino, Michael; Lee, James; Fernandez, Victor; Heyrman, Reinilde

    2013-07-01

    Hypertension is often inadequately controlled in older people. This prespecified subgroup analysis assessed the efficacy and safety of an olmesartan medoxomil (OM) 40 mg/amlodipine besylate (AML) 10 mg/hydrochlorothiazide (HCTZ) 25 mg triple-combination treatment compared with the 3 components as dual-combination treatments in participants with hypertension who were 9 %). Participants were randomized, stratified by age, diabetes status, and race to one of four treatment assignments: OM 40/AML 10/HCTZ 25 mg, OM 40/AML 10 mg, OM 40/HCTZ 25 mg, or AML 10/HCTZ 25 mg. Least squares (LS) mean change from baseline in seated diastolic blood pressure (SeDBP) at week 12 (last observation carried forward) in each age subgroup (prespecified analysis). Of the 2492 randomized participants in the study (total cohort), 2021 (81.1 %) were <65 and 471 (18.9 %) were ≥ 65 years of age, including 79 (3.2 %) who were ≥ 75 years of age. OM 40/AML 10/HCTZ 25 mg triple-combination treatment resulted in a significantly greater reduction in LS mean SeDBP at week 12 than dual-combination component treatments in participants in both cohorts: <65 years (21.0 vs. 14.2-17.2 mmHg; p < 0.0001) and ≥ 65 years (23.7 vs. 17.3-20.0 mmHg; p ≤ 0.002). Similarly, triple-combination treatment resulted in a greater reduction in LS mean seated systolic blood pressure (SeSBP) at week 12 than dual-combination component treatments: <65 years (38.2 vs. 28.3-31.4 mmHg; p < 0.0001) and ≥ 65 years (39.2 vs. 29.3-31.1 mmHg; p < 0.0001). Triple-combination treatment was more effective than dual-combination treatments in enabling participants to reach SeBP goal (<140/90 mmHg [<130/80 mmHg in participants with diabetes, chronic kidney disease, or chronic cardiovascular disease]) in both age subgroups (<65 years: 65 vs. 34-50 %, respectively, p < 0.0001 and ≥ 65 years: 63 vs. 32-39 %; p ≤ 0.0004). All 4 treatments were safe and well tolerated with low discontinuation rates in both age subgroups. There were

  8. Randomized Controlled Trial on the Effects of a Combined Sleep Hygiene Education and Behavioral Approach Program on Sleep Quality in Workers with Insomnia

    National Research Council Canada - National Science Library

    KAKU, Akiko; NISHINOUE, Nao; TAKANO, Tomoki; ETO, Risa; KATO, Noritada; ONO, Yutaka; TANAKA, Katsutoshi

    2012-01-01

    To evaluate the effects of a combined sleep hygiene education and behavioral approach program on sleep quality in workers with insomnia, we conducted a randomized controlled trial at a design engineering unit in Japan...

  9. Maintaining a politicised climate of opinion? Examining how political framing and journalistic logic combine to shape speaking opportunities in UK elite newspaper reporting of climate change.

    Science.gov (United States)

    Matthews, Julian

    2017-05-01

    This article explores the importance of issue politicisation and mediation for the reporting of climate change in UK elite newspapers. Specifically, this investigates how journalistic logic mediates political framing to produce commentaries on and discussion about climate change in the news. In analysing elite newspaper coverage over time in this case, the article shows that (1) various frames introduce the issue as a legitimate problem within coverage and that (2) the news stories these inform are opened to specific commentaries according to 'elite journalistic logic'. This configuration of coverage orders the speaking opportunities of established voices of science, politics and industry as well as those less established voices that enter to explain and qualify these elite accounts. The article concludes that the ingrained combination of issue politicisation and journalistic logic observed here will likely shape future elite reporting and those voices that it will include.

  10. Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial.

    Science.gov (United States)

    Masutani, Kosuke; Tsuchimoto, Akihiro; Yamada, Tomomi; Hirakawa, Makoto; Mitsuiki, Koji; Katafuchi, Ritsuko; Hirakata, Hideki; Kitazono, Takanari; Tsuruya, Kazuhiko

    2016-12-01

    The significance of immunosuppressants as an adjunct treatment with corticosteroids for IgA nephropathy (IgAN) has not been well demonstrated. This study was performed to compare two treatment regimens, steroid-pulse therapy or combined with mizoribine (MZR) in progressive IgAN. Study design was a prospective randomized controlled trial of 40 patients with moderate to severe glomerular injuries who were randomly administered either pulse methylprednisolone followed by a 25-month course of oral prednisolone (P group, n = 20) or in combination with MZR (150 mg/day for 24 months, M + P group, n = 20). The primary endpoint was a reduction of proteinuria by ≥50 % of the baseline value. Secondary endpoints were increased serum creatinine (Cr) by ≥50 %, or a decrease in estimated glomerular filtration rate by ≤50 %. Twenty-five months after the initiation of treatment, urinary protein excretion significantly declined from the median of 0.98 to 0.17 g/gCr in the P group (P proteinuria between two groups (P = 0.81). All patients reached the primary endpoint, and the cumulative incidence of the reduction of proteinuria was not significantly different (P = 0.76). No patient reached the secondary endpoint during the 25 months of treatment. Both therapeutic regimens significantly reduced the levels of proteinuria. We could not find the additional effect of MZR in combination with steroid-pulses in this small-scale controlled trial. Steroid-pulse therapy with a 25-month course of oral steroids seems to be effective for progressive IgAN.

  11. A randomized trial of upper limb botulimun toxin versus placebo injection, combined with physiotherapy, in children with hemiplegia.

    Science.gov (United States)

    Ferrari, Adriano; Maoret, Anna Rosa; Muzzini, Simonetta; Alboresi, Silvia; Lombardi, Francesco; Sgandurra, Giuseppina; Paolicelli, Paola Bruna; Sicola, Elisa; Cioni, Giovanni

    2014-10-01

    The main goal of this study was to investigate the efficacy of Botulinum Toxin A (BoNT-A), combined with an individualized intensive physiotherapy/orthoses treatment, in improving upper limb activity and competence in daily activity in children with hemiplegia, and to compare its effectiveness with that of non-pharmacological instruments. It was a Randomized Clinical Trial of 27 children with spastic hemiplegic cerebral palsy, outpatients of two high speciality Centres for child rehabilitation. Each child was assigned by simple randomization to experimental group (BoNT-A) or control group (placebo). Assisting Hand Assessment (AHA) was chosen as primary outcome measure; other measures were selected according to ICF dimensions. Participants were assessed at baseline (T0), at T1, T2, T3 (1-3-6 months after injection, respectively). Every patient was given a specific physiotherapeutic treatment, consisting of individualized goal directed exercises, task oriented activities, daily stretching manoeuvres, functional and/or static orthoses. BoNT-A group showed a significant increase of AHA raw scores at T2, compared to control group (T2-T0: p=.025) and functional goals achievement (GAS) was also slightly better in the same group (p=.033). Other measures indicated some improvement in both groups, without significant intergroup differences. Children with intermediate severity of hand function at House scale for upper limb impairment seem to have a better benefit from BoNT-A protocol. BoNT-A was effective in improving manipulation in the activity domain, in association with individualized goal-directed physiotherapy and orthoses; the combined treatment is recommended. The study brings more evidence for the efficacy of a combined treatment botulinum toxin injection-physiotherapy-orthoses, and it gives some suggestions for candidate selection and individualized treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2016-07-01

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

  13. Nifurtimox-eflornithine combination therapy for second-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Congo.

    Science.gov (United States)

    Priotto, Gerardo; Kasparian, Serena; Ngouama, Daniel; Ghorashian, Sara; Arnold, Ute; Ghabri, Salah; Karunakara, Unni

    2007-12-01

    Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second-stage disease. A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the nifurtimox-eflornithine arm. The nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies.

  14. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial.

    Science.gov (United States)

    Francois, Monique E; Durrer, Cody; Pistawka, Kevin J; Halperin, Frank A; Chang, Courtney; Little, Jonathan P

    2017-01-01

    Background: High-intensity interval training (HIIT) can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown. Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT) intervention improves cardiometabolic health in individuals with type 2 diabetes. Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo) consumed after exercise (3 days/week) during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max) and one session involved resistance-based exercises (at RPE of 5-6; CR-10 scale) in the same interval pattern. Continuous glucose monitoring (CGM), glycosylated hemoglobin (HbA1c), body composition (dual-energy X-ray absorptiometry), cardiorespiratory fitness ([Formula: see text]), blood pressure, and endothelial function (%FMD) were measured before and after the intervention. Results: There were significant main effects of time (all p 0.71) for CGM 24-h mean glucose (-0.5 ± 1.1 mmol/L), HbA1c (-0.2 ± 0.4%), percent body fat (-0.8 ± 1.6%), and lean mass (+1.1 ± 2.8 kg). Similarly, [Formula: see text] (+2.5 ± 1.6 mL/kg/min) and %FMD (+1.4 ± 1.9%) were increased, and mean arterial blood pressure reduced (-6 ± 7 mmHg), after 12 weeks of HIIT (all p 0.11). Conclusion: High-intensity interval training is a potent stimulus for improving several important metabolic and cardiovascular risk factors in type 2 diabetes. The benefits of

  15. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Monique E. Francois

    2017-07-01

    Full Text Available Background: High-intensity interval training (HIIT can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown.Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT intervention improves cardiometabolic health in individuals with type 2 diabetes.Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo consumed after exercise (3 days/week during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max and one session involved resistance-based exercises (at RPE of 5–6; CR-10 scale in the same interval pattern. Continuous glucose monitoring (CGM, glycosylated hemoglobin (HbA1c, body composition (dual-energy X-ray absorptiometry, cardiorespiratory fitness (V˙O2peak, blood pressure, and endothelial function (%FMD were measured before and after the intervention.Results: There were significant main effects of time (all p < 0.05 but no difference between groups (Interaction: all p > 0.71 for CGM 24-h mean glucose (−0.5 ± 1.1 mmol/L, HbA1c (−0.2 ± 0.4%, percent body fat (−0.8 ± 1.6%, and lean mass (+1.1 ± 2.8 kg. Similarly, V˙O2peak (+2.5 ± 1.6 mL/kg/min and %FMD (+1.4 ± 1.9% were increased, and mean arterial blood pressure reduced (−6 ± 7 mmHg, after 12 weeks of HIIT (all p < 0.01 with no difference between beverage groups (Interaction: all p > 0.11.Conclusion: High-intensity interval training is a

  16. Ozone Gas Bath Combined with Endovenous Laser Therapy for Lower Limb Venous Ulcers: A Randomized Clinical Trial.

    Science.gov (United States)

    Zhou, Yi-Ting; Zhao, Xu-Dong; Jiang, Jian-Wei; Li, Xin-Sheng; Wu, Zhen-Hai

    2016-10-01

    Endovenous laser therapy (EVLT) is safe and effective for lower limb venous ulcers. However, severe necrosis and infection in the ulcer area are contraindications of puncture and EVLT. Local bath with ozone gas has been shown to improve the condition of ulcer areas. The aim of this study was to evaluate the clinical efficacy of ozone gas bath combined with EVLT in comparison with EVLT alone for the treatment for lower limb venous ulcers. Ninety-two patients with venous ulcers were randomized to receive ozone gas bath combined with EVLT (OEVLT group) or EVLT alone (EVLT group). In the OEVLT group, the venous ulcers were preconditioned with ozone gas bath prior to EVLT. The minimum follow-up time was 12 months. The two groups were compared in terms of complete occlusion of the treated veins, ulcer healing ratio, ratio of ulcer recurrence, patient satisfaction, complications, and side effects. There was no significant difference in venous occlusion between the two groups. The ratio of ulcer healing in the OEVLT group was significantly higher than the EVLT group at 12 months follow-up. Patients in the OEVLT group showed better satisfaction and a lower recurrence ratio than the OEVLT group. No severe complications or side effects occurred in either groups. Ozone gas bath combined with EVLT showed improved efficacy for the treatment of lower limb venous ulcers and lower recurrence ratio comparison with EVLT alone. This procedure is a safe and technically feasible.

  17. Combined laser acupuncture and desmopressin for treating resistant cases of monosymptomatic nocturnal enuresis: a randomized comparative study.

    Science.gov (United States)

    Moursy, Essam Eldin S; Kamel, Naglaa F; Kaseem, Ahmed F

    2014-12-01

    Monosymptomatic nocturnal enuresis (MNE) is a common sociomedical problem affecting children that may persist until adulthood despite various lines of therapy. The aim of this study was to assess the efficacy of combined laser acupuncture and desmopressin in managing patients with resistant MNE, compared with their efficacy when used as monotherapy. The study included 186 patients with a mean age of 15.7 years (range 10-21 years) presenting with persistent MNE. All patients were evaluated clinically and investigated with urine analysis, plain X-ray of the urinary tract and abdominal ultrasonography. They were randomized into three equal groups based on the line of management: group A, managed with laser acupuncture alone; group B, managed with desmopressin alone; and group C, managed with a combination of laser acupuncture and desmopressin, with a treatment course of 3 months and follow-up period of 6 months to record the efficacy of therapy, side-effects and bladder capacity. A statistically significant higher cure rate was reported in group C patients, being reported in 33, 35 and 46 patients in groups A, B and C, respectively. Improvement was reported in 18, 17 and 13 cases in groups A, B and C, respectively, but the difference was not statistically significant. Bladder capacity significantly increased only in patients receiving acupuncture (groups A and C). Combined laser acupuncture and desmopressin is a promising and valid option to manage resistant cases of MNE.

  18. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure

    Directory of Open Access Journals (Sweden)

    Curt Hartleben

    2017-01-01

    Full Text Available Objective. To evaluate the efficacy and safety of triple fixed-combination bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% (TFC versus dual fixed-combination brimonidine 0.2%/timolol 0.5% (DFC in primary open-angle glaucoma and ocular hypertension. Methods. Patients with intraocular pressure (IOP ≥23 and ≤34 mmHg were randomized to twice-daily TFC or DFC. The primary variable is the change in worse eye mean IOP from baseline at week 12 (modified intent-to-treat (mITT population. Secondary endpoints are mean IOP and mean change from baseline at weeks 1, 2, 4, 8, and 12 (mITT population. TFC superiority was demonstrated if the primary variable favored TFC (p≤0.05. Sensitivity analyses were conducted, and safety was assessed at all visits. Results. TFC (n=93 provided greater IOP reductions from baseline than DFC (n=97 at week 12 (treatment difference, 0.85 mmHg; p=0.028 and all other visits. TFC was also superior to DFC in patients with high baseline IOP (i.e., IOP ≥ 25 mmHg; p≤0.011. Conjunctival hyperemia, ocular irritation, and dry eye were reported more often with TFC (p≤0.016; however, discontinuations for ocular adverse events were similar between treatments. Conclusions. TFC demonstrated IOP-lowering benefits that outweigh the risk of predominantly mild ocular side effects, which may be particularly relevant in patients who require greater IOP lowering to prevent/delay disease progression. This trial is registered with ClinicalTrials.gov registry number: NCT01241240.

  19. Randomized comparison of bleeding patterns in women using a combined contraceptive vaginal ring or a low-dose combined oral contraceptive on a menstrually signaled regimen.

    Science.gov (United States)

    Weisberg, Edith; Merki-Feld, Gabriele S; McGeechan, Kevin; Fraser, Ian S

    2015-02-01

    To compare bleeding patterns for 12 months continuous use of a contraceptive ring [contraceptive vaginal ring (CVR)] and pill [combined oral contraceptive (COC)] on a menstrually signaled regimen and the effectiveness of 4 days "treatment withdrawal" to stop bleeding. Women, 66 to each group, were randomized to continuous use of a CVR (15 mcg ethinyl estradiol/150 mcg etonogestrel) or a low-dose pill (20 mcg ethinyl estradiol/100 mcg levonorgestrel) for 360 days on a menstrually signaled regimen. Bleeding/spotting days, daily use of ring or pill, was recorded. Endpoint was the total number of bleeding/spotting days for each method over four 90-day reference periods (RP) plus the analysis of bleeding patterns using modified World Health Organization criteria. There was a reduction in the mean (±S.D.) number of bleeding/spotting days from RP1 (CVR 14.2±10; pill 16.6±10.9) to RP4 (CVR 8.8±9.6; pill 8.8±9.1). Fifteen percent of CVR and 4% COC users experienced amenorrhea or infrequent bleeding throughout the study. Amenorrhea increased over time (RP1 vs. RP4: CVR 10% vs. 21% and COC 2% vs. 30%). Compliance with the menstrually signaled regimen was poor. Ceasing hormones for 4 days stopped a bleeding episode within 5 days in the majority of episodes and many stopped spontaneously. Bleeding patterns with continuous use of the CVR and COC are similar and improve over 1 year of use. The unpredictability, but short duration, of bleeding episodes should be stressed during counseling. This information for clinicians and women about breakthrough bleeding patterns with use of a CVR or combined pill over 12 months using a menstrually signaled regimen will give women an indication of what to expect with continuous use. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD

    Directory of Open Access Journals (Sweden)

    Zhong N

    2015-06-01

    Full Text Available Nanshan Zhong,1 Changzheng Wang,2 Xiangdong Zhou,3 Nuofu Zhang,1 Michael Humphries,4 Linda Wang,4 Chau Thach,5 Francesco Patalano,6 Donald Banerji5On behalf of the LANTERN Investigators 1State Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 2Institute of Respiratory Disease, Xin Qiao Hospital, 3Department of Respiratory Medicine, Southwest Hospital, Third Military Medical University, Chongqing City, Chongqing, 4Beijing Novartis Pharma Co. Ltd., Shanghai, People’s Republic of China; 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 6Novartis Pharma AG, Basel, SwitzerlandBackground: The current Global initiative for chronic Obstructive Lung Disease (GOLD treatment strategy recommends the use of one or more bronchodilators according to the patient’s airflow limitation, their history of exacerbations, and symptoms. The LANTERN study evaluated the effect of the long-acting β2-agonist (LABA/long-acting muscarinic antagonist (LAMA dual bronchodilator, QVA149 (indacaterol/glycopyrronium, as compared with the LABA/inhaled corticosteroid, salmeterol/fluticasone (SFC, in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year.Methods: In this double-blind, double-dummy, parallel-group study, 744 patients with moderate-to-severe COPD with a history of ≤1 exacerbations in the previous year were randomized (1:1 to QVA149 110/50 µg once daily or SFC 50/500 µg twice daily for 26 weeks. The primary endpoint was noninferiority of QVA149 versus SFC for trough forced expiratory volume in 1 second (FEV1 at week 26.Results: Overall, 676 patients completed the study. The primary objective of noninferiority between QVA149 and SFC in trough FEV1 at week 26 was met. QVA149 demonstrated statistically significant superiority to SFC for trough FEV1 (treatment difference [∆]=75 mL; P<0.001. QVA149 demonstrated a statistically significant

  1. Quantitative assessment of similarity between randomly acquired characteristics on high quality exemplars and crime scene impressions via analysis of feature size and shape.

    Science.gov (United States)

    Richetelli, Nicole; Nobel, Madonna; Bodziak, William J; Speir, Jacqueline A

    2017-01-01

    Forensic footwear evidence can prove invaluable to the resolution of a criminal investigation. Naturally, the value of a comparison varies with the rarity of the evidence, which is a function of both manufactured as well as randomly acquired characteristics (RACs). When focused specifically on the latter of these two types of features, empirical evidence demonstrates high discriminating power for the differentiation of known match and known non-match samples when presented with exemplars of high quality and exhibiting a sufficient number of clear and complex RACs. However, given the dynamic and unpredictable nature of the media, substrate, and deposition process encountered during the commission of a crime, RACs on crime scene prints are expected to exhibit a large range of variability in terms of reproducibility, clarity, and quality. Although the pattern recognition skill of the expert examiner is adept at recognizing and evaluating this type of natural variation, there is little research to suggest that objective and numerical metrics can globally process this variation when presented with RACs from degraded crime scene quality prints. As such, the goal of this study was to mathematically compare the loss and similarity of RACs in high quality exemplars versus crime-scene-like quality impressions as a function of RAC shape, perimeter, area, and common source. Results indicate that the unpredictable conditions associated with crime scene print production promotes RAC loss that varies between 33% and 100% with an average of 85%, and that when the entire outsole is taken as a constellation of features (or a RAC map), 64% of the crime-scene-like impressions exhibited 10 or fewer RACs, resulting in a 0.72 probability of stochastic dominance. Given this, individual RAC description and correspondence were further explored using five simple, but objective, numerical metrics of similarity. Statistically significant differences in similarity scores for RAC shape and size

  2. Duloxetine-bupropion combination for treatment-resistant atypical depression: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Fornaro, Michele; Martino, Matteo; Mattei, Chiara; Prestia, Davide; Vinciguerra, Valentina; De Berardis, Domenico; De Pasquale, Concetta; Iasevoli, Felice; Mungo, Sergio; Fornaro, Pantaleo

    2014-08-01

    The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300 mg/day bupropion vs. placebo, which was added to 60 to 120 mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7%) patients receiving duloxetine+placebo vs. six (26.1%) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3%) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9%) [Exp(B)=0.353; p=0.028] non-responder cases in the "+placebo" and "+bupropion" groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  3. Flutamide versus a cyproterone acetate-ethinyl estradiol combination in moderate acne: a pilot randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2011-07-01

    Full Text Available Hassan Adalatkhah1, Farhad Pourfarzi2, Homayoun Sadeghi-Bazargani31Department of Dermatology, 2Department of Social Medicine, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil; 3Statistics and Epidemiology Department, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, IranBackground: The use of oral flutamide is rarely investigated in acne therapy. The aim of this study was to compare the efficacy of oral flutamide with that of a cyproterone-estradiol combination in treating acne lesions.Methods: A randomized clinical trial enrolled patients with moderate acne into two equal groups to receive either oral flutamide or the cyproterone-estradiol combination for 6 months. Lesion count, Acne Severity Index, and Global Acne Grading system (GAGS scores were used to assess improvement in acne lesions. The dichotomous measurement scale for primary endpoint assessment was defined as improvement from moderate to mild acne based on GAGS score. Patient satisfaction and dermal fat were also assessed. Intention to treat and per protocol analyses were done, reporting related effect sizes.Results: Both treatments resulted in substantial improvement in acne lesions. Although flutamide seemed to have higher efficacy, an intention to treat analysis did not find the two treatment protocols to be different. The relative risk in intention to treat analysis was 1.8 (95% confidence interval [CI] 0.89–1.6, and was 1.33 (95% CI 1.03–1.72 for the per protocol analysis. The number needed to treat for flutamide compared with the cyproterone-estradiol combination was 7.7 and 4.2 in the intention to treat and per protocol analyses, respectively.Conclusion: Flutamide appears to be more effective than a cyproterone-estradiol combination in some aspects of acne treatment, but this requires confirmation in a larger trial.Keywords: acne vulgaris, flutamide, cyproterone acetate, ethinyl estradiol, androgen antagonists

  4. Classification of Potential Water Bodies Using Landsat 8 OLI and a Combination of Two Boosted Random Forest Classifiers.

    Science.gov (United States)

    Ko, Byoung Chul; Kim, Hyeong Hun; Nam, Jae Yeal

    2015-06-11

    This study proposes a new water body classification method using top-of-atmosphere (TOA) reflectance and water indices (WIs) of the Landsat 8 Operational Land Imager (OLI) sensor and its corresponding random forest classifiers. In this study, multispectral images from the OLI sensor are represented as TOA reflectance and WI values because a classification result using two measures is better than raw spectral images. Two types of boosted random forest (BRF) classifiers are learned using TOA reflectance and WI values, respectively, instead of the heuristic threshold or unsupervised methods. The final probability is summed linearly using the probabilities of two different BRFs to classify image pixels to water class. This study first demonstrates that the Landsat 8 OLI sensor has higher classification rate because it provides improved signal-to-ratio radiometric by using 12-bit quantization of the data instead of 8-bit as available from other sensors. In addition, we prove that the performance of the proposed combination of two BRF classifiers shows robust water body classification results, regardless of topology, river properties, and background environment.

  5. Classification of Potential Water Bodies Using Landsat 8 OLI and a Combination of Two Boosted Random Forest Classifiers

    Directory of Open Access Journals (Sweden)

    Byoung Chul Ko

    2015-06-01

    Full Text Available This study proposes a new water body classification method using top-of-atmosphere (TOA reflectance and water indices (WIs of the Landsat 8 Operational Land Imager (OLI sensor and its corresponding random forest classifiers. In this study, multispectral images from the OLI sensor are represented as TOA reflectance and WI values because a classification result using two measures is better than raw spectral images. Two types of boosted random forest (BRF classifiers are learned using TOA reflectance and WI values, respectively, instead of the heuristic threshold or unsupervised methods. The final probability is summed linearly using the probabilities of two different BRFs to classify image pixels to water class. This study first demonstrates that the Landsat 8 OLI sensor has higher classification rate because it provides improved signal-to-ratio radiometric by using 12-bit quantization of the data instead of 8-bit as available from other sensors. In addition, we prove that the performance of the proposed combination of two BRF classifiers shows robust water body classification results, regardless of topology, river properties, and background environment.

  6. Combination of music with lifestyle modification versus lifestyle modification alone on blood pressure reduction - A randomized controlled trial.

    Science.gov (United States)

    Kunikullaya, Kirthana Ubrangala; Goturu, Jaisri; Muradi, Vijayadas; Hukkeri, Preethi Avinash; Kunnavil, Radhika; Doreswamy, Venkatesh; Prakash, Vadagenahalli S; Murthy, Nandagudi Srinivasa

    2016-05-01

    To evaluate the change in blood pressure (BP) after 3 months of music intervention combined with lifestyle modifications, in comparison with conventional lifestyle modifications. A Prospective randomized control trial was conducted on hundred prehypertensives or stage I hypertensives who were randomly divided into two groups (n = 50 each). Both the groups were given lifestyle modifications while one had added music intervention (raga bhimpalas) for 3 months. Main outcome measures were 24 h ambulatory BP monitoring, stress levels, and biomarkers of hypertension. Mean (SD) of diastolic BP (DBP) pre and post intervention were overall = 85.1(6.8) and 83(8.7){P = 0.004}, awake = 87.7(7.6) and 85.9(9.2){P = 0.021}. Regression analysis showed association between diastolic BP change and post-intervention stress score in the music intervention group. Significant change in BP was seen among those who were prehypertensives prior to intervention. Music decreased DBP and when used as an adjunct benefitted subjects with initial BP in prehypertension range. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Effect of combining multiple micronutrients with iron supplementation on Hb response in children: systematic review of randomized controlled trials.

    Science.gov (United States)

    Gera, Tarun; Sachdev, Harsh Pal Singh; Nestel, Penelope

    2009-06-01

    To study the effect of combining multiple (two or more) micronutrients with Fe supplementation on Hb response, when compared with placebo and with Fe supplementation, in children. Electronic databases, personal files, hand search of reviews, bibliographies of books, and abstracts and proceedings of international conferences. Randomized controlled trials evaluating change in Hb levels with interventions that included Fe and multiple-micronutrient supplementation in comparison to placebo alone or Fe alone were analysed in two systematic reviews. Twenty-five trials were included in the review comparing Fe and micronutrient supplementation with placebo. The pooled estimate (random effects model) for change in Hb with Fe and micronutrient supplementation (weighted mean difference) was 0.65 g/dl (95 % CI 0.50, 0.80, P micronutrients' and malarial non-hyperendemic region were significant predictors of greater Hb response and heterogeneity. Thirteen trials were included in the review comparing Fe and micronutrient supplementation with Fe alone. The pooled estimate for change in Hb with Fe and micronutrient supplementation (weighted mean difference) was 0.14 g/dl (95 % CI 0.00, 0.28, P = 0.04). None of the variables were found to be significant predictors of Hb response. Synthesized evidence indicates that addition of multiple micronutrients to Fe supplementation may only marginally improve Hb response compared with Fe supplementation alone. However, addition of 'other micronutrients' may have a negative effect. Routine addition of unselected multiple micronutrients to Fe therefore appears unjustified for nutritional anaemia control programmes.

  8. Progressive muscle relaxation combined with Chinese medicine five-element music on depression for cancer patients: A randomized controlled trial.

    Science.gov (United States)

    Liao, Juan; Wu, Yu; Zhao, Yang; Zhao, Yuan-Chen; Zhang, Xu; Zhao, Nan; Lee, Chun-Ging; Yang, Yu-Fei

    2017-05-11

    To evaluate the effects of progressive muscle relaxation training (PMRT) combined with fifive elements music therapy of Chinese medicine (CM) for improving anxiety and depression of cancer patients. From June 2015 to March 2016, 60 cancer patients were included into the study. The patients were randomly assigned to a control group and a treatment group by envelope randomization, receiving PMRT and PMRT plus CM five elements music therapy, respectively, for 8 weeks. Hospital Anxiety and Depression Scale (HADS), Benefit Finding Scales (BFS), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), and Intervention Expectations Questionnaire (IEQU) were adopted to assess the depression of the two groups before and after the treatment. Four cases dropped out during the study, and 29 cases in the treatment group and 27 in the control group were included in the fifinal analysis. Prior to the treatments, the baselines of the 4 questionnaires in the two groups showed no difference. After the 8-week treatment, the treatment group presented better levels of HADS, BFS and FACIT-Sp scores compared with the control group (Pmusic therapy mitigated anxiety and depression of cancer patients. Cancer patients have been found to respond well to psychological intervention in areas regarding stabilisation of emotions, disease awareness, and therapeutic compliance. This brings about a great difference in improving their quality of life and psychological state, offers an effective approach to better self-management in cancer treatment.

  9. Treatment of panic disorder with agoraphobia: randomized placebo-controlled trial of four psychosocial treatments combined with imipramine or placebo.

    Science.gov (United States)

    Marchand, Andre; Coutu, Marie-France; Dupuis, Gilles; Fleet, Richard; Borgeat, Francois; Todorov, Christo; Mainguy, Nicole

    2008-01-01

    Few randomized controlled trials have included panic disorder patients with moderate to severe agoraphobia. Therefore, this population was studied using pharmacotherapy as well as psychotherapy. At the time of the study, imipramine was widely used as a pharmacological treatment. Also, current practice guidelines for patients with panic disorder find selective serotonin reuptake inhibitors and tricyclic antidepressants roughly comparable in terms of efficacy. Therefore, the main objective of this study is to compare four psychosocial treatments-cognitive and graded in vivo exposure treatments, graded in vivo exposure, cognitive treatment, and supportive therapy-to evaluate the benefits of combining cognitive therapy with exposure in vivo. These treatments were combined with imipramine or placebo for a total of eight experimental conditions. Participants presented moderate to severe agoraphobia. The method involved a randomized, double-blind, placebo-controlled trial with 137 participants who completed a 14-session protocol involving the treatments just mentioned. Measures were taken at baseline and posttreatment and at 3-, 6-, and 12-month follow-up. All treatment conditions were statistically and clinically effective in reducing self-reported panic-agoraphobia symptoms over the 1-year follow-up. No statistical differences were observed between imipramine and placebo conditions. This study found that all treatment modalities helped reduce panic and agoraphobic symptomatology over a 1-year follow-up period. These surprising results support the need to document the relations among the various components of an intervention. This would make it possible to assess the relative efficacy of the treatment components rather than of the intervention as a whole.

  10. Treatment of Symptomatic Geographic Tongue with Triamcinolone Acetonide Alone and in Combination with Retinoic Acid: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shamsolmoulouk Najafi

    2016-08-01

    Full Text Available Objectives: Geographic tongue or migratory glossitis is an inflammatory disorder with unknown etiology. Considering the accompanied burning pain, taste dysfunction, and lack of definite cure, it is important to treat this condition symptomatically. The objective of the current study was to compare the efficacy of a combination of 0.05% retinoic acid and 0.1% triamcinolone acetonide with that of triamcinolone acetonide alone for treatment of symptomatic geographic tongue.Materials and Methods: This randomized controlled double-blind clinical trial was performed on 28 patients with symptomatic geographic tongue, who were referred to two dental clinics. Participants were randomly divided into two groups and treated with triamcinolone alone or retinoic acid plus triamcinolone for 10 days. Patients were assessed for the level of pain, burning sensation and size of lesion at the beginning and at the end of the study. Participants were followed up for two months after cessation of treatment (at the end of each month. SPSS 11 was applied to compare the two therapeutic modalities.Results: Twenty-eight participants with a mean age of 40 years were evaluated including Seven (25% males and 21(75% females. There was a positive family history of geographic tongue in 21 patients. Despite the diminished pain and burning sensation as well as smaller size of lesions following treatment (P<0.05, no statistically significant differences were found between the two groups (P> 0.05. No side effect was reported. Conclusion: The combination of triamcinolone and retinoic acid was not more effective than triamcinolone alone for symptomatic treatment of geographic tongue.

  11. Polaprezinc combined with clarithromycin-based triple therapy for Helicobacter pylori-associated gastritis: A prospective, multicenter, randomized clinical trial.

    Science.gov (United States)

    Tan, Bei; Luo, Han-Qing; Xu, Hong; Lv, Nong-Hua; Shi, Rui-Hua; Luo, He-Sheng; Li, Jian-Sheng; Ren, Jian-Lin; Zou, Yi-You; Li, Yan-Qing; Ji, Feng; Fang, Jing-Yuan; Qian, Jia-Ming

    2017-01-01

    The efficacy and safety of polaprezinc combined with triple therapy was compared with triple therapy alone in the eradication of Helicobacter pylori. A randomized, parallel-group, open-label, controlled, prospective multicenter study was conducted in 11 cities in China. Treatment-naive patients with H. pylori-associated gastritis were randomly assigned to one of three arms for a 14-day treatment: Arm A triple therapy (omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily) plus polaprezinc 75 mg twice daily; Arm B triple therapy plus polaprezinc 150 mg twice daily, or Arm C triple therapy alone. The rate of H. pylori eradication was the primary endpoint. Secondary endpoints were symptom improvement and lower incidence of adverse events. 303 patients completed the study- 106, 96, and 101 patients in Arms A, B, and C, respectively. Intention-to-treat (ITT) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (77.0%) and B (75.9%) compared to Arm C (58.6%) (P P = 0.90). Per-protocol (PP) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (81.1%) and B (83.3%) compared to Arm C (61.4%) (P P = 0.62). All three groups reported significant symptom improvement at 7, 14, and 28 days after treatment, compared to baseline (P P = 0.04) and C (1.9%) (P = 0.02). There were no serious adverse events in any group. It appears that standard dose polaprezinc combined with triple therapy can significantly improve the H. pylori eradication rate, without an increase in toxicity.

  12. Combination Therapy Is Superior to Sequential Monotherapy for the Initial Treatment of Hypertension: A Double-Blind Randomized Controlled Trial.

    Science.gov (United States)

    MacDonald, Thomas M; Williams, Bryan; Webb, David J; Morant, Steve; Caulfield, Mark; Cruickshank, J Kennedy; Ford, Ian; Sever, Peter; Mackenzie, Isla S; Padmanabhan, Sandosh; McCann, Gerald P; Salsbury, Jackie; McInnes, Gordon; Brown, Morris J

    2017-11-18

    Guidelines for hypertension vary in their preference for initial combination therapy or initial monotherapy, stratified by patient profile; therefore, we compared the efficacy and tolerability of these approaches. We performed a 1-year, double-blind, randomized controlled trial in 605 untreated patients aged 18 to 79 years with systolic blood pressure (BP) ≥150 mm Hg or diastolic BP ≥95 mm Hg. In phase 1 (weeks 0-16), patients were randomly assigned to initial monotherapy (losartan 50-100 mg or hydrochlorothiazide 12.5-25 mg crossing over at 8 weeks), or initial combination (losartan 50-100 mg plus hydrochlorothiazide 12.5-25 mg). In phase 2 (weeks 17-32), all patients received losartan 100 mg and hydrochlorothiazide 12.5 to 25 mg. In phase 3 (weeks 33-52), amlodipine with or without doxazosin could be added to achieve target BP. Hierarchical primary outcomes were the difference from baseline in home systolic BP, averaged over phases 1 and 2 and, if significant, at 32 weeks. Secondary outcomes included adverse events, and difference in home systolic BP responses between tertiles of plasma renin. Home systolic BP after initial monotherapy fell 4.9 mm Hg (range: 3.7-6.0 mm Hg) less over 32 weeks (P150/95 mm Hg. URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00994617. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  13. Using a Combination of FEM and Perturbation Method in Frequency Split Calculation of a Nearly Axisymmetric Shell with Middle Surface Shape Defect

    Directory of Open Access Journals (Sweden)

    D. S. Vakhlyarskiy

    2016-01-01

    Full Text Available This paper proposes a method to calculate the splitting of natural frequency of the shell of hemispherical resonator gyro. (HRG. The paper considers splitting that arises from the small defect of the middle surface, which makes the resonator different from the rotary shell. The presented method is a combination of the perturbation method and the finite element method. The method allows us to find the frequency splitting caused by defects in shape, arbitrary distributed in the circumferential direction. This is achieved by calculating the perturbations of multiple natural frequencies of the second and higher orders. The proposed method allows us to calculate the splitting of multiple frequencies for the shell with the meridian of arbitrary shape.A developed finite element is an annular element of the shell and has two nodes. Projections of movements are used on the axis of the global cylindrical system of coordinates, as the unknown. To approximate the movements are used polynomials of the second degree. Within the finite element the geometric characteristics are arranged in a series according to the small parameter of perturbations of the middle surface geometry.Movements on the final element are arranged in series according to the small parameter, and in a series according to circumferential angle. With computer used to implement the method, three-dimensional arrays are used to store the perturbed quantities. This allows the use of regular expressions for the mass and stiffness matrices, when building the finite element, instead of analytic dependencies for each perturbation of these matrices of the required order with desirable mathematical operations redefined in accordance with the perturbation method.As a test task, is calculated frequency splitting of non-circular cylindrical resonator with Navier boundary conditions. The discrepancy between the results and semi-analytic solution to this problem is less than 1%. For a cylindrical shell is

  14. Oral Tranexamic Acid with Fluocinolone-Based Triple Combination Cream Versus Fluocinolone-Based Triple Combination Cream Alone in Melasma: An Open Labeled Randomized Comparative Trial

    National Research Council Canada - National Science Library

    Padhi, Tanmay; Pradhan, Swetalina

    2015-01-01

    .... To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients...

  15. Combination of taping with Back School in patients with chronic low back pain: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Andres Tana

    2016-11-01

    Full Text Available Introduction: 70-85% of the general population suffers from back pain. Back School programs have being effective in the treatment of chronic low back pain. Taping may be useful in reducing pain and normalizing muscle function. The objective of this study was to evaluate the effectiveness of the combination of taping with Back School at short- and long-term. Methods: Randomized controlled clinical trial. The experimental group used tape and made Back Scholl and the control group only made Back School. At the beginning and the end of treatment, pain was evaluated with a visual analogue scale, the flexibility determined with the Modified Finger Tip-to-Floor Test and functionality was calculated with the Roland Morris Disability Questionnaire. Depression was recorded with the Depression Beck Inventory just at the beginning. Results: 220 patients were enrolled, only 42 in the experimental group and 33 in the control group completed the treatment. The variation of pain between the first and the fifth session showed no differences between groups regardless of time (p = 0.329. There were no differences between groups in functionality (p = 0.75, flexibility (p = 0.20 and depression. Conclusion: The combination of taping and Back School compared with only Back School was not more effective in reducing pain, increasing functionality and flexibility in patients with chronic low back pain. Key words: Taping; chronic low back pain; spine school; therapy exercises; flexibility; depression.

  16. Premedication with oral alprazolam and melatonin combination: a comparison with either alone--a randomized controlled factorial trial.

    Science.gov (United States)

    Pokharel, Krishna; Tripathi, Mukesh; Gupta, Pramod Kumar; Bhattarai, Balkrishna; Khatiwada, Sindhu; Subedi, Asish

    2014-01-01

    We assessed if the addition of melatonin to alprazolam has superior premedication effects compared to either drug alone. A prospective, double blind placebo controlled trial randomly assigned 80 adult patients (ASA 1&2) with a Visual Analogue Score (VAS) for anxiety ≥ 3 to receive a tablet containing a combination of alprazolam 0.5 mg and melatonin 3 mg, alprazolam 0.5 mg, melatonin 3 mg, or placebo orally 90 min before a standard anesthetic. Primary end points were change in anxiety and sedation score at 15, 30, and 60 min after premedication, and number of patients with loss of memory for the five pictures shown at various time points when assessed after 24 h. One-way ANOVA, Friedman repeated measures analysis of variance, Kruskal Wallis and chi square tests were used as relevant. Combination drug produced the maximum reduction in anxiety VAS (3 (1.0-4.3)) from baseline at 60 min (P alprazolam alone. Addition of melatonin to alprazolam had superior anxiolysis compared with either drugs alone or placebo. Adding melatonin neither worsened sedation score nor the amnesic effect of alprazolam alone. This study was registered, approved, and released from ClinicalTrials.gov. Identifier number: NCT01486615.

  17. Premedication with Oral Alprazolam and Melatonin Combination: A Comparison with Either Alone—A Randomized Controlled Factorial Trial

    Science.gov (United States)

    Pokharel, Krishna; Tripathi, Mukesh; Gupta, Pramod Kumar; Khatiwada, Sindhu; Subedi, Asish

    2014-01-01

    We assessed if the addition of melatonin to alprazolam has superior premedication effects compared to either drug alone. A prospective, double blind placebo controlled trial randomly assigned 80 adult patients (ASA 1&2) with a Visual Analogue Score (VAS) for anxiety ≥3 to receive a tablet containing a combination of alprazolam 0.5 mg and melatonin 3 mg, alprazolam 0.5 mg, melatonin 3 mg, or placebo orally 90 min before a standard anesthetic. Primary end points were change in anxiety and sedation score at 15, 30, and 60 min after premedication, and number of patients with loss of memory for the five pictures shown at various time points when assessed after 24 h. One-way ANOVA, Friedman repeated measures analysis of variance, Kruskal Wallis and chi square tests were used as relevant. Combination drug produced the maximum reduction in anxiety VAS (3 (1.0–4.3)) from baseline at 60 min (P alprazolam alone. Addition of melatonin to alprazolam had superior anxiolysis compared with either drugs alone or placebo. Adding melatonin neither worsened sedation score nor the amnesic effect of alprazolam alone. This study was registered, approved, and released from ClinicalTrials.gov. Identifier number: NCT01486615. PMID:24527443

  18. Cryotherapy versus imiquimod 5% cream combined with a keratolytic lotion in cutaneous warts in children: A randomized study.

    Science.gov (United States)

    Stefanaki, Christina; Lagogiani, Irini; Kouris, Anargyros; Kontochristopoulos, George; Antoniou, Christina; Katsarou, Alexandra

    2016-01-01

    Although cutaneous warts are extremely common in children effective treatment does not exist. We combined imiquimod with a salicylic acid solution 15% (SA) on areas, with thick keratin, like palms and soles to increase its penetration through the epithelium. Patients were randomly divided into two groups. The first group was subjected to cryotherapy with liquid nitrogen every two weeks for a maximum of 3 months. The second group was subjected to treatment with imiquimod 5% daily for 6-10 h onto the warts for five consecutive days per week for a maximum of 3 months. Eighty-six children were included, 35 girls and 51 boys, 49 in the cryotherapy group and 37 in the imiquimod and SA group. At the end of the third month no statistically significant difference could be noted between the imiquimod 5% and salicylic acid and cryotherapy groups (p = 0.154). Thirty (81.1%) children treated with imiquimod 5% and salicylic acid were free from their warts in comparison to 33 (67.3%) children treated with cryotherapy. Imiquimod 5% cream as a monotherapy or in combination with SA can be used safely in children with warts and is equally effective and more effective than cryotherapy in plantar warts. Our study is not placebo controlled and spontaneous resolution cannot be ruled out.

