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Sample records for cams rationale design

  1. Child/Adolescent Anxiety Multimodal Study (CAMS: rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Waslick Bruce D

    2010-01-01

    Full Text Available Abstract Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS, a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT, sertraline (SRT, and their combination (COMB against pill placebo (PBO for the treatment of separation anxiety disorder (SAD, generalized anxiety disorder (GAD and social phobia (SoP in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488 children and adolescents (ages 7-17 years with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT and pharmacologic (SSRI treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results

  2. Appendix C: safety design rationale

    International Nuclear Information System (INIS)

    Ghose, S.

    1985-01-01

    A brief discussion of the rationale for safety design of fusion plants is presented in the main text. Further detail safety considerations are presented in this appendix in the form of charts and tables. The author present some of the major safety criteria and other criteria used in blanket selection here

  3. CAM and stack air sampler design guide

    International Nuclear Information System (INIS)

    Phillips, T.D.

    1994-01-01

    About 128 air samplers and CAMs presently in service to detect and document potential radioactive release from 'H' and 'F' area tank farm ventilation stacks are scheduled for replacement and/or upgrade by Projects S-5764, S-2081, S-3603, and S-4516. The seven CAMs scheduled to be upgraded by Project S-4516 during 1995 are expected to provide valuable experience for the three remaining projects. The attached document provides design guidance for the standardized High Level Waste air sampling system

  4. Using design rationale to improve SPL traceability

    NARCIS (Netherlands)

    Galvao, I.; Aksit, Mehmet; van den Broek, P.M.; Hendriks, M.F.H.; Rashid, Awais; Royer, Jean-Claude; Rummler, Andreas

    In order to improve SPL traceability by using design rationale, this chapter introduces the traceability analysis framework (TAF), which, when combined with the AMPLE Traceability Framework, provides extra traceability capabilities for variability management. The TAF is a programmable and extensible

  5. Valve cam design using numerical step-by-step method

    OpenAIRE

    Vasilyev, Aleksandr; Bakhracheva, Yuliya; Kabore, Ousman; Zelenskiy, Yuriy

    2014-01-01

    This article studies the numerical step-by-step method of cam profile design. The results of the study are used for designing the internal combustion engine valve gear. This method allows to profile the peak efficiency of cams in view of many restrictions, connected with valve gear serviceability and reliability.

  6. Rationale for reduced tornado design bases

    International Nuclear Information System (INIS)

    Rutherford, P.D.; Ho, H.W.; Hartung, J.A.; Kastenberg, W.E.

    1985-01-01

    This paper provides a rationale for relaxing the present NRC tornado design requirements, which are based on a design basis tornado (DBT) whose frequency of exceedance is 10 -7 per year. It is proposed that a reduced DBT frequency of 10 -5 to 10 -6 per year is acceptable. This change in the tornado design bases for LMFBRs (and possibly all types of nuclear plants) is justified based on (1) existing NRC regulations and guidelines, (2) probabilistic arguments, (3) consistency with NRC trial safety goals, and (4) cost-benefit analysis

  7. HAMMLAB 1999 experimental control room: design - design rationale - experiences

    International Nuclear Information System (INIS)

    Foerdestroemmen, N. T.; Meyer, B. D.; Saarni, R.

    1999-01-01

    A presentation of HAMMLAB 1999 experimental control room, and the accumulated experiences gathered in the areas of design and design rationale as well as user experiences. It is concluded that HAMMLAB 1999 experimental control room is a realistic, compact and efficient control room well suited as an Advanced NPP Control Room (ml)

  8. CAD/CAM: improved design quality, increased productivity

    Energy Technology Data Exchange (ETDEWEB)

    Evans, D. E.; England, J.

    1980-01-01

    Maintaining productivity levels while assuring the quality of engineering products grows increasingly more difficult and costly for industries such as the energy industry which are heavily committed to product design. The man/machine interface made possible through the development of computer-aided design/computer-aided manufacturing (CAD/CAM) technology can be applied to the design process as a tool for increased control to assure the quality of the final engineering product. The quality-control aspects of CAD/CAM technology are addressed in this presentation.

  9. Hermeneutics framework: integration of design rationale and optimizing software modules

    NARCIS (Netherlands)

    Aksit, Mehmet; Malakuti Khah Olun Abadi, Somayeh

    To tackle the evolution challenges of adaptive systems, this paper argues on the necessity of hermeneutic approaches that help to avoid too early elimination of design alternatives. This visionary paper proposes the Hermeneutics Framework, which computationally integrates a design rationale

  10. CAD-CAM printed circuit board design

    Science.gov (United States)

    Agy, W. E.

    A step-by-step procedure for a printed circuit design achieved by CAD is presented. The operator at the interactive CRT station moves a stylus across a graphics tablet and intersperses commands which result in computer-generated pictorial forms on the screen that were drawn on the pad. Standard symbols are used for commands allowing, for instance, connections to be made of specific types in certain locations, which can be automatically edited from a materials list. An entire network of drawn lines can be referenced by a signal name for recall, and a finished circuit schematic can be checked for designs rules compliance, including fault reporting in terms of designator/pin number. A map may be present delineating the boundaries of the circuitry area, and previously completed circuitry segments can be recalled for piece-by-piece assembly of the circuit board.

  11. design analysis of cam-follower system for beat up motion

    African Journals Online (AJOL)

    User

    A cam swing roller-follower mechanism is designed for the beat-up motion of a horizontal narrow loom. The system consists of a radial plate-cam driven by a camshaft keyed to the plate cam. A slay bar which act as the beater is attached to the radial swing roller-follower and assembled on the plate cam. A continuous ...

  12. Innovative Design of Cam-Controlled Planetary Gear Trains

    Directory of Open Access Journals (Sweden)

    Wen-Hsiang Hsieh

    2011-10-01

    Full Text Available The objective of this paper is to perform the innovation design for the new structures of cam-controlled planetary gear trains (CCPGTs, based on the creative mechanism design methodology. Firstly, the design requirements and design constraints are summarized according to the kinematics characteristics of existing CCPGTs. Then, the (4, 5 and (5, 7 graphs are generated by the theory of number synthesis. After that, the atlas of feasible specialized graphs is obtained. Finally, the atlas of new designs is obtained through the particularization process. In addition, an illustrated example is given, and the feasibility of the design is verified by computer simulation using ADAMS software. The result indicates that new design can produce a more wide range of non-uniform motion than the existing design. Therefore, they are better alternatives for driving a variable speed input mechanism.

  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. Exploration in Ways and Rationales of Designing A Desirable Webquest

    Institute of Scientific and Technical Information of China (English)

    覃靓

    2017-01-01

    WebQuest is an advanced tool which could provide the significant scaffolding to support instructors through incorpo-rating learning objects within systematic designs of learning activities. The focus of this article is to explore how a Webquest is designed reasonably and what rationales are implied in such a design through a case study of Webquest design for a group of ESL/EFL learners in Grade 12. The result indicates that a Webquest which is guided by the principles of constructivist problem solving, social interaction and scaffolding learning can be regarded as a desirable Webquest.

  15. New knowledge network evaluation method for design rationale management

    Science.gov (United States)

    Jing, Shikai; Zhan, Hongfei; Liu, Jihong; Wang, Kuan; Jiang, Hao; Zhou, Jingtao

    2015-01-01

    Current design rationale (DR) systems have not demonstrated the value of the approach in practice since little attention is put to the evaluation method of DR knowledge. To systematize knowledge management process for future computer-aided DR applications, a prerequisite is to provide the measure for the DR knowledge. In this paper, a new knowledge network evaluation method for DR management is presented. The method characterizes the DR knowledge value from four perspectives, namely, the design rationale structure scale, association knowledge and reasoning ability, degree of design justification support and degree of knowledge representation conciseness. The DR knowledge comprehensive value is also measured by the proposed method. To validate the proposed method, different style of DR knowledge network and the performance of the proposed measure are discussed. The evaluation method has been applied in two realistic design cases and compared with the structural measures. The research proposes the DR knowledge evaluation method which can provide object metric and selection basis for the DR knowledge reuse during the product design process. In addition, the method is proved to be more effective guidance and support for the application and management of DR knowledge.

