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Sample records for cams rationale design

  1. Does Design Rationale Enhance Creativity?

    Directory of Open Access Journals (Sweden)

    Jing Wang

    2010-01-01

    Full Text Available Creativity and rationale are often viewed as two contrasting facets in software design. A lack in recognizing the facilitative relationship between creativity and rationale not only underestimates the benefits designers can obtain from rationale practices, but also confines the approaches that support creativity in software design. Our exploratory study provides empirical evidence of the positive correlation between rationale and creativity. Furthermore, we found that the feasibility of design alternatives and the comprehensiveness of tradeoff evaluation are critical to enhancing novelty, persuasiveness, and insightfulness. We also discuss future directions to further understand how these properties, or rationale quality in general, affects design creativity.

  2. THE CAM DESIGN FOR A BETTER EFFICIENCY

    Directory of Open Access Journals (Sweden)

    PETRESCU Ion Florian

    2006-12-01

    Full Text Available The paper presents an original method to determine the efficiency of a mechanism with cam and follower. The originality of this method consists in eliminate of the friction modulus. In this paper on analyze three types of cam mechanisms: 1.The mechanism with rotary cam and plate translated follower; 2.The mechanism with rotary cam and translated follower with roll; 3.The mechanism with rotary cam and rocking-follower with roll. In every kind of cam and follower mechanism on utilize a different method for the best efficiency design.

  3. Rationale and design of WEBCARE

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Spek, Viola; Theuns, Dominic A M J

    2009-01-01

    The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitiga...... the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial....

  4. A compositional approach to modelling design rationale

    NARCIS (Netherlands)

    Brazier, F.M.; van Langen, P.H.G.; Treur, J.

    1997-01-01

    Design support systems need to be developed on the basis of an understanding of the human design process, in order to be useful during design. The explicit representation of design history and rationale are of particular importance for explanation and re-use. Within the DESIRE framework for

  5. CamBAfx: Workflow Design, Implementation and Application for Neuroimaging

    Science.gov (United States)

    Ooi, Cinly; Bullmore, Edward T.; Wink, Alle-Meije; Sendur, Levent; Barnes, Anna; Achard, Sophie; Aspden, John; Abbott, Sanja; Yue, Shigang; Kitzbichler, Manfred; Meunier, David; Maxim, Voichita; Salvador, Raymond; Henty, Julian; Tait, Roger; Subramaniam, Naresh; Suckling, John

    2009-01-01

    CamBAfx is a workflow application designed for both researchers who use workflows to process data (consumers) and those who design them (designers). It provides a front-end (user interface) optimized for data processing designed in a way familiar to consumers. The back-end uses a pipeline model to represent workflows since this is a common and useful metaphor used by designers and is easy to manipulate compared to other representations like programming scripts. As an Eclipse Rich Client Platform application, CamBAfx's pipelines and functions can be bundled with the software or downloaded post-installation. The user interface contains all the workflow facilities expected by consumers. Using the Eclipse Extension Mechanism designers are encouraged to customize CamBAfx for their own pipelines. CamBAfx wraps a workflow facility around neuroinformatics software without modification. CamBAfx's design, licensing and Eclipse Branding Mechanism allow it to be used as the user interface for other software, facilitating exchange of innovative computational tools between originating labs. PMID:19826470

  6. CAD/CAM Preparation Design Effects on Endodontically Treated and Restored Molars

    Science.gov (United States)

    2016-05-24

    CAD /CAM Preparation Design Effects on Endodontically Treated and Restored Molars Aaron T. Krance CAD /CAM Preparation Design Effect on...manuscript entitled: CAD /CAM Preparation Design Effect on Endodonticallv Treated and Restored Molars is appropriately acknowledged and beyond brief...by a CAD /CAM technique on endodontically treated molars restored with the endocrown method versus ceramic full coverage based on amalgam cores with

  7. Design of the OmegaCAM Instrument Software

    Science.gov (United States)

    Baruffolo, Andrea; Bortolussi, Alessandro; De Pizzol, Luigi; Magagna, Carlo E.

    2002-12-01

    OmegaCAM is a wide field optical imager that is expected to start its operations towards the end of 2003, at the VLT Survey Telescope (VST), part of the VLT Observatory, operated in Paranal (Chile) by the European Southern Observatory (ESO). OmegaCAM will almost completely fill VST one squared degree field of view with a CCD imaging mosaic 16k x 16k pixels in size. In addition to the scientific array, four auxiliary CCDs will be used for autoguiding and image analysis. Despite its conceptual simplicity and due to the large size of the CCD mosaic, OmegaCAM posed several challenges in the design of its mechanics, electronics, cryogenics and software. In this paper we report on the design of the OmegaCAM Instrument Software (INS), which is in charge of the control and operations of the instrument. We first introduce the instrument control system characteristics and the INS software development process. We then describe the main characteristics of the INS subsystems in charge of instrument functions control, autoguiding, image analysis and operations coordination. Finally, we discuss the performances expected from the software in the acquisition and storage of the large amount of data that will come from the scientific array.

  8. CAD/CAM from the graphic-design perspective

    Energy Technology Data Exchange (ETDEWEB)

    Marcus, A.

    1982-11-01

    CAD/CAM systems have evolved elaborate human-computer interfaces in order to facilitate the creation of highly detailed and specialized schematic diagrams and texts. Although these systems have powerful capacities in terms of graphics editing, data manipulation, and data storage, insufficient attention has been given to making the online interface (together with supporting documentation) user-friendly, i.e., understandable, memorable, and appealing to the general user. Graphic-design considerations in particular have been routinely overlooked. Graphic design concerns typography, symbol design, color, spatial layout, and temporal sequencing. Graphic design can assist computer science by providing insight and expertise in designing effective communication between human being and machine.

  9. Collaborative Design Rationale And Social Creativity In Cultures Of Participation

    Directory of Open Access Journals (Sweden)

    Gerhard Fischer

    2011-01-01

    Full Text Available The rise in social computing has facilitated a shift from consumer cultures, focused on producing finished media to be consumed passively, to cultures of participation, where people can access the means to participate actively in personally meaningful problems. These developments represent unique and fundamental opportunities and challenges for rethinking and reinventing design rationale and creativity, as people acclimate to taking part in computer-mediated conversations of issues and their solutions. Grounded in our long-term research exploring these topics, this paper articulates arguments, describes and discusses conceptual frameworks and system developments (in the context of three case studies, and provides evidence that design rationale and creativity need not be at odds with each other. Coordinating and integrating collective design rationale and social creatively provide new synergies and opportunities, particularly amid complex, open-ended, and ill-defined design problems requiring contributions and collaboration of multiple stakeholders supported by socio-technical environments in cultures of participation.

  10. Optimal Design of Grooved Cam Profile Using Non-uniform Rational B-splines

    Directory of Open Access Journals (Sweden)

    Xuan Guantao

    2017-01-01

    Full Text Available In order to reduce the fatigue damage in grooved cam mechanisms, grooved cam profile was reconstructed with non-uniform rational B-splines (NURBS. Considering joint friction, dynamic model of grooved cam mechanisms was established and the contact stress between grooved cam and follower was calculated using Hertz contact theory. Taking the minimum contact stress and the minimum acceleration as optimal objectives, integrated design model for respective kinematic and dynamic design approaches was set up. The integrated design mode was optimized to search Pareto-optimal solution by an improved artificial fish swarm algorithm, and optimized NURBS profile for grooved cam was acquired. The results show NURBS profile has better kinematic and dynamic performances. The impacts on grooved cam mechanism are reduced and wear characteristics are improved.

  11. HL-20 concept - Design rationale and approach

    Science.gov (United States)

    Ehrlich, Carl F., Jr.

    1993-10-01

    Design approaches for new space transportation systems strive to lower the cost per flight at affordable lifecycle costs in the 2000 plus era. Achieving efficiency in all operational activities is a major goal for all future systems. The key design drivers are adequate margins, the use of airline/aircraft approaches to certification, and ease of maintenance via subsystem accessibility. These goals have driven the design of the Rockwell HL-20 personnel launch system (PLS) concept. The entire system, both the spacecraft and support systems, has been designed for maintainability and producibility in order to minimize life-cycle costs. In these studies, the aircraft/airline approach to aircraft certification and flightworthiness was used. The vehicle and vehicle subsystems are certified one time, and regular maintenance is scheduled to ensure that flightworthiness is maintained throughout the life of the system. The resulting system-design concept described here reflects these goals through design features that facilitate operations, manufacturing, maintenance, and inspection and overhaul.

  12. Principles and Design Rationale of Composition Filters

    NARCIS (Netherlands)

    Bergmans, Lodewijk; Filman, Robert E.; Elrad, Tzilla; Clarke, Siobhán; Aksit, Mehmet

    2004-01-01

    A wide range of aspect-oriented programming languages has appeared in the past years [7]. Current research on future generation AOP languages is addressing issues like flexibility, expressive power and safety. We think that it is important to understand the motivations and design decisions of the

  13. Supporting awareness in creative group work by exposing design rationale

    Directory of Open Access Journals (Sweden)

    Umer Farooq

    2011-01-01

    Full Text Available When creativity is taken as a long-term, complex, and collaborative activity, support for awareness is required for group members to monitor the development of ideas, track how these ideas became narrowed, and understand how alternatives are being implemented and integrated by colleagues. In this paper, we investigate the effects of exposing design rationale to convey awareness, specifically activity awareness, in group creativity. Through evaluating a prototype, we investigate status updates that convey design rationale, and to what consequences, in small groups in fully distributed collaboration. We found that status updates are used for a variety of purposes and that participants’ comments on their collaborators’ status updates provided feedback. Overall, results suggest that participants’ awareness about their collaborators’ future plans increased over time. Majority of participants found the status updates useful, particularly those with higher metacognitive knowledge. Based on our results, two design strategies for activity awareness are proposed.

  14. Optimal Design of a Cam Mechanism with Translating Flat-Face Follower using Genetic Algorithm

    Directory of Open Access Journals (Sweden)

    I. Tsiafis

    2013-12-01

    Full Text Available The optimum design of a cam mechanism is a time consuming task, due to the numerous alternatives considerations. In the present work, the problem of design parameters optimization of a cam mechanism with translating flat - face follower is investigated from a multi - objective point of view. The design parameters, just like the cam base circle radius, the follower face width and the follower offset can be determined considering as the optimization criteria minimization of the cam size, of the input torque and of the contact stress. During the optimization procedure, a number of constraints regarding the pressure angle, the contact stress, etcare taken into account. The optimization approach, based on genetic algorithm, is applied to find the optimal solutions with respect to the a fore - mentioned objective function and to Ensure the kinematic requirements. Finally, the dynamic behavior of the designed cam mechanism is investigated considering the frictional forces.

  15. Hyper Suprime-Cam: conceptual design to introduce spectroscopic mode

    Science.gov (United States)

    Komiyama, Yutaka; Tanaka, Yoko; Miyazaki, Satoshi; Kawanomoto, Satoshi; Kamata, Yukiko; Nakaya, Hidehiko; Obuchi, Yoshiyuki; Uraguchi, Fumihiro; Utsumi, Yousuke

    2012-09-01

    Hyper Suprime-Cam (HSC) is the wide-field CCD camera which is attached to the prime focus of Subaru Telescope. It covers the field of view of 1.5 degree in diameter by 116 2k x 4k fully-depleted CCDs. In this paper, we present the conceptual design of optics and mechanics how to introduce spectroscopic mode to this simple imager HSC. The design is based on the idea that the optical elements such as collimeter, grisms and camera lenses are integrated as a 'filter' of HSC. The incident light is folded by pickup mirror at filter layer and introduced to the filter space. After passing the slit, the incident light is collimated by the collimeter lens and divided into three wavelength ranges by dichroic mirrors. The collimated beam in each wavelength range is fed to the grism and dispersed. The dispersed beam is converged by the camera lens and folded by 45 degree mirror to the direction parallel to the optical axis. The resultant spectra are imaged on the main CCDs on the focal plane. The space allowed for filters is 600 mm in diameter and 42 mm thick, which is very tight but we are able to design spectroscopic optics with some difficulties. The spectral resolution is designed to be more than 1000 and the wavelength coverage is targeted to be 370-1050 nm to realize medium-resolution spectroscopy for various type of objects. We show the optical design of collimeter, grism and camera lenses together with the mechanical layout of the spectroscopic optics.

  16. Active Mothers Postpartum (AMP): rationale, design, and baseline characteristics.

    Science.gov (United States)

    Østbye, Truls; Krause, Katrina M; Brouwer, Rebecca J N; Lovelady, Cheryl A; Morey, Miriam C; Bastian, Lori A; Peterson, Bercedis L; Swamy, Geeta K; Chowdhary, Jaspreet; McBride, Colleen M

    2008-12-01

    Pregnancy and the postpartum period have been suggested as important contributors to overweight and obesity among women. This paper presents the design, rationale, and baseline participant characteristics of a randomized controlled intervention trial to enhance weight loss in postpartum women who entered pregnancy overweight or obese. Active Mothers Postpartum (AMP) is based on the rationale that the birth of a child can be a teachable moment. AMP's primary objectives are to promote and sustain a reduction in body mass index (BMI) up to 2 years postpartum via changes in diet and exercise behavior, with a secondary aim to assess racial differences in these outcomes. Women in the intervention arm participate in ten physical activity group sessions, eight healthy eating classes, and six telephone counseling sessions over a 9-month period. They also receive motivational tools, including a workbook with recipes and exercises, a pedometer, and a sport stroller. Four hundred fifty women aged > or =18 (mean 30.9), with a BMI > or = 25 kg/m(2) (mean 33.0) at baseline (6 weeks postpartum) were enrolled; 45% of the final sample are black and 53% are white. Baseline characteristics by study arm and by race are presented. Our intervention is designed to be disseminated broadly to benefit the public health. Behavior change interventions based on principles of social cognitive theory, stage of readiness, and other models that coincide with a teachable moment, such as the birth of a child, could be important motivators for postpartum weight loss.

  17. The Danish Alzheimer Intervention Study: Rationale, Study Design and Baseline Characteristics of the Cohort

    DEFF Research Database (Denmark)

    Waldemar, G.; Waldorff, F.B.; Buss, D.V.

    2011-01-01

    There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteristics...

  18. Design of a cam-form tool in precision reuse of a digital paper display

    Energy Technology Data Exchange (ETDEWEB)

    Pa, Pai-Shan, E-mail: myhow@seed.net.t [Department of Digital Content Design, Graduate School of Toy and Game Design, National Taipei University of Education, No 134, Sec 2, Heping E Rd, Taipei City 106, Taiwan (China)

    2010-05-01

    A reuse fabrication module that uses micro electroremoving as a precision machining process with a new design of the cam-form tool to remove defective indium-tin-oxide (ITO) thin film from the optical PET surfaces of a digital paper display is presented. A small diameter of the cathode of the cam-form tool corresponds to a higher removal rate for the ITO nanostructure. A small edge radius of the anode and a small gap width between the cathode and the ITO surface takes less time for the same amount of ITO removal. A higher feed rate of the optical PET diaphragm combines with enough electric power to drive fast micro-electroremoving. The high rotational speed of the cam-form tool can improve the effect of dreg discharge and is advantageous to associate with the fast feed rate of the optical PET diaphragm.

  19. Cam-follower mechanism design for narrow loom beat up motion ...

    African Journals Online (AJOL)

    The conceptual design for the mechanism is based on the fundamental generalized synthesis procedure. The topology of the kinematics is developed by using the graph theory method of kinematic synthesis. The forces required to drive the plate-cam and follower system were modeled and the components such as the ...

  20. Cocaine Use Reduction with Buprenorphine (CURB): Rationale, design, and methodology☆

    Science.gov (United States)

    Mooney, Larissa J.; Nielsen, Suzanne; Saxon, Andrew; Hillhouse, Maureen; Thomas, Christie; Hasson, Albert; Stablein, Don; McCormack, Jennifer; Lindblad, Robert; Ling, Walter

    2013-01-01

    Background Effective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence. This paper describes the design and rationale for this study. Methods This multi-site, double-blind, placebo-controlled study will randomize 300 participants across 11 sites. Participants must meet the DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Participants are inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone and are then randomly assigned to one of three medication conditions (4 mg BUP, 16 mg BUP, or placebo) for 8 weeks. Participants receive a second injection of XR-NTX 4 weeks after the initial injection, and follow-up visits are scheduled at 1 and 3 months post-treatment. Participants receive weekly cognitive behavioral therapy (CBT). Recruitment commenced in September, 2011. Enrollment, active medication, and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates. Conclusions This research using 2 medications will demonstrate whether BUP, administered in the presence of XR-NTX, reduces cocaine use in adults with cocaine dependence and opioid use disorders and will demonstrate if XR-NTX prevents development of physiologic dependence on BUP. PMID:23159524

  1. Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology.

    Science.gov (United States)

    Mooney, Larissa J; Nielsen, Suzanne; Saxon, Andrew; Hillhouse, Maureen; Thomas, Christie; Hasson, Albert; Stablein, Don; McCormack, Jennifer; Lindblad, Robert; Ling, Walter

    2013-03-01

    Effective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence. This paper describes the design and rationale for this study. This multi-site, double-blind, placebo-controlled study will randomize 300 participants across 11 sites. Participants must meet the DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Participants are inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone and are then randomly assigned to one of three medication conditions (4 mg BUP, 16 mg BUP, or placebo) for 8 weeks. Participants receive a second injection of XR-NTX 4 weeks after the initial injection, and follow-up visits are scheduled at 1 and 3 months post-treatment. Participants receive weekly cognitive behavioral therapy (CBT). Recruitment commenced in September, 2011. Enrollment, active medication, and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates. This research using 2 medications will demonstrate whether BUP, administered in the presence of XR-NTX, reduces cocaine use in adults with cocaine dependence and opioid use disorders and will demonstrate if XR-NTX prevents development of physiologic dependence on BUP. Copyright © 2012 Elsevier Inc. All rights reserved.

  2. Tool application CAD / CAM for design and construction of a prototype of plastic injection mold

    Directory of Open Access Journals (Sweden)

    Albert Miyer Suárez Castrillón

    2015-11-01

    Full Text Available The study, development and production of injection molds comes with the implementation of CAD and CAM tools available on the market; using these tools, a prototype injection mold for thermoplastic materials was designed and built, based on a mold is injection in the laboratory of the University of Pamplona, in which a couple of modifications were made in order to experiment with its design. The prototype was manufactured through a 3D scan of the original mold to provide the CAD / CAM files with the simulated 3D printing technique for performing an experimental study with the prototype for adjusting temperature and pressure sensors and for coatings metallic materials for use in the injection molding process.

  3. 3D fitting accuracy evaluation of CAD/CAM copings - comparison with spacer design settings.

    Science.gov (United States)

    Boitelle, Philippe; Tapie, Laurent; Mawussi, Bernardin; Fromentin, Olivier

    2016-01-01

    The accuracy of computer-aided design/computer- aided manufacturing (CAD/CAM) systems is linked to their technical characteristics and reliability for manufacturing the restoration designed. The aim of this study was to compare the accuracy of fit of zirconia copings manufactured with different CAD/CAM systems and their capacity to conform to pre-established spacer design settings. Sixty zirconia copings were manufactured by three CAD/CAM systems, with their spacers set as recommended by their manufacturer on occlusal, axial, and marginal surfaces. The 3D triple-scan optical technique was used to obtain a fit mapping and to analyze the marginal and axial accuracy of fit. The reliability of the 3D measurement method was estimated using intraclass correlation and repeatability coefficients. The preparation coping interface width results were statistically analyzed using non-parametric analysis (Kruskal-Wallis, one-way ANOVA, and Wilcoxon signedrank tests) (P < 0.05). The repeatability coefficient was 6, 8, and 15 μm for axial, marginal, and occlusal interface width measurements, respectively. For the three systems tested, no differences were found in the marginal area of the copings studied, with a mean fitting accuracy ranging from 54.3 to 66.6 μm interface width. Statistically significant differences between groups were observed for the fitting accuracy measured in axial and occlusal areas. With the spacers set in the different areas, mean fit measurements of the zirconia copings were significantly larger, with an increased fit width ranging from 30 to 73 μm. The three CAD/CAM systems evaluated allowed similar marginal accuracy but failed to reproduce the pre-established spacer parameters, with larger spacing showing throughout.

  4. Maxillary sinus augmentation using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.

    Science.gov (United States)

    Mangano, F; Zecca, P; Pozzi-Taubert, S; Macchi, A; Ricci, M; Luongo, G; Mangano, C

    2013-09-01

    Maxillary sinus augmentation is a common method for increasing bone height for insertion of dental implants. In most cases, the graft is manually cut into a roughly appropriate shape by visual estimation during the operation; accordingly, the shape of the graft depends considerably on the experience of the surgeon. We have developed a computer-aided design/computer-aided manufacturing (CAD/CAM) technique to generate custom-made block grafts for sinus augmentation, and a customized cutting guide to precisely position the lateral wall and facilitate membrane elevation, using cone-beam computed tomography (CBCT). Custom-made blocks of hydroxyapatite (HA) were preoperatively cut to the required shape, based on a three-dimensional (3D) simulation, using CAD/CAM technology. The custom-made HA blocks were used for sinus augmentation. Five patients underwent bilateral sinus elevation with custom-made HA blocks. Six months later, implants were placed. Two years after placement, all implants were in function. No clinical or prosthetic complications were encountered. We present a CAD/CAM technique for the fabrication of custom-made block grafts for sinus augmentation. Copyright © 2012 John Wiley & Sons, Ltd.

  5. CAD/CAM and analysis - A production tool for spacecraft design

    Science.gov (United States)

    Bergsten, F. C.

    1983-01-01

    This paper describes an integrated Computer-Aided Design, Manufacturing, Assemby and Test System to achieve increased productivity and quality. The term CADMAT has been used to emphasize the importance of integrating the familiar CAD, CAM and CAT functions. The CADMAT methodology encompasses all automated and computer augmented processes throughout the product and business organizations. In Electronics, Design Simulation and Verification, Interactive Graphics (IAG), Automated Board Layout, and Automatic Test Vector Generation are discussed. In the mechanical area, the use of 2D and 3D graphics techniques, computerized finite element modeling, and structural analysis programs are described. The use of the design database in N/C manufacturing, automated inspection and testing is also examined.

  6. Task based displays - rationale, design, user test and assessment

    Energy Technology Data Exchange (ETDEWEB)

    Foerdestroemmen, Nils

    2004-04-15

    The report summarizes the work that has been done on task-based displays within the Halden Reactor Project in the period 1998-2003. The development work on task-based displays was initiated in 1998, and the prototype design was reported in 1999. In 2001, four realised task displays were exposed to a user test, and the display design and user test results were reported in 2002. During 2003, the previous work was reviewed, summarised and assessed. The work presented in this report forms the basis for the future planned work on task-based displays. (Author)

  7. Lessons Learnt from Experts in Design Rationale Knowledge Capture

    DEFF Research Database (Denmark)

    Hall, Mark; Bermell-Garcia, Pablo; Ravindranath, Ranjitun

    2017-01-01

    The focus of this paper is on the use of argumentation models and software tools to support knowledge capture in the design of long-life engineering products. The results of semi-structured interviews with a number of experts in the field are presented, exploring their collective experience...... of knowledge capture and eliciting guidelines for successful implementation of such models and tools. The results of this research may be used as the basis for the design of future tools and techniques for knowledge capture....

  8. Rationale for the Design of the ADA (Tradename) Programming Language,

    Science.gov (United States)

    1986-01-01

    The access value (an internal name) contained by an access constant cannot be changed. Consider, for example, the constant declarations: YOUNOW ...dynamically allocated record designated by YOU at the time of the initialization. It means that YOUNOW will always contain this access value even if

  9. Elastin-like polypeptide based nanoparticles: design rationale toward nanomedicine.

    Science.gov (United States)

    Smits, Ferdinanda C M; Buddingh, Bastiaan C; van Eldijk, Mark B; van Hest, Jan C M

    2015-01-01

    Elastin-like polypeptides (ELPs) are characterized by a high sequence control, temperature responsiveness and biocompatibility, which make them highly interesting as smart materials for application in nanomedicine. In particular the construction of ELP-based nanoparticles has recently become a focal point of attention in materials research. This review will give an overview of the ELP-based nanoparticles that have been developed until now and their underlying design principles. First a short introduction on ELPs and their stimulus-responsive behavior will be given. This characteristic has been applied for the development of ELP-based block copolymers that can self-assemble into nanoparticles. Both the fully ELP-based as well as several ELP hybrid materials that have been reported to form nanoparticles will be discussed, which is followed by a concise description of the promising biomedical applications reported for this class of materials. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Activity in GEriatric acute CARe (AGECAR: rationale, design and methods

    Directory of Open Access Journals (Sweden)

    Fleck Steven J

    2012-06-01

    Full Text Available Abstract Background The Activity in GEriatric acute CARe (AGECAR is a randomised control trial to assess the effectiveness of an intrahospital strength and walk program during short hospital stays for improving functional capacity of patients aged 75 years or older. Methods/Design Patients aged 75 years or older admitted for a short hospital stay (≤14 days will be randomly assigned to either a usual care (control group or an intervention (training group. Participants allocated in the usual care group will receive normal hospital care and participants allocated in the intervention group will perform multiple sessions per day of lower limb strength training (standing from a seated position and walking (10 min bouts while hospitalized. The primary outcome to be assessed pre and post of the hospital stay will be functional capacity, using the Short Physical Performance Battery (SPPB, and time to walk 10 meters. Besides length of hospitalization, the secondary outcomes that will also be assessed at hospital admission and discharge will be pulmonary ventilation (forced expiratory volume in one second, FEV1 and peripheral oxygen saturation. The secondary outcomes that will be assessed by telephone interview three months after discharge will be mortality, number of falls since discharge, and ability to cope with activities of daily living (ADLs, using the Katz ADL score and Barthel ADL index. Discussion Results will help to better understand the potential of regular physical activity during a short hospital stay for improving functional capacity in old patients. The increase in life expectancy has resulted in a large segment of the population being over 75 years of age and an increase in hospitalization of this same age group. This calls attention to health care systems and public health policymakers to focus on promoting methods to improve the functional capacity of this population. Trial registration ClinicalTrials.gov ID: NCT01374893.

  11. Rationales, design and recruitment of the Taizhou Longitudinal Study

    Directory of Open Access Journals (Sweden)

    Lu Daru

    2009-07-01

    Full Text Available Background Rapid economic growth in China in the past decades has been accompanied by dramatic changes in lifestyle and environmental exposures. The burdens of non-communicable diseases, such as cardiovascular diseases, diabetes and cancer, have also increased substantially. Methods/design We initiated a large prospective cohort–the Taizhou Longitudinal Study–in Taizhou (a medium-size city in China to explore the environmental and genetic risk factors for common non-communicable diseases. The sample size of the cohort will be at least 100,000 adults aged 30–80 years drawn from the general residents of the districts of Hailin, Gaogang, and Taixing (sample frame, 1.8 million of Taizhou. A three-stage stratified sampling method will be applied. Baseline investigations include interviewer-administered questionnaire, anthropometric measurements, and collection of buccal mucosal cells and blood specimens. DNA will be extracted for genetic studies and serum samples will be used for biochemical examinations. A follow-up survey will be conducted every three years to obtain information on disease occurrence and information on selected lifestyle exposures. Study participants will be followed-up indefinitely by using a chronic disease register system for morbidity and cause-specific mortality. Information on non-fatal events will be obtained for certain major categories of disease (e.g., cancer, stroke, myocardial infarction through established registry systems. Discussion The Taizhou Longitudinal Study will provide a good basis for exploring the roles of many important environmental factors (especially those concomitant with the economic transformation in China for common chronic diseases, solely or via interaction with genetic factors.

  12. China suboptimal health cohort study: rationale, design and baseline characteristics.

    Science.gov (United States)

    Wang, Youxin; Ge, Siqi; Yan, Yuxiang; Wang, Anxin; Zhao, Zhongyao; Yu, Xinwei; Qiu, Jing; Alzain, Mohamed Ali; Wang, Hao; Fang, Honghong; Gao, Qing; Song, Manshu; Zhang, Jie; Zhou, Yong; Wang, Wei

    2016-10-13

    Suboptimal health status (SHS) is a physical state between health and disease, characterized by the perception of health complaints, general weakness, chronic fatigue and low energy levels. SHS is proposed by the ancient concept of traditional Chinese medicine (TCM) from the perspective of preservative, predictive and personalized (precision) medicine. We previously created the suboptimal health status questionnaire 25 (SHSQ-25), a novel instrument to measure SHS, validated in various populations. SHSQ-25 thus affords a window of opportunity for early detection and intervention, contributing to the reduction of chronic disease burdens. To investigate the causative effect of SHS in non-communicable chronic diseases (NCD), we initiated the China suboptimal health cohort study (COACS), a longitudinal study starting from 2013. Phase I of the study involved a cross-sectional survey aimed at identifying the risk/protective factors associated with SHS; and Phase II: a longitudinal yearly follow-up study investigating how SHS contributes to the incidence and pattern of NCD. (1) Cross-sectional survey: in total, 4313 participants (53.8 % women) aged from 18 to 65 years were included in the cohort. The prevalence of SHS was 9.0 % using SHS score of 35 as threshold. Women showed a significantly higher prevalence of SHS (10.6 % in the female vs. 7.2 % in the male, P differed significantly between subjects of SHS (SHS score ≥35) and those of ideal health (SHS score difference in prevalence of SHS might partly explain the gender difference of incidence of certain chronic diseases. The COACS will enable a thorough characterization of SHS and establish a cohort that will be used for longitudinal analyses of the interaction between the genetic, lifestyle and environmental factors that contribute to the onset and etiology of targeted chronic diseases. The study together with the designed prospective cohort provides a chance to characterize and evaluate the effect of SHS

  13. Cam-Follower Mechanism Design for Narrow Loom Beat Up Motion ...

    African Journals Online (AJOL)

    The topology of the kinematics is developed by using the graph theory method of kinematic synthesis. The forces required to drive the plate-cam and follower system were modeled and the components such as the plate-cam, camshaft, the follower and the drive mechanism were synthesized for smooth operation of the ...

  14. Capturing Design : Improving conceptual ship design through the capture of design rationale

    NARCIS (Netherlands)

    DeNucci, T.W.

    2012-01-01

    As the complexity of ship design increases, the knowledge used to resolve these complexities is decreasing due to a loss of intellectual resources. In order to remedy these losses, Naval Architects must capitalize on the knowledge available in design teams. The solution to this quandary involves the

  15. 3D correction of AIS in braces designed using CAD/CAM and FEM: a randomized controlled trial.

    Science.gov (United States)

    Cobetto, Nikita; Aubin, Carl-Éric; Parent, Stefan; Barchi, Soraya; Turgeon, Isabelle; Labelle, Hubert

    2017-01-01

    Recent studies showed that finite element model (FEM) combined to CAD/CAM improves the design of braces for the conservative treatment of adolescent idiopathic scoliosis (AIS), using 2D measurements from in-brace radiographs. We aim to assess the immediate effectiveness on curve correction in all three planes of braces designed using CAD/CAM and numerical simulation compared to braces designed with CAD/CAM only. SRS standardized criteria for bracing were followed to recruit 48 AIS patients who were randomized into two groups. For both groups, 3D reconstructions of the spine and patient's torso, respectively built from bi-planar radiographs and surface topography, were obtained and braces were designed using the CAD/CAM approach. For the test group, 3D reconstructions of the spine and patient's torso were additionally used to generate a personalized FEM to simulate and iteratively improve the brace design with the objective of curve correction maximization in three planes and brace material minimization. For the control group (CtrlBraces), average Cobb angle prior to bracing was 29° (thoracic, T) and 25° (lumbar, L) with the planes of maximal curvature (PMC) respectively oriented at 63° and 57° on average with respect to the sagittal plane. Average apical axial rotation prior to bracing was 7° (T) and 9° (L). For the test group (FEMBraces), initial Cobb angles were 33° (T) and 28° (L) with the PMC at 68° (T) and 56° (L) and average apical axial rotation prior to bracing at 9° (T and L). On average, FEMBraces were 50% thinner and had 20% less covering surface than CtrlBraces while reducing T and L curves by 47 and 48%, respectively, compared to 25 and 26% for CtrlBraces. FEMBraces corrected apical axial rotation by 46% compared to 30% for CtrlBraces. The combination of numerical simulation and CAD/CAM approach allowed designing more efficient braces in all three planes, with the advantages of being lighter than standard CAD/CAM braces. Bracing in AIS may

  16. Hyper Suprime-Cam: System design and verification of image quality

    Science.gov (United States)

    Miyazaki, Satoshi; Komiyama, Yutaka; Kawanomoto, Satoshi; Doi, Yoshiyuki; Furusawa, Hisanori; Hamana, Takashi; Hayashi, Yusuke; Ikeda, Hiroyuki; Kamata, Yukiko; Karoji, Hiroshi; Koike, Michitaro; Kurakami, Tomio; Miyama, Shoken; Morokuma, Tomoki; Nakata, Fumiaki; Namikawa, Kazuhito; Nakaya, Hidehiko; Nariai, Kyoji; Obuchi, Yoshiyuki; Oishi, Yukie; Okada, Norio; Okura, Yuki; Tait, Philip; Takata, Tadafumi; Tanaka, Yoko; Tanaka, Masayuki; Terai, Tsuyoshi; Tomono, Daigo; Uraguchi, Fumihiro; Usuda, Tomonori; Utsumi, Yousuke; Yamada, Yoshihiko; Yamanoi, Hitomi; Aihara, Hiroaki; Fujimori, Hiroki; Mineo, Sogo; Miyatake, Hironao; Oguri, Masamune; Uchida, Tomohisa; Tanaka, Manobu M.; Yasuda, Naoki; Takada, Masahiro; Murayama, Hitoshi; Nishizawa, Atsushi J.; Sugiyama, Naoshi; Chiba, Masashi; Futamase, Toshifumi; Wang, Shiang-Yu; Chen, Hsin-Yo; Ho, Paul T. P.; Liaw, Eric J. Y.; Chiu, Chi-Fang; Ho, Cheng-Lin; Lai, Tsang-Chih; Lee, Yao-Cheng; Jeng, Dun-Zen; Iwamura, Satoru; Armstrong, Robert; Bickerton, Steve; Bosch, James; Gunn, James E.; Lupton, Robert H.; Loomis, Craig; Price, Paul; Smith, Steward; Strauss, Michael A.; Turner, Edwin L.; Suzuki, Hisanori; Miyazaki, Yasuhito; Muramatsu, Masaharu; Yamamoto, Koei; Endo, Makoto; Ezaki, Yutaka; Ito, Noboru; Kawaguchi, Noboru; Sofuku, Satoshi; Taniike, Tomoaki; Akutsu, Kotaro; Dojo, Naoto; Kasumi, Kazuyuki; Matsuda, Toru; Imoto, Kohei; Miwa, Yoshinori; Suzuki, Masayuki; Takeshi, Kunio; Yokota, Hideo

    2018-01-01

    The Hyper Suprime-Cam (HSC) is an 870 megapixel prime focus optical imaging camera for the 8.2 m Subaru telescope. The wide-field corrector delivers sharp images of 0{^''.}2 (FWHM) in the HSC-i band over the entire 1.5° diameter field of view. The collimation of the camera with respect to the optical axis of the primary mirror is done with hexapod actuators, the mechanical accuracy of which is a few microns. Analysis of the remaining wavefront error in off-focus stellar images reveals that the collimation of the optical components meets design specifications. While there is a flexure of mechanical components, it also is within the design specification. As a result, the camera achieves its seeing-limited imaging on Maunakea during most of the time; the median seeing over several years of observing is 0.67" (FWHM) in the i band. The sensors use p-channel, fully depleted CCDs of 200 μm thickness (2048 × 4176 15 μm square pixels) and we employ 116 of them to pave the 50 cm diameter focal plane. The minimum interval between exposures is 34 s, including the time to read out arrays, to transfer data to the control computer, and to save them to the hard drive. HSC on Subaru uniquely features a combination of a large aperture, a wide field of view, sharp images and a high sensitivity especially at longer wavelengths, which makes the HSC one of the most powerful observing facilities in the world.

  17. Post-Cam Design and Contact Stress on Tibial Posts in Posterior-Stabilized Total Knee Prostheses: Comparison Between a Rounded and a Squared Design.

    Science.gov (United States)

    Watanabe, Toshifumi; Koga, Hideyuki; Horie, Masafumi; Katagiri, Hiroki; Sekiya, Ichiro; Muneta, Takeshi

    2017-12-01

    The post-cam mechanism in posterior stabilized (PS) prostheses plays an important role in total knee arthroplasty (TKA). The purpose of this study is to clarify the difference of the contact stress on the tibial post between a rounded post-cam design and a squared design during deep knee flexion and at hyperextension using the three-dimensional (3D) finite element models. We created 2 types of 3D, finite element models of PS prostheses (types A and B), whose surfaces were identical except for the post-cam geometries: type A has a rounded post-cam design, while type B has a squared design. Both types have a similar curved-shape intercondylar notch of the femoral component. Stress distributions, peak contact stresses, and contact areas on the tibial posts at 90°, 120°, and 150° flexion with/without 10° tibial internal rotation and at 10° hyperextension were compared between the 2 models. Type B demonstrated more concentrated stress distribution compared to type A. The peak contact stresses were similar in both groups during neutral flexion; however, the stresses were much higher in type B during flexion with 10° rotation and at hyperextension. The higher peak contact stresses corresponded to the smaller contact areas in the tibial post. A rounded post-cam design demonstrated less stress concentration during flexion with rotation and at hyperextension compared with a squared design. The results would be useful for development of implant designs and prediction of the contact stress on the tibial post in PS total knee arthroplasty. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Coronary Artery Calcium Imaging in the ROBINSCA Trial: Rationale, Design, and Technical Background.

    Science.gov (United States)

    Vonder, Marleen; van der Aalst, Carlijn M; Vliegenthart, Rozemarijn; van Ooijen, Peter M A; Kuijpers, Dirkjan; Gratama, Jan Willem; de Koning, Harry J; Oudkerk, Matthijs

    2018-01-01

    To describe the rationale, design, and technical background of coronary artery calcium (CAC) imaging in the large-scale population-based cardiovascular disease screening trial (Risk Or Benefit IN Screening for CArdiovascular Diseases [ROBINSCA]). First, literature search was performed to review the logistics, setup, and settings of previously performed CAC imaging studies, and current clinical CAC imaging protocols of participating centers in the ROBINSCA trial were evaluated. A second literature search was performed to evaluate the impact of computed tomography parameter settings on CAC score. Based on literature reviews and experts opinion an imaging protocol accompanied by data management protocol was created for ROBINSCA. The imaging protocol should consist of a fixed tube voltage, individually tailored tube current setting, mid-diastolic electrocardiography-triggering, fixed field-of-view, fixed reconstruction kernel, fixed slice thickness, overlapping reconstruction and without iterative reconstruction. The analysis of scans is performed with one type and version of CAC scoring software, by two dedicated and experienced researchers. The data management protocol describes the organization of data handling between the coordinating center, participating centers, and core analysis center. In this paper we describe the rationale and technical considerations to be taken in developing CAC imaging protocol, and we present a detailed protocol that can be implemented for CAC screening purposes. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  19. Addressing holistic healthcare needs of oncology patients: Implementation and evaluation of a complementary and alternative medicine (CAM) course within an elective module designed for healthcare professionals.

    Science.gov (United States)

    Klafke, Nadja; Homberg, Angelika; Glassen, Katharina; Mahler, Cornelia

    2016-12-01

    Patients, and especially oncology patients, increasingly demand information and application of complementary therapies to supplement their conventional medical treatment and follow-up care. Due to the widespread interest in holistic treatment opportunities in oncology populations, healthcare professionals need to be prepared in differentiating evidence-based methods of the complementary and alternative medicine (CAM) spectrum and how to consult with patients about it. This paper reports on the implementation and evaluation of a newly designed module "Complementary and Alternative Medicine in oncological healthcare" in the bachelor degree program Interprofessional Health Care (B.Sc.). The study applied a developed evaluation questionnaire to capture students' perspectives on the CAM contents. This assessment instrument was administered pre and post the CAM teaching unit. Interprofessional medical education, University Hospital Heidelberg, Germany. The integration of the CAM elective module was possible and was met by positive response. Students' interest was reflected in an increase of their self-reported knowledge gain and positive CAM attitude. Comparison of pre and post evaluation data demonstrate that, particularly, students' expectations on developing their own opinion about CAM, and getting an overview of the evidence-base of different CAM methods have been met. Evaluation results indicate that the module content was in line with the students' expectations and may have positively impacted on their general CAM attitude. The results support us in continuing to offer this CAM course within the elective module to prepare today's healthcare professionals for patient-oriented healthcare delivery. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

    Science.gov (United States)

    Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

    2008-01-01

    This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

  1. Conceptual design studies for the European DEMO divertor: Rationale and first results

    Energy Technology Data Exchange (ETDEWEB)

    You, J.H., E-mail: you@ipp.mpg.de [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Mazzone, G.; Visca, E. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Bachmann, Ch. [EUROfusion PMU, c/o IPP, Boltzmann Str. 2, 85748 Garching (Germany); Autissier, E. [CEA, IRFM, F-13108 Saint Paul Lez Durance (France); Barrett, T. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Cocilovo, V.; Crescenzi, F. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Domalapally, P.K. [Research Cnter Rez, Hlavní 130, 250 68 Husinec–Řež (Czech Republic); Dongiovanni, D. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Entler, S. [Institute of Plasma Physics CAS, Za Slovankou 3, 182 00 Praha 8 (Czech Republic); Federici, G. [EUROfusion PMU, c/o IPP, Boltzmann Str. 2, 85748 Garching (Germany); Frosi, P. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Fursdon, M. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Greuner, H. [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Hancock, D. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Marzullo, D. [CREATE, University of Naples Federico II, P.le Tecchio 80, 80125 Napoli (Italy); McIntosh, S. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Müller, A.V. [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Porfiri, M.T. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); and others

    2016-11-01

    Highlights: • A brief overview is given on the overall R&D activities of the work package Divertor which is a project of the EUROfusion Consortium. • The rationale of the hydraulic, thermal and structural design scheme is described. • The first results obtained for the preliminary DEMO divertor cassette model are presented. - Abstract: In the European fusion roadmap, reliable power handling has been defined as one of the most critical challenges for realizing a commercially viable fusion power. In this context, the divertor is the key in-vessel component, as it is responsible for power exhaust and impurity removal for which divertor target is subjected to very high heat flux loads. To this end, an integrated R&D project was launched in the EUROfusion Consortium in order to deliver a holistic conceptual design solution together with the core technologies for the entire divertor system of a DEMO reactor. The work package ‘Divertor’ consists of two project areas: ‘Cassette design and integration’ and ‘Target development’. The essential mission of the project is to develop and verify advanced design concepts and the required technologies for a divertor system being capable of meeting the physical and system requirements defined for the next-generation European DEMO reactor. In this contribution, a brief overview is presented of the works from the first project year (2014). Focus is put on the loads specification, design boundary conditions, materials requirements, design approaches, and R&D strategy. Initial ideas and first estimates are presented.

  2. The Cannabis Youth Treatment (CYT) experiment: rationale, study design and analysis plans.

    Science.gov (United States)

    Dennis, Michael; Titus, Janet C; Diamond, Guy; Donaldson, Jean; Godley, Susan H; Tims, Frank M; Webb, Charles; Kaminer, Yifrah; Babor, Thomas; Roebuck, M C; Godley, Mark D; Hamilton, Nancy; Liddle, Howard; Scott, Christy K

    2002-12-01

    This paper provides a description of the rationale, study design, treatments and assessment procedures used in the Cannabis Youth Treatment (CYT) experiment. CYT was designed to (a) test the relative effectiveness, cost and benefit-cost of five promising treatment interventions under field conditions and (b) provide evidence based manual-guided models of these interventions to the treatment field. The study involved two community-based treatment programs and two major medical centers. Participants were 600 adolescents recruited from the regular intake who were between the ages of 12 and 18, had used marijuana in the past 90 days, and met one or more criteria of dependence or abuse. Participants were randomly assigned to one of five interventions: Motivational Enhancement Therapy (MET), Cognitive Behavioral Therapy (CBT), Family Support Network (FSN), Adolescent Community Reinforcement Approach (ACRA), or Multidimensional Family Therapy (MDFT). Self-report data were collected at intake, 3, 6, 9 and 12 months post discharge using the Global Appraisal of Individual Needs (GAIN), as well as several supplemental self-reports, collateral reports, urine testing, and service logs. This paper reports on the study's implementation including the psychometric properties of the measures (alphas over 0.8), validity of self-report (kappa over 0.6), high rates of treatment completion (81% completed two or more months), and high rates of follow-up (over 94% per wave). The feasibility of implementing the CYT manual-guided treatment and quality assurance model in community-based adolescent treatment programs is discussed.

  3. Deep brain stimulation for obesity: rationale and approach to trial design.

    Science.gov (United States)

    Ho, Allen L; Sussman, Eric S; Pendharkar, Arjun V; Azagury, Dan E; Bohon, Cara; Halpern, Casey H

    2015-06-01

    Obesity is one of the most serious public health concerns in the US. While bariatric surgery has been shown to be successful for treatment of morbid obesity for those who have undergone unsuccessful behavioral modification, its associated risks and rates of relapse are not insignificant. There exists a neurological basis for the binge-like feeding behavior observed in morbid obesity that is believed to be due to dysregulation of the reward circuitry. The authors present a review of the evidence of the neuroanatomical basis for obesity, the potential neural targets for deep brain stimulation (DBS), as well as a rationale for DBS and future trial design. Identification of an appropriate patient population that would most likely benefit from this type of therapy is essential. There are also significant cost and ethical considerations for such a neuromodulatory intervention designed to alter maladaptive behavior. Finally, the authors present a consolidated set of inclusion criteria and study end points that should serve as the basis for any trial of DBS for obesity.

  4. The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress.

    Science.gov (United States)

    Antic, Nick A; Heeley, Emma; Anderson, Craig S; Luo, Yuanming; Wang, Jiguang; Neal, Bruce; Grunstein, Ron; Barbe, Ferran; Lorenzi-Filho, Geraldo; Huang, Shaoguang; Redline, Susan; Zhong, Nanshan; McEvoy, R Doug

    2015-08-01

    The Sleep Apnea cardioVascular Endpoints (SAVE) study is an ongoing investigator-initiated and conducted, international, multicenter, open, blinded endpoint, randomized controlled trial that was designed to determine whether treatment of obstructive sleep apnea (OSA) with continuous positive airways pressure (CPAP) can reduce the risk of serious cardiovascular (CV) events in patients with established CV disease (clinical trial registration NCT00738179). The results of this study will have important implications for the provision of health care to patients with sleep apnea around the world. The SAVE study has brought together respiratory, sleep, CV and stroke clinicians-scientists in an interdisciplinary collaboration with industry and government sponsorship to conduct an ambitious clinical trial. Following its launch in Australia and China in late 2008, the recruitment network expanded across 89 sites that included New Zealand, India, Spain, USA, and Brazil for a total of 2,717 patients randomized by December 2013. These patients are being followed until December 2015 so that the average length of follow-up of the cohort will be over 4 y. This article describes the rationale for the SAVE study, considerations given to the design including how various cultural and ethical challenges were addressed, and progress in establishing and maintaining the recruitment network, patient follow-up, and adherence to CPAP and procedures. The assumptions underlying the original trial sample size calculation and why this was revised downward in 2012 are also discussed. NCT00738179. ACTRN12608000409370. © 2015 Associated Professional Sleep Societies, LLC.

  5. Holonic Rationale and Bio-inspiration on Design of Complex Emergent and Evolvable Systems

    Science.gov (United States)

    Leitao, Paulo

    Traditional centralized and rigid control structures are becoming inflexible to face the requirements of reconfigurability, responsiveness and robustness, imposed by customer demands in the current global economy. The Holonic Manufacturing Systems (HMS) paradigm, which was pointed out as a suitable solution to face these requirements, translates the concepts inherited from social organizations and biology to the manufacturing world. It offers an alternative way of designing adaptive systems where the traditional centralized control is replaced by decentralization over distributed and autonomous entities organized in hierarchical structures formed by intermediate stable forms. In spite of its enormous potential, methods regarding the self-adaptation and self-organization of complex systems are still missing. This paper discusses how the insights from biology in connection with new fields of computer science can be useful to enhance the holonic design aiming to achieve more self-adaptive and evolvable systems. Special attention is devoted to the discussion of emergent behavior and self-organization concepts, and the way they can be combined with the holonic rationale.

  6. Influence of different cavity preparation designs on fracture resistance of onlay and overlay restorations using different CAD/CAM materials.

    Science.gov (United States)

    Ön Salman, Gizem; Tacír, Ɣbrahim Halil; Polat, Zelal Seyfioğlu; Salman, Afşin

    2017-06-01

    To evaluate fracture strength of different preparation designed onlay and overlay restorations produced by Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) and three different new ceramic-polymer blocks. Ninety-one extracted human mandibular molars were used in this study. Preparations were made as (1) Only functional cusps reduction, (2) Only functional cusps reduction+rounded shoulder finish line, (3) All cusps reduction, or (4) All cusps reduction+rounded shoulder finish line. Then these four cavity types were restored with three different materials: VITA Enamic, GC Cerasmart, Lava Ultimate. Thirteen groups were created by added control group (n= 7). Adhesive cementation was achieved by using a dual cured composite resin adhesive cement RelyX Ultimate. All samples were subjected to thermocycling for 5,000 cycles in water baths between 50°C and 55°C. The fracture resistance of specimens was determined under compressive loads along the long axis of the restored teeth at 0.5 mm/minute crosshead speed until fracture with a universal test machine. Fracture types of restored groups were evaluated. For fracture resistance data, one-way ANOVA; for correlation between material type and preparation design, two-way ANOVA were used. Percentage table and Kruskal-Wallis test were performed for analysis of fracture types. There was no significant difference between all the groups (one-way ANOVA, P> 0.05). Group 4 showed statistically higher fracture strength values than Group 1 and no significant difference was found among other preparation designs by two-way ANOVA that compared all types of preparation designs regardless of material difference (Pmaterials and type of preparations should be selected for onlay and overlay restorations produced with newly introduced ceramic-polymer CAD/CAM materials.

  7. Designing a combined casting mold for manufacture of a gasoline centrifugal pump body using CAD/CAM-systems

    Science.gov (United States)

    Galin, N. E.; Ogol, I. I.; Chervach, Yu B.; Dammer, V. Kh; Ru, Jia Hong

    2017-02-01

    The present paper examines designing of a combined casting mold for manufacture of a gasoline centrifugal pump body. The paper offers technological solutions for obtaining high quality castings at the testing stage of the finished mold. The paper is intended for practical use and prepared by order of JSC ‘Tomsk Electrical Engineering Plant’ using software and equipment of the department ‘Technologies of Computer-Aided Machinery Manufacturing’ of the Tomsk Polytechnic University (TPU) under the economic contract within state import substitution program. In preparing the paper, CAD/CAM-systems KOMPAS-3D and PowerMILL were used. In 2015, the designed casting mold was introduced into the production process at JSC ‘Tomsk Electrical Engineering Plant’.

  8. Rationale and Design of the Echocardiographic Study of Hispanics/Latinos (ECHO-SOL).

    Science.gov (United States)

    Rodriguez, Carlos J; Dharod, Ajay; Allison, Matthew A; Shah, Sanjiv J; Hurwitz, Barry; Bangdiwala, Shrikant I; Gonzalez, Franklyn; Kitzman, Dalane; Gillam, Linda; Spevack, Daniel; Dadhania, Rupal; Langdon, Sarah; Kaplan, Robert

    2015-01-01

    Information regarding the prevalence and determinants of cardiac structure and function (systolic and diastolic) among the various Hispanic background groups in the United States is limited. The Echocardiographic Study of Latinos (ECHO-SOL) ancillary study recruited 1,824 participants through a stratified-sampling process representative of the population-based Hispanic Communities Health Study - Study of Latinos (HCHS-SOL) across four sites (Bronx, NY; Chicago, Ill; San Diego, Calif; Miami, Fla). The HCHS-SOL baseline cohort did not include an echo exam. ECHO-SOL added the echocardiographic assessment of cardiac structure and function to an array of existing HCHS-SOL baseline clinical, psychosocial, and socioeconomic data and provides sufficient statistical power for comparisons among the Hispanic subgroups. Standard two-dimensional (2D) echocardiography protocol, including M-mode, spectral, color and tissue Doppler study was performed. The main objectives were to: 1) characterize cardiac structure and function and its determinants among Hispanics and Hispanic subgroups; and 2) determine the contributions of specific psychosocial factors (acculturation and familismo) to cardiac structure and function among Hispanics. We describe the design, methods and rationale of currently the largest and most comprehensive study of cardiac structure and function exclusively among US Hispanics. ECHO-SOL aims to enhance our understanding of Hispanic cardiovascular health as well as help untangle the relative importance of Hispanic subgroup heterogeneity and sociocultural factors on cardiac structure and function.

  9. Rationale and Design of the Women and Inclusion in Academic Medicine Study.

    Science.gov (United States)

    Hill, Emorcia V; Wake, Michael; Carapinha, René; Normand, Sharon-Lise; Wolf, Robert E; Norris, Keith; Reede, Joan Y

    2016-04-21

    Women of color (WOC) (African American, Hispanic, Native American/Alaskan Native, and Asian American) faculty remain disproportionately underrepresented among medical school faculty and especially at senior ranks compared with White female faculty. The barriers or facilitators to the career advancement of WOC are poorly understood. The Women and Inclusion in Academic Medicine (WIAM) study was developed to characterize individual, institutional and sociocultural factors that influence the entry, progression and persistence, and advancement of women faculty in academic medical careers with a focus on WOC. Using a purposive sample of 13 academic medical institutions, we collected qualitative interview data from 21 WOC junior faculty and quantitative data from 3,127 (38.9% of 8,053 eligible women) respondents via an online survey. To gather institutional data, we used an online survey and conducted 23 key administrative informant interviews from the 13 institutions. Grounded theory methodology will be used to analyze qualitative data. Multivariable analysis including hierarchical linear modeling will be used to investigate outcomes, such as the inclusiveness of organizational gender climate and women faculty's intent to stay. We describe the design, methods, rationale and limitations of one of the largest and most comprehensive studies of women faculty in academic medicine with a focus on WOC. This study will enhance our understanding of challenges that face women, and, especially WOC, faculty in academic medicine and will provide solutions at both the individual and institutional levels.

  10. The Mediterranean healthy eating, ageing, and lifestyle (MEAL) study: rationale and study design.

    Science.gov (United States)

    Grosso, Giuseppe; Marventano, Stefano; D'Urso, Maurizio; Mistretta, Antonio; Galvano, Fabio

    2017-08-01

    There is accumulating evidence suggesting that Mediterranean lifestyles, including nutrition and sleeping patterns as well as social integration, may play a role in reducing age-related diseases. However, the literature is mostly deficient of evidence provided by Italian Mediterranean islands that more closely adhered to the originally described lifestyles. In this paper, we described the rationale and the study design of the Mediterranean healthy Eating, Ageing, and Lifestyle (MEAL) study, a prospective population-based cohort established in Sicily, southern Italy. The main exposures investigated are classical determinants of health, including demographic, nutritional habits, smoking and physical activity status, as well as eating-related behaviors, sleeping habits, sun exposure, social resources, and perceived stress. Anthropometric measurements will be collected. The main outcomes included depression, quality of life, and, after the follow-up period, also cardiovascular disease and cancer. The MEAL study may provide important data to increase our knowledge regarding the prevalence, incidence, and risk factors of age-related disorders in the Mediterranean region.

  11. Placement Of Cardiac PacemaKEr Trial (POCKET) - rationale and design: a randomized controlled trial.

    Science.gov (United States)

    Magnusson, Peter; Wennström, Leo; Kastberg, Robert; Liv, Per

    2017-01-01

    A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs) to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET). The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years) and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS) 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device). POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  12. Rationale and design of the multinational observational study assessing insulin use: the MOSAIc study

    Directory of Open Access Journals (Sweden)

    Polinski Jennifer M

    2012-09-01

    Full Text Available Abstract Background Although consensus guidelines recommend insulin progression among patients with type 2 diabetes (T2DM who fail to meet glycemic targets over time, many fewer patients are progressed than may benefit. We describe the rationale and design of the MOSAIc (Multinational Observational Study Assessing Insulin use study, a multinational observational cohort study to identify patient-, physician, and health care environment-based factors associated with insulin progression for patients with T2DM in real-world practice. Methods/design We will enroll 4,500 patients with T2DM taking initial insulin therapy for ≥3 months across 175 physician practice sites in 18 countries. Extensive demographic, clinical, and psychosocial data at the patient and physician level and practice site characteristics will be collected at baseline and regular intervals during a 24-month follow-up period. We will use a multivariable logistic regression model to identify predictors of insulin progression and highlight potential opportunities for health behavior intervention to improve insulin progression rates. Secondary outcomes include evaluating factors associated with glycemic control, hypoglycemia, and treatment adherence among patients who do and do not progress beyond their initial insulin therapy and exploring geographic heterogeneity in treatment. Discussion Practice site and patient recruitment began in 2011 and baseline data will be available in late 2012. The MOSAIC study’s longitudinal observational design as well as the breadth and depth of data will be used to explore and quantify predictors of insulin progression and to identify potential opportunities for health behavior intervention in order to improve T2DM treatment and clinical outcomes.

