WorldWideScience

Sample records for randomly combined shapes

  1. Iterated random walks with shape prior

    DEFF Research Database (Denmark)

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

    2016-01-01

    the parametric probability density function. Then, random walks is performed iteratively aligning the prior with the current segmentation in every iteration. We tested the proposed approach with natural and medical images and compared it with the latest techniques with random walks and shape priors......We propose a new framework for image segmentation using random walks where a distance shape prior is combined with a region term. The shape prior is weighted by a confidence map to reduce the influence of the prior in high gradient areas and the region term is computed with k-means to estimate....... The experiments suggest that this method gives promising results for medical and natural images....

  2. 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...

  3. Statistical shape model with random walks for inner ear segmentation

    DEFF Research Database (Denmark)

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

    2016-01-01

    is required. We propose a new framework for segmentation of micro-CT cochlear images using random walks combined with a statistical shape model (SSM). The SSM allows us to constrain the less contrasted areas and ensures valid inner ear shape outputs. Additionally, a topology preservation method is proposed...

  4. 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 sh...

  5. 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

    Purpose Cochlear implantation is a safe and effective surgical procedure to restore hearing in deaf patients. However, the level of restoration achieved may vary due to differences in anatomy, implant type and surgical access. In order to reduce the variability of the surgical outcomes, we...... propose a new framework for cochlea segmentation in ex vivo μCT images using random walks where a distance-based shape prior is combined with a region term estimated by a Gaussian mixture model. The prior is also weighted by a confidence map to adjust its influence according to the strength of the image...... contour. Random walks is performed iteratively, and the prior mask is aligned in every iteration. Results We tested the proposed approach in ten μCT data sets and compared it with other random walks-based segmentation techniques such as guided random walks (Eslami et al. in Med Image Anal 17...

  6. 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.

  7. 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...... 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...... using Markov random field relaxation of a spectral classifier. Keywords: the Ising model, the Potts model, stochastic sampling, discriminant analysis, expectation maximization....

  8. Limit Shapes and Fluctuations of Bounded Random Partitions

    DEFF Research Database (Denmark)

    Beltoft, Dan

    Random partitions of integers, bounded both in the number of summands and the size of each summand are considered, subject to the probability measure which assigns a probability proportional to some fixed positive number to the power of the number being partitioned. This corresponds to considering...

  9. Optimal Preventive Bank Supervision: Combining Random Audits and Continuous Intervention

    OpenAIRE

    Mohamed Belhaj; Nataliya Klimenko

    2012-01-01

    Early regulator interventions into problem banks are one of the key suggestions of Basel II. However, no guidance is given on their design. To fill this gap, we outline an incentive-based preventive supervision strategy that eliminates bad asset management in banks. Two supervision techniques are combined: continuous regulator intervention and random audits. Random audit technologies differ as to quality and cost. Our design ensures good management without excessive supervision costs, through...

  10. 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...

  11. Random River Fluctuations Shape the Root Profile of Riparian Plants

    Science.gov (United States)

    Perona, P.; Tron, S.; Gorla, L.; Schwarz, M.; Laio, F.; Ridolfi, L.

    2015-12-01

    Plant roots are recognized to play a key role in the riparian ecosystems: they contribute to the plant as well as to the streambank and bedforms stability, help to enhance the water quality of the river, and sustain the belowground biodiversity. The complexity of the root-system architecture recalls their remarkable ability to respond to environmental conditions, notably including soil heterogeneity, resource availability, and climate. In fluvial environments where nutrient availability is not a limiting factor for plant to grow, the root growth of phreatophytic plants is strongly influenced by water and oxygen availability in the soil. In this work, we demonstrate that the randomness of water table fluctuations, determined by streamflow stochastic variability, is likely to be the main driver for the root development strategy of riparian plants. A collection of root measurements from field and outdoor controlled experiments is used to demonstrate that the vertical root density distribution can be described by a simple analytical expression, whose parameters are linked to properties of soil, plant and water table fluctuations. This physically-based expression is able to predict riparian plant roots adaptability to different hydrological and pedologic scenarios in riverine environments. Hence, this model has great potential towards the comprehension of the effects of future climate and environmental changing conditions on plant adaptation and river ecomorphodynamic processes. Finally, we present an open access graphical user interface that we developed in order to estimate the vertical root distribution in fluvial environments and to make the model easily available to a wider scientific and professional audience.

  12. 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

    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...... 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...

  13. 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

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

    International Nuclear Information System (INIS)

    Lian, Haojie; Christiansen, Asger N.; Tortorelli, Daniel A.; Sigmund, Ole; Aage, Niels

    2017-01-01

    Here, 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. By performing repeated topology and shape optimizations and adaptive mesh updates, we can minimize the maximum von Mises stress using the p-norm stress measure with p-values as high as 30, provided that the stress is calculated with sufficient accuracy.

  15. 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....... By performing repeated topology and shape optimizations and adaptive mesh updates, we can minimize the maximum von Mises stress using the p-norm stress measure with p-values as high as 30, provided that the stress is calculated with sufficient accuracy....

  16. 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.

  17. 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.

  18. Chinese wine classification system based on micrograph using combination of shape and structure features

    Science.gov (United States)

    Wan, Yi

    2011-06-01

    Chinese wines can be classification or graded by the micrographs. Micrographs of Chinese wines show floccules, stick and granule of variant shape and size. Different wines have variant microstructure and micrographs, we study the classification of Chinese wines based on the micrographs. Shape and structure of wines' particles in microstructure is the most important feature for recognition and classification of wines. So we introduce a feature extraction method which can describe the structure and region shape of micrograph efficiently. First, the micrographs are enhanced using total variation denoising, and segmented using a modified Otsu's method based on the Rayleigh Distribution. Then features are extracted using proposed method in the paper based on area, perimeter and traditional shape feature. Eight kinds total 26 features are selected. Finally, Chinese wine classification system based on micrograph using combination of shape and structure features and BP neural network have been presented. We compare the recognition results for different choices of features (traditional shape features or proposed features). The experimental results show that the better classification rate have been achieved using the combinational features proposed in this paper.

  19. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser

    2017-12-01

    There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.

  20. The combined influence of binocular disparity and shading on pictorial shape

    NARCIS (Netherlands)

    Doorschot, P. C A; Kappers, A. M L; Koenderink, Jan J.

    The combined influence of binocular disparity and shading on pictorial shape was studied. Stimuli were several pairs of stereo photographs of real objects. The stereo base was 0, 7, or 14 cm, and the location of the light source was varied over three positions (one from about the viewpoint of the

  1. 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...

  2. 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

  3. A randomized controlled trial of positioning treatments in infants with positional head shape deformities.

    Science.gov (United States)

    Hutchison, B Lynne; Stewart, Alistair W; De Chalain, Tristan B; Mitchell, Edwin A

    2010-10-01

    Randomized controlled trials of treatment for deformational plagiocephaly and brachycephaly have been lacking in the literature. Infants (n = 126) presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep™ positioning wrap. Head shape was measured using a digital photographic technique, and neck function was assessed. They were followed up at home 3, 6 and 12 months later. There was no difference in head shape outcomes for the two treatment groups after 12 months of follow-up, with 42% of infants having head shapes in the normal range by that time. Eighty per cent of children showed good improvement. Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic. Most infants improved over the 12-month study period, although the use of a sleep positioning wrap did not increase the rate of improvement. © 2010 The Author(s)/Journal Compilation © 2010 Foundation Acta Paediatrica.

  4. Characterization of a Poly(styrene-block-methylacrylate-random-octadecylacrylate-block-styrene) Shape Memory ABA Triblock Copolymer

    Science.gov (United States)

    Fei, Pengzhan; Cavicchi, Kevin

    2011-03-01

    A new ABA triblock copolymer of poly(styrene-block- methylacrylate-random-octadecylacrylate-block-styrene) (PS-b- PMA-r-PODA-b-PS) was synthesized by reversible addition fragmentation chain transfer polymerization. The triblock copolymer can generate a three-dimensional, physically crosslinked network by self-assembly, where the glassy PS domains physically crosslink the midblock chains. The side chain crystallization of the polyoctadecylacrylare (PODA) side chain generates a second reversible network enabling shape memory properties. Shape memory tests by uniaxial deformation and recovery of molded dog-bone shape samples demonstrate that shape fixities above 96% and shape recoveries above 98% were obtained for extensional strains up to 300%. An outstanding advantage of this shape memory material is that it can be very easily shaped and remolded by elevating the temperature to 140circ; C, and after remolding the initial shape memory properties are totally recovered by eliminating the defects introduced by the previous deformation cycling.

  5. 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.

  6. In the eye of the beholder: Inhomogeneous distribution of high-resolution shapes within the random-walk ensemble

    Science.gov (United States)

    Müller, Christian L.; Sbalzarini, Ivo F.; van Gunsteren, Wilfred F.; Žagrović, Bojan; Hünenberger, Philippe H.

    2009-06-01

    The concept of high-resolution shapes (also referred to as folds or states, depending on the context) of a polymer chain plays a central role in polymer science, structural biology, bioinformatics, and biopolymer dynamics. However, although the idea of shape is intuitively very useful, there is no unambiguous mathematical definition for this concept. In the present work, the distributions of high-resolution shapes within the ideal random-walk ensembles with N =3,…,6 beads (or up to N =10 for some properties) are investigated using a systematic (grid-based) approach based on a simple working definition of shapes relying on the root-mean-square atomic positional deviation as a metric (i.e., to define the distance between pairs of structures) and a single cutoff criterion for the shape assignment. Although the random-walk ensemble appears to represent the paramount of homogeneity and randomness, this analysis reveals that the distribution of shapes within this ensemble, i.e., in the total absence of interatomic interactions characteristic of a specific polymer (beyond the generic connectivity constraint), is significantly inhomogeneous. In particular, a specific (densest) shape occurs with a local probability that is 1.28, 1.79, 2.94, and 10.05 times (N =3,…,6) higher than the corresponding average over all possible shapes (these results can tentatively be extrapolated to a factor as large as about 1028 for N =100). The qualitative results of this analysis lead to a few rather counterintuitive suggestions, namely, that, e.g., (i) a fold classification analysis applied to the random-walk ensemble would lead to the identification of random-walk "folds;" (ii) a clustering analysis applied to the random-walk ensemble would also lead to the identification random-walk "states" and associated relative free energies; and (iii) a random-walk ensemble of polymer chains could lead to well-defined diffraction patterns in hypothetical fiber or crystal diffraction experiments

  7. Combined Pyroelectric, Piezoelectric and Shape Memory Effects for Thermal Energy Harvesting

    International Nuclear Information System (INIS)

    Zakharov, D; Gusarov, B; Cugat, O; Delamare, J; Gimeno, L; Gusarova, E; Viala, B

    2013-01-01

    This work proposes an enhanced method for thermal energy harvesting exploiting combined pyroelectric, piezoelectric and shape memory (SME) effects, and presents its experimental validation. A material which is pyroelectric is also piezoelectric. If it is combined with a material with SME, which generates large strain and stress in a rather narrow temperature range, the resulting composite material would generate voltage from temperature variations using two different energy conversion principles at once: (1) pyroelectric effect, (2) piezoelectric effect driven by SME. A Macro Fiber Composite piezoelectric was shown here to exhibit significant pyroelectric effect (∼4 V/°C). When combining it with a SME Ti-Ni-Cu alloy into a laminated structure, this effect increased by 50%. This increase may be an order of magnitude higher for an optimized system. Such composites open an opportunity to harvest thermal energy from natural sources, since this method can increase the rather low efficiency of current pyroelectric materials especially for small temperature variations

  8. Thread angle dependency on flame spread shape over kenaf/polyester combined fabric

    Science.gov (United States)

    Azahari Razali, Mohd; Sapit, Azwan; Nizam Mohammed, Akmal; Nor Anuar Mohamad, Md; Nordin, Normayati; Sadikin, Azmahani; Faisal Hushim, Mohd; Jaat, Norrizam; Khalid, Amir

    2017-09-01

    Understanding flame spread behavior is crucial to Fire Safety Engineering. It is noted that the natural fiber exhibits different flame spread behavior than the one of the synthetic fiber. This different may influences the flame spread behavior over combined fabric. There is a research has been done to examined the flame spread behavior over kenaf/polyester fabric. It is seen that the flame spread shape is dependent on the thread angle dependency. However, the explanation of this phenomenon is not described in detail in that research. In this study, explanation about this phenomenon is given in detail. Results show that the flame spread shape is dependent on the position of synthetic thread. For thread angle, θ = 0°, the polyester thread is breaking when the flame approach to the thread and the kenaf thread tends to move to the breaking direction. This behavior produces flame to be ‘V’ shape. However, for thread angle, θ = 90°, the polyester thread melts while the kenaf thread decomposed and burned. At this angle, the distance between kenaf threads remains constant as flame approaches.

  9. Honeybees in a virtual reality environment learn unique combinations of colour and shape.

    Science.gov (United States)

    Rusch, Claire; Roth, Eatai; Vinauger, Clément; Riffell, Jeffrey A

    2017-10-01

    Honeybees are well-known models for the study of visual learning and memory. Whereas most of our knowledge of learned responses comes from experiments using free-flying bees, a tethered preparation would allow fine-scale control of the visual stimuli as well as accurate characterization of the learned responses. Unfortunately, conditioning procedures using visual stimuli in tethered bees have been limited in their efficacy. In this study, using a novel virtual reality environment and a differential training protocol in tethered walking bees, we show that the majority of honeybees learn visual stimuli, and need only six paired training trials to learn the stimulus. We found that bees readily learn visual stimuli that differ in both shape and colour. However, bees learn certain components over others (colour versus shape), and visual stimuli are learned in a non-additive manner with the interaction of specific colour and shape combinations being crucial for learned responses. To better understand which components of the visual stimuli the bees learned, the shape-colour association of the stimuli was reversed either during or after training. Results showed that maintaining the visual stimuli in training and testing phases was necessary to elicit visual learning, suggesting that bees learn multiple components of the visual stimuli. Together, our results demonstrate a protocol for visual learning in restrained bees that provides a powerful tool for understanding how components of a visual stimulus elicit learned responses as well as elucidating how visual information is processed in the honeybee brain. © 2017. Published by The Company of Biologists Ltd.

  10. First passage times for combinations of random loads

    OpenAIRE

    Jacobs, Patricia A.

    1985-01-01

    Structures are subject to changing loads from various sources. In many instances these loads fluctuate in time apparently random fashion. Models are considered for which the stress put on the structure by various loads simultaneously can be described by a regenerative process. The distribution of the first time until the stress on the structure exceeds a given level x is studied. Asymptotic properties of the distribution are given for a large stress level x and for the tail of the distributio...

  11. 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.

  12. Dynamic evolution of Rayleigh-Taylor bubbles from sinusoidal, W-shaped, and random perturbations

    Science.gov (United States)

    Zhou, Zhi-Rui; Zhang, You-Sheng; Tian, Bao-Lin

    2018-03-01

    Implicit large eddy simulations of two-dimensional Rayleigh-Taylor instability at different density ratios (i.e., Atwood number A =0.05 , 0.5, and 0.9) are conducted to investigate the late-time dynamics of bubbles. To produce a flow field full of bounded, semibounded, and chaotic bubbles, three problems with distinct perturbations are simulated: (I) periodic sinusoidal perturbation, (II) isolated W-shaped perturbation, and (III) random short-wave perturbations. The evolution of height h , velocity v , and diameter D of the (dominant) bubble with time t are formulated and analyzed. In problem I, during the quasisteady stage, the simulations confirm Goncharov's prediction of the terminal speed v∞=Fr√{A g λ /(1 +A ) } , where Fr=1 /√{3 π } . Moreover, the diameter D at this stage is found to be proportional to the initial perturbation wavelength λ as D ≈λ . This differed from Daly's simulation result of D =λ (1 +A )/2 . In problem II, a W-shaped perturbation is designed to produce a bubble environment similar to that of chaotic bubbles in problem III. We obtain a similar terminal speed relationship as above, but Fr is replaced by Frw≈0.63 . In problem III, the simulations show that h grows quadratically with the bubble acceleration constant α ≡h /(A g t2)≈0.05 , and D expands self-similarly with a steady aspect ratio β ≡D /h ≈(1 +A )/2 , which differs from existing theories. Therefore, following the mechanism of self-similar growth, we derive a relationship of β =4 α (1 +A ) /Frw2 to relate the evolution of chaotic bubbles in problem III to that of semibounded bubbles in problem II. The validity of this relationship highlights the fact that the dynamics of chaotic bubbles in problem III are similar to the semibounded isolated bubbles in problem II, but not to that of bounded periodic bubbles in problem I.

  13. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study

    OpenAIRE

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-01-01

    PURPOSE: Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. METHODS: Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and ...

  14. Shape measurement system for single point incremental forming (SPIF) manufacts by using trinocular vision and random pattern

    International Nuclear Information System (INIS)

    Setti, Francesco; Bini, Ruggero; Lunardelli, Massimo; Bosetti, Paolo; Bruschi, Stefania; De Cecco, Mariolino

    2012-01-01

    Many contemporary works show the interest of the scientific community in measuring the shape of artefacts made by single point incremental forming. In this paper, we will present an algorithm able to detect feature points with a random pattern, check the compatibility of associations exploiting multi-stereo constraints and reject outliers and perform a 3D reconstruction by dense random patterns. The algorithm is suitable for a real-time application, in fact it needs just three images and a synchronous relatively fast processing. The proposed method has been tested on a simple geometry and results have been compared with a coordinate measurement machine acquisition. (paper)

  15. 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...

  16. [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 (P<0.05); In each treatment group, the cleaning rate of the apex was significantly lower than that of the crown and central part (P<0.05); The cutting score of ProTaper+ultrasonic 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 (P<0.05); The cutting score and cleaning rate were negatively correlated (r=-0.712, P=0.000 ), the linear regression was the cleaning rate =98.325-4.325 × wall cutting score (R=0.454, P<0.05). In the process of shaping and cleaning of C-shaped canal, it is recommended that the ProTaper nickel-titanium rotary endodontic file should be chosen to clean the top of the taproot pipe and combined with ultrasonic rinsing to achieve better results.

  17. 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.

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

    International Nuclear Information System (INIS)

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

    2013-01-01

    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

  19. 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.

  20. Bayesian reconstruction of seafloor shape from side-scan sonar measurements using a Markov Random Field

    OpenAIRE

    Woock, P.; Pak, Alexey

    2014-01-01

    To explore the seafloor, a side-scan sonar emits a directed acoustic signal and then records the returning (reflected) signal intensity as a function of time. The inversion of that process is not unique: multiple shapes may lead to identical measured responses. In this work, we suggest a Bayesian approach to reconstructing the 3D shape of the seafloor from multiple sonar measurements, inspired by the state-of-the-art methods of inverse raytracing that originated in computer vision. The space ...

  1. 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.

  2. Thermosetting epoxy resin/thermoplastic system with combined shape memory and self-healing properties

    International Nuclear Information System (INIS)

    Yao, Yongtao; Wang, Jingjie; Lu, Haibao; Liu, Yanju; Leng, Jinsong; Xu, Ben; Fu, Yongqing

    2016-01-01

    A novel and facile strategy was proposed to construct a thermosetting/thermoplastic system with both shape memory and self-healing properties based on commercial epoxy resin and poly(ϵ-caprolactone)-PCL. Thermoplastic material is capable of re-structuring and changing the stiffness/modulus when the temperature is above melting temperature. PCL microfiber was used as a plasticizer in epoxy resin–based blends, and served as a ‘hard segment’ to fix a temporary shape of the composites during shape memory cycles. In this study, the electrospun PCL membrane with a porous network structure enabled a homogenous PCL fibrous distribution and optimized interaction between fiber and epoxy resin. The self-healing capability is achieved by phase transition during curing of the composites. The mechanism of the shape memory effect of the thermosetting (rubber)/thermoplastic composite is attributed to the structural design of the thermoplastic network inside the thermosetting resin/rubber matrix. (paper)

  3. Neutron-Gamma Pulse Shape Discrimination With Ne-213 Liquid Scintillator By Using Digital Signal Processing Combined With Similarity Method

    International Nuclear Information System (INIS)

    Mardiyanto

    2008-01-01

    Neutron-Gamma Pulse Shape Discrimination with a NE-213 Liquid Scintillator by Using Digital Signal Processing Combined with Similarity Method. Measurement of mixed neutron-gamma radiation is difficult because a nuclear detector is usually sensitive to both radiations. A new attempt of neutron-gamma pulse shape discrimination for a NE-213 liquid scintillator is presented by using digital signal processing combined with an off-line similarity method. The output pulse shapes are digitized with a high speed digital oscilloscope. The n-γ discrimination is done by calculating the index of each pulse shape, which is determined by the similarity method, and then fusing it with its corresponding pulse height. Preliminary results demonstrate good separation of neutron and gamma-ray signals from a NE-213 scintillator with a simple digital system. The results were better than those with a conventional rise time method. Figure of Merit is used to determine the quality of discrimination. The figure of merit of the discrimination using digital signal processing combined with off-line similarity method are 1.9; 1.7; 1.1; 1.1; and 0.8; on the other hand by using conventional method the rise time are 0.9; 0.9; 0.9; 0.7; and 0.4 for the equivalent electron energy of 800; 278; 139; 69; and 30 keV. (author)

  4. 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...

  5. Randomized double-blind comparison of metoprolol, nifedipine, and their combination in chronic stable angina

    DEFF Research Database (Denmark)

    Egstrup, K

    1988-01-01

    In a randomized double-blind study, treatment with either metoprolol, nifedipine, or their combination was compared for effects on ischemic variables and heart rate obtained during ambulatory monitoring in 42 patients with chronic stable angina. All patients had severe chronic stable angina...... could be detected during nifedipine monotherapy. It is concluded that metoprolol monotherapy, as well as its combination with nifedipine, effectively reduces total ischemic activity compared with placebo and nifedipine monotherapy. Control of ischemic activity in chronic stable angina may have...

  6. Combining thermodynamic principles with Preisach models for superelastic shape memory alloy wires

    International Nuclear Information System (INIS)

    Doraiswamy, S; Rao, A; Srinivasa, A R

    2011-01-01

    We present a simple model for simulating the response of a superelastic shape memory alloy wire based on the thermodynamics of irreversible processes, which can simulate the full thermomechanical response including internal hysteresis loops, at different temperatures, with minimal data input. The key idea is to separate the dissipative response and the elastic response of shape memory alloys using a Gibbs potential based formulation, and then use a Preisach model for the dissipative part of the response. This enables better handling of the features observed in the superelastic response such as those due to changes in temperature and internal hysteresis loops. We compare the predicted response with experiments performed on 0.75 mm NiTi shape memory alloy wires at three different temperatures

  7. Combined use of random access and ELISA analyzers in the microbiological serology laboratory

    Directory of Open Access Journals (Sweden)

    Alessandra Moroni

    2008-09-01

    Full Text Available In the last years the trend of centralizing small laboratories in large reference centers led to a careful evaluation of the diagnostic profiles. In the serology laboratory of Microbiology Unit, St. Orsola-Malpighi Hospital, Bologna, Italy the choice has been to combine random access analyzers (ARCHITECT Abbott and ELISA analyzers (BEPIII Dade Behring.

  8. 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

  9. Enantiopure distorted ribbon-shaped nanographene combining two-photon absorption-based upconversion and circularly polarized luminescence.

    Science.gov (United States)

    Cruz, Carlos M; Márquez, Irene R; Mariz, Inês F A; Blanco, Victor; Sánchez-Sánchez, Carlos; Sobrado, Jesús M; Martín-Gago, José A; Cuerva, Juan M; Maçôas, Ermelinda; Campaña, Araceli G

    2018-04-28

    Herein we describe a distorted ribbon-shaped nanographene exhibiting unprecedented combination of optical properties in graphene-related materials, namely upconversion based on two-photon absorption (TPA-UC) together with circularly polarized luminescence (CPL). The compound is a graphene molecule of ca. 2 nm length and 1 nm width with edge defects that promote the distortion of the otherwise planar lattice. The edge defects are an aromatic saddle-shaped ketone unit and a [5]carbohelicene moiety. This system is shown to combine two-photon absorption and circularly polarized luminescence and a remarkably long emission lifetime of 21.5 ns. The [5]helicene is responsible for the chiroptical activity while the push-pull geometry and the extended network of sp 2 carbons are factors favoring the nonlinear absorption. Electronic structure theoretical calculations support the interpretation of the results.

  10. Analytical calculation of geometric and chromatic aberrations in a bi-potential electrostatic and bell-shaped magnetic combined lens

    International Nuclear Information System (INIS)

    Ximen Jiye; Liu Zhixiong

    2000-01-01

    In the present paper, Gaussian optical property in the bi-potential electrostatic and the bell-shaped magnetic combined lens - a new theoretical model first proposed in electron optics - has been thoroughly studied. Meanwhile, based on electron optical canonical aberration theory, analytical formulas of third-order geometrical and first-order chromatic aberration coefficients and their computational results have first been derived for this bi-potential electrostatic and bell-shaped magnetic combined lens. It is to emphasized that this theoretical study can be used to estimate third-order geometric and first-order chromatic aberrations and to provide a theoretical criterion for numerical computation in a rotationally symmetric electromagnetic lens

  11. The γ-ray self-absorption correction for sources with random geometrical shape

    International Nuclear Information System (INIS)

    Lu Xiangdong

    2003-01-01

    The regularities followed by γ-ray self-absorption corrections of nuclear materials under common geometry conditions have been studied by the numeric simulation. Many models were adopted. The results show that the self-absorption corrections are not related to shape and size of the sources. The method is succinct, and the conclusions are useful for actual situation and offer bases for data analyzing. The component of a sample is analyzed by means of the self-absorption correction

  12. 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.

  13. 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

    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....... 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......We discuss the benefits and limitations of optical time-division multiplexing 22 (OTDM) techniques based on the optical generation of a periodic train of sinc pulses for 23 wavelength-division multiplexing (WDM) transmission at high baud rates. It is shown 24 how the modulated OTDM spectrum...

  14. 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.

  15. 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.

  16. Generation, combination and extension of random set approximations to coherent lower and upper probabilities

    International Nuclear Information System (INIS)

    Hall, Jim W.; Lawry, Jonathan

    2004-01-01

    Random set theory provides a convenient mechanism for representing uncertain knowledge including probabilistic and set-based information, and extending it through a function. This paper focuses upon the situation when the available information is in terms of coherent lower and upper probabilities, which are encountered, for example, when a probability distribution is specified by interval parameters. We propose an Iterative Rescaling Method (IRM) for constructing a random set with corresponding belief and plausibility measures that are a close outer approximation to the lower and upper probabilities. The approach is compared with the discrete approximation method of Williamson and Downs (sometimes referred to as the p-box), which generates a closer approximation to lower and upper cumulative probability distributions but in most cases a less accurate approximation to the lower and upper probabilities on the remainder of the power set. Four combination methods are compared by application to example random sets generated using the IRM

  17. 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.

  18. Combining Generalized Phase Contrast with matched filtering into a versatile beam shaping approach

    DEFF Research Database (Denmark)

    Glückstad, Jesper; Palima, Darwin

    2010-01-01

    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...... manipulation, high-speed sorting and other parallel spatial light applications [1]....

  19. Correlated continuous time random walks: combining scale-invariance with long-range memory for spatial and temporal dynamics

    International Nuclear Information System (INIS)

    Schulz, Johannes H P; Chechkin, Aleksei V; Metzler, Ralf

    2013-01-01

    Standard continuous time random walk (CTRW) models are renewal processes in the sense that at each jump a new, independent pair of jump length and waiting time are chosen. Globally, anomalous diffusion emerges through scale-free forms of the jump length and/or waiting time distributions by virtue of the generalized central limit theorem. Here we present a modified version of recently proposed correlated CTRW processes, where we incorporate a power-law correlated noise on the level of both jump length and waiting time dynamics. We obtain a very general stochastic model, that encompasses key features of several paradigmatic models of anomalous diffusion: discontinuous, scale-free displacements as in Lévy flights, scale-free waiting times as in subdiffusive CTRWs, and the long-range temporal correlations of fractional Brownian motion (FBM). We derive the exact solutions for the single-time probability density functions and extract the scaling behaviours. Interestingly, we find that different combinations of the model parameters lead to indistinguishable shapes of the emerging probability density functions and identical scaling laws. Our model will be useful for describing recent experimental single particle tracking data that feature a combination of CTRW and FBM properties. (paper)

  20. The Structure of a Thermophilic Kinase Shapes Fitness upon Random Circular Permutation.

    Science.gov (United States)

    Jones, Alicia M; Mehta, Manan M; Thomas, Emily E; Atkinson, Joshua T; Segall-Shapiro, Thomas H; Liu, Shirley; Silberg, Jonathan J

    2016-05-20

    Proteins can be engineered for synthetic biology through circular permutation, a sequence rearrangement in which native protein termini become linked and new termini are created elsewhere through backbone fission. However, it remains challenging to anticipate a protein's functional tolerance to circular permutation. Here, we describe new transposons for creating libraries of randomly circularly permuted proteins that minimize peptide additions at their termini, and we use transposase mutagenesis to study the tolerance of a thermophilic adenylate kinase (AK) to circular permutation. We find that libraries expressing permuted AKs with either short or long peptides amended to their N-terminus yield distinct sets of active variants and present evidence that this trend arises because permuted protein expression varies across libraries. Mapping all sites that tolerate backbone cleavage onto AK structure reveals that the largest contiguous regions of sequence that lack cleavage sites are proximal to the phosphotransfer site. A comparison of our results with a range of structure-derived parameters further showed that retention of function correlates to the strongest extent with the distance to the phosphotransfer site, amino acid variability in an AK family sequence alignment, and residue-level deviations in superimposed AK structures. Our work illustrates how permuted protein libraries can be created with minimal peptide additions using transposase mutagenesis, and it reveals a challenge of maintaining consistent expression across permuted variants in a library that minimizes peptide additions. Furthermore, these findings provide a basis for interpreting responses of thermophilic phosphotransferases to circular permutation by calibrating how different structure-derived parameters relate to retention of function in a cellular selection.

  1. Multimodal biometric method that combines veins, prints, and shape of a finger

    Science.gov (United States)

    Kang, Byung Jun; Park, Kang Ryoung; Yoo, Jang-Hee; Kim, Jeong Nyeo

    2011-01-01

    Multimodal biometrics provides high recognition accuracy and population coverage by using various biometric features. A single finger contains finger veins, fingerprints, and finger geometry features; by using multimodal biometrics, information on these multiple features can be simultaneously obtained in a short time and their fusion can outperform the use of a single feature. This paper proposes a new finger recognition method based on the score-level fusion of finger veins, fingerprints, and finger geometry features. This research is novel in the following four ways. First, the performances of the finger-vein and fingerprint recognition are improved by using a method based on a local derivative pattern. Second, the accuracy of the finger geometry recognition is greatly increased by combining a Fourier descriptor with principal component analysis. Third, a fuzzy score normalization method is introduced; its performance is better than the conventional Z-score normalization method. Fourth, finger-vein, fingerprint, and finger geometry recognitions are combined by using three support vector machines and a weighted SUM rule. Experimental results showed that the equal error rate of the proposed method was 0.254%, which was lower than those of the other methods.

  2. Control of periodic surface structures on silicon by combined temporal and polarization shaping of femtosecond laser pulses

    Science.gov (United States)

    Fraggelakis, F.; Stratakis, E.; Loukakos, P. A.

    2018-06-01

    We demonstrate the capability to exercise advanced control on the laser-induced periodic surface structures (LIPSS) on silicon by combining the effect of temporal shaping, via tuning the interpulse temporal delay between double femtosecond laser pulses, along with the independent manipulation of the polarization state of each of the individual pulses. For this, cross-polarized (CP) as well as counter-rotating (CR) double circularly polarized pulses have been utilized. The pulse duration was 40 fs and the central wavelength of 790 nm. The linearly polarized double pulses are generated by a modified Michelson interferometer allowing the temporal delay between the pulses to vary from Δτ = -80 ps to Δτ = +80 ps with an accuracy of 0.2 fs. We show the significance of fluence balance between the two pulse components and its interplay with the interpulse delay and with the order of arrival of the individually polarized pulse components of the double pulse sequence on the final surface morphology. For the case of CR pulses we found that when the pulses are temporally well separated the surface morphology attains no axial symmetry. But strikingly, when the two CP pulses temporally overlap, we demonstrate, for the first time in our knowledge, the detrimental effect that the phase delay has on the ripple orientation. Our results provide new insight showing that temporal pulse shaping in combination with polarization control gives a powerful tool for drastically controlling the surface nanostructure morphology.

  3. Theoretical study on the combined systems of peanut-shaped carbon nanotubes encapsulated in single-walled carbon nanotubes

    International Nuclear Information System (INIS)

    Wang, Guo; Huang, Yuanhe

    2012-01-01

    Highlights: ► The combined systems of peanut-shaped carbon nanotubes encapsulated in single-walled carbon nanotubes are investigated. ► The band structures and related electronic properties are calculated by using crystal orbital method. ► The carrier mobility and mean free path are evaluated under the deformation potential theory. -- Abstract: The combined systems of peanut-shaped carbon nanotubes encapsulated in both semiconducting and metallic single-walled carbon nanotubes are investigated by using self-consistent field crystal orbital method based on the density functional theory. The investigation indicates that the interaction between the two constituents is mainly contributed by the π orbitals. The encapsulation does not change the semiconducting or metallic nature of the single-walled carbon nanotubes, but significantly changes the band dispersion and decreases the frontier band width of the metallic one. The carrier mobility and mean free path of the metallic single-walled carbon nanotube increase greatly after the encapsulation. The calculated mobilities have the order of 10 3 cm 2 V −1 s −1 for both of the semiconducting and metallic double-walled carbon nanotubes.

  4. 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.

  5. 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 life satisfaction, mood, and sleep quality at most observation times (P fibromyalgia and to enhance the quality of life in affected individuals. © 2016 World Institute of Pain.

  6. Randomized combined modality trial in small cell carcinoma of the lung

    International Nuclear Information System (INIS)

    Maurer, L.H.; Tulloh, M.; Weiss, R.B.; Blom, J.; Leone, L.; Glidewell, O.; Pajak, T.F.

    1980-01-01

    A randomized trial of combined modality therapy employing combination chemotherapy (cyclophosphamide (CTX) and methotrexate (MTX), CTX, MTX and Vincristine (VCR) and CTX, VCR, and high-dose MTX with citrovorum rescue), and radiation therapy was compared to cyclophosphamide and radiation therapy in 258 patients with pulmonary small cell carcinoma. Patients were also randomized: (1) to determine the effects of prophylactic whole brain irradiation; (2) to establish the effects of maintenance chemotherapy. Survival, frequency of response, and site of relapse were different in patients with limited disease (LD) (disease confined to lung, mediastinum, and supraclavicular lymph nodes) when compared with disease spread beyond these sites (extensive disease) (ED). No survival advantage was seen in LD when combination chemotherapy was employed, although the frequency of complete remission was greater with three drugs than with one or two drugs (48% vs 32%). In ED frequency of response was greater for three drugs than for one and two drugs (60% vs 40%), but there was no survival advantage. The median survival time for complete responders was similar for limited or extensive disease (12.1 months), but 23.8% were alive at 24 months with LD compared to none with ED. Maintenance chemotherapy significantly prolonged survival by 16.8 months with 33% alive at 24 months compared to 9% who were unmaintained. Prophylactic whole brain irradiation prevented brain metastases with only 4% developing this complication as compared to 18% of control subjects, but did not influence survival

  7. Multi-kW coherent combining of fiber lasers seeded with pseudo random phase modulated light

    Science.gov (United States)

    Flores, Angel; Ehrehreich, Thomas; Holten, Roger; Anderson, Brian; Dajani, Iyad

    2016-03-01

    We report efficient coherent beam combining of five kilowatt-class fiber amplifiers with a diffractive optical element (DOE). Based on a master oscillator power amplifier (MOPA) configuration, the amplifiers were seeded with pseudo random phase modulated light. Each non-polarization maintaining fiber amplifier was optically path length matched and provides approximately 1.2 kW of near diffraction-limited output power (measured M2polarization control. A low power sample of the combined beam after the DOE provided an error signal for active phase locking which was performed via Locking of Optical Coherence by Single-Detector Electronic-Frequency Tagging (LOCSET). After phase stabilization, the beams were coherently combined via the 1x5 DOE. A total combined output power of 4.9 kW was achieved with 82% combining efficiency and excellent beam quality (M2splitter loss was 5%. Similarly, losses due in part to non-ideal polarization, ASE content, uncorrelated wavefront errors, and misalignment errors contributed to the efficiency reduction.

  8. 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....

  9. A combination of independent transcriptional regulators shapes bacterial virulence gene expression during infection.

    Directory of Open Access Journals (Sweden)

    Samuel A Shelburne

    2010-03-01

    Full Text Available Transcriptional regulatory networks are fundamental to how microbes alter gene expression in response to environmental stimuli, thereby playing a critical role in bacterial pathogenesis. However, understanding how bacterial transcriptional regulatory networks function during host-pathogen interaction is limited. Recent studies in group A Streptococcus (GAS suggested that the transcriptional regulator catabolite control protein A (CcpA influences many of the same genes as the control of virulence (CovRS two-component gene regulatory system. To provide new information about the CcpA and CovRS networks, we compared the CcpA and CovR transcriptomes in a serotype M1 GAS strain. The transcript levels of several of the same genes encoding virulence factors and proteins involved in basic metabolic processes were affected in both DeltaccpA and DeltacovR isogenic mutant strains. Recombinant CcpA and CovR bound with high-affinity to the promoter regions of several co-regulated genes, including those encoding proteins involved in carbohydrate and amino acid metabolism. Compared to the wild-type parental strain, DeltaccpA and DeltacovRDeltaccpA isogenic mutant strains were significantly less virulent in a mouse myositis model. Inactivation of CcpA and CovR alone and in combination led to significant alterations in the transcript levels of several key GAS virulence factor encoding genes during infection. Importantly, the transcript level alterations in the DeltaccpA and DeltacovRDeltaccpA isogenic mutant strains observed during infection were distinct from those occurring during growth in laboratory medium. These data provide new knowledge regarding the molecular mechanisms by which pathogenic bacteria respond to environmental signals to regulate virulence factor production and basic metabolic processes during infection.

  10. Toward combining thematic information with hierarchical multiscale segmentations using tree Markov random field model

    Science.gov (United States)

    Zhang, Xueliang; Xiao, Pengfeng; Feng, Xuezhi

    2017-09-01

    It has been a common idea to produce multiscale segmentations to represent the various geographic objects in high-spatial resolution remote sensing (HR) images. However, it remains a great challenge to automatically select the proper segmentation scale(s) just according to the image information. In this study, we propose a novel way of information fusion at object level by combining hierarchical multiscale segmentations with existed thematic information produced by classification or recognition. The tree Markov random field (T-MRF) model is designed for the multiscale combination framework, through which the object type is determined as close as the existed thematic information. At the same time, the object boundary is jointly determined by the thematic labels and the multiscale segments through the minimization of the energy function. The benefits of the proposed T-MRF combination model include: (1) reducing the dependence of segmentation scale selection when utilizing multiscale segmentations; (2) exploring the hierarchical context naturally imbedded in the multiscale segmentations. The HR images in both urban and rural areas are used in the experiments to show the effectiveness of the proposed combination framework on these two aspects.

  11. Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

    Science.gov (United States)

    Margolis, Karen L; O'Connor, Patrick J; Morgan, Timothy M; Buse, John B; Cohen, Robert M; Cushman, William C; Cutler, Jeffrey A; Evans, Gregory W; Gerstein, Hertzel C; Grimm, Richard H; Lipkin, Edward W; Narayan, K M Venkat; Riddle, Matthew C; Sood, Ajay; Goff, David C

    2014-06-01

    To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50-0.91), BP (HR 0.74; 95% CI 0.55-1.00), or both (HR 0.71; 95% CI 0.52-0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02-1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group. In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality. © 2014 by the American Diabetes Association.

  12. Secular changes in Earth's shape and surface mass loading derived from combinations of reprocessed global GPS networks

    Science.gov (United States)

    Booker, David; Clarke, Peter J.; Lavallée, David A.

    2014-09-01

    The changing distribution of surface mass (oceans, atmospheric pressure, continental water storage, groundwater, lakes, snow and ice) causes detectable changes in the shape of the solid Earth, on time scales ranging from hours to millennia. Transient changes in the Earth's shape can, regardless of cause, be readily separated from steady secular variation in surface mass loading, but other secular changes due to plate tectonics and glacial isostatic adjustment (GIA) cannot. We estimate secular station velocities from almost 11 years of high quality combined GPS position solutions (GPS weeks 1,000-1,570) submitted as part of the first international global navigation satellite system service reprocessing campaign. Individual station velocities are estimated as a linear fit, paying careful attention to outliers and offsets. We remove a suite of a priori GIA models, each with an associated set of plate tectonic Euler vectors estimated by us; the latter are shown to be insensitive to the a priori GIA model. From the coordinate time series residuals after removing the GIA models and corresponding plate tectonic velocities, we use mass-conserving continental basis functions to estimate surface mass loading including the secular term. The different GIA models lead to significant differences in the estimates of loading in selected regions. Although our loading estimates are broadly comparable with independent estimates from other satellite missions, their range highlights the need for better, more robust GIA models that incorporate 3D Earth structure and accurately represent 3D surface displacements.

  13. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy : A Double-Blinded Randomized Study

    NARCIS (Netherlands)

    Thijs, Karin M; Zwerver, Johannes; Backx, Frank J G; Steeneken, Victor; Rayer, Stephan; Groenenboom, Petra; Moen, Maarten H

    OBJECTIVE: To evaluate the effectiveness of a combined treatment of focused shockwave therapy (ESWT) and eccentric training compared with sham-shockwave therapy (placebo) and eccentric training in participants with patellar tendinopathy (PT) after 24 weeks. DESIGN: Randomized controlled trial.

  14. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy : A Double-Blinded Randomized Study

    NARCIS (Netherlands)

    Thijs, Karin M.; Zwerver, Johannes; Backx, Frank J. G.; Steeneken, Victor; Rayer, Stephan; Groenenboom, Petra; Moen, Maarten H.

    2017-01-01

    OBJECTIVE: To evaluate the effectiveness of a combined treatment of focused shockwave therapy (ESWT) and eccentric training compared with sham-shockwave therapy (placebo) and eccentric training in participants with patellar tendinopathy (PT) after 24 weeks. DESIGN: Randomized controlled trial.

  15. Combined Effects of Ezetimibe and Phytosterols on Cholesterol Metabolism: A Randomized, Controlled Feeding Study in Humans

    Science.gov (United States)

    Lin, Xiaobo; Racette, Susan B.; Lefevre, Michael; Ma, Lina; Spearie, Catherine Anderson; Steger-May, Karen; Ostlund, Richard E.

    2011-01-01

    Background Both ezetimibe and phytosterols inhibit cholesterol absorption. We tested the hypothesis that ezetimibe combined with phytosterols is more effective than ezetimibe alone in altering cholesterol metabolism. Methods and Results Twenty-one mildly hypercholesterolemic subjects completed a randomized, double-blind, placebo-controlled, triple crossover study. Each subject received a phytosterol-controlled diet plus (1) ezetimibe placebo + phytosterol placebo, (2) 10 mg ezetimibe/day + phytosterol placebo, and (3) 10 mg ezetimibe/day + 2.5 g phytosterols/day, for 3 weeks each. All meals were prepared in a metabolic kitchen. Primary outcomes were intestinal cholesterol absorption, fecal cholesterol excretion, and LDL cholesterol levels. The combined treatment resulted in significantly lower intestinal cholesterol absorption (598 mg/day, 95% CI 368 to 828) relative to control (2161 mg/day, 1112 to 3209) and ezetimibe alone (1054 mg/day, 546 to 1561, both P phytosterols averaged 129 (95% CI: 116 to 142), 108 (97 to 119), and 101 (90 to 112) mg/dL (P phytosterols to ezetimibe significantly enhanced the effects of ezetimibe on whole-body cholesterol metabolism and plasma LDL cholesterol. The large cumulative action of combined dietary and pharmacologic treatment on cholesterol metabolism emphasizes the potential importance of dietary phytosterols as adjunctive therapy for the treatment of hypercholesterolemia. PMID:21768544

  16. Combining numerical simulations with time-domain random walk for pathogen risk assessment in groundwater

    Science.gov (United States)

    Cvetkovic, V.; Molin, S.

    2012-02-01

    We present a methodology that combines numerical simulations of groundwater flow and advective transport in heterogeneous porous media with analytical retention models for computing the infection risk probability from pathogens in aquifers. The methodology is based on the analytical results presented in [1,2] for utilising the colloid filtration theory in a time-domain random walk framework. It is shown that in uniform flow, the results from the numerical simulations of advection yield comparable results as the analytical TDRW model for generating advection segments. It is shown that spatial variability of the attachment rate may be significant, however, it appears to affect risk in a different manner depending on if the flow is uniform or radially converging. In spite of the fact that numerous issues remain open regarding pathogen transport in aquifers on the field scale, the methodology presented here may be useful for screening purposes, and may also serve as a basis for future studies that would include greater complexity.

  17. 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.

  18. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study.

    Science.gov (United States)

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-12-01

    Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and 64% were assessed again after 4 years. Measures included anthropometry, fasting blood samples, and a health assessment questionnaire. Participants scored one point for each negative lifestyle factor at baseline: overweight; physical inactivity; high media consumption; little outdoor time; skipping breakfast; and having a parent who has ever smoked, is inactive, or overweight. A CVR score at follow-up was constructed by averaging sex- and age-related z-scores of waist circumference, blood pressure, glucose, inverted high-density lipoprotein, and triglycerides. The age-, sex-, pubertal stage-, and social class-adjusted probabilities (95% confidence interval) for being in the highest CVR score tertile at follow-up for children who had at most one (n = 48), two (n = 64), three (n = 56), four (n = 41), or five or more (n = 14) risky lifestyle factors were 15.4% (8.9-25.3), 24.3% (17.4-32.8), 36.0% (28.6-44.2), 49.8% (38.6-61.0), and 63.5% (47.2-77.2), respectively. Even in childhood, an accumulation of negative lifestyle factors is associated with higher CVR scores after 4 years. These negative lifestyle factors are easy to assess in clinical practice and allow early detection and prevention of CVR in childhood. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  19. Conservative treatment of lateral epicondylitis: brace versus physical therapy or a combination of both: a randomized clinical trial

    NARCIS (Netherlands)

    Struijs, P. A. A.; Kerkhoffs, G. M. M. J.; Assendelft, W. J. J.; van Dijk, C. N.

    2004-01-01

    BACKGROUND: The authors evaluated the effectiveness of brace-only treatment, physical therapy, and the combination of these for patients with tennis elbow. METHODS: Patients were randomized over 3 groups: brace-only treatment, physical therapy, and the combination of these. Main outcome measures

  20. Management of Facial Synkinesis with a Combination of BTX-A and Biofeedback: A Randomized Trial.

    Science.gov (United States)

    Pourmomeny, Abbas Ali; Asadi, Sahar; Cheatsaz, Ahmad

    2015-11-01

    Synkinesis and facial asymmetry due to facial nerve palsy are distressing conditions that affect quality of life. Unfortunately, these sequelae of facial nerve palsy are unresolved. The aim of this study was to investigate the efficacy of a combination of biofeedback therapy and botulinum toxin A (BTX-A) injection for the management of synkinesis and asymmetry of facial muscles. Among referrals from three university hospitals, 34 patients with facial synkinesis were divided randomly into two groups. All participants were evaluated using Photoshop software, videotape, and facial grading system (FGS). The first group received a single dose of BTX-A at the start of treatment, while the second group received normal saline as a control. Both groups received electromyography (EMG) biofeedback three times a week for 4 months. The mean FGS values for the BTX group before and after treatment were 55.17 and 74.17, respectively, and those for the biofeedback group were 66.31 and 81.37, respectively. Moreover, it was shown that in both groups oral-ocular and oculo-oral synkinesis decreased significantly after treatment compared with before treatment (PPhotoshop and videotape, these differences were even greater. Despite the decrease in synkinesis in both groups after treatment, there were no significant differences between the two treatment groups (P>0.05). Biofeedback therapy is as effective as the combination of biofeedback and BTX in reducing synkinesis and recovery of facial symmetry in Bell's palsy.