  19. Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

    Science.gov (United States)

    Arentz, Susan; Smith, Caroline A; Abbott, Jason; Fahey, Paul; Cheema, Birinder S; Bensoussan, Alan

    2017-09-01

    Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

  20. Computer-Aided Lung Nodule Recognition by SVM Classifier Based on Combination of Random Undersampling and SMOTE

    Directory of Open Access Journals (Sweden)

    Yuan Sui

    2015-01-01

    Full Text Available In lung cancer computer-aided detection/diagnosis (CAD systems, classification of regions of interest (ROI is often used to detect/diagnose lung nodule accurately. However, problems of unbalanced datasets often have detrimental effects on the performance of classification. In this paper, both minority and majority classes are resampled to increase the generalization ability. We propose a novel SVM classifier combined with random undersampling (RU and SMOTE for lung nodule recognition. The combinations of the two resampling methods not only achieve a balanced training samples but also remove noise and duplicate information in the training sample and retain useful information to improve the effective data utilization, hence improving performance of SVM algorithm for pulmonary nodules classification under the unbalanced data. Eight features including 2D and 3D features are extracted for training and classification. Experimental results show that for different sizes of training datasets our RU-SMOTE-SVM classifier gets the highest classification accuracy among the four kinds of classifiers, and the average classification accuracy is more than 92.94%.

  1. Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial.

    Science.gov (United States)

    van Dam, Debora; Ehring, Thomas; Vedel, Ellen; Emmelkamp, Paul M G

    2013-06-19

    This randomized controlled trial (RCT) investigated the effectiveness of a combined treatment for co-morbid Posttraumatic Stress Disorder (PTSD) and severe Substance Use Disorder (SUD). Structured Writing Therapy for PTSD (SWT), an evidence-based traumafocused intervention, was added on to Treatment As Usual (TAU), consisting of an intensive cognitive behavioral inpatient or day group treatment for SUD. The outcomes of the combined treatment (TAU + SWT) were compared to TAU alone in a sample of 34 patients. Results showed a general reduction of SUD symptoms for both TAU + SWT and TAU. Treatment superiority of TAU + SWT was neither confirmed by interaction effects (time x condition) for SUD or PTSD symptoms, nor by a group difference for SUD diagnostic status at post-treatment. However, planned contrasts revealed that improvements for PTSD severity over time were only significant within the TAU + SWT group. In addition, within the TAU + SWT group the remission of PTSD diagnoses after treatment was significant, which was not the case for TAU. Finally, at post-treatment a trend was noticed for between group differences for the number of PTSD diagnoses favoring TAU + SWT above TAU. In sum, the current study provides preliminary evidence that adding a trauma-focused treatment on to standard SUD treatment may be beneficial.

  2. Reconstruction of the 3-D Shape and Crystal Preferred Orientation of Olivine: A Combined X-ray µ-CT and EBSD-SEM approach

    Science.gov (United States)

    Kahl, Wolf-Achim; Hidas, Károly; Dilissen, Nicole; Garrido, Carlos J.; López-Sánchez Vizcaíno, Vicente; Jesús Román-Alpiste, Manuel

    2017-04-01

    The complete reconstruction of the microstructure of rocks requires, among others, a full description of the shape preferred orientation (SPO) and crystal preferred orientation (CPO) of the constituent mineral phases. New advances in instrumental analyses, particularly electron backscatter diffraction (EBSD) coupled to focused ion beam-scanning electron microscope (FIB-SEM), allows a complete characterization of SPO and CPO in rocks at the micron scale [1-2]. Unfortunately, the large grain size of many crystalline rocks, such as peridotite, prevents a representative characterization of the CPO and SPO of their constituent minerals by this technique. Here, we present a new approach combining X-ray micro computed tomography (µ-CT) and EBSD to reconstruct the geographically oriented, 3-D SPO and CPO of cm- to mm-sized olivine crystals in two contrasting fabric types of chlorite harzburgites (Almírez ultramafic massif, SE Spain). The semi-destructive sample treatment involves drilling of geographically oriented micro drills in the field and preparation of oriented thin sections from µ-CT scanned cores. This allows for establishing the link among geological structures, macrostructure, fabric, and 3-D SPO-CPO at the thin section scale. Based on EBSD analyses, different CPO groups of olivine crystals can be discriminated in the thin sections and allocated to 3-D SPO in the µ-CT volume data. This approach overcomes the limitations of both methods (i.e., no crystal orientation data in µ-CT and no spatial information in EBSD), hence 3-D orientation of the crystallographic axes of olivines from different orientation groups could be correlated with the crystal shapes of olivine grains. This combined µ-CT and EBSD technique enables the correlation of both SPO and CPO and representative grain size, and is capable to characterize the 3-D microstructure of olivine-bearing rocks at the hand specimen scale. REFERENCES 1. Zaefferer, S., Wright, S.I., Raabe, D., 2008. Three

  3. Exercise training combined with electromyostimulation in the rehabilitation of patients with chronic heart failure: A randomized trial.

    Science.gov (United States)

    Soska, Vladimir; Dobsak, Petr; Pohanka, Michal; Spinarova, Lenka; Vitovec, Jiri; Krejci, Jan; Hude, Petr; Homolka, Pavel; Novakova, Marie; Eicher, Jean-Christophe; Wolf, Jean-Eric; Dusek, Ladislav; Siegelova, Jarmila

    2014-01-01

    Both aerobic training (AT) and electromyostimulation (EMS) of leg muscles improve exercise tolerance in patients suffering from chronic heart failure (CHF). It was speculated that combination of both methods might have an additive effect. This study was performed to evaluate the effects of a combination of AT and EMS in rehabilitation (RHB) of CHF patients. Patients (n=71; age 59 ± 10.2 yrs, NYHA II/III, EF 32 ± 7.1%) were randomized into 3 groups: a) group AT, b) group EMS, and c) group AT+EMS. AT protocol included standard activity on bicycle 3x a week at the level of individual anaerobic threshold. EMS (10 Hz, mode 20s "on"/20s "off") was applied to leg extensors for 2 h/day. Total time of given type of RHB was 12 weeks. Data analysis revealed statistically significant improvements of patients in all experimental groups (averaged difference after 12 weeks of exercise as related to initial value: ∆VO2peak: +12.9%, ∆VO2AT: +9.3%, ∆Wpeak: +22.7%). No statistically significant difference among experimental groups was found. Quality of life (Minnesota Living with Heart Failure - MLHF) global score was significantly improved in all 3 groups: AT (∆MLHF: -27.9%; P=0.001), AT+EMS (∆MLHF: -29.1%; P=0.002), and EMS (∆MLHF: -16.6%; P=0.008). MLHF score in EMS group showed the smallest time-related improvement compared to AT and AT+EMS groups, and this difference in improvement between the groups was statistically significant (P=0.021). No significant difference was found between the two types of exercise training.and nor did, their combination have any significant additional improvement.

  4. A randomized, crossover study to evaluate the pharmacokinetics of amantadine and oseltamivir administered alone and in combination.

    Directory of Open Access Journals (Sweden)

    Dennis Morrison

    2007-12-01

    Full Text Available The threat of potential pandemic influenza requires a reevaluation of licensed therapies for the prophylaxis or treatment of avian H5N1 infection that may adapt to man. Among the therapies considered for use in pandemic influenza is the co-administration of ion channel and neuraminidase inhibitors, both to potentially increase efficacy as well as to decrease the emergence of resistant isolates. To better understand the potential for drug interactions, a cross-over, randomized, open-label trial was conducted with amantadine, 100 mg po bid, and oseltamivir, 75 mg po bid, given alone or in combination for 5 days. Each subject (N = 17 served as their own control and was administered each drug alone or in combination, with appropriate wash-out. Co-administration with oseltamivir had no clinically significant effect on the pharmacokinetics (PK of amantadine [mean ratios (90% CI for AUC(0-12 0.93 (0.89, 0.98 and C(max 0.96 (0.90, 1.02]. Similarly, amantadine co-administration did not affect oseltamivir PK [AUC(0-12 0.92 (0.86, 0.99 and C(max 0.85 (0.73, 0.99] or the PK of the metabolite, oseltamivir carboxylate [AUC(0-12 0.98 (0.95, 1.02 and C(max 0.95 (0.89, 1.01]. In this small trial there was no evidence of an increase in adverse events. Although many more subjects would need to be studied to rule out a synergistic increase in adverse events, the combination in this small human drug-drug interaction trial appears safe and without pharmacokinetic consequences.ClinicalTrials.gov NCT00416962.

  5. Premedication with Oral Alprazolam and Melatonin Combination: A Comparison with Either Alone—A Randomized Controlled Factorial Trial

    Directory of Open Access Journals (Sweden)

    Krishna Pokharel

    2014-01-01

    Full Text Available We assessed if the addition of melatonin to alprazolam has superior premedication effects compared to either drug alone. A prospective, double blind placebo controlled trial randomly assigned 80 adult patients (ASA 1&2 with a Visual Analogue Score (VAS for anxiety ≥3 to receive a tablet containing a combination of alprazolam 0.5 mg and melatonin 3 mg, alprazolam 0.5 mg, melatonin 3 mg, or placebo orally 90 min before a standard anesthetic. Primary end points were change in anxiety and sedation score at 15, 30, and 60 min after premedication, and number of patients with loss of memory for the five pictures shown at various time points when assessed after 24 h. One-way ANOVA, Friedman repeated measures analysis of variance, Kruskal Wallis and chi square tests were used as relevant. Combination drug produced the maximum reduction in anxiety VAS (3 (1.0–4.3 from baseline at 60 min (P<0.05. Sedation scores at various time points and number of patients not recognizing the picture shown at 60 min after premedication were comparable between combination drug and alprazolam alone. Addition of melatonin to alprazolam had superior anxiolysis compared with either drugs alone or placebo. Adding melatonin neither worsened sedation score nor the amnesic effect of alprazolam alone. This study was registered, approved, and released from ClinicalTrials.gov. Identifier number: NCT01486615.

  6. Comparison of two combinations of opioid and non-opioid analgesics for acute periradicular abscess: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Manuela Favarin Santini

    Full Text Available Abstract Acute periradicular abscess is a condition characterized by the formation and propagation of pus in the periapical tissues and generally associated with debilitating pain. Objective: The aim of this study was to compare the overall analgesic effectiveness of two combinations of opioid and non-opioid analgesics for acute periradicular abscess. Material and Methods: This study included 26 patients who sought emergency care in a Brazilian dental school. The patients were randomly divided into two groups: Co/Ac - oral prescription of codeine (30 mg plus acetaminophen (500 mg, every 4 h, for 3 days or Tr/Ac - oral prescription of tramadol hydrochloride (37.5 mg plus acetaminophen (500 mg on the same schedule. Two factors were evaluated: (1 pain scores recorded by the patients in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale; and (2 the occurrence of adverse effects. Results: In both groups, there was a reduction in pain scores over time. For the Co/Ac group, there was a significant reduction in the scores 12, 24, 48, and 72 hours after treatment (P0.05, i.e., both treatments were effective in controlling pain caused by APA; however, the combination of Tr/Ac caused more adverse reactions as two patients had to stop using the medication. Conclusion: This study suggests that, considering both analgesic efficacy and safety, the combination of codeine and acetaminophen is more effective to control moderate to severe pain from acute periradicular abscesses.

  7. Effects of interferential therapy parameter combinations upon experimentally induced pain in pain-free participants: a randomized controlled trial.

    Science.gov (United States)

    Dounavi, Myrto D; Chesterton, Linda S; Sim, Julius

    2012-07-01

    Little evidence exists regarding parameter selection for hypoalgesia using interferential therapy (IFT). This study investigated segmental and extrasegmental hypoalgesic effects of different IFT parameter combinations upon experimentally induced pressure pain threshold (PPT) in pain-free volunteers. The participants were randomly assigned to 6 groups: control, placebo, bipolar constant amplitude modulation frequency (AMF), bipolar sweep AMF, quadripolar constant AMF, and quadripolar sweep AMF. The study was conducted in a university laboratory. One hundred eighty adults who were healthy and pain-free participated in the study. Interferential therapy was delivered to all groups at high, to-tolerance intensity and at high AMF. Stimulation to the dominant forearm was delivered for 30 minutes, with monitoring for a further 30 minutes. Pain pressure threshold was measured at the area of first dorsal interosseous muscle of the dominant and nondominant hands (segmental measurements) and over the tibialis anterior muscle (extrasegmental measurement) at baseline and at 10-minute intervals using a pressure algometer. Square root transformed PPT data were analyzed using repeated-measures analysis of variance. There was a significant change in PPT over time, but no significant between-subjects difference in segmental or extrasegmental PPT between any of the IFT groups and the placebo or control group. Thus, IFT delivered in any of these parameter combinations did not significantly affect the PPT of pain-free participants compared with the control or placebo group. Success of blinding was not evaluated. This study showed that IFT delivered at high, to-tolerance intensity and high AMF does not produce significant segmental and extrasegmental hypoalgesic effects on PPT in participants who were healthy compared with a control or placebo group. Further research is warranted to investigate the hypoalgesic effect of different IFT parameter combinations and to explain its possible

  8. Infliximab Versus Conventional Combination Treatment and Seven-Year Work Loss in Early Rheumatoid Arthritis: Results of a Randomized Swedish Trial.

    Science.gov (United States)

    Eriksson, Jonas K; Wallman, Johan K; Miller, Heather; Petersson, Ingemar F; Ernestam, Sofia; Vivar, Nancy; van Vollenhoven, Ronald F; Neovius, Martin

    2016-12-01

    To compare long-term work loss in methotrexate-refractory early rheumatoid arthritis (RA) patients randomized to the addition of infliximab or conventional combination treatment. This study was a multicenter, 2-arm, parallel, randomized, active-controlled, open-label trial. RA patients with infliximab or conventional combination treatment with sulfasalazine plus hydroxychloroquine. Yearly sick leave and disability pension days >7 years after randomization were retrieved from nationwide registers kept by the Swedish Social Insurance Agency. Of 210 working-age patients, 109 were randomized to infliximab (mean age 48.4 years, 73% women) and 101 to conventional treatment (mean age 48.7 years, 77% women). The year before randomization, the mean number of annual work days lost was 127 in the infliximab arm and 118 in the conventional treatment group (mean difference 9 [95% confidence interval (95% CI) -23, 39]). Compared to the year before randomization, the mean changes at 7 years were -25 days in the infliximab and -26 days in the conventional treatment group (adjusted mean difference 10 [95% CI -25, 46]). The cumulative mean for work-loss days was 846 in the infliximab group and 701 in the conventional treatment group (adjusted mean difference 104 [95% CI -56, 284]). Long-term work loss improved significantly in early RA patients randomized to infliximab plus methotrexate or conventional combination therapy. No difference was detected between strategies, and the level of work-loss days remained twice that observed in the general population. © 2016, American College of Rheumatology.

  9. Randomized controlled trial assessing the efficacy of a reusable fish-shaped iron ingot to increase hemoglobin concentration in anemic, rural Cambodian women.

    Science.gov (United States)

    Rappaport, Aviva I; Whitfield, Kyly C; Chapman, Gwen E; Yada, Rickey Y; Kheang, Khin Meng; Louise, Jennie; Summerlee, Alastair J; Armstrong, Gavin R; Green, Timothy J

    2017-08-01

    Background: Anemia affects 45% of women of childbearing age in Cambodia. Iron supplementation is recommended in populations in which anemia prevalence is high. However, there are issues of cost, distribution, and adherence. A potential alternative is a reusable fish-shaped iron ingot, which, when added to the cooking pot, leaches iron into the fluid in which it is prepared.Objective: We sought to determine whether there was a difference in hemoglobin concentrations in rural Cambodian anemic women (aged 18-49 y) who cooked with the iron ingot or consumed a daily iron supplement compared with a control after 1 y.Design: In Preah Vihear, 340 women with mild or moderate anemia were randomly assigned to 1) an iron-ingot group, 2) an iron-supplement (18 mg/d) group, or 3) a nonplacebo control group. A venous blood sample was taken at baseline and at 6 and 12 mo. Blood was analyzed for hemoglobin, serum ferritin, and serum transferrin receptor. Hemoglobin electrophoresis was used to detect structural hemoglobin variants.Results: Anemia prevalence was 44% with the use of a portable hemoglobinometer during screening. At baseline, prevalence of iron deficiency was 9% on the basis of a low serum ferritin concentration. There was no significant difference in mean hemoglobin concentrations between the iron-ingot group (115 g/L; 95% CI: 113, 118 g/L; P = 0.850) or iron-supplement group (115 g/L; 95% CI: 113, 117 g/L; P = 0.998) compared with the control group (115 g/L; 95% CI: 113, 117 g/L) at 12 mo. Serum ferritin was significantly higher in the iron-supplement group (73 μg/L; 95% CI: 64, 82 μg/L; P = 0.002) than in the control group at 6 mo; however, this significance was not maintained at 12 mo (73 μg/L; 95% CI: 58, 91 μg/L; P = 0.176).Conclusions: Neither the iron ingot nor iron supplements increased hemoglobin concentrations in this population at 6 or 12 mo. We do not recommend the use of the fish-shaped iron ingot in Cambodia or in countries where the prevalence of

  10. The effectiveness of ibuprofen and lorazepam combination therapy in treating the symptoms of acute Migraine: A randomized clinical trial

    Science.gov (United States)

    Rad, Reza Ebrahimi; Ghaffari, Fatemeh; Fotokian, Zahra; Ramezani, Azadeh

    2017-01-01

    Background Migraine is a common, episodic and debilitating disease. The migraineur not only suffers from pain, but also lives with a diminished to poor quality of life. Several medicinal therapies are used to abate the debilitating symptoms of this disease. Objective The present study was conducted to determine the effectiveness of Ibuprofen and Lorazepam combination therapy in treating the symptoms of acute migraine. Methods The present randomized clinical trial study used the pretest-posttest design with three comparison treatments, to examine 90 patients with an average of two to six attacks per month and an initial diagnosis of migraine based on the International Headache Society (HIS) criteria. The study was conducted on patients during the first half of 2014 with a diagnosis of acute migraine attack who were referred to Babol Ayatollah Rouhani Hospital in Iran. The patients were randomly divided into three groups of 30. The first group was administered 200 mg Ibuprofen capsules, the second group 400 mg Ibuprofen capsules and the third group a combination of 200 mg Ibuprofen capsules and 1 mg Lorazepam tablets. The medications were taken in the presence of the researcher. A checklist was used to assess the severity of headache and other migraine symptoms such as nausea, vomiting, photophobia and phonophobia in the patients, before and two hours after the intervention. Data were analyzed in SPSS-18 using the Mann-Whitney test, the McNemar test, Wilcoxon’s test, the NOVA and the Chi-squared test at the significance level of p<0.05, and power analysis with 30 patients in each group to perform this study was 0.8(1-β). Results The mean age of participants was reported as 52±8 years and the condition was more frequent in women (56%). All three treatment regimens reduced the severity of headache significantly in the patients (p<0.001); nevertheless, the combination therapy used, produced the lowest mean severity of headache (p<0.001). The highest reduction in

  11. Management of Neuropathic Chronic Pain with Methadone Combined with Ketamine: A Randomized, Double Blind, Active-Controlled Clinical Trial.

    Science.gov (United States)

    Rigo, Flavia Karine; Trevisan, Gabriela; Godoy, Maria C; Rossato, Mateus Fortes; Dalmolin, Gerusa D; Silva, Mariane A; Menezes, Mirian S; Caumo, Wolnei; Ferreira, Juliano

    2017-03-01

    Methadone and ketamine are used in neuropathic pain management. However, the benefits of both drugs association are uncertain in the treatment of neuropathic pain. Our primary objective was test the hypothesis that oral methadone combined with oral ketamine is more effective than oral methadone or ketamine alone in reducing neuropathic pain. We conducted a randomized, double blind, active-controlled parallel-group clinical trial. Forty-two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive oral methadone (n = 14), ketamine (n = 14), or methadone plus ketamine (n = 14) over a 3-month period. During these 90 days, we observed pain scores using a visual analogical scale (VAS), allodynia, burning/shooting pain, and some side effects. All treatments were effective in reducing pain scores by at least 40%. However, a significant improvement in pain was observed only in the ketamine alone group compared with both the methadone or methadone/ketamine groups. No significant differences were observed among the treatment groups for the reduction of burning or shooting pain, while ketamine alone was more effective than methadone or methadone/ketamine for the reduction of allodynia. Formal assessment for awareness of the allocation was not performed, some co-intervention bias may have occurred, our results could be only relevant to the patient population investigated and the use of VAS as the primary outcome detect changes in pain intensity but not to assess neuropathic pain symptoms. This study indicates that ketamine was better than methadone or methadone/ketamine for treating neuropathic pain.Key words: Multimodal analgesia, refractory pain, NMDA receptor, opioid.

  12. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2011-03-01

    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  13. Discontinuation of benzodiazepines among older insomniac adults treated with cognitive-behavioural therapy combined with gradual tapering: a randomized trial.

    Science.gov (United States)

    Baillargeon, Lucie; Landreville, Philippe; Verreault, René; Beauchemin, Jean-Pierre; Grégoire, Jean-Pierre; Morin, Charles M

    2003-11-11

    Long-term use of hypnotics is not recommended because of risks of dependency and adverse effects on health. The usual clinical management of benzodiazepine dependency is gradual tapering, but when used alone this method is not highly effective in achieving long-term discontinuation. We compared the efficacy of tapering plus cognitive-behavioural therapy for insomnia with tapering alone in reducing the use of hypnotics by older adults with insomnia. People with chronic insomnia who had been taking a benzodiazepine every night for more than 3 months were recruited through media advertisements or were referred by their family doctors. They were randomly assigned to undergo either cognitive-behavioural therapy plus gradual tapering of the drug (combined treatment) or gradual tapering only. The cognitive-behavioural therapy was provided by a psychologist in 8 weekly small-group sessions. The tapering was supervised by a physician, who met weekly with each participant over an 8-week period. The main outcome measure was benzodiazepine discontinuation, confirmed by blood screening performed at each of 3 measurement points (immediately after completion of treatment and at 3- and 12-month follow-ups). Of the 344 potential participants, 65 (mean age 67.4 years) met the inclusion criteria and entered the study. The 2 study groups (35 subjects in the combined treatment group and 30 in the tapering group) were similar in terms of demographic characteristics, duration of insomnia and hypnotic dosage. Immediately after completion of treatment, a greater proportion of patients in the combined treatment group had withdrawn from benzodiazepine use completely (77% [26/34] v. 38% [11/29]; odds ratio [OR] 5.3, 95% confidence interval [CI] 1.8-16.2; OR after adjustment for initial benzodiazepine daily dose 7.9, 95% CI 2.4-30.9). At the 12-month follow-up, the favourable outcome persisted (70% [23/33] v. 24% [7/29]; OR 7.2, 95% CI 2.4-23.7; adjusted OR 7.6, 95% CI 2.5-26.6); similar

  14. The walk is never random: subtle landscape effects shape gene flow in a continuous white-tailed deer population in the Midwestern United States

    Science.gov (United States)

    Robinson, Stacie J.; Samuel, Michael D.; Lopez, Davin L.; Shelton, Paul

    2012-01-01

    One of the pervasive challenges in landscape genetics is detecting gene flow patterns within continuous populations of highly mobile wildlife. Understanding population genetic structure within a continuous population can give insights into social structure, movement across the landscape and contact between populations, which influence ecological interactions, reproductive dynamics or pathogen transmission. We investigated the genetic structure of a large population of deer spanning the area of Wisconsin and Illinois, USA, affected by chronic wasting disease. We combined multiscale investigation, landscape genetic techniques and spatial statistical modelling to address the complex questions of landscape factors influencing population structure. We sampled over 2000 deer and used spatial autocorrelation and a spatial principal components analysis to describe the population genetic structure. We evaluated landscape effects on this pattern using a spatial autoregressive model within a model selection framework to test alternative hypotheses about gene flow. We found high levels of genetic connectivity, with gradients of variation across the large continuous population of white-tailed deer. At the fine scale, spatial clustering of related animals was correlated with the amount and arrangement of forested habitat. At the broader scale, impediments to dispersal were important to shaping genetic connectivity within the population. We found significant barrier effects of individual state and interstate highways and rivers. Our results offer an important understanding of deer biology and movement that will help inform the management of this species in an area where overabundance and disease spread are primary concerns.

  15. Effect of exercise training combined with isoflavone supplementation on bone and lipids in postmenopausal women: a randomized clinical trial.

    Science.gov (United States)

    Chilibeck, Philip D; Vatanparast, Hassanali; Pierson, Roger; Case, Allison; Olatunbosun, Olufemi; Whiting, Susan J; Beck, Thomas J; Pahwa, Punam; Biem, H Jay

    2013-04-01

    We determined the effects of 2 years of exercise training and soy isoflavone supplementation on bone mass and lipids in postmenopausal women provided with calcium and vitamin D. Women were randomized to four groups: exercise training (Ex); isoflavone supplementation (Iso: 165 mg/d [105 mg/d aglycone equivalent]); combined Ex and Iso (ExIso); and placebo (control). Exercise included resistance training (2 days/week) and walking (4 days/week). Our primary outcomes were lumbar spine and hip bone mineral density (BMD). Secondary outcomes included hip geometry, tibia and radius speed of sound (SOS), dynamic balance (6 m backward tandem walking), blood lipids, mammography, and endometrial thickness. A total of 351 women (Ex = 86, Iso = 90, ExIso = 87, control = 88) were randomized, with 298 analyzed at 2 years (Ex = 77, Iso = 76, ExIso = 72, control = 73). There was a significant interaction for total hip BMD (p bone SOS. Exercise groups improved dynamic balance as measured by a decrease in backward tandem walking time over 6 m (p = 0.017). Isoflavone groups decreased low density lipoproteins (Iso: -0.20 [-0.37, -0.02] mmol/L; ExIso: -0.23 [-0.40, -0.06] mmol/L; p = 0.003) compared to non-isoflavone groups (Ex: 0.01 [-0.16, 0.18] mmol/L; control: -0.09 [-0.27, 0.08] mmol/L) and had lower adverse reports of menopausal symptoms (14% versus 33%; p = 0.01) compared to non-isoflavone groups. Isoflavone supplementation did not increase endometrial thickness or abnormal mammograms. We conclude exercise training and isoflavone supplementation maintain hip BMD compared to control, but these two interventions interfere with each other when combined. Isoflavone supplementation decreased LDL and adverse events related to menopausal symptoms. Copyright © 2013 American Society for Bone and Mineral Research.

  16. A prospective, randomized controlled trial of conscious sedation using propofol combined with inhaled nitrous oxide for dental treatment.

    Science.gov (United States)

    Yokoe, Chizuko; Hanamoto, Hiroshi; Sugimura, Mitsutaka; Morimoto, Yoshinari; Kudo, Chiho; Niwa, Hitoshi

    2015-03-01

    Adverse reactions during propofol sedation include a decrease in arterial blood pressure, propofol-induced pain on injection, and airway complications. The purpose of this study was to investigate whether combined use of intravenous propofol and inhaled nitrous oxide could decrease the hypotensive and other adverse effects of propofol. We designed and implemented a prospective, randomized controlled trial. Patients undergoing dental procedures requiring intravenous sedation were randomly allocated to 2 groups: group P comprised those receiving sedation with propofol alone, and group N+P comprised those receiving sedation with 40% nitrous oxide inhalation and propofol. During the dental procedures, the sedation level was maintained at an Observer's Assessment of Alertness/Sedation scale score of 4 by adjusting propofol's target plasma concentration. Nitrous oxide inhalation was the predictor variable, whereas the hemodynamic changes, amount and concentration of propofol, and adverse events were the outcome variables. Eighty-eight patients were successfully analyzed without any complications. The total amount of propofol was significantly less in group N+P (249.8 ± 121.7 mg) than in group P (310.3 ± 122.4 mg) (P = .022), and the mean concentration of propofol was significantly less in group N+P (1.81 ± 0.34 μg/mL) than in group P (2.05 ± 0.44 μg/mL) (P = .006). The mean blood pressure reduction in group N+P (11.0 ± 8.0 mm Hg) was significantly smaller than that in group P (15.8 ± 10.2 mm Hg) (P = .034). Pain associated with the propofol injection and memory of the procedure were less in group N+P (P = .011 and P = .048, respectively). Nitrous oxide did not affect respiratory conditions or recovery characteristics. The results of this study suggest that nitrous oxide inhalation combined with propofol sedation attenuates the hypotensive effect and pain associated with propofol injections, along with potentiating the amnesic effect. Copyright © 2015 American

  17. Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial

    Science.gov (United States)

    Duval, Xavier; van der Werf, Sylvie; Blanchon, Thierry; Mosnier, Anne; Bouscambert-Duchamp, Maude; Tibi, Annick; Enouf, Vincent; Charlois-Ou, Cécile; Vincent, Corine; Andreoletti, Laurent; Tubach, Florence; Lina, Bruno; Mentré, France; Leport, Catherine

    2010-01-01

    Background Neuraminidase inhibitors are thought to be efficacious in reducing the time to alleviation of symptoms in outpatients with seasonal influenza. The objective of this study was to compare the short-term virological efficacy of oseltamivir-zanamivir combination versus each monotherapy plus placebo. Methods and Findings We conducted a randomized placebo-controlled trial with 145 general practitioners throughout France during the 2008–2009 seasonal influenza epidemic. Patients, general practitioners, and outcome assessors were all blinded to treatment assignment. Adult outpatients presenting influenza-like illness for less than 36 hours and a positive influenza A rapid test diagnosis were randomized to oseltamivir 75 mg orally twice daily plus zanamivir 10 mg by inhalation twice daily (OZ), oseltamivir plus inhaled placebo (O), or zanamivir plus oral placebo (Z). Treatment efficacy was assessed virologically according to the proportion of patients with nasal influenza reverse transcription (RT)-PCR below 200 copies genome equivalent (cgeq)/µl at day 2 (primary outcome), and clinically to the time to alleviation of symptoms until day 14. Overall 541 patients (of the 900 planned) were included (OZ, n = 192; O, n = 176; Z, n = 173), 49% male, mean age 39 years. In the intention-to-treat analysis conducted in the 447 patients with RT-PCR-confirmed influenza A, 46%, 59%, and 34% in OZ (n = 157), O (n = 141), and Z (n = 149) arms had RT-PCR<200 cgeq/µl (−13.0%, 95% confidence interval [CI] −23.1 to −2.9, p = 0.025; +12.3%, 95% CI 2.39–22.2, p = 0.028 for OZ/O and OZ/Z comparisons). Mean day 0 to day 2 viral load decrease was 2.14, 2.49, and 1.68 log10 cgeq/µl (p = 0.060, p = 0.016 for OZ/O and OZ/Z). Median time to alleviation of symptoms was 4.0, 3.0, and 4.0 days (+1.0, 95% CI 0.0–4.0, p = 0.018; +0.0, 95% CI −3.0 to 3.0, p = 0.960 for OZ/O and OZ/Z). Four severe adverse events were observed. Nausea

  18. Efficacy of oseltamivir-zanamivir combination compared to each monotherapy for seasonal influenza: a randomized placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Xavier Duval

    2010-11-01

    Full Text Available Neuraminidase inhibitors are thought to be efficacious in reducing the time to alleviation of symptoms in outpatients with seasonal influenza. The objective of this study was to compare the short-term virological efficacy of oseltamivir-zanamivir combination versus each monotherapy plus placebo.We conducted a randomized placebo-controlled trial with 145 general practitioners throughout France during the 2008-2009 seasonal influenza epidemic. Patients, general practitioners, and outcome assessors were all blinded to treatment assignment. Adult outpatients presenting influenza-like illness for less than 36 hours and a positive influenza A rapid test diagnosis were randomized to oseltamivir 75 mg orally twice daily plus zanamivir 10 mg by inhalation twice daily (OZ, oseltamivir plus inhaled placebo (O, or zanamivir plus oral placebo (Z. Treatment efficacy was assessed virologically according to the proportion of patients with nasal influenza reverse transcription (RT-PCR below 200 copies genome equivalent (cgeq/µl at day 2 (primary outcome, and clinically to the time to alleviation of symptoms until day 14. Overall 541 patients (of the 900 planned were included (OZ,  =192; O, n=176; Z, n=173, 49% male, mean age 39 years. In the intention-to-treat analysis conducted in the 447 patients with RT-PCR-confirmed influenza A, 46%, 59%, and 34% in OZ (n=157, O (n=141, and Z (n=149 arms had RT-PCR<200 cgeq/µl (-13.0%, 95% confidence interval [CI] -23.1 to -2.9, p=0.025; +12.3%, 95% CI 2.39-22.2, p=0.028 for OZ/O and OZ/Z comparisons. Mean day 0 to day 2 viral load decrease was 2.14, 2.49, and 1.68 log(10 cgeq/µl (p=0.060, p=0.016 for OZ/O and OZ/Z. Median time to alleviation of symptoms was 4.0, 3.0, and 4.0 days (+1.0, 95% CI 0.0-4.0, p=0.018; +0.0, 95% CI -3.0 to 3.0, p=0.960 for OZ/O and OZ/Z. Four severe adverse events were observed. Nausea and/or vomiting tended to be more frequent in the combination arm (OZ, n=13; O, n=4; and Z, n=5 patients

  19. Efficacy of combined physical and occupational therapy in patients with conservatively treated distal radius fracture: randomized controlled trial.

    Science.gov (United States)

    Filipova, Verica; Lonzarić, Dragan; Jesenšek Papež, Breda

    2015-12-01

    To evaluate the efficacy of combined physical and occupational therapy in comparison with physical therapy alone in patients with conservatively treated distal radius fracture. Sixty-one participants, conservatively treated after a distal radius fracture, were included in a randomized and single-blind trial. Group A had physical therapy only (n = 31) and group B had physical and occupational therapy (n = 30). The assessment was performed three times: upon inclusion in the study in the first week after removal of the cast (T1), immediately after the end of the rehabilitation (T2), and 1 month after completing the rehabilitation (T3). The passive wrist range-of-motion, grip strength, and Disabilities of Arm, Shoulder and Hand (DASH) score were used as rehabilitation outcomes. Rehabilitation outcomes were analyzed using two-way mixed analysis of variance. The effect of time was statistically significant (p therapy) factor was statistically significant for grip strength only (p = 0.038). The interaction effect was statistically significant for rotation (p = 0.034) and grip strength (p = 0.021). A comparison between time points T3:T1 showed statistically significant difference in grip strength in favor of group B 67 % (95 % CI 60-74 %) versus group A 53 % (95 % CI 45-61 %), p = 0.024. The combined therapy resulted in a statistically significant increase of grip strength in comparison with isolated physical therapy in the period of 12-16 weeks after the fracture. This effectiveness was not confirmed with DASH score results.

  20. Pain Reduction in Myofascial Pain Syndrome by Anodal Transcranial Direct Current Stimulation Combined with Standard Treatment: A Randomized Controlled Study

    Science.gov (United States)

    Sakrajai, Piyaraid; Janyacharoen, Taweesak; Jensen, Mark P.; Sawanyawisuth, Kittisak; Auvichayapat, Narong; Tunkamnerdthai, Orathai; Keeratitanont, Keattichai; Auvichayapat, Paradee

    2014-01-01

    Background Myofascial pain syndrome (MPS) in the shoulder is among the most prevalent pain problems in the middle-aged population worldwide. Evidence suggests that peripheral and central sensitization may play an important role in the development and maintenance of shoulder MPS. Given previous research supporting the potential efficacy of anodal transcranial direct current stimulation (tDCS) for modulating pain-related brain activity in individuals with refractory central pain, we hypothesized that anodal tDCS when applied over the primary motor cortex (M1) combined with standard treatment will be more effective for reducing pain in patients with MPS than standard treatment alone. Method Study participants were randomized to receive either (1) standard treatment with 5-consecutive days of 1 mA anodal tDCS over M1 for 20 min or (2) standard treatment plus sham tDCS. Measures of pain intensity, shoulder passive range of motion, analgesic medication use, and self-reported physical functioning were administered before treatment and again at post-treatment and 1-, 2-, 3-and 4-week follow-up. Results Thirty-one patients with MPS were enrolled. Participants assigned to the active tDCS condition reported significantly more pre- to post-treatment reductions in pain intensity that were maintained at 1-week post-treatment, and significant improvement in shoulder adduction PROM at 1-week follow-up than participants assigned to the sham tDCS condition. Conclusion 5 consecutive days of anodal tDCS over M1 combined with standard treatment appears to reduce pain intensity, and may improve PROM, faster than standard treatment alone. Further tests of the efficacy and duration of effects of tDCS in the treatment of MPS are warranted. PMID:25373724

  1. Oral tranexamic acid with fluocinolone-based triple combination cream versus fluocinolone-based triple combination cream alone in melasma: An open labeled randomized comparative trial

    OpenAIRE

    Tanmay Padhi; Swetalina Pradhan

    2015-01-01

    Background : Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy. Tranexamic acid, a plasmin inhibitor, has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results. Objectives : To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients...

  2. Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial

    Science.gov (United States)

    Smith, Caroline A.; Abbott, Jason; Fahey, Paul; Cheema, Birinder S.; Bensoussan, Alan

    2017-01-01

    Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first‐line intervention; however, there are barriers to success for this form of self‐care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty‐two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3–42.6, p herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd PMID:28685911

  3. A combined analysis of 2 randomized clinical studies of tretinoin gel 0.05% for the treatment of acne.

    Science.gov (United States)

    Webster, Guy; Cargill, D Innes; Quiring, John; Vogelson, Cullen T; Slade, Herbert B

    2009-03-01

    Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (Ptretinoin gel 0.05% group compared with the vehicle group (Ptretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(Ptretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.

  4. Identification of velvet antler by random amplified polymorphism DNA combined with non-gel sieving capillary electrophoresis.

    Science.gov (United States)

    Yuan, Guangxin; Sun, Jiyan; Li, Hongyu; Fu, Guilian; Xu, Guangyu; Li, Mingcheng; Zhang, Lihua; Fan, Xintian

    2016-01-01

    Mitochondrial DNA of velvet antler was amplified with random amplified polymorphic DNA (RAPD) technique and the PCR products were detected with non-gel sieving capillary electrophoresis to establish a RAPD-HPCE method used for identifying the authenticity of velvet antler or it counterfeits. Factors that could affect the PCR amplification and capillary electrophoresis were optimized. Under the optimized conditions, namely, 20 mmol L(-1) NaH2PO4-Na2HPO4-2 mmol L(-1) EDTA buffer solution [0.8% (W/V) HPMC, 15 mmol L(-1) TBAP and pH 7.3], -10 kV injection voltage and -8 kV separation voltage, Cervus nippon Temminck antler, Cervus elaphus Linnaeus antler, Rangifer tarandus antler, Cervus canadensis antler and Elaphurus davidianus antler were analyzed. The analysis on the similarity of obtained elctrophoretograms showed that there were significant differences in similarities of different velvet antlers, which could be used for the quick identification of the authenticity of velvet antler samples. It can be found that the technique of RAPD combined with HPCE is advantageous in rich polymorphism, high detection rate, simple and convenient performance, high efficiency, rapidness and sensitivity, indicating that it should be suitable for the quick identification of the authenticity of velvet antler samples.

  5. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  6. 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial.

    Science.gov (United States)

    Feldman, Gregory; Walker, Robert R; Brooks, Jean; Mehta, Rashmi; Crater, Glenn

    2012-12-01

    Umeclidinium (UMEC; GSK573719) is a new long-acting muscarinic antagonist (LAMA) currently in development in combination with vilanterol (VI), an inhaled, long-acting beta₂ agonist for the treatment of chronic obstructive pulmonary disease (COPD). The primary aim of this study was to evaluate the safety and tolerability of repeat dosing of UMEC and VI in combination once daily for 28 days in patients with COPD. This was a multicenter, double-blind, placebo-controlled, parallel group study. Patients aged ≥40 years with post-bronchodilator FEV₁ ≤80% of predicted normal values and FEV₁/FVC ratio ≤0.70, and a smoking history of ≥10 pack-years, were randomized 4:1 to once-daily UMEC/VI (500/25 mcg; n = 42) or placebo (n = 9). UMEC/VI was non-inferior to placebo in weighted mean pulse rate over 0-6 h at Day 28 (primary endpoint: difference of -0.5 bpm, 95% CI: -5.5 to 4.5). There was no evidence of a difference between UMEC/VI compared with placebo in blood pressure, minimum and maximum pulse rate, or QTcF assessments. Adverse events (AEs) were reported by 11 (26%) patients in the UMEC/VI group and one (11%) patient in the placebo group. No serious AEs were reported. Both UMEC and VI showed rapid absorption (median t(max) ∼6 min for both drugs) with no evidence of accumulation for AUC or C(max) on Day 28 compared with Day 1 for UMEC or VI. There was no correlation between individual steady-state C(max) and pulse rate on Day 28. Change from baseline in trough FEV₁ on Day 29 showed numerically greater improvements with UMEC/VI compared with placebo. Once-daily dosing with UMEC in combination with VI in patients with moderate-to-very-severe COPD was well tolerated over 28 days. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Randomized trial of combined cabergoline and coasting in preventing ovarian hyperstimulation syndrome during in vitro fertilization/intracytoplasmic sperm injection cycles.

    Science.gov (United States)

    Bassiouny, Yasmin A; Dakhly, Dina M R; Bayoumi, Yomna A; Salaheldin, Noha M; Gouda, Hisham M; Hassan, Ayman A

    2018-02-01

    To assess the efficacy of coasting alone, cabergoline alone, or combining both interventions for preventing ovarian hyperstimulation syndrome (OHSS) among high-risk patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment cycles. The present randomized controlled trial was conducted at the IVF unit of a university hospital in Cairo between October 28, 2013, and July 31, 2015. Patients undergoing IVF/ICSI considered at risk of OHSS were randomly allocated to coasting, cabergoline, or combined coasting and cabergoline. The primary outcome was the rate and degree of symptomatically assessed OHSS. Data were analyzed on a per-protocol basis. There were 100 patients recruited to each group. The occurrence of early OHSS was lowest in the combination group compared with the other groups (P=0.002). Combining coasting and cabergoline was associated with a lower OHSS rate compared with either therapy alone. CLINICALTRIALS.GOV: NCT01984320. © 2017 International Federation of Gynecology and Obstetrics.

  8. Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.

    Directory of Open Access Journals (Sweden)

    Alireza Khatami

    Full Text Available BACKGROUND: Cutaneous leishmaniasis (CL is a neglected infectious disease and a major health problem in several developing countries. Despite some reasonable explanation for their potential benefits, there is only trace evidence regarding the role of dressings in the treatment of CL. METHODS: This randomized, assessor-blind, controlled, clinical trial was conducted in an endemic area for CL caused by Leishmania major in Iran to assess the efficacy of administration of weekly intralesional meglumine antimoniate (i.l.MA either alone or combined with application of a silver or a non-silver polyester dressing on their lesions for 6 weeks. After screening of 241 patients with CL lesions, 83 eligible patients with 158 lesions were randomly allocated in three arms of the study. Eligibility criteria included parasitologically confirmed CL, age of 12 to 60 years; willingness to participate, duration of lesion<3 months, number of lesions<5, largest ulcer diameter<5 cm. Pregnant or lactating women were excluded. The primary outcome was absolute risk reduction (ARR based on the proportion of complete healing, which was defined as more than 75% reduction in the size of the lesion compared with baseline in each group at the termination of treatment and 1 month later. FINDINGS: ARR (95% Confidence Interval [CI] in i.l.MA versus i.l.MA+non-silver dressing groups was 5.98% (-7.07% to 20.25%, between i.l.MA versus i.l.MA+silver dressing groups was -0.23% (-13.53% to 14.82%, and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was -6.21%(-18.28% to 6.52% after 6 weeks of treatment. ARR (95% CI in i.l.MA versus i.l.MA+non-silver dressing groups was -2.22% (-22.12% to 18.10%, between i.l.MA versus i.l.MA+silver dressing groups was 3.64% (-15.36% to 22.82%, and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was 5.86% (-12.86% to 24.31% 1 month later. CONCLUSION: It could not be demonstrated that the efficacy of i

  9. Price discounts significantly enhance fruit and vegetable purchases when combined with nutrition education: a randomized controlled supermarket trial.