  16. Achieving Both Creativity And Rationale: Reuse In Design With Images And Claims

    Directory of Open Access Journals (Sweden)

    D. Scott McCrickard

    2011-01-01

    Full Text Available Although designers often try to create novel designs, many designs are based on previous work. In this paper we argue for the reuse of rationale, in the form of claims, as a central activity in design, and explore how this can be used to inspire creativity. We present a design activity in which images and claims are reused to create a storyboard and illustrate how creativity and rationale complement each other. Our work serves to demonstrate that an appropriate design activity can be used to leverage creativity with the use of rationale.

  17. Design and rationale for examining neuroimaging genetics in ischemic stroke

    Science.gov (United States)

    Giese, Anne-Katrin; Schirmer, Markus D.; Donahue, Kathleen L.; Cloonan, Lisa; Irie, Robert; Winzeck, Stefan; Bouts, Mark J.R.J.; McIntosh, Elissa C.; Mocking, Steven J.; Dalca, Adrian V.; Sridharan, Ramesh; Xu, Huichun; Frid, Petrea; Giralt-Steinhauer, Eva; Holmegaard, Lukas; Roquer, Jaume; Wasselius, Johan; Cole, John W.; McArdle, Patrick F.; Broderick, Joseph P.; Jimenez-Conde, Jordi; Jern, Christina; Kissela, Brett M.; Kleindorfer, Dawn O.; Lemmens, Robin; Lindgren, Arne; Meschia, James F.; Rundek, Tatjana; Sacco, Ralph L.; Schmidt, Reinhold; Sharma, Pankaj; Slowik, Agnieszka; Thijs, Vincent; Woo, Daniel; Worrall, Bradford B.; Kittner, Steven J.; Mitchell, Braxton D.; Rosand, Jonathan; Golland, Polina; Wu, Ona

    2017-01-01

    Objective: To describe the design and rationale for the genetic analysis of acute and chronic cerebrovascular neuroimaging phenotypes detected on clinical MRI in patients with acute ischemic stroke (AIS) within the scope of the MRI–GENetics Interface Exploration (MRI-GENIE) study. Methods: MRI-GENIE capitalizes on the existing infrastructure of the Stroke Genetics Network (SiGN). In total, 12 international SiGN sites contributed MRIs of 3,301 patients with AIS. Detailed clinical phenotyping with the web-based Causative Classification of Stroke (CCS) system and genome-wide genotyping data were available for all participants. Neuroimaging analyses include the manual and automated assessments of established MRI markers. A high-throughput MRI analysis pipeline for the automated assessment of cerebrovascular lesions on clinical scans will be developed in a subset of scans for both acute and chronic lesions, validated against gold standard, and applied to all available scans. The extracted neuroimaging phenotypes will improve characterization of acute and chronic cerebrovascular lesions in ischemic stroke, including CCS subtypes, and their effect on functional outcomes after stroke. Moreover, genetic testing will uncover variants associated with acute and chronic MRI manifestations of cerebrovascular disease. Conclusions: The MRI-GENIE study aims to develop, validate, and distribute the MRI analysis platform for scans acquired as part of clinical care for patients with AIS, which will lead to (1) novel genetic discoveries in ischemic stroke, (2) strategies for personalized stroke risk assessment, and (3) personalized stroke outcome assessment. PMID:28852707

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

    International Nuclear Information System (INIS)

    Pa, Pai-Shan

    2010-01-01

    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. 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...

  20. Marginal adaptation of CAD-CAM onlays: Influence of preparation design and impression technique.

    Science.gov (United States)

    Lima, Fernanda Ferruzzi; Neto, Constantino Fernandes; Rubo, José H; Santos, Gildo Coelho; Moraes Coelho Santos, Maria Jacinta

    2018-03-15

    Factors that may affect the marginal adaptation of computer-aided design and computer-aided manufacturing (CAD-CAM) restorations include preparation design, impression technique, and CAD-CAM system. The influence of impression technique and preparation design on CAD-CAM partial coverage restorations has not been fully addressed. The purpose of this in vitro study was to investigate the influence of direct and indirect digital impression techniques and 2 preparation designs on the marginal adaptation of CAD-CAM onlays. Two mesio-occlusal buccal onlay preparations with reduction of the mesiobuccal cusp were made: conventional preparation (CP) with a 1.2-mm modified shoulder margin and modified preparation (MP) flat cuspal reduction without shoulder. Virtual models were generated from each preparation by using a digital scanner (BlueCam; Dentsply Sirona) from the plastic teeth (direct digital impression) or from the stone dies (indirect digital impression). Onlays were designed using a CAD-CAM system (CEREC 4.0; Dentsply Sirona), and nanoceramic resin blocks (Lava Ultimate Restorative; 3M ESPE) were milled using the CEREC MCX milling machine. Marginal discrepancy was evaluated using an optical stereomicroscope at ×25 magnification in 18 locations distributed along the margins of the preparation. The data were analyzed by using 3-way ANOVA followed by the Tukey HSD test (α=.05). CP presented a statistically significant reduced average marginal adaptation (59 ±50 μm) than did MP (69 ±58 μm) (Pmarginal discrepancy in the mesial and buccal locations of MP when compared with CP. Regarding impression techniques, the buccal location presented the smallest average marginal discrepancy in restorations fabricated with indirect impression when compared with direct impression (42 ±33 μm and 60 ±39 μm) (Pmargin presented improved marginal adaptation compared with modified preparation with flat cuspal reduction. Direct and indirect digital impression techniques produced

  1. 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.

  2. Post-cam mechanics and tibiofemoral kinematics: a dynamic in vitro analysis of eight posterior-stabilized total knee designs.

    Science.gov (United States)

    Arnout, N; Vanlommel, L; Vanlommel, J; Luyckx, J P; Labey, L; Innocenti, B; Victor, J; Bellemans, J

    2015-11-01

    Posterior cruciate ligament (PCL)-substituting total knee arthroplasty (TKA) designs were introduced to avoid paradoxical roll forward of the femur and to optimize knee kinematics. The aim of this in vitro study was to investigate post-cam function and contact mechanics and relate it to knee kinematics during squatting in eight contemporary posterior-stabilized TKA designs. All prostheses were fixed on custom-designed metal fixtures and mounted in a knee rig and five sequential-loaded squats were performed between 30° and 130° of flexion. Contact pressure and contact area were measured using pressure-sensitive Tekscan sensors on the posterior face of the post. Kinematics was recorded with reflective markers and infrared light-capturing cameras. The post-cam mechanisms analyzed in this study are very variable in terms of design features. This leads to large variations in terms of the flexion angle at which the post and cam engage maximal contact force, contact pressure and contact area. We found that more functional post-cam mechanisms, which engage at lower flexion angle and have a similar behavior as normal PCL function, generally show more normal rollback and tibial rotation at the expense of higher contact forces and pressures. All designs show high contact forces. A positive correlation was found between contact force and initial contact angle. Post-cam contact mechanics and kinematics were documented in a standardized setting. Post-cam contact mechanics are correlated with post-cam function. Outcomes of this study can help to develop more functional designs in future. Nevertheless, a compromise will always be made between functional requirements and risk of failure. We assume that more normal knee kinematics leads to more patient satisfaction because of better mobility. Understanding of the post-cam mechanism, and knowing how this system really works, is maybe the clue in further development of new total knee designs.

  3. Virtual Design of a Controller for a Hydraulic Cam Phasing System

    Science.gov (United States)

    Schneider, Markus; Ulbrich, Heinz

    2010-09-01

    Hydraulic vane cam phasing systems are nowadays widely used for improving the performance of combustion engines. At stationary operation, these systems should achieve a constant phasing angle, which however is badly disturbed by the alternating torque generated by the valve actuation. As the hydraulic system shows a non-linear characteristic over the full operation range and the inductivity of the hydraulic pipes generates a significant time delay, a full model based control emerges very complex. Therefore a simple feed-forward controller is designed, bridging the time delay of the hydraulic system and improving the system behaviour significantly.

  4. A G-function-based reliability-based design methodology applied to a cam roller system

    International Nuclear Information System (INIS)

    Wang, W.; Sui, P.; Wu, Y.T.