  1. Artemisinin versus Nonartemisinin Combination Therapy for Uncomplicated Malaria: Randomized Clinical Trials from Four Sites in Uganda

    Science.gov (United States)

    Yeka, Adoke; Banek, Kristin; Bakyaita, Nathan; Staedke, Sarah G; Kamya, Moses R; Talisuna, Ambrose; Kironde, Fred; Nsobya, Samuel L; Kilian, Albert; Slater, Madeline; Reingold, Arthur; Rosenthal, Philip J; Wabwire-Mangen, Fred; Dorsey, Grant

    2005-01-01

    Background Drug resistance in Plasmodium falciparum poses a major threat to malaria control. Combination antimalarial therapy including artemisinins has been advocated recently to improve efficacy and limit the spread of resistance, but artemisinins are expensive and relatively untested in highly endemic areas. We compared artemisinin-based and other combination therapies in four districts in Uganda with varying transmission intensity. Methods and Findings We enrolled 2,160 patients aged 6 mo or greater with uncomplicated falciparum malaria. Patients were randomized to receive chloroquine (CQ) + sulfadoxine-pyrimethamine (SP); amodiaquine (AQ) + SP; or AQ + artesunate (AS). Primary endpoints were the 28-d risks of parasitological failure either unadjusted or adjusted by genotyping to distinguish recrudescence from new infections. A total of 2,081 patients completed follow-up, of which 1,749 (84%) were under the age of 5 y. The risk of recrudescence after treatment with CQ + SP was high, ranging from 22% to 46% at the four sites. This risk was significantly lower (p AQ + SP or AQ + AS (7%–18% and 4%–12%, respectively). Compared to AQ + SP, AQ + AS was associated with a lower risk of recrudescence but a higher risk of new infection. The overall risk of repeat therapy due to any recurrent infection (recrudescence or new infection) was similar at two sites and significantly higher for AQ + AS at the two highest transmission sites (risk differences = 15% and 16%, pAQ + AS was the most efficacious regimen for preventing recrudescence, but this benefit was outweighed by an increased risk of new infection. Considering all recurrent infections, the efficacy of AQ + SP was at least as efficacious at all sites and superior to AQ + AS at the highest transmission sites. The high endemicity of malaria in Africa may impact on the efficacy of artemisinin-based combination therapy. The registration number for this trial is ISRCTN67520427 (http

  2. Controlling the Laser Guide Star power density distribution at Sodium layer by combining Pre-correction and Beam-shaping

    Science.gov (United States)

    Huang, Jian; Wei, Kai; Jin, Kai; Li, Min; Zhang, YuDong

    2018-06-01

    The Sodium laser guide star (LGS) plays a key role in modern astronomical Adaptive Optics Systems (AOSs). The spot size and photon return of the Sodium LGS depend strongly on the laser power density distribution at the Sodium layer and thus affect the performance of the AOS. The power density distribution is degraded by turbulence in the uplink path, launch system aberrations, the beam quality of the laser, and so forth. Even without any aberrations, the TE00 Gaussian type is still not the optimal power density distribution to obtain the best balance between the measurement error and temporal error. To optimize and control the LGS power density distribution at the Sodium layer to an expected distribution type, a method that combines pre-correction and beam-shaping is proposed. A typical result shows that under strong turbulence (Fried parameter (r0) of 5 cm) and for a quasi-continuous wave Sodium laser (power (P) of 15 W), in the best case, our method can effectively optimize the distribution from the Gaussian type to the "top-hat" type and enhance the photon return flux of the Sodium LGS; at the same time, the total error of the AOS is decreased by 36% with our technique for a high power laser and poor seeing.

  3. 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.

  4. Does the bracket–ligature combination affect the amount of orthodontic space closure over three months? A randomized controlled trial

    OpenAIRE

    Wong, Henry; Collins, Jill; Tinsley, David; Sandler, Jonathan; Benson, Philip

    2013-01-01

    Objective: To investigate the effect of bracket–ligature combination on the amount of orthodontic space closure over three months. Design: Randomized clinical trial with three parallel groups. Setting: A hospital orthodontic department (Chesterfield Royal Hospital, UK). Participants: Forty-five patients requiring upper first premolar extractions. Methods: Informed consent was obtained and participants were randomly allocated into one of three groups: (1) conventional pre-adjusted edgewise bra...

  5. 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.

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

    International Nuclear Information System (INIS)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying

    2017-01-01

    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.

  7. Effects of combined endurance and resistance training in Amyotrophic Lateral Sclerosis: A pilot, randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Antonio Merico

    2018-03-01

    Full Text Available Based on available evidence, muscle strengthening and cardiovascular exercises can help maintain function and not adversely affect the progression of disease in patients with ALS. However, this evidence is not sufficiently detailed to recommend a specific exercise prescription. The purpose of this project was to assess clinical outcomes of a combined exercise programme to increase knowledge of rehabilitation in ALS patients. 38 ALS patients were assigned randomly to two groups: one group underwent a specific exercise programme (ALS-EP based on a moderate aerobic workout and isometric contractions, and the second group followed a standard neuromotor rehabilitation treatment. Objective evaluation consisted of cardiovascular measures, muscle strength and fatigue. Some positive effects of physical activity on ALS patients were found. Among the benefits, an overall improvement of functional independence in all patients, independently of the type of exercise conducted was seen. In addition, improvements in muscle power, oxygen consumption and fatigue were specifically observed in the ALS-EP group, all hallmarks of a training effect for the specific exercises. In conclusion, moderate intensity exercise is beneficial in ALS, helping in avoiding deconditioning and muscle atrophy resulting from progressive inactivity.

  8. Artemisinin versus nonartemisinin combination therapy for uncomplicated malaria: randomized clinical trials from four sites in Uganda.

    Directory of Open Access Journals (Sweden)

    Adoke Yeka

    2005-07-01

    Full Text Available BACKGROUND: Drug resistance in Plasmodium falciparum poses a major threat to malaria control. Combination antimalarial therapy including artemisinins has been advocated recently to improve efficacy and limit the spread of resistance, but artemisinins are expensive and relatively untested in highly endemic areas. We compared artemisinin-based and other combination therapies in four districts in Uganda with varying transmission intensity. METHODS AND FINDINGS: We enrolled 2,160 patients aged 6 mo or greater with uncomplicated falciparum malaria. Patients were randomized to receive chloroquine (CQ + sulfadoxine-pyrimethamine (SP; amodiaquine (AQ + SP; or AQ + artesunate (AS. Primary endpoints were the 28-d risks of parasitological failure either unadjusted or adjusted by genotyping to distinguish recrudescence from new infections. A total of 2,081 patients completed follow-up, of which 1,749 (84% were under the age of 5 y. The risk of recrudescence after treatment with CQ + SP was high, ranging from 22% to 46% at the four sites. This risk was significantly lower (p < 0.01 after AQ + SP or AQ + AS (7%-18% and 4%-12%, respectively. Compared to AQ + SP, AQ + AS was associated with a lower risk of recrudescence but a higher risk of new infection. The overall risk of repeat therapy due to any recurrent infection (recrudescence or new infection was similar at two sites and significantly higher for AQ + AS at the two highest transmission sites (risk differences = 15% and 16%, p < 0.003. CONCLUSION: AQ + AS was the most efficacious regimen for preventing recrudescence, but this benefit was outweighed by an increased risk of new infection. Considering all recurrent infections, the efficacy of AQ + SP was at least as efficacious at all sites and superior to AQ + AS at the highest transmission sites. The high endemicity of malaria in Africa may impact on the efficacy of artemisinin-based combination therapy. The registration number for this trial is ISRCTN

  9. A generic, geometric cocalibration method for a combined system of fluorescence molecular tomography and microcomputed tomography with arbitrarily shaped objects

    International Nuclear Information System (INIS)

    Fu Jianwei; Yang Xiaoquan; Wang Kan; Luo Qingming; Gong Hui

    2011-01-01

    Purpose: A combined system of fluorescence molecular tomography and microcomputed tomography (FMT and mCT) can provide molecular and anatomical information of small animals in a single study with intrinsically coregistered images. The anatomical information provided by the mCT subsystem is commonly used as a reference to locate the fluorophore distribution or as a priori structural information to improve the performance of FMT. Therefore, the transformation between the coordinate systems of the subsystem needs to be determined in advanced. Methods: A cocalibration method for the combined system of FMT and mCT is proposed. First, linear models are adopted to describe the galvano mirrors and the charge-coupled device (CCD) camera in the FMT subsystem. Second, the position and orientation of the galvano mirrors are determined with the input voltages of the galvano mirrors and the markers, whose positions are predetermined. The position, orientation and normalized pixel size of the CCD camera are obtained by analysing the projections of a point-like marker at different positions. Finally, the orientation and position of sources and the corresponding relationship between the detectors and their projections on the image plane are predicted. Because the positions of the markers are acquired with mCT, the registration of the FMT and mCT could be realized by direct image fusion. Results: The accuracy and consistency of this method in the presence of noise is evaluated by computer simulation. Next, a practical implementation for an experimental FMT and mCT system is carried out and validated. The maximum prediction error of the source positions on the surface of a cylindrical phantom is within 0.375 mm and that of the projections of a point-like marker is within 0.629 pixel. Finally, imaging experiments of the fluorophore distribution in a cylindrical phantom and a phantom with a complex shape demonstrate the feasibility of the proposed method. Conclusions: This method is

  10. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jaillette, Emmanuelle; Brunin, Guillaume; Girault, Christophe; Zerimech, Farid; Chiche, Arnaud; Broucqsault-Dedrie, Céline; Fayolle, Cyril; Minacori, Franck; Alves, Isabelle; Barrailler, Stephanie; Robriquet, Laurent; Tamion, Fabienne; Delaporte, Emmanuel; Thellier, Damien; Delcourte, Claire; Duhamel, Alain; Nseir, Saad

    2015-09-25

    Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs. BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015. ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).

  11. 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

  12. 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…

  13. 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

  14. Effects of Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Auwal Abdullahi

    2018-01-01

    Full Text Available Background. Constraint-induced movement therapy (CIMT is effective in improving motor outcomes after stroke. However, its existing protocols are resource-intensive and difficult to implement. The aim of this study is to design an easier CIMT protocol using number of repetitions of shaping practice. Method. The study design was randomized controlled trial. Participants within 4 weeks after stroke were recruited at Murtala Muhammad Specialist Hospital. They were randomly assigned to groups A, B, C, and D. Group A received 3 hours of traditional therapy. Groups B, C, and D received modified CIMT consisting of 3 hours of shaping practice per session, 300 repetitions of shaping practice in 3 sessions, and 600 repetitions of shaping practice in 3 sessions per day, respectively, and constraint for 90% of the waking hours. All treatment protocols were administered 5 times per week for 4 weeks. The primary outcome was measured using upper limb Fugl-Meyer assessment, while the secondary outcome was measured using motor activity log, Wolf Motor Function Test, and upper limb self-efficacy test at baseline, 2 weeks, and 4 weeks after intervention. Result. There were 48 participants 4 weeks after intervention. The result showed that there was no significant difference between groups at baseline (p>0.05. Within-group improvements attained minimal clinically important difference (MCID in modified CIMT and 300 repetitions and 600 repetitions groups. Conclusion. Number of repetitions of shaping practice significantly improved motor function, real-world arm use, and upper limb self-efficacy after stroke. Therefore, it seems to be a simple alternative for the use of number of hours. Trial Registration. This trial is registered with Pan African Clinical Trial Registry (registration number: PACTR201610001828172 (date of registration: 21/10/2016.

  15. Scattering from randomly oriented scatterers of arbitrary shape in the low-frequency limit with application to vegetation

    Science.gov (United States)

    Karam, M. A.; Fung, A. K.

    1984-01-01

    A general theory of intensity scattering from small particles of arbitrary shape was developed based on the radiative transfer theory. Upon permitting the particles to orient in accordance with any prescribed distribution, scattering models can be derived. By making an appropriate choice of the particle size, the scattering model may be used to estimate scattering from media such as snow, vegetation and sea ice. For the purpose of illustration only comparisons with measurements from a vegetated medium are shown. The difference in scattering between elliptic and circular shaped leaves is demonstrated. In the low frequency limit, the major factors on backscattering from vegetation are found to be the depth of the vegetation layer and the orientation distribution of the leaves. The shape of the leaf is of secondary importance.

  16. 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.

  17. 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.

  18. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  20. Implementation, recruitment and baseline characteristics: A randomized trial of combined treatments for smoking cessation and weight control

    Directory of Open Access Journals (Sweden)

    Terry Bush

    2017-09-01

    Full Text Available Background: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. Methods: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management. Study participants were recruited via tobacco quitlines from August 5, 2013 to December 15, 2014. Results: Statistical analysis on baseline data was conducted in 2015/2016. Among 5082 potentially eligible callers to a tobacco quitline, 2540 were randomized (50% of eligible. Compared with individuals eligible but not randomized, those randomized were significantly more likely to be female (65.7% vs 54.5%, p < 0.01, overweight or obese (76.3% vs 62.5%, p < 0.01, more confident in quitting (p < 0.01, more addicted (first cigarette within 5 min: 50.0% vs 44.4%, p < 0.01, and have a chronic disease (28.6% vs. 24.4%, p < 0.01. Randomized groups were not statistically significantly different on demographics, tobacco or weight variables. Two-thirds of participants were female and white with a mean age of 43. Conclusions: Adding weight management interventions to tobacco cessation quitlines was feasible and acceptable to smokers. If successful for cessation and weight outcomes, a combined intervention may provide a treatment approach for addressing weight gain with smoking cessation through tobacco quitlines. Trial registration: Clinicaltrials.gov NCT01867983. Keywords: Smoking, Weight gain, Quitlines, Simultaneous, Sequential

  1. [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 cupping and medicine on fibromyalgia syndrome is superior to that of the simple acupuncture combined with cupping or the simple medicine.

  2. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy: A Double-Blinded Randomized Study

    OpenAIRE

    Thijs, Karin M.; Zwerver, Johannes; Backx, Frank J. G.; Steeneken, Victor; Rayer, Stephan; Groenenboom, Petra; Moen, Maarten H.

    2017-01-01

    OBJECTIVE: To evaluate the effectiveness of a combined treatment of focused shockwave therapy (ESWT) and eccentric training compared with sham-shockwave therapy (placebo) and eccentric training in participants with patellar tendinopathy (PT) after 24 weeks. DESIGN: Randomized controlled trial. SETTING: Sports medicine departments of a university hospital and a general hospital in the Netherlands. PARTICIPANTS: Fifty-two physically active male and female participants with a clinical diagnosis ...

  3. Expected number of real roots for random linear combinations of orthogonal polynomials associated with radial weights

    OpenAIRE

    Bayraktar, Turgay

    2017-01-01

    In this note, we obtain asymptotic expected number of real zeros for random polynomials of the form $$f_n(z)=\\sum_{j=0}^na^n_jc^n_jz^j$$ where $a^n_j$ are independent and identically distributed real random variables with bounded $(2+\\delta)$th absolute moment and the deterministic numbers $c^n_j$ are normalizing constants for the monomials $z^j$ within a weighted $L^2$-space induced by a radial weight function satisfying suitable smoothness and growth conditions.

  4. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study.

    Science.gov (United States)

    Dellis, Athanasios E; Papatsoris, Athanasios G; Keeley, Francis X; Bamias, Aristotelis; Deliveliotis, Charalambos; Skolarikos, Andreas A

    2017-01-01

    To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents. After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p tamsulosin or solifenacin expressed significantly lower urinary (p tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.

  5. The study of combining Latin Hypercube Sampling method and LU decomposition method (LULHS method) for constructing spatial random field

    Science.gov (United States)

    WANG, P. T.

    2015-12-01

    Groundwater modeling requires to assign hydrogeological properties to every numerical grid. Due to the lack of detailed information and the inherent spatial heterogeneity, geological properties can be treated as random variables. Hydrogeological property is assumed to be a multivariate distribution with spatial correlations. By sampling random numbers from a given statistical distribution and assigning a value to each grid, a random field for modeling can be completed. Therefore, statistics sampling plays an important role in the efficiency of modeling procedure. Latin Hypercube Sampling (LHS) is a stratified random sampling procedure that provides an efficient way to sample variables from their multivariate distributions. This study combines the the stratified random procedure from LHS and the simulation by using LU decomposition to form LULHS. Both conditional and unconditional simulations of LULHS were develpoed. The simulation efficiency and spatial correlation of LULHS are compared to the other three different simulation methods. The results show that for the conditional simulation and unconditional simulation, LULHS method is more efficient in terms of computational effort. Less realizations are required to achieve the required statistical accuracy and spatial correlation.

  6. 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.

  7. Image compression-encryption algorithms by combining hyper-chaotic system with discrete fractional random transform

    Science.gov (United States)

    Gong, Lihua; Deng, Chengzhi; Pan, Shumin; Zhou, Nanrun

    2018-07-01

    Based on hyper-chaotic system and discrete fractional random transform, an image compression-encryption algorithm is designed. The original image is first transformed into a spectrum by the discrete cosine transform and the resulting spectrum is compressed according to the method of spectrum cutting. The random matrix of the discrete fractional random transform is controlled by a chaotic sequence originated from the high dimensional hyper-chaotic system. Then the compressed spectrum is encrypted by the discrete fractional random transform. The order of DFrRT and the parameters of the hyper-chaotic system are the main keys of this image compression and encryption algorithm. The proposed algorithm can compress and encrypt image signal, especially can encrypt multiple images once. To achieve the compression of multiple images, the images are transformed into spectra by the discrete cosine transform, and then the spectra are incised and spliced into a composite spectrum by Zigzag scanning. Simulation results demonstrate that the proposed image compression and encryption algorithm is of high security and good compression performance.

  8. A Method of Reducing Random Drift in the Combined Signal of an Array of Inertial Sensors

    Science.gov (United States)

    2015-09-30

    stability of the collective output, Bayard et al, US Patent 6,882,964. The prior art methods rely upon the use of Kalman filtering and averaging...including scale-factor errors, quantization effects, temperature effects, random drift, and additive noise. A comprehensive account of all of these

  9. Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

    Science.gov (United States)

    Furst, Daniel E; Venkatraman, Manorama M; McGann, Mary; Manohar, P Ram; Booth-LaForce, Cathryn; Sarin, Reshmi; Sekar, P G; Raveendran, K G; Mahapatra, Anita; Gopinath, Jidesh; Kumar, P R Krishna

    2011-06-01

    To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

  10. 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

    2018-04-01

    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 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.

  11. [The randomized controlled trial of influences of T shape approach on the function of knee joint in the treatment of proximal tibial fractures].

    Science.gov (United States)

    Peng, Wei-xiong; Zhang, Zhi; Liang, Jie-hong

    2008-04-01

    To investigate the clinical value of T shape approach in the treatment of proximal tibial fractures. One handrend and thirteen patients of proximal tibial fractures were randomly divided into two groups. Group A: 62 cases underwent the traditional exposure approach. According to Schatzker classification,the cases of II to VI type was 25, 10, 16, 6, 5 respectively. Group B:51 cases underwent T shape approach ahead of knee joint, the cases of II to VI type was 21, 8, 13, 5, 4 respectively. All data were analyzed by SPSS 10.0 to compare operation time, blood loss, duration of hospitalization, healing time, the time of osseous union and complications after operation. Sixty patients in group A and 50 patients in group B were followed-up from 12 to 24 months. (1) Operation time:group B was longer than A (P time:group B was shorter. (4) Mean time of osseous union: 48 group B was shorter. Function of knee: group B was better than group A. (Complication: group B was less than group A. As compared with traditional exposure approach, T shape approach of knee joint had advantages of small scar, fewer complications, faster union of fracture and earlier recovery of joint function. The approach is valuable for the treatment of proximal tibial fractures.

  12. Randomized study: small cell anaplastic lung cancer treated by combination chemotherapy and adjuvant radiotherapy

    International Nuclear Information System (INIS)

    Fox, R.M.; Woods, R.L.; Brodie, G.N.; Tattersall, M.H.N.

    1980-01-01

    Chemotherapy and primary site radiation therapy were compared to chemotherapy alone in a randomized study of 125 patients with small cell cancer of the lung. The sites of initial relapse, as well as disease free and overall survival were analyzed. Radiotherapy to the primary site reduced the rate of local relapse, but median survival was not prolonged in patients with either limited or extensive disease, when the radiation therapy-chemotherapy group was compared to the group that received chemotherapy alone

  13. 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.

  14. Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Francavilla, Ruggiero; Polimeno, Lorenzo; Demichina, Antonella; Maurogiovanni, Giovanni; Principi, Beatrice; Scaccianoce, Giuseppe; Ierardi, Enzo; Russo, Francesco; Riezzo, Giuseppe; Di Leo, Alfredo; Cavallo, Luciano; Francavilla, Antonio; Versalovic, James

    2014-01-01

    The goals of this study were to investigate the role of a new probiotic preparation (Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475) in Helicobacter pylori infection. Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis, prevent antibiotic-associated side effects, and increase the eradication rate. This is a prospective, double-blind, randomized, placebo-controlled study in a tertiary care setting. A total of 100 H. pylori-positive naive patients received either L. reuteri combination (2×10 Colony Forming Units) or placebo during a 3-phase study (pre-eradication, eradication, and follow-up). All underwent C urea breath test (C-UBT), blood assessments of gastrin-17 (G17), endoscopy, and the Gastrointestinal Symptom Rating Scale. Eradication was confirmed by C-UBT 8 weeks after the completion of therapy. Fifty patients were allocated in each group. During pre-eradication period, C-UBT δ decreased by 13% in L. reuteri combination as compared with a 4% increase in placebo (-13.2±34% vs. 4.3±27%; Preuteri combination (6.8±2.9 vs. 4±3.1; Preuteri combination as compared with placebo-reported side effects (40.9% vs. 62.8%; Preuteri combination (28% vs. 12%; Preuteri combination and 65.9% in placebo (P=NS). L. reuteri combination increased eradication rate by 9.1% (odds ratio: 1.5). L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth, and when administered with eradication therapy, it determines a significant reduction in antibiotic-associated side effects. Moreover, L. reuteri combination was able to decrease serum G17 levels and to (not significantly) increase the H. pylori-eradication rate.

  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. 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...... and sixteen patients were randomly assigned to either group A (paracetamol+placebo x 2), group B (paracetamol+pregabalin+placebo) or group C (paracetamol+pregabalin+dexamethasone). According to randomization and preoperatively, patients received paracetamol 1000 mg, pregabalin 300 mg, dexamethasone 8 mg...... or placebo. General anaesthesia was performed. Postoperative pain treatment was paracetamol 1000 mg x 4 and patient-controlled intravenous morphine, 2.5 mg bolus. Nausea was treated with ondansetron. Morphine consumption, pain score (visual analogue scale) at rest and during mobilization, nausea, sedation...

  17. 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.

  18. 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.

  19. Automated grain extraction and classification by combining improved region growing segmentation and shape descriptors in electromagnetic mill classification system

    Science.gov (United States)

    Budzan, Sebastian

    2018-04-01

    In this paper, the automatic method of grain detection and classification has been presented. As input, it uses a single digital image obtained from milling process of the copper ore with an high-quality digital camera. The grinding process is an extremely energy and cost consuming process, thus granularity evaluation process should be performed with high efficiency and time consumption. The method proposed in this paper is based on the three-stage image processing. First, using Seeded Region Growing (SRG) segmentation with proposed adaptive thresholding based on the calculation of Relative Standard Deviation (RSD) all grains are detected. In the next step results of the detection are improved using information about the shape of the detected grains using distance map. Finally, each grain in the sample is classified into one of the predefined granularity class. The quality of the proposed method has been obtained by using nominal granularity samples, also with a comparison to the other methods.

  20. 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.

  1. 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

    with tramadol. During 4-week treatment periods, daily oral doses of either GRT9906 120-240 mg, or placebo, or tramadol 200-400 mg were given. These were separated by 1-week washout periods. The primary endpoint was the average pain intensity (average of daily current pain intensity over the last 3 days of each......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...... treatment period rated on a 0 to 10-point numeric rating scale). One hundred seventeen patients were enrolled and 64 were randomized to one of six treatment sequences. Forty-seven patients qualified for the per protocol analysis. GRT9906 reduced average pain intensity by 2.1 points compared with a reduction...

  2. Combination therapy versus gemcitabine monotherapy in the treatment of elderly pancreatic cancer: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Jin JM

    2018-03-01

    Full Text Available Jiamin Jin, Chunbo Teng, Tao Li College of Life Science, Northeast Forestry University, Harbin, China Purpose: We aimed to compare the efficacy of combination therapy versus gemcitabine monotherapy in the treatment of elderly pancreatic cancer (PC by using a meta-analysis.Materials and methods: Databases were searched to identify relevant clinical trials. Hazard ratios (HRs were used to estimate overall survival (OS and progression-free survival (PFS. Statistical analyses were conducted by using Comprehensive Meta Analysis software (version 2.0.Results: A total of 3,401 elderly PC patients from six randomized controlled trials were included for analysis. In comparison with gemcitabine alone, combination therapy in elderly PC patients did not significantly improve OS (HR 0.93, 95% CI: 0.82–1.06, p=0.29. Sub-group analysis according to treatment regimens showed that combined chemotherapy significantly improved OS in comparison with gemcitabine alone (HR 0.73, 95% CI: 0.56–0.94, p=0.016, while gemcitabine plus targeted agents did not improve OS (HR 1.02, 95% CI: 0.87–1.19, p=0.83. Additionally, gemcitabine plus nab-paclitaxel significantly improved PFS in elderly PC patients (HR 0.69, 95% CI: 0.52–0.91, p=0.009 in comparison with gemcitabine alone. No publication bias was detected by Begg’s and Egger’s tests for OS.Conclusion: The findings of this study suggest that combined chemotherapy, but not for gemcitabine plus targeted agents, could be recommended for elderly PC patients due to its survival benefits. Further studies are still needed to assess the treatment tolerance of combination chemotherapy in these patient populations. Keywords: pancreatic cancer, elderly, randomized controlled trials, meta-analysis, targeted agents

  3. Effects of Combining a Brief Cognitive Intervention with Transcranial Direct Current Stimulation on Pain Tolerance: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Powers, Abigail; Madan, Alok; Hilbert, Megan; Reeves, Scott T; George, Mark; Nash, Michael R; Borckardt, Jeffrey J

    2018-04-01

    Cognitive behavioral therapy has been shown to be effective for treating chronic pain, and a growing literature shows the potential analgesic effects of minimally invasive brain stimulation. However, few studies have systematically investigated the potential benefits associated with combining approaches. The goal of this pilot laboratory study was to investigate the combination of a brief cognitive restructuring intervention and transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in affecting pain tolerance. Randomized, double-blind, placebo-controlled laboratory pilot. Medical University of South Carolina. A total of 79 healthy adult volunteers. Subjects were randomized into one of six groups: 1) anodal tDCS plus a brief cognitive intervention (BCI); 2) anodal tDCS plus pain education; 3) cathodal tDCS plus BCI; 4) cathodal tDCS plus pain education; 5) sham tDCS plus BCI; and 6) sham tDCS plus pain education. Participants underwent thermal pain tolerance testing pre- and postintervention using the Method of Limits. A significant main effect for time (pre-post intervention) was found, as well as for baseline thermal pain tolerance (covariate) in the model. A significant time × group interaction effect was found on thermal pain tolerance. Each of the five groups that received at least one active intervention outperformed the group receiving sham tDCS and pain education only (i.e., control group), with the exception of the anodal tDCS + education-only group. Cathodal tDCS combined with the BCI produced the largest analgesic effect. Combining cathodal tDCS with BCI yielded the largest analgesic effect of all the conditions tested. Future research might find stronger interactive effects of combined tDCS and a cognitive intervention with larger doses of each intervention. Because this controlled laboratory pilot employed an acute pain analogue and the cognitive intervention did not authentically represent cognitive behavioral

  4. Effect of Kangaroo care combined with music on the mother–premature neonate attachment: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Maryam Vahdati

    2017-01-01

    Full Text Available Background: 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. Materials and Methods: 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. Results: 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. Conclusions: 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.

  5. Random Forest Approach to QSPR Study of Fluorescence Properties Combining Quantum Chemical Descriptors and Solvent Conditions.

    Science.gov (United States)

    Chen, Chia-Hsiu; Tanaka, Kenichi; Funatsu, Kimito

    2018-04-22

    The Quantitative Structure - Property Relationship (QSPR) approach was performed to study the fluorescence absorption wavelengths and emission wavelengths of 413 fluorescent dyes in different solvent conditions. The dyes included the chromophore derivatives of cyanine, xanthene, coumarin, pyrene, naphthalene, anthracene and etc., with the wavelength ranging from 250 nm to 800 nm. An ensemble method, random forest (RF), was employed to construct nonlinear prediction models compared with the results of linear partial least squares and nonlinear support vector machine regression models. Quantum chemical descriptors derived from density functional theory method and solvent information were also used by constructing models. The best prediction results were obtained from RF model, with the squared correlation coefficients [Formula: see text] of 0.940 and 0.905 for λ abs and λ em , respectively. The descriptors used in the models were discussed in detail in this report by comparing the feature importance of RF.

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

    OpenAIRE

    Yan, Ying; Suo, Bin

    2017-01-01

    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 b...

  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. High electron mobility through the edge states in random networks of c-axis oriented wedge-shaped GaN nanowalls grown by molecular beam epitaxy

    International Nuclear Information System (INIS)

    Bhasker, H. P.; Dhar, S.; Sain, A.; Kesaria, Manoj; Shivaprasad, S. M.

    2012-01-01

    Transport and optical properties of random networks of c-axis oriented wedge-shaped GaN nanowalls grown spontaneously on c-plane sapphire substrates through molecular beam epitaxy are investigated. Our study suggests a one dimensional confinement of carriers at the top edges of these connected nanowalls, which results in a blue shift of the band edge luminescence, a reduction of the exciton-phonon coupling, and an enhancement of the exciton binding energy. Not only that, the yellow luminescence in these samples is found to be completely suppressed even at room temperature. All these changes are highly desirable for the enhancement of the luminescence efficiency of the material. More interestingly, the electron mobility through the network is found to be significantly higher than that is typically observed for GaN epitaxial films. This dramatic improvement is attributed to the transport of electrons through the edge states formed at the top edges of the nanowalls.

  9. 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.

  10. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

    Science.gov (United States)

    Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

    2015-05-01

    Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

  11. 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.

  12. Combination of dexmedetomidine and remifentanil for labor analgesia: A double-blinded, randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Waleed Abdalla

    2015-01-01

    Full Text Available Background: Satisfactory analgesia is of great importance in the labor. The clinical efficacy and side effects of remifentanil in the management of labor pain had been evaluated. Dexmedetomidine (DMET demonstrates an antinociceptive effect in visceral pain conditions. Aims of the study were to assess whether the combination of DMET with remifentanil would produce a synergistic effect that results in lower analgesic requirements. Furthermore, whether this combination would have less maternal and neonatal adverse effects. Patients and Methods: Sixty American Society of Anesthesiologists physical status I-II pregnant women had been enrolled into this study. All were full term (37-40 weeks′ gestation, singleton fetus with cephalic presentation in the first stage of spontaneous labor. They were divided into two groups group (I Patient-controlled IV remifentanil analgesia (bolus dose 0.25 μg/kg, lockout interval 2 min increased by 0.25 μg/kg to a maximum bolus dose 1 μg/kg in addition to a loading dose of DMET 1 μg/kg over 20 min, followed by infusion at 0.5 μg/kg/h group (II Patient-controlled IV remifentanil analgesia (PCA (bolus dose 0.25 μg/kg, lockout interval 2 min increased by 0.25 μg/kg to a maximum bolus dose 1 μg/kg in addition to a the same volume of normal saline as a loading dose, followed by a continuous saline infusion. Visual analog scale score, maternal, and fetal complications and patients′ satisfaction were recorded. Results: Patients receiving a combination of PCA remifentanil and DMET had a lower pain score compared with remifentanil alone in the second stage of labor (P = 0.001. The Total consumption of remifentanil was reduced by 53.3% in group I. There was an increased incidence of maternal complications and a lower patient satisfaction score in group II. Conclusion: DMET has an opioid sparing effect; a combination of DMET and remifentanil produces a synergistic effect that results in lower analgesic requirements

  13. Analysis of random response of structure with uncertain parameters. Combination of substructure synthesis method and hierarchy method

    International Nuclear Information System (INIS)

    Iwatsubo, Takuzo; Kawamura, Shozo; Mori, Hiroyuki.

    1995-01-01

    In this paper, the method to obtain the random response of a structure with uncertain parameters is proposed. The proposed method is a combination of the substructure synthesis method and the hierarchy method. The concept of the proposed method is that the hierarchy equation of each substructure is obtained using the hierarchy method, and the hierarchy equation of the overall structure is obtained using the substructure synthesis method. Using the proposed method, the reduced order hierarchy equation can be obtained without analyzing the original whole structure. After the calculation of the mean square value of response, the reliability analysis can be carried out based on the first passage problem and Poisson's excursion rate. As a numerical example of structure, a simple piping system is considered. The damping constant of the support is considered as the uncertainty parameter. Then the random response is calculated using the proposed method. As a result, the proposed method is useful to analyze the random response in terms of the accuracy, computer storage and calculation time. (author)

  14. 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.

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

    Science.gov (United States)

    Turek, Dušan; Klimeš, Pavel; Mazura, Pavel; Brzobohatý, Břetislav

    2014-01-01

    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.

  16. Shapes of isolated domains and field induced evolution of regular and random 2D domain structures in LiNbO3 and LiTaO3

    International Nuclear Information System (INIS)

    Chernykh, A.; Shur, V.; Nikolaeva, E.; Shishkin, E.; Shur, A.; Terabe, K.; Kurimura, S.; Kitamura, K.; Gallo, K.

    2005-01-01

    The variety of the shapes of isolated domains, revealed in congruent and stoichiometric LiTaO 3 and LiNbO 3 by chemical etching and visualized by optical and scanning probe microscopy, was obtained by computer simulation. The kinetic nature of the domain shape was clearly demonstrated. The kinetics of domain structure with the dominance of the growth of the steps formed at the domain walls as a result of domain merging was investigated experimentally in slightly distorted artificial regular two-dimensional (2D) hexagonal domain structure and random natural one. The artificial structure has been realized in congruent LiNbO 3 by 2D electrode pattern produced by photolithography. The polarization reversal in congruent LiTaO 3 was investigated as an example of natural domain growth limited by merging. The switching process defined by domain merging was studied by computer simulation. The crucial dependence of the switching kinetics on the nuclei concentration has been revealed

  17. Combining drug and music therapy in patients with moderate Alzheimer's disease: a randomized study.

    Science.gov (United States)

    Giovagnoli, Anna Rita; Manfredi, Valentina; Schifano, Letizia; Paterlini, Chiara; Parente, Annalisa; Tagliavini, Fabrizio

    2018-06-01

    Alzheimer's disease (AD) can impair language, but active music therapy (AMT) and memantine (M) can improve communication. This study aimed to clarify whether adding AMT to M may improve language in comparison with drugs alone in patients with moderate AD on stable therapy with acetylcholinesterase inhibitors (AchEI). Forty-five AD patients treated with stable dose of AchEI were randomized to receive AMT plus M 20 mg/day or M 20 mg/day for 24 weeks. The Severe Impairment Battery-Language (SIB-l), SIB, Mini Mental State Examination, Neuropsychiatric Inventory (NPI), Lubben Social Network Scale, Activities of Daily Living, and Instrumental Activities of Daily Living scores at baseline and 12 and 24 weeks assessed language (primary variable) and overall cognitive, psycho-behavior, social, and functional aspects (secondary variables). The SIB-l showed a stabilization of the baseline condition in both groups, in the absence of between-group differences. The NPI depression and appetite scores significantly improved in the M-AMT group. Moreover, significantly less patients in the M-AMT group than those in the M group showed worsening of the NPI total score. Daily activities, social relationships, and overall cognitive performance did not deteriorate. In patients with moderate AD, AMT added to pharmacotherapy has no further benefits for language in comparison with pharmacotherapy alone. However, this integrated treatment can improve the psycho-behavioral profile.

  18. Midportion achilles tendon microcirculation after intermittent combined cryotherapy and compression compared with cryotherapy alone: a randomized trial.

    Science.gov (United States)

    Knobloch, Karsten; Grasemann, Ruth; Spies, Marcus; Vogt, Peter M

    2008-11-01

    The effect of combined cryotherapy/compression versus cryotherapy alone on the Achilles tendon is undetermined. Standardized combined cryotherapy/compression changes in midportion Achilles tendon microcirculation are superior to those with cryotherapy during intermittent application. Controlled laboratory study. Sixty volunteers were randomized for either combined cryotherapy/compression (Cryo/Cuff, DJO Inc, Vista, California: n = 30; 32 +/- 11 years) or cryotherapy alone (KoldBlue, TLP Industries, Kent, United Kingdom: n = 30; 33 +/- 12 years) with intermittent 3 x 10-minute application. Midportion Achilles tendon microcirculation was determined (O2C, LEA Medizintechnik, Giessen, Germany). Both Cryo/Cuff and KoldBlue significantly reduced superficial and deep capillary tendon blood flow within the first minute of application (43 +/- 46 arbitrary units [AU] vs 10 +/- 19 AU and 42 +/- 46 AU vs 12 +/- 10 AU; P = .0001) without a significant difference throughout all 3 applications. However, during recovery, superficial and deep capillary blood flow was reestablished significantly faster using Cryo/Cuff (P = .023). Tendon oxygen saturation was reduced in both groups significantly (3 minutes Cryo/Cuff: 36% +/- 20% vs 16% +/- 15%; KoldBlue: 42% +/- 19% vs 28% +/- 20%; P cryotherapy and compression with significantly increased tendon oxygen saturation during recovery in contrast to cryotherapy alone. Both regimens lead to a significant amelioration of tendinous venous outflow. Combined cryotherapy and compression is superior to cryotherapy alone regarding the Achilles tendon microcirculation. Further studies in tendinopathy and tendon rehabilitation are warranted to elucidate its value regarding functional issues.

  19. [Effects of granisetron/lidocaine combination on propofol injection-induced pain: a double-blind randomized clinical trial].

    Science.gov (United States)

    Ma, Yu-shan; Lin, Xue-mei; Zhou, Jun

    2009-05-01

    To investigate the alleviation effect of vein pretreatment and granisetron/lidocaine combination on propofol injection-induced pain. Two hundreds patients scheduled for gynaecological laparoscopic operations were randomly divided into four groups: control group (group I), lidocaine group (group II), granisetron group (group III) and granisetron/lidocaine combination group (group IV), with 50 patients in each group. The patients in the above four groups received placebo (saline), lidocaine 20 mg, granisetron 2 mg and granisetron 2 mg plus lidocaine intravenously respectively. The patients were injected with one-forth of scheduled propofol via a dorsal hand vein after one minute of venous occlusion. The pain during the injection of propofol was evaluated. Pain occurred in 84% of patients in the control group, 46% in the lidocaine group, 52% in the granisetron group and 24% in the granisetron/lidocaine combination group. There was a significant reduction in pain incidence in the three experimental groups compared with the control group (Pgranisetron/lidocaine combination group than in the control group (Pgranisetron/lidocaine may be effective not only in attenuating pains during i.v. injection of propofol, but also in preventing postoperative nausea, vomiting and shivering.

  20. 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.

  1. Effect of progestin vs. combined oral contraceptive pills on lactation: A double-blind randomized controlled trial

    Science.gov (United States)

    Espey, Eve; Ogburn, Tony; Leeman, Larry; Singh, Rameet; Schrader, Ronald

    2013-01-01

    Objective To estimate the effect of progestin-only vs. combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation and patient satisfaction with breastfeeding and contraceptive method. Methods In this randomized controlled trial, postpartum breastfeeding women who desired oral contraceptives were assigned to progestin-only vs. combined hormonal contraceptive pills. At two and eight weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length and head circumference were assessed at eight weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation and satisfaction were completed at 3-7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using chi-square tests, Fisher’s Exact test, or two-sample t-tests as appropriate. Results Breastfeeding continuation rates, contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. Conclusions Choice of combined or progestin-only birth control pills administered two weeks postpartum did not adversely affect breastfeeding continuation. PMID:22143258

  2. 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.

  3. 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.

  4. 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.

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

    Science.gov (United States)

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

    2018-06-01

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

  6. Foot shape and its effect on functioning in Royal Australian Air Force recruits. Part 2: Pilot, randomized, controlled trial of orthotics in recruits with flat feet.

    Science.gov (United States)

    Esterman, Adrian; Pilotto, Louis

    2005-07-01

    As part of a larger study of the effect of foot shape on functioning, 47 Royal Australian Air Force recruits with flexible flat feet who were embarking on a 10-week basic training course took part in a randomized controlled trial of orthotic therapy. In particular, recruits were assigned at random to an untreated group or a group that received Australian Orthotics Laboratory, three-quarter-length, flexible, shoe inserts. The groups were assessed at baseline and week 8. Outcome measures included pain, injury, foot health, and quality of life. The untreated group (n = 22) had a greater proportion of heavier recruits than did the treated group (n = 25). There were no significant differences in outcome measures at baseline. Only one-half of the group assigned to orthotic therapy wore the orthotics most or all of the time. At the end of the trial, although the results were not statistically significant, those who were provided with orthotics and wore them had the least lower limb pain and the best general foot health and quality of life. Notably, none of the recruits who wore their orthotics most or all of the time sustained a training injury.

  7. Body shaping with acoustic wave therapy AWT(®)/EPAT(®): randomized, controlled study on 14 subjects.

    Science.gov (United States)

    Adatto, Maurice A; Adatto-Neilson, Robin; Novak, Pavel; Krotz, Alexander; Haller, Gerd

    2011-12-01

    Reduction of localised adiposities by non invasive means is a very frequent request among the female and male population. The objective of this study is to demonstrate the efficacy and safety of AWT(®), combining two different mechanical waves, planar AWT and radial AWT during the same session, in volume reduction of saddle bags in women. Treatment was performed on the saddle bag areas of 14 female patients, with the CELLACTOR(®) SC1 (Storz Medical AG, Tägerwilen, Switzerland) using extracorporeal pulse activation technology, EPAT(®). This device includes two handpieces, the C-ACTOR(®) and the D-ACTOR(®). Within 4 weeks, eight AWT(®) treatment sessions have been performed with both applicators. Follow-up visits were performed 1, 4 and 12 weeks after the last treatment. Measurements with the ultrasound system clearly demonstrate a significant diminution in the subcutaneous fat layer thickness and a reduction of the averaged circumference of thighs. This study, although performed on a small number of patients, tends to show the safety and efficacy of AWT(®) in treating localized fat areas in a non-invasive way. There is also an additional benefit for patients in reducing the cellulite appearance and improving the skin firmness at the same time by using AWT(®).

  8. Dynamical implications of sample shape for avalanches in 2-dimensional random-field Ising model with saw-tooth domain wall

    Science.gov (United States)

    Tadić, Bosiljka

    2018-03-01

    We study dynamics of a built-in domain wall (DW) in 2-dimensional disordered ferromagnets with different sample shapes using random-field Ising model on a square lattice rotated by 45 degrees. The saw-tooth DW of the length Lx is created along one side and swept through the sample by slow ramping of the external field until the complete magnetisation reversal and the wall annihilation at the open top boundary at a distance Ly. By fixing the number of spins N =Lx ×Ly = 106 and the random-field distribution at a value above the critical disorder, we vary the ratio of the DW length to the annihilation distance in the range Lx /Ly ∈ [ 1 / 16 , 16 ] . The periodic boundary conditions are applied in the y-direction so that these ratios comprise different samples, i.e., surfaces of cylinders with the changing perimeter Lx and height Ly. We analyse the avalanches of the DW slips between following field updates, and the multifractal structure of the magnetisation fluctuation time series. Our main findings are that the domain-wall lengths materialised in different sample shapes have an impact on the dynamics at all scales. Moreover, the domain-wall motion at the beginning of the hysteresis loop (HLB) probes the disorder effects resulting in the fluctuations that are significantly different from the large avalanches in the central part of the loop (HLC), where the strong fields dominate. Specifically, the fluctuations in HLB exhibit a wide multi-fractal spectrum, which shifts towards higher values of the exponents when the DW length is reduced. The distributions of the avalanches in this segments of the loops obey power-law decay and the exponential cutoffs with the exponents firmly in the mean-field universality class for long DW. In contrast, the avalanches in the HLC obey Tsallis density distribution with the power-law tails which indicate the new categories of the scale invariant behaviour for different ratios Lx /Ly. The large fluctuations in the HLC, on the other

  9. Randomized trial of amino acid mixture combined with physical activity promotion for abdominal fat reduction in overweight adults.

    Science.gov (United States)

    Ueda, Keisuke; Sasai, Hiroyuki; Tsujimoto, Takehiko; Sanbongi, Chiaki; Ikegami, Shuji; Kobayashi, Hiroyuki; Shioya, Nobuhiko; Suzuki, Satoru; Nakata, Yoshio

    2018-01-01

    The purpose of this study was to test the efficacy of arginine, alanine, and phenylalanine mixture (A-mix) ingestion at 1,500 mg/day in combination with the promotion of physical activity for abdominal fat reduction in overweight adults. A placebo-controlled, double-blind, parallel-group, randomized trial for 12 weeks combined with a 4-week follow-up period was conducted at a single center in Minato-ku, Tokyo, Japan, between December 2016 and May 2017. Data were analyzed between June and August 2017. The study participants were 200 overweight adults within the age range of 20-64 years. The participants were randomly assigned to the A-mix group (n=100) or a placebo group (n=100) and were administered 500 mL of test beverage containing 1,500 or 0 mg of A-mix, respectively, for 12 weeks. All participants maintained a physically active lifestyle between week 0 and week 12 through monthly sessions of physical activity. The primary outcomes were the 12-week changes in the abdominal total, subcutaneous, and visceral fat areas, as assessed by computed tomography. Of the 200 enrolled participants, 199 (99%) accomplished the 12-week intervention and 4-week follow-up period. The per-protocol-based analysis for 194 participants demonstrated that the abdominal total fat area decreased significantly in the A-mix group compared with that in the placebo group (difference, 10.0 cm 2 ; 95% confidence interval [CI]: 0.4-19.6 cm 2 ; P =0.041). Comparable outcomes were obtained for the abdominal subcutaneous fat area (difference, 7.4 cm 2 ; 95% CI: 0.1-14.7 cm 2 ; P =0.047). No study-related unfavorable events occurred. A-mix supplementation in combination with physical activity promotion facilitated abdominal fat reduction in overweight adults.

  10. 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.

  11. Combined Use of Hyperbaric and Hypobaric Ropivacaine Significantly Improves Hemodynamic Characteristics in Spinal Anesthesia for Caesarean Section: A Prospective, Double-Blind, Randomized, Controlled Study

    OpenAIRE

    Quan, ZheFeng; Tian, Ming; Chi, Ping; Li, Xin; He, HaiLi; Luo, Chao

    2015-01-01

    Purpose 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. Methods 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 heig...

  12. 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

  13. 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 (HbA 1c ), 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), HbA 1c (-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

  14. Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.

    Science.gov (United States)

    Suzuki, Katsuyoshi; Otsuka, Naomi; Hizaki, Hiroko; Hashimoto, Masayo; Kuwayama, Yasuaki

    2018-06-05

    This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM). This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire. In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group. TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores. UMIN Clinical Trials Registry Identifier

  15. 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

  16. [Randomized controlled trials of needle knife therapy combined with rotation traction manipulation for the treatment of cervical spondylotic radiculopathy].

    Science.gov (United States)

    Zhou, Zhong-Liang; Su, Guo-Hong; Zheng, Bao-Zhu; Zuo, Yu-Zhu; Wei, Fu-Liang

    2016-09-25

    To compare the therapeutic effects between needle knife therapy combined with rotation traction manipulation and rotation traction manipulation for the treatment of cervical spondylotic radiculopathy. From November 2013 to June 2015, 80 patients with cervical spondylotic radiculopathy meeting the inclusion criteria were divided into two groups randomly:the control group in which 39 patients were treated with rotation traction manipulation, and the treatment group in which 41 patients were treated with needle knife combined with rotation traction manipulation. The patients in the control group were treated once dayly for 2 weeks, which was 1 course. The patients in the treatment group were treated with needle knife firstly once a week for 2 weeks, which was 1 course;then were treated with the same methods as the patients in the control group. The symptoms, signs score and the therapeutic effects of the two groups before and after treatment were observed. After treatment, symptoms and signs scores declined in both groups( P knife combined with rotation traction manipulation is an effective method for the treatment of cervical spondylotic radiculopathy, which is better than using manipulation method simply. Needle knife therapy has follow advantages:improving local blood circulation, reducing local content of pain substance, increasing production of substances resisting pain, opening channels and collaterals, and make body reaching new static and dynamic balance on the new foundation.