  13. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

    Directory of Open Access Journals (Sweden)

    March John S

    2009-01-01

    Full Text Available Abstract This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II, which investigates two different cognitive-behavior therapy (CBT augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test an easily disseminated protocol whereby child psychiatrists would provide instructions in core CBT procedures recommended for pediatric OCD (e.g., hierarchy development, in vivo exposure homework during routine medical management of OCD (I-CBT. The conventional "dual doctor" CBT protocol consists of 14 visits over 12 weeks involving: (1 psychoeducation, (2, cognitive training, (3 mapping OCD, and (4 exposure with response prevention (EX/RP. I-CBT is a 7-session version of CBT that does not include imaginal exposure or therapist-assisted EX/RP. In this study, we compared 12 weeks of medication management (MM provided by a study psychiatrist (MM only with two types of CBT augmentation: (1 the dual doctor model (MM+CBT; and (2 the single doctor model (MM+I-CBT. The design balanced elements of an efficacy study (e.g., random assignment, independent ratings with effectiveness research aims (e.g., differences in specific SRI medications, dosages, treatment providers. The study is wrapping up recruitment of 140 youth ages 7–17 with a primary diagnosis of OCD. Independent evaluators (IEs rated participants at weeks 0,4,8, and 12 during acute treatment and at 3,6, and 12 month follow-up visits. Trial registration NCT00074815

  14. Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial.

    Science.gov (United States)

    Tronieri, Jena Shaw; Alfaris, Nasreen; Chao, Ariana M; Pearl, Rebecca L; Alamuddin, Naji; Bakizada, Zayna M; Berkowitz, Robert I; Wadden, Thomas A

    2017-08-01

    Few studies have examined the efficacy of recently approved medications for chronic weight management in facilitating the maintenance of lost weight. This paper provides an overview of the design and rationale for a trial investigating whether lorcaserin, when combined with behavioral weight loss maintenance sessions (WLM), will facilitate the maintenance of losses of ≥5% of initial weight. In this two-phase trial, participants with obesity will enroll in a 14-week run-in diet program consisting of weekly group lifestyle modification sessions and a 1000-1200kcal/d meal replacement diet. Participants who complete this weight induction phase and lose at least 5% of initial weight will then be randomized to 52weeks of WLM plus lorcaserin or WLM plus placebo. We hypothesize that at 52weeks post randomization, participants assigned to WLM plus lorcaserin will achieve significantly better maintenance of the prior 5% weight loss. We will recruit 182 adults with obesity to participate in the diet run-in, 136 of whom (75%) are expected to become eligible for the randomized controlled trial. Co-primary outcomes include the percentage of participants who maintain a loss of at least 5% of initial weight at week 52 and change in weight (kg) from randomization to week 52. This two-phase design will allow us to determine the potential efficacy of chronic weight management using lorcaserin for maintaining initial losses of at least 5% body weight, induced by the use of a structured meal-replacement diet. This combined approach holds promise of achieving larger long-term weight losses. NCT02388568 on ClinicalTrials.gov. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Assessing physicians' use of treatment algorithms: Project IMPACTS study design and rationale.

    Science.gov (United States)

    Trivedi, Madhukar H; Claassen, Cynthia A; Grannemann, Bruce D; Kashner, T Michael; Carmody, Thomas J; Daly, Ella; Kern, Janet K

    2007-02-01

    Effective treatments for major depressive disorder have been available for 35 years, yet inadequate pharmacotherapy continues to be widespread leading to suboptimal outcomes. Evidence-based medication algorithms have the potential to bring much-needed improvement in effectiveness of antidepressant treatment in "real-world" clinical settings. Project IMPACTS (Implementation of Algorithms using Computerized Treatment Systems) addresses the critical question of how best to facilitate integration of depression treatment algorithms into routine care. It tests an algorithm implemented through a computerized decision support system using a measurement-based care approach for depression against a paper-and-pencil version of the same algorithm and non-algorithm-based, specialist-delivered usual care. This paper reviews issues related to the Project IMPACTS study rationale, design, and procedures. Patient outcomes include symptom severity, social and work function, and quality of life. The economic impact of treatment is assessed in terms of health care utilization and cost. Data collected on physician behavior include degree of adherence to guidelines and physician attitudes about the perceived utility, ease of use, and self-reported effect of the use of algorithms on workload. Novel features of the design include a two-tiered study enrollment procedure, which initially enroll physicians as subjects, and then following recruitment of physicians, enrollment of subjects takes place based initially on an independent assessment by study staff to determine study eligibility. The study utilizes brief, easy-to-use symptom severity measures that facilitate physician decision making, and it employs a validated, phone-based, follow-up assessment protocol in order to minimize missing data, a problem common in public sector and longitudinal mental health studies. IMPACTS will assess the success of algorithm implementation and subsequent physician adherence using study

  16. Establishing the bidirectional relationship between depression and subclinical arteriosclerosis – rationale, design, and characteristics of the BiDirect Study

    OpenAIRE

    Teismann, H. (Henning); Wersching, H. (Heike); Nagel, M.; Arolt, V.; Heindel, W.L. (Walter); Baune, B T; Wellmann, J; Hense, H.; Berger, K

    2014-01-01

    Background: Depression and cardiovascular diseases due to arteriosclerosis are both frequent and impairing conditions. Depression and (subclinical) arteriosclerosis appear to be related in a bidirectional way, and it is plausible to assume a partly joint causal relationship. However, the biological mechanisms and the behavioral pathways that lead from depression to arteriosclerosis and vice versa remain to be exactly determined. Methods/design: This study protocol describes the rationale and ...

  17. The use of computer-aided design/manufacturing (CAD/CAM) technology to aid in the reconstruction of congenitally deficient pediatric mandibles: A case series.

    Science.gov (United States)

    Gougoutas, Alexander J; Bastidas, Nicholas; Bartlett, Scott P; Jackson, Oksana

    2015-12-01

    Microvascular reconstruction of the pediatric mandible, particularly when necessitated by severe, congenital hypoplasia, presents a formidable challenge. Complex cases, however, may be simplified by computer-aided design/computer-aided manufacturing (CAD/CAM) assisted surgical planning. This series represents the senior authors' preliminary experiences with CAD/CAM assisted, microvascular reconstruction of the pediatric mandible. Presented are two patients with hemifacial/bifacial microsomia, both with profound mandibular hypoplasia, who underwent CAD/CAM assisted reconstruction of their mandibles with vascularized fibula flaps. Surgical techniques, CAD/CAM routines employed, complications, and long-term outcomes are reported. Successful mandibular reconstructions were achieved in both patients with centralization of their native mandibles and augmentation of deficient mandibular subunits. No long-term complications were observed. CAD/CAM technology can be utilized in pediatric mandibular reconstruction, and is particularly beneficial in cases of profound, congenital hypoplasia requiring extensive, multi-planar, bony reconstructions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  18. The Reversal Intervention for Metabolic Syndrome (TRIMS study: rationale, design, and baseline data

    Directory of Open Access Journals (Sweden)

    Troughton Jacqui

    2011-05-01

    Full Text Available Abstract Background Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM and its major vascular sequelae. Metabolic syndrome (MetS comprises a constellation of factors that increase the risk of cardiovascular disease (CVD and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data. Methods Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up. Results 82 participants (44% male, 22% South Asian were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42 and control groups (n = 40. Median age was 63 years (IQR 57 - 67, mean waist size 106 cm (SD ± 11, and prescribing of statins and anti-hypertensives was 51% in each case. Conclusion Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable. Trial registration The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

  19. Rationale and design of the Henry Ford Exercise Testing Project (the FIT project).

    Science.gov (United States)

    Al-Mallah, Mouaz H; Keteyian, Steven J; Brawner, Clinton A; Whelton, Seamus; Blaha, Michael J

    2014-08-01

    Although physical fitness is a powerful prognostic marker in clinical medicine, most cardiovascular population-based studies do not have a direct measurement of cardiorespiratory fitness. In line with the call from the National Heart Lung and Blood Institute for innovative, low-cost, epidemiologic studies leveraging electronic medical record (EMR) data, we describe the rationale and design of the Henry Ford ExercIse Testing Project (The FIT Project). The FIT Project is unique in its combined use of directly measured clinical exercise data retrospective collection of medical history and medication treatment data at the time of the stress test, retrospective supplementation of supporting clinical data using the EMR and administrative databases and epidemiologic follow-up for cardiovascular events and total mortality via linkage with claims files and the death registry. The FIT Project population consists of 69 885 consecutive physician-referred patients (mean age, 54 ± 10 years; 54% males) who underwent Bruce protocol treadmill stress testing at Henry Ford Affiliated Hospitals between 1991 and 2009. Patients were followed for the primary outcomes of death, myocardial infarction, and need for coronary revascularization. The median estimated peak metabolic equivalent (MET) level was 10, with 17% of the patients having a severely reduced fitness level (METs < 6). At the end of the follow-up duration, 15.9%, 5.6%, and 6.7% of the patients suffered all-cause mortality, myocardial infarction, or revascularization procedures, respectively. The FIT Project is the largest study of physical fitness to date. With its use of modern electronic clinical epidemiologic techniques, it is poised to answer many clinically relevant questions related to exercise capacity and prognosis. © 2014 Wiley Periodicals, Inc.

  20. [Rationale, design and methodology of physical attributes identification of the fear of falling syndrome (FISTAC study)].

    Science.gov (United States)

    Esbrí Víctor, Mariano; Huedo Rodenas, Isabel; López Utiel, Melisa; Martínez Reig, Marta; López Jiménez, Esther; Herizo Muñoz, María Ángeles; Sánchez Nievas, Ginés; Abizanda Soler, Pedro

    The aim of this study was to identify the physical determining factors of the Fear of Falling Syndrome (FoF) in older adults with a history of falls. An observational study was conducted on 183 subjects older than 64 years with a fall in the previous year, with data collected from the geriatrics outpatient clinic of the Complejo Hospitalario Universitario from Albacete, Spain. Sociodemographic and anthropometric data, as well as comorbidity, drugs usually taken, functional status, physical function, frailty, cognitive and affective status were collected. Muscle mass was measured using bioimpedancy meter (BIA), and densitometry (DXA), strength with digital hand-held JAMAR dynamometer and with a Leg-press machine, muscle potency with a T-Force instrument, gait variability with the Gait-Rite instrument, and postural stability with the Neurocom Balance Master posturograph were also determined. An analysis was performed to determine if the FoF is associated with physical impairments adjusted for the study covariates. The study included 140 subjects with FoF, and 43 without it. The mean age was 78.4 years, and 147 were women. Posturography could be measured in 182 participants, DXA in 117, BIA in 165, and muscle potency in 146. FoF was associated with female sex, frailty, depressed mood, social risk, muscle strength and power, physical function, number of drugs used, and orthostatic hypotension in the overall sample. After adjusting for sex, only frailty, depressed mood, and number of drugs remained associated. Rationale, design, and methods of the FISTAC study are presented. Copyright © 2016 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

  1. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  2. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  3. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods.

    Science.gov (United States)

    Humphrey, Jean H; Jones, Andrew D; Manges, Amee; Mangwadu, Goldberg; Maluccio, John A; Mbuya, Mduduzi N N; Moulton, Lawrence H; Ntozini, Robert; Prendergast, Andrew J; Stoltzfus, Rebecca J; Tielsch, James M

    2015-12-15

    among a subgroup of infants enrolled in an EED substudy. This article describes the rationale, design, and methods underlying the SHINE trial. NCT01824940. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

  4. Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress

    Directory of Open Access Journals (Sweden)

    M. Dillwyn Bartholomeusz

    2017-09-01

    Full Text Available There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5 participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS.

  5. Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods.

    Science.gov (United States)

    Reeves, Gloria M; Keeton, Courtney; Correll, Christoph U; Johnson, Jacqueline L; Hamer, Robert M; Sikich, Linmarie; Hazzard, Lindsey; Alderman, Cheryl; Scheer, Abigail; Mabe, Micah; Kapoor, Sandeep; Sheridan, Eva; Borner, Irmgard; Bussell, Kristin; Pirmohamed, Sara; Bethea, Terrence C; Chekuri, Raja; Gottfried, Rhoda; Reinblatt, Shauna P; Santana, Erin; Riddle, Mark A

    2013-08-15

    Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain. The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research. The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8-19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth. Antipsychotic-related weight gain is an important public health issue for youth requiring ongoing antipsychotic treatment to

  6. Predicting asthma in preschool children with asthma symptoms: study rationale and design

    Directory of Open Access Journals (Sweden)

    Hafkamp-de Groen Esther

    2012-10-01

    Full Text Available Abstract Background In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1 to externally validate and update the PIAMA Risk Score, 2 to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of preschool children with asthma symptoms and 3 to test implementation of the Asthma Risk Appraisal Tool in well-child care. Methods and design The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth. The (updated PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care. Discussion Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear. This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups

  7. Prospective study of one million deaths in India: rationale, design, and validation results.

    Directory of Open Access Journals (Sweden)

    Prabhat Jha

    2006-02-01

    Full Text Available Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity, behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history, and biological (such as blood lipids and gene polymorphisms measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality.We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates. Household case-control, proportional

  8. Prospective Study of One Million Deaths in India: Rationale, Design, and Validation Results.

    Directory of Open Access Journals (Sweden)

    2005-12-01

    Full Text Available BACKGROUND: Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity, behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history, and biological (such as blood lipids and gene polymorphisms measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality. METHODS AND FINDINGS: We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates

  9. Predicting asthma in preschool children with asthma symptoms: study rationale and design.

    Science.gov (United States)

    Hafkamp-de Groen, Esther; Lingsma, Hester F; Caudri, Daan; Wijga, Alet; Jaddoe, Vincent Wv; Steyerberg, Ewout W; de Jongste, Johan C; Raat, Hein

    2012-10-16

    In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy) Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1) to externally validate and update the PIAMA Risk Score, 2) to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of) preschool children with asthma symptoms and 3) to test implementation of the Asthma Risk Appraisal Tool in well-child care. The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index) and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth). The (updated) PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care. Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear.This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups of) preschool children, who present with asthma symptoms at well

  10. The Land Use Model Intercomparison Project (LUMIP) contribution to CMIP6: rationale and experimental design

    Science.gov (United States)

    Lawrence, David M.; Hurtt, George C.; Arneth, Almut; Brovkin, Victor; Calvin, Kate V.; Jones, Andrew D.; Jones, Chris D.; Lawrence, Peter J.; de Noblet-Ducoudré, Nathalie; Pongratz, Julia; Seneviratne, Sonia I.; Shevliakova, Elena

    2016-09-01

    complementary to simulations requested in the CMIP6 DECK and historical simulations and other CMIP6 MIPs including ScenarioMIP, C4MIP, LS3MIP, and DAMIP. LUMIP includes a two-phase experimental design. Phase one features idealized coupled and land-only model simulations designed to advance process-level understanding of LULCC impacts on climate, as well as to quantify model sensitivity to potential land-cover and land-use change. Phase two experiments focus on quantification of the historic impact of land use and the potential for future land management decisions to aid in mitigation of climate change. This paper documents these simulations in detail, explains their rationale, outlines plans for analysis, and describes a new subgrid land-use tile data request for selected variables (reporting model output data separately for primary and secondary land, crops, pasture, and urban land-use types). It is essential that modeling groups participating in LUMIP adhere to the experimental design as closely as possible and clearly report how the model experiments were executed.

  11. Integrating a facial scan, virtual smile design, and 3D virtual patient for treatment with CAD-CAM ceramic veneers: A clinical report.

    Science.gov (United States)

    Lin, Wei-Shao; Harris, Bryan T; Phasuk, Kamolphob; Llop, Daniel R; Morton, Dean

    2017-06-13

    This clinical report describes a digital workflow using the virtual smile design approach augmented with a static 3-dimensional (3D) virtual patient with photorealistic appearance to restore maxillary central incisors by using computer-aided design and computer-aided manufacturing (CAD-CAM) monolithic lithium disilicate ceramic veneers. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  12. Cam Design Projects in an Advanced CAD Course for Mechanical Engineers

    Science.gov (United States)

    Ault, H. K.

    2009-01-01

    The objective of this paper is to present applications of solid modeling aimed at modeling of complex geometries such as splines and blended surfaces in advanced CAD courses. These projects, in CAD-based Mechanical Engineering courses, are focused on the use of the CAD system to solve design problems for applications in machine design, namely the…

  13. Application of design rationale for a robotic system for single-incision laparoscopic surgery and natural orifice transluminal endoscopic surgery.

    Science.gov (United States)

    Yao, Wei; Childs, Peter R N

    2013-07-01

    Current endoscopes and instruments are inadequate in some respects for complex intra-abdominal surgery because they are too flexible and cannot provide robust grasping and anatomic retraction. Minimal invasive surgery devices represent a sophisticated class of mechanical instruments making use of a range of mechanisms integrated into modular platforms that can be combined to undertake complex medical procedures. Although the machine elements concerned represent classic mechanical engineering devices, issues of miniaturization, surgical procedure compliance and location control conspire to present a design challenge. In order to capture, document and resolve the design requirements for this complex application, quality functional deployment has been applied in combination with design rationale, captured through issue-based information system mapping. This article reports the use of these tools to produce robot designs with improved dexterity and triangulation that are basic requirements in laparoscopy.

  14. Engineering specification and system design for CAD/CAM of custom shoes: UMC project effort

    Science.gov (United States)

    Bao, Han P.

    1990-01-01

    Further experimentations were made to improve the design and fabrication techniques of the integrated sole. The sole design is shown to be related to the foot position requirements and the actual shape of the foot including presence of neurotropic ulcers or other infections. Factors for consideration were: heel pitch, balance line, and rigidity conditions of the foot. Machining considerations were also part of the design problem. Among these considerations, widths of each contour, tool motion, tool feed rate, depths of cut, and slopes of cut at the boundary were the key elements. The essential fabrication techniques evolved around the idea of machining a mold then, using quick-firm latex material, casting the sole through the mold. Two main mold materials were experimented with: plaster and wood. Plaster was very easy to machine and shape but could barely support the pressure in the hydraulic press required by the casting process. Wood was found to be quite effective in terms of relative cost, strength, and surface smoothness except for the problem of cutting against the fibers which could generate ragged surfaces. The programming efforts to convert the original dBase programs into C programs so that they could be executed on the SUN Computer at North Carolina State University are discussed.

  15. Rationale for the Design of a Web-based Programming Course for Adults

    DEFF Research Database (Denmark)

    Bennedsen, Jens; Caspersen, Michael Edelgaard

    2003-01-01

    assistant as well as the other students. Another serious drawback is the reduced bandwidth in communication among the different actors. Precautions have to be taken in order to compensate for these and other drawbacks. We describe a web-based introductory programming course for adults and the rationale......Web-based distance education is becoming more and more popular in particular for part-time educations primarily because it flexibly adapts to a busy life where family and work has first priority. Students can follow the course without wasting precious time traveling to and from campus several...... for choosing technologies and organizing the course in order to compensate for the drawbacks inherent in this kind of teaching. Our conclusions, although presented in the context of an introductory programming course, holds for most other construction-based courses as well. In the first part we set the stage...

  16. Methodology for Benefit Analysis of CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing) in USN Shipyards.

    Science.gov (United States)

    1984-03-01

    34’ 1C.V r . *F - - I YW COMuts ’ IAC NC CAD CAL CAM I 1919 Niai1oapatew...on the system. This relationship can be described mathematically and once determined, can be used to compute the desired efficiency correction

  17. Cryogenic Cam Butterfly Valve

    Science.gov (United States)

    McCormack, Kenneth J. (Inventor)

    2016-01-01

    A cryogenic cam butterfly valve has a body that includes an axially extending fluid conduit formed there through. A disc lug is connected to a back side of a valve disc and has a circular bore that receives and is larger than a cam of a cam shaft. The valve disc is rotatable for a quarter turn within the body about a lug axis that is offset from the shaft axis. Actuating the cam shaft in the closing rotational direction first causes the camming side of the cam of the cam shaft to rotate the disc lug and the valve disc a quarter turn from the open position to the closed position. Further actuating causes the camming side of the cam shaft to translate the valve disc into sealed contact with the valve seat. Opening rotational direction of the cam shaft reverses these motions.

  18. Is prayer CAM?

    Science.gov (United States)

    Tippens, Kim; Marsman, Kevin; Zwickey, Heather

    2009-04-01

    Alternative medicine researchers and policy makers have classified prayer as a mind-body intervention, and thus, a modality of complementary and alternative medicine (CAM). As such, numerous epidemiological surveys of CAM utilization-which have included prayer-depict increasing CAM use, particularly in specific racial and ethnic groups. This paper discusses the implications of conflating prayer and CAM, especially regarding the definitions of both concepts and the resulting statistics of CAM utilization.

  19. Computer-aided design and computer-aided modeling (CAD/CAM) generated surgical splints, cutting guides and custom-made implants: Which indications in orthognathic surgery?

    Science.gov (United States)

    Scolozzi, P

    2015-12-01

    The purpose of the present report was to describe our indications, results and complications of computer-aided design and computer-aided modeling CAD/CAM surgical splints, cutting guides and custom-made implants in orthognathic surgery. We analyzed the clinical and radiological data of ten consecutive patients with dentofacial deformities treated using a CAD/CAM technique. Four patients had surgical splints and cutting guides for correction of maxillomandibular asymmetries, three had surgical cutting guides and customized internal distractors for correction of severe maxillary deficiencies and three had custom-made implants for additional chin contouring and/or mandibular defects following bimaxillary osteotomies and sliding genioplasty. We recorded age, gender, dentofacial deformity, surgical procedure and intra- and postoperative complications. All of the patients had stable cosmetic results with a high rate of patient satisfaction at the 1-year follow-up examination. No intra- and/or postoperative complications were encountered during any of the different steps of the procedure. This study demonstrated that the application of CAD/CAM patient-specific surgical splints, cutting guides and custom-made implants in orthognathic surgery allows for a successful outcome in the ten patients presented in this series. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  20. Effects of tributylborane-activated adhesive and two silane agents on bonding computer-aided design and manufacturing (CAD/CAM) resin composite.

    Science.gov (United States)

    Shinohara, Ayano; Taira, Yohsuke; Sawase, Takashi

    2017-10-01

    The present study was conducted to evaluate the effects of an experimental adhesive agent [methyl methacrylate-tributylborane liquid (MT)] and two adhesive agents containing silane on the bonding between a resin composite block of a computer-aided design and manufacturing (CAD/CAM) system and a light-curing resin composite veneering material. The surfaces of CAD/CAM resin composite specimens were ground with silicon-carbide paper, treated with phosphoric acid, and then primed with either one of the two silane agents [Scotchbond Universal Adhesive (SC) and GC Ceramic Primer II (GC)], no adhesive control (Cont), or one of three combinations (MT/SC, MT/GC, and MT/Cont). A light-curing resin composite was veneered on the primed CAD/CAM resin composite surface. The veneered specimens were subjected to thermocycling between 4 and 60 °C for 10,000 cycles, and the shear bond strengths were determined. All data were analyzed using analysis of variance and a post hoc Tukey-Kramer HSD test (α = 0.05, n = 8). MT/SC (38.7 MPa) exhibited the highest mean bond strengths, followed by MT/GC (30.4 MPa), SC (27.9 MPa), and MT/Cont (25.7 MPa), while Cont (12.9 MPa) and GC (12.3 MPa) resulted in the lowest bond strengths. The use of MT in conjunction with a silane agent significantly improved the bond strength. Surface treatment with appropriate adhesive agents was confirmed as a prerequisite for veneering CAD/CAM resin composite restorations.

  1. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT.

    Science.gov (United States)

    Emery, Sean; Abrams, Donald I; Cooper, David A; Darbyshire, Janet H; Lane, H Clifford; Lundgren, Jens D; Neaton, James D

    2002-04-01

    The Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3). The primary objective is to determine whether the addition of IL-2 to combination antiretroviral therapy improves morbidity and mortality. The aim is to recruit 4000 participants and follow them for an average of 5 years. Eligible subjects will be recruited at 275 investigational sites in 23 countries around the world. Coupled with broad eligibility criteria this will ensure widely applicable results. A range of secondary objectives will also be addressed in this setting that will include the conduct of observational studies and nested substudies with a public health focus. This article describes the rationale supporting the trial in addition to reviewing the study design, coordination, and governance.

  2. A cascaded charge-sharing technique for an EDP-efficient match-line design in CAMs

    Science.gov (United States)

    Jianwei, Zhang; Yizheng, Ye; Binda, Liu; Jinbao, Lan

    2009-06-01

    A novel cascaded charge-sharing technique is presented in content-addressable memories (CAMs), which not only effectively reduces the match-line (ML) power by using a pre-select circuit, but also realizes a high search speed. Pre-layout simulation results show a 75.9% energy-delay-product (EDP) reduction of the MLs over the traditional precharge-high ML scheme and 41.3% over the segmented ML method. Based on this technique, a test-chip of 64-word × 144-bit ternary CAM (TCAM) is implemented using a 0.18-μm 1.8-V CMOS process, achieving an 1.0 ns search delay and 4.81 fJ/bit/search for the MLs.

  3. The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned.

    Science.gov (United States)

    Yusen, Roger D; Criner, Gerard J; Sternberg, Alice L; Au, David H; Fuhlbrigge, Anne L; Albert, Richard K; Casaburi, Richard; Stoller, James K; Harrington, Kathleen F; Cooper, J Allen D; Diaz, Philip; Gay, Steven; Kanner, Richard; MacIntyre, Neil; Martinez, Fernando J; Piantadosi, Steven; Sciurba, Frank; Shade, David; Stibolt, Thomas; Tonascia, James; Wise, Robert; Bailey, William C

    2018-01-01

    The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

  4. The effect of preparation design on the fracture resistance of zirconia crown copings (computer associated design/computer associated machine, CAD/CAM system).

    Science.gov (United States)

    Jalalian, E; Atashkar, B; Rostami, R

    2011-01-01

    One of the major problems of all ceramic restorations is their probable fracture against the occlusal force. The aim of the present in-vitro study is was to compare the effect of two marginal designs (chamfer & shoulder) on the fracture resistance of zirconia copings, CERCON (CAD/CAM). This in vitro study was done with single blind experimental technique. One stainless steel dye with 50' chamfer finish line design (0.8 mm depth) was prepared using milling machine. Ten epoxy resin dyes were made, The same dye was retrieved and 50' chamfer was converted into shoulder (1 mm).again ten epoxy resin dyes were made from shoulder dyes. Zirconia cores with 0.4 mm thickness and 35 μm cement Space fabricated on the 20 epoxy resin dyes (10 samples chamfer and 10 samples shoulder) in a dental laboratory. Then the zirconia cores were cemented on the epoxy resin dyes and underwent a fracture test with a universal testing machine (GOTECH AI-700LAC, Arson, USA) and samples were investigated from the point of view of the origin of the failure. The mean value of fracture resistance for shoulder margins were 788.90±99.56 N and for the chamfer margins were 991.75±112.00 N. The student's T-test revealed a statistically significant difference between groups (P=0.001). The result of this study indicates that marginal design of the zirconia cores effects on their fracture resistance. A chamfer margin could improve the biomechanical performance of posterior single zirconia crown restorations. This may be because of strong unity and round internal angle in chamfer margin.

  5. Rationale, design and methods of the HEALTHY study nutrition intervention component

    OpenAIRE

    Gillis, B; Mobley, C.; Stadler, DD; Hartstein, J; Virus, A; Volpe, SL; El ghormli, L; Staten, MA; Bridgman, J; McCormick, S.

    2009-01-01

    The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakf...

  6. Rationale and design of the Feeding Dynamic Intervention (FDI) study for self-regulation of energy intake in preschoolers.

    Science.gov (United States)

    Eneli, Ihuoma U; Tylka, Tracy L; Hummel, Jessica; Watowicz, Rosanna P; Perez, Susana A; Kaciroti, Niko; Lumeng, Julie C

    2015-03-01

    In 2011, the Institute of Medicine Early Childhood Prevention Policies Report identified feeding dynamics as an important focus area for childhood obesity prevention and treatment. Feeding dynamics includes two central components: (1) caregiver feeding practices (i.e., determining how, when, where, and what they feed their children) and (2) child eating behaviors (i.e., determining how much and what to eat from what food caregivers have provided). Although there has been great interest in overweight and obesity prevention and treatment in young children, they have not focused comprehensively on feeding dynamics. Interventions on feeding dynamics that reduce caregivers' excessive controlling and restrictive feeding practices and encourage the development of children's self-regulation of energy intake may hold promise for tackling childhood obesity especially in the young child but currently lack an evidence base. This manuscript describes the rationale and design for a randomized controlled trial designed to compare a group of mothers and their 3-to 5-year old children who received an intervention focused primarily on feeding dynamics called the Feeding Dynamic Intervention (FDI) with a Wait-list Control Group (WLC). The primary aim of the study will be to investigate the efficacy of the FDI for decreasing Eating in the Absence of Hunger (EAH) and improving energy compensation (COMPX). The secondary aim will be to examine the effect of the FDI in comparison to the WLC on maternal self-reported feeding practices and child satiety responsiveness. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. FENG SHUI IN MODERN HOUSE DESIGN SEARCHING FOR THE RATIONALE AND POSSIBLE IMPACTS ASSESSMENT

    Directory of Open Access Journals (Sweden)

    OCTAVIA Linda

    2014-07-01

    Full Text Available The Feng Shui, the "wind-water", is a Chinese system of geomancy using the laws of both Heaven and Earth for harmony and balance of life with the positive qi. Feng Shui is widely used to orient temples, palaces, shops, houses, and other structures, with the reference to local features such as bodies of water, stars, or a compass. The Feng Shui also informs the physical arrangements for manipulation and channeling the qi (positive or negative energy. Although Feng Shui is related to traditional believe and propitious manner, but some of its principles are rational. The current research is conducted to investigate any positive impacts of the Feng Shui application in modern house design. A house in Jakarta designed with Feng Shui was analyzed. The strategies were later examined based on the sustainable architectural design principles, especially its impact on the house functionality.

  8. The potential for distributed generation in Japanese prototype buildings: A DER-CAM analysis of policy, tariff design, building energy use, and technology development (Japanese translation)

    Energy Technology Data Exchange (ETDEWEB)

    Zhou, Nan; Marnay, Chris; Firestone, Ryan; Gao, Weijun; Nishida, Masaru

    2004-10-15

    The August 2003 blackout of the northeastern U.S. and CANADA caused great economic losses and inconvenience to New York City and other affected areas. The blackout was a warning to the rest of the world that the ability of conventional power systems to meet growing electricity demand is questionable. Failure of large power systems can lead to serious emergencies. Introduction of on-site generation, renewable energy such as solar and wind power and the effective utilization of exhaust heat is needed, to meet the growing energy demands of the residential and commercial sectors. Additional benefit can be achieved by integrating these distributed technologies into distributed energy resource (DER) systems. This work demonstrates a method for choosing and designing economically optimal DER systems. An additional purpose of this research is to establish a database of energy tariffs, DER technology cost and performance characteristics, and building energy consumption for Japan. This research builds on prior DER studies at the Ernest Orlando Lawrence Berkeley National Laboratory (LBNL) and with their associates in the Consortium for Electric Reliability Technology Solutions (CERTS) and operation, including the development of the microgrid concept, and the DER selection optimization program, the Distributed Energy Resources Customer Adoption Model (DER-CAM). DER-CAM is a tool designed to find the optimal combination of installed equipment and an idealized operating schedule to minimize a site's energy bills, given performance and cost data on available DER technologies, utility tariffs, and site electrical and thermal loads over a test period, usually an historic year. Since hourly electric and thermal energy data are rarely available, they are typically developed by building simulation for each of six end use loads used to model the building: electric-only loads, space heating, space cooling, refrigeration, water heating, and natural-gas-only loads. DER-CAM provides a

  9. Rationale for designing cavity preparations in light of current knowledge and technology.

    Science.gov (United States)

    Welk, D A; Laswell, H R

    1976-04-01

    No restorative material presently available is as good as supported tooth structure and it is unlikely that a usable dental restorative material with the physical properties of enamel will ever be developed. The purpose of cavity preparation is to remove carious material and preserve sound tooth structure. Any additional removal of tooth structure is necessary for the convenience of the operator or because of limitations of the restorative materials. Presently available esthetic restorative systems for nonfunctional areas and selected anterior functional areas allow for designing cavity preparations where the only two considerations are removal of caries (and unsupported enamel) and placement of retentive features. The problem of cavity design for restoration of functional surfaces is not answered easily, but there is reasonable hope that in the near future an esthetic restorative material will be available that has the strength and other necessary properties to serve in functional areas. There should be no specific "ideal" design for cavity preparation. Each defect should be custom designed to remove the caries or defect and perform the additional steps necessitated by the limitations of the operator or restorative material. As advocated by Black in one of his later publications, it is necessary to make mouth-by-mouth and tooth-by-tooth judgements concerning the most desirable outline form to be obtained.

  10. Rationale and design of the multiethnic Pharmacogenomics in Childhood Asthma consortium

    NARCIS (Netherlands)

    Farzan, Niloufar; Vijverberg, Susanne J.; Andiappan, Anand K.; Arianto, Lambang; Berce, Vojko; Blanca-Lopez, Natalia; Bisgaard, Hans; Bonnelykke, Klaus; Burchard, Esteban G.; Campo, Paloma; Canino, Glorisa; Carleton, Bruce; Celedon, Juan C.; Chew, Fook Tim; Chiang, Wen Chin; Cloutier, Michelle M.; Daley, Denis; Den Dekker, Herman T.; Dijk, Nicole F.; Duijts, Liesbeth; Flores, Carlos; Forno, Erick; Hawcutt, Daniel B.; Hernandez-Pacheco, Natalia; de Jongste, Johan C.; Kabesch, Michael; Koppelman, Gerard H.; Manolopoulos, Vangelis G.; Melen, Erik; Mukhopadhyay, Somnath; Nilsson, Sara; Palmer, Colin N.; Pino-Yanes, Maria; Pirmohamed, Munir; Potocnki, Uros; Raaijmakers, Jan A.; Repnik, Katja; Schieck, Maximilian; Sio, Yang Yie; Smyth, Rosalind L.; Szalai, Csaba; Tantisira, Kelan G.; Turner, Steve; van der Schee, Marc P.; Verhamme, Katia M.; Maitland-van der Zee, Anke H.

    2017-01-01

    Aim: International collaboration is needed to enable large-scale pharmacogenomics studies in childhood asthma. Here, we describe the design of the Pharmacogenomics in Childhood Asthma (PiCA) consortium.  Materials & methods: Investigators of each study participating in PiCA provided data on the

  11. European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

    NARCIS (Netherlands)

    Slimani, N.; Kaaks, R.; Ferrari, P.; Casagrande, C.; Clavel-Chapelon, F.; Lotze, G.; Kroke, A.; Trichopoulos, D.; Trichopoulou, A.; Lauria, C.; Bellegotti, M.; Ocké, M.C.; Peeters, P.H.M.; Engeset, D.; Lund, E.; Agudo, A.; Larranaga, N.; Mattisson, I.; Andren, C.; Johansson, I.; Davey, G.; Welch, A.A.; Overvad, K.; Tjonneland, A.; Staveren, van W.A.; Saracci, R.; Riboli, E.

    2002-01-01

    The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer.

  12. Rationale and design of the multiethnic Pharmacogenomics in Childhood Asthma consortium

    DEFF Research Database (Denmark)

    Farzan, Niloufar; Vijverberg, Susanne J; Andiappan, Anand K

    2017-01-01

    AIM: International collaboration is needed to enable large-scale pharmacogenomics studies in childhood asthma. Here, we describe the design of the Pharmacogenomics in Childhood Asthma (PiCA) consortium. MATERIALS & METHODS: Investigators of each study participating in PiCA provided data...

  13. Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

    DEFF Research Database (Denmark)

    Lundby Christensen, L; Almdal, T; Boesgaard, T

    2009-01-01

    unknown whether a combination of metformin and insulin analogues is superior to insulin analogues alone. Nor is it known which insulin analogue regimen is the optimal. OBJECTIVE: The primary objective of this trial is to evaluate the effect of an 18-month treatment with metformin vs. placebo...... in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients. DESIGN: A randomized, stratified, multicentre trial having a 2 x 3 factorial design. The metformin part is double masked and placebo controlled. The insulin...... treatment is open. The intervention period is 18 months. PATIENT POPULATION: Nine hundred and fifty patients with T2DM and HbA1c > or = 7.5% on treatment with oral hypoglycaemic agents or on insulin treatment and deemed able, by the investigator, to manage once-daily insulin therapy with a long...

  14. Optimization of diagnostic imaging use in patients with acute abdominal pain (OPTIMA: Design and rationale

    Directory of Open Access Journals (Sweden)

    Bossuyt Patrick MM

    2007-08-01

    Full Text Available Abstract Background The acute abdomen is a frequent entity at the Emergency Department (ED, which usually needs rapid and accurate diagnostic work-up. Diagnostic work-up with imaging can consist of plain X-ray, ultrasonography (US, computed tomography (CT and even diagnostic laparoscopy. However, no evidence-based guidelines exist in current literature. The actual diagnostic work-up of a patient with acute abdominal pain presenting to the ED varies greatly between hospitals and physicians. The OPTIMA study was designed to provide the evidence base for constructing an optimal diagnostic imaging guideline for patients with acute abdominal pain at the ED. Methods/design Thousand consecutive patients with abdominal pain > 2 hours and Discussion This study aims to provide the evidence base for the development of a diagnostic algorithm that can act as a guideline for ED physicians to evaluate patients with acute abdominal pain.

  15. A Trial of In-Hospital, Electronic Alerts for Acute Kidney Injury: Design and Rationale

    Science.gov (United States)

    Wilson, F. Perry; Reese, Peter P.; Shashaty, Michael G.S.; Ellenberg, Susan S.; Gitelman, Yevgeniy; Bansal, Amar D; Urbani, Richard; Feldman, Harold I; Fuchs, Barry

    2014-01-01

    Background Acute Kidney Injury (AKI) is common in hospitalized patients, increases morbidity and mortality, and is under-recognized. To improve provider recognition we previously developed an electronic alert system for AKI. To test the hypothesis that this electronic AKI alert could improve patient outcome, we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients. The study design presented several methodologic, ethical, and statistical challenges. Purpose To highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early, electronic alert for AKI would improve outcomes in hospitalized patients. Challenges included how to randomize the delivery of the alert system, and the ethical framework for waiving informed consent. Other methodologic challenges included the selection and statistical evaluation of our study outcome, a ranked-composite of a continuous covariate (creatinine) and two dichotomous outcomes (dialysis and death), and the use of the medical record as a source of trial data. Methods We have designed a randomized trial to assess the effectiveness of an electronic alert system for AKI. With broad inclusion criteria, and a waiver of informed consent, we enroll and randomize virtually every patient with AKI in our hospital. Results As of March 31, 2014, we have enrolled 2373 patients of 2400 targeted. Pre-alert data demonstrated a strong association between severity of AKI and inpatient mortality with a range of 6.4% in those with mild, stage 1 AKI, to 29% among those with stage 3 AKI (p<0.001). We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention. Conclusions Our study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for AKI without obtaining

  16. Rationale, design and methods of the HEALTHY study nutrition intervention component.

    Science.gov (United States)

    Gillis, B; Mobley, C; Stadler, D D; Hartstein, J; Virus, A; Volpe, S L; El ghormli, L; Staten, M A; Bridgman, J; McCormick, S

    2009-08-01

    The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakfast, lunch, after school snack and supper programs; a la carte venues, including snack bars and school stores; vending machines; fundraisers; and classroom parties and celebrations. Study staff implemented the intervention using core and toolbox strategies to achieve and maintain the following five intervention goals: (1) lower the average fat content of foods, (2) increase the availability and variety of fruits and vegetables, (3) limit the portion sizes and energy content of dessert and snack foods, (4) eliminate whole and 2% milk and all added sugar beverages, with the exception of low fat or nonfat flavored milk, and limit 100% fruit juice to breakfast in small portions and (5) increase the availability of higher fiber grain-based foods and legumes. Other nutrition intervention component elements were taste tests, cafeteria enhancements, cafeteria line messages and other messages about healthy eating, cafeteria learning laboratory (CLL) activities, twice-yearly training of food service staff, weekly meetings with food service managers, incentives for food service departments, and twice yearly local meetings and three national summits with district food service directors. Strengths of the intervention design were the integration of nutrition with the other HEALTHY intervention components (physical education, behavior change and communications), and the collaboration and rapport between the nutrition intervention study staff members and food service personnel at both school

  17. “ASUKI Step” pedometer intervention in university staff: rationale and design

    Directory of Open Access Journals (Sweden)

    Ainsworth Barbara E

    2012-08-01

    Full Text Available Abstract Background We describe the study design and methods used in a 9-month pedometer-based worksite intervention called “ASUKI Step” conducted at the Karolinska Institutet (KI in Stockholm, Sweden and Arizona State University (ASU in the greater Phoenix area, Arizona. Methods/design “ASUKI Step” was based on the theory of social support and a quasi-experimental design was used for evaluation. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712 and KI (n = 1,406 who participated in teams of 3–4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Study aims were: 1 to have a minimum of 400 employee participants from each university site reach a level of 10, 000 steps per day on at least 100 days (3.5 months during the trial period; 2 to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day; 3 to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and 4 to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness. Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden

  18. European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

    DEFF Research Database (Denmark)

    Slimani, N.; Kaaks, R.; Ferrari, P.

    2002-01-01

    The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer...... population differed slightly from the overall cohort but the differences were small for most characteristics and centres. The overall results suggest that, after adjustment for age, dietary intakes estimated from calibration samples can reasonably be interpreted as representative of the main cohorts in most...

  19. Perioperative rehabilitation in operation for lung cancer (PROLUCA) – rationale and design

    DEFF Research Database (Denmark)

    Sommer, Maja S; Trier, Karen; Vibe-Petersen, Jette

    2014-01-01

    BACKGROUND: The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise. METHODS: Using a 2x2 factorial design with continuous effect endpoint ...... study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery. TRIAL REGISTRATION: NCT01893580.......BACKGROUND: The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise. METHODS: Using a 2x2 factorial design with continuous effect endpoint...... (Maximal Oxygen Uptake (VO2peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late...

  20. Fluorescent probes for hydrogen polysulfides (H2Sn, n > 1): from design rationale to applications.

    Science.gov (United States)

    Gupta, Neha; Reja, Shahi Imam; Bhalla, Vandana; Kumar, Manoj

    2017-08-16

    Hydrogen polysulfides (H2Sn, n > 1) being active members of the reactive sulphur species family are gaining much research interest these days due to their involvement in signal transduction, anti-cancer activity and cytoprotection. The importance of H2Sn particularly in human health makes it desirable to explore selective and sensitive techniques for their detection. Out of the several techniques and tools available, fluorescence spectroscopy seems advantageous due to its high sensitivity, non-destructive nature and applicability to living systems. Remarkable progress has been made in this field and different approaches have been adopted for the selective detection of H2Snin vitro as well as in vivo. The present review discusses the importance of H2Sn in living systems and highlights recent advances in the design of fluorescent probes for the detection of H2Sn. It offers a critical overview of the designing strategies adopted for H2Sn detection with emphasis on various ways for achieving selectivity over other reactive sulphur species (RSS) and their applications in biological systems. Further, the fundamental challenges and future prospects in this field are also discussed.

  1. POL-TAVI - Polish Registry of Transcatheter Aortic Valve Implantation - simple tool, great value, rationale and design.

    Science.gov (United States)

    Zembala-John, Joanna; Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-12-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer.

  2. POL-TAVI – Polish Registry of Transcatheter Aortic Valve Implantation – simple tool, great value, rationale and design

    Science.gov (United States)

    Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-01-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer. PMID:28096826

  3. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.

    Science.gov (United States)

    Riddler, Sharon A; Husnik, Marla; Gorbach, Pamina M; Levy, Lisa; Parikh, Urvi; Livant, Edward; Pather, Arendevi; Makanani, Bonus; Muhlanga, Felix; Kasaro, Margaret; Martinson, Francis; Elharrar, Vanessa; Balkus, Jennifer E

    2016-09-01

    As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.

  4. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fischer Mary

    2010-03-01

    Full Text Available Abstract Background Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks. Methods/Design A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen, bone formation (osteocalcin, and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry. Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16 to explore the feasibility of modeling skeletal

  5. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening

    Directory of Open Access Journals (Sweden)

    Bullard Emily

    2009-12-01

    Full Text Available Abstract Background High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. Methods/Design The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask. Primary outcomes will be: 1 calls to the Cancer Information Service; 2 timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3 patient satisfaction with provider-patient communication at follow-up. Discussion The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a

  6. Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial.

    Science.gov (United States)

    Courtright, Katherine R; Madden, Vanessa; Gabler, Nicole B; Cooney, Elizabeth; Small, Dylan S; Troxel, Andrea; Casarett, David; Ersek, Mary; Cassel, J Brian; Nicholas, Lauren Hersch; Escobar, Gabriel; Hill, Sarah H; O'Brien, Dan; Vogel, Mark; Halpern, Scott D

    2016-09-01

    The substantial nationwide investment in inpatient palliative care services stems from their great promise to improve patient-centered outcomes and reduce costs. However, robust experimental evidence of these benefits is lacking. The Randomized Evaluation of Default Access to Palliative Services (REDAPS) study is a pragmatic, stepped-wedge, cluster randomized trial designed to test the efficacy and costs of specialized palliative care consultative services for hospitalized patients with advanced chronic obstructive pulmonary disease, dementia, or end-stage renal disease, as well as the overall effectiveness of ordering such services by default. Additional aims are to identify the types of services that are most beneficial and the types of patients most likely to benefit, including comparisons between ward and intensive care unit patients. We hypothesize that patient-centered outcomes can be improved without increasing costs by simply changing the default option for palliative care consultation from opt-in to opt-out for patients with life-limiting illnesses. Patients aged 65 years or older are enrolled at 11 hospitals using an integrated electronic health record. As a pragmatic trial designed to enroll between 12,000 and 15,000 patients, eligibility is determined using a validated, electronic health record-based algorithm, and all outcomes are captured via the electronic health record and billing systems data. The time at which each hospital transitions from control, opt-in palliative care consultation to intervention, opt-out consultation is randomly assigned. The primary outcome is a composite measure of in-hospital mortality and length of stay. Secondary outcomes include palliative care process measures and clinical and economic outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT02505035).

  7. Rationale and design: telephone-delivered behavioral skills interventions for Blacks with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Strom Joni L

    2010-03-01

    Full Text Available Abstract Background African Americans with Type 2 diabetes (T2DM have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Americans with T2DM can be attributed to patient, provider, and health systems level factors. Provider and health system factors account for Methods/Design We describe an ongoing four-year randomized clinical trial, using a 2 × 2 factorial design, which will test the efficacy of separate and combined telephone-delivered, diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM (HbA1c ≥ 9%. Two-hundred thirty-two (232 male and female African-American participants, 18 years of age or older and with an HbA1c ≥ 9%, will be randomized into one of four groups for 12-weeks of phone interventions: (1 an education group, (2 a motivation/skills group, (3 a combined group or (4 a usual care/general health education group. Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among African Americans with poorly controlled T2DM, patients randomized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group. Discussion Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM. Trial registration National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT00929838.

  8. Nurse forecasting in Europe (RN4CAST: Rationale, design and methodology

    Directory of Open Access Journals (Sweden)

    Brzostek Tomasz

    2011-04-01

    Full Text Available Abstract Background Current human resources planning models in nursing are unreliable and ineffective as they consider volumes, but ignore effects on quality in patient care. The project RN4CAST aims innovative forecasting methods by addressing not only volumes, but quality of nursing staff as well as quality of patient care. Methods/Design A multi-country, multilevel cross-sectional design is used to obtain important unmeasured factors in forecasting models including how features of hospital work environments impact on nurse recruitment, retention and patient outcomes. In each of the 12 participating European countries, at least 30 general acute hospitals were sampled. Data are gathered via four data sources (nurse, patient and organizational surveys and via routinely collected hospital discharge data. All staff nurses of a random selection of medical and surgical units (at least 2 per hospital were surveyed. The nurse survey has the purpose to measure the experiences of nurses on their job (e.g. job satisfaction, burnout as well as to allow the creation of aggregated hospital level measures of staffing and working conditions. The patient survey is organized in a sub-sample of countries and hospitals using a one-day census approach to measure the patient experiences with medical and nursing care. In addition to conducting a patient survey, hospital discharge abstract datasets will be used to calculate additional patient outcomes like in-hospital mortality and failure-to-rescue. Via the organizational survey, information about the organizational profile (e.g. bed size, types of technology available, teaching status is collected to control the analyses for institutional differences. This information will be linked via common identifiers and the relationships between different aspects of the nursing work environment and patient and nurse outcomes will be studied by using multilevel regression type analyses. These results will be used to simulate

  9. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening.

    Science.gov (United States)

    Cofta-Woerpel, Ludmila; Randhawa, Veenu; McFadden, H Gene; Fought, Angela; Bullard, Emily; Spring, Bonnie

    2009-12-02

    High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter) or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask). Primary outcomes will be: 1) calls to the Cancer Information Service; 2) timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3) patient satisfaction with provider-patient communication at follow-up. The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a public service (the Cancer Information Service) with real

  10. Nurse Forecasting in Europe (RN4CAST): Rationale, design and methodology

    LENUS (Irish Health Repository)

    Sermeus, Walter

    2011-04-18

    Abstract Background Current human resources planning models in nursing are unreliable and ineffective as they consider volumes, but ignore effects on quality in patient care. The project RN4CAST aims innovative forecasting methods by addressing not only volumes, but quality of nursing staff as well as quality of patient care. Methods\\/Design A multi-country, multilevel cross-sectional design is used to obtain important unmeasured factors in forecasting models including how features of hospital work environments impact on nurse recruitment, retention and patient outcomes. In each of the 12 participating European countries, at least 30 general acute hospitals were sampled. Data are gathered via four data sources (nurse, patient and organizational surveys and via routinely collected hospital discharge data). All staff nurses of a random selection of medical and surgical units (at least 2 per hospital) were surveyed. The nurse survey has the purpose to measure the experiences of nurses on their job (e.g. job satisfaction, burnout) as well as to allow the creation of aggregated hospital level measures of staffing and working conditions. The patient survey is organized in a sub-sample of countries and hospitals using a one-day census approach to measure the patient experiences with medical and nursing care. In addition to conducting a patient survey, hospital discharge abstract datasets will be used to calculate additional patient outcomes like in-hospital mortality and failure-to-rescue. Via the organizational survey, information about the organizational profile (e.g. bed size, types of technology available, teaching status) is collected to control the analyses for institutional differences. This information will be linked via common identifiers and the relationships between different aspects of the nursing work environment and patient and nurse outcomes will be studied by using multilevel regression type analyses. These results will be used to simulate the impact of

  11. Nurse forecasting in Europe (RN4CAST): Rationale, design and methodology

    Science.gov (United States)

    2011-01-01

    Background Current human resources planning models in nursing are unreliable and ineffective as they consider volumes, but ignore effects on quality in patient care. The project RN4CAST aims innovative forecasting methods by addressing not only volumes, but quality of nursing staff as well as quality of patient care. Methods/Design A multi-country, multilevel cross-sectional design is used to obtain important unmeasured factors in forecasting models including how features of hospital work environments impact on nurse recruitment, retention and patient outcomes. In each of the 12 participating European countries, at least 30 general acute hospitals were sampled. Data are gathered via four data sources (nurse, patient and organizational surveys and via routinely collected hospital discharge data). All staff nurses of a random selection of medical and surgical units (at least 2 per hospital) were surveyed. The nurse survey has the purpose to measure the experiences of nurses on their job (e.g. job satisfaction, burnout) as well as to allow the creation of aggregated hospital level measures of staffing and working conditions. The patient survey is organized in a sub-sample of countries and hospitals using a one-day census approach to measure the patient experiences with medical and nursing care. In addition to conducting a patient survey, hospital discharge abstract datasets will be used to calculate additional patient outcomes like in-hospital mortality and failure-to-rescue. Via the organizational survey, information about the organizational profile (e.g. bed size, types of technology available, teaching status) is collected to control the analyses for institutional differences. This information will be linked via common identifiers and the relationships between different aspects of the nursing work environment and patient and nurse outcomes will be studied by using multilevel regression type analyses. These results will be used to simulate the impact of changing

  12. Web-based CAD and CAM for optomechatronics

    Science.gov (United States)

    Han, Min; Zhou, Hai-Guang

    2001-10-01

    CAD & CAM technologies are being used in design and manufacturing process, and are receiving increasing attention from industries and education. We have been researching to develop a new kind of software that is for web-course CAD & CAM. It can be used either in industries or in training, it is supported by IE. Firstly, we aim at CAD/CAM for optomechatronics. We have developed a kind of CAD/CAM, which is not only for mechanics but also for optics and electronic. That is a new kind of software in China. Secondly, we have developed a kind of software for web-course CAD & CAM, we introduce the basis of CAD, the commands of CAD, the programming, CAD/CAM for optomechatronics, the joint application of CAD & CAM. We introduce the functions of MasterCAM, show the whole processes of CAD/CAM/CNC by examples. Following the steps showed on the web, the trainer can not miss. CAD & CAM are widely used in many areas, development of web-course CAD & CAM is necessary for long- distance education and public education. In 1992, China raised: CAD technique, as an important part of electronic technology, is a new key technique to improve the national economic and the modernization of national defence. As so for, the education. Of CAD & CAM is mainly involved in manufacturing industry in China. But with the rapidly development of new technology, especially the development of optics and electronics, CAD & CAM will receive more attention from those areas.

  13. Introduction to Analytical Methods for Internal Combustion Engine Cam Mechanisms

    CERN Document Server

    Williams, J J

    2013-01-01

    Modern design methods of Automotive Cam Design require the computation of a range of parameters. This book provides a logical sequence of steps for the derivation of the relevant equations from first principles, for the more widely used cam mechanisms. Although originally derived for use in high performance engines, this work is equally applicable to the design of mass produced automotive and other internal combustion engines.   Introduction to Analytical Methods for Internal Combustion Engine Cam Mechanisms provides the equations necessary for the design of cam lift curves with an associated smooth acceleration curve. The equations are derived for the kinematics and kinetics of all the mechanisms considered, together with those for cam curvature and oil entrainment velocity. This permits the cam shape, all loads, and contact stresses to be evaluated, and the relevant tribology to be assessed. The effects of asymmetry on the manufacture of cams for finger follower and offset translating curved followers is ...

  14. The Korean Study of Women's Health-Related Issues (K-Stori): Rationale and Study Design.

    Science.gov (United States)

    Cho, Ha Na; Choi, Eunji; Seo, Da Hea; Suh, Mina; Lee, Hoo-Yeon; Park, Boyoung; Park, Sohee; Cho, Juhee; Kim, Sue; Park, Yeong-Ran; Lim, Joong-Yeon; Ahn, Younjihin; Park, Hyun-Young; Choi, Kui Son; Rhee, Yumie

    2017-06-29

    Measures to address gender-specific health issues are essential due to fundamental, biological differences between the sexes. Studies have increasingly stressed the importance of customizing approaches directed at women's health issues according to stages in the female life cycle. In Korea, however, gender-specific studies on issues affecting Korean women in relation to stages in their life cycle are lacking. Accordingly, the Korean Study of Women's Health-Related Issues (K-Stori) was designed to investigate life cycle-specific health issues among women, covering health status, awareness, and risk perceptions. K-Stori was conducted as a nationwide cross-sectional survey targeting Korean women aged 14-79 years. Per each stage in the female life cycle (adolescence, childbearing age, pregnancy & postpartum, menopause, and older adult stage), 3000 women (total 15,000) were recruited by stratified multistage random sampling for geographic area based on the 2010 Resident Registration Population in Korea. Specialized questionnaires per each stage (total of five) were developed in consultation with multidisciplinary experts and by reflecting upon current interests into health among the general population of women in Korea. This survey was conducted from April 1 to June 31, 2016, at which time investigators from a professional research agency went door-to-door to recruit residents and conducted in-person interviews. The study's findings may help with elucidating health issues and unmet needs specific to each stage in the life cycle of Korean women that have yet to be identified in present surveys.

  15. Rationale, design and baseline characteristics of the survival and ventricular enlargement trial. SAVE Investigators.

    Science.gov (United States)

    Moyé, L A; Pfeffer, M A; Braunwald, E

    1991-11-18

    Heart failure, often associated with ventricular enlargement and recurrent myocardial infarction, is one of the major causes of postinfarction mortality. This observation suggests that measures used to prevent ventricular enlargement may improve postinfarction survival. The Survival and Ventricular Enlargement (SAVE) trial is a randomized, double-blind, placebo-controlled clinical trial with the purpose of evaluating the effect of angiotensin-converting enzyme (ACE) inhibition on postinfarction death and ventricular dilation. This multicenter trial had a sample size goal of 2,220 patients between 21 and 79 years of age who had recently sustained a myocardial infarction and who have an ejection fraction determined by radionuclide ventriculogram (RVG-EF) of less than or equal to 40%. In addition to conventional therapy, patients were randomly assigned to captopril or placebo therapy commencing within 3-16 days following their myocardial infarction. A second RVG-EF is performed on all surviving participants at the end of the average 3.5-year treatment and follow-up period. The study has 90% power to detect a 25% improvement in postinfarction mortality or prevention of greater than or equal to 9 unit absolute reduction in radionuclide ejection fraction. Additional end points, design features, and the administrative organization of the trial are described.

  16. Optimization of diagnostic imaging use in patients with acute abdominal pain (OPTIMA): Design and rationale.

    Science.gov (United States)

    Laméris, Wytze; van Randen, Adrienne; Dijkgraaf, Marcel G W; Bossuyt, Patrick M M; Stoker, Jaap; Boermeester, Marja A

    2007-08-06

    The acute abdomen is a frequent entity at the Emergency Department (ED), which usually needs rapid and accurate diagnostic work-up. Diagnostic work-up with imaging can consist of plain X-ray, ultrasonography (US), computed tomography (CT) and even diagnostic laparoscopy. However, no evidence-based guidelines exist in current literature. The actual diagnostic work-up of a patient with acute abdominal pain presenting to the ED varies greatly between hospitals and physicians. The OPTIMA study was designed to provide the evidence base for constructing an optimal diagnostic imaging guideline for patients with acute abdominal pain at the ED. Thousand consecutive patients with abdominal pain > 2 hours and post hoc assignment of the final diagnosis by an expert panel. The focus of the analysis will be on the added value of the imaging modalities over history and clinical examination, relative to the incremental costs. This study aims to provide the evidence base for the development of a diagnostic algorithm that can act as a guideline for ED physicians to evaluate patients with acute abdominal pain.