    1996-01-01

    Conventional reliability-based design optimization methods treats the reliability function as an ordinary function and applies existing mathematical programming techniques to solve the design problem. As a result, the conventional approach requires nested loops with respect to g-function, and is very time consuming. A new reliability-based design method is proposed in this paper that deals with the g-function directly instead of the reliability function. This approach has the potential of significantly reducing the number of calls for g-function calculations since it requires only one full reliability analysis in a design iteration. A cam roller system in a typical high pressure fuel injection diesel engine is designed using both the proposed and the conventional approach. The proposed method is much more efficient for this application

  5. Efficacy, safety and tolerability of simvastatin in children with familial hypercholesterolaemia - Rationale, design and baseline characteristics

    NARCIS (Netherlands)

    de Jongh, S.; Stalenhoef, A. F. H.; Tuohy, M. B.; Mercuri, M.; Bakker, H. D.; Kastelein, J. J. P.

    2002-01-01

    Objective: To describe the rationale, design and baseline data of a study conducted to determine the efficacy, safety and tolerability of simvastatin in children and adolescents with heterozygous familial hypercholesterolaemia (heFH). Methods: Patients were recruited from nine lipid clinics

  6. 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....

  7. The design rationale of the Integral Fast Reactor (IFR)

    International Nuclear Information System (INIS)

    Wade, D.C.; Hill, R.N.

    1997-01-01

    The Integral Fast Reactor (IFR) concept has been developed over the last ten years to provide technical solutions to perceptual concerns associated with nuclear power. Beyond the traditional advanced reactor objectives of increased safety, improved economy and more efficient fuel utilization, the IFR is designed to simplify waste disposal and increase resistance to proliferation. Only a fast reactor with an efficient recycle technology can provide for total consumption of actinides. The basic physics governing reactor design dictates that, for efficient recycle, the fuel form should be limited in burnup only by radiation damage to fuel cladding. The recycle technology must recover essentially all actinides. In a fast reactor, not all fission products need to be removed from the recycled fuel, and there is no need to produce pure plutonium. Recovery, recycle, and ultimate consumption of all actinides resolves several waste-disposal concerns. The IFR can be configured to achieve safe passive response to any of the traditional postulated reactor accident initiators, and can be configured for a variety of power output levels. Passive heat removal is achieved by use of a large inventory sodium coolant and a physical configuration that emphasizes natural circulation. An IFR can be designed to consume excess fissile material, to produce a surplus, or to maintain inventory. It appears that commercial designs should be economically competitive with other available alternatives. (author)

  8. A method for extracting design rationale knowledge based on Text Mining

    Directory of Open Access Journals (Sweden)

    Liu Jihong

    2017-01-01

    Full Text Available Capture design rationale (DR knowledge and presenting it to designers by good form, which have great significance for design reuse and design innovation. Since the 1970s design rationality began to develop, many teams have developed their own design rational system. However, the DR acquisition system is not intelligent enough, and it still requires designers to do a lot of operations. In addition, the existing design documents contain a large number of DR knowledge, but it has not been well excavated. Therefore, a method and system are needed to better extract DR knowledge in design documents. We have proposed a DRKH (design rationale knowledge hierarchy model for DR representation. The DRKH model has three layers, respectively as design intent layer, design decision layer and design basis layer. In this paper, we use text mining method to extract DR from design documents and construct DR model. Finally, the welding robot design specification is taken as an example to demonstrate the system interface.

  9. Exercise for methamphetamine dependence: rationale, design, and methodology.

    Science.gov (United States)

    Mooney, Larissa J; Cooper, Christopher; London, Edythe D; Chudzynski, Joy; Dolezal, Brett; Dickerson, Daniel; Brecht, Mary-Lynn; Peñate, Jose; Rawson, Richard A

    2014-01-01

    Effective pharmacotherapies to treat methamphetamine (MA) dependence have not been identified, and behavioral therapies are marginally effective. Based on behavioral studies demonstrating the potential efficacy of aerobic exercise for improving depressive symptoms, anxiety, cognitive deficits, and substance use outcomes, the study described here is examining exercise as a potential treatment for MA-dependent individuals. This study is randomizing 150 participants with MA dependence at a residential treatment facility for addictive disorders to receive either a thrice-weekly structured aerobic and resistance exercise intervention or a health education condition. Recruitment commenced in March, 2010. Enrollment and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates. Seeking evidence for a possibly effective adjunct to traditional behavioral approaches for treatment of MA dependence, this study is assessing the ability of an 8-week aerobic and resistance exercise protocol to reduce relapse to MA use during a 12-week follow-up period after discharge from residential-based treatment. The study also is evaluating improvements in health and functional outcomes during and after the protocol. This paper describes the design and methods of the study. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. Rationale for a home dialysis virtual ward: design and implementation.

    Science.gov (United States)

    Schachter, Michael E; Bargman, Joanne M; Copland, Michael; Hladunewich, Michelle; Tennankore, Karthik K; Levin, Adeera; Oliver, Matthew; Pauly, Robert P; Perl, Jeffrey; Zimmerman, Deborah; Chan, Christopher T

    2014-02-14

    Home-based renal replacement therapy (RRT) [peritoneal dialysis (PD) and home hemodialysis (HHD)] offers independent quality of life and clinical advantages compared to conventional in-center hemodialysis. However, follow-up may be less complete for home dialysis patients following a change in care settings such as post hospitalization. We aim to implement a Home Dialysis Virtual Ward (HDVW) strategy, which is targeted to minimize gaps of care. The HDVW Pilot Study will enroll consecutive PD and HHD patients who fulfilled any one of our inclusion criteria: 1. following discharge from hospital, 2. after interventional procedure(s), 3. prescription of anti-microbial agents, or 4. following completion of home dialysis training. Clinician-led telephone interviews are performed weekly for 2 weeks until VW discharge. Case-mix (modified Charlson Comorbidity Index), symptoms (the modified Edmonton Symptom Assessment Scale) and patient satisfaction are assessed serially. The number of VW interventions relating to eight pre-specified domains will be measured. Adverse events such as re-hospitalization and health-services utilization will be ascertained through telephone follow-up after discharge from the VW at 2, 4, 12 weeks. The VW re-hospitalization rate will be compared with a contemporary cohort (matched for age, gender, renal replacement therapy and co-morbidities). Our protocol has been approved by research ethics board (UHN: 12-5397-AE). Written informed consent for participation in the study will be obtained from participants. This report serves as a blueprint for the design and implementation of a novel health service delivery model for home dialysis patients. The major goal of the HDVW initiative is to provide appropriate and effective supports to medically complex patients in a targeted window of vulnerability. (NCT01912001).

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

    OpenAIRE

    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

    2013-01-01

    Background 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) stu...

  12. 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 ...

  13. Using a mixed methods research design to investigate complementary alternative medicine (CAM) use among women with breast cancer in Ireland.

    Science.gov (United States)

    Fox, Patricia; Butler, Michelle; Coughlan, Barbara; Murray, Mary; Boland, Noreen; Hanan, Terry; Murphy, Hilary; Forrester, Pauline; O' Brien, Marie; O' Sullivan, Nollaig

    2013-08-01

    To investigate complementary and alternative medicine (CAM) use among women with breast cancer in Ireland using a mixed methods modified sequential explanatory design. Semi-structured interviews were conducted with oncology professionals (n = 20) and CAM practitioners (n = 20) and this was followed by a survey of 406 women with breast cancer using the 'Use of Complementary and Alternative Therapies Survey' questionnaire (UCATS) (Lengacher et al., 2003). Follow up interviews were subsequently undertaken with a subset of this survey sample (n = 31). Over half of those surveyed (55.7%, n = 226) used some form of CAM since diagnosis. The most frequently used therapies were massage, herbal supplements (including herbs with oestrogenic properties), antioxidants, relaxation, counselling, health supplements, reflexology, reiki and support groups. Dietary interventions were used primarily to reduce symptoms and/or side effects while reduction of psychological stress was the primary reason for use of stress-reducing therapies. Most respondents reported that the CAM therapies they had used were helpful. The qualitative data elaborated on and provided clarification of the survey results. Similar to international studies, CAM is popular among women with breast cancer in Ireland. As such, the challenge for Irish oncology professionals is to identify low risk CAM therapies that are likely to benefit patients while educating patients and themselves on therapies which may be of concern. This study clearly illustrates the benefits of using a mixed methods approach to enhance our understanding of a complex clinical issue and thus we recommend that this method should be the method of choice when planning health services research. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. Design and Experimental Investigation of Pneumatic Movement Mechanism Supported by Mechanic Cam and Crank Shaft

    Directory of Open Access Journals (Sweden)

    Salih KORUCU

    2015-02-01

    Full Text Available The pressurized air is applied to many sectors required purity and velocity. One of these sectors is to use of air as impulsive force in the moving mechanisms. In this study, the movement mechanism prototype worked with compressed air was designed and produced forlight vehicle engine as motorbike and ATV (All-Terrain Vehicle. In developed mechanisms, pneumatic artificial muscles were used for a given movement of crankshaft. A cam system was also designed for synchronization pneumatic muscles. In this way, these muscles transmit the synchronous movement to crankshaft. At the end of the study, the developed mechanism was mounted on an ATV vehicle(110 cc/ Cubic Centimeter, engine displacement capacityand its performance was tested using the four different weights (50, 75, 100 and 150 kg, three different pressures (4, 5 and 6 bar and two different hoses (Ø 6 and Ø 8 mm. By considering experimental results and design criteria, power of the movement mechanism was obtained as 886 Watt. With this study, minimization of energy consumption for movement of passenger cars, and using clean and cheap energy as ATV which can be alternative for single or two passenger vehicles.