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

    Science.gov (United States)

    Santini, Manuela Favarin; Rosa, Ricardo Abreu da; Ferreira, Maria Beatriz Cardoso; Fischer, Maria Isabel; Souza, Erick Miranda; Só, Marcus Vinícius Reis

    2017-01-01

    Acute periradicular abscess is a condition characterized by the formation and propagation of pus in the periapical tissues and generally associated with debilitating pain. 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. 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. 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. 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.

  18. Randomized trial of amino acid mixture combined with physical activity promotion for abdominal fat reduction in overweight adults

    Directory of Open Access Journals (Sweden)

    Ueda K

    2018-02-01

    Full Text Available Keisuke Ueda,1,2 Hiroyuki Sasai,3 Takehiko Tsujimoto,4 Chiaki Sanbongi,1 Shuji Ikegami,1 Hiroyuki Kobayashi,5 Nobuhiko Shioya,6 Satoru Suzuki,7 Yoshio Nakata5 1Food Science and Technology Research Laboratories, Meiji Co., Ltd, Hachiouji, 2Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, 3Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, 4Faculty of Human Sciences, Shimane University, Matsue, 5Faculty of Medicine, University of Tsukuba, Tsukuba, 6KSO Corporation, Tokyo, 7Shinagawa Season Terrace Health Care Clinic, Tokyo, Japan Purpose: The purpose of this study was to test the efficacy of arginine, alanine, and phenylalanine mixture (A-mix ingestion at 1,500 mg/day in combination with the promotion of physical activity for abdominal fat reduction in overweight adults.Methods: A placebo-controlled, double-blind, parallel-group, randomized trial for 12 weeks combined with a 4-week follow-up period was conducted at a single center in Minato-ku, Tokyo, Japan, between December 2016 and May 2017. Data were analyzed between June and August 2017. The study participants were 200 overweight adults within the age range of 20–64 years. The participants were randomly assigned to the A-mix group (n=100 or a placebo group (n=100 and were administered 500 mL of test beverage containing 1,500 or 0 mg of A-mix, respectively, for 12 weeks. All participants maintained a physically active lifestyle between week 0 and week 12 through monthly sessions of physical activity. The primary outcomes were the 12-week changes in the abdominal total, subcutaneous, and visceral fat areas, as assessed by computed tomography.Results: Of the 200 enrolled participants, 199 (99% accomplished the 12-week intervention and 4-week follow-up period. The per-protocol-based analysis for 194 participants demonstrated that the abdominal total fat area decreased significantly in the A-mix group compared with

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

    Directory of Open Access Journals (Sweden)

    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

  20. Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

    Science.gov (United States)

    Sriprasert, Intira; Suerungruang, Suparerk; Athilarp, Porntip; Matanasarawoot, Anuchart

    2015-01-01

    This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice. PMID:26346199

  1. Randomized trial of electrodynamic microneedle combined with 5% minoxidil topical solution for the treatment of Chinese male Androgenetic alopecia.

    Science.gov (United States)

    Bao, Linlin; Gong, Lin; Guo, Menger; Liu, Taoming; Shi, Anyu; Zong, Haifeng; Xu, Xuegang; Chen, Hongduo; Gao, Xinghua; Li, Yuanhong

    2017-10-13

    In treating androgenetic alopecia, 5% minoxidil is a commonly used topical drug. By using electrodynamic microneedle at the same time may increase absorption of minoxidil and further stimulate hair growth. A 24-week, randomized, evaluator blinded, comparative study was performed to evaluate the efficacy of treating Chinese male androgenetic alopecia using microneedle combined with 5% minoxidil topical solution. Randomized subjects received topical 5% minoxidil (group 1, n = 20), local electrodynamic microneedle treatments (group 2, n = 20), or local electrodynamic microneedle treatments plus topical 5% minoxidil (group 3, n = 20). A total of 12 microneedle treatments were performed every 2 weeks with 2ml 5% minoxidil delivery in group 3 during each microneedle treatment. Patient receiving topical 5% minoxidil applied 1 ml of the solution twice daily over the course of the study. A total of 60 Chinese male subjects with Norwood-Hamilton type III-VI androgenetic alopecia were treated. The mean improvement in total hair density from baseline to 24 weeks was 18.8/cm 2 in group 1, 23.4/cm 2 in group 2, and 38.3/cm 2 in group 3. The hair growth in the 3 groups was significantly different (P = 0.002), but there were no significant differences in toxicity found between the 3 groups. Treatment with microneedle plus topical 5% minoxidil was associated with the best hair growth.

  2. 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

  3. Hyperuniformity, quasi-long-range correlations, and void-space constraints in maximally random jammed particle packings. II. Anisotropy in particle shape.

    Science.gov (United States)

    Zachary, Chase E; Jiao, Yang; Torquato, Salvatore

    2011-05-01

    We extend the results from the first part of this series of two papers by examining hyperuniformity in heterogeneous media composed of impenetrable anisotropic inclusions. Specifically, we consider maximally random jammed (MRJ) packings of hard ellipses and superdisks and show that these systems both possess vanishing infinite-wavelength local-volume-fraction fluctuations and quasi-long-range pair correlations scaling as r(-(d+1)) in d Euclidean dimensions. Our results suggest a strong generalization of a conjecture by Torquato and Stillinger [Phys. Rev. E 68, 041113 (2003)], namely, that all strictly jammed saturated packings of hard particles, including those with size and shape distributions, are hyperuniform with signature quasi-long-range correlations. We show that our arguments concerning the constrained distribution of the void space in MRJ packings directly extend to hard-ellipse and superdisk packings, thereby providing a direct structural explanation for the appearance of hyperuniformity and quasi-long-range correlations in these systems. Additionally, we examine general heterogeneous media with anisotropic inclusions and show unexpectedly that one can decorate a periodic point pattern to obtain a hard-particle system that is not hyperuniform with respect to local-volume-fraction fluctuations. This apparent discrepancy can also be rationalized by appealing to the irregular distribution of the void space arising from the anisotropic shapes of the particles. Our work suggests the intriguing possibility that the MRJ states of hard particles share certain universal features independent of the local properties of the packings, including the packing fraction and average contact number per particle.

  4. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial

    NARCIS (Netherlands)

    Appelhof, Bente C.; Fliers, Eric; Wekking, Ellie M.; Schene, Aart H.; Huyser, Jochanan; Tijssen, Jan G. P.; Endert, Erik; van Weert, Henk C. P. M.; Wiersinga, Wilmar M.

    2005-01-01

    Controversy remains about the value of combined treatment with levothyroxine (LT4) and liothyronine (LT3), compared with LT4 alone in primary hypothyroidism. We compared combined treatment with LT4 and LT3 in a ratio of 5: 1 or 10: 1 with LT4 monotherapy. We conducted a double-blind, randomized,

  5. Combination of microfluidic high-throughput production and parameter screening for efficient shaping of gold nanocubes using Dean-flow mixing.

    Science.gov (United States)

    Thiele, Matthias; Knauer, Andrea; Malsch, Daniéll; Csáki, Andrea; Henkel, Thomas; Köhler, J Michael; Fritzsche, Wolfgang

    2017-04-11

    Metal nanoparticles and their special optical properties, the so-called localized surface plasmon resonance (LSPR), facilitate many applications in various fields. Due to the strong dependency of the LSPR on particle geometry, their synthesis is a challenging and time-consuming procedure especially for non-spherical shapes. In contrast, micromixers offer new experimental approaches and therefore enable the simplification of several processes. By using a zigzag micromixer (Dean-Flow-Mixer, DFM) that induces Dean-flow secondary flow patterns, we theoretically and experimentally show the mixing efficiency. Thus, we highlight the advantages of using it in the multistep synthesis of Au nanoparticles. Based on a narrow size distribution of Au nanocubes and an increased yield in combination with higher reproducibility, we depict the need for and advantage of the DFM to control the incubation times during the growth process. We further show that, by using the DFM, easy and very fast Au nanocube edge length tuning (53 nm, 58 nm, 70 nm and 75 nm) is possible by simultaneously reducing the consumption of the materials by up to 95%. We finally demonstrate the versatile abilities by using the DFM for parameter screening on examples of different halides and accessible bromide in the growth solutions. Therefore, we highlight the optimal concentration for the different growth regimes and the influences on the Au nanoparticle morphology (spheres, cubes and rods) and their defined shaping.

  6. 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

  7. [Flying needling therapy combined with clomiphene for ovulation failure in polycystic ovary syndrome:a randomized controlled trial].

    Science.gov (United States)

    Ma, Hong; Quan, Xiaohong; Chen, Xiuhua; Dong, Ying

    2016-11-12

    To compare the efficacy among the combined treatment of flying needling therapy and clomiphene, the simple application of flying needling therapy and simple clomiphene in the treatment of ovulation failure in polycystic ovary syndrome (PCOS). Ninety patients of PCOS were randomized into a flying needling therapy group, a medication group and a combined treatment group, 30 cases in each one. In the flying needling therapy group, the flying needling therapy was simply applied to Ganshu (BL 18), Shenshu (BL 23), Zhongwan (CV 12), Shuifen (CV 9), Guanyuan (CV 4) and Zhongji (CV 3). The unilateral back- shu points were used alternatively in each treatment. The needles were inserted rapidly with rotation technique and even-needling manipulation. The needles were retained for 30 min. The treatment was given once every two days, 3 times a week. In the medication group, clomiphene was taken orally on the 5th day of menstruation, continuously for 5 days. In the combined treatment group, the flying needling therapy and clomiphene were used in combination. All of the patients were treated for 3 months and followed up for 1 month. The ovulation rates were compared among the three groups. The levels of androgen testosterone were compared before and after treatment. In the combined treatment group, the ovulation rate was 86.2% (100/116), better than 66.7% (80/120) in the flying needling therapy group and 69.6% (78/112) in the medication group (both P medication group ( P >0.05). After treatment, the level of testosterone was reduced in the three groups (all P medication group (both P medication group ( P >0.05). The adverse reactions in the combined treatment group and the flying needling therapy group were lower than those in the medication group (both P <0.05). The flying needling therapy effectively improves in the ovulation failure of PCOS and its effect is similar to clomiphene. The allied treatment of them apparently improves the clinical efficacy and alleviates the adverse

  8. Mapping Sub-Antarctic Cushion Plants Using Random Forests to Combine Very High Resolution Satellite Imagery and Terrain Modelling

    Science.gov (United States)

    Bricher, Phillippa K.; Lucieer, Arko; Shaw, Justine; Terauds, Aleks; Bergstrom, Dana M.

    2013-01-01

    Monitoring changes in the distribution and density of plant species often requires accurate and high-resolution baseline maps of those species. Detecting such change at the landscape scale is often problematic, particularly in remote areas. We examine a new technique to improve accuracy and objectivity in mapping vegetation, combining species distribution modelling and satellite image classification on a remote sub-Antarctic island. In this study, we combine spectral data from very high resolution WorldView-2 satellite imagery and terrain variables from a high resolution digital elevation model to improve mapping accuracy, in both pixel- and object-based classifications. Random forest classification was used to explore the effectiveness of these approaches on mapping the distribution of the critically endangered cushion plant Azorella macquariensis Orchard (Apiaceae) on sub-Antarctic Macquarie Island. Both pixel- and object-based classifications of the distribution of Azorella achieved very high overall validation accuracies (91.6–96.3%, κ = 0.849–0.924). Both two-class and three-class classifications were able to accurately and consistently identify the areas where Azorella was absent, indicating that these maps provide a suitable baseline for monitoring expected change in the distribution of the cushion plants. Detecting such change is critical given the threats this species is currently facing under altering environmental conditions. The method presented here has applications to monitoring a range of species, particularly in remote and isolated environments. PMID:23940805

  9. 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.

  10. Combination of intracostal sutures with muscle flap to decrease post thoracotomy pain: A single blinded randomized clinical trial.

    Science.gov (United States)

    Montazer, Majid; Hashemzade, Shahryar; Gargari, Reza Movassaghi; Ramouz, Ali; Sanaie, Sarvin; Rasihashemi, Seyed Ziaeddin

    2017-01-01

    To assess the efficacy of intercostal nerve protection by intercostal muscle (ICM) flap in post-thoracotomy pain improvement compared to intracostal suturing. In a randomized controlled trial, ninety-four patients undergoing posterolateral thoracotomy surgery were divided into two subgroups. Intracostal sutures in isolation and in combination with ICM flap techniques were used for thoracotomy closure in both groups. Numeric Pain Scale and Visual Pain Scale as pain scores were assessed on the first, second, third, fourth, fifth, sixth and seventh postoperative days and follow-up visits during the 2 nd week, 1 st , 2 nd , 4 th and 6 th months after thoracotomy. Out of 94 patients, 58 were male and 36 were females. While the mean age of patients in intracostal group was 45.3 ± 17.6 years, it was 47.4 ± 16.1 years in intracostal plus ICM flap group. The mean operation time for the first group was 191.0 ± 74.7 minutes, while it was 219.3 ± 68.8 minutes in the second (p>0.05). Numeric rating score and visual pain scale did not demonstrate any significant difference in pain severity on postoperative days and follow-up visits between both groups (p>0.05). Although the trend of pain reduction was significant in each group (p0.001). Intracostal sutures in combination with muscle flap did not reduce postoperative pain in thoracotomy compared with intracostal sutures alone in thoracotomy closure.

  11. 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.

  12. [Post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training: a randomized controlled trial].

    Science.gov (United States)

    Wang, Ling; Liu, Shao-ming; Liu, Min; Li, Bao-jun; Hui, Zhen-liang; Gao, Xiang

    2011-06-01

    To assess the clinical efficacy on post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training. The multi-central randomized controlled study was adopted. One hundred and twenty cases of brain stroke were divided into a speech rehabilitation group (control group), a speech rehabilitation plus acupuncture group (observation group 1) and a speech rehabilitation plus acupuncture combined with psychotherapy group (observation group 2), 40 cases in each one. The rehabilitation training was conducted by a professional speech trainer. In acupuncture treatment, speech function area in scalp acupuncture, Jinjin (EX-HN 12) and Yuye (EX-HN 13) in tongue acupuncture and Lianquan (CV 23) were the basic points. The supplementary points were selected according to syndrome differentiation. Bloodletting method was used in combination with acupuncture. Psychotherapy was applied by the physician in psychiatric department of the hospital. The corresponding programs were used in each group. Examination of Aphasia of Chinese of Beijing Hospital was adopted to observe the oral speech expression, listening comprehension and reading and writing ability. After 21-day treatment, the total effective rate was 92.5% (37/40) in observation group 1, 97.5% (39/40) in observation group 2 and 87.5% (35/40) in control group. The efficacies were similar in comparison among 3 groups. The remarkable effective rate was 15.0% (6/40) in observation group 1, 50.0% (20/40) in observation group 2 and 2.5% (1/40) in control group. The result in observation group 2 was superior to the other two groups (Prehabilitation training is obviously advantageous in the treatment of post-stroke speech disorder.

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

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    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.

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

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    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.

  15. Endurance Enhancement and High Speed Set/Reset of 50 nm Generation HfO2 Based Resistive Random Access Memory Cell by Intelligent Set/Reset Pulse Shape Optimization and Verify Scheme

    Science.gov (United States)

    Higuchi, Kazuhide; Miyaji, Kousuke; Johguchi, Koh; Takeuchi, Ken

    2012-02-01

    This paper proposes a verify-programming method for the resistive random access memory (ReRAM) cell which achieves a 50-times higher endurance and a fast set and reset compared with the conventional method. The proposed verify-programming method uses the incremental pulse width with turnback (IPWWT) for the reset and the incremental voltage with turnback (IVWT) for the set. With the combination of IPWWT reset and IVWT set, the endurance-cycle increases from 48 ×103 to 2444 ×103 cycles. Furthermore, the measured data retention-time after 20 ×103 set/reset cycles is estimated to be 10 years. Additionally, the filamentary based physical model is proposed to explain the set/reset failure mechanism with various set/reset pulse shapes. The reset pulse width and set voltage correspond to the width and length of the conductive-filament, respectively. Consequently, since the proposed IPWWT and IVWT recover set and reset failures of ReRAM cells, the endurance-cycles are improved.

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

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    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.

  17. Combination therapy with milrinone and esmolol for heart protection in patients with severe sepsis: a prospective, randomized trial.

    Science.gov (United States)

    Wang, Zenggeng; Wu, Qinghua; Nie, Xiangbi; Guo, Jinghua; Yang, Chunli

    2015-11-01

    As a β-adrenoceptor antagonist (β-blocker), esmolol can reduce cardiac output and the phosphodiesterase III inhibitor milrinone has been shown to improve heart contractility in patients with septic shock. This study was performed to assess the effects of esmolol combined with milrinone in patients with severe sepsis. This prospective randomized study was conducted in patients with severe sepsis in the intensive care unit of the Jiangxi Provincial People's Hospital (Nanchang, Jiangsu, China) between June 2013 and June 2014. Patients were randomly divided into control (C), milrinone (M), and milrinone-esmolol (ME) groups. The primary outcome was the rate of controlling the heart rate (HR) to achieve target levels. Secondary outcomes included the 28-day survival rate and changes in hemodynamic variables, organ function variables, myocardial injury markers, and the serum levels of proinflammatory factors. A total of 90 patients with severe sepsis were included in this study (30 per group). The HR in the ME group was lower than in the M and C groups after 12 h. The rate of successful HR control during the first 96 h was significantly higher in the ME group (60.0 vs. 33.3 % in the M group, vs. 26.7 % in the C group). Also, patients in the ME group had higher 28-day overall survival compared with the M (Log rank statistic = 5.452; P = 0.020) and C groups (Log rank statistic = 10.206; P = 0.001). Additionally, several variables showed significant improvement in the ME group 96 h after treatment compared with the M and C groups (P milrinone and esmolol could improve cardiac function and the 28-day survival rate in patients with severe sepsis.

  18. Dry weight assessment by combined ultrasound and bioimpedance monitoring in low cardiovascular risk hemodialysis patients: a randomized controlled trial.

    Science.gov (United States)

    Siriopol, Dimitrie; Onofriescu, Mihai; Voroneanu, Luminita; Apetrii, Mugurel; Nistor, Ionut; Hogas, Simona; Kanbay, Mehmet; Sascau, Radu; Scripcariu, Dragos; Covic, Adrian

    2017-01-01

    Fluid overload is associated with adverse outcomes in hemodialysis (HD) patients. The precise assessment of hydration status in HD patients remains a major challenge for nephrologists. Our study aimed to explore whether combining two bedside methods, lung ultrasonography (LUS) and bioimpedance, may provide complementary information to guide treatment in specific HD patients. In total, 250 HD patients from two dialysis units were included in this randomized clinical trial. Patients were randomized 1:1 to have a dry weight assessment based on clinical (control) or LUS with bioimpedance in case of clinical hypovolemia (active)-guided protocol. The primary outcome was to assess the difference between the two groups on a composite of all-cause mortality and first cardiovascular event (CVE)-including death, stroke, and myocardial infarction. During a mean follow-up period was 21.3 ± 5.6 months, there were 54 (21.6%) composite events in the entire population. There was a nonsignificant 9% increase in the risk of this outcome in the active arm (HR = 1.09, 95% CI 0.64-1.86, p = 0.75). Similarly, there were no differences between the two groups when analyzing separately the all-cause mortality and CVE outcomes. However, patients in the active arm had a 19% lower relative risk of pre-dialytic dyspnea (rate ratio-0.81, 95% CI 0.68-0.96), but a 26% higher relative risk of intradialytic cramps (rate ratio-1.26, 95% CI 1.16-1.37). This study shows that a LUS-bioimpedance-guided dry weight adjustment protocol, as compared to clinical evaluation, does not reduce all-cause mortality and/or CVE in HD patients. A fluid management protocol based on bioimpedance with LUS on indication might be a better strategy.

  19. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy: A Double-Blinded Randomized Study.

    Science.gov (United States)

    Thijs, Karin M; Zwerver, Johannes; Backx, Frank J G; Steeneken, Victor; Rayer, Stephan; Groenenboom, Petra; Moen, Maarten H

    2017-03-01

    To evaluate the effectiveness of a combined treatment of focused shockwave therapy (ESWT) and eccentric training compared with sham-shockwave therapy (placebo) and eccentric training in participants with patellar tendinopathy (PT) after 24 weeks. Randomized controlled trial. Sports medicine departments of a university hospital and a general hospital in the Netherlands. Fifty-two physically active male and female participants with a clinical diagnosis of PT (mean age: 28.6 years; range, 18-45) were randomly allocated to the ESWT (n = 22) or sham shockwave (n = 30). Extracorporeal shockwave therapy and sham shockwave were applied in 3 sessions at 1-week intervals with a piezoelectric device. All participants were instructed to perform eccentric exercises (3 sets of 15 repetitions twice a day) for 3 months on a decline board at home. The Victorian Institute of Sport Assessment-Patella (VISA-P) scores (primary), pain scores during functional knee loading tests, and Likert score (secondary) were registered at baseline and at 6, 12, and 24 weeks after the start with the ESWT or sham-shockwave treatment. No significant differences for the primary and secondary outcome measures were found between the groups. In the ESWT/eccentric group, the VISA-P increased from 54.5 ± 15.4 to 70.9 ± 17.8, whereas the VISA-P in the sham-shockwave/eccentric group increased from 58.9 ± 14.6 to 78.2 ± 15.8 (between-group change in VISA-P at 24 weeks -4.8; 95% confidence interval, -12.7 to 3.0, P = 0.150). This study showed no additional effect of 3 sessions ESWT in participants with PT treated with eccentric exercises. The results should be interpreted with caution because of small sample size and considerable loss to follow-up, particularly in the ESWT group.

  20. 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

  1. Does the bracket-ligature combination affect the amount of orthodontic space closure over three months? A randomized controlled trial.

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    Wong, Henry; Collins, Jill; Tinsley, David; Sandler, Jonathan; Benson, Philip

    2013-06-01

    To investigate the effect of bracket-ligature combination on the amount of orthodontic space closure over three months. Randomized clinical trial with three parallel groups. A hospital orthodontic department (Chesterfield Royal Hospital, UK). Forty-five patients requiring upper first premolar extractions. Informed consent was obtained and participants were randomly allocated into one of three groups: (1) conventional pre-adjusted edgewise brackets and elastomeric ligatures; (2) conventional pre-adjusted edgewise brackets and Super Slick(®) low friction elastomeric ligatures; (3) Damon 3MX(®) passive self-ligating brackets. Space closure was undertaken on 0·019×0·025-inch stainless steel archwires with nickel-titanium coil springs. Participants were recalled at four weekly intervals. Upper alginate impressions were taken at each visit (maximum three). The primary outcome measure was the mean amount of space closure in a 3-month period. A one-way ANOVA was undertaken [dependent variable: mean space closure (mm); independent variable: group allocation]. The amount of space closure was very similar between the three groups (1 mm per 28 days); however, there was a wide variation in the rate of space closure between individuals. The differences in the amount of space closure over three months between the three groups was very small and non-significant (P = 0·718). The hypothesis that reducing friction by modifying the bracket/ligature interface increases the rate of space closure was not supported. The major determinant of orthodontic tooth movement is probably the individual patient response.

  2. Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT).

    Science.gov (United States)

    Carvajal, Richard D; Piperno-Neumann, Sophie; Kapiteijn, Ellen; Chapman, Paul B; Frank, Stephen; Joshua, Anthony M; Piulats, Josep M; Wolter, Pascal; Cocquyt, Veronique; Chmielowski, Bartosz; Evans, T R Jeffry; Gastaud, Lauris; Linette, Gerald; Berking, Carola; Schachter, Jacob; Rodrigues, Manuel J; Shoushtari, Alexander N; Clemett, Delyth; Ghiorghiu, Dana; Mariani, Gabriella; Spratt, Shirley; Lovick, Susan; Barker, Peter; Kilgour, Elaine; Lai, Zhongwu; Schwartz, Gary K; Nathan, Paul

    2018-04-20

    Purpose Uveal melanoma is the most common primary intraocular malignancy in adults with no effective systemic treatment option in the metastatic setting. Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective MEK1/2 inhibitor with a short half-life, which demonstrated single-agent activity in patients with metastatic uveal melanoma in a randomized phase II trial. Methods The Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) study was a phase III, double-blind trial ( ClinicalTrial.gov identifier: NCT01974752) in which patients with metastatic uveal melanoma and no prior systemic therapy were randomly assigned (3:1) to selumetinib (75 mg twice daily) plus dacarbazine (1,000 mg/m 2 intravenously on day 1 of every 21-day cycle) or placebo plus dacarbazine. The primary end point was progression-free survival (PFS) by blinded independent central radiologic review. Secondary end points included overall survival and objective response rate. Results A total of 129 patients were randomly assigned to receive selumetinib plus dacarbazine (n = 97) or placebo plus dacarbazine (n = 32). In the selumetinib plus dacarbazine group, 82 patients (85%) experienced a PFS event, compared with 24 (75%) in the placebo plus dacarbazine group (median, 2.8 v 1.8 months); the hazard ratio for PFS was 0.78 (95% CI, 0.48 to 1.27; two-sided P = .32). The objective response rate was 3% with selumetinib plus dacarbazine and 0% with placebo plus dacarbazine (two-sided P = .36). At 37% maturity (n = 48 deaths), analysis of overall survival gave a hazard ratio of 0.75 (95% CI, 0.39 to 1.46; two-sided P = .40). The most frequently reported adverse events (selumetinib plus dacarbazine v placebo plus dacarbazine) were nausea (62% v 19%), rash (57% v 6%), fatigue (44% v 47%), diarrhea (44% v 22%), and peripheral edema (43% v 6%). Conclusion In patients with metastatic uveal melanoma, the combination of selumetinib plus dacarbazine had a tolerable safety

  3. 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

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

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    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

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

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    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

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

    Science.gov (United States)

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

    2018-05-01

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

  7. Influence of combined resistance training and healthy diet on muscle mass in healthy elderly women: a randomized controlled trial.

    Science.gov (United States)

    Strandberg, Emelie; Edholm, Peter; Ponsot, Elodie; Wåhlin-Larsson, Britta; Hellmén, Erik; Nilsson, Andreas; Engfeldt, Peter; Cederholm, Tommy; Risérus, Ulf; Kadi, Fawzi

    2015-10-15

    The delivery of efficient nonpharmacological treatment to prevent the loss of muscle mass in older adults is a major challenge, and information on the combined effects of training and diet is particularly important. Here we aimed to evaluate the effects of 24 wk of resistance training combined with a healthy dietary approach (n-6/n-3 ratio healthy and physically active older women (65-70 years). The three-armed randomized controlled trial included a resistance training + healthy diet group (RT-HD), a resistance training group (RT), and controls (CON). All subjects included in the study were physically active and had low levels of serum inflammatory markers. In accordance with the dietary goals, the n-6/n-3 ratio dietary intake significantly decreased only in RT-HD by 42%. An increase in 1 repetition maximum in leg extension occurred in RT (+20.4%) and RT-HD (+20.8%), but not in CON. Interestingly, leg lean mass significantly increased only in RT-HD (+1.8%). While there were no changes in serum C-reactive protein and IL-6 levels, a significant decrease in serum level of the pro-inflammatory precursor arachidonic acid (-5.3 ± 9.4%) together with an increase in serum n-3 docosahexaenoic acid (+8.3%) occurred only in RT-HD. Altogether, this study demonstrates that the effects of resistance training on muscle mass in healthy older adults can be optimized by the adoption of a healthy diet. Copyright © 2015 the American Physiological Society.

  8. Acupuncture Combined with Hydrotherapy in Diabetes Patients with Mild Lower-Extremity Arterial Disease: A Prospective, Randomized, Nonblinded Clinical Study.

    Science.gov (United States)

    Qi, Zhengqin; Pang, Yan; Lin, Lin; Zhang, Bing; Shao, Juntao; Liu, Xiaodong; Zhang, Xin

    2018-05-08

    BACKGROUND The aim of this pragmatic study was to explore the intervention of acupuncture combined with hydrotherapy and perceived effects in type 2 diabetic patients with recently diagnosed, mild, lower-extremity arterial disease (LEAD) in comparison with a control group. MATERIAL AND METHODS One hundred twenty-six diabetes patients who were diagnosed mild LEAD according to ankle-brachial blood pressure index (ABPI) and peripheral neuropathy symptom were randomly assigned to either an experimental (n=64) or control group (n=62). The experimental group attended and completed (1) a 30-min session of acupuncture in certain selected points, and (2) a 30-min hydrotherapy exercise every 2 days for 15 weeks. The outcome parameters were assessed at baseline, after intervention, and at 6-week follow-up. RESULTS The intervention was associated with an improvement in leg flow conductance and partial physical capacities, including chair-sit-and-reach, the walking impairment questionnaire (WIQ), and physical component summary score (PCS), compared to the control group. The treatment benefits were sustained throughout the 6-week follow-up endpoint. There was no difference in fasting glucose levels, Hb1Ac, blood pressure, or BMI after the intervention. At the endpoint of 6-week follow-up, acupuncture plus hydrotherapy appeared to reduce inflammatory response by decreasing IL-6, TNF-α, malondialdehyde, and SOD, and increasing glutathione. CONCLUSIONS Acupuncture plus hydrotherapy, without significant glycemic-controlling effects in the type 2 diabetic patients with mild LEAD, exerts a measurable benefit in disease-specific physical functions and health-related quality of life. Our results suggest that the combined therapy regulates the inflammatory process and oxidative stress and contributes to immune protection.

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

    Science.gov (United States)

    Espinoza, Felix; Tregnaghi, Miguel; Gentile, Angela; Abarca, Katia; Casellas, Javier; Collard, Alix; Lefevre, Inge; Jacquet, Jeanne-Marie

    2010-10-15

    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). 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. 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. 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. http://www.clinicaltrials.gov NCT00332566.

  10. Fast method to compute scattering by a buried object under a randomly rough surface: PILE combined with FB-SA.

    Science.gov (United States)

    Bourlier, Christophe; Kubické, Gildas; Déchamps, Nicolas

    2008-04-01

    A fast, exact numerical method based on the method of moments (MM) is developed to calculate the scattering from an object below a randomly rough surface. Déchamps et al. [J. Opt. Soc. Am. A23, 359 (2006)] have recently developed the PILE (propagation-inside-layer expansion) method for a stack of two one-dimensional rough interfaces separating homogeneous media. From the inversion of the impedance matrix by block (in which two impedance matrices of each interface and two coupling matrices are involved), this method allows one to calculate separately and exactly the multiple-scattering contributions inside the layer in which the inverses of the impedance matrices of each interface are involved. Our purpose here is to apply this method for an object below a rough surface. In addition, to invert a matrix of large size, the forward-backward spectral acceleration (FB-SA) approach of complexity O(N) (N is the number of unknowns on the interface) proposed by Chou and Johnson [Radio Sci.33, 1277 (1998)] is applied. The new method, PILE combined with FB-SA, is tested on perfectly conducting circular and elliptic cylinders located below a dielectric rough interface obeying a Gaussian process with Gaussian and exponential height autocorrelation functions.

  11. 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

  12. 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.

  13. A randomized trial of combined multidrug chemotherapy and radiotherapy in advanced squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    1986-01-01

    This report concerns the design and results of a randomized prospective trial (SECOG I) in the treatment of advanced Stage III and IV head and neck cancer with radical radiotherapy combined with polychemotherapy. Synchronous administration of chemotherapy and radiotherapy was compared with sequential chemotherapy and radiotherapy and VBM (vincristine, bleomycin and methotrexate) compared with VBM plus 5-fluorouracil in a 2 x 2 standard factorial design. Two-hundred-and-seventy patients were entered and 267 were included in the analysis. Treatment did not present serious problems of toxicity. The addition of 5-fluorouracil to VBM produced a significant improvement in disease-free survival (P=0.04) though not in overall survival. Synchronous chemotherapy was similarly better than sequential chemotherapy, though not significantly so (P=0.1). A new study (SECOG II), based on this was started in February 1984, and one-third of the patients are now being allocated to treatment by radiotherapy as the sole method of treatment. (author)

  14. The Effect of Entonox, Play Therapy and a Combination on Pain Relief in Children: A Randomized Controlled Trial.

    Science.gov (United States)

    Mohan, Simi; Nayak, Ruma; Thomas, Reju Joseph; Ravindran, Vinitha

    2015-12-01

    Pediatric pain is often undertreated/neglected due to time constraints, difficulties in timing of oral analgesics, fear of side effects of opioids and anxiolytics, and apprehension of additional pain in the use of local anesthetic injections. In this study, the researcher was prompted to choose rapidly acting interventions that were low dose and allowed the child to stay alert, suitable for a quick discharge. The purpose of this study was to evaluate the effects of Entonox, play therapy, and a combination to relieve procedural pain in children aged 4-15 years. The study was designed as a randomized controlled trial; the subjects were divided into four groups using a sequential allocation plan from 123 total subjects. Group A received Entonox, Group B received play therapy, Group C received both Entonox and play therapy, and Group D received existing standard interventions. The study was vetted by the departmental study review committee. The pain level was assessed using FLACC scale for children aged 4-9 years and the Wong Bakers Faces Pain Scale for children aged 10-15 years; scores ranged from 0 to 10. All the data were analyzed using SPSS 16.0 with descriptive statistics and, inferential statistics. The mean pain scores were as follows: Entonox group, 2.87; Play therapy group, 4; combination group, 3; and control group, 5.87. When statistical testing was applied, a significant reduction in the pain score in all the three experimental groups when compared to the control group was found (p = .002), but not in the pain score among the three experimental groups (p = .350). The findings of this study indicated that all three interventions were effective in lowering pain scores when compared to the control group. Play therapy is as potent as Entonox in relieving procedural pain, though there was no additive effect on pain relief when play therapy and Entonox were combined. A protocol for age-related choice between play therapy and Entonox administration was introduced

  15. 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.

  16. Dose-response and failure pattern for bulky or barrel-shaped stage IB cervical cancer treated by combined photon irradiation and extrafascial hysterectomy

    International Nuclear Information System (INIS)

    Maruyama, Y.; van Nagell, J.R.; Yoneda, J.; Donaldson, E.; Gallion, H.H.; Higgins, R.; Powell, D.; Kryscio, R.; Berner, B.

    1989-01-01

    From 1975 to 1987, 80 patients with bulky or barrel-shaped Stage IB cervical cancer were treated with preoperative irradiation and Cs-137 intracavitary implant therapy, before a planned extrafascial abdominal hysterectomy, using a consistent treatment policy. Of the hysterectomy specimens obtained, 37% were positive histologically at 89 +/- 2.3 days after the start of radiotherapy and at 4 to 6 weeks after the completion of radiation therapy. Sixty-three percent were negative after a total external and internal cervix irradiation dose of 9642 cGy at point T. The average point A dose contributed by intracavitary therapy was 2104 cGy. The survival rate at 5 years was 84%: At 10 years the survival rate was 78%. The failure pattern was analyzed for patients who had positive and negative specimens. The patients with positive specimens failed pelvically or pelvically and distantly. Patients with negative specimens failed in extrapelvic or distant metastatic sites. Preoperative radiotherapy led to excellent local and pelvic control of tumor, and the failures became predominantly distant metastases. The combined radiosurgical therapy was tolerated well and allowed surgical staging of disease. This permitted earlier and selective consideration of adjunctive therapy (i.e., paraaortic irradiation, chemotherapy, or chemoradiotherapy). The dose-response data give insight into the effects of photon radiotherapy on bulky or barrel Stage IB cervical cancers and correlate histologic status with failure pattern, outcome, and long-term survival

  17. A randomized trial of a low-dose Rasagiline and Pramipexole combination (P2B001) in early Parkinson's disease.

    Science.gov (United States)

    Olanow, C Warren; Kieburtz, Karl; Leinonen, Mika; Elmer, Lawrence; Giladi, Nir; Hauser, Robert A; Klepiskaya, Olga S; Kreitzman, David L; Lew, Mark F; Russell, David S; Kadosh, Shaul; Litman, Pninit; Friedman, Hadas; Linvah, Nurit; The P B Study Group, For

    2017-05-01

    Rasagiline and pramipexole act to improve striatal dopaminergic transmission in PD via distinct and potentially synergistic mechanisms. We performed a placebo-controlled study to determine whether 2 doses of a novel slow-release, low-dose combination of rasagiline and pramipexole (P2B001) are effective and have a good safety profile in patients with early untreated PD. Previously untreated patients with early PD were randomized (1:1:1) to once-daily treatment with P2B001 (0.3 mg pramipexole/0.75 mg rasagiline), P2B001 (0.6 mg pramipexole/0.75 mg rasagiline) or placebo in a 12-week multicenter double-blind, placebo-controlled trial. The primary endpoint was the change from baseline to final visit in Total-UPDRS score versus placebo. Secondary measures included responder analyses of patients achieving ≥4 UPDRS point reduction, and changes in Parkinson Disease Quality of Life Scale-39 and UPDRS activities of daily living and motor scores. A total of 149 participants were randomized and 136 (91.3%) completed the study. Adjusted mean change from baseline to final visit versus placebo in Total-UPDRS score was -4.67 ± 1.28 points for the P2B001 0.6/0.75 mg group (P = .0004) and -3.84 ± 1.25 points for the 0.3/0.75 mg group (P = .003). Significant benefits were also observed for both doses in the responder analysis (P = .0002 and P = .0001), Parkinson Disease Quality of Life Scale-39 scores (P = .05 and P = .01), and the UPDRS motor (P = .02 and P = .006) and activities of daily living (P = .005 and P = .0004) subscores. Adverse events of P2B001 were comparable to placebo apart from transient nausea and somnolence, which were more common with P2B001 treatment. P2B001 offers a promising treatment option for patients with early PD with good clinical efficacy and a low risk of adverse events. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder

  18. 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.

  19. 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

  20. Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial

    Directory of Open Access Journals (Sweden)

    Trimarco V

    2016-10-01

    Full Text Available Valentina Trimarco,1 Francesco Rozza,2 Raffaele Izzo,3 Vincenzo De Leo,4 Valentina Cappelli,4 Carla Riccardi,1 Costantino Di Carlo1 1Department of Neuroscience, Reproductive Sciences and Dentistry, 2Department of Biomedical Sciences, 3Department of Translational Medical Sciences, Federico II University of Naples, Naples, 4Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy Objectives: This study was designed to measure the beneficial effects of a combination of nutraceutics (NUT; AkP04, Morestril®, Akademy Pharma containing soy isoflavones (80 mg, dry extract of Angelica sinensis (50 mg, dry extract of Morus alba leaf (200 mg and magnesium (56.25 mg in the relief of somatic, psychological, and urogenital symptoms in postmenopausal patients, using the validated Menopause Rating Scale (MRS and cardiovascular risk factors.Materials and methods: A total of 43 symptomatic postmenopausal women (MRS ≥20 were enrolled in a crossover trial. After a 2-week run-in period, patients were randomized into two arms. One arm received probiotics plus placebo over 4 weeks, followed by a 4-week treatment with probiotics plus NUT. The second arm received probiotics plus NUT for 4 weeks, followed by a 4-week treatment with probiotics plus placebo.Results: After the NUT period, participants showed a significant reduction in MRS score (18.4±5.4 in comparison to baseline (28.4±5 and the placebo period (28±5.2 (P<0.0001 for both comparisons. Furthermore, at the end of the active-treatment period, we observed a significant reduction in triglycerides, total and low-density lipoprotein cholesterol plasma levels and an increase in high-density lipoprotein cholesterol plasma concentration versus baseline and versus placebo (all P<0.04. Moreover, during the NUT period, we detected a significant reduction in diastolic blood pressure in comparison to baseline, but not in comparison to the placebo period.Conclusion: This NUT combination was

  1. [Micro-invasive embedding combined with montelukast sodium for children cough variant asthma:a randomized controlled trial].

    Science.gov (United States)

    Wang, Xiaoyan; Liu, Baoqin; Lu, Bin; Zhang, Yanmei; Wang, Liran; Li, Haijin; Han, Xue; Ding, Dan

    2017-03-12

    To observe the effects of micro-invasive embedding combined with montelukast sodium and simple montelukast sodium for children cough variant asthma (CVA). A total of 240 patients were randomly assigned into an observation group and a control group, 120 cases in each one. Considering of cases dropping, 101 patients in the observation group and 105 cases in the control group were included. Montelukast sodium chewable tablets were applied before sleep for 3 months in the control group, 5 mg a time, once a day. Based on the treatment as the control group, micro-invasive embedding was used for 3 months in the observation group, twice in the first month and once in the other two months. The acupoints were Feishu (BL 13), Danzhong (CV 17), Dingchuan (EX-B 1), and Zusanli (ST 36). Follow-up was conducted 9 months after treatment in the two groups. The cough score, serum immunoglobulin (IgE, IgG, IgA), platelet activating factor (PAF) were observed before and after treatment. The indices were compared before and after treatment and at follow-up, including pulmonary function indices[peak expiratory flow rate (PEF), forced expiratory volume at the 1st second (FEV1)], and small airway function indices[forced expiratory flow rate with remaining 25% vital capacity (MEF25%), forced expiratory flow rate with remaining 50% vital capacity (MEF50%), forced expiratory flow rate with remaining 75% vital capacity (MEF75%) and mid expiratory flow rate (MEF25%-75%)]. Also, the total effects were evaluated. ①The total effective rate in the observation group was 93.1% (94/101), which was better than 87.6% (92/105) in the control group ( P disappearance time of the cured children in the observation group was (10.38±2.64) d, and it was shorter than (10.72 ±2.60) d of those in the control group ( P 0.05). ④ There was no statistically significance before and after treatment on small airway function indices in the two groups (all P >0.05). The indices at follow-up increased compared with

  2. 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

  3. 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

  4. 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 treatment based on restricted diet and exercise in senior people with metabolic syndrome, the lower threshold intake for protein must be set at 1.2 g/kg/day to maintain blood protein homeostasis.

  5. Combinations of laxatives and green banana biomass on the treatment of functional constipation in children and adolescents: a randomized study.

    Science.gov (United States)

    Cassettari, Vanessa Mello Granado; Machado, Nilton Carlos; Lourenção, Pedro Luiz Toledo de Arruda; Carvalho, Marry Assis; Ortolan, Erika Veruska Paiva

    2018-01-05

    Evaluate the effect of combinations of green banana biomass and laxatives in children and adolescents with chronic constipation. This was a randomized study of 80 children and adolescents with functional constipation according to the Rome IV Criteria, who were divided into five groups: (1) green banana biomass alone; (2) green banana biomass plus PEG 3350 with electrolytes; (3) green banana biomass plus sodium picosulfate; (4) PEG 3350 with electrolytes alone; and (5) sodium picosulfate alone. Primary outcome measure was the reduction of the proportion of patients with Bristol Stool Form Scale ratings 1 or 2. Secondary outcome measures were: increase of the proportion of >3 bowel movements/week and reduction of the proportion of fecal incontinence, straining on defecation, painful defecation, blood in stool, abdominal pain, and decreased laxative doses. On consumption of green banana biomass alone, a statistically significant reduction was observed in the proportion of children with Bristol Stool Form Scale rating 1 or 2, straining on defecation, painful defecation, and abdominal pain. Conversely, no reduction was observed in fecal incontinence episodes/week, blood in stool, and no increase was observed in the proportion of children with >3 bowel movements/week. The percentage of children who required decreased laxative dose was high when green banana biomass was associated with sodium picosulfate (87%), and PEG 3350 with electrolytes (63%). Green banana biomass alone and associated with laxatives was well tolerated, and no adverse effects were reported. Green banana biomass is advantageous as an adjunct therapy on functional constipation, mainly for reducing doses of laxatives. Copyright © 2017 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  6. 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.

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

    Science.gov (United States)

    Trigo, Jose M; Soliman, Alexandra; Quilty, Lena C; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J; Huestis, Marilyn A; George, Tony P; Streiner, David L; Staios, Gregory; Le Foll, Bernard

    2018-01-01

    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.

  8. 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

  9. 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)

    E. van Weert (Ellen); A.M. May (Anne); I. Korstjens (Irene); W.J. Post (Wendy); C.P. van der Schans (Cees); B. van den Borne (Bart); I. Mesters (Ilse); W.J.G. Ros (Wynand); J.E.H.M. Hoekstra-Weebers (Josette)

    2010-01-01

    textabstractBackground. 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 cancerrelated fatigue of physical training combined

  10. Simultaneous determination of environmental α-radionuclides using liquid scintillation counting combined with time interval analysis (TIA) and pulse shape discrimination (PSD)

    International Nuclear Information System (INIS)

    Hashimoto, T.; Sato, K.; Yoneyama, Y.; Fukuyama, N.

    1997-01-01

    Some improvements of the detection sensitivity in pulse time interval analysis (TIA) based on selective extraction of successively α-α correlated decay events within millisecond order from random or background events, were established by the utilization of PSD, to reject β/γ-pulses from α-ones and a simple chemical procedure of radium separation, together with the use of well resolved scintillator. By applying the PSD, the contribution of β-decay events was completely eliminated in both the α-spectra and the TIA distribution curves as well as the improvement into clear energy resolution and the enhancement of detection sensitivity for the TIA. As a result, the TIA and α-spectrometric analysis of 226 Ra-extract showed the existence of 223 Ra (Ac-series) and β/α-correlated events with correlated life (due to 0.16 ms due to 214 Bi(β)-> 214 Po(α)->) along with a singly well resolved α-peak to be useful for the determination of 226 Ra (U-series). The difference of half-lives (145 and 1.78 ms) due to 216 Po and 215 Po (direct daughters of 224 Ra for Th-series and 223 Ra for Ac-series, respectively) was also proven for the possibility of the simultaneous determination of both correlated events by using the TIA/PSD combined with chemical separation and liquid scintillation counting method. Finally, the simultaneous determination of three natural decay series, which include U-, Th- and Ac-series nuclides, have been conveniently carried out for some environmental samples using the present method combined with 225 Ra yield tracer (Np-series). (author)

  11. 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

  12. Combining Internet-Based and Postal Survey Methods in a Survey among Gynecologists: Results of a Randomized Trial.

    Science.gov (United States)

    Ernst, Sinja Alexandra; Brand, Tilman; Lhachimi, Stefan K; Zeeb, Hajo

    2018-04-01

    To assess whether a combination of Internet-based and postal survey methods (mixed-mode) compared to postal-only survey methods (postal-only) leads to improved response rates in a physician survey, and to compare the cost implications of the different recruitment strategies. All primary care gynecologists in Bremen and Lower Saxony, Germany, were invited to participate in a cross-sectional survey from January to July 2014. The sample was divided into two strata (A; B) depending on availability of an email address. Within each stratum, potential participants were randomly assigned to mixed-mode or postal-only group. In Stratum A, the mixed-mode group had a lower response rate compared to the postal-only group (12.5 vs. 20.2 percent; RR = 0.61, 95 percent CI: 0.44-0.87). In stratum B, no significant differences were found (15.6 vs. 16.2 percent; RR = 0.95, 95 percent CI: 0.62-1.44). Total costs (in €) per valid questionnaire returned (Stratum A: 399.72 vs. 248.85; Stratum B: 496.37 vs. 455.15) and per percentage point of response (Stratum A: 1,379.02 vs. 861.02; Stratum B 1,116.82 vs. 1,024.09) were higher, whereas variable costs were lower in mixed-mode compared to the respective postal-only groups (Stratum A cost ratio: 0.47, Stratum B cost ratio: 0.71). In this study, primary care gynecologists were more likely to participate by traditional postal-only than by mixed-mode survey methods that first offered an Internet option. However, the lower response rate for the mixed-mode method may be partly due to the older age structure of the responding gynecologists. Variable costs per returned questionnaire were substantially lower in mixed-mode groups and indicate the potential for cost savings if the sample population is sufficiently large. © Health Research and Educational Trust.

  13. [Shaping ability of two nickel-titanium rotary systems in simulated S-shaped canals].

    Science.gov (United States)

    Luo, Hong-xia; Huang, Ding-ming; Zhang, Fu-hua; Tan, Hong; Zhou, Xue-dong

    2008-01-01

    To evaluate the shaping ability of two nickel-titanium rotary systems (ProTaper and Hero642) in simulated S-shaped canals. Thirty simulated S-shaped canals were randomly divided into three groups and prepared by ProTaper, Hero642, ProTaper combined with Hero642 respectively. All the canals were scanned before and after instrumentation, and the amount of material removed in the inner and outer wall and the canal width after instrumentation were measured with a computer image analysis program. There was significant difference in the amount of material removed at the inner side of apical curvature and outer side of apex between ProTaper combined with Hero642 and ProTaper files (P Hero642, and the taper of canals were better than those prepared by Hero642. ProTaper combined with Hero 642 had better shaping ability to maintain the original shape and could create good taper canals in the simulated S-shaped canal model.

  14. 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.