    Science.gov (United States)

    Waterlander, Wilma E; de Boer, Michiel R; Schuit, Albertine J; Seidell, Jacob C; Steenhuis, Ingrid H M

    2013-04-01

    Reducing fruit and vegetable (F&V) prices is a frequently considered policy to improve dietary habits in the context of health promotion. However, evidence on the effectiveness of this intervention is limited. The objective was to examine the effects of a 50% price discount on F&Vs or nutrition education or a combination of both on supermarket purchases. A 6-mo randomized controlled trial within Dutch supermarkets was conducted. Regular supermarket shoppers were randomly assigned to 1 of 4 conditions: 50% price discounts on F&Vs, nutrition education, 50% price discounts plus nutrition education, or no intervention. A total of 199 participants provided baseline data; 151 (76%) were included in the final analysis. F&V purchases were measured by using supermarket register receipts at baseline, at 1 mo after the start of the intervention, at 3 mo, at 6 mo (end of the intervention period), and 3 mo after the intervention ended (9 mo). Adjusted multilevel models showed significantly higher F&V purchases (per household/2 wk) as a result of the price discount (+3.9 kg; 95% CI: 1.5, 6.3 kg) and the discount plus education intervention (+5.6 kg; 95% CI: 3.2, 7.9 kg) at 6 mo compared with control. Moreover, the percentage of participants who consumed recommended amounts of F&Vs (≥400 g/d) increased from 42.5% at baseline to 61.3% at 6 mo in both discount groups (P = 0.03). Education alone had no significant effect. Discounting F&Vs is a promising intervention strategy because it resulted in substantially higher F&V purchases, and no adverse effects were observed. Therefore, pricing strategies form an important focus for future interventions or policy. However, the long-term effects and the ultimate health outcomes require further investigation. This trial was registered at the ISRCTN Trial Register as number ISRCTN56596945 and at the Dutch Trial Register (http://www.trialregister.nl/trialreg/index.asp) as number NL22568.029.08.

  10. A Placebo-Controlled Double-Blinded Randomized Pilot Study of Combination Phytotherapy in Biochemically Recurrent Prostate Cancer.

    Science.gov (United States)

    van Die, M Diana; Williams, Scott G; Emery, Jon; Bone, Kerry M; Taylor, Jeremy M G; Lusk, Elizabeth; Pirotta, Marie V

    2017-05-01

    Men with biochemical recurrence of prostate cancer following local therapies often use natural supplements in an attempt to delay metastases and/or avoid the need for more aggressive treatments with undesirable side-effects. While there is a growing body of research into phytotherapeutic agents in this cohort, with some promising results, as yet no definitive recommendations can be made. This pilot study was undertaken to assess the feasibility of a fully-powered study to examine the effects of this phytotherapeutic intervention (containing turmeric, resveratrol, green tea and broccoli sprouts) on PSA doubling time in men with biochemical recurrence with a moderate PSA rise rate. A double blind, randomized, placebo-controlled parallel trial was conducted with 22 men with biochemically recurrent prostate cancer and a moderate rise rate (PSA doubling time of 4-15 months and no evidence of metastases from conventional imaging methods). Patients were randomized to either the active treatment arm or placebo for 12 weeks. The primary endpoints were feasibility of study recruitment and procedures, and measurement of proposed secondary endpoints (prostate symptoms, quality of life, anxiety, and depression as measured on the EORTC QLQ-C30 and PR-25, the IPSS and HADS). Data were collected to estimate PSA-log slopes and PSA-doubling times, using a mixed model, for both the pre-intervention and post-intervention periods. Adherence to study protocol was excellent, and the phytotherapeutic intervention was well-tolerated, with similar numbers of mild-to-moderate adverse events in the active and placebo arms. Both the intervention and data collection methods were acceptable to participants. No statistical difference between groups on clinical outcomes was expected in this pilot study. There was between-subject variation in the PSA post treatment, but on average the active treatment group experienced a non-significant increase in the log-slope of PSA (pre-treatment doubling time

  11. The walk is never random: subtle landscape effects shape gene flow in a continuous white-tailed deer population in the Midwestern United States.

    Science.gov (United States)

    Robinson, Stacie J; Samuel, Michael D; Lopez, Davin L; Shelton, Paul

    2012-09-01

    One of the pervasive challenges in landscape genetics is detecting gene flow patterns within continuous populations of highly mobile wildlife. Understanding population genetic structure within a continuous population can give insights into social structure, movement across the landscape and contact between populations, which influence ecological interactions, reproductive dynamics or pathogen transmission. We investigated the genetic structure of a large population of deer spanning the area of Wisconsin and Illinois, USA, affected by chronic wasting disease. We combined multiscale investigation, landscape genetic techniques and spatial statistical modelling to address the complex questions of landscape factors influencing population structure. We sampled over 2000 deer and used spatial autocorrelation and a spatial principal components analysis to describe the population genetic structure. We evaluated landscape effects on this pattern using a spatial autoregressive model within a model selection framework to test alternative hypotheses about gene flow. We found high levels of genetic connectivity, with gradients of variation across the large continuous population of white-tailed deer. At the fine scale, spatial clustering of related animals was correlated with the amount and arrangement of forested habitat. At the broader scale, impediments to dispersal were important to shaping genetic connectivity within the population. We found significant barrier effects of individual state and interstate highways and rivers. Our results offer an important understanding of deer biology and movement that will help inform the management of this species in an area where overabundance and disease spread are primary concerns. Published 2012. This article is a US Government work and is in the public domain in the USA.

  12. 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

  13. The Opioid-Sparing Effect of Perioperative Dexmedetomidine Combined with Oxycodone Infusion during Open Hepatectomy: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Benhou Zhang

    2018-01-01

    Full Text Available Background: A large right subcostal incision performed by open hepatectomy is associated with significant post-operative pain and distress. However, post-operative analgesia solutions still need to be devised. We investigated the effects of intra- and post-operative infusion of dexmedetomidine (Dex combined with oxycodone during open hepatectomy.Methods: In this prospective, randomized and double-blind investigation, 52 patients undergoing selective open hepatectomy were divided into Dex group (DEX infusion at an initial loading dose of 0.5 μg⋅kg-1 over 10 min before intubation then adjusted to a maintenance dose of 0.3 μg⋅kg-1⋅h-1 until incision suturing or control (Con group (0.9% sodium chloride was administered. Patient-controlled analgesia was administered for 48 h after surgery (Dex group: 60 mg oxycodone and 360 μg DEX diluted to 120 ml and administered at a bolus dose of 2 ml, with 5 min lockout interval and a 1 h limit of 20 ml. Con group: 60 mg oxycodone alone with the same regimen. The primary outcome was post-operative oxycodone consumption. The secondary outcomes included requirement of narcotic and vasoactive drugs, hemodynamics, incidence of adverse effects, satisfaction, first exhaust time, pain intensity, and the Ramsay Sedation Scale.Results: Post-operative oxycodone consumption was significantly reduced in Dex group from 4 to 48 h after surgery (P < 0.05. Heart rate in Dex group was statistically decreased from T1 (just before intubation to T6 (20 min after arriving at the post-anesthesia care unit, while mean arterial pressure was significantly decreased from T1 to T3 (during surgical incision; P < 0.05. The consumption of propofol and remifentanil were significantly decreased in Dex group (P < 0.05. The VAS scores at rest at 1, 4, and 8 h and with cough at 24, and 48 h after surgery were lower, the first exhaust time were shorter, satisfaction with pain control was statistically higher and the incidence of nausea

  14. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Collard Alix

    2010-10-01

    Full Text Available Abstract Background Diphtheria-tetanus-whole-cell pertussis (DTPw-based combination vaccines are an attractive option to rapidly achieve high coverage and protection against other important pathogens, such as hepatitis B virus (HBV and Haemophilus influenzae type B (Hib. To ensure adequate antigen supply, GlaxoSmithKline Biologicals has introduced a new DTPw antigen source and developed a new DTPw-HBV/Hib combination vaccine containing a reduced amount of Hib polyribosylribitol phosphate (PRP. This study was undertaken to compare the immunogenicity and reactogenicity of this new DTPw-HBV/Hib vaccine with a licensed DTPw-HBV/Hib vaccine (Tritanrix™-HBV/Hib. Methods This was a randomized, partially-blind, multicenter study in three countries in Latin America (Argentina, Chile and Nicaragua. Healthy children received either the new DTPw-HBV/Hib vaccine (1 of 3 lots; n = 439; double-blind or Tritanrix™-HBV/Hib (n = 146; single-blind co-administered with oral poliovirus vaccine (OPV at 2, 4 and 6 months, with a booster dose at 18-24 months. Results One month after the end of the 3-dose primary vaccination course, the new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; ≥97.3% and ≥93.9% of subjects in the two groups, respectively, had seroprotective levels of antibodies against diphtheria, tetanus, hepatitis B and Hib and a vaccine response to the pertussis component. Persistence of antibodies against all vaccine antigens was comparable between groups, with marked increases in all antibody concentrations after booster administration in both groups. Both vaccines were generally well-tolerated as primary and booster doses. Conclusions Results confirm the suitability of this new DTPw-HBV/Hib vaccine comprising antigens from a new source and a reduced PRP content for inclusion into routine childhood vaccination programs. Trial registration http

  15. Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pastor, María-Ángeles; López-Roig, Sofía; Lledó, Ana; Peñacoba, Cecilia; Velasco, Lilian; Schweiger-Gallo, Inge; Cigarán, Margarita; Ecija, Carmen; Limón, Ramón; Sanz, Yolanda

    2014-04-11

    Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. The first data gathered have allowed us to identify the characteristics of the study population and

  16. Does physiotherapeutic intervention affect motor outcome in high-risk infants? An approach combining a randomized controlled trial and process evaluation

    NARCIS (Netherlands)

    Hielkema, Tjitske; Blauw-Hospers, Cornill H.; Dirks, Tineke; Drijver-Messelink, Marieke; Bos, Arend F.; Hadders-Algra, Mijna

    AIM The aim of this study was to examine the effects of intervention in infants at risk of developmental disorders onmotor outcome, as measured by the InfantMotor Profile (IMP) and using the combined approach of a randomized controlled trial and process evaluation. METHOD At a corrected age of 3

  17. Cancer-Related Fatigue and Rehabilitation : A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    NARCIS (Netherlands)

    van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    Background. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancer-related fatigue of physical training combined with

  18. The combined effect of lower-limb multilevel botulinum toxin type A and comprehensive rehabilitation on mobility in children with cerebral palsy: A randomized clinical trial

    NARCIS (Netherlands)

    Scholtes, V.A.; Dallmeijer, A.J.; Knol, D.L.; Speth, L.A.; Maathuis, C.G.; Jongerius, P.H.; Becher, J.G.

    2006-01-01

    Objective: To evaluate the combined effect on mobility of treatment with multilevel botulinum toxin type A (BTX-A) and comprehensive rehabilitation in children with cerebral palsy (CP). Design: Randomized clinical trial using a multiple baseline design. The intervention group was treated 6 weeks

  19. The combined effect of lower-limb multilevel botulinum toxin type A and comprehensive rehabilitation on mobility in children with cerebral palsy : A randomized clinical trial

    NARCIS (Netherlands)

    Scholtes, Vanessa A.; Dallmeijer, Annet J.; Knol, Dirk L.; Speth, Lucianne A.; Maathuis, Carel G.; Jongerius, Peter H.; Becher, Jules G.

    2006-01-01

    Objective: To evaluate the combined effect on mobility of treatment with multilevel botulinum toxin type A (BTX-A) and comprehensive rehabilitation in children with cerebral palsy (CP). Design: Randomized clinical trial using a multiple baseline design. The intervention group was treated 6 weeks

  20. Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke.

    Science.gov (United States)

    You, Young-Nim; Cho, Myung-Rae; Kim, Jae-Hong; Park, Ju-Hyung; Park, Gwang-Cheon; Song, Min-Yeong; Choi, Jin-Bong; Han, Jae-Young

    2017-09-06

    This study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke. The following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured. The original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items 'trial design', 'sample size', 'ancillary analyses', and 'harms' had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with 'allocation concealment and implementation' and 'intent-to-treat analysis (ITT) analysis' having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items 'sample size' and 'intent-to-treat analysis' were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture

  1. Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Jose M Trigo

    Full Text Available The current lack of pharmacological treatments for cannabis use disorder (CUD warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC/ 25 mg/ml cannabidiol (CBD, Sativex® can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT. Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.Medication was well tolerated and no serious adverse events (SAEs were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS. There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS. Cannabis use was reduced in the nabiximols (70.5% and placebo groups (42.6%. Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

  2. [Randomized Controlled Clinical Trials for Treatment of Child Amblyopia with Otopoint Pellet-pressure Combined with Chinese Medical Herbs].

    Science.gov (United States)

    Han, Zhi-hong; Qiu, Min

    2015-06-01

    To observe the clinical effedt of auricular pressure combined with Chinese herbal medicine for amblyopia. A total of 66 child patients with amblyopia were randomly divided into Chinese herbal medicine (control) and herbal medicine+ auricular pressure (treatment) groups, with 33 patients in each group. The patients in the control group were treated with Chinese medical herbs as Danggui (Radix Angelicae Sinensis), Gouqizi (Fructus Lycii), Baijuhua (Flos Chrysanthemi), Baizhu (Rhizoma Atractylodis Macrocephalae), Shudi (Radix Rehmanniae Proeparata), Baishao (Radix Paeoniae Alba) , etc. according to syndrome differentiation, while the patients in the treatment group were treated by auricular pressure of otopoints Yan (Eye), Gan (Liver), Shen (Kidney), Xin (Heart), Mu 1 (Eye-1), Mu 2(Eye-2), and Pi (Spleen) and herbal medicines (being the same to the control group). The treatment was conducted for 6 months. After the treatment, the clinical effect, improvement degree of vision, onset time of improvement, and recurrence rate in the 3 and 6 months' follow-up visit were analyzed. Of the 45 and 47 eyes in the treatment and control groups, 22 and 15 were basically cured, 12 and 5 had marked improvement, 9 and 20 were improved, 2 and 7 failed in the treatment, with the effective rates being 75. 56% and 42.55%, respectively. In comparison with pre-treatment, the visual acuity in both control group and treatment group were improved (Ptreatment group were 26 and 31 eyes, 10 and 11 eyes, respectively. The recurrence rate 6 months after the treatment was 50. 00 % in the control group and 16. 28% in the treatment group. The effective rate of the treatment group was significantly superior to that of the control group (Ptreatment is effective in improving visual acuity, and had a higher efficacy, faster action, and lower recurrence rate in amblyopia children in comparison with simple herbal medicine treatment.

  3. Treatment of metabolic syndrome by combination of physical activity and diet needs an optimal protein intake: a randomized controlled trial.

    Science.gov (United States)

    Dutheil, Frédéric; Lac, Gérard; Courteix, Daniel; Doré, Eric; Chapier, Robert; Roszyk, Laurence; Sapin, Vincent; Lesourd, Bruno

    2012-09-17

    The recommended dietary allowance (RDA) for protein intake has been set at 1.0-1.3 g/kg/day for senior. To date, no consensus exists on the lower threshold intake (LTI = RDA/1.3) for the protein intake (PI) needed in senior patients ongoing both combined caloric restriction and physical activity treatment for metabolic syndrome. Considering that age, caloric restriction and exercise are three increasing factors of protein need, this study was dedicated to determine the minimal PI in this situation, through the determination of albuminemia that is the blood marker of protein homeostasis. Twenty eight subjects (19 M, 9 F, 61.8 ± 6.5 years, BMI 33.4 ± 4.1 kg/m²) with metabolic syndrome completed a three-week residential programme (Day 0 to Day 21) controlled for nutrition (energy balance of -500 kcal/day) and physical activity (3.5 hours/day). Patients were randomly assigned in two groups: Normal-PI (NPI: 1.0 g/kg/day) and High-PI (HPI: 1.2 g/kg/day). Then, patients returned home and were followed for six months. Albuminemia was measured at D0, D21, D90 and D180. At baseline, PI was spontaneously 1.0 g/kg/day for both groups. Albuminemia was 40.6 g/l for NPI and 40.8 g/l for HPI. A marginal protein under-nutrition appeared in NPI with a decreased albuminemia at D90 below 35 g/l (34.3 versus 41.5 g/l for HPI, p metabolic syndrome, the lower threshold intake for protein must be set at 1.2 g/kg/day to maintain blood protein homeostasis.

  4. Parecoxib, propacetamol, and their combination for analgesia after total hip arthroplasty: a randomized non-inferiority trial.

    Science.gov (United States)

    Camu, F; Borgeat, A; Heylen, R J; Viel, E J; Boye, M E; Cheung, R Y

    2017-01-01

    This study assessed non-inferiority of parecoxib vs. combination parecoxib+propacetamol and compared the opioid-sparing effects of parecoxib, propacetamol, and parecoxib+propacetamol vs. placebo after total hip arthroplasty. In this randomized, placebo-controlled, parallel-group, non-inferiority study, patients received one of four IV treatments after surgery: parecoxib 40 mg bid (n = 72); propacetamol 2 g qid (n = 71); parecoxib 40 mg bid plus propacetamol 2 g qid (n = 72); or placebo (n = 38) with supplemental IV patient-controlled analgesia (morphine). Patients and investigators were blinded to treatment. Pain intensity at rest and with movement was assessed regularly, together with functional recovery (modified Brief Pain Inventory-Short Form) and opioid-related side effects (Opioid-Related Symptom Distress Scale) questionnaires up to 48 h. After 24 h, cumulative morphine consumption was reduced by 59.8% (P < 0.001), 38.9% (P < 0.001), and 26.8% (P = 0.005) in the parecoxib+propacetamol, parecoxib, and propacetamol groups, respectively, compared with placebo. Parecoxib did not meet criteria for non-inferiority to parecoxib+propacetamol. Parecoxib+propacetamol and parecoxib significantly reduced least-squares mean pain intensity scores at rest and with movement compared with propacetamol (P < 0.05). One day after surgery, parecoxib+propacetamol significantly reduced opioid-related symptom distress and decreased pain interference with function compared with propacetamol or placebo. Parecoxib and parecoxib+propacetamol provided significant opioid-sparing efficacy compared with placebo; non-inferiority of parecoxib to parecoxib+propacetamol was not demonstrated. Opioid-sparing efficacy was accompanied by significant reductions in pain intensity on movement, improved functional outcome, and less opioid-related symptom distress. Study medications were well tolerated. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  5. Omeprazole versus doxycycline combination therapy with topical erythromycin the treatment of acne vulgaris: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fariba Jaffary

    2017-04-01

    Full Text Available Background: Acne vulgaris is self-limiting, multifactorial disease involving sebaceous glands. Omeprazole is a proton pump inhibitor with in vitro antibacterial effects against staphylococcus aureus and anti-androgen that can be potential treatment of acne vulgaris. This study was designed to evaluate the efficacy of oral omeprazole and erythromycin 4% compared to doxycycline combination therapy in the treatment of acne vulgaris. Methods: In this clinical trial study, patients with moderate acne were referred to Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Science, Iran, during August 2014 until November 2015 and were randomized into two groups receiving topical erythromycin 4% plus omeprazole (34 patients or doxycycline (35 patients for 3 months. Moderate acne, lack of sensitivity to proton pump inhibitors, lack of warfarin, phenytoin, diazepam consumption, lack of active liver or kidney disease, being older than 12 years, were considered as inclusion criteria. Pregnant or lactating patients, patients with drug allergy history, patients taking oral contraceptives, acne topical medications (including retinoids or systemic treatment within 30 days of study, patients with oligomenorrhea, hirsutism, acne conglobata, acne fulminant or body acne alone were excluded from the study. All patients were tested for Helicobacter pylori test at the beginning of the study. Results: Both inflammatory and non-inflammatory lesions decreased in both groups with negative correlation with age (P< 0.05. There was no significant correlation between positive Helicobacter pylori test and inflammatory or non-inflammatory lesion reduction (P= 0.794, P= 0.514. Also, patient satisfaction and rate of total drug side effects was not different between two treatment groups. Rate of skin reactions was 20.58% in omeprazole treated group and 11.42% in doxycycline group. For side effects, other than skin it was 2.94% versus 14.28% respectively

  6. Midpoint Shapes.

    Science.gov (United States)

    Welchman, Rosamond; Urso, Josephine

    2000-01-01

    Emphasizes the importance of children exploring hands-on and minds-on mathematics. Presents a midpoint shape activity for students to explore the midpoint shape of familiar quadrilaterals, such as squares and rectangles. (KHR)

  7. Perspectives in shape analysis

    CERN Document Server

    Bruckstein, Alfred; Maragos, Petros; Wuhrer, Stefanie

    2016-01-01

    This book presents recent advances in the field of shape analysis. Written by experts in the fields of continuous-scale shape analysis, discrete shape analysis and sparsity, and numerical computing who hail from different communities, it provides a unique view of the topic from a broad range of perspectives. Over the last decade, it has become increasingly affordable to digitize shape information at high resolution. Yet analyzing and processing this data remains challenging because of the large amount of data involved, and because modern applications such as human-computer interaction require real-time processing. Meeting these challenges requires interdisciplinary approaches that combine concepts from a variety of research areas, including numerical computing, differential geometry, deformable shape modeling, sparse data representation, and machine learning. On the algorithmic side, many shape analysis tasks are modeled using partial differential equations, which can be solved using tools from the field of n...

  8. Predictive Toxicology: Modeling Chemical Induced Toxicological Response Combining Circular Fingerprints with Random Forest and Support Vector Machine

    Directory of Open Access Journals (Sweden)

    Alexios eKoutsoukas

    2016-03-01

    Full Text Available Modern drug discovery and toxicological research are under pressure, as the cost of developing and testing new chemicals for potential toxicological risk is rising. Extensive evaluation of chemical products for potential adverse effects is a challenging task, due to the large number of chemicals and the possible hazardous effects on human health. Safety regulatory agencies around the world are dealing with two major challenges. First, the growth of chemicals introduced every year in household products and medicines that need to be tested, and second the need to protect public welfare. Hence, alternative and more efficient toxicological risk assessment methods are in high demand. The Toxicology in the 21st Century (Tox21 consortium a collaborative effort was formed to develop and investigate alternative assessment methods. A collection of 10,000 compounds composed of environmental chemicals and approved drugs were screened for interference in biochemical pathways and released for crowdsourcing data analysis. The physicochemical space covered by Tox21 library was explored, measured by Molecular Weight (MW and the octanol/water partition coefficient (cLogP. It was found that on average chemical structures had MW of 272.6 Daltons. In case of cLogP the average value was 2.476. Next relationships between assays were examined based on compounds activity profiles across the assays utilizing the Pearson correlation coefficient r. A cluster was observed between the Androgen and Estrogen Receptors and their ligand bind domains accordingly indicating presence of cross talks among the receptors. The highest correlations observed were between NR.AR and NR.AR_LBD, where it was r=0.66 and between NR.ER and NR.ER_LBD, where it was r=0.5.Our approach to model the Tox21 data consisted of utilizing circular molecular fingerprints combined with Random Forest and Support Vector Machine by modeling each assay independently. In all of the 12 sub-challenges our modeling

  9. Citalopram, Methylphenidate, or Their Combination in Geriatric Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

    National Research Council Canada - National Science Library

    Lavretsky, Helen; Reinlieb, Michelle; St. Cyr, Natalie; Siddarth, Prabha; Ercoli, Linda M; Senturk, Damla

    2015-01-01

    ... patients.Method:The authors conducted a 16-week randomized double-blind placebo-controlled trial for geriatric depression in 143 older outpatients diagnosed with major depression comparing treatment response in three treatment groups...

  10. The undue influence of shape and weight on self-evaluation in anorexia nervosa, bulimia nervosa and restrained eaters: a combined ERP and behavioral study.

    Science.gov (United States)

    Blechert, J; Ansorge, U; Beckmann, S; Tuschen-Caffier, B

    2011-01-01

    Current theories and nosology assume that the self-evaluation (SE) of individuals with eating disorders (EDs) is unduly influenced by body shape and weight. However, experimental data supporting this link are scarce, and it is not specified which subdomains of SE might be affected. We studied patients with anorexia nervosa (AN), bulimia nervosa (BN) and healthy controls (HC) with an affective priming (AP) procedure (Study 1) to unveil explicit and implicit associations between shape/weight and SE. We used weight/shape-related prime sentences, complemented by affectively congruent and incongruent target words from two SE domains. AP effects were assessed by event-related potentials (ERPs), reaction times (RTs) and subjective ratings. The ratings were also assessed (Study 2) in undergraduate restrained (RES) and unrestrained eaters (UNRES). Study 1 demonstrated stronger AP effects in both ED groups compared to HC on RTs and subjective ratings. ERPs showed AP effects only in the BN group. Restrained eaters showed similar, albeit less pronounced, priming effects on subjective ratings. ED patients associate shape/weight concerns with the non-appearance-related SE domains of interpersonal relationships and achievement/performance. These associations seem to be encoded deeper in BN patients relative to the other groups. Links between shape/weight and SE explain how body dissatisfaction impacts on self-esteem and mood in ED. The existence of similar associations in restrained eaters supports a continuum model according to which increasing associations between shape/weight and SE go along with increasing levels of ED symptoms.

  11. Classification of Potential Water Bodies Using Landsat 8 OLI and a Combination of Two Boosted Random Forest Classifiers

    OpenAIRE

    Ko, Byoung; Kim, Hyeong; Nam, Jae

    2015-01-01

    This study proposes a new water body classification method using top-of-atmosphere (TOA) reflectance and water indices (WIs) of the Landsat 8 Operational Land Imager (OLI) sensor and its corresponding random forest classifiers. In this study, multispectral images from the OLI sensor are represented as TOA reflectance and WI values because a classification result using two measures is better than raw spectral images. Two types of boosted random forest (BRF) classifiers are learned using TOA r...

  12. Paroxetine, Cognitive Therapy or Their Combination in the Treatment of Social Anxiety Disorder with and without Avoidant Personality Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Nordahl, Hans M; Vogel, Patrick A; Morken, Gunnar; Stiles, Tore C; Sandvik, Pål; Wells, Adrian

    2016-01-01

    The most efficacious treatments for social anxiety disorder (SAD) are the SSRIs and cognitive therapy (CT). Combined treatment is advocated for SAD but has not been evaluated in randomized trials using CT and SSRI. Our aim was to evaluate whether one treatment is more effective than the other and whether combined treatment is more effective than the single treatments. A total of 102 patients were randomly assigned to paroxetine, CT, the combination of CT and paroxetine, or pill placebo. The medication treatment lasted 26 weeks. Of the 102 patients, 54% fulfilled the criteria for an additional diagnosis of avoidant personality disorder. Outcomes were measured at posttreatment and 12-month follow-up assessments. CT was superior to paroxetine alone and to pill placebo at the end of treatment, but it was not superior to the combination treatment. At the 12-month follow-up, the CT group maintained benefits and was significantly better than placebo and paroxetine alone, whereas there were no significant differences among combination treatment, paroxetine alone, and placebo. Recovery rates at 12 months were much higher in the CT group (68%) compared to 40% in the combination group, 24% in the paroxetine group, and 4% in the pill placebo group. CT was the most effective treatment for SAD at both posttreatment and follow-up compared to paroxetine and better than combined treatment at the 12-month follow-up on the Liebowitz Social Anxiety Scale. Combined treatment provided no advantage over single treatments; rather there was less effect of the combined treatment compared to CT alone. © 2016 The Author(s) Published by S. Karger AG, Basel.

  13. Cost-effectiveness and cost-utility of combination therapy in early rheumatoid arthritis: randomized comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone. COBRA Trial Group. Combinatietherapie Bij Reumatoïde Artritis.

    Science.gov (United States)

    Verhoeven, A C; Bibo, J C; Boers, M; Engel, G L; van der Linden, S

    1998-10-01

    Assessment of the cost-effectiveness and cost-utility of early intervention in rheumatoid arthritis (RA) patients, with combined step-down prednisolone, methotrexate and sulphasalazine, compared to sulphasalazine alone. Multicentre 56 week randomized double-blind trial with full economic analysis of direct costs and utility analysis with rating scale and standard gamble measurement techniques. The combined-treatment group included 76 patients and the sulphasalazine group 78 patients. The mean total costs per patient in the first 56 weeks of follow-up were $5519 for combined treatment and $6511 for treatment with sulphasalazine alone (P = 0.37). Out-patient care, in-patient care and non-health care each contributed about one-third to the total costs. The combined-treatment group appeared to generate savings in the length of hospital stay for RA, non-protocol drugs and costs of home help, but comparisons were not statistically significant. Protocol drugs and monitoring were slightly more expensive in the combined-treatment group. Clinical, radiographic and functional outcomes significantly favoured combined treatment at week 28 (radiography also at week 56). Utility scores also favoured combined treatment. Combined treatment is cost-effective due to enhanced efficacy at lower or equal direct costs.

  14. An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol

    OpenAIRE

    Baillie, Andrew J; Sannibale, Claudia; Stapinski, Lexine A.; Teesson, Maree; Rapee, Ronald M; Haber, Paul S

    2013-01-01

    Background Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for...

  15. Effects of electron-withdrawing group and electron-donating core combinations on physical properties and photovoltaic performance in D-pi-A star-shaped small molecules

    NARCIS (Netherlands)

    Luponosov, Yuriy N.; Min, Jie; Solodukhin, Alexander N.; Kozlov, Oleg V.; Obrezkova, Marina A.; Peregudova, Svetlana M.; Ameri, Tayebeh; Chvalun, Sergei N.; Pshenichnikov, Maxim S.; Brabec, Christoph J.; Ponomarenko, Sergei A.

    The first representatives of star-shaped molecules having 3-alkylrhodanine (alkyl-Rh) electron-withdrawing groups, linked through bithiophene pi-spacer with electron-donating either triphenylamine (TPA) or tris(2-methoxyphenyl)amine (m-TPA) core were synthesized. The physical properties and

  16. A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal.

    Science.gov (United States)

    Ivanova, Anastasia; Tamura, Roy N

    2015-12-01

    A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first-stage data, and second-stage data from first-stage placebo non-responders and first-stage drug responders, are utilized in the efficacy analysis. The authors developed one, two and three degrees of freedom score tests for treatment effect in the TED and give formulae for asymptotic power and for sample size computations. The authors compute the optimal allocation ratio between drug and placebo in the first stage for the TED and compare the operating characteristics of the design to the standard parallel clinical trial, placebo lead-in and randomized withdrawal designs. Two motivating examples from different disease areas are presented to illustrate the possible design considerations. © The Author(s) 2011.

  17. Addition of non-invasive ventilatory support to combined aerobic and resistance training improves dyspnea and quality of life in heart failure patients: a randomized controlled trial.

    Science.gov (United States)

    Bittencourt, Hugo Souza; Cruz, Cristiano Gonçalves; David, Bruno Costa; Rodrigues-Jr, Erenaldo; Abade, Camille Magalhães; Junior, Roque Aras; Carvalho, Vitor Oliveira; Dos Reis, Francisco Borges Faria; Gomes Neto, Mansueto

    2017-11-01

    To test the hypothesis that combined aerobic and resistance training and non-invasive ventilatory support result in additional benefits compared with combined aerobic and resistance training alone in heart failure patients. A randomized, single-blind, controlled study. Cardiac rehabilitation center. A total of 46 patients with New York Heart Association class II/III heart failure were randomly assigned to a 10-week program of combined aerobic and resistance training, plus non-invasive ventilatory support ( n = 23) or combined aerobic and resistance training alone ( n = 23). Before and after intervention, results for the following were obtained: 6-minute walk test, forced vital capacity, forced expiratory volume at one second, maximal inspiratory muscle pressure, and maximal expiratory muscle pressure, with evaluation of dyspnea by the London Chest Activity of Daily Living scale, and quality of life with the Minnesota Living With Heart Failure questionnaire. Of the 46 included patients, 40 completed the protocol. The combined aerobic and resistance training plus non-invasive ventilatory support, as compared with combined aerobic and resistance training alone, resulted in significantly greater benefit for dyspnea (mean change: 4.8 vs. 1.3, p = 0.004), and quality of life (mean change: 19.3 vs. 6.8, p = 0.017 ). In both groups, the 6-minute walk test improved significantly (mean change: 45.7 vs. 44.1, p = 0.924), but without a statistically significant difference. Non-invasive ventilatory support combined with combined aerobic and resistance training provides additional benefits for dyspnea and quality of life in moderate heart failure patients. ClinicalTrials.gov identifier: NCT02384798. Registered 03 April 2015.

  18. Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients.

    Science.gov (United States)

    Robinson, Dudley; Kelleher, Con; Staskin, David; Mueller, Elizabeth R; Falconer, Christian; Wang, Jianye; Ridder, Arwin; Stoelzel, Matthias; Paireddy, Asha; van Maanen, Rob; Hakimi, Zalmai; Herschorn, Sender

    2017-07-13

    To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial. Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL) Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires. Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups (P ≤ 0.002). For both combination groups, the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy (P < 0.05). The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups. PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters, including OAB-q Symptom Bother score, HRQOL Total score, and PPBC. © 2017 Wiley Periodicals, Inc.

  19. Effect of combined dexamethasone therapy with nebulized r-epinephrine or salbutamol in infants with bronchiolitis: A randomized, double-blind, controlled trial

    OpenAIRE

    Bawazeer, Manal; Aljeraisy, Majed; Albanyan, Esam; Abdullah, Alanazi; Al Thaqafi, Wesam; Alenazi, Jaber; Al otaibi, Zaam; Al Ghaihab, Mohammed

    2014-01-01

    Background: This study investigated the effect of combining oral dexamethasone with either nebulized racemic epinephrine or salbutamol compared to bronchodilators alone for the treatment of infants with bronchiolitis. Materials and Methods: This was a double-blind, randomized controlled trial on infants (1 to 12 months) who were diagnosed in the emergency department with moderate-to-severe bronchiolitis. The primary outcome was the rate of hospital admission within 7 days of the first dose of...

  20. SU-E-I-87: Automated Liver Segmentation Method for CBCT Dataset by Combining Sparse Shape Composition and Probabilistic Atlas Construction

    Energy Technology Data Exchange (ETDEWEB)

    Li, Dengwang [Shandong Normal University, Jinan, Shandong Province (China); Liu, Li [Shandong Normal University, Jinan, Shandong (China); Chen, Jinhu; Li, Hongsheng [Shandong Cancer Hospital and Institute, Jinan, Shandong (China)

    2014-06-01

    Purpose: The aiming of this study was to extract liver structures for daily Cone beam CT (CBCT) images automatically. Methods: Datasets were collected from 50 intravenous contrast planning CT images, which were regarded as training dataset for probabilistic atlas and shape prior model construction. Firstly, probabilistic atlas and shape prior model based on sparse shape composition (SSC) were constructed by iterative deformable registration. Secondly, the artifacts and noise were removed from the daily CBCT image by an edge-preserving filtering using total variation with L1 norm (TV-L1). Furthermore, the initial liver region was obtained by registering the incoming CBCT image with the atlas utilizing edge-preserving deformable registration with multi-scale strategy, and then the initial liver region was converted to surface meshing which was registered with the shape model where the major variation of specific patient was modeled by sparse vectors. At the last stage, the shape and intensity information were incorporated into joint probabilistic model, and finally the liver structure was extracted by maximum a posteriori segmentation.Regarding the construction process, firstly the manually segmented contours were converted into meshes, and then arbitrary patient data was chosen as reference image to register with the rest of training datasets by deformable registration algorithm for constructing probabilistic atlas and prior shape model. To improve the efficiency of proposed method, the initial probabilistic atlas was used as reference image to register with other patient data for iterative construction for removing bias caused by arbitrary selection. Results: The experiment validated the accuracy of the segmentation results quantitatively by comparing with the manually ones. The volumetric overlap percentage between the automatically generated liver contours and the ground truth were on an average 88%–95% for CBCT images. Conclusion: The experiment demonstrated

  1. The Impact of Combined Music and Tai Chi on Depressive Symptoms Among Community-Dwelling Older Persons: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Liao, S J; Tan, M P; Chong, M C; Chua, Y P

    2018-02-13

    The effectiveness of pharmacological treatment may be limited in older persons. Several studies using Tai Chi or music therapy separately confirmed positive effects in the reduction of depressive symptoms. We conducted a cluster randomized controlled trial to evaluate the possible synergistic effect of combined music and Tai Chi on depressive symptoms. One hundred and seven older adults with mild to moderate depressive symptoms were recruited from Ya'an city. Fifty-five participants were cluster randomized to combined music and Tai Chi group for three months, while the other fifty-two individuals were randomized to the control group that entailed routine health education delivered monthly by community nurses. The primary outcome of depressive symptoms was measured with the Geriatric Depression Scale (GDS) at baseline and monthly for three months. At three-month follow-up, a statistically significant improvement in depressive symptoms was found in the intervention group compared with control group (F(3,315) = 69.661, P < 0.001). Following adjustments for socio-demographic data, the true effect of intervention on depressive symptoms was significant (F = 41.725, P < 0.01, η p 2 = 0.574). Combined music and Tai Chi reduced depressive symptoms among community-dwelling older persons. This represents an economically viable solution to the management of depression in highly populous developing nations.

  2. Shapes of binary asteroid primaries from photometric observations

    Science.gov (United States)

    Scheirich, Peter

    2016-10-01

    I will present results from a method which combine lightcurve inversion for single bodies and the method for inversion of lightcurves of occulting/eclipsing binary systems. A code developed by M. Kaasalainen and J. Durech for inversion of lightcurves of single bodies is adapted to fit our purposes. The original code uses a slightly elongated ellipsoid as an initial shape for optimization. We substituted this ellipsoid with a variety of shapes using Gaussian random spheres. This allowed the optimization algorithm to iterate to a range of final shapes.For each binary system, the short-period (rotational) component of its lightcurve is inverted using this code and a set of possible shapes of the primary are obtained. In the next step these shape models of the primary are, one by one, incorporated into the full model of the binary system and complete photometric data including the mutual events are fitted. Comparing synthetic lightcurves of the best-fit solutions with the observed data enables another narrowing of the selection of the possible shapes of the primary. This process is based on the times of phases of mutual events occurring on different geometries (i.e. the secondary passing in front of/behind the primary not only equator-on).We will also test a hypothesis that most of the primaries of the binary systems are similar in shape to each other. A figure resembling the shape of the primary of 1999 KW4, i.e., the top-shaped object with an equatorial ridge, will be used for the primary's shape. Its main characteristics - a polar flattening and width and height of the equatorial ridge, will be used as independent parameters. A variety of the shapes generated by a combination of these parameters will be used as an initial shapes for the optimization using the code described above.The work is supported by the Grant Agency of the Czech Republic, Grant 15-07193S.

  3. Randomized Controlled Trial of Sertraline, Prolonged Exposure Therapy and Their Combination in OEF/OIF with PTSD

    Science.gov (United States)

    2015-12-01

    include exposure therapy (such as PE) and selective serotonin reuptake inhibitors (SSRIs; such as SERT). To date, there have been no randomized, direct... Depression and Anxiety, 2004. 19(2): p. 112-120. 9. Cahill, S.P., et al. Cognitive-behavioral therapy for adults, in Effective treatments for PTSD

  4. OVULATION INDUCTION IN PREMATURE OVARIAN FAILURE - A PLACEBO-CONTROLLED RANDOMIZED TRIAL COMBINING PITUITARY SUPPRESSION WITH GONADOTROPIN STIMULATION

    NARCIS (Netherlands)

    VANKASTEREN, YM; HOEK, A; SCHOEMAKER, J

    Objectives: To determine the effect of pituitary suppression with a GnRH agonist (GnRH-a) on the success of ovulation induction with exogenous gonadotropins in patients with premature ovarian failure (POF). Design: Placebo-controlled, randomized, double-blind study. The data were analyzed with a

  5. Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma.

    Science.gov (United States)

    Chesney, Jason; Puzanov, Igor; Collichio, Frances; Singh, Parminder; Milhem, Mohammed M; Glaspy, John; Hamid, Omid; Ross, Merrick; Friedlander, Philip; Garbe, Claus; Logan, Theodore F; Hauschild, Axel; Lebbé, Celeste; Chen, Lisa; Kim, Jenny J; Gansert, Jennifer; Andtbacka, Robert H I; Kaufman, Howard L

    2017-10-05

    Purpose We evaluated the combination of talimogene laherparepvec plus ipilimumab versus ipilimumab alone in patients with advanced melanoma in a phase II study. To our knowledge, this was the first randomized trial to evaluate addition of an oncolytic virus to a checkpoint inhibitor. Methods Patients with unresectable stages IIIB to IV melanoma, with no more than one prior therapy if BRAF wild-type, no more than two prior therapies if BRAF mutant, measurable/injectable disease, and without symptomatic autoimmunity or clinically significant immunosuppression were randomly assigned 1:1 to receive talimogene laherparepvec plus ipilimumab or ipilimumab alone. Talimogene laherparepvec treatment began in week 1 (first dose, ≤ 4 mL × 10(6) plaque-forming units/mL; after 3 weeks, ≤ 4 mL × 10(8) plaque-forming units/mL every 2 weeks). Ipilimumab (3 mg/kg every 3 weeks; up to four doses) began week 1 in the ipilimumab alone arm and week 6 in the combination arm. The primary end point was objective response rate evaluated by investigators per immune-related response criteria. Results One hundred ninety-eight patients were randomly assigned to talimogene laherparepvec plus ipilimumab (n = 98), or ipilimumab alone( n = 100). Thirty-eight patients (39%) in the combination arm and 18 patients (18%) in the ipilimumab arm had an objective response (odds ratio, 2.9; 95% CI, 1.5 to 5.5; P = .002). Responses were not limited to injected lesions; visceral lesion decreases were observed in 52% of patients in the combination arm and 23% of patients in the ipilimumab arm. Frequently occurring adverse events (AEs) included fatigue (combination, 59%; ipilimumab alone, 42%), chills (combination, 53%; ipilimumab alone, 3%), and diarrhea (combination, 42%; ipilimumab alone, 35%). Incidence of grade ≥ 3 AEs was 45% and 35%, respectively. Three patients in the combination arm had fatal AEs; none were treatment related. Conclusion The study met its primary end point; the objective

  6. Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: randomized, placebo-controlled pharmaco-clinical trial.

    Science.gov (United States)

    Melzer, Jörg; Schrader, Ewald; Brattström, Axel; Schellenberg, Rüdiger; Saller, Reinhard

    2009-09-01

    Herbal drugs are often used in patients with somatoform disorders yet, the available evidence is limited. The aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 = 4-combination versus 3-combination without butterbur and placebo) in patients with somatoform disorders.For a 2-week treatment in patients with somatization disorder (F45.0) and undifferentiated somatoform disorder (F45.1), 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo). Anxiety (visual analogue scale - VAS) and depression (Beck's Depression Inventory - BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter.The 4-combination was significantly superior to the 3-combination and placebo (4-combination > 3-combination > placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety, no serious adverse events occurred. In total 9 non-serious adverse events were documented but the distribution did not differ significantly between the treatment groups.This herbal preparation (Ze185) showed to be an efficacious and safe short-term treatment in patients with somatoform disorders.

  7. Random, double- and single-strand DNA breaks can be differentiated in the method of Comet assay by the shape of the comet image.