  15. 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.

  16. Design and Rationale for an In Situ Cryogenic Deformation Capability at a Neutron Source

    International Nuclear Information System (INIS)

    Livescu, V.; Clausen, B.; Sisneros, T.; Bourke, M.A.M.; Woodruff, T.R.; Vaidyanathan, R.; Notardonato, W.U.

    2004-01-01

    When performed in conjunction with neutron diffraction, in situ loading offers unique insights on microstructural deformation mechanisms. This is by virtue of the penetration and phase sensitivity of neutrons. At Los Alamos National Laboratory room and high temperature (up to 1500 deg. C) polycrystalline constitutive response is modeled using finite element and self-consistent models. The models are compared to neutron diffraction measurements. In doing so the implications of slip and creep to microstructural response have been explored. Recently we have been considering low temperature phenomena. This includes changes in deformation mechanisms such as the increased predilection for twinning over slip. Since this is associated with measurable texture changes as well as microstructural strain effects, it is well suited for study using neutron diffraction. This paper outlines the design and rationale for a cryogenic loading capability that will be used on the Spectrometer for MAterials Research at Temperature and Stress (SMARTS) at the Los Alamos Neutron Science Center (LANSCE)

  17. 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.

  18. 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…

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

    International Nuclear Information System (INIS)

    You, J.H.; Mazzone, G.; Visca, E.; Bachmann, Ch.; Autissier, E.; Barrett, T.; Cocilovo, V.; Crescenzi, F.; Domalapally, P.K.; Dongiovanni, D.; Entler, S.; Federici, G.; Frosi, P.; Fursdon, M.; Greuner, H.; Hancock, D.; Marzullo, D.; McIntosh, S.; Müller, A.V.; Porfiri, M.T.

    2016-01-01

    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.

  20. 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.

  1. SPLPKG WFCMPR WFAPPX, Wilson-Fowler Spline Generator for Computer Aided Design And Manufacturing (CAD/CAM) Systems

    International Nuclear Information System (INIS)

    Fletcher, S.K.

    2002-01-01

    1 - Description of program or function: The three programs SPLPKG, WFCMPR, and WFAPPX provide the capability for interactively generating, comparing and approximating Wilson-Fowler Splines. The Wilson-Fowler spline is widely used in Computer Aided Design and Manufacturing (CAD/CAM) systems. It is favored for many applications because it produces a smooth, low curvature fit to planar data points. Program SPLPKG generates a Wilson-Fowler spline passing through given nodes (with given end conditions) and also generates a piecewise linear approximation to that spline within a user-defined tolerance. The program may be used to generate a 'desired' spline against which to compare other Splines generated by CAD/CAM systems. It may also be used to generate an acceptable approximation to a desired spline in the event that an acceptable spline cannot be generated by the receiving CAD/CAM system. SPLPKG writes an IGES file of points evaluated on the spline and/or a file containing the spline description. Program WFCMPR computes the maximum difference between two Wilson-Fowler Splines and may be used to verify the spline recomputed by a receiving system. It compares two Wilson-Fowler Splines with common nodes and reports the maximum distance between curves (measured perpendicular to segments) and the maximum difference of their tangents (or normals), both computed along the entire length of the Splines. Program WFAPPX computes the maximum difference between a Wilson- Fowler spline and a piecewise linear curve. It may be used to accept or reject a proposed approximation to a desired Wilson-Fowler spline, even if the origin of the approximation is unknown. The maximum deviation between these two curves, and the parameter value on the spline where it occurs are reported. 2 - Restrictions on the complexity of the problem - Maxima of: 1600 evaluation points (SPLPKG), 1000 evaluation points (WFAPPX), 1000 linear curve breakpoints (WFAPPX), 100 spline Nodes

  2. The PROgnostic Value of unrequested Information in Diagnostic Imaging (PROVIDI) Study: rationale and design

    International Nuclear Information System (INIS)

    Gondrie, M. J. A.; Mali, W. P. Th. M.; Buckens, C. F. M.; Jacobs, P. C. A.; Grobbee, D. E.; Graaf, Y van der

    2010-01-01

    We describe the rationale for a new study examining the prognostic value of unrequested findings in diagnostic imaging. The deployment of more advanced imaging modalities in routine care means that such findings are being detected with increasing frequency. However, as the prognostic significance of many types of unrequested findings is unknown, the optimal response to such findings remains uncertain and in many cases an overly defensive approach is adopted, to the detriment of patient-care. Additionally, novel and promising image findings that are newly available on many routine scans cannot be used to improve patient care until their prognostic value is properly determined. The PROVIDI study seeks to address these issues using an innovative multi-center case-cohort study design. PROVIDI is to consist of a series of studies investigating specific, selected disease entities and clusters. Computed Tomography images from the participating hospitals are reviewed for unrequested findings. Subsequently, this data is pooled with outcome data from a central population registry. Study populations consist of patients with endpoints relevant to the (group of) disease(s) under study along with a random control sample from the cohort. This innovative design allows PROVIDI to evaluate selected unrequested image findings for their true prognostic value in a series of manageable studies. By incorporating unrequested image findings and outcomes data relevant to patients, truly meaningful conclusions about the prognostic value of unrequested and emerging image findings can be reached and used to improve patient-care.

  3. The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics.

    Science.gov (United States)

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

    2013-07-01

    The workplace can be an important setting for addressing obesity. An increasing number of employers offer weight management programs. Present the design, rationale and baseline characteristics of the Steps to Health study (STH), a randomized trial to evaluate the effectiveness of two preexisting employee weight management programs offered at Duke University and Medical Center. 550 obese (BMI ≥30) employee volunteers were randomized 1:1 to two programs. Baseline data, collected between January 2011 and July 2012, included height/weight, accelerometry, workplace injuries, health care utilization, and questionnaires querying socio-cognitive factors, perceptions of health climate, physical activity, and dietary intake. In secondary analyses participants in the two programs will also be compared to a non-randomized observational control group of obese employees. At baseline, the mean age was 45 years, 83% were female, 41% white, and 53% black. Mean BMI was 37.2. Participants consumed a mean of 2.37 servings of fruits and vegetables per day (in the past week), participated in 11.5 min of moderate-to-vigorous physical activity, and spent 620 min being sedentary. STH addresses the need for evaluation of worksite interventions to promote healthy weight. In addition to having direct positive effects on workers' health, worksite programs have the potential to increase productivity and reduce health care costs. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. 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.

  5. 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.

  6. Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design.

    Science.gov (United States)

    Liu, Liping; Wang, Yilong; Meng, Xia; Li, Na; Tan, Ying; Nie, Ximing; Liu, Dacheng; Zhao, Xingquan

    2017-04-01

    Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy. Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign. Design The tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign (TRAIGE) is a prospective, multicenter, placebo-controlled, double-blind, investigator-led, randomized clinical trial that will include an estimated 240 participants. Patients with intracerebral hemorrhage demonstrating symptom onset within 8 h and with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy, will be enrolled to receive either tranexamic acid or placebo. The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6 ml from baseline to 24 ± 2 h. The secondary outcomes include safety and clinical outcomes. Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.

  7. 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.