  15. A Two-Way Shape Memory Study on Ni-Rich NiTi Shape Memory Alloy by Combination of the All-Round Treatment and the R-Phase Transformation

    Science.gov (United States)

    Wu, Z. H.; Vokoun, D.; Leu, C. C.; Hu, C. T.

    2017-12-01

    Ni4Ti3 precipitates are formed in Ni-rich NiTi shape memory alloys (SMAs) after a certain heat treatment. Such a treatment then results in the changed phase transformation behavior of the alloy switching from the one-step reversible phase change B2 ↔ B19' to the two-step, B2 ↔ R ↔ B19', phase change. The present study reports a two-way shape memory (TWSM) due to an all-round treatment followed by an R-phase constraint aging at room temperature. The enhanced TWSM behavior was observed upon temperature cycling between 273 K (R-phase) and 77 K (B19' phase). The effect of various constraint strains in R-phase aging by employing different diameters of the constraint ring was studied. However, the TWSM effect due to constraining the R-phase will be eliminated after a temperature rise of specimen to the fully parent phase (373 K).

  16. 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, 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.

  17. 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

    2018-05-01

    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.

  18. On contact numbers in random rod packings

    NARCIS (Netherlands)

    Wouterse, A.; Luding, Stefan; Philipse, A.P.

    2009-01-01

    Random packings of non-spherical granular particles are simulated by combining mechanical contraction and molecular dynamics, to determine contact numbers as a function of density. Particle shapes are varied from spheres to thin rods. The observed contact numbers (and packing densities) agree well

  19. Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

    Science.gov (United States)

    Dowling, S.; Hubert, J.; White, S.; Hollins, S.

    2006-01-01

    Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

  20. 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

  1. A randomized controlled trial of enemas in combination with oral laxative therapy for children with chronic constipation

    NARCIS (Netherlands)

    Bongers, Marloes E. J.; van den Berg, Maartje M.; Reitsma, Johannes B.; Voskuijl, Wieger P.; Benninga, Marc A.

    2009-01-01

    After 5 years of intensive oral laxative use, up to 30% of constipated children still have an unsuccessful outcome. Children refractory to oral laxatives might benefit from regular rectal evacuation by enemas. This randomized controlled trial compared the effects of additional treatment with rectal

  2. Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe).

    Science.gov (United States)

    Kim, Kyung-Jin; Kim, Sang-Hyun; Yoon, Young Won; Rha, Seung-Woon; Hong, Soon-Jun; Kwak, Choong-Hwan; Kim, Weon; Nam, Chang-Wook; Rhee, Moo-Yong; Park, Tae-Ho; Hong, Taek-Jong; Park, Sungha; Ahn, Youngkeun; Lee, Namho; Jeon, Hui-Kyung; Jeon, Dong-Woon; Han, Kyoo-Rok; Moon, Keon-Woong; Chae, In-Ho; Kim, Hyo-Soo

    2016-10-01

    We aimed to compare the effects of fixed-dose combinations of ezetimibe plus rosuvastatin to rosuvastatin alone in patients with primary hypercholesterolemia, including a subgroup analysis of patients with diabetes mellitus (DM) or metabolic syndrome (MetS). This multicenter eight-week randomized double-blind phase III study evaluated the safety and efficacy of fixed-dose combinations of ezetimibe 10 mg plus rosuvastatin, compared with rosuvastatin alone in patients with primary hypercholesterolemia. Four hundred and seven patients with primary hypercholesterolemia who required lipid-lowering treatment according to the ATP III guideline were randomized to one of the following six treatments for 8 weeks: fixed-dose combinations with ezetimibe 10 mg daily plus rosuvastatin (5, 10, or 20 mg daily) or rosuvastatin alone (5, 10, or 20 mg daily). Fixed-dose combination of ezetimibe plus rosuvastatin significantly reduced LDL cholesterol, total cholesterol, and triglyceride levels compared with rosuvastatin alone. Depending on the rosuvastatin dose, these fixed-dose combinations of ezetimibe plus rosuvastatin provided LDL cholesterol, total cholesterol, and triglyceride reductions of 56%-63%, 37%-43%, and 19%-24%, respectively. Moreover, the effect of combination treatment on cholesterol levels was more pronounced in patients with DM or MetS than in non-DM or non-MetS patients, respectively, whereas the effect of rosuvastatin alone did not differ between DM vs non-DM or MetS vs non-MetS patients. Fixed-dose combinations of ezetimibe and rosuvastatin provided significantly superior efficacy to rosuvastatin alone in lowering LDL cholesterol, total cholesterol, and triglyceride levels. Moreover, the reduction rate was greater in patients with DM or MetS. © 2016 The Authors Cardiovascular Therapeutics Published by John Wiley & Sons Ltd.

  3. 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...

  4. Jianpi Bushen, a Traditional Chinese Medicine Therapy, Combined with Chemotherapy for Gastric Cancer Treatment: A Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Chen, Yunbo; Zhang, Guijuan; Chen, Xiaoping; Jiang, Xuefeng; Yuan, Naijun; Wang, Yurong; Hao, Xiaoqian

    2018-01-01

    Objective. To investigate the effects of Jianpi Bushen (JPBS), a traditional Chinese medicine that is used to invigorate the spleen and tonify the kidney, combined with chemotherapy for the treatment of gastric cancer. Methods. Literature retrieval was performed in PubMed, EMBASE, Cochrane Library, MEDLINE, CNKI, Wanfang Data Information Site, and VIP from inception to October 2017. Randomized controlled trials to evaluate the effects of JPBS combined with chemotherapy were identified. The primary reported outcomes were KPS (Karnofsky Performance Status), clinical curative efficiency, immune function, blood system, and nonhematologic system. Review Manager 5.3 (RevMan 5.3) was used for data analysis, and the quality of the studies was also appraised. Results. A total of 26 studies were included with 3098 individuals. The results of the meta-analysis indicated that treatment of gastric cancer with the combination of JPBS and chemotherapy resulted in better outcomes compared to chemotherapy alone. Conclusion. Evidence from the meta-analysis suggested that JPBS combined with chemotherapy has a positive effect on gastric cancer treatment. However, additional rigorously designed and large sample randomized controlled trials are required to confirm the efficacy and safety of this treatment. PMID:29675052

  5. 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.

  6. Immediate combined effect of gastrocnemius stretching and sustained talocrural joint mobilization in individuals with limited ankle dorsiflexion: A randomized controlled trial.

    Science.gov (United States)

    Kang, Min-Hyeok; Oh, Jae-Seop; Kwon, Oh-Yun; Weon, Jong-Hyuk; An, Duk-Hyun; Yoo, Won-Gyu

    2015-12-01

    Although gastrocnemius stretching and talocrural joint mobilization have been suggested as effective interventions to address limited ankle dorsiflexion passive range of motion (DF PROM), the effects of a combination of the two interventions have not been identified. The aim of the present study was to compare the effects of gastrocnemius stretching combined with joint mobilization and gastrocnemius stretching alone. A randomized controlled trial. In total, 24 individuals with limited ankle DF PROM were randomized to undergo gastrocnemius stretching combined with joint mobilization (12 feet in 12 individuals) or gastrocnemius stretching alone (12 feet in 12 individuals) for 5 min. Ankle kinematics during gait (time to heel-off and ankle DF before heel-off), ankle DF PROM, posterior talar glide, and displacement of the myotendinous junction (MTJ) of the gastrocnemius were assessed before and after the interventions. The groups were compared using two-way repeated measures analysis of variance. Greater increases in the time to heel-off and ankle DF before heel-off during gait and posterior talar glide were observed in the stretching combined with joint mobilization group versus the stretching alone group. Ankle DF PROM and displacement of the MTJ of the gastrocnemius were increased significantly after the interventions in both groups, with no significant difference between them. These findings suggest that gastrocnemius stretching with joint mobilization needs to be considered to improve ankle kinematics during gait. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. 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.

  8. 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

  9. Oral contraceptive use changes brain activity and mood in women with previous negative affect on the pill--a double-blinded, placebo-controlled randomized trial of a levonorgestrel-containing combined oral contraceptive.

    Science.gov (United States)

    Gingnell, Malin; Engman, Jonas; Frick, Andreas; Moby, Lena; Wikström, Johan; Fredrikson, Mats; Sundström-Poromaa, Inger

    2013-07-01

    Most women on combined oral contraceptives (COC) report high levels of satisfaction, but 4-10% complain of adverse mood effects. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate if COC use would induce more pronounced mood symptoms than placebo in women with previous history of COC-induced adverse mood. A second aim was to determine if COC use is associated with changes in brain reactivity in regions previously associated with emotion processing. Thirty-four women with previous experience of mood deterioration during COC use were randomized to one treatment cycle with a levonorgestrel-containing COC or placebo. An emotional face matching task (vs. geometrical shapes) was administered during functional magnetic resonance imaging (fMRI) prior to and during the COC treatment cycle. Throughout the trial, women recorded daily symptom ratings on the Cyclicity Diagnoser (CD) scale. During the last week of the treatment cycle COC users had higher scores of depressed mood, mood swings, and fatigue than placebo users. COC users also had lower emotion-induced reactivity in the left insula, left middle frontal gyrus, and bilateral inferior frontal gyri as compared to placebo users. In comparison with their pretreatment cycle, the COC group had decreased emotion-induced reactivity in the bilateral inferior frontal gyri, whereas placebo users had decreased reactivity in the right amygdala. COC use in women who previously had experienced emotional side effects resulted in mood deterioration, and COC use was also accompanied by changes in emotional brain reactivity. These findings are of relevance for the understanding of how combined oral contraceptives may influence mood. Placebo-controlled fMRI studies in COC sensitive women could be of relevance for future testing of adverse mood effects in new oral contraceptives. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. 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.

  11. 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.

  12. Regional hyperthermia combined with radiotherapy for locally advanced non-small cell lung cancers. A multi-institutional prospective randomized trial of the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    Mitsumori, Michihide; Hiraoka, Masahiro; Zeng Zhifan; Oliynychenko, P.; Park, Jeong-Ho; Choi, Ihl-Bohng; Tatsuzaki, Hideo; Tanaka, Yoshiaki

    2007-01-01

    An International Atomic Energy Agency (IAEA)-sponsored, multi-institutional prospective randomized trial was conducted to clarify whether the combination of hyperthermia and radiotherapy improves the local response rate of locally advanced non-small cell lung cancer (NSCLC) compared with that obtained by radiotherapy alone. Between October 1998 and April 2002, 80 patients with locally advanced NSCLC were randomized to receive either standard radiation therapy alone (RT) or radiation therapy combined with hyperthermia (RT+HT). The primary endpoint was the local response rate. The secondary endpoints were local progression-free survival and overall survival. The median follow-up period was 204 days for all patients and 450 days for surviving patients. There were no significant differences between the two arms with regard to local response rate (P=0.49) or overall survival rate (P=0.868). However, local progression-free survival was significantly better in the RT+HT arm (P=0.036). Toxicity was generally mild and no grade 3 late toxicity was observed in either arm. Although improvement of local progression-free survival was observed in the RT+HT arm, this prospective randomized study failed to show any substantial benefit from the addition of hyperthermia to radiotherapy in the treatment of locally advanced NSCLC. (author)

  13. 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.

  14. 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.; Monninkhof, Evelyn M.

    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

  15. 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

  16. 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.

  17. 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.

  18. The Random-Map Technique: Enhancing Mind-Mapping with a Conceptual Combination Technique to Foster Creative Potential

    Science.gov (United States)

    Malycha, Charlotte P.; Maier, Günter W.

    2017-01-01

    Although creativity techniques are highly recommended in working environments, their effects have been scarcely investigated. Two cognitive processes are often considered to foster creative potential and are, therefore, taken as a basis for creativity techniques: knowledge activation and conceptual combination. In this study, both processes were…

  19. A randomized controlled study of the efficacy of tamsulosin monotherapy and its combination with mirabegron for overactive bladder induced by benign prostatic obstruction.

    Science.gov (United States)

    Ichihara, Koji; Masumori, Naoya; Fukuta, Fumimasa; Tsukamoto, Taiji; Iwasawa, Akihiko; Tanaka, Yoshinori

    2015-03-01

    We evaluated the efficacy and safety of add-on treatment with a β3-adrenoceptor agonist (mirabegron) for overactive bladder symptoms remaining after α1-blocker (tamsulosin) treatment in men with benign prostatic obstruction. Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study. They were randomly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks. The primary end point was change in total OABSS. Safety assessments included change in post-void residual urine volume and adverse events. From January 2012 through September 2013 a total of 94 patients were randomized. Of these patients 76 completed the protocol treatment. In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group (-2.21 vs -0.87, p=0.012). The changes in scores for urinary urgency, daytime frequency, International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group. The change in post-void residual urine volume was significantly greater in the combination group. Although 6 patients experienced adverse events in the combination group, urinary retention was observed in only 1 patient. Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  20. Effects of repetitive transcranial magnetic stimulation combined with sensory cueing on unilateral neglect in subacute patients with right hemispheric stroke: a randomized controlled study.

    Science.gov (United States)

    Yang, Nicole Yh; Fong, Kenneth Nk; Li-Tsang, Cecilia Wp; Zhou, D

    2017-09-01

    To compare the effects of rTMS combined with sensory cueing, rTMS alone, and conventional rehabilitation on unilateral neglect, hemiplegic arm functions and performance of activities of daily living. A single-blinded randomized controlled trial. A convalescent hospital. Sixty inpatients with left unilateral neglect after stroke. Patients were randomly assigned to three groups: rTMS combined with sensory cueing, rTMS, and conventional rehabilitation alone. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and 6 weeks follow-up. Neglect and arm motor performance. Both rTMS combined with sensory cueing (99.6±33.0) and rTMS alone (88.2±28.7) significantly reduced unilateral neglect than conventional rehabilitation (72.7±33.1) when measured using the conventional subtests of the Behavioural Inattention Test, but the combination was better than rTMS alone. Hemiplegic arm functions and activities of daily living improved in all patients across the three groups but no significant differences were found between the groups. The combination of inhibitory P5-rTMS with sensory cueing was better than either rTMS or conventional rehabilitation alone in producing a stronger and long-lasting improvement in unilateral neglect, but the improvement was not associated with improved arm function or independence in activities of daily living.

  1. Effect of Combined Systematized Behavioral Modification Education Program With Desmopressin in Patients With Nocturia: A Prospective, Multicenter, Randomized, and Parallel Study

    Directory of Open Access Journals (Sweden)

    Sung Yong Cho

    2014-12-01

    Full Text Available Purpose The aims of this study were to investigate the efficacy of combining the systematized behavioral modification program (SBMP with desmopressin therapy and to compare this with desmopressin monotherapy in the treatment of nocturnal polyuria (NPU. Methods Patients were randomized at 8 centers to receive desmopressin monotherapy (group A or combination therapy, comprising desmopressin and the SBMP (group B. Nocturia was defined as an average of 2 or more nightly voids. The primary endpoint was a change in the mean number of nocturnal voids from baseline during the 3-month treatment period. The secondary endpoints were changes in the bladder diary parameters and questionnaires scores, and improvements in self-perception for nocturia. Results A total of 200 patients were screened and 76 were excluded from the study, because they failed the screening process. A total of 124 patients were randomized to receive treatment, with group A comprising 68 patients and group B comprising 56 patients. The patients' characteristics were similar between the groups. Nocturnal voids showed a greater decline in group B (-1.5 compared with group A (-1.2, a difference that was not statistically significant. Significant differences were observed between groups A and B with respect to the NPU index (0.37 vs. 0.29, P=0.028, the change in the maximal bladder capacity (-41.3 mL vs. 13.3 mL, P<0.001, and the rate of patients lost to follow up (10.3% [7/68] vs. 0% [0/56], P=0.016. Self-perception for nocturia significantly improved in both groups. Conclusions Combination treatment did not have any additional benefits in relation to reducing nocturnal voids in patients with NPU; however, combination therapy is helpful because it increases the maximal bladder capacity and decreases the NPI. Furthermore, combination therapy increased the persistence of desmopressin in patients with NPU.

  2. [Interactive dynamic scalp acupuncture combined with occupational therapy for upper limb motor impairment in stroke: a randomized controlled trial].

    Science.gov (United States)

    Wang, Jun; Pei, Jian; Cui, Xiao; Sun, Kexing; Ni, Huanhuan; Zhou, Cuixia; Wu, Ji; Huang, Mei; Ji, Li

    2015-10-01

    To compare the clinical efficacy on upper limb motor impairment in stroke between the interactive dynamic scalp acupuncture therapy and the traditional scalp acupuncture therapy. The randomized controlled trial and MINIMIZE layering randomization software were adopted. Seventy patients of upper limb with III to V grade in Brunnstrom scale after stroke were randomized into an interactive dynamic scalp acupuncture group and a traditional scalp acupuncture group, 35 cases in each one. In the interactive dynamic scalp acupuncture group, the middle 2/5 of Dingnieqianxiexian (anterior oblique line of vertex-temporal), the middle 2/5 of Dingniehouxiexian (posterior oblique line of vertex-temporal) and Dingpangerxian (lateral line 2 of vertex) on the affected side were selected as the stimulation areas. Additionally, the rehabilitation training was applied during scalp acupuncture treatment. In the traditional scalp acupuncture group, the scalp stimulation areas were same as the interactive dynamic scalp acupuncture group. But the rehabilitation training was applied separately. The rehabilitation training was applied in the morning and the scalp acupuncture was done in the afternoon. The results in Fugl-Meyer for the upper limb motor function (U-FMA), the Wolf motor function measure scale (WM- FT) and the modified Barthel index in the two groups were compared between the two groups before treatment and in 1 and 2 months of treatment, respectively. After treatment, the U-FMA score, WMFT score and the score of the modified Barthel index were all apparently improved as compared with those before treatment (all P acupuncture group was better than that in the traditional scalp acupuncture group (P acupuncture group were improved apparently as compared with those in the traditional scalp acupuncture group (P acupuncture group were not different significantly as compared with those in the traditional scalp acupuncture group (both P > 0.05). For the patients of IV to V grade in

  3. 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

  4. Combined-stent covered technique and single covered stent technique for transjugular intrahepatic porto-systemic shunt: a prospective randomized controlled study

    International Nuclear Information System (INIS)

    Wang Changming; Li Xuan; Fu Jun; Lu Xianjun; Luan Jingyuan; Li Tianrun; Zhao Jun; Dong Guoxiang

    2014-01-01

    Objective: To compare the technique of combined stents with that of single stent-graft for the construction of transjugular intrahepatic porto-systemic shunt (TIPS) and to discuss their clinical outcomes. Methods: During the period from April 2011 to Dec. 2012, a total of 30 patients with upper gastrointestinal bleeding due to portal hypertension were admitted to the hospital. TIPS procedure was carried out in all the 30 patients. The patients were randomly allocated into either combined-stent group (n=17) or stent-graft group (control group, n=13) on the basis of a computer-generated randomization sequence. The PSC quality control, the patency rate of portal vein branches and the shunts, the incidence of encephalopathy and the survival rate of the two groups were documented and analyzed. Results: Technical success rate was 100%. After the treatment, in both groups the PSG became significantly lower than the PSG determined before the treatment (P<0.000). According to quality control chart, the of combined stents was superior to stent-graft technique in effectively controlling PSG. Five days after TIPS, the ammonia level in the combined- stent group was significantly decreased (P=0.029), while in the control group the ammonia level showed no significant changes (P=0.065). One patient died shortly after TIPS. The median follow- up time was 181 days. During the follow-up period death occurred in 3 cases in each group. The difference in the survival rate between the two groups was no significant (P=0.906). Of the three patients who developed encephalopathy, two were in the combined-stent group and one was in the control group. After medication the symptoms of encephalopathy were relieved. The patency rate of the shunts was 100% and the re-bleeding rate was 0% for both groups. The patency rate of portal vein branches was significantly higher in the combined-stent group than that in the control group (P=0.039). Conclusion: For the construction of TIPS, the technique of

  5. 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

  6. Combination of Deep Recurrent Neural Networks and Conditional Random Fields for Extracting Adverse Drug Reactions from User Reviews.

    Science.gov (United States)

    Tutubalina, Elena; Nikolenko, Sergey

    2017-01-01

    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.

  7. 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.

  8. 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...

  9. Sufentanil and Bupivacaine Combination versus Bupivacaine Alone for Spinal Anesthesia during Cesarean Delivery: A Meta-Analysis of Randomized Trials

    Science.gov (United States)

    Yan, Jianqin; Wang, Ruike; Wang, Ying; Xu, Mu

    2016-01-01

    Objective The addition of lipophilic opioids to local anesthetics for spinal anesthesia has become a widely used strategy for cesarean anesthesia. A meta-analysis to quantify the benefits and risks of combining sufentanil with bupivacaine for patients undergoing cesarean delivery was conducted. Methods A comprehensive literature search without language or date limitation was performed to identify clinical trials that compared the addition of sufentanil to bupivacaine with bupivacaine alone for spinal anesthesia in healthy parturients choosing cesarean delivery. The Q and I2 tests were used to assess heterogeneity of the data. Data from each trial were combined using relative ratios (RRs) for dichotomous data or weighted mean differences (WMDs) for continuous data and corresponding 95% confidence intervals (95% CIs) for each trial. Sensitivity analysis was conducted by removing one study a time to assess the quality and consistency of the results. Begg’s funnel plots and Egger’s linear regression test were used to detect any publication bias. Results This study included 9 trials containing 578 patients in the final meta-analysis. Sufentanil addition provided a better analgesia quality with less breakthrough pain during surgery than bupivacaine alone (RR = 0.10, 95% CI 0.06 to 0.18, P bupivacaine-alone group (WMD = −1.0 min, 95% CI −1.5 to −0.58, P Bupivacaine and sufentanil combination is superior to that of bupivacaine alone for spinal anesthesia for cesarean delivery in analgesia quality. Women receiving the combined two drugs had less breakthrough pain, shorter sensory block onset time, and longer first analgesic request time. However, the addition of sufentanil to bupivacaine increased the incidence of pruritus. PMID:27032092

  10. Anesthetic Efficacy of a Combination of 4% Prilocaine/2% Lidocaine with Epinephrine for the Inferior Alveolar Nerve Block: A Prospective, Randomized, Double-blind Study.

    Science.gov (United States)

    Cook, Olivia; Nusstein, John; Drum, Melissa; Fowler, Sara; Reader, Al; Draper, John

    2018-05-01

    Prilocaine plain has a high pH and concentration (4%), which could decrease the pain of injection and increase success. The purpose of this study was to compare pain associated with anesthetic solution deposition and the degree of pulpal anesthesia obtained with the combination of prilocaine and lidocaine versus a lidocaine and lidocaine combination when used for inferior alveolar nerve blocks (IANBs). One hundred eighteen asymptomatic subjects were randomly given a combination of 1 cartridge of 4% prilocaine plain plus 1 cartridge of 2% lidocaine with 1:100,000 epinephrine or a combination of 2 cartridges of 2% lidocaine with 1:100,000 epinephrine for the IANB at 2 separate appointments. Subjects rated the pain associated with anesthetic solution deposition of injection. Mandibular teeth were tested with an electric pulp tester every 4 minutes for 57 minutes. Anesthesia was considered successful when 2 consecutive 80 readings were obtained within 17 minutes and the 80 reading was continuously sustained for 57 minutes. Comparisons for anesthetic success were analyzed using the exact McNemar test, and pain ratings associated with anesthetic solution deposition were analyzed using multiple Wilcoxon matched pairs signed rank tests; both were adjusted using the step-down Bonferroni method of Holm. Four percent prilocaine plain was significantly less painful upon anesthetic solution deposition. Pulpal anesthetic success was not significantly different between the 2 combinations. The combination of 4% prilocaine plain plus 2% lidocaine with 1:100,000 epinephrine did not increase pulpal anesthetic success for IANBs compared with a combination of 2 cartridges of 2% lidocaine with 1:100,000 epinephrine. Pain associated with anesthetic solution deposition from the first cartridge of 4% prilocaine plain was significantly less when compared with the first cartridge of 2% lidocaine with 1:100,000 epinephrine. Copyright © 2018 American Association of Endodontists. Published

  11. Modeling of mechanical response of NiTi shape memory alloy subjected to combined thermal and non-proportional mechanical loading: A case study on helical spring actuator

    Czech Academy of Sciences Publication Activity Database

    Frost, Miroslav; Sedlák, Petr; Kadeřávek, Lukáš; Heller, Luděk; Šittner, Petr

    2016-01-01

    Roč. 27, č. 14 (2016), s. 1927-1938 ISSN 1045-389X R&D Projects: GA ČR(CZ) GP14-28306P; GA ČR GA14-15264S; GA ČR GAP107/12/0800 Institutional support: RVO:61388998 ; RVO:68378271 Keywords : shape memory alloys * R-phase * modeling * elastic anisotropy * helical spring Subject RIV: BM - Solid Matter Physics ; Magnetism; BM - Solid Matter Physics ; Magnetism (FZU-D) Impact factor: 2.255, year: 2016 http://jim.sagepub.com/content/27/14/1927.full.pdf

  12. Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial.

    Science.gov (United States)

    Cantekin, E I; Mandel, E M; Bluestone, C D; Rockette, H E; Paradise, J L; Stool, S E; Fria, T J; Rogers, K D

    1983-02-10

    In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion ("secretory" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children.

  13. Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004).

    Science.gov (United States)

    Ruers, T; Punt, C; Van Coevorden, F; Pierie, J P E N; Borel-Rinkes, I; Ledermann, J A; Poston, G; Bechstein, W; Lentz, M A; Mauer, M; Van Cutsem, E; Lutz, M P; Nordlinger, B

    2012-10-01

    This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively. This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.

  14. 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

  15. An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation in Patients with Resected Pancreatic Carcinoma: A Trial of the ECOG-ACRIN Cancer Research Group (E2204).

    Science.gov (United States)

    Berlin, Jordan D; Feng, Yang; Catalano, Paul; Abbruzzese, James L; Philip, Philip A; McWilliams, Robert R; Lowy, Andrew M; Benson, Al B; Blackstock, A William

    2018-01-01

    Evaluate toxicity of two treatment arms, A (cetuximab) and B (bevacizumab), when combined with gemcitabine, and chemoradiation in patients with completely resected pancreatic carcinoma. Secondary objectives included overall survival (OS) and disease-free survival (DFS). Patients with R0/R1 resection were randomized 1:1 to cetuximab or bevacizumab administered in combination with gemcitabine for two treatment cycles. Next three cycles included concurrent cetuximab/bevacizumab plus chemoradiation, followed by one cycle of cetuximab/bevacizumab. Cycles 7-12 included cetuximab/bevacizumab with gemcitabine. Cycles were 2 weeks. Frequency of specific toxicities was summarized for each treatment arm at two times during the study, after chemotherapy but prior to chemoradiation and after all therapy. A total of 127 patients were randomized (A, n = 65; B, n = 62). Prior to chemoradiation, the overall rate for toxicities of interest was 10% for arm A and 2% for arm B. After all therapy, the overall rates for toxicities of interest were 30 and 25% for arms A and B, respectively. Overall median OS and DFS were 17 and 11 months, respectively, which is not a significant improvement over expected survival rates for historical controls. Both treatments were tolerable with manageable toxicities, and were safe enough for a phase III trial had this been indicated. © 2017 S. Karger AG, Basel.

  16. Shape and depth determinations from second moving average residual self-potential anomalies

    International Nuclear Information System (INIS)

    Abdelrahman, E M; El-Araby, T M; Essa, K S

    2009-01-01

    We have developed a semi-automatic method to determine the depth and shape (shape factor) of a buried structure from second moving average residual self-potential anomalies obtained from observed data using filters of successive window lengths. The method involves using a relationship between the depth and the shape to source and a combination of windowed observations. The relationship represents a parametric family of curves (window curves). For a fixed window length, the depth is determined for each shape factor. The computed depths are plotted against the shape factors, representing a continuous monotonically increasing curve. The solution for the shape and depth is read at the common intersection of the window curves. The validity of the method is tested on a synthetic example with and without random errors and on two field examples from Turkey and Germany. In all cases examined, the depth and the shape solutions obtained are in very good agreement with the true ones

  17. 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.

  18. An innovative approach to achieve re-centering and ductility of cement mortar beams through randomly distributed pseudo-elastic shape memory alloy fibers

    Science.gov (United States)

    Shajil, N.; Srinivasan, S. M.; Santhanam, M.

    2012-04-01

    Fibers can play a major role in post cracking behavior of concrete members, because of their ability to bridge cracks and distribute the stress across the crack. Addition of steel fibers in mortar and concrete can improve toughness of the structural member and impart significant energy dissipation through slow pull out. However, steel fibers undergo plastic deformation at low strain levels, and cannot regain their shape upon unloading. This is a major disadvantage in strong cyclic loading conditions, such as those caused by earthquakes, where self-centering ability of the fibers is a desired characteristic in addition to ductility of the reinforced cement concrete. Fibers made from an alternative material such as shape memory alloy (SMA) could offer a scope for re-centering, thus improving performance especially after a severe loading has occurred. In this study, the load-deformation characteristics of SMA fiber reinforced cement mortar beams under cyclic loading conditions were investigated to assess the re-centering performance. This study involved experiments on prismatic members, and related analysis for the assessment and prediction of re-centering. The performances of NiTi fiber reinforced mortars are compared with mortars with same volume fraction of steel fibers. Since re-entrant corners and beam columns joints are prone to failure during a strong ground motion, a study was conducted to determine the behavior of these reinforced with NiTi fiber. Comparison is made with the results of steel fiber reinforced cases. NiTi fibers showed significantly improved re-centering and energy dissipation characteristics compared to the steel fibers.

  19. The effects of Lactobacillus reuteri probiotics combined with azithromycin on peri-implantitis: A randomized placebo-controlled study.

    Science.gov (United States)

    Tada, Hiroaki; Masaki, Chihiro; Tsuka, Shintaro; Mukaibo, Taro; Kondo, Yusuke; Hosokawa, Ryuji

    2018-01-01

    The aim of this randomized placebo-controlled clinical study was to investigate the effects of a probiotic tablet containing Lactobacillus reuteri in peri-implantitis patients. Subjects comprised 30 patients with mild to moderate peri-implantitis. A baseline clinical examination and microbiological assessment were conducted, followed by an antibiotics treatment (azithromycin, 500mg, once a day for 3 days). Subjects were divided into probiotic and placebo groups. The clinical examination and bacterial sampling were performed 0, 4, 12 and 24 weeks after the intake of probiotics. The clinical examination included probing pocket depth (PPD), bleeding on probing (BOP), the modified plaque index (mPI), and modified bleeding index (mBI). The number of bacteria was assessed using the PCR-invader method. The Wilcoxon rank-sum test and Wilcoxon signed-rank test with Bonferroni corrections were used for data analyses. Although the number of bacteria decreased after the administration of azithromycin in both groups, they increased again thereafter. No significant difference was observed in bacterial numbers between the two groups. Although PPD in the probiotics group was significantly lower at 4 and 24 weeks than at 0 weeks (pprobiotics group than in the placebo group (pprobiotics prevent inflammation by affecting host responses rather than improving microbial flora in peri-implant sulci in peri-implantitis patients. Copyright © 2017 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  20. Combination therapy with biofeedback, loperamide, and stool-bulking agents is effective for the treatment of fecal incontinence in women - a randomized controlled trial.

    Science.gov (United States)

    Sjödahl, Jenny; Walter, Susanna A; Johansson, Elin; Ingemansson, Anna; Ryn, Ann-Katrine; Hallböök, Olof

    2015-08-01

    Biofeedback and medical treatments have been extensively used for moderate fecal incontinence (FI). There is limited data comparing and combining these two treatments. The objective of this study was to evaluate the effect of biofeedback and medical treatments, separately and in combination. Sixty-four consecutive female patients, referred to a tertiary centre for FI, were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination of treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments. Fifty-seven patients completed the study. Median number of leakage episodes during two weeks decreased from 6 to 3 (p biofeedback and medical treatment is effective for symptom relief in FI. The symptom improvement was associated with improved fecal consistency, reduced urgency, and increased rectal sensory thresholds.

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

    Science.gov (United States)

    Quan, ZheFeng; Tian, Ming; Chi, Ping; Li, Xin; He, HaiLi; Luo, Chao

    2015-01-01

    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 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.

  2. Vitamin E and fish oil, separately or in combination, on treatment of primary dysmenorrhea: a double-blind, randomized clinical trial.

    Science.gov (United States)

    Sadeghi, Narges; Paknezhad, Farnoush; Rashidi Nooshabadi, Mohamadreza; Kavianpour, Maria; Jafari Rad, Sima; Khadem Haghighian, Hossein

    2018-03-15

    Primary dysmenorrhea is one of the most common complaints of women. The aim of this study was to investigate the adjuvant effect of vitamin E and omega-3 fatty acids, separately or in combination, supplements on pain in the treatment of primary dysmenorrhea. This clinical trial conducted on students of university. Qualified girls completed the VAS before randomization. Arrangement was determined according to the severity of the pain (mild 0-3; moderate 3.1-6; severe 6.1-10). One hundred patients were randomly assigned to four groups receiving omega-3 (n = 25), vitamin E (n = 25), vitamin E- omega-3 (n = 25), or placebo (n = 25). Three hundred milligrams of omega-3 capsules (180 mg EPA and 120 mg DHA) and 200 international units (IU) vitamin E were administered daily. Severity of the pain measured in the beginning and the end of the study. Omega-3 and vitamin E supplements effectively relieved menstrual pain compared with the placebo. But in group with combination of vitamin E + omega-3 has a considerable effect on menstrual pain when compared with other groups (p E are helpful in reducing of dysmenorrhea pain and can be replaced with them.

  3. A randomized 9-month study of blood pressure and body fat responses to aerobic training versus combined aerobic and resistance training in older men.

    Science.gov (United States)

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

    2013-08-01

    This randomized study evaluated the impact of different exercise training modalities on blood pressure and body fat responses in apparently healthy older men. Forty-eight elderly men (aged 65-75 years) were randomly assigned to an aerobic training group (ATG, n=15), a combined aerobic and resistance training group (CTG, n=16), or a control group (n=17). Both exercise training programs were moderate-to-vigorous intensity, three days/week for 9-months. Strength, aerobic endurance, body fat and blood pressure were measured on five different occasions. The data were analyzed using a mixed-model ANOVA, and the independence between systolic blood pressure (SBP), diastolic blood pressure (DBP) and group was tested. A significant main effect of group (pendurance, with higher performance observed in the CTG. A significant main effect of group (ptraining programs reduce resting blood pressure. However, only the combined exercise training was effective at reducing body fat percentage; consequently, there were larger changes in blood pressure, which result in a significant reduction in hypertensive subjects. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. To evaluate and compare the efficacy of combined sucrose and non-nutritive sucking for analgesia in newborns undergoing minor painful procedure: a randomized controlled trial.

    Science.gov (United States)

    Thakkar, P; Arora, K; Goyal, K; Das, R R; Javadekar, B; Aiyer, S; Panigrahi, S K

    2016-01-01

    The objective of this study was to evaluate and compare the efficacy of combined sucrose and non-nutritive sucking (NNS) for analgesia in newborn infants undergoing heel-stick procedures. This randomized control trial was conducted in the neonatal intensive care unit of a tertiary care hospital over a period of 1 year. One hundred and eighty full-term neonates with birth weight >2200 g and age >24 h were randomized to one of four interventions administered 2 min before the procedure: 2 ml of 30% sucrose (group I, n=45) or NNS (group II, n=45) or both (group III, n=45) or none (group IV, n=45). Primary outcome was composite score based on Premature Infant Pain Profile (PIPP) score. Baseline variables were comparable among the groups. Median (interquartile range) PIPP score was 3 (2 to 4) in group III as compared with 7 (6.5 to 8) in group I, 9 (7 to 11) in group II and 13 (10.5 to 15) in group IV. Group III had significant decrease in the median PIPP score compared with other groups (P=0.000). Median PIPP score also decreased significantly with any intervention as compared with no intervention (P=0.000). Sucrose and/or NNS are effective in providing analgesia in full-term neonates undergoing heel-stick procedures, with the combined intervention being more effective compared with any single intervention.

  5. 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.

  6. Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

    2018-01-30

    It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

  7. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Sivalingam, Sri; Streeper, Necole M; Sehgal, Priyanka D; Sninsky, Brian C; Best, Sara L; Nakada, Stephen Y

    2016-02-01

    Ureteral stent discomfort is a significant postoperative problem for many patients. Despite the use of narcotics and α-blockers patients often experience bothersome lower urinary tract symptoms and pain, which impair daily activities. We compared combination therapy with an α-blocker and an anticholinergic to monotherapy with an α-blocker. A double-blind, randomized, controlled trial was performed from December 2012 to April 2014. A total of 80 patients were randomized, including 44 to the combination group (tamsulosin 0.4 mg and tolterodine early release 4 mg) and 36 to the monotherapy group (tamsulosin 0.4 mg and placebo). Patients with preexisting ureteral stent placement or current anticholinergic therapy were excluded from study. Patients completed USSQ (Urinary Stent Symptom Questionnaire) before stent placement on the day of surgery, the day after stent placement, the morning of stent removal and the day after stent removal. The questionnaire included questions regarding urinary symptoms, general health, body pain, and work and sexual history. A total of 80 patients (40 males and 40 females) were studied. Mean age was 51.5 vs 51.3 years (p = 0.95) and mean body mass index was 33.6 vs 31.9 kg/m(2) (p = 0.44) in monotherapy group 1 vs combination therapy group 2. Between the 2 groups there was no significant difference in urinary symptoms, body pain and activities of daily living from baseline to just before stent removal (p = 0.95, 0.40 and 0.95, respectively). Although there was no difference between the groups, both showed improvement in urinary symptoms from the time of initial stent insertion to just prior to stent removal (difference -0.50 for combination therapy and -0.40 for monotherapy). The mean stent indwelling time of 9.6 and 8.7 days in the combination and monotherapy groups, respectively, did not differ (p = 0.67). On ANOVA it had no significant impact on results (p = 0.64). Combination therapy with tamsulosin and tolterodine does not

  8. Combining physical training with transcranial direct current stimulation to improve gait in Parkinson's disease: a pilot randomized controlled study.

    Science.gov (United States)

    Kaski, D; Dominguez, R O; Allum, J H; Islam, A F; Bronstein, A M

    2014-11-01

    To improve gait and balance in patients with Parkinson's disease by combining anodal transcranial direct current stimulation with physical training. In a double-blind design, one group (physical training; n = 8) underwent gait and balance training during transcranial direct current stimulation (tDCS; real/sham). Real stimulation consisted of 15 minutes of 2 mA transcranial direct current stimulation over primary motor and premotor cortex. For sham, the current was switched off after 30 seconds. Patients received the opposite stimulation (sham/real) with physical training one week later; the second group (No physical training; n = 8) received stimulation (real/sham) but no training, and also repeated a sequential transcranial direct current stimulation session one week later (sham/real). Hospital Srio Libanes, Buenos Aires, Argentina. Sixteen community-dwelling patients with Parkinson's disease. Transcranial direct current stimulation with and without concomitant physical training. Gait velocity (primary gait outcome), stride length, timed 6-minute walk test, Timed Up and Go Test (secondary outcomes), and performance on the pull test (primary balance outcome). Transcranial direct current stimulation with physical training increased gait velocity (mean = 29.5%, SD = 13; p transcranial direct current stimulation alone. There was no isolated benefit of transcranial direct current stimulation alone. Although physical training improved gait velocity (mean = 15.5%, SD = 12.3; p = 0.03), these effects were comparatively less than with combined tDCS + physical therapy (p stimulation-related improvements were seen in patients with more advanced disease. Anodal transcranial direct current stimulation during physical training improves gait and balance in patients with Parkinson's disease. Power calculations revealed that 14 patients per treatment arm (α = 0.05; power = 0.8) are required for a definitive trial. © The Author(s) 2014.

  9. 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

  10. Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: a randomized controlled trial.

    Science.gov (United States)

    Loguercio, Carmela; Andreone, Pietro; Brisc, Ciprian; Brisc, Michaela Cristina; Bugianesi, Elisabetta; Chiaramonte, Maria; Cursaro, Carmela; Danila, Mirela; de Sio, Ilario; Floreani, Annarosa; Freni, Maria Antonietta; Grieco, Antonio; Groppo, Marzia; Lazzari, Roberta; Lobello, Salvatore; Lorefice, Elisabetta; Margotti, Marzia; Miele, Luca; Milani, Stefano; Okolicsanyi, Lajos; Palasciano, Giuseppe; Portincasa, Piero; Saltarelli, Patrizia; Smedile, Antonina; Somalvico, Francesco; Spadaro, Aldo; Sporea, Ioan; Sorrentino, Paolo; Vecchione, Raffaela; Tuccillo, Concetta; Del Vecchio Blanco, Camillo; Federico, Alessandro

    2012-05-01

    The only currently recommended treatment for nonalcoholic fatty liver disease (NAFLD) is lifestyle modification. Preliminary studies of silybin showed beneficial effects on liver function. Realsil (RA) comprises the silybin phytosome complex (silybin plus phosphatidylcholine) coformulated with vitamin E. We report on a multicenter, phase III, double-blind clinical trial to assess RA in patients with histologically documented NAFLD. Patients were randomized 1:1 to RA or placebo (P) orally twice daily for 12 months. Prespecified primary outcomes were improvement over time in clinical condition, normalization of liver enzyme plasma levels, and improvement of ultrasonographic liver steatosis, homeostatic model assessment (HOMA), and quality of life. Secondary outcomes were improvement in liver histologic score and/or decrease in NAFLD score without worsening of fibrosis and plasma changes in cytokines, ferritin, and liver fibrosis markers. We treated 179 patients with NAFLD; 36 were also HCV positive. Forty-one patients were prematurely withdrawn and 138 patients analyzed per protocol (69 per group). Baseline patient characteristics were generally well balanced between groups, except for steatosis, portal infiltration, and fibrosis. Adverse events (AEs) were generally transient and included diarrhea, dysgeusia, and pruritus; no serious AEs were recorded. Patients receiving RA but not P showed significant improvements in liver enzyme plasma levels, HOMA, and liver histology. Body mass index normalized in 15% of RA patients (2.1% with P). HCV-positive patients in the RA but not the P group showed improvements in fibrogenesis markers. This is the first study to systematically assess silybin in NAFLD patients. Treatment with RA but not P for 12 months was associated with improvement in liver enzymes, insulin resistance, and liver histology, without increases in body weight. These findings warrant further investigation. Copyright © 2012 Elsevier Inc. All rights reserved.

  11. 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.

  12. 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.

  13. 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

  14. Effect of combined maternal and infant food-allergen avoidance on development of atopy in early infancy: a randomized study.

    Science.gov (United States)

    Zeiger, R S; Heller, S; Mellon, M H; Forsythe, A B; O'Connor, R D; Hamburger, R N; Schatz, M

    1989-07-01

    The effect of maternal and infant avoidance of allergenic foods on food allergy was examined in a prenatally randomized, controlled trial of infants of atopic parents. The diet of the prophylactic-treated group (N = 103) included (1) maternal avoidance of cow's milk, egg, and peanut during the third trimester of pregnancy and lactation and (2) infant use of casein hydrolysate (Nutramigen) for supplementation or weaning, and avoidance of solid foods for 6 months; cow's milk, corn, soy, citrus, and wheat, for 12 months; and egg, peanut, and fish, for 24 months. In the control group (N = 185), mothers had unrestricted diets, and infants followed American Academy of Pediatrics feeding guidelines. The cumulative prevalence of atopy was lower at 12 months in the prophylactic-treated (16.2%) compared to the control (27.1%) group (p = 0.039), resulting from reduced food-associated atopic dermatitis, urticaria and/or gastrointestinal disease by 12 months (5.1% versus 16.4%; p = 0.007), and any positive food skin test by 24 months (16.5% versus 29.4%; p = 0.019), caused primarily by fewer positive milk skin tests (1% versus 12.4%; p = 0.001). The prevalences of allergic rhinitis, asthma, and inhalant skin tests were unaffected. Serum IgE levels in the prophylactic-treated group were marginally lower only at 4 months. Thus, reduced exposure of infants to allergenic foods appeared to reduce food sensitization and allergy primarily during the first year of life.

  15. Comparison between the combination of gabapentin, ketamine, lornoxicam, and local ropivacaine and each of these drugs alone for pain after laparoscopic cholecystectomy: a randomized trial.

    Science.gov (United States)

    Kotsovolis, Georgios; Karakoulas, Konstantinos; Grosomanidis, Vasileios; Tziris, Nikolaos

    2015-04-01

    The main purpose of the study was to test whether the combination of gabapentin (600 mg 4 hours before surgery, 600 mg after 24 hours), ketamine (0.3 mg/kg before anesthesia), lornoxicam (8 mg before anesthesia and 8 mg/12 hours), and local ropivacaine (5 mL 7.5% at insertion sites) provides superior analgesia to each of these drugs alone in the first 24 hours after laparoscopic cholecystectomy. The secondary purpose was to examine whether this combination has less opioid-related side effects. This was a 2-center randomized placebo-controlled trial. One hundred forty-eight patients, between 18 and 70 years of age, were randomly assigned to 6 groups (28 in each group) with the use of computer software: A(gabapentin/ketamine/lornoxicam/ropivacaine); B(gabapentin/placebo/placebo/placebo); C (placebo/ketamine/placebo/placebo); D (placebo/placebo/lornoxicam/placebo); E (placebo/placebo/placebo/ropivacaine); and F (placebo/placebo/placebo/placebo). Only the principal investigator was aware of patients' allocation and provided drugs and placebo in covered prefilled syringes. The primary outcome of the study was the 24-hour morphine consumption. Secondary outcomes were frequency of opioid-related side effects (nausea, vomiting, sedation, pruritus, and dysuria). Only groups A (6.4 mg), B (9.46 mg), and D (9.36 mg) had lower morphine consumption than control group (20.29 mg) (P ketamine, lornoxicam, and local ropivacaine does not provide superior analgesia than gabapentin alone or lornoxicam alone after laparoscopic cholecystectomy. The combination reduces only the frequency of postoperative nausea, but larger studies are needed for safer results. © 2014 World Institute of Pain.

  16. 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.

    Science.gov (United States)

    Thibaut, Aurore; Russo, Cristina; Hurtado-Puerto, Aura Maria; Morales-Quezada, Jorge Leon; Deitos, Alícia; Petrozza, John Christopher; Freedman, Steven; Fregni, Felipe

    2017-01-01

    Chronic 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. A pilot crossover randomized controlled study. Out-patient. Adults with CVP (>3 months). Participants 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. We 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. This 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.

  17. 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.

  18. 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.

  19. Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.

    Science.gov (United States)

    Strand, Vibeke; Kremer, Joel M; Gruben, David; Krishnaswami, Sriram; Zwillich, Samuel H; Wallenstein, Gene V

    2017-04-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). In a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with ≥1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). At month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo. © 2016, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

  20. 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.

  1. Combining random forest and 2D correlation analysis to identify serum spectral signatures for neuro-oncology.

    Science.gov (United States)

    Smith, Benjamin R; Ashton, Katherine M; Brodbelt, Andrew; Dawson, Timothy; Jenkinson, Michael D; Hunt, Neil T; Palmer, David S; Baker, Matthew J

    2016-06-07

    Fourier transform infrared (FTIR) spectroscopy has long been established as an analytical technique for the measurement of vibrational modes of molecular systems. More recently, FTIR has been used for the analysis of biofluids with the aim of becoming a tool to aid diagnosis. For the clinician, this represents a convenient, fast, non-subjective option for the study of biofluids and the diagnosis of disease states. The patient also benefits from this method, as the procedure for the collection of serum is much less invasive and stressful than traditional biopsy. This is especially true of patients in whom brain cancer is suspected. A brain biopsy is very unpleasant for the patient, potentially dangerous and can occasionally be inconclusive. We therefore present a method for the diagnosis of brain cancer from serum samples using FTIR and machine learning techniques. The scope of the study involved 433 patients from whom were collected 9 spectra each in the range 600-4000 cm(-1). To begin the development of the novel method, various pre-processing steps were investigated and ranked in terms of final accuracy of the diagnosis. Random forest machine learning was utilised as a classifier to separate patients into cancer or non-cancer categories based upon the intensities of wavenumbers present in their spectra. Generalised 2D correlational analysis was then employed to further augment the machine learning, and also to establish spectral features important for the distinction between cancer and non-cancer serum samples. Using these methods, sensitivities of up to 92.8% and specificities of up to 91.5% were possible. Furthermore, ratiometrics were also investigated in order to establish any correlations present in the dataset. We show a rapid, computationally light, accurate, statistically robust methodology for the identification of spectral features present in differing disease states. With current advances in IR technology, such as the development of rapid discrete

  2. NUMERICAL MODELING OF THE DISRUPTION OF COMET D/1993 F2 SHOEMAKER-LEVY 9 REPRESENTING THE PROGENITOR BY A GRAVITATIONALLY BOUND ASSEMBLAGE OF RANDOMLY SHAPED POLYHEDRA

    Energy Technology Data Exchange (ETDEWEB)

    Movshovitz, Naor; Asphaug, Erik; Korycansky, Donald, E-mail: nmovshov@ucsc.edu [Department of Earth and Planetary Sciences, University of California, Santa Cruz, 1156 High Street, Santa Cruz, CA 95064 (United States)

    2012-11-10

    We advance the modeling of rubble-pile solid bodies by re-examining the tidal breakup of comet Shoemaker-Levy 9, an event that occurred during a 1.33 R encounter with Jupiter in 1992 July. Tidal disruption of the comet nucleus led to a chain of sub-nuclei {approx}100-1000 m diameter; these went on to collide with the planet two years later. They were intensively studied prior to and during the collisions, making SL9 the best natural benchmark for physical models of small-body disruption. For the first time in the study of this event, we use numerical codes treating rubble piles as collections of polyhedra. This introduces forces of dilatation and friction, and inelastic response. As in our previous studies we conclude that the progenitor must have been a rubble pile, and we obtain approximately the same pre-breakup diameter ({approx}1.5 km) in our best fits to the data. We find that the inclusion of realistic fragment shapes leads to grain locking and dilatancy, so that even in the absence of friction or other dissipation we find that disruption is overall more difficult than in our spheres-based simulations. We constrain the comet's bulk density at {rho}{sub bulk} {approx} 300-400 kg m{sup -3}, half that of our spheres-based predictions and consistent with recent estimates derived from spacecraft observations.