  17. Improving physical activity in arthritis clinical trial (IMPAACT): study design, rationale, recruitment, and baseline data.

    Science.gov (United States)

    Chang, Rowland W; Semanik, Pamela A; Lee, Jungwha; Feinglass, Joseph; Ehrlich-Jones, Linda; Dunlop, Dorothy D

    2014-11-01

    Over 21 million Americans report an arthritis-attributable activity limitation. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of the most common/disabling forms of arthritis. Various forms of physical activity (PA) can improve a variety of health outcomes and reduce health care costs, but the proportion of the US population engaging in the recommended amount of PA is low and even lower among those with arthritis. The Improving Motivation for Physical Activity in Arthritis Clinical Trial (IMPAACT) is a randomized clinical trial that studied the effects of a lifestyle PA promotion intervention on pain and physical function outcomes. The IMPAACT intervention was based on a chronic care/disease management model in which allied health professionals promote patient self-management activities outside of traditional physician office encounters. The program was a motivational interviewing-based, individualized counseling and referral intervention, directed by a comprehensive assessment of individual patient barriers and strengths related to PA performance. The specific aims of IMPAACT were to test the efficacy of the IMPAACT intervention for persons with arthritis (N=185 persons with RA and 155 persons with knee OA) in improving arthritis-specific and generic self-reported pain and Physical Function outcomes, observed measures of function, and objectively measured and self-reported PA levels. Details of the stratified-randomized study design, subject recruitment, and data collection are described. The results from IMPAACT will generate empiric evidence pertaining to increasing PA levels in persons with arthritis and result in widely applicable strategies for health behavior change. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Donepezil treatment of older adults with cognitive impairment and depression (DOTCODE study): clinical rationale and design.

    Science.gov (United States)

    Pelton, Gregory H; Andrews, Howard; Roose, Steven P; Marcus, Sue M; D'Antonio, Kristina; Husn, Hala; Petrella, Jeffrey R; Zannas, Anthony S; Doraiswamy, P Murali; Devanand, D P

    2014-03-01

    Treatment strategies for patients with depression and cognitive impairment (DEP-CI), who are at high risk to develop a clinical diagnosis of dementia, are not established. This issue is addressed in the donepezil treatment of cognitive impairment and depression (DOTCODE) pilot clinical trial. The DOTCODE study is the first long-term treatment trial that assesses differences in conversion to dementia and cognitive change in DEP-CI patients using a study design of open antidepressant medication plus add-on randomized, double-blind, placebo-controlled treatment with the acetylcholinesterase inhibitor donepezil. In Phase 1, DEP-CI patients receive optimized antidepressant treatment for 16 weeks. In Phase 2, antidepressant treatment is continued with the addition of randomized, double-blind treatment with donepezil or placebo. The total study duration for each patient is 78 weeks (18 months). Eighty DEP-CI outpatients (age 55 to 95 years) are recruited: 40 at New York State Psychiatric Institute/Columbia University and 40 at Duke University Medical Center. The primary outcome is conversion to a clinical diagnosis of dementia. The secondary outcomes are cognitive change scores in Selective Reminding Test (SRT) total recall and the modified Alzheimer's Disease Assessment Scale (ADAS-cog). Other key assessments include the 24-item Hamilton Depression Rating Scale and antidepressant response; Clinical Global Impression (CGI) for depression, cognition, and global status; neuropsychological test battery for diagnosis; informant report of functional abilities (Pfeffer FAQ); and Treatment Emergent Symptom Scale (TESS) for somatic side effects. Apolipoprotein E ε4 status, odor identification deficits, and MRI entorhinal/hippocampal cortex atrophy at baseline are evaluated as neurobiological moderators of donepezil treatment effects. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale.

    Science.gov (United States)

    Reeves, Gordon R; Whellan, David J; Duncan, Pamela; O'Connor, Christopher M; Pastva, Amy M; Eggebeen, Joel D; Hewston, Leigh Ann; Morgan, Timothy M; Reed, Shelby D; Rejeski, W Jack; Mentz, Robert J; Rosenberg, Paul B; Kitzman, Dalane W

    2017-03-01

    Acute decompensated heart failure (ADHF) is a leading cause of hospitalization in older persons in the United States. Reduced physical function and frailty are major determinants of adverse outcomes in older patients with hospitalized ADHF. However, these are not addressed by current heart failure (HF) management strategies and there has been little study of exercise training in older, frail HF patients with recent ADHF. Targeting physical frailty with a multi-domain structured physical rehabilitation intervention will improve physical function and reduce adverse outcomes among older patients experiencing a HF hospitalization. REHAB-HF is a multi-center clinical trial in which 360 patients ≥60 years hospitalized with ADHF will be randomized either to a novel 12-week multi-domain physical rehabilitation intervention or to attention control. The goal of the intervention is to improve balance, mobility, strength and endurance utilizing reproducible, targeted exercises administered by a multi-disciplinary team with specific milestones for progression. The primary study aim is to assess the efficacy of the REHAB-HF intervention on physical function measured by total Short Physical Performance Battery score. The secondary outcome is 6-month all-cause rehospitalization. Additional outcome measures include quality of life and costs. REHAB-HF is the first randomized trial of a physical function intervention in older patients with hospitalized ADHF designed to determine if addressing deficits in balance, mobility, strength and endurance improves physical function and reduces rehospitalizations. It will address key evidence gaps concerning the role of physical rehabilitation in the care of older patients, those with ADHF, frailty, and multiple comorbidities. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Rationale for an early aldosterone blockade in acute myocardial infarction and design of the ALBATROSS trial.

    Science.gov (United States)

    Beygui, Farzin; Vicaut, Eric; Ecollan, Patrick; Machecourt, Jacques; Van Belle, Eric; Zannad, Faiez; Montalescot, Gilles

    2010-10-01

    Aldosterone is at its highest levels at presentation for acute myocardial infarction (AMI). High aldosterone levels are predictive of poor outcome regardless of heart failure. Angiotensin-converting enzyme inhibitors have delayed partial and temporary effects on aldosterone levels. We hypothesize that aldosterone receptor blockade, early after AMI onset on top of standard therapy, may improve clinical outcome. ALBATROSS is a nationwide, multicenter, open-labeled, randomized trial designed to assess the superiority of aldosterone blockade by a 200-mg intravenous bolus of potassium canrenoate followed by a daily 25-mg dose of spirinolactone for 6 months, on top of standard therapy compared to standard therapy alone among 1,600 patients admitted for ST-segment elevation or high risk non-ST-segment elevation acute AMI -TIMI score ≥3-within 72 hours after symptom onset regardless of heart failure and treatment strategy. The primary efficacy end point of the study is the 6-month rate of the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, class IA American College of Cardiology/American Heart Association/European Society of Cardiology indication for implantable cardioverter device, and new or worsening heart failure. Secondary end points include each of the components of the primary end point, different combinations of such components, the primary end point assessed at hospital discharge and 30-day follow-up, and rates of acute renal failure. Safety end points include rates of hyperkalemia and premature drug discontinuation. ALBATROSS will assess the cardiovascular benefit of a low-cost aldosterone receptor blocker on top of standard therapy in all-coming AMI patients. Copyright © 2010 Mosby, Inc. All rights reserved.

  1. Rationale, design and baseline results of the Guangxi manganese-exposed workers healthy cohort (GXMEWHC) study

    Science.gov (United States)

    Lv, Yingnan; Zou, Yunfeng; Liu, Jing; Chen, Kangcheng; Huang, Damin; Shen, Yuefei; Zhong, Yaoqiu; Liu, Zhihao; Jiang, Bei; Li, Qin; Qing, Li; Zhang, Wei; Chen, Lang; Wang, Fenfen; Xia, Bing; Yang, Li; Yang, Xiaobo

    2014-01-01

    Objective To determine the relationship between biomarkers of exposure, disease and susceptibility, and early health effects and long-term diseases related to occupational manganese (Mn) exposure. Design Baseline survey of a longitudinal cohort study of workers in a ferromanganese refinery. Participants A total of 1888 individuals (1197 men, 691 women; average seniority 15.34 years) were enrolled in the Guangxi manganese-exposed workers healthy cohort (GXMEWHC) study. Participants were between 18 and 60 years of age (mean 40.31 years), had worked in the ferromanganese refinery for at least 1 year and lived in the local area. Results The GXMEWHC study included a baseline survey. Participants were divided into four groups according to manganese (Mn) cumulative exposure index (Mn-CEI) levels: an internal control group (Mn-CEI <1.0 mg/m3 year), a low exposure group (1.0 mg/m3 year≤Mn-CEI<2.0 mg/m3 year), a medium exposure group (2.0 mg/m3 year≤Mn-CEI<5.0 mg/m3 year) and a high exposure group (Mn-CEI≥5.0 mg/m3 year). Genome-wide association studies of quantitative trait loci and binary trait loci in 500 Mn-exposed workers were performed using Illumina Infinium HumanExome BeadChip arrays. Stored plasma, DNA, hair and urine are available for further study. Participants will be followed up every 3 years. Conclusions The GXMEWHC study provides abundant data for exploring the systemic health effects of occupational Mn exposure using biomarkers of exposure, disease and susceptibility. PMID:24993760

  2. Exercise videogames for physical activity and fitness: Design and rationale of the Wii Heart Fitness trial.

    Science.gov (United States)

    Bock, Beth C; Thind, Herpreet; Dunsiger, Shira I; Serber, Eva R; Ciccolo, Joseph T; Cobb, Victoria; Palmer, Kathy; Abernathy, Sean; Marcus, Bess H

    2015-05-01

    Despite numerous health benefits, less than half of American adults engage in regular physical activity. Exercise videogames (EVG) may be a practical and attractive alternative to traditional forms of exercise. However there is insufficient research to determine whether EVG play alone is sufficient to produce prolonged engagement in physical activity or improvements in cardiovascular fitness and overall health risk. The goal of the present study is to test the efficacy of exercise videogames to increase time spent in moderate to vigorous physical activity (MVPA) and to improve cardiovascular risk indices among adults. Wii Heart Fitness is a rigorous 3-arm randomized controlled trial with adults comparing three 12-week programs: (1) supervised EVGs, (2) supervised standard exercise, and (3) a control condition. Heart rate is monitored continuously throughout all exercise sessions. Assessments are conducted at baseline, end of intervention (week 12), 6 and 9 months. The primary outcome is time spent in MVPA physical activity. Secondary outcomes include changes in cardiovascular fitness, body composition, blood lipid profiles and maintenance of physical activity through six months post-treatment. Changes in cognitive and affective constructs derived from Self Determination and Social Cognitive Theories will be examined to explain the differential outcomes between the two active treatment conditions. The Wii Heart Fitness study is designed to test whether regular participation in EVGs can be an adequate source of physical activity for adults. This study will produce new data on the effect of EVGs on cardiovascular fitness indices and prolonged engagement with physical activity. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Rationale and Design of the PRegnancy and Infant DEvelopment (PRIDE) Study

    Science.gov (United States)

    van Gelder, Marleen M H J; Bretveld, Reini W; Roukema, Jolt; Steenhoek, Morac; Drongelen, Joris; Spaanderman, Marc E A; van Rumpt, Dick; Zielhuis, Gerhard A; Verhaak, Chris M; Roeleveld, Nel

    2013-01-01

    Background To optimise the health of pregnant women and their children by evidence-based primary and secondary prevention, more scientific knowledge is needed. To overcome the methodological limitations of many studies on pregnancy and child health, which often use a retrospective design, we established the PRIDE (PRegnancy and Infant DEvelopment) Study. Methods and Results The PRIDE Study is a large prospective cohort study that aims at including 150 000–200 000 women in early pregnancy to study a broad range of research questions pertaining to pregnancy complications, maternal and child health, and adverse developmental effects in offspring. Women are invited to participate by their prenatal care provider before or at their first prenatal care visit and are asked to fill out web-based questionnaires in gestational weeks 8–10, 17, and 34, as well as biannually throughout childhood. In addition, a food frequency questionnaire and a paternal questionnaire are administered and medical records are consulted. Multiple validation studies will be conducted and paper-and-pencil questionnaires are available for women who cannot or do not want to participate through the Internet. For subgroups of participants, blood and saliva samples for genetic and biochemical analyses are being collected. The pilot phase, which started in July 2011, showed a response rate of 47%. Recruitment will eventually cover all of the Netherlands. Conclusions We expect that this study, which will be the largest birth cohort in the world so far, will provide new insights in the aetiology of disorders and diseases that originate in pregnancy. The PRIDE Study is open for collaboration. PMID:23215710

  4. Enhancing cancer screening in primary care: rationale, design, analysis plan, and recruitment results.

    Science.gov (United States)

    Murray, David M; Katz, Mira L; Post, Doug M; Pennell, Michael L; Young, Gregory S; Tatum, Cathy M; Paskett, Electra D

    2013-03-01

    Colorectal cancer (CRC) is the third leading type of cancer and the third leading cause of cancer death in the United States. National policy-making organizations recognize and support a variety of CRC screening strategies among average-risk adults aged 50 and older based on strong evidence showing that screening decreases mortality from CRC and can also reduce the incidence of the disease. The goal of this study was to test a multi-level stepped intervention to increase CRC screening rates. We used a group-randomized trial design where the units of assignment were clinics and the units of observation were eligible patients receiving care at those clinics, with stratified random assignment of clinics to study conditions. The primary analysis was planned as a mixed-model logistic regression to account for the expected positive intraclass correlation associated with clinics. Our recruitment experience reflected the difficulties of conducting research in the real world where changes in economic conditions, staff turnover/layoff, inadequate medical records, and poor acceptance of research can significantly impact study plans. It demonstrated the problems that can emerge when procedures used in the study depart from those used in the pilot work to generate parameter estimates for power analysis. It also demonstrated the importance of allowing for attrition at the group and patient levels so that if recruitment falls short, it is possible to maintain adequate power with only a slight increase in the detectable difference. This experience should assist others planning group-randomized trials, whether in cancer screening or in other areas. Published by Elsevier Inc.

  5. A Randomized Trial of Coenzyme Q10 in Patients with Statin Myopathy: Rationale and Study Design

    Science.gov (United States)

    Parker, Beth A.; Gregory, Sara M.; Lorson, Lindsay; Polk, Donna; White, C. Michael; Thompson, Paul D.

    2013-01-01

    Background Statins are the most commonly prescribed and effective medications for reducing low-density lipoprotein levels. Some patients experience myopathic symptoms during statin treatment. The etiology is not known, but depletion of mevalonate pathway metabolites, including coenzyme Q10 (CoQ10), has been suggested. CoQ10 supplementation has been recommended to patients who experience myalgic symptoms despite a lack of conclusive evidence supporting its utility. Objective The Co-Enzyme Q10 in Statin Myopathy study is designed to examine the effect of CoQ10 supplementation on the extent and intensity of muscle pain during treatment with simvastatin. Methods We will recruit patients with a documented history of myalgia during statin treatment. The presence of statin-related myalgia will be confirmed in a crossover run-in trial during which presence and absence of symptoms will be documented during statin and placebo treatment, respectively. Individuals with myalgic symptoms while on statin but not placebo will be randomized to receive simvastatin 20 mg daily plus either 600 mg daily of CoQ10 or placebo. Muscle pain intensity will be documented during weekly phone calls using the Brief Pain Inventory (Short Form) (BPI-SF). Treatment will continue for 8 weeks or until muscle symptoms are reported continuously for one week or become intolerable, and then subjects will crossover to the alternative treatment (CoQ10 or placebo). Results This study is an ongoing clinical trial. Conclusions This study will determine the utility of CoQ10 for reducing pain intensity in myalgic patients and will provide guidance for clinicians treating patients with hypercholesterolemia who are intolerant to statins. PMID:23725917

  6. The Intensive Diet and Exercise for Arthritis (IDEA trial: design and rationale

    Directory of Open Access Journals (Sweden)

    Eckstein Felix

    2009-07-01

    Full Text Available Abstract Background Obesity is the most modifiable risk factor, and dietary induced weight loss potentially the best nonpharmacologic intervention to prevent or to slow osteoarthritis (OA disease progression. We are currently conducting a study to test the hypothesis that intensive weight loss will reduce inflammation and joint loads sufficiently to alter disease progression, either with or without exercise. This article describes the intervention, the empirical evidence to support it, and test-retest reliability data. Methods/Design This is a prospective, single-blind, randomized controlled trial. The study population consists of 450 overweight and obese (BMI = 27–40.5 kg/m2 older (age ≥ 55 yrs adults with tibiofemoral osteoarthritis. Participants are randomized to one of three 18-month interventions: intensive dietary restriction-plus-exercise; exercise-only; or intensive dietary restriction-only. The primary aims are to compare the effects of these interventions on inflammatory biomarkers and knee joint loads. Secondary aims will examine the effects of these interventions on function, pain, and mobility; the dose response to weight loss on disease progression; if inflammatory biomarkers and knee joint loads are mediators of the interventions; and the association between quadriceps strength and disease progression. Results Test-retest reliability results indicated that the ICCs for knee joint load variables were excellent, ranging from 0.86 – 0.98. Knee flexion/extension moments were most affected by BMI, with lower reliability with the highest tertile of BMI. The reliability of the semi-quantitative scoring of the knee joint using MRI exceeded previously reported results, ranging from a low of 0.66 for synovitis to a high of 0.99 for bone marrow lesion size. Discussion The IDEA trial has the potential to enhance our understanding of the OA disease process, refine weight loss and exercise recommendations in this prevalent disease, and

  7. The Family Spirit trial for American Indian teen mothers and their children: CBPR rationale, design, methods and baseline characteristics.

    Science.gov (United States)

    Mullany, Britta; Barlow, Allison; Neault, Nicole; Billy, Trudy; Jones, Tanya; Tortice, Iralene; Lorenzo, Sherilynn; Powers, Julia; Lake, Kristin; Reid, Raymond; Walkup, John

    2012-10-01

    The purpose of this paper is to describe the rationale, design, methods and baseline results of the Family Spirit trial. The goal of the trial is to evaluate the impact of the paraprofessional-delivered "Family Spirit" home-visiting intervention to reduce health and behavioral risks for American Indian teen mothers and their children. A community based participatory research (CBPR) process shaped the design of the current randomized controlled trial of the Family Spirit intervention. Between 2006 and 2008, 322 pregnant teens were randomized to receive the Family Spirit intervention plus Optimized Standard Care, or Optimized Standard Care alone. The Family Spirit intervention is a 43-session home-visiting curriculum administered by American Indian paraprofessionals to teen mothers from 28 weeks gestation until the baby's third birthday. A mixed methods assessment administered at nine intervals measures intervention impact on parental competence, mother's and children's social, emotional and behavioral risks for drug use, and maladaptive functioning. Participants are young (mean age = 18.1 years), predominantly primiparous, unmarried, and challenged by poverty, residential instability and low educational attainment. Lifetime and pregnancy drug use were ~2-4 times higher and ~5-6 times higher, respectively, than US All Races. Baseline characteristics were evenly distributed between groups, except for higher lifetime cigarette use and depressive symptoms among intervention mothers. If study aims are achieved, the public health field will have new evidence supporting multi-generational prevention of behavioral health disparities affecting young American Indian families and the utility of indigenous paraprofessional interventionists in under-resourced communities.

  8. Male infertility after endoscopic Totally Extraperitoneal (Tep) hernia repair (Main): rationale and design of a prospective observational cohort study.

    Science.gov (United States)

    Schouten, Nelleke; van Dalen, Thijs; Smakman, Niels; Elias, Sjoerd G; van de Water, Cees; Spermon, Roan J; Mulder, Laurens Sibinga; Burgmans, Ine P J

    2012-05-21

    To describe the rationale and design of an observational cohort study analyzing the effects of endoscopic Totally Extraperitoneal (TEP) hernia repair on male fertility (MAIN study). The MAIN study is an observational cohort study designed to assess fertility after endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specialized in TEP hernia repair. Male patients of 18-60 years of age, with primary, reducible, bilateral inguinal hernias and no contraindications for endoscopic TEP repair are eligible for inclusion in this study. Patients with an ASA-classification≥III and patients with recurrent and/or scrotal hernias and/or a medical history of pelvic surgery and/or radiotherapy, known fertility problems, diabetes and/or other diseases associated with a risk of fertility problems, will be excluded. The primary outcome is the testicular perfusion before and 6 months after TEP hernia repair (assessed by means of a scrotal ultrasonography). Secondary endpoints are the testicular volume (Ultrasound), semen quality and quantity and the endocrinological status, based on serum levels of the sexual hormones follicle-stimulating hormone (FSH), luteinizing hormone (LSH), testosterone and inhibin B before and 6 months after TEP hernia repair. The use of polypropylene mesh is associated with a strong foreign body reaction which could play a role in chronic groin pain development. Since the mesh in (endoscopic) inguinal hernia repair is placed in close contact to the vas deferens and spermatic vessels, the mesh-induced inflammatory reaction could lead to a dysfunction of these structures. Relevant large and prospective clinical studies on the problem are limited. This study will provide a complete assessment of fertility in male patients who undergo simultaneous bilateral endoscopic TEP hernia repair, by analyzing testicular perfusion and volume, semen quantity and quality and endocrinological status before and 6 months after TEP repair

  9. Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol

    Science.gov (United States)

    Koth, Laura L.; Maier, Lisa A.; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K.; Collman, Ronald G.; Hamzeh, Nabeel; Sweiss, Nadera J.; Zhang, Yingze; O’Neal, Scott; Senior, Robert M.; Becich, Michael; Hochheiser, Harry S.; Kaminski, Naftali; Wisniewski, Stephen R.; Gibson, Kevin F.

    2015-01-01

    Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant’s clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis. PMID:26193069

  10. Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

    Science.gov (United States)

    Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

    2015-10-01

    Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

  11. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  12. Child abuse inventory at emergency rooms: CHAIN-ER rationale and design

    Directory of Open Access Journals (Sweden)

    Nieuwenhuis Edward ES

    2011-10-01

    Full Text Available Abstract Background Child abuse and neglect is an important international health problem with unacceptable levels of morbidity and mortality. Although maltreatment as a cause of injury is estimated to be only 1% or less of the injured children attending the emergency room, the consequences of both missed child abuse cases and wrong suspicions are substantial. Therefore, the accuracy of ongoing detection at emergency rooms by health care professionals is highly important. Internationally, several diagnostic instruments or strategies for child abuse detection are used at emergency rooms, but their diagnostic value is still unknown. The aim of the study 'Child Abuse Inventory at Emergency Rooms' (CHAIN-ER is to assess if active structured inquiry by emergency room staff can accurately detect physical maltreatment in children presenting at emergency rooms with physical injury. Methods/design CHAIN-ER is a multi-centre, cross-sectional study with 6 months diagnostic follow-up. Five thousand children aged 0-7 presenting with injury at an emergency room will be included. The index test - the SPUTOVAMO-R questionnaire- is to be tested for its diagnostic value against the decision of an expert panel. All SPUTOVAMO-R positives and a 15% random sample of the SPUTOVAMO-R negatives will undergo the same systematic diagnostic work up, which consists of an adequate history being taken by a pediatrician, inquiry with other health care providers by structured questionnaires in order to obtain child abuse predictors, and by additional follow-up information. Eventually, an expert panel (reference test determines the true presence or absence of child abuse. Discussion CHAIN-ER will determine both positive and negative predictive value of a child abuse detection instrument used in the emergency room. We mention a benefit of the use of an expert panel and of the use of complete data. Conducting a diagnostic accuracy study on a child abuse detection instrument is also

  13. Chlamyweb Study I: rationale, design and acceptability of an internet-based chlamydia testing intervention.

    Science.gov (United States)

    Lydié, Nathalie; de Barbeyrac, Bertille; Bluzat, Lucile; Le Roy, Chloé; Kersaudy-Rahib, Delphine

    2017-05-01

    In recent years, the internet has widely facilitated Chlamydia trachomatis home-sampling. In France (2012), the Chlamyweb Study evaluated an intervention (Chlamyweb) involving home-based self-sampling via the internet. One element of the study consisted of a randomised controlled trial (RCT), which is reported in detail elsewhere. The focus of this paper, however, is on describing the Chlamyweb Intervention and reporting on the non-RCT element of the evaluation of that intervention by the Chlamyweb Study. This involves (1) describing the design and roll-out of the Chlamyweb Intervention, (2) comparing the socio-behavioural profiles of the participants in the intervention with a nationally representative general population sample and (3) examining the factors that influence the acceptance and return of a self-sampling kit supplied to participants in the course of the intervention. Self-sampling kits were offered to sexually active people aged 18-24 years living on the mainland French. Participants' characteristics were compared with the general population to describe recruited and participant populations. Multivariate analyses by conditional logistic regression were performed to determine factors that were predictors of kit acceptation and use. 7215 people aged 18-24 years were included. Compared with the general population, Chlamyweb reached larger proportions of women, younger people and people with several partners in the previous year. 3372 (46.7%) agreed to receive a self-sampling kit and 2084 (61.8%) returned it, with more women doing so than men. The participation rate was associated with age, place of birth, occupational status, number of partners and condom use, differently for men and women. The offer of easy-to-use, self-sampling kits free of charge appeared to be a logistically feasible strategy for testing in France and reached a large and diverse population including individuals who have limited access to the traditional healthcare system. AFFSAPS

  14. Security controls in an integrated Biobank to protect privacy in data sharing: rationale and study design.

    Science.gov (United States)

    Takai-Igarashi, Takako; Kinoshita, Kengo; Nagasaki, Masao; Ogishima, Soichi; Nakamura, Naoki; Nagase, Sachiko; Nagaie, Satoshi; Saito, Tomo; Nagami, Fuji; Minegishi, Naoko; Suzuki, Yoichi; Suzuki, Kichiya; Hashizume, Hiroaki; Kuriyama, Shinichi; Hozawa, Atsushi; Yaegashi, Nobuo; Kure, Shigeo; Tamiya, Gen; Kawaguchi, Yoshio; Tanaka, Hiroshi; Yamamoto, Masayuki

    2017-07-06

    With the goal of realizing genome-based personalized healthcare, we have developed a biobank that integrates personal health, genome, and omics data along with biospecimens donated by volunteers of 150,000. Such a large-scale of data integration involves obvious risks of privacy violation. The research use of personal genome and health information is a topic of global discussion with regard to the protection of privacy while promoting scientific advancement. The present paper reports on our plans, current attempts, and accomplishments in addressing security problems involved in data sharing to ensure donor privacy while promoting scientific advancement. Biospecimens and data have been collected in prospective cohort studies with the comprehensive agreement. The sample size of 150,000 participants was required for multiple researches including genome-wide screening of gene by environment interactions, haplotype phasing, and parametric linkage analysis. We established the T ohoku M edical M egabank (TMM) data sharing policy: a privacy protection rule that requires physical, personnel, and technological safeguards against privacy violation regarding the use and sharing of data. The proposed policy refers to that of NCBI and that of the Sanger Institute. The proposed policy classifies shared data according to the strength of re-identification risks. Local committees organized by TMM evaluate re-identification risk and assign a security category to a dataset. Every dataset is stored in an assigned segment of a supercomputer in accordance with its security category. A security manager should be designated to handle all security problems at individual data use locations. The proposed policy requires closed networks and IP-VPN remote connections. The mission of the biobank is to distribute biological resources most productively. This mission motivated us to collect biospecimens and health data and simultaneously analyze genome/omics data in-house. The biobank also has the

  15. Combined Dietary Nitrate and Exercise Intervention in Peripheral Artery Disease: Protocol Rationale and Design.

    Science.gov (United States)

    Woessner, Mary N; VanBruggen, Mitch D; Pieper, Carl F; O'Reilly, Erin K; Kraus, William E; Allen, Jason D

    2017-10-03

    Peripheral artery disease (PAD) is caused by atherosclerotic occlusions in the legs. It affects approximately 8-12 million people in the United States alone, one-third of whom suffer from intermittent claudication (IC), defined as ischemic leg pain that occurs with walking and improves with rest. Patients with IC suffer a markedly impaired quality of life and a high perception of disability. Improving pain-free walking time is a primary goal of rehabilitation in this population. The nitric oxide (NO)-PAD trial is designed to compare the effects that 12 weeks of supervised exercise training, in combination with a high inorganic nitrate-content (beetroot [BR] juice) beverage or placebo (PL) beverage, has on clinical outcomes of exercise and functional capacity in two groups of PAD+IC patients: exercise training plus beetroot (EX+BR) and exercise training plus placebo (EX+PL). The primary aims of this randomized controlled, double-blind pilot study are to determine group differences following 12 weeks of EX+BR versus EX+PL in the changes for (1) exercise capacity: pain-free walking time (claudication onset time, COT), peak walk time (PWT), and maximal exercise capacity (peak oxygen uptake, VO2peak) during a maximal-graded cardiopulmonary exercise test (max CPX) and (2) functional capacity: 6-minute walk (6MW) distance. The secondary aims will provide mechanistic insights into the exercise outcome measures and will include (1) gastrocnemius muscle oxygenation during exercise via near-infrared spectroscopy (NIRS); (2) gastrocnemius muscle angiogenesis: capillaries per unit area and per muscle fiber, and relative fraction of type I, IIa, IIb, and IId/x fibers; and (3) vascular health/function via brachial artery flow-mediated dilation, lower-limb blood flow via plethysmography, and pulse wave velocity and reflection. A total of 30 subjects between 40 and 80 years of age with PAD who are limited by IC will undergo exercise training 3 days per week for 12 weeks (ie, 36

  16. Influence of no-ferrule and no-post buildup design on the fatigue resistance of endodontically treated molars restored with resin nanoceramic CAD/CAM crowns.

    Science.gov (United States)

    Magne, P; Carvalho, A O; Bruzi, G; Anderson, R E; Maia, H P; Giannini, M

    2014-01-01

    To evaluate the influence of adhesive core buildup designs-4-mm buildup, 2-mm buildup, and no buildup (endocrown)-on the fatigue resistance and failure mode of endodontically treated molar teeth restored with resin nanoceramic (RNC) CAD/CAM complete crowns placed with self-adhesive resin cement. Forty-five extracted molars were decoronated at the level of the cementoenamel junction, and the roots were endodontically treated. Specimens received different Filtek Z100 adhesive core buildups (4-mm buildup, 2-mm buildup, and no buildup, endocrown preparation) and were restored with Cerec 3 CAD/CAM RNC crowns (Lava Ultimate). Restorations (n=15) and prepared teeth were treated with airborne-particle abrasion, followed by cementation with RelyX Unicem 2 Automix. Specimens were then subjected to cyclic isometric loading at 10 Hz, beginning with a load of 200 N (for 5000 cycles), followed by stages of 400, 600, 800, 1000, 1200, and 1400 N at a maximum of 30,000 cycles each. Specimens were loaded until failure or to a maximum of 185,000 cycles (10-mm-diameter composite resin sphere antagonist). The failure mode was assessed: "catastrophic" (tooth/root fracture that would require tooth extraction), "possibly reparable" (cohesive/adhesive failure with fragment and minor damage, chip or crack, of underlying tooth structure), or "reparable" fracture (cohesive or cohesive/adhesive fracture of restoration only). Groups were compared using the life table survival analysis. Intact specimens were loaded to failure and compared with one-way analysis of variance. All specimens survived the fatigue test until the 800 N-step. The survival rates for 4-mm, 2-mm, and no buildup (endocrown) were 53%, 87%, and 87%, respectively, and were not statistically different even though crowns with 2-mm buildups only started to fail at 1200 N. Minor cohesive chips were detected in many samples despite having survived all 185,000 cycles. Postfatigue load-to-failure ranged from 2969 N with 4-mm buildup

  17. Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial

    OpenAIRE

    Soubeyran, Pierre; Terret, Catherine; Bellera, Carine; Bonnetain, Franck; Jean, Olivier Saint; Galvin, Ang?line; Chakiba, Camille; Zwolakowski, Marie-Dominique; Mathoulin-P?lissier, Simone; Rainfray, Muriel

    2016-01-01

    Background In the general geriatric population, programs linking geriatric evaluation with interventions are effective for improving functional status and survival of the patients. Whether or not these interventions improve health related quality of life (HRQoL) or overall survival (OS) in older patients with cancer is not yet clear. Indeed, randomized data on the effect of such interventions on survival and HRQoL are rare and conflicting. We describe the rationale and design of a phase III m...

  18. Taking the Blood Bank to the Field: The Design and Rationale of the Prehospital Air Medical Plasma (PAMPer) Trial.

    Science.gov (United States)

    Brown, Joshua B; Guyette, Francis X; Neal, Matthew D; Claridge, Jeffrey A; Daley, Brian J; Harbrecht, Brian G; Miller, Richard S; Phelan, Herb A; Adams, Peter W; Early, Barbara J; Peitzman, Andrew B; Billiar, Timothy R; Sperry, Jason L

    2015-01-01

    Hemorrhage and trauma induced coagulopathy remain major drivers of early preventable mortality in military and civilian trauma. Interest in the use of prehospital plasma in hemorrhaging patients as a primary resuscitation agent has grown recently. Trauma center-based damage control resuscitation using early and aggressive plasma transfusion has consistently demonstrated improved outcomes in hemorrhaging patients. Additionally, plasma has been shown to have several favorable immunomodulatory effects. Preliminary evidence with prehospital plasma transfusion has demonstrated feasibility and improved short-term outcomes. Applying state-of-the-art resuscitation strategies to the civilian prehospital arena is compelling. We describe here the rationale, design, and challenges of the Prehospital Air Medical Plasma (PAMPer) trial. The primary objective is to determine the effect of prehospital plasma transfusion during air medical transport on 30-day mortality in patients at risk for traumatic hemorrhage. This study is a multicenter cluster randomized clinical trial. The trial will enroll trauma patients with profound hypotension (SBP ≤ 70 mmHg) or hypotension (SBP 71-90 mmHg) and tachycardia (HR ≥ 108 bpm) from six level I trauma center air medical transport programs. The trial will also explore the effects of prehospital plasma transfusion on the coagulation and inflammatory response following injury. The trial will be conducted under exception for informed consent for emergency research with an investigational new drug approval from the U.S. Food and Drug Administration utilizing a multipronged community consultation process. It is one of three ongoing Department of Defense-funded trials aimed at expanding our understanding of the optimal therapeutic approaches to coagulopathy in the hemorrhaging trauma patient.

  19. Rationale, design, methodology, and baseline data of a population-based study in rural China: the Handan Eye Study.

    Science.gov (United States)

    Liang, Yuan Bo; Friedman, David S; Wong, Tien Yin; Wang, Feng Hua; Duan, Xin Rong; Yang, Xiao Hui; Zhou, Qiang; Tao, Qiushan; Zhan, Si Yan; Sun, Lan Ping; Wang, Ning Li

    2009-01-01

    To describe the rationale, design, methodology and baseline characteristics of the Handan Eye Study (HES), a population-based study to determine the prevalence and impact of visual impairment and major ocular diseases in Chinese adults living in a rural region north China. Population-based, cross-sectional study. 6830 Han people aged 30 years and older from 13 villages of Yongnian County, Handan city, Hebei province, China were recruited. The interviews covered demographic, behavioral, and ocular risk factors as well as health-related and vision-related quality of life. Ocular examination included measurement of visual acuity (VA), intraocular pressure, anterior and posterior segment examinations, visual field testing, and anterior segment, fundus and optic disc photography/imaging. Physical examination included measurement of height and weight, blood pressure, electrocardiogram, fasting blood glucose, lipid levels, urea nitrogen and creatinine as well as tests of physical function including walking speed. Of the 7557 individuals eligible for the Handan Eye Study (HES), 6830 (90.4%) subjects participated the study. The majority of participants were female (53.6%), the average (+/- standard deviation) age was 52.3 (+/- 12.3) years, and 100% were self-identified Han people. In contrast to the non-participants, those who participated were more likely to be female, elderly, married, and had more years of education (P < 0.05). The HES successfully examined over 90% of eligible Han Chinese adults aged 30 and older from a rural region of north China. Results from the HES will provide key information about the prevalence, risk factors, impact, and trends of ocular disease in rural regions of China.

  20. Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study.

    Science.gov (United States)

    Myer, Landon; Phillips, Tamsin K; Zerbe, Allison; Ronan, Agnes; Hsiao, Nei-Yuan; Mellins, Claude A; Remien, Robert H; Le Roux, Stanzi M; Brittain, Kirsty; Ciaranello, Andrea; Petro, Greg; McIntyre, James A; Abrams, Elaine J

    2016-08-01

    Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women. We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study, an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART during pregnancy and their HIV-exposed infants. MCH-ART is composed of 3 interrelated study designs across the antenatal and postnatal periods. Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women seeking antenatal care; phase 2 is an observational cohort of all women from phase 1 who are eligible for initiation of ART following local guidelines; and phase 3 is a randomized trial of strategies for delivering ART to breastfeeding women from phase 2 during the postpartum period. During each phase, a set of study measurement visits is carried out separately from antenatal care and ART services; a maximum of 9 visits takes place from the beginning of antenatal care through 12 months postpartum. In parallel, in-depth interviews are used to examine issues of ART adherence and retention qualitatively, and costs and cost-effectiveness of models of care are examined. Separate substudies examine health outcomes in HIV-uninfected women and their HIV-unexposed infants, and the role of the adherence club model for long-term adherence and retention. Combining observational and experimental components, the MCH-ART study presents a novel approach to understand and optimize ART delivery for MCH.

  1. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods.

    Science.gov (United States)

    Williamson, Jeff D; Miller, Michael E; Bryan, R Nick; Lazar, Ronald M; Coker, Laura H; Johnson, Janice; Cukierman, Tali; Horowitz, Karen R; Murray, Anne; Launer, Lenore J

    2007-06-18

    Type 2 diabetes mellitus and cognitive impairment are 2 of the most common chronic conditions found in persons aged > or = 60 years. Clinical studies have shown a greater prevalence of global cognitive impairment, incidence of cognitive decline, and incidence of Alzheimer disease in patients with type 2 diabetes. To date, there have been no randomized trials of the effects of long-term glycemic control on cognitive function and structural brain changes in patients with type 2 diabetes. The primary aim of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes Study (ACCORD-MIND) is to test whether there is a difference in the rate of cognitive decline and structural brain change in patients with diabetes treated with standard-care guidelines compared with those treated with intensive-care guidelines. This comparison will be made in a subsample of 2,977 patients with diabetes participating in the ongoing ACCORD trial, a clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) with support from the National Institute on Aging (NIA). Data from this ACCORD substudy on the possible beneficial or adverse effects of intensive treatment on cognitive function will be obtained from a 30-minute test battery, administered at baseline and 20-month and 40-month visits. In addition, full-brain magnetic resonance imaging will be performed on 630 participants at baseline and at 40 months to assess the relation between the ACCORD treatments and structural brain changes. The general aim of ACCORD-MIND is to determine whether the intensive treatment of diabetes, a major risk factor for Alzheimer disease and vascular dementia, can reduce the early decline in cognitive function that could later evolve into more cognitively disabling conditions. This report presents the design, rationale, and methods of the ACCORD-MIND substudy.

  2. Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS).

    Science.gov (United States)

    Woller, Scott C; Stevens, Scott M; Kaplan, David A; Branch, D Ware; Aston, Valerie T; Wilson, Emily L; Gallo, Heather M; Johnson, Eric G; Rondina, Matthew T; Lloyd, James F; Evans, R Scott; Elliott, C Gregory

    2016-04-01

    Antiphospholipid syndrome (APS) is an acquired thrombophilia characterized by thrombosis, pregnancy morbidity, and the presence of characteristic antibodies. Current therapy for patients having APS with a history of thrombosis necessitates anticoagulation with the vitamin K antagonist warfarin, a challenging drug to manage. Apixaban, approved for the treatment and prevention of venous thrombosis with a low rate of bleeding observed, has never been studied among patients with APS. We report study rationale and design of Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome (ASTRO-APS), a prospective randomized open-label blinded event pilot study that will randomize patients with a clinical diagnosis of APS receiving therapeutic anticoagulation to either adjusted-dose warfarin or apixaban 2.5 mg twice a day. We aim to report our ability to identify, recruit, randomize, and retain patients with APS randomized to apixaban compared with warfarin. We will report clinically important outcomes of thrombosis and bleeding. All clinical outcomes will be adjudicated by a panel blinded to the treatment arm. A unique aspect of this study is the enrollment of patients with an established clinical diagnosis of APS. Also unique is our use of electronic medical record interrogation techniques to identify patients who would likely meet our inclusion criteria and use of an electronic portal for follow-up visit data capture. ASTRO-APS will be the largest prospective study to date comparing a direct oral anticoagulant with warfarin among patients with APS for the secondary prevention of thrombosis. Our inclusion criteria assure that outcomes obtained will be clinically applicable to the routine management of patients with APS receiving indefinite anticoagulation. © The Author(s) 2015.

  3. Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial.

    Science.gov (United States)

    Crowley, Matthew J; Edelman, David; Voils, Corrine I; Maciejewski, Matthew L; Coffman, Cynthia J; Jeffreys, Amy S; Turner, Marsha J; Gaillard, Leslie A; Hinton, Teresa A; Strawbridge, Elizabeth; Zervakis, Jennifer; Barton, Anna Beth; Yancy, William S

    2017-07-01

    Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m 2 ) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes. Copyright © 2017. Published by Elsevier Inc.

  4. Male infertility after endoscopic Totally Extraperitoneal (Tep hernia repair (Main: rationale and design of a prospective observational cohort study

    Directory of Open Access Journals (Sweden)

    Schouten Nelleke

    2012-05-01

    Full Text Available Abstract Background To describe the rationale and design of an observational cohort study analyzing the effects of endoscopic Totally Extraperitoneal (TEP hernia repair on male fertility (MAIN study. Methods and design The MAIN study is an observational cohort study designed to assess fertility after endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specialized in TEP hernia repair. Male patients of 18-60 years of age, with primary, reducible, bilateral inguinal hernias and no contraindications for endoscopic TEP repair are eligible for inclusion in this study. Patients with an ASA-classification ≥ III and patients with recurrent and/or scrotal hernias and/or a medical history of pelvic surgery and/or radiotherapy, known fertility problems, diabetes and/or other diseases associated with a risk of fertility problems, will be excluded. The primary outcome is the testicular perfusion before and 6 months after TEP hernia repair (assessed by means of a scrotal ultrasonography. Secondary endpoints are the testicular volume (Ultrasound, semen quality and quantity and the endocrinological status, based on serum levels of the sexual hormones follicle-stimulating hormone (FSH, luteinizing hormone (LSH, testosterone and inhibin B before and 6 months after TEP hernia repair. Discussion The use of polypropylene mesh is associated with a strong foreign body reaction which could play a role in chronic groin pain development. Since the mesh in (endoscopic inguinal hernia repair is placed in close contact to the vas deferens and spermatic vessels, the mesh-induced inflammatory reaction could lead to a dysfunction of these structures. Relevant large and prospective clinical studies on the problem are limited. This study will provide a complete assessment of fertility in male patients who undergo simultaneous bilateral endoscopic TEP hernia repair, by analyzing testicular perfusion and volume, semen quantity and quality

  5. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

    Science.gov (United States)

    Berry, Diane C; Neal, Madeline; Hall, Emily G; Schwartz, Todd A; Verbiest, Sarah; Bonuck, Karen; Goodnight, William; Brody, Seth; Dorman, Karen F; Menard, Mary K; Stuebe, Alison M

    2013-10-10

    Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to

  6. Establishing the bidirectional relationship between depression and subclinical arteriosclerosis – rationale, design, and characteristics of the BiDirect Study

    Science.gov (United States)

    2014-01-01

    Background Depression and cardiovascular diseases due to arteriosclerosis are both frequent and impairing conditions. Depression and (subclinical) arteriosclerosis appear to be related in a bidirectional way, and it is plausible to assume a partly joint causal relationship. However, the biological mechanisms and the behavioral pathways that lead from depression to arteriosclerosis and vice versa remain to be exactly determined. Methods/design This study protocol describes the rationale and design of the prospective BiDirect Study that aims at investigating the mutual relationship between depression and (subclinical) arteriosclerosis. BiDirect is scheduled to follow-up three distinct cohorts of individuals ((i) patients with acute depression (N = 999), (ii) patients after an acute cardiac event (N = 347), and (iii) reference subjects from the general population (N = 912)). Over the course of 12 years, four personal examinations are planned to be conducted. The core examination program, which will remain identical across follow-ups, comprises a personal interview (e.g. medical diagnoses, health care utilization, lifestyle and risk behavior), a battery of self-administered questionnaires (e.g. depressive symptoms, readiness to change health behavior, perceived health-related quality of life), sensory (e.g. olfaction, pain) and neuropsychological (e.g. memory, executive functions, emotional processing, manual dexterity) assessments, anthropometry, body impedance measurement, a clinical work-up regarding the vascular status (e.g. electrocardiogram, blood pressure, intima media thickness), the taking of blood samples (serum and plasma, DNA), and structural and functional resonance imaging of the brain (e.g. diffusion tensor imaging, resting-state, emotional faces processing). The present report includes BiDirect-Baseline, the first data collection wave. Discussion Due to its prospective character, the integration of three distinct cohorts, the long follow

  7. Academic doctors' views of complementary and alternative medicine (CAM and its role within the NHS: an exploratory qualitative study

    Directory of Open Access Journals (Sweden)

    Shaw Alison

    2007-05-01

    Full Text Available Abstract Background There has been a marked increase in the use of complementary and alternative medicine (CAM in the UK population in recent years. Surveys of doctors' perspectives on CAM have identified a variety of views and potential information needs. While these are useful for describing the proportions of doctors who hold particular attitudes towards CAM, they are less helpful for understanding why. In addition, while the views of non-academic doctors have begun to be studied, the perspective and rationales of academic doctors remains under-researched. It seems important to investigate the views of those with a research-orientation, given the emphasis on the need for more scientific evidence in recent debates on CAM. Methods This exploratory study used qualitative methods to explore academic doctors' views of CAM and the rationales they provided for their views. A purposeful sampling strategy was used to identify doctors with a dual clinical and academic role in the Bristol area, with an anticipated variety of views on CAM. Semi-structured interviews were conducted with nine doctors. The data were analysed thematically, drawing on the Framework Approach. Results The doctors expressed a spectrum of views on CAM, falling into three broad groups: the 'enthusiasts', the 'sceptics' and the 'undecided'. Scepticism or uncertainty about the value of CAM was prominent, except among those practising a form of CAM. A variety of rationales underpinned their perspectives on CAM, a key recurring rationale being their perspective on the scientific evidence base. The main themes arising included: the role of doctors' professional experiences of conventional medicine and CAM in shaping their attitudes towards CAM, doctor-patient communication about CAM and patient disclosure, whether there is a need for training and education in CAM for doctors, a hierarchy of acceptability of CAM and the nature of evidence; and the role of CAM within the NHS. Conclusion

  8. The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design study.

    Science.gov (United States)

    Huffman, Jeffery C; Albanese, Ariana M; Campbell, Kirsti A; Celano, Christopher M; Millstein, Rachel A; Mastromauro, Carol A; Healy, Brian C; Chung, Wei-Jean; Januzzi, James L; Collins, Linda M; Park, Elyse R

    2017-04-01

    Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises

  9. Influence of surface roughness on mechanical properties of two computer-aided design/computer-aided manufacturing (CAD/CAM) ceramic materials.

    Science.gov (United States)

    Flury, S; Peutzfeldt, A; Lussi, A

    2012-01-01

    The aim of this study was to evaluate the influence of surface roughness on surface hardness (Vickers; VHN), elastic modulus (EM), and flexural strength (FLS) of two computer-aided design/computer-aided manufacturing (CAD/CAM) ceramic materials. One hundred sixty-two samples of VITABLOCS Mark II (VMII) and 162 samples of IPS Empress CAD (IPS) were ground according to six standardized protocols producing decreasing surface roughnesses (n=27/group): grinding with 1) silicon carbide (SiC) paper #80, 2) SiC paper #120, 3) SiC paper #220, 4) SiC paper #320, 5) SiC paper #500, and 6) SiC paper #1000. Surface roughness (Ra/Rz) was measured with a surface roughness meter, VHN and EM with a hardness indentation device, and FLS with a three-point bending test. To test for a correlation between surface roughness (Ra/Rz) and VHN, EM, or FLS, Spearman rank correlation coefficients were calculated. The decrease in surface roughness led to an increase in VHN from (VMII/IPS; medians) 263.7/256.5 VHN to 646.8/601.5 VHN, an increase in EM from 45.4/41.0 GPa to 66.8/58.4 GPa, and an increase in FLS from 49.5/44.3 MPa to 73.0/97.2 MPa. For both ceramic materials, Spearman rank correlation coefficients showed a strong negative correlation between surface roughness (Ra/Rz) and VHN or EM and a moderate negative correlation between Ra/Rz and FLS. In conclusion, a decrease in surface roughness generally improved the mechanical properties of the CAD/CAM ceramic materials tested. However, FLS was less influenced by surface roughness than expected.

  10. Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971]1

    National Research Council Canada - National Science Library

    Daksha Trivedi; Michael Kirby; Felicity Norman; Izabela Przybytniak; Shehzad Ali; David M. Wellsted

    2011-01-01

    ... *To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health-related quality of life in men aged...

  11. Establishing the bidirectional relationship between depression and subclinical arteriosclerosis--rationale, design, and characteristics of the BiDirect Study.

    Science.gov (United States)

    Teismann, Henning; Wersching, Heike; Nagel, Maren; Arolt, Volker; Heindel, Walter; Baune, Bernhard T; Wellmann, Jürgen; Hense, Hans-Werner; Berger, Klaus

    2014-06-13

    Depression and cardiovascular diseases due to arteriosclerosis are both frequent and impairing conditions. Depression and (subclinical) arteriosclerosis appear to be related in a bidirectional way, and it is plausible to assume a partly joint causal relationship. However, the biological mechanisms and the behavioral pathways that lead from depression to arteriosclerosis and vice versa remain to be exactly determined. This study protocol describes the rationale and design of the prospective BiDirect Study that aims at investigating the mutual relationship between depression and (subclinical) arteriosclerosis. BiDirect is scheduled to follow-up three distinct cohorts of individuals ((i) patients with acute depression (N = 999), (ii) patients after an acute cardiac event (N = 347), and (iii) reference subjects from the general population (N = 912)). Over the course of 12 years, four personal examinations are planned to be conducted. The core examination program, which will remain identical across follow-ups, comprises a personal interview (e.g. medical diagnoses, health care utilization, lifestyle and risk behavior), a battery of self-administered questionnaires (e.g. depressive symptoms, readiness to change health behavior, perceived health-related quality of life), sensory (e.g. olfaction, pain) and neuropsychological (e.g. memory, executive functions, emotional processing, manual dexterity) assessments, anthropometry, body impedance measurement, a clinical work-up regarding the vascular status (e.g. electrocardiogram, blood pressure, intima media thickness), the taking of blood samples (serum and plasma, DNA), and structural and functional resonance imaging of the brain (e.g. diffusion tensor imaging, resting-state, emotional faces processing). The present report includes BiDirect-Baseline, the first data collection wave. Due to its prospective character, the integration of three distinct cohorts, the long follow-up time window, the diligent diagnosis of depression

  12. Model Documentation for the MiniCAM

    Energy Technology Data Exchange (ETDEWEB)

    Brenkert, Antoinette L.; Smith, Steven J.; Kim, Son H.; Pitcher, Hugh M.

    2003-07-17

    The MiniCAM, short for the Mini-Climate Assessment Model, is an integrated assessment model of moderate complexity focused on energy and agriculture sectors. The model produces emissions of greenhouse gases (carbon dioxide, methane and nitrous oxide) and other radiatively important substances such as sulfur dioxide. Through incorporation of the simple climate model MAGICC, the consequences of these emissions for climate change and sea-level rise can be examined. The MiniCAM is designed to be fast and flexible.

  13. Engineering specification and system design for CAD/CAM of custom shoes. Phase 5: UMC involvement (January 1, 1989 - June 30, 1989)

    Science.gov (United States)

    Bao, Han P.

    1989-01-01

    The CAD/CAM of custom shoes is discussed. The solid object for machining is represented by a wireframe model with its nodes or vertices specified systematically in a grid pattern covering its entire length (point-to-point configuration). Two sets of data from CENCIT and CYBERWARE were used for machining purposes. It was found that the indexing technique (turning the stock by a small angle then moving the tool on a longitudinal path along the foot) yields the best result in terms of ease of programming, savings in wear and tear of the machine and cutting tools, and resolution of fine surface details. The work done using the LASTMOD last design system results in a shoe last specified by a number of congruent surface patches of different sizes. This data format was converted into a form amenable to the machine tool. It involves a series of sorting algorithms and interpolation algorithms to provide the grid pattern that the machine tool needs as was the case in the point to point configuration discussed above. This report also contains an in-depth treatment of the design and production technique of an integrated sole to complement the task of design and manufacture of the shoe last. Clinical data and essential production parameters are discussed. Examples of soles made through this process are given.

  14. Design Rationale Behind the Serious Self-Regulation Game Intervention "Balance It": Overweight Prevention Among Secondary Vocational Education Students in The Netherlands.

    Science.gov (United States)

    Spook, Jorinde E; Paulussen, Theo; Paulissen, Rosie; Visschedijk, Gillian; Kok, Gerjo; van Empelen, Pepijn

    2015-10-01

    This article describes the design rationale behind a serious self-regulation game intervention. The aim of the game is to promote healthy dietary intake and physical activity among secondary vocational educational students in The Netherlands (approximately 16-20 years of age). The game "Balance It" was developed according to an intervention mapping (IM) protocol. Following IM, we specified health promotion and usability objectives and linked these objectives to selected behavior change and persuasive methods. Accordingly, these methods were translated into a coherent intervention program. The health behavior change objectives were derived from the determinants of the behavior and from Self-Regulation Theory (e.g., students are asked to set goals, monitor and evaluate their behavior, and create coping plans). Usability objectives were derived from the RE-AIM model (i.e., Reach, Effectiveness, Adoption, Implementation, and Maintenance). Next, behavior change and persuasive techniques were selected (e.g., goal setting and prompting, respectively) that did fit with the targeted change objectives and were translated in the design of a (mobile) serious self-regulation game intervention. Subsequently, three concept and usability tests were performed to improve intervention usability, and an evaluation plan was developed. The aim of this study was to provide a design rationale for game interventions targeting health-related behaviors. We developed a coherent program design in which both health behavior change and usability factors are addressed. The IM protocol can serve as a useful guide for decision making in program development and evaluation.

  15. Bridging CAM practice and research: teaching CAM practitioners about research methodology.

    Science.gov (United States)

    Zick, Suzanna M; Benn, Rita

    2004-01-01

    The National Institutes of Health (NIH) is continuing to provide funds directed to support research in complementary and alternative medicine (CAM). CAM providers typically have insufficient knowledge of scientific language or research methodology to develop rigorous proposals. Their ability to contribute meaningfully as advisors, teachers, or research partners in academic settings, is hence limited. To address this issue, we have developed and implemented a 7-week course designed to teach community-based CAM providers: (1) to understand scientific terminology, research design and grantsmanship; (2) to critically evaluate the research literature; and (3) to design pilot studies in areas of their interest. In this article, we describe the recruitment process for selecting course participants, the course design and instructional process and the evaluation results based on qualitative and quantitative methodology. We offer suggestions for developing training opportunities both at the local and national level that would increase the expertise of CAM providers in participating and seeking funded research.

  16. CAM and NK Cells

    Directory of Open Access Journals (Sweden)

    Kazuyoshi Takeda

    2004-01-01

    Full Text Available It is believed that tumor development, outgrowth and metastasis are under the surveillance of the immune system. Although both innate and acquired immune systems play roles, innate immunity is the spearhead against tumors. Recent studies have revealed the critical role of natural killer (NK cells in immune surveillance and that NK cell activity is considerably influenced by various agents, such as environmental factors, stress, foods and drugs. Some of these NK cell stimulants have been used in complementary and alternative medicine (CAM since ancient times. Therefore, the value of CAM should be re-evaluated from this point of view. In this review, we overview the intimate correlation between NK cell functions and CAM agents, and discuss possible underlying mechanisms mediating this. In particular, neuro-immune crosstalk and receptors for CAM agents are the most important and interesting candidates for such mechanisms.

  17. CAM: A Collaborative Object Memory System

    NARCIS (Netherlands)

    Vyas, Dhaval; Nijholt, Antinus; Kröner, Alexander

    2010-01-01

    Physical design objects such as sketches, drawings, collages, storyboards and models play an important role in supporting communication and coordination in design studios. CAM (Cooperative Artefact Memory) is a mobile-tagging based messaging system that allows designers to collaboratively store

  18. [Evaluation of production and clinical working time of computer-aided design/computer-aided manufacturing (CAD/CAM) custom trays for complete denture].

    Science.gov (United States)

    Wei, L; Chen, H; Zhou, Y S; Sun, Y C; Pan, S X

    2017-02-18

    To compare the technician fabrication time and clinical working time of custom trays fabricated using two different methods, the three-dimensional printing custom trays and the conventional custom trays, and to prove the feasibility of the computer-aided design/computer-aided manufacturing (CAD/CAM) custom trays in clinical use from the perspective of clinical time cost. Twenty edentulous patients were recruited into this study, which was prospective, single blind, randomized self-control clinical trials. Two custom trays were fabricated for each participant. One of the custom trays was fabricated using functional suitable denture (FSD) system through CAD/CAM process, and the other was manually fabricated using conventional methods. Then the final impressions were taken using both the custom trays, followed by utilizing the final impression to fabricate complete dentures respectively. The technician production time of the custom trays and the clinical working time of taking the final impression was recorded. The average time spent on fabricating the three-dimensional printing custom trays using FSD system and fabricating the conventional custom trays manually were (28.6±2.9) min and (31.1±5.7) min, respectively. The average time spent on making the final impression with the three-dimensional printing custom trays using FSD system and the conventional custom trays fabricated manually were (23.4±11.5) min and (25.4±13.0) min, respectively. There was significant difference in the technician fabrication time and the clinical working time between the three-dimensional printing custom trays using FSD system and the conventional custom trays fabricated manually (Ptime spent on fabricating three-dimensional printing custom trays using FSD system and making the final impression with the trays are less than those of the conventional custom trays fabricated manually, which reveals that the FSD three-dimensional printing custom trays is less time-consuming both in the

  19. Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).