  8. Design and rationale for examining neuroimaging genetics in ischemic stroke: The MRI-GENIE study.

    Science.gov (United States)

    Giese, Anne-Katrin; Schirmer, Markus D; Donahue, Kathleen L; Cloonan, Lisa; Irie, Robert; Winzeck, Stefan; Bouts, Mark J R J; McIntosh, Elissa C; Mocking, Steven J; Dalca, Adrian V; Sridharan, Ramesh; Xu, Huichun; Frid, Petrea; Giralt-Steinhauer, Eva; Holmegaard, Lukas; Roquer, Jaume; Wasselius, Johan; Cole, John W; McArdle, Patrick F; Broderick, Joseph P; Jimenez-Conde, Jordi; Jern, Christina; Kissela, Brett M; Kleindorfer, Dawn O; Lemmens, Robin; Lindgren, Arne; Meschia, James F; Rundek, Tatjana; Sacco, Ralph L; Schmidt, Reinhold; Sharma, Pankaj; Slowik, Agnieszka; Thijs, Vincent; Woo, Daniel; Worrall, Bradford B; Kittner, Steven J; Mitchell, Braxton D; Rosand, Jonathan; Golland, Polina; Wu, Ona; Rost, Natalia S

    2017-10-01

    To describe the design and rationale for the genetic analysis of acute and chronic cerebrovascular neuroimaging phenotypes detected on clinical MRI in patients with acute ischemic stroke (AIS) within the scope of the MRI-GENetics Interface Exploration (MRI-GENIE) study. MRI-GENIE capitalizes on the existing infrastructure of the Stroke Genetics Network (SiGN). In total, 12 international SiGN sites contributed MRIs of 3,301 patients with AIS. Detailed clinical phenotyping with the web-based Causative Classification of Stroke (CCS) system and genome-wide genotyping data were available for all participants. Neuroimaging analyses include the manual and automated assessments of established MRI markers. A high-throughput MRI analysis pipeline for the automated assessment of cerebrovascular lesions on clinical scans will be developed in a subset of scans for both acute and chronic lesions, validated against gold standard, and applied to all available scans. The extracted neuroimaging phenotypes will improve characterization of acute and chronic cerebrovascular lesions in ischemic stroke, including CCS subtypes, and their effect on functional outcomes after stroke. Moreover, genetic testing will uncover variants associated with acute and chronic MRI manifestations of cerebrovascular disease. The MRI-GENIE study aims to develop, validate, and distribute the MRI analysis platform for scans acquired as part of clinical care for patients with AIS, which will lead to (1) novel genetic discoveries in ischemic stroke, (2) strategies for personalized stroke risk assessment, and (3) personalized stroke outcome assessment.

  9. Rationale and design of a large registry on renal denervation: the Global SYMPLICITY registry.

    Science.gov (United States)

    Böhm, Michael; Mahfoud, Felix; Ukena, Christian; Bauer, Axel; Fleck, Eckart; Hoppe, Uta C; Kintscher, Ulrich; Narkiewicz, Krzysztof; Negoita, Manuela; Ruilope, Luis; Rump, L Christian; Schlaich, Markus; Schmieder, Roland; Sievert, Horst; Weil, Joachim; Williams, Bryan; Zeymer, Uwe; Mancia, Giuseppe

    2013-08-22

    Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

  10. 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’.

  11. Apixaban for treatment of embolic stroke of undetermined source (ATTICUS randomized trial): Rationale and study design.

    Science.gov (United States)

    Geisler, Tobias; Poli, Sven; Meisner, Christoph; Schreieck, Juergen; Zuern, Christine S; Nägele, Thomas; Brachmann, Johannes; Jung, Werner; Gahn, Georg; Schmid, Elisabeth; Bäezner, Hansjörg; Keller, Timea; Petzold, Gabor C; Schrickel, Jan-Wilko; Liman, Jan; Wachter, Rolf; Schön, Frauke; Schabet, Martin; Lindner, Alfred; Ludolph, Albert C; Kimmig, Hubert; Jander, Sebastian; Schlegel, Uwe; Gawaz, Meinrad; Ziemann, Ulf

    2017-12-01

    Rationale Optimal secondary prevention of embolic stroke of undetermined source is not established. The current standard in these patients is acetylsalicylic acid, despite high prevalence of yet undetected paroxysmal atrial fibrillation. Aim The ATTICUS randomized trial is designed to determine whether the factor Xa inhibitor apixaban administered within 7 days after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of new ischemic lesions documented by brain magnetic resonance imaging within 12 months after index stroke. Design Prospective, randomized, blinded, parallel-group, open-label, German multicenter phase III trial in approximately 500 patients with embolic stroke of undetermined source. A key inclusion criterion is the presence or the planned implantation of an insertable cardiac monitor. Patients are 1:1 randomized to apixaban or acetylsalicylic acid and treated for a 12-month period. It is an event-driven trial aiming for core-lab adjudicated primary outcome events. Study outcomes The primary outcome is the occurrence of at least one new ischemic lesion identified by axial T2-weighted FLAIR magnetic resonance imaging and/or axial DWI magnetic resonance imaging at 12 months when compared with the baseline magnetic resonance imaging. Key secondary outcomes are the combination of recurrent ischemic strokes, hemorrhagic strokes, systemic embolism; combination of MACE including recurrent stroke, myocardial infarction, and cardiovascular death and combination of major and clinically relevant non-major bleeding defined according to ISTH, and change of cognitive function and quality of life (EQ-5D, Stroke Impact Scale). Discussion Embolic stroke of undetermined source is caused by embolic disease and associated with a high risk of recurrent ischemic strokes and clinically silent cerebral ischemic lesions. ATTICUS will investigate the impact of atrial fibrillation detected by insertable cardiac monitor and the effects of

  12. 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

  13. CAMS achievements in 1995

    International Nuclear Information System (INIS)

    Berg, Oe.; Fantoni, P.; Iguchi, Y.; Meyer, G.; Soerensen, A.; Dyck, C. van.

    1996-01-01

    CAMS (Computerized Accident Management Support) is a system being developed as a joint research activity at the Halden Reactor Project with additional financing from the Swedish Nuclear Inspectorate (SKI) and the Nordic NKS/RAK-2 project. Three types of users are envisaged: the staff in the control room, the staff in the technical support centre and the staff at a national emergency centre. It is still an experimental system. The Swedish Nuclear Inspectorate kindly accepted to test CAMS at a safety exercise on the 4th of May, 1995. CAMS is designed assuming automatic data transfer from the plant. Missing the data link, a simulator running in the next room was updated now and then with data received by phone. As seen from CAMS, it did not matter if the data came from a fake plant or from a real plant, except that the data were delayed. Overall, it seemed that CAMS can be a very important tool for a national authority. A data link from the plant would increase its usefulness. Several comments on design features were collected and will be used to improve the system. The model needs more inputs to control the main parameters, and a larger repertoire of fault conditions should be put into the model. In the second half of 1995 the work on CAMS has concentrated upon designing new modules for signal validation, tracking simulation and state identification. This will provide better capabilities for on-line monitoring and assessment of the plant state. Further, it has been proposed to introduce Probabilistic Safety Assessment (PSA) to assist in risk monitoring. A first prototype has been made on a personal computer showing the main features of such a PSA module. (au)

  14. Cognitive interviews guide design of a new CAM patient expectations questionnaire.

    Science.gov (United States)

    Sherman, Karen J; Eaves, Emery R; Ritenbaugh, Cheryl; Hsu, Clarissa; Cherkin, Daniel C; Turner, Judith A

    2014-01-25

    No consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire. We reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions - verbs, nouns, response options, terms and phrases describing back pain - were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators. The questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. "Back pain" was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as "complete relief". The use of words to describe midpoints was found to be confusing. The word "expect" held different and shifting meanings for participants. Thus paired items comparing "hope" and "realistically expect" were chosen to evaluate 5 different aspects of treatment expectations (back pain; back dysfunction and global effects; impact of back pain on specific areas of life; sleep, mood, and energy; coping). "Impact of back pain" on various areas of life was found to be a consistently meaningful concept, and more global than "interference

  15. Kids and adults now! Defeat Obesity (KAN-DO): rationale, design and baseline characteristics.

    Science.gov (United States)

    Ostbye, Truls; Zucker, Nancy L; Krause, Katrina M; Lovelady, Cheryl A; Evenson, Kelly R; Peterson, Bercedis L; Bastian, Lori A; Swamy, Geeta K; West, Deborah G; Brouwer, Rebecca J N

    2011-05-01

    Prevention of childhood obesity is a public health priority. Parents influence a child's weight by modeling healthy behaviors, controlling food availability and activity opportunities, and appropriate feeding practices. Thus interventions should target education and behavioral change in the parent, and positive, mutually reinforcing behaviors within the family. This paper presents the design, rationale and baseline characteristics of Kids and Adults Now! - Defeat Obesity (KAN-DO), a randomized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight, and weight reduction in overweight children. 400 children aged 2-5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are randomized equally to control or the KAN-DO intervention, consisting of mailed family kits encouraging healthy lifestyle change. Eight (monthly) kits are supported by motivational counseling calls and a single group session. Mothers are targeted during a hypothesized "teachable moment" for health behavior change (the birth of a new baby), and intervention content addresses: parenting skills ((e.g., emotional regulation, authoritative parenting), healthy eating, and physical activity. The 400 mother-child dyads randomized to trial are 75% white and 22% black; 19% have a household income of $30,000 or below. At baseline, 15% of children are overweight (85th-95th percentile for body mass index) and 9% are obese (≥ 95th percentile). This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. Copyright © 2011 Elsevier Inc. All rights reserved.