    Science.gov (United States)

    Georgieva, Milena; Zagorchev, Plamen; Miloshev, George

    2015-10-01

    Comet assay is an invaluable tool in DNA research. It is widely used to detect DNA damage as an indicator of exposure to genotoxic stress. A canonical set of parameters and specialized software programs exist for Comet assay data quantification and analysis. None of them so far has proven its potential to employ a computer-based algorithm for assessment of the shape of the comet as an indicator of the exact mechanism by which the studied genotoxins cut in the molecule of DNA. Here, we present 14 unique measurements of the comet image based on the comet morphology. Their mathematical derivation and statistical analysis allowed precise description of the shape of the comet image which in turn discriminated the cause of genotoxic stress. This algorithm led to the development of the "CometShape" software which allowed easy discrimination among different genotoxins depending on the type of DNA damage they induce. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  8. Electroacupuncture and Rosiglitazone Combined Therapy as a Means of Treating Insulin Resistance and Type 2 Diabetes Mellitus: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Rong-Tsung Lin

    2013-01-01

    Full Text Available Aims. To evaluate the efficacy of rosiglitazone (TZD and electroacupuncture (EA combined therapy as a treatment for type 2 diabetes mellitus (T2DM patients by randomized single-blind placebo controlled clinical trial. Methods. A total of 31 newly diagnostic T2DM patients, who fulfilled the study's eligibility criteria, were recruited. The individuals were randomly assigned into two groups, the control group (TZD, N=15 and the experimental group (TZD + EA, N=16. Changes in their plasma free fatty acid (FFA, glucose, and insulin levels, together with their homeostasis model assessment (HOMA indices, were statistically compared before and after treatment. Hypoglycemic activity (% was also compared between these two groups. Results. There was no significant difference in hypoglycemic activity between the TZD and TZD + EA group. The effectiveness of the combined therapy seems to derive from an improvement in insulin resistance and a significant lowering of the secreted insulin rather than the effect of TZD alone on T2DM. The combined treatment had no significant adverse effects. A lower plasma FFA concentration is likely to be the mechanism that causes this effect. Conclusion. This combined therapy seems to suppress endogenous insulin secretion by improving insulin resistance via a mechanism involving a reduction in plasma FFA. This trial is registered with ClinicalTrials.gov NCT01577095.

  9. Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH).

    Science.gov (United States)

    Preuss, H G; Marcusen, C; Regan, J; Klimberg, I W; Welebir, T A; Jones, W A

    2001-01-01

    Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients were enrolled from 3 urological practices in the USA. 144 subjects were randomized for study. 17 subjects eventually withdrew, leaving 70 patients in the test group and 57 in the placebo group to complete the study. Inclusion criteria consisted of a diagnosis of BPH, no evidence of cancer, and a maximal urinary flow rate between 5 and 15 ml/second. Patients received either placebo or the combined natural products for 3 months. Evaluations were performed via the American Urological Association (AUA) Symptom Index score, urinary flow rate, PSA measurement, and residual bladder volume. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo (p saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.

  10. Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial

    DEFF Research Database (Denmark)

    Rasmussen, M L; Dierking, G; Lech, K

    2008-01-01

    BACKGROUND: Multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. We investigated the analgesic effect of pregabalin and dexamethasone in combination with paracetamol after abdominal hysterectomy. METHODS: One hundred a...

  11. Effect of weight loss with or without exercise on inflammatory markers and adipokines in postmenopausal women : The SHAPE-2 Trial, a randomized controlled trial

    NARCIS (Netherlands)

    Van Gemert, Willemijn A.; May, Anne M.|info:eu-repo/dai/nl/304818658; Schuit, Albertine J.; Oosterhof, Blanche Y M; Peeters, Petra H.|info:eu-repo/dai/nl/074099655; Monninkhof, Evelyn M.|info:eu-repo/dai/nl/260610178

    2016-01-01

    Background: We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. Methods: Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both

  12. Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women : The SHAPE-2 Trial, A Randomized Controlled Trial

    NARCIS (Netherlands)

    van Gemert, Willemijn A; May, Anne M; Schuit, Albertine J; Oosterhof, Blanche Y M; Peeters, Petra H M; Monninkhof, Evelyn M.

    BACKGROUND: We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. METHODS: Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both

  13. Evaluating an Organizational-Level Occupational Health Intervention in a Combined Regression Discontinuity and Randomized Control Design.

    Science.gov (United States)

    Sørensen, By Ole H

    2016-10-01

    Organizational-level occupational health interventions have great potential to improve employees' health and well-being. However, they often compare unfavourably to individual-level interventions. This calls for improving methods for designing, implementing and evaluating organizational interventions. This paper presents and discusses the regression discontinuity design because, like the randomized control trial, it is a strong summative experimental design, but it typically fits organizational-level interventions better. The paper explores advantages and disadvantages of a regression discontinuity design with an embedded randomized control trial. It provides an example from an intervention study focusing on reducing sickness absence in 196 preschools. The paper demonstrates that such a design fits the organizational context, because it allows management to focus on organizations or workgroups with the most salient problems. In addition, organizations may accept an embedded randomized design because the organizations or groups with most salient needs receive obligatory treatment as part of the regression discontinuity design. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  14. Identification of Random Dynamic Force Using an Improved Maximum Entropy Regularization Combined with a Novel Conjugate Gradient

    Directory of Open Access Journals (Sweden)

    ChunPing Ren

    2017-01-01

    Full Text Available We propose a novel mathematical algorithm to offer a solution for the inverse random dynamic force identification in practical engineering. Dealing with the random dynamic force identification problem using the proposed algorithm, an improved maximum entropy (IME regularization technique is transformed into an unconstrained optimization problem, and a novel conjugate gradient (NCG method was applied to solve the objective function, which was abbreviated as IME-NCG algorithm. The result of IME-NCG algorithm is compared with that of ME, ME-CG, ME-NCG, and IME-CG algorithm; it is found that IME-NCG algorithm is available for identifying the random dynamic force due to smaller root mean-square-error (RMSE, lower restoration time, and fewer iterative steps. Example of engineering application shows that L-curve method is introduced which is better than Generalized Cross Validation (GCV method and is applied to select regularization parameter; thus the proposed algorithm can be helpful to alleviate the ill-conditioned problem in identification of dynamic force and to acquire an optimal solution of inverse problem in practical engineering.

  15. Efficacy of systemic and intratympanic corticosteroid combination therapy versus intratympanic or systemic therapy in patients with idiopathic sudden sensorineural hearing loss: a randomized controlled trial.

    Science.gov (United States)

    Ashtiani, Mohammadtaghi Khorsandi; Firouzi, Farzad; Bastaninejad, Shahin; Dabiri, Sasan; Nasirmohtaram, Sevil; Saeedi, Niloufar; Ghazavi, Hossein; Sahebi, Leyla

    2017-11-17

    The present study was conducted to compare the rates of recovery from idiopathic sudden deafness after the treatment with oral and intratympanic corticosteroids in both mono and combination therapies. Triple-blind randomized clinical trial. Tertiary referral hospital. A total of 112 patients who were admitted to the ENT emergency department randomly divided into three groups: an oral corticosteroid plus intratympanic placebo (systemic corticosteroid monotherapy group); an intratympanic corticosteroid plus oral placebo group (IT monotherapy group); and a combination therapy group (IT plus systemic combination group). All patients were treated additionally with antiviral and proton pomp inhibitor. An audiometry was performed once before beginning the therapies and again at the end of the therapy. Of the total of 112 patients, 32 received intratympanic (IT) corticosteroids, 45 were receiving systemic corticosteroids, and 35 were receiving a combination of the two. A total of 74 patients (66.1%) responded positively [response to treatment was calculated as gain of at least 10 dB in 10 dB in average threshold or with the minimum improvement of 15% in speech discrimination scores (SDS)] to corticosteroid therapy. No significant differences were observed between the three groups (IT, systemic group, and combination therapy group) in their overall response to treatment (p = 0.5). Patients who suffered from concomitant tinnitus and dizziness responded less positively to the treatment (p < 0.002). Positive family history of SSNHL seems to be negative prognostic factors in the response to treatment (p < 0.001). The response to treatment was not related to the pattern (p = 0.04) and initial severity of hearing loss (p = 0.9). This study did not find any difference in the rate of hearing improvement between systemic, intratympanic, and combined corticosteroid therapy for sudden hearing loss. 1b.

  16. Combining imagination and reason in the treatment of depression: a randomized controlled trial of internet-based cognitive-bias modification and internet-CBT for depression.

    Science.gov (United States)

    Williams, Alishia D; Blackwell, Simon E; Mackenzie, Anna; Holmes, Emily A; Andrews, Gavin

    2013-10-01

    Computerized cognitive-bias modification (CBM) protocols are rapidly evolving in experimental medicine yet might best be combined with Internet-based cognitive behavioral therapy (iCBT). No research to date has evaluated the combined approach in depression. The current randomized controlled trial aimed to evaluate both the independent effects of a CBM protocol targeting imagery and interpretation bias (CBM-I) and the combined effects of CBM-I followed by iCBT. Patients diagnosed with a major depressive episode were randomized to an 11-week intervention (1 week/CBM-I + 10 weeks/iCBT; n = 38) that was delivered via the Internet with no face-to-face patient contact or to a wait-list control (WLC; n = 31). Intent-to-treat marginal models using restricted maximum likelihood estimation demonstrated significant reductions in primary measures of depressive symptoms and distress corresponding to medium-large effect sizes (Cohen's d = 0.62-2.40) following CBM-I and the combined (CBM-I + iCBT) intervention. Analyses demonstrated that the change in interpretation bias at least partially mediated the reduction in depression symptoms following CBM-I. Treatment superiority over the WLC was also evident on all outcome measures at both time points (Hedges gs = .59-.98). Significant reductions were also observed following the combined intervention on secondary measures associated with depression: disability, anxiety, and repetitive negative thinking (Cohen's d = 1.51-2.23). Twenty-seven percent of patients evidenced clinically significant change following CBM-I, and this proportion increased to 65% following the combined intervention. The current study provides encouraging results of the integration of Internet-based technologies into an efficacious and acceptable form of treatment delivery. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

  17. Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women.

    Science.gov (United States)

    Christen, William G; Glynn, Robert J; Chew, Emily Y; Albert, Christine M; Manson, JoAnn E

    2016-01-01

    To examine the incidence of cataract and cataract extraction in a trial of folic acid and vitamins B6 and B12. In a randomized, double-masked, placebo-controlled trial, 5442 female health professionals aged 40 years or older with preexisting cardiovascular disease (CVD) or three or more CVD risk factors were randomly assigned to receive a combination of folic acid (2.5 mg/day), vitamin B6 (50 mg/day), and vitamin B12 (1 mg/day), or placebo. A total of 3925 of these women did not have a diagnosis of cataract at baseline and were included in this analysis. The primary endpoint was age-related cataract, defined as an incident age-related lens opacity, responsible for a reduction in best-corrected visual acuity to 20/30 or worse, based on self-report confirmed by medical record review. Extraction of incident age-related cataract was a secondary endpoint of the trial. During an average of 7.3 years of treatment and follow-up, 408 cataracts and 275 cataract extractions were documented. There were 215 cataracts in the combination treatment group and 193 in the placebo group (hazard ratio, HR, 1.10, 95% confidence interval, CI, 0.90-1.33; p = 0.36). For the secondary endpoint of cataract extraction, there were 155 in the combination treatment group and 120 in the placebo group (HR 1.28, 95% CI 1.01-1.63; p = 0.04). In this large-scale randomized trial of women at high risk of CVD, daily supplementation with a combination of folic acid, vitamin B6, and vitamin B12 had no significant effect on cataract, but may have increased the risk of cataract extraction.

  18. Add-on effects of fluvastatin in simeprevir/pegylated-interferon/ribavirin combination therapy for patients with genotype 1 hepatitis C virus infection: A randomized controlled study.

    Science.gov (United States)

    Suda, Goki; Ito, Jun; Nagasaka, Atsushi; Yamamoto, Yoshiya; Furuya, Ken; Okamoto, Munenori; Terashita, Katsumi; Kobayashi, Tomoe; Tsunematsu, Izumi; Yoshida, Junichi; Meguro, Takashi; Ohara, Masatsugu; Kawagishi, Naoki; Kimura, Megumi; Umemura, Machiko; Izumi, Takaaki; Tsukuda, Yoko; Nakai, Masato; Sho, Takuya; Natsuizaka, Mitsuteru; Morikawa, Kenichi; Ogawa, Koji; Sakamoto, Naoya

    2017-07-19

    The Japan Society of Hepatology guidelines indicate that hepatitis C virus (HCV) protease inhibitor combination therapy with simeprevir (SMV), pegylated-interferon (Peg-IFN), and ribavirin (RBV) is a therapeutic option for patients who fail to respond to a direct direct-acting antiviral-containing regimen. However, treatment outcomes have room for improvement. Fluvastatin (FLV) add-on treatment in Peg-IFN and RBV combination therapy for HCV-infected patients significantly improved the sustained virologic response (SVR), but the add-on effect of FLV on SMV combination therapy is not well understood. This was a prospective, randomized, multicenter study in which a total of 61 HCV genotype 1b-infected patients were recruited and 60 eligible patients were randomly allocated to two groups that received 12 weeks of SMV/Peg-IFN/RBV followed by 12 weeks of Peg-IFN/RBV with or without 24 weeks of FLV. The SVR rate and adverse events were compared between the two groups. Thirty-one patients were allocated to the FLV add-on group and 29 patients were allocated to the control group. Baseline clinical factors, including median age, baseline platelet count, alanine aminotransferase level, HCV RNA titer, Fibrosis-4 index, and rate of IL28B minor genotype, were all similar between the two groups. The rapid virologic response, end-of-treatment response rates, SVR rates at 24 weeks after treatment, and safety profiles were also similar between the two groups. This prospective, randomized, multicenter study indicated that FLV had no add-on effect when given with SMV/Peg-IFN/RBV combination therapy for genotype 1b HCV-infected patients. © 2017 The Japan Society of Hepatology.

  19. Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study.

    Science.gov (United States)

    Nanas, John N; Tsagalou, Eleftheria P; Kanakakis, John; Nanas, Serafim N; Terrovitis, John V; Moon, Thomas; Anastasiou-Nana, Maria I

    2004-04-01

    To examine the effects of long-term intermittent dobutamine infusion, combined with oral amiodarone in patients with congestive heart failure (CHF) refractory to standard medical treatment. Prospective, randomized, double-blind, placebo-controlled clinical trial. Inpatient and outpatient heart failure clinic in a university teaching hospital. Thirty patients with end-stage CHF refractory to standard medical treatment who could be weaned from dobutamine therapy after a first 72-h infusion were randomized in a double-blind manner to receive IV infusions of placebo (group 1; 14 patients) vs dobutamine in a dose of 10 micro g/kg/min (group 2; 16 patients) for 8 h every 14 days. All patients received standard medical therapy and also were treated with oral amiodarone, 400 mg/d, which was started at least 2 weeks before randomization. Kaplan-Meier survival analysis showed a 60% reduction in the risk of death from any cause in the group treated with the combination of dobutamine and amiodarone, compared with the group treated with placebo and amiodarone (hazard ratio, 0.403; 95% confidence interval, 0.164 to 0.992; p = 0.048). The 1-year and 2-year survival rates were 69% and 44%, respectively, in the dobutamine-treated group, vs 28% and 21%, respectively, in the placebo-treated group (p amiodarone added to the conventional drugs improved the survival of patients with advanced CHF that was refractory to conventional treatment.

  20. Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Dennis L Kelleher

    Full Text Available Umeclidinium bromide (GSK573719; UMEC, a new long-acting muscarinic receptor antagonist (LAMA, is in development with vilanterol (GW642444; VI, a selective long-acting β(2 agonist (LABA, as a once-daily inhaled combination therapy for the treatment of chronic obstructive pulmonary disease (COPD. A single dose healthy volunteer study was conducted to assess the safety and tolerability, pharmacodynamics (PD and pharmacokinetics (PK of inhaled umeclidinium (500 µg and vilanterol (50 µg when administered separately and in combination using a novel dry powder inhaler (NDPI. Co-administration of single inhaled doses of umeclidinium and vilanterol to healthy Japanese subjects was well tolerated and not associated with meaningful changes in systemic exposure or PD effects compared with administration of either compound individually. Pharmacokinetic assessments showed rapid absorption for both drugs (Tmax = 5 min for both umeclidinium and vilanterol followed by rapid elimination with median tlast of 4-5 h for umeclidinium and median tlast of 1.5-2.0 h for vilanterol. Assessments of pharmacokinetic interaction were inconclusive since for umeclidinium, Cmax following combination was higher than umeclidinium alone but not AUC whereas for vilanterol, AUC following combination was higher than vilanterol alone but not Cmax. There were no obvious trends observed between individual maximum supine heart rate and umeclidinium Cmax or vilanterol Cmax when delivered as umeclidinium 500 µg and vilanterol 50 µg combination or when delivered as umeclidinium or vilanterol alone.Clinicaltrials.gov NCT00976144.

  1. Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial.

    Science.gov (United States)

    Kelleher, Dennis L; Mehta, Rashmi S; Jean-Francois, Bernadette M; Preece, Andrew F; Blowers, James; Crater, Glenn D; Thomas, Paul

    2012-01-01

    Umeclidinium bromide (GSK573719; UMEC), a new long-acting muscarinic receptor antagonist (LAMA), is in development with vilanterol (GW642444; VI), a selective long-acting β(2) agonist (LABA), as a once-daily inhaled combination therapy for the treatment of chronic obstructive pulmonary disease (COPD). A single dose healthy volunteer study was conducted to assess the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of inhaled umeclidinium (500 µg) and vilanterol (50 µg) when administered separately and in combination using a novel dry powder inhaler (NDPI). Co-administration of single inhaled doses of umeclidinium and vilanterol to healthy Japanese subjects was well tolerated and not associated with meaningful changes in systemic exposure or PD effects compared with administration of either compound individually. Pharmacokinetic assessments showed rapid absorption for both drugs (Tmax = 5 min for both umeclidinium and vilanterol) followed by rapid elimination with median tlast of 4-5 h for umeclidinium and median tlast of 1.5-2.0 h for vilanterol. Assessments of pharmacokinetic interaction were inconclusive since for umeclidinium, Cmax following combination was higher than umeclidinium alone but not AUC whereas for vilanterol, AUC following combination was higher than vilanterol alone but not Cmax. There were no obvious trends observed between individual maximum supine heart rate and umeclidinium Cmax or vilanterol Cmax when delivered as umeclidinium 500 µg and vilanterol 50 µg combination or when delivered as umeclidinium or vilanterol alone. Clinicaltrials.gov NCT00976144.

  2. Stability of modulation transfer function calibration of surface profilometers using binary pseudo-random gratings and arrays with nonideal groove shapes

    Energy Technology Data Exchange (ETDEWEB)

    Barber, Samuel K.; Anderson, Erik H.; Cambie, Rossana; Marchesini, Stefano; McKinney, Wayne R.; Takacs, Peter Z.; Voronov, Dmitry L.; Yashchuk, Valeriy V.

    2010-03-31

    The major problem of measurement of a power spectral density (PSD) distribution of surface heights with surface profilometers arises due to the unknown Modulation Transfer Function (MTF) of the instruments, which tends to distort the PSD at higher spatial frequencies. The special mathematical properties of binary pseudo-random patterns make them an ideal basis for developing MTF calibration test surfaces. Two-dimensional binary pseudo-random arrays (BPRAs) have been fabricated and used for the MTF calibration of the MicroMap{trademark}-570 interferometric microscope with all available objectives. An investigation into the effects of fabrication imperfections on the quality of the MTF calibration and a procedure for accounting for such imperfections are presented.

  3. Omeprazole-Domperidone Fixed Dose Combination vs Omeprazole Monotherapy: A Phase 4, Open-Label, Comparative, Parallel Randomized Controlled Study in Mild to Moderate Gastroesophageal Reflux Disease

    Directory of Open Access Journals (Sweden)

    KY Marakhouski

    2017-05-01

    Full Text Available Aim: To compare the efficacy and safety of omeprazole-domperidone combination vs omeprazole monotherapy in gastroesophageal reflux disease (GERD. Methods: In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole 20 mg + domperidone 30 mg or group 2 (omeprazole 20 mg in an equal ratio; 2 capsules daily in the morning were administered for 8 weeks. Results: Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately, 83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole. There were no safety concerns. Conclusions: Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse events. Trial registration: This trial is registered with http://clinicaltrials.gov , number NCT02140073.

  4. Randomized controlled trial to evaluate the efficacy of oral lycopene in combination with vitamin E and selenium in the treatment of oral leukoplakia

    Directory of Open Access Journals (Sweden)

    Jyotsna Sandeep Patel

    2014-01-01

    Full Text Available Aims and Objectives: A randomized controlled study was carried out to evaluate the efficacy of lycopene in combination with vitamin E and selenium in the treatment of oral leukoplakia in patients visiting the Government Dental College and Hospital, Mumbai. Materials and Methods: Forty-one patients of leukoplakia were randomly categorized (irrespective of size and severity of the lesions in two groups: Group A and B. Group A consisting of 21 patients were administered combination of lycopene (3 mg, vitamin E (200 I.U. and selenium (100 mcg twice daily and group B consisting of 20 patients were given placebo capsules once daily for a period of 3 months. Post-treatment follow-up period was 3-4 months. The product used in the study was LYC-O-MATO soft gels, manufactured by Mano pharmaceuticals, Chennai, India. The treatment outcome was evaluated both clinically and histologically and the results were statistically evaluated using Student′s unpaired ′t′ test. Results: The results showed that the patients receiving lycopene in combination with vitamin E and selenium have statistically significant improvements both clinically and histologically as compared to those receiving placebo and with no side effects. Conclusion: The study results proved the efficacy and safety of lycopene along with selenium and vitamin E in the management of oral leukoplakia.

  5. Combined use of hyperbaric and hypobaric ropivacaine significantly improves hemodynamic characteristics in spinal anesthesia for caesarean section: a prospective, double-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    ZheFeng Quan

    Full Text Available To observe the hemodynamic changes of parturients in the combined use of hyperbaric (4 mg and hypobaric (6 mg ropivacaine during spinal anesthesia for caesarean section in this randomized double-blind study.Parturients (n = 136 undergoing elective cesarean delivery were randomly and equally allocated to receive either combined hyperbaric and hypobaric ropivacaine (Group A or hyperbaric ropivacaine (Group B. Outcome measures were: hemodynamic characteristics, maximum height of sensory block, time to achieve T8 sensory blockade level, incidence of complications, Apgar scores at 1 and 5 min, and neonatal blood gas analysis.Group A had a lower level of sensory blockade (T6 [T6-T7] and longer time to achieve T8 sensory blockade level (8 ± 1.3 min than did patients in Group B (T3 [T2-T4] and 5 ± 1.0 min, respectively; P < 0.001, both. The incidence rates for hypotension, nausea, and vomiting were significantly lower in Group A (13%, 10%, and 3%, respectively than Group B (66%, 31%, and 13%; P < 0.001, P = 0.003, P = 0.028.Combined use of hyperbaric (4 mg and hypobaric (6 mg ropivacaine significantly decreased the incidences of hypotension and complications in spinal anesthesia for caesarean section by extending induction time and decreasing the level of sensory blockade.Chinese Clinical Trial Register ChiCTR-TRC-13004622.

  6. Effect of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia: A randomized, 1-year study.

    Science.gov (United States)

    Guo, Xiaofeng; Zhai, Jinguo; Liu, Zhening; Fang, Maosheng; Wang, Bo; Wang, Chuanyue; Hu, Bin; Sun, Xueli; Lv, Luxian; Lu, Zheng; Ma, Cui; He, Xiaolin; Guo, Tiansheng; Xie, Shiping; Wu, Renrong; Xue, Zhimin; Chen, Jindong; Twamley, Elizabeth W; Jin, Hua; Zhao, Jingping

    2010-09-01

    Antipsychotic drugs are limited in their ability to improve the overall outcome of schizophrenia. Adding psychosocial treatment may produce greater improvement in functional outcome than does medication treatment alone. To evaluate the effectiveness of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia. Randomized controlled trial. Ten clinical sites in China. Clinical sample of 1268 patients with early-stage schizophrenia treated from January 1, 2005, through October 31, 2007. Intervention Patients were randomly assigned to receive antipsychotic medication treatment only or antipsychotic medication plus 12 months of psychosocial intervention consisting of psychoeducation, family intervention, skills training, and cognitive behavior therapy administered during 48 group sessions. The rate of treatment discontinuation or change due to any cause, relapse or remission, and assessments of insight, treatment adherence, quality of life, and social functioning. The rates of treatment discontinuation or change due to any cause were 32.8% in the combined treatment group and 46.8% in the medication-alone group. Comparisons with medication treatment alone showed lower risk of any-cause discontinuation with combined treatment (hazard ratio, 0.62; 95% confidence interval, 0.52-0.74; P psychosocial intervention have a lower rate of treatment discontinuation or change, a lower risk of relapse, and improved insight, quality of life, and social functioning. clinicaltrials.gov Identifier: NCT00654576.

  7. Effects of a psychosocial intervention programme combined with exercise in community-dwelling older adults with chronic pain: A randomized controlled trial.

    Science.gov (United States)

    Hirase, T; Kataoka, H; Nakano, J; Inokuchi, S; Sakamoto, J; Okita, M

    2017-11-21

    Although researchers have recommended exercise training and psychosocial intervention to manage chronic pain, an effective intervention for Japanese community-dwelling older adults with chronic pain has not been established. This randomized controlled trial examined whether exercise training combined with psychosocial intervention more effectively improves pain, psychological status and physical activity than does exercise training alone in this population. We randomized 128 older adults with chronic pain to either an intervention group (n = 64) involving exercise training combined with psychosocial intervention, or a control group (n = 64) involving only exercise training. Exercise training comprised weekly 60-min sessions for 12 weeks. Psychosocial intervention involved changing participants' focus on pain using self-management education and cognitive behavioural therapy, and participants recorded their daily pain intensity and step counts. Pain intensity, psychological status and physical activity were assessed before and 12 weeks after the intervention. A time-by-group interaction emerged for psychological status (p = 0.003) and physical activity (p psychosocial intervention improves key outcome indicators more effectively than does exercise training alone in older adults with chronic pain. Although research has shown that combined exercise and psychosocial intervention is optimal for managing chronic pain, our study is the first, to the best of our knowledge, to test a specific intervention of this type in community-dwelling older adults with chronic pain in Japan. © 2017 European Pain Federation - EFIC®.

  8. A Combined Motivation and Parent-Child Interaction Therapy Package Reduces Child Welfare Recidivism in a Randomized Dismantling Field Trial

    Science.gov (United States)

    Chaffin, Mark; Funderburk, Beverly; Bard, David; Valle, Linda Anne; Gurwitch, Robin

    2011-01-01

    Objective: A package of parent-child interaction therapy (PCIT) combined with a self-motivational (SM) orientation previously was found in a laboratory trial to reduce child abuse recidivism compared with services as usual (SAU). Objectives of the present study were to test effectiveness in a field agency rather than in a laboratory setting and to…

  9. Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCT randomized trial results.

    Science.gov (United States)

    Kjeldsen, Sverre E; Sica, Domenic; Haller, Hermann; Cha, Gloria; Gil-Extremera, Blas; Harvey, Peter; Heyvaert, Frank; Lewin, Andrew J; Villa, Giuseppe; Mancia, Giuseppe

    2014-12-01

    DISTINCT (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) aimed to determine the dose-response and tolerability of nifedipine GITS and/or candesartan cilexetil therapy in participants with hypertension. In this 8-week, multinational, multicentre, randomized, double-blind, placebo-controlled study, adults with mean seated DBP of at least 95 to less than 110 mmHg received combination or monotherapy with nifedipine GITS (N) 20, 30 or 60 mg and candesartan cilexetil (C) 4, 8, 16 or 32 mg, or placebo. The primary endpoint, change in DBP from baseline to Week 8, was analysed using the response surface model (RSM); this analysis was repeated for mean seated SBP. Overall, 1381 participants (mean baseline SBP/DBP: 156.5/99.6 mmHg) were randomized. Both N and C contributed independently to SBP/DBP reductions [P < 0.0001 (RSM)]. A positive dose-response was observed, with all combinations providing statistically better blood pressure (BP) reductions from baseline versus respective monotherapies (P < 0.05) and N60C32 achieving the greatest reduction [-23.8/-16.5 mmHg; P < 0.01 versus placebo (-5.3/-6.7 mmHg) and component monotherapies]. Even very low-dose (N20 and C4) therapy provided significant BP-lowering, and combination therapy was similarly effective in different racial groups. N/C combination demonstrated a lower incidence of vasodilatory adverse events than N monotherapy (18.3 versus 23.6%), including headache (5.5 versus 11.0%; P = 0.003, chi-square test) and peripheral oedema over time (3.6 versus 5.8%; n.s.). N/C combination was effective in participants with hypertension and showed an improved side effect profile compared with N monotherapy.

  10. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial

    Directory of Open Access Journals (Sweden)

    Ho Suleen S

    2012-08-01

    Full Text Available Abstract Background Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Methods Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16; Group 2 (Aerobic, n = 15; Group 3 (Resistance, n = 16; Group 4 (Combination, n = 17. Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Results Significant improvements in body weight (−1.6%, p = 0.044 for the Combination group compared to Control and Resistance groups and total body fat compared to Control (−4.4%, p = 0.003 and Resistance (−3%, p = 0.041. Significant improvements in body fat percentage (−2.6%, p = 0.008, abdominal fat percentage (−2.8%, p = 0.034 and cardio-respiratory fitness (13.3%, p = 0.006 were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04. Conclusion A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese

  11. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial.

    Science.gov (United States)

    Ho, Suleen S; Dhaliwal, Satvinder S; Hills, Andrew P; Pal, Sebely

    2012-08-28

    Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16); Group 2 (Aerobic, n = 15); Group 3 (Resistance, n = 16); Group 4 (Combination, n = 17). Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Significant improvements in body weight (-1.6%, p = 0.044) for the Combination group compared to Control and Resistance groups and total body fat compared to Control (-4.4%, p = 0.003) and Resistance (-3%, p = 0.041). Significant improvements in body fat percentage (-2.6%, p = 0.008), abdominal fat percentage (-2.8%, p = 0.034) and cardio-respiratory fitness (13.3%, p = 0.006) were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04). A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese participants compared to no exercise. From our observations, combination exercise gave greater benefits for weight loss

  12. Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study

    Science.gov (United States)

    Chen, Ming; Bao, Yong; Ma, Hong-Lian; Wang, Jin; Wang, Yan; Peng, Fang; Zhou, Qi-Chao; Xie, Cong-Hua

    2013-01-01

    This prospective randomized study is to evaluate the locoregional failure and its impact on survival by comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) in combination with concurrent chemotherapy for locally advanced non-small cell lung cancer. It appears that higher dose could be delivered in IFRT arm than that in ENI arm, and IFRT did not increase the risk of initially uninvolved or isolated nodal failures. Both a tendency of improved locoregional progression-free survival and a significant increased overall survival rate are in favor of IFRT arm in this study. PMID:23762840

  13. Glycolic Acid peels/azelaic Acid 20% cream combination and low potency triple combination lead to similar reduction in melasma severity in ethnic skin: results of a randomized controlled study.

    Science.gov (United States)

    Mahajan, Rahul; Kanwar, Amrinder Jit; Parsad, Davinder; Kumaran, Muthu Sendhil; Sharma, Reena

    2015-01-01

    Numerous therapeutic options have been tried in the management of melasma. This prospective randomized study was planned to assess the efficacy of low potency triple combination (TC) cream (TC-hydroquinone 2%/tretinoin 0.05%/fluocinolone 0.01%) versus glycolic acid (GA) peels/azelaic acid (AA) 20% cream (GA/AA) combination in melasma. Forty patients with melasma were recruited into this study and randomized into two groups. Group A consisting 20 patients received TC cream once a day for night time application for 3 months. Group B comprising of 20 patients received GA/AA 20% cream combination for 3 months. The disease severity was monitored with digital photography, melasma area and severity index (MASI) score, which was calculated at baseline, 6 weeks and 12 weeks, and visual analog scale (VAS) score, which was calculated at baseline and 12 weeks. Of 40 patients, 38 were completed the study. A significant reduction in MASI and VAS was recorded after 6 weeks and 12 weeks of treatment in both groups A and B (P = 0.001). However, there was no significant difference in the mean MASI scores between the two groups at baseline, 6 weeks and 12 weeks. Similarly, there was no difference in the mean VAS scores between the two groups at baseline and 12 weeks. Four patients in group A and 3 in group B experienced adverse effects such as irritation, dryness, and photosensitivity. Both low potency TC cream and GA/AA 20% cream combination are effective in treating melasma among Indian patients.

  14. Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Umeclidinium and Vilanterol Alone and in Combination: A Randomized Crossover Trial

    OpenAIRE

    Kelleher, Dennis L.; Mehta, Rashmi S.; Jean-Francois, Bernadette M.; Preece, Andrew F.; Blowers, James; Crater, Glenn D.; Thomas, Paul

    2012-01-01

    Umeclidinium bromide (GSK573719; UMEC), a new long-acting muscarinic receptor antagonist (LAMA), is in development with vilanterol (GW642444; VI), a selective long-acting ?2 agonist (LABA), as a once-daily inhaled combination therapy for the treatment of chronic obstructive pulmonary disease (COPD). A single dose healthy volunteer study was conducted to assess the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of inhaled umeclidinium (500 ?g) and vilanterol (50 ?g) w...

  15. A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix.

    Science.gov (United States)

    El Khouly, Nabih I

    2017-04-01

    The purpose of this study was to evaluate the effectiveness and safety of transcervical Foley catheter with and without oxytocin versus oxytocin alone for labour induction with unfavourable cervix. This trial enrolled 108 women with singleton pregnancies presented for labour induction with unfavourable cervix. Patients were randomly assigned to receive Foley catheter alone (I), Foley catheter plus oxytocin (II) or oxytocin alone (III). Outcomes were analysed in terms of success of induction, induction delivery interval, route of delivery, dose and duration of oxytocin, and complications. Successful normal vaginal delivery was more common in group I (p = .02) compared to group III. Induction delivery time was statistically shorter in group II and group III (p oxytocin dose and duration (p oxytocin increases success rate of normal vaginal delivery; however, it has a longer induction delivery interval with similar complications.

  16. Combined bioavailable isoflavones and probiotics improve bone status and estrogen metabolism in postmenopausal osteopenic women: a randomized controlled trial

    DEFF Research Database (Denmark)

    Lambert, Max Norman Tandrup; Thybo, Catrine Bundgaard; Lykkeboe, Simon

    2017-01-01

    estrogen receptor affinity show potential to prevent and treat osteoporosis while minimizing or eliminating carcinogenic side effects. Objective: In this study, we sought to determine the beneficial effects of a bioavailable isoflavone and probiotic treatment against postmenopausal osteopenia. Design: We...... used a novel red clover extract (RCE) rich in isoflavone aglycones and probiotics to concomitantly promote uptake and a favorable intestinal bacterial profile to enhance isoflavone bioavailability. This was a 12-mo, double-blind, parallel design, placebo-controlled, randomized controlled trial of 78...... postmenopausal osteopenic women supplemented with calcium (1200 mg/d), magnesium (550 mg/d), and calcitriol (25 mg/d) given either RCE (60 mg isoflavone aglycones/d and probiotics) or a masked placebo [control (CON)]. Results: RCE significantly attenuated bone mineral density (BMD) loss at the L2–L4 lumbar spine...

  17. Combination of Deep Recurrent Neural Networks and Conditional Random Fields for Extracting Adverse Drug Reactions from User Reviews

    Directory of Open Access Journals (Sweden)

    Elena Tutubalina

    2017-01-01

    Full Text Available Adverse drug reactions (ADRs are an essential part of the analysis of drug use, measuring drug use benefits, and making policy decisions. Traditional channels for identifying ADRs are reliable but very slow and only produce a small amount of data. Text reviews, either on specialized web sites or in general-purpose social networks, may lead to a data source of unprecedented size, but identifying ADRs in free-form text is a challenging natural language processing problem. In this work, we propose a novel model for this problem, uniting recurrent neural architectures and conditional random fields. We evaluate our model with a comprehensive experimental study, showing improvements over state-of-the-art methods of ADR extraction.

  18. Evaluation of the efficacy of a combined formulation (Grippostad-C) in the therapy of symptoms of common cold: a randomized, double-blind, multicenter trial.

    Science.gov (United States)

    Koytchev, R; Vlahov, V; Bacratcheva, N; Giesel, B; Gawronska-Szklarz, B; Wojcicki, J; Mrozikiewiczs, A; van der Meer, M; Alken, R G

    2003-03-01

    The aim of the present trial was to evaluate the efficacy of a combined product in the treatment of common cold and to examine the contribution of the separate components. In the published literature there is conflicting data on the efficacy of agents used in the treatment of common cold, especially when given in drug combinations. A prospective, randomized, double-blind, multicenter, 4-arm, controlled trial was carried out in 1,167 patients with common cold treated with one of the following medications: Grippostad-C, a combination of acetaminophen, caffeine, chlorpheniramine and ascorbic acid (verum), ascorbic acid (control), chlorpheniramine and ascorbic acid (reference 1), as well as acetaminophen, caffeine, and ascorbic acid (reference 2). A score of common cold symptoms (headache, throat pain, extremities and joint pain, cough, blocked nose, and disturbances of sleep quality) was the primary outcome. The test drug was first compared with the control using a hierarchic test strategy, then with reference 1, followed by reference 2 with the aim of proving superiority. A clinically relevant and statistically significant difference was demonstrated at each level of the hierarchy. Grippostad-C was significantly superior to all other treatment groups, the combination of acetaminophen, caffeine, and ascorbic acid was significantly superior to the control, and the combination of chlorpheniramine and ascorbic acid was not statistically different from the control. The efficacy of Grippostad-C for the treatment of common cold was proven. The findings demonstrate that the combination is superior to each of its separate components and each of the components has its own distinctive contribution to the efficacy of the combination product.

  19. Effect of the combination of music and nature sounds on pain and anxiety in cardiac surgical patients: a randomized study.

    Science.gov (United States)

    Bauer, Brent A; Cutshall, Susanne A; Anderson, Patricia G; Prinsen, Sharon K; Wentworth, Laura J; Olney, Tammy J; Messner, Penny K; Brekke, Karen M; Li, Zhuo; Sundt, Thoralf M; Kelly, Ryan F; Bauer, Brent A

    2011-01-01

    Postoperative pain and anxiety are common in cardiac surgery patients. Studies have suggested that music can decrease anxiety in hospitalized patients. Primary Study Objective This study focused on the efficacy and feasibility of special music, which included nature sounds, for pain and anxiety. In this randomized controlled trial, postoperative cardiovascular surgery patients were randomly assigned to a music group to receive 20 minutes of standard postoperative care and music twice daily on postoperative days 2 through 4 or to a control group to receive 20 minutes of standard care with a quiet resting period twice daily on postoperative days 2 through 4. Cardiovascular surgical unit of Saint Marys Hospital, Rochester, Minnesota. One hundred patients completed the study (music group, n = 49; control group, n = 51). Intervention The music was delivered through CD players in the patients' rooms. Pain, anxiety, satisfaction, and relaxation were evaluated from visual analog scales. Data showed a significant decrease in mean (SD) pain scores after the second session of day 2 for the music group (change, ?1.4 [1.4]) compared with the control group (change, ?0.4 [1.4]) (P = .001). Mean relaxation scores improved more at the first session of day 2 for the music group (change, 1.9 [2.7]) compared with the control group (change, 0.3 [2.9]) (P = .03). The music group also showed lower anxiety and increased satisfaction overall, but these differences were not statistically significant. No major barriers to using the therapy were identified. Recorded music and nature sounds can be integrated into the postoperative care of cardiovascular surgery patients. The recordings may provide an additional means for addressing common symptoms of pain and anxiety while providing a means of relaxation for these patients.

  20. A comparative evaluation of intranasal midazolam, ketamine and their combination for sedation of young uncooperative pediatric dental patients: a triple blind randomized crossover trial.

    Science.gov (United States)

    Bahetwar, S K; Pandey, R K; Saksena, A K; Chandra, Girish

    2011-01-01

    The purpose of this study was to evaluate and compare the efficacy and safety of intranasal (IN) administration of midazolam (M), ketamine (K) and their combination (MK) to produce moderate sedation in young, uncooperative pediatric dental patients. In this three stage crossover trial forty five uncooperative ASA type-1 children, who required dental treatment, were randomly assigned to receive one of the three drugs/combination by IN route during three subsequent visits. The efficacy and safety of the agents were assessed by overall success rate and by monitoring of vital signs, respectively. The onset of sedation was rapid with K as compared to M and MK. The difference was statistically significant (P pediatric dental patients who have been otherwise indicated for treatment under general anesthesia.

  1. Monochromatic excimer light versus combination of topical steroid with vitamin D3 analogue in the treatment of nonsegmental vitiligo: a randomized blinded comparative study.

    Science.gov (United States)

    Abdel Latif, Azmy Ahmed; Ibrahim, Shady Mahmoud Attia

    2015-01-01

    Vitiligo is a difficult disease to treat, socially stigmatizing its patients. Monochromatic excimer light (MEL) was developed for use in dermatology and adapted for the treatment of vitiligo. Comparing the efficacy of MEL versus topical combination therapy of vitamin D3 analogue and steroid in the treatment of nonsegmental vitiligo. Forty-four patients with localized and stable nonsegmental vitiligo participated in the present study. In each patient, two lesions were selected and divided randomly into two groups, group A was treated with daily topical combination of calcipotriol and betamethasone and group B was treated with biweekly sessions of MEL for 3 months. Efficacy based on repigmentation percentages were blindly evaluated by two independent physicians and patient's satisfaction. There was significant improvement in both treatment modalities at the end of the study, but without significant differences in both groups. There was a significant difference between both groups regarding the onset of repigmentation (p-value vitiligo. © 2015 Wiley Periodicals, Inc.

  2. Deep peeling using phenol versus percutaneous collagen induction combined with trichloroacetic acid 20% in atrophic post-acne scars; a randomized controlled trial.

    Science.gov (United States)

    Leheta, Tahra Mohamed; Abdel Hay, Rania Mounir; El Garem, Yehia Farouk

    2014-04-01

    Deep peeling using phenol and percutaneous collagen induction (PCI) are used in treating acne scars. To compare deep peeling using phenol and PCI combined with trichloroacetic acid (TCA) 20% in treating atrophic acne scars. 24 patients with post-acne atrophic scars were randomly divided into two groups; group 1 was subjected to one session of deep peeling using phenol, and group 2 was subjected to four sessions of PCI combined with TCA 20%. As a secondary outcome measure, side effects were recorded and patients were asked to assess their % of improvement by a questionnaire completed 8 months after the procedure. Scar severity scores improved by a mean of 75.12% (p scars, within the same group after treatment, revealed a significant highest degree of improvement in the rolling type (p = 0.005) in group 2. Deep peeling using phenol and PCI with TCA 20% were effective in treating post-acne atrophic scars.

  3. A randomized trial comparing initial HAART regimens of nelfinavir/nevirapine and ritonavir/saquinavir in combination with two nucleoside reverse transcriptase inhibitors

    DEFF Research Database (Denmark)

    Kirk, Ole; Lundgren, Jens D; Pedersen, Court

    2003-01-01

    BACKGROUND: A triple-class HAART regimen may be associated with a better virological effect than conventional regimens, but may also lead to toxicity and more profound resistance. METHODS: Randomized, controlled, open-label trial of 233 protease inhibitor- and non-nucleoside reverse transcriptase...... inhibitor-naive HIV-infected patients allocated to a regimen of nelfinavir and nevirapine (1250/200 mg twice daily; n = 118) or ritonavir and saquinavir (400/400 mg twice daily; n = 115), both in combination with two nucleoside reverse transcriptase inhibitors. The primary end-point was HIV RNA ....037. CONCLUSION: A regimen of nelfinavir/nevirapine had a favourable virological effect and tolerability over a 48-week period compared with ritonavir/saquinavir, when administered in combination with two nucleoside reverse transcriptase inhibitors. However, more extensive follow-up is required to determine...

  4. Effects on office and home blood pressure of the lercanidipine-enalapril combination in patients with Stage 2 hypertension: a European randomized, controlled clinical trial.