    Science.gov (United States)

    Walsh, Timothy S; Kydonaki, Kalliopi; Antonelli, Jean; Stephen, Jacqueline; Lee, Robert J; Everingham, Kirsty; Hanley, Janet; Uutelo, Kimmo; Peltola, Petra; Weir, Christopher J

    2016-03-04

    To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs). 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis. Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period. The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured. Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed. The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex

  20. The failure load of CAD/CAM generated zirconia and glass-ceramic laminate veneers with different preparation designs.

    Science.gov (United States)

    Alghazzawi, Tariq F; Lemons, Jack; Liu, Perng-Ru; Essig, Milton E; Janowski, Gregg M

    2012-12-01

    Fracture of feldspathic porcelain laminate veneers represents a significant mode of clinical failure. Therefore, ceramic materials that withstand a higher load to fracture, especially for patients with parafunctional habits, are needed. The purpose of this study was to examine the correlation of material (zirconia, TZP, glass-ceramic, IEC, and feldspathic porcelain, FP) design (incisal overlapped preparation, IOP, and three-quarter preparation, TQP), and fracture mode to failure load for veneers supported by composite resin abutments. A typodont tooth prepared with 2 designs (IOP, TQP) and the corresponding 2 definitive dies were used to fabricate the composite resin abutments (30 for IOP and 30 for TQP). Ten veneer specimens for each system (Y-TZP, IEC, and FP), were fabricated for each design. The veneers were cemented, invested, and tested in compression until failure by using a universal testing machine. Significant differences were evaluated by 2-factor ANOVA (α=.05). No statistical mean load difference was noted between the preparation designs for Y-TZP (IOP: 244 ±81 and TQP: 224 ±58 N), IEC (IOP: 306 ±101 and TQP: 263 ±77 N), and FP veneers (IOP: 161 ±93 and TQP: 246 ±45 N). No statistical difference in the mean load was found among the 3 veneer materials for each preparation design except between IEC (306 ±101 N) and FP (161 ±93 N) veneers for TQP. Preparation design did not influence the failure load of the veneer materials. Zirconia veneers were the least likely to fracture but the most likely to completely debond; feldspathic porcelain veneers exhibited the opposite characteristics. Copyright © 2012 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

  1. The potential for distributed generation in Japanese prototype buildings: A DER-CAM analysis of policy, tariff design, building energy use, and technology development (English Version)

    Energy Technology Data Exchange (ETDEWEB)

    Zhou, Nan; Marnay, Chris; Firestone, Ryan; Gao, Weijun; Nishida, Masaru

    2004-10-15

    The August 2003 blackout of the northeastern U.S. and CANADA caused great economic losses and inconvenience to New York City and other affected areas. The blackout was a warning to the rest of the world that the ability of conventional power systems to meet growing electricity demand is questionable. Failure of large power systems can lead to serious emergencies. Introduction of on-site generation, renewable energy such as solar and wind power and the effective utilization of exhaust heat is needed, to meet the growing energy demands of the residential and commercial sectors. Additional benefit can be achieved by integrating these distributed technologies into distributed energy resource (DER) systems. This work demonstrates a method for choosing and designing economically optimal DER systems. An additional purpose of this research is to establish a database of energy tariffs, DER technology cost and performance characteristics, and building energy consumption for Japan. This research builds on prior DER studies at the Ernest Orlando Lawrence Berkeley National Laboratory (LBNL) and with their associates in the Consortium for Electric Reliability Technology Solutions (CERTS) and operation, including the development of the microgrid concept, and the DER selection optimization program, the Distributed Energy Resources Customer Adoption Model (DER-CAM). DER-CAM is a tool designed to find the optimal combination of installed equipment and an idealized operating schedule to minimize a site's energy bills, given performance and cost data on available DER technologies, utility tariffs, and site electrical and thermal loads over a test period, usually an historic year. Since hourly electric and thermal energy data are rarely available, they are typically developed by building simulation for each of six end use loads used to model the building: electric-only loads, space heating, space cooling, refrigeration, water heating, and natural-gas-only loads. DER-CAM provides a

  2. Fit of CAD/CAM implant frameworks: a comprehensive review.

    Science.gov (United States)

    Abduo, Jaafar

    2014-12-01

    Computer-aided design and computer-aided manufacturing (CAD/CAM) is a strongly emerging prosthesis fabrication method for implant dentistry. Currently, CAD/CAM allows the construction of implant frameworks from different materials. This review evaluates the literature pertaining to the precision fit of fixed implant frameworks fabricated by CAD/CAM. Following a comprehensive electronic search through PubMed (MEDLINE), 14 relevant articles were identified. The results indicate that the precision fit of CAD/CAM frameworks exceeded the fit of the 1-piece cast frameworks and laser-welded frameworks. A similar fit was observed for CAD/CAM frameworks and bonding of the framework body to prefabricated cylinders. The influence of CAD/CAM materials on the fit of a framework is minimal.

  3. Evaluation of the marginal fit of three margin designs of resin composite crowns using CAD/CAM.

    Science.gov (United States)

    Tsitrou, Effrosyni A; Northeast, Simon E; van Noort, Richard

    2007-01-01

    To examine the marginal fit of resin composite crowns manufactured with the CEREC 3 system employing three different margin designs; bevel, chamfer and shoulder, by means of a replica technique and a luting agent. Three master casts were fabricated from an impression of a typodont molar tooth and a full-coverage crown prepared with a marginal finish of a bevel, a chamfer and a shoulder. Each cast was replicated 10 times (n=10). Scanning of the replicas and crown designing was performed using the CEREC Scan system. The crowns were milled from Paradigm MZ100 composite resin blocks. The marginal fit of the crowns was evaluated with a replica technique (Aquasil LV, Dentsply), and with a resin composite cement (RelyX Unicem, Aplicap) and measured with a travelling microscope. Statistical analysis was performed using two-way ANOVA. For the replica technique the average marginal gaps recorded were: Bevel Group 105+/-34 microm, Chamfer Group 94+/-27 microm and Shoulder Group 91+/-22 microm. For the resin composite cement the average marginal gaps were: Bevel Group 102+/-28 microm, Chamfer Group 91+/-11 microm and Shoulder Group 77+/-8 microm. Two-way ANOVA analysis showed that there was no statistically significant difference between the three groups of finishing lines regardless of the cementation technique used. The marginal gap of resin composite crowns manufactured with the CEREC 3 system is within the range of clinical acceptance, regardless of the finishing line prepared or the cementation technique used.

  4. Rationale and design of the Glitazones and the Endothelium (GATE) study: evaluation of rosiglitazone on endothelial function in patients with diabetes.

    Science.gov (United States)

    Hubacek, Jaroslav; Verma, Subodh; Shewchuk, Lana; Ross, Stuart J; Edwards, Alun; Anderson, Todd J

    2004-12-01

    The vascular endothelium has emerged as a critical determinant of cardiovascular health and disease, and improving endothelial function is an important target for therapy. Accumulating evidence suggests that insulin resistance in patients with diabetes and the metabolic syndrome may impair endothelial function, uncovering a proinflammatory, proatherosclerotic vascular phenotype. The rationale and design of the Glitazones and the Endothelium (GATE) study is presented. The GATE study is a randomized, double-blind study for the evaluation of the effects of rosiglitazone versus placebo on endothelial function when used as an add-on therapy in patients with diabetes currently treated with oral therapy. It is hypothesized that the peroxisome proliferator-activated receptor-gamma agonist rosiglitazone will improve endothelium-dependent vasodilation, and that this effect will be related to improvements in insulin sensitivity, with concomitant reductions in whole-body insulin resistance. Furthermore, the beneficial effects of rosiglitazone will be additive to those of existing oral therapies that may modulate endothelial function. Because endothelial dysfunction plays a pivotal role in the development and progression of atherosclerosis, the GATE study may provide the rationale and impetus for the aggressive treatment of insulin-resistant patients with glitazone therapy.

  5. CAD/CAM-designed 3D-printed electroanalytical cell for the evaluation of nanostructured gas-diffusion electrodes.

    Science.gov (United States)

    Chervin, Christopher N; Parker, Joseph F; Nelson, Eric S; Rolison, Debra R; Long, Jeffrey W

    2016-04-29

    The ability to effectively screen and validate gas-diffusion electrodes is critical to the development of next-generation metal-air batteries and regenerative fuel cells. The limiting electrode in a classic two-terminal device such as a battery or fuel cell is difficult to discern without an internal reference electrode, but the flooded electrolyte characteristic of three-electrode electroanalytical cells negates the prime function of an air electrode-a void volume freely accessible to gases. The nanostructured catalysts that drive the energy-conversion reactions (e.g., oxygen reduction and evolution in the air electrode of metal-air batteries) are best evaluated in the electrode structure as-used in the practical device. We have designed, 3D-printed, and characterized an air-breathing, thermodynamically referenced electroanalytical cell that allows us to mimic the Janus arrangement of the gas-diffusion electrode in a metal-air cell: one face freely exposed to gases, the other wetted by electrolyte.

  6. CAD/CAM-designed 3D-printed electroanalytical cell for the evaluation of nanostructured gas-diffusion electrodes

    Science.gov (United States)

    Chervin, Christopher N.; Parker, Joseph F.; Nelson, Eric S.; Rolison, Debra R.; Long, Jeffrey W.

    2016-04-01

    The ability to effectively screen and validate gas-diffusion electrodes is critical to the development of next-generation metal-air batteries and regenerative fuel cells. The limiting electrode in a classic two-terminal device such as a battery or fuel cell is difficult to discern without an internal reference electrode, but the flooded electrolyte characteristic of three-electrode electroanalytical cells negates the prime function of an air electrode—a void volume freely accessible to gases. The nanostructured catalysts that drive the energy-conversion reactions (e.g., oxygen reduction and evolution in the air electrode of metal-air batteries) are best evaluated in the electrode structure as-used in the practical device. We have designed, 3D-printed, and characterized an air-breathing, thermodynamically referenced electroanalytical cell that allows us to mimic the Janus arrangement of the gas-diffusion electrode in a metal-air cell: one face freely exposed to gases, the other wetted by electrolyte.

  7. Comparison of Marginal Fit and Fracture Strength of a CAD/CAM Zirconia Crown with Two Preparation Designs

    Directory of Open Access Journals (Sweden)

    Hamid Jalali

    2016-08-01

    Full Text Available Objectives: The purpose of this in vitro study was to compare the marginal adaptation and fracture resistance of a zirconia-based all-ceramic restoration with two preparation designs.Materials and Methods: Twenty-four mandibular premolars were randomly divided into two groups (n=12; the conventional group received a peripheral shoulder preparation and the modified group received a buccal shoulder and proximal/lingual chamfer preparation. The marginal fit of the zirconia crowns (Cercon was evaluated using a stereomicroscope. After cementation, load was applied to the crowns. The mean fracture load and the mean marginal gap for each group were analyzed using t-test (P=0.05.Results: The mean marginal gap was 71±16µm in the conventional group and 80±10µm in the modified group, with no significant difference (P=0.161. The mean fracture strength was 830±153N for the conventional group and 775±125N for the modified group, with no significant difference (P=0.396. All but one fracture occurred in the veneering ceramic.Conclusion: Less aggressive preparation of proximal and lingual finish lines for the preservation of tooth structure in all-ceramic restorations does not adversely affect the marginal adaptation or fracture strength of the final restoration.

  8. PreCam

    Energy Technology Data Exchange (ETDEWEB)

    Allam, Sahar S. [Fermilab; Tucker, Douglas L. [Fermilab

    2015-01-01

    The Dark Energy Survey (DES) will be taking the next step in probing the properties of Dark Energy and in understanding the physics of cosmic acceleration. A step towards the photometric calibration of DES is to have a quick, bright survey in the DES footprint (PreCam), using a pre-production set of the Dark Energy Camera (DECam) CCDs and a set of 100 mm×100 mm DES filters. The objective of the PreCam Survey is to create a network of calibrated DES grizY standard stars that will be used for DES nightly calibrations and to improve the DES global relative calibrations. Here, we describe the first year of PreCam observation, results, and photometric calibrations.

  9. The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

    DEFF Research Database (Denmark)

    Krarup, L.H.; Gluud, C.; Truelsen, T.

    2008-01-01

    of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS....... Physical activity is assessed in both groups seven times during follow-up using the Physical Activity Scale for the Elderly (PASE) questionnaire, which quantifies the amount of physical activity done in the last seven days prior to interview. The PASE score constitutes the primary outcome measure....... The secondary outcome is the time from randomization to recurrent stroke, myocardial infarction, or all-cause mortality. Further outcome measures include: time from randomization to recurrent stroke, myocardial infarction, and vascular death; recurrent stroke; modified Rankin Scale; quality of life; occurrence...

  10. Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry.

    Science.gov (United States)

    DeVore, Adam D; Thomas, Laine; Albert, Nancy M; Butler, Javed; Hernandez, Adrian F; Patterson, J Herbert; Spertus, John A; Williams, Fredonia B; Turner, Stuart J; Chan, Wing W; Duffy, Carol I; McCague, Kevin; Mi, Xiaojuan; Fonarow, Gregg C

    2017-07-01

    Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. A better understanding of current practice patterns has the potential to improve patients' outcomes. The CHAnge the Management of Patients with Heart Failure (CHAMP-HF) registry will evaluate the care and outcomes of patients with chronic HFrEF by assessing real-world treatment patterns, as well as the reasons for and barriers to medication treatment changes. CHAMP-HF will enroll approximately 5,000 patients with chronic HFrEF (left ventricular ejection fraction ≤40%) at approximately 150 US sites, and patients will be followed for a maximum duration of 24 months. Participating sites will collect data from both providers (HF history, examination findings, results of diagnostic studies, pharmacotherapy treatment patterns, decision-making factors, and clinical outcomes) and patients (medication adherence and patient-reported outcomes). The CHAMP-HF registry will provide a unique opportunity to study practice patterns and the adoption of new HF therapies across a diverse mix of health care providers and outpatient practices in the United States that care for HFrEF patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Patients’ views of CAM as spiritual practice

    DEFF Research Database (Denmark)

    Ulrich, Anita; Evron, Lotte; Ostenfeld-Rosenthal, Ann

    2011-01-01

    Objectives: This paper explores Danish cancer patients’ narratives on spiritual beliefs, practices and the relationship these practices may have to complementary and alternative medicine (CAM). Design: Narrative inquiry was used to understand how spiritual beliefs and practices might be related...... significantly elaborated upon in narratives by four female participants to warrant more detailed consideration and analysis. Conclusion: It is suggested that for some cancer patients CAM may function, not just as a treatment for cancer related symptoms and side effects, but also as a form of spiritual practice...

  12. Development and validation of the CAM Health Belief Questionnaire (CHBQ and CAM use and attitudes amongst medical students

    Directory of Open Access Journals (Sweden)

    Boker John

    2004-01-01

    impact these already positive attitudes. Unlike the IMAQ, which was intended for use with physicians, the CHBQ is generic in design and content and applicable to a variety of learner types. Evaluation measures must be appropriate for specific CAM instructional outcomes.

  13. A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION: Rationale and design

    Directory of Open Access Journals (Sweden)

    Clarke Simon D

    2011-03-01

    Full Text Available Abstract Background The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD. The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study. Methods Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment, Session 2 (six weeks, atomoxetine or placebo, and Session 3 (13 weeks, cross-over after one-week washout period. The standardized touch-screen battery, "IntegNeuro™", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo. Results The methodology for the ACTION study has been detailed. Conclusions The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD

  14. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Directory of Open Access Journals (Sweden)

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  15. Incorporation of CAD/CAM Restoration Into Navy Dentistry

    Science.gov (United States)

    2017-09-26

    Aided Design and Computer- Aided Manufacturing Restorations: A Review of the Literature. Journal of international oral health : JIOH 2015;7:96-104...CAD/CAM Computer-aided design /Computer-assisted manufacturing CDT Common Dental Terminology DENCAS Dental Common Access System DTF Dental...to reduce avoidable dental emergencies for deployed sailors and marines. Dental Computer-aided design /Computer-assisted manufacturing (CAD/CAM

  16. Camønoen

    DEFF Research Database (Denmark)

    Gyimóthy, Szilvia; Widtfeld Meged, Jane

    2016-01-01

    communitarian business models, such as car-sharing, social dining and peer rental of property. These sharing models thrive primarily in urban settings with a high density of assets, triggering the question: how can sparse and loosely connected coastal resources be mobilized to create value for tourists...... is augmented by a digital platform on which hikers may directly connect with local citizens and book experiences ranging from private dinners to bird-watching and berry-picking. The platform Camønoen.org is hosted by the regional museum, which neither charges for intermediation, nor is responsible for vetting...... and control procedures. Our paper will follow the consolidation of Camønoen by analyzing its business model, the institutionalization of brokers and coordination roles as well as the emerging relationships, trust and exchange mechanisms between small, local providers and visitors. By doing so, we will be able...

  17. Rationale of Cruciate Retaining Design in Rheumatoid Arthritis: A Review of Clinical Analysis and its Role in Rheumatoid Arthritis.

    Science.gov (United States)

    Ashraf, Munis; Sharma, Om Prakash; Priyavadhana, Sruthi; Sambandam, Senthil Nathan; Mounasamy, Varatharaj

    2017-01-01

    Over the years, proponents of total knee designs (cruciate retaining and posterior stabilised) have conducted several long-term studies to claim the potential of these designs in several subsets of patients. Total knee arthroplasty (TKA) in patients with rheumatoid arthritis has also been one such domain where numerous studies were conducted in the past. A general perception among majority of arthroplasty surgeons is that, posterior stabilised (PS) is the implanted design of choice among patients with Rheumatoid arthritis (RA). However, with the available literature there is a significant disparity related to the selection of implants in patients with rheumatoid RA. In this review of literature, an attempt is made to identify the clinical performance and role of one such implant design, the cruciate retaining (CR) prosthesis in rheumatoid arthritis. The review was conducted after a series of advanced search in the following medical databases; Pub med, Biomed central, Cochrane and Google scholar for articles related to long term follow up studies of cruciate retaining total knee arthroplasty in rheumatoid arthritis using the keywords cruciate retaining prosthesis, total knee arthroplasty, rheumatoid arthritis. The available data demonstrate that the CR design is attributed with an excellent long term survivorship and functional outcome even in follow up studies up to twenty-five years. The advantages of using a CR design are long term survivorship, controlled femoral roll back and preservation of bone stock. Thus, the data gathered in this review lead to a consideration that the CR design is an implant design on par with PS design in patients with RA.

  18. Cam Drive Step Mechanism of a Quadruped Robot

    Directory of Open Access Journals (Sweden)

    Qun Sun

    2014-01-01

    Full Text Available Bionic quadruped robots received considerable worldwide research attention. For a quadruped robot walking with steady paces on a flat terrain, using a cam drive control mechanism instead of servomotors provides theoretical and practical benefits as it reduces the system weight, cost, and control complexities; thus it may be more cost beneficial for some recreational or household applications. This study explores the robot step mechanism including the leg and cam drive control systems based on studying the bone structure and the kinematic step sequences of dog. The design requirements for the cam drive robot legs have been raised, and the mechanical principles of the leg operating mechanism as well as the control parameters have been analyzed. A cam drive control system was constructed using three cams to control each leg. Finally, a four-leg demo robot was manufactured for experiments and it showed stable walking patterns on a flat floor.

  19. PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

    Science.gov (United States)

    Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

    2017-04-01

    Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization

  20. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    Science.gov (United States)

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  1. Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial.

    Science.gov (United States)

    Lee, Joshua D; Friedmann, Peter D; Boney, Tamara Y; Hoskinson, Randall A; McDonald, Ryan; Gordon, Michael; Fishman, Marc; Chen, Donna T; Bonnie, Richard J; Kinlock, Timothy W; Nunes, Edward V; Cornish, James W; O'Brien, Charles P

    2015-03-01

    Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use. We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial.

    Science.gov (United States)

    Soubeyran, Pierre; Terret, Catherine; Bellera, Carine; Bonnetain, Franck; Jean, Olivier Saint; Galvin, Angéline; Chakiba, Camille; Zwolakowski, Marie-Dominique; Mathoulin-Pélissier, Simone; Rainfray, Muriel

    2016-12-01

    In the general geriatric population, programs linking geriatric evaluation with interventions are effective for improving functional status and survival of the patients. Whether or not these interventions improve health related quality of life (HRQoL) or overall survival (OS) in older patients with cancer is not yet clear. Indeed, randomized data on the effect of such interventions on survival and HRQoL are rare and conflicting. We describe the rationale and design of a phase III multicenter trial aimed at assessing the efficacy of geriatric intervention in the management of elderly patients with cancer. Approximately 1200 patients, 70 years and older, considered in need of a geriatric intervention based on the G8 screening tool will be randomized into two intervention arms. The 'Usual-care' arm involves standard oncological care based on pre-defined oncological protocols. In addition to the standard oncological care, the 'Case-management' arm involves a multidimensional geriatric assessment and interventions tailored for the patient. Efficacy will be assessed using a co-primary endpoint encompassing OS and HRQoL. This trial has been designed to assess whether focused geriatric case management can either improve OS or HRQoL in elderly cancer patients considered in need of geriatric assessment. Clinicaltrials.gov ID: NCT02704832 .

  3. The Multicenter Pediatric and Adult Congenital EP Quality (MAP-IT) Initiative-rationale and design: report from the pediatric and congenital electrophysiology society's MAP-IT taskforce.

    Science.gov (United States)

    Seslar, Stephen P; Kugler, John; Batra, Anjan S; Collins, Kathryn K; Crosson, Jane; Dubin, Anne M; Etheridge, Susan; Kanter, Ronald; Papez, Andrew; Radbill, Andrew E; Serwer, Gerald A; Tanel, Ronn E; Tsao, Sabrina; Webster, Gregory; Saarel, Elizabeth V

    2013-01-01

    Multicenter clinical registries are increasingly recognized as valuable tools for establishing benchmarks, facilitating patient-centered quality improvement and research. In 2010, the Pediatric and Congenital Electrophysiology Society convened a taskforce of its members to design, construct, and implement a clinical registry known as the Multicenter Pediatric and Adult Congenital EP Quality (MAP-IT) Initiative. The present aim of the MAP-IT Initiative is to create an infrastructure by which we can measurably improve patient-centered outcomes and reduce complications associated with electrophysiology studies and catheter ablation in pediatric and congenital heart disease patients. The purpose of this writing is to report the progress to date from three of the four subcommittees of the MAP-IT taskforce. Specifically, we present our initial set of key data elements and definitions, recommended database table structure, and considerations regarding wide-scale implementation of the registry. Development of a risk/complexity score for use in the MAP-IT registry is presented in a separate companion manuscript. It is our intent that these manuscripts will serve to introduce the electrophysiology and pediatric cardiology community to the MAP-IT initiative and provide a rationale for its design and recommended implementation strategy. © 2013 Wiley Periodicals, Inc.

  4. Rationale and design of the plate or pin (pop study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meylaerts Sven AG

    2011-07-01

    Full Text Available Abstract Background To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN with a Titanium Elastic Nail (TEN for adults with a dislocated midshaft clavicular fracture. Methods/Design Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures. Discussion Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed. Trial registration The POP study is registered in the Dutch Trial Register (NTR NTR2438.

  5. Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: Rationale and design

    Science.gov (United States)

    Young African American girls have a high risk of obesity. Online behavior change programs promoting healthy diet and physical activity are convenient and may be effective for reducing disparities related to obesity. This report presents the protocol guiding the design and evaluation of a culturally ...

  6. Web Design Rationale for Online Self-Monitoring and Self-Enhancing in EFL at the University of Sassari, Italy.

    Science.gov (United States)

    Pinna, Antonio

    2000-01-01

    Addresses some problematic aspects posed by the design and implementation of a Web site aimed at providing some extracurricular online EFL (English as a foreign language) resources to science students at the University of Sassari (Italy). Discusses teacher training, needs analysis, content organization, teaching of grammar, and evaluation and…

  7. Rationale and design of the vitamin D and type 2 diabetes (D2d) study: a diabetes prevention trial

    Science.gov (United States)

    OBJECTIVE: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supp...

  8. Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study: Rationale and Study design of the HOMERUS Trial

    NARCIS (Netherlands)

    Verberk, W. J.; Kroon, A. A.; Kessels, A. G. H.; Dirksen, C.; Nelemans, P. J.; Lenders, J. W. M.; Thien, Th A. B. M.; van Montfrans, G. A.; Smit, A. J.; de Leeuw, P. W.

    2003-01-01

    The Home versus Office MEasurements, Reduction of Unnecessary treatment Study (HOMERUS) is a multicentre prospective study, primarily designed to examine in subjects with mild to moderate hypertension whether treatment decisions based on home blood pressure measurements can lead to reduction in the

  9. Home versus Office blood pressure MEasurements : Reduction of Unnecessary treatment Study: Rationale and Study design of the HOMERUS Trial

    NARCIS (Netherlands)

    Verberk, WJ; Kroon, AA; Kessels, AGH; Dirksen, C; Nelemans, PJ; Lenders, JWM; Thien, TABM; van Montfrans, GA; Smit, AJ; de Leeuw, PW

    2003-01-01

    The Home versus Office MEasurements, Reduction of Unnecessary treatment Study (HOMERUS) is a multicentre prospective study, primarily designed to examine in subjects with mild to moderate hypertension whether treatment decisions based on home blood pressure measurements can lead to reduction in the

  10. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    DEFF Research Database (Denmark)

    Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær

    2016-01-01

    BACKGROUND: Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom......-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. METHODS: The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools...... was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using...

  11. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    DEFF Research Database (Denmark)

    Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær

    2016-01-01

    BACKGROUND: Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom...... their children's PA behavior in leisure time. DISCUSSION: The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom-based PA to improve cognition and academic achievement in children. TRIAL REGISTRATION......-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. METHODS: The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools...

  12. Community health workers assisting Latinos manage stress and diabetes (CALMS-D): rationale, intervention design, implementation, and process outcomes.

    Science.gov (United States)

    Wagner, Julie; Bermudez-Millan, Angela; Damio, Grace; Segura-Perez, Sofia; Chhabra, Jyoti; Vergara, Cunegundo; Perez-Escamilla, Rafael

    2015-12-01

    Latinos have high rates of diabetes and mental distress, but lack appropriate services. A study was designed to compare enhanced standard diabetes care with enhanced standard care plus community health worker (CHW) delivered stress management for Latinos with type 2 diabetes. This paper reports intervention design and process outcomes. A formative process was used to develop and implement an eight-session, group stress management intervention. One hundred twenty-one participants completed baseline assessments; n = 107 attended diabetes education and were then randomized. Recruits reported high credibility and treatment expectancies. Treatment fidelity was high. Participants reported high treatment satisfaction and therapeutic alliance and their diabetes knowledge and affect improved over the short term. Retention and attendance at group sessions was challenging but successful relative to similar trials. This comprehensive and culturally sensitive stress management intervention, delivered by a well-trained CHW, was successfully implemented.

  13. Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma

    OpenAIRE

    Qiao You-Lin; Orsini Lucinda S; Therneau Terry; Chen Minshan

    2011-01-01

    Abstract Background More than 50% of the worldwide cases of hepatocellular carcinoma occur in China, and this malignancy currently represents the country's second leading cause of cancer death in cities and the leading cause in rural areas. Despite recent advances in the control and management of hepatocellular carcinoma within China, this disease remains a major health care issue. The global HCC BRIDGE study, designed to assess patterns of hepatocellular carcinoma therapy use and associated ...

  14. Dual-Purpose Gastric Decompression and Enteral Feeding Tubes Rationale and Design of Novel Nasogastric and Nasogastrojejunal Tubes.

    Science.gov (United States)

    Silk, David B A; Quinn, David G

    2015-07-01

    The importance of early postoperative nutrition in surgical patients and early institution of enteral nutrition in intensive care unit (ICU) patients have recently been highlighted. Unfortunately, institution of enteral feeding in both groups of patients often has to be postponed due to delayed gastric emptying and the need for gastric decompression. The design of current polyvinylchloride (PVC) gastric decompression tubes (Salem Sump [Covidien, Mansfield, MA] in the United States; Ryles [Penine Health Care Ltd, Derby, UK] in the United Kingdom and Europe) make them unsuitable for their subsequent use as either nasogastric enteral feeding tubes or for continued gastric decompression during postpyloric enteral feeding. To overcome these problems, we have designed a range of polyurethane (PU) dual-purpose gastric decompression and enteral feeding tubes that include 2 nasogastric tubes (double lumen to replace Salem Sump; single lumen to replace Ryles). Two novel multilumen nasogastrojejunal tubes (triple lumen for the United States; double lumen for the United Kingdom and Europe) complete the range. By using PU, a given internal diameter (ID) and flow area can be incorporated into a lower outside diameter (OD) compared with that achieved with PVC. The ID and lumen and flow area of an 18Fr (OD 6.7 mm) PVC Salem Sump can be incorporated into a 14Fr (OD 4.7 mm) PU tube. The design of aspiration/infusion ports of current PVC and PU tubes invites occlusion by gastrointestinal mucosa and clogging by mucus and enteral feed. To overcome this, we have designed long, single, widened, smooth, and curved edge ports with no "dead space" to trap mucus or curdled diet. Involving up to 214° of the circumference, these ports have up to 11 times the flow areas of the aspiration ports of current PVC tubes. The proposed designs will lead to the development of dual-purpose nasogastric and nasojejunal tubes that will significantly improve the clinical and nutrition care of postoperative

  15. Integrating 3D facial scanning in a digital workflow to CAD/CAM design and fabricate complete dentures for immediate total mouth rehabilitation.

    Science.gov (United States)

    Hassan, Bassam; Greven, Marcus; Wismeijer, Daniel

    2017-10-01

    To integrate extra-oral facial scanning information with CAD/CAM complete dentures to immediately rehabilitate terminal dentition. Ten patients with terminal dentition scheduled for total extraction and immediate denture placement were recruited for this study. The patients were submitted to a facial scanning procedure using the in-office PritiMirror scanner with bite registration records in-situ. Definitive stone cast models and bite records were subsequently submitted to a lab scanning procedure using the lab scanner (iSeries DWOS; Dental Wings). The scanned models were used to create a virtual teeth setup of a complete denture. Using the intra-oral bite records as a reference, the virtual setup was incorporated in the facial scan thereby facilitating a virtual clinical evaluation (teeth try-in) phase. After applying necessary adjustments, the virtual setup was submitted to a CAM procedure where a 5-axis industrial milling machine (M7 CNC; Darton AG General) was used to fabricate a full-milled PMMA immediate provisional prosthesis. Total extractions were performed, the dentures were immediately inserted, and subjective clinical fit was evaluated. The immediate provisional prostheses were inserted and clinical fit, occlusion/articulation, and esthetics were subjectively assessed; the results were deemed satisfactory. All provisional prostheses remained three months in function with no notable technical complications. Ten patients with terminal dentition were treated using a complete digital approach to fabricate complete dentures using CAD/CAM technology. The proposed technique has the potential to accelerate the rehabilitation procedure starting from immediate denture to final implant-supported prosthesis leading to more predictable functional and aesthetics outcomes.

  16. Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: rationale and design.

    Science.gov (United States)

    Thompson, Debbe; Mahabir, Rory; Bhatt, Riddhi; Boutte, Cynthia; Cantu, Dora; Vazquez, Isabel; Callender, Chishinga; Cullen, Karen; Baranowski, Tom; Liu, Yan; Walker, Celeste; Buday, Richard

    2013-08-02

    Young African American girls have a high risk of obesity. Online behavior change programs promoting healthy diet and physical activity are convenient and may be effective for reducing disparities related to obesity. This report presents the protocol guiding the design and evaluation of a culturally and developmental appropriate online obesity prevention program for young African American girls. The Butterfly Girls and the Quest for Founder's Rock is an 8-episode online program delivered as an animated, interactive comic. The program promotes healthy diet and physical activity and is specifically designed for 8-10 year old African American girls. Girls, parents, and community representatives provided formative feedback on cultural relevance and developmental appropriateness. A three-group (treatment, comparison, wait-list control) randomized design (n=390 parent/child dyads) is employed, with child as the unit of assignment. Change in body mass index is the primary outcome; change in fruit and vegetable consumption, water, and physical activity are secondary outcomes. Data collection occurs at baseline, approximately 3 months after baseline (i.e., completion of the online program), and approximately three months later (i.e., maintenance assessment). Two dietary recalls are collected at each data collection period by trained interviewers using the Nutrient Data System for Research (NDSR 2012) system. Physical activity is objectively measured by seven days of accelerometry. Psychosocial and process data are also collected. Girls in the treatment and comparison groups will be interviewed at post 1 to obtain information on personal reactions to the program. This research will develop and evaluate the efficacy of an online program for reducing obesity risk among girls at risk of obesity and related diseases. Online programs offer the potential for wide dissemination, thus reducing disparities related to obesity. NCT01481948.

  17. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  18. Rationale and Design of Low-dose Administration of Carperitide for Acute Heart Failure (LASCAR-AHF).

    Science.gov (United States)

    Nagai, Toshiyuki; Honda, Yasuyuki; Nakano, Hiroki; Honda, Satoshi; Iwakami, Naotsugu; Mizuno, Atsushi; Komiyama, Nobuyuki; Yamane, Takafumi; Furukawa, Yutaka; Miyagi, Tadayoshi; Nishihara, Syuzo; Tanaka, Nobuhiro; Adachi, Taichi; Hamasaki, Toshimitsu; Asaumi, Yasuhide; Tahara, Yoshio; Aiba, Takeshi; Sugano, Yasuo; Kanzaki, Hideaki; Noguchi, Teruo; Kusano, Kengo; Yasuda, Satoshi; Ogawa, Hisao; Anzai, Toshihisa

    2017-12-01

    Despite current therapies, acute heart failure (AHF) remains a major public health burden with high rates of in-hospital and post-discharge morbidity and mortality. Carperitide is a recombinantly produced intravenous formulation of human atrial natriuretic peptide that promotes vasodilation with increased salt and water excretion, which leads to reduction of cardiac filling pressures. A previous open-label randomized controlled study showed that carperitide improved long-term cardiovascular mortality and heart failure (HF) hospitalization for patients with AHF, when adding to standard therapy. However, the study was underpowered to detect a difference in mortality because of the small sample size. Low-dose Administration of Carperitide for Acute Heart Failure (LASCAR-AHF) is a multicenter, randomized, open-label, controlled study designed to evaluate the efficacy of intravenous carperitide in hospitalized patients with AHF. Patients hospitalized for AHF will be randomly assigned to receive either intravenous carperitide (0.02 μg/kg/min) in addition to standard treatment or matching standard treatment for 72 h. The primary end point is death or rehospitalization for HF within 2 years. A total of 260 patients will be enrolled between 2013 and 2018. The design of LASCAR-AHF will provide data of whether carperitide reduces the risk of mortality and rehospitalization for HF in selected patients with AHF.

  19. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study

    Directory of Open Access Journals (Sweden)

    Schultheiss Heinz-Peter

    2010-07-01

    Full Text Available Abstract Background Catheter ablation of the pulmonary veins has become accepted as a standard therapeutic approach for symptomatic paroxysmal atrial fibrillation (AF. However, there is some evidence for an ablation associated (silent stroke risk, lowering the hope to limit the stroke risk by restoration of rhythm over rate control in AF. The purpose of the prospective randomized single-center study "Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation" (MACPAF is to compare the efficacy and safety of two balloon based pulmonary vein ablation systems in patients with symptomatic paroxysmal AF. Methods/Design Patients are randomized 1:1 for the Arctic Front® or the HD Mesh Ablator® catheter for left atrial catheter ablation (LACA. The predefined endpoints will be assessed by brain magnetic resonance imaging (MRI, neuro(psychological tests and a subcutaneously implanted reveal recorder for AF detection. According to statistics 108 patients will be enrolled. Discussion Findings from the MACPAF trial will help to balance the benefits and risks of LACA for symptomatic paroxysmal AF. Using serial brain MRIs might help to identify patients at risk for LACA-associated cerebral thromboembolism. Potential limitations of the study are the single-center design, the existence of a variety of LACA-catheters, the missing placebo-group and the impossibility to assess the primary endpoint in a blinded fashion. Trial registration clinicaltrials.gov NCT01061931

  20. High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON Study.

    Science.gov (United States)

    Zheng, Jin-Ping; Wen, Fu-Qiang; Bai, Chun-Xue; Wan, Huan-Ying; Kang, Jian; Chen, Ping; Yao, Wan-Zhen; Ma, Li-Jun; Xia, Qi-Kui; Gao, Yi; Zhong, Nan-Shan

    2013-04-01

    Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation; from a pathophysiological point of view it involves many components, including mucus hypersecretion, oxidative stress and inflammation. N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is controversial; a dose-effect relationship has been demonstrated, but at present it is not known whether a higher dose provides clinical benefits. The PANTHEON Study is a prospective, ICS stratified, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial designed to assess the efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to first exacerbation, as well as quality of life and pulmonary function. The hypothesis, design and methodology are described and baseline characteristics of recruited patients are presented. 1006 COPD patients (444 treated with maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China. Final results of this study will provide objective data on the effects of high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD exacerbations and other outcome variables.

  1. Rationale for the design of an oncology trial using a generic targeted therapy multi-drug regimen for NSCLC patients without treatment options (Review)

    Science.gov (United States)

    LANGHAMMER, STEFAN

    2013-01-01

    Despite more than 70 years of research concerning medication for cancer treatment, the disease still remains one of the leading causes of mortality worldwide. Many cancer types lead to death within a period of months to years. The original class of chemotherapeutics is not selective for tumor cells and often has limited efficacy, while treated patients suffer from adverse side-effects. To date, the concept of tumor-specific targeted therapy drugs has not fulfilled its expectation to provide a key for a cure. Today, many oncology trials are designed using a combination of chemotherapeutics with targeted therapy drugs. However, these approaches have limited outcomes in most cancer indications. This perspective review provides a rationale to combine targeted therapy drugs for cancer treatment based on observations of evolutionary principles of tumor development and HIV infections. In both diseases, the mechanisms of immune evasion and drug resistance can be compared to some extent. However, only for HIV is a breakthrough treatment available, which is the highly active antiretroviral therapy (HAART). The principles of HAART and recent findings from cancer research were employed to construct a hypothetical model for cancer treatment with a multi-drug regimen of targeted therapy drugs. As an example of this hypothesis, it is proposed to combine already marketed targeted therapy drugs against VEGFRs, EGFR, CXCR4 and COX2 in an oncology trial for non-small cell lung cancer patients without further treatment options. PMID:23877481

  2. Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial.

    Science.gov (United States)

    Siebenhofer, Andrea; Rakovac, Ivo; Kleespies, Caroline; Piso, Brigitte; Didjurgeit, Ulrike

    2007-03-01

    Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.

  3. Community-based physical activity as adjunctive smoking cessation treatment: Rationale, design, and baseline data for the Lifestyle Enhancement Program (LEAP) randomized controlled trial.

    Science.gov (United States)

    Vander Weg, Mark W; Coday, Mace; Stockton, Michelle B; McClanahan, Barbara; Relyea, George; Read, Mary C; Wilson, Nancy; Connelly, Stephanie; Richey, Phyllis; Johnson, Karen C; Ward, Kenneth D

    2018-03-01

    Despite advances in behavioral and pharmacological treatment for tobacco use and dependence, quit rates remain suboptimal. Increasing physical activity has shown some promise as a strategy for improving cessation outcomes. However, initial efficacy studies focused on intensive, highly structured exercise programs that may not be applicable to the general population of smokers. We describe the rationale and study design and report baseline participant characteristics from the Lifestyle Enhancement Program (LEAP), a two-group, randomized controlled trial. Adult smokers who engaged in low levels of leisure time physical activity were randomly assigned to treatment conditions consisting of an individualized physical activity intervention delivered by health fitness instructors in community-based exercise facilities or an equal contact wellness control. All participants received standard cognitive behavioral smoking cessation counseling combined with nicotine replacement therapy. The primary outcomes are seven-day point prevalence abstinence at seven weeks, six- and 12 months. Secondary outcomes include self-reported physical activity, dietary intake, body mass index, waist circumference, percent body fat, and nicotine withdrawal symptoms. Participants consist of 392 sedentary smokers (mean [standard deviation] age = 44.6 [10.2] = years; 62% female; 31% African American). Results reported here provide information regarding experiences recruiting smokers willing to change multiple health behaviors including smoking and physical activity.

  4. A community-based obesity prevention program for minority children: rationale and study design for Hip-Hop to Health Jr.

    Science.gov (United States)

    Fitzgibbon, Marian L; Stolley, Melinda R; Dyer, Alan R; VanHorn, Linda; KauferChristoffel, Katherine

    2002-02-01

    BACKGROUND; The increasing prevalence of overweight among children in the United States presents a national health priority. Higher rates of overweight/obesity among minority women place their children at increased risk. Although increased rates of overweight are observed in 4- to 5-year-old children, they are not observed in 2- to 3-year-old children. Therefore, early prevention efforts incorporating families are critical. The primary aim of Hip-Hop to Health Jr. is to alter the trajectory toward overweight/obesity among preschool African-American and Latino children. This 5-year randomized intervention is conducted in 24 Head Start programs, where each site is randomized to either a 14-week dietary/physical activity intervention or a general health intervention. This paper presents the rationale and design of the study. Efficacy of the intervention will be determined by weight change for the children and parent/caretaker. Secondary measures include reductions in dietary fat and increases in fiber, fruit/vegetable intake, and physical activity. Baseline data will be presented in future papers. The problem of overweight/obesity is epidemic in the United States. Behaviors related to diet and physical activity are established early in life and modeled by family members. Early intervention efforts addressing the child and family are needed to prevent obesity later in life. This paper describes a comprehensive, family-oriented obesity prevention program for minority preschool children. Copyright 2002 American Health Foundation and Elsevier Science (USA).

  5. COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

    Science.gov (United States)

    Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

    2011-05-01

    Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

  6. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Science.gov (United States)

    2011-01-01

    Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

  7. Clinical Evaluation of Effects of Chronic Resveratrol Supplementation on Cerebrovascular Function, Cognition, Mood, Physical Function and General Well-Being in Postmenopausal Women—Rationale and Study Design

    Directory of Open Access Journals (Sweden)

    Hamish Michael Evans

    2016-03-01

    Full Text Available Background: This methodological paper presents both a scientific rationale and a methodological approach for investigating the effects of resveratrol supplementation on mood and cognitive performance in postmenopausal women. Postmenopausal women have an increased risk of cognitive decline and dementia, which may be at least partly due to loss of beneficial effects of estrogen on the cerebrovasculature. We hypothesise that resveratrol, a phytoestrogen, may counteract this risk by enhancing cerebrovascular function and improving regional blood flow in response to cognitive demands. A clinical trial was designed to test this hypothesis. Method: Healthy postmenopausal women were recruited to participate in a randomised, double-blind, placebo-controlled (parallel comparison dietary intervention trial to evaluate the effects of resveratrol supplementation (75 mg twice daily on cognition, cerebrovascular responsiveness to cognitive tasks and overall well-being. They performed the following tests at baseline and after 14 weeks of supplementation: Rey Auditory Verbal Learning Test, Cambridge Semantic Memory Battery, the Double Span and the Trail Making Task. Cerebrovascular function was assessed simultaneously by monitoring blood flow velocity in the middle cerebral arteries using transcranial Doppler ultrasound. Conclusion: This trial provides a model approach to demonstrate that, by optimising circulatory function in the brain, resveratrol and other vasoactive nutrients may enhance mood and cognition and ameliorate the risk of developing dementia in postmenopausal women and other at-risk populations.

  8. Cancer Survivor Study (CASUS) on colorectal patients: longitudinal study on physical activity, fitness, nutrition, and its influences on quality of life, disease recurrence, and survival. Rationale and design.

    Science.gov (United States)

    Soares-Miranda, Luisa; Abreu, Sandra; Silva, Marco; Peixoto, Armando; Ramalho, Rosa; da Silva, Pedro Correia; Costa, Carla; Teixeira, João Paulo; Gonçalves, Carla; Moreira, Pedro; Mota, Jorge; Macedo, Guilherme

    2017-01-01

    Evidence suggests that being physically active in combination with a healthy diet contributes to diminish colorectal cancer risk. However, if this is true for colorectal cancer primary prevention, the same is not clear for its recurrence after colorectal cancer treatments. Data on cancer survival are scarce, and there is a need for greater attention on these survivors' lifestyle behavior. This manuscript describes rationale and design of the Cancer Survival Study (CASUS) on colorectal patients, a longitudinal observational study with the aim of investigating how physical activity, physical fitness, and dietary intake are related with their quality of life, disease recurrence, and survival. The CASUS on colorectal patients is a longitudinal cohort study on colorectal survivors, aged 18 years or older, recruited 6, 12, and 24 months after surgery. Upon recruitment, patients fill in a battery of questionnaires about physical activity, dietary intake, and quality of life, donate blood samples, do physical fitness tests, and use an accelerometer during 7 days. Repeated analyses will be performed to assess changes over time in physical activity, physical fitness, dietary intake, and other factors in relation to recurrence and survival. Results will contribute to highlight the role of physical activity, physical fitness, and nutrition in the quality of life of colorectal cancer survivors, recurrence, and survival. This study will provide important information for policymakers on the potential benefits of future physical activity and nutritional interventions, which are inexpensive, as a way to improve general health of colorectal cancer survivors.

  9. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

    Science.gov (United States)

    Nobels, Frank; Debacker, Noëmi; Brotons, Carlos; Elisaf, Moses; Hermans, Michel P; Michel, Georges; Muls, Erik

    2011-09-22

    To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Recruitment was completed in December 2008 with 3994 evaluable patients. This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. NCT00681850.

  10. Readiness for diabetes prevention and barriers to lifestyle change in women with a history of gestational diabetes mellitus: rationale and study design.

    Science.gov (United States)

    Lipscombe, Lorraine L; Banerjee, Ananya Tina; McTavish, Sarah; Mukerji, Geetha; Lowe, Julia; Ray, Joel; Evans, Marilyn; Feig, Denice S

    2014-10-01

    Women with gestational diabetes mellitus (GDM) have a high risk of future diabetes, which can be prevented with lifestyle modification. Prior diabetes prevention programmes in this population have been limited by lack of adherence. The aim of this study is to evaluate readiness for behaviour change at different time points after GDM diagnosis and identify barriers and facilitators, to inform a lifestyle modification programme specifically designed for this group. The objective of this paper is to present the rationale and methodological design of this study. The ongoing prospective cohort study has recruited a multi-ethnic cohort of 1353 women with GDM from 7 Ontario, Canada hospitals during their pregnancy. A questionnaire was developed to evaluate stage of readiness for behaviour change, and sociodemographic, psychosocial, and clinical predictors of healthy diet and physical activity. Thus far, 960 women (71%) have completed a baseline survey prior to delivery. Prospective postpartum follow-up is ongoing. We are surveying women at 2 time-points after delivery: 3-12 months postpartum, and 13-24 months postpartum. Survey data will be linked to health care administrative databases for long-term follow-up for diabetes. Qualitative interviews were conducted in a subset of women to gain a deeper understanding of barriers and facilitators to lifestyle change. Our study is a fundamental first step in effectively addressing diabetes prevention in women with GDM. Our findings will aid in the design of a diabetes prevention intervention specifically targeted to women with recent GDM, which can then be evaluated in a clinical trial. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  11. Rationale, design and methodology of the image analysis protocol for studies of patients with cerebral small vessel disease and mild stroke.

    Science.gov (United States)

    Valdés Hernández, Maria Del C; Armitage, Paul A; Thrippleton, Michael J; Chappell, Francesca; Sandeman, Elaine; Muñoz Maniega, Susana; Shuler, Kirsten; Wardlaw, Joanna M

    2015-12-01

    Cerebral small vessel disease (SVD) is common in ageing and patients with dementia and stroke. Its manifestations on magnetic resonance imaging (MRI) include white matter hyperintensities, lacunes, microbleeds, perivascular spaces, small subcortical infarcts, and brain atrophy. Many studies focus only on one of these manifestations. A protocol for the differential assessment of all these features is, therefore, needed. To identify ways of quantifying imaging markers in research of patients with SVD and operationalize the recommendations from the STandards for ReportIng Vascular changes on nEuroimaging guidelines. Here, we report the rationale, design, and methodology of a brain image analysis protocol based on our experience from observational longitudinal studies of patients with nondisabling stroke. The MRI analysis protocol is designed to provide quantitative and qualitative measures of disease evolution including: acute and old stroke lesions, lacunes, tissue loss due to stroke, perivascular spaces, microbleeds, macrohemorrhages, iron deposition in basal ganglia, substantia nigra and brain stem, brain atrophy, and white matter hyperintensities, with the latter separated into intense and less intense. Quantitative measures of tissue integrity such as diffusion fractional anisotropy, mean diffusivity, and the longitudinal relaxation time are assessed in regions of interest manually placed in anatomically and functionally relevant locations, and in others derived from feature extraction pipelines and tissue segmentation methods. Morphological changes that relate to cognitive deficits after stroke, analyzed through shape models of subcortical structures, complete the multiparametric image analysis protocol. Final outcomes include guidance for identifying ways to minimize bias and confounds in the assessment of SVD and stroke imaging biomarkers. It is intended that this information will inform the design of studies to examine the underlying pathophysiology of SVD

  12. DATA TRANSLATION BETWEEN PADS AND CAM350

    Directory of Open Access Journals (Sweden)

    E. B. Romanova

    2015-07-01

    Full Text Available The subject matter of the paper is the process of data translation between computer-aided design system for electronic devices PADS VX and system for technological preparation of production of printed circuit boards CAM350 10. The object of this study is two-way translation of data in these systems. Experimental researches are applied as research methods based on repeated playback of forward and reverse data translation process between PADS and CAM350 systems. The aim is to examine the challenges of data exchange between systems and to find out the ways of their solution. The basis of the work is functionality analysis of PADS and CAM350 systems while data translation, which was carried out in the course of operating experience of these systems. The paper presents advantages and disadvantages of translation methods and their comparison. Errors arising in the process are analyzed. Possible reasons of errors origination are described. The main results are recommendations for data exchange between PADS and CAM350 systems. The proposed recommendations give the possibility to optimize the exchange of data between these systems. Practical significance of the work lies in the implementation of results at LLC «Abeo». Recommendations have been used in the development of dozens of different electronic devices. The use of these results made it possible to reduce the production run-up time, to increase data transmission correctness, thereby improving the quality of products and reduction of their cost.

  13. Adhesive Bonding to Computer-aided Design/ Computer-aided Manufacturing Esthetic Dental Materials: An Overview.

    Science.gov (United States)

    Awad, Mohamed Moustafa; Alqahtani, H; Al-Mudahi, A; Murayshed, M S; Alrahlah, A; Bhandi, Shilpa H

    2017-07-01

    To review the adhesive bonding to different computer-aided design/computer-aided manufacturing (CAD/CAM) esthetic restorative materials. The use of CAD/CAM esthetic restorative materials has gained popularity in recent years. Several CAD/ CAM esthetic restorative materials are commercially available. Adhesive bonding is a major determinant of success of CAD/ CAM restorations. Review result: An account of the currently available bonding strategies are discussed with their rationale in various CAD/ CAM materials. Different surface treatment methods as well as adhesion promoters can be used to achieve reliable bonding of CAD/CAM restorative materials. Selection of bonding strategy to such material is determined based on its composition. Further evidence is required to evaluate the effect of new surface treatment methods, such as nonthermal atmospheric plasma and self-etching ceramic primer on bonding to different dental ceramics. An understanding of the currently available bonding strategies to CA/CAM materials can help the clinician to select the most indicated system for each category of materials.

  14. Composite hybrid cam carrier

    Energy Technology Data Exchange (ETDEWEB)

    Madin, Mark Michael; Wicks, Christopher Donald

    2017-11-21

    A cam carrier assembly includes a body made of a material lighter than aluminum. The body has a first side operably coupled with a cylinder head and a second side having bearing surfaces with bearing inserts. The bearing inserts support the camshaft. A series of apertures extend between the first and second sides of the body. Lobes of the camshaft operably couple with the valves of the cylinder head through the series of apertures extending between the first and second sides of the body.

  15. Integration of Digital Dentistry into a Predoctoral Implant Program: Program Description, Rationale, and Utilization Trends.

    Science.gov (United States)

    Afshari, Fatemeh S; Sukotjo, Cortino; Alfaro, Maria F; McCombs, Jeri; Campbell, Stephen D; Knoernschild, Kent L; Yuan, Judy Chia-Chun

    2017-08-01

    A recently revised predoctoral implant curriculum at the University of Illinois at Chicago College of Dentistry integrated digital dentistry into both the preclinical dental implant course and clinical activities. Traditionally, competence in the didactic and clinical parts of predoctoral education in single tooth implant restorations has emphasized the analog impression technique and subsequent mounting of soft tissue working casts. However, computer-aided design/computer-aided manufacturing (CAD/CAM) implant restorations can play a significant role in predoctoral dental education utilizing digital technologies. The goal of the curriculum expansion is to transition from analog to partially digital and, finally, complete digital workflow. The aim of this article is to describe the specific components, implementation, and rationale for the new digitally integrated implant curriculum and present short-term clinical utilization trends.

  16. Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF - rationale and design

    DEFF Research Database (Denmark)

    Støylen, Asbjørn; Conraads, Viviane; Halle, Martin

    2011-01-01

    interval training at high relative intensity would yield significantly larger effects in terms of left ventricular remodelling compared to moderate continuous exercise training. Study design: In a three-armed randomized multicentre study of stable heart failure patients with left ventricular ejection...... fraction =35%, the effects of a 12-week programme of high-intensity interval training (HIT; 85-90% of peak oxygen uptake, VO(2peak)) will be compared to actual practice in Europe, represented by either an isocaloric programme of moderate continuous training (MCT; 50-60% of VO(2peak)) and a recommendation......Background: The large randomized controlled multicentre clinical trial, HF-ACTION, recently demonstrated that a programme of recommendation of regular exercise training at moderate intensity is safe, improves quality of life, and reduces the combined endpoint of all-cause death and hospitalization...

  17. Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial

    DEFF Research Database (Denmark)

    Fröbert, Ole; Götberg, Matthias; Angerås, Oskar

    2017-01-01

    BACKGROUND: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following...... influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. METHODS/DESIGN: The Influenza...... vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly...

  18. Implementation of treat-to-target in rheumatoid arthritis through a Learning Collaborative: Rationale and design of the TRACTION trial.

    Science.gov (United States)

    Solomon, Daniel H; Lee, Sara B; Zak, Agnes; Corrigan, Cassandra; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie; Losina, Elena; Lu, Bing; Pincus, Ted; Radner, Helga; Smolen, Josef; Katz, Jeffrey N; Fraenkel, Liana

    2016-08-01

    Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1-9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10-18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan-do-study-act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility.

    Science.gov (United States)

    Bourque, Kevin; Cotter, Christopher; Dague, Charles; Harjes, Daniel; Dur, Onur; Duhamel, Julien; Spink, Kaitlyn; Walsh, Kelly; Burke, Edward

    2016-01-01

    The HeartMate 3 (HM3) left ventricular assist device (LVAD) is designed to support advanced heart failure patients. This centrifugal flow pump has a magnetically levitated rotor, artificial pulse, textured blood-contacting surfaces, optimized fluid dynamics, large blood-flow gaps, and low shear stress. Preclinical tests were conducted to assess hemocompatibility. A computational fluid dynamics (CFD) model guided design for low shear stress and sufficient washing. Hemolysis testing was conducted on six pumps. Plasma-free hemoglobin (PfHb) and modified index of hemolysis (MIH) were compared with HeartMate II (HMII). CFD showed secondary flow path residence times between 27 and 798 min, comparable with main flow residence times between 118 and 587 min; HM3 vs. HMII shear stress exposure above 150 Pa was 3.3 vs. 11 mm within the pump volume and 134 vs. 604 mm on surfaces. In in vitro hemolysis tests at 2, 5, and 10 L/min, average pfHb 6 hours after test initiation was 58, 74, and 157 mg/dl, compared with 112, 123, and 353 mg/dl for HMII. The HM3/HMII ratio of average MIH at 2, 5, and 10 L/min was 0.29, 0.36, and 0.22. Eight 60 day bovine implants were tested with average flow rates from 5.6 to 6.4 L/min with no device failures, thrombosis, or hemolysis. Results support advancing HM3 to clinical trials.

  20. Hydroxyurea Therapy for Children With Sickle Cell Anemia in Sub-Saharan Africa: Rationale and Design of the REACH Trial.