  16. 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.

  17. 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.

  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. 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.

  20. 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. Keywords: Childhood-stress, Adverse-childhood-events, Childhood-trauma questionnaire, Parental-bonding-instrument, Type D scale (DS14

  1. Longitudinal Andhra Pradesh Eye Disease Study: rationale, study design and research methodology.

    Science.gov (United States)

    Khanna, Rohit C; Murthy, Gudlavalleti Vs; Marmamula, Srinivas; Mettla, Asha Latha; Giridhar, Pyda; Banerjee, Seema; Shekhar, Konegari; Chakrabarti, Subhabrata; Gilbert, Clare; Rao, Gullapalli N

    2016-03-01

    The rationale, objectives, study design and procedures for the longitudinal Andhra Pradesh Eye Disease Study are described. A longitudinal cohort study was carried out. Participants include surviving cohort from the rural component of Andhra Pradesh Eye Disease Study. During 1996-2000, Andhra Pradesh Eye Disease Survey was conducted in three rural (n = 7771) and one urban (n = 2522) areas (now called Andhra Pradesh Eye Disease Study 1). In 2009-2010, a feasibility exercise (Andhra Pradesh Eye Disease Study 2) for a longitudinal study (Andhra Pradesh Eye Disease Study 3) was undertaken in the rural clusters only, as urban clusters no longer existed. In Andhra Pradesh Eye Disease Study 3, a detailed interview will be carried out to collect data on sociodemographic factors, ocular and systemic history, risk factors, visual function, knowledge of eye diseases and barriers to accessing services. All participants will also undergo a comprehensive eye examination including photography of lens, optic disc and retina, Optic Coherence Tomography of the posterior segment, anthropometry, blood pressure and frailty measures. Measures include estimates of the incidence of visual impairment and age-related eye disease (lens opacities, glaucoma and age-related macular degeneration) and the progression of eye disease (lens opacities and myopia) and associated risk factors. Of the 7771 respondents examined in rural areas in Andhra Pradesh Eye Disease Study 1, 5447 (70.1%) participants were traced in Andhra Pradesh Eye Disease Study 2. These participants will be re-examined. Andhra Pradesh Eye Disease Study 3 will provide data on the incidence and progression of visual impairment and major eye diseases and their associated risk factors in India. The study will provide further evidence to aid planning eye care services. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

  2. Canadian nuclear power principles for beyond design basis events - supporting rationale

    International Nuclear Information System (INIS)

    Elliott, M.; Newman, G.; Bhaloo, A.

    2014-01-01

    The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

  3. Canadian nuclear power principles for beyond design basis events - supporting rationale

    Energy Technology Data Exchange (ETDEWEB)

    Elliott, M. [OPG Nuclear, Ontario (Canada); Newman, G. [Bruce Power, Ontario (Canada); Bhaloo, A. [New Brunswick Power, New Brunswick (Canada)

    2014-09-15

    The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

  4. Canadian nuclear power principles for beyond design basis events - supporting rationale

    Energy Technology Data Exchange (ETDEWEB)

    Elliott, M. [Ontario Power Generation Nuclear, Pickering, ON (Canada); Newman, G. [Bruce Power, Tiverton, ON (Canada); Bhaloo, A. [New Brunswick Power, Fredericton, NB (Canada)

    2014-07-01

    The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

  5. The Hyper Suprime-Cam SSP Survey: Overview and survey design

    Science.gov (United States)

    Aihara, Hiroaki; Arimoto, Nobuo; Armstrong, Robert; Arnouts, Stéphane; Bahcall, Neta A.; Bickerton, Steven; Bosch, James; Bundy, Kevin; Capak, Peter L.; Chan, James H. H.; Chiba, Masashi; Coupon, Jean; Egami, Eiichi; Enoki, Motohiro; Finet, Francois; Fujimori, Hiroki; Fujimoto, Seiji; Furusawa, Hisanori; Furusawa, Junko; Goto, Tomotsugu; Goulding, Andy; Greco, Johnny P.; Greene, Jenny E.; Gunn, James E.; Hamana, Takashi; Harikane, Yuichi; Hashimoto, Yasuhiro; Hattori, Takashi; Hayashi, Masao; Hayashi, Yusuke; Hełminiak, Krzysztof G.; Higuchi, Ryo; Hikage, Chiaki; Ho, Paul T. P.; Hsieh, Bau-Ching; Huang, Kuiyun; Huang, Song; Ikeda, Hiroyuki; Imanishi, Masatoshi; Inoue, Akio K.; Iwasawa, Kazushi; Iwata, Ikuru; Jaelani, Anton T.; Jian, Hung-Yu; Kamata, Yukiko; Karoji, Hiroshi; Kashikawa, Nobunari; Katayama, Nobuhiko; Kawanomoto, Satoshi; Kayo, Issha; Koda, Jin; Koike, Michitaro; Kojima, Takashi; Komiyama, Yutaka; Konno, Akira; Koshida, Shintaro; Koyama, Yusei; Kusakabe, Haruka; Leauthaud, Alexie; Lee, Chien-Hsiu; Lin, Lihwai; Lin, Yen-Ting; Lupton, Robert H.; Mandelbaum, Rachel; Matsuoka, Yoshiki; Medezinski, Elinor; Mineo, Sogo; Miyama, Shoken; Miyatake, Hironao; Miyazaki, Satoshi; Momose, Rieko; More, Anupreeta; More, Surhud; Moritani, Yuki; Moriya, Takashi J.; Morokuma, Tomoki; Mukae, Shiro; Murata, Ryoma; Murayama, Hitoshi; Nagao, Tohru; Nakata, Fumiaki; Niida, Mana; Niikura, Hiroko; Nishizawa, Atsushi J.; Obuchi, Yoshiyuki; Oguri, Masamune; Oishi, Yukie; Okabe, Nobuhiro; Okamoto, Sakurako; Okura, Yuki; Ono, Yoshiaki; Onodera, Masato; Onoue, Masafusa; Osato, Ken; Ouchi, Masami; Price, Paul A.; Pyo, Tae-Soo; Sako, Masao; Sawicki, Marcin; Shibuya, Takatoshi; Shimasaku, Kazuhiro; Shimono, Atsushi; Shirasaki, Masato; Silverman, John D.; Simet, Melanie; Speagle, Joshua; Spergel, David N.; Strauss, Michael A.; Sugahara, Yuma; Sugiyama, Naoshi; Suto, Yasushi; Suyu, Sherry H.; Suzuki, Nao; Tait, Philip J.; Takada, Masahiro; Takata, Tadafumi; Tamura, Naoyuki; Tanaka, Manobu M.; Tanaka, Masaomi; Tanaka, Masayuki; Tanaka, Yoko; Terai, Tsuyoshi; Terashima, Yuichi; Toba, Yoshiki; Tominaga, Nozomu; Toshikawa, Jun; Turner, Edwin L.; Uchida, Tomohisa; Uchiyama, Hisakazu; Umetsu, Keiichi; Uraguchi, Fumihiro; Urata, Yuji; Usuda, Tomonori; Utsumi, Yousuke; Wang, Shiang-Yu; Wang, Wei-Hao; Wong, Kenneth C.; Yabe, Kiyoto; Yamada, Yoshihiko; Yamanoi, Hitomi; Yasuda, Naoki; Yeh, Sherry; Yonehara, Atsunori; Yuma, Suraphong

    2018-01-01

    Hyper Suprime-Cam (HSC) is a wide-field imaging camera on the prime focus of the 8.2-m Subaru telescope on the summit of Mauna Kea in Hawaii. A team of scientists from Japan, Taiwan, and Princeton University is using HSC to carry out a 300-night multi-band imaging survey of the high-latitude sky. The survey includes three layers: the Wide layer will cover 1400 deg2 in five broad bands (grizy), with a 5 σ point-source depth of r ≈ 26. The Deep layer covers a total of 26 deg2 in four fields, going roughly a magnitude fainter, while the UltraDeep layer goes almost a magnitude fainter still in two pointings of HSC (a total of 3.5 deg2). Here we describe the instrument, the science goals of the survey, and the survey strategy and data processing. This paper serves as an introduction to a special issue of the Publications of the Astronomical Society of Japan, which includes a large number of technical and scientific papers describing results from the early phases of this survey.