    Science.gov (United States)

    Mancia, Giuseppe; Coca, Antonio; Chazova, Irina; Girerd, Xavier; Haller, Hermann; Pauletto, Paolo; Pupek-Musialik, Danuta; Svyshchenko, Yevgeniya

    2014-08-01

    The aim of this study was to evaluate the efficacy and safety of combinations of lercanidipine (L) and enalapril (E) at different doses on office and home blood pressure (BP) in patients with Stage 2 hypertension. This was a randomized, double-blind, placebo-controlled, factorial study conducted in 100 centres from seven countries. Patients with office DBP 100-109 mmHg and home DBP at least 85 mmHg at the end of a 2-week placebo run-in period were randomized to a 10-week treatment with placebo, L (10 or 20 mg), E (10 or 20 mg) or the four L-E combinations. The efficacy parameters were office DBP at trough (primary), SBP at trough and home SBP and DBP. Office BP was measured at each visit in both the sitting and the standing position, while home BP was measured twice in the morning and twice in the evening for at least 3 days before treatment and at study end. Safety parameters included adverse events, laboratory tests and 12-lead ECG. A total of 1039 patients were randomized (48% men, mean age 54 years, mean BMI 30 kg/m, 40% obese patients). Baseline BP was similar in all groups and lower for home than for office values (149/95 and 159/103 mmHg, respectively). A marked placebo effect was observed on office but not on home BP. Combination therapy was superior to placebo at all doses for both office and home BP. The greatest effect was observed in the L20/E20 group, in which the SBP/DBP fall amounted to -19.2/-15.2 and -13.2/-7.5 mmHg for sitting office and home BP, respectively. Similar reductions were observed on standing office BP. The L20/E20 combination was associated with less cough, palpitations and leg oedema than monotherapies, with no increased rate of dizziness or hypotension. In Stage 2 hypertension, a fixed-dose combination of L and E ensures a control of both office and out-of-office BP, with a favourable tolerability profile.

  5. Combined application of eicosapentaenoic acid and docosahexaenoic acid on depression in women: a meta-analysis of double-blind randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Yang JR

    2015-08-01

    Full Text Available Jia-run Yang, Dong Han, Zheng-xue Qiao, Xue Tian, Dong Qi, Xiao-hui QiuDepartment of Medical Psychology, Public Health Institute of Harbin Medical University, Harbin, Heilongjiang Province, People’s Republic of ChinaObjectives: Previous randomized controlled trials (RCTs suggest that depression can be effectively treated by omega-3 polyunsaturated fatty acids (PUFAs. Therefore, we conducted this meta-analysis to systematically evaluate the clinical applicability of the combination of docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA, which are the two major bioactive types of PUFAs, in depressed women.Methods: RCTs that compared the combination of DHA and EPA to placebo for short-course treatment of depression in women were systematically reviewed up to March 2015. Outcome measurement was the standardized difference in means in clinical measure of depression severity. Random effect model was performed. Meta-regression analysis was performed to assess the effects of baseline depression scores.Results: Data were obtained from eight RCTs. In these RCTs, 182 patients received placebo and 185 patients received DHA and EPA. The pooled standardized difference in mean was 0.65 with 95% CI = [0.18, 1.12]. There was no relation between the efficacy and the baseline depression scores. The sensitivity analysis found that the combination of EPA and DHA as monotherapy yielded a standardized difference in means of 0.65 (95% CI =0.41, 0.90 without heterogeneity.Discussion: These results indicate a beneficial effect of the combination of EPA and DHA on depressed mood in women compared with placebo. The clinical applicability of EPA and DHA showed greater promise and should be further explored.Keywords: depression, omega-3 polyunsaturated fatty acids, PUFAs, docosahexaenoic acid, DHA, eicosapentaenoic acid, EPA

  6. A fast, easy circumcision procedure combining a CO2 laser and cyanoacrylate adhesive: a non-randomized comparative trial

    Directory of Open Access Journals (Sweden)

    Tahsin Gorgulu

    2016-02-01

    Full Text Available ABSTRACT Background Circumcision is performed as a routine operation in many countries, more commonly for religious and cultural reasons than for indicated conditions, such as phimosis and balanitis. There are many techniques available, and recently electrocautery and both Nd:YAG and CO2 lasers, instead of blades, have been used for skin and mucosal incisions. However, the infection risk in circumcisions performed using a CO2 laser was 10% higher. There are also reports of sutureless procedures using cyanoacrylate, but these have higher risks of hematoma and hemorrhage. We combined a CO2 laser and cyanoacrylate to shorten the operation time and to decrease bleeding complications. Materials and Methods : Circumcisions were performed under general anesthesia with CO2 laser and cyanoacrylate combination in 75 6–9-year-old boys between May 2013 and August 2014 only for religious reasons. As a control, we compared them retrospectively with 75 age-matched patients who were circumcised using the conventional guillotine method in our clinic. Results No hematomas, bleeding, or wound infections were observed. One wound dehiscence (1.33% occurred during the early postoperative period and healed without any additional procedures. The median operating time was 7 (range 6–9 minutes. The conventional guillotine group comprised one hematoma (1.3%, two wound dehiscences (2.6%, and two hemorrhages (2.6%, and the median operating time was 22 (range 20–26 minutes. The difference in surgical time was significant (p<0.001, with no significant difference in the rate of complications between the two groups. Conclusion The combined CO2 laser and cyanoacrylate procedure not only decreased the operating time markedly, but also eliminated the disadvantages associated with each individual procedure alone.

  7. Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments.

    Science.gov (United States)

    Henry, James A; McMillan, Garnett; Dann, Serena; Bennett, Keri; Griest, Susan; Theodoroff, Sarah; Silverman, Shien Pei; Whichard, Susan; Saunders, Gabrielle

    2017-06-01

    Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4-5 months, participants returned to complete final outcome measures, which concluded their study participation. Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A "clinically significant" improvement in reaction to tinnitus (at least 13-point

  8. Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, prospective trial.

    Science.gov (United States)

    Hajheydari, Zohreh; Saeedi, Majid; Morteza-Semnani, Katayoun; Soltani, Aida

    2014-04-01

    Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events. The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle. The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatory lesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale). Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046). The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.

  9. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial.

    Science.gov (United States)

    Gazal, Giath; Mackie, Iain C

    2007-05-01

    This study was designed to compare the effectiveness of different oral analgesics for relieving pain and distress in children following the extraction of teeth under general anaesthesia (GA). The analgesics included paracetamol alone, ibuprofen alone, and paracetamol and ibuprofen in combination. Two hundred and one subjects were randomly allocated to one of four groups. Forty-seven children were included in the ibuprofen alone (5 mg kg(-1)) group, 51 in the paracetamol/ibuprofen combination (15/5 mg kg(-1)) group, 48 in the high-dose paracetamol (20 mg kg(-1)) group, and 55 children were included in the usual-dose paracetamol (15 mg kg(-1)) group (control group). Evaluation of distress for children was made immediately pre-operatively, on recovery from anaesthesia and again after 15 min by using a five-point face scale. Furthermore, each child was observed immediately postoperatively and 15 min postoperatively for signs of pain using the Children's Hospital of Eastern Ontario Pain Scale. There were significant decreases in the mean pain and distress scores for both the ibuprofen alone and paracetamol/ibuprofen combination groups compared to the control group (usual-dose paracetamol) at 15 min postoperatively. This study provides evidence to support the oral administration of ibuprofen alone or in combination with paracetamol for postoperative analgesia in children who are having teeth extracted under GA.

  10. Switch Rates During Acute Treatment for Bipolar II Depression With Lithium, Sertraline, or the Two Combined: A Randomized Double-Blind Comparison.

    Science.gov (United States)

    Altshuler, Lori L; Sugar, Catherine A; McElroy, Susan L; Calimlim, Brian; Gitlin, Michael; Keck, Paul E; Aquino-Elias, Ana; Martens, Brian E; Fischer, E Grace; English, Teri L; Roach, Janine; Suppes, Trisha

    2017-03-01

    The authors compared medication-induced mood switch risk (primary outcome), as well as treatment response and side effects (secondary outcomes) with three acute-phase treatments for bipolar II depression. In a 16-week, double-blind, multisite comparison study, 142 participants with bipolar II depression were randomly assigned to receive lithium monotherapy (N=49), sertraline monotherapy (N=45), or combination treatment with lithium and sertraline (N=48). At each visit, mood was assessed using standardized rating scales. Rates of switch were compared, as were rates of treatment response and the presence and severity of treatment-emergent side effects. Twenty participants (14%) experienced a switch during the study period (hypomania, N=17; severe hypomania, N=3). Switch rates did not differ among the three treatment groups, even after accounting for dropout. No patient had a manic switch or was hospitalized for a switch. Most switches occurred within the first 5 weeks of treatment. The treatment response rate for the overall sample was 62.7% (N=89), without significant differences between groups after accounting for dropout. The lithium/sertraline combination group had a significantly higher overall dropout rate than the monotherapy groups but did not have an accelerated time to response. Lithium monotherapy, sertraline monotherapy, and lithium/sertraline combination therapy were associated with similar switch and treatment response rates in participants with bipolar II depression. The dropout rate was higher in the lithium/sertraline combination treatment group, without any treatment acceleration advantage.

  11. Fusing Markov random fields with anatomical knowledge and shape-based analysis to segment multiple sclerosis white matter lesions in magnetic resonance images of the brain

    Science.gov (United States)

    AlZubi, Stephan; Toennies, Klaus D.; Bodammer, N.; Hinrichs, Herman

    2002-05-01

    This paper proposes an image analysis system to segment multiple sclerosis lesions of magnetic resonance (MR) brain volumes consisting of 3 mm thick slices using three channels (images showing T1-, T2- and PD -weighted contrast). The method uses the statistical model of Markov Random Fields (MRF) both at low and high levels. The neighborhood system used in this MRF is defined in three types: (1) Voxel to voxel: a low-level heterogeneous neighborhood system is used to restore noisy images. (2) Voxel to segment: a fuzzy atlas, which indicates the probability distribution of each tissue type in the brain, is registered elastically with the MRF. It is used by the MRF as a-priori knowledge to correct miss-classified voxels. (3) Segment to segment: Remaining lesion candidates are processed by a feature based classifier that looks at unary and neighborhood information to eliminate more false positives. An expert's manual segmentation was compared with the algorithm.

  12. Towards robust and effective shape modeling: sparse shape composition.

    Science.gov (United States)

    Zhang, Shaoting; Zhan, Yiqiang; Dewan, Maneesh; Huang, Junzhou; Metaxas, Dimitris N; Zhou, Xiang Sean

    2012-01-01

    Organ shape plays an important role in various clinical practices, e.g., diagnosis, surgical planning and treatment evaluation. It is usually derived from low level appearance cues in medical images. However, due to diseases and imaging artifacts, low level appearance cues might be weak or misleading. In this situation, shape priors become critical to infer and refine the shape derived by image appearances. Effective modeling of shape priors is challenging because: (1) shape variation is complex and cannot always be modeled by a parametric probability distribution; (2) a shape instance derived from image appearance cues (input shape) may have gross errors; and (3) local details of the input shape are difficult to preserve if they are not statistically significant in the training data. In this paper we propose a novel Sparse Shape Composition model (SSC) to deal with these three challenges in a unified framework. In our method, a sparse set of shapes in the shape repository is selected and composed together to infer/refine an input shape. The a priori information is thus implicitly incorporated on-the-fly. Our model leverages two sparsity observations of the input shape instance: (1) the input shape can be approximately represented by a sparse linear combination of shapes in the shape repository; (2) parts of the input shape may contain gross errors but such errors are sparse. Our model is formulated as a sparse learning problem. Using L1 norm relaxation, it can be solved by an efficient expectation-maximization (EM) type of framework. Our method is extensively validated on two medical applications, 2D lung localization in X-ray images and 3D liver segmentation in low-dose CT scans. Compared to state-of-the-art methods, our model exhibits better performance in both studies. Copyright © 2011 Elsevier B.V. All rights reserved.

  13. Prenatal vitamin D supplementation reduces risk of asthma/recurrent wheeze in early childhood: A combined analysis of two randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Helene M Wolsk

    Full Text Available We recently published two independent randomized controlled trials of vitamin D supplementation during pregnancy, both indicating a >20% reduced risk of asthma/recurrent wheeze in the offspring by 3 years of age. However, neither reached statistical significance.To perform a combined analysis of the two trials and investigate whether maternal 25-hydroxy-vitamin D (25(OHD level at trial entry modified the intervention effect.VDAART (N = 806 and COPSAC2010. (N = 581 randomized pregnant women to daily high-dose vitamin D3 (4,000 IU/d and 2,400 IU/d, respectively or placebo. All women also received a prenatal vitamin containing 400 IU/d vitamin D3. The primary outcome was asthma/recurrent wheeze from 0-3yrs. Secondary end-points were specific IgE, total IgE, eczema and lower respiratory tract infections (LRTI. We conducted random effects combined analyses of the treatment effect, individual patient data (IPD meta-analyses, and analyses stratified by 25(OHD level at study entry.The analysis showed a 25% reduced risk of asthma/recurrent wheeze at 0-3yrs: adjusted odds ratio (aOR = 0.74 (95% CI, 0.57-0.96, p = 0.02. The effect was strongest among women with 25(OHD level ≥30ng/ml at study entry: aOR = 0.54 (0.33-0.88, p = 0.01, whereas no significant effect was observed among women with 25(OHD level <30ng/ml at study entry: aOR = 0.84 (0.62-1.15, p = 0.25. The IPD meta-analyses showed similar results. There was no effect on the secondary end-points.This combined analysis shows that vitamin D supplementation during pregnancy results in a significant reduced risk of asthma/recurrent wheeze in the offspring, especially among women with 25(OHD level ≥ 30 ng/ml at randomization, where the risk was almost halved. Future studies should examine the possibility of raising 25(OHD levels to at least 30 ng/ml early in pregnancy or using higher doses than used in our studies.COPSAC2010: ClinicalTrials.gov NCT00856947; VDAART: ClinicalTrials.gov NCT00920621.

  14. Treating low back pain resulted from lumbar degenerative instability using Chinese Tuina combined with core stability exercises: A randomized controlled trial.

    Science.gov (United States)

    Tang, Shujie; Qian, Xiuling; Zhang, Yingjie; Liu, Yuanmei

    2016-04-01

    The therapeutic effect of Tuina combined with core stability exercises on low back pain resulted from lumbar degenerative instability is unclear. This article aims to evaluate whether core stability exercises can improve the effect of Tuina in this regard. This trial was designed as a randomized controlled trial and carried out in Qingzhou hospital of Traditional Chinese medicine between June 2011 and June 2013. Eighty-eight patients with low-grade lumbar degenerative instability were included and divided randomly into experimental and control groups, 44 in each. The experimental group were treated using Tuina combined with core stability exercises, but the control group using Tuina alone. The evaluation of Visual analogue scale (VAS), Japanese Orthopaedic Association scores (JOA) and recurrence rate were performed. Two weeks after treatment, JOA scores increased (p0.05) between the two groups. At the end of six weeks, VAS scores (pcore stability exercises has better effect than Tuina alone in treating low back pain resulted from low-grade lumbar degenerative instability. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Effect of combining therapy with traditional chinese medicine-based psychotherapy and herbal medicines in women with menopausal syndrome: a randomized controlled clinical trial.

    Science.gov (United States)

    Yang, Hongyan; Yang, Jing; Wen, Zehuai; Zha, Qinglin; Nie, Guangning; Huang, Xuchun; Zhang, Chunlin; Lu, Aiping; Jiang, Miao; Wang, Xiaoyun

    2012-01-01

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome.

  16. A single-blinded, randomized pilot study of botulinum toxin type A combined with non-pharmacological treatment for spastic foot.

    Science.gov (United States)

    Baricich, Alessio; Carda, Stefano; Bertoni, Michele; Maderna, Luca; Cisari, Carlo

    2008-11-01

    To explore the effect of treatment after botulinum toxin type A combined with treatments for the spastic foot. Single-blind, randomized trial, with 3-month follow-up. Twenty-three chronic hemiplegic adult patients with spastic equinus foot. Following botulinum toxin type A injection at the medial and lateral gastrocnemius, patients were assigned randomly to 3 groups, and treated with taping, electrical stimulation or stretching. They were evaluated before treatment (t0), and at 10 (t1), 20 (t2) and 90 (t3) days after treatment. Outcome measures were: Modified Ashworth Scale; passive range of motion at the ankle; measurement of muscle action potential at the gastrocnemius medialis; and measurement of maximum ankle dorsiflexion angle in stance using gait analysis. The group treated with electrical stimulation performed better at t1 on the Modified Ashworth Scale. The taping and electrical stimulation groups performed better in all outcome measures at t3. The taping group performed better mainly for maximum ankle dorsiflexion angle in stance. The stretching group showed a less durable result, with some worsening at the t3 evaluation compared with the assessment performed before treatment. This pilot study indicates that combining botulinum toxin type A administration for the ankle plantar flexors with taping and electrical stimulation might be beneficial.

  17. Prolonged exposure, paroxetine and the combination in the treatment of PTSD following a motor vehicle accident. A randomized clinical trial - The "TRAKT" study.

    Science.gov (United States)

    Popiel, Agnieszka; Zawadzki, Bogdan; Pragłowska, Ewa; Teichman, Yona

    2015-09-01

    Little is known about direct comparisons of the efficacy of trauma-focused psychotherapies and SSRIs. This is the first randomized clinical trial comparing the efficacy of prolonged exposure (PE), paroxetine (Ph) and their combination (Comb) in a sample of adults diagnosed with PTSD following motor vehicle accidents (MVA). A total of 228 people were randomly assigned to a twelve-week treatment of PE (N = 114), Ph (N = 57) or Comb (N = 57). The ITT analyses showed that the remission rate of PTSD was significantly greater after PE (65.5%) compared with Ph (43.3%), whereas Comb (51.2%) did not differ from either. The differences in dropout rates were not significant between treatments (18.4% - PE; 12.2% - Ph; 22.8% - Comb), while the differences in numbers of refusers were significant (3.5% PE paroxetine and combination treatment in PTSD PE was more effective than Ph in achieving remission of PTSD. The additive effect of Comb over any monotherapy was not shown. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. [Acute lumbar sprain treated with massage combined with acupuncture at different distal acupoints: a randomized controlled trial].

    Science.gov (United States)

    Cao, Ye; Wang, Yueqiu

    2015-05-01

    To observe treatment efficacy of acupuncture at different distal acupoints for acute lumbar sprain after massage. One hundred and fifty patients with acute lumbar sprain were randomly divided into a Yaotongdian (Extra) group, a Houxi (SI 3) group, a Weizhong (BL 40) group, a Chengshan (BL 57) group and a Shuigou (GV 26) group, total 5 groups, 30 cases in each one. After the same massage treatment and based on groups divided, different distal acupoints above-mentioned were selected to be acupunctured. Visual analogue scale (VAS) scores, lumbar activity and treatment efficacy of patients in 5 groups were evaluated. With acupuncture at distal acupoints after massage,VAS scores of patients in 5 groups were decreased compared with those after massage treatment (all Plumbar activity was all obviously improved (all Plumbar activity and cured and markedly effective rates were not statistically significant(all P>0.05). Based on massage treatment, acupuncture at distal acupoints could further improve the treatment efficacy for acute lumbar sprain, but there is no obvious effective difference among every distal acupoint. As long as choosing acupoints with lower pain threshold and stimulating enough, good efficacy could be acquired for acute lumbar sprain.

  19. A prospective randomized controlled study comparing two doses of gestodene in cyclic combined HRT preparations on endometrial physiology.

    Science.gov (United States)

    Okon, M A; Lee, S; Laird, S M; Li, T C

    2001-06-01

    Postmenopausal women taking oestradiol 17-beta 2 mg daily were randomized to receive either 25 or 50 microg gestodene from day 17 to 28 of the cycle in a double-blind study. Placental protein P14 (PP14) and CA 125 concentrations in uterine flushing, endometrial morphology and irregular bleeding after 12 cycles of study were observed. Eleven and 12 women in the 25 and 50 microg groups respectively completed the study. There were no significant differences in pre-treatment biochemical and morphological indices between the groups. The median PP14 concentration increased from 332 to 5800 ng/ml (P gestodene groups respectively. No between-group significant rise of PP14 was observed. Similarly, no significant change was seen between the initial and post-treatment concentrations of CA 125 for either group. All biopsies were atrophic at inception of the study, and both regimens produced secretory endometrial transformation in the majority of biopsies. No between-group difference was observed in the morphometric indices measured, or any significant correlation between the concentrations of PP14 or CA 125 and morphology. The mean number of days of withdrawal bleeding (3.8 and 4.2 days for 25 and 50 microg respectively) were similar. In conclusion, both regimens produced a significant rise in uterine flushing concentrations of PP14, but not CA 125. PP14 is a sensitive biochemical marker in the assessment of endometrial response to hormone replacement therapy.

  20. Two refractory Wild 2 terminal particles from a carrot-shaped track characterized combining MIR/FIR/Raman microspectroscopy and FE-SEM/EDS analyses

    Science.gov (United States)

    Rotundi, A.; Rietmeijer, F. J. M.; Ferrari, M.; Della Corte, V.; Baratta, G. A.; Brunetto, R.; Dartois, E.; Djouadi, Z.; Merouane, S.; Borg, J.; Brucato, J. R.; Sergeant D'Hendecourt, L.; Mennella, V.; Palumbo, M. E.; Palumbo, P.

    2014-04-01

    We present the analyses results of two bulk Terminal Particles, C2112,7,171,0,0 and C2112,9,171,0,0, derived from the Jupiter-family comet 81P/Wild 2 returned by the Stardust mission. Each particle embedded in a slab of silica aerogel was pressed in a diamond cell. This preparation, as expected, made it difficult to identify the minerals and organic materials present in these particles. This problem was overcome using a combination of three different analytical techniques, viz. FE-SEM/EDS, IR, and Raman microspectroscopy that allowed identifying the minerals and small amounts of amorphous carbon present in both particles. TP2 and TP3 were dominated by Ca-free and low-Ca, Mg-rich, Mg,Fe-olivine. The presence of melilite in both particles is supported by IR microspectroscopy, but is not confirmed by Raman microspectroscopy, possibly because the amounts are too small to be detected. TP2 and TP3 show similar silicate mineral compositions, but Ni-free and low-Ni, subsulfur (Fe,Ni)S grains are present in TP2 only. TP2 contains indigenous amorphous carbon hot spots; no indigenous carbon was identified in TP3. These nonchondritic particles probably originated in a differentiated body. This work found an unanticipated carbon contamination following the FE-SEM/EDS analyses. It is suggested that organic materials in the embedding silica aerogel are irradiated during FE-SEM/EDS analyses creating a carbon gas that develops a strong fluorescence continuum. The combination of the selected analytical techniques can be used to characterize bulk Wild 2 particles without the need of extraction and removal of the encapsulating aerogel. This approach offers a relatively fast sample preparation procedure, but compressing the samples can cause spurious artifacts, viz. silica contamination. Because of the combination of techniques, we account for these artifacts.

  1. PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer.

    Science.gov (United States)

    Naumann, R Wendel; Coleman, Robert L; Burger, Robert A; Sausville, Edward A; Kutarska, Elzbieta; Ghamande, Sharad A; Gabrail, Nashat Y; Depasquale, Stephen E; Nowara, Elzbieta; Gilbert, Lucy; Gersh, Robert H; Teneriello, Michael G; Harb, Wael A; Konstantinopoulos, Panagiotis A; Penson, Richard T; Symanowski, James T; Lovejoy, Chandra D; Leamon, Christopher P; Morgenstern, David E; Messmann, Richard A

    2013-12-10

    Vintafolide (EC145) is a folic acid-desacetylvinblastine conjugate that binds to the folate receptor (FR), which is expressed on the majority of epithelial ovarian cancers. This randomized phase II trial evaluated vintafolide combined with pegylated liposomal doxorubicin (PLD) compared with PLD alone. The utility of an FR-targeted imaging agent, (99m)Tc-etarfolatide (EC20), in selecting patients likely to benefit from vintafolide was also examined. Women with recurrent platinum-resistant ovarian cancer who had undergone ≤ two prior cytotoxic regimens were randomly assigned at a 2:1 ratio to PLD (50 mg/m(2) intravenously [IV] once every 28 days) with or without vintafolide (2.5 mg IV three times per week during weeks 1 and 3). Etarfolatide scanning was optional. The primary objective was to compare progression-free survival (PFS) between the groups. The intent-to-treat population comprised 149 patients. Median PFS was 5.0 and 2.7 months for the vintafolide plus PLD and PLD-alone arms, respectively (hazard ratio [HR], 0.63; 95% CI, 0.41 to 0.96; P = .031). The greatest benefit was observed in patients with 100% of lesions positive for FR, with median PFS of 5.5 compared with 1.5 months for PLD alone (HR, 0.38; 95% CI, 0.17 to 0.85; P = .013). The group of patients with FR-positive disease (10% to 90%) experienced some PFS improvement (HR, 0.873), whereas patients with disease that did not express FR experienced no PFS benefit (HR, 1.806). Vintafolide plus PLD is the first combination to demonstrate an improvement over standard therapy in a randomized trial of patients with platinum-resistant ovarian cancer. Etarfolatide can identify patients likely to benefit from vintafolide.

  2. Theory-Based Interventions Combining Mental Simulation and Planning Techniques to Improve Physical Activity: Null Results from Two Randomized Controlled Trials.

    Science.gov (United States)

    Meslot, Carine; Gauchet, Aurélie; Allenet, Benoît; François, Olivier; Hagger, Martin S

    2016-01-01

    Interventions to assist individuals in initiating and maintaining regular participation in physical activity are not always effective. Psychological and behavioral theories advocate the importance of both motivation and volition in interventions to change health behavior. Interventions adopting self-regulation strategies that foster motivational and volitional components may, therefore, have utility in promoting regular physical activity participation. We tested the efficacy of an intervention adopting motivational (mental simulation) and volitional (implementation intentions) components to promote a regular physical activity in two studies. Study 1 adopted a cluster randomized design in which participants (n = 92) were allocated to one of three conditions: mental simulation plus implementation intention, implementation intention only, or control. Study 2 adopted a 2 (mental simulation vs. no mental simulation) × 2 (implementation intention vs. no implementation intention) randomized controlled design in which fitness center attendees (n = 184) were randomly allocated one of four conditions: mental simulation only, implementation intention only, combined, or control. Physical activity behavior was measured by self-report (Study 1) or fitness center attendance (Study 2) at 4- (Studies 1 and 2) and 19- (Study 2 only) week follow-up periods. Findings revealed no statistically significant main or interactive effects of the mental simulation and implementation intention conditions on physical activity outcomes in either study. Findings are in contrast to previous research which has found pervasive effects for both intervention strategies. Findings are discussed in light of study limitations including the relatively small sample sizes, particularly for Study 1, deviations in the operationalization of the intervention components from previous research and the lack of a prompt for a goal intention. Future research should focus on ensuring uniformity in the format of the

  3. Case studies combined with or without concept maps improve critical thinking in hospital-based nurses: a randomized-controlled trial.

    Science.gov (United States)

    Huang, Yu-Chuan; Chen, Hsing-Hsia; Yeh, Mei-Ling; Chung, Yu-Chu

    2012-06-01

    Critical thinking (CT) is essential to the exercise of professional judgment. As nurses face increasingly complex health-care situations, critical thinking can promote appropriate clinical decision-making and improve the quality of nursing care. This study aimed to evaluate the effects of a program of case studies, alone (CS) or combined with concept maps (CSCM), on improving CT in clinical nurses. The study was a randomized controlled trial. The experimental group participated in a 16-week CSCM program, whereas the control group participated in a CS program of equal duration. A randomized-controlled trial with a multistage randomization process was used to select and to assign participants, ultimately resulting in 67 nurses in each group. Data were collected before and after the program using the California Critical Thinking Skill Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI). After the programs, there were significant differences between the two groups in the critical thinking skills of analysis, evaluation, inference, deduction, and induction. There was also an overall significant difference, and a significant difference in the specific disposition of open-mindedness. This study supports the application of case studies combined with concept maps as a hospital-based teaching strategy to promote development of critical thinking skills and encourage dispositions for nurses. The CSCM resulted in greater improvements in all critical thinking skills of as well as the overall and open-minded affective dispositions toward critical thinking, compared with the case studies alone. An obvious improvement in the CSCM participants was the analytic skill and disposition. Further longitudinal studies and data collection from multisite evaluations in a range of geographic locales are warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. Combining Exergame Training with Omega-3 Fatty Acid Supplementation: Protocol for a Randomized Controlled Study assessing the Effect on Neuronal Structure/Function in the Elderly Brain

    Directory of Open Access Journals (Sweden)

    Alexandra Schättin

    2016-11-01

    Full Text Available A common problem in the older population is the risk of falling that might lead to injury, immobility, and reduced survival. Age-related neuronal changes, e.g. decline in grey- and white-matter, affect neuronal, cognitive, and motor functioning. The improvement of these factors might decrease fall events in elderly. Studies showed that the sole administration of video game-based physical exercise, a so-called exergame, or omega-3 fatty acid (FA may improve motor and/or cognitive functioning through neuronal changes in the brain of older adults. The aim of this study is to assess the effects of a combination of exergame training with omega-3 FA supplementation on the elderly brain. We hypothesize that an intervention using a combination approach differently effects on the neuronal structure and function of the elderly’s brain as compared to the sole administration of exergame training. The study is a parallel, double-blinded, randomized controlled trial lasting 26 weeks. Sixty autonomous living, non-smoking, and right-handed healthy older (>65 years adults who live independently or in a senior residency are included, randomized, and allocated to one of two study groups. The experimental group receives a daily amount of 13.5ml fish oil (including 2.9g of omega-3 FA, whereas the control group receives a daily amount of 13.5ml olive oil for 26 weeks. After 16 weeks, both groups start with an exergame training program three times per week. Measurements are performed on three time-points by treatment blinded investigators: pre-intervention measurement, blood sample after 16 week, and post-intervention measurements. The main outcomes are motor evoked potentials of the right M. tibialis anterior (transcranial magnetic stimulation and response-related potentials (electroencephalography during a cognitive test. For secondary outcomes, reaction times during cognitive tests and spatio-temporal parameters during gait performance are measured. Statistics

  5. Retreatment of hepatitis C non-responsive to interferon. A placebo controlled randomized trial of ribavirin monotherapy versus combination therapy with Ribavirin and Interferon in 121 patients in the Benelux [ISRCTN53821378].

    NARCIS (Netherlands)

    B.J. Veldt (Bart); J.T. Brouwer (Johannes); M. Adler (Michael); F. Nevens (Frederik); P. Michielsen (Peter); J. Delwaide (Jean); B.E. Hansen (Bettina); S.W. Schalm (Solko)

    2003-01-01

    textabstractBACKGROUND: Evidence based medicine depends on unbiased selection of completed randomized controlled trials. For completeness it is important to publish all trials. This report describes the first large randomised controlled trial where combination therapy was compared

  6. Combined influence of CT random noise and HU-RSP calibration curve nonlinearities on proton range systematic errors

    Science.gov (United States)

    Brousmiche, S.; Souris, K.; Orban de Xivry, J.; Lee, J. A.; Macq, B.; Seco, J.

    2017-11-01

    Proton range random and systematic uncertainties are the major factors undermining the advantages of proton therapy, namely, a sharp dose falloff and a better dose conformality for lower doses in normal tissues. The influence of CT artifacts such as beam hardening or scatter can easily be understood and estimated due to their large-scale effects on the CT image, like cupping and streaks. In comparison, the effects of weakly-correlated stochastic noise are more insidious and less attention is drawn on them partly due to the common belief that they only contribute to proton range uncertainties and not to systematic errors thanks to some averaging effects. A new source of systematic errors on the range and relative stopping powers (RSP) has been highlighted and proved not to be negligible compared to the 3.5% uncertainty reference value used for safety margin design. Hence, we demonstrate that the angular points in the HU-to-RSP calibration curve are an intrinsic source of proton range systematic error for typical levels of zero-mean stochastic CT noise. Systematic errors on RSP of up to 1% have been computed for these levels. We also show that the range uncertainty does not generally vary linearly with the noise standard deviation. We define a noise-dependent effective calibration curve that better describes, for a given material, the RSP value that is actually used. The statistics of the RSP and the range continuous slowing down approximation (CSDA) have been analytically derived for the general case of a calibration curve obtained by the stoichiometric calibration procedure. These models have been validated against actual CSDA simulations for homogeneous and heterogeneous synthetical objects as well as on actual patient CTs for prostate and head-and-neck treatment planning situations.

  7. Combined effects of repeated oral hygiene motivation and type of toothbrush on orthodontic patients: a blind randomized clinical trial.

    Science.gov (United States)

    Marini, Ida; Bortolotti, Francesco; Parenti, Serena Incerti; Gatto, Maria Rosaria; Bonetti, Giulio Alessandri

    2014-09-01

    To investigate the effects on plaque index (PI) scores of manual or electric toothbrush with or without repeated oral hygiene instructions (OHI) and motivation on patients wearing fixed orthodontic appliances. One month after the orthodontic fixed appliance bonding on both arches, 60 patients were randomly assigned to four groups; groups E1 (n  =  15) and E2 (n  =  15) received a powered rotating-oscillating toothbrush, and groups M1 (n  =  15) and M2 (n  =  15) received a manual toothbrush. Groups E1 and M1 received OHI and motivation at baseline (T0) and after 4, 8, 12, 16, and 20 weeks (T4, T8, T12, T16, and T20, respectively) by a Registered Dental Hygienist; groups E2 and M2 received OHI and motivation only at baseline. At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI. In all groups the PI score decreased significantly over time, and there were differences among groups at T8, T12, T16, and T20. At T8, PI scores of group E1 were lower than those of group E2, and at T12, T16, and T20, PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2. A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant, independently from the use of manual or electric toothbrush. The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients, independent of the type of toothbrush used.

  8. Treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy – study protocol for a randomized clinical trial

    Science.gov (United States)

    2013-01-01

    Background Sufficient evidence is lacking to draw final conclusions on the efficiency of medical and psychological treatments of traumatized refugees with PTSD. The pharmacological treatments of choice today for post-traumatic stress disorder are antidepressants from the subgroup selective serotonin reuptake inhibitors, especially Sertraline. The evidence for the use of selective serotonin reuptake inhibitors in the treatment of complex post-traumatic stress disorder in traumatized refugees is very limited. Venlafaxine is a dual-action antidepressant that works on several pathways in the brain. It influences areas in the brain which are responsible for the enhanced anxiety and hyper-arousal experienced by traumatized refugees and which some studies have found to be enlarged among patients suffering from post-traumatic stress disorder. Design This study will include approximately 150 patients, randomized into two different groups treated with either Sertraline or Venlafaxine. Patients in both groups will receive the same manual-based cognitive behavioral therapy, which has been especially adapted to this group of patients. The treatment period will be 6 to 7 months. The trial endpoints will be post-traumatic stress disorder and depressive symptoms and social functioning, all measured on validated ratings scales. Furthermore the study will examine the relation between a psycho-social resources and treatment outcome based on 15 different possible outcome predictors. Discussion This study is expected to bring forward new knowledge on treatment and clinical evaluation of traumatized refugees and the results are expected to be used in reference programs and clinical guidelines. Trial registration ClinicalTrials.gov NCT01569685 PMID:23663588

  9. Dynamic shape.

    Science.gov (United States)

    Koenderink, J J; van Doorn, A J

    1986-01-01

    Many useful notions of partial order and/or similarity and relatedness of different geometrical features of smooth shapes that occur in psychologically valid descriptions of shape have no equivalents in the usual geometrical shape theories. This is especially true where similarities are noted between objects of different connectivity: in almost all of the present theories the topological type generates the primary categorization. It is argued that such relations find a logical place only in shape theories that involve morphogenesis. Any object can be embedded uniquely in a morphogenetic sequence if one takes resolution as the parameter of the sequence. A theory of measurement is presented that allows one to define surfaces and (boundary-) curves on multiple levels of resolution. The embedding is essentially unique and is generated via a partial differential equation that governs the evolution. A canonical projection connects any high resolution specimen to lower resolution versions. The bifurcation set of the projection generates natural part boundaries. Singularities of the evolution are completely characterized as emergence, accretion and versification processes (involving topological change) and singularities by which inflections (inflection points for curves, parabolic curves for surfaces) are generated. The latter singularities involve a single process for the generation of inflections and three other processes by which the existing inflection structure may be changed. Relations with existing theories in vogue in robotics and AI, as well as in psychophysics are discussed.

  10. An Open-Label, Multicenter, Randomized, Phase II Study of Pazopanib in Combination with Pemetrexed in First-Line Treatment of Patients with Advanced-Stage Non-Small-Cell Lung Cancer

    DEFF Research Database (Denmark)

    Scagliotti, Giorgio V; Felip, Enriqueta; Besse, Benjamin

    2013-01-01

    This randomized open-label phase II study evaluated the efficacy, safety, and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated, advanced, nonsquamous non-small-cell lung cancer.......This randomized open-label phase II study evaluated the efficacy, safety, and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated, advanced, nonsquamous non-small-cell lung cancer....

  11. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study.

    Science.gov (United States)

    Ortonne, J-P; Nikkels, A F; Reich, K; Ponce Olivera, R M; Lee, J H; Kerrouche, N; Sidou, F; Faergemann, J

    2011-07-01

    Topical antifungals and corticosteroids are the mainstay of treatment for seborrhoeic dermatitis. The short-contact clobetasol propionate 0·05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis. To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis. This randomized and investigator-blinded study consisted of three phases, each lasting 4 weeks. During the treatment phase, subjects were randomized to receive KC twice weekly (K2), CP twice weekly (C2), CP twice weekly alternating with KC twice weekly (C2 + K2) or CP four times weekly alternating with KC twice weekly (C4+K2). All subjects received KC once weekly during the maintenance phase and were untreated during the follow-up phase. At the end of the treatment phase, all three CP-containing regimens were significantly more efficacious than K2 in decreasing the overall disease severity (P < 0·05). Both combination regimens were also significantly more efficacious than K2 in decreasing each individual sign of the disease (P < 0·05). While the C2 and C4 + K2 groups experienced slight worsening during the maintenance phase, the efficacy of C2 + K2 was sustained and remained the highest among all groups. All regimens were well tolerated without inducing any skin atrophy. Similarly low incidences of telangiectasia, burning and adverse events were observed among the four groups. The combination therapy of twice-weekly CP alternating with twice-weekly KC provided significantly greater efficacy than KC alone and a sustained effect in the treatment of moderate to severe scalp seborrhoeic dermatitis. © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011.

  12. Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial.

    Science.gov (United States)

    Longland, Thomas M; Oikawa, Sara Y; Mitchell, Cameron J; Devries, Michaela C; Phillips, Stuart M

    2016-03-01

    A dietary protein intake higher than the Recommended Dietary Allowance during an energy deficit helps to preserve lean body mass (LBM), particularly when combined with exercise. The purpose of this study was to conduct a proof-of-principle trial to test whether manipulation of dietary protein intake during a marked energy deficit in addition to intense exercise training would affect changes in body composition. We used a single-blind, randomized, parallel-group prospective trial. During a 4-wk period, we provided hypoenergetic (~40% reduction compared with requirements) diets providing 33 ± 1 kcal/kg LBM to young men who were randomly assigned (n = 20/group) to consume either a lower-protein (1.2 g · kg(-1) · d(-1)) control diet (CON) or a higher-protein (2.4 g · kg(-1) · d(-1)) diet (PRO). All subjects performed resistance exercise training combined with high-intensity interval training for 6 d/wk. A 4-compartment model assessment of body composition was made pre- and postintervention. As a result of the intervention, LBM increased (P mass than did the CON group (PRO: -4.8 ± 1.6 kg; CON: -3.5 ± 1.4kg; P mass when combined with a high volume of resistance and anaerobic exercise. Changes in serum cortisol were associated with changes in body fat and LBM, but did not explain much variance in either measure. This trial was registered at clinicaltrials.gov as NCT01776359. © 2016 American Society for Nutrition.

  13. Comparative evaluation of safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus: Indian multicentric randomized trial - START Study

    Directory of Open Access Journals (Sweden)

    T V Devarajan

    2017-01-01

    Full Text Available Background and Objective: Modern sulfonylureas like glimepiride offer effective glycemic control with extrapancreatic benefits and good tolerability. The objective of the present study was to evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM. Methods: In this open-label, randomized, comparative, multicenter study, a total of 305 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 202 or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 103 for 12 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c. Secondary endpoints were change in fasting plasma glucose (FPG, postprandial plasma glucose (PPG, body mass index (BMI and to assess overall safety profile. Results: At 12 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.42% as compared to sitagliptin group (0.30% (P = 0.001. Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group (P = 0.008. There was no significant difference in terms of change in BMI (0.07 ± 0.39 kg/m2 vs. 0.08 ± 0.31 kg/m2 in glimepiride and sitagliptin groups, respectively, (P = 0.644 between both the groups. The incidences of hypoglycemic events were also comparable among both the groups. Conclusion: In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycemia.

  14. Shortening cardioplegic arrest time in patients undergoing combined coronary and valve surgery: results from a multicentre randomized controlled trial: the SCAT trial.

    Science.gov (United States)

    Rogers, Chris A; Capoun, Radek; Scott, Lauren J; Taylor, Jodi; Jain, Anil; Angelini, Gianni D; Narayan, Pradeep; Suleiman, M-Saadeh; Sarkar, Kunal; Ascione, Raimondo

    2017-08-01

    Combined coronary artery bypass grafting and valve surgery requires a prolonged period of cardioplegic arrest (CA) predisposing to myocardial injury and postoperative cardiac-specific complications. The aim of this trial was to reduce the CA time in patients undergoing combined coronary artery bypass grafting and valve surgery and assess if this was associated with less myocardial injury and related complications. Participants were randomized to (i) coronary artery bypass grafting performed on the beating heart with cardiopulmonary bypass support followed by CA for the valve procedure (hybrid) or (ii) both procedures under CA (conventional). To assess complications related to myocardial injury, we used the composite of death, myocardial infarction, arrhythmia, need for pacing or inotropes for >12 h. To assess myocardial injury, we used serial plasma troponin T and markers of metabolic stress in myocardial biopsies. Hundred and sixty patients (80 hybrid and 80 conventional) were randomized. Mean age was 66.5 years and 74% were male. Valve procedures included aortic (61.8%) and mitral (33.1%) alone or in combination (5.1%). CA time was 16% lower in the hybrid group [median 98 vs 89 min, geometric mean ratio (GMR) 0.84, 95% confidence interval (CI) 0.77-0.93, P  = 0.0004]. Complications related to myocardial injury occurred in 131/160 patients (64/80 conventional, 67/80 hybrid), odds ratio 1.24, 95% CI 0.54-2.86, P  = 0.61. Release of troponin T was similar between groups (GMR 1.04, 95% CI 0.87-1.24, P  = 0.68). Adenosine monophosphate was 28% lower in the hybrid group (GMR 0.72, 95% CI 0.51-1.02, P  = 0.056). The hybrid procedure reduced the CA time but myocardial injury outcomes were not superior to conventional approach. ISRCTN65770930.