    Science.gov (United States)

    McGann, Patrick T; Tshilolo, Léon; Santos, Brigida; Tomlinson, George A; Stuber, Susan; Latham, Teresa; Aygun, Banu; Obaro, Stephen K; Olupot-Olupot, Peter; Williams, Thomas N; Odame, Isaac; Ware, Russell E

    2016-01-01

    Sickle cell anemia (SCA) is an inherited hematological disorder that causes a large but neglected global health burden, particularly in Africa. Hydroxyurea represents the only available disease-modifying therapy for SCA, and has proven safety and efficacy in high-resource countries. In sub-Saharan Africa, there is minimal use of hydroxyurea, due to lack of data, absence of evidence-based guidelines, and inexperience among healthcare providers. A partnership was established between investigators in North America and sub-Saharan Africa, to develop a prospective multicenter research protocol designed to provide data on the safety, feasibility, and benefits of hydroxyurea for children with SCA. The Realizing Effectiveness Across Continents with Hydroxyurea (REACH, ClinicalTrials.gov NCT01966731) trial is a prospective, phase I/II open-label dose escalation study of hydroxyurea that will treat a total of 600 children age 1-10 years with SCA: 150 at each of four different clinical sites within sub-Saharan Africa (Angola, Democratic Republic of Congo, Kenya, and Uganda). The primary study endpoint will be severe hematological toxicities that occur during the fixed-dose treatment phase. REACH has an adaptive statistical design that allows for careful assessment of toxicities to accurately identify a safe hydroxyurea dose. REACH will provide data that address critical gaps in knowledge for the treatment of SCA in sub-Saharan Africa. By developing local expertise with the use of hydroxyurea and helping to establish treatment guidelines, the REACH trial results will have the potential to transform care for children with SCA in Africa. © 2015 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

  1. Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism.

    Science.gov (United States)

    Avgerinos, Efthymios D; Mohapatra, Abhisekh; Rivera-Lebron, Belinda; Toma, Catalin; Kabrhel, Christopher; Fish, Larry; Lacomis, Joan; Ocak, Iclal; Chaer, Rabih A

    2018-01-01

    Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question. Adults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic, functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm. SUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results of our study to inform future guidelines on choice of thrombolysis modality in this population of challenging

  2. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement.

    Science.gov (United States)

    Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær; Thomsen Ernst, Martin; Fredens, Kjeld; Støckel, Jan Toftegaard; Wedderkopp, Niels; Domazet, Sidsel Louise; Gudex, Claire; Grøntved, Anders; Kristensen, Peter Lund

    2016-04-11

    Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children's PA behavior in leisure time. The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom

  3. Rationale and design of active play @ home: a parent-led physical activity program for children with and without disability.

    Science.gov (United States)

    Rubin, Daniela A; Wilson, Kathleen S; Wiersma, Lenny D; Weiss, Jie W; Rose, Debra J

    2014-02-14

    Compared to other children, those with disability have additional challenges to being physically active. Prader-Willi Syndrome is a genetic form of childhood obesity that is characterized by hypotonia, growth hormone deficiency, behavioral, and cognitive disability. In children, the low prevalence of this syndrome (1 in 10,000 to 15,000 live births) makes group-based physical activity interventions difficult. In contrast, the home environment presents a natural venue to establish a physical activity routine for this population. This manuscript describes the design of a parent-led physical activity intervention incorporating playground and interactive console-based games to increase physical activity participation in youth with and without Prader-Willi Syndrome. The study participants will be 115 youth ages 8-15 y (45 with the syndrome and 70 without the syndrome but categorized as obese). The study will use a parallel design with the control group receiving the intervention after serving as control. Participants will be expected to complete a physical activity curriculum 4 days a week for 6 months including playground games 2 days a week and interactive console games 2 days a week. Parents will be trained at baseline and then provided with a curriculum and equipment to guide their implementation of the program. Tips related to scheduling and coping with barriers to daily program implementation will be provided. Throughout, parents will be contacted by phone once a week (weeks 1-4) and then every other week to receive support in between visits. Measurements of children and parents will be obtained at baseline, 12 weeks, and at the end (week 24) of the intervention. Children main outcomes include physical activity (accelerometry), body composition (dual x-ray absorptiometry), motor proficiency (Bruininks-Oseretsky Test of Motor Proficiency), quality of life and physical activity self-efficacy (questionnaires). Intervention compliance will be monitored using mail

  4. Evaluation of primary care midwifery in the Netherlands: design and rationale of a dynamic cohort study (DELIVER

    Directory of Open Access Journals (Sweden)

    Manniën Judith

    2012-03-01

    Full Text Available Abstract Background In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care. Methods/Design Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle. These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice. Discussion In total, 7685

  5. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

    Science.gov (United States)

    Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H

    2014-09-08

    Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind

  6. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    Directory of Open Access Journals (Sweden)

    Mona Have

    2016-04-01

    Full Text Available Abstract Background Integration of physical activity (PA into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. Methods The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools’ math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF questionnaire filled out by the parents, creativity (using the Torrance Tests of Creative Thinking, TTCT, aerobic fitness (by the Andersen intermittent shuttle-run test and body mass index. PA during math lessons and total PA (including time spent outside school were assessed using accelerometry. Math teachers used Short Message Service (SMS-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children’s PA behavior in leisure time. Discussion The results of this randomized controlled trial are expected to provide schools and policy-makers with

  7. Evaluation of primary care midwifery in the Netherlands: design and rationale of a dynamic cohort study (DELIVER)

    Science.gov (United States)

    2012-01-01

    Background In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care. Methods/Design Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle). These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice. Discussion In total, 7685 clients completed at least

  8. Rationale, design, and protocol for the prevention of low back pain in the military (POLM trial (NCT00373009

    Directory of Open Access Journals (Sweden)

    Dugan Jessica L

    2007-09-01

    Full Text Available Abstract Background There are few effective strategies reported for the primary prevention of low back pain (LBP. Core stabilization exercises targeting the deep abdominal and trunk musculature and psychosocial education programs addressing patient beliefs and coping styles represent the current best evidence for secondary prevention of low back pain. However, these programs have not been widely tested to determine if they are effective at preventing the primary onset and/or severity of LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core stabilization exercise and education program is effective in preventing the onset and/or severity of LBP. The effect of the combined program will be compared to three other standard programs. Methods/Design Consecutive Soldiers participating in advanced individual training (AIT will be screened for eligibility requirements and consented to study participation, as appropriate. Companies of Soldiers will be randomly assigned to receive the following standard prevention programs; a core stabilization exercise program (CSEP alone, a CSEP with a psychosocial education (PSEP, a traditional exercise (TEP, or a TEP with a PSEP. Proximal outcome measures will be assessed at the conclusion of AIT (a 12 week training period and include imaging of deep lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness of selected deep lumbar musculature (transversus abdominus, multifidi, and erector spinae muscles. We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal outcomes of LBP occurrence and severity. This information will be collected during the subsequent 2 years following completion of AIT using a web-based data entry system

  9. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study.

    Science.gov (United States)

    Haeusler, Karl Georg; Koch, Lydia; Ueberreiter, Juliane; Endres, Matthias; Schultheiss, Heinz-Peter; Heuschmann, Peter U; Schirdewan, Alexander; Fiebach, Jochen B

    2010-07-21

    Catheter ablation of the pulmonary veins has become accepted as a standard therapeutic approach for symptomatic paroxysmal atrial fibrillation (AF). However, there is some evidence for an ablation associated (silent) stroke risk, lowering the hope to limit the stroke risk by restoration of rhythm over rate control in AF. The purpose of the prospective randomized single-center study "Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation" (MACPAF) is to compare the efficacy and safety of two balloon based pulmonary vein ablation systems in patients with symptomatic paroxysmal AF. Patients are randomized 1:1 for the Arctic Front(R) or the HD Mesh Ablator(R) catheter for left atrial catheter ablation (LACA). The predefined endpoints will be assessed by brain magnetic resonance imaging (MRI), neuro(psycho)logical tests and a subcutaneously implanted reveal recorder for AF detection. According to statistics 108 patients will be enrolled. Findings from the MACPAF trial will help to balance the benefits and risks of LACA for symptomatic paroxysmal AF. Using serial brain MRIs might help to identify patients at risk for LACA-associated cerebral thromboembolism. Potential limitations of the study are the single-center design, the existence of a variety of LACA-catheters, the missing placebo-group and the impossibility to assess the primary endpoint in a blinded fashion. clinicaltrials.gov NCT01061931.

  10. The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study.

    Science.gov (United States)

    Roberts, Matthew A; Pilmore, Helen L; Ierino, Francesco L; Badve, Sunil V; Cass, Alan; Garg, Amit X; Hawley, Carmel M; Isbel, Nicole M; Krum, Henry; Pascoe, Elaine M; Tonkin, Andrew M; Vergara, Liza A; Perkovic, Vlado

    2015-03-01

    The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study aims to determine the feasibility of a large-scale randomized controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol with placebo in patients receiving dialysis. The BLOCADE Feasibility Study is a randomized, double-blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol with placebo. Patients receiving dialysis for ≥3 months and who are aged ≥50 years, or who are ≥18 years and have diabetes or cardiovascular disease, were eligible. The primary outcome was the proportion of participants who complete a 6-week run-in phase in which all participants received carvedilol titrated from 3.125 mg twice daily to 6.25 mg twice daily. Other measures included how many patients are screened, the proportion recruited, the overall recruitment rate, the proportion of participants who remain on study drug for 12 months and the incidence of intra-dialytic hypotension while on randomized treatment. The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand. The BLOCADE Feasibility Study will inform the design of a larger clinical endpoint study to determine whether beta-blocking agents provide benefit to patients receiving dialysis, and define whether such a study is feasible. © 2014 Asian Pacific Society of Nephrology.

  11. Tolvaptan in Patients Hospitalized With Acute Heart Failure: Rationale and Design of the TACTICS and the SECRET of CHF Trials.

    Science.gov (United States)

    Felker, G Michael; Mentz, Robert J; Adams, Kirkwood F; Cole, Robert T; Egnaczyk, Gregory F; Patel, Chetan B; Fiuzat, Mona; Gregory, Douglas; Wedge, Patricia; O'Connor, Christopher M; Udelson, James E; Konstam, Marvin A

    2015-09-01

    Congestion is a primary reason for hospitalization in patients with acute heart failure (AHF). Despite inpatient diuretics and vasodilators targeting decongestion, persistent congestion is present in many AHF patients at discharge and more severe congestion is associated with increased morbidity and mortality. Moreover, hospitalized AHF patients may have renal insufficiency, hyponatremia, or an inadequate response to traditional diuretic therapy despite dose escalation. Current alternative treatment strategies to relieve congestion, such as ultrafiltration, may also result in renal dysfunction to a greater extent than medical therapy in certain AHF populations. Truly novel approaches to volume management would be advantageous to improve dyspnea and clinical outcomes while minimizing the risks of worsening renal function and electrolyte abnormalities. One effective new strategy may be utilization of aquaretic vasopressin antagonists. A member of this class, the oral vasopressin-2 receptor antagonist tolvaptan, provides benefits related to decongestion and symptom relief in AHF patients. Tolvaptan may allow for less intensification of loop diuretic therapy and a lower incidence of worsening renal function during decongestion. In this article, we summarize evidence for decongestion benefits with tolvaptan in AHF and describe the design of the Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure Study (TACTICS) and Study to Evaluate Challenging Responses to Therapy in Congestive Heart Failure (SECRET of CHF) trials. © 2015 American Heart Association, Inc.

  12. Rationale and design of the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial.

    Science.gov (United States)

    Morawski, Kyle; Ghazinouri, Roya; Krumme, Alexis; McDonough, Julianne; Durfee, Erin; Oley, Leslie; Mohta, Namita; Juusola, Jessie; Choudhry, Niteesh K

    2017-04-01

    Hypertension is a major contributor to the health and economic burden imposed by stroke, heart disease, and renal insufficiency. Antihypertensives can prevent many of the harmful effects of elevated blood pressure, but medication nonadherence is a known barrier to the effectiveness of these treatments. Smartphone-based applications that remind patients to take their medications, provide education, and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing. The MedISAFE-BP study is a prospective, randomized control trial designed to evaluate the impact on blood pressure and medication adherence of an mhealth application (Medisafe). Four hundred thirteen patients with uncontrolled hypertension have been enrolled and randomized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform. Patients will be followed up for 12 weeks and the trial's co-primary outcomes will be change in systolic blood pressure and self-reported medication adherence. The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application's effect on blood pressure and medication adherence. The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Coping effectively with heart failure (COPE-HF): design and rationale of a telephone-based coping skills intervention.

    Science.gov (United States)

    Sherwood, Andrew; O'Connor, Christopher M; Routledge, Faye S; Hinderliter, Alan L; Watkins, Lana L; Babyak, Michael A; Koch, Gary G; Adams, Kirkwood F; Dupree, Carla Sueta; Chang, Patricia P; Hoffman, Benson M; Johnson, Julie; Bowers, Margaret; Johnson, Kristy S; Blumenthal, James A

    2011-03-01

    Coping Effectively with Heart Failure (COPE-HF) is an ongoing randomized clinical trial funded by the National Institutes of Health to evaluate if a coping skills training (CST) intervention will result in improved health status and quality of life as well as reduced mortality and hospitalizations compared with a heart failure education (HFE) intervention. Two hundred heart failure (HF) patients recruited from the Duke University Medical Center and the University of North Carolina Hospital system will be randomized to a CST intervention (16 weekly 30-minute telephone counseling sessions including motivational interviewing and individually tailored cognitive behavioral therapy) or to an HFE intervention (16 weekly 30-minute telephone sessions including education and symptom monitoring). Primary outcomes will include postintervention effects on HF biomarkers (B-type natriuretic peptide, ejection fraction) and quality of life, as well as long-term clinical outcomes (hospitalizations and death). Secondary analyses will include an evaluation of treatment effects across subpopulations, and potential mechanisms by which CST may improve clinical outcomes. COPE-HF is a proof-of-concept study that should provide important insights into the health benefits of a CST intervention designed to enhance HF self-management, improve health behaviors, and reduce psychologic distress. Copyright © 2011 Elsevier Inc. All rights reserved.

  14. The rationale and design of TransCon Growth Hormone for the treatment of growth hormone deficiency

    Directory of Open Access Journals (Sweden)

    Kennett Sprogøe

    2017-10-01

    Full Text Available The fundamental challenge of developing a long-acting growth hormone (LAGH is to create a more convenient growth hormone (GH dosing profile while retaining the excellent safety, efficacy and tolerability of daily GH. With GH receptors on virtually all cells, replacement therapy should achieve the same tissue distribution and effects of daily (and endogenous GH while maintaining levels of GH and resulting IGF-1 within the physiologic range. To date, only two LAGHs have gained the approval of either the Food and Drug Administration (FDA or the European Medicines Agency (EMA; both released unmodified GH, thus presumably replicating distribution and pharmacological actions of daily GH. Other technologies have been applied to create LAGHs, including modifying GH (for example, protein enlargement or albumin binding such that the resulting analogues possess a longer half-life. Based on these approaches, nearly 20 LAGHs have reached various stages of clinical development. Although most have failed, lessons learned have guided the development of a novel LAGH. TransCon GH is a LAGH prodrug in which GH is transiently bound to an inert methoxy polyethylene glycol (mPEG carrier. It was designed to achieve the same safety, efficacy and tolerability as daily GH but with more convenient weekly dosing. In phase 2 trials of children and adults with growth hormone deficiency (GHD, similar safety, efficacy and tolerability to daily GH was shown as well as GH and IGF-1 levels within the physiologic range. These promising results support further development of TransCon GH.

  15. Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design.

    Science.gov (United States)

    Sürder, Daniel; Radrizzani, Marina; Turchetto, Lucia; Cicero, Viviana Lo; Soncin, Sabrina; Muzzarelli, Stefano; Auricchio, Angelo; Moccetti, Tiziano

    2013-08-01

    Treatment with bone marrow-derived mononuclear cells (BM-MNC) may improve left ventricular (LV) function in patients with chronic ischemic heart disease (IHD). Delivery method of the cell product may be crucial for efficacy. We aimed to demonstrate that the combination of intramyocardial and intracoronary injection of BM-MNC is safe and improves LV function in patients with chronic IHD. After a safety/feasibility phase of 10 patients, 54 patients will be randomly assigned in a 1:1:1 pattern to 1 control and 2 BM-MNC treatment groups. The control group will be treated with state-of-the-art medical management. The treatment groups will receive either exclusively intramyocardial injection or a combination of intramyocardial and intracoronary injection of autologous BM-MNC. Left ventricular function as well as scar size, transmural extension, and regional wall-motion score will be assessed by cardiac magnetic resonance imaging studies at baseline and after 6 months. The primary endpoint is the change in global LV ejection fraction by cardiac magnetic resonance from 6 months to baseline. The results, it is hoped, will have important clinical impact and provide essential information to improve the design of future regenerative-medicine protocols in cardiology. As cell delivery may play an important role in chronic IHD, we aim to demonstrate feasibility and efficacy of a combined cell-delivery approach in patients with decreased LV function. © 2013 Wiley Periodicals, Inc.

  16. A new approach to physical activity maintenance: Rationale, design, and baseline data from the Keep Active Minnesota trial

    Directory of Open Access Journals (Sweden)

    Crain A Lauren

    2008-07-01

    Full Text Available Abstract Background Since many individuals who initiate physical activity programs are highly likely to return to a sedentary lifestyle, innovative strategies to efforts to increase the number of physically active older adults who successfully maintain beneficial levels of PA for a substantial length of time are needed. Methods/Design The Keep Active Minnesota Trial is a randomized controlled trial of an interactive phone- and mail-based intervention to help 50–70 year old adults who have recently increased their physical activity level, maintain that activity level over a 24-month period in comparison to usual care. Baseline, 6, 12, and 24 month measurement occurred via phone surveys with kilocalories expended per week in total and moderate-to-vigorous physical activity (CHAMPS Questionnaire as the primary outcome measures. Secondary outcomes include hypothesized mediators of physical activity change (e.g., physical activity enjoyment, self-efficacy, physical activity self-concept, body mass index, and depression. Seven day accelerometry data were collected on a sub-sample of participants at baseline and 24-month follow-up. Discussion The Keep Active Minnesota study offers an innovative approach to the perennial problem of physical activity relapse; by focusing explicitly on physical activity maintenance, the intervention holds considerable promise for modifying the typical relapse curve. Moreover, if shown to be efficacious, the use of phone- and mail-based intervention delivery offers potential for widespread dissemination. Trial registration ClinicalTrials.gov Identifier: NCT00283452.

  17. A Cloud-Based Virtual Reality App for a Novel Telemindfulness Service: Rationale, Design and Feasibility Evaluation.

    Science.gov (United States)

    Cikajlo, Imre; Cizman Staba, Ursa; Vrhovac, Suzana; Larkin, Frances; Roddy, Mark

    2017-06-05

    Worldwide, there has been a marked increase in stress and anxiety, also among patients with traumatic brain injury (TBI). Access to psychology services is limited, with some estimates suggesting that over 50% of sufferers are not accessing the existing services available to them for reasons such as inconvenience, embarrassment, or stigmatization concerns around mental health. Health service providers have increasingly been turning to drug-free therapies, such as mindfulness programs, as complementary treatments. Virtual reality (VR) as a new delivery method for meditation-based stress and anxiety reduction therapy offers configurable environments and privacy protection. Our objective was to design a serious learning-meditation environment and to test the feasibility of the developed telemindfulness approach based on cloud technologies. We developed a cloud-based system, which consisted of a Web interface for the mindfulness instructor and remote clients, who had 3D VR headsets. The mindfulness instructor could communicate over the Web interface with the participants using the headset. Additionally, the Web app enabled group sessions in virtual rooms, 360-degree videos, and real interactions or standalone meditation. The mindfulness program was designed as an 8-week Mindfulness-Based Stress Reduction course specifically for the developed virtual environments. The program was tested with four employees and four patients with TBI. The effects were measured with psychometric tests, the Mindful Attention Awareness Scale (MAAS) and the Satisfaction With Life Scale (SWLS). Patients also carried out the Mini-Mental State Examination (MMSE). An additional objective evaluation has also been carried out by tracking head motion. Additionally, the power spectrum analyses of similar tasks between sessions were tested. The patients achieved a higher level of life satisfaction during the study (SWLS: mean 23.0, SD 1.8 vs mean 18.3, SD 3.9) and a slight increase of the MAAS score

  18. Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study

    Directory of Open Access Journals (Sweden)

    Cimminiello Claudio

    2010-08-01

    Full Text Available Abstract Background Lower extremity peripheral arterial disease (PAD is a marker of widespread atherosclerosis. Individuals with PAD, most of whom do not show typical PAD symptoms ('asymptomatic' patients, are at increased risk of cardiovascular ischaemic events. American College of Cardiology/American Heart Association guidelines recommend that individuals with asymptomatic lower extremity PAD should be identified by measurement of ankle-brachial index (ABI. However, despite its associated risk, PAD remains under-recognised by clinicians and the general population and office-based ABI detection is still poorly-known and under-used in clinical practice. The Prevalence of peripheral Arterial disease in patients with a non-high cardiovascular disease risk, with No overt vascular Diseases nOR diAbetes mellitus (PANDORA study has a primary aim of assessing the prevalence of lower extremity PAD through ABI measurement, in patients at non-high cardiovascular risk, with no overt cardiovascular diseases (including symptomatic PAD, or diabetes mellitus. Secondary objectives include documenting the prevalence and treatment of cardiovascular risk factors and the characteristics of both patients and physicians as possible determinants for PAD under-diagnosis. Methods/Design PANDORA is a non-interventional, cross-sectional, pan-European study. It includes approximately 1,000 primary care participating sites, across six European countries (Belgium, France, Greece, Italy, The Netherlands, Switzerland. Investigator and patient questionnaires will be used to collect both right and left ABI values at rest, presence of cardiovascular disease risk factors, current pharmacological treatment, and determinants for PAD under-diagnosis. Discussion The PANDORA study will provide important data to estimate the prevalence of asymptomatic PAD in a population otherwise classified at low or intermediate risk on the basis of current risk scores in a primary care setting. Trial

  19. Rationale, Design, Samples, and Baseline Sun Protection in a Randomized Trial on a Skin Cancer Prevention Intervention in Resort Environments

    Science.gov (United States)

    Buller, David B.; Andersen, Peter A.; Walkosz, Barbara J.; Scott, Michael D.; Beck, Larry; Cutter, Gary R.

    2016-01-01

    Introduction Exposure to solar ultraviolet radiation during recreation is a risk factor for skin cancer. A trial evaluating an intervention to promote advanced sun protection (sunscreen pre-application/reapplication; protective hats and clothing; use of shade) during vacations. Materials and Methods Adult visitors to hotels/resorts with outdoor recreation (i.e., vacationers) participated in a group-randomized pretest-posttest controlled quasi-experimental design in 2012–14. Hotels/resorts were pair-matched and randomly assigned to the intervention or untreated control group. Sun protection (e.g., clothing, hats, shade and sunscreen) was measured in cross-sectional samples by observation and a face-to-face intercept survey during two-day visits. Results Initially, 41 hotel/resorts (11%) participated but 4 dropped out before posttest. Hotel/resorts were diverse (employees=30 to 900; latitude=24o 78′ N to 50o 52′ N; elevation=2 ft. to 9,726 ft. above sea level), and had a variety of outdoor venues (beaches/pools, court/lawn games, golf courses, common areas, and chairlifts). At pretest, 4,347 vacationers were observed and 3,531 surveyed. More females were surveyed (61%) than observed (50%). Vacationers were mostly 35–60 years old, highly educated (college education = 68%) and non-Hispanic white (93%), with high-risk skin types (22%). Vacationers reported covering 60% of their skin with clothing. Also, 40% of vacationers used shade; 60% applied sunscreen; and 42% had been sunburned. Conclusions The trial faced challenges recruiting resorts but result show that the large, multi-state sample of vacationers were at high risk for solar UV exposure. PMID:26593781

  20. Weight management for individuals with intellectual and developmental disabilities: rationale and design for an 18 month randomized trial.

    Science.gov (United States)

    Donnelly, J E; Saunders, R R; Saunders, M; Washburn, R A; Sullivan, D K; Gibson, C A; Ptomey, L T; Goetz, J R; Honas, J J; Betts, J L; Rondon, M R; Smith, B K; Mayo, M S

    2013-09-01

    Weight management for individuals with intellectual and developmental disabilities (IDD) has received limited attention. Studies on weight management in this population have been conducted over short time frames, in small samples with inadequate statistical power, infrequently used a randomized design, and have not evaluated the use of emerging effective dietary strategies such as pre-packaged meals (PMs). Low energy/fat PMs may be useful in individuals with IDD as they simplify meal planning, limit undesirable food choices, teach appropriate portion sizes, are convenient and easy to prepare, and when combined with fruits and vegetables provide a high volume, low energy dense meal. A randomized effectiveness trial will be conducted in 150 overweight/obese adults with mild to moderate IDD, and their study partners to compare weight loss (6 months) and weight maintenance (12 months) between 2 weight management approaches: 1. A Stop Light Diet enhanced with reduced energy/fat PMs (eSLD); and 2. A recommended care reduced energy/fat meal plan diet (RC). The primary aim is to compare weight loss (0-6 months) and weight maintenance (7-18 months) between the eSLD and RC diets. Secondarily, changes in chronic disease risk factors between the eSLD and RC diets including blood pressure, glucose, insulin, LDL-cholesterol, and HDL-cholesterol will be compared during both weight loss and weight maintenance. Finally, potential mediators of weight loss including energy intake, physical activity, data recording, adherence to the diet, study partner self-efficacy and daily stress related to dietary change will be explored. © 2013. Published by Elsevier Inc. All rights reserved.

  1. Ticagrelor with aspirin or alone in high-risk patients after coronary intervention: Rationale and design of the TWILIGHT study.

    Science.gov (United States)

    Baber, Usman; Dangas, George; Cohen, David J; Gibson, C Michael; Mehta, Shamir R; Angiolillo, Dominick J; Pocock, Stuart J; Krucoff, Mitchell W; Kastrati, Adnan; Ohman, E Magnus; Steg, Philippe Gabriel; Badimon, Juan; Zafar, M Urooj; Chandrasekhar, Jaya; Sartori, Samantha; Aquino, Melissa; Mehran, Roxana

    2016-12-01

    Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT. TWILIGHT is a randomized, double-blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES. Upon enrollment after successful PCI, all patients will be treated with open label low-dose aspirin (81-100 mg daily) plus ticagrelor (90 mg twice daily) for 3 months. Event-free patients will then be randomized in a double-blind fashion to low-dose aspirin versus matching placebo with continuation of open-label ticagrelor for an additional 12 months. The primary hypothesis is that a strategy of ticagrelor monotherapy will be superior with respect to the primary endpoint of bleeding academic research consortium type 2, 3 or 5, while maintaining non-inferiority for ischemic events compared with ticagrelor plus ASA. TWILIGHT is the largest study to date that is specifically designed and powered to demonstrate reductions in bleeding with ticagrelor monotherapy versus ticagrelor plus ASA beyond 3 months post-procedure in a high-risk PCI population treated with DES. The trial will provide novel insights with respect to the potential role of ticagrelor monotherapy as an alternative for long-term platelet inhibition in a broad population of patients undergoing PCI with DES. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Studying variability in human brain aging in a population-based German cohort – Rationale and design of 1000BRAINS

    Directory of Open Access Journals (Sweden)

    Svenja eCaspers

    2014-07-01

    Full Text Available The ongoing 1000 brains study (1000BRAINS is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions & language; examination of motor skills; ratings of personality, life quality, mood & daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla of the brain. The latter includes (i 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fibre tracking and for diffusion kurtosis imaging; (iii resting-state and task-based functional MRI; and (iv fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates.

  3. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.

    Science.gov (United States)

    2009-09-01

    The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. TRA*CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least 1 year. The TRA*CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. TRA*CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.

  4. Studying variability in human brain aging in a population-based German cohort-rationale and design of 1000BRAINS.

    Science.gov (United States)

    Caspers, Svenja; Moebus, Susanne; Lux, Silke; Pundt, Noreen; Schütz, Holger; Mühleisen, Thomas W; Gras, Vincent; Eickhoff, Simon B; Romanzetti, Sandro; Stöcker, Tony; Stirnberg, Rüdiger; Kirlangic, Mehmet E; Minnerop, Martina; Pieperhoff, Peter; Mödder, Ulrich; Das, Samir; Evans, Alan C; Jöckel, Karl-Heinz; Erbel, Raimund; Cichon, Sven; Nöthen, Markus M; Sturma, Dieter; Bauer, Andreas; Jon Shah, N; Zilles, Karl; Amunts, Katrin

    2014-01-01

    The ongoing 1000 brains study (1000BRAINS) is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR) Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions and language; examination of motor skills; ratings of personality, life quality, mood and daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla) of the brain. The latter includes (i) 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii) three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fiber tracking and for diffusion kurtosis imaging; (iii) resting-state and task-based functional MRI; and (iv) fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i) comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii) identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates.

  5. A systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure: rationale, design, and baseline characteristics of BIOSTAT-CHF.

    Science.gov (United States)

    Voors, Adriaan A; Anker, Stefan D; Cleland, John G; Dickstein, Kenneth; Filippatos, Gerasimos; van der Harst, Pim; Hillege, Hans L; Lang, Chim C; Ter Maaten, Jozine M; Ng, Leong; Ponikowski, Piotr; Samani, Nilesh J; van Veldhuisen, Dirk J; Zannad, Faiz; Zwinderman, Aeilko H; Metra, Marco

    2016-06-01

    Despite major improvements in pharmacological and device treatments, heart failure remains a syndrome with high morbidity and mortality, poor quality of life, and high health-care costs. Given the extensive heterogeneity among patients with heart failure, substantial differences in the response to therapy can be expected. We hypothesize that individualized therapy is an essential next step to improve outcomes in patients with heart failure. The BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF) included 2516 patients with worsening signs and/or symptoms of heart failure from 11 European countries, who were considered to be on suboptimal medical treatment. Another 1738 patients from Scotland were included in a validation cohort. Overall, both patient cohorts were well matched. The majority of patients were hospitalized for acute heart failure, and the remainder presented with worsening signs and/or symptoms of heart failure at outpatient clinics. Approximately half of the patients were in New York Heart Association class III, and 7% vs 34% of patients of the index vs validation cohort had heart failure with preserved ejection fraction. According to study design, all patients used diuretics, but owing to the inclusion criteria of both cohorts, patients were not on optimal, evidence-based medical therapy. In the follow-up phase, uptitration to guideline-recommended doses was encouraged. By using a novel systems biology approach, incorporating demographics, biomarkers, genome-wide analysis, and proteomics, a model that predicts response to therapy will be developed, which should be instrumental in developing alternative therapies for patients with suboptimal response to currently recommended therapies and thus further improve care for patients with heart failure. © 2016 The Authors European Journal of Heart Failure © 2016 European Society of Cardiology.

  6. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  7. Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

    Science.gov (United States)

    Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

    2018-01-01

    Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Fast assessment and management of chest pain without ST-elevation in the pre-hospital gateway: rationale and design.

    Science.gov (United States)

    Ishak, Maycel; Ali, Danish; Fokkert, Marion J; Slingerland, Robbert J; Dikkeschei, Bert; Tolsma, Rudolf T; Lichtveld, Rob A; Bruins, Wendy; Boomars, René; Bruheim, Kim; van Eenennaam, Fred; Timmers, Leo; Voskuil, Michiel; Doevendans, Pieter A; Mosterd, Arend; Hoes, Arno W; ten Berg, Jurriën M; van 't Hof, Arnoud W J

    2015-04-01

    For chest pain patients without ST-segment elevation in the pre-hospital setting, current clinical guidelines merely offer in-hospital risk stratification and management, as opposed to chest pain patients with ST-segment elevation for whom there is a straightforward pre-hospital strategy for diagnosis, medication regimen and logistics. The FAMOUS TRIAGE study will assess the effects of introducing a pre-hospital triage system that reliably stratifies chest pain patients without ST-segment elevation into 1) patients at high risk for NSTEMI requiring a direct transfer to a PCI-hospital; 2) patients at intermediate risk for a major adverse cardiac event (MACE) who could be evaluated at the nearest non-PCI hospital; and 3) patients at low risk for MACE (benign non-cardiac chest pain) who could have further evaluation at home or in a primary care setting. The FAMOUS TRIAGE study will be performed in three phases. In the first phase an appropriate pre-hospital risk stratification tool will be designed for chest pain patients without ST-segment elevation by means of a retrospective and a prospective study. The second phase of the project represents the external validation of the risk stratification models, and in the third and final phase an optimal risk stratification tool will be implemented into clinical practice. Clinical and economical endpoints before and after implementation of the pre-hospital risk stratification tool will be compared to assess clinical benefit and cost-effectiveness. The FAMOUS TRIAGE project is a triple phase study that aims to optimize the pre-hospital management of chest pain patients without ST-segment elevation by providing tools for pre-hospital identification of NSTEMI or exclusion of acute coronary syndrome at home. NTR4205. Dutch Trial Register [http://www.trialregister.nl]: trial number 4205. © The European Society of Cardiology 2014.

  9. Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

    Science.gov (United States)

    Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

    2016-03-01

    Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

  10. SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity

    Directory of Open Access Journals (Sweden)

    Callahan Randi

    2008-06-01

    Full Text Available Abstract Background Although several previous projects have attempted to address the issue of child obesity through school-based interventions, the overall effectiveness of school-based programs on health-related outcomes in youth has been poor. Thus, it has been suggested that multi-level interventions that aim to influence healthy lifestyle behaviors at the community, school and family levels may prove more successful in the prevention of childhood obesity. Methods/Design This paper describes the rationale, design, and implementation of a community-, school-, and family-based intervention aimed at modifying key behaviors (physical activity, screen time (Internet, television, video games, and nutrition related to childhood obesity among third through fifth graders in two mid-western cities. The intervention involves a randomized study of 10 schools (5 intervention and 5 control schools. The intervention is being conducted during the duration of the academic year – approximately 9 months – and includes baseline and post-intervention measurements of physical activity, dietary intake, screen time and body composition. Discussion We hope this report will be useful to researchers, public health professionals, and school administrators and health professionals (nurses and physical/health educators seeking to develop similar prevention programs. It is obvious that more collaborative, inter-disciplinary, multi-level work is needed before a proven, effective intervention package to modify behaviors related to childhood obesity can be generally recommended. It is our hope that SWITCH is a step in that direction. Trial Registration ClinicalTrials.gov NCT00685555

  11. Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Cyrus Cooper

    2013-01-01

    Full Text Available Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trialsreport that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describethe rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.Research design, methods, and results: This double-blind, placebo-controlled trial (98 centres, 18 countries includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibiofemoralcompartment (Kellgren and Lawrence grade 2 or 3, joint space width (JSW 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale. Patients are randomly allocated to three groups (strontium ranelate 1 or 2g/day, or placebo. Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ±10% between-group difference in change in JSW over 3 years. Recruitment started in April 2006. The results are expected in spring 2012.Clinical trial registration: The trial is registered on www.controlled-trials.com (number ISRCTN41323372.Conclusions: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.

  12. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods.

    Science.gov (United States)

    Bugge, Anna; Tarp, Jakob; Østergaard, Lars; Domazet, Sidsel Louise; Andersen, Lars Bo; Froberg, Karsten

    2014-09-18

    The aim of the study; LCoMotion - Learning, Cognition and Motion was to develop, document, and evaluate a multi-component physical activity (PA) intervention in public schools in Denmark. The primary outcome was cognitive function. Secondary outcomes were academic skills, body composition, aerobic fitness and PA. The primary aim of the present paper was to describe the rationale, design and methods of the LCoMotion study. LCoMotion was designed as a cluster-randomized controlled study. Fourteen schools from all five regions in Denmark participated. All students from 6th and 7th grades were invited to participate (n = 869) and consent was obtained for 87% (n = 759). Baseline measurements were obtained in November/December 2013 and follow-up measurements in May/June 2014. The intervention lasted five months and consisted of a "package" of three main components: PA during academic lessons, PA during recess and PA homework. Furthermore a cycling campaign was conducted during the intervention period. Intervention schools should endeavor to ensure that students were physically active for at least 60 min every school day. Cognitive function was measured by a modified Eriksen flanker task and academic skills by a custom made mathematics test. PA was objectively measured by accelerometers (ActiGraph, GT3X and GT3X+) and aerobic fitness assessed by an intermittent shuttle-run test (the Andersen intermittent running test). Furthermore, compliance with the intervention was assessed by short message service (SMS)-tracking and questionnaires were delivered to students, parents and teachers. LCoMotion has ability to provide new insights on the effectiveness of a multicomponent intervention on cognitive function and academic skills in 6th and 7th grade students. Clinicaltrials.gov: NCT02012881 (10/10/2013).

  13. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

    Science.gov (United States)

    Thilly, Nathalie; Chanliau, Jacques; Frimat, Luc; Combe, Christian; Merville, Pierre; Chauveau, Philippe; Bataille, Pierre; Azar, Raymond; Laplaud, David; Noël, Christian; Kessler, Michèle

    2017-04-05

    Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14

  14. Efficacy of LOw-dose DObutamine stress-echocardiography to predict cardiac resynchronization therapy response (LODO-CRT) multicenter prospective study: design and rationale.

    Science.gov (United States)

    Muto, Carmine; Gasparini, Maurizio; Iacopino, Saverio; Peraldo, Carlo; Curnis, Antonio; Sassone, Biagio; Diotallevi, Paolo; Davinelli, Mario; Valsecchi, Sergio; Tuccillo, Bernardino

    2008-10-01

    Although cardiac resynchronization therapy (CRT) has a well-demonstrated therapeutic effect in selected patients with advanced heart failure on optimized drug therapy, nonresponder rate remains high. The LODO-CRT is designed to improve patient selection for CRT. Design and rationale of this study are presented herein. LODO-CRT is a multicenter prospective study, started in late 2006, that enrolls patients with conventional indications for CRT (symptomatic stable New York Heart Association class III-IV on optimized drug therapy, QRS > or =120 milliseconds, left ventricular [LV] dilatation, LV ejection fraction 5 units), in predicting CRT response during follow-up. Assessment of CRT effects will follow 2 sequential phases: in phase 1, CRT response end point is defined as LV end-systolic volume reduction > or =10% at 6 months; in phase 2, both LV end-systolic volume reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 (with 95% confidence, 80% power, alpha LODO-CRT trial is testing the hypothesis that LVCR assessment, using low-dose dobutamine stress echocardiography test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.

  15. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion

    Directory of Open Access Journals (Sweden)

    Reid Christopher M

    2012-02-01

    Full Text Available Abstract Background This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH lesions and silent brain infarction (SBI. Additional aims include determining whether a changes in retinal vascular imaging (RVI parameters parallel changes in brain magnetic resonance imaging (MRI; b changes in RVI parameters are observed with aspirin therapy; c baseline cognitive function correlates with MRI and RVI parameters; d changes in cognitive function correlate with changes in brain MRI and RVI and e whether factors such as age, gender or blood pressure influence the above associations. Methods/Design Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis. Discussion This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline. Trial Registration clinicaltrials.gov Identifier: NCT01038583

  16. Neurobiological mechanisms of exercise and psychotherapy in depression: The SPeED study-Rationale, design, and methodological issues.

    Science.gov (United States)

    Heinzel, Stephan; Rapp, Michael A; Fydrich, Thomas; Ströhle, Andreas; Terán, Christina; Kallies, Gunnar; Schwefel, Melanie; Heissel, Andreas

    2018-02-01

    ), (neuro)biological measures (neural activations during working memory, monetary incentive delay task, and emotion regulation, as well as cortisol levels and brain-derived neurotrophic factor), neuropsychological test performance, and questionnaires (psychological needs, self-efficacy, and quality of life) are assessed. In this article, we report the design of the SPeED study and refer to important methodological issues such as including both high- and low-intensity endurance exercise groups to allow the investigation of dose-response effects and physiological components of the therapy effects. The main aims of this research project are to study effects of endurance exercise and cognitive behavioral therapy on depressive symptoms and to investigate underlying physiological and neurobiological mechanisms of these effects. Results may provide important implications for the development of effective treatment strategies in major depressive disorder, specifically concerning the augmentation of cognitive behavioral therapy by endurance exercise.

  17. EpCAM in morphogenesis

    NARCIS (Netherlands)

    Trzpis, Monika; Bremer, Edwin; McLaughlin, Pamela M. J.; de Leij, Lou F. M. H.; Harmsen, Martin C.

    Embryonic development is one of the most complex biological phenomena that involves the appropriate expression and synchronized interactions of a plethora of proteins, including cell adhesion molecules (CAMs). Many members of the diverse family of CAMs have been shown to be critically involved in

  18. Optimisation Methods for Cam Mechanisms

    Directory of Open Access Journals (Sweden)

    Claudia–Mari Popa

    2010-01-01

    Full Text Available In this paper we present the criteria which represent the base of optimizing the cam mechanisms and also we perform the calculations for several types of mechanisms. We study the influence of the constructive parameters in case of the simple machines with rotation cam and follower (flat or curve of translation on the curvature radius and that of the transmission angle. As it follows, we present the optimization calculations of the cam and flat rotation follower mechanisms, as well as the calculations for optimizing the cam mechanisms by circular groove followers’ help. For an easier interpretation of the results, we have visualized the obtained cam in AutoCAD according to the script files generated by a calculation program.

  19. A CAD/CAM designed, semi-fixed, high strength, all-ceramic prosthesis for maxillary rehabilitation--a case report.

    Science.gov (United States)

    Bhakta, Shashwat; Deakin, Karl; Joshi, Rajendra

    2014-01-01

    The clinical and laboratory steps involved in rehabilitating the maxillary arch following the loss of several teeth due to periodontal disease are outlined in this case report. This article illustrates the use of a laboratory based CAD/CAM system (Sirona In-Lab) and a copy milling technique in the fabrication of a fixed-movable bridge, high strength, all-ceramic, cross-arch bridge. Adopting a semi-fixed approach in cross-arch rehabilitation has conventionally involved the use of porcelain fused to metal (PFM) components but the demands placed by patients and clinicians have led to the development of novel techniques in order to achieve highly aesthetic and functional results.

  20. Endoscopic totally extraperitoneal (TEP) hernia repair for inguinal disruption (Sportsman's hernia): rationale and design of a prospective observational cohort study (TEP-ID-study).

    Science.gov (United States)

    Voorbrood, C E H; Goedhart, E; Verleisdonk, E J M M; Sanders, F; Naafs, D; Burgmans, J P J

    2016-01-06

    Chronic inguinal pain is a frequently occurring problem in athletes. A diagnosis of inguinal disruption is performed by exclusion of other conditions causing groin pain. Up to now, conservative medical management is considered to be the primary treatment for this condition. Relevant large and prospective clinical studies regarding the treatment of inguinal disruption are limited; however, recent studies have shown the benefits of the totally extraperitoneal patch (TEP) technique.This study provides a complete assessment of the inguinal area in athletes with chronic inguinal pain before and after treatment with the TEP hernia repair technique. We describe the rationale and design of an observational cohort study for surgical treatment with the endoscopic TEP hernia repair technique in athletes with a painful groin (inguinal disruption).The study is being conducted in a high-volume, single centre hospital with specialty in TEP hernia repair. Patients over 18 years, suffering from inguinal pain for at least 3 months during or after playing sports, and whom have not undergone previous inguinal surgery and have received no benefit from physiotherapy are eligible for inclusion. Patients with any another cause of inguinal pain, proven by physical examination, inguinal ultrasound, X-pelvis/hip or MRI are excluded.Primary outcome is reduction in pain after 3 months. Secondary outcomes are pain reduction, physical functioning, and resumption of sport (in frequency and intensity). An unrestricted research grant for general study purposes was assigned to the Hernia Centre. This study itself is not directly subject to the above mentioned research grant or any other financial sponsorship. We intend to publish the outcome of the study, regardless of the findings. All authors will give final approval of the manuscript version to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion).

    Science.gov (United States)

    Reid, Christopher M; Storey, Elsdon; Wong, Tien Y; Woods, Robyn; Tonkin, Andrew; Wang, Jie Jin; Kam, Anthony; Janke, Andrew; Essex, Rowan; Abhayaratna, Walter P; Budge, Marc M

    2012-02-08

    This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH) lesions and silent brain infarction (SBI). Additional aims include determining whether a) changes in retinal vascular imaging (RVI) parameters parallel changes in brain magnetic resonance imaging (MRI); b) changes in RVI parameters are observed with aspirin therapy; c) baseline cognitive function correlates with MRI and RVI parameters; d) changes in cognitive function correlate with changes in brain MRI and RVI and e) whether factors such as age, gender or blood pressure influence the above associations. Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis. This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline. clinicaltrials.gov Identifier: NCT01038583.

  2. Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica.

    Science.gov (United States)

    Gonzalez, Paula; Hildesheim, Allan; Herrero, Rolando; Katki, Hormuzd; Wacholder, Sholom; Porras, Carolina; Safaeian, Mahboobeh; Jimenez, Silvia; Darragh, Teresa M; Cortes, Bernal; Befano, Brian; Schiffman, Mark; Carvajal, Loreto; Palefsky, Joel; Schiller, John; Ocampo, Rebeca; Schussler, John; Lowy, Douglas; Guillen, Diego; Stoler, Mark H; Quint, Wim; Morales, Jorge; Avila, Carlos; Rodriguez, Ana Cecilia; Kreimer, Aimée R

    2015-04-27

    The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routine vaccination was enrolled, and will be followed by cervical cancer screening over 6 years. To form the UCG, 5000 women were selected from a local census, of whom 2836 women (61% of eligible women) agreed to participate. Over 90% of participants complied with an interview, blood and cervical specimen collection. Evaluation of comparability between the original (Hepatitis-A arm of CVT) and new (UCG) control groups showed that women's characteristics, as well as their predicted future risk for cervical HPV acquisition, were similar, thus validating use of the UCG. LTFU is poised to comprehensively address many important questions related to long-term effects of prophylactic HPV vaccines. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Study design, rationale and methods for a population-based study of myopia in schoolchildren: the Myopia Investigation study in Taipei.

    Science.gov (United States)

    Tsai, Der-Chong; Lin, Li-Ju; Huang, Nicole; Hsu, Chih-Chien; Chen, Shing-Yi; Chiu, Allen Wen-Hsiang; Liu, Catherine Jui-Ling

    2015-01-01

    To describe the study design, rationale and methodology of the Myopia Investigation Study in Taipei (MIT). The MIT was a city-wide, population-based cohort study. Participants were grade 2 students (Fall 2013) of all 153 elementary schools in Taipei City. The baseline data on the risk factors for myopia development was collected by parent-administered questionnaire surveys covering demographics, medical history, parental myopia, time spent on near work and outdoor activities, reading habits and eye care-seeking behaviour. Ocular examinations focused on the measurement of visual acuity (unaided and best-corrected) and refractive status (before and after cycloplegia), which will be carried out for the eligible schoolchildren biannually for 3 years consecutively. Once myopic children are identified, case manager-led telecoaching for health-care instructions and reminders will be delivered to parents or caregivers. To build a comprehensive database for prevalence, incidence and risk factors of early childhood myopia over a 3-year follow-up period. Of all 19 374 eight-year-old schoolchildren (10 210 [52.7%] boys) eligible for the MIT, 16 486 (85.1%) responded to the questionnaire, 12 019 (62.0%) were examined during the third quarter of 2013 and 11 590 (59.8%) (6267 [52.9%] boys) completed cycloplegic autorefraction on both eyes and were enrolled for further data analysis. There was no significant difference in terms of demographics between the analysed participants and all grade 2 students in Taipei City. Data from the MIT will provide population-based information concerning the prevalence, incidence and risk factors for myopia development among young schoolchildren in a metropolitan area of Taiwan. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

  4. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods.

    Science.gov (United States)

    Apers, Silke; Kovacs, Adrienne H; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M; Jackson, Jamie L; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip

    2015-01-20

    Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research methods. The APPROACH-IS consortium (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study) was created for this purpose and investigates PROs in adults with CHD worldwide. This paper outlines the project rationale, design, and methods. APPROACH-IS is a cross-sectional study. The goal is to recruit 3500-4000 adults with CHD from 15 countries in five major regions of the world (Asia, Australia, Europe, North and South America). Self-report questionnaires are administered to capture information on PRO domains: (i) perceived health status (12-item Short-form Health Survey & EuroQOL-5D); (ii) psychological functioning (Hospital Anxiety and Depression Scale); (iii) health behaviors (Health-Behavior Scale-Congenital Heart Disease); and (iv) quality of life (Linear Analog Scale & Satisfaction With Life Scale). Additionally, potential explanatory variables are assessed: (i) socio-demographic variables; (ii) medical history (chart review); (iii) sense of coherence (Orientation to Life Questionnaire); and (iv) illness perceptions (Brief Illness Perception Questionnaire). Descriptive analyses and multilevel models will examine differences in PROs and investigate potential explanatory variables. APPROACH-IS represents a global effort to increase research understanding and capacity in the field of CHD, and will have major implications for patient care. Results will generate valuable information for developing interventions to optimize patients' health and well-being. ClinicalTrials.gov: NCT02150603. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Rationale, design and baseline data for the Activating Consumers to Exercise through Peer Support (ACE trial): A randomized controlled trial to increase fitness among adults with mental illness

    Science.gov (United States)

    Jerome, Gerald J.; Dalcin, Arlene T.; Young, Deborah Rohm; Stewart, Kerry J.; Crum, Rosa M.; Latkin, Carl; Cullen, Bernadette A.; Charleston, Jeanne; Leatherman, Elisabeth; Appel, Lawrence J.; Daumit, Gail L.

    2012-01-01

    Background The benefits of regular physical activity are particularly salient to persons with serious mental illness (SMI) who have increased prevalence of obesity, diabetes, and earlier mortality from cardiovascular disease. Methods The Activating Consumers to Exercise through Peer Support (ACE) trial will examine the effectiveness of peer support on adherence to a 4-month pilot exercise program for adults with SMI. Design, rationale and baseline data are reported. Baseline measures included: graded treadmill test; six-minute walk; height, weight and blood pressure; body composition; fasting blood; and self-reported psychiatric symptoms. Fitness levels were compared with national data and relationships among fitness parameters, psychological factors and cardiovascular disease risk factors were examined. Results There were 93 participants and 18 peer leaders recruited from community psychiatry programs with an average age of 47 years (SD 10). There were no differences in demographics (76% female, 72% African American) or mental health symptoms between participants and peer leaders. Ninety-five percent of the sample had below average fitness levels for their age and sex with average MET levels of 5.9(SD 2.2) for participants and 6.2(SD 2.3) for peer leaders. Fitness evaluated during the treadmill test and the six-minute-walk were associated (rs = 0.36, p<.001). Lower MET levels were associated with a higher BMI (rs = −0.35, p<.001) and percent body fat (rs = −0.36, p <.001). Conclusion The uniformly low baseline cardiovascular fitness and the association of fitness with BMI and adiposity underscore the importance of suitably tailored programs to increase physical activity among adults with SMI. PMID:23471190

  6. Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

    Science.gov (United States)

    Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

    2015-10-09

    The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

  7. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison.

    Science.gov (United States)

    Cury, Ricardo C; Kitt, Therese M; Feaheny, Kathleen; Akin, Jamie; George, Richard T

    2014-01-01

    Pharmacologic stress myocardial CT perfusion (CTP) has been reported to be a viable imaging modality for detection of myocardial ischemia compared with single-photon emission CT (SPECT) in several single-center studies. However, regadenoson-stress CTP has not previously been compared with SPECT in a multicenter, multivendor study. The rationale and design of a phase 2, randomized, cross-over study of regadenoson-stress myocardial perfusion imaging by CTP compared with SPECT are described herein. The study will be conducted at approximately 25 sites by using 6 different CT scanner models, including 64-, 128-, 256-, and 320-slice systems. Subjects with known/suspected coronary artery disease will be randomly assigned to 1 of 2 imaging procedure sequences; rest and regadenoson-stress SPECT on day 1, then regadenoson-stress CTP and rest CTP/coronary CT angiography (same acquisition) on day 2; or regadenoson-stress CTP and rest CTP/CT angiography on day 1, then rest and regadenoson-stress SPECT on day 2. The prespecified primary analysis examines the agreement rate between CTP and SPECT for detecting or excluding ischemia (≥2 or 0-1 reversible defects, respectively), as assessed by 3 independent blinded readers for each modality. Non-inferiority will be indicated if the lower boundary of the 95% CI for the agreement rate is within 0.15 of 0.78 (the observed agreement rate in the regadenoson pivotal trials). The protocol described herein will support the first evaluation of regadenoson-stress CTP by using multiple scanner types compared with SPECT. Copyright © 2014 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  8. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica.

    Science.gov (United States)

    Herrero, Rolando; Hildesheim, Allan; Rodríguez, Ana C; Wacholder, Sholom; Bratti, Concepción; Solomon, Diane; González, Paula; Porras, Carolina; Jiménez, Silvia; Guillen, Diego; Morales, Jorge; Alfaro, Mario; Cyr, Jean; Morrisey, Kerrygrace; Estrada, Yenory; Cortés, Bernal; Morera, Lidia Ana; Freer, Enrique; Schussler, John; Schiller, John; Lowy, Douglas; Schiffman, Mark

    2008-09-02

    We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.

  9. Circle of life: rationale, design, and baseline results of an HIV prevention intervention among young American Indian adolescents of the Northern Plains.

    Science.gov (United States)

    Kaufman, Carol E; Mitchell, Christina M; Beals, Janette; Desserich, Jennifer A; Wheeler, Cindy; Keane, Ellen M; Whitesell, Nancy Rumbaugh; Sam, Angela; Sedey, Cory

    2010-03-01

    In spite of significant disparities in sexual health outcomes for American Indian youth, no studies exist examining the effectiveness of HIV-prevention interventions. Circle of Life is an HIV-prevention intervention specifically developed for American Indian middle-school youth. We describe the rationale, methodology, and baseline results of a longitudinal randomized trial of Circle of Life conducted among American Indian youth aged 11-15 in a reservation community. The innovative design includes two pre-intervention waves to determine patterns of behavior prior to the intervention that might be associated with a differential impact of the intervention on sexual risk. We used one-way analysis of variance and chi-square tests to test for significant differences between randomized group assignment at each baseline wave and generalized estimating equations (GEE) to test significant differences in the rate of change in outcomes by group longitudinally. We present the collaborative and adaptive strategies for consenting, assenting, and data collection methodology in this community. Achieved response rates are comparable to other similar studies. Results from the two baseline waves indicate that few outcomes significantly varied by randomized intervention assignment. Ten percent of youth reported having had sex at Wave 1, rising to 15% at Wave 2. Among those who had had sex, the majority (>70%) reported using a condom at last sex. The project is well positioned to carry out the longitudinal assessments of the intervention to determine the overall impact of the Circle of Life and the differential impact by pre-intervention patterns of behavior across youth.

  10. The Study of Cardiovascular Risk in Adolescents--ERICA: rationale, design and sample characteristics of a national survey examining cardiovascular risk factor profile in Brazilian adolescents.

    Science.gov (United States)

    Bloch, Katia Vergetti; Szklo, Moyses; Kuschnir, Maria Cristina C; Abreu, Gabriela de Azevedo; Barufaldi, Laura Augusta; Klein, Carlos Henrique; de Vasconcelos, Maurício T L; da Veiga, Glória Valéria; Figueiredo, Valeska C; Dias, Adriano; Moraes, Ana Julia Pantoja; Souza, Ana Luiza Lima; de Oliveira, Ana Mayra Andrade; Schaan, Beatriz D'Argord; Tavares, Bruno Mendes; de Oliveira, Cecília Lacroix; Cunha, Cristiane de Freitas; Giannini, Denise Tavares; Belfort, Dilson Rodrigues; Ribas, Dulce Lopes Barboza; Santos, Eduardo Lima; de Leon, Elisa Brosina; Fujimori, Elizabeth; Oliveira, Elizabete Regina Araújo; Magliano, Erika da Silva; Vasconcelos, Francisco de Assis Guedes; Azevedo, George Dantas; Brunken, Gisela Soares; Dias, Glauber Monteiro; Filho, Heleno R Correa; Monteiro, Maria Inês; Guimarães, Isabel Cristina Britto; Faria Neto, José Rocha; Oliveira, Juliana Souza; de Carvalho, Kenia Mara B; Gonçalves, Luis Gonzaga de Oliveira; Santos, Marize M; Muniz, Pascoal Torres; Jardim, Paulo César B Veiga; Ferreira, Pedro Antônio Muniz; Montenegro, Renan Magalhães; Gurgel, Ricardo Queiroz; Vianna, Rodrigo Pinheiro; Vasconcelos, Sandra Mary; da Matta, Sandro Silva; Martins, Stella Maris Seixas; Goldberg, Tamara Beres Lederer; da Silva, Thiago Luiz Nogueira

    2015-02-07

    The Study of Cardiovascular Risk in Adolescents (Portuguese acronym, "ERICA") is a multicenter, school-based country-wide cross-sectional study funded by the Brazilian Ministry of Health, which aims at estimating the prevalence of cardiovascular risk factors, including those included in the definition of the metabolic syndrome, in a random sample of adolescents aged 12 to 17 years in Brazilian cities with more than 100,000 inhabitants. Approximately 85,000 students were assessed in public and private schools. Brazil is a continental country with a heterogeneous population of 190 million living in its five main geographic regions (North, Northeast, Midwest, South and Southeast). ERICA is a pioneering study that will assess the prevalence rates of cardiovascular risk factors in Brazilian adolescents using a sample with national and regional representativeness. This paper describes the rationale, design and procedures of ERICA. Participants answered a self-administered questionnaire using an electronic device, in order to obtain information on demographic and lifestyle characteristics, including physical activity, smoking, alcohol intake, sleeping hours, common mental disorders and reproductive and oral health. Dietary intake was assessed using a 24-hour dietary recall. Anthropometric measures (weight, height and waist circumference) and blood pressure were also be measured. Blood was collected from a subsample of approximately 44,000 adolescents for measurements of fasting glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, glycated hemoglobin and fasting insulin. The study findings will be instrumental to the development of public policies aiming at the prevention of obesity, atherosclerotic diseases and diabetes in an adolescent population.

  11. The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: design, rationale, and characteristics of patients enrolled in the first 12 months.