  3. Improving visual functions in adult amblyopia with combined perceptual training and transcranial random noise stimulation (tRNS

    Directory of Open Access Journals (Sweden)

    Gianluca eCampana

    2014-12-01

    Full Text Available Amblyopia is a visual disorder due to an abnormal pattern of functional connectivity of the visual cortex and characterized by several visual deficits of spatial vision including impairments of visual acuity (VA and of the contrast sensitivity function (CSF. Despite being a developmental disorder caused by reduced visual stimulation during early life (critical period, several studies have shown that extensive visual perceptual training can improve VA and CSF in people with amblyopia even in adulthood. With the present study we assessed whether a much shorter perceptual training regime, in association with high-frequency transcranial electrical stimulation (hf-tRNS, was able to improve visual functions in a group of adult participants with amblyopia. Results show that, in comparison with previous studies where a large number sessions with a similar training regime were used (Polat, Ma-Naim, Belkin & Sagi, 2004, here just eight sessions of training in contrast detection under lateral masking conditions combined with hf-tRNS, were able to substantially improve VA and CSF in adults with amblyopia.

  4. A JASTRO study group report. A randomized phase III trial of hyperthermia in combination with radiotherapy for superficial tumors

    International Nuclear Information System (INIS)

    Hiraoka, Masahiro; Nishimura, Yasumasa; Mitsumori, Michihide

    1998-01-01

    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.)

  5. Mindfulness-based relapse prevention combined with virtual reality cue exposure for methamphetamine addiction: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chen, XiJing; Wang, Dongmei; Zhou, Lidan; Winkler, Markus; Pauli, Paul; Sui, Nan; Li, Yonghui

    2018-04-18

    Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research shows that MBRP can effectively reduce negative emotions and craving in people with substance use disorders (SUDs). An important part of MBRP is to practice mindfulness meditation to cope with high-risk situations for relapse, such as stimuli and situations associated with drug taking. Virtual reality cue exposure (VRCE) may be a complementary approach to MBRP as it allows for controlled and graded presentations of various high-risk situations with distal and proximal drug cues. The aim of the study is to investigate the effects of MBRP combined with VRCE, in comparison to MBRP alone or treatment as usual, on craving and emotional responses in people with methamphetamine use disorders. The study is a parallel randomized controlled study including 180 participants with methamphetamine use disorders. Three parallel groups will receive 8 weeks of MBRP combined with VRCE, MBRP alone, or treatment as usual, respectively. Craving, virtual cue reactivity, anxiety, depression, emotion regulation, mindfulness and drug-related attention bias will be assessed at pre-treatment, post-treatment, and 3 and 6 months of follow-up. This innovative study aims at investigating the effects of MBRP combined with VRCE in people with SUDs. The combined intervention may have important clinical implications for relapse prevention due to its ease of application and high cost-effectiveness. This study may also stimulate research on the neuronal and psychological mechanisms of MBRP in drug addiction. ChiCTR-INR-17013041. Copyright © 2018. Published by Elsevier Inc.

  6. 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.

  7. 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.

  8. A cluster randomized controlled cross-over bed net acceptability and preference trial in Solomon Islands: community participation in shaping policy for malaria elimination

    Directory of Open Access Journals (Sweden)

    Appleyard Bridget

    2009-12-01

    Full Text Available Abstract Background A key component of the malaria elimination strategy in Solomon Islands (SI is widespread coverage of long-lasting insecticidal nets (LLINs. The success of this strategy is dependent on LLIN acceptability and compliance. There has been unresolved debate among policy makers and donors as to which type of LLIN would be most appropriate for large-scale distribution in SI, and anecdotal reports of a lack of acceptability of certain brands of LLINs. A cluster randomized controlled crossover bed net acceptability and preference trial was therefore carried out from July to September, 2008 to inform policy and to facilitate community engagement and participation in the selection of the most appropriate LLIN for use in SI. Method A three-stage sampling method was used to randomly select the study population from Malaita Province, SI. Three brands of LLINs were assessed in this study: Olyset®, PermaNet® and DuraNet®. Bed net acceptability and preference were evaluated through surveys at three defined time points after short and longer-term trial of each LLIN. Results The acceptability of PermaNet® after short-term use (96.5% was significantly greater than Olyset® (67.3%, p and DuraNet® (69.8%, p . The acceptability of DuraNet® and Olyset® after short-term use was not significantly different at the 5% level. LLINs that were perceived not to prevent mosquito bites were significantly less acceptable than LLINs that were perceived to prevent mosquito bites (OR 0.15; 95%CI 0.03 to 0.6. LLINs that allow a pleasant night's sleep (OR 6.3; 95%CI:3.3-12.3 and have a soft texture (OR 5.7; 95%CI:1.9-20.5 were considered more acceptable than those that did not. Olyset®'s acceptability decreased over time and this was due to net wrinkling/shrinkage after washing resulting in reduced efficiency in preventing mosquito bites. The increase in DuraNet® acceptability was a result of a reduction in minor adverse events following longer-term use

  9. 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.

  10. Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms

    Directory of Open Access Journals (Sweden)

    Essam Shalaby

    2013-01-01

    Full Text Available Purpose. We evaluated the effectiveness and safety of tamsulosin, solifenacin, and combination of both in reducing double-J stent-related lower urinary symptoms. Materials and Methods. A total of 338 patients with double-J ureteral stenting were randomly divided, postoperatively, into 4 groups. In group I (, no treatment was given (control group, group II ( received tamsulosin 0.4 mg daily, group III ( received solifenacin 10 mg daily, and group IV ( received a combination of both medications. Before insertion and 2 weeks after, all patients completed the International Prostate Symptom Score (IPSS, quality of life component of the IPSS (IPSS/Qol, Overactive Bladder Questionnaire (OAB-q, and Visual Analogue Pain Scale (VAPS questionnaire. Results. The demographics and preoperative questionnaires scores of all groups were comparable. There were statistically significant differences in all scores in favour of groups II, III, and IV as compared to control group ( value < 0.005. Group IV showed statistically significant differences in total IPSS, QoL score, and OAB-q score as compared to groups II and III ( value < 0.001. Conclusions. Combined therapy of tamsulosin and solifenacin significantly alleviated lower urinary symptoms associated with double-J stents as compared to either medication alone.

  11. 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.

  12. Travoprost 0.004%/timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled-masked comparison of safety and efficacy.

    Science.gov (United States)

    Kitazawa, Y; Smith, P; Sasaki, N; Kotake, S; Bae, K; Iwamoto, Y

    2011-09-01

    The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension. In this prospective randomized controlled trial, subjects with IOP of at least 22  mm Hg in one or both eyes at 0900  h, and IOP of at least 21  mm Hg in one or both eyes at 1100  h and 1600  h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900  h) for 6 weeks. IOP was assessed at 0900  h, 1100  h, and 1600  h at each scheduled visit (baseline, 2 and 6 weeks after randomization). Mean IOP reduction across all visits and time points was 8.0  mm Hg in the TRA/TIM BAK-free group and 8.4  mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7  mm Hg across visits and time points, with a mean pooled difference of 0.4  mm Hg (95% CI: -0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group. Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified.

  13. Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial.

    Science.gov (United States)

    Roehrborn, Claus G; Barkin, Jack; Siami, Paul; Tubaro, Andrea; Wilson, Timothy H; Morrill, Betsy B; Gagnier, R Paul

    2011-03-01

    • To investigate the influence of baseline variables on the 4-year incidence of acute urinary retention (AUR), benign prostatic hyperplasia (BPH)-related surgery and overall clinical progression in men treated with tamsulosin, dutasteride, or a combination of both. • The 4-year Combination of Avodart® and Tamsulosin (CombAT) study was a multicenter, randomized, double-blind, parallel-group study of clinical outcomes in men aged ≥ 50 years with symptomatic (International Prostate Symptom Score [IPSS]≥ 12) BPH, with prostate-specific antigen (PSA) levels of ≥ 1.5 ng/mL and ≤ 10 ng/mL, and a prostate volume (PV) of ≥ 30 mL. • Eligible patients received tamsulosin 0.4 mg, dutasteride 0.5 mg, or a combination of both. • The primary endpoint was time to first AUR or BPH-related surgery. Secondary endpoints included clinical progression of BPH and symptoms. Posthoc analyses of the influence of baseline variables (including age, IPSS health-related quality of life [HRQL], PV, PSA, IPSS, peak urinary flow rate [Q(max) ] and body-mass index [BMI]) on the incidence of AUR or BPH-related surgery, clinical progression of BPH, and symptoms were performed. • There were 4844 men in the intent-to-treat population. Overall baseline characteristics were similar across all patient groups. • Regardless of baseline subgroup, the incidence of AUR or BPH-related surgery was higher in men treated with tamsulosin than in those treated with dutasteride or combined therapy. • Combined therapy was statistically better than tamsulosin in reducing the risk of AUR or BPH-related surgery in subgroups of baseline PV > 42.0 mL, in all subgroups of baseline PSA level, and all other baseline subgroups (P ≤ 0.001). • Across treatment groups, the incidence of clinical progression was highest in men with a baseline IPSS of BPH-related surgery and greater reductions in the RR of clinical progression and symptom deterioration on combined therapy or dutasteride monotherapy than

  14. Magnetic shape memory behaviour

    International Nuclear Information System (INIS)

    Brown, P.J.; Gandy, A.P.; Ishida, K.; Kainuma, R.; Kanomata, T.; Matsumoto, M.; Morito, H.; Neumann, K.-U.; Oikawa, K.; Ouladdiaf, B.; Ziebeck, K.R.A.

    2007-01-01

    Materials that can be transformed at one temperature T F , then cooled to a lower temperature T M and plastically deformed and on heating to T F regain their original shape are currently receiving considerable attention. In recovering their shape the alloys can produce a displacement or a force, or a combination of the two. Such behaviour is known as the shape memory effect and usually takes place by change of temperature or applied stress. For many applications the transformation is not sufficiently rapid or a change in temperature/pressure not appropriate. As a result, considerable effort is being made to find a ferromagnetic system in which the effect can be controlled by an applied magnetic field. The results of recent experiments on ferromagnetic shape memory compounds aimed at understanding the underlying mechanism will be reviewed

  15. Computation of mean and variance of the radiotherapy dose for PCA-modeled random shape and position variations of the target.

    Science.gov (United States)

    Budiarto, E; Keijzer, M; Storchi, P R M; Heemink, A W; Breedveld, S; Heijmen, B J M

    2014-01-20

    Radiotherapy dose delivery in the tumor and surrounding healthy tissues is affected by movements and deformations of the corresponding organs between fractions. The random variations may be characterized by non-rigid, anisotropic principal component analysis (PCA) modes. In this article new dynamic dose deposition matrices, based on established PCA modes, are introduced as a tool to evaluate the mean and the variance of the dose at each target point resulting from any given set of fluence profiles. The method is tested for a simple cubic geometry and for a prostate case. The movements spread out the distributions of the mean dose and cause the variance of the dose to be highest near the edges of the beams. The non-rigidity and anisotropy of the movements are reflected in both quantities. The dynamic dose deposition matrices facilitate the inclusion of the mean and the variance of the dose in the existing fluence-profile optimizer for radiotherapy planning, to ensure robust plans with respect to the movements.

  16. Computation of mean and variance of the radiotherapy dose for PCA-modeled random shape and position variations of the target

    International Nuclear Information System (INIS)

    Budiarto, E; Keijzer, M; Heemink, A W; Storchi, P R M; Breedveld, S; Heijmen, B J M

    2014-01-01

    Radiotherapy dose delivery in the tumor and surrounding healthy tissues is affected by movements and deformations of the corresponding organs between fractions. The random variations may be characterized by non-rigid, anisotropic principal component analysis (PCA) modes. In this article new dynamic dose deposition matrices, based on established PCA modes, are introduced as a tool to evaluate the mean and the variance of the dose at each target point resulting from any given set of fluence profiles. The method is tested for a simple cubic geometry and for a prostate case. The movements spread out the distributions of the mean dose and cause the variance of the dose to be highest near the edges of the beams. The non-rigidity and anisotropy of the movements are reflected in both quantities. The dynamic dose deposition matrices facilitate the inclusion of the mean and the variance of the dose in the existing fluence-profile optimizer for radiotherapy planning, to ensure robust plans with respect to the movements. (paper)

  17. Combining registration and active shape models for the automatic segmentation of the lymph node regions in head and neck CT images

    International Nuclear Information System (INIS)

    Chen Antong; Deeley, Matthew A.; Niermann, Kenneth J.; Moretti, Luigi; Dawant, Benoit M.

    2010-01-01

    Purpose: Intensity-modulated radiation therapy (IMRT) is the state of the art technique for head and neck cancer treatment. It requires precise delineation of the target to be treated and structures to be spared, which is currently done manually. The process is a time-consuming task of which the delineation of lymph node regions is often the longest step. Atlas-based delineation has been proposed as an alternative, but, in the authors' experience, this approach is not accurate enough for routine clinical use. Here, the authors improve atlas-based segmentation results obtained for level II-IV lymph node regions using an active shape model (ASM) approach. Methods: An average image volume was first created from a set of head and neck patient images with minimally enlarged nodes. The average image volume was then registered using affine, global, and local nonrigid transformations to the other volumes to establish a correspondence between surface points in the atlas and surface points in each of the other volumes. Once the correspondence was established, the ASMs were created for each node level. The models were then used to first constrain the results obtained with an atlas-based approach and then to iteratively refine the solution. Results: The method was evaluated through a leave-one-out experiment. The ASM- and atlas-based segmentations were compared to manual delineations via the Dice similarity coefficient (DSC) for volume overlap and the Euclidean distance between manual and automatic 3D surfaces. The mean DSC value obtained with the ASM-based approach is 10.7% higher than with the atlas-based approach; the mean and median surface errors were decreased by 13.6% and 12.0%, respectively. Conclusions: The ASM approach is effective in reducing segmentation errors in areas of low CT contrast where purely atlas-based methods are challenged. Statistical analysis shows that the improvements brought by this approach are significant.

  18. 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 ... the long-term consequences of triple class HAART regimens, including the development of broad drug resistance....

  19. 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

  20. 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.

  1. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials.

    Science.gov (United States)

    Sheridan, Stacey L; Golin, Carol; Bunton, Audrina; Lykes, John B; Schwartz, Bob; McCormack, Lauren; Driscoll, David; Bangdiwala, Shrikant I; Harris, Russell P

    2012-11-13

    Professional societies recommend shared decision making (SDM) for prostate cancer screening, however, most efforts have promoted informed rather than shared decision making. The objective of this study is to 1) examine the effects of a prostate cancer screening intervention to promote SDM and 2) determine whether framing prostate information in the context of other clearly beneficial men's health services affects decisions. We conducted two separate randomized controlled trials of the same prostate cancer intervention (with or without additional information on more clearly beneficial men's health services). For each trial, we enrolled a convenience sample of 2 internal medicine practices, and their interested physicians and male patients with no prior history of prostate cancer (for a total of 4 practices, 28 physicians, and 128 men across trials). Within each practice site, we randomized men to either 1) a video-based decision aid and researcher-led coaching session or 2) a highway safety video. Physicians at each site received a 1-hour educational session on prostate cancer and SDM. To assess intervention effects, we measured key components of SDM, intent to be screened, and actual screening. After finding that results did not vary by trial, we combined data across sites, adjusting for the random effects of both practice and physician. Compared to an attention control, our prostate cancer screening intervention increased men's perceptions that screening is a decision (absolute difference +41%; 95% CI 25 to 57%) and men's knowledge about prostate cancer screening (absolute difference +34%; 95% CI 19% to 50%), but had no effect on men's self-reported participation in shared decisions or their participation at their preferred level. Overall, the intervention decreased screening intent (absolute difference -34%; 95% CI -50% to -18%) and actual screening rates (absolute difference -22%; 95% CI -38 to -7%) with no difference in effect by frame. SDM interventions can

  2. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy.

    Science.gov (United States)

    Wood, Robert A; Kim, Jennifer S; Lindblad, Robert; Nadeau, Kari; Henning, Alice K; Dawson, Peter; Plaut, Marshall; Sampson, Hugh A

    2016-04-01

    Although studies of oral immunotherapy (OIT) for food allergy have shown promise, treatment is frequently complicated by adverse reactions and, even when successful, has limited long-term efficacy because benefits usually diminish when treatment is discontinued. We sought to examine whether the addition of omalizumab to milk OIT reduces treatment-related reactions, improves outcomes, or both. This was a double-blind, placebo-controlled trial with subjects randomized to omalizumab or placebo. Open-label milk OIT was initiated after 4 months of omalizumab/placebo with escalation to maintenance over 22 to 40 weeks, followed by daily maintenance dosing through month 28. At month 28, omalizumab was discontinued, and subjects passing an oral food challenge (OFC) continued OIT for 8 weeks, after which OIT was discontinued with rechallenge at month 32 to assess sustained unresponsiveness (SU). Fifty-seven subjects (7-32 years) were randomized, with no significant baseline differences in age, milk-specific IgE levels, skin test results, or OFC results. At month 28, 24 (88.9%) omalizumab-treated subjects and 20 (71.4%) placebo-treated subjects passed the 10-g "desensitization" OFC (P = .18). At month 32, SU was demonstrated in 48.1% in the omalizumab group and 35.7% in the placebo group (P = .42). Adverse reactions were markedly reduced during OIT escalation in omalizumab-treated subjects for percentages of doses per subject provoking symptoms (2.1% vs 16.1%, P = .0005), dose-related reactions requiring treatment (0.0% vs 3.8%, P = .0008), and doses required to achieve maintenance (198 vs 225, P = .008). In this first randomized, double-blind, placebo-controlled trial of omalizumab in combination with food OIT, we found significant improvements in measurements of safety but not in outcomes of efficacy (desensitization and SU). Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  3. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods.

    Science.gov (United States)

    Dieli-Conwright, Christina M; Mortimer, Joanne E; Schroeder, E Todd; Courneya, Kerry; Demark-Wahnefried, Wendy; Buchanan, Thomas A; Tripathy, Debu; Bernstein, Leslie

    2014-04-03

    Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments. This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation. This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform

  4. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods

    International Nuclear Information System (INIS)

    Dieli-Conwright, Christina M; Mortimer, Joanne E; Schroeder, E Todd; Courneya, Kerry; Demark-Wahnefried, Wendy; Buchanan, Thomas A; Tripathy, Debu; Bernstein, Leslie

    2014-01-01

    Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments. This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation. This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform

  5. Effects of Combined Physical and Cognitive Exercises on Cognition and Mobility in Patients With Mild Cognitive Impairment: A Randomized Clinical Trial.

    Science.gov (United States)

    Shimada, Hiroyuki; Makizako, Hyuma; Doi, Takehiko; Park, Hyuntae; Tsutsumimoto, Kota; Verghese, Joe; Suzuki, Takao

    2017-11-17

    Although participation in physical and cognitive activities is encouraged to reduce the risk of dementia, the preventive efficacy of these activities for patients with mild cognitive impairment is unestablished. To compare the cognitive and mobility effects of a 40-week program of combined cognitive and physical activity with those of a health education program. A randomized, parallel, single-blind controlled trial. A population-based study of participants recruited from Obu, a residential suburb of Nagoya, Japan. Between August 2011 and February 2012, we evaluated 945 adults 65 years or older with mild cognitive impairment, enrolled 308, and randomly assigned them to the combined activity group (n = 154) or the health education control group (n = 154). The combined activity program involved weekly 90-minute sessions for 40 weeks focused on physical and cognitive activities. The control group attended 90-minute health promotion classes thrice during the 40-week trial period. The outcome measures were assessed at the study's beginning and end by personnel blinded to mild cognitive impairment subtype and group. The primary endpoints were postintervention changes in scores on (1) the Mini-Mental State Examination as a measure of general cognitive status and memory, (2) the Wechsler Memory Scale-Revised-Logical Memory II, and (3) the Rey Auditory Verbal Learning Test. We applied mobility assessments and assessed brain atrophy with magnetic resonance imaging. Compared with the control group, the combined activity group showed significantly greater scores on the Mini-Mental State Examination (difference = 0.8 points, P = .012) and Wechsler Memory Scale-Revised-Logical Memory II (difference = 1.0, P = .004), significant improvements in mobility and the nonmemory domains and reduced left medial temporal lobe atrophy in amnestic mild cognitive impairment (Z-score difference = -31.3, P physical and cognitive activity improves or maintains

  6. Medium-Chain Triglycerides in Combination with Leucine and Vitamin D Increase Muscle Strength and Function in Frail Elderly Adults in a Randomized Controlled Trial.

    Science.gov (United States)

    Abe, Sakiko; Ezaki, Osamu; Suzuki, Motohisa

    2016-05-01

    Sarcopenia, the loss of skeletal muscle mass, strength, and function, is common in elderly individuals but difficult to treat. A combination of nutrients was investigated to treat sarcopenia in very frail elderly adults. We enrolled 38 elderly nursing home residents (11 men and 27 women with a mean ± SD age of 86.6 ± 4.8 y) in a 3-mo randomized, controlled, single-blind, parallel group trial. The participants were randomly allocated to 3 groups. The first group received a daily l-leucine (1.2 g) and cholecalciferol (20 μg)-enriched supplement with 6 g medium-chain triglycerides (TGs) (MCTs) (LD + MCT); the second group received the same leucine and cholecalciferol-enriched supplement with 6 g long-chain TGs (LD + LCT); and the third group did not receive any supplements (control). The supplement and oils were taken at dinner, and changes in muscle mass, strength, and function were monitored. The increase in body weight in the LD + MCT (1.1 ± 1.0 kg) and LD + LCT (0.8 ± 1.1 kg) groups was greater than that in the control group (-0.5 ± 0.9 kg) (P elderly individuals. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000017567. © 2016 American Society for Nutrition.

  7. Randomized Clinical Trial of Periarticular Drug Injection used in combination Patient-Controlled Analgesia versus Patient-Controlled Analgesia Alone in Total Knee Arthroplasty

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    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.

  8. Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2015-01-01

    Regular physical activity is an important aspect of self-management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalized feedback (PF) or peer support (PS); and there was no study on older people of Asian heritage. Hence, this trial evaluated whether PF only or combined with PS improves physical activity among older Malays with type 2 diabetes (T2DM) compared to usual care only. A three-arm randomized controlled trial was conducted in a primary healthcare clinic in Malaysia. Sixty-nine sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomized to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life, and psychosocial wellbeing. Fifty-two (75.4%) completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p = 0.001). The PS group also had greater improvement in weekly duration (p fitness, and support from friends. Current Controlled Trials ISRCTN71447000.

  9. 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

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    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.

  10. Efficacy of ‘Itrifal Saghir’, a combination of three medicinal plants in the treatment of obesity; A randomized controlled trial

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    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.

  11. Efficacy of tiotropium and indacaterol monotherapy and their combination on dynamic lung hyperinflation in COPD: a random open-label crossover study

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    Fujimoto K

    2017-11-01

    Full Text Available Keisaku Fujimoto,1 Haruna Yamazaki,2 Midori Ura,2 Yoshiaki Kitaguchi3 1Department of Clinical Laboratory Sciences, School of Health Sciences, 2Department of Biomedical Laboratory Science, Graduate School of Medicine, 3First Department of Internal Medicine, School of Medicine, Shinshu University, Matsumoto, Japan Background and objective: The difference in efficacy of long-acting muscarinic antagonists (LAMAs and long-acting β2-agonists (LABAs for dynamic lung hyperinflation (DLH in COPD is unclear. The purpose of this study was to elucidate the difference in efficacy of LAMA and LABA alone and the combination thereof for DLH. Subjects and methods: Thirty stable patients were enrolled and randomly divided into two groups following baseline measurements. One group was treated with 5 µg tiotropium (Respimat inhaler for 4 weeks following a 4-week treatment with 150 µg indacaterol, while the other group was treated with indacaterol for 4 weeks following a 4-week treatment with tiotropium. For both groups, these treatments were followed by a combination of the two drugs for 4 weeks. Pulmonary function tests, including DLH evaluated by metronome-paced incremental hyperventilation and exercise tolerance evaluated by the shuttle-walk test, were performed at the end of each treatment period. Results: In total, 23 patients completed this study. Both tiotropium and indacaterol alone significantly increased forced expiratory volume in 1 second, exercise tolerance, and improved health status. Tiotropium significantly improved DLH, but indacaterol did not. The combination therapy resulted in further improvements in lung function and exercise tolerance, but not in DLH. Conclusion: The efficacy of tiotropium in inhibiting DLH following metronome-paced incremental hyperventilation may be superior to that of 150 µg indacaterol, although the effects on airflow obstruction were the same, and the combination therapy showed further improvement in airflow

  12. Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

    Science.gov (United States)

    Rawal, Narinder; Macquaire, Valery; Catalá, Elena; Berti, Marco; Costa, Rui; Wietlisbach, Markus

    2011-01-01

    This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set) and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable) was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24) and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain) had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0) on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment). Rescue medication leading to withdrawal (diclofenac 50 mg) was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness, somnolence, vomiting, and increased sweating) occurred less frequently in patients under combination treatment (P = 0.004). Tramadol/paracetamol combination tablets provided comparable analgesic efficacy with a better safety profile to tramadol capsules in patients experiencing postoperative pain following ambulatory hand surgery. PMID:21559356

  13. Efficacy of vitamins C, E, and their combination for treatment of restless legs syndrome in hemodialysis patients: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Sagheb, Mohammad Mahdi; Dormanesh, Banafshe; Fallahzadeh, Mohammad Kazem; Akbari, Hamideh; Sohrabi Nazari, Sahar; Heydari, Seyed Taghi; Behzadi, Saeed

    2012-05-01

    Restless legs syndrome (RLS) is a common disorder in hemodialysis patients that leads to insomnia and impaired quality of life. Because high oxidative stress has been implicated in the pathogenesis of RLS, we sought to evaluate the efficacy of vitamins C and E and their combination in reducing the severity of RLS symptoms in hemodialysis patients in this randomized, double-blind, placebo-controlled, four-arm parallel trial. Sixty stable hemodialysis patients who had all four diagnostic criteria for RLS developed by the International Restless Legs Syndrome Group with no acute illness or history of renal stone were randomly allocated to four fifteen-patient parallel groups to receive vitamin C (200 mg) and vitamin E (400 mg), vitamin C (200 mg) and placebo, vitamin E (400 mg) and placebo, and double placebo daily for eight weeks. International Restless Legs Scale (IRLS) scores were measured for all patients at baseline and at the end of treatment phase. The primary outcome was absolute change in IRLS sum score from baseline to the end of treatment phase. Means of IRLS sum score decreased significantly in the vitamins C and E (10.3 ± 5.3, 95% CI: 7.4-13.3), vitamin C and placebo (10 ± 3.5, 95% CI: 8.1-11.9), and vitamin E and placebo groups (10.1 ± 6, 95% CI: 6.8-13.5) compared with the double placebo group (3.1 ± 3, 95% CI: 1.5-4.8), (PVitamins C and E and their combination are safe and effective treatments for reducing the severity of RLS in hemodialysis patients over the short-term. Copyright © 2012 Elsevier B.V. All rights reserved.

  14. Medium-Chain Triglycerides in Combination with Leucine and Vitamin D Benefit Cognition in Frail Elderly Adults: A Randomized Controlled Trial.

    Science.gov (United States)

    Abe, Sakiko; Ezaki, Osamu; Suzuki, Motohisa

    2017-01-01

    The combined supplementation of medium-chain triglycerides (MCTs), L-leucine-rich amino acids, and cholecalciferol (vitamin D 3 ) increase muscle strength and function in frail elderly individuals. However, their effects on cognition are unknown. We enrolled 38 elderly nursing home residents (mean age±SD, 86.6±4.8 y) in a 3-mo randomized, controlled, parallel group trial. The participants were randomly allocated to 3 groups: the first group received a L-leucine (1.2 g)- and cholecalciferol (20 μg)-enriched supplement with 6 g of MCT (LD+MCT); the second group received the same supplement with 6 g of long-chain triglycerides (LD+LCT); and the third group did not receive any supplements (control). Cognition was assessed at baseline and after the 3-mo intervention. The difference in changes among the groups was assessed with ANCOVA, adjusting for age and the baseline value as covariates. After 3 mo, the Mini-Mental State Examination (MMSE) score in the LD+MCT group increased by 10.6% (from 16.6 to 18.4 points, p<0.05). After 3 mo, the Nishimura geriatric rating scale for mental status (NM scale) score in the LD+MCT group increased by 30.6% (from 24.6 to 32.2 points, p<0.001), whereas that in the LD+LCT and control groups decreased by 11.2% (from 31.2 to 27.7 points, p<0.05) and 26.1% (from 27.2 to 20.1 points, p<0.001), respectively. The combined supplementation of MCTs (6 g), L-leucine-rich amino acids, and cholecalciferol may improve cognitive function in frail elderly individuals.

  15. Combined versus single application of tranexamic acid in total knee and hip arthroplasty: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Peng Zhang, M M; Jifeng Li, M M; Xiao Wang, M M

    2017-07-01

    To compare the efficacy and safety of the combined application of both intravenous and topical tranexamic acid versus the single use of either application in patients with total knee and hip arthroplasty. Potentially relevant studies were identified from electronic databases including Medline, PubMed, Embase, ScienceDirect and the Cochrane Library. Patients undergoing primary total knee and hip arthroplasty were included in our studies, with an experimental group that received combined intravenous and topical application of tranexamic acid and a control group that received a single application of tranexamic acid or normal saline. The primary outcomes were total blood loss, hemoglobin decline and transfusion requirements. The secondary outcomes were length of stay, operation time and tranexamic acid-related adverse effects, such as superficial infection, deep vein thrombosis or pulmonary embolism. Modified Jadad scores were used to assess the quality of the included randomized controlled trials (RCTs). The data was pooled using RevMan 5.3. After testing for heterogeneity across studies, the data were aggregated using random-effects modeling when appropriate. We have registered the trial at http://www.researchregistry.com. Six RCTs that included 704 patients met the inclusion criteria. The present meta-analysis indicated significant differences existed in the total blood loss (MD = -134.65, 95% CI: -191.66 to -77.64, P tranexamic acid in total knee and hip arthroplasty was associated with significantly reduced total blood loss, postoperative hemoglobin decline, drainage volume, and transfusion requirements. Based on the limitations of current meta-analysis, well-designed, high-quality RCTs with long-term follow-up are still required. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  16. 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 < .05). A combination of GGNB and IANB could improve the efficacy of anesthesia in mandibular molars with symptomatic 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.

  17. Short-term combined effects of thoracic spine thrust manipulation and cervical spine nonthrust manipulation in individuals with mechanical neck pain: a randomized clinical trial.

    Science.gov (United States)

    Masaracchio, Michael; Cleland, Joshua A; Hellman, Madeleine; Hagins, Marshall

    2013-03-01

    Randomized clinical trial. To investigate the short-term effects of thoracic spine thrust manipulation combined with cervical spine nonthrust manipulation (experimental group) versus cervical spine nonthrust manipulation alone (comparison group) in individuals with mechanical neck pain. Research has demonstrated improved outcomes with both nonthrust manipulation directed at the cervical spine and thrust manipulation directed at the thoracic spine in patients with neck pain. Previous studies have not determined if thoracic spine thrust manipulation may increase benefits beyond those provided by cervical nonthrust manipulation alone. Sixty-four participants with mechanical neck pain were randomized into 1 of 2 groups, an experimental or comparison group. Both groups received 2 treatment sessions of cervical spine nonthrust manipulation and a home exercise program consisting of active range-of-motion exercises, and the experimental group received additional thoracic spine thrust manipulations. Outcome measures were collected at baseline and at a 1-week follow-up, and included the numeric pain rating scale, the Neck Disability Index, and the global rating of change. Participants in the experimental group demonstrated significantly greater improvements (Ppain rating scale and Neck Disability Index at the 1-week follow-up compared to those in the comparison group. In addition, 31 of 33 (94%) participants in the experimental group, compared to 11 of 31 participants (35%) in the comparison group, indicated a global rating of change score of +4 or higher at the 1-week follow-up, with an associated number needed to treat of 2. Individuals with neck pain who received a combination of thoracic spine thrust manipulation and cervical spine nonthrust manipulation plus exercise demonstrated better overall short-term outcomes on the numeric pain rating scale, the Neck Disability Index, and the global rating of change.

  18. 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

  19. A methodology to accurately quantify patellofemoral cartilage contact kinematics by combining 3D image shape registration and cine-PC MRI velocity data.

    Science.gov (United States)

    Borotikar, Bhushan S; Sipprell, William H; Wible, Emily E; Sheehan, Frances T

    2012-04-05

    Patellofemoral osteoarthritis and its potential precursor patellofemoral pain syndrome (PFPS) are common, costly, and debilitating diseases. PFPS has been shown to be associated with altered patellofemoral joint mechanics; however, an actual variation in joint contact stresses has not been established due to challenges in accurately quantifying in vivo contact kinematics (area and location). This study developed and validated a method for tracking dynamic, in vivo cartilage contact kinematics by combining three magnetic resonance imaging (MRI) techniques, cine-phase contrast (CPC), multi-plane cine (MPC), and 3D high-resolution static imaging. CPC and MPC data were acquired from 12 healthy volunteers while they actively extended/flexed their knee within the MRI scanner. Since no gold standard exists for the quantification of in vivo dynamic cartilage contact kinematics, the accuracy of tracking a single point (patellar origin relative to the femur) represented the accuracy of tracking the kinematics of an entire surface. The accuracy was determined by the average absolute error between the PF kinematics derived through registration of MPC images to a static model and those derived through integration of the CPC velocity data. The accuracy ranged from 0.47 mm to 0.77 mm for the patella and femur and from 0.68 mm to 0.86 mm for the patellofemoral joint. For purely quantifying joint kinematics, CPC remains an analytically simpler and more accurate (accuracy <0.33 mm) technique. However, for application requiring the tracking of an entire surface, such as quantifying cartilage contact kinematics, this combined imaging approach produces accurate results with minimal operator intervention. Published by Elsevier Ltd.

  20. Efficacy and safety of gemcitabine-fluorouracil combination therapy in the management of advanced pancreatic cancer: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Qin Li

    Full Text Available Gemcitabine (GEM is the standard first-line chemotherapy that provides limited clinical benefits for patients with locally advanced/metastatic pancreatic adenocarcinoma (LA/MPC. However, the fluorouracil derivatives (CAP and S-1 show promising efficacy in these patients. This study compared the efficacy and safety of GEM with GEM plus fluorouracil drugs in the treatment of LA/MPC.Pubmed, EMBASE and Cochrane Library databases were searched for relevant randomized controlled trials published on or before January 2014. The Cochrane Collaboration's tool was used to assess the risk of bias in randomized trials. The primary end point was overall survival (OS; the secondary end points were one-year survival rate, objective response rate (ORR and toxicity rates (TRs.A total of 8 randomized controlled trials involving 2,126 patients were included in the systematic evaluation. The results showed that OS was significantly improved (HR 0.83, P<0.01; HR 0.87, P = 0.03; HR 0.80, P = 0.01; respectively and ORR was significantly increased (OR 0.51, P<0.01; OR 0.66, P = 0.03; OR 0.35, P<0.01; respectively in the GEM+5-FU/CAP/S-1, GEM+CAP and GEM+S-1 groups compared to the GEM alone group. In addition, the one-year survival rate was significantly increased (OR 0.78 P = 0.01; OR 0.47, P = 0.04; respectively in the GEM+5-FU/CAP/S-1 and GEM+S-1 groups compared to the GEM alone group. The frequency of grade 3/4 TRs were higher in GEM+5-FU/CAP/S-1 group, the significant increase of grade 3/4 neutropenia, thrombocytopenia and diarrhea were observed.GEM combined with fluorouracil drugs significantly improved OS and increased one-year survival rate and ORR compared to GEM alone in LA/MPC patients. GEM combined with fluorouracil drugs may be considered as an acceptable alternative treatment for LA/MPC patients.

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. Combination of support vector machine, artificial neural network and random forest for improving the classification of convective and stratiform rain using spectral features of SEVIRI data

    Science.gov (United States)

    Lazri, Mourad; Ameur, Soltane

    2018-05-01

    A model combining three classifiers, namely Support vector machine, Artificial neural network and Random forest (SAR) is designed for improving the classification of convective and stratiform rain. This model (SAR model) has been trained and then tested on a datasets derived from MSG-SEVIRI (Meteosat Second Generation-Spinning Enhanced Visible and Infrared Imager). Well-classified, mid-classified and misclassified pixels are determined from the combination of three classifiers. Mid-classified and misclassified pixels that are considered unreliable pixels are reclassified by using a novel training of the developed scheme. In this novel training, only the input data corresponding to the pixels in question to are used. This whole process is repeated a second time and applied to mid-classified and misclassified pixels separately. Learning and validation of the developed scheme are realized against co-located data observed by ground radar. The developed scheme outperformed different classifiers used separately and reached 97.40% of overall accuracy of classification.

  6. Evaluation of a fixed-dose combination of benazepril and pimobendan in dogs with congestive heart failure: a randomized non-inferiority clinical trial.

    Science.gov (United States)

    King, Jonathan N; Hirakawa, Atsushi; Sonobe, Junko; Otaki, Hiroshi; Sakakibara, Nobuhiro; Seewald, Wolfgang; Forster, Sophie

    2018-01-31

    A fixed-dose combination tablet of benazepril and pimobendan (Fortekor Plus; Elanco Animal Health) was tested in dogs with congestive heart failure (CHF) caused by myxomatous mitral valve disease (MMVD) in a three-arm, masked, randomized, non-inferiority clinical trial in Japan. The test group (n = 34) received Fortekor Plus twice daily. Two control groups received registered formulations of benazepril (Fortekor; Elanco Animal Health) and pimobendan (Vetmedin; Boehringer Ingelheim Vetmedica) with administration of Vetmedin twice daily and Fortekor twice (Control I, n = 14) or once (Control II, n = 19) daily. Diuretics were used in 22 dogs (32.8%). Global clinical scores decreased significantly from baseline in all groups; there were no significant differences between groups, and non-inferiority of Fortekor Plus compared to Control I, Control II, and combined Control I + II groups was demonstrated. There were no significant differences between groups for relevant clinical chemistry and hematology variables or frequency of all adverse events. Frequency of emesis was significantly ( p = 0.0042) lower in the Fortekor Plus (8.8%) group than in the Control I + II (39.4%) group. In conclusion, Fortekor Plus had non-inferior efficacy and was associated with significantly less emesis compared to Fortekor and Vetmedin in dogs with CHF caused by MMVD.

  7. The protein kinase C (PKC) inhibitors combined with chemotherapy in the treatment of advanced non-small cell lung cancer: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, L L; Cao, F F; Wang, Y; Meng, F L; Zhang, Y; Zhong, D S; Zhou, Q H

    2015-05-01

    The application of newer signaling pathway-targeted agents has become an important addition to chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). In this study, we evaluated the efficacy and toxicities of PKC inhibitors combined with chemotherapy versus chemotherapy alone for patients with advanced NSCLC systematically. Literature retrieval, trials selection and assessment, data collection, and statistic analysis were performed according to the Cochrane Handbook 5.1.0. The outcome measures were tumor response rate, disease control rate, progression-free survival (PFS), overall survival (OS), and adverse effects. Five randomized controlled trials, comprising totally 1,005 patients, were included in this study. Meta-analysis showed significantly decreased response rate (RR 0.79; 95 % CI 0.64-0.99) and disease control rate (RR 0.90; 95 % CI 0.82-0.99) in PKC inhibitors-chemotherapy groups versus chemotherapy groups. There was no significant difference between the two treatment groups regarding progression-free survival (PFS, HR 1.05; 95 % CI 0.91-1.22) and overall survival (OS, HR 1.00; 95 % CI 0.86-1.16). The risk of grade 3/4 neutropenia, leucopenia, and thrombosis/embolism increased significantly in PKC inhibitors combination groups as compared with chemotherapy alone groups. The use of PKC inhibitors in addition to chemotherapy was not a valid alternative for patients with advanced NSCLC.

  8. Comparison of Continuous Femoral Nerve Block with and Without Combined Sciatic Nerve Block after Total Hip Arthroplasty: A Prospective Randomized Study.

    Science.gov (United States)

    Nishio, Shoji; Fukunishi, Shigeo; Fukui, Tomokazu; Fujihara, Yuki; Okahisa, Shohei; Takeda, Yu; Yoshiya, Shinichi

    2017-06-23

    In association with the growing interests in pain management, several modalities to control postoperative pain have been proposed and examined for the efficacy in the recent studies. Various modes of peripheral nerve block have been proposed and the effectiveness and safety have been examined for each of those techniques. We have described our clinical experiences, showing that continuous femoral nerve block could provide a satisfactory analgesic effect after total hip arthroplasty (THA) procedure. In this study, we compared the effectiveness and safety of continuous femoral nerve block with and without sciatic nerve blockade on pain control after THA. Forty patients scheduled for THA were included in the study and randomly divided into 2 groups. Postoperative analgesic measure was continuous femoral nerve block alone, while the identical regimen of continuous femoral nerve block was combined with sciatic nerve block. The amount of postoperative pain was evaluated in the immediate postoperative period, 6 hours, and 12 hours after surgery. Moreover, postoperative complications as well as requirement of supplemental analgesics during the initial 12 hours after surgery were reviewed in the patient record. The obtained study results showed that the supplemental sciatic nerve blockade provided no significant effect on arrival at the postoperative recovery room, while the NRS pain score was significantly reduced by the combined application of sciatic nerve blockade at 6 and 12 hours after surgery. In the investigation of postoperative analgesiarelated complications, no major complication was encountered without significant difference in complication rate between the groups.

  9. Clomiphene citrate, metformin or a combination of both as the first line ovulation induction drug for Asian Indian women with polycystic ovarian syndrome: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sujata Kar

    2015-01-01

    Full Text Available Aim: To compare clomiphene citrate (CC, metformin or the combination of CC and metformin as the first line ovulation induction drug in Asian Indian women with polycystic ovary syndrome (PCOS. Methods: One hundred and five newly diagnosed, treatment naive PCOS women were recruited. They were randomized into any of the three groups: Group I (CC 50-150 mg/day, Group II (metformin 1700 mg/day, and Group III (CC + metformin in similar dosage to Groups I and II. Patients underwent follicular monitoring and advice on timed intercourse. The study period was 6 months, or till pregnant, or till CC resistant. Primary outcome studied was live birth rate (LBR. Secondary outcomes were ovulation rate, pregnancy rate, and early pregnancy loss rate. Results: There was no significant difference among the groups in baseline characteristics and biochemical parameters. LBR was 41.6%, 37.5%, and 28.1%, respectively in Groups III, II, and I. Group III (CC + metformin had the highest ovulation (83.3%, pregnancy (50%, and LBRs (41.6%. Group II (metformin was as good as Group I (CC in all the outcomes. CC + metformin (Group III had statistically significantly higher ovulation rate as compared to CC alone (Group I (P = 0.03; odds ratio: 95% confidence interval: 3.888 [1.08-13.997]. Conclusion: Thus, our study shows that metformin was as good as CC in terms of "LBR" and the combination of CC and metformin gave the highest ovulation and LBR.

  10. 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

  11. The Efficacy and Safety of Tamsulosin Combined with Extracorporeal Shockwave Lithotripsy for Urolithiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Chen, Kai; Mi, Hua; Xu, Guangyu; Liu, Lin; Sun, Xiubin; Wang, Shiping; Meng, Qingrong; Lv, Tao

    2015-10-01

    Many studies have been conducted to investigate adjunctive tamsulosin therapy after extracorporeal shockwave lithotripsy (SWL) for urolithiasis. The results from those studies, however, are still inconsistent. Therefore, we performed a meta-analysis to provide an update on the clinical efficacy and safety of tamsulosin combined with SWL for urolithiasis. A systematic search was performed in PubMed, Cochrane Library, and Embase to identify all relevant randomized controlled trials until January 2015. Two reviewers independently assessed trial quality and extracted data. Meta-analysis was conducted with Review Manager (RevMan), version 5.1. Twenty-one studies (2093 subjects in total) were identified in the current meta-analysis. Compared with a control group, the experimental group (tamsulosin combined with SWL) showed an increased overall benefit for stone expulsion, with pooled risk ratio (RR) of 1.20 (95% confidence interval [CI], 1.15-1.26). With respect to the different geographic regions, European and American had a high possibility of improvement in stone expulsion (RR: 1.33, 95% CI, 1.19-1.49). According to the stone locations (renal, upper and lower ureteral) and sizes (4-10 mm and 11-24 mm), tamsulosin is more useful for lower ureteral stone (RR: 1.28; 95% CI, 1.14-1.43) and larger sized stones (RR: 1.49; 95% CI, 1.28-1.75). The effect estimates did not vary markedly when stratified by follow-up durations but varied by dose of tamsulosin. Furthermore, a shorter expulsion time, reduced occurrence of steinstrasse, fewer incidences of colic, and lower analgesic requirements were observed within the experimental group. In addition, tamsulosin is well tolerated, and its adverse events rarely led to dropouts of patients. Overall, evidence suggests that tamsulosin combined with SWL is safe and effective in enhancing stone expulsion for patients with urolithiasis. Furthermore, high-quality, randomized and placebo-controlled trials evaluating the efficacy and

  12. 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

  13. Efficacy and safety of fixed dose combination of atorvastatin and hydroxychloroquine: a randomized, double-blind comparison with atorvastatin alone among Indian patients with dyslipidemia.

    Science.gov (United States)

    Pareek, Anil; Chandurkar, Nitin; Thulaseedharan, N K; Legha, R; Agarwal, Manish; Mathur, S L; Salkar, H R; Pednekar, Sangeeta; Pai, Vikas; Sriram, Usha; Khyalappa, Rajesh; Parmar, Mahendra; Agrawal, Navneet; Dhruv, Urman; Saxena, Subhash

    2015-11-01

    To evaluate the efficacy and safety of atorvastatin + hydroxychloroquine fixed-dose combination tablets in comparison with atorvastatin alone in treatment of dyslipidemia. This double-blind, randomized, out-patient study was conducted in 328 patients with primary dyslipidemia having low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dL (3.37 mmol/L) to ≤ 250 mg/dL (6.48 mmol/L) and triglycerides ≤ 400 mg/dL (4.52 mmol/L). Eligible patients were randomized to receive either atorvastatin 10 mg (n = 167) or atorvastatin 10 mg + hydroxychloroquine 200 mg (n = 161) for 24 weeks. CTRI/2010/091/006138. To compare percentage change in LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12 and Week 24 between groups. To compare mean change in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), high-sensitivity C-reactive protein (Hs-CRP), and percentage of patients achieving lipid goals at Week 12 and Week 24. At Week 24, percentage reduction in LDL-C (-32.52 [-36.13 to -28.91] vs -39.54 [-43.25 to -35.83]; p = 0.008), TC (-24.41 [-27.10 to -21.72] vs -29.30 [-32.07 to -26.54]; p = 0.013), and non-HDL-C (-30.37 [-33.71 to -27.04] vs -36.76 [-40.18 to -33.33]; p = 0.009) was significantly greater in combination treated patients. Both the treatments showed a significant reduction in triglycerides at Week 24 from baseline, however, this reduction was not statistically significantly different between treatment groups. No significant change in HDL-C was observed in patients from both the treatment groups. At Week 24, change in HbA1c (0.22 [0.07 to 0.37] vs -0.13 [-0.28 to 0.03]; p = 0.002) and FBG was also statistically significant in favor of combination therapy (0.37 [0.07 to 0.67] vs -0.29 [-0.59 to 0.03]; p = 0.003), whereas no statistically significant difference was observed in change in Hs-CRP (p = 0.310). Significantly more patients from the

  14. Vector Triggering Random Decrement for High Identification Accuracy

    DEFF Research Database (Denmark)

    Ibrahim, S. R.; Asmussen, J. C.; Brincker, Rune

    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. W...