  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. 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.

  8. 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…

  9. Alternative concepts for design of air monitoring instruments: In-line and open face reference samplers and a new method of demonstrating alpha CAM performance

    International Nuclear Information System (INIS)

    Rodgers, J.C.; McFarland, A.R.

    1993-01-01

    Over the past several years Los Alamos, Texas A ampersand M University and Canberra Instruments have been collaborating on the development of advanced continuous air monitoring and air sampling concepts and technology. We have successfully completed the design of an alpha CAM which embodies a number of innovations in the way radon progeny background interference is controlled and compensated, and in the way data processing, alarm generation, and data communication are handled

  10. 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.

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

    DEFF Research Database (Denmark)

    Bennedsen, Jens; Caspersen, Michael Edelgaard

    2003-01-01

    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...... evenings a week, and participation can take place also in situations where it would otherwise be impossible (e.g. a sick child or a business trip). However, these advantages don't come for free: the students lose the social relations following from face-to-face contact with the lecturer and teaching...... 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...

  12. 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.

  13. Mechanism of inhibition of human secretory phospholipase A2 by flavonoids: rationale for lead design

    Science.gov (United States)

    Lättig, Jens; Böhl, Markus; Fischer, Petra; Tischer, Sandra; Tietböhl, Claudia; Menschikowski, Mario; Gutzeit, Herwig O.; Metz, Peter; Pisabarro, M. Teresa

    2007-08-01

    The human secretory phospholipase A2 group IIA (PLA2-IIA) is a lipolytic enzyme. Its inhibition leads to a decrease in eicosanoids levels and, thereby, to reduced inflammation. Therefore, PLA2-IIA is of high pharmacological interest in treatment of chronic diseases such as asthma and rheumatoid arthritis. Quercetin and naringenin, amongst other flavonoids, are known for their anti-inflammatory activity by modulation of enzymes of the arachidonic acid cascade. However, the mechanism by which flavonoids inhibit Phospholipase A2 (PLA2) remained unclear so far. Flavonoids are widely produced in plant tissues and, thereby, suitable targets for pharmaceutical extractions and chemical syntheses. Our work focuses on understanding the binding modes of flavonoids to PLA2, their inhibition mechanism and the rationale to modify them to obtain potent and specific inhibitors. Our computational and experimental studies focused on a set of 24 compounds including natural flavonoids and naringenin-based derivatives. Experimental results on PLA2-inhibition showed good inhibitory activity for quercetin, kaempferol, and galangin, but relatively poor for naringenin. Several naringenin derivatives were synthesized and tested for affinity and inhibitory activity improvement. 6-(1,1-dimethylallyl)naringenin revealed comparable PLA2 inhibition to quercetin-like compounds. We characterized the binding mode of these compounds and the determinants for their affinity, selectivity, and inhibitory potency. Based on our results, we suggest C(6) as the most promising position of the flavonoid scaffold to introduce chemical modifications to improve affinity, selectivity, and inhibition of PLA2-IIA by flavonoids.

  14. 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.

  15. 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.

  16. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study : a cluster randomised controlled trial

    NARCIS (Netherlands)

    Valk, Mark J.; Hoes, Arno W.; Mosterd, Arend; Landman, Marcel A.; Broekhuizen, Berna D L; Rutten, Frans H.

    2015-01-01

    BACKGROUND: Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the

  17. Rationale and design of Mi-CARE: The mile square colorectal cancer screening, awareness and referral and education project.

    Science.gov (United States)

    Buscemi, Joanna; Miguel, Yazmin San; Tussing-Humphreys, Lisa; Watts, Elizabeth A; Fitzgibbon, Marian L; Watson, Karriem; Winn, Robert A; Matthews, Kameron L; Molina, Yamile

    2017-01-01

    Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, access to health care facilities, lack of recommendation to screen, and psychosocial factors such as embarrassment, fear of the test, anxiety about testing preparation and fear of a cancer diagnosis. Various intervention approaches to improve CRC screening rates have been developed. However, comparative effectiveness research (CER) to investigate the relative performance of different approaches has been understudied, especially across different real-life practice settings. Assessment of differential efficacy across diverse vulnerable populations is also lacking. The current paper describes the rationale and design for the Mile Square Colorectal Cancer Screening, Awareness and Referral and Education Project (Mi-CARE), which aims to increase CRC screening rates in 3 clinics of a large Federally Qualified Health Center (FQHC) by reducing prominent barriers to screening for low-income, minority and underserved patients. Patients attending these clinics will receive one of three interventions to increase screening uptake: lay patient navigator (LPN)-based navigation, provider level navigation, or mailed birthday CRC screening reminders. The design of our program allows for comparison of the effectiveness of the tailored interventions across sites and patient populations. Data from Mi-CARE may help to inform the dissemination of tailored interventions across FQHCs to reduce health disparities in CRC. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. 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-López, Natalia; Bisgaard, Hans; Bønnelykke, Klaus; Burchard, Esteban G.; Campo, Paloma; Canino, Glorisa; Carleton, Bruce; Celedón, Juan C.; Chew, Fook Tim; Chiang, Wen Chin; Cloutier, Michelle M.; Daley, Denis; den Dekker, Herman T.; Dijk, F. Nicole; Duijts, Liesbeth; Flores, Carlos; Forno, Erick; Hawcutt, Daniel B.; Hernandez-Pacheco, Natalia; de Jongste, Johan C.; Kabesch, Michael; Koppelman, Gerard H.; Manolopoulos, Vangelis G.; Melén, Erik; Mukhopadhyay, Somnath; Nilsson, Sara; Palmer, Colin N.; Pino-Yanes, Maria; Pirmohamed, Munir; Potočnik, 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 study

  19. 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

  20. A Novel Radiation Hardened CAM

    CERN Document Server

    Shojaii, Seyed Ruhollah; The ATLAS collaboration

    2018-01-01

    This poster describes an innovative Content Addressable Memory cell with radiation hardened (RH-CAM) architecture. The RH-CAM is designed in a commercial 28 nm CMOS technology. The circuit has been simulated in worst-case conditions, and the effects due to single particles are analyzed injecting a fault current into a circuit node. The proposed architecture can perform on-time pattern recognition tasks in harsh environments, such as very front-end electronics in hadron colliders and in space applications.

  1. 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......, a calibration approach was developed. This approach involved an additional dietary assessment common across study populations to re-express individual dietary intakes according to the same reference scale. A single 24-hour diet recall was therefore collected, as the EPIC reference calibration method, from...... in a large multi-centre European study. These studies showed that, despite certain inherent methodological and logistic constraints, a study design such as this one works relatively well in practice. The average response in the calibration study was 78.3% and ranged from 46.5% to 92.5%. The calibration...

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

    Czech Academy of Sciences Publication Activity Database

    You, J.H.; Mazzone, F.; Visca, E.; Bachmann, Ch.; Autissier, E.; Barrett, T.; Cocilovo, V.; Crescenzi, F.; Domalapally, P.K.; Dongiovanni, D.; Entler, Slavomír; Federici, G.; Frosi, P.; Fursdon, M.; Greuner, H.; Hancock, D.; Marzullo, D.; McIntosh, S.; Müller, A.V.; Porfiri, M.T.; Ramogida, G.; Reiser, J.; Richou, M.; Rieth, M.; Rydzy, A.; Villari, R.; Widak, V.