    Science.gov (United States)

    Beukelman, Timothy; Kimura, Yukiko; Ilowite, Norman T; Mieszkalski, Kelly; Natter, Marc D; Burrell, Grendel; Best, Brian; Jones, Jason; Schanberg, Laura E

    2017-04-17

    Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12 months of operation. The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6 months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10 years for each participant and is facilitated by a telephone call center. As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4 years old and median disease duration was 2.6 years. Owing to preferential enrollment, patients with systemic JIA (13%) and with a polyarticular course (75%) were over-represented compared to patients in typical clinical practice. Approximately 49% were currently using biologic agents and ever use of oral glucocorticoids was common (47%). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12 months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.

  12. Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial.

    Science.gov (United States)

    Napolitano, Melissa A; Whiteley, Jessica A; Mavredes, Meghan N; Faro, Jamie; DiPietro, Loretta; Hayman, Laura L; Neighbors, Charles J; Simmens, Samuel

    2017-09-01

    The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912. Copyright © 2017. Published by Elsevier Inc.

  13. A school-based intervention to promote physical activity among adolescent girls: rationale, design, and baseline data from the Girls in Sport group randomised controlled trial.

    Science.gov (United States)

    Okely, Anthony D; Cotton, Wayne G; Lubans, David R; Morgan, Philip J; Puglisi, Lauren; Miller, Judy; Wright, Jan; Batterham, Marijka J; Peralta, Louisa R; Perry, Janine

    2011-08-19

    Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA) among adolescent girls. A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the primary objective (preventing the decline in accelerometer-derived MVPA). Academic partners and the State Department of Education and Training act as critical friends. Control schools continue with their usual school programming. 24 schools were matched then randomized into intervention (n = 12) and control (n = 12) groups. A total of 1518 girls (771 intervention and 747 control) completed baseline assessments (86% response rate). Useable accelerometer data (≥ 10 hrs/day on at least 3 days) were obtained from 79% of this sample (n = 1199). Randomisation resulted in no differences between intervention and control groups on any of the outcomes. The mean age (SE) of the sample was 13.6 (± 0.02) years and they spent less than 5% of their waking hours in MVPA (4.85 ± 0.06). Girls in Sport will test the effectiveness of schools working towards the same goal, but developing individual, targeted interventions that bring about changes in curriculum, school environment and policy, and community links. By using community-based participatory research and an action learning framework in a secondary school setting, it aims to add to the body of literature on effective school-based interventions through promoting and sustaining increased physical

  14. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain.

    Science.gov (United States)

    Hausmann, Leslie R M; Ibrahim, Said A; Kwoh, C Kent; Youk, Ada; Obrosky, D Scott; Weiner, Debra K; Vina, Ernest; Gallagher, Rollin M; Mauro, Genna T; Parks, Acacia

    2018-01-01

    Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management. Activities to cultivate positive psychological skills have been developed and validated; however, they have not been tested in patients with osteoarthritis, their effects on racial differences in health outcomes have not been examined, and evidence of their effects on health outcomes in patients with other chronic illnesses is of limited quality. In this article we describe the rationale and design of Staying Positive with Arthritis (SPA) study, a randomized controlled trial in which 180 African American and 180 White primary care patients with chronic pain from knee osteoarthritis will be randomized to a 6-week program of either positive skill-building activities or neutral control activities. The primary outcomes will be self-reported pain and functioning as measured by the WOMAC Osteoarthritis Index. We will assess these primary outcomes and potential, exploratory psychosocial mediating variables at an in-person baseline visit and by telephone at 1, 3, and 6months following completion of the assigned program. If effective, the SPA program would be a novel, theoretically-informed psychosocial intervention to improve quality and equity of care in the management of chronic pain from osteoarthritis. Published by Elsevier Inc.

  15. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica

    Science.gov (United States)

    Herrero, Rolando; Hildesheim, Allan; Rodríguez, Ana C; Wacholder, Sholom; Bratti, Concepción; Solomon, Diane; González, Paula; Porras, Carolina; Jiménez, Silvia; Guillen, Diego; Morales, Jorge; Alfaro, Mario; Cyr, Jean; Morrisey, Kerrygrace; Estrada, Yenory; Cortés, Bernal; Morera, Lidia Ana; Freer, Enrique; Schussler, John; Schiller, John; Lowy, Douglas; Schiffman, Mark

    2008-01-01

    We report the rationale, design, methods and details of participation of a community-based, double blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7,466 women (30% of those prescreened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and Gonorrhea testing. Eighty percent of the women received 3 doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self-collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant. PMID:18640170

  16. Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

    Science.gov (United States)

    Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

    2014-11-01

    Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anna-Carlotta Zarski

    2018-01-01

    Full Text Available IntroductionGenito-pelvic pain/penetration disorder (GPPPD not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD.MethodTwo hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG or a 6-month waitlist control group. Assessments take place at baseline (T1, peritreatment after completion of Session 5 in IG (T2, after completion of Session 8 or 12 weeks after randomization (T3, and after 6 months (T4. Data will be analyzed on an intention-to-treat and a completer basis.Main outcome measuresThe primary outcome will be sexual intercourse involving the insertion of the partner’s penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1 and investigated as a potential moderator of the primary treatment outcome.DiscussionGiven the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap.Clinical Trial RegistrationGerman Register of Clinical Studies (DRKS

  18. Rad Pole Cam Development

    Energy Technology Data Exchange (ETDEWEB)

    Heckendorn, F. M.; Odell, D. M. C; Harpring, L. J.; Peterson, K. D.

    2005-10-05

    The RadPoleCam was developed to provide Department Of Energy (DOE) first responders the capability to assess the radiological and visual condition of remote or inaccessible locations. Real time gamma isotopic identification is provided to the first responder in the form of audio feedback (i.e. spoken through head phones) from a gamma detector mounted on a collapsible pole that can extend from 1 to 9 meters (6 to 29 feet). Simultaneously, selectable direct and side looking visual images are provided from the 5cm (2in) diameter, waterproof probe tip. The lightweight, self contained, ruggedized, system will provide a rapidly deployable field system for visual and radiological search and assessment of confined spaces and extended reach locations.

  19. Rationale for designing cavity preparations.

    Science.gov (United States)

    Laswell, H R; Welk, D A

    1985-04-01

    Increased resistance to caries, increased dental awareness, superior diagnostic capabilities, better illumination, optical aids that significantly enhance vision, improved and standardized materials for restoration, and a deeper understanding of the caries process enable a far more conservative approach to tooth preparation. The dentist can concentrate on preserving as much sound tooth structure as possible with less attention being devoted to resistance and retention form that previously demanded in bulk restorations and massive channels and locks that are no longer appropriate. Although caries inhibitory effects have been shown with materials such as silicate cement, glass ionomers, and resins that leach fluoride, in general, dentists should not rely on restorative materials to inhibit the development of future decay. Characteristics of the carious lesion are unique for each tooth according to many factors centering around the plaque pattern for that tooth and not according to zones of natural susceptibility or immunity strictly dictated by morphology. Therefore, no single cavity preparation duplicated from a textbook is likely to be satisfactory for an individual tooth. Furthermore, novices learning the subject of cavity preparation often leave decalcified enamel when they attempt to replicate under clinical conditions that which they have learned in technique courses. This is the major invitation to future caries reappearing adjacent to restorations. Also, failure to duplicate the exact morphology of the tooth surface that has been replaced is likely to alter the pattern of plaque accumulation and create other caries prone areas.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Rationale and design of XAMOS

    DEFF Research Database (Denmark)

    Turpie, Alexander G G; Schmidt, André C; Kreutz, Reinhold

    2012-01-01

    , noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects) and effectiveness (prevention of symptomatic thromboembolic events) of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after major orthopedic surgery in approximately 200 centers...

  1. Rationale and design of ARTS

    DEFF Research Database (Denmark)

    Pitt, Bertram; Filippatos, Gerasimos; Gheorghiade, Mihai

    2012-01-01

    AIMS: BAY 94-8862 is a novel, non-steroidal, mineralocorticoid receptor antagonist with greater selectivity than spironolactone and stronger mineralocorticoid receptor binding affinity than eplerenone. The aims of the MinerAlocorticoid Receptor Antagonist Tolerability Study (ARTS; NCT01345656......) are to evaluate the safety and tolerability of BAY 94-8862 in patients with heart failure associated with a reduced left ventricular ejection fraction (HFREF) and chronic kidney disease (CKD), and to examine the effects on biomarkers of cardiac and renal function. Methods ARTS is a multicentre, randomized, double....... placebo (primary endpoint) and vs. spironolactone, safety and tolerability, biomarkers of cardiac and renal function or injury, eGFR, and albuminuria. BAY 94-8862 pharmacokinetics are also assessed. Perspectives ARTS is the first phase II clinical trial of BAY 94-8862 and is expected to provide a wealth...

  2. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design

    Directory of Open Access Journals (Sweden)

    Cho Alex H

    2012-01-01

    Full Text Available Abstract Background Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Methods/Design Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm, or the SRA alone ("SRA" arm. Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm. Risk counseling is provided by clinic staff (not study staff external to the clinic. Fasting plasma glucose, insulin levels, body mass index (BMI, and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. Discussion The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk

  3. First-line antihypertensive treatment in patients with pre-diabetes: Rationale, design and baseline results of the ADaPT investigation

    Directory of Open Access Journals (Sweden)

    Bramlage Peter

    2008-07-01

    Full Text Available Abstract Background Recent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents. Therefore the role of these agents in preventing diabetes is still not well defined. Ramipril is an ACE inhibitor (ACEi, that has been shown to reduce cardiovascular events in high risk patients and post-hoc analyses of the HOPE trial have provided evidence for its beneficial action in the prevention of diabetes. Methods The ADaPT investigation ("ACE inhibitor-based versus diuretic-based antihypertensive primary treatment in patients with pre-diabetes" is a 4-year open, prospective, parallel group phase IV study. It compares an antihypertensive treatment regimen based on ramipril versus a treatment based on diuretics or betablockers. The primary evaluation criterion is the first manifestation of type 2 diabetes. The study is conducted in primary care to allow the broadest possible application of its results. The present article provides an outline of the rationale, the design and baseline characteristics of AdaPT and compares these to previous studies including ASCOT-BLPA, VALUE and DREAM. Results Until March 2006 a total of 2,015 patients in 150 general practices (general physicians and internists throughout Germany were enrolled. The average age of patients enrolled was 67.1 ± 10.3 years, with 47% being male and a BMI of 29.9 ± 5.0 kg/m2. Dyslipidemia was present in 56.5%. 37.8% reported a family history of diabetes, 57.8% were previously diagnosed with hypertension (usually long standing. The HbA1c value at baseline was 5.6 %. Compared to the DREAM study patients were older, had more frequently hypertension and patients with cardiovascular disease were not excluded. Conclusion Comparing the ADaPT design and baseline data to previous randomized controlled trial it can be acknowledged that AdaPT included patients with a high risk for diabetes development. Results are expected to be available in 2010. Data

  4. First-line antihypertensive treatment in patients with pre-diabetes: rationale, design and baseline results of the ADaPT investigation.

    Science.gov (United States)

    Zidek, Walter; Schrader, Joachim; Lüders, Stephan; Matthaei, Stephan; Hasslacher, Christoph; Hoyer, Joachim; Bramlage, Peter; Sturm, Claus-Dieter; Paar, W Dieter

    2008-07-24

    Recent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents. Therefore the role of these agents in preventing diabetes is still not well defined. Ramipril is an ACE inhibitor (ACEi), that has been shown to reduce cardiovascular events in high risk patients and post-hoc analyses of the HOPE trial have provided evidence for its beneficial action in the prevention of diabetes. The ADaPT investigation ("ACE inhibitor-based versus diuretic-based antihypertensive primary treatment in patients with pre-diabetes") is a 4-year open, prospective, parallel group phase IV study. It compares an antihypertensive treatment regimen based on ramipril versus a treatment based on diuretics or betablockers. The primary evaluation criterion is the first manifestation of type 2 diabetes. The study is conducted in primary care to allow the broadest possible application of its results. The present article provides an outline of the rationale, the design and baseline characteristics of AdaPT and compares these to previous studies including ASCOT-BLPA, VALUE and DREAM. Until March 2006 a total of 2,015 patients in 150 general practices (general physicians and internists) throughout Germany were enrolled. The average age of patients enrolled was 67.1 +/- 10.3 years, with 47% being male and a BMI of 29.9 +/- 5.0 kg/m2. Dyslipidemia was present in 56.5%. 37.8% reported a family history of diabetes, 57.8% were previously diagnosed with hypertension (usually long standing). The HbA1c value at baseline was 5.6 %. Compared to the DREAM study patients were older, had more frequently hypertension and patients with cardiovascular disease were not excluded. Comparing the ADaPT design and baseline data to previous randomized controlled trial it can be acknowledged that AdaPT included patients with a high risk for diabetes development. Results are expected to be available in 2010. Data will be highly valuable for clinical practice due to the

  5. Resin-composite blocks for dental CAD/CAM applications.

    Science.gov (United States)

    Ruse, N D; Sadoun, M J

    2014-12-01

    Advances in digital impression technology and manufacturing processes have led to a dramatic paradigm shift in dentistry and to the widespread use of computer-aided design/computer-aided manufacturing (CAD/CAM) in the fabrication of indirect dental restorations. Research and development in materials suitable for CAD/CAM applications are currently the most active field in dental materials. Two classes of materials are used in the production of CAD/CAM restorations: glass-ceramics/ceramics and resin composites. While glass-ceramics/ceramics have overall superior mechanical and esthetic properties, resin-composite materials may offer significant advantages related to their machinability and intra-oral reparability. This review summarizes recent developments in resin-composite materials for CAD/CAM applications, focusing on both commercial and experimental materials. © International & American Associations for Dental Research.

  6. Engine testing of ceramic cam-roller followers

    Energy Technology Data Exchange (ETDEWEB)

    Kalish, Y. (Detroit Diesel Corp., MI (United States))

    1992-04-01

    For several years, DDC has been developing monolithic ceramic heat engine components. One of the components, developed for an application in our state-of-the-art on-highway, heavy-duty diesel engine, the Series 60, is a silicon nitride cam-roller follower. Prior to starting this program, each valve train component in the Series 60 was considered for conversion to a ceramic material. Many advantages and disadvantages (benefits and risks) were considered. From this effort, one component was selected, the cam-roller follower. Using a system design approach, a ceramic cam-roller follower offered functional improvement at a reasonable cost. The purpose of the project was to inspect and test 100 domestically produced silicon nitride cam-roller followers built to the requirements of the DDC series 60 engine.

  7. Engine testing of ceramic cam-roller followers. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Kalish, Y. [Detroit Diesel Corp., MI (United States)

    1992-04-01

    For several years, DDC has been developing monolithic ceramic heat engine components. One of the components, developed for an application in our state-of-the-art on-highway, heavy-duty diesel engine, the Series 60, is a silicon nitride cam-roller follower. Prior to starting this program, each valve train component in the Series 60 was considered for conversion to a ceramic material. Many advantages and disadvantages (benefits and risks) were considered. From this effort, one component was selected, the cam-roller follower. Using a system design approach, a ceramic cam-roller follower offered functional improvement at a reasonable cost. The purpose of the project was to inspect and test 100 domestically produced silicon nitride cam-roller followers built to the requirements of the DDC series 60 engine.

  8. Crystallization method providing composition autocontrol in situ (CAM-S)

    Energy Technology Data Exchange (ETDEWEB)

    Venkrbec, J.J. (Czech Technical University in Prague, Faculty of Electrical Engineering, 16627 Prague 6 (Czechoslovakia)); Rosick, V.; Kohout, J. (Institute of Radioelectronics, Czechoslovak Academy of Sciences, Prague (Czechoslovakia))

    1993-01-14

    A novel approach to crystal growth from a molten solution zone (MSZ) is presented. There are five variants of CAM-S, which is a modification of the travelling heater method (THM), which can solve crystal growth problems as THM does, especially synthesis, repeated creation of the MSZ, zoning operations with vibrational stirring, and perform all these operations in situ. The combination of CAM-S with calculation method of optimal molten-solution composition (COM-S) has been applied to the growth of bulk crystals of the ternary solid solutions Ga[sub x]In[sub 1-x]Sb. Extreme constancy of the lattice parameter throughout the crystalline length has been achieved. Both methods are based on the knowledge of phase diagrams.

  9. CAM/LIFTER forces and friction

    Energy Technology Data Exchange (ETDEWEB)

    Gabbey, D.J.; Lee, J.; Patterson, D.J.

    1992-02-01

    This report details the procedures used to measure the cam/lifter forces and friction. The present effort employed a Cummins LTA-10, and focuses on measurements and dynamic modeling of the injector train. The program was sponsored by the US Department of Energy in support of advanced diesel engine technology. The injector train was instrumented to record the instantaneous roller speed, roller pin friction torque, pushrod force, injector link force and cam speed. These measurements, together with lift profiles for pushrod and injector link displacement, enabled the friction work loss in the injector train to be determined. Other significant design criteria such as camshaft roller follower slippage and maximum loads on components were also determined. Future efforts will concentrate on the dynamic model, with tests run as required for correlation.

  10. CAD/CAM-assisted breast reconstruction

    Energy Technology Data Exchange (ETDEWEB)

    Melchels, Ferry; Hutmacher, Dietmar Werner [Institute of Health and Biomedical Innovation, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove, QLD 4059 (Australia); Wiggenhauser, Paul Severin; Schantz, Jan-Thorsten [Department of Plastic and Hand Surgery, Klinikum rechts der Isar, Technische Universitaet Muenchen, Ismaninger Strasse 22, 81675 Munich (Germany); Warne, David; Barry, Mark [High Performance Computing and Research Support, Queensland University of Technology, Gardens Point Road, Brisbane, QLD 4000 (Australia); Ong, Fook Rhu; Chong, Woon Shin, E-mail: Dietmar.Hutmacher@qut.edu.au, E-mail: jtschantz@lrz.tu-muenchen.de [Singapore Polytechnic, 500 Dover Road, 139651 Singapore (Singapore)

    2011-09-15

    The application of computer-aided design and manufacturing (CAD/CAM) techniques in the clinic is growing slowly but steadily. The ability to build patient-specific models based on medical imaging data offers major potential. In this work we report on the feasibility of employing laser scanning with CAD/CAM techniques to aid in breast reconstruction. A patient was imaged with laser scanning, an economical and facile method for creating an accurate digital representation of the breasts and surrounding tissues. The obtained model was used to fabricate a customized mould that was employed as an intra-operative aid for the surgeon performing autologous tissue reconstruction of the breast removed due to cancer. Furthermore, a solid breast model was derived from the imaged data and digitally processed for the fabrication of customized scaffolds for breast tissue engineering. To this end, a novel generic algorithm for creating porosity within a solid model was developed, using a finite element model as intermediate.

  11. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    2012-08-01

    Full Text Available Abstract Background Acute respiratory distress syndrome (ARDS is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART. Methods/Design ART is a pragmatic, multicenter, randomized (concealed, controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy. We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet. In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight and targeting plateau pressure ≤30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves

  12. Rationale, design and methods for the RIGHT Track Health Study: pathways from childhood self-regulation to cardiovascular risk in adolescence

    Directory of Open Access Journals (Sweden)

    Laurie Wideman

    2016-06-01

    Full Text Available Abstract Background Cardiovascular risk factors during adolescence—including obesity, elevated lipids, altered glucose metabolism, hypertension, and elevated low-grade inflammation—is cause for serious concern and potentially impacts subsequent morbidity and mortality. Despite the importance of these cardiovascular risk factors, very little is known about their developmental origins in childhood. In addition, since adolescence is a time when individuals are navigating major life changes and gaining increasing autonomy from their parents or parental figures, it is a period when control over their own health behaviors (e.g. drug use, sleep, nutrition also increases. The primary aim of this paper is to describe the rationale, design and methods for the RIGHT Track Health Study. This study examines self-regulation as a key factor in the development of cardiovascular risk, and further explores health behaviors as an explanatory mechanism of this association. We also examine potential moderators (e.g. psychosocial adversities such as harsh parenting of this association. Method/design RIGHT Track is a longitudinal study that investigates social and emotional development. The RIGHT Track Health Study prospectively follows participants from age 2 through young adulthood in an effort to understand how self-regulatory behavior throughout childhood alters the trajectories of various cardiovascular risk factors during late adolescence via health behaviors. Individuals from RIGHT Track were re-contacted and invited to participate in adolescent data collection (~16.5, 17.5 and 18+ years old. Individuals completed assessments of body composition, anthropometric indicators, fitness testing (via peak oxygen consumption, heart rate variability during orthostatic challenge, 7-day accelerometry for physical activity and sleep, 24-h dietary recalls, and blood analysis for biomarkers related to metabolic syndrome, inflammatory status and various hormones and

  13. A school-based intervention to promote physical activity among adolescent girls: Rationale, design, and baseline data from the Girls in Sport group randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Puglisi Lauren

    2011-08-01

    Full Text Available Abstract Background Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA among adolescent girls. Methods/Design A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the primary objective (preventing the decline in accelerometer-derived MVPA. Academic partners and the State Department of Education and Training act as critical friends. Control schools continue with their usual school programming. 24 schools were matched then randomized into intervention (n = 12 and control (n = 12 groups. A total of 1518 girls (771 intervention and 747 control completed baseline assessments (86% response rate. Useable accelerometer data (≥10 hrs/day on at least 3 days were obtained from 79% of this sample (n = 1199. Randomisation resulted in no differences between intervention and control groups on any of the outcomes. The mean age (SE of the sample was 13.6 (± 0.02 years and they spent less than 5% of their waking hours in MVPA (4.85 ± 0.06. Discussion Girls in Sport will test the effectiveness of schools working towards the same goal, but developing individual, targeted interventions that bring about changes in curriculum, school environment and policy, and community links. By using community-based participatory research and an action learning framework in a secondary school setting, it aims to add to the body of literature on effective school

  14. Brain aging, cognition in youth and old age and vascular disease in the Lothian Birth Cohort 1936: rationale, design and methodology of the imaging protocol.

    Science.gov (United States)

    Wardlaw, Joanna M; Bastin, Mark E; Valdés Hernández, Maria C; Maniega, Susana Muñoz; Royle, Natalie A; Morris, Zoe; Clayden, Jonathan D; Sandeman, Elaine M; Eadie, Elizabeth; Murray, Catherine; Starr, John M; Deary, Ian J

    2011-12-01

    As the population of the world ages, age-related cognitive decline is becoming an ever-increasing problem. However, the changes in brain structure that accompany normal aging, and the role they play in cognitive decline, remain to be fully elucidated. This study aims to characterize changes in brain structure in old age, and to investigate relationships between brain aging and cognitive decline using the Lothian Birth Cohort 1936. Here, we report the rationale, design and methodology of the brain and neurovascular imaging protocol developed to study this cohort. An observational, longitudinal study of the Lothian Birth Cohort 1936, which comprises 1091 relatively healthy individuals now in their 70s and living in the Edinburgh area. They are surviving participants of the Scottish Mental Survey 1947, which involved a test of general intelligence taken at age 11 years. At age 70 years, the Lothian Birth Cohort 1936 undertook detailed cognitive, medical and genetic testing, and provided social, family, nutritional, quality of life and physical activity information. At mean age 73 years they underwent detailed brain MRI and neurovascular ultrasound imaging, repeat cognitive and other testing. The MRI protocol is designed to provide qualitative and quantitative measures of gray and white matter atrophy, severity and location of white matter lesions, enlarged perivascular spaces, brain mineral deposits, microbleeds and integrity of major white matter tracts. The neurovascular ultrasound imaging provides velocity, stenosis and intima-media thickness measurements of the carotid and vertebral arteries. This valuable imaging dataset will be used to determine which changes in brain structural parameters have the largest effects on cognitive aging. Analysis will include multimodal image analysis and multivariate techniques, such as factor analysis and structural equation modelling. Especially valuable is the ability within this sample to examine the influence that early life

  15. Novel-design ultra-thin CAD/CAM composite resin and ceramic occlusal veneers for the treatment of severe dental erosion.

    Science.gov (United States)

    Schlichting, Luís Henrique; Maia, Hamilton Pires; Baratieri, Luiz Narciso; Magne, Pascal

    2011-04-01

    Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional inlays and complete coverage crowns for the treatment of severe erosive lesions. There is a lack of data regarding selection of the most appropriate material and its influence on fatigue resistance, which may affect restoration longevity. The purpose of this study was to assess the influence of CAD/CAM restorative material (ceramic vs. composite resin) on fatigue resistance of ultra-thin occlusal veneers. A standardized nonretentive tooth preparation (simulating advanced occlusal erosion) was applied to 40 extracted molars including removal of occlusal enamel, and immediate dentin sealing (Optibond FL). All teeth were restored with a 0.6 mm-thick occlusal veneer (Cerec3 chairside CAD/CAM system). Reinforced ceramics (Empress CAD and e.max CAD) and composite resins (Paradigm MZ100 and XR (experimental blocks)) were used to mill the restorations (n=10). The intaglio surfaces were HF-etched and silanated (reinforced ceramics) or airborne-particle abraded and silanated (composite resins). Preparations were airborne-particle abraded and etched before restoration insertion. All restorations were adhesively luted with preheated Filtek Z100. Cyclic isometric loading was applied at 5 Hz, beginning with a load of 200N (x5,000), followed by stages of 400, 600, 800, 1000, 1200 and 1,400N at a maximum of 30,000 cycles each. The number of cycles at initial failure (first cracks) was recorded. Specimens were loaded until catastrophic failure (lost restoration fragment) or to a maximum of 185,000 cycles. Groups were compared using the life table survival analysis (α=.008, Bonferroni-method). Empress CAD and e.max CAD initially failed at an average load of 500N and 800N, respectively with no specimen withstanding all 185,000 load cycles (survival 0%); with MZ100 and XR the survival rate was 60% and 100%, respectively. Both composite resins (MZ100 and XR) increased the fatigue

  16. The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies.

    Science.gov (United States)

    Kayıkçıoğlu, Meral; Tokgözoğlu, Lale

    2017-04-01

    Familial hypercholesterolemia (FH) is a genetic disease characterized by extremely high levels of cholesterol, leading to premature atherosclerosis. Although many countries have already addressed the burden of FH by means of national registries, Turkey has no national FH registry or national screening program to detect FH. Creation of a series of FH registries is planned as part of Turkish FH Initiative endorsed by the Turkish Society of Cardiology to meet this need. This article provides detailed information on the rationale and design of the first 2 FH registries (A-HIT1 and A-HIT2). A-HIT1 is a nationwide survey of adult homozygous FH (HoFH) patients undergoing low-density lipoprotein (LDL) apheresis (LA) in Turkey. A-HIT1 will provide insight into the clinical status of HoFH patients undergoing LA. Primary objective of this cross-sectional study is to identify how HoFH patients on LA are managed. Inclusion criteria are age >12 years, diagnosis of HoFH, and regular LA treatment. All available apheresis centers were electronically invited to participate in the study. The principal physicians of each center will respond to a questionnaire regarding their attitude toward LA. For each patient, another questionnaire will be used to collect data on clinical status, medication use, and disease data. In addition, patients will be asked to complete self-report questionnaires that provide information on quality of life, disease-related anxiety, and depression. A-HIT2 is a registry of adult FH patients presenting at outpatient clinics. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 statistical regions in Turkey based on the EU NUTS classification. Sites specializing in cardiology, internal medicine, and endocrinology were invited to participate. The primary objective of this cross-sectional study is to determine clinical status and management of patients in Turkey diagnosed with FH. Eligibility for screening was defined as having

  17. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.: Study rationale and design

    Directory of Open Access Journals (Sweden)

    2008-06-01

    Full Text Available Abstract Background Surgeons agree on the benefits of operative treatment of tibial fractures – the most common of long bone fractures – with an intramedullary rod or nail. Rates of re-operation remain high – between 23% and 60% in prior trials – and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better. Methods/Design The objective of this trial was to assess the impact of reamed versus non-reamed intramedullary nailing on rates of re-operation in patients with open and closed fractures of the tibial shaft. The study to prospectively evaluate reamed intramedullary nails in tibial fractures (S.P.R.I.N.T was a multi-center, randomized trial including 29 clinical sites in Canada, the United States and the Netherlands which enrolled 1200 skeletally mature patients with open (Gustilo Types I-IIIB or closed (Tscherne Types 0–3 fractures of the tibial shaft amenable to surgical treatment with an intramedullary nail. Patients received a statically locked intramedullary nail with either reamed or non-reamed insertion. The first strategy involved fixation of the fracture with an intramedullary nail following reaming to enlarge the intramedullary canal (Reamed Group. The second treatment strategy involved fixation of the fracture with an intramedullary nail without prior reaming of the intramedullary canal (Non-Reamed Group. Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were proscribed. Patients were followed at discharge, 2 weeks post-discharge, and at 6 weeks, 3, 6, 9, and 12 months post surgery. A committee, blinded to allocation, adjudicated all outcomes. Discussion The primary outcome was re-operation to promote healing, treat infection, or preserve the limb (fasciotomy for compartment syndrome after

  18. Detecting Heart Failure Decompensation by Measuring Transthoracic Bioimpedance in the Outpatient Setting: Rationale and Design of the SENTINEL-HF Study.

    Science.gov (United States)

    Dovancescu, Silviu; Saczynski, Jane S; Darling, Chad E; Riistama, Jarno; Sert Kuniyoshi, Fatima; Meyer, Theo; Goldberg, Robert; McManus, David D

    2015-10-09

    Recurrent hospital admissions are common among patients admitted for acute decompensated heart failure (ADHF), but identification of patients at risk for rehospitalization remains challenging. Contemporary heart failure (HF) management programs have shown modest ability to reduce readmissions, partly because they monitor signs or symptoms of HF worsening that appear late during decompensation. Detecting early stages of HF decompensation might allow for immediate application of effective HF therapies, thereby potentially reducing HF readmissions. One of the earliest indicators of HF decompensation is intrathoracic fluid accumulation, which can be assessed using transthoracic bioimpedance. The SENTINEL-HF study is a prospective observational study designed to test a novel, wearable HF monitoring system as a predictor of HF decompensation among patients discharged after hospitalization for ADHF. SENTINEL-HF tests the hypothesis that a decline in transthoracic bioimpedance, as assessed daily with the Philips fluid accumulation vest (FAV) and transmitted using a mobile phone, is associated with HF worsening and rehospitalization. According to pre-specified power calculations, 180 patients admitted with ADHF are enrolled. Participants transmit daily self-assessments using the FAV-mobile phone dyad for 45 days post-discharge. The primary predictor is the deviation of transthoracic bioimpedance for 3 consecutive days from a patient-specific normal variability range. The ADHF detection algorithm is evaluated in relation with a composite outcome of HF readmission, diuretic up-titration, and self-reported HF worsening (Kansas City Cardiomyopathy Questionnaire) during a 90-day follow-up period. Here, we provide the details and rationale of SENTINEL-HF. Enrollment in the SENTINEL-HF study is complete and the 90-days follow-up is currently under way. Once data collection is complete, the study dataset will be used to evaluate our ADHF detection algorithm and the results

  19. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  20. Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: Design and Rationale of the EFFORTLESS S-ICD Registry

    DEFF Research Database (Denmark)

    Pedersen, Susanne S; Lambiase, Pier; Boersma, Lucas V A

    2012-01-01

    or in the vasculature. We present the rationale and study design of the Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (EFFORTLESS S-ICD) Registry which was designed to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource......) complication-free rate, 360-day complication-free rate, and percentage of inappropriate shocks for atrial fibrillation and supraventricular ventricular tachyarrhythmia. Other endpoints include patient-reported outcomes (e.g., quality of life) and hospital personnel implant and follow-up experience with the S...

  1. Special Section: Complementary and Alternative Medicine (CAM): Low Back Pain and CAM

    Science.gov (United States)

    ... Home Current Issue Past Issues Special Section CAM Low Back Pain and CAM Past Issues / Winter 2009 Table of ... benefit from CAM treatment for conditions such as low back pain. Photo courtesy of Glenn Scimonelli "Oh, my aching ...

  2. Rationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun" - a program designed to enhance physical and mental health in young children

    Directory of Open Access Journals (Sweden)

    McLaren Sue

    2010-11-01

    Full Text Available Abstract Background Children with poor motor ability have been found to engage less in physical activities than other children, and a lack of physical activity has been linked to problems such as obesity, lowered bone mineral density and cardiovascular risk factors. Furthermore, if children are confident with their fine and gross motor skills, they are more likely to engage in physical activities such as sports, crafts, dancing and other physical activity programs outside of the school curriculum which are important activities for psychosocial development. The primary objective of this project is to comprehensively evaluate a whole of class physical activity program called Animal Fun designed for Pre-Primary children. This program was designed to improve the child's movement skills, both fine and gross, and their perceptions of their movement ability, promote appropriate social skills and improve social-emotional development. Methods The proposed randomized and controlled trial uses a multivariate nested cohort design to examine the physical (motor coordination and psychosocial (self perceptions, anxiety, social competence outcomes of the program. The Animal Fun program is a teacher delivered universal program incorporating animal actions to facilitate motor skill and social skill acquisition and practice. Pre-intervention scores on motor and psychosocial variables for six control schools and six intervention schools will be compared with post-intervention scores (end of Pre-Primary year and scores taken 12 months later after the children's transition to primary school Year 1. 520 children aged 4.5 to 6 years will be recruited and it is anticipated that 360 children will be retained to the 1 year follow-up. There will be equal numbers of boys and girls. Discussion If this program is found to improve the child's motor and psychosocial skills, this will assist in the child's transition into the first year of school. As a result of these changes

  3. Prevalence and Characteristics of CAM Use among People Living with HIV and AIDS in Lebanon: Implications for Patient Care

    Directory of Open Access Journals (Sweden)

    Joana Abou-Rizk

    2016-01-01

    Full Text Available This study aimed to assess the prevalence and determinants of Complementary and Alternative Medicine (CAM use among People Living with HIV and AIDS (PLWHA in Lebanon and to identify related issues that may affect patient care. A cross-sectional survey design was used to interview 116 PLWHA in Beirut. The questionnaire addressed sociodemographic and disease characteristics as well as CAM use. The main outcome of the study was CAM use since diagnosis. Data analysis included descriptive statistics and logistic regression analyses. Overall, 46.6% of participants reported using one or more CAM therapies, with herbs and herbal products being the most commonly used (63%. A higher education level was associated with a 3-fold increase in the odds of CAM use. Among users, 20% used CAM as alternative to conventional treatment, 48% were not aware of CAM-drug interactions, 89% relied on nonhealth care sources for their choice of CAM, and 44% did not disclose CAM use to their physician. CAM use is prevalent among Lebanese PLWHA. Findings of this study highlighted the need to educate health care practitioners to have an open communication and a patient-centered approach discussing CAM use during routine care and to enhance awareness of PLWHA on safe use of CAM.

  4. Verification of Kaplan turbine cam curves realization accuracy at power plant

    Directory of Open Access Journals (Sweden)

    Džepčeski Dane

    2016-01-01

    Full Text Available Sustainability of approximately constant value of Kaplan turbine efficiency, for relatively large net head changes, is a result of turbine runner variable geometry. Dependence of runner blades position change on guide vane opening represents the turbine cam curve. The cam curve realization accuracy is of great importance for the efficient and proper exploitation of turbines and consequently complete units. Due to the reasons mentioned above, special attention has been given to the tests designed for cam curves verification. The goal of this paper is to provide the description of the methodology and the results of the tests performed in the process of Kaplan turbine cam curves verification.

  5. An open CAM system for dentistry on the basis of China-made 5-axis simultaneous contouring CNC machine tool and industrial CAM software.

    Science.gov (United States)

    Lu, Li; Liu, Shusheng; Shi, Shenggen; Yang, Jianzhong

    2011-10-01

    China-made 5-axis simultaneous contouring CNC machine tool and domestically developed industrial computer-aided manufacture (CAM) technology were used for full crown fabrication and measurement of crown accuracy, with an attempt to establish an open CAM system for dental processing and to promote the introduction of domestic dental computer-aided design (CAD)/CAM system. Commercially available scanning equipment was used to make a basic digital tooth model after preparation of crown, and CAD software that comes with the scanning device was employed to design the crown by using domestic industrial CAM software to process the crown data in order to generate a solid model for machining purpose, and then China-made 5-axis simultaneous contouring CNC machine tool was used to complete machining of the whole crown and the internal accuracy of the crown internal was measured by using 3D-MicroCT. The results showed that China-made 5-axis simultaneous contouring CNC machine tool in combination with domestic industrial CAM technology can be used for crown making and the crown was well positioned in die. The internal accuracy was successfully measured by using 3D-MicroCT. It is concluded that an open CAM system for dentistry on the basis of China-made 5-axis simultaneous contouring CNC machine tool and domestic industrial CAM software has been established, and development of the system will promote the introduction of domestically-produced dental CAD/CAM system.

  6. JunoCam's Imaging of Jupiter

    Science.gov (United States)

    Orton, Glenn; Hansen, Candice; Momary, Thomas; Caplinger, Michael; Ravine, Michael; Atreya, Sushil; Ingersoll, Andrew; Bolton, Scott; Rogers, John; Eichstaedt, Gerald

    2017-04-01

    Juno's visible imager, JunoCam, is a wide-angle camera (58° field of view) with 4 color filters: red, green and blue (RGB) and methane at 889 nm, designed for optimal imaging of Jupiter's poles. Juno's elliptical polar orbit offers unique views of Jupiter's polar regions with spatial scales as good as 50 km/pixel. At closest approach ("perijove") the images have spatial scale down to ˜3 km/pixel. As a push-frame imager on a rotating spacecraft, JunoCam uses time-delayed integration to take advantage of the spacecraft spin to extend integration time to increase signal. Images of Jupiter's poles reveal a largely uncharted region of Jupiter, as nearly all earlier spacecraft except Pioneer 11 have orbited or flown by close to the equatorial plane. Poleward of 64-68° planetocentric latitude, Jupiter's familiar east-west banded structure breaks down. Several types of discrete features appear on a darker, bluish-cast background. Clusters of circular cyclonic spirals are found immediately around the north and south poles. Oval-shaped features are also present, ranging in size down to JunoCam's resolution limits. The largest and brightest features usually have chaotic shapes; animations over ˜1 hour can reveal cyclonic motion in them. Narrow linear features traverse tens of degrees of longitude and are not confined in latitude. JunoCam also detected optically thin clouds or hazes that are illuminated beyond the nightside ˜1-bar terminator; one of these detected at Perijove lay some 3 scale heights above the main cloud deck. Tests have been made to detect the aurora and lightning. Most close-up images of Jupiter have been acquired at lower latitudes within 2 hours of closest approach. These images aid in understanding the data collected by other instruments on Juno that probe deeper in the atmosphere. When Jupiter was too close to the sun for ground-based observers to collect data between perijoves 1 and 2, JunoCam took a sequence of routine images to monitor large

  7. Scleroderma, Stress and CAM Utilization

    Directory of Open Access Journals (Sweden)

    Ka-Kit Hui

    2009-01-01

    Full Text Available Scleroderma is an autoimmune disease influenced by interplay among genetic and environmental factors, of which one is stress. Complementary and alternative medicine (CAM is frequently used to treat stress and those diseases in which stress has been implicated. Results are presented from a survey of patients with scleroderma. Respondents were a convenient sample of those attending a national conference in Las Vegas in 2002. Findings implicate stress in the onset, continuation and exacerbation of scleroderma. The implication is that CAM providers may be filling an important patient need in their provision of services that identify and treat stress and its related disorders.

  8. Monitoring the photometric behavior of OmegaCAM with Astro-WISE

    NARCIS (Netherlands)

    Verdoes Kleijn, G. A.; Kuijken, K. H.; Valentijn, E. A.; Boxhoorn, D. R.; Begeman, K. G.; Deul, E. R.; Helmich, E. M.; Rengelink, R.

    The OmegaCAM wide-field optical imager is the sole instrument on the VLT Survey Telescope at ESO's Paranal Observatory. The instrument, as well as the telescope, have been designed for surveys with very good, natural seeing-limited image quality over a 1 square degree field. OmegaCAM was

  9. IBD and Complementary and Alternative Medicine (CAM)

    Science.gov (United States)

    ... Alternative Medicine (CAM) Go Back Complementary and Alternative Medicine (CAM) Email Print + Share Crohn’s disease and ulcerative ... Energy Medicine, and Biologically-Based Practices. Mind-Body Medicine Mind-body medicine is a set of interventions ...

  10. Computer Aided Design and Manufacturing (CAD/CAM) Techniques for Optimum Preform and Finish Forging of Spiral Bevel Gears. Phase 2

    Science.gov (United States)

    1982-10-01

    conducted at Battelle with some input from Eaton Corporation and Mr. M. L. Baxter , subcontractor and consultant to the program, respectively. Phase I...the amount of fill desired, die design and scale. To improve the die design, the die was to be vented to allow entrapped gases and lubricants to

  11. The Z CamPaign: Year Five

    Science.gov (United States)

    Simonsen, Mike

    2014-05-01

    Entering into the fifth year of the Z CamPaign, the author has developed a website summarizing our findings which will also act as a living catalog of bona fide Z Cam stars, suspected Z Cams, and Z Cam impostors. In this paper we summarize the findings of the first four years of research, introduce the website and its contents to the public, and discuss the way forward into year five and beyond.

  12. Marginal Integrity of CAD/CAM Fixed Partial Dentures

    OpenAIRE

    Rosentritt, Martin; Behr, Michael; Kolbeck, Carola; Handel, Gerhard

    2007-01-01

    Objectives Computer-aided design (CAD) and manufacturing (CAM) allows the milling of high strength zirconia fixed partial dentures (FPD), however bonding to an inert ZrO2 ceramic surface may effect the marginal integrity of the FPDs. The aim of this investigation was to evaluate the marginal adaptation of zirconia FPDs at the interfaces between zirconia, cement, and tooth. Methods 32 3-unit FPDs were fabricated of the CAD/CAM Y-TZP zirconia (Lava, 3M Espe, Germany) according to the manufactur...

  13. Illness narratives in cancer: CAM and spiritual practices

    DEFF Research Database (Denmark)

    Ulrich, Anita; Evron, Lotte; Ostenfeld-Rosenthal, Ann

    2011-01-01

    Objectives: In this paper,we investigate Danish cancer patients’ narratives on spiritual beliefs and practices and the relationship these practices may have to complementary and alternative medicine (CAM). Design: Narrative inquiry is used to uncover how spiritual beliefs and practices may......, religious and spiritual issues were not extensively unfolded in participants’ illness narratives. However, these issues were significantly elaborated on in narratives by four female participants. Conclusion: We propose that for some cancer patients CAM may function, not only or primarily as a treatment...

  14. JunoCam's Images of Jupiter

    Science.gov (United States)

    Hansen, C. J.; Ravine, M. A.; Caplinger, M. A.; Orton, G. S.; Ingersoll, A. P.; Jensen, E.; Lipkaman, L.; Krysak, D.; Zimdar, R.; Bolton, S. J.

    2016-12-01

    JunoCam is a visible imager on the Juno spacecraft in orbit around Jupiter. It is a wide angle camera (58 deg field of view) with 4 color filters: red, green and blue (RGB) and methane at 889 nm, designed for optimal imaging of Jupiter's poles. Juno's elliptical polar orbit will offer unique views of Jupiter's polar regions with a spatial scale of 50 km/pixel. At closest approach the images will have a spatial scale of 3 km/pixel. As a push-frame imager on a rotating spacecraft, JunoCam uses time-delayed integration to take advantage of the spacecraft spin to extend integration time to increase signal. Images of Jupiter's poles reveal a largely uncharted region of Jupiter, as nearly all earlier spacecraft have orbited or flown by in the equatorial plane. Most of the images of Jupiter will be acquired in the +/-2 hours surrounding closest approach. The polar vortex, polar cloud morphology, and winds will be investigated. RGB color images of the aurora will be acquired if detectable. Stereo images and images taken with the methane filter will allow us to estimate cloud-top heights. Images of the cloud-tops will aid in understanding the data collected by other instruments on Juno that probe deeper in the atmosphere. During the two months that Jupiter is too close to the sun for ground-based observers to collect data, JunoCam will take images routinely to monitor large-scale features. Occasional, opportunistic images of the Galilean moons will be acquired.

  15. The application of CAD / CAM technology in Dentistry

    Science.gov (United States)

    Susic, I.; Travar, M.; Susic, M.

    2017-05-01

    Information and communication technologies have found their application in the healthcare sector, including the frameworks of modern dentistry. CAD / CAM application in dentistry is the process by which is attained finished dental restoration through fine milling process of ready ceramic blocks. CAD / CAM is an acronym of english words Computer-Aided-Design (CAD) / Computer-Aided-Manufacture (CAM), respectively dental computer aided design and computer aided manufacture of inlays, onlays, crowns and bridges. CAD / CAM technology essentially allows you to create a two-dimensional and three-dimensional models and their materialization by numerical controlled machines. In order to operate more efficiently, reduce costs, increase user/patient satisfaction and ultimately achieve profits, many dental offices in the world have their attention focused on implementation of modern IT solutions in everyday practice. In addition to the specialized clinic management software, inventory control, etc., or hardware such as the use of lasers in cosmetic dentistry or intraoral scanning, recently the importance is given to the application of CAD / CAM technology in the field of prosthetic. After the removal of pathologically altered tooth structure, it is necessary to achieve restoration that will be most similar to the anatomy of a natural tooth. Applying CAD / CAM technology on applicable ceramic blocks it can be obtained very quick, but also very accurate restoration, in the forms of inlays, onlays, bridges and crowns. The paper presents the advantages of using this technology as well as satisfaction of the patients and dentists by using systems as: Cercon, Celay, Cerec, Lava, Everest, which represent imperative of modern dentistry in creating fixed dental restorations.

  16. Fundamento e desenho do teste randomizado PAINT Fundamento y diseño del test randomizado PAINT Rationale and design for the PAINT randomized trial

    Directory of Open Access Journals (Sweden)

    Pedro A. Lemos

    2009-12-01

    óricas y el formato del "Estudio PAINT - Intervención percutánea con stents recubiertos de paclitaxel o sirolimus en polímero biodegradable comparados con stents no recubiertos en el tratamiento de lesiones coronarias de novo". OBJETIVO: Evaluar dos nuevas formulaciones de stents con liberación de paclitaxel o sirolimus en comparación con un stent de estructura metálica idéntica, pero sin recubierto polimérico o liberación de droga. MÉTODOS: El PAINT es un estudio randomizado, multicéntrico, de 3 brazos, llevado a cabo en centros terciaros brasileños, que incluyó a 275 pacientes destinados a tratamiento con los stents InfinniumR (paclitaxel, the SupralimusR (sirolimus o Milennium MatrixR (no recubierto en la proporción 2:2:1. Los pacientes presentaban lesiones coronarias de novo en vasos nativos con un diámetro entre 2,5 y 3,5 mm, pasibles de tratamiento con un único stent de hasta 29 mm de longitud. El objetivo primario era comparar la pérdida luminal tardía a los nueve meses de ambos stents con paclitaxel- o sirolimus versus la pérdida luminal de los stents convencionales de control. Los objetivos secundarios importantes incluían la comparación angiográfica entre los dos tipos de stents farmacológicos, así como el análisis de la ocurrencia de eventos clínicos adversos. RESULTADOS Y CONCLUSIONES: El estudio PAINT presenta un formato peculiar y único que permitió la evaluación de la seguridad y eficacia de dos nuevas formulaciones de stents farmacológicos, con transportador polimérico biodegradable, y liberación de paclitaxel o sirolimus, los que fueron comparados con un stent metálico convencional (objetivo primario. Dado que los stents farmacológicos diferían entre sí solamente por la droga, pero eran idénticos en sus otras características, el estudio también permitió la comparación del efecto antireestenótico entre sirolimus y paclitaxel (objetivo secundario.BACKGROUND: We describe the rationale and design for the "Percut

  17. Establishment of a Computer-Aided Design (CAD)/Computer-Aided Manufacturing (CAM) Process for the Production of Cold Forged Gears

    Science.gov (United States)

    1984-01-01

    required to adequately define the forming process. Additionally, a Finite Element Method (FEM) analysis , applicable to metalforming (14), was done to...Computer Graphics, Gear Geometry, Finite Element Analysis , Slab Analysis , Forging, Extrusion, Die Design, Modelling Trials. 20b A95"RACT (Cioatfnue...and cutters. Analysis of forging load was done using both slab and finite element methods. These computed loads were compared in modeling trials with

  18. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

    Science.gov (United States)

    Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; Mahmoud, Taysir G; Triedman, Nellie A; Kalia, Sarah S; Atkinson, Michael L; Lu, Bing; Deane, Kevin D; Costenbader, Karen H; Green, Robert C; Karlson, Elizabeth W

    2014-09-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. SenseCam: a wearable camera that stimulates and rehabilitates autobiographical memory.

    Science.gov (United States)

    Hodges, Steve; Berry, Emma; Wood, Ken

    2011-10-01

    SenseCam is a wearable digital camera that captures an electronic record of the wearer's day. It does this by automatically recording a series of still images through its wide-angle lens, and simultaneously capturing a log of data from a number of built-in electronic sensors. Subsequently reviewing a sequence of images appears to provide a powerful autobiographical memory cue. A preliminary evaluation of SenseCam with a patient diagnosed with severe memory impairment was extremely positive; periodic review of images of events recorded by SenseCam resulted in significant recall of those events. Following this, a great deal of work has been undertaken to explore this phenomenon and there are early indications that SenseCam technology may be beneficial to a variety of patients with physical and mental health problems, and is valuable as a tool for investigating normal memory through behavioural and neuroimaging means. Elsewhere, it is becoming clear that judicious use of SenseCam could significantly impact the study of human behaviour. Meanwhile, research and development of the technology itself continues with the aim of providing robust hardware and software tools to meet the needs of clinicians, patients, carers, and researchers. In this paper we describe the history of SenseCam, and the design and operation of the SenseCam device and the associated viewing software, and we discuss some of the ongoing research questions being addressed with the help of SenseCam.

  20. CAD/CAM/CAI Application for High-Precision Machining of Internal Combustion Engine Pistons

    Directory of Open Access Journals (Sweden)

    V. V. Postnov

    2014-07-01

    Full Text Available CAD/CAM/CAI application solutions for internal combustion engine pistons machining was analyzed. Low-volume technology of internal combustion engine pistons production was proposed. Fixture for CNC turning center was designed.

  1. BENEFITS OF APPLICATION OF CAD/CAM SYSTEMS IN METAL PROCESSING COMPANIES

    National Research Council Canada - National Science Library

    Zoran Pandilov; Aleksandar Naumov

    2017-01-01

    .... The crucial benefits of using the CAD/CAM technology in the metal processing companies are increased productivity of the engineers-designers, increased production productivity, high and repeatable quality and high production flexibility.

  2. Rationale Management Challenges in Requirements Engineering

    NARCIS (Netherlands)

    Liang, Peng; Avgeriou, Paris; He, Keqing

    2010-01-01

    Rationale and rationale management have been playing an increasingly prominent role in software system development mainly due to the knowledge demand during system evaluation, maintenance, and evolution, especially for large and complex systems. The rationale management for requirements engineering,

  3. Early childhood intervention : rationale, timing, and efficacy

    OpenAIRE

    Orla Doyle; Richard E. Tremblay; Colm Harmon; James J. Heckman

    2007-01-01

    This paper provides a brief review of the economic rationale for investing in early childhood. It discusses the optimal timing of intervention, with reference to recent work in developmental neuroscience, and asks how early is early? It motivates the need for early intervention by providing an overview of the impact of adverse factors during the antenatal and early childhood period on outcomes later in life. Early childhood interventions, even poorly designed ones, are costly to implement,...

  4. Rationale and cross-sectional study design of the Research on Obesity and type 2 Diabetes among African Migrants: the RODAM study.

    Science.gov (United States)

    Agyemang, Charles; Beune, Erik; Meeks, Karlijn; Owusu-Dabo, Ellis; Agyei-Baffour, Peter; Aikins, Ama de-Graft; Dodoo, Francis; Smeeth, Liam; Addo, Juliet; Mockenhaupt, Frank P; Amoah, Stephen K; Schulze, Matthias B; Danquah, Ina; Spranger, Joachim; Nicolaou, Mary; Klipstein-Grobusch, Kerstin; Burr, Tom; Henneman, Peter; Mannens, Marcel M; van Straalen, Jan P; Bahendeka, Silver; Zwinderman, A H; Kunst, Anton E; Stronks, Karien

    2014-03-21

    Obesity and type 2 diabetes (T2D) are highly prevalent among African migrants compared with European descent populations. The underlying reasons still remain a puzzle. Gene-environmental interaction is now seen as a potential plausible factor contributing to the high prevalence of obesity and T2D, but has not yet been investigated. The overall aim of the Research on Obesity and Diabetes among African Migrants (RODAM) project is to understand the reasons for the high prevalence of obesity and T2D among sub-Saharan Africans in diaspora by (1) studying the complex interplay between environment (eg, lifestyle), healthcare, biochemical and (epi)genetic factors, and their relative contributions to the high prevalence of obesity and T2D; (2) to identify specific risk factors within these broad categories to guide intervention programmes and (3) to provide a basic knowledge for improving diagnosis and treatment. RODAM is a multicentre cross-sectional study among homogenous sub-Saharan African participants (ie, Ghanaians) aged >25 years living in rural and urban Ghana, the Netherlands, Germany and the UK (http://rod-am.eu/). Standardised data on the main outcomes, genetic and non-genetic factors are collected in all locations. The aim is to recruit 6250 individuals comprising five subgroups of 1250 individuals from each site. In Ghana, Kumasi and Obuasi (urban stratum) and villages in the Ashanti region (rural stratum) are served as recruitment sites. In Europe, Ghanaian migrants are selected through the municipality or Ghanaian organisations registers. Ethical approval has been obtained in all sites. This paper gives an overview of the rationale, conceptual framework and methods of the study. The differences across locations will allow us to gain insight into genetic and non-genetic factors contributing to the occurrence of obesity and T2D and will inform targeted intervention and prevention programmes, and provide the basis for improving diagnosis and treatment in these

  5. Marginal adaptation and CAD-CAM technology: A systematic review of restorative material and fabrication techniques.

    Science.gov (United States)

    Papadiochou, Sofia; Pissiotis, Argirios L

    2017-09-27

    The comparative assessment of computer-aided design and computer-aided manufacturing (CAD-CAM) technology and other fabrication techniques pertaining to marginal adaptation should be documented. Limited evidence exists on the effect of restorative material on the performance of a CAD-CAM system relative to marginal adaptation. The purpose of this systematic review was to investigate whether the marginal adaptation of CAD-CAM single crowns, fixed dental prostheses, and implant-retained fixed dental prostheses or their infrastructures differs from that obtained by other fabrication techniques using a similar restorative material and whether it depends on the type of restorative material. An electronic search of English-language literature published between January 1, 2000, and June 30, 2016, was conducted of the Medline/PubMed database. Of the 55 included comparative studies, 28 compared CAD-CAM technology with conventional fabrication techniques, 12 contrasted CAD-CAM technology and copy milling, 4 compared CAD-CAM milling with direct metal laser sintering (DMLS), and 22 investigated the performance of a CAD-CAM system regarding marginal adaptation in restorations/infrastructures produced with different restorative materials. Most of the CAD-CAM restorations/infrastructures were within the clinically acceptable marginal discrepancy (MD) range. The performance of a CAD-CAM system relative to marginal adaptation is influenced by the restorative material. Compared with CAD-CAM, most of the heat-pressed lithium disilicate crowns displayed equal or smaller MD values. Slip-casting crowns exhibited similar or better marginal accuracy than those fabricated with CAD-CAM. Cobalt-chromium and titanium implant infrastructures produced using a CAD-CAM system elicited smaller MD values than zirconia. The majority of cobalt-chromium restorations/infrastructures produced by DMLS displayed better marginal accuracy than those fabricated with the casting technique. Compared with copy

  6. The Hyper Suprime-Cam software pipeline

    Science.gov (United States)

    Bosch, James; Armstrong, Robert; Bickerton, Steven; Furusawa, Hisanori; Ikeda, Hiroyuki; Koike, Michitaro; Lupton, Robert; Mineo, Sogo; Price, Paul; Takata, Tadafumi; Tanaka, Masayuki; Yasuda, Naoki; AlSayyad, Yusra; Becker, Andrew C.; Coulton, William; Coupon, Jean; Garmilla, Jose; Huang, Song; Krughoff, K. Simon; Lang, Dustin; Leauthaud, Alexie; Lim, Kian-Tat; Lust, Nate B.; MacArthur, Lauren A.; Mandelbaum, Rachel; Miyatake, Hironao; Miyazaki, Satoshi; Murata, Ryoma; More, Surhud; Okura, Yuki; Owen, Russell; Swinbank, John D.; Strauss, Michael A.; Yamada, Yoshihiko; Yamanoi, Hitomi

    2018-01-01

    In this paper, we describe the optical imaging data processing pipeline developed for the Subaru Telescope's Hyper Suprime-Cam (HSC) instrument. The HSC Pipeline builds on the prototype pipeline being developed by the Large Synoptic Survey Telescope's Data Management system, adding customizations for HSC, large-scale processing capabilities, and novel algorithms that have since been reincorporated into the LSST codebase. While designed primarily to reduce HSC Subaru Strategic Program (SSP) data, it is also the recommended pipeline for reducing general-observer HSC data. The HSC pipeline includes high-level processing steps that generate coadded images and science-ready catalogs as well as low-level detrending and image characterizations.