  15. A randomized controlled trial to compare fentanyl-propofol and ketamine-propofol combination for procedural sedation and analgesia in laparoscopic tubal ligation

    Directory of Open Access Journals (Sweden)

    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.

  16. Efficacy of Punch Elevation Combined with Fractional Carbon Dioxide Laser Resurfacing in Facial Atrophic Acne Scarring: A Randomized Split-face Clinical Study

    Science.gov (United States)

    Faghihi, Gita; Nouraei, Saeid; Asilian, Ali; Keyvan, Shima; Abtahi-Naeini, Bahareh; Rakhshanpour, Mehrdad; Nilforoushzadeh, Mohammad Ali; Hosseini, Sayed Mohsen

    2015-01-01

    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 (CO2) laser resurfacing combined with punch elevation with fractional CO2 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 CO2 laser treatment and the other received one session of punch elevation combined with two sessions of laser fractional CO2 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 CO2 laser treatment combined with punch elevation had greater efficacy than that with fractional CO2 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 CO2 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. PMID:26538695

  17. Efficacy of punch elevation combined with fractional carbon dioxide laser resurfacing in facial atrophic acne scarring: A randomized split-face clinical study

    Directory of Open Access Journals (Sweden)

    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.

  18. 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; Piriyajarukul, Apatchanee

    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.

  19. A prospective randomized trial of aspirin-clopidogrel combination therapy and dose-adjusted warfarin on indices of thrombogenesis and platelet activation in atrial fibrillation.

    Science.gov (United States)

    Kamath, Sridhar; Blann, Andrew D; Chin, Bernard S P; Lip, Gregory Y H

    2002-08-07

    This study was designed to investigate whether or not combination aspirin-clopidogrel therapy would reduce markers of thrombogenesis and platelet activation in atrial fibrillation (AF), in a manner similar to warfarin. Dose-adjusted warfarin is beneficial as thromboprophylaxis in AF, but potentially serious side effects and regular monitoring leave room for alternative therapies. METHODS; We randomized 70 patients with nonvalvular AF who were not on any antithrombotic therapy to either dose-adjusted warfarin (international normalized ratio 2 to 3) (Group I) or combination therapy with aspirin 75 mg and clopidogrel 75 mg (Group II). Plasma indices of thrombogenesis (fibrin D-dimer, prothrombin fragment 1+2) and platelet activation (beta-thromboglobulin [TG] and soluble P-selectin) were quantified, along with platelet aggregation responses to standard agonists, at baseline (pretreatment) and at six weeks posttreatment. RESULTS; Pretreatment levels of fibrin D-dimer (p = 0.001), beta-TG (p = 0.01) and soluble P-selectin (p = 0.03) were raised in patients with AF, whereas plasma prothrombin fragment 1+2 levels and platelet aggregation were not significantly different compared with controls. Dose-adjusted warfarin reduced plasma levels of fibrin D-dimer, prothrombin fragment 1+2 and beta-thromboglobulin levels at six weeks (all p failed to reduce plasma indices of thrombogenesis and platelet activation in AF, although some aspects of ex vivo platelet aggregation were altered. Anticoagulation with warfarin may be superior to combination aspirin-clopidogrel therapy as thromboprophylaxis in AF.

  20. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia

    Science.gov (United States)

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    Background Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. Material/Methods In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. Results A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). Conclusions Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH. PMID:27260129

  1. [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.

  2. Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

    Directory of Open Access Journals (Sweden)

    Rawal N

    2011-04-01

    Full Text Available Narinder Rawal1, Valery Macquaire2, Elena Catalá3, Marco Berti4, Rui Costa5, Markus Wietlisbach61Department of Anesthesiology and Intensive Care, Örebro University Hospital, Örebro, Sweden; 2Clinique du Parc Leopold, Brussels, Belgium; 3Pain Clinic, Department Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 4Department of Anesthesiology and Reanimation, Parma Hospital, Parma, Italy; 5Garcia de Orta Hospital, Almada, Portugal; 6Department of Anesthesiology, Sursee Hospital, Sursee, SwitzerlandAbstract: This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24 and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0 on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment. Rescue medication leading to withdrawal (diclofenac 50 mg was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness

  3. Preemptive Epidural Analgesia for Postoperative Pain Relief Revisited: Comparison of Combination of Buprenorphine and Neostigmine with Combination of Buprenorphine and Ketamine in Lower Abdominal Surgeries, A Double-blind Randomized Trial.

    Science.gov (United States)

    Choubey, Sanjay; Singh, Raj Bahadur

    2017-01-01

    Postoperative pain relief provides subjective comfort to patient in addition to blunting of autonomic and somatic reflex responses to pain, subsequently enhancing restoration of function by allowing the patient to breathe, cough, and move easily. The aim is to evaluate and compare the effects of neostigmine + buprenorphine and ketamine + buprenorphine for preemptive epidural analgesia for postoperative pain relief in patients undergoing abdominal surgeries under general anesthesia (GA). A double-blind randomized trial. A total of 60 American Society of Anesthesiologists physical status Classes I and II patients undergoing abdominal surgeries under GA were taken up for the study. They were randomly allocated into two groups, Group A and Group B of thirty patients each. Preemptive epidural analgesia for postoperative pain relief was provided by a combination of neostigmine 1 μg/kg + buprenorphine 2 μg/kg in Group A patients and ketamine 1 mg/kg + buprenorphine 2 μg/kg in Group B patients after induction of GA but before surgical incision. Postoperatively, vital parameters, pain score, requirement of top up doses, and side effects in the two groups were observed and recorded at 2, 4, 6, 10, 18, and 22 h. Mean values within each of the Group A and Group B were compared using one-way analysis of variance (one-way ANOVA). Mean values between Group A and Group B were compared using double analysis of variance (two-way ANOVA). Group A patients had a significant analgesia (visual analog scale [VAS] pain scores reduced significantly from 54.6 ± 6.3 at 2 h to 8.1 ± 8.9 at 22 h postoperatively). Group B patients had significant analgesia too (VAS pain scores reduced significantly from 36 ± 12.5 at 2 h to 5.3 ± 10.9 at 22 h postoperatively). There was however no significant difference between the two groups with respect to the degree of postoperative analgesia on comparison of VAS scores, effect on vital parameters, and incidence of side effects. Either of the two

  4. A randomized controlled trial of the effect of combined spinal-epidural analgesia on the success of external cephalic version for breech presentation.

    Science.gov (United States)

    Sullivan, J T; Grobman, W A; Bauchat, J R; Scavone, B M; Grouper, S; McCarthy, R J; Wong, C A

    2009-10-01

    Improving the success of external cephalic version (ECV) for breech presentation may help avoid some cesarean deliveries. The results of randomized trials comparing the success of ECV with neuraxial analgesia compared to control are inconsistent. We hypothesized that combined spinal-epidural (CSE) analgesia would increase the success of ECV when compared with systemic opioid analgesia. Parturients with singleton breech presentation (n=96) were randomized to receive CSE analgesia with bupivacaine 2.5mg and fentanyl 15 microg (CSE group) or intravenous fentanyl 50 microg (SYS group) before ECV attempt. The primary outcome was ECV success. The success rate of ECV was 47% with CSE and 31% in the SYS group (P=0.14). Subsequent vaginal delivery was 36% for CSE and 25% for SYS (P=0.27). Median [IQR] visual analog pain scores (0-100mm scale) were lower with CSE (3 [0-12]) compared to SYS analgesia (36 [16 to 54]) (P<0.005) and patient satisfaction (0-10 scale) was higher (CSE 10 [9 to 10] versus SYS 7 [4 to 9]) (P<0.005). There were no differences in fetal heart rate patterns, but median time to return to fetal heart rate reactivity after analgesia was shorter with CSE (13 [IQR 9-21] min) compared to the SYS group (39 [IQR 23-51] min) (P=0.02). There was no difference in the rate of successful ECV or vaginal delivery with CSE compared to intravenous fentanyl analgesia. Pain scores were lower and satisfaction higher with CSE analgesia, and median time to fetal heart rate reactivity was shorter in the CSE group.

  5. Lercanidipine, enalapril and their combination in the treatment of elderly hypertensive patients: placebo-controlled, randomized, crossover study with four ABPM.

    Science.gov (United States)

    Puig, J G; Calvo, C; Luurila, O; Luurila, H; Sulosaari, S; Strandberg, A; Ghezzi, C

    2007-12-01

    This double-blind, placebo-controlled, four-way balanced design crossover study included hypertensive patients aged 60-85 years with mean office-measured sitting systolic blood pressure (SBP) 160-179 mm Hg and daytime SBP > or =135 mm Hg. After a 2-week run-in period, during which previous medications were discontinued, each patient received the following four treatments in randomized order for 4 weeks each: lercanidipine 10 mg (L), enalapril 20 mg (E), lercanidipine 10 mg plus enalapril 20 mg (L/E) and placebo (P). At the end of each treatment period, office trough blood pressure (BP) was measured and a 24-h Ambulatory Blood Pressure Monitoring (ABPM) was performed. Seventy-five patients (mean age 66 years, office BP 168/92 mm Hg, daytime SBP 151 mm Hg) were randomized and 62 completed the study with four valid post-baseline ABPMs. The administration of P, L, E and L/E was associated with a mean 24-h SBP of 144, 137, 133 and 127 mm Hg, respectively. All active treatments significantly reduced the mean 24-h SBP in comparison with placebo, but L/E was significantly more effective than L and E alone. Similarly, office SBP was significantly more reduced with L/E (-16.9 mm Hg) than with L (-5.0 mm Hg) or E (-5.9 mm Hg). A BP <140/90 mm Hg was recorded in 18% of patients with L, 19% with E and 45% with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events. In conclusion, combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated.

  6. Combined chemotherapy and radiation therapy in advanced inoperable squamous cell carcinoma of the head and neck. The final report of a randomized trial

    International Nuclear Information System (INIS)

    Merlano, M.; Corvo, R.; Margarino, G.; Benasso, M.; Rosso, R.; Sertoli, M.R.; Cavallari, M.; Scala, M.; Guenzi, M.; Siragusa, A.

    1991-01-01

    Between 1983 and 1986, the National Institute for Cancer Research in Genoa and affiliated institutions conducted a randomized study to compare two different ways of combining chemotherapy (CT) and radiation therapy (RT). One hundred sixteen patients were randomized to receive neoadjuvant CT followed by definitive RT (treatment arm A) or alternating CT and RT. In treatment arm A, RT consisted of 70 Gy to the involved areas and 50 Gy to the uninvolved neck at 2 Gy/fraction, five fractions per week. In treatment arm B, RT consisted of 60 Gy to involved areas and 50 Gy to the uninvolved neck in three courses of 20 Gy each, 2 Gy/fraction, ten fractions/2 weeks alternated with four courses of CT. CT consisted of vinblastine 6 mg/m2 intravenously followed 6 hours later by bleomycin 30 IU intramuscularly, day 1; methotrexate 200 mg intravenously, day 2; leucovorin rescue, day 3. CT was repeated every 2 weeks up to four courses. The same CT was used in both treatment arms of the study. Fifty-five patients were entered in treatment arm A and 61 in treatment arm B. Complete responses were 7/48 and 19/57 in treatment arms A and B, respectively (P less than 0.03). Four-year progression-free survival was 4% in treatment arm A and 12% in treatment arm B (P less than 0.02), and four-year survival was 10% in A and 22% in B (P less than 0.02). Mucosal tolerance was significantly worse in treatment arm B (P less than 0.00004). The subgroup analysis shows the major improvement of alternating CT and RT in patients with the worst prognostic characteristics

  7. TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study.

    Science.gov (United States)

    Kwek, Boon Eu Andrew; Ang, Tiing Leong; Ong, Peng Lan Jeannie; Tan, Yi Lyn Jessica; Ang, Shih Wen Daphne; Law, Ngai Moh; Thurairajah, Prem Harichander; Fock, Kwong Ming

    2017-06-01

    Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding. However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT). Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata. This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers. Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group. TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer. Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group. One patient required angio-embolization therapy while three had successful conventional endotherapy. Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related. In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding. Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers. Larger trials are necessary for definitive results. © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  8. Manual therapy in joint and nerve structures combined with exercises in the treatment of recurrent ankle sprains: A randomized, controlled trial.

    Science.gov (United States)

    Plaza-Manzano, Gustavo; Vergara-Vila, Marta; Val-Otero, Sandra; Rivera-Prieto, Cristina; Pecos-Martin, Daniel; Gallego-Izquierdo, Tomás; Ferragut-Garcías, Alejandro; Romero-Franco, Natalia

    2016-12-01

    Recurrent ankle sprains often involve residual symptoms for which subjects often perform proprioceptive or/and strengthening exercises. However, the effectiveness of mobilization to influence important nerve structures due to its anatomical distribution like tibial and peroneal nerves is unclear. To analyze the effects of proprioceptive/strengthening exercises versus the same exercises and manual therapy including mobilizations to influence joint and nerve structures in the management of recurrent ankle sprains. A randomized single-blind controlled clinical trial. Fifty-six patients with recurrent ankle sprains and regular sports practice were randomly assigned to experimental or control group. The control group performed 4 weeks of proprioceptive/strengthening exercises; the experimental group performed 4 weeks of the same exercises combined with manual therapy (mobilizations to influence joint and nerve structures). Pain, self-reported functional ankle instability, pressure pain threshold (PPT), ankle muscle strength, and active range of motion (ROM) were evaluated in the ankle joint before, just after and one month after the interventions. The within-group differences revealed improvements in all of the variables in both groups throughout the time. Between-group differences revealed that the experimental group exhibited lower pain levels and self-reported functional ankle instability and higher PPT, ankle muscle strength and ROM values compared to the control group immediately after the interventions and one month later. A protocol involving proprioceptive and strengthening exercises and manual therapy (mobilizations to influence joint and nerve structures) resulted in greater improvements in pain, self-reported functional joint stability, strength and ROM compared to exercises alone. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study.

    Science.gov (United States)

    Dallari, Dante; Stagni, Cesare; Rani, Nicola; Sabbioni, Giacomo; Pelotti, Patrizia; Torricelli, Paola; Tschon, Matilde; Giavaresi, Gianluca

    2016-03-01

    The effectiveness of intra-articular platelet-rich plasma (PRP) injections has been evaluated in knee chondroplasty and osteoarthritis (OA); however, little evidence of its efficacy in hip OA exists. To compare the therapeutic efficacy of autologous PRP, hyaluronic acid (HA), or a combination of both (PRP+HA) in hip OA. Randomized controlled trial; Level of evidence, 1. Patients aged between 18 and 65 years who were treated with outpatient surgery and who had hip OA and pain intensity at baseline of >20 on a 100-mm visual analog scale (VAS) were recruited for this study. Exclusion criteria were extensive surgery; presence of excessive deformities; or rheumatic, infective, cardiovascular, or immune system disorders. The primary outcome measure was a change in pain intensity as assessed by the VAS at 2, 6, and 12 months after treatment. Secondary outcome measures were the Harris Hip Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and concentration of growth factors in PRP and their correlation with clinical outcomes. Clinical outcomes were evaluated by assessors and collectors blinded to the type of treatment administered. A total of 111 patients were randomly assigned to 3 groups and received 3 weekly injections of either PRP (44 patients), PRP+HA (31 patients), or HA (36 patients). At all follow-ups, the PRP group had the lowest VAS scores. In particular, at 6-month follow-up, the mean VAS score was 21 (95% CI, 15-28) in the PRP group, 35 (95% CI, 26-45) in the PRP+HA group, and 44 (95% CI, 36-52) in the HA group (P injections offer a significant clinical improvement in patients with hip OA without relevant side effects. The benefit was significantly more stable up to 12 months as compared with the other tested treatments. The addition of PRP+HA did not lead to a significant improvement in pain symptoms. © 2016 The Author(s).

  10. 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. This will be analyzed by negative binomial regression, yielding density ratios. This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources. Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

  11. Combination of Tramadol and Lidocaine for Pain Control During Transrectal Ultrasound-guided Prostate Biopsy: A Randomized Double-blinded Study.

    Science.gov (United States)

    Sen, Haluk; Seckiner, Ilker; Bayrak, Omer; Sen, Elzem; Erturhan, Sakip; Yagci, Faruk

    2015-06-01

    To evaluate the efficacy of tramadol, lidocaine, and a combination of tramadol with lidocaine in pain relief using periprostatic nerve block technique by guidance of transrectal ultrasound (TRUS) before the prostate biopsy (PBx). For the indication of TRUS-PBx, the patients with a prostate-specific antigen (PSA) level >4.0 ng/mL or abnormal digital examination findings were selected. The patients were randomized through random method. Group 1: patients were administered 5 mL of 2% lidocaine; group 2: patients were administered 5 mL of 25-mg tramadol; and group 3: patients were administered 5 mL of 2% lidocaine + 25-mg tramadol. The procedures were completed in 10 minutes, and a visual pain scale was administered to the patients to question the pain severity. TRUS-guided PBx was performed in 60 patients with an age range of 57-77 years (mean age, 66.2 ± 7.49 years) and a PSA range of 1-1000 ng/mL. The mean PSA level of the groups was 28.5 (±7.5), 16.1 (±5.0), and 14.9 (±2.9) ng/mL, respectively. The postprocedural pain scores by visual pain scale were 4.6 ± 1.2, 5.4 ± 1.2, and 3.6 ± 0.9 in lidocaine, tramadol, and lidocaine + tramadol groups, respectively. Periprostatic nerve block is the current golden standard method owing to pain management and comfort provided, independent of the patient age and the number of core biopsies. We suggest that tramadol may also be used in this field to achieve better pain management by improving lidocaine's effect or as an alternative to lidocaine. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Platelet rich fibrin combined with decalcified freeze-dried bone allograft for the treatment of human intrabony periodontal defects: a randomized split mouth clinical trail.

    Science.gov (United States)

    Agarwal, Ashish; Gupta, Narinder Dev; Jain, Avikal

    2016-01-01

    Polypeptide growth factors of platelet rich fibrin (PRF) have the potential to regenerate periodontal tissues. Osteoinductive property of demineralized freeze-dried bone allograft (DFDBA) has been successfully utilized in periodontal regeneration. The aim of the present randomized, split mouth, clinical trial was to determine the additive effects of PRF with a DFDBA in the treatment of human intrabony periodontal defects. Sixty interproximal infrabony defects in 30 healthy, non-smoker patients diagnosed with chronic periodontitis were randomly assigned to PRF/DFDBA group or the DFDBA/saline. Clinical [pocket depth (PD), clinical attachment level (CAL) and gingival recession (REC)] and radiographic (bone fill, defect resolution and alveolar crest resorption) measurements were made at baseline and at a 12-month evaluation. Compared with baseline, 12-month results indicated that both treatment modalities resulted in significant changes in all clinical and radiographic parameters. However, the PRP/DFDBA group exhibited statistically significantly greater changes compared with the DFDBA/saline group in PD (4.15 ± 0.84 vs 3.60 ± 0.51 mm), CAL (3.73 ± 0.74 vs 2.61 ± 0.68 mm), REC (0.47 ± 0.56 vs 1.00 ± 0.61 mm), bone fill (3.50 ± 0.67 vs 2.49 ± 0.64 mm) and defect resolution (3.73 ± 0.63 vs 2.75 ± 0.57 mm). Observations indicate that a combination of PRF and DFDBA is more effective than DFDBA with saline for the treatment of infrabony periodontal defects.

  13. 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

    2018-04-01

    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.

  14. Randomized Phase IIA Trial of Gemcitabine Compared With Bleomycin Plus Vincristine for Treatment of Kaposi’s Sarcoma in Patients on Combination Antiretroviral Therapy in Western Kenya

    Directory of Open Access Journals (Sweden)

    Naftali W. Busakhala

    2018-01-01

    Full Text Available Purpose: Kaposi’s sarcoma (KS is a spindle cell tumor resulting from growth dysregulation in the setting of infection with human herpes virus-8 (also called KS herpes virus. Advanced KS is characterized by poor responses to antiretroviral therapy and some of the chemotherapy readily accessible to patients in low-resource areas. Gemcitabine induced partial and complete regression of AIDS-associated KS (AIDS-KS in 11 of 24 patients in a pilot study. The current study compares the antimetabolite gemcitabine with the standard care bleomycin and vincristine (BV in the treatment of chemotherapy-naïve patients with AIDS-KS in a resource-limited setting. Patients and Methods: Patients with persistent or progressive KS despite treatment with combined antiretroviral therapy were randomly assigned to receive gemcitabine 1,000 mg/m2 or bleomycin 15 IU/ m2 and vincristine 1.4 mg/m2 given twice weekly. The main end point was objective response by bidirectional measurement, adverse events, and quality of life after three cycles of chemotherapy. Results: Of 70 participants enrolled, 36 received gemcitabine and 34 received BV. Complete response was achieved in 12 patients (33.3% in the gemcitabine arm and six (17.6% in the BV arm (P = .175. The partial response rate was 52.8% (n = 19 in the gemcitabine arm and 58.8% (n = 20 in the BV arm. Both study arms reported similar neurologic and hematologic adverse events; there was statistically significant baseline to post-treatment improvement in health-related quality-of-life scores. Conclusion: The results of this randomized, phase IIA trial demonstrate gemcitabine activity in chemotherapy-naïve patients with AIDS-KS, on the basis of response rates, adverse events, and health-related quality-of-life scores.

  15. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Sheridan Stacey L

    2012-11-01

    Full Text Available Abstract Background Professional societies recommend shared decision making (SDM for prostate cancer screening, however, most efforts have promoted informed rather than shared decision making. The objective of this study is to 1 examine the effects of a prostate cancer screening intervention to promote SDM and 2 determine whether framing prostate information in the context of other clearly beneficial men’s health services affects decisions. Methods We conducted two separate randomized controlled trials of the same prostate cancer intervention (with or without additional information on more clearly beneficial men’s health services. For each trial, we enrolled a convenience sample of 2 internal medicine practices, and their interested physicians and male patients with no prior history of prostate cancer (for a total of 4 practices, 28 physicians, and 128 men across trials. Within each practice site, we randomized men to either 1 a video-based decision aid and researcher-led coaching session or 2 a highway safety video. Physicians at each site received a 1-hour educational session on prostate cancer and SDM. To assess intervention effects, we measured key components of SDM, intent to be screened, and actual screening. After finding that results did not vary by trial, we combined data across sites, adjusting for the random effects of both practice and physician. Results Compared to an attention control, our prostate cancer screening intervention increased men’s perceptions that screening is a decision (absolute difference +41%; 95% CI 25 to 57% and men’s knowledge about prostate cancer screening (absolute difference +34%; 95% CI 19% to 50%, but had no effect on men’s self-reported participation in shared decisions or their participation at their preferred level. Overall, the intervention decreased screening intent (absolute difference −34%; 95% CI −50% to −18% and actual screening rates (absolute difference −22%; 95% CI −38 to

  16. A Randomized Double-Blind Placebo-Controlled Study of Omalizumab Combined with Oral Immunotherapy for the Treatment of Cow’s Milk Allergy

    Science.gov (United States)

    Wood, Robert A.; Kim, Jennifer S.; Lindblad, Robert; Nadeau, Kari; Henning, Alice K.; Dawson, Peter; Plaut, Marshall; Sampson, Hugh A.

    2017-01-01

    Background Although studies of oral immunotherapy (OIT) for food allergy have shown promise, treatment is frequently complicated by adverse reactions and, even when successful, has limited long-term efficacy as benefits usually diminish when treatment is discontinued. Objective We sought to examine whether the addition of omalizumab to milk OIT (MOIT) reduces treatment-related reactions and/or improves outcomes. Methods This was a double-blind placebo-controlled trial with subjects randomized to omalizumab or placebo. Open-label MOIT was initiated after 4 months of omalizumab/placebo with escalation to maintenance over 22–40 weeks, followed by daily maintenance dosing through month-28. At month-28, omalizumab was discontinued and subjects passing an oral food challenge (OFC) continued OIT for 8 weeks, after which OIT was discontinued with re-challenge at month-32 to assess sustained unresponsiveness (SU). Results Fifty-seven subjects (7–32 years) were randomized, with no significant baseline differences in age, milk-specific IgE, skin tests, or OFCs. At month-28, 24 (88.9%) omalizumab-treated subjects and 20 (71.4%) placebo-treated subjects passed the 10 gram “desensitization” OFC (p=0.18). At month-32, SU was demonstrated in 48.1% in the omalizumab group and 35.7% in the placebo group (p=0.42). Adverse reactions were markedly reduced during OIT escalation in omalizumab subjects for percent doses/subject provoking symptoms (2.1% versus 16.1%; p=0.0005), dose-related reactions requiring treatment (0.0% versus 3.8%, p=0.0008), and doses required to achieve maintenance (198 versus 225; p=0.008). Conclusions In this first randomized double-blinded placebo-controlled trial of omalizumab in combination with food OIT, we found significant improvements in measurements of safety, but not in outcomes of efficacy (desensitization and SU). Trial Registration OIT and XolairR (Omalizumab) in Cow’s Milk Allergy, NCT01157117, http://clinicaltrials.gov/show/NCT01157117

  17. Phase I randomized clinical trial of N-acetylcysteine in combination with an adjuvant probenecid for treatment of severe traumatic brain injury in children.

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    Robert S B Clark

    Full Text Available There are no therapies shown to improve outcome after severe traumatic brain injury (TBI in humans, a leading cause of morbidity and mortality. We sought to verify brain exposure of the systemically administered antioxidant N-acetylcysteine (NAC and the synergistic adjuvant probenecid, and identify adverse effects of this drug combination after severe TBI in children.IRB-approved, randomized, double-blind, placebo controlled Phase I study in children 2 to 18 years-of-age admitted to a Pediatric Intensive Care Unit after severe TBI (Glasgow Coma Scale [GCS] score ≤8 requiring an externalized ventricular drain for measurement of intracranial pressure (ICP. Patients were recruited from November 2011-August 2013. Fourteen patients (n = 7/group were randomly assigned after obtaining informed consent to receive probenecid (25 mg/kg load, then 10 mg/kg/dose q6h×11 doses and NAC (140 mg/kg load, then 70 mg/kg/dose q4h×17 doses, or placebos via naso/orogastric tube. Serum and CSF samples were drawn pre-bolus and 1-96 h after randomization and drug concentrations were measured via UPLC-MS/MS. Glasgow Outcome Scale (GOS score was assessed at 3 months.There were no adverse events attributable to drug treatment. One patient in the placebo group was withdrawn due to adverse effects. In the treatment group, NAC concentrations ranged from 16,977.3±2,212.3 to 16,786.1±3,285.3 in serum and from 269.3±113.0 to 467.9±262.7 ng/mL in CSF, at 24 to 72 h post-bolus, respectively; and probenecid concentrations ranged from 75.4.3±10.0 to 52.9±25.8 in serum and 5.4±1.0 to 4.6±2.1 μg/mL in CSF, at 24 to 72 h post-bolus, respectively (mean±SEM. Temperature, mean arterial pressure, ICP, use of ICP-directed therapies, surveillance serum brain injury biomarkers, and GOS at 3 months were not different between groups.Treatment resulted in detectable concentrations of NAC and probenecid in CSF and was not associated with undesirable effects after TBI in children

  18. Magnetoencephalography for the Detection of Intervention Effects of a Specific Nutrient Combination in Patients with Mild Alzheimer's Disease: Results from an Exploratory Double-Blind, Randomized, Controlled Study.

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    van Straaten, Elisabeth C W; de Waal, Hanneke; Lansbergen, Marieke M; Scheltens, Philip; Maestu, Fernando; Nowak, Rafal; Hillebrand, Arjan; Stam, Cornelis J

    2016-01-01

    Synaptic loss is an early pathological finding in Alzheimer's disease (AD) and correlates with memory impairment. Changes in macroscopic brain activity measured with electro- and magnetoencephalography (EEG and MEG) in AD indicate synaptic changes and may therefore serve as markers of intervention effects in clinical trials. EEG peak frequency and functional networks have shown, in addition to improved memory performance, to be sensitive to detect an intervention effect in mild AD patients of the medical food Souvenaid containing the specific nutrient combination Fortasyn ® Connect, which is designed to enhance synapse formation and function. Here, we explore the value of MEG, with higher spatial resolution than EEG, in identifying intervention effects of the nutrient combination by comparing MEG spectral measures, functional connectivity, and networks between an intervention and a control group. Quantitative markers describing spectral properties, functional connectivity, and graph theoretical aspects of MEG from the exploratory 24-week, double-blind, randomized, controlled Souvenir II MEG sub-study (NTR1975, http://www.trialregister.nl) in drug naïve patients with mild AD were compared between a test group ( n  = 27), receiving Souvenaid, and a control group ( n  = 28), receiving an isocaloric control product. The groups were unbalanced at screening with respect to Mini-Mental State Examination. Peak frequencies of MEG were compared with EEG peak frequencies, recorded in the same patients at similar time points, were compared with respect to sensitivity to intervention effects. No consistent statistically significant intervention effects were detected. In addition, we found no difference in sensitivity between MEG and EEG peak frequency. This exploratory study could not unequivocally establish the value of MEG in detecting interventional effects on brain activity, possibly due to small sample size and unbalanced study groups. We found no indication that

  19. Combined metformin-clomiphene in clomiphene-resistant polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials.

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    Abu Hashim, Hatem; Foda, Osama; Ghayaty, Essam

    2015-09-01

    Our objective was to compare the effectiveness of metformin plus clomiphene citrate vs. gonadotrophins, laparoscopic ovarian diathermy, aromatase inhibitors, N-acetyl-cysteine and other insulin sensitizers+clomiphene for improving fertility outcomes in women with clomiphene-resistant polycystic ovary syndrome. PubMed, SCOPUS and CENTRAL databases were searched until April 2014 with the key words: PCOS, polycystic ovary syndrome, metformin, clomiphene citrate, ovulation induction and pregnancy. The search was limited to articles conducted with humans and published in English. The PRISMA statement was followed. Twelve randomized controlled trials (n = 1411 women) were included. Ovulation and clinical pregnancy rates per woman randomized. Compared with gonadotrophins, the metformin+clomiphene combination resulted in significantly fewer ovulations (odds ratio 0.25; 95% confidence interval 0.15-0.41; p < 0.00001, 3 trials, I(2) = 85%, n = 323) and pregnancies (odds ratio 0.45; 95% confidence interval 0.27-0.75; p = 0.002, 3 trials, I(2) = 0%, n = 323). No significant differences were found when metformin+clomiphene was compared with laparoscopic ovarian diathermy (odds ratio 0.88; 95% confidence interval 0.53-1.47; p = 0.62, 1 trial, n = 282; odds ratio 0.96; 95% confidence interval 0.60-1.54; p = 0.88, 2 trials, I(2) = 0%, n = 332, for ovulation and pregnancy rates, respectively). Likewise, no differences were observed in comparison with aromatase inhibitors (odds ratio 0.88; 95% confidence interval 0.58-1.34; p = 0.55, 3 trials, I(2) = 3%, n = 409; odds ratio 0.85; 95% confidence interval 0.53-1.36; p = 0.50, 2 trials, n = 309, for ovulation and pregnancy rates, respectively). There is evidence for the superiority of gonadotrophins, but the metformin+clomiphene combination is mainly relevant for clomiphene-resistant polycystic ovary syndrome patients and, if not effective, a next step could be gonadotrophins. More attempts with metformin+clomiphene are only relevant

  20. Effects of cognitive-motor dual-task training combined with auditory motor synchronization training on cognitive functioning in individuals with chronic stroke: A pilot randomized controlled trial.

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    Park, Myoung-Ok; Lee, Sang-Heon

    2018-06-01

    Preservation and enhancement of cognitive function are essential for the restoration of functional abilities and independence following stroke. While cognitive-motor dual-task training (CMDT) has been utilized in rehabilitation settings, many patients with stroke experience impairments in cognitive function that can interfere with dual-task performance. In the present study, we investigated the effects of CMDT combined with auditory motor synchronization training (AMST) utilizing rhythmic cues on cognitive function in patients with stroke. The present randomized controlled trial was conducted at a single rehabilitation hospital. Thirty patients with chronic stroke were randomly divided an experimental group (n = 15) and a control group (n = 15). The experimental group received 3 CMDT + AMST sessions per week for 6 weeks, whereas the control group received CMDT only 3 times per week for 6 weeks. Changes in cognitive function were evaluated using the trail making test (TMT), digit span test (DST), and stroop test (ST). Significant differences in TMT-A and B (P = .001, P = .001), DST-forward (P = .001, P = .001), DST-backward (P = .000, P = .001), ST-word (P = .001, P = .001), and ST-color (P = .002, P = .001) scores were observed in both the control and experimental groups, respectively. Significant differences in TMT-A (P = .001), DST-forward (P = .027), DST-backward (P = .002), and ST-word (P = .025) scores were observed between the 2 groups. Performance speed on the TMT-A was faster in the CMDT + AMST group than in the CMDT group. Moreover, DST-forward and DST-backward scores were higher in the CMDT + AMST group than in the CDMT group. Although ST-color results were similar in the 2 groups, ST-word scores were higher in the CMDT + AMST group than in the CMDT group. This finding indicates that the combined therapy CMDT and AMST can be used to increase attention, memory, and executive

  1. Combined short- and long-axis ultrasound-guided central venous catheterization is superior to conventional techniques: A cross-over randomized controlled manikin trial.

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    Jun Takeshita

    Full Text Available Visualizing the needle tip using the short-axis (SA ultrasound-guided central venous catheterization approach can be challenging. It has been suggested to start the process with the SA approach and then switch to the long-axis (LA; however, to our knowledge, this combination has not been evaluated. We compared the combined short- and long-axis (SLA approach with the SA approach in a manikin study.We performed a prospective randomized controlled cross-over study in an urban emergency department and intensive care unit. Resident physicians in post-graduate years 1-2 performed a simulated ultrasound-guided internal jugular vein puncture using the SA and SLA approaches on manikins. Twenty resident physicians were randomly assigned to two equal groups: (1 one group performed punctures using the SA approach followed by SLA; and (2 the other performed the same procedures in the opposite order. We compared the success rate and procedure duration for the two approaches. Procedural success was defined as insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture, without penetrating the posterior wall.Six resident physicians (30% performed both approaches successfully, while 12 (60% performed the SLA approach, but not the SA, successfully. Those who performed the SA approach successfully also succeeded with the SLA approach. Two resident physicians (10% failed to perform both approaches. The SLA approach had a significantly higher success rate than the SA approach (P < 0.001. The median (interquartile range procedure duration was 59.5 [46.0-88.5] seconds and 45.0 [37.5-84.0] seconds for the SLA and SA approaches, respectively. The difference of the duration between the two procedures was 15.5 [0-28.5] seconds. There was no significant difference in duration between the two approaches (P = 0.12.Using the SLA approach significantly improved the success rate of internal jugular vein puncture performed by

  2. Randomized controlled trial of the effects of metformin versus combined oral contraceptives in adolescent PCOS women through a 24 month follow up period

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    H.A. El Maghraby

    2015-09-01

    Full Text Available Objective: To compare metformin and combined oral contraceptive pill (COC effects over 24 months in adolescent PCOS. Design: Randomized controlled study. Setting: Alexandria ICSI centre. Patients: 117 adolescent girls with PCOS, were randomized to: group A (n = 40: metformin, group B (n = 40: COC, and group C (n = 39: control. Interventions: Group A: received metformin, group B: received combined oral contraceptives. Main outcome measures: Improvement in cycle rhythm and hirsutism. Results: In group B a significant decline in serum testosterone reached the lowest value by the end of the second year (0.7 ± 0.2 versus 1.3 ± 0.5 μg/ml. By the end of the study, group A showed a significant decline in fasting (18.6 ± 3.0–10.0 ± 3.0 μIU/ml and after-load insulin levels (126 ± 43–64 ± 15 μIU/ml with a significant rise in glucose/insulin ratio (GIR from 4.1 ± 0.3 to 4.6 ± 0.5. Group B showed a significant rise in fasting and after-load insulin (from 15.0 ± 3.0 μIU/ml and 103.0 ± 91.0 μIU/ml to 19.0 ± 4.0 and 187.0 ± 22.0 μIU/ml, respectively and GIR dropped significantly from 4.4 ± 0.2 to 3.1 ± 0.3. Metformin was associated with a significant loss of weight from 87.0 ± 6.0 to 72.0 ± 0.5 kg while COC was associated with a non-significant gain in weight (from 84.0 ± 6.0 to 91.0 ± 9.0 kg. Conclusions: Metformin and COC have comparable therapeutic effectiveness on cycle regularity and hirsutism. Metformin was associated with a significant improvement in metabolic syndrome, while COC was associated with a deterioration of metabolic syndrome.

  3. The Effect of Interdialytic Combined Resistance and Aerobic Exercise Training on Health Related Outcomes in Chronic Hemodialysis Patients: The Tunisian Randomized Controlled Study

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    Bechir Frih

    2017-05-01

    Full Text Available Background: Tunisia has the highest prevalence of hemodialysis patients compared to the other countries in North Africa. Dialysis centers rarely offer an exercise program to prevent physiological and psychological dialysis therapy-related alterations in chronic hemodialysis patients.Aim: To examine the effect of combined endurance-resistance training program on physiological and psychological outcomes in patients undergoing hemodialysis.Methods: We designed a single blinded, randomized, controlled study for a period of 4 months. Patients were randomized to intervention group or control group. Intervention group patients received 4 training sessions per week, held on non-hemodialysis days for a period of 4 months, whereas control group patients continued their regular lifestyle practice without direct intervention from the personnel of this investigation. Patients were evaluated at baseline (initial assessment and after the four-month study period (final assessment by the same investigator blinded to treatment group assignment using physical, physiological, and psychological measurements.Results: Compared with control group, intervention group showed significant improvement in physical performance during the sit-to-stand-to-sit tests (STS-10: −16.2%, ES = −1.65; STS-60: +23.43%, ES = 1.18, handgrip force task (+23.54%, ES = 1.16, timed up and go test (−13.86%, ES = −1.13, and 6-min walk test (+15.94%, ES = 2.09. Likewise, mini nutritional assessment long form scores after intervention period were significantly higher in the intervention group compared to the control group (ES = 1.43. Physical and mental component scores of SF-36 questionnaire increased significantly in the intervention group (ES = 1.10 and ES = 2.06, respectively, whereas hospital anxiety and depression scale scores decreased significantly (ES = −1.65 and ES = −2.72, respectively. Regarding biological parameters, intervention group displayed improvement in systolic

  4. Limited Effect of Rebamipide in Addition to Proton Pump Inhibitor (PPI) in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers: A Randomized Controlled Trial Comparing PPI Plus Rebamipide Combination Therapy with PPI Monotherapy

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    Nakamura, Kazuhiko; Ihara, Eikichi; Akiho, Hirotada; Akahoshi, Kazuya; Harada, Naohiko; Ochiai, Toshiaki; Nakamura, Norimoto; Ogino, Haruei; Iwasa, Tsutomu; Aso, Akira; Iboshi, Yoichiro; Takayanagi, Ryoichi

    2016-01-01

    Background/Aims The ability of endoscopic submucosal dissection (ESD) to resect large early gastric cancers (EGCs) results in the need to treat large artificial gastric ulcers. This study assessed whether the combination therapy of rebamipide plus a proton pump inhibitor (PPI) offered benefits over PPI monotherapy. Methods In this prospective, randomized, multicenter, open-label, and comparative study, patients who had undergone ESD for EGC or gastric adenoma were randomized into groups recei...

  5. Effectiveness of a combination strategy for linkage and retention in adult HIV care in Swaziland: The Link4Health cluster randomized trial.

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    Margaret L McNairy

    2017-11-01

    Full Text Available Gaps in the HIV care continuum contribute to poor health outcomes and increase HIV transmission. A combination of interventions targeting multiple steps in the continuum is needed to achieve the full beneficial impact of HIV treatment.Link4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS versus the standard of care (SOC on the primary outcome of linkage to care within 1 month plus retention in care at 12 months after HIV-positive testing. Ten clusters of HIV clinics in Swaziland were randomized 1:1 to CIS versus SOC. The CIS included point-of-care CD4+ testing at the time of an HIV-positive test, accelerated antiretroviral therapy (ART initiation for treatment-eligible participants, mobile phone appointment reminders, health educational packages, and noncash financial incentives. Secondary outcomes included each component of the primary outcome, mean time to linkage, assessment for ART eligibility, ART initiation and time to ART initiation, viral suppression defined as HIV-1 RNA < 1,000 copies/mL at 12 months after HIV testing among patients on ART ≥6 months, and loss to follow-up and death at 12 months after HIV testing. A total of 2,197 adults aged ≥18 years, newly tested HIV positive, were enrolled from 19 August 2013 to 21 November 2014 (1,096 CIS arm; 1,101 SOC arm and followed for 12 months. The median participant age was 31 years (IQR 26-39, and 59% were women. In an intention-to-treat analysis, 64% (705/1,096 of participants at the CIS sites achieved the primary outcome versus 43% (477/1,101 at the SOC sites (adjusted relative risk [RR] 1.52, 95% CI 1.19-1.96, p = 0.002. Participants in the CIS arm versus the SOC arm had the following secondary outcomes: linkage to care regardless of retention at 12 months (RR 1.08, 95% CI 0.97-1.21, p = 0.13, mean time to linkage (2.5 days versus 7.5 days, p = 0.189, retention in care at 12 months regardless of time to linkage (RR

  6. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Malfliet, Anneleen; Kregel, Jeroen; Coppieters, Iris; De Pauw, Robby; Meeus, Mira; Roussel, Nathalie; Cagnie, Barbara; Danneels, Lieven; Nijs, Jo

    2018-04-16

    Effective treatments for chronic spinal pain are essential to reduce the related high personal and socioeconomic costs. To compare pain neuroscience education combined with cognition-targeted motor control training with current best-evidence physiotherapy for reducing pain and improving functionality, gray matter morphologic features, and pain cognitions in individuals with chronic spinal pain. Multicenter randomized clinical trial conducted from January 1, 2014, to January 30, 2017, among 120 patients with chronic nonspecific spinal pain in 2 outpatient hospitals with follow-up at 3, 6, and 12 months. Participants were randomized into an experimental group (combined pain neuroscience education and cognition-targeted motor control training) and a control group (combining education on back and neck pain and general exercise therapy). Primary outcomes were pain (pressure pain thresholds, numeric rating scale, and central sensitization inventory) and function (pain disability index and mental health and physical health). There were 22 men and 38 women in the experimental group (mean [SD] age, 39.9 [12.0] years) and 25 men and 35 women in the control group (mean [SD] age, 40.5 [12.9] years). Participants in the experimental group experienced reduced pain (small to medium effect sizes): higher pressure pain thresholds at primary test site at 3 months (estimated marginal [EM] mean, 0.971; 95% CI, -0.028 to 1.970) and reduced central sensitization inventory scores at 6 months (EM mean, -5.684; 95% CI, -10.589 to -0.780) and 12 months (EM mean, -6.053; 95% CI, -10.781 to -1.324). They also experienced improved function (small to medium effect sizes): significant and clinically relevant reduction of disability at 3 months (EM mean, -5.113; 95% CI, -9.994 to -0.232), 6 months (EM mean, -6.351; 95% CI, -11.153 to -1.550), and 12 months (EM mean, -5.779; 95% CI, -10.340 to -1.217); better mental health at 6 months (EM mean, 36.496; 95% CI, 7.998-64.995); and better physical

  7. 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.

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

    2013-07-30

    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 the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment. A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation. The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems. Australian New Zealand Clinical Trials Registry: ACTRN12608000228381.

  8. Cost-effectiveness of invitation to food supplementation early in pregnancy combined with multiple micronutrients on infant survival: analysis of data from MINIMat randomized trial, Bangladesh.

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    Shaheen, Rubina; Persson, Lars Åke; Ahmed, Shakil; Streatfield, Peter Kim; Lindholm, Lars

    2015-05-28

    Absence of cost-effectiveness (CE) analyses limits the relevance of large-scale nutrition interventions in low-income countries. We analyzed if the effect of invitation to food supplementation early in pregnancy combined with multiple micronutrient supplements (MMS) on infant survival represented value for money compared to invitation to food supplementation at usual time in pregnancy combined with iron-folic acid. Outcome data, infant mortality (IM) rates, came from MINIMat trial (Maternal and Infant Nutrition Interventions, Matlab, ISRCTN16581394). In MINIMat, women were randomized to early (E around 9 weeks of pregnancy) or usual invitation (U around 20 weeks) to food supplementation and daily doses of 30 mg, or 60 mg iron with 400 μgm of folic acid, or MMS with 15 micronutrients including 30 mg iron and 400 μgm of folic acid. In MINIMat, EMMS significantly reduced IM compared to UFe60F (U plus 60 mg iron 400 μgm Folic acid). We present incremental CE ratios for incrementing UFe60F to EMMS. Costing data came mainly from a published study. By incrementing UFe60F to EMMS, one extra IM could be averted at a cost of US$907 and US$797 for NGO run and government run CNCs, respectively, and at US$1024 for a hypothetical scenario of highest cost. These comparisons generated one extra life year (LY) saved at US$30, US$27, and US$34, respectively. Incrementing UFe60F to EMMS in pregnancy seems worthwhile from health economic and public health standpoints. Maternal and Infant Nutrition Interventions, Matlab; ISRCTN16581394 ; Date of registration: Feb 16, 2009.

  9. Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial.

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    Monique Wasunna

    2016-09-01

    Full Text Available SSG&PM over 17 days is recommended as first line treatment for visceral leishmaniasis in eastern Africa, but is painful and requires hospitalization. Combination regimens including AmBisome and miltefosine are safe and effective in India, but there are no published data from trials of combination therapies including these drugs from Africa.A phase II open-label, non-comparative randomized trial was conducted in Sudan and Kenya to evaluate the efficacy and safety of three treatment regimens: 10 mg/kg single dose AmBisome plus 10 days of SSG (20 mg/kg/day, 10 mg/kg single dose AmBisome plus 10 days of miltefosine (2.5mg/kg/day and miltefosine alone (2.5 mg/kg/day for 28 days. The primary endpoint was initial parasitological cure at Day 28, and secondary endpoints included definitive cure at Day 210, and pharmacokinetic (miltefosine and pharmacodynamic assessments.In sequential analyses with 49-51 patients per arm, initial cure was 85% (95% CI: 73-92 in all arms. At D210, definitive cure was 87% (95% CI: 77-97 for AmBisome + SSG, 77% (95% CI 64-90 for AmBisome + miltefosine and 72% (95% CI 60-85 for miltefosine alone, with lower efficacy in younger patients, who weigh less. Miltefosine pharmacokinetic data indicated under-exposure in children compared to adults.No major safety concerns were identified, but point estimates of definitive cure were less than 90% for each regimen so none will be evaluated in Phase III trials in their current form. Allometric dosing of miltefosine in children needs to be evaluated.The study was registered with ClinicalTrials.gov, number NCT01067443.

  10. Theory-based interventions combining mental simulation and planning techniques to improve physical activity: Null results from two randomized controlled trials

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    Carine Meslot

    2016-11-01

    Full Text Available Interventions to assist individuals in initiating and maintaining regular participation in physical activity are not always effective. Psychological and behavioural theories advocate the importance of both motivation and volition in interventions to change health behaviour. 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 randomised design students 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 x 2 (implementation intention vs. no implementation intention randomised controlled design in which fitness centre attendees (n=184 were randomly allocated one of four conditions: mental simulation only, implementation intention only, combined, or control. Physical activity behaviour was measured by self-report (Study 1 or fitness centre 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. Despite adopting protocols consistent with previous research, utilizing objective behavioural measures, and having sufficient statistical power, results provide evidence that, in contrast to previous findings, the motivational and volitional components are not effective in changing physical activity behaviour. Future research should focus on the format of the intervention components, test the effects of each component alone and

  11. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study.