  15. Effects of Transcranial Direct Current Stimulation, Transcranial Pulsed Current Stimulation, and Their Combination on Brain Oscillations in Patients with Chronic Visceral Pain: A Pilot Crossover Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Aurore Thibaut

    2017-11-01

    Full Text Available ObjectiveChronic visceral pain (CVP syndromes are persistently painful disorders with a remarkable lack of effective treatment options. This study aimed at evaluating the effects of different neuromodulation techniques in patients with CVP on cortical activity, through electreocephalography (EEG and on pain perception, through clinical tests.DesignA pilot crossover randomized controlled study.SettingsOut-patient.SubjectsAdults with CVP (>3 months.MethodsParticipants received four interventions in a randomized order: (1 transcranial pulsed current stimulation (tPCS and active transcranial direct current stimulation (tDCS combined, (2 tPCS alone, (3 tDCS alone, and (4 sham condition. Resting state quantitative electroencephalography (qEEG and pain assessments were performed before and after each intervention. Results were compared with a cohort of 47 healthy controls.ResultsWe enrolled six patients with CVP for a total of 21 visits completed. Compared with healthy participants, patients with CVP showed altered cortical activity characterized by increased power in theta, alpha and beta bands, and a significant reduction in the alpha/beta ratio. Regarding tES, the combination of tDCS with tPCS had no effect on power in any of the bandwidths, nor brain regions. Comparing tPCS with tDCS alone, we found that tPCS induced higher increase in power within the theta and alpha bandwidths.ConclusionThis study confirms that patients with CVP present abnormal EEG-indexed cortical activity compared with healthy controls. Moreover, we showed that combining two types of neurostimulation techniques had no effect, whereas the two interventions, when applied individually, have different neural signatures.

  16. Recovery of overall exercise ability, quality of life, and continence after 12-week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study.

    Science.gov (United States)

    Park, Sung-Woo; Kim, Tae Nam; Nam, Jong-Kil; Ha, Hong Koo; Shin, Dong Gil; Lee, Wan; Kim, Mi-Sook; Chung, Moon Kee

    2012-08-01

    To examine the changes from a combined exercise intervention after radical prostatectomy (RP) in elderly patients with prostate cancer, because randomized controlled trials addressing exercise intervention after RP have been lacking. From May 2009 to May 2010, all patients who underwent laparoscopic RP were assessed for eligibility. A total of 66 patients were randomized to an exercise or a control group. The exercise group received a combined exercise intervention (resistance, flexibility, and Kegel exercises) twice a week for 12 weeks, and the control group received only Kegel exercises. The primary outcome was physical function, and the secondary outcomes were continence status and quality of life after the exercise intervention. A total of 49 patients completed follow-up to the end of study. After the 12-week exercise intervention, except for grip strength, all physical functions were better in the exercise group than in the control group. The 24-hour pad test results (12.2 g in the exercise group, 46.2 g in the control group) and continence rate (73.1% in exercise group, 43.5% in the control group) recovered more promptly in the exercise group. On a questionnaire study using the International Consultation on Incontinence questionnaire, Beck Depression Inventory, and Medical Outcomes Study 36-item short-form health survey, only the exercise group showed improvement at the last follow-up visit. A 12-week combined exercise intervention after RP results in improvement of physical function, continence rate, and quality of life. These results could help with prompt recovery of daily activities. Copyright © 2012 Elsevier Inc. All rights reserved.

  17. Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men: a randomized, controlled trial.

    Science.gov (United States)

    Borst, Stephen E; Yarrow, Joshua F; Conover, Christine F; Nseyo, Unyime; Meuleman, John R; Lipinska, Judyta A; Braith, Randy W; Beck, Darren T; Martin, Jeffrey S; Morrow, Matthew; Roessner, Shirley; Beggs, Luke A; McCoy, Sean C; Cannady, Darryl F; Shuster, Jonathan J

    2014-02-15

    Testosterone acts directly at androgen receptors and also exerts potent actions following 5α-reduction to dihydrotestosterone (DHT). Finasteride (type II 5α-reductase inhibitor) lowers DHT and is used to treat benign prostatic hyperplasia. However, it is unknown whether elevated DHT mediates either beneficial musculoskeletal effects or prostate enlargement resulting from higher-than-replacement doses of testosterone. Our purpose was to determine whether administration of testosterone plus finasteride to older hypogonadal men could produce musculoskeletal benefits without prostate enlargement. Sixty men aged ≥60 yr with a serum testosterone concentration of ≤300 ng/dl or bioavailable testosterone ≤70 ng/dl received 52 wk of treatment with testosterone enanthate (TE; 125 mg/wk) vs. vehicle, paired with finasteride (5 mg/day) vs. placebo using a 2 × 2 factorial design. Over the course of 12 mo, TE increased upper and lower body muscle strength by 8-14% (P = 0.015 to finasteride did not alter any of these effects. Over 12 mo, testosterone also increased prostate volume 11.4 cm(3) (P = 0.0051), an effect that was completely prevented by finasteride (P = 0.0027). We conclude that a higher-than-replacement TE combined with finasteride significantly increases muscle strength and BMD and reduces body fat without causing prostate enlargement. These results demonstrate that elevated DHT mediates testosterone-induced prostate enlargement but is not required for benefits in musculoskeletal or adipose tissue.

  18. A JASTRO study group report. A randomized phase III trial of hyperthermia in combination with radiotherapy for superficial tumors

    Energy Technology Data Exchange (ETDEWEB)

    Hiraoka, Masahiro; Nishimura, Yasumasa; Mitsumori, Michihide [Kyoto Univ. (Japan). Faculty of Medicine] [and others

    1998-06-01

    Result of study about local effect of hyperthermia in combination with radiotherapy for superficial tumors was reported. The irradiation was more than 90% isodose for lesion, and total dose was 60 Gy in cases with anamnesis and 40-50 Gy and without anamnesis at a rate of five times a week and 2 Gy at one time. Hyperthermia was carried out four times; once a week, at 42.5 degrees on tumor side edge, and for 40 minutes. Total 53 cases (neck lymph node metastasis 30 cases, relapse breast cancer 11, advanced breast cancer 1, other superficial tumor 11) were divided into 2 groups. Radiotherapy without hyperthermia (group R) was 27 cases, radiotherapy with hyperthermia (group H) was 26 cases. CR and CR+PR within 2 months after treatment were as follows: Group R: 50%, 85%, Group H: 64%, 100%. The CR+PR was superior in group H (p=0.0497). The CR at maximum effect after treatment was 65% of group R and 86% of group H (p=0.17). The local control rate after CR was not different in both groups. (K.H.)

  19. Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma.

    Science.gov (United States)

    Penas-Prado, Marta; Hess, Kenneth R; Fisch, Michael J; Lagrone, Lore W; Groves, Morris D; Levin, Victor A; De Groot, John F; Puduvalli, Vinay K; Colman, Howard; Volas-Redd, Gena; Giglio, Pierre; Conrad, Charles A; Salacz, Michael E; Floyd, Justin D; Loghin, Monica E; Hsu, Sigmund H; Gonzalez, Javier; Chang, Eric L; Woo, Shiao Y; Mahajan, Anita; Aldape, Kenneth D; Yung, W K Alfred; Gilbert, Mark R

    2015-02-01

    Chemoradiation, followed by adjuvant temozolomide, is the standard treatment for newly diagnosed glioblastoma. Adding other active agents may enhance treatment efficacy. The primary objective of this factorial phase II study was to determine if one of 3 potential chemotherapy agents added to dose-dense temozolomide (ddTMZ) improves progression-free survival (PFS) for patients with newly diagnosed glioblastoma. A prior phase I trial established the safety of combining ddTMZ with isotretinoin, celecoxib, and/or thalidomide. Adults with good performance status and no evidence of progression post chemoradiation were randomized into 8 arms: ddTMZ alone (7 days on/7 days off) or doublet, triplet, and quadruplet combinations with isotretinoin, celecoxib, and thalidomide. The study enrolled 155 participants with a median age of 53 years (range, 18-84 y). None of the agents demonstrated improved PFS when compared with arms not containing that specific agent. There was no difference in PFS for triplet compared with doublet regimens, although a trend for improved overall survival (OS) was seen (20.1 vs 17.0 months, P = .15). Compared with ddTMZ, the ddTMZ + isotretinoin doublet had worse PFS (10.5 vs 6.5 months, P = .043) and OS (21.2 vs 11.7 months, P = .037). Trends were also seen for worse outcomes with isotretinoin-containing regimens, but there was no impact with celecoxib or thalidomide combinations. Treatment was well tolerated with expected high rates of lymphopenia. The results do not establish a benefit for these combinations but indicate that adding isotretinoin to ddTMZ may be detrimental. This study demonstrated the feasibility and utility of the factorial design in efficiently testing drug combinations in newly diagnosed glioblastoma. NCT00112502. © The Author(s) 2014. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. Efficacy of functional microarray of microneedles combined with topical tranexamic acid for melasma: A randomized, self-controlled, split-face study.

    Science.gov (United States)

    Xu, Yang; Ma, Renyan; Juliandri, Juliandri; Wang, Xiaoyan; Xu, Bai; Wang, Daguang; Lu, Yan; Zhou, Bingrong; Luo, Dan

    2017-05-01

    To evaluate the efficacy of a functional microarray of microneedles (MNs) plus topical tranexamic acid (TA) for melasma in middle-aged women in China.Thirty female subjects with melasma were enrolled in this study. The left or right side of the face was chosen randomly to be pretreated with a functional microarray of MNs, followed by topical 0.5% TA solution once per week for 12 weeks. The other half-face was the control, treated with a sham device plus topical 0.5% TA solution. At baseline and at weeks 4, 8, and 12 of treatment, clinical (photographic) evaluations and parameters determined by Visia were recorded. At baseline and week 12, patient satisfaction scores and the biophysical parameters measured by Mexameter were also recorded. Side effects were evaluated at baseline and at the end of the 12 weeks.In total, 28 women (93.3%) completed the study. The brown spots' scores measured by Visia were significantly lower on the combined therapy side than on the control side at 12 weeks after starting treatment; there was no significant difference between sides at 4 or 8 weeks. After 12 weeks, melanin index (MI) decreased significantly in both 2 groups, and the MI was significantly less on the combined side at week 12. Transepidermal water loss, roughness, skin hydration, skin elasticity, and erythema index showed no significant differences between 2 sides at baseline, 4, 8, and 12 weeks after treatment. Physicians' evaluations of photographs showed better results at week 12 with combined therapy: >25% improvement was observed in the MNs plus TA side in 25 patients, and in the TA side in only 10 patients. Subjective satisfaction scores on both sides increased significantly. The participants were more satisfied with the results of the combined therapy side than the control side. No obvious adverse reactions were observed throughout the study.Combined therapy with a functional microarray of MNs and topical TA solution is a promising treatment for melasma.

  1. Transcranial direct current stimulation combined with aerobic exercise to optimize analgesic responses in fibromyalgia: A randomized placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Mariana Emerenciano Mendonça

    2016-03-01

    Full Text Available Fibromyalgia is a chronic pain syndrome that is associated with maladaptive plasticity in neural central circuits. One of the neural circuits that are involved in pain in fibromyalgia is the primary motor cortex. We tested a combination intervention that aimed to modulate the motor system: transcranial direct current stimulation (tDCS of the primary motor cortex (M1 and aerobic exercise (AE. In this phase II, sham-controlled randomized clinical trial, 45 subjects were assigned to 1 of 3 groups: tDCS + AE, AE only, and tDCS only. The following outcomes were assessed: intensity of pain, level of anxiety, quality of life, mood, pressure pain threshold, and cortical plasticity, as indexed by transcranial magnetic stimulation. There was a significant effect for the group-time interaction for intensity of pain, demonstrating that tDCS/AE was superior to AE (F(13,364=2.25, p=0.007 and tDCS (F(13.364=2.33, p=0.0056 alone. Post hoc adjusted analysis showed a difference between tDCS/AE and tDCS group after the first week of stimulation and after one month intervention period (p=0.02 and p=0.03, respectively. Further, after treatment there was a significant difference between groups in anxiety and mood levels. The combination treatment effected the greatest response. The three groups had no differences regarding responses in motor cortex plasticity, as assessed by TMS. The combination of tDCS with aerobic exercise is superior compared with each individual intervention (cohen’s d effect sizes > 0.55. The combination intervention had a significant effect on pain, anxiety and mood. Based on the similar effects on cortical plasticity outcomes, the combination intervention might have affected other neural circuits, such as those that control the affective-emotional aspects of pain.

  2. Switching from latanoprost to fixed-combination latanoprost-timolol: a 21-day, randomized, double-masked, active-control study in patients with glaucoma and ocular hypertension.

    Science.gov (United States)

    Olander, Kenneth; Zimmerman, Thom J; Downes, Nina; Schoenfelder, John

    2004-10-01

    Approximately 40% of patients with glaucoma are concomitantly prescribed >or=2 different intraocular pressure (IOP)-lowering medications. An effective and well-tolerated fixed combination of agents requiring once-daily instillation may improve patient compliance. The purpose of this study was to compare the efficacy and safety profile of the fixed combination latanoprost 0.005% + timolol maleate 0.5% QD with those of latanoprost 0.005% monotherapy QD in patients whose elevated IOP (>or=21 mm Hg) was inadequately controlled by latanoprost. This 21-day, randomized, double-masked, active-control study was conducted at 49 study sites in Argentina, Brazil, Colombia, Mexico, Peru, the United States, and Venezuela. Adults with glaucoma or ocular hypertension who had failed to reach an IOP of or=2 mm Hg from the baseline level on day 21. Proportions of patients demonstrating IOP decreases >or=3, >or=4, or >or=5 mm Hg from the baseline level and of patients reaching an 10P vs 51.4%, respectively; P or=3, >or=4, or >or=5 mm Hg (for each target level, P vs latanoprost group) or final IOP 18 mm Hg (fixed -combination, 35.1%; latanoprost, 17.8%; P < 0.001). Both treatments were well tolerated. Similar proportions of patients in the fixed-combination and latanoprost groups reported at least 1 treatment-emergent AE (10.9% and 12.1%, respectively). In this selected population of patients with an inadequate initial IOP response to latanoprost, switching to fixed-combination latanoprosttimolol resulted in a greater decrease in IOP and similar tolerability compared with continuing latanoprost therapy.

  3. GnRH antagonist rescue protocol combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome: a randomized controlled trial.

    Science.gov (United States)

    Fouda, Usama M; Sayed, Ahmed M; Elshaer, Hesham S; Hammad, Bahaa Eldin M; Shaban, Mona M; Elsetohy, Khaled A; Youssef, Mohamed A

    2016-05-17

    The aim of this study was to compare the efficacy of antagonist rescue protocol (replacing GnRH agonist with GnRH antagonist and reducing the dose of gonadotropins) combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who were at high risk for OHSS. Two hundred and thirty six patients were randomized in a 1:1 ratio to the cabergoline group or the antagonist rescue combined with cabergoline group. Both groups received oral cabergoline (0.5 mg/day) for eight days beginning on the day of HCG administration. In the antagonist rescue combined with cabergoline group, when the leading follicle reached 16 mm, GnRH agonist (triptorelin) was replaced with GnRH antagonist (cetrorelix acetate) and the dose of HP-uFSH was reduced to 75 IU/day. HCG (5,000 IU/I.M) was administered when the serum estradiol level dropped below 3500 pg/ml. The study was open label and the outcome assessors (laboratory staff and the doctor who performed oocyte retrieval) were blind to treatment allocation. The incidence of moderate/severe OHSS was significantly lower in the antagonist rescue combined with cabergoline group [5.08 % Vs 13.56 %, P value =0.025, OR = 0.342, 95 % CI, 0.129-0.906]. Four cycles were cancelled in the cabergoline group. There were no significant differences between the groups with respect to the number of retrieved oocytes, metaphase II oocytes, high quality embryos and fertilization rate. Moreover, the implantation and pregnancy rates were comparable between both groups. GnRH antagonist rescue protocol combined with cabergoline is more effective than cabergoline alone in the prevention of OHSS. Clinical trial.gov ( NCT02461875 ).

  4. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee

    Directory of Open Access Journals (Sweden)

    Lana JFSD

    2016-11-01

    Full Text Available Objective: This study aims to evaluate the clinical effects of Platelet Rich Plasma (PRP and Hyaluronic Acid (HA as individual treatments for mild to moderate Osteoarthritis (OA, and also examine the potential synergistic effects of PRP in combination with HA. Research continues to emerge examining the potential therapeutic efficacy of HA and PRP as autologous injectable treatments for joint arthritis. However, there is a paucity of research investigating the effects of combining HA and PRP on pain and functional status in patients with OA. Design: In this multicenter, randomized, controlled, double blind, prospective trial, 105 patients with mild to moderate knee osteoarthritis who met the study criteria were randomly allocated to one of three interventions: HA (n=36, PRP (n=36, or HA+PRP (n=33. Each patient received 3 intaarticular knee injections of their assigned substance, with 2 week intervals between each injection. Clinical outcomes were evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC and Visual Analogue Scale (VAS questionnaire at baseline and after 1,3,6, and 12 months. Results: The study showed that the PRP group have significant reduction in VAS scores at 1 (p= 0.003, 3 (p= 0.0001, 6 (p= 0.0001 and 12 (p= 0.000 months when compared to HA. In addition, the PRP group illustrated greater improvement in WOMAC physical activity scale at 12 months (p= 0.008 when compared to the HA group. Combining HA and PRP resulted in a significant decreases in pain (p=0.0001 and functional limitation (p=0.0001 when compared to HA alone at 1 year post treatment; and significantly increased physical function at 1 (p=0.0004 and 3 (p=.011 months when compared to PRP alone. Conclusion: The findings of the study support the use of autologous PRP as an effective treatment of mild to moderate knee osteoarthritis. It also shows that the combination of HA and PRP resulted to better outcomes than HA alone up to 1 year and PRP

  5. Prenatal vitamin D supplementation reduces risk of asthma/recurrent wheeze in early childhood: A combined analysis of two randomized controlled trials.

    Science.gov (United States)

    Wolsk, Helene M; Chawes, Bo L; Litonjua, Augusto A; Hollis, Bruce W; Waage, Johannes; Stokholm, Jakob; Bønnelykke, Klaus; Bisgaard, Hans; Weiss, Scott T

    2017-01-01

    We recently published two independent randomized controlled trials of vitamin D supplementation during pregnancy, both indicating a >20% reduced risk of asthma/recurrent wheeze in the offspring by 3 years of age. However, neither reached statistical significance. To perform a combined analysis of the two trials and investigate whether maternal 25-hydroxy-vitamin D (25(OH)D) level at trial entry modified the intervention effect. VDAART (N = 806) and COPSAC2010. (N = 581) randomized pregnant women to daily high-dose vitamin D3 (4,000 IU/d and 2,400 IU/d, respectively) or placebo. All women also received a prenatal vitamin containing 400 IU/d vitamin D3. The primary outcome was asthma/recurrent wheeze from 0-3yrs. Secondary end-points were specific IgE, total IgE, eczema and lower respiratory tract infections (LRTI). We conducted random effects combined analyses of the treatment effect, individual patient data (IPD) meta-analyses, and analyses stratified by 25(OH)D level at study entry. The analysis showed a 25% reduced risk of asthma/recurrent wheeze at 0-3yrs: adjusted odds ratio (aOR) = 0.74 (95% CI, 0.57-0.96), p = 0.02. The effect was strongest among women with 25(OH)D level ≥30ng/ml at study entry: aOR = 0.54 (0.33-0.88), p = 0.01, whereas no significant effect was observed among women with 25(OH)D level vitamin D supplementation during pregnancy results in a significant reduced risk of asthma/recurrent wheeze in the offspring, especially among women with 25(OH)D level ≥ 30 ng/ml at randomization, where the risk was almost halved. Future studies should examine the possibility of raising 25(OH)D levels to at least 30 ng/ml early in pregnancy or using higher doses than used in our studies. COPSAC2010: ClinicalTrials.gov NCT00856947; VDAART: ClinicalTrials.gov NCT00920621.

  6. Orthosis-Shaped Sandals Are as Efficacious as In-Shoe Orthoses and Better than Flat Sandals for Plantar Heel Pain: A Randomized Control Trial.

    Directory of Open Access Journals (Sweden)

    Bill Vicenzino

    Full Text Available To investigate efficacy of a contoured sandal being marketed for plantar heel pain with comparison to a flat flip-flop and contoured in-shoe insert/orthosis.150 volunteers aged 50 (SD: 12 years with plantar heel pain (>4 weeks were enrolled after responding to advertisements and eligibility determined by telephone and at first visit. Participants were randomly allocated to receive commercially available contoured sandals (n = 49, flat flip-flops (n = 50 or over the counter, pre-fabricated full-length foot orthotics (n = 51. Primary outcomes were a 15-point Global Rating of Change scale (GROC: 1 = a very great deal worse, 15 = a very great deal better, 13 to 15 representing an improvement and the 20-item Lower Extremity Function Scale (LEFS on which participants rate 20 common weight bearing activities and activities of daily living on a 5-point scale (0 = extreme difficulty, 4 = no difficulty. Secondary outcomes were worst level of heel pain in the preceding week, and the foot and ankle ability measure. Outcomes were collected blind to allocation. Analyses were done on an intention to treat basis with 12 weeks being the primary outcome time of interest.The contoured sandal was 68% more likely to report improvement in terms of GROC compared to flat flip-flop. On the LEFS the contoured sandal was 61% more likely than flat flip-flop to report improvement. The secondary outcomes in the main reflected the primary outcomes, and there were no differences between contoured sandal and shoe insert.Physicians can have confidence in supporting a patient's decision to wear contoured sandals or in-shoe orthoses as one of the first and simple strategies to manage their heel pain.The Australian New Zealand Clinical Trials Registry ACTRN12612000463875.

  7. The Academy for Future Science Faculty: randomized controlled trial of theory-driven coaching to shape development and diversity of early-career scientists.

    Science.gov (United States)

    Thakore, Bhoomi K; Naffziger-Hirsch, Michelle E; Richardson, Jennifer L; Williams, Simon N; McGee, Richard

    2014-08-02

    Approaches to training biomedical scientists have created a talented research community. However, they have failed to create a professional workforce that includes many racial and ethnic minorities and women in proportion to their representation in the population or in PhD training. This is particularly true at the faculty level. Explanations for the absence of diversity in faculty ranks can be found in social science theories that reveal processes by which individuals develop identities, experiences, and skills required to be seen as legitimate within the profession. Using the social science theories of Communities of Practice, Social Cognitive Career Theory, identity formation, and cultural capital, we have developed and are testing a novel coaching-based model to address some of the limitations of previous diversity approaches. This coaching intervention (The Academy for Future Science Faculty) includes annual in-person meetings of students and trained faculty Career Coaches, along with ongoing virtual coaching, group meetings and communication. The model is being tested as a randomized controlled trial with two cohorts of biomedical PhD students from across the U.S., one recruited at the start of their PhDs and one nearing completion. Stratification into the experimental and control groups, and to coaching groups within the experimental arms, achieved equal numbers of students by race, ethnicity and gender to the extent possible. A fundamental design element of the Academy is to teach and make visible the social science principles which highly influence scientific advancement, as well as acknowledging the extra challenges faced by underrepresented groups working to be seen as legitimate within the scientific communities. The strategy being tested is based upon a novel application of the well-established principles of deploying highly skilled coaches, selected and trained for their ability to develop talents of others. This coaching model is intended to be a

  8. Effects of Robot-assisted Gait Training Combined with Functional Electrical Stimulation on Recovery of Locomotor Mobility in Chronic Stroke Patients: A Randomized Controlled Trial.

    Science.gov (United States)

    Bae, Young-Hyeon; Ko, Young Jun; Chang, Won Hyuk; Lee, Ju Hyeok; Lee, Kyeong Bong; Park, Yoo Jung; Ha, Hyun Geun; Kim, Yun-Hee

    2014-12-01

    [Purpose] The purpose of the present study was to investigate the effects of robot-assisted gait training combined with functional electrical stimulation on locomotor recovery in patients with chronic stroke. [Subjects] The 20 subjects were randomly assigned into either an experimental group (n = 10) that received a combination of robot-assisted gait training and functional electrical stimulation on the ankle dorsiflexor of the affected side or a control group (n = 10) that received robot-assisted gait training only. [Methods] Both groups received the respective therapies for 30 min/day, 3 days/week for 5 weeks. The outcome was measured using the Modified Motor Assessment Scale (MMAS), Timed Up-and-Go Test (TUG), Berg Balance Scale (BBS), and gait parameters through gait analysis (Vicon 370 motion analysis system, Oxford Metrics Ltd., Oxford, UK). All the variables were measured before and after training. [Results] Step length and maximal knee extension were significantly greater than those before training in the experimental group only. Maximal Knee flexion showed a significant difference between the experimental and control groups. The MMAS, BBS, and TUG scores improved significantly after training compared with before training in both groups. [Conclusion] We suggest that the combination of robot-assisted gait training and functional electrical stimulation encourages patients to actively participate in training because it facilitates locomotor recovery without the risk of adverse effects.

  9. Effect of methylphenidate and/or levodopa combined with physiotherapy on mood and cognition after stroke: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Delbari, Ahmad; Salman-Roghani, Reza; Lokk, Johan

    2011-01-01

    Stimulant medications can enhance mood and cognition in stroke rehabilitation, but human clinical trial results are inconclusive. We sought to prospectively study the effects of levodopa (LD) and/or methylphenidate (MPH) in combination with physiotherapy on mood and cognition following stroke in human subjects. Ischemic stroke patients were enrolled in our study 15 to 180 days after stroke onset. The patients were randomized into four medication groups (MPH, LD, MPH + LD, or placebo) and received a 15-day course of medication therapy (1 dose daily) and 45-min standard physiotherapy treatment daily. Mood and cognitive function were assessed at the study onset and 15, 90 and 180 days after study enrollment. The strongest improvement of mood and cognition was found between baseline and the first follow-up immediately after the intervention. A significant improvement in mood was also found in the combined treatment group (MPH + LD) at 90 and 180 days, compared to the placebo group. A 15-day course of daily MPH + LD combined with physiotherapy over a 3-week period was safe and significantly improved mood status in ischemic stroke patients. Future studies are needed which determine the optimal therapeutic window for and dosage of psychostimulants as well as identify those stroke patients who might benefit the most from treatment. Copyright © 2011 S. Karger AG, Basel.

  10. Combined transcranial direct current stimulation and home-based occupational therapy for upper limb motor impairment following intracerebral hemorrhage: a double-blind randomized controlled trial.

    Science.gov (United States)

    Mortensen, Jesper; Figlewski, Krystian; Andersen, Henning

    2016-01-01

    To investigate the combined effect of transcranial direct current stimulation (tDCS) and home-based occupational therapy on activities of daily living (ADL) and grip strength, in patients with upper limb motor impairment following intracerebral hemorrhage (ICH). A double-blind randomized controlled trial with one-week follow-up. Patients received five consecutive days of occupational therapy at home, combined with either anodal (n = 8) or sham (n = 7) tDCS. The primary outcome was ADL performance, which was assessed with the Jebsen-Taylor test (JTT). Both groups improved JTT over time (p occupational therapy provided greater improvements in grip strength compared with occupational therapy alone. tDCS is a promising add-on intervention regarding training of upper limb motor impairment. It is well tolerated by patients and can easily be applied for home-based training. Larger studies with long-term follow-up are needed to further explore possible effects of tDCS in patients with ICH. Five consecutive days of tDCS combined with occupational therapy provided greater improvements in grip strength compared with occupational therapy alone. tDCS is well tolerated by patients and can easily be applied for home-based rehabilitation.

  11. A Randomized, Controlled Trial to Assess the Efficacy of Arthroscopic Debridement in Combination with Oral Medication Versus Oral Medication in Patients with Gouty Knee Arthritis.

    Science.gov (United States)

    Wang, Xin; Wanyan, Pingping; Wang, Jian Min; Tian, Jin Hui; Hu, Long; Shen, Xi Ping; Yang, Ke Hu

    2015-12-01

    Gouty knee arthritis refers to a form of inflammatory diseases caused by deposits of needle-like crystals of uric acid in knee joint. The aim of this study was to assess the efficacy and safety of arthroscopic debridement in combination with oral medication versus oral medication alone for the treatment of gouty knee arthritis. A total of 60 patients with gouty knee arthritis were randomized to receive either arthroscopic surgery in combination with oral medication or oral medication alone. Efficacy was assessed with the angle of motion, functions, and visual analog scale (VAS). These indices were measured prior to treatment and at 2, 4, 12, 24, and 48 weeks posttreatment. Surgery- and medication-related complications were observed. Significant differences in flexion and extension of the knee joint, lymphoma scores, and VAS were detected between the two groups at 2, 4, and 12 weeks posttreatment (P  0.05) . Significant differences in these indices were detected at different time points in each group (P  0.05). Arthroscopic surgery in combination with oral medication is superior to single oral medication in the flexion and extension of the knee joint, lymphoma scores, and pain relief (VAS) before 24 weeks, although no statistical differences were detected in the efficacy after 24 weeks, and in medication-related safety between the two groups. Although arthroscopic debridement cannot replace systemic uric acid-lowering treatments such as medication and dietary control, it is still an effective approach.

  12. Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to moderate acne vulgaris: A randomized control trial

    Directory of Open Access Journals (Sweden)

    NilFroushzadeh Mohammad

    2009-01-01

    Full Text Available Background: Acne vulgaris is a common skin disease that affects 85% to 100% of people at some time during their lives. It is characterized by noninflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. Aims: To compare the efficacy of combination treatment of clindamycin+salicylic acid, versus clindamycin+tretinoin versus clindamycin alone in the treatment of the mild-to-moderate acne vulgaris. Methods: This was a single-blinded, randomized clinical trial.Forty-two female patients (age range: 15-25 years with mild-to-moderate acne vulgaris were selected randomly and subsequently randomized to 3 groups. Group A patients were treated with 1% clindamycin lotion (C lotion twice daily. Group B patients were treated with 1% clindamycin+0.025% tretinoin lotion once nightly (CT lotion. Group C patients were treated with 1% clindamycin+2% salicylic acid lotion twice daily (CS lotion for 12 weeks. For comparison of efficacy of these treatments, and regarding the skewed distribution of the data, Kruskal-Wallis Test and Mann-Whitney U test were used. SPSS software was used for statistical analysis. Results: There was a significant difference between 3 types of treatment in the respect of the total lesion count (TLC improvement ( P = 0.039. The efficacy of treatment on Acne Severity Index (ASI was maximum for CS lotion (81.80% reduction in ASI. CT lotion reduced ASI by as much as 73.73% during 12 weeks of treatment. The efficacy of C lotion was calculated to be 37.87% in the reduction of ASI. Conclusions: Our data suggested that the efficacy of CS lotion was significantly more than C lotion with respect to the TLC and ASI, although there was no significant difference between CS and CT lotion.

  13. Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to moderate acne vulgaris: a randomized control trial.

    Science.gov (United States)

    NilFroushzadeh, Mohammad Ali; Siadat, Amir Hossein; Baradaran, Elahe Haft; Moradi, Shahram

    2009-01-01

    Acne vulgaris is a common skin disease that affects 85% to 100% of people at some time during their lives. It is characterized by noninflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. To compare the efficacy of combination treatment of clindamycin+salicylic acid, versus clindamycin+tretinoin versus clindamycin alone in the treatment of the mild-to-moderate acne vulgaris. This was a single-blinded, randomized clinical trial.Forty-two female patients (age range: 15-25 years) with mild-to-moderate acne vulgaris were selected randomly and subsequently randomized to 3 groups. Group A patients were treated with 1% clindamycin lotion (C lotion) twice daily. Group B patients were treated with 1% clindamycin+0.025% tretinoin lotion once nightly (CT lotion). Group C patients were treated with 1% clindamycin+2% salicylic acid lotion twice daily (CS lotion) for 12 weeks. For comparison of efficacy of these treatments, and regarding the skewed distribution of the data, Kruskal-Wallis Test and Mann-Whitney U test were used. SPSS software was used for statistical analysis. There was a significant difference between 3 types of treatment in the respect of the total lesion count (TLC) improvement (P = 0.039). The efficacy of treatment on Acne Severity Index (ASI) was maximum for CS lotion (81.80% reduction in ASI). CT lotion reduced ASI by as much as 73.73% during 12 weeks of treatment. The efficacy of C lotion was calculated to be 37.87% in the reduction of ASI. Our data suggested that the efficacy of CS lotion was significantly more than C lotion with respect to the TLC and ASI, although there was no significant difference between CS and CT lotion.

  14. Bacterial fitness shapes the population dynamics of antibiotic-resistant and -susceptible bacteria in a model of combined antibiotic and anti-virulence treatment.

    Science.gov (United States)

    Ternent, Lucy; Dyson, Rosemary J; Krachler, Anne-Marie; Jabbari, Sara

    2015-05-07

    Bacterial resistance to antibiotic treatment is a huge concern: introduction of any new antibiotic is shortly followed by the emergence of resistant bacterial isolates in the clinic. This issue is compounded by a severe lack of new antibiotics reaching the market. The significant rise in clinical resistance to antibiotics is especially problematic in nosocomial infections, where already vulnerable patients may fail to respond to treatment, causing even greater health concern. A recent focus has been on the development of anti-virulence drugs as a second line of defence in the treatment of antibiotic-resistant infections. This treatment, which weakens bacteria by reducing their virulence rather than killing them, should allow infections to be cleared through the body׳s natural defence mechanisms. In this way there should be little to no selective pressure exerted on the organism and, as such, a predominantly resistant population should be less likely to emerge. However, before the likelihood of resistance to these novel drugs emerging can be predicted, we must first establish whether such drugs can actually be effective. Many believe that anti-virulence drugs would not be powerful enough to clear existing infections, restricting their potential application to prophylaxis. We have developed a mathematical model that provides a theoretical framework to reveal the circumstances under which anti-virulence drugs may or may not be successful. We demonstrate that by harnessing and combining the advantages of antibiotics with those provided by anti-virulence drugs, given infection-specific parameters, it is possible to identify treatment strategies that would efficiently clear bacterial infections, while preventing the emergence of antibiotic-resistant subpopulations. Our findings strongly support the continuation of research into anti-virulence drugs and demonstrate that their applicability may reach beyond infection prevention. Copyright © 2015 The Authors. Published by

  15. Randomized cross-over study of patient preference for oral or intravenous vinorelbine in combination with carboplatin in the treatment of advanced NSCLC

    DEFF Research Database (Denmark)

    Jensen, Lars Henrik; Osterlind, Kell; Rytter, Carsten

    2008-01-01

    BACKGROUND: Most chemotherapeutics are administrated intravenously (iv), but some are also available in an oral (po) formulation. This study was designed with the primary objective to estimate the patients' preference for po or iv vinorelbine in combination with carboplatin for the palliative...... treatment of non-small cell lung cancer (NSCLC). Secondary aims were to evaluate toxicity, efficacy, and subjective reasons the preference. PATIENTS AND METHODS: Sixty-one patients were randomized in a cross-over trial to two cycles of carboplatin day 1 and vinorelbine day 1 and day 8 iv followed by two...... cycles of carboplatin and vinorelbine po, or the opposite. Patients, who did not show progressive disease after four cycles, had a free choice of iv or po vinorelbine for the next two cycles. RESULTS: Forty-three patients were evaluable for preference and 32 (74%, 95% CI 61-88%) chose po (p

  16. Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes.

    Science.gov (United States)

    Fonseca, Vivian; Staels, Bart; Morgan, Jerry D; Shentu, Yue; Golm, Gregory T; Johnson-Levonas, Amy O; Kaufman, Keith D; Goldstein, Barry J; Steinberg, Helmut

    2013-01-01

    To assess efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in combination therapy with metformin (≥1500 mg/day) and pioglitazone (≥30 mg/day) in patients with type 2 diabetes (T2DM) with inadequate glycemic control (hemoglobin A1c [HbA1c] ≥7.5% and ≤11%). This placebo-controlled, double-blind study included 313 patients, mean baseline HbA1c=8.7%, who were randomized to receive sitagliptin 100 mg/day or placebo for 26 weeks. The addition of sitagliptin led to significant (Pmetformin and pioglitazone improved glycemic control and was generally well tolerated. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Chinese Herbal Medicine Combined with Conventional Therapy for Blood Pressure Variability in Hypertension Patients: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Zhuo Chen

    2015-01-01

    Full Text Available Objective. The aim of this systematic review is to evaluate effect of Chinese medicine combined with conventional therapy on blood pressure variability (BPV in hypertension patients. Methods. All randomized clinical trials (RCTs comparing Chinese medicine with no intervention or placebo on the basis of conventional therapy were included. Data extraction, analyses, and quality assessment were performed according to the Cochrane standards. Results. We included 13 RCTs and assessed risk of bias for all the trials. Chinese medicine has a significant effect in lowering blood pressure (BP, reducing BPV in the form of standard deviation (SD or coefficient of variability (CV, improving nighttime BP decreased rate, and reversing abnormal rhythm of BP. Conclusions. Chinese medicine was safe and showed beneficial effects on BPV in hypertension patients. However, more rigorous trials with high quality are warranted to give high level of evidence before recommending Chinese medicine as an alternative or complementary medicine to improve BPV in hypertension patients.

  18. Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a β-TCP-Collagen Matrix.

    Science.gov (United States)

    Daniels, Timothy R; Younger, Alastair S E; Penner, Murray J; Wing, Kevin J; Le, Ian L D; Russell, Iain S; Lalonde, Karl-André; Evangelista, Peter T; Quiton, Jovelyn D; Glazebrook, Mark; DiGiovanni, Christopher W

    2015-07-01

    Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (β-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions. Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/β-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/β-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/β-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P BB/β-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P BB/β-TCP-collagen patients and 120 of 154 (78%) autograft patients (P BB/β-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting. Level I, prospective randomized

  19. Intratissue percutaneous electolysis combined with active physical therapy for the treatment of adductor longus enthesopathy-related groin pain: a randomized trial.

    Science.gov (United States)

    Moreno, Carlos; Mattiussi, Gabriele; Núñez, Francisco J; Messina, Giovanni; Rejc, Enrico

    2017-10-01

    Adductor longus enthesopathy-related groin pain (ALErGP) is the most common cause of groin pain in soccer players. The aim of this study was to evaluate the therapeutic utility of intratissue percutaneous electrolysis (EPI®) technique in combination with an active physical therapy (APT) program to treat ALErGP. Twenty-four non-professional male soccer players diagnosed with ALErGP were included in this study and randomly divided into two groups. Group A was treated with EPI® technique in combination with a standardized APT program. Group B only underwent the APT program. The Numeric Rating Scale (NRS) and the Patient Specific Functional Scale (PSFS) were used to assess the effectiveness of the two interventions. The follow-up covered a 6-month period. Both groups significantly improved pain and functional scores after treatment and maintained this therapeutic result throughout the follow-up. The combined intervention of APT program and EPI® ensured a greater and faster reduction of pain in group A. In addition, functional recovery tended to be greater in group A than B after the treatment and throughout the follow-up by 7.8±3.8% (P=0.093). EPI® treatment in association with APT ensured a greater and more rapid reduction of pain and tended to promote greater functional recovery in soccer players with ALErGP compared to APT only. This positive therapeutic result lasted for at least 6 months after the end of the treatment. These findings support the combined use of EPI® and APT to treat ALErGP.

  20. The combined effects of on-road and simulator training with feedback on older drivers' on-road performance: Evidence from a randomized-controlled trial.

    Science.gov (United States)

    Sawula, Erica; Polgar, Jan; Porter, Michel M; Gagnon, Sylvain; Weaver, Bruce; Nakagawa, Satoru; Stinchcombe, Arne; Bédard, Michel

    2017-10-24

    A number of training programs that seek to improve driving performance among older drivers are available accompanied by a growing interest in their effectiveness. The purpose of the present investigation was to examine the combined effect of 1) basic in-class training (BT); 2) on-road training with individualized feedback (OR); and 3) training on a driving simulator (S). Using a randomized controlled trial study design, 78 older drivers were randomly assigned to one of three groups (BT, BT+OR, or BT+OR+S). All participants completed a pre- and post-intervention on-road driving evaluation on a standardized route. The driving evaluations were recorded using video and GPS equipment and were scored by a blind assessor. The results indicated a significant reduction of approximately 30% in overall number of driving errors/omissions among participants in the BT+OR and the BT+OR+S groups in comparison to participants in the BT group. This study adds to the mounting evidence demonstrating the effectiveness of individualized driver training in improving safe driving among older adults.

  1. Two-year follow-up of a randomized trial of spectacles alone or combined with Bangerter filters for treating anisometropic amblyopia.

    Science.gov (United States)

    Agervi, Pia; Kugelberg, Ulla; Kugelberg, Maria; Zetterström, Charlotta

    2013-02-01

    To compare spectacle correction alone to spectacle correction with Bangerter filters as treatments for anisometropic amblyopia in children 1 year after completion of a 1-year randomized trial. In a randomized clinical trial, 80 children (mean age, 4.4 years) with anisometropic amblyopia and a best median visual acuity (VA) in the amblyopic eye of 0.4 logarithm of the minimum angle of resolution (logMAR) were assigned to treatment with either spectacles or spectacles in combination with a Bangerter filter for 1 year. After 1 year, treatment with spectacles continued. If the VA differed by ≥ 2 lines, treatment with Bangerter filters was continued if originally prescribed. The main outcome measure was the median change in VA of the amblyopic eye after 2 years. The median change in VA of the amblyopic eye did not differ significantly between the groups (0.4 log unit for both groups) at the 2-year visit. At that time, the VA in the amblyopic eyes and the fellow eyes was 0.0 median logMAR in both groups. Between years 1 and 2, the median VA improved in the amblyopic eyes; in the spectacles group (p = 0.0181) and in the Bangerter filter group (p = 0.0342). The median anisometropia decreased in both groups (p spectacles alone did not differ significantly from that after treatment with spectacles and a Bangerter filter for anisometropic amblyopia. © 2011 The Authors. Acta Ophthalmologica © 2011 Acta Ophthalmologica Scandinavica Foundation.

  2. The HIKCUPS trial: a multi-site randomized controlled trial of a combined physical activity skill-development and dietary modification program in overweight and obese children

    Directory of Open Access Journals (Sweden)

    Warren Janet M

    2007-01-01

    Full Text Available Abstract Background Childhood obesity is one of the most pressing health issues of our time. Key health organizations have recommended research be conducted on the effectiveness of well-designed interventions to combat childhood obesity that can be translated into a variety of settings. This paper describes the design and methods used in the Hunter Illawarra Kids Challenge Using Parent Support (HIKCUPS trial, an ongoing multi-site randomized controlled trial, in overweight/obese children comparing the efficacy of three interventions: 1 a parent-centered dietary modification program; 2 a child-centered physical activity skill-development program; and 3 a program combining both 1 and 2 above. Methods/Design Each intervention consists of three components: i 10-weekly face-to-face group sessions; ii a weekly homework component, completed between each face-to-face session and iii three telephone calls at monthly intervals following completion of the 10-week program. Details of the programs' methodological aspects of recruitment, randomization and statistical analyses are described here a priori. Discussion Importantly this paper describes how HIKCUPS addresses some of the short falls in the current literature pertaining to the efficacy of child obesity interventions. The HIKCUPS trial is funded by the National Medical Research Council, Australia.

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

    Science.gov (United States)

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

    2015-08-01

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

  4. Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial.

    Science.gov (United States)

    Gillani, Syed Wasif; Sulaiman, Syed Azhar Syed; Abdul, Mohi Iqbal Mohammad; Baig, Mirza R

    2017-08-14

    We aimed to investigate the efficacy of ascorbic acid and acetylsalicylic acid among type II diabetes mellitus patients using metformin (only) for diabetes management therapy. A 12-month single blinded multicenter randomized control trial was designed to investigate the measured variables [Glycated Hemoglobin (HbA1c), Renal function, Albumin Creatinine Ratio (ACR) etc.]. The trial was randomized into 2 experimental parallel arms (ascorbic acid vs acetylsalicylic acid) were blinded with study supplements in combination with metformin and findings were compared to control arm with metformin alone and blinded with placebo. Withdrawal criteria was defined to maintain the equity and balance in the participants in the whole trial. Patients with metformin and ascorbic acid (parallel arm I) was twice more likely to reduce HbA1c than metformin alone (control arm) in a year (OR 2.31 (95% CI 1.87-4.42) p ascorbic acid with metformin is more effective against reducing risks for diabetes related long-term complications (including ACR). TRIAL details Registration No: NTR-6100, Registry Name: Netherlands Trial Registry, URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6100 , Date of Registration: 20th October, 2016, Date of first Enrollment: 1 November, 2015.