  7. The path to CAM6: coupled simulations with CAM5.4 and CAM5.5

    Directory of Open Access Journals (Sweden)

    P. A. Bogenschutz

    2018-01-01

    Full Text Available This paper documents coupled simulations of two developmental versions of the Community Atmosphere Model (CAM towards CAM6. The configuration called CAM5.4 introduces new microphysics, aerosol, and ice nucleation changes, among others to CAM. The CAM5.5 configuration represents a more radical departure, as it uses an assumed probability density function (PDF-based unified cloud parameterization to replace the turbulence, shallow convection, and warm cloud macrophysics in CAM. This assumed PDF method has been widely used in the last decade in atmosphere-only climate simulations but has never been documented in coupled mode. Here, we compare the simulated coupled climates of CAM5.4 and CAM5.5 and compare them to the control coupled simulation produced by CAM5.3. We find that CAM5.5 has lower cloud forcing biases when compared to the control simulations. Improvements are also seen in the simulated amplitude of the Niño-3.4 index, an improved representation of the diurnal cycle of precipitation, subtropical surface wind stresses, and double Intertropical Convergence Zone biases. Degradations are seen in Amazon precipitation as well as slightly colder sea surface temperatures and thinner Arctic sea ice. Simulation of the 20th century results in a credible simulation that ends slightly colder than the control coupled simulation. The authors find this is due to aerosol indirect effects that are slightly stronger in the new version of the model and propose a solution to ameliorate this. Overall, in these early coupled simulations, CAM5.5 produces a credible climate that is appropriate for science applications and is ready for integration into the National Center for Atmospheric Research's (NCAR's next-generation climate model.

  8. The path to CAM6: coupled simulations with CAM5.4 and CAM5.5

    Science.gov (United States)

    Bogenschutz, Peter A.; Gettelman, Andrew; Hannay, Cecile; Larson, Vincent E.; Neale, Richard B.; Craig, Cheryl; Chen, Chih-Chieh

    2018-01-01

    This paper documents coupled simulations of two developmental versions of the Community Atmosphere Model (CAM) towards CAM6. The configuration called CAM5.4 introduces new microphysics, aerosol, and ice nucleation changes, among others to CAM. The CAM5.5 configuration represents a more radical departure, as it uses an assumed probability density function (PDF)-based unified cloud parameterization to replace the turbulence, shallow convection, and warm cloud macrophysics in CAM. This assumed PDF method has been widely used in the last decade in atmosphere-only climate simulations but has never been documented in coupled mode. Here, we compare the simulated coupled climates of CAM5.4 and CAM5.5 and compare them to the control coupled simulation produced by CAM5.3. We find that CAM5.5 has lower cloud forcing biases when compared to the control simulations. Improvements are also seen in the simulated amplitude of the Niño-3.4 index, an improved representation of the diurnal cycle of precipitation, subtropical surface wind stresses, and double Intertropical Convergence Zone biases. Degradations are seen in Amazon precipitation as well as slightly colder sea surface temperatures and thinner Arctic sea ice. Simulation of the 20th century results in a credible simulation that ends slightly colder than the control coupled simulation. The authors find this is due to aerosol indirect effects that are slightly stronger in the new version of the model and propose a solution to ameliorate this. Overall, in these early coupled simulations, CAM5.5 produces a credible climate that is appropriate for science applications and is ready for integration into the National Center for Atmospheric Research's (NCAR's) next-generation climate model.

  9. Discrimination in health care and CAM use in a representative sample of U.S. adults.

    Science.gov (United States)

    Thorburn, Sheryl; Faith, Jennifer; Keon, Karen Levy; Tippens, Kimberly M

    2013-06-01

    Discrimination in medical settings may influence patient attitudes about health care and health-seeking behaviors. Patients who experience discrimination may seek alternative means of health care, including use of complementary and alternative medicine (CAM). The objective of this study was to examine the relationship between discrimination in health care and CAM use. Data come from the 2001 Health Care Quality Survey (HCQS), which used a multistage sampling design with random-digit dialing, oversampling telephone exchanges with higher densities of African-American, Hispanic, and Asian households. The 2001 HCQS sample consisted of 6722 adults living in the continental United States. To correct for the disproportionate sample design, data were adjusted using sample weights to make the results representative of the U.S. population 18 years and older. Present analyses were limited to 6008 respondents who had visited a doctor or clinic or had been admitted to the hospital in the last 2 years. Outcome measures were CAM use, practitioner-provided CAM use, and herbal medicine use. In adjusted logistic regression analyses, discrimination in health care was significantly associated with use of herbal medicines alone (adjusted odds ratio=1.47, confidence interval: 1.05, 2.04), but not with use of practitioner-provided CAM (i.e., use of acupuncture, chiropractor, traditional healer or herbalist, alone or in combination with herbal medicines). Further research is needed to examine the direction of the relationship between discrimination and CAM use and differences by CAM modality.

  10. Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project.

    Science.gov (United States)

    Hilderson, Deborah; Westhovens, Rene; Wouters, Carine; Van der Elst, Kristien; Goossens, Eva; Moons, Philip

    2013-12-02

    To describe (1) the content of a transition programme for young people with juvenile idiopathic arthritis (JIA) designed as a brief intervention, (2) the rationale and design of a mixed-methods study evaluating the clinical impact of this transition programme and (3) to provide baseline data of the intervention group. An 'embedded experimental' design is used for the evaluation of the transition programme. A 'one-group pretest-posttest, with a non-equivalent posttest-only comparison group design' is used to quantitatively evaluate the impact of the transition programme, applying both longitudinal and comparative analyses. Subsequently, experiences of adolescents and their parents who participated in the experimental group will be analysed qualitatively using content analysis. Participants in the intervention are recruited at a tertiary care centre in Belgium. The comparison group participants are recruited from one tertiary and three secondary care centres in Belgium. The intervention group consists of 33 young people (25 females; 8 males) with a median age of 16 years. Main diagnoses are persistent or extended oligoarticular JIA (33%), polyarticular JIA (30%), enthesitis-related JIA (21%) or systemic arthritis (15%). The transition programme comprises eight key components: (1) transition coordinator; (2) providing information and education; (3) availability by telephone; (4) information about and contact with an adult care programme; (5) guidance of parents; (6) meeting with peers; (7) transfer plan; and (8) actual transfer to adult care. The primary outcome is health status, as perceived by the adolescents. Secondary outcomes are health status, as perceived by the parents; medication adherence; illness-related knowledge; quality of life; fatigue; promotion of independence; support of autonomy; behavioural control and psychological control. At baseline, the median score was 69.2 (Q1=60.0;Q3=92.9) on psychosocial health and 68.8 (Q1=56.3; Q3=89.1) on physical

  11. Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture.

    Science.gov (United States)

    Rua, Tiago; Vijayanathan, Sanjay; Parkin, David; Goh, Vicky; McCrone, Paul; Gidwani, Sam

    2017-12-01

    Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures. Methods Review of design and implementation challenges associated with the identification and subsequent recruitment of eligible patients, implementation of a novel clinical pathway in an acute setting, rationale behind the primary and secondary outcomes selected and measurement of the primary outcome. Results The Scaphoid Magnetic Resonance Imaging in Trauma trial is a single-site prospective, randomised, non-blinded, parallel design trial that aims to evaluate the use of immediate magnetic resonance imaging in the management of patients presenting to the acute setting with suspected scaphoid fractures. The primary outcome is the total 3-month cost per patient associated with the diagnosis and treatment of suspected scaphoid fractures. It is hypothesised that the immediate use of magnetic resonance imaging, a more accurate but expensive imaging modality, in patients with negative findings in the initial four-view radiography, will reduce the overall National Health Service costs by promoting definitive care and avoiding unnecessary diagnostic and treatment procedures. Other rationale design considerations in the recruitment, randomisation, data acquisition and intervention implementation are also discussed. Several of these challenges derive from real-world operational issues associated with the provision of magnetic resonance imaging in an

  12. DYNAMIC ANALYSIS OF A CRIMPING DEVICE WITH MULTIPLE CAMS USING MSC ADAMS II

    Directory of Open Access Journals (Sweden)

    Gheorghe Popescu

    2012-05-01

    Full Text Available Through the present paper, the author presents the results of the dynamic analysis with MSC ADAMS of the mechanism with a crimping device with 12 tightening cams, designed and used in the technological process of assembly of the indigenous electrical detonators. In this sense, the mechanism with multiple cams is considered a mechanical system and is treated as an assembly of rigid bodies connected by mechanical connections and elastic elements. For shaping and simulation of the mechanism with multiple cams using ADAMS program, the author got through the following stages: construction of the pattern, its testing and simulation, validation, finishing, parametrization, optimization of the pattern.

  13. Using bluetooth and GPS metadata to measure event similarity in SenseCam Images

    OpenAIRE

    Byrne, Daragh; Lavelle, Barry; Doherty, Aiden R.; Jones, Gareth J.F.; Smeaton, Alan F.

    2007-01-01

    The Microsoft SenseCam is a small multi-sensor camera worn around the user's neck. It was designed primarily for lifelog recording. At present, the SenseCam passively records up to 3,000 images per day as well as logging data from several on-board sensors. The sheer volume of image and sensor data captured by the SenseCam creates a number of challenges in the areas of segmenting whole day recordings into events, and searching for events. In this paper, we use content and contextual informatio...

  14. Complete Dentures Fabricated with CAD/CAM Technology and a Traditional Clinical Recording Method.

    Science.gov (United States)

    Janeva, Nadica; Kovacevska, Gordana; Janev, Edvard

    2017-10-15

    The introduction of computer-aided design/computer-aided manufacturing (CAD/CAM) technology into complete denture (CD) fabrication ushered in a new era in removable prosthodontics. Commercially available CAD/CAM denture systems are expected to improve upon the disadvantages associated with conventional fabrication. The purpose of this report is to present the workflow involved in fabricating a CD with a traditional clinical recording method and CAD/CAM technology and to summarize the advantages to the dental practitioner and the patient.

  15. Machinability of CAD-CAM materials.

    Science.gov (United States)

    Chavali, Ramakiran; Nejat, Amir H; Lawson, Nathaniel C

    2017-08-01

    Although new materials are available for computer-aided design and computer-aided manufacturing (CAD-CAM) fabrication, limited information is available regarding their machinability. The depth of penetration of a milling tool into a material during a timed milling cycle may indicate its machinability. The purpose of this in vitro study was to compare the tool penetration rate for 2 polymer-containing CAD-CAM materials (Lava Ultimate and Enamic) and 2 ceramic-based CAD-CAM materials (e.max CAD and Celtra Duo). The materials were sectioned into 4-mm-thick specimens (n=5/material) and polished with 320-grit SiC paper. Each specimen was loaded into a custom milling apparatus. The apparatus pushed the specimens against a milling tool (E4D Tapered 2016000) rotating at 40 000 RPM with a constant force of 0.98 N. After a 6-minute timed milling cycle, the length of each milling cut was measured with image analysis software under a digital light microscope. Representative specimens and milling tools were examined with scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy. The penetration rate of Lava Ultimate (3.21 ±0.46 mm/min) and Enamic (2.53 ±0.57 mm/min) was significantly greater than that of e.max CAD (1.12 ±0.32 mm/min) or Celtra Duo (0.80 ±0.21 mm/min) materials. SEM observations showed little tool damage, regardless of material type. Residual material was found on the tools used with polymer-containing materials, and wear of the embedding medium was seen on the tools used with the ceramic-based materials. Edge chipping was noted on cuts made in the ceramic-based materials. Lava Ultimate and Enamic have greater machinability and less edge chipping than e.max CAD and Celtra Duo. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  16. IMC & CAMS meeting in Egmond, the Netherlands

    Science.gov (United States)

    Roggemans, Paul

    2016-02-01

    The 35th IMC broke a few records: the largest total number of participants, the largest number of presentations, both talks and posters and the thickest IMC Proceedings ever. After the IMC the Benelux CAMS group had its meeting in Egmond. A summary is presented of the highlights of this IMC and CAMS day.

  17. CamOn: A Real-Time Autonomous Camera Control System

    DEFF Research Database (Denmark)

    Burelli, Paolo; Jhala, Arnav Harish

    2009-01-01

    This demonstration presents CamOn, an autonomous cam- era control system for real-time 3D games. CamOn employs multiple Artificial Potential Fields (APFs), a robot motion planning technique, to control both the location and orienta- tion of the camera. Scene geometry from the 3D environment...... on real-time motion planning of the camera. Moreover, the recasting of camera constraints into potential fields is visually more accessible to game designers and has the potential to be implemented as a plug-in to 3D level design and editing tools currently avail- able with games. Introduction...... contributes to the potential field that is used to determine po- sition and movement of the camera. Composition constraints for the camera are modelled as potential fields for controlling the view target of the camera. CamOn combines the compositional benefits of constraint- based camera systems, and improves...

  18. Comparative fracture strength analysis of Lava and Digident CAD/CAM zirconia ceramic crowns

    Science.gov (United States)

    Kwon, Taek-Ka; Pak, Hyun-Soon; Han, Jung-Suk; Lee, Jai-Bong; Kim, Sung-Hun

    2013-01-01

    PURPOSE All-ceramic crowns are subject to fracture during function. To minimize this common clinical complication, zirconium oxide has been used as the framework for all-ceramic crowns. The aim of this study was to compare the fracture strengths of two computer-aided design/computer-aided manufacturing (CAD/CAM) zirconia crown systems: Lava and Digident. MATERIALS AND METHODS Twenty Lava CAD/CAM zirconia crowns and twenty Digident CAD/CAM zirconia crowns were fabricated. A metal die was also duplicated from the original prepared tooth for fracture testing. A universal testing machine was used to determine the fracture strength of the crowns. RESULTS The mean fracture strengths were as follows: 54.9 ± 15.6 N for the Lava CAD/CAM zirconia crowns and 87.0 ± 16.0 N for the Digident CAD/CAM zirconia crowns. The difference between the mean fracture strengths of the Lava and Digident crowns was statistically significant (Pveneering porcelain and the core whereas the Digident CAD/CAM zirconia crowns showed fracture only of the veneering porcelain. CONCLUSION The fracture strengths of CAD/CAM zirconia crowns differ depending on the compatibility of the core material and the veneering porcelain. PMID:23755332

  19. Comparative evaluation of RetCam vs. gonioscopy images in congenital glaucoma

    Directory of Open Access Journals (Sweden)

    Raj V Azad

    2014-01-01

    Full Text Available Purpose: To compare clarity, exposure and quality of anterior chamber angle visualization in congenital glaucoma patients, using RetCam and indirect gonioscopy images. Design: Cross-sectional study Participants. Congenital glaucoma patients over age of 5 years. Materials and Methods: A prospective consecutive pilot study was done in congenital glaucoma patients who were older than 5 years. Methods used are indirect gonioscopy and RetCam imaging. Clarity of the image, extent of angle visible and details of angle structures seen were graded for both methods, on digitally recorded images, in each eye, by two masked observers. Outcome Measures: Image clarity, interobserver agreement. Results: 40 eyes of 25 congenital glaucoma patients were studied. RetCam image had excellent clarity in 77.5% of patients versus 47.5% by gonioscopy. The extent of angle seen was similar by both methods. Agreement between RetCam and gonioscopy images regarding details of angle structures was 72.50% by observer 1 and 65.00% by observer 2. Conclusions: There was good agreement between RetCam and indirect gonioscopy images in detecting angle structures of congenital glaucoma patients. However, RetCam provided greater clarity, with better quality, and higher magnification images. RetCam can be a useful alternative to gonioscopy in infants and small children without the need for general anesthesia.

  20. A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study

    National Research Council Canada - National Science Library

    Ferrara, Assiamira; Hedderson, Monique M; Albright, Cheryl L; Brown, Susan D; Ehrlich, Samantha F; Caan, Bette J; Sternfeld, Barbara; Gordon, Nancy P; Schmittdiel, Julie A; Gunderson, Erica P; Mevi, Ashley A; Tsai, Ai-Lin; Ching, Jenny; Crites, Yvonne; Quesenberry, Jr, Charles P

    2014-01-01

    .... In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level...

  1. Accuracy and safety of second-generation PillCam COLON capsule for colorectal polyp detection

    OpenAIRE

    Spada, Cristiano; De Vincentis, Fabio; Cesaro, Paola; Hassan, Cesare; Riccioni, Maria Elena; Minelli Grazioli, Leonardo; Bolivar, Santiago; Zurita, Andrade; Costamagna, Guido

    2012-01-01

    PillCam COLON capsule endoscopy (CCE) (Given Imaging Ltd, Yoqneam, Israel) is one of the most recent diagnostic, endoscopic technologies designed to explore the colon. CCE is a noninvasive, patient-friendly technique that is able to explore the colon without requiring sedation and air insufflation. The first generation of CCE was released onto the market in 2006 and although it generated great enthusiasm, it showed suboptimal accuracy. Recently, a second-generation system (PillCam COLON 2) (C...

  2. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

    Science.gov (United States)

    Bekelman, David B; Allen, Larry A; Peterson, Jamie; Hattler, Brack; Havranek, Edward P; Fairclough, Diane L; McBryde, Connor F; Meek, Paula M

    2016-11-01

    While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness. Published by Elsevier Inc.

  3. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT

    Directory of Open Access Journals (Sweden)

    van Assen Luite

    2010-01-01

    Full Text Available Abstract Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum till one year (maximum will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy, also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE and functional status (Neck Disability Index (NDI-DV. Secondary outcomes are neck pain (Numeric Rating Scale (NRS, Eurocol, costs and quality of life (SF36. Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843

  4. The Netherlands Obsessive Compulsive Disorder Association (NOCDA) study: design and rationale of a longitudinal naturalistic study of the course of OCD and clinical characteristics of the sample at baseline.

    Science.gov (United States)

    Schuurmans, Josien; van Balkom, Anton J L M; van Megen, Harold J G M; Smit, Johannes H; Eikelenboom, Merijn; Cath, Danielle C; Kaarsemaker, Maarten; Oosterbaan, Desiree; Hendriks, Gert-Jan; Schruers, Koen R J; van der Wee, Nic J A; Glas, Gerrit; van Oppen, Patricia

    2012-12-01

    In half of Obsessive Compulsive Disorder (OCD) patients the disorder runs a chronic course despite treatment. The factors determining this unfavourable outcome remain unknown. The Netherlands Obsessive Compulsive Disorder Association (NOCDA) study is a multicentre naturalistic cohort study of the biological, psychological and social determinants of chronicity in a clinical sample. Recruitment of OCD patients took place in mental health organizations. Its design is a six-year longitudinal cohort study among a representative clinical sample of 419 OCD patients. All five measurements within this six-year period involved validated semi-structured interviews and self-report questionnaires which gathered information on the severity of OCD and its co-morbidity as well as information on general wellbeing, quality of life, daily activities, medical consumption and key psychological and social factors. The baseline measurements also include DNA and blood sampling and data on demographic and personality variables. The current paper presents the design and rationale of the study, as well as data on baseline sample characteristics. Demographic characteristics and co-morbidity ratings in the NOCDA sample closely resemble other OCD study samples. Lifetime co-morbid Axis I disorders are present in the majority of OCD patients, with high current and lifetime co-morbidity ratings for affective disorders (23.4% and 63.7%, respectively) and anxiety disorders other than OCD (36% current and 46.5% lifetime). Copyright © 2012 John Wiley & Sons, Ltd.

  5. The prevalence extent of Complementary and Alternative Medicine (CAM) use among Saudis.

    Science.gov (United States)

    Alrowais, Norah A; Alyousefi, Nada A

    2017-03-01

    Introduction: There is worldwide interest in the use of CAM. Studying CAM in Saudi population is important as it will reflect the influence of psychosocial, cultural and religious factors on health beliefs and behaviors. The objective of this study was to present an updated review on the use of CAM practices in Saudi Arabia including commonly used types, common conditions for which it has been used and who uses CAM. Methods: This review used data from national surveys conducted in Saudi Arabia and published between 2000 and 2015. The literature search was performed considering standards adopted such as Moose guidelines for observational studies. Two authors independently reviewed each article. The search yielded 73 articles, and a total of 36 articles were included. Further careful data extraction was carried out by two independents reviewers. Results: Most of the reviewed studies were cross-sectional in design and were published between 2014 and 2015, and mostly in Riyadh region. Substantial difference in the findings for the patterns of CAM use was revealed. The most commonly employed practice was of spiritual type such as prayer and reciting Quran alone or on water. Other types include herbs (8-76%), honey (14-73%) and dietary products (6-82%). Cupping (Alhijamah) was least used (4-45%). Acupuncture was more practiced among professionals. Conclusion: The utilization of CAM is widely practiced in Saudi Arabia. There is need for efforts to promote research in the field of CAM to address each practice individually. Population surveys should be encouraged supported by mass media to raise knowledge and awareness about the practice of different CAM modalities. The national center of CAM should play a major role in these efforts.

  6. International Study on Syncope of Uncertain Etiology 2: the management of patients with suspected or certain neurally mediated syncope after the initial evaluation Rationale and study design

    NARCIS (Netherlands)

    Brignole, M.; Sutton, R.; Menozzi, C.; Moya, A.; Garcia-Civera, R.; Benditt, D.; Vardas, P.; Wieling, W.; Andresen, D.; Migliorini, R.; Hollinworth, D.

    2003-01-01

    Study design Multi-centre, prospective observational study Objectives Main objective is to verify the value of implantable loop recorder (ILR) in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence. Inclusion criteria Patients who met the following

  7. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS: Rationale, design, and uptake of online study intervention material

    Directory of Open Access Journals (Sweden)

    Maria I. Danila

    2016-12-01

    Conclusion: We developed and implemented a novel tailored multi-modal intervention to improve initiation of osteoporosis therapy. An email address provided on the survey was the most important factor independently associated with accessing the intervention online. The design and uptake of this intervention may have implications for future studies in osteoporosis or other chronic diseases.

  8. Rationale and design of ASSAF-K (A study of the safety and efficacy of anticoagulant therapy in the treatment of atrial fibrillation in Kanagawa

    Directory of Open Access Journals (Sweden)

    Yutaka Hatori, MD, PhD

    2017-04-01

    Conclusions: The results of the study are expected to serve as the basis for providing clinical practice guidance to healthcare institutions in Japan, with the ultimate goals of better characterizing the appropriate use of OACs and providing clinical decision support to physicians to facilitate the design of appropriate therapeutic strategies and the selection of anticoagulants for the management of AF.

  9. Gliucose-insulin-potassium and reperfusion in acute myocardial infarction : Rationale and design of the glucose insulin-potassium study-2 (GIPS-2)

    NARCIS (Netherlands)

    van der Horst, ICC; Timmer, [No Value; Ottervanger, JP; Bilo, HJG; Gans, ROB; de Boer, MJ; Zijlstra, F

    Background The combination of reperfusion therapy and high-dose glucose-insulin-potassium (GIK) infusion seems beneficial in acute myocardial infarction (MI). Current evidence, however, is not considered conclusive. Study Design The Glucose-Insulin-Potassium Study-2 (GIPS-2) will investigate whether

  10. International study on syncope of uncertain aetiology 3 (ISSUE 3): pacemaker therapy for patients with asystolic neurally-mediated syncope: rationale and study design

    NARCIS (Netherlands)

    Brignole, M.; Andresen, Dietrich; Benditt, David; Blanc, Jean Jacques; Garcia-Civera, Roberto; Khran, Andrew; Menozzi, Carlo; Moya, Angel; Sutton, Richard; Vardas, Panos; Wieling, Wouter

    2007-01-01

    Aim To assess the effectiveness of pacing therapy for preventing syncope recurrence in patients with a high probability of cardio-inhibitory neurally-mediated syncope (NMS). Methods Study design: Multi-centre, prospective, double-blind, randomized placebo-controlled study. Inclusion criteria:

  11. Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study.

    Science.gov (United States)

    Fiuzat, Mona; Oldenberg, Olaf; Whellan, David J; Woehrle, Holger; Punjabi, Naresh M; Anstrom, Kevin J; Blase, Amy B; Benjafield, Adam V; Lindenfeld, JoAnn; O'Connor, Christopher M

    2016-03-01

    The CAT-HF Study was designed to evaluate the safety and efficacy of minute ventilation-targeted adaptive servo-ventilation (MV-ASV) during sleep in addition to optimized medical therapy (active therapy) versus optimized medical therapy alone (usual care) at 6 months, initiated in patients after hospitalization for acute decompensated heart failure (ADHF). This paper outlines the rationale, design and information learned at the time of study discontinuation. Sleep disordered breathing (SDB) is common in heart failure patients and is associated with worse outcomes in this patient population. Based on a belief that MV-ASV was safe in stable HF patients, CAT-HF was designed to examine whether MV-ASV improved outcomes in hospitalized HF patients During the course of CAT-HF, new results from SERVE-HF indicated that ASV therapy may be harmful in patients with left ventricular ejection fractions (LVEF)≤45% and central sleep apnea, a subgroup of patients enrolled in CAT-HF. CAT-HF was a prospective, randomized, controlled, multicenter clinical trial (NCT: 01953874) in HF patients with either reduced or preserved ejection fraction and an Apnea-Hypopnea Index ≥15 events per hour randomized to usual care or active treatment in a 1:1 ratio. 215 patients were intended to be randomized following a hospitalization for ADHF. At the time of discontinuation, 126 patients were randomized. The primary endpoint is a global rank composite endpoint of death, CV hospitalizations, and Six minute walk distance (6MWD). Secondary endpoints will include changes in functional parameters, biomarkers, quality of life (QOL), sleep, and breathing. The CAT-HF study was designed to assess the efficacy and safety of MV ASV treatment in patients after hospitalization for ADHF, but was stopped early due to safety concerns in HF patients with (LVEF)≤45% and predominant central sleep apnea. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. CAM Photosynthesis in Submerged Aquatic Plants

    Science.gov (United States)

    Keeley, J.E.

    1998-01-01

    Crassulacean acid metabolism (CAM) is a CO2-concentrating mechanism selected in response to aridity in terrestrial habitats, and, in aquatic environments, to ambient limitations of carbon. Evidence is reviewed for its presence in five genera of aquatic vascular plants, including Isoe??tes, Sagittaria, Vallisneria, Crassula, and Littorella. Initially, aquatic CAM was considered by some to be an oxymoron, but some aquatic species have been studied in sufficient detail to say definitively that they possess CAM photosynthesis. CO2-concentrating mechanisms in photosynthetic organs require a barrier to leakage; e.g., terrestrial C4 plants have suberized bundle sheath cells and terrestrial CAM plants high stomatal resistance. In aquatic CAM plants the primary barrier to CO2 leakage is the extremely high diffusional resistance of water. This, coupled with the sink provided by extensive intercellular gas space, generates daytime CO2(Pi) comparable to terrestrial CAM plants. CAM contributes to the carbon budget by both net carbon gain and carbon recycling, and the magnitude of each is environmentally influenced. Aquatic CAM plants inhabit sites where photosynthesis is potentially limited by carbon. Many occupy moderately fertile shallow temporary pools that experience extreme diel fluctuations in carbon availability. CAM plants are able to take advantage of elevated nighttime CO2 levels in these habitats. This gives them a competitive advantage over non-CAM species that are carbon starved during the day and an advantage over species that expend energy in membrane transport of bicarbonate. Some aquatic CAM plants are distributed in highly infertile lakes, where extreme carbon limitation and light are important selective factors. Compilation of reports on diel changes in titratable acidity and malate show 69 out of 180 species have significant overnight accumulation, although evidence is presented discounting CAM in some. It is concluded that similar proportions of the aquatic

  13. A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity): rationale, design and methodology of a randomized controlled trial in Nanjing city, China

    Science.gov (United States)

    2012-01-01

    Background The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. Methods/design We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group). Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a) classroom curriculum, (including physical education and healthy diet education), b) school environment support, c) family involvement, and d) fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. Discussion The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools’ regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. Trial registration Registration number: ChiCTR-ERC-11001819 PMID:22545755

  14. A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity: rationale, design and methodology of a randomized controlled trial in Nanjing city, China

    Directory of Open Access Journals (Sweden)

    Xu Fei

    2012-06-01

    Full Text Available Abstract Background The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. Methods/design We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group. Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a classroom curriculum, (including physical education and healthy diet education, b school environment support, c family involvement, and d fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. Discussion The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools’ regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. Trial registration Registration number: ChiCTR-ERC-11001819

  15. The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vanhaecht Kris

    2012-05-01

    Full Text Available Abstract Background Proximal femur fracture (PFF is associated with considerable morbidity and mortality. The European Quality of Care Pathway (EQCP study on PFF (NCT00962910 was designed to determine how care pathways (CP for hospital treatment of PFF affect consistency of care, adherence to evidence-based key interventions, and clinical outcome. Methods/Design An international cluster-randomized controlled trial (cRCT will be performed in Belgium, Ireland, Italy and Portugal. Based on power analyses, a sample of 44 hospital teams and 437 patients per arm will be included in the study. In the control arm, usual care will be provided. Experimental teams will implement a care pathway which will include three active components: a formative evaluation of quality and organization of the care setting, a set of evidence-based key interventions, and support of the development and implementation of the CP. Main outcome will be the six-month mortality rate. Discussion The EQCP study constitutes the first international cRCT on care pathways. The EQCP project was designed as both a research and a quality improvement project and will provide a real-world framework for process evaluation to improve our understanding of why and when CP can really work. Trial registration number NCT00962910

  16. A Unique Opportunity for an Intercultural Discussion on CAM and Liver Disease

    Directory of Open Access Journals (Sweden)

    Francesco Marotta

    2005-01-01

    Full Text Available The meeting of the APASL, Asian Pacific Association for the Study of the Liver, was held in December 2004, in New Delhi, India. The meeting was held under the patronage of the APASL Committee and Board of Presidents of the National Liver Association and in conjunction with the annual conference of the Indian Association for the Study of Liver (INASL. The congress was designed to have a core meeting with three parallel sessions running throughout, dedicated research workshops and intensive breakfast sessions. This report concentrates on the two sessions devoted to complementary and alternative medicine (CAM and shows the latest research in CAM for liver disease and the concerns of doctors about integrating CAM with more traditional treatments. With researchers and practitioners gathering from all over the world, it was a unique opportunity for an intercultural discussion on CAM and liver disease.

  17. Kelston Beverages Pilot Study: Rationale, design and implementation of a community and school based intervention to reduce sugary drink consumption among children and youth.

    Science.gov (United States)

    Sundborn, G; Ni Mhurchu, C; Ness, C; Latu, H; Jackson, R

    2014-03-01

    The Kelston Beverages Study was designed to increase awareness of the sugar content of sugary drinks, the poor health consequences that high intake of these drinks have, and inform on ways to reduce intake of students. The aims of this pilot study were to refine interventions and processes designed to raise awareness of the harms that sugar sweetened beverages (SSBs) have on health, and to reduce their consumption among the youth of a small West Auckland suburb. There were three arms to this interventional study, one in schools, another in community organisations (churches, sports clubs and community groups), and the final arm is in the local retail sector. The school arm was the most extensive component and initially involved a survey of children's knowledge and consumption of sugar sweetened beverages (SSBs) using a brief questionnaire. The study evaluated any SSB policies in schools and for schools that did not have policies, opportunities were scoped to develop and implement them; a canteen AUDIT focussed particularly on beverages was carried out; and finally a student partnered social marketing exercise was undertaken that comprised 2 competitions, one to design a poster, and another to write and perform a rap. Children were re-surveyed at the completion of the intervention (7 months later) to determine change in knowledge and self-reported consumption of SSBs. Both the community organisations and retail arms of this study focussed on raising awareness into the harmful effects of SSBs and establishing healthy beverage policy in the respective organisations. Promising results with regards to acceptability, feasibility, and recruitment as well as valuable learnings with regard to process support the development of a proposal to conduct a cluster randomised trial of the interventions successfully tested in this pilot study.

  18. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study

    Directory of Open Access Journals (Sweden)

    Jennings Ernestine

    2010-04-01

    Full Text Available Abstract Background Tobacco smoking remains the leading preventable cause of death among American women. Exercise has shown promise as an aid to smoking cessation because it reduces weight gain and weight concerns, improves affect, and reduces nicotine withdrawal symptoms and cigarette craving. Studies have shown that the practice of yoga improves weight control, and reduces perceived stress and negative affect. Yoga practice also includes regulation of breathing and focused attention, both of which may enhance stress reduction and improve mood and well-being and may improve cessation outcomes. Methods/Design This pilot efficacy study is designed to examine the rates of cessation among women randomized to either a novel, 8-week Yoga plus Cognitive Behavioral Therapy (CBT smoking cessation intervention versus a Wellness program plus the same CBT smoking cessation intervention. Outcome measures include 7-day point prevalence abstinence at end of treatment, 3 and 6 months follow up and potential mediating variables (e.g., confidence in quitting smoking, self-efficacy. Other assessments include measures of mindfulness, spirituality, depressive symptoms, anxiety and perceived health (SF-36. Discussion Innovative treatments are needed that address barriers to successful smoking cessation among men and women. The design chosen for this study will allow us to explore potential mediators of intervention efficacy so that we may better understand the mechanism(s by which yoga may act as an effective complementary treatment for smoking cessation. If shown to be effective, yoga can offer an alternative to traditional exercise for reducing negative symptoms that often accompany smoking cessation and predict relapse to smoking among recent quitters. Trial Registration ClinicalTrials NCT00492310

  19. CAM Stochastic Volatility Model for Option Pricing

    Directory of Open Access Journals (Sweden)

    Wanwan Huang

    2016-01-01

    Full Text Available The coupled additive and multiplicative (CAM noises model is a stochastic volatility model for derivative pricing. Unlike the other stochastic volatility models in the literature, the CAM model uses two Brownian motions, one multiplicative and one additive, to model the volatility process. We provide empirical evidence that suggests a nontrivial relationship between the kurtosis and skewness of asset prices and that the CAM model is able to capture this relationship, whereas the traditional stochastic volatility models cannot. We introduce a control variate method and Monte Carlo estimators for some of the sensitivities (Greeks of the model. We also derive an approximation for the characteristic function of the model.

  20. Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED study

    Directory of Open Access Journals (Sweden)

    Rosman Johan

    2009-01-01

    Full Text Available Abstract Background Haemodialysis (HD is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF. The Primary failure rate of an AVF ranges between 20–54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. Methods/Design The study population is adult patients with stage IV or V chronic kidney disease (CKD currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid. Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted patency time, and adverse events, particularly bleeding. Discussion This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty

  1. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation

    DEFF Research Database (Denmark)

    Jons, Christian; Hansen, Peter Steen; Johannessen, Arne

    2009-01-01

    (MANTRA-PAF) trial is a randomized, controlled, parallel group, multicentre study designed to test whether catheter-based RFA is superior to optimized AAD therapy in suppressing relapse within 24 months of symptomatic and/or asymptomatic AF in patients with paroxysmal AF without prior AAD therapy...... centres in Scandinavia and Germany are participating in the study. Enrolment was started in 2005 and as of November 2008, 260 patients have been enrolled into the study. It is expected that enrolment will end by March 2009, when 300 patients have been included. CONCLUSION: The MANTRA-PAF trial...

  2. A multi-center, randomized, controlled trial of parenteral nutrition titrated to resting energy expenditure in children undergoing hematopoietic stem cell transplantation (“PNTREE”): Rationale and design

    Science.gov (United States)

    Bechard, Lori J.; Feldman, Henry A.; Gordon, Catherine; Gura, Kathleen; Sonis, Andrew; Leung, Kathryn; Venick, Robert; Guinan, Eva C.; Duggan, Christopher

    2013-01-01

    Background Children undergoing hematopoietic stem cell transplantation (HSCT) frequently require prolonged courses of parenteral nutrition (PN) as a consequence of gastrointestinal dysfunction related to preparative chemotherapy and radiation. PN has been associated with shorter engraftment time and decreased mortality during HSCT, however, it is also linked with complications, including infections, liver disease, and metabolic disturbances. Some of these complications may be a result of providing PN in excess of nutrient requirements. We previously described significant reductions in resting energy expenditure (REE), as measured by indirect calorimetry, over the course of HSCT. We also documented a decline in mid-arm muscle area, suggesting depletion of muscle mass, while triceps skinfold, a marker of fat stores, was unchanged. These results suggested the need for further study of energy expenditure, body composition and nutritional intake in this group of high risk patients. Design and hypothesis We hypothesize that changes in body composition affect REE during HSCT, and that standard nutritional support may lead to overfeeding. We are performing a randomized controlled trial of parenteral nutrition among children undergoing allogeneic HSCT. Subjects are randomized to receive PN designed to provide 100% of measured REE, or standard PN, i.e., 140% of estimated energy expenditure. The primary outcome variable is change in percent body fat. Secondary outcomes include glycemic control and frequency of infections, changes in REE and body composition. Conclusion This study will provide unique and comprehensive nutritional data and its results will guide nutritional therapy for children undergoing HSCT and possibly other catabolic patients. PMID:20004739

  3. Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM – a Pan Canadian cohort study

    Directory of Open Access Journals (Sweden)

    Sonia S. Anand

    2016-07-01

    Full Text Available Abstract Background The Canadian Alliance for Healthy Hearts and Minds (CAHHM is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Methods/Design Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity, cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. Discussion CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

  4. Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial: design and rationale of a randomised controlled multicenter trial

    Directory of Open Access Journals (Sweden)

    Schaapherder Alexander F

    2011-03-01

    Full Text Available Abstract Background In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. Methods/Design The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission. During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention, intolerance of enteral feeding and total costs from a societal perspective. Discussion The PYTHON trial is designed to show that a very early ( Trial Registration ISRCTN: ISRCTN18170985

  5. Impact of Perinatal Different Intrauterine Environments on Child Growth and Development in the First Six Months of Life--IVAPSA Birth Cohort: rationale, design, and methods.

    Science.gov (United States)

    Bernardi, Juliana Rombaldi; Ferreira, Charles Francisco; Nunes, Marina; da Silva, Clécio Homrich; Bosa, Vera Lúcia; Silveira, Patrícia Pelufo; Goldani, Marcelo Zubaran

    2012-04-02

    In the last twenty years, retrospective studies have shown that perinatal events may impact the individual health in the medium and long term. However, only a few prospective studies were designed to address this phenomenon. This study aims to describe the design and methods of the Impact of Perinatal Environmental Variations in the First Six Months of Life - the IVAPSA Birth Cohort. This is a clinical study and involves the recruitment of a birth cohort from hospitals in Porto Alegre, Rio Grande do Sul, Brazil. Mothers from different clinical backgrounds (hypertensive, diabetics, smokers, having an intrauterine growth restricted child for idiopathic reasons, and controls) will be invited to join the study twenty-four hours after the birth of their child. Data on economic, social, and maternal health care, feeding practices, anthropometric measures, physical activity, and neuropsychological evaluation will be obtained in interviews at postpartum, 7 and 15 days, 1, 3 and 6 months of life. To our knowledge, this is the first thematic cohort focused on the effects of intrauterine growth restriction to prospectively enroll mothers from different clinical backgrounds. The IVAPSA Birth Cohort is a promising research platform that can contribute to the knowledge on the relationship between perinatal events and their consequences on the children's early life.

  6. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk.

    Science.gov (United States)

    Müller-Wieland, Dirk; Leiter, Lawrence A; Cariou, Bertrand; Letierce, Alexia; Colhoun, Helen M; Del Prato, Stefano; Henry, Robert R; Tinahones, Francisco J; Aurand, Lisa; Maroni, Jaman; Ray, Kausik K; Bujas-Bobanovic, Maja

    2017-05-25

    Type 2 diabetes mellitus (T2DM) is often associated with mixed dyslipidaemia, where non-high-density lipoprotein cholesterol (non-HDL-C) levels may more closely align with cardiovascular risk than low-density lipoprotein cholesterol (LDL-C). We describe the design and rationale of the ODYSSEY DM-DYSLIPIDEMIA study that assesses the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk with non-HDL-C inadequately controlled despite maximally tolerated statin therapy. For the first time, atherogenic cholesterol-lowering with a PCSK9 inhibitor will be assessed with non-HDL-C as the primary endpoint with usual care as the comparator. DM-DYSLIPIDEMIA is a Phase 3b/4, randomised, open-label, parallel group, multinational study that planned to enrol 420 individuals. Main inclusion criteria were T2DM and mixed dyslipidaemia (non-HDL-C ≥100 mg/dl [≥2.59 mmol/l], and triglycerides ≥150 and DM-DYSLIPIDEMIA will provide information on the efficacy and safety of alirocumab versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk using non-HDL-C as the primary efficacy endpoint. Trial registration NCT02642159 (registered December 24, 2015).

  7. The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristics.

    Science.gov (United States)

    Samavat, Hamed; Dostal, Allison M; Wang, Renwei; Bedell, Sarah; Emory, Tim H; Ursin, Giske; Torkelson, Carolyn J; Gross, Myron D; Le, Chap T; Yu, Mimi C; Yang, Chung S; Yee, Douglas; Wu, Anna H; Yuan, Jian-Min; Kurzer, Mindy S

    2015-10-01

    The Minnesota Green Tea Trial (MGTT) was a randomized, placebo-controlled, double-blinded trial investigating the effect of daily green tea extract consumption for 12 months on biomarkers of breast cancer risk. Participants were healthy postmenopausal women at high risk of breast cancer due to dense breast tissue with differing catechol-O-methyltransferase (COMT) genotypes. The intervention was a green tea catechin extract containing 843.0 ± 44.0 mg/day epigallocatechin gallate or placebo capsules for 1 year. Annual digital screening mammograms were obtained at baseline and month 12, and fasting blood and 24-h urine samples were provided at baseline and at months 6 and 12. Primary endpoints included changes in percent mammographic density, circulating endogenous sex hormones, and insulin-like growth factor axis proteins; secondary endpoints were changes in urinary estrogens and estrogen metabolites and circulating F2-isoprostanes, a biomarker of oxidative stress. The MGTT screened more than 100,000 mammograms and randomized 1,075 participants based on treatment (green tea extract vs. placebo), stratified by COMT genotype activity (high COMT vs. low/intermediate COMT genotype activity). A total of 937 women successfully completed the study and 138 dropped out (overall dropout rate = 12.8 %). In this paper we report the rationale, design, recruitment, participant characteristics, and methods for biomarker and statistical analyses.

  8. Understanding dental CAD/CAM for restorations--accuracy from a mechanical engineering viewpoint.

    Science.gov (United States)

    Tapie, Laurent; Lebon, Nicolas; Mawussi, Bernardin; Fron-Chabouis, Hélène; Duret, Francois; Attal, Jean-Pierre

    2015-01-01

    As is the case in the field of medicine, as well as in most areas of daily life, digital technology is increasingly being introduced into dental practice. Computer-aided design/ computer-aided manufacturing (CAD/CAM) solutions are available not only for chairside practice but also for creating inlays, crowns, fixed partial dentures (FPDs), implant abutments, and other dental prostheses. CAD/CAM dental practice can be considered as the handling of devices and software processing for the almost automatic design and creation of dental restorations. However, dentists who want to use dental CAD/CAM systems often do not have enough information to understand the variations offered by such technology practice. Knowledge of the random and systematic errors in accuracy with CAD/CAM systems can help to achieve successful restorations with this technology, and help with the purchasing of a CAD/CAM system that meets the clinical needs of restoration. This article provides a mechanical engineering viewpoint of the accuracy of CAD/ CAM systems, to help dentists understand the impact of this technology on restoration accuracy.

  9. Rationale and design of a multi-centre randomised controlled trial of individualised cooled dialysate to prevent left ventricular systolic dysfunction in haemodialysis patients

    Directory of Open Access Journals (Sweden)

    Odudu Aghogho

    2012-06-01

    Full Text Available Abstract Background The main hypothesis of this study is that patients having regular conventional haemodialysis (HD will have a smaller decline in cardiac systolic function by using cooler dialysate. Cooler dialysate may also be beneficial for brain function. Methods/Design The trial is a multicentre, prospective, randomised, un-blinded, controlled trial. Patients will be randomised 1:1 to use a dialysate temperature of 37°C for 12 months or an individualised cooled dialysate. The latter will be set at 0.5°C less than the patient’s own temperature, determined from the mean of 6 prior treatment sessions with a tympanic thermometer, up to a maximum of 36°C. Protocol adherence will be regularly checked. Inclusion criteria are incident adult HD patients within 180 days of commencing in-centre treatment 3 times per week with capacity to consent for the trial and without contra-indications for magnetic resonance imaging. Exclusion criteria include not meeting inclusion criteria, inability to tolerate magnetic resonance imaging and New York Heart Association Grade IV heart failure. During the study period, resting cardiac and cerebral magnetic resonance imaging will be performed at baseline and 12 months on an inter-dialytic day. Cardiovascular performance during HD will also be assessed by continuous cardiac output monitors, intra-dialytic echocardiography and biomarkers at baseline and 12 months. The primary outcome measure is a 5% between-group difference in left ventricular ejection fraction measured by cardiac magnetic resonance imaging at 12 months compared to baseline. Analysis will be by intention-to-treat. Secondary outcome measures will include changes in cerebral microstructure and changes in cardiovascular performance during HD. A total of 73 patients have been recruited into the trial from four UK centres. The trial is funded by a Research for Patient Benefit Grant from the National Institute of Healthcare Research. AO is

  10. Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

    Science.gov (United States)

    Irish, Ashley; Dogra, Gursharan; Mori, Trevor; Beller, Elaine; Heritier, Stephane; Hawley, Carmel; Kerr, Peter; Robertson, Amanda; Rosman, Johan; Paul-Brent, Peta-Anne; Starfield, Melissa; Polkinghorne, Kevan; Cass, Alan

    2009-01-21

    Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20-54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding. This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that

  11. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome

    DEFF Research Database (Denmark)

    Schwartz, Gregory G; Olsson, Anders G; Ballantyne, Christie M

    2009-01-01

    BACKGROUND: Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol......, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent...... of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest...

  12. Rationale and design for the Asia BP@Home study on home blood pressure control status in 12 Asian countries and regions.

    Science.gov (United States)

    Kario, Kazuomi; Tomitani, Naoko; Buranakitjaroen, Peera; Chen, Chen-Huan; Chia, Yook-Chin; Divinagracia, Romeo; Park, Sungha; Shin, Jinho; Siddique, Saulat; Sison, Jorge; Soenarta, Arieska Ann; Sogunuru, Guru Prasad; Tay, Jam Chin; Turana, Yuda; Wang, Ji-Guang; Wong, Lawrence; Zhang, Yuqing; Wanthong, Sirisawat; Hoshide, Satoshi; Kanegae, Hiroshi

    2018-01-01

    Home blood pressure (BP) monitoring is endorsed in multiple guidelines as a valuable adjunct to office BP measurements for the diagnosis and management of hypertension. In many countries throughout Asia, physicians are yet to appreciate the significant contribution of BP variability to cardiovascular events. Furthermore, data from Japanese cohort studies have shown that there is a strong association between morning BP surge and cardiovascular events, suggesting that Asians in general may benefit from more effective control of morning BP. We designed the Asia BP@Home study to investigate the distribution of hypertension subtypes, including white-coat hypertension, masked morning hypertension, and well-controlled and uncontrolled hypertension. The study will also investigate the determinants of home BP control status evaluated by the same validated home BP monitoring device and the same standardized method of home BP measurement among 1600 or more medicated patients with hypertension from 12 countries/regions across Asia. ©2017 Wiley Periodicals, Inc.

  13. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    Science.gov (United States)

    Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

    2005-01-01

    Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

  14. Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

    Science.gov (United States)

    Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

    2014-01-01

    Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

  15. Trial design: Computer guided normal-low versus normal-high potassium control in critically ill patients: Rationale of the GRIP-COMPASS study

    Directory of Open Access Journals (Sweden)

    van der Maaten Joost MAA

    2010-12-01

    Full Text Available Abstract Background Potassium depletion is common in hospitalized patients and can cause serious complications such as cardiac arrhythmias. In the intensive care unit (ICU the majority of patients require potassium suppletion. However, there are no data regarding the optimal control target in critically ill patients. After open-heart surgery, patients have a strongly increased risk of atrial fibrillation or atrial flutter (AFF. In a novel trial design, we examined if in these patients different potassium control-targets within the normal range may have different effects on the incidence of AFF. Methods/Design The "computer-driven Glucose and potassium Regulation program in Intensive care Patients with COMparison of PotASSium targets within normokalemic range (GRIP-COMPASS trial" is a single-center prospective trial in which a total of 1200 patients are assigned to either a potassium control-target of 4.0 mmol/L or 4.5 mmol/L in consecutive alternating blocks of 50 patients each. Potassium levels are regulated by the computer-assisted potassium suppletion algorithm called GRIP-II (Glucose and potassium regulation for Intensive care Patients. Primary endpoint is the in-hospital incidence of AFF after cardiac surgery. Secondary endpoints are: in-hospital AFF in medical patients or patients after non-cardiac surgery, actually achieved potassium levels and their variation, electrolyte and glucose levels, potassium and insulin requirements, cumulative fluid balance, (ICU length of stay, ICU mortality, hospital mortality and 90-day mortality. Discussion The GRIP-COMPASS trial is the first controlled clinical trial to date that compares potassium targets. Other novel methodological elements of the study are that it is performed in ICU patients where both targets are within the normal range and that a computer-assisted potassium suppletion algorithm is used. Trial registration NCT 01085071 at ClinicalTrials.gov

  16. Using IT to improve access, communication, and asthma in African American and Hispanic/Latino Adults: Rationale, design, and methods of a randomized controlled trial.

    Science.gov (United States)

    Apter, Andrea J; Bryant-Stephens, Tyra; Morales, Knashawn H; Wan, Fei; Hardy, Sharmaine; Reed-Wells, Shakira; Dominguez, Maria; Gonzalez, Rodalyn; Mak, NaDea; Nardi, Alyssa; Park, Hami; Howell, John T; Localio, Russell

    2015-09-01

    Asthma morbidity is high among inner-city minority adults. Improving access to care and patient-provider communication are believed to be essential for improving outcomes. Access and communication in turn increasingly rely on information technology including features of the Electronic Health Record. Its patient portal offers web-based communication with providers and practices. How patients with limited resources and educational opportunities can benefit from this portal is unclear. In contrast, home visits by community health workers (CHWs) have improved access to care for asthmatic children and promoted caretaker-clinician communication. We describe the planning, design, and methodology of an ongoing randomized controlled trial for 300 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods who are directed to the most convenient internet access and taught to use the portal, with and without home visits from a CHW. The study 1) compares the effects of the 1-year interventions on asthma outcomes (improved asthma control, quality of life; fewer ED visits and hospitalizations for asthma or any cause), 2) evaluates whether communication (portal use) and access (appointments made/kept) mediate the interventions' effects on asthma outcomes, and 3) investigates effect modification by literacy level, primary language, and convenience of internet access. In home visits, CHWs 1) train patients to competency in portal use, 2) enhance care coordination, 3) communicate the complex social circumstances of patients' lives to providers, and 4) compensate for differences in patients' health literacy skills. The practical challenges to design and implementation in the targeted population are presented. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment. Methods/Design The present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied. Discussion The study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients. Trial

  18. Rationale and study design of the REM-HF study: remote management of heart failure using implanted devices and formalized follow-up procedures.

    Science.gov (United States)

    Morgan, John M; Dimitrov, Borislav D; Gill, Jas; Kitt, Sue; Ng, G Andre; McComb, Janet M; Raftery, James; Roderick, Paul; Seed, Alison; Williams, Simon G; Witte, Klaus K; Wright, D Jay; Yao, Guiqing Lily; Cowie, Martin R

    2014-09-01

    We wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices. REM-HF is a multicentre, randomized, non-blinded, parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices (ICD, CRT-D, or CRT-P). The trial is event driven, and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis. We have randomized 1650 patients to be followed up for a minimum of 2 years. Patients will remain in the trial up to study termination. The first patient was randomized in September 2011 and the study is expected to complete in early 2016. The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons. An economic evaluation will be performed, estimating the cost per quality-adjusted life year, with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D, Short-Form 12, and Kansas City Cardiomyopathy Questionnaires. The study design has been informed by a feasibility study. REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality, as well as the cost-effectiveness of this approach. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

  19. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  20. Rationale and Design of a Randomized Clinical Trial Comparing Stress Reduction Treatment to Usual Cardiac Care: The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial

    Science.gov (United States)

    Donahue, Rebecca G.; Lampert, Rachel; Dornelas, Ellen; Clemow, Lynn; Burg, Matthew M.

    2010-01-01

    Objective Present the design of a multicenter randomized trial testing the effects of Stress Reduction Treatment (SRT) on the prevalence of shock treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials. Methods New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the past 6 months (n=304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6-, 12-, and 24-months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), ATP events, medication changes, hospitalizations, deaths, and quality of life. Results Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on lab stress induced and 24-hour arrhythmogenic electrophysiological indices from pre- to post-treatment, and both quality of life and measures of anger across the 2-years of the study. Conclusions The RISTA Trial is the first large scale randomized clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia provoked shock and improve quality of life. PMID:20028832

  1. PRevalence of Abuse and Intimate Partner Violence Surgical Evaluation (P.R.A.I.S.E.: rationale and design of a multi-center cross-sectional study.

    Directory of Open Access Journals (Sweden)

    2010-04-01

    Full Text Available Abstract Background Intimate partner violence (IPV is described by the American Medical Association as "a pattern of coercive behaviors that may include repeated battering and injury, psychological abuse, sexual assault, progressive social isolation, deprivation, and intimidation." The long-term consequences of IPV include health risks, posttraumatic stress disorder, depression, and staggering economic costs for health care of victims. Intimate partner violence is often underreported among women who seek medical attention. The current study seeks to address the issue of possible underreporting of IPV in orthopaedic fracture clinics by establishing prevalence rates of IPV among women seeking treatment for musculoskeletal injuries. Methods/Design We propose a cross-sectional multicenter study wherein 3,600 women will complete a self-reported written questionnaire across clinical sites in North America, Europe, and Australia. Recruitment of participants will take place at orthopaedic fracture clinics at each clinical site. The questionnaire will contain a validated set of questions used to screen for IPV, as well as questions that pertain to the participant's demographic, injury characteristics, and experiences with health care utilization. Female patients presenting to the orthopaedic fracture clinics will complete two validated self-reported written questionnaires (Woman Abuse Screening Tool (WAST and the Partner Violence Screen (PVS to determine the prevalence of IPV in the past 12 months and in their lifetime. The two questionnaires were designed for rapid assessment of IPV status in emergency departments, family practice, and women's health clinics that we believe are similar to our intended setting of an orthopaedic clinic. Discussion If the prevalence of IPV among women attending orthopaedic clinics is greater than the current perceptions of orthopaedic surgeons, this study will serve to advocate for the continued education of medical

  2. Web-Based Study of Risk Factors for Pain Exacerbation in Osteoarthritis of the Knee (SPARK-Web): Design and Rationale.

    Science.gov (United States)

    Makovey, Joanna; Metcalf, Ben; Zhang, Yuqing; Chen, Jian Sheng; Bennell, Kim; March, Lyn; Hunter, David J

    2015-07-08

    Knee osteoarthritis (OA) is the most frequent cause of limited mobility and diminished quality of life. Pain is the main symptom that drives individuals with knee OA to seek medical care and a recognized antecedent to disability and eventually joint replacement. Many persons with symptomatic knee OA experience recurrent pain exacerbations. Knowledge and clarification of risk factors for pain exacerbation may allow those affected to minimize reoccurrence of these episodes. The aim of this study is to use a Web-based case-crossover design to identify risk factors for knee pain exacerbations in persons with symptomatic knee OA. Web-based case-crossover design is used to study persons with symptomatic knee OA. Participants with knee pain and radiographic knee OA will be recruited and followed for 90 days. Participants will complete an online questionnaire at the baseline and every 10 days thereafter (totaling up to 10 control-period questionnaires); participants will also be asked to report online when they experience an episode of increased knee pain. Pain exacerbation will be defined as an increase in knee pain severity of two points from baseline on a numeric rating scale (NRS 0-10). Physical activity, footwear, knee injury, medication use, climate, psychological factors, and their possible interactions will be assessed as potential triggers for pain exacerbation using conditional logistic regression models. This project has been funded by the National Health and Medical Research Council (NHMRC). The enrollment for the study has started. So far, 343 participants have been enrolled. The study is expected to be finished in October 2015. This study will identify risk factors for pain exacerbations in knee OA. The identification and possible modification/elimination of such risk factors will help to prevent the reoccurrence of pain exacerbation episodes and therefore improve knee OA management.

  3. A Serious Video Game to Increase Fruit and Vegetable Consumption Among Elementary Aged Youth (Squire’s Quest! II): Rationale, Design, and Methods

    Science.gov (United States)

    Bhatt, Riddhi; Cullen, Karen; Baranowski, Janice; Baranowski, Tom

    2012-01-01

    Background Youths eat fewer fruits and vegetables than recommended. Effective methods are needed to increase and maintain their fruit and vegetable consumption. Goal setting has been an effective behavior change procedure among adults, but has had limited effectiveness among youths. Implementation intentions are specific plans to facilitate goal attainment. Redefining goal setting to include implementation intentions may be an effective way to increase effectiveness. Video games offer a controlled venue for conducting behavioral research and testing hypotheses to identify mechanisms of effect. Objective This report describes the protocol that guided the design and evaluation of Squire’s Quest! II, a video game aimed to increase child fruit and vegetable consumption. Methods Squire’s Quest! II is a 10-episode videogame promoting fruit and vegetable consumption to 4th and 5th grade children (approximately 9-11 year old youths). A four group randomized design (n=400 parent/child dyads) was used to systematically test the effect of two types of implementation intentions (action, coping) on fruit and vegetable goal attainment and consumption of 4th and 5th graders. Data collection occurred at baseline, immediately post game-play, and 3 months later. Child was the unit of assignment. Three dietary recalls were collected at each data collection period by trained interviewers using the Nutrient Data System for Research (NDSR 2009). Psychosocial and process data were also collected. Results To our knowledge, this is the first research to explore the effect of implementation intentions on child fruit and vegetable goal attainment and consumption. Conclusions This intervention will contribute valuable information regarding whether implementation intentions are effective with elementary age children. Trial Registration ClinicalTrials.gov NCT01004094 PMID:23612366

  4. The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses

    Science.gov (United States)

    2014-01-01

    Background Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. Methods/Design The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Discussion Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks. PMID:24475944

  5. Rationale, design, and baseline characteristics of the Salt Substitute and Stroke Study (SSaSS)-A large-scale cluster randomized controlled trial.