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    Kim, Kyung Mi; Huh, Jin; Lee, Soo Kyung; Park, Eun Young; Lee, Jung Min; Kim, Hyo Ju

    2017-05-19

    As a drug originally introduced for its anticonvulsant effects, gabapentin has been recently shown to be effective in the treatment of nausea and vomiting in various clinical settings. This study compared the antiemetic efficacy of oral gabapentin, intravenous ramosetron and gabapentin plus ramosetron in patients receiving fentanyl-based patient-controlled analgesia after laparoscopic gynecologic surgery. One hundred and thirty two patients undergoing laparoscopic gynecologic surgery under general anesthesia were allocated randomly into three groups: group G received 300 mg oral gabapentin 1 h before anesthesia, group R received 0.3 mg intravenous ramosetron at the end of surgery, and group GR received a combination of 300 mg oral gabapentin 1 h before anesthesia and 0.3 mg intravenous ramosetron at the end of surgery. Postoperative nausea, retching, vomiting, rescue antiemetic drug use, pain, rescue analgesic requirements and adverse effects were assessed at 0-2, 2-24 and 24-48 h after surgery. Postoperative nausea and vomiting (PONV) was defined as the presence of nausea, retching or vomiting. The incidence of complete response (no PONV and no rescue antiemetics up to 48 h postoperatively) was significantly higher in group GR (26/40, 65%) than group G (16/40, 40%; P = 0.025) and group R (18/44, 41%; P = 0.027), whereas there was no significant difference between group G and group R (P = 0.932). There were no significant between-group differences in the incidence of emetic episodes, use of rescue antiemetics, severe emesis, use of rescue analgesics or any adverse effects. Postoperative pain scores were also similar among groups. The combination with gabapentin and ramosetron is superior to either drug alone for prevention of PONV after laparoscopic gynecologic surgery. ClinicalTrials.gov NCT02617121 , registered November 25, 2015.

  12. The effectiveness of combining inspiratory muscle training with manual therapy and a therapeutic exercise program on maximum inspiratory pressure in adults with asthma: a randomized clinical trial.

    Science.gov (United States)

    López-de-Uralde-Villanueva, Ibai; Candelas-Fernández, Pablo; de-Diego-Cano, Beatriz; Mínguez-Calzada, Orcález; Del Corral, Tamara

    2018-06-01

    The objective of this study was to evaluate whether the addition of manual therapy and therapeutic exercise protocol to inspiratory muscle training was more effective in improving maximum inspiratory pressure than inspiratory muscle training in isolation. This is a single-blinded, randomized controlled trial. In total, 43 patients with asthma were included in this study. The patients were allocated into one of the two groups: (1) inspiratory muscle training ( n = 21; 20-minute session) or (2) inspiratory muscle training (20-minute session) combined with a program of manual therapy (15-minute session) and therapeutic exercise (15-minute session; n = 22). All participants received 12 sessions, two days/week, for six weeks and performed the domiciliary exercises protocol. The main measures such as maximum inspiratory pressure, spirometric measures, forward head posture, and thoracic kyphosis were recorded at baseline and after the treatment. For the per-protocol analysis, between-group differences at post-intervention were observed in maximum inspiratory pressure (19.77 cmH 2 O (11.49-28.04), P < .05; F = 22.436; P < .001; η 2 p  = 0.371) and forward head posture (-1.25 cm (-2.32 to -0.19), P < .05; F = 5.662; P = .022; η 2 p  = 0.13). The intention-to-treat analysis showed the same pattern of findings. The inspiratory muscle training combined with a manual therapy and therapeutic exercise program is more effective than its application in isolation for producing short-term maximum inspiratory pressure and forward head posture improvements in patients with asthma.

  13. Randomized phase III trial of piroxicam in combination with mitoxantrone or carboplatin for first-line treatment of urogenital tract transitional cell carcinoma in dogs.

    Science.gov (United States)

    Allstadt, S D; Rodriguez, C O; Boostrom, B; Rebhun, R B; Skorupski, K A

    2015-01-01

    Reported response rates of transitional cell carcinoma (TCC) in dogs to piroxicam in combination with either mitoxantrone or carboplatin are similar; however, it is unknown whether either drug might provide superior duration of response. To determine if the progression-free interval (PFI) of dogs with TCC treated with mitoxantrone and piroxicam was different than that of dogs receiving carboplatin and piroxicam. The hypothesis was that the efficacy of mitoxantrone is no different from carboplatin. Fifty dogs with TCC without azotemia. Prospective open-label phase III randomized study. Either mitoxantrone or carboplatin was administered every 3 weeks concurrently with piroxicam with restaging at 6-week intervals. Twenty-four dogs received carboplatin and 26 received mitoxantrone. Response was not different between groups (P = .56). None of the dogs showed complete response. In the mitoxantrone group, there were 2 (8%) partial responses (PR) and 18 (69%) dogs with stable disease (SD). In the carboplatin group, there were 3 PR (13%) and 13 (54%) dogs with SD. The PFI was not significantly different between groups (mitoxantrone = 106 days; carboplatin = 73.5 days; P = .62; hazard ratio 0.86; 95% confidence interval 0.47-1.56). Dogs with prostatic involvement experienced a shorter survival (median, 109 days) compared to dogs with urethral, trigonal, or apically located tumors; this difference was significant (median 300, 190, and 645 days, respectively; P = .005). This study did not detect a different in outcome in dogs with TCC treated with either mitoxantrone or carboplatin in combination with piroxicam. Copyright © 2015 by the American College of Veterinary Internal Medicine.

  14. Acute effects of combined exercise and oscillatory positive expiratory pressure therapy on sputum properties and lung diffusing capacity in cystic fibrosis: a randomized, controlled, crossover trial.

    Science.gov (United States)

    Radtke, Thomas; Böni, Lukas; Bohnacker, Peter; Maggi-Beba, Marion; Fischer, Peter; Kriemler, Susi; Benden, Christian; Dressel, Holger

    2018-06-14

    Regular airway clearance by chest physiotherapy and/or exercise is critical to lung health in cystic fibrosis (CF). Combination of cycling exercise and chest physiotherapy using the Flutter® device on sputum properties has not yet been investigated. This prospective, randomized crossover study compared a single bout of continuous cycling exercise at moderate intensity (experiment A, control condition) vs a combination of interval cycling exercise plus Flutter® (experiment B). Sputum properties (viscoelasticity, yield stress, solids content, spinnability, and ease of sputum expectoration), pulmonary diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) were assessed at rest, directly and 45 min post-exercise (recovery) at 2 consecutive visits. Primary outcome was change in sputum viscoelasticity (G', storage modulus; G", loss modulus) over a broad frequency range (0.1-100 rad.s - 1 ). 15 adults with CF (FEV 1 range 24-94% predicted) completed all experiments. No consistent differences between experiments were observed for G' and G" and other sputum properties, except for ease of sputum expectoration during recovery favoring experiment A. DLNO, DLCO, alveolar volume (V A ) and pulmonary capillary blood volume (V cap ) increased during experiment A, while DLCO and V cap increased during experiment B (all P < 0.05). We found no differences in absolute changes in pulmonary diffusing capacity and its components between experiments, except a higher V A immediately post-exercise favoring experiment A (P = 0.032). The additional use of the Flutter® to moderate intensity interval cycling exercise has no measurable effect on the viscoelastic properties of sputum compared to moderate intensity continuous cycling alone. Elevations in diffusing capacity represent an acute exercise-induced effect not sustained post-exercise. ClinicalTrials.gov; No.: NCT02750722 ; URL: clinical.trials.gov; Registration date: April 25th, 2016.

  15. A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

    Science.gov (United States)

    Linde, Jennifer A; Simon, Gregory E; Ludman, Evette J; Ichikawa, Laura E; Operskalski, Belinda H; Arterburn, David; Rohde, Paul; Finch, Emily A; Jeffery, Robert W

    2011-02-01

    Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. This study examined treatment outcomes among women with comorbid obesity and depression. Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

  16. Constraint-Induced Movement Therapy Combined with Transcranial Direct Current Stimulation over Premotor Cortex Improves Motor Function in Severe Stroke: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Suellen M. Andrade

    2017-01-01

    Full Text Available Objective. We compared the effects of transcranial direct current stimulation at different cortical sites (premotor and motor primary cortex combined with constraint-induced movement therapy for treatment of stroke patients. Design. Sixty patients were randomly distributed into 3 groups: Group A, anodal stimulation on premotor cortex and constraint-induced movement therapy; Group B, anodal stimulation on primary motor cortex and constraint-induced movement therapy; Group C, sham stimulation and constraint-induced movement therapy. Evaluations involved analysis of functional independence, motor recovery, spasticity, gross motor function, and muscle strength. Results. A significant improvement in primary outcome (functional independence after treatment in the premotor group followed by primary motor group and sham group was observed. The same pattern of improvement was highlighted among all secondary outcome measures regarding the superior performance of the premotor group over primary motor and sham groups. Conclusions. Premotor cortex can contribute to motor function in patients with severe functional disabilities in early stages of stroke. This study was registered in ClinicalTrials.gov database (NCT 02628561.

  17. Combined low-volume polyethylene glycol solution plus stimulant laxatives versus standard-volume polyethylene glycol solution: A prospective, randomized study of colon cleansing before colonoscopy

    Science.gov (United States)

    Hookey, Lawrence C; Depew, William T; Vanner, Stephen J

    2006-01-01

    INTRODUCTION The effectiveness of polyethylene glycol solutions (PEG) for colon cleansing is often limited by the inability of patients to drink adequate portions of the 4 L solution. The aim of the present study was to determine whether a reduced volume of PEG combined with stimulant laxatives would be better tolerated and as or more effective than the standard dose. METHODS Patients undergoing outpatient colonoscopy were randomly assigned to receive either low-volume PEG plus sennosides (120 mg oral sennosides syrup followed by 2 L PEG) or the standard volume preparation (4 L PEG). The subjects rated the tolerability of the preparations and their symptoms. Colonoscopists were blind to the colonic cleansing preparation and graded the cleansing efficacy using a validated tool (the Ottawa scale). RESULTS The low-volume PEG plus sennosides preparation was significantly better tolerated than the standard large volume PEG (Psennosides preparation was better tolerated, it was not as effective as standard large-volume PEG. However, in view of the significant difference in tolerance, further research investigating possible improvements in the reduced-volume regimen seems warranted. PMID:16482236

  18. Efficiency and Safety of One-Step Procedure Combined Laparoscopic Cholecystectomy and Eretrograde Cholangiopancreatography for Treatment of Cholecysto-Choledocholithiasis: A Randomized Controlled Trial.

    Science.gov (United States)

    Liu, Zhiyi; Zhang, Luyao; Liu, Yanling; Gu, Yang; Sun, Tieliang

    2017-11-01

    We aimed to evaluate the efficiency and safety of one-step procedure combined endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic cholecystectomy (LC) for treatment of patients with cholecysto-choledocholithiasis. A prospective randomized study was performed on 63 consecutive cholecysto-choledocholithiasis patients during 2008 and 2011. The efficiency and safety of one-step procedure was assessed by comparing the two-step LC with ERCP + endoscopic sphincterotomy (EST). Outcomes including intraoperative features, postoperative features (length of stay and postoperative complications) were evaluated. One- or two-step procedure of LC with ERCP + EST was successfully performed in all patients, and common bile duct stones were completely removed. Statistical analyses showed that length of stay and pulmonary infection rate were significantly lower in the test group compared with that in the control group (P 0.05). The one-step procedure of LC with ERCP + EST is superior to the two-step procedure for treatment of patients with cholecysto-choledocholithiasis regarding to the reduced hospital stay and inhibited occurrence of pulmonary infections. Compared with two-step procedure, one-step procedure of LC with ERCP + EST may be a superior option for cholecysto-choledocholithiasis patients treatment regarding to hospital stay and pulmonary infections.

  19. Optimization of incremental structure from motion combining a random k-d forest and pHash for unordered images in a complex scene

    Science.gov (United States)

    Zhan, Zongqian; Wang, Chendong; Wang, Xin; Liu, Yi

    2018-01-01

    On the basis of today's popular virtual reality and scientific visualization, three-dimensional (3-D) reconstruction is widely used in disaster relief, virtual shopping, reconstruction of cultural relics, etc. In the traditional incremental structure from motion (incremental SFM) method, the time cost of the matching is one of the main factors restricting the popularization of this method. To make the whole matching process more efficient, we propose a preprocessing method before the matching process: (1) we first construct a random k-d forest with the large-scale scale-invariant feature transform features in the images and combine this with the pHash method to obtain a value of relatedness, (2) we then construct a connected weighted graph based on the relatedness value, and (3) we finally obtain a planned sequence of adding images according to the principle of the minimum spanning tree. On this basis, we attempt to thin the minimum spanning tree to reduce the number of matchings and ensure that the images are well distributed. The experimental results show a great reduction in the number of matchings with enough object points, with only a small influence on the inner stability, which proves that this method can quickly and reliably improve the efficiency of the SFM method with unordered multiview images in complex scenes.

  20. Combinations of coupled cluster, density functionals, and the random phase approximation for describing static and dynamic correlation, and van der Waals interactions

    Science.gov (United States)

    Garza, Alejandro J.; Bulik, Ireneusz W.; Alencar, Ana G. Sousa; Sun, Jianwei; Perdew, John P.; Scuseria, Gustavo E.

    2016-04-01

    Contrary to standard coupled cluster doubles (CCD) and Brueckner doubles (BD), singlet-paired analogues of CCD and BD (denoted here as CCD0 and BD0) do not break down when static correlation is present, but neglect substantial amounts of dynamic correlation. In fact, CCD0 and BD0 do not account for any contributions from multielectron excitations involving only same-spin electrons at all. We exploit this feature to add - without introducing double counting, self-interaction, or increase in cost - the missing correlation to these methods via meta-GGA (generalised gradient approximation) density functionals (Tao-Perdew-Staroverov-Scuseria and strongly constrained and appropriately normed). Furthermore, we improve upon these CCD0+DFT blends by invoking range separation: the short- and long-range correlations absent in CCD0/BD0 are evaluated with density functional theory and the direct random phase approximation, respectively. This corrects the description of long-range van der Waals forces. Comprehensive benchmarking shows that the combinations presented here are very accurate for weakly correlated systems, while also providing a reasonable description of strongly correlated problems without resorting to symmetry breaking.

  1. Comparison between Combination Therapy of Oral Terbinafine and Cryotherapy versus Systemic Meglumine Antimoniate and Cryotherapy in Cutaneous Leishmaniasis: A Randomized Clinical Trial.

    Science.gov (United States)

    Farajzadeh, Saeedeh; Esfandiarpour, Iraj; Haghdoost, Ali Akbar; Mohammadi, Saman; Mohebbi, Azadeh; Mohebbi, Elham; Mostafavi, Mahshid

    2015-01-01

    Leishmaniasis is a parasitic infection that may lead to a variety of manifestations. In Iran, cutaneous leishmaniasis (CL) has a high prevalence. There are many treatment modalities for CL. The use of oral terbinafine in the treatment of CL has recently been considered. The aim of this study was to compare combination of oral terbinafine plus cryotherapy versus systemic meglumine antimoniate plus cryotherapy in CL. Patients with proven direct smear for CL were divided randomly in 2 groups of 40 cases. For the first group systemic glucantime prescribed (IM, 15 mg/kg/day) for 3 weeks. For the second group oral terbinafine as two folds of usual dose in the treatment of fungal diseases prescribed [125 mg/day for body weight (BW) 40 kg] for 4 weeks. Both groups received cryotherapy every 2 weeks for 4 weeks. The patients were followed monthly for 3 months after the treatment. Partial (HR= 0.55, CI 95%= 0.3-1.1) and complete (HR= 0.53, CI 95%= 0.3-0.98) clinical improvement in terbinafine group was much slower than glucantime group, although at the end of treatment protocols no significant difference between groups were statistically observed (P=0.27). Considering more convenient suitable route of administration and approximately comparable results, it seems that terbinafine can be used as an alternative treatment, especially in the case of allergy or resistance to systemic glucantime.

  2. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study.

    Science.gov (United States)

    Tanglertsampan, Chuchai

    2012-10-01

    Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction. To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA. Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination. At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups. Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.

  3. Intravenous artesunate plus Artemisnin based Combination Therapy (ACT) or intravenous quinine plus ACT for treatment of severe malaria in Ugandan children: a randomized controlled clinical trial.

    Science.gov (United States)

    Byakika-Kibwika, Pauline; Achan, Jane; Lamorde, Mohammed; Karera-Gonahasa, Carine; Kiragga, Agnes N; Mayanja-Kizza, Harriet; Kiwanuka, Noah; Nsobya, Sam; Talisuna, Ambrose O; Merry, Concepta

    2017-12-28

    Severe malaria is a medical emergency associated with high mortality. Adequate treatment requires initial parenteral therapy for fast parasite clearance followed by longer acting oral antimalarial drugs for cure and prevention of recrudescence. In a randomized controlled clinical trial, we evaluated the 42-day parasitological outcomes of severe malaria treatment with intravenous artesunate (AS) or intravenous quinine (QNN) followed by oral artemisinin based combination therapy (ACT) in children living in a high malaria transmission setting in Eastern Uganda. We enrolled 300 participants and all were included in the intention to treat analysis. Baseline characteristics were similar across treatment arms. The median and interquartile range for number of days from baseline to parasite clearance was significantly lower among participants who received intravenous AS (2 (1-2) vs 3 (2-3), P malaria symptoms. In this high transmission setting, we observed adequate initial treatment outcomes followed by very high rates of malaria re-infection post severe malaria treatment. The impact of recurrent antimalarial treatment on the long term efficacy of antimalarial regimens needs to be investigated and surveillance mechanisms for resistance markers established since recurrent malaria infections are likely to be exposed to sub-therapeutic drug concentrations. More strategies for prevention of recurrent malaria infections in the most at risk populations are needed. The study was registered with the Pan African Clinical Trial Registry ( PACTR201110000321348 ).

  4. Comparison of the treatment effects of methoxamine and combining methoxamine with atropine infusion to maintain blood pressure during spinal anesthesia for cesarean delivery: a double blind randomized trial.

    Science.gov (United States)

    Luo, X-J; Zheng, M; Tian, G; Zhong, H-Y; Zou, X-J; Jian, D-L

    2016-01-01

    Hypotension is a common complication of spinal anesthesia for cesarean delivery. Atropine is a vagus nerve blocker that can antagonize vagus excitation to mitigate the reflex bradycardia. We aimed to assess the effect of methoxamine-atropine therapy in treating spinal anesthesia hypotension for cesarean section. This is a double-blind randomized controlled study. Women under spinal anesthesia for elective caesarean delivery received boluses of methoxamine 2 mg alone (Group M, n = 40), or with addition of atropine 0.1 mg (Group MA1, n = 40), atropine 0.2 mg (Group MA2, n = 40) or atropine 0.3 mg (Group MA3, n = 40) upon a maternal systolic pressure ≤ 80% of baseline. The primary endpoint was systolic blood pressure and the secondary endpoints were maternal heart rates, instant neonatal heart rates, umbilical artery pH and umbilical artery base excess. Changes in systolic blood pressure were similar among the four groups. The incidences of bradycardia in groups M and MA1 were significantly higher than those in group MA2 and MA3. The fetal heart rates after delivery in groups MA2 and MA3 were higher than those in group M and MA1 but within the normal range. The acid-base status had no difference in the four groups. Methoxamine-atropine combination has a similar efficacy to methoxamine alone but has an increased hemodynamic stability and a less adverse effect occurrence.

  5. Randomized controlled trial on the effects of a combined sleep hygiene education and behavioral approach program on sleep quality in workers with insomnia.

    Science.gov (United States)

    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. Employees evaluated for insomnia by the Athens Insomnia Scale (≥6 points) were divided into an intervention and control group. The intervention group received a short-term intervention (30 min) program that included sleep hygiene education and behavioral approaches (relaxation training, stimulus control, and sleep restriction) performed by occupational health professionals. We calculated differences in change in Pittsburgh Sleep Quality Index (PSQI) scores between the two groups from baseline to three months after the start of intervention after adjusting for gender, age, job title, job category, average number of hours of overtime during the study period, marital status, smoking habit, average number of days of alcohol consumption per week, exercise habits, K6 score, and baseline PSQI score. Results showed that the average PSQI score decreased by 1.0 in the intervention group but increased by 0.9 in the control group. Additionally, the difference in variation between the two groups was 1.9 (95% confidence interval: 0.6 to 3.4), which was significant. Taken together, these results indicate that the intervention program significantly improved the sleep quality of workers with insomnia.

  6. Memory improvements in elderly women following 16 weeks treatment with a combined multivitamin, mineral and herbal supplement: A randomized controlled trial.

    Science.gov (United States)

    Macpherson, Helen; Ellis, Kathryn A; Sali, Avni; Pipingas, Andrew

    2012-03-01

    There is potential for multivitamin supplementation to improve cognition in the elderly. This randomized, double-blind, placebo-controlled trial was conducted to investigate the effects of 16 weeks multivitamin supplementation (Swisse Women's 50+ Ultivite ®) on cognition in elderly women. Participants in this study were 56 community dwelling, elderly women, with subjective complaints of memory loss. Cognition was assessed using a computerized battery of memory and attention tasks designed to be sensitive to age-related declines to fluid intelligence, and a measure of verbal recall. Biochemical measures of selected nutrients, homocysteine, markers of inflammation, oxidative stress, and blood safety parameters were also collected. All cognitive and haematological parameters were assessed at baseline and 16 weeks post-treatment. The multivitamin improved speed of response on a measure of spatial working memory, however benefits to other cognitive processes were not observed. Multivitamin supplementation decreased levels of homocysteine and increased levels of vitamin B(6) and B(12), with a trend for vitamin E to increase. There were no hepatotoxic effects of the multivitamin formula indicating this supplement was safe for everyday usage in the elderly. Sixteen weeks ssupplementation with a combined multivitamin, mineral and herbal formula may benefit working memory in elderly women at risk of cognitive decline.

  7. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study.

    Science.gov (United States)

    Montaner, J S; Reiss, P; Cooper, D; Vella, S; Harris, M; Conway, B; Wainberg, M A; Smith, D; Robinson, P; Hall, D; Myers, M; Lange, J M

    1998-03-25

    Current guidelines recommend that individuals infected with the human immunodeficiency virus type 1 (HIV-1) be treated using combinations of antiretroviral agents to achieve sustained suppression of viral replication as measured by the plasma HIV-1 RNA assay, in the hopes of achieving prolonged remission of the disease. However, until recently, many drug combinations have not led to sustained suppression of HIV-1 RNA. To compare the virologic effects of various combinations of nevirapine, didanosine, and zidovudine. Double-blind, controlled, randomized trial. University-affiliated ambulatory research clinics in Italy, the Netherlands, Canada and Australia (INCAS). Antiretroviral therapy-naive adults free of the acquired immunodeficiency syndrome with CD4 cell counts between 0.20 and 0.60x10(9)/L (200-600/microL). Patients received zidovudine plus nevirapine (plus didanosine placebo), zidovudine plus didanosine (plus nevirapine placebo), or zidovudine plus didanosine plus nevirapine. Plasma HIV-1 RNA. Of the 153 enrolled patients, 151 were evaluable. At week 8, plasma HIV-1 RNA levels had decreased by log 2.18, 1.55, and 0.90 in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.05). The proportions of patients with plasma HIV-1 RNA levels below 20 copies per milliliter at week 52 were 51%, 12%, and 0% in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.001). Viral amplification was attempted in 59 patients at 6 months. Viral isolation was unsuccessful in 19 (79%) of 24, 10 (53%) of 19, and 5 (31%) of 16 patients in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively. Among patients from whom virus could be amplified, resistance to nevirapine was found in all 11 patients receiving zidovudine plus nevirapine and in all 5 patients receiving triple drug therapy. Rates of disease progression or death

  8. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Inagaki, Nobuya; Harashima, Shin-Ichi; Maruyama, Nobuko; Kawaguchi, Yutaka; Goda, Maki; Iijima, Hiroaki

    2016-06-18

    Combination therapy with canagliflozin and insulin was investigated in a prescribed substudy of the canagliflozin Cardiovascular Assessment Study (CANVAS); however, it was not evaluated in Japanese patients with type 2 diabetes mellitus (T2DM). Since the usage profile of insulin therapy and pathologic features of Japanese patients differ from those of Caucasian patients, we determined the clinical benefit of such a combination therapy in Japanese patients. Patients who had inadequate glycemic control despite insulin, diet and exercise therapies were randomized into placebo (n = 70) and canagliflozin 100 mg (n = 76) groups that were administered once daily in addition to their prior insulin therapy in this double-blind, placebo-controlled study. The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from the baseline to week 16. There was a statistically significant decrease in HbA1c levels from the baseline in the canagliflozin group (-0.97 ± 0.08 %) compared with the placebo group (0.13 ± 0.08 %) at week 16 [last observation carried forward (LOCF)]. The decrease in HbA1c levels in the canagliflozin group was independent of the insulin regimen (premixed, long-acting and long-acting plus rapid- or short-acting). Compared with the placebo group, canagliflozin significantly decreased fasting plasma glucose levels (-34.1 ± 4.8 vs -1.4 ± 5.0 mg/dL) and body weights (-2.13 ± 0.25 vs 0.24 ± 0.26 %), and significantly increased HDL cholesterol (3.3 ± 1.0 vs -0.5 ± 1.0 mg/dL) and HOMA2- %B (10.15 ± 1.37 vs 0.88 ± 1.42 %). The overall incidence of adverse events was similar between the two groups. The incidence and incidence per subject-year exposure of hypoglycemia (hypoglycemic symptoms and/or decreased blood glucose) were slightly higher in the canagliflozin group (40.0 % and 7.97) than in the placebo group (29.6 % and 4.51). However, hypoglycemic events in both groups were mild in severity and dose-reduction of insulin by 10 % from the

  9. Effects of arthroscopy-guided suprascapular nerve block combined with ultrasound-guided interscalene brachial plexus block for arthroscopic rotator cuff repair: a randomized controlled trial.

    Science.gov (United States)

    Lee, Jae Jun; Hwang, Jung-Taek; Kim, Do-Young; Lee, Sang-Soo; Hwang, Sung Mi; Lee, Na Rea; Kwak, Byung-Chan

    2017-07-01

    The aim of this study was to compare the pain relieving effect of ultrasound-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with that of ultrasound-guided ISB alone within the first 48 h after arthroscopic rotator cuff repair. Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients in group 1 received ultrasound-guided ISB and arthroscopy-guided SSNB; the remaining 24 patients in group 2 underwent ultrasound-guided ISB alone. Visual analogue scale pain score and patient satisfaction score were checked at 1, 3, 6, 12, 18, 24, and 48 h post-operatively. Group 1 had a lower visual analogue scale pain score at 3, 6, 12, 18, 24, and 48 h post-operatively (1.7  6.0, 6.2 > 4.3, 6.4 > 5.1, 6.9 > 5.9, 7.9 > 7.1). Six patients in group 1 developed rebound pain twice, and the others in group 1 developed it once. All of the patients in group 2 had one rebound phenomenon each (p = 0.010). The mean timing of rebound pain in group 1 was later than that in group 2 (15.5 > 9.3 h, p  4.0, p = 0.001). Arthroscopy-guided SSNB combined with ultrasound-guided ISB resulted in lower visual analogue scale pain scores at 3-24 and 48 h post-operatively, and higher patient satisfaction scores at 6-36 h post-operatively with the attenuated rebound pain compared to scores in patients who received ultrasound-guided ISB alone after arthroscopic rotator cuff repair. The combined blocks may relieve post-operative pain more effectively than the single block within 48 h after arthroscopic cuff repair. Randomized controlled trial, Level I. ClinicalTrials.gov Identifier: NCT02424630.

  10. A meta-analysis of combination therapy versus single-agent therapy in anthracycline- and taxane-pretreated metastatic breast cancer: results from nine randomized Phase III trials

    Directory of Open Access Journals (Sweden)

    Xu L

    2016-07-01

    Full Text Available Liang Xu,1,2,* Xiaobo Wu,3,* Chun Hu,1,2 Zhiying Zhang,4 Le Zhang,1,2 Shujing Liang,1,2 Yingchun Xu,5 Fengchun Zhang1,2 1Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine, Suzhou, 2Department of Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 3Prevention and Cure Center of Breast Disease, Third Hospital of Nanchang, Nanchang, 4Graduate School, Xuzhou Medical College, Xuzhou, 5Department of Oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China *These authors contributed equally to this work Abstract: Nowadays, the philosophy of treating metastatic breast cancer (MBC is slowly evolving. Especially for the anthracycline- and taxane-pretreated MBC patients, no standard therapy exists in this setting. Whether to choose doublet agents or single agent as salvage treatment remains fiercely debated. Thus, we conducted a meta-analysis to resolve this problem. Databases including PubMed, EMBASE, and Cochrane library were searched for Phase III randomized clinical trials (published before August 2015 comparing the efficacy and adverse effects between the combination therapy and single-agent therapy in anthracycline- and taxane-pretreated MBC patients. The primary end point was the overall survival (OS, and the secondary end points were the progression-free survival (PFS, overall response rate (ORR, and grade 3 or 4 toxicities. The pooled hazard ratio (HR and pooled risk ratio (RR were used to evaluate the efficacy. Analyses were also performed to estimate the side effects and safety of both groups. In all, nine eligible randomized clinical trials were included in this meta-analysis. Improvements were proven in the doublet agents group on OS (HR 0.90, 95% confidence interval [CI] 0.84–0.96, P=0.002, PFS (HR 0.81, 95% CI 0.76–0.88, P<0.001, and ORR (RR 1.72, 95% CI 1.34–2.21, P<0.001. Notably, subgroup analysis

  11. Effectiveness of intensive practice nurse counselling versus brief general practitioner advice, both combined with varenicline, for smoking cessation: a randomized pragmatic trial in primary care.

    Science.gov (United States)

    van Rossem, Carolien; Spigt, Mark; Viechtbauer, Wolfgang; Lucas, Annelies E M; van Schayck, Onno C P; Kotz, Daniel

    2017-12-01

    To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. A multi-site (n = 10), two-group, parallel, pragmatic randomized controlled trial. A network of primary health-care centres in the Netherlands. A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Patients were randomized to receive individual counselling by a practice nurse (PN) (n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Abstinence rates in the PN versus GP groups were 32.2% (n = 48) versus 39.0% [n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% (n = 38) versus 28.8% (n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. © 2017 Society for the Study of Addiction.

  12. Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial.

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    Job G Godino

    2016-11-01

    Full Text Available Information about genetic and phenotypic risk of type 2 diabetes is now widely available and is being incorporated into disease prevention programs. Whether such information motivates behavior change or has adverse effects is uncertain. We examined the effect of communicating an estimate of genetic or phenotypic risk of type 2 diabetes in a parallel group, open, randomized controlled trial.We recruited 569 healthy middle-aged adults from the Fenland Study, an ongoing population-based, observational study in the east of England (Cambridgeshire, UK. We used a computer-generated random list to assign participants in blocks of six to receive either standard lifestyle advice alone (control group, n = 190 or in combination with a genetic (n = 189 or a phenotypic (n = 190 risk estimate for type 2 diabetes (intervention groups. After 8 wk, we measured the primary outcome, objectively measured physical activity (kJ/kg/day, and also measured several secondary outcomes (including self-reported diet, self-reported weight, worry, anxiety, and perceived risk. The study was powered to detect a between-group difference of 4.1 kJ/kg/d at follow-up. 557 (98% participants completed the trial. There were no significant intervention effects on physical activity (difference in adjusted mean change from baseline: genetic risk group versus control group 0.85 kJ/kg/d (95% CI -2.07 to 3.77, p = 0.57; phenotypic risk group versus control group 1.32 (95% CI -1.61 to 4.25, p = 0.38; and genetic risk group versus phenotypic risk group -0.47 (95% CI -3.40 to 2.46, p = 0.75. No significant differences in self-reported diet, self-reported weight, worry, and anxiety were observed between trial groups. Estimates of perceived risk were significantly more accurate among those who received risk information than among those who did not. Key limitations include the recruitment of a sample that may not be representative of the UK population, use of self-reported secondary outcome

  13. Minimally invasive computer-navigated total hip arthroplasty, following the concept of femur first and combined anteversion: design of a blinded randomized controlled trial

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    Woerner Michael

    2011-08-01

    Full Text Available Abstract Background Impingement can be a serious complication after total hip arthroplasty (THA, and is one of the major causes of postoperative pain, dislocation, aseptic loosening, and implant breakage. Minimally invasive THA and computer-navigated surgery were introduced several years ago. We have developed a novel, computer-assisted operation method for THA following the concept of "femur first"/"combined anteversion", which incorporates various aspects of performing a functional optimization of the cup position, and comprehensively addresses range of motion (ROM as well as cup containment and alignment parameters. Hence, the purpose of this study is to assess whether the artificial joint's ROM can be improved by this computer-assisted operation method. Second, the clinical and radiological outcome will be evaluated. Methods/Design A registered patient- and observer-blinded randomized controlled trial will be conducted. Patients between the ages of 50 and 75 admitted for primary unilateral THA will be included. Patients will be randomly allocated to either receive minimally invasive computer-navigated "femur first" THA or the conventional minimally invasive THA procedure. Self-reported functional status and health-related quality of life (questionnaires will be assessed both preoperatively and postoperatively. Perioperative complications will be registered. Radiographic evaluation will take place up to 6 weeks postoperatively with a computed tomography (CT scan. Component position will be evaluated by an independent external institute on a 3D reconstruction of the femur/pelvis using image-processing software. Postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements. Discussion In the past, computer navigation has improved the accuracy of component positioning. So far, there are only few objective data quantifying the risks and benefits of computer navigated THA. Therefore, this

  14. Efficacy and Safety of a Single-Pill Combination of Vildagliptin and Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Trial

    OpenAIRE

    Odawara, Masato; Yoshiki, Mika; Sano, Misako; Hamada, Izumi; Lukashevich, Valentina; Kothny, Wolfgang

    2015-01-01

    Introduction The use of dipeptidyl peptidase-4 inhibitors in combination with metformin is increasing in Japanese patients with type 2 diabetes mellitus (T2DM), but no single-pill combination (SPC) is currently available in Japan. The objective of this study was to assess the efficacy and safety of vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. Methods This was a 14-week, randomized, double-blind, parallel-group, placebo-contro...

  15. Randomized study of chemotherapy/radiation therapy combinations for favorable patients with locally advanced inoperable nonsmall cell lung cancer: radiation therapy oncology group (RTOG) 92-04

    International Nuclear Information System (INIS)

    Komaki, Ritsuko; Scott, Charles; Ettinger, David; Lee, Jin S.; Fossella, Frank V.; Curran, Walter; Evans, R.F.; Rubin, Philip; Byhardt, Roger W.

    1997-01-01

    Purpose: The purpose of this study was to compare the severity and distribution of the toxicities associated with the two different combinations of chemotherapy and radiotherapy. Methods and Materials: This prospective randomized trial studied toxicities associated with induction chemotherapy followed by concurrent treatment (Arm 1) vs. immediate concurrent chemotherapy/radiotherapy (CT/RT) (Arm 2). Arm 1 consisted of vinblastine (VB), 5 mg/M 2 IV bolus weekly, weeks 1-5 and cisplatin (DDP), 100 mg/M 2 days 1 and 29, DDP 75 mg/M 2 , days 50, 71, and 92. Daily RT started on day 50; a total dose of 63 Gy was given in 34 fractions in 7 weeks. In Arm 2 RT started day 1; a total dose of 69.6 Gy was given in 58 fractions of 1.2 Gy bid, 5 days per week for 6 weeks with DDP 50 mg/M 2 i.v. days 1 and 8, and oral VP-16 50 mg b.i.d. during the first 10 days of RT. DDP/VP-16 were repeated beginning day 29. Survival was used as the Phase II endpoint. Results: Between July 1992 and February 1994, 168 patients were randomized; 162 evaluable patients had minimum follow-up of 20 months. Eighty patients were registered to Arm 1 and 82 to Arm 2. Pretreatment characteristics were distributed evenly. Arm 1 had significantly more Grade 4 hematologic toxicity (62%) than Arm 2 (33%) (p = 0.021). Acute nonhematologic Grade 3+ toxicity was also greater (p = 0.018) in Arm 2 than Arm 1 due mainly to esophagitis (38 vs. 6%; p < 0.0001). Grade 3+ late esophageal toxicity was 12% on Arm 2 compared to 3% on Arm 1 (p = 0.006). There were no differences between the two arms in compliance with protocol specifications for either RT or CT. At 1 year, 31.7% of patients had in-field progression on Arm 1 compared to 19.8% on Arm 2 (p = 0.042), but overall progression-free survival rates were nearly identical; 50 and 49% for Arms I and II, respectively, at 12 months. One-year and median survivals were 65% and 15.5 months on Arm 1 compared to 58% and 14.4 months on Arm 2. Conclusion: Whereas hematologic

  16. Dose-ranging pilot randomized trial of amino acid mixture combined with physical activity promotion for reducing abdominal fat in overweight adults

    Directory of Open Access Journals (Sweden)

    Sasai H

    2017-07-01

    Full Text Available Hiroyuki Sasai,1–3,* Keisuke Ueda,4,5,* Takehiko Tsujimoto,6,7 Hiroyuki Kobayashi,1 Chiaki Sanbongi,4 Shuji Ikegami,4 Yoshio Nakata1 1Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, 2Japan Society for the Promotion of Science, Chiyoda, Tokyo, 3Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Meguro, Tokyo, 4Food Science Research Laboratories, Meiji Co., Ltd., Odawara, Kanagawa, 5Graduate School of Comprehensive Human Sciences, 6Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, 7Faculty of Human Sciences, Shimane University, Matsue, Shimane, Japan *These authors contributed equally to this work Objective: The objective of this study was to determine the effective dose of an amino acid mixture comprising arginine, alanine, and phenylalanine combined with physical activity promotion in reducing abdominal fat among overweight adults.Methods: A 12-week randomized, double-blind, placebo-controlled, dose-ranging, pilot trial was conducted in Mito, Japan, from January through April 2016, and the data were analyzed from May through November 2016. The study participants were 35 overweight adults, aged 20–64 years, with no regular exercise habit. Participants were randomly assigned to high-dose (3,000 mg/d, n=9, medium-dose (1,500 mg/d, n=9, low-dose (750 mg/d, n=8, or placebo (0 mg/d, n=9 groups, and the test beverage containing the amino acid mixture or placebo was administered for 12 weeks. All participants maintained a physically active lifestyle during the study period through monthly physical activity promotion sessions and smartphone-based self-monitoring with wearable trackers. Primary outcomes were changes in abdominal total, subcutaneous, and visceral fat areas, assessed by computed tomography.Results: Of the 35 enrolled participants, 32 completed the 12-week follow-up visit. The intention-to-treat analysis revealed that the changes in abdominal total fat

  17. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.

    Science.gov (United States)

    Jensterle, Mojca; Kravos, Nika Aleksandra; Goričar, Katja; Janez, Andrej

    2017-01-31

    Liraglutide 3 mg was recently approved as an anti-obesity drug. Metformin is weight neutral, yet it could enhance the therapeutic index of GLP-1 agonist. We compared weight-lowering potential of liraglutide 1.2 mg in combination with metformin to liraglutide 3 mg monotherapy in obese PCOS. Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m 2 ) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks. The primary outcome was change in anthropometric measures of obesity. Both treatments led to significant weight loss (-3.6 ± 2.5 kg, p = 0.002 in COMBO vs -6.3 ± 3.7 kg, p = 0.001 in LIRA3). BMI and waist circumference reduction in LIRA3 was greater than in COMBO (-2.2 ± 1.3 vs -1.3 ± 0.9 kg/m 2 , p = 0.05 and -4.2 ± 3.4 vs -2.2 ± 6.2 cm, p = 0.014, respectively). Both interventions resulted in a significant decrease of post-OGTT glucose levels. COMBO significantly reduced total testosterone and was associated with less nausea. Short-term interventions with COMBO and LIRA3 both led to significant improvement of measures of obesity in obese PCOS, LIRA3 being superior to COMBO. However, COMBO further improved androgen profile beyond weight reduction and was associated with better tolerability. The study was retrospectively registered with ClinicalTrials.gov ( NCT02909933 ) on 16 th of September 2016.

  18. The Effects of Double Oscillation Exercise Combined with Elastic Band Exercise on Scapular Stabilizing Muscle Strength and Thickness in Healthy Young Individuals: A Randomized Controlled Pilot Trial

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    Jieun Cho, Kyeongbong Lee, Minkyu Kim, Joohee Hahn, Wanhee Lee

    2018-03-01

    Full Text Available This study aimed to investigate the effect of double oscillation exercise combined with elastic band exercise on the strength and thickness ratio of the scapular stabilizing muscles in healthy young individuals. A total of 30 subjects (17 male, 13 female were randomly assigned to an elastic band exercise group (EBG (n = 15 or an elastic band plus double oscillation exercise group (EB-DOG (n = 15. A total of 28 subjects completed the experiment and evaluation. Patients in the EBG performed the elastic band exercise for shoulder flexion, extension, abduction, adduction, horizontal abduction/adduction, and internal/external rotation for 30 minutes/session, five times/week, for four weeks. Patients in the EB-DOG performed the elastic band exercise for 15 minutes and the double oscillation exercise in three planes of motion (frontal, sagittal, and transverse, using a Bodyblade® for 15 minutes/session, five times/week, for four weeks. Shoulder muscle strength was assessed using a manual muscle test device during maximal voluntary isometric contraction (MVIC, while the thicknesses of the scapular stabilizing muscles were assessed using rehabilitative ultrasound imaging both at rest and during MVIC. Both groups had significant effects on shoulder muscle strength, however, there was no significant difference between the two groups for change value of shoulder muscle strength (Bonferroni correction p < 0.005. Significant differences were observed in the group × time interactions for horizontal abduction, external rotation, and protraction. There was a statistically significant improvement in thickness ratio of LT and SA in the EB-DOG and no significant difference was founded in EBG (Bonferroni correction p < 0.006. In comparison between the two groups, EB-DOG showed a significant change in the thickness ratio of LT compared to EBG. In addition, significant differences were observed for the group × time interactions for the thickness ratio of the LT (F

  19. Efficacy of mepivacaine-tramadol combination on the success of inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis: a randomized clinical trial.

    Science.gov (United States)

    Rodríguez-Wong, L; Pozos-Guillen, A; Silva-Herzog, D; Chavarría-Bolaños, D

    2016-04-01

    To compare the success of an inferior alveolar nerve block (IANB) after injecting a combination of mepivacaine and tramadol or mepivacaine alone in patients with symptomatic irreversible pulpitis (SIP) in mandibular permanent molars. This study was a double-blind, randomized, controlled clinical trial. Two study groups were selected, each consisting of 28 patients who exhibited SIP on the first or second mandibular molars. All included patients presented with moderate-to-severe preoperative pain according to the modified Heft-Parker visual analogue scale (VAS). Patients were anaesthetized using the IANB technique employing identical cartridges that contained either 1.3 mL of 2% mepivacaine with epinephrine 1 : 100 000 plus 0.5 mL of tramadol 50 mg mL(-1) (experimental group) or 1.8 mL of 2% mepivacaine with epinephrine 1 : 100 000 (control group). After 15 min, anaesthesia was evaluated by a progressive four-test examination, that is numbness of the lip, positive or negative cold test, asymptomatic management of dental hard tissues and access to dental pulp. Success of the IANB was defined as the absence of pain during any of these evaluations. The data were analysed with a chi-square, Fisher's or Mann-Whitney U test. A total of 74 patients were initially assessed, with 56 patients eventually included and 18 excluded. No significant differences in age (P = 0.384) or gender (P = 1) were found between the two groups. The success rates of anaesthesia with the IANB for the experimental and control groups were 57.1 and 46.4%, respectively. The success rate of anaesthesia in the experimental group was not significantly different (P ˃ 0.05) from that of the control group. The duration of the anaesthetic effect was significantly longer for the experimental group (P = 0.026). The combination of mepivacaine-tramadol achieved similar success rates for IANB when compared to mepivacaine 2% epinephrine 1 : 100 000. There was no significant difference in the anaesthetic efficacy

  20. Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.

    Science.gov (United States)

    Chae, Dong Woo; Son, Mijeong; Kim, Yukyung; Son, Hankil; Jang, Seong Bok; Seo, Jeong Min; Nam, Su Youn; Park, Kyungsoo

    2015-10-01

    As hypertension and dyslipidemia are frequent comorbidities, antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment. Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia. A combination formulation of these two drugs would improve patient compliance due to ease of dosing. The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination (FDC) tablet containing telmisartan/rosuvastatin 80/20 mg (test treatment) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet (reference treatment) in healthy Korean male volunteers. This was a single-dose, randomized, open-label, 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2. Each subject received a single dose of the reference and test treatments with a 14-day washout period. Blood sampling was performed at prespecified intervals for up to 72 hours after dosing. Primary pharmacokinetic parameters were Cmax, AUClast, and AUC0-∞ of telmisartan, rosuvastatin, and N-desmethyl rosuvastatin. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) of the geometric mean ratios (test treatment/reference treatment) of these parameters were within the standard range of 80% to 125%. Adverse events were monitored via regular interviews with the subjects and by physical examinations. 60 subjects were enrolled and 55 completed the study. The 90% CIs of the geometric mean ratios of Cmax, AUClast, and AUC00-∞ were 0.9262-1.1498, 0.9294-1.0313, and 0.9312-1.0320 for telmisartan, 0.9041-1.0428, 0.9262-1.0085, and 0.9307-1.0094 for rosuvastatin, and 0.8718-1.0022, 0.8901-0.9904, and 0.8872-0.9767 for N-desmethyl rosuvastatin, respectively. There was no statistical difference in the incidence of adverse events (AEs) (all of which were mild or moderate) between the reference and test

  1. A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: a randomized crossover study in healthy human volunteers.

    Science.gov (United States)

    Gorain, B; Choudhury, H; Halder, D; Sarkar, A K; Sarkar, P; Biswas, E; Ghosh, B; Pal, T K

    2013-04-01

    This study was aimed to investigate the relative bioavailability of fixed-dose-combination (FDC) product of amlodipine, telmisartan and hydrochlorothiazide with individual marketed products in healthy male volunteers. Control of blood pressure with fixed dose combination of the above drugs acting through different mechanism have a benefit of convenient dosing in terms of compliance, lower the dose and subsequently reduce the side effects. The authors investigated the relative bioavailability under a fasting state of the 3 drugs in a randomized, open-label, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study with a washout period of 21 days. Plasma concentration of the analytes were assayed in timed samples with a simple, highly sensitive and rapid validated method using HPLC coupled to tandem mass spectrometry that had a lower limit of quantification of 1 ng/mL for all the 3 components. Test and reference formulations gave a mean Cmax of 5.234±0.914 ng/mL and 4.991±0.563 ng/mL, 108.839±13.601 ng/mL and 114.783±12.315 ng/mL and 97.814±10.779 ng/mL and 93.731±10.018 ng/mL for amlodipine, telmisartan and hydrochlorothiazide respectively. The AUC0-t of amlodipine, telmisartan and hydrochlorothiazide was 161.484 ng.h/mL, 1 917.644 ng.h/mL and 822.847 ng.h/mL for test formulation and 162.108 ng.h/mL, 2 014.764 ng.h/mL and 829.323 ng.h/mL for reference in the fasting state. The 90% confidence intervals for the test/reference ratio of the pharmacokinetic parameters in fasting state (mean Cmax, AUC0-t, and AUC0-∞) were within the acceptable range of 80.00-125.00. Thus, these findings clearly indicate that the FDC product is bioequivalent with the individual marketed products in terms of rate and extent of drug absorption and is well tolerated with no significant adverse reactions. © Georg Thieme Verlag KG Stuttgart · New York.

  2. Regular activity breaks combined with physical activity improve postprandial plasma triglyceride, nonesterified fatty acid, and insulin responses in healthy, normal weight adults: A randomized crossover trial.