  5. Anesthetic Efficacy of Gow-Gates Nerve Block, Inferior Alveolar Nerve Block, and Their Combination in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Prospective, Randomized Clinical Trial.

    Science.gov (United States)

    Saatchi, Masoud; Shafiee, Maryam; Khademi, Abbasali; Memarzadeh, Bahareh

    2018-03-01

    The purpose of this prospective, randomized clinical trial was to evaluate the anesthetic efficacy of the Gow-Gates nerve block (GGNB), the inferior alveolar nerve block (IANB), and their combination for mandibular molars in patients with symptomatic irreversible pulpitis. One hundred fifty patients diagnosed with symptomatic irreversible pulpitis of a mandibular molar were selected. The patients randomly received 2 GGNB injections, 2 IANB injections, or 1 GGNB injection plus 1 IANB injection of 1.8 mL 2% lidocaine with 1:80,000 epinephrine. Access cavity preparation was initiated 15 minutes after injections. Lip numbness was a requisite for all of the patients. Success was specified as no or mild pain on the basis of Heft-Parker visual analog scale recordings during access cavity preparation or initial instrumentation. Data were analyzed with the chi-square, Kruskal-Wallis, and analysis of variance tests. The success rates of anesthesia were 40%, 44%, and 70% for the GGNB, IANB, and GGNB + IANB groups, respectively. There was no statistically significant difference in the success rate of anesthesia between the GGNB and IANB groups (P > .05). The anesthesia success rate for the GGNB + IANB group was significantly different from those of the GGNB and IANB groups (P irreversible pulpitis, but it would still require supplemental anesthesia. Further research may be needed to confirm the results of this study. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. Randomized Clinical Trial of Periarticular Drug Injection used in combination Patient-Controlled Analgesia versus Patient-Controlled Analgesia Alone in Total Knee Arthroplasty

    Directory of Open Access Journals (Sweden)

    MN Sabran

    2008-11-01

    Full Text Available This is a prospective randomized clinical trial to compare use of a combination of periarticular drug injection with patient- controlled analgesia (PCA to PCA alone in post-total knee arthroplasty (TKA. Thirty patients who were admitted for unilateral total knee arthroplasty were selected randomly into an Injection group or a Standard group. The periarticular injection contained Ropivacaine, Ketorolac and Adrenaline, given intra-operatively. The mean amount of opioid used was 22.87 mmol/L in the Injection group as compared to 39.78 mmol/L in the Standard group (p = 0.026. The Injection group had lower pain score at rest and during exercise (p=0.021, p=0.041, respectively, as well as better return to function (p=0.026 and shorter hospital stay (6.1 days, Injection; 7.5 days, Standard, p=0.027. Overall, the group receiving periarticular drugs injection had less pain, less narcotic usage, earlier return to function, similar experience of adverse effects and shorter hospital stays.

  7. A Randomized, Double-Blind Study Assessing Changes in Cognitive Function in Indian School Children Receiving a Combination of Bacopa monnieri and Micronutrient Supplementation vs. Placebo

    Directory of Open Access Journals (Sweden)

    Tora Mitra-Ganguli

    2017-11-01

    Full Text Available Several studies have indicated a chronic cognitive enhancing effect of Bacopa monnieri across different ages and cognitive impairment associated with vitamin and mineral deficiencies in children. Therefore, we investigated the effects of 4-month supplementation with a combination of B. monnieri extract and multiple micronutrients on cognitive functions in Indian school children aged 7–12 years. This was a randomized, double-blind, parallel design, single-center study in which 300 children were randomized to receive a beverage either fortified with B. monnieri and multiple micronutrients (“fortified” or a non-fortified isocaloric equivalent (“control” twice-daily for 4 months. Cognitive function was assessed by the Cambridge Neuropsychological Automated Test Battery (CANTAB administered at baseline, Day 60 and Day 121. The primary endpoint was change in short-term memory (working memory from baseline in subjects receiving “fortified” vs. “control” beverages after 4 months. Secondary endpoints included sustained attention, episodic memory, and executive function. The “fortified” beverage did not significantly improve short-term memory or any of the secondary outcomes tested relative to the “control” beverage. However, the spatial working memory “strategy” score showed significant improvement on Day 60 (difference between groups in change from baseline: −0.55; p < 0.05, but not on Day 121 due to the active intervention. Study products were well-tolerated. Reasons for these unexpected findings are discussed.

  8. Effect of combined dexamethasone therapy with nebulized r-epinephrine or salbutamol in infants with bronchiolitis: A randomized, double-blind, controlled trial.

    Science.gov (United States)

    Bawazeer, Manal; Aljeraisy, Majed; Albanyan, Esam; Abdullah, Alanazi; Al Thaqa, Wesam; Alenazi, Jaber; Al Otaibi, Zaam; Al Ghaihab, Mohammed

    2014-07-01

    This study investigated the effect of combining oral dexamethasone with either nebulized racemic epinephrine or salbutamol compared to bronchodilators alone for the treatment of infants with bronchiolitis. This was a double-blind, randomized controlled trial on infants (1 to 12 months) who were diagnosed in the emergency department with moderate-to-severe bronchiolitis. The primary outcome was the rate of hospital admission within 7 days of the first dose of treatment, and the secondary outcomes were changes in respiratory distress assessment instrument score, heart rate, respiratory rate, and oxygen saturation (O2 Sat) over a 4-hour observation period. Infants (n = 162) were randomly assigned to four groups: A (dexamethasone + racemic epinephrine) = 45, B (placebo and racemic epinephrine) =39, C (dexamethasone and salbutamol) = 40, or D (placebo and salbutamol) = 38. Patients who had received dexamethasone + epinephrine exhibited similar admission rates compared to placebo + epinephrine or salbutamol (P = 0.64). Similarly, no statistically significant difference was observed in the rate of hospitalization for patients who received dexamethasone + salbutamol compared to those who received placebo + epinephrine or salbutamol (P = 0.51). Clinical parameters were improved at the end of the 4-hour observation period for all treatment groups. Treatment with dexamethasone + epinephrine resulted in a statistically significant change in HR over time (P < 0.005) compared to the other groups. This study adds to a body of evidence suggesting that corticosteroids have no role in the management of bronchiolitis for young infants who are first time wheezers with no risk of atopy.

  9. Effect of combined low-frequency repetitive transcranial magnetic stimulation and virtual reality training on upper limb function in subacute stroke: a double-blind randomized controlled trail.

    Science.gov (United States)

    Zheng, Chan-juan; Liao, Wei-jing; Xia, Wen-guang

    2015-04-01

    The effect of combined low-frequency repetitive transcranial magnetic stimulation (LF rTMS) and virtual reality (VR) training in patients after stroke was assessed. In a double-blind randomized controlled trial, 112 patients with hemiplegia after stroke were randomly divided into two groups: experimental and control. In experimental group, the patients received LF rTMS and VR training treatment, and those in control group received sham rTMS and VR training treatment. Participants in both groups received therapy of 6 days per week for 4 weeks. The primary endpoint including the upper limb motor function test of Fugl-meyer assessment (U-FMA) and wolf motor function test (WMFT), and the secondary endpoint including modified Barthel index (MBI) and 36-item Short Form Health Survey Questionnaire (SF-36) were assessed before and 4 weeks after treatment. Totally, 108 subjects completed the study (55 in experimental group and 53 in control group respectively). After 4-week treatment, the U-FMA scores [mean difference of 13.2, 95% confidence interval (CI) 3.6 to 22.7, Pstroke, which may provide a better rehabilitation treatment for subacute stroke.

  10. Does a combined technical and didactical training program improve the acceptance of student tutors in the dissection course? A prospective controlled randomized study.

    Science.gov (United States)

    Shiozawa, Thomas; Hirt, Bernhard; Celebi, Nora; Werner, Anne; Weyrich, Peter; Lammerding-Koeppel, Maria

    2010-12-20

    student tutors in the dissection course are expected to meet high demands on their job. We developed a combined technical and didactical training on the basis of literature review and needs assessment. The three-week training program comprised dissection as well as presentation techniques, group dynamics and activating teaching methods. A randomized, controlled, single-blind study was set up to test whether there is a difference between the tutee's perception of the tutor competences, comparing trained and untrained tutors. a total of 10 trained and 10 untrained tutors (control group) were enlisted in the study. The acceptance of the training program was measured with a questionnaire (11 items, 5-point Likert scale) where the tutees rated the competences of the tutors. The tutees were assigned randomly to their tutor and blinded to his/her training. the tutees assessed the trained tutors better in all categories compared to the untrained tutors. A significantly better score (pcompetencies, is well accepted by the tutees and tutors. 2010 Elsevier GmbH. All rights reserved.

  11. A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia.

    Science.gov (United States)

    Sayed, Gamal H; Zakherah, Mahmoud S; El-Nashar, Sherif A; Shaaban, Mamdouh M

    2011-02-01

    To compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) with that of a low-dose combined oral contraceptive (COC) in reducing fibroid-related menorrhagia. In this single-center, open, randomized clinical trial, 58 women with menorrhagia who desired contraception were randomized to receive a LNG-IUS or COC. The outcomes included treatment failure, defined as the need for another treatment; menstrual blood loss (MBL) by the alkaline hematin method and a pictorial assessment chart (PBAC); hemoglobin levels; and "lost days." Treatment failed in 6 women (23.1%) in the LNG-IUS group and 11 (37.9%) in the COC group, for a hazard ratio of 0.46 (95% CI, 0.17-1.17, P=0.101). Using the alkaline hematin test, the reduction of MBL was significantly greater in the LNG-IUS group (90.9% ± 12.8% vs 13.4% ± 11.1%; Pmenorrhagia. Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  12. Efficacy of ‘Itrifal Saghir’, a combination of three medicinal plants in the treatment of obesity; A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kamali Seyed Hamid

    2012-09-01

    Full Text Available Abstract Background Herbal combination of Itrifal Saghir (triphala has been widely used in traditional medicine. And brings health benefits such as antioxidant effect and scavenger of hydroxyl radicals and nitric oxide radicals activity and substantiated in traditional medicine a anti-obesity. Material and method In this study we aimed to assess the efficacy of this herbal medicinal on reduction of weight and body mass index (BMI of simple obese subjects in comparison with placebo. Obese subjects aged between 16 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial using a parallel design. Subjects were randomly assigned to take 5 grams of either the Itrifal Saghir (n = 31 or placebo (n = 31, 2 times daily for 12 weeks. Measures of body weight, BMI, waist circumference (WC, hip circumference (HC, were assessed at baseline and once every four weeks during the 12 week treatment period. The safety was evaluated by means of measuring the liver and kidney function. Homeostasis model of insulin resistance (HOMA-IR was calculated as [fasting insulin (μU/mL × fasting glucose (mmol/L/22.5]. Results Compared to placebo group, in treatment group the mean difference of effective weight loss was 4.82Kg (CI95% 3.52 - 6.11, ρ  Conclusions Itrifal Saghir appears to produce a positive effect on weight loss in obese subjects.

  13. Post-laparoscopic oral contraceptive combined with Chinese herbal mixture in treatment of infertility and pain associated with minimal or mild endometriosis: a randomized controlled trial.

    Science.gov (United States)

    Zhu, Shaomi; Liu, Dong; Huang, Wei; Wang, Qiushi; Wang, Qiuyi; Zhou, Lu; Feng, Guimei

    2014-07-05

    Endometriosis affects fertility negatively. The study aims to evaluate whether laparoscopic surgery combined with oral contraceptive or herbs were more effective than laparoscopic alone in improving fecundity and pelvic pain in women with minimal/mild endometriosis. A randomized controlled trial (RCT) was conducted in 156 infertile women with minimal/mild endometriosis. After laparoscopic surgery, patients were randomized to three groups: in Group A (n = 52) oral contraceptive (OC) was administered one pill a day, continuous for 63 days without intervals, in Group B (n = 52) OC was administered as above and then Dan'e mixture was added 30 g/day for the latter 30 days, and in control Group C (n = 52) patients tried to get pregnant after surgery without complementary treatment. The follow-up periods were 12 months in Group C and 14 months in complementary medical treatment Group A and B. The pregnant women were further followed up, and labor and pregnancy outcomes were assessed. Primary outcome was pregnancy rate (PR) and live birth rate (LBR). Secondary outcomes included changes of pelvic pain visual analog scale scores and side effects. Analyses were done as intention-to-treat. The PR was 46.80% (73/156), and the LBR was 69.86% (51/73). Of the 73 pregnancies, 60 occurred within 12 months of follow-up and 7 of the remaining 13 patients underwent assisted reproductive technology for >1 year. No significant difference was observed in PR and LBR among the three groups. Patients given medical treatment (OCs or OCs plus herbal medicine) had significantly decreased pain scores compared with the laparoscopy alone group. Combination of laparoscopy with OCs or OCs and herbal medicine does not have more advantages than laparoscopy alone in improving fertility of women with minimal/mild endometriosis. ChiCTR-TRC-11001820.

  14. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial.

    Science.gov (United States)

    Fritsche, Andreas; Schweitzer, Matthias Axel; Häring, Hans-Ulrich

    2003-06-17

    Patients with type 2 diabetes are often treated with oral antidiabetic agents plus a basal insulin. To investigate the efficacy and safety of glimepiride combined with either morning or bedtime insulin glargine or bedtime neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes. Open-label, randomized, controlled trial. 111 centers in 13 European countries. 695 patients with type 2 diabetes who were previously treated with oral antidiabetic agents. Randomization to treatment with morning insulin glargine, bedtime NPH insulin, or bedtime insulin glargine for 24 weeks in addition to 3 mg of glimepiride. The insulin dose was titrated by using a predefined regimen to achieve fasting blood glucose levels of 5.56 mmol/L or lower (weight. Hemoglobin A(1c) levels improved by -1.24% (two-sided 90% CI, -1.10% to -1.38%) with morning insulin glargine, by -0.96% (CI, -0.81% to -1.10%) with bedtime insulin glargine, and by -0.84% (CI, -0.69% to -0.98%) with bedtime NPH insulin. Hemoglobin A(1c) improvement was more pronounced with morning insulin glargine than with NPH insulin (0.40% [CI, 0.23% to 0.58%]; P = 0.001) or bedtime insulin glargine (0.28% [CI, 0.11% to 0.46%]; P = 0.008). Baseline to end-point fasting blood glucose levels improved similarly in all three groups. Nocturnal hypoglycemia was less frequent with morning (39 of 236 patients [17%]) and bedtime insulin glargine (52 of 227 patients [23%]) than with bedtime NPH insulin (89 of 232 patients [38%]) (P bedtime insulin glargine than with glimepiride in combination with bedtime NPH insulin in patients with type 2 diabetes. Morning insulin glargine provided better glycemic control than did bedtime insulin glargine or bedtime NPH insulin.

  15. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Parul Uppal Malhotra

    2016-01-01

    Full Text Available Background: Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment. Objective: Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam–ketamine in a group of children with uncooperative behavior requiring dental treatment. Materials and Methods: This was a prospective, randomized, double-blind study that included patients 3–9 years old with American Society of Anesthesiologists-I status. About 36 children presenting early childhood caries were randomly assigned to one of three groups studied: Group MK received intranasal saline and oral midazolam (0.5 mg/kg with ketamine (5 mg/kg mixed in mango juice; Group DX received intranasal dexmedetomidine (1 μg/kg and oral mango juice; and Group C received intranasal saline and oral mango juice. Patients' heart rate, blood pressure, and oxygen saturation were recorded before, during, and at the end of the procedure. Patients' behavior, sedation status, and wake up behavior were evaluated with modified observer assessment of alertness and sedation scale. Ease of treatment completion was evaluated according to Houpt scale. Results: Hemodynamic changes were statistically insignificant in Group MK and Group DX. About 75% patients in Group MK were successfully sedated as compared to 53.9% Group DX and none of the patients in Group C. Ease of treatment completion was better with Group MK as compared to Group DX and least with Group C. Around 50% patients in Group MK had postoperative complications. Conclusion: Oral midazolam–ketamine combination and intranasal dexmedetomidine evaluated in the present study can be used safely and effectively in uncooperative pediatric dental patients for producing conscious sedation.

  16. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Picon, Paulo Dornelles; Costa, Marisa Boff; da Veiga Picon, Rafael; Fendt, Lucia Costa Cabral; Suksteris, Maurício Leichter; Saccilotto, Indara Carmanim; Dornelles, Alicia Dorneles; Schmidt, Luis Felipe Carissimi

    2013-11-22

    The common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults. This study enrolled 146 individuals aged 18 to 60 years who had moderate to severe flu-like syndrome or common cold. After clinical examination and laboratory tests, individuals were randomly assigned to receive the fixed-dose combination (73) or placebo (73), five capsules per day for 48 to 72 hours. The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale. To evaluate treatment safety, the occurrence of adverse events was also measured. Mean age was 33.5 (±9.5) years in the placebo group and 33.8 (±11.5) in the treatment group. There were 55 women and 18 men in the placebo group, and 46 women and 27 men in the treatment group. Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group (p = 0.015). Analysis at the first 13 dose intervals (± 66 h of treatment) showed a greater reduction of symptom scores in the treatment group than in the placebo group (p paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults. NCT01389518.

  17. Treatment with modafinil and escitalopram, alone and in combination, on cocaine-induced effects: a randomized, double blind, placebo-controlled human laboratory study.

    Science.gov (United States)

    Verrico, Christopher D; Haile, Colin N; Mahoney, James J; Thompson-Lake, Daisy G Y; Newton, Thomas F; De La Garza, Richard

    2014-08-01

    Concurrent administration of dopamine and serotonin reuptake inhibitors reduces cocaine self-administration in monkeys. Consonant with this, clinical trials assessing modafinil and selective serotonin reuptake inhibitors alone show some efficacy as potential pharmacotherapies for cocaine dependence. We hypothesized that combining modafinil with escitalopram would attenuate the euphoric effects of cocaine to a greater degree than modafinil alone. In a randomized, double blind, parallel groups design participants received either placebo (0mg/day; n=16), modafinil (200mg/day; n=16), escitalopram (20mg/day; n=17), or modafinil+escitalopram (200+20mg/day; n=15) for 5 days. On day 5, during separate sessions participants received an intravenous sample of cocaine (0 or 20mg; randomized) and five $1 bills. Participants rated the subjective effects of the infusions and subsequently made choices to either return $1 and receive another infusion or keep $1 and receive no infusion. Compared to saline, cocaine (20mg) significantly (p≤0.008) increased most ratings, including "good effects", "stimulated", and "high". Relative to placebo, modafinil significantly (p≤0.007) attenuated subject-rated increases of "any drug effect", "high", "good effects", and "stimulated" produced by cocaine. Compared to saline, participants chose cocaine infusions significantly more; however, no treatment significantly reduced choices for cocaine infusions. Escitalopram did not enhance the efficacy of modafinil to reduce any measure. Modafinil attenuated many positive subjective effects produced by cocaine; however, escitalopram combined with modafinil did not enhance the efficacy of modafinil to reduce cocaine effects. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  18. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial.

    Science.gov (United States)

    Malhotra, Parul Uppal; Thakur, Seema; Singhal, Parul; Chauhan, Deepak; Jayam, Cheranjeevi; Sood, Ritu; Malhotra, Yagyeshwar

    2016-01-01

    Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment. Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam-ketamine in a group of children with uncooperative behavior requiring dental treatment. This was a prospective, randomized, double-blind study that included patients 3-9 years old with American Society of Anesthesiologists-I status. About 36 children presenting early childhood caries were randomly assigned to one of three groups studied: Group MK received intranasal saline and oral midazolam (0.5 mg/kg) with ketamine (5 mg/kg) mixed in mango juice; Group DX received intranasal dexmedetomidine (1 μg/kg) and oral mango juice; and Group C received intranasal saline and oral mango juice. Patients' heart rate, blood pressure, and oxygen saturation were recorded before, during, and at the end of the procedure. Patients' behavior, sedation status, and wake up behavior were evaluated with modified observer assessment of alertness and sedation scale. Ease of treatment completion was evaluated according to Houpt scale. Hemodynamic changes were statistically insignificant in Group MK and Group DX. About 75% patients in Group MK were successfully sedated as compared to 53.9% Group DX and none of the patients in Group C. Ease of treatment completion was better with Group MK as compared to Group DX and least with Group C. Around 50% patients in Group MK had postoperative complications. Oral midazolam-ketamine combination and intranasal dexmedetomidine evaluated in the present study can be used safely and effectively in uncooperative pediatric dental patients for producing conscious sedation.

  19. A multicenter, randomized, controlled trial of S-1 monotherapy versus S-1 and interferon-α combination therapy for hepatocellular carcinoma with extrahepatic metastases.

    Science.gov (United States)

    Nagano, Hiroaki; Obi, Shuntaro; Hatano, Etsuro; Kaneko, Shuichi; Kanai, Fumihiko; Omata, Masao; Tsuji, Akihito; Itamoto, Toshiyuki; Yamamoto, Kazuhide; Tanaka, Masatoshi; Kubo, Shoji; Hirata, Koichi; Nakamura, Hideji; Tomimaru, Yoshito; Yamanaka, Takeharu; Kojima, Shinsuke; Monden, Morito

    2018-01-27

    No effective therapies for extrahepatic metastases from hepatocellular carcinoma (HCC) have yet been identified. Previous studies suggested a potentially promising anti-tumor effect of combination therapy of S-1, a novel oral dihydropyrimidine dehydrogenase (DPD) inhibitor, and interferon (IFN)-α. The present study aimed to investigate the clinical efficacy of single agent S-1 and S-1/IFN-α for HCC patients with extrahepatic metastases in a randomized, open-label, multicenter trial. A total of 103 patients with HCC with extrahepatic metastases were randomly assigned to the S-1/IFN-α group, receiving the combination of S-1 and IFN-α, or the S-1 group, receiving the single agent of S-1. Clinical efficacy and adverse events were compared between the two groups. Forty-nine patients in the S-1/IFN-α group and 51 patients in the S-1 group were included in the efficacy analysis. The response rate was 22.4% (11/49) in the S-1/IFN-α group and 13.7% (7/51) in the S-1 group; there was no significant difference. Overall and progression-free survivals in the two groups were also not significantly different (1-year overall survival 50.8% vs 72.4%, median progression-free survival 127 days vs 157 days). The incidence of grade ≥ 3 adverse events in the S-1/IFN-α group was 62.7% (32/51), which tended to be higher than in the S-1 group [43.1% (22/51)]. Oncologic outcomes in both treatment groups were favorable compared to previous reports, though there was no significant beneficial effect of adding IFN-α to S-1 for the treatment of HCC patients with extrahepatic metastases. This article is protected by copyright. All rights reserved.

  20. Clinical and biochemical effects of a combination botanical product (ClearGuard™ for allergy: a pilot randomized double-blind placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Lin Yumei

    2008-07-01

    Full Text Available Abstract Background Botanical products are frequently used for treatment of nasal allergy. Three of these substances, Cinnamomum zeylanicum, Malpighia glabra, and Bidens pilosa, have been shown to have a number of anti-allergic properties in-vitro. The current study was conducted to determine the effects of these combined ingredients upon the nasal response to allergen challenge in patients with seasonal allergic rhinitis. Methods Twenty subjects were randomized to receive the combination botanical product, (CBP 2 tablets three times a day, loratadine, 10 mg once a day in the morning, or placebo, using a randomized, double-blinded crossover design. Following 2 days of each treatment and during the third day of treatment, subjects underwent a nasal allergen challenge (NAC, in which nasal symptoms were assessed after each challenge dose and every 2 hours for 8 hours. Nasal lavage fluid was assessed for tryptase, prostaglandin D2, and leukotriene E4 concentrations and inflammatory cells. Results Loratadine significantly reduced the total nasal symptom score during the NAC compared with placebo (P = 0.04 while the CBP did not. During the 8 hour period following NAC, loratadine and the CBP both reduced NSS compared with placebo (P = 0.034 and P = 0.029, respectively. Analysis of nasal lavage fluid demonstrated that the CBP prevented the increase in prostaglandin D2 release following NAC, while neither loratadine nor placebo had this effect. None of the treatments significantly affected tryptase or leukotriene E4 release or inflammatory cell infiltration. Conclusion The CBP significantly reduced NSS during the 8 hours following NAC and marginally inhibited the release of prostaglandin D2 into nasal lavage fluid, suggesting potential clinical utility in patients with allergic rhinitis.

  1. Point-by-Point Radiofrequency Ablation Versus the Cryoballoon or a Novel Combined Approach: A Randomized Trial Comparing 3 Methods of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation (The Cryo Versus RF Trial).

    Science.gov (United States)

    Hunter, Ross J; Baker, Victoria; Finlay, Malcolm C; Duncan, Edward R; Lovell, Matthew J; Tayebjee, Muzahir H; Ullah, Waqas; Siddiqui, M Shoaib; McLEAN, Ailsa; Richmond, Laura; Kirkby, Claire; Ginks, Matthew R; Dhinoja, Mehul; Sporton, Simon; Earley, Mark J; Schilling, Richard J

    2015-12-01

    Catheter ablation of paroxysmal AF using the Cryoballoon (CRYO) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation (RFCA), but randomized data are lacking. Pilot data suggested a high success rate with a combined approach (COMBINED) using wide encirclement with RFCA followed by 2 CRYO applications to each vein. We compared these 3 strategies in a randomized controlled trial. Patients undergoing first time paroxysmal AF ablation were randomized to RFCA, CRYO, or COMBINED. Patients were followed up at 3, 6, and 12 months with 7 days of ambulatory ECG monitoring. Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure. A total of 237 patients were randomized. Success at 1 year was achieved in 47% in the RFCA group, 67% in the CRYO group, and 76% in the COMBINED group (P CRYO, PCRYO vs. COMBINED). Procedure time was 211 (IQR 174-256) minutes for RFCA compared to 167 (136-202) minutes for CRYO and 278 (243-327) minutes for COMBINED (P CRYO, and CRYO vs. COMBINED groups). Pulmonary vein isolation for paroxysmal AF is faster with CRYO and results in a higher single procedure success rate than conventional point by point RFCA. The COMBINED approach was not superior to CRYO alone. © 2015 Wiley Periodicals, Inc.

  2. A randomized phase 2 study of combination cediranib and olaparib versus olaparib alone as recurrence therapy in platinum-sensitive ovarian cancer

    Science.gov (United States)

    Liu, Joyce F.; Barry, William T.; Birrer, Michael; Lee, Jung-Min; Buckanovich, Ronald J.; Fleming, Gini F.; Rimel, BJ; Buss, Mary K.; Nattam, Sreenivasa; Hurteau, Jean; Luo, Weixiu; Quy, Philippa; Whalen, Christin; Obermayer, Lisa; Lee, Hang; Winer, Eric P.; Kohn, Elise C.; Ivy, S. Percy; Matulonis, Ursula A.

    2015-01-01

    Background Olaparib is an oral poly(ADP-ribose) polymerase inhibitor and cediranib is an oral anti-angiogenic with activity against VEGFR-1, 2, and 3. Both agents have antitumor activity in women with recurrent ovarian cancer, and the combination of these agents was active and had manageable toxicities in a Phase 1 trial. We asked whether the combination of cediranib and olaparib could improve progression-free survival compared to olaparib monotherapy in women with recurrent platinum-sensitive ovarian cancer. Methods We conducted a randomized, open-label, phase 2 study to evaluate the activity of olaparib monotherapy compared with combination cediranib and olaparib in women with ovarian cancer with measurable platinum-sensitive, relapsed, high-grade serous or endometrioid disease or those with deleterious germline BRCA1/2 mutations (gBRCAm). Patients were randomized using permuted blocks within stratum defined by gBRCA status and prior anti-angiogenic therapy to receive olaparib capsules 400mg twice daily or the combination at the recommended phase 2 dose of cediranib 30mg daily and olaparib capsules 200mg twice daily. The primary endpoint was progression-free survival (PFS) analyzed under intention to treat. The trial is registered with ClinicalTrials.gov, NCT01116648. The Phase 2 portion of the trial reported here is no longer accruing patients. Findings Forty-six of 90 randomized patients received olaparib alone, and 44 received cediranib/olaparib. Median PFS was significantly longer with cediranib/olaparib (17.7 vs. 9.0 mos, HR 0.42; p = 0.005). Grade 3 and 4 adverse events were more common with cediranib/olaparib, including fatigue (12 vs. 5), diarrhea (10 vs. 0), and hypertension (18 vs. 0). Subset analysis within stratum defined by BRCA1/2 status demonstrated activity of cediranib/olaparib in both gBRCAm and gBRCAwt/u (wild-type/unknown) patients. Significant improvement in PFS occurred in gBRCAwt/u women receiving cediranib/olaparib (16.5 vs. 5.7 mos, p = 0

  3. ESR powder line shape calculations

    Energy Technology Data Exchange (ETDEWEB)

    Vitko, J. Jr.; Huddleston, R.E.

    1976-05-01

    A program has been developed for computing the ESR spectrum of a collection of randomly oriented spins subject only to an electronic Zeeman interaction and having a Lorentzian single crystal line shape. Other single crystal line shapes, including numerical solutions of the Bloch equations, can be accommodated with minor modifications. The program differs in several features from those existing elsewhere, thus enabling one to study saturation effects, over-modulation effects, both absorptive and dispersive signals, and second and higher order derivative signals.

  4. Vector Triggering Random Decrement for High Identification Accuracy

    DEFF Research Database (Denmark)

    Ibrahim, S. R.; Asmussen, J. C.; Brincker, Rune

    1998-01-01

    Using the Random Decrement (RD) technique to obtain free response estimates and combining this with time domain modal identification methods to obtain the poles and the mode shapes is acknowledged as a fast and accurate way of analysing measured responses of structures subject to ambient loads...

  5. Effects of Dexamethasone and Insulin Alone or in Combination on Energy and Protein Metabolism Indicators and Milk Production in Dairy Cows in Early Lactation - A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Mehrdad Sami

    Full Text Available This study investigated the effects of dexamethasone and insulin, when administered at 3rd or 10th day of lactation on energy and protein metabolism in dairy cows.Two hundred Holstein cows were enrolled in a randomized controlled clinical trial. The cows were randomly assigned to receive 1 of 4 treatments at 3 or 10 days in milk: control group, 10-mL i.m. injection of sterile water, group insulin, s.c. injection of 100 units of insulin, group dexamethasone, i.m. injection of 20 mg of dexamethasone, group insulin plus dexamethasone, i.m. injection of 20 mg of dexamethasone and 100 units of insulin. The cows randomly assigned to receive the treatments on 3 or 10 days of lactation. Serum samples obtained at the time of enrollment, time of treatment and at 2, 4, 7 and 14 days after intervention. The sera were analyzed for β-hydroxybutyrate (BHBA, nonesterified fatty acids (NEFA, glucose, cholesterol, albumin, urea, and aspartate amino transferase (AST. Data were analyzed using a repeated measures mixed model that accounted for the effects of parity, body condition score, dystocia, retained placenta, metritis and the random effect of cow.There was no significant interaction of group of treatment and time of intervention (day 3 or 10 post-partum on serum components. Cows that received insulin or dexamethasone alone or in combination, had lower BHBA 2 days after treatment compared with control cows, whereas concentrations of NEFA, were unaffected suggesting that glucocorticoids lipolytic effects do not appear to be important in healthy cows. AST activities significantly reduced in cows that received dexamethasone with or without insulin at 2 and 4 days after treatment. Albumin and urea concentrations 2 days after treatment were higher for cows that received dexamethasone only or dexamethasone plus insulin compared with control and Ins received cows. There were no treatment effects on test-day milk production, milk fat and protein percentages

  6. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial.

    Science.gov (United States)

    Baker, Timothy B; Piper, Megan E; Stein, James H; Smith, Stevens S; Bolt, Daniel M; Fraser, David L; Fiore, Michael C

    2016-01-26

    Smoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality. To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates. Three-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization. Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n = 241); (2) varenicline only (including 1 prequit week; n = 424); and (3) C-NRT (nicotine patch + nicotine lozenge; n = 421). Six counseling sessions were offered. The primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52. Among 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did

  7. Effects of Dexamethasone and Insulin Alone or in Combination on Energy and Protein Metabolism Indicators and Milk Production in Dairy Cows in Early Lactation - A Randomized Controlled Trial.

    Science.gov (United States)

    Sami, Mehrdad; Mohri, Mehrdad; Seifi, Hesam A

    2015-01-01

    This study investigated the effects of dexamethasone and insulin, when administered at 3rd or 10th day of lactation on energy and protein metabolism in dairy cows. Two hundred Holstein cows were enrolled in a randomized controlled clinical trial. The cows were randomly assigned to receive 1 of 4 treatments at 3 or 10 days in milk: control group, 10-mL i.m. injection of sterile water, group insulin, s.c. injection of 100 units of insulin, group dexamethasone, i.m. injection of 20 mg of dexamethasone, group insulin plus dexamethasone, i.m. injection of 20 mg of dexamethasone and 100 units of insulin. The cows randomly assigned to receive the treatments on 3 or 10 days of lactation. Serum samples obtained at the time of enrollment, time of treatment and at 2, 4, 7 and 14 days after intervention. The sera were analyzed for β-hydroxybutyrate (BHBA), nonesterified fatty acids (NEFA), glucose, cholesterol, albumin, urea, and aspartate amino transferase (AST). Data were analyzed using a repeated measures mixed model that accounted for the effects of parity, body condition score, dystocia, retained placenta, metritis and the random effect of cow. There was no significant interaction of group of treatment and time of intervention (day 3 or 10 post-partum) on serum components. Cows that received insulin or dexamethasone alone or in combination, had lower BHBA 2 days after treatment compared with control cows, whereas concentrations of NEFA, were unaffected suggesting that glucocorticoids lipolytic effects do not appear to be important in healthy cows. AST activities significantly reduced in cows that received dexamethasone with or without insulin at 2 and 4 days after treatment. Albumin and urea concentrations 2 days after treatment were higher for cows that received dexamethasone only or dexamethasone plus insulin compared with control and Ins received cows. There were no treatment effects on test-day milk production, milk fat and protein percentages. The results suggested

  8. Effect of Korean Herbal Medicine Combined with a Probiotic Mixture on Diarrhea-Dominant Irritable Bowel Syndrome: A Double-Blind, Randomized, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Seok-Jae Ko

    2013-01-01

    Full Text Available Introduction. Although combination therapy with herbal medicine and probiotics is gaining popularity for controlling diarrhea-dominant irritable bowel syndrome (D-IBS symptoms, few studies have investigated its clinical effects. Materials and Methods. Fifty-three patients with D-IBS were randomly allocated into 1 of the following 4 groups: herbal medicine (Gwakhyangjeonggisan; GJS plus probiotics (Duolac7S; DUO, GJS plus placebo DUO, placebo GJS plus DUO, and placebo GJS plus placebo DUO. The study period consisted of a 2-week run-in, 8 weeks of administration, and 2 weeks of follow-up. The primary outcomes were weekly adequate relief (AR of overall IBS symptoms and the proportion of responders (PR during the administration period. The secondary outcomes included individual IBS symptoms, stool assessment, and quality of life. Changes of intestinal microbiota and intestinal permeability were also analyzed. Results and Discussion. Weekly AR was not different among the 4 groups throughout the treatment period. However, the 3 treatment groups exhibited significant improvements in PR compared to the findings in the placebo group. In the intestinal microbiota assessment, herbal medicine and probiotics synergistically increased beneficial bacteria counts. Conclusion. Combination therapy with herbal medicine and probiotics appears to relieve overall IBS symptoms by synergistically increasing beneficial intestinal microbe counts.

  9. Randomized clinical study for comparative evaluation of fourth-generation fluoroquinolones with the combination of fortified antibiotics in the treatment of bacterial corneal ulcers.

    Science.gov (United States)

    Shah, Vinit Mahendra; Tandon, Radhika; Satpathy, Gita; Nayak, Niranjan; Chawla, Bhavna; Agarwal, Tushar; Sharma, Namrata; Titiyal, Jeewan S; Vajpayee, Rasik B

    2010-07-01

    Comparative evaluation of efficacy of monotherapy with moxifloxacin (0.5%) or gatifloxacin (0.3%) with combination therapy of cefazolin (5%) and tobramycin (1.3%) in treatment of bacterial corneal ulcers. Patients diagnosed with bacterial keratitis (ulcer diameter 2-8 mm) were randomized to 1 of the 3 treatment groups (tobramycin 1.3% and cefazolin 5%, gatifloxacin 0.3%, or moxifloxacin 0.5%). After obtaining corneal scrapings, assigned study medication was instilled hourly for 48 hours and tapered as per clinical response. Healing of ulcer, duration to cure, adverse reactions, antibiogram profile, treatment failures, final visual acuity, and corneal opacity size were evaluated. A total of 61 patients were enrolled [cefazolin and tobramycin (n = 20), gatifloxacin (n = 21), and moxifloxacin (n = 20)]. Overall, 57 patients (93%) healed on treatment. On comparison of the mean time taken to heal, no statistically significant difference was found among all the 3 treatment groups (P = 0.98). Positive bacterial culture was obtained in only 38 patients (62%). There was no significant difference in the bacterial isolates in each treatment group. There were 4 (7%) treatment failures (perforation or nonhealing ulcer): 1 (5%) each in moxifloxacin and gatifloxacin group and 2 (10%) in fortified antibiotics group. All regimens were well tolerated. The study failed to find a difference in the efficacy of monotherapy with fourth-generation fluoroquinolones in the treatment of bacterial corneal ulcers of 2-8 mm size when compared with combination therapy of fortified antibiotics.

  10. Treatment of primary chronic glomerulonephritis with Rehmannia glutinosa acteosides in combination with the angiotensin receptor blocker irbesartan: a randomized controlled trial.

    Science.gov (United States)

    Qiu, HongYu; Fu, Ping; Fan, WenXing; Zuo, Chuan; Feng, Ping; Shi, Peng; Cao, Lina; Liu, Fang; Zhou, Li; Chen, Feng; Zhong, Hui; Gou, ZhongPing; Liang, YaPing; Shi, Mei

    2014-01-01

    This study aims to assess the efficacy and safety of Rehmannia glutinosa acteosides used in combination with the angiotensin receptor blocker irbesartan to treat primary chronic glomerulonephritis. A total of 479 patients diagnosed with primary chronic glomerulonephritis were recruited from outpatient clinics and were randomly assigned to the treatment group (Rehmannia glutinosa acteosides, two 200-mg capsules, bid; and irbesartan, one 150-mg tablet, qd) or the control group (irbesartan, one 150-mg tablet, qd). The primary outcome was 24-h urinary protein. Secondary outcome measures included blood pressure, estimated glomerular filtration rate, erythrocyturia, serum alanine aminotransferase, aspartate transaminase and electrolytes. After 8 weeks of treatment, the treatment group showed a mean reduction in 24-h proteinuria of 36.42% compared to baseline, which was significantly higher than the mean reduction from baseline of 27.97% in the control group (P = 0.0278).Adverse drug reactions occurred at a similarly low rate in the treatment group (0.4%) and control group (1.2%, P = 0.3724). In the treatment of chronic glomerulonephritis, the combination of Rehmannia glutinosa acteosides and irbesartan can reduce proteinuria more effectively than irbesartan alone. Copyright © 2013 John Wiley & Sons, Ltd.

  11. Pilot Cluster Randomized Controlled Trials to Evaluate Adoption of Water, Sanitation, and Hygiene Interventions and Their Combination in Rural Western Kenya

    Science.gov (United States)

    Christensen, Garret; Dentz, Holly N.; Pickering, Amy J.; Bourdier, Tomoé; Arnold, Benjamin F.; Colford, John M.; Null, Clair

    2015-01-01

    In preparation for a larger trial, the Water, Sanitation, and Hygiene (WASH) Benefits pilot study enrolled 72 villages and 499 subjects in two closely related randomized trials of WASH interventions in rural western Kenya. Intervention households received hardware and promotion for one of the following: water treatment, sanitation and latrine improvements, handwashing with soap, or the combination of all three. Interventions were clustered by village. A follow-up survey was conducted 4 months after intervention delivery to assess uptake. Intervention households were significantly more likely than controls to have chlorinated stored water (36–60 percentage point increases), covers over latrine drop holes (55–75 percentage point increases), less stool visible on latrine floors (16–47 percentage point reductions), and a place for handwashing (71–85 percentage point increases) with soap available (49–66 percentage point increases). The high uptake in all arms shows that combined interventions can achieve high short-term adoption rates if well-designed. PMID:25422394

  12. Feasibility study of a combined treatment of electromyography-triggered neuromuscular stimulation and mirror therapy in stroke patients: a randomized crossover trial.

    Science.gov (United States)

    Kojima, Kosuke; Ikuno, Koki; Morii, Yuta; Tokuhisa, Kentaro; Morimoto, Shigeru; Shomoto, Koji

    2014-01-01

    Mirror therapy (MT) and electromyography-triggered neuromuscular stimulation (ETMS) are both effective treatments for impaired upper limbs following stroke. A combination of these two treatments (ETMS-MT) may result in greater gain than either treatment alone. The feasibility and possible effects of ETMS-MT upon upper extremity function were investigated in stroke patients. Thirteen post-acute stroke patients were randomly assigned to an immediate ETMS-MT group or a delayed ETMS-MT group and then underwent an 8-week training program. The immediate ETMS-MT group received ETMS-MT in addition to physical and occupational therapy (PT+OT) for 4 weeks. They then received only PT+OT for the next 4 weeks. In the delayed ETMS-MT group, interventions were provided in the reverse order. The main outcome measure was the Fugl-Meyer Assessment (FMA). The immediate ETMS-MT group showed significantly greater gain in FMA in the first 4 weeks. The delayed ETMS-MT group showed significantly greater gain in active range of motion during the latter 4 weeks. No adverse effects were reported following ETMS-MT. ETMS-MT might be as effective as independent MT or ETMS without causing any side effects. Future research should focus upon the direct comparisons between independent and combined interventions.

  13. A randomized two-way crossover bioequivalence study in healthy adult volunteers of paediatric zidovudine/lamivudine/nevirapine fast-disintegrating fixed-dose combination tablet.

    Science.gov (United States)

    Joshi, Anjali; Gbadero, Daniel; Esseku, Fredrick; Adesanya, Olufikayo J; Adeyeye, Moji C

    2017-04-01

    The bioequivalence study was conducted to compare the developed paediatric fixed-dose combination (FDC) zidovudine/lamivudine/nevirapine (60/30/50 mg) tablet - the test formulation - with the combined mixture of single-entity innovator products (reference product). A single-dose open-label randomized two-way crossover study was conducted in healthy adult African volunteers after an informed consent was obtained. The 24 volunteers, divided into two groups, were administered the products after an overnight fast on two treatment days with 14 days of washout period. Blood samples were collected for 96 h and analysed using a validated RP-HPLC-UV assay method. Pharmacokinetic (PK) parameters (non-compartmental model) were assessed with WinNonlin® software. Analysis of variance (ANOVA) and FDA bioequivalence statistical criterion of 90% CI or 80% to 125% range (set at P 0.05). The 90% CIs for all the drugs were within the 80% to 125% range. The developed FDC tablet is bioequivalent to the reference product. © 2016 Royal Pharmaceutical Society.

  14. The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer's disease patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Peng, Weina; Zhou, Jing; Xu, Min; Feng, Qing; Bin, Lulu; Liu, Zhishun

    2017-07-03

    Alzheimer's disease is a progressive neurodegenerative disease. Although some of the current treatments offer some symptomatic relief, this disease cannot be cured at present. Electroacupuncture may be effective for Alzheimer's disease for cognitive function, but the evidence for its effectiveness is still limited. The aim of this study is to evaluate the add-on effect of electroacupuncture to donepezil for improving the cognitive function of Alzheimer's disease. A total of 334 participants with Alzheimer's disease will be randomly assigned to either an electroacupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the electroacupuncture combined with donepezil group will receive electroacupuncture in addition to donepezil for 12 weeks and will keep taking donepezil for the following 24 weeks. Participants in the control group will take donepezil only. The primary outcome is the change from baseline in the total score of the Alzheimer's Disease Assessment Scale-cognition at week 12. A follow-up will be conducted 24 weeks after the treatment. We expect to verify the hypothesis that acupuncture in addition to donepezil is better than donepezil in improving the cognitive function of patients with Alzheimer's disease. This trial has a limitation that participant blinding is impossible. Clinical Trials.gov: ID: NCT02305836 . Registered on 13 November 2014.