    Science.gov (United States)

    Neal, Bruce; Tian, Maoyi; Li, Nicole; Elliott, Paul; Yan, Lijing L; Labarthe, Darwin R; Huang, Liping; Yin, Xuejun; Hao, Zhixin; Stepien, Sandrine; Shi, Jingpu; Feng, Xiangxian; Zhang, Jianxin; Zhang, Yuhong; Zhang, Ruijuan; Wu, Yangfeng

    2017-06-01

    Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater relative risk reduction for stroke. The power estimate assumes a primary outcome event rate of 3.5% per year and a systolic blood pressure difference of 3.0mm Hg between randomized groups. Recruitment is complete and there are 20,996 participants (about 35 per village) that have been enrolled. Mean age is 65years and 49% are female. There were 73% enrolled on the basis of a history of stroke. The trial is well placed to describe the effects of salt substitution on the risks of vascular disease and death and will provide important policy-relevant data. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Diabetes MILES – The Netherlands: rationale, design and sample characteristics of a national survey examining the psychosocial aspects of living with diabetes in Dutch adults

    Directory of Open Access Journals (Sweden)

    Nefs Giesje

    2012-10-01

    Full Text Available Abstract Background As the number of people with diabetes is increasing rapidly worldwide, a more thorough understanding of the psychosocial aspects of living with this condition has become an important health care priority. While our knowledge has grown substantially over the past two decades with respect to the physical, emotional and social difficulties that people with diabetes may encounter, many important issues remain to be elucidated. Under the umbrella of the Diabetes MILES (Management and Impact for Long-term Empowerment and Success Study International Collaborative, Diabetes MILES – The Netherlands aims to examine how Dutch adults with diabetes manage their condition and how it affects their lives. Topics of special interest in Diabetes MILES - The Netherlands include subtypes of depression, Type D personality, mindfulness, sleep and sexual functioning. Methods/design Diabetes MILES – The Netherlands was designed as a national online observational study among adults with diabetes. In addition to a main set of self-report measures, the survey consisted of five complementary modules to which participants were allocated randomly. From September to October 2011, a total of 3,960 individuals with diabetes (40% type 1, 53% type 2 completed the battery of questionnaires covering a broad range of topics, including general health, self-management, emotional well-being and contact with health care providers. People with self-reported type 1 diabetes (specifically those on insulin pump therapy were over-represented, as were those using insulin among respondents with self-reported type 2 diabetes. People from ethnic minorities were under-represented. The sex distribution was fairly equal in the total sample, participants spanned a broad age range (19–90 years, and diabetes duration ranged from recent diagnosis to living with the condition for over fifty years. Discussion The Diabetes MILES Study enables detailed investigation of the

  7. Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ambresin Gilles

    2012-10-01

    Full Text Available Abstract Background A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. Methods/Design The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions. Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. Discussion Despite the large number of studies

  8. Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data.

    Science.gov (United States)

    Gelli, Aulo; Masset, Edoardo; Folson, Gloria; Kusi, Anthoni; Arhinful, Daniel K; Asante, Felix; Ayi, Irene; Bosompem, Kwabena M; Watkins, Kristie; Abdul-Rahman, Lutuf; Agble, Rosanna; Ananse-Baden, Getrude; Mumuni, Daniel; Aurino, Elisabetta; Fernandes, Meena; Drake, Lesley

    2016-01-20

    'Home-grown' school feeding programmes are complex interventions with the potential to link the increased demand for school feeding goods and services to community-based stakeholders, including smallholder farmers and women's groups. There is limited rigorous evidence, however, that this is the case in practice. This evaluation will examine explicitly, and from a holistic perspective, the simultaneous impact of a national school meals programme on micronutrient status, alongside outcomes in nutrition, education and agriculture domains. The 3-year study involves a cluster-randomised control trial designed around the scale-up of the national school feeding programme, including 116 primary schools in 58 districts in Ghana. The randomly assigned interventions are: 1) a school feeding programme group, including schools and communities where the standard government programme is implemented; 2) 'home-grown' school feeding, including schools and communities where the standard programme is implemented alongside an innovative pilot project aimed at enhancing nutrition and agriculture; and 3) a control group, including schools and households from communities where the intervention will be delayed by at least 3 years, preferably without informing schools and households. Primary outcomes include child health and nutritional status, school participation and learning, and smallholder farmer income. Intermediate outcomes along the agriculture and nutrition pathways will also be measured. The evaluation will follow a mixed-method approach, including child-, household-, school- and community-level surveys as well as focus group discussions with project stakeholders. The baseline survey was completed in August 2013 and the endline survey is planned for November 2015. The tests of balance show significant differences in the means of a number of outcome and control variables across the intervention groups. Important differences across groups include marketed surplus, livestock income

  9. Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Ørner Roderick

    2009-01-01

    Full Text Available Abstract Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs. Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults

  10. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

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    Thorsen Lene

    2012-03-01

    Full Text Available Abstract Background Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Methods/design Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life assessed by questionnaires. Muscle cellular outcomes are a muscle fiber size b regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy and c regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes

  11. Diabetes MILES – The Netherlands: rationale, design and sample characteristics of a national survey examining the psychosocial aspects of living with diabetes in Dutch adults

    Science.gov (United States)

    2012-01-01

    Background As the number of people with diabetes is increasing rapidly worldwide, a more thorough understanding of the psychosocial aspects of living with this condition has become an important health care priority. While our knowledge has grown substantially over the past two decades with respect to the physical, emotional and social difficulties that people with diabetes may encounter, many important issues remain to be elucidated. Under the umbrella of the Diabetes MILES (Management and Impact for Long-term Empowerment and Success) Study International Collaborative, Diabetes MILES – The Netherlands aims to examine how Dutch adults with diabetes manage their condition and how it affects their lives. Topics of special interest in Diabetes MILES - The Netherlands include subtypes of depression, Type D personality, mindfulness, sleep and sexual functioning. Methods/design Diabetes MILES – The Netherlands was designed as a national online observational study among adults with diabetes. In addition to a main set of self-report measures, the survey consisted of five complementary modules to which participants were allocated randomly. From September to October 2011, a total of 3,960 individuals with diabetes (40% type 1, 53% type 2) completed the battery of questionnaires covering a broad range of topics, including general health, self-management, emotional well-being and contact with health care providers. People with self-reported type 1 diabetes (specifically those on insulin pump therapy) were over-represented, as were those using insulin among respondents with self-reported type 2 diabetes. People from ethnic minorities were under-represented. The sex distribution was fairly equal in the total sample, participants spanned a broad age range (19–90 years), and diabetes duration ranged from recent diagnosis to living with the condition for over fifty years. Discussion The Diabetes MILES Study enables detailed investigation of the psychosocial aspects of living

  12. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics

    Science.gov (United States)

    Fitzpatrick, Lorraine A.; Bilezikian, John P.; Wooddell, Margaret; Paul, Gitanjali; Kolatkar, Nikheel S.; Nino, Antonio J.; Miller, Colin G.; Bogado, Cesar E.; Arnaud, Claude D.; Cobitz, Alexander R.

    2012-01-01

    Objectives Post-hoc analyses have shown an increase incidence of fractures among type 2 diabetes (T2DM) patients treated with thiazolidinediones (TZDs). The mechanisms by which TZDs may be associated with increased fracture risk is not well understood. This article describes the study design and baseline characteristics for a prospective, randomized, double-blind, active-controlled trial to evaluate the effects of rosiglitazone on changes in measures of skeletal structure, surrogates of bone strength and metabolism. Methods Postmenopausal women without osteoporosis and diagnosed with T2DM were randomized in a double-blind design to either rosiglitazone or metformin for 52 weeks, then all subjects received open-label metformin for 24 weeks. Study endpoints included changes in bone mineral density (BMD), quantitative computed tomography (QCT), digitized hip radiography (HXR) and high resolution magnetic resonance imaging (hrMRI). Serum markers of bone metabolism and indices of glycemic control were assessed within and between treatment groups. Results A total of 226 subjects were randomized. Baseline characteristics included: age 63.8 ± 6.5 years; years postmenopausal 16.9 ± 8.4; duration of diabetes 3.5 (1.8–7.8) years; body mass index (BMI) 31.4 ± 5.9 kg/m2; and glycated hemoglobin (HbA1c) 6.4 ± 0.65%. At baseline, mean T-scores were −0.95 ± 0.91 at the femoral neck, −0.02 ± 0.97 at the total hip and −0.55 ± 1.25 at the total spine. Since there are no well recognized techniques to determine bone mass and structure at the distal limbs (cortical bone sites where fractures were reported in RSG subjects), using the femoral neck as a surrogate for these areas may be a potential limitation of the study. Conclusion This is the first randomized trial utilizing multiple techniques to evaluate bone mass, structure, serum markers of bone remodeling, and potential reversibility of changes after discontinuation of rosiglitazone. This

  13. Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR randomized trial in primary care

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    Wisnivesky Juan

    2011-09-01

    Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative

  14. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

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    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  15. Non-invasive cardiac assessment in high risk patients (The GROUND study: rationale, objectives and design of a multi-center randomized controlled clinical trial

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    Moll Frans L

    2008-08-01

    Full Text Available Abstract Background Peripheral arterial disease (PAD is a common disease associated with a considerably increased risk of future cardiovascular events and most of these patients will die from coronary artery disease (CAD. Screening for silent CAD has become an option with recent non-invasive developments in CT (computed tomography-angiography and MR (magnetic resonance stress testing. Screening in combination with more aggressive treatment may improve prognosis. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by treatment will reduce the risk of cardiovascular disease in PAD patients free from cardiac symptoms. Design The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but without symptomatic cardiac disease will be asked to participate. All patients receive a proper risk factor management before randomization. Half of the recruited patients will enter the 'control group' and only undergo CT calcium scoring. The other half of the recruited patients (index group will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First, patients are submitted to CT calcium scoring and CT angiography. Patients with a left main (or equivalent coronary artery stenosis of > 50% on CT will be referred to a cardiologist without further imaging. All other patients in this group will undergo dobutamine stress magnetic resonance (DSMR testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. These patients are candidates for conventional coronary angiography and cardiac interventions (coronary artery bypass grafting (CABG or percutaneous cardiac interventions (PCI, if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of cardiovascular events. Sequential interim analysis will take place. Based on sample size

  16. The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design

    Directory of Open Access Journals (Sweden)

    Crawford Jeffrey

    2010-04-01

    Full Text Available Abstract Background The Lung Cancer Exercise Training Study (LUNGEVITY is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak, patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC patients. Methods/Design Using a single-center, randomized design, 160 subjects (40 patients/study arm with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1 aerobic training alone, (2 resistance training alone, (3 the combination of aerobic and resistance training, or (4 attention-control (progressive stretching. The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks, social interaction (participants will receive one-on-one instruction, and duration (30-45 mins/session. The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs (e.g., quality of life, fatigue, depression, etc. and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function. All endpoints will be assessed at baseline and postintervention (16 weeks. Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes

  17. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics.

    Science.gov (United States)

    Fitzpatrick, Lorraine A; Bilezikian, John P; Wooddell, Margaret; Paul, Gitanjali; Kolatkar, Nikheel S; Nino, Antonio J; Miller, Colin G; Bogado, Cesar E; Arnaud, Claude D; Cobitz, Alexander R

    2012-01-01

    Post-hoc analyses have shown an increase incidence of fractures among type 2 diabetes (T2DM) patients treated with thiazolidinediones (TZDs). The mechanisms by which TZDs may be associated with increased fracture risk is not well understood. This article describes the study design and baseline characteristics for a prospective, randomized, double-blind, active-controlled trial to evaluate the effects of rosiglitazone on changes in measures of skeletal structure, surrogates of bone strength and metabolism. Postmenopausal women without osteoporosis and diagnosed with T2DM were randomized in a double-blind design to either rosiglitazone or metformin for 52 weeks, then all subjects received open-label metformin for 24 weeks. Study endpoints included changes in bone mineral density (BMD), quantitative computed tomography (QCT), digitized hip radiography (HXR) and high resolution magnetic resonance imaging (hrMRI). Serum markers of bone metabolism and indices of glycemic control were assessed within and between treatment groups. A total of 226 subjects were randomized. Baseline characteristics included: age 63.8 ± 6.5 years; years postmenopausal 16.9 ± 8.4; duration of diabetes 3.5 (1.8-7.8) years; body mass index (BMI) 31.4 ± 5.9 kg/m(2); and glycated hemoglobin (HbA1c) 6.4 ± 0.65%. At baseline, mean T-scores were -0.95 ± 0.91 at the femoral neck, -0.02 ± 0.97 at the total hip and -0.55 ± 1.25 at the total spine. Since there are no well recognized techniques to determine bone mass and structure at the distal limbs (cortical bone sites where fractures were reported in RSG subjects), using the femoral neck as a surrogate for these areas may be a potential limitation of the study. This is the first randomized trial utilizing multiple techniques to evaluate bone mass, structure, serum markers of bone remodeling, and potential reversibility of changes after discontinuation of rosiglitazone. This study will provide information about RSG

  18. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation

    Directory of Open Access Journals (Sweden)

    Johnson Jeffrey A

    2012-08-01

    Full Text Available Abstract Background When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting. Methods/design We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1 improving depressive symptoms, 2 improving blood glucose, blood pressure and cholesterol, and 3 improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled “on-off” trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol. Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all

  19. A self-determination theory and motivational interviewing intervention to decrease racial/ethnic disparities in physical activity: rationale and design.

    Science.gov (United States)

    Miller, Lauren S; Gramzow, Richard H

    2016-08-11

    Although the mental and physical benefits of physical activity are well-established, there is a racial/ethnic disparity in activity such that minorities are much less likely to engage in physical activity than are White individuals. Research suggests that a lack of motivation may be an important barrier to physical activity for racial/ethnic minorities. Therefore, interventions that increase participants' motivation may be especially useful in promoting physical activity within these groups. Physical activity interventions that utilized the clinical technique of motivational interviewing (MI) in conjunction with the theoretical background of self-determination theory (SDT) have been effective in increasing White individuals' physical activity. Nevertheless, it remains unclear the extent to which these results apply to minority populations. The current study involves conducting a 12-week physical activity intervention based on SDT and MI to promote physical activity in a racially/ethnically-diverse sample. It is hypothesized that this intervention will successfully increase physical activity in participants. Specifically, it is expected that minorities will experience a greater relative increase in physical activity than Whites within the intervention group because minorities are expected to have lower baseline levels of activity. Results from this study will give us a greater understanding of the generalizability of SDT interventions designed to improve motivation for physical activity and level of physical activity. Clinical Trials Gov. Identifier NCT02250950 Registered 24 September 2014.

  20. Framework for the design and delivery of organized physical activity sessions for children and adolescents: rationale and description of the 'SAAFE' teaching principles.

    Science.gov (United States)

    Lubans, David R; Lonsdale, Chris; Cohen, Kristen; Eather, Narelle; Beauchamp, Mark R; Morgan, Philip J; Sylvester, Benjamin D; Smith, Jordan J

    2017-02-23

    The economic burden of inactivity is substantial, with conservative estimates suggesting the global cost to health care systems is more than US$50 billion. School-based programs, including physical education and school sport, have been recommended as important components of a multi-sector, multi-system approach to address physical inactivity. Additionally, community sporting clubs and after-school programs (ASPs) offer further opportunities for young people to be physically active outside of school. Despite demonstrating promise, current evidence suggests school-based physical activity programs, community sporting clubs and ASPs are not achieving their full potential. For example, physical activity levels in physical education (PE) and ASP sessions are typically much lower than recommended. For these sessions to have the strongest effects on young people's physical activity levels and their on-going physical literacy, they need to improve in quality and should be highly active and engaging. This paper presents the Supportive, Active, Autonomous, Fair, Enjoyable (SAAFE) principles, which represent an evidence-based framework designed to guide the planning, delivery and evaluation of organized physical activity sessions in school, community sport and ASPs. In this paper we provide a narrative and integrative review of the conceptual and empirical bases that underpin this framework and highlight implications for knowledge translation and application.

  1. Design and rationale of a matched cohort study to assess the effectiveness of a combined household-level piped water and sanitation intervention in rural Odisha, India.

    Science.gov (United States)

    Reese, Heather; Routray, Parimita; Torondel, Belen; Sclar, Gloria; Delea, Maryann G; Sinharoy, Sheela S; Zambrano, Laura; Caruso, Bethany; Mishra, Samir R; Chang, Howard H; Clasen, Thomas

    2017-03-31

    Government efforts to address massive shortfalls in rural water and sanitation in India have centred on construction of community water sources and toilets for selected households. However, deficiencies with water quality and quantity at the household level and community coverage and actual use of toilets have led Gram Vikas, a local non-governmental organization in Odisha, India, to develop an approach that provides household-level piped water connections contingent on full community-level toilet coverage. This matched cohort study was designed to assess the effectiveness of a combined piped water and sanitation intervention. Households with children environmental enteric dysfunction. In addition, intervention effects on sanitation and water coverage, access and use, environmental fecal contamination, women's empowerment, as well as collective efficacy, and intervention cost and cost-effectiveness will be assessed. The study protocol has been reviewed and approved by the ethics boards of the London School of Hygiene and Tropical Medicine, UK and KIIT University, Bhubaneswar, India. Findings will be disseminated via peer-reviewed literature and presentation to stakeholders, government officials, implementers and researchers. NCT02441699. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD

    Directory of Open Access Journals (Sweden)

    Hansen Jørgen

    2009-04-01

    Full Text Available Abstract Background The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome. Methods Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures. Discussion This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00140257

  3. Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

    Science.gov (United States)

    Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

    2017-04-01

    Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

  4. OPTImal CArdiac REhabilitation (OPTICARE) following Acute Coronary Syndromes: Rationale and design of a randomised, controlled trial to investigate the benefits of expanded educational and behavioural intervention programs.

    Science.gov (United States)

    Sunamura, M; Ter Hoeve, N; van den Berg-Emons, H J G; Haverkamp, M; Redekop, K; Geleijnse, M L; Stam, H J; Boersma, E; van Domburg, R T

    2013-07-01

    The majority of cardiac rehabilitation (CR) referrals consist of patients who have survived an acute coronary syndrome (ACS). Although major changes have been implemented in ACS treatment since the 1980s, which highly influenced mortality and morbidity, CR programs have barely changed and only few data are available on the optimal CR format in these patients. We postulated that standard CR programs followed by relatively brief maintenance programs and booster sessions, including behavioural techniques and focusing on incorporating lifestyle changes into daily life, can improve long-term adherence to lifestyle modifications. These strategies might result in improved (cardiac) mortality and morbidity in a cost-effective fashion. In the OPTImal CArdiac REhabilitation (OPTICARE) trial we will assess the effects of two advanced and extended CR programs that are designed to stimulate permanent adaption of a heart-healthy lifestyle, compared with current standard CR, in ACS patients. We will study the effects in terms of cardiac risk profile, levels of daily physical activity, quality of life and health care consumption.

  5. Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients (PAM-ICD): Rationale and Design of an RCT Currently Underway.

    Science.gov (United States)

    Serber, Eva R; Fava, Joseph L; Christon, Lillian M; Buxton, Alfred E; Goldberger, Jeffrey J; Gold, Michael R; Rodrigue, James R; Frisch, Michael B

    2016-05-01

    Improving mental and physical health of patients with implantable cardioverter defibrillators (ICD) is critical because this group is at high risk for ventricular arrhythmias and sudden death and depressed or anxious cardiovascular disease (CVD) patients appear to be at even higher risk for mortality compared to nondepressed or nonanxious CVD patients. Further, autonomic dysfunction is present in these patients, and negative emotions and arrhythmias form a downward spiral further worsening mood, well-being, and cardiovascular health. Much research demonstrates that positive emotion is related to health benefits, improved physiology, and increased survival. This is a two-arm randomized controlled trial aiming to recruit 60 adult ICD patients comparing 12 individually delivered, weekly sessions of: (1) a positive emotion-focused cognitive-behavioral therapy (Quality of Life Therapy [QOLT]), and (2) Heart Healthy Education. Autonomic functioning, heart rhythm indices, and psychosocial health are measured at baseline, 3 months, and 9 months. The first goal is feasibility and acceptability, with the primary outcome being arrhythmic event frequency data. This study is designed to test whether QOLT produces changes in mood, quality of life/well-being, autonomic function, and arrhythmic and ICD therapy event rates. This feasibility trial is a foundational step for the next trial of QOLT to help determine whether a 3-month QOLT trial can reduce arrhythmias occurrences among ICD patients, and examine a mechanism of autonomic functioning. This study may help to develop and implement new medical or psychological therapies for ICD patients. ©2016 Wiley Periodicals, Inc.

  6. Randomized evaluation of efficacy and safety of ferric carboxymaltose in patients with iron deficiency anaemia and impaired renal function (REPAIR-IDA): rationale and study design.

    Science.gov (United States)

    Szczech, Lynda A; Bregman, David B; Harrington, Robert A; Morris, David; Butcher, Angelia; Koch, Todd A; Goodnough, Lawrence T; Wolf, Myles; Onken, Jane E

    2010-07-01

    Patients with iron deficiency anaemia (IDA) in the setting of non-dialysis-dependent chronic kidney disease (NDD-CKD) may benefit from treatment with intravenous (IV) iron. Ferric carboxymaltose (FCM) is a novel IV iron formulation designed to permit larger infusions compared to currently available IV standards such as Venofer(R) (iron sucrose). The primary objective of REPAIR-IDA is to estimate the cardiovascular safety and efficacy of FCM (two doses at 15 mg/kg to a maximum of 750 mg per dose) compared to Venofer(R) (1000 mg administered as five infusions of 200 mg) in subjects who have IDA and NDD-CKD. REPAIR-IDA is a multi-centre, randomized, active-controlled, open-label study. Eligible patients must have haemoglobin (Hgb) IDA will assess the efficacy and safety of two 750-mg infusions of FCM compared to an FDA-approved IV iron regimen in patients with NDD-CKD at increased risk for cardiovascular disease.

  7. Meeting the ranging of informational needs of chronic low back pain sufferers: conceptual design and rationale of the interactive website ONESELF.

    Science.gov (United States)

    Schulz, Peter J; Rubinelli, Sara; Mariotti, Guido; Keller, Nicola

    2009-01-01

    Information plays an important role in the management and treatment of chronic pain conditions. Often, however, delivered information does not address specific difficulties of consumers. The present study illustrates the design and implementation of the website ONESELF - run by the Institute of Communication and Health of the University of Lugano - which has been created to meet the ranging of informational needs of chronic low back pain sufferers. ONESELF rests on an integrated idea of health literacy that highlights the kind of information consumers need to inform their decisions about back pain. This idea has been tested through a qualitative analysis of requests posted by users in the forum of ONESELF between July 2006 and December 2007. Users seek information to build their declarative (factual) and procedural knowledge, as well as to evaluate that knowledge and apply it to the context of their own life. Online interactional tools such as ONESELF are a promising source of health communication, provided that the content manager of the website and the health professionals collaborate in a rigorously structured manner. ONESELF can benefit traditional medical consultations in helping screen requests from patients that do not need to see a doctor, and in acting as a repository of background information that saves consultation time for more urgent matters.

  8. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: Rationale and study design of a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Klarenbach Scott

    2006-02-01

    Full Text Available Abstract Background Nocturnal hemodialysis (NHD is an alternative to conventional three times per week hemodialysis (CvHD and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV mass, as measured by cardiac magnetic resonance imaging (cMR. Methodology/design All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP to a goal of Discussion To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

  9. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial: design and rationale of a randomised controlled multicenter trial [ISRCTN13975868

    Directory of Open Access Journals (Sweden)

    Houdijk Lex PJ

    2006-04-01

    Full Text Available Abstract Background The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL. In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach was conceived to yield the evidence needed for a considered policy decision. Methods/design 88 patients with (suspected infected necrotizing pancreatitis will be randomly allocated to either group A minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD or group B maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. Discussion The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected infected necrotizing pancreatitis.

  10. An intervention to reduce sitting and increase light-intensity physical activity at work: Design and rationale of the 'Stand & Move at Work' group randomized trial.

    Science.gov (United States)

    Buman, Matthew P; Mullane, Sarah L; Toledo, Meynard J; Rydell, Sarah A; Gaesser, Glenn A; Crespo, Noe C; Hannan, Peter; Feltes, Linda; Vuong, Brenna; Pereira, Mark A

    2017-02-01

    American workers spend 70-80% of their time at work being sedentary. Traditional approaches to increase moderate-vigorous physical activity (MVPA) may be perceived to be harmful to productivity. Approaches that target reductions in sedentary behavior and/or increases in standing or light-intensity physical activity [LPA] may not interfere with productivity and may be more feasible to achieve through small changes accumulated throughout the workday METHODS/DESIGN: This group randomized trial (i.e., cluster randomized trial) will test the relative efficacy of two sedentary behavior focused interventions in 24 worksites across two states (N=720 workers). The MOVE+ intervention is a multilevel individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace. The STAND+ intervention is the MOVE+ intervention with the addition of the installation and use of sit-stand workstations to reduce sedentary behavior and enhance light-intensity physical activity opportunities. Our primary outcome will be objectively-measured changes in sedentary behavior and light-intensity physical activity over 12months, with additional process measures at 3months and longer-term sustainability outcomes at 24months. Our secondary outcomes will be a clustered cardiometabolic risk score (comprised of fasting glucose, insulin, triglycerides, HDL-cholesterol, and blood pressure), workplace productivity, and job satisfaction DISCUSSION: This study will determine the efficacy of a multi-level workplace intervention (including the use of a sit-stand workstation) to reduce sedentary behavior and increase LPA and concomitant impact on cardiometabolic health, workplace productivity, and satisfaction. ClinicalTrials.gov Identifier: NCT02566317 (date of registration: 10/1/2015). Copyright © 2016 Elsevier Inc. All rights reserved.

  11. An intervention strategy for improving residential environment and positive mental health among public housing tenants: rationale, design and methods of Flash on my neighborhood!

    Directory of Open Access Journals (Sweden)

    Janie Houle

    2017-09-01

    Full Text Available Abstract Background In Canada, public housing programs are an important part of governmental strategies to fight poverty and public exclusion. The Flash on my neighborhood! project is a four-year multiphase community-based participatory action research strategy currently implemented in six public housing developments (n = 1009 households across the province of Québec, Canada. The goal is to reduce the mental health disparities faced by these public housing tenants compared to the general population, while identifying which environmental and policy changes are needed to turn public housing settings into healthier environments. Methods The protocol involves three successive, interconnected phases: 1 Strengths and needs assessment, including community outreach and recruitment of tenants to collaborate as peer researchers, an exploratory qualitative component (photovoice, a systematic neighborhood observation, and a household survey; 2 Action plan development, including a community forum and interactive capacity-building and discussion sessions; 3 Action plan implementation and monitoring. The entire intervention is evaluated using a mixed-method design, framed within a multiple case study perspective. Throughout the project and particularly in the evaluation phase, data will be collected to record a contextual factors (tenants’ previous experience of participation, history of public housing development, etc.; b activities that took place and elements from the action plan that were implemented; and c short- and medium-term outcomes (objective and perceived improvements in the quality of the residential setting, both physically and in terms of mental health and social capital. Discussion The study will provide unprecedented evidence-based information on the key ingredients of a collective intervention process associated with the increased collective empowerment and positive mental health of public housing tenants.

  12. Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.

    Science.gov (United States)

    Pilgrim, Thomas; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Heg, Dik; Jüni, Peter; Windecker, Stephan

    2014-09-01

    Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF. Copyright © 2014 Mosby, Inc. All rights reserved.

  13. Trial design: Computer guided normal-low versus normal-high potassium control in critically ill patients: Rationale of the GRIP-COMPASS study.

    Science.gov (United States)

    Hoekstra, Miriam; Vogelzang, Mathijs; van der Horst, Iwan Cc; Lansink, Annemieke Oude; van der Maaten, Joost Maa; Ismael, Farouq; Zijlstra, Felix; Nijsten, Maarten Wn

    2010-12-31

    Potassium depletion is common in hospitalized patients and can cause serious complications such as cardiac arrhythmias. In the intensive care unit (ICU) the majority of patients require potassium suppletion. However, there are no data regarding the optimal control target in critically ill patients. After open-heart surgery, patients have a strongly increased risk of atrial fibrillation or atrial flutter (AFF). In a novel trial design, we examined if in these patients different potassium control-targets within the normal range may have different effects on the incidence of AFF. The "computer-driven Glucose and potassium Regulation program in Intensive care Patients with COMparison of PotASSium targets within normokalemic range (GRIP-COMPASS) trial" is a single-center prospective trial in which a total of 1200 patients are assigned to either a potassium control-target of 4.0 mmol/L or 4.5 mmol/L in consecutive alternating blocks of 50 patients each. Potassium levels are regulated by the computer-assisted potassium suppletion algorithm called GRIP-II (Glucose and potassium regulation for Intensive care Patients). Primary endpoint is the in-hospital incidence of AFF after cardiac surgery. Secondary endpoints are: in-hospital AFF in medical patients or patients after non-cardiac surgery, actually achieved potassium levels and their variation, electrolyte and glucose levels, potassium and insulin requirements, cumulative fluid balance, (ICU) length of stay, ICU mortality, hospital mortality and 90-day mortality. The GRIP-COMPASS trial is the first controlled clinical trial to date that compares potassium targets. Other novel methodological elements of the study are that it is performed in ICU patients where both targets are within the normal range and that a computer-assisted potassium suppletion algorithm is used. NCT 01085071 at ClinicalTrials.gov.

  14. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial.

    Science.gov (United States)

    Simons, Monique; Chinapaw, Mai J M; van de Bovenkamp, Maaike; de Boer, Michiel R; Seidell, Jacob C; Brug, Johannes; de Vet, Emely

    2014-03-24

    Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games--i.e. active games--may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12-16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents' measured BMI-SDS (SDS=adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents' self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents. Dutch Trial register NTR3228.

  15. Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids.

    Science.gov (United States)

    Seitz, Christian; Bumbuliene, Žana; Costa, Ana Rosa; Heikinheimo, Oskari; Heweker, Andrea; Hudeček, Robert; Jacquemyn, Yves; Melis, Gian Benedetto; Parashar, Pooja; Rechberger, Tomasz; Sánchez, Antonio Cano; van Aken, Bart; Zatik, János; Gemzell-Danielsson, Kristina

    2017-04-01

    Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan. Copyright © 2017 Bayer AG. Published by Elsevier Inc. All rights reserved.

  16. Research into the effect Of SGLT2 inhibition on left ventricular remodelling in patients with heart failure and diabetes mellitus (REFORM) trial rationale and design.

    Science.gov (United States)

    Singh, Jagdeep S S; Fathi, Amir; Vickneson, Keeran; Mordi, Ify; Mohan, Mohapradeep; Houston, J Graeme; Pearson, Ewan R; Struthers, Allan D; Lang, Chim C

    2016-07-15

    Heart failure (HF) and diabetes (DM) are a lethal combination. The current armamentarium of anti-diabetic agents has been shown to be less efficacious and sometimes even harmful in diabetic patients with concomitant cardiovascular disease, especially HF. Sodium glucose linked co-transporter type 2 (SGLT2) inhibitors are a new class of anti-diabetic agent that has shown potentially beneficial cardiovascular effects such as pre-load and after load reduction through osmotic diuresis, blood pressure reduction, reduced arterial stiffness and weight loss. This has been supported by the recently published EMPA-REG trial which showed a striking 38 and 35 % reduction in cardiovascular death and HF hospitalisation respectively. The REFORM trial is a novel, phase IV randomised, double blind, placebo controlled clinical trial that has been ongoing since March 2015. It is designed specifically to test the safety and efficacy of the SLGT2 inhibitor, dapagliflozin, on diabetic patients with known HF. We utilise cardiac-MRI, cardio-pulmonary exercise testing, body composition analysis and other tests to quantify the cardiovascular and systemic effects of dapagliflozin 10 mg once daily against standard of care over a 1 year observation period. The primary outcome is to detect the change in left ventricular (LV) end systolic and LV end diastolic volumes. The secondary outcome measures include LV ejection fraction, LV mass index, exercise tolerance, fluid status, quality of life measures and others. This trial will be able to determine if SGLT2 inhibitor therapy produces potentially beneficial effects in patients with DM and HF, thereby replacing current medications as the drug of choice when treating patients with both DM and HF. Trial registration Clinical Trials.gov: NCT02397421. Registered 12th March 2015.

  17. Proof-of-concept trial to evaluate haemoglobin based oxygen therapeutics in elective percutaneous coronary revascularisation. Rationale, protocol design and haemodynamic results.

    Science.gov (United States)

    Meliga, Emanuele; Vranckx, Pascal; Regar, Evelyn; Kint, Peter-Paul; Duncker, Dirk J; Serruys, Patrick W

    2008-05-01

    To test the hypothesis that intracoronary infusion of pre-oxygenated HBOC-201 during brief, total coronary artery occlusion would preserve left ventricular function. Immediately following a successful PCI, the target coronary artery was occluded without ("dry occlusion")--or with--infusion of pre-oxygenated HBOC-201 distal to the stent via the guidewire shaft of an over-the-wire balloon for up to three minutes at an infusion rate of 48 ml/min. A cross-over design was applied. Early signs of myocardial ischaemia were evaluated by left ventricular pressure-volume loops and intracoronary ECG. A 12-lead Holter ECG was activated before the PCI and deactivated four hours after the study period. Primary endpoints were change in left ventricular relaxation indices and in the sum of ST segment deviations. None of the measured parameters differed significantly from their respective baseline values during HBOC-201 infusion. By contrast, ejection fraction (EF), cardiac output (CO) and minimal rate of LV pressure change (dP/dTMIN) decreased significantly and the end diastolic pressure (EDP) and time constant of relaxation increased significantly during dry occlusions (P<0.05). The end diastolic pressure-volume relationship (EDPVR) at the fixed pressure level of 30 mmHg (V30), an index of myocardial compliance, reflected greater myocardial stiffness during dry occlusions compared to occlusions with HBOC-201 infusion. Intracoronary infusion of oxygenated HBOC-201 is capable of preserving left ventricular function, likely through maintenance of myocardial oxygenation. It is hypothesised, that in an acute setting, HBOC-201 could serve as an oxygen bridge to reperfusion by PCI extending the "golden" time period during which permanent myocardial damage is unlikely.

  18. A patient advocate to facilitate access and improve communication, care, and outcomes in adults with moderate or severe asthma: Rationale, design, and methods of a randomized controlled trial.

    Science.gov (United States)

    Apter, Andrea J; Morales, Knashawn H; Han, Xiaoyan; Perez, Luzmercy; Huang, Jingru; Ndicu, Grace; Localio, Anna; Nardi, Alyssa; Klusaritz, Heather; Rogers, Marisa; Phillips, Alexis; Cidav, Zuleyha; Schwartz, J Sanford

    2017-05-01

    Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices. The PA coaches, models, and assists participants with preparations for a visit with the asthma clinician; attends the visit with permission of participant and provider; and confirms participants' understanding of what transpired at the visit. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice and transfer of information between providers and patients. PA activities are individualized, take account of comorbidities, and are generalizable to other chronic diseases. PAs are recent college graduates interested in health-related careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential participants. We test whether the PA intervention, compared to usual care, is associated with improved and sustained asthma control and other asthma outcomes (prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline. Mediators and moderators of the PA-asthma outcome relationship are examined along with the intervention's cost-effectiveness. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses.

    Science.gov (United States)

    Pijpe, Anouk; Slottje, Pauline; van Pelt, Cres; Stehmann, Floor; Kromhout, Hans; van Leeuwen, Flora E; Vermeulen, Roel C H; Rookus, Matti A

    2014-01-29

    Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks.

  20. Angiotensin Receptor Neprilysin Inhibition in Heart Failure With Preserved Ejection Fraction: Rationale and Design of the PARAGON-HF Trial.

    Science.gov (United States)

    Solomon, Scott D; Rizkala, Adel R; Gong, Jianjian; Wang, Wenyan; Anand, Inder S; Ge, Junbo; Lam, Carolyn S P; Maggioni, Aldo P; Martinez, Felipe; Packer, Milton; Pfeffer, Marc A; Pieske, Burkert; Redfield, Margaret M; Rouleau, Jean L; Van Veldhuisen, Dirk J; Zannad, Faiez; Zile, Michael R; Desai, Akshay S; Shi, Victor C; Lefkowitz, Martin P; McMurray, John J V

    2017-07-01

    The PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HF With Preserved Ejection Fraction) trial is designed to determine the efficacy and safety of the angiotensin receptor neprilysin inhibitor sacubitril/valsartan compared with valsartan in patients with chronic heart failure and preserved ejection fraction (HFpEF). HFpEF is highly prevalent, associated with substantial morbidity and mortality, and in need of effective therapies that improve outcomes. The angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan, which has been shown to benefit patients with heart failure (HF) and reduced ejection fraction, demonstrated favorable physiologic effects in a phase II HFpEF trial. The PARAGON-HF trial is a randomized, double-blind, parallel group, active-controlled, event-driven trial comparing the long-term efficacy and safety of valsartan and sacubitril/valsartan in patients with chronic HFpEF (left ventricular ejection fraction ≥45%), New York Heart Association functional class II to IV symptoms, elevated natriuretic peptides, and evidence of structural heart disease. Before randomization, all patients entered sequential single-blind run-in periods to ensure tolerability of both drugs at half the target doses (i.e., valsartan titrated to 80 mg bid followed by sacubitril/valsartan 49/51 mg [100 mg] bid). The primary outcome is the composite of cardiovascular death and total (first and recurrent) HF hospitalizations. PARAGON-HF will determine whether sacubitril/valsartan is superior to angiotensin receptor blockade alone in patients with chronic symptomatic HFpEF. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Knee Joint Distraction as an Alternative Surgical Treatment for Osteoarthritis: Rationale and Design of two Randomized Controlled Trials (vs High Tibial Osteotomy and Total Knee Prosthesis

    Directory of Open Access Journals (Sweden)

    Karen Wiegant

    2015-08-01

    Full Text Available AIM: In case of refractory knee osteoarthritis at a relatively young age causing persisting pain, treatment options are limited. In case of medial degeneration high tibial osteotomy (HTO may be considered, or in case of more generalized OA, a total knee prosthesis (TKP. However, these young and active patients have a major risk of revision surgery. Knee joint distraction (KJD could be an alternative treatment; prolonged clinical benefit and cartilage tissue repair have been demonstrated. Therefore, two RCTs were designed, evaluating clinical efficacy and for HTO additionally comparing cartilage tissue repair. MATERIALS AND METHODS: Patients<65 years of age considered in regular clinical practice for TKP or HTO were included. TKP and HTO were performed according to usual standard of care. KJD was performed for six continuous weeks by use of an external fixator bridging the joint, fixed at each side to two bone pins. RESULTS: Inclusion rate was stable over time and took 42 and 22 months for TKP vs KJD and HTO vs KJD, respectively. At baseline, patient characteristics differed: age was 55.2±0.9 and 50.0±0.7 p<0.000, KOOS-score was 36.6±1.4 and 42.2±1.6 p=0.012, and VAS-pain was 68.7±2.1 and 61.4±2.4 p=0.028, in the KJD-TKP cohort and KJD-HTO cohort, respectively. CONCLUSIONS: For implementation of KJD a comparison with available surgical alternatives is needed. TKP and HTO were chosen as the most relevant comparators. Inclusion is closed, and all treatments are completed. Data have to be awaited to determine the position of KJD in surgical treatment of refractory knee OA.

  2. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

    Science.gov (United States)

    Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

    2010-02-01

    Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

  3. Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE

    Directory of Open Access Journals (Sweden)

    Schwartz Marc

    2011-11-01

    Full Text Available Abstract Background A registry of patients with cervical dystonia (Cervical Dystonia Patient Registry for Observation of onaBotulinumtoxinA Efficacy [CD PROBE] was initiated to capture data regarding physician practices and patient outcomes with onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA, USA. Methods and baseline demographics from an interim analysis are provided. Methods/Design This is a prospective, multicenter, clinical registry in the United States enrolling subjects with cervical dystonia (CD who are toxin naïve and/or new to the physicians' practices, or who had been in a clinical trial but received their last injection ≥ 16 weeks prior to enrollment. Subjects are followed over 3 injection cycles of onabotulinumtoxinA, with assessments at time of injection and 4-6 weeks later. Information on physician's practice, patient demographics, CD disease history, duration of treatment intervals and neurotoxin dose, dilution, use of electromyography, and muscles injected are collected. Outcomes are assessed by physicians and subjects using various questionnaires. Discussion This ongoing registry includes 609 subjects with the following baseline data: 75.9% female, 93.6% Caucasian, mean age 57.6 ± 14.3, age at symptom onset 48.3 ± 16.2, and time to diagnosis 5.4 ± 8.6 years, with an additional 1.0 ± 3.5 years before treatment. Of those employed at the time of diagnosis, 36.6% stopped working as a result of CD. CD PROBE, the largest clinical registry of CD treatment, will provide useful data on current treatment practices with onabotulinumtoxinA, potentially leading to refinements for optimization of outcomes. Trial registration NCT00836017

  4. Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics.

    Science.gov (United States)

    Motie, Marjan; Evangelista, Lorraine S; Horwich, Tamara; Hamilton, Michele; Lombardo, Dawn; Cooper, Dan M; Galassetti, Pietro R; Fonarow, Gregg C

    2013-11-01

    There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS. © 2013 Elsevier Inc. All rights reserved.

  5. A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.

    Science.gov (United States)

    Yan, Lijing L; Chen, Shu; Zhou, Bo; Zhang, Jing; Xie, Bin; Luo, Rong; Wang, Ninghua; Lindley, Richard; Zhang, Yuhong; Zhao, Yi; Li, Xian; Liu, Xiao; Peoples, Nicholas; Bettger, Janet Prvu; Anderson, Craig; Lamb, Sarah E; Wu, Yangfeng; Shi, Jingpu

    2016-10-01

    Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. This 2-year randomized controlled trial is being conducted in 2-3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. The primary outcome is patients' Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. The results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care. © 2016 World Stroke Organization.

  6. The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study.

    Science.gov (United States)

    Bolognese, Leonardo; Falsini, Giovanni; Grotti, Simone; Limbruno, Ugo; Liistro, Francesco; Carrera, Arcangelo; Angioli, Paolo; Picchi, Andrea; Ducci, Kenneth; Pierli, Carlo

    2010-03-01

    Contrast-induced acute kidney injury (CI-AKI) is a complex syndrome of acute renal failure occurring after the administration of contrast media and contributing to prolonged hospital stay and mortality. The risk of CI-AKI is higher among patients undergoing primary percutaneous coronary interventions for acute myocardial infarction (AMI), but its clinical relevance in such setting has only been evaluated by small sample size single-center studies and retrospective or observational analyses. Furthermore, whereas high-osmolar contrast media was shown to have direct nephrotoxicity, the role of low-osmolar and iso-osmolar agents is still debated. The CONTRAST-AMI study is a prospective, multicenter, controlled, randomized, single-blind, parallel-group trial, designed to show the noninferiority of the effects of iopromide (low-osmolar) compared with iodixanol (iso-osmolar) contrast media on the incidence of CI-AKI and tissue-level perfusion in patients with AMI. All consecutive patients admitted to participating centers for ST-segment elevation AMI undergoing primary percutaneous coronary intervention will be enrolled. All patients will be treated with high-dose N-acetylcysteine (1200 mg intravenously during the procedure and 1200 mg orally two times daily for the next 48 h after percutaneous coronary intervention) and hydration according to a standardized protocol. The primary endpoint is the proportion of patients with a relative increase in serum creatinine (sCr) of at least 25% from baseline to 72 h after agent administration. The secondary endpoints are absolute and relative increases in sCr of at least 50%, thrombolysis in myocardial infarction (TIMI) perfusion grade, and major adverse cardiac events at 1, 6, and 12 months. The CONTRAST-AMI study will provide information on the effects of iodixanol and iopromide on the incidence of CI-AKI and tissue-level perfusion in patients with AMI.

  7. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

    Directory of Open Access Journals (Sweden)

    van Dijk Arie PJ

    2008-12-01

    Full Text Available Abstract Background - Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST-elevation myocardial infarction based on proximal lesions of the infarct-related artery. Methods/design - In our multicenter, randomized, placebo controlled clinical trial we will include patients between 18 and 80 years of age with their first ST-elevation myocardial infarction based on a proximal lesion of the infarct-related artery. After receiving a single bolus alteplase 50 mg IV (Actilyse® Boehringer Ingelheim GmbH, a loading dose of aspirin 500 mg, and heparin 5000 IU in the ambulance according to the prehospital thrombolysis protocol, patients, following oral informed consent, are randomized to undergo 15 minutes of pulsatile ultrasound with intravenous administration of ultrasound contrast agent or placebo without ultrasound. Afterwards coronary angiography and, if indicated, percutaneous coronary intervention will take place. A total of 60 patients will be enrolled in approximately 1 year. The primary endpoints are based on the coronary angiogram and consist of TIMI flow, corrected TIMI frame count, and myocardial blush grade. Follow-up includes 12-lead ECG, 2D-echocardiography, cardiac MRI, and enzyme markers to obtain our secondary endpoints, including the infarct size, wall motion abnormalities, and the global left ventricular function. Discussion - The Sonolysis study is the first multicenter, randomized, placebo controlled clinical trial investigating the therapeutic application of ultrasound and microbubbles in acute ST-elevation myocardial infarction patients. A positive finding may stimulate further research and technical innovations to implement the treatment in the ambulance and maybe obtain even more patency at an earlier stage

  8. Rationale and design of the randomised clinical trial comparing early medication change (EMC strategy with treatment as usual (TAU in patients with Major Depressive Disorder - the EMC trial

    Directory of Open Access Journals (Sweden)

    Wachtlin Daniel

    2010-02-01

    Full Text Available Abstract Background In Major Depressive Disorder (MDD, the traditional belief of a delayed onset of antidepressants' effects has lead to the concept of current guidelines that treatment durations should be between 3-8 weeks before medication change in case of insufficient outcome. Post hoc analyses of clinical trials, however, have shown that improvement usually occurs within the first 10-14 days of treatment and that such early improvement (Hamilton Depression Rating Scale [HAMD] decrease ≥20% has a substantial predictive value for final treatment outcome. Even more important, non-improvement (HAMD decrease Methods/Design The EMC trial is a phase IV, multi-centre, multi-step, randomized, observer-blinded, actively controlled parallel-group clinical trial to investigate for the first time prospectively, whether non-improvers after 14 days of antidepressant treatment with an early medication change (EMC are more likely to attain remission (HAMD-17 ≤7 on treatment day 56 compared to patients treated according to current guideline recommendation (treatment as usual; TAU. In level 1 of the EMC trial, non-improvers after 14 days of antidepressant treatment will be randomised to an EMC strategy or TAU. The EMC strategy for this study schedules a first medication change on day 15; in case of non-improvement between days 15-28, a second medication change will be performed. TAU schedules the first medication change after 28 days in case of non-response (HAMD-17 decrease Discussion If the EMC strategies lead to significantly more remitters, changes of clinical practice, guidelines for the treatment of MDD as well as research settings can be expected. Trial Registration Clincaltrials.gov Identifier: NCT00974155; EudraCT: 2008-008280-96.

  9. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study.

    Science.gov (United States)

    Westermann, Dirk; Goodman, Shaun G; Nicolau, José C; Requena, Gema; Maguire, Andrew; Chen, Ji Yan; Granger, Christopher B; Grieve, Richard; Pocock, Stuart J; Blankenberg, Stefan; Vega, Ana Maria; Yasuda, Satoshi; Simon, Tabassome; Brieger, David

    2017-12-01

    The long-term progression of coronary artery disease as defined by the natural disease course years after a myocardial infarction (MI) is an important but poorly studied area of clinical research. The long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study was designed to address this knowledge gap by evaluating patient management and clinical outcomes following MI in different regions worldwide. TIGRIS (ClinicalTrials.gov Identifier: NCT01866904) is a multicenter, observational, prospective, longitudinal study enrolling patients with history of MI 1 to 3 years previously and high risk of developing atherothrombotic events in a general-practice setting. The primary objective of TIGRIS is to evaluate clinical events (time to first occurrence of any event from the composite cardiovascular endpoint of MI, unstable angina with urgent revascularization, stroke, or death from any cause), and healthcare resource utilization associated with hospitalization for these events (hospitalization duration and procedures) during follow-up. Overall, 9225 patients were enrolled between June 2013 and November 2014 and are being followed in 369 different centers worldwide. This will allow for the description of regional differences in patient characteristics, risk profiles, medical treatment patterns, clinical outcomes, and healthcare resource utilization. Patients will be followed for up to 3 years. Here we report the rationale, design, patient distribution, and selected baseline characteristics of the TIGRIS study. TIGRIS will describe real-world management, quality of life (self-reported health), and healthcare resource utilization for patients with stable coronary artery disease ≥1 year post-MI. © 2017 Wiley Periodicals, Inc.

  10. Learning about Activity and Understanding Nutrition for Child Health (LAUNCH): Rationale, design, and implementation of a randomized clinical trial of a family-based pediatric weight management program for preschoolers.

    Science.gov (United States)

    Stark, Lori J; Filigno, Stephanie Spear; Bolling, Christopher; Ratcliff, Megan B; Kichler, Jessica C; Robson, Shannon L; Simon, Stacey L; McCullough, Mary Beth; Clifford, Lisa M; Stough, Cathleen O; Zion, Cynthia; Ittenbach, Richard F

    2017-01-01

    Obesity affects nearly 2 million preschool age children in the United States and is not abating. However, research on interventions for already obese preschoolers is limited. To address this significant gap in the literature, we developed an intervention targeting obesity reduction in 2 to 5year olds, Learning about Activity and Understanding Nutrition for Child Health (LAUNCH). This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively. Whereas LAUNCH was designed as a skills based intervention, MI focused on addressing the guardian's motivation to make changes in diet and activity and providing tools to do so at the guardian's level of readiness to implement changes. Child body mass index z-score was the primary outcome, assessed at pretreatment, posttreatment (Month 6), and 6 and 12month follow-ups (Months 12 and 18). Mechanisms of weight change (e.g., dietary intake, physical activity) and environmental factors associated with weight (e.g., foods available in the home, caregiver diet) were also assessed. This study is unique because it is one of the few randomized controlled trials to examine a developmentally informed, clinic and home skills based behavioral family intervention for preschoolers who are already obese. Being obese during the preschool years increases the likelihood of remaining obese as an adult and is associated with serious health conditions; if this intervention is successful, it has the potential to change the health trajectories for young children with obesity. Copyright © 2016. Published by Elsevier Inc.

  11. Scientific and political challenges in North America’s first randomized controlled trial of heroin-assisted treatment for severe heroin addiction: Rationale and design of the NAOMI study

    Science.gov (United States)

    Oviedo-Joekes, Eugenia; Nosyk, Bohdan; Marsh, David C; Guh, Daphne; Brissette, Suzanne; Gartry, Candice; Krausz, Michael; Anis, Aslam; Schechter, Martin T

    2016-01-01

    Background Heroin addiction is a chronic relapsing disease, best treated with opioid-agonist substitution therapy such as methadone maintenance. However, a subset of the most severely affected individuals do not benefit sufficiently from this treatment. The North American Opiate Medication Initiative (NAOMI) is a randomized clinical trial (RCT) to evaluate the hypothesis that pharmaceutical-grade heroin, diacetylmorphine (DAM) is more effective in retaining patients and improving their outcomes than Methadone Maintenance Treatment (MMT) among those with chronic, refractory injection opioid dependence. Purpose/Methods The study aimed at randomizing 253 participants to two intervention arms: (1) MMT alone or (2) injectable opioids (DAM or hydromorphone) plus adjunctive MMT if deemed appropriate. The planned study duration was 3 years, with a 1-year intake period, 1 year of treatment, and an additional year of follow-up. The NAOMI trial was initiated in March 2005 at two Canadian sites (Vancouver and Montreal). This was the first multicenter RCT in North America to compare the relative efficacy of these different therapeutic strategies. We discuss the rationale behind the NAOMI study design, as well as the scientific and political issues and methodological challenges arising from the conduct of a trial that involves the prescription of a controlled substance to individuals with dependence on that substance. Limitations Restrictive entry criteria led to the exclusion of many otherwise eligible participants, slowing recruitment into the study. Inability to offer DAM treatment beyond 12 months led to artificial boundary effects in the trial. Conclusions Addiction treatment research navigates between science and politics, and evidence-based medicine is many times confronted by moral beliefs. Political considerations influence study design to a further degree than in RCTs treating less-stigmatized disorders with more-reputable medications. PMID:19528135

  12. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes): A multicenter retrospective nationwide Italian study and crowdsourcing opportunity.

    Science.gov (United States)

    Fadini, G P; Zatti, G; Consoli, A; Bonora, E; Sesti, G; Avogaro, A

    2017-12-01

    Randomized controlled trials (RCTs) in the field of diabetes have limitations inherent to the fact that design, setting, and patient characteristics may be poorly transferrable to clinical practice. Thus, evidence from studies using routinely accumulated clinical data are increasingly valued. We herein describe rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes), a multicenter retrospective nationwide study conducted at 50 specialist outpatient clinics in Italy and promoted by the Italian Diabetes Society. The primary objective of the study is to describe the baseline clinical characteristics (particularly HbA1c) of patients initiated on dapagliflozin from marketing authorization approval to the end of 2016. Secondary and exploratory objectives will evaluate the changes in glycaemic and extraglycaemic efficacy parameters after initiation of dapagliflozin or after initiation of comparator glucose lowering medications (DPP-4 inhibitors, gliclazide extended release, and long-acting GLP-1 receptor agonists). An automated software will extract relevant data from the same electronic chart system at all centres, thereby minimizing data treatment and human intervention. The study is expected to collect an enormous dataset of information on dapagliflozin- and comparator-using patients. After study completion, the Italian Diabetes Society will launch an open crowdsourcing call on the DARWIN-T2D database, challenging diabetes researchers to apply their ideas and approaches to address new unmet needs and knowledge gaps in diabetes. We believe this will move DARWIN-T2D to the next generation of real world studies. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  13. The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS: rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    André Russowsky Brunoni

    Full Text Available CONTEXT AND OBJECTIVE: Major depressive disorder (MDD is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study, which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS.DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São Paulo, Brazil.METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3:3:2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging.RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS.CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.

  14. Chiropractic and CAM Utilization: A Descriptive Review

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    Meeker William C

    2007-01-01

    Full Text Available Abstract Objective To conduct a descriptive review of the scientific literature examining use rates of modalities and procedures used by CAM clinicians to manage chronic LBP and other conditions Data Sources A literature of PubMed and MANTIS was performed using the key terms Chiropractic; Low Back Pain; Utilization Rate; Use Rate; Complementary and Alternative Medicine; and Health Services in various combinations. Data Selection A total of 137 papers were selected, based upon including information about chiropractic utilization, CAM utilization and low back pain and other conditions. Data Synthesis Information was extracted from each paper addressing use of chiropractic and CAM, and is summarized in tabular form. Results Thematic analysis of the paper topics indicated that there were 5 functional areas covered by the literature: back pain papers, general chiropractic papers, insurance-related papers, general CAM-related papers; and worker's compensation papers. Conclusion Studies looking at chiropractic utilization demonstrate that the rates vary, but generally fall into a range from around 6% to 12% of the population, most of whom seek chiropractic care for low back pain and not for organic disease or visceral dysfunction. CAM is itself used by people suffering from a variety of conditions, though it is often used not as a primary intervention, but rather as an additional form of care. CAM and chiropractic often offer lower costs for comparable results compared to conventional medicine.

  15. 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)

    2014-01-01

    Background 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. Methods/Design 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. Discussion 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

  16. A prospective study of symptoms, function, and medication use during acute illness in nursing home residents: design, rationale and cohort description

    Directory of Open Access Journals (Sweden)

    Liu Sophia

    2010-07-01

    incidence of 1.5 (SD 2.0 episodes per resident per year; 74% were managed in the nursing home and 26% managed in the acute care setting. Conclusion In this report, we describe the conceptual model and methods of designing a longitudinal cohort to measure acute illness patterns and symptoms among nursing home residents, and describe the characteristics of our cohort at baseline. In our planned analysis, we will further estimate the effect of the use and interruption of medications on withdrawal and relapse symptoms and illness outcomes.

  17. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material.

    Science.gov (United States)

    Danila, Maria I; Outman, Ryan C; Rahn, Elizabeth J; Mudano, Amy S; Thomas, Tammi F; Redden, David T; Allison, Jeroan J; Anderson, Fred A; Anderson, Julia P; Cram, Peter M; Curtis, Jeffrey R; Fraenkel, Liana; Greenspan, Susan L; LaCroix, Andrea Z; Majumdar, Sumit R; Miller, Michael J; Nieves, Jeri W; Safford, Monika M; Silverman, Stuart L; Siris, Ethel S; Solomon, Daniel H; Warriner, Amy H; Watts, Nelson B; Yood, Robert A; Saag, Kenneth G

    2016-12-15

    implemented a novel tailored multi-modal intervention to improve initiation of osteoporosis therapy. An email address provided on the survey was the most important factor independently associated with accessing the intervention online. The design and uptake of this intervention may have implications for future studies in osteoporosis or other chronic diseases.

  18. Rationale and design of FORTH: a randomised controlled trial assessing the effectiveness of HIV self-testing in increasing HIV testing frequency among gay and bisexual men.

    Science.gov (United States)

    Jamil, Muhammad S; Prestage, Garrett; Fairley, Christopher K; Smith, Kirsty S; Kaldor, John M; Grulich, Andrew E; McNulty, Anna M; Chen, Marcus; Holt, Martin; Conway, Damian P; Wand, Handan; Keen, Phillip; Batrouney, Colin; Bradley, Jack; Bavinton, Benjamin R; Ryan,