    Science.gov (United States)

    Homer, Ashleigh R; Fenemor, Stephen P; Perry, Tracy L; Rehrer, Nancy J; Cameron, Claire M; Skeaff, C Murray; Peddie, Meredith C

    Compared with prolonged sitting, regular activity breaks immediately lower postprandial glucose and insulin, but not triglyceride responses. Postprandial triglycerides can be lowered by physical activity but the effect is often delayed by ∼12 to 24 hours. The objective of the study was to determine whether regular activity breaks affect postprandial triglyceride response in a delayed manner similar to physical activity. In a randomized crossover trial, 36 adults (body mass index 23.9 kg/m 2 [standard deviation 3.9]) completed four 2-day interventions: (1) prolonged sitting (SIT); (2) prolonged sitting with 30 minutes of continuous walking (60% VO 2max ), at the end of Day 1 (SIT + PA D1 ); (3) Sitting with 2 minutes of walking (60% VO 2max ) every 30 minutes (RAB); (4) A combination of the continuous walking and regular activity breaks in 2 and 3 above (RAB + PA D1 ). Postprandial plasma triglyceride, nonesterified fatty acids, glucose, and insulin responses were measured in venous blood over 5 hours on Day 2. Compared with SIT, both RAB (difference: -43.61 mg/dL·5 hours; 95% confidence interval [CI] -83.66 to -2.67; P = .035) and RAB + PA D1 (-65.86 mg/dL·5 hours; 95% CI -112.14 to -19.58; P = .005) attenuated triglyceride total area under the curve (tAUC). RAB + PA D1 produced the greatest reductions in insulin tAUC (-23%; 95% CI -12% to -31%; P glucose tAUC (P = .290). Postprandial triglyceride response is attenuated by regular activity breaks, when measured ∼24 hours after breaks begin. Combining regular activity breaks with 30 minutes of continuous walking further improves insulinemic and lipidemic responses. Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  3. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial

    Directory of Open Access Journals (Sweden)

    Wada JT

    2016-10-01

    Full Text Available Juliano T Wada,1 Erickson Borges-Santos,1 Desiderio Cano Porras,1 Denise M Paisani,1 Alberto Cukier,2 Adriana C Lunardi,1 Celso RF Carvalho1 1Department of Physical Therapy, 2Department of Cardiopneumology, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil Background: Patients with COPD present a major recruitment of the inspiratory muscles, predisposing to chest incoordination, increasing the degree of dyspnea and impairing their exercise capacity. Stretching techniques could decrease the respiratory muscle activity and improve their contractile capacity; however, the systemic effects of stretching remain unknown.Objective: The aim of this study was to evaluate the effects of aerobic training combined with respiratory muscle stretching on functional exercise capacity and thoracoabdominal kinematics in patients with COPD.Design: This study was a randomized and controlled trial.Participants: A total of 30 patients were allocated to a treatment group (TG or a control group (CG; n=15, each group.Intervention: The TG was engaged in respiratory muscle stretching and the CG in upper and lower limb muscle stretching. Both groups performed 24 sessions (twice a week, 12 weeks of aerobic training.Evaluations: Functional exercise capacity (6-minute walk test, thoracoabdominal kinematics (optoelectronic plethysmography, and respiratory muscle activity (surface electromyography were evaluated during exercise. Analysis of covariance was used to compare the groups at a significance level of 5%.Results: After the intervention, the TG showed improved abdominal (ABD contribution, compartmental volume, mobility, and functional exercise capacity with decreased dyspnea when compared with the CG (P<0.01. The TG also showed a decreased respiratory muscle effort required to obtain the same pulmonary volume compared to the CG (P<0.001.Conclusion: Our results suggest that aerobic training combined with respiratory muscle stretching increases the functional

  4. Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer for the treatment of acne vulgaris: a 12-week, randomized, double-blind study.

    Science.gov (United States)

    Fleischer, Alan B; Shalita, Alan; Eichenfield, Lawrence F; Abramovits, William; Lucky, Anne; Garrett, Steven

    2010-01-01

    To evaluate the safety and efficacy of dapsone gel 5% in the treatment of acne when used in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer. This was a twelve-week, randomized, double-blind study. Patients aged 12 years and older (n=301) applied dapsone gel twice daily and were randomly assigned (1:1:1) to one of three additional treatments, applied once daily. By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions. However, the authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination). Patients treated with dapsone gel combined with adapalene showed a significantly better response in reduction in non-inflammatory and total acne lesion count than those who received the moisturizer combination. Local adverse reactions in all three treatment groups were minimal and generally mild in severity. Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris.

  5. Histologic Evaluation of Wound Healing After Ridge Preservation With Cortical, Cancellous, and Combined Cortico-Cancellous Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Demetter, Randy S; Calahan, Blaine G; Mealey, Brian L

    2017-09-01

    Cortical and cancellous mineralized freeze-dried bone allografts (FDBA) are available for use in alveolar ridge preservation after tooth extraction. There are currently no data regarding use of a combination 50%/50% cortico-cancellous FDBA compared with a 100% cortical or 100% cancellous FDBA in ridge preservation. The primary objective of this study is to dimensionally and histologically evaluate healing after ridge preservation in non-molar sites using 50%/50% cortico-cancellous FDBA versus 100% cortical and 100% cancellous FDBA. Sixty-six patients requiring extraction of a non-molar tooth were enrolled and randomized into three groups to receive ridge preservation with the following: 1) 100% cortical FDBA; 2) 100% cancellous FDBA; or 3) 50%/50% cortico-cancellous FDBA. After 18 to 20 weeks of healing, a biopsy was harvested, and an implant was placed. The alveolar ridge was measured pre- and postoperatively to evaluate change in ridge height and width. Percentages of vital bone, residual graft, and connective tissue (CT)/other were determined via histomorphometric analysis. Histomorphometric analysis revealed no significant differences among groups regarding percentage of vital bone or CT/other. The 100% cortical FDBA group had significantly greater residual graft material (P = 0.04). Dimensional analysis revealed no significant between-group differences in any parameter measured. To the best knowledge of the authors, this study offers the first histologic evidence demonstrating no significant difference in vital bone formation or dimensional changes among 50%/50% cortico-cancellous FDBA, 100% cortical FDBA, and 100% cancellous FDBA when used in ridge preservation of non-molar tooth sites.

  6. Prospective randomized controlled study on the effects of Saccharomyces boulardii CNCM I-745 and amoxicillin-clavulanate or the combination on the gut microbiota of healthy volunteers.

    Science.gov (United States)

    Kabbani, Toufic A; Pallav, Kumar; Dowd, Scot E; Villafuerte-Galvez, Javier; Vanga, Rohini R; Castillo, Natalia E; Hansen, Joshua; Dennis, Melinda; Leffler, Daniel A; Kelly, Ciarán P

    2017-01-02

    Probiotics are believed to be beneficial in maintaining a healthy gut microbiota whereas antibiotics are known to induce dysbiosis. This study aimed to examine the effects of the probiotic Saccharomyces boulardii CNCM I-745 (SB), the antibiotic Amoxicillin-Clavulanate (AC) and the combination on the microbiota and symptoms of healthy humans. Healthy subjects were randomized to one of 4 study groups: SB for 14 days, AC for 7 days, SB plus AC, Control (no treatment). Participants gave stool samples and completed gastro-intestinal symptom questionnaires. Microbiota changes in stool specimens were analyzed using 16s rRNA gene pyrosequencing (bTEFAP). Only one subject withdrew prematurely due to adverse events. Subjects treated by S boulardii + AC had fewer adverse events and tolerated the study regimen better than those receiving the AC alone. Control subjects had a stable microbiota throughout the study period. Significant microbiota changes were noted in the AC alone group during antibiotic treatment. AC associated changes included reduced prevalence of the genus Roseburia and increases in Escherichia, Parabacteroides, and Enterobacter. Microbiota alterations reverted toward baseline, but were not yet completely restored 2 weeks after antibiotherapy. No significant shifts in bacterial genera were noted in the SB alone group. Adding SB to AC led to less pronounced microbiota shifts including less overgrowth of Escherichia and to a reduction in antibiotic-associated diarrhea scores. Antibiotic treatment is associated with marked microbiota changes with both reductions and increases in different genera. S. boulardii treatment can mitigate some antibiotic-induced microbiota changes (dysbiosis) and can also reduce antibiotic-associated diarrhea.

  7. 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....

  8. Superiority of cisplatin or carboplatin in combination with teniposide and vincristine in the induction chemotherapy of small-cell lung cancer. A randomized trial with 5 years follow up

    DEFF Research Database (Denmark)

    Lassen, U; Kristjansen, P E; Osterlind, K

    1996-01-01

    . PATIENTS AND METHODS: From November 1985 to September 1991, 484 consecutive, previously untreated patients with SCLC, performance status 0-4, entered a three armed randomized trial with three cycles of cisplatin (arm I) or carboplatin (arm II) in combination with teniposide and vincristine alternating...

  9. A Facile and General Approach to Recoverable High-Strain Multishape Shape Memory Polymers.

    Science.gov (United States)

    Li, Xingjian; Pan, Yi; Zheng, Zhaohui; Ding, Xiaobin

    2018-03-01

    Fabricating a single polymer network with no need to design complex structures to achieve an ideal combination of tunable high-strain multiple-shape memory effects and highly recoverable shape memory property is a great challenge for the real applications of advanced shape memory devices. Here, a facile and general approach to recoverable high-strain multishape shape memory polymers is presented via a random copolymerization of acrylate monomers and a chain-extended multiblock copolymer crosslinker. As-prepared shape memory networks show a large width at the half-peak height of the glass transition, far wider than current classical multishape shape memory polymers. A combination of tunable high-strain multishape memory effect and as high as 1000% recoverable strain in a single chemical-crosslinking network can be obtained. To the best of our knowledge, this is the first thermosetting material with a combination of highly recoverable strain and tunable high-strain multiple-shape memory effects. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial.

    Science.gov (United States)

    Trimarco, Valentina; Izzo, Raffaele; Stabile, Eugenio; Rozza, Francesco; Santoro, Mario; Manzi, Maria Virginia; Serino, Federica; Schiattarella, Gabriele Giacomo; Esposito, Giovanni; Trimarco, Bruno

    2015-06-01

    Nutraceuticals (NUT) are forms of compounds with biological activity commonly used to improve health in dosage largely exceeding those obtainable in food. We compared, in a double blind randomized cross-over trial, the effects of two NUT combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins. At study start patients were given dietary counseling and received placebo for 2 weeks. After this run-in period, patients were randomized: (1) Combination A [Policosanol, Red yeast rice (Monakolin K 3 mg), Berberine 500 mg, Astaxantine, Folic Acid and Coenzyme Q10] for 4 weeks followed by 4 weeks of Combination B [Red yeast rice (Monakolin K 3.3 mg), Berberine 531.25 mg and leaf extract of Morus alba]; (2) Combination B for 4 weeks followed by 4 weeks of Combination A. Combination B reduced LDL cholesterol below 130 mg/dl in 56.5 % of the patients, and Cambination A only in 21.7 % of them (p ≤ 0.027). Both treatments reduced plasma levels of triglycerides, total and LDL cholesterol and increased HDL cholesterol (all p Morus alba extract improves the effect on plasma cholesterol and on glucose metabolism of the NUT Combination. These effects may allow the speculation of a more marked improvement in cardiovascular prognosis.

  11. Shaped detector

    International Nuclear Information System (INIS)

    Carlson, R.W.

    1981-01-01

    A radiation detector or detector array which has a non-constant spatial response, is disclosed individually and in combination with a tomographic scanner. The detector has a first dimension which is oriented parallel to the plane of the scan circle in the scanner. Along the first dimension, the detector is most responsive to radiation received along a centered segment of the dimension and less responsive to radiation received along edge segments. This non-constant spatial response can be achieved in a detector comprised of a scintillation crystal and a photoelectric transducer. The scintillation crystal in one embodiment is composed of three crystals arranged in layers, with the center crystal having the greatest light conversion efficiency. In another embodiment, the crystal is covered with a reflective substance around the center segment and a less reflective substance around the remainder. In another embodiment, an optical coupling which transmits light from adjacent the center segment with the greatest intensity couples the scintillation crystal and the photoelectric transducer. In yet another embodiment, the photoelectric transducer comprises three photodiodes, one receiving light produced adjacent the central segment and the other two receiving light produced adjacent the edge segments. The outputs of the three photodiodes are combined with a differential amplifier

  12. Excited-State Conformational/Electronic Responses of Saddle-Shaped N,N'-Disubstituted-Dihydrodibenzo[a,c]phenazines: Wide-Tuning Emission from Red to Deep Blue and White Light Combination.

    Science.gov (United States)

    Zhang, Zhiyun; Wu, Yu-Sin; Tang, Kuo-Chun; Chen, Chi-Lin; Ho, Jr-Wei; Su, Jianhua; Tian, He; Chou, Pi-Tai

    2015-07-08

    A tailored strategy is utilized to modify 5,10-dimethylphenazine (DMP) to donor-acceptor type N,N'-disubstituted-dihydrodibenzo[a,c]phenazines. The representative compounds DMAC (N,N'-dimethyl), DPAC (N,N'-diphenyl), and FlPAC (N-phenyl-N'-fluorenyl) reveal significant nonplanar distortions (i.e., a saddle shape) and remarkably large Stokes-shifted emission independent of the solvent polarity. For DPAC and FlPAC with higher steric hindrance on the N,N'-substituents, normal Stokes-shifted emission also appears, for which the peak wavelength reveals solvent-polarity dependence. These unique photophysical behaviors are rationalized by electronic configuration coupled conformation changes en route to the geometry planarization in the excited state. This proposed mechanism is different from the symmetry rule imposed to explain the anomalously long-wavelength emission for DMP and is firmly supported by polarity-, viscosity-, and temperature-dependent steady-state and nanosecond time-resolved spectroscopy. Together with femtosecond early dynamics and computational simulation of the reaction energy surfaces, the results lead us to establish a sequential, three-step kinetics. Upon electronic excitation of N,N'-disubstituted-dihydrodibenzo[a,c]phenazines, intramolecular charge-transfer takes place, followed by the combination of polarization stabilization and skeletal motion toward the planarization, i.e., elongation of the π-delocalization over the benzo[a,c]phenazines moiety. Along the planarization, DPAC and FlPAC encounter steric hindrance raised by the N,N'-disubstitutes, resulting in a local minimum state, i.e., the intermediate. The combination of initial charge-transfer state, intermediate, and the final planarization state renders the full spectrum of interest and significance in their anomalous photophysics. Depending on rigidity, the N,N'-disubstituted-dihydrodibenzo[a,c]phenazines exhibit multiple emissions, which can be widely tuned from red to deep blue and

  13. Effectiveness and safety of celecoxib combined with diacerein in the treatment of senile degenerative knee osteoarthritis: study protocol and preliminary results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Guo-dong Wang

    2017-01-01

    Full Text Available Background and objectives: The non-steroidal anti-inflammatory drug celecoxib, used for the treatment of senile degenerative knee osteoarthritis, has a rapid onset of action and few side effects. However, it cannot prevent the occurrence and development of knee osteoarthritis. Celecoxib withdrawal is likely to induce a rebound increase in inflammation that may aggravate symptoms. Diacerein is a drug used to improve articular cartilage metabolism. It can delay the progression of senile degenerative knee osteoarthritis, but has a slow onset of action. Whether combined treatment with celecoxib and diacerein provides complimentary actions to achieve a better therapeutic effect on senile degenerative knee osteoarthritis remains unclear. >Design: A prospective, single-center, randomized controlled trial. Methods: Three hundred patients with senile degenerative knee osteoarthritis who receive treatment at the Department of Orthopedics, Second Affiliated Hospital of Nanjing Medical University, China will be randomly assigned to the celecoxib (200 mg, once a day, orally, diacerein (50 mg, twice a day, orally, and celecoxib + diacerein (celecoxib 200 mg, once a day, orally and diacerein 50 mg, twice a day, orally groups, with 100 patients in each group. Patients in each group will be treated for 12 successive weeks, and a 36-week follow-up will be performed. At 24 weeks after treatment, the VAS score for pain during the 20-meter walk test and osteoarthritis index were significantly decreased in the diacerein and celecoxib + diacerein groups compared to pre-treatment (P Outcome measures and preliminary results: The primary outcome measure of this study is the Visual Analogue Scale (VAS score for pain during the 20-meter walk test before and 1, 4, 12, 24, and 36 weeks after treatment. The secondary outcome measures of this study include osteoarthritis index and X-ray image findings of the knee before and 1, 4, 12, 24, and 36 weeks after treatment, as well

  14. Linear shaped charge

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, David; Stofleth, Jerome H.; Saul, Venner W.

    2017-07-11

    Linear shaped charges are described herein. In a general embodiment, the linear shaped charge has an explosive with an elongated arrowhead-shaped profile. The linear shaped charge also has and an elongated v-shaped liner that is inset into a recess of the explosive. Another linear shaped charge includes an explosive that is shaped as a star-shaped prism. Liners are inset into crevices of the explosive, where the explosive acts as a tamper.

  15. Effect of oxycodone hydrochloride combined with flurbiprofen axetil for intravenous patient-controlled analgesia in lower abdominal patients: A randomized trial.

    Science.gov (United States)

    Xiang, Xiaobing; Yuan, Xiaohong; Lian, Yanhong; Fang, Jun; Wu, Yingli

    2018-02-01

    Problems like postoperative pain are still common phenomena after general anesthesia. Oxycodone hydrochloride is a semisynthetic opioid with a safe and excellent therapeutic effect on visceral pain. Flurbiprofen axetil has the efficacy of targeted analgesia. We hypothesize that different doses of oxycodone hydrochloride combined with flurbiprofen axetil would generate great results on postoperative intravenous analgesia in lower abdominal patients. In the clinical trial, 90 American Society of Anesthesiologists I or II patients scheduled for elective general anesthesia were randomly divided into 3 groups, 30 cases in each group. Group I: oxycodone hydrochloride 0.5 mg/kg + flurbiprofen axetil 150 mg, group II: oxycodone hydrochloride 0.75 mg/kg + flurbiprofen axetil 150 mg, group III: oxycodone hydrochloride 1.0 mg/kg + flurbiprofen axetil 150 mg. Dilute them with 0.9% saline to 150 mL, respectively, with the background dose of 2 mL/h, patient-controlled analgesia 2 mL per time, with an interval of 10 min, and the loading dose of 0.1 mL/kg. Record the preoperative situation, 24 h (T0) before surgery, postoperative situation, 1 h (T1), 4 h (T2), 8 h (T3), 12 h (T4), 24 h (T5), 48 h (T6), 72 h (T7) after the surgery, including the mean arterial pressure, heart rate, saturation of pulse oximetry, static and dynamic pain rating (NRS) and Ramsay sedation score, effective pressing and total pressing ratio (referred to as the pressing ratio), patient satisfaction, and occurrence of adverse reactions. There was no significant statistic difference in mean arterial blood pressure, heart rate, arterial oxygen saturation, and adverse reactions among the 2 groups at each time point (P > .05). Compared with group I, the static NRS rating in group II and group III were significantly lower than that in group I (P  .05). Compared with group III, the Ramsay sedation scores of group I and group II were significantly lower from T1 to T4 (P

  16. The effect of preoperative suggestions on perioperative dreams and dream recalls after administration of different general anesthetic combinations: a randomized trial in maxillofacial surgery.

    Science.gov (United States)

    Gyulaházi, Judit; Varga, Katalin; Iglói, Endre; Redl, Pál; Kormos, János; Fülesdi, Béla

    2015-01-01

    Images evoked immediately before the induction of anesthesia with the help of suggestions may influence dreaming during anesthesia.The aim of the study was to assess the incidence of evoked dreams and dream recalls by employing suggestions before induction of anesthesia while administering different general anesthetic combinations. This is a single center, prospective randomized including 270 adult patients scheduled for maxillofacial surgical interventions. Patients were assigned to control, suggestion and dreamfilm groups according to the psychological method used. According to the anesthetic protocol there were also three subgroups: etomidate & sevoflurane, propofol & sevoflurane, propofol & propofol groups. Primary outcome measure was the incidence of postoperative dreams in the non-intervention group and in the three groups receiving different psychological interventions. Secondary endpoint was to test the effect of perioperative suggestions and dreamfilm-formation training on the occurrance of dreams and recallable dreams in different general anesthesiological techniques. Dream incidence rates measured in the control group did not differ significantly (etomidate & sevoflurane: 40%, propofol & sevoflurane: 26%, propofol & propofol: 39%). A significant increase could be observed in the incidence rate of dreams between the control and suggestion groups in the propofol & sevoflurane (26%-52%) group (p = 0.023). There was a significant difference in the incidence of dreams between the control and dreamfilm subgroup in the propofol & sevoflurane (26% vs. 57%), and in the propofol & propofol group (39% vs.70%) (p = 0.010, and p = 0.009, respectively). Similar to this, there was a significant difference in dream incidence between the dreamfilm and the suggestion subgroups (44% vs. 70%) in the propofol & propofol group (p = 0.019). Propofol as an induction agent contributed most to dream formation and recalls (χ2-test p value: 0.005). The content of images and dreams

  17. Effects of a Supervised versus an Unsupervised Combined Balance and Strength Training Program on Balance and Muscle Power in Healthy Older Adults: A Randomized Controlled Trial.

    Science.gov (United States)

    Lacroix, André; Kressig, Reto W; Muehlbauer, Thomas; Gschwind, Yves J; Pfenninger, Barbara; Bruegger, Othmar; Granacher, Urs

    2016-01-01

    Losses in lower extremity muscle strength/power, muscle mass and deficits in static and particularly dynamic balance due to aging are associated with impaired functional performance and an increased fall risk. It has been shown that the combination of balance and strength training (BST) mitigates these age-related deficits. However, it is unresolved whether supervised versus unsupervised BST is equally effective in improving muscle power and balance in older adults. This study examined the impact of a 12-week BST program followed by 12 weeks of detraining on measures of balance and muscle power in healthy older adults enrolled in supervised (SUP) or unsupervised (UNSUP) training. Sixty-six older adults (men: 25, women: 41; age 73 ± 4 years) were randomly assigned to a SUP group (2/week supervised training, 1/week unsupervised training; n = 22), an UNSUP group (3/week unsupervised training; n = 22) or a passive control group (CON; n = 22). Static (i.e., Romberg Test) and dynamic (i.e., 10-meter walk test) steady-state, proactive (i.e., Timed Up and Go Test, Functional Reach Test), and reactive balance (e.g., Push and Release Test), as well as lower extremity muscle power (i.e., Chair Stand Test; Stair Ascent and Descent Test) were tested before and after the active training phase as well as after detraining. Adherence rates to training were 92% for SUP and 97% for UNSUP. BST resulted in significant group × time interactions. Post hoc analyses showed, among others, significant training-related improvements for the Romberg Test, stride velocity, Timed Up and Go Test, and Chair Stand Test in favor of the SUP group. Following detraining, significantly enhanced performances (compared to baseline) were still present in 13 variables for the SUP group and in 10 variables for the UNSUP group. Twelve weeks of BST proved to be safe (no training-related injuries) and feasible (high attendance rates of >90%). Deficits of balance and lower extremity muscle power can be

  18. Mapping Robinia Pseudoacacia Forest Health Conditions by Using Combined Spectral, Spatial, and Textural Information Extracted from IKONOS Imagery and Random Forest Classifier

    Directory of Open Access Journals (Sweden)

    Hong Wang

    2015-07-01

    Full Text Available The textural and spatial information extracted from very high resolution (VHR remote sensing imagery provides complementary information for applications in which the spectral information is not sufficient for identification of spectrally similar landscape features. In this study grey-level co-occurrence matrix (GLCM textures and a local statistical analysis Getis statistic (Gi, computed from IKONOS multispectral (MS imagery acquired from the Yellow River Delta in China, along with a random forest (RF classifier, were used to discriminate Robina pseudoacacia tree health levels. Specifically, eight GLCM texture features (mean, variance, homogeneity, dissimilarity, contrast, entropy, angular second moment, and correlation were first calculated from IKONOS NIR band (Band 4 to determine an optimal window size (13 × 13 and an optimal direction (45°. Then, the optimal window size and direction were applied to the three other IKONOS MS bands (blue, green, and red for calculating the eight GLCM textures. Next, an optimal distance value (5 and an optimal neighborhood rule (Queen’s case were determined for calculating the four Gi features from the four IKONOS MS bands. Finally, different RF classification results of the three forest health conditions were created: (1 an overall accuracy (OA of 79.5% produced using the four MS band reflectances only; (2 an OA of 97.1% created with the eight GLCM features calculated from IKONOS Band 4 with the optimal window size of 13 × 13 and direction 45°; (3 an OA of 93.3% created with the all 32 GLCM features calculated from the four IKONOS MS bands with a window size of 13 × 13 and direction of 45°; (4 an OA of 94.0% created using the four Gi features calculated from the four IKONOS MS bands with the optimal distance value of 5 and Queen’s neighborhood rule; and (5 an OA of 96.9% created with the combined 16 spectral (four, spatial (four, and textural (eight features. The most important feature ranked by RF

  19. Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: a randomized phase II study

    International Nuclear Information System (INIS)

    Lee, Su Jin; Kim, Sungmin; Kim, Moonjin; Lee, Jeeyun; Park, Yeon Hee; Im, Young-Hyuck; Park, Se Hoon

    2015-01-01

    The aim of this study was to assess the efficacy and safety of a combination regimen of capecitabine plus cisplatin (CC) or capecitabine plus paclitaxel (CP) as a first-line treatment in patients with metastatic esophageal squamous cell carcinoma. Patients with recurrent or metastatic esophageal squamous cell carcinoma were enrolled in this open-label, phase II, randomized trial. Patients were assigned to either the CC arm (days [D]1–14 capecitabine 1000 mg/m 2 twice daily + D1 cisplatin 75 mg/m 2 , every 3 weeks) or the CP arm (D1–14 capecitabine 1000 mg/m 2 twice daily + D1, 8 paclitaxel 80 mg/m 2 , every 3 weeks). The primary endpoint of the study was response rate and secondary endpoints were progression-free survival (PFS), overall survival (OS), toxicity and quality of life. A total of 94 patients were entered into this study between October 2008 and October 2012, 46 patients in the CC arm and 48 in the CP arm. Patients in both arms received a median of six cycles of treatment (range, 1–14) and the response rates were 57 and 58 % in the cisplatin and paclitaxel arm, respectively. With a median follow-up of 23 months, the median PFS was 5.1 months (95 % CI 4.0–6.2 months) in the cisplatin arm and 6.7 months (95 % CI 4.9–8.5 months) in the paclitaxel arm, whereas the median OS was 10.5 months (95 % CI 9.2–11.9 months) in the cisplatin arm and 13.2 months (95 % CI 9.4–17.0 months) in the paclitaxel arm. Patients in the cisplatin arm were more likely to experience neutropenia and thrombocytopenia, whereas patients in the paclitaxel arm had a higher frequency of neuropathy and alopecia. Quality of life was similar between treatment arms. Both CC and CP regimens were effective and well tolerated as a first-line treatment in patients with metastatic esophageal squamous cell carcinoma

  20. Combined oral contraceptives plus spironolactone compared with metformin in women with polycystic ovary syndrome: a one-year randomized clinical trial.

    Science.gov (United States)

    Alpañés, Macarena; Álvarez-Blasco, Francisco; Fernández-Durán, Elena; Luque-Ramírez, Manuel; Escobar-Morreale, Héctor F

    2017-11-01

    We aimed to compare a combined oral contraceptive (COC) plus the antiandrogen spironolactone with the insulin sensitizer metformin in women with polycystic ovary syndrome (PCOS). We conducted a randomized, parallel, open-label, clinical trial comparing COC (30 μg of ethinylestradiol and 150 μg of desogestrel) plus spironolactone (100 mg/day) with metformin (850 mg b.i.d.) for one year in women with PCOS (EudraCT2008-004531-38). The composite primary outcome included efficacy (amelioration of hirsutism, androgen excess and menstrual dysfunction) and cardiometabolic safety (changes in the frequencies of disorders of glucose tolerance, dyslipidemia and hypertension). A complete anthropometric, biochemical, hormonal and metabolic evaluation was conducted every three months and data were submitted to intention-to-treat analyses. Twenty-four patients were assigned to COC plus spironolactone and 22 patients to metformin. Compared with metformin, COC plus spironolactone caused larger decreases in hirsutism score (mean difference 4.6 points, 95% CI: 2.6-6.7), total testosterone (1.1 nmol/L, 0.4-1.7), free testosterone (25 pmol/L, 12-39), androstenedione (5.5 nmol/L, 1.8-9.2) and dehydroepiandrosterone sulfate (2.7 μmol/L, 1.4-4.0). Menstrual dysfunction was less frequent with COC plus spironolactone (OR: 0.06, 95% CI: 0.02-0.23). No differences were found in frequencies of abnormal glucose tolerance (OR: 1.7, 95% CI: 0.7-4.4), dyslipidemia (OR: 0.6, 95% CI: 0.2-1.8) or hypertension (OR: 0.3, 95% CI: 0.5-2.0). No major adverse events occurred and biochemical markers were similarly safe with both treatments. COC plus spironolactone was more effective than metformin for symptoms of PCOS showing similar safety and overall neutral effects on cardiometabolic risk factors. © 2017 European Society of Endocrinology.

  1. Effect of Low-Magnitude Whole-Body Vibration Combined with Alendronate in Ovariectomized Rats: A Random Controlled Osteoporosis Prevention Study

    Science.gov (United States)

    Zhong, Zhao-Ming; Wu, Xiu-Hua; Huang, Zhi-Ping; Li, Wei; Ding, Ruo-Ting; Yu, Hui; Chen, Jian-Ting

    2014-01-01

    Background Alendronate (ALE) is a conventional drug used to treat osteoporosis. Low-magnitude whole-body vibration (WBV) exercise has been developed as a potential treatment for osteoporosis. The aim of this study was to investigate whether low-magnitude WBV could enhance the protective effect of ALE on bone properties in ovariectomized rats. Methods A total of 128 Sprague-Dawley rats were randomly divided into five groups (SHAM, OVX+VEH, OVX+WBV, OVX + ALE, OVX+WBV+ALE). The level of WBV applied was 0.3 g at 45–55 Hz for 20 min/day, 5 day/week and for 3 months. ALE was administered in dose of 1 mg/Kg once a week. Every four weeks eight rats from each group were sacrificed and their blood and both tibiae were harvested. The expression of osteocalcin and CTX in serum was measured by enzyme-linked immunosorbent assay (ELISA) and the tibiae were subjected to metaphyseal three-point bending and μCT analysis. Results Osteocalcin rose after ovariectomy and was not appreciably changed by either alendronate or WBV alone or in combination. Alendronate treatment significantly prevented an increase in CTX. WBV alone treatment did not alter this effect. Compared with the OVX+WBV group, nearly all tested indices such as the BV/TV, TV apparent, Tb.N, Tb.Th, and Conn.D were higher in the OVX+ALE group at week 12.Compared with the OVX+WBV group, certain tested indices such as BV/TV, TV apparent, Tb.N, and Con.D, were higher in the OVX+WBV+ALE group at week 12. At week 12, tibiae treated with WBV+ALE exhibited a significantly higher Fmax compared to the OVX+VEH group, and a significant difference was also found in energy absorption between the OVX+WBV+ALE and OVX+VEH groups. Conclusions Compared with the WBV, ALE was more effective at preventing bone loss and improved the trabecular architecture. However, WBV enhanced the effect of alendronate in ovariectomized rats by inducing further improvements in trabecular architecture. PMID:24796785

  2. Effect of Adding Motolimod to Standard Combination Chemotherapy and Cetuximab Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck: The Active8 Randomized Clinical Trial.

    Science.gov (United States)

    Ferris, Robert L; Saba, Nabil F; Gitlitz, Barbara J; Haddad, Robert; Sukari, Ammar; Neupane, Prakash; Morris, John C; Misiukiewicz, Krzysztof; Bauman, Julie E; Fenton, Moon; Jimeno, Antonio; Adkins, Douglas R; Schneider, Charles J; Sacco, Assuntina G; Shirai, Keisuke; Bowles, Daniel W; Gibson, Michael; Nwizu, Tobenna; Gottardo, Raphael; Manjarrez, Kristi L; Dietsch, Gregory N; Bryan, James Kyle; Hershberg, Robert M; Cohen, Ezra E W

    2018-06-21

    Immunotherapy for recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is promising. The toll-like receptor 8 (TLR8) agonist motolimod may stimulate innate and adaptive immunity. To determine whether motolimod improves outcomes for R/M SCCHN when combined with standard therapy. The Active8 study was a multicenter, randomized, double-blind, placebo-controlled clinical trial enrolling adult patients (age ≥18 years) with histologically confirmed R/M SCCHN of the oral cavity, oropharynx, hypopharynx, or larynx between October 2013 and August 2015. Follow-up ended September 2016. Analysis for the present report was conducted between June 2016 and December 2017. Combination treatment with platinum (carboplatin or cisplatin), fluorouracil, cetuximab (the EXTREME regimen), and either placebo or motolimod, each administered intravenously every 3 weeks. Patients received a maximum of 6 chemotherapy cycles, after which patients received weekly cetuximab with either placebo or motolimod every 4 weeks. Progression-free survival (PFS) as determined by independent central review using immune-related RECIST (Response Evaluation Criteria in Solid Tumors). Key secondary end points included overall survival (OS) and safety. Of 195 patients enrolled, 85% were men (n = 166); 82% were white (n = 159); median age was 58 years (range 23-81 years). Median PFS was 6.1 vs 5.9 months (hazard ratio [HR], 0.99; 1-sided 90% CI, 0.00-1.22; P = .47), and median OS was 13.5 vs 11.3 months (HR, 0.95; 1-sided 90% CI, 0.00-1.22; P = .40) for motolimod vs placebo. Increased incidence of injection site reactions, pyrexia, chills, anemia, and acneiform rash were noted with motolimod. Of 83 cases oropharyngeal cancer, 52 (63%) were human papillomavirus (HPV) positive. In a prespecified subgroup analysis of HPV-positive participants, motolimod vs placebo resulted in significantly longer PFS (7.8 vs 5.9 months; HR, 0.58; 1-sided 90% CI, 0.00-0.90; P

  3. Comparison of efficacy and tolerance between combination therapy and monotherapy as first-line chemotherapy in elderly patients with advanced gastric cancer: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Lee, Keun-Wook; Zang, Dae Young; Ryu, Min-Hee; Kim, Ki Hyang; Kim, Mi-Jung; Han, Hye Sook; Koh, Sung Ae; Park, Jin Hyun; Kim, Jin Won; Nam, Byung-Ho; Choi, In Sil

    2017-12-01

    The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy. This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety. We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.

  4. Classification of Strawberry Fruit Shape by Machine Learning

    Science.gov (United States)

    Ishikawa, T.; Hayashi, A.; Nagamatsu, S.; Kyutoku, Y.; Dan, I.; Wada, T.; Oku, K.; Saeki, Y.; Uto, T.; Tanabata, T.; Isobe, S.; Kochi, N.

    2018-05-01

    Shape is one of the most important traits of agricultural products due to its relationships with the quality, quantity, and value of the products. For strawberries, the nine types of fruit shape were defined and classified by humans based on the sampler patterns of the nine types. In this study, we tested the classification of strawberry shapes by machine learning in order to increase the accuracy of the classification, and we introduce the concept of computerization into this field. Four types of descriptors were extracted from the digital images of strawberries: (1) the Measured Values (MVs) including the length of the contour line, the area, the fruit length and width, and the fruit width/length ratio; (2) the Ellipse Similarity Index (ESI); (3) Elliptic Fourier Descriptors (EFDs), and (4) Chain Code Subtraction (CCS). We used these descriptors for the classification test along with the random forest approach, and eight of the nine shape types were classified with combinations of MVs + CCS + EFDs. CCS is a descriptor that adds human knowledge to the chain codes, and it showed higher robustness in classification than the other descriptors. Our results suggest machine learning's high ability to classify fruit shapes accurately. We will attempt to increase the classification accuracy and apply the machine learning methods to other plant species.

  5. The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Jepsen, Ditte Beck; Ryg, Jesper; Jørgensen, Niklas Rye

    2018-01-01

    Background: PaVOS is a randomized controlled trial (RCT) which aims to address the use of whole-body vibration exercise (WBV) in combination with parathyroid hormone 1-34 fragment teriparatide (PTH 1-34) treatment in patients with osteoporosis. PTH 1-34 is an effective but expensive anabolic...... fracture risk. Methods/design: PaVOS is a multicenter, assessor-blinded, superiority, two-armed randomized controlled trial (RCT). Postmenopausal women (n = 40, aged 50 years and older) starting taking PTH 1-34 from outpatient clinics will be randomized and assigned to a PTH 1-34 + WBV-exercise group...... (intervention group), or a PTH 1-34-alone group (control group). The intervention group will undergo WBV three sessions a week (12 min each, including 1:1 ratio of exercise: rest, 30 Hz, 1 mm amplitude) for a 12-month intervention period. Both the intervention and the control group will receive PTH 1...

  6. Modeling Linguistic Variables With Regression Models: Addressing Non-Gaussian Distributions, Non-independent Observations, and Non-linear Predictors With Random Effects and Generalized Additive Models for Location, Scale, and Shape.

    Science.gov (United States)

    Coupé, Christophe

    2018-01-01

    As statistical approaches are getting increasingly used in linguistics, attention must be paid to the choice of methods and algorithms used. This is especially true since they require assumptions to be satisfied to provide valid results, and because scientific articles still often fall short of reporting whether such assumptions are met. Progress is being, however, made in various directions, one of them being the introduction of techniques able to model data that cannot be properly analyzed with simpler linear regression models. We report recent advances in statistical modeling in linguistics. We first describe linear mixed-effects regression models (LMM), which address grouping of observations, and generalized linear mixed-effects models (GLMM), which offer a family of distributions for the dependent variable. Generalized additive models (GAM) are then introduced, which allow modeling non-linear parametric or non-parametric relationships between the dependent variable and the predictors. We then highlight the possibilities offered by generalized additive models for location, scale, and shape (GAMLSS). We explain how they make it possible to go beyond common distributions, such as Gaussian or Poisson, and offer the appropriate inferential framework to account for 'difficult' variables such as count data with strong overdispersion. We also demonstrate how they offer interesting perspectives on data when not only the mean of the dependent variable is modeled, but also its variance, skewness, and kurtosis. As an illustration, the case of phonemic inventory size is analyzed throughout the article. For over 1,500 languages, we consider as predictors the number of speakers, the distance from Africa, an estimation of the intensity of language contact, and linguistic relationships. We discuss the use of random effects to account for genealogical relationships, the choice of appropriate distributions to model count data, and non-linear relationships. Relying on GAMLSS, we

  7. Modeling Linguistic Variables With Regression Models: Addressing Non-Gaussian Distributions, Non-independent Observations, and Non-linear Predictors With Random Effects and Generalized Additive Models for Location, Scale, and Shape

    Directory of Open Access Journals (Sweden)

    Christophe Coupé

    2018-04-01

    Full Text Available As statistical approaches are getting increasingly used in linguistics, attention must be paid to the choice of methods and algorithms used. This is especially true since they require assumptions to be satisfied to provide valid results, and because scientific articles still often fall short of reporting whether such assumptions are met. Progress is being, however, made in various directions, one of them being the introduction of techniques able to model data that cannot be properly analyzed with simpler linear regression models. We report recent advances in statistical modeling in linguistics. We first describe linear mixed-effects regression models (LMM, which address grouping of observations, and generalized linear mixed-effects models (GLMM, which offer a family of distributions for the dependent variable. Generalized additive models (GAM are then introduced, which allow modeling non-linear parametric or non-parametric relationships between the dependent variable and the predictors. We then highlight the possibilities offered by generalized additive models for location, scale, and shape (GAMLSS. We explain how they make it possible to go beyond common distributions, such as Gaussian or Poisson, and offer the appropriate inferential framework to account for ‘difficult’ variables such as count data with strong overdispersion. We also demonstrate how they offer interesting perspectives on data when not only the mean of the dependent variable is modeled, but also its variance, skewness, and kurtosis. As an illustration, the case of phonemic inventory size is analyzed throughout the article. For over 1,500 languages, we consider as predictors the number of speakers, the distance from Africa, an estimation of the intensity of language contact, and linguistic relationships. We discuss the use of random effects to account for genealogical relationships, the choice of appropriate distributions to model count data, and non-linear relationships

  8. Clinical Efficacy of Jinshuibao Capsules Combined with Angiotensin Receptor Blockers in Patients with Early Diabetic Nephropathy: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Qiang Lu

    2018-01-01

    Full Text Available Background. Jinshuibao capsules (JSB have been widely used to treat early diabetic nephropathy (DN, but the specific effects are still inconsistent. A meta-analysis of randomized controlled trials (RCTs was conducted to evaluate the clinical efficacy of JSB for early DN. Methods. Four international databases and four Chinese databases were searched from publication dates to March 1, 2018. The RCTs reporting the results of JSB’s specific effects were included, and comparisons were between JSB combined with Angiotensin Receptor Blockers (ARBs as experimental intervention and ARBs as the control. Included studies’ quality was evaluated and the extracted data were analyzed with RevMan 5.3 software. Results. Twenty-six RCTs including 2198 early DN participants were adopted in the meta-analysis. The results showed that, compared with the ARBs alone, JSB could remarkably improve the ORR (OR = 3.84; 95% CI: 2.37~6.24; P<0.00001 and decrease 24 h UTP (MD = −93.32; 95% CI: −128.60 ~-58.04; P<0.00001, UAER (MD = −24.02; 95% CI: −30.93 ~-17.11; P<0.00001, BUN (MD = −0.26; 95%: −0.44 ~-0.08; P=0.005, Scr (MD = −9.07; 95% CI: −14.26 ~-3.88; P=0.0006, ACR (MD = −17.55; 95% CI: −22.81 ~-12.29; P<0.00001, Cys-C (MD = −0.60; 95% CI: −0.88 ~-0.32; P<0.00001, SBP (MD = −3.08; 95% CI: −4.65 ~-1.52; P=0.0001, DBP (MD = −2.09; 95% CI: −4.00 ~-0.19; P=0.03, and TG (MD = −0.36; 95% CI: −0.50 ~-0.21; P<0.00001. However, it showed no significant differences in TC (MD = −0.32; 95% CI: −0.69~0.04; P=0.08, FBG (MD = 0.04; 95% CI: −0.39~0.47; P=0.87, HbA1c (MD = −0.26; 95% CI: −0.59~0.06; P=0.11, and β2-MG (MD = −15.61; 95% CI: −32.95~1.73; P=0.08. Conclusions. This study indicates that JSB is an effective accessory therapeutic medicine for patients with early DN. It contributes to decreasing blood pressure and the content of triglyceride and improving the renal function of early DN patients. However, there is still a

  9. Personalized Web-Based Advice in Combination With Well-Child Visits to Prevent Overweight in Young Children: Cluster Randomized Controlled Trial.

    Science.gov (United States)

    van Grieken, Amy; Vlasblom, Eline; Wang, Lu; Beltman, Maaike; Boere-Boonekamp, Magda M; L'Hoir, Monique P; Raat, Hein

    2017-07-27

    Overweight is a major health issue, and parent-targeted interventions to promote healthy development in children are needed. The study aimed to evaluate E-health4Uth Healthy Toddler, an intervention that educates parents of children aged 18 to 24 months regarding health-related behaviors, as compared with usual care. The effect of this intervention on the following primary outcomes was evaluated when the children were 36 months of age: health-related behaviors (breakfast daily, activity and outside play, sweetened beverage consumption, television (TV) viewing and computer time), body mass index (BMI), and the prevalence of overweight and obesity. The BeeBOFT (acronym for breastfeeding, breakfast daily, outside playing, few sweet drinks, less TV viewing) study is a cluster randomized controlled trial involving 51 Youth Health Care (YHC) teams. In total, 1094 parents participated in the control group, and 1008 parents participated in the E-health4Uth Healthy Toddler intervention group. The intervention consisted of Web-based personalized advice given to parents who completed an eHealth module and discussion of the advice during a regular well-child visit. In this study the eHealth module was offered to parents before two regular well-child visits at 18 and 24 months of age. During the well-child visits, the parents' personalized advice was combined with face-to-face counseling provided by the YHC professional. Parents in the control group received usual care, consisting of the regular well-child visits during which general information on child health-related behavior was provided to parents. Parents completed questionnaires regarding family characteristics and health-related behaviors when the child was 1 month (inclusion), 6 months, 14 months, and 36 months (follow-up) of age. The child's height and weight were measured by trained health care professionals from birth through 36 months of age at fixed time points. Multilevel linear and logistic regression models were

  10. A randomized feasibility study evaluating the effect of radiotherapy alone or combined with 5-fluorouracil in the treatment of locally recurrent or inoperable colorectal carcinoma

    DEFF Research Database (Denmark)

    Overgaard, M; Bertelsen, K; Dalmark, M

    1993-01-01

    The effect of radiotherapy alone or given simultaneously with 5-FU in the treatment of locally recurrent or inoperable colorectal carcinoma was investigated in a randomized feasibility trial. Twenty-nine patients were randomized to radiotherapy alone (50 Gy/5 weeks + 10-20 Gy boost), and 30....... The 3-year actuarial survival rate was 9% (median 12 months). Only patients who achieved CR became long-time survivors (63% 3-year actuarial survival). Similarly, performance status had a strong association with survival. Multivariate analysis showed complete response and high performance status...

  11. Hypothyroid Patients Encoding Combined MCT10 and DIO2 Gene Polymorphisms May Prefer L-T3 + L-T4 Combination Treatment - Data Using a Blind, Randomized, Clinical Study

    DEFF Research Database (Denmark)

    Carlé, Allan; Faber, Jens; Steffensen, Rudi

    2017-01-01

    on the cellular membrane transport-facilitating monocarboxylate transporter (MCT10) gene (rs17606253), and asked in which of the 2 treatment periods patients felt better (i.e., which treatment was preferred). RESULTS: 27 out of 45 patients (60%) preferred the combination therapy. Two polymorphisms (rs225014 (DIO2......, Thr92Ala) and rs17606253 (MCT10)) were combined yielding 3 groups: none vs. 1 of 2 vs. both SNPs present, and 42 vs. 63 vs. 100% of our patients in the 3 groups preferred the combined treatment (Jongheere-Terpstra trend test, p = 0.009). CONCLUSION: The present study indicates that the combination...... of polymorphisms in DIO2 (rs225014) and MCT10 (rs17606253) enhances hypothyroid patients' preference for L-T4 + L-T3 replacement therapy. In the future, combination therapy may be restricted or may be even recommended to individuals harbouring certain polymorphisms....

  12. Spatial shape of avalanches

    Science.gov (United States)

    Zhu, Zhaoxuan; Wiese, Kay Jörg

    2017-12-01

    In disordered elastic systems, driven by displacing a parabolic confining potential adiabatically slowly, all advance of the system is in bursts, termed avalanches. Avalanches have a finite extension in time, which is much smaller than the waiting time between them. Avalanches also have a finite extension ℓ in space, i.e., only a part of the interface of size ℓ moves during an avalanche. Here we study their spatial shape 〈S(x ) 〉 ℓ given ℓ , as well as its fluctuations encoded in the second cumulant 〈S2(x ) 〉 ℓ c. We establish scaling relations governing the behavior close to the boundary. We then give analytic results for the Brownian force model, in which the microscopic disorder for each degree of freedom is a random walk. Finally, we confirm these results with numerical simulations. To do this properly we elucidate the influence of discretization effects, which also confirms the assumptions entering into the scaling ansatz. This allows us to reach the scaling limit already for avalanches of moderate size. We find excellent agreement for the universal shape and its fluctuations, including all amplitudes.

  13. CLUMP-3D: Testing ΛCDM with Galaxy Cluster Shapes

    Science.gov (United States)

    Sereno, Mauro; Umetsu, Keiichi; Ettori, Stefano; Sayers, Jack; Chiu, I.-Non; Meneghetti, Massimo; Vega-Ferrero, Jesús; Zitrin, Adi

    2018-06-01

    The ΛCDM model of structure formation makes strong predictions on the concentration and shape of dark matter (DM) halos, which are determined by mass accretion processes. Comparison between predicted shapes and observations provides a geometric test of the ΛCDM model. Accurate and precise measurements needs a full three-dimensional (3D) analysis of the cluster mass distribution. We accomplish this with a multi-probe 3D analysis of the X-ray regular Cluster Lensing and Supernova survey with Hubble (CLASH) clusters combining strong and weak lensing, X-ray photometry and spectroscopy, and the Sunyaev–Zel’dovich effect (SZe). The cluster shapes and concentrations are consistent with ΛCDM predictions. The CLASH clusters are randomly oriented, as expected given the sample selection criteria. Shapes agree with numerical results for DM-only halos, which hints at baryonic physics being less effective in making halos rounder.

  14. Analgesic activity of fixed dose combinations of paracetamol with diclofenac sodium and paracetamol with tramadol on different pain models in healthy volunteers - A randomized double blind crossover study

    Directory of Open Access Journals (Sweden)

    Sachidanand Tripathi

    2012-01-01

    Conclusion: Paracetamol with tramadol combination was more effective than paracetamol with diclofenac sodium combination on the radiant heat model. In human pain models, there is an incomplete understanding of mechanisms and activated pathways are not precisely determined that needs further evaluation.

  15. Progression from high-grade prostatic intraepithelial neoplasia to cancer: a randomized trial of com