  15. Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial.

    Science.gov (United States)

    Lee, Banghyun; Hong, Seung Hwa; Kim, Kidong; Kang, Wee Chang; No, Jae Hong; Lee, Jung Ryeol; Jee, Byung Chul; Yang, Eun Joo; Cha, Eun-Jong; Kim, Yong Beom

    2015-11-01

    To investigate the efficacy and safety of the combined therapy with high-frequency transcutaneous electrical nerve stimulation (hf-TENS) and thermotherapy in relieving primary dysmenorrheal pain. In this randomized, single-blind, placebo-controlled study, 115 women with moderate or severe primary dysmenorrhea were assigned to the study or control group at a ratio of 1:1. Subjects in the study group used an integrated hf-TENS/thermotherapy device, whereas control subjects used a sham device. A visual analog scale was used to measure pain intensity. Variables related to pain relief, including reduction rate of dysmenorrheal score, were compared between the groups. The dysmenorrheal score was significantly reduced in the study group compared to the control group following the use of the devices. The duration of pain relief was significantly increased in the study group compared to the control group. There were no differences between the groups in the brief pain inventory scores, numbers of ibuprofen tablets taken orally, and World Health Organization quality of life-BREF scores. No adverse events were observed related to the use of the study device. The combination of hf-TENS and thermotherapy was effective in relieving acute pain in women with moderate or severe primary dysmenorrhea. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Valproic Acid, a Histone Deacetylase Inhibitor, in Combination with Paclitaxel for Anaplastic Thyroid Cancer: Results of a Multicenter Randomized Controlled Phase II/III Trial

    Directory of Open Access Journals (Sweden)

    Maria Graziella Catalano

    2016-01-01

    Full Text Available Anaplastic thyroid cancer (ATC has a median survival less than 5 months and, to date, no effective therapy exists. Taxanes have recently been stated as the main drug treatment for ATC, and the histone deacetylase inhibitor valproic acid efficiently potentiates the effects of paclitaxel in vitro. Based on these data, this trial assessed the efficacy and safety of the combination of paclitaxel and valproic acid for the treatment of ATC. This was a randomized, controlled phase II/III trial, performed on 25 ATC patients across 5 centers in northwest Italy. The experimental arm received the combination of paclitaxel (80 mg/m2/weekly and valproic acid (1,000 mg/day; the control arm received paclitaxel alone. Overall survival and disease progression, evaluated in terms of progression-free survival, were the primary outcomes. The secondary outcome was the pharmacokinetics of paclitaxel. The coadministration of valproic acid did not influence the pharmacokinetics of paclitaxel. Neither median survival nor median time to progression was statistically different in the two arms. Median survival of operated-on patients was significantly better than that of patients who were not operated on. The present trial demonstrates that the addition of valproic acid to paclitaxel has no effect on overall survival and disease progression of ATC patients. This trial is registered with EudraCT 2008-005221-11.

  17. Transcranial magnetic stimulation combined with speech and language training in early aphasia rehabilitation: a randomized double-blind controlled pilot study.

    Science.gov (United States)

    Seniów, Joanna; Waldowski, Konrad; Leśniak, Marcin; Iwański, Szczepan; Czepiel, Wojciech; Członkowska, Anna

    2013-01-01

    Functional neuroimaging studies with poststroke aphasia patients have shown increased activation of the unaffected hemisphere, which hypothetically reflects a maladaptive strategy of brain reorganization. We investigated whether repetitive transcranial magnetic stimulation (rTMS) inhibiting the right-hemisphere homologue of Broca's area improves language restitution if combined with speech/language therapy. Forty aphasic patients during the subacute phase of ischemic stroke were randomized to a 3-week aphasia rehabilitation protocol in combination with real or sham rTMS. Naming, repetition, and comprehension were assessed using the Boston Diagnostic Aphasia Examination at baseline, immediately after therapy, and 15 weeks after completing treatment. Although language functions improved in both experimental and control groups after 3 weeks, only slight group differences in degree of recovery were revealed between patients receiving rTMS and control participants. Follow-up revealed that severely aphasic rTMS patients demonstrated significantly greater improvement than patients receiving sham stimulation in repetition. Inhibitory rTMS applied to the right frontal language homologue is not effective for all poststroke aphasia patients, although it might benefit selected patients.

  18. Effects of two low-dose combined oral contraceptives containing drospirenone on bone turnover and bone mineral density in young fertile women: a prospective controlled randomized study.

    Science.gov (United States)

    Gargano, Virginia; Massaro, Mariangela; Morra, Ilaria; Formisano, Carmen; Di Carlo, Costantino; Nappi, Carmine

    2008-07-01

    The effects of a 21-day combined oral contraceptive containing 30 mcg ethinyl estradiol plus 3 mg drospirenone with a 21-day preparation containing 20 mcg ethinyl estradiol plus 3 mg drospirenone on bone turnover and bone mineral density (BMD) in young fertile women were compared. A randomized, controlled trial was conducted on healthy fertile women treated with 30 mcg ethinyl estradiol plus 3 mg drospirenone (Group A; n=21), 20 mcg ethinyl estradiol plus 3 mg drospirenone (Group B; n=23) and healthy controls (Group C; n=21). At 3, 6, 9 and 12 months, serum and urinary calcium, osteocalcin (BGP), urinary pyridinoline and deoxypyridinoline were measured. At baseline and after 12 months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry. In Groups A and B, urinary pyridinoline and deoxypyridinoline at 6, 9 and 12 months were significantly reduced in comparison with basal values and Group C (pbasal values. Both combined oral contraceptives exert a similar positive influence on bone turnover in young postadolescent women.

  19. Combined use of crystalloid preload and low dose spinal anesthesia for preventing hypotension in spinal anesthesia for cesarean delivery: a randomized controlled trial.

    Science.gov (United States)

    Ouerghi, Sonia; Bougacha, Mohamed A; Frikha, Nabil; Mestiri, Taher; Ben Ammar, Mohamed S; Mebazaa, Mhamed S

    2010-06-01

    Spinal anaesthesia for caesarean section is commonly associated with hypotension and crystalloid preload is widely recommended. Low-dose spinal appears to cause less hypotension. The aim of this study was to investigate whether the combined use of crystalloid preload and low dose spinal anaesthesia might further reduce the rates of hypotension. Sixty-two patients were randomly assigned to two groups: crystalloid preload anaesthesia (P): received a rapid infusion of 20 mL/kg lactated Ringer's solution (LR), and no preload anaesthesia (N). The incidence of hypotension and the amount of ephedrine used to treat it were compared. Spinal anaesthesia was performed with 0.5% isobaric bupivacaine 7.5 mg and fentanyl 10 microg and morphine 100 microg. The incidence of hypotension was similar in the P and N groups. Same doses of ephedrine were required to treat hypotension in the two groups. Crystalloid preload combined with low-dose spinal anaesthesia do not reduce the incidence of hypotension nor its severity.

  20. The effect of arm support combined with rehabilitation games on upper-extremity function in subacute stroke: a randomized controlled trial.

    Science.gov (United States)

    Prange, Gerdienke B; Kottink, Anke I R; Buurke, Jaap H; Eckhardt, Martine M E M; van Keulen-Rouweler, Bianca J; Ribbers, Gerard M; Rietman, Johan S

    2015-02-01

    Use of rehabilitation technology, such as (electro)mechanical devices or robotics, could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke. Arm support (AS) training showed improvement of unsupported arm function in chronic stroke. To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity, compared with dose-matched conventional reach training in subacute stroke patients. In a single-blind, multicenter, randomized controlled trial, 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training (CON). Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment (FM), maximal reach distance, Stroke Upper Limb Capacity Scale (SULCS), and arm pain via Visual Analogue Scale, in addition to perceived motivation by Intrinsic Motivation Inventory posttraining. FM and SULCS scores and reach distance improved significantly within both groups. These improvements and experienced pain did not differ between groups. The AS group reported higher interest/enjoyment during training than the CON group. AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation, when applied at the same dose. © The Author(s) 2014.

  1. Topiramate Combined with Cognitive Restructuring for the Treatment of Gambling Disorder: A Two-Center, Randomized, Double-Blind Clinical Trial.

    Science.gov (United States)

    de Brito, Antonio Marcelo Cabrita; de Almeida Pinto, Moema Galindo; Bronstein, Gabriel; Carneiro, Elizabeth; Faertes, Daniela; Fukugawa, Viviane; Duque, Angela; Vasconcellos, Fatima; Tavares, Hermano

    2017-03-01

    Gambling disorder (GD) is a prevalent condition for which no pharmacological treatment has yet been approved, although there is evidence that topiramate can reduce impulsivity in GD and craving in various addictive behaviors. The goal of this study was to investigate the effectiveness of topiramate combined with cognitive restructuring for GD in a two-center, randomized, double-blind clinical trial. Participants were individuals seeking outpatient treatment for GD (n = 30), treated with either topiramate or placebo combined with a brief cognitive intervention, over a 12-week period, the dose of topiramate being tapered up during the first 8 weeks. The main outcome measures were gambling craving, behavior, and cognitive distortions; impulsivity; depression and social adjustment. Topiramate proved superior to placebo in reducing gambling craving (P = 0.017); time and money spent gambling (P = 0.007 and P = 0.047, respectively); cognitive distortions related to gambling (P = 0.003); and social adjustment (P = 0.040). We found no significant effects on impulsivity or depression. These findings are in contrast with data from a previous clinical trial with topiramate for GD. In the current study, we found that topiramate affects features specifically related to gambling addiction and had no significant effect on associated phenomena such as impulsiveness and depression. We believe that this response could be due to synergistic interaction between topiramate and the cognitive intervention.

  2. [Periarthritis of shoulder treated with deep puncture by elongated needle combined with spike-hooked needle and cupping: a multicentral randomized controlled study].

    Science.gov (United States)

    Zhang, Jiang-Ceng; Liu, Shuai; Lü, Jun-Ling; Chen, Zhong-Xin; Li, Jian

    2011-10-01

    To assess the clinical efficacy and the safety for periarthritis of shoulder treated with deep puncture by elongated needle combined with spike-hooked needle and cupping. A multicentral randomized controlled study was adopted. One hundred and twenty cases were divided into an observation group and a control group, 60 cases in each one. In observation group, elongated needle, spike-hooked needle and cupping were used to stimulate Jianyu (LI 15), Naoshu (SI 10), Naohui (TE 13) and Jianqian (Extra). In control group, a conventional needling and cupping were applied to the same points as observation group. Visual Analogue Scale (VAS) and Melle evaluation for the function activity of shoulder joint were adopted to assess and compare the efficacy on analgesia and the effect on shoulder joint range of motion before and after treatment in two groups. In observation group, the cured and markedly effective rate of analgesia was 91.7% (55/60), which was obviously better than 20.4% (12/59) in control group (P treatment were apparently improved as compared with those before treatment in two groups (all P treatment in two groups. The deep puncture by elongated needle combined with spike-hooked needle and cupping achieves a significant clinical efficacy on periarthritis of shoulder and has no adverse reaction reported.

  3. Impact of combining intermittent preventive treatment with home management of malaria in children less than 10 years in a rural area of Senegal: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Tine Roger CK

    2011-12-01

    Full Text Available Abstract Background Current malaria control strategies recommend (i early case detection using rapid diagnostic tests (RDT and treatment with artemisinin combination therapy (ACT, (ii pre-referral rectal artesunate, (iii intermittent preventive treatment and (iv impregnated bed nets. However, these individual malaria control interventions provide only partial protection in most epidemiological situations. Therefore, there is a need to investigate the potential benefits of integrating several malaria interventions to reduce malaria prevalence and morbidity. Methods A randomized controlled trial was carried out to assess the impact of combining seasonal intermittent preventive treatment in children (IPTc with home-based management of malaria (HMM by community health workers (CHWs in Senegal. Eight CHWs in eight villages covered by the Bonconto health post, (South Eastern part of Senegal were trained to diagnose malaria using RDT, provide prompt treatment with artemether-lumefantrine for uncomplicated malaria cases and pre-referral rectal artesunate for complicated malaria occurring in children under 10 years. Four CHWs were randomized to also administer monthly IPTc as single dose of sulphadoxine-pyrimethamine (SP plus three doses of amodiaquine (AQ in the malaria transmission season, October and November 2010. Primary end point was incidence of single episode of malaria attacks over 8 weeks of follow up. Secondary end points included prevalence of malaria parasitaemia, and prevalence of anaemia at the end of the transmission season. Primary analysis was by intention to treat. The study protocol was approved by the Senegalese National Ethical Committee (approval 0027/MSP/DS/CNRS, 18/03/2010. Results A total of 1,000 children were enrolled. The incidence of malaria episodes was 7.1/100 child months at risk [95% CI (3.7-13.7] in communities with IPTc + HMM compared to 35.6/100 child months at risk [95% CI (26.7-47.4] in communities with only HMM (a

  4. Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moura, Renata Calhes Franco; Santos, Cibele Almeida; Grecco, Luanda André Collange; Lazzari, Roberta Delasta; Dumont, Arislander Jonathan Lopes; Duarte, Natalia Carvalho de Almeida; Braun, Luiz Alfredo; Lopes, Jamile Benite Palma; Santos, Ligia Abram Dos; Rodrigues, Eliane Lopes Souza; Albertini, Giorgio; Cimolin, Veronica; Galli, Manuela; Oliveira, Claudia Santos

    2016-08-17

    The aim of the proposed study is to perform a comparative analysis of functional training effects for the paretic upper limb with and without transcranial direct current stimulation over the primary motor cortex in children with spastic hemiparetic cerebral palsy. The sample will comprise 34 individuals with spastic hemiparetic cerebral palsy, 6 to 16 years old, classified at level I, II, or III of the Manual Ability Classification System. Participants will be randomly allocated to two groups: (1) functional training of the paretic upper limb combined with anodic transcranial stimulation; (2) functional training of the paretic upper limb combined with sham transcranial stimulation. Evaluation will involve three-dimensional movement analysis and electromyography using the SMART-D 140® system (BTS Engineering) and the FREEEMG® system (BTS Engineering), the Quality of Upper Extremity Skills Test, to assess functional mobility, the Portable Device and Ashworth Scale, to measure movement resistance and spasticity, and the Pediatric Evaluation of Disability Inventory, to evaluate performance. Functional reach training of the paretic upper limb will include a range of manual activities using educational toys associated with an induced constraint of the non-paretic limb during the training. Training will be performed in five weekly 20-minute sessions for two weeks. Transcranial stimulation over the primary motor cortex will be performed during the training sessions at an intensity of 1 mA. Findings will be analyzed statistically considering a 5 % significance level (P ≤ 0.05). This paper presents a detailed description of a prospective, randomized, controlled, double-blind, clinical trial designed to demonstrate the effects of combining transcranial direct current stimulation over the primary motor cortex and functional training of the paretic limb in children with cerebral palsy classified at level I, II, or III of the Manual Ability Classification System. The

  5. Bioavailability and tolerability of combination treatment with revaprazan 200 mg + itopride 150 mg: a randomized crossover study in healthy male Korean volunteers.

    Science.gov (United States)

    Choi, Hee Youn; Noh, Yook-Hwan; Jin, Seok-Joon; Kim, Yo Han; Kim, Mi-Jo; Sung, Hyeryoung; Jang, Seong Bok; Lee, Sung Jae; Bae, Kyun-Seop; Lim, Hyeong-Seok

    2012-09-01

    To date, no definitive treatment of functional dyspepsia (FD) has been proven to be effective and reasonably well-tolerated. Proton pump inhibitors (PPIs) combined with prokinetic agents are considered an effective option. Revaprazan is a selective potassium-competitive acid blocker that reversibly inhibits gastric H(+)/K(+)-ATPase and shows effective acid suppression comparable to PPIs. Itopride is a prokinetic agent that has anticholinesterase activity as well as dopamine D(2) receptor antagonistic activity. For this reason, revaprazan and itopride have been prescribed for FD; however, no available studies have reported the pharmacokinetic interactions of these 2 drugs. The objective of this study was to compare the bioavailability and tolerability of revaprazan and itopride combination therapy to those of equally dosed monotherapies to acquire basic drug-drug interaction information about revaprazan. This multiple-dose, randomized crossover study was conducted in healthy male Korean subjects. Subjects received, in randomized sequence, a 7-day oral dose of revaprazan 200 mg once daily, itopride 50 mg TID, or both. Each treatment period was separated by a 7-day washout period. Blood samples were collected for up to 24 hours following the last dose at steady state, and drug concentrations were determined using validated LC/MS-MS. Pharmacokinetic properties were obtained using noncompartmental analysis. Drug tolerability was assessed throughout the study, using measurements of vital signs, clinical chemistry testing, and interviews. A total of 30 subjects were enrolled in the study. Among them, 28 subjects completed revaprazan treatment, and 27 completed the study (3 subjects were withdrawn). The geometric mean ratios (GMRs) (90% CI) of C(max,ss), and AUC(τ,ss) with revaprazan were 0.92 (0.84-1.00) and 0.96 (0.89-1.03), respectively. The GMRs of C(max,ss) and AUC(τ,ss) with itopride were 1.07 (0.96-1.20) and 1.12 (1.06-1.18), respectively. A total of 15 adverse

  6. A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study.

    Directory of Open Access Journals (Sweden)

    Batya Elul

    2017-11-01

    Full Text Available Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique.In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC. The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS health messages and appointment reminders. A pre-post intervention 2-sample design was nested within the CIS arm to assess the effectiveness of CIS+, an enhanced version of the CIS that additionally included conditional non-cash financial incentives for linkage and retention. The primary outcome was a combined outcome of linkage to care within 1 month and retention at 12 months after diagnosis. From April 22, 2013, to June 30, 2015, we enrolled 2,004 out of 5,327 adults ≥18 years of age diagnosed with HIV in the voluntary counseling and testing clinics of participating health facilities: 744 (37% in the CIS group, 493 (25% in the CIS+ group, and 767 (38% in the SOC group. Fifty-seven percent of the CIS group achieved the primary outcome versus 35% in the SOC group (relative risk [RR]CIS vs SOC = 1.58, 95% CI 1.05-2.39. Eighty-nine percent of the CIS group linked to care on the day of diagnosis versus 16% of the SOC group (RRCIS vs SOC = 9.13, 95% CI 1.65-50.40. There was no significant benefit of adding financial incentives to the CIS in terms of the combined outcome (55% of the CIS+ group achieved the primary outcome, RRCIS+ vs CIS = 0.96, 95% CI 0.81-1.16. Key limitations include the use of existing medical records to assess outcomes, the inability to isolate the effect of each component of the CIS, non-concurrent enrollment of the CIS+ group, and exclusion of many patients newly diagnosed with HIV.The CIS

  7. [Randomized controlled clinical trials of individualized treatment of cerebral palsy children by warm-reinforcing needling combined with Bobath rehabilitation training].

    Science.gov (United States)

    Zhang, Ning-Xia; Wang, Xiang-Yu; Liu, Gui-Zhen; Li, Yun-Bo; Zhang, Hong-Ying

    2014-08-01

    To observe the effect of warm-reinforcing needling combined with modern rehabilitation training on motor function of cerebral palsy (CP) children. Sixty cases of CP children were randomly divided into acupuncture combined with rehabilitation (Acu + Rehab, n = 30) group and Rehab (n = 30) group. Patients of the Acu + Rehab group were treated by warm-reinforcing needling stimulation of Jiaji (EX-B 2), Jianyu (LI 15), Quchi (LI 11), Hegu (LI 4), Zusanli (ST 36), Yinlingquan (GB 34), Sanyinjiao (SP 6), Juegu (GB 39), Yanglingquan (GB 34), etc., combined with Bobath rehabilitation therapy, and those of the Rehab group treated by Bobath rehabilitation (stimulating key control points in the body, triggering reflexes that provide head and body control). The treatment was conducted every day,with three months being a therapeutic course,two courses in all. The Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate the CP children's motor function [1) gross motor: posture (straightness ratio), locomotion and object manipulation; 2) fine motor: grasping and visual-Motor integration]. After the treatment, of the 30 and 30 cases in the Acu+ Rehab and Rehab groups, 1 (3.33%) and 0 (0%) were cured, 20 (66.67%) and 18 (60.00%) experienced marked improvement, 9 (30.00%) and 12 (40.00%) were invalid, with the effective rates being 70.00% and 60.00% respectively. The therapeutic effect of the Acu + Rehab group was markedly superior to that of the Rehab group (P Bobath rehabilitation has a better therapeutic effect in improving gross motor and fine motor functions of CP children.

  8. Open-Label, Randomized, 6-Way Crossover, Single-Dose Study to Determine the Pharmacokinetics of Batefenterol (GSK961081) and Fluticasone Furoate When Administered Alone or in Combination.

    Science.gov (United States)

    Ambery, Claire; Riddell, Kylie; Daley-Yates, Peter

    2016-09-01

    To investigate the pharmacokinetics of inhaled batefenterol (BAT) and fluticasone furoate (FF) given alone or in combination via ELLIPTA® dry powder inhaler (DPI-E), and BAT monotherapy via DISKUS® DPI (DPI-D). In this open-label, 6-way crossover study, 48 healthy subjects were randomized to 1 of 6 treatment sequences, comprising 6 single-dose treatment regimens: (1) BAT 1200 μg via DPI-D; (2) BAT 1200 μg via DPI-E without a lactose-filled second strip; (3) BAT 1200 μg via DPI-E with a lactose-filled second strip; (4) BAT/FF 1200/300 μg via DPI-E; (5) FF 300 μg via DPI-E with a lactose-filled second strip; and (6) BAT/FF 900/300 μg via DPI-E. Pharmacokinetic data were analyzed using noncompartmental methods. Plasma BAT area under the curve (AUC) and maximum plasma concentration (Cmax ) were similar for all treatments containing BAT 1200 μg (geometric least-squares means [GLSM] ratio, 0.90-1.06). Plasma FF AUC and Cmax were reduced following BAT/FF 1200/300 μg and 900/300 μg versus FF 300 μg monotherapy (GLSM ratio, 0.62-0.77). BAT 1200 μg administered via DPI-E, alone or in combination with FF, resulted in similar systemic exposure versus BAT administered by DPI-D. FF exposure was reduced when administered in combination with BAT compared with FF alone. © 2016, The American College of Clinical Pharmacology.

  9. Efficacy of punch elevation combined with fractional carbon dioxide laser resurfacing in facial atrophic acne scarring: A randomized split-face clinical study

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    Gita Faghihi

    2015-01-01

    Full Text Available Background: A number of treatments for reducing the appearance of acne scars are available, but general guidelines for optimizing acne scar treatment do not exist. The aim of this study was to compare the clinical effectiveness and side effects of fractional carbon dioxide (CO 2 laser resurfacing combined with punch elevation with fractional CO 2 laser resurfacing alone in the treatment of atrophic acne scars. Materials and Methods: Forty-two Iranian subjects (age range 18-55 with Fitzpatrick skin types III to IV and moderate to severe atrophic acne scars on both cheeks received randomized split-face treatments: One side received fractional CO 2 laser treatment and the other received one session of punch elevation combined with two sessions of laser fractional CO 2 laser treatment, separated by an interval of 1 month. Two dermatologists independently evaluated improvement in acne scars 4 and 16 weeks after the last treatment. Side effects were also recorded after each treatment. Results: The mean ± SD age of patients was 23.4 ± 2.6 years. Clinical improvement of facial acne scarring was assessed by two dermatologists blinded to treatment conditions. No significant difference in evaluation was observed 1 month after treatment (P = 0.56. Their evaluation found that fractional CO 2 laser treatment combined with punch elevation had greater efficacy than that with fractional CO 2 laser treatment alone, assessed 4 months after treatment (P = 0.02. Among all side effects, coagulated crust formation and pruritus at day 3 after fractional CO 2 laser treatment was significant on both treatment sides (P < 0.05. Conclusion: Concurrent use of fractional laser skin resurfacing with punch elevation offers a safe and effective approach for the treatment of acne scarring.

  10. Efficacy of a Combined Strategy to Improve Low-density Lipoprotein Cholesterol Control Among Patients With Hypercholesterolemia: A Randomized Clinical Trial.

    Science.gov (United States)

    Párraga-Martínez, Ignacio; Escobar-Rabadán, Francisco; Rabanales-Sotos, Joseba; Lago-Deibe, Fernando; Téllez-Lapeira, Juan M; Villena-Ferrer, Alejandro; Blasco-Valle, Mariano; Ferreras-Amez, José M; Morena-Rayo, Susana; Del Campo-Del Campo, José M; Ayuso-Raya, M Candelaria; Pérez-Pascual, José J

    2018-01-01

    Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise). A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months. At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6mg/dL [95%CI, 8.9-20.4]; P=.034). The mean LDL-C decrease was 13.1%±28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P=.011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P=.029) and exercise (64.9% vs 35.8; P<.001), but not to diet. The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. A randomized controlled trial to compare fentanyl-propofol and ketamine-propofol combination for procedural sedation and analgesia in laparoscopic tubal ligation

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    Ranju Singh

    2013-01-01

    Full Text Available Background: Procedural sedation and analgesia is widely being used for female laparoscopic sterilization using combinations of different drugs at varying doses. This study compared the combination of fentanyl and propofol, and ketamine and propofol in patients undergoing outpatient laparoscopic tubal ligation, with respect to their hemodynamic effects, postoperative recovery characteristics, duration of hospital stay, adverse effects, and patient comfort and acceptability. Settings and Design: Randomized, double blind. Methods: Patients were assigned to receive premixed injection of either fentanyl 1.5 μg/kg + propofol 2 mg/kg (Group PF, n0=50 or ketamine 0.5 mg/kg + propofol 2 mg/kg (Group PK, n=50. Hemodynamic data, peripheral oxygen saturation, and respiratory rate were recorded perioperatively. Recovery time, time to discharge, and comfort score were noted. Statistical Analysis: Chi-square (χ2 test was used for categorical data. Student′s t-test was used for quantitative variables for comparison between the two groups. For intragroup comparison, paired t-test was used. SPSS 14.0 was used for analysis. Results: Although the heart rate was comparable, blood pressures were consistently higher in group PK. Postoperative nausea and vomiting and delay in voiding were more frequent in group PK ( P<0.05. The time to reach Aldrete score ≥8 was significantly longer in group PK (11.14±3.29 min in group PF vs. 17.3±6.32 min in group PK, P<0.01. The time to discharge was significantly longer in group PK (105.8±13.07 min in group PF vs.138.18±13.20 min in group PK, P<0.01. Patient comfort and acceptability was better in group PF, P<0.01. Conclusion: As compared to ketamine-propofol, fentanyl-propofol combination is associated with faster recovery, earlier discharge, and better patient acceptability.

  12. Effects of metronidazole combined probiotics over metronidazole alone for the treatment of bacterial vaginosis: a meta-analysis of randomized clinical trials.

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    Tan, Hongying; Fu, Yunque; Yang, Chunlin; Ma, Jianting

    2017-06-01

    To evaluate the curative effect of metronidazole combined probiotics over metronidazole alone in the treatment of BV. We are searching randomized controlled trials on major online databases including PubMed, Science Direct, and Cochrane Database between 1990 and 2015. The primary outcome measure was the cure rate of BV. Cochran's Chi-square test (Q test) was used to test for heterogeneity among trials, and the I 2 index. We used mixed-effects modeling for parameters of the summary hazard ratios (HRs), odds ratios (ORs), and their 95% confidence intervals (CIs). Analysis suggests the cure rate of BV [RR = 1.12, 95% CI (0.94-1.32), p = 0.20], and the I 2 index was 83%. The value of I 2 index decreased to 16% after removing the study of Anukam et al., and Amsel 1.04 (95% CI 0.96-1.13) (p = 0.35), Nugent 1.02 (95% CI 0.94-1.11), short-term 1.01 (95% CI 0.93-1.10) (p = 0.79), long-term 1.06 (95% CI 0.98-1.14) (p = 0.13), Europe 1.06 (95% CI 0.95-1.19) (p = 0.32), Non-Europe 0.99 (95% CI 0.94-1.05) (p = 0.83). When the two same groups data were combined, respectively, the RRs for all studies were the same as 1.03 (95% CI 0.96-1.09) (p = 0.42) showing that there is not statistically significant in relevant stratums. The result has showed an overall little significance for the efficacy of metronidazole combined probiotics over metronidazole alone for the treatment of BV. We need more further studies to provide enough evidence to confirm the benefits of probiotics in the treatment of BV.

  13. Initial Use of High-Dose Anticholinergics Combined with Alpha-Blockers for Male Lower Urinary Tract Symptoms with Overactive Bladder: A Prospective, Randomized Preliminary Study.

    Science.gov (United States)

    Lee, Kyu Won; Hur, Kyung Jae; Kim, Sang Hoon; Cho, Su Yeon; Bae, Sang Rak; Park, Bong Hee; Lee, Yong Seok; Han, Chang Hee; Kim, Hyun Woo

    2017-09-01

    To evaluate the clinical efficacy of initial combined treatment of alpha-blocker plus dose-dependent anticholinergic agent compared to the alpha-blocker monotherapy in benign prostatic hyperplasia patients with overactive bladder. Male lower urinary tract symptoms (LUTS) patients with International Prostate Symptom Score (IPSS) of 8 or higher, total overactive bladder Symptom Score (OABSS) of 3 or higher, and 2 points or higher in the OABSS questionnaire number 2 were enrolled. Eligible subjects (total n = 146) were randomly assigned to receive tamsulosin 0.2 mg (Group I, n = 44), tamsulosin 0.2 mg plus solifenacin 5 mg (Group II, n = 55), or tamsulosin 0.2 mg plus solifenacin 10 mg (Group III, n = 47) for 12 weeks. Efficacy and safety assessments for each group were done using detailed questionnaires, and evaluating urinary parameters such as maximal urinary flow rate (Qmax) and postvoid residual volume (PVR) at 4 and 12 weeks. Groups II and III (combined use of tamsulosin and solifenacin) showed significant improvement in storage symptoms compared to group I (tamsulosin monotherapy), as reflected by IPSS storage subscore and OABSS (P < 0.05). Dry mouth developed in four (7%) and eight (17%) cases in group II and III, respectively, so that one (2%) and three (6%) cases dropped out in group II and III, respectively. Two cases (4%) of AUR developed in group III, and one of them was withdrawn (2%) from the study. Initial combined treatment of tamsulosin plus solifenacin for men with LUTS improves storage symptoms significantly, but dose modification is necessary to prevent adverse events. © 2016 John Wiley & Sons Australia, Ltd.

  14. Ultrasound combined transcutaneous electrical nerve stimulation (UltraTENS) versus phonophoresis of piroxicam (PhP) in symptomatic knee osteoarthritis: A randomized double-blind, controlled trial.

    Science.gov (United States)

    Boonhong, Jariya; Suntornpiyapan, Phitsanu

    2018-02-02

    Ultrasound combined with transcutaneous electrical nerve stimulation (UltraTENS) and phonophoresis of piroxicam (PhP) are combined modality therapy that frequently used in musculoskeletal pain including knee osteoarthritis (OA). But it is lack of a good clinical trial to prove and compare their effects. To compare the effects of UltraTENS with PhP on mild to moderate degree of symptomatic knee OA. Sixty-one patients (55 women), mean age of 63.4 ± 8.1 y, 50-90 mm VAS of knee pain and Kellgren-Lawrence score of grade I-III were randomly allocated into UltraTENS and PhP (N = 31 and 30, respectively). The UltraTENS group received a combined ultrasound with TENS program and a non-drug gel, whereas the PhP group got an ultrasound program with piroxicam gel and sham TENS. All patients were treated for a total of 10 sessions, consisting of five times per week and 10 min per session. Before and after treatment, patients were evaluated knee pain by using the 100-mm VAS and functional performance by Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index. The UltraTENS and PhP groups experienced considerable improvement in both VAS and total WOMAC scores post-treatment (PPhP had better VAS of pain and WOMAC scores but no statistical significance. Results show that UltraTENS and PhP were effective for relieving pain and improve functionality knee OA without significant differences between their effects.

  15. Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial

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    Shuai Yin

    2017-01-01

    Full Text Available Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups: the low-He point group (puncturing at Zusanli (ST36, Mu point group (puncturing at Zhongwan (CV12, and He-Mu point combination group (puncturing at ST36 and CV12. Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensation and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the

  16. The effects on ovarian activity of ulipristal acetate when 'quickstarting' a combined oral contraceptive pill: a prospective, randomized, double-blind parallel-arm, placebo-controlled study.

    Science.gov (United States)

    Cameron, S T; Berger, C; Michie, L; Klipping, C; Gemzell-Danielsson, K

    2015-07-01

    What is the effect on ovarian activity of a preceding intake of ulipristal acetate (UPA) when starting a combined oral contraceptive (COC) in the mid- to late-follicular phase of the cycle? This study shows that UPA does not affect the ability of the COC to induce ovarian quiescence. UPA is a progesterone receptor modulator that is available for emergency contraception (EC). In theory, UPA could alter the effectiveness of hormonal contraception started immediately following it and vice versa. Current guidelines regarding quick starting a COC following UPA are based on expert opinion only. A double-blind, randomized, placebo-controlled trial was conducted at three separate sites, Edinburgh (Scotland), Stockholm (Sweden) and Groningen (the Netherlands), over a 5-month period in 2012. Healthy female volunteers were randomized to take either UPA or an identically packaged placebo, at mid-cycle (once a lead ovarian follicle was determined to be >13 mm on transvaginal ultrasound imaging). Participants were randomized by a computer-generated randomization schedule, allocated by sequential, sealed envelopes. All women then started 21 days of the same COC the following day. The study was designed to show non-inferiority of UPA compared with placebo in terms of the proportion of women attaining ovarian quiescence, as measured by the Hoogland scoring system, while taking COC. A total of 76 women were recruited over the three sites, Edinburgh (n = 18), Stockholm (n = 13), Groningen (n = 45) and received either UPA (n = 39) or placebo (n = 37). There were no significant differences in demographic characteristics of women in the UPA and placebo groups. Among the 76 participants treated, 47 (61.8%) reached quiescence and 25 (32.9%) ovulated. There were no significant differences between the groups in the odds ratio (OR) of reaching ovarian quiescence or not; OR 0.97 (95% CI: 0.39-2.46). All women who reached quiescence had done so after taking COCs for 14 days. The main

  17. Independent and combined effects of calcium-vitamin D3 and exercise on bone structure and strength in older men: an 18-month factorial design randomized controlled trial.

    Science.gov (United States)

    Kukuljan, Sonja; Nowson, Caryl A; Sanders, Kerrie M; Nicholson, Geoff C; Seibel, Markus J; Salmon, Jo; Daly, Robin M

    2011-04-01

    Exercise and calcium-vitamin D are independently recognized as important strategies to prevent osteoporosis, but their combined effects on bone strength and its determinants remain uncertain. To assess whether calcium-vitamin D(3) fortified milk could enhance the effects of exercise on bone strength, structure, and mineral density in middle-aged and older men. An 18-month factorial design randomized controlled trial in which 180 men aged 50-79 years were randomized to the following: exercise + fortified milk; exercise; fortified milk; or controls. Exercise consisted of progressive resistance training with weight-bearing impact activities performed 3 d/week. Men assigned to fortified milk consumed 400 ml/d of 1% fat milk containing 1000 mg/d calcium and 800 IU/d vitamin D(3). Changes in bone mineral density (BMD), bone structure, and strength at the lumbar spine (LS), proximal femur, mid-femur, and mid-tibia measured by dual energy x-ray absorptiometry and/or quantitative computed tomography. There were no exercise-by-fortified milk interactions at any skeletal site. Main effect analysis showed that exercise led to a 2.1% (95% confidence interval, 0.5-3.6) net gain in femoral neck section modulus, which was associated with an approximately 1.9% gain in areal BMD and cross-sectional area. Exercise also improved LS trabecular BMD [net gain 2.2% (95% confidence interval, 0.2-4.1)], but had no effect on mid-femur or mid-tibia BMD, structure, or strength. There were no main effects of the fortified milk at any skeletal site. A community-based multi-component exercise program successfully improved LS and femoral neck BMD and strength in healthy older men, but providing additional calcium-vitamin D(3) to these replete men did not enhance the osteogenic response.

  18. Does physiotherapeutic intervention affect motor outcome in high-risk infants? An approach combining a randomized controlled trial and process evaluation.

    Science.gov (United States)

    Hielkema, Tjitske; Blauw-Hospers, Cornill H; Dirks, Tineke; Drijver-Messelink, Marieke; Bos, Arend F; Hadders-Algra, Mijna

    2011-03-01

    The aim of this study was to examine the effects of intervention in infants at risk of developmental disorders on motor outcome, as measured by the Infant Motor Profile (IMP) and using the combined approach of a randomized controlled trial and process evaluation. At a corrected age of 3 months, 46 infants (20 males, 26 females) recruited from the neonatal intensive care unit at the University Medical Centre Groningen (median birthweight 1210 g, range 585-4750 g; median gestational age 30 wks, range 25-40 wks) were included on the basis of definitely abnormal general movements. Exclusion criteria were severe congenital disorders and insufficient understanding of the Dutch language. The infants were assigned to either the family-centred COPing with and CAring for Infants with Special Needs (COPCA) intervention group (n=21; 9 males, 12 females) or the traditional infant physiotherapy (TIP) intervention group (n=25; 11 males, 14 females) for a period of 3 months. Three infants assigned to the TIP group (one male, two females) did not receive physiotherapy. IMP scores were measured by blinded assessors at 3, 4, 5, 6, and 18 months. At each age, the infants were neurologically examined. Physiotherapeutic sessions at 4 and 6 months were videotaped. Quantified physiotherapeutic actions were correlated with IMP scores at 6 and 18 months. The IMP scores of both the COPCA and TIP groups before, during, and after the intervention did not differ. Some physiotherapeutic actions were associated with IMP outcomes; the associations differed for infants who developed cerebral palsy (n=10) and those who did not (n=33). At randomized controlled trial level, the scores of both the TIP and COPCA groups did not differ in effect on motor outcome, as measured with the IMP. The analysis of physiotherapeutic actions revealed associations between these actions and IMP outcomes. However, the small sample size of this study precludes pertinent conclusions. © The Authors. Journal compilation

  19. Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin).

    Science.gov (United States)

    Montaner, Joan; Bustamante, Alejandro; García-Matas, Silvia; Martínez-Zabaleta, Maite; Jiménez, Carmen; de la Torre, Javier; Rubio, Francisco R; Segura, Tomás; Masjuán, Jaime; Cánovas, David; Freijo, Mar; Delgado-Mederos, Raquel; Tejada, Javier; Lago, Aida; Bravo, Yolanda; Corbeto, Natália; Giralt, Dolors; Vives-Pastor, Bárbara; de Arce, Anna; Moniche, Francisco; Delgado, Pilar; Ribó, Marc

    2016-11-01

    The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke. STARS07 was a multicentre, phase IV, prospective, randomized, double-blind, placebo-controlled trial. Patients with Acute ischemic stroke recruited within 12 hours from symptom onset were randomized to oral simvastatin 40 mg or placebo, once daily for 90 days. Primary outcome was proportion of independent patients (modified Rankin Scale score of ≤2) at 90 days. Safety end points were hemorrhagic transformation, hemorrhagic events, death, infections, and serious adverse events. From April 2009 to March 2014, 104 patients were included. Fifty-five patients received intravenous tissue-type plasminogen activator. No differences were found between treatment arms regarding the primary outcome (adjusted odds ratio, 0.99 [0.35-2.78]; P=0.98). Concerning safety, no significant differences were found in the rate of hemorrhagic transformation of any type, nor symptomatic hemorrhagic transformation. There were no differences in other predefined safety outcomes. In post hoc analyses, for patients receiving tissue-type plasminogen activator, a favorable effect for simvastatin treatment was noted with higher proportion of patients experiencing major neurological recovery (adjusted odds ratio, 4.14 [1.18-14.4]; P=0.02). Simvastatin plus tissue-type plasminogen activator combination seems safe in acute stroke, with low rates of bleeding complications. Because of the low recruitment, the STARS trial was underpowered to detect differences in simvastatin efficacy. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01073007. © 2016 American Heart Association, Inc.

  20. The effect of myofascial release and microwave diathermy combined with acupuncture versus acupuncture therapy in tension-type headache patients: A pragmatic randomized controlled trial.

    Science.gov (United States)

    Georgoudis, George; Felah, Bledjana; Nikolaidis, Pantelis; Damigos, Dimitrios

    2017-12-20

    Nonpharmacological therapies for tension-type headache (TTH) and cervicogenic cephalalgia are often a treatment choice, despite the weak to moderate evidence. The aim of this study was to compare the effectiveness of an acupuncture/stretching protocol versus acupuncture/stretching plus physiotherapy techniques, in patients with TTH cephalalgia. A single-blind, prospective, multicentre, randomized controlled trial was designed considering the pragmatic situation of administering such protocols and treating the 44 headache patients participating in this study. The patients were randomly assigned in 2 treatment groups (control group, n = 20, acupuncture/stretching; experimental group, n = 24, acupuncture/stretching plus physiotherapy) and completed 10 treatment sessions within 4 weeks with measurements taking place before treatment, after the fifth treatment and after the 10th treatment. The mechanical pressure pain threshold (PPT) was considered as the main outcome measure, using a mechanical algometer to measure 7 bilateral somatic points. Acupuncture in both groups included 17-20 acupuncture points, whereas stretching was initially taught and subsequently self-administered (self-stretches), following a standardized set of movements of the cervical spine. Physiotherapy consisted of microwave diathermy and myofascial release with hands-on techniques. An improvement was noted in both groups/treatments regarding the main outcome measure PPT, all the way from the first to fifth and the 10th treatment, at all measuring sites and at all measurements in both groups (p acupuncture and stretching but further PPT improvements were evidenced when physiotherapy hands-on techniques were added. In clinical terms, the combination of physiotherapy in the form of myofascial release and microwave diathermy with acupuncture and stretching in order to improve the analgesic effect (PPT) is strongly recommended. Copyright © 2017 John Wiley & Sons, Ltd.

  1. A randomized trial of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain.

    Science.gov (United States)

    Niemistö, Leena; Lahtinen-Suopanki, Tiina; Rissanen, Pekka; Lindgren, Karl-August; Sarna, Seppo; Hurri, Heikki

    2003-10-01

    A prospective randomized controlled trial. To examine the effectiveness of combined manipulative treatment, stabilizing exercises, and physician consultation compared with physician consultation alone for chronic low back pain. Strong evidence exists that manual therapy provides more effective short-term pain relief than does placebo treatment in the management of chronic low back pain. The evidence for long-term effect is lacking. Two hundred four chronic low back pain patients, whose Oswestry disability index was at least 16%, were randomly assigned to either a manipulative-treatment group or a consultation group. All were clinically examined, informed about their back pain, provided with an educational booklet, and were given specific instructions based on the clinical evaluation. The treatment included four sessions of manipulation and stabilizing exercises aiming to correct the lumbopelvic rhythm. Questionnaires inquired about pain intensity, self-rated disability, mental depression, health-related quality of life, health care costs, and production costs. At the baseline, the groups were comparable, except for the percentage of employees (P = 0.01). At the 5- and 12-month follow-ups, the manipulative-treatment group showed more significant reductions in pain intensity (P < 0.001) and in self-rated disability (P = 0.002) than the consultation group. However, we detected no significant difference between the groups in health-related quality of life or in costs. The manipulative treatment with stabilizing exercises was more effective in reducing pain intensity and disability than the physician consultation alone. The present study showed that short, specific treatment programs with proper patient information may alter the course of chronic low back pain.

  2. Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

    2017-08-04

    Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. Th