    109-111, November (2016), s. 1598-1603 ISSN 0920-3796. [International Symposium on Fusion Nuclear Technology (ISFNT-12)/12./. Jeju, 14.09.2015-18.09.2015] EU Projects: European Commission(XE) 633053 - EUROfusion Institutional support: RVO:61389021 Keywords : DEMO * Tokamak * Divertor * Plasma-facing component * Conceptual design * Eurofusiona Subject RIV: JF - Nuclear Energetics OBOR OECD: Nuclear related engineering Impact factor: 1.319, year: 2016 http://www.sciencedirect.com/science/article/pii/S0920379615303331

  3. Learning Environments’ Activity Potential for Preschoolers (LEAPP): Study Rationale and Design

    OpenAIRE

    Tucker, Patricia; Vanderloo, Leigh M.; Newnham-Kanas, Courtney; Burke, Shauna M.; Irwin, Jennifer D.; Johnson, Andrew M.; van Zandvoort, Melissa M.

    2013-01-01

    Background The purpose of this paper is to provide an overview of the study protocol for the Learning Environments’ Activity Potential for Preschoolers (LEAPP) study, the goal of which is to describe the activity levels of preschoolers attending various early learning venues and explore which attributes of these facilities (e.g. curriculum, policies, equipment, etc.) support activity participation. Design and methods This cross-sectional study aimed to recruit approximately 30 early learning ...

  4. 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...... corticosteroid users. Among patients from 13 studies with available data on asthma exacerbations, a third reported exacerbations despite inhaled corticosteroid use. In the future pharmacogenomics studies within the consortium, the pharmacogenomics analyses will be performed separately in each center...

  5. A new design and rationale for 3D orthogonally oversampled k-space trajectories.

    Science.gov (United States)

    Pipe, James G; Zwart, Nicholas R; Aboussouan, Eric A; Robison, Ryan K; Devaraj, Ajit; Johnson, Kenneth O

    2011-11-01

    A novel center-out 3D trajectory for sampling magnetic resonance data is presented. The trajectory set is based on a single Fermat spiral waveform, which is substantially undersampled in the center of k-space. Multiple trajectories are combined in a "stacked cone" configuration to give very uniform sampling throughout a "hub," which is very efficient in terms of gradient performance and uniform trajectory spacing. The fermat looped, orthogonally encoded trajectories (FLORET) design produces less gradient-efficient trajectories near the poles, so multiple orthogonal hub designs are shown. These multihub designs oversample k-space twice with orthogonal trajectories, which gives unique properties but also doubles the minimum scan time for critical sampling of k-space. The trajectory is shown to be much more efficient than the conventional stack of cones trajectory, and has nearly the same signal-to-noise ratio efficiency (but twice the minimum scan time) as a stack of spirals trajectory. As a center-out trajectory, it provides a shorter minimum echo time than stack of spirals, and its spherical k-space coverage can dramatically reduce Gibbs ringing. Copyright © 2011 Wiley Periodicals, Inc.

  6. The Managed Ventricular pacing versus VVI 40 Pacing (MVP) Trial: clinical background, rationale, design, and implementation.

    Science.gov (United States)

    Sweeney, Michael O; Ellenbogen, Kenneth A; Miller, Elaine Hogan; Sherfesee, Lou; Sheldon, Todd; Whellan, David

    2006-12-01

    Implantable cardioverter defibrillators (ICDs) reduce mortality among appropriately selected patients who have had or are at risk for life-threatening ventricular arrhythmia. Right ventricular apical (RVA) pacing has been implicated in worsening heart failure and death. The optimal pacemaker mode for bradycardia support while minimizing unnecessary and potentially harmful RVA pacing has not been determined. The Managed Ventricular pacing vs. VVI 40 Pacing Trial (MVP) is a prospective, multicenter, randomized, single-blind, parallel, controlled clinical trial designed to establish whether atrial-based dual-chamber managed ventricular pacing mode (MVP) is equivalent or superior to back-up only ventricular pacing (VVI 40) among patients with standard indications for ICD therapy and no indication for bradycardia pacing. The MVP Trial is designed with 80% power to detect a 10% reduction in the primary endpoint of new or worsening heart failure or all-cause mortality in the MVP-treated group. Approximately 1,000 patients at 80 centers in the United States, Canada, Western Europe, and Israel will be randomized to MVP or VVI 40 pacing after successful implantation of a dual-chamber ICD. Heart failure therapies will be optimized in accordance with evidence-based guidelines. Prespecified secondary endpoints will include ventricular arrhythmias, atrial fibrillation, new indication for bradycardia pacing, health-related quality of life, and cost effectiveness. Enrollment began in October 2004 and concluded in April 2006. The study will be terminated upon recommendation of the Data Monitoring Committee or when the last patient enrolled and surviving has reached a minimum 2 years of follow-up. The MVP Trial will meet the clinical need for carefully designed prospective studies to define the benefits of atrial-based dual-chamber minimal ventricular pacing versus single-chamber ventricular pacing in conventional ICD patients.

  7. 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

  8. Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.

    Science.gov (United States)

    Blumenthal, James A; Smith, Patrick J; Welsh-Bohmer, Kathleen; Babyak, Michael A; Browndyke, Jeffrey; Lin, Pao-Hwa; Doraiswamy, P Murali; Burke, James; Kraus, William; Hinderliter, Alan; Sherwood, Andrew

    2013-01-01

    Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and diet are associated with lower CVD risk and reduced incidence of dementia, no randomized controlled trial (RCT) has examined the independent effects of exercise and diet on neurocognitive function among individuals at risk for dementia. The ENLIGHTEN trial is a RCT of patients with CVD risk factors who also are characterized by subjective cognitive complaints and objective evidence of neurocognitive impairment without dementia (CIND) STUDY DESIGN: A 2 by 2 design will examine the independent and combined effects of diet and exercise on neurocognition. 160 participants diagnosed with CIND will be randomly assigned to 6 months of aerobic exercise, the DASH diet, or a combination of both exercise and diet; a (control) group will receive health education but otherwise will maintain their usual dietary and activity habits. Participants will complete comprehensive assessments of neurocognitive functioning along with biomarkers of CVD risk including measures of blood pressure, glucose, endothelial function, and arterial stiffness. The ENLIGHTEN trial will (a) evaluate the effectiveness of aerobic exercise and the DASH diet in improving neurocognitive functioning in CIND patients with CVD risk factors; (b) examine possible mechanisms by which exercise and diet improve neurocognition; and (c) consider potential moderators of treatment, including subclinical CVD. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. Protein structures in Alzheimer's disease: The basis for rationale therapeutic design.

    Science.gov (United States)

    Montoliu-Gaya, Laia; Villegas, Sandra

    2015-12-15

    Alzheimer's disease (AD) is a neurodegenerative disorder that affects memory, behavior, thinking and emotion. Current therapies to treat AD patients are only capable for temporarily slowing-down the cognitive decline, as they are focused on ameliorating symptoms instead of targeting its underlying causes. The aim of this review is to describe what is known about the protein structures implicated in AD pathogenesis, amyloid cascade members, as well as those structures involved in Aβ clearance. Thus, structural information available for APP, α- β- and γ-secretases, CTFβ and derived Aβ peptides, AICDs, apoE and apoJ, LRP-1 and RAGE, and neprilysin and insulin-degrading enzyme is provided. The recently solved structure for the γ-secretase complex opens the rational design of a new generation of inhibitors, whereas that for Aβ oligomers offers a putative mechanism explaining why monoclonal antibodies targeted to the N-terminus are effective. Then, an overview on therapies targeting some of these molecules presents their benefits and drawbacks. As a general conclusion our knowledge on the protein structures involved in AD has recently substantially advanced, allowing for the rational design of different therapeutic approaches. Hopefully, we are getting closer to finding a strong disease-modifying drug to cure this devastating disease. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Rationale, Design, and Methods for Process Evaluation in the Childhood Obesity Research Demonstration Project.

    Science.gov (United States)

    Joseph, Sitara; Stevens, Andria M; Ledoux, Tracey; O'Connor, Teresia M; O'Connor, Daniel P; Thompson, Debbe

    2015-01-01

    The cross-site process evaluation plan for the Childhood Obesity Research Demonstration (CORD) project is described here. The CORD project comprises 3 unique demonstration projects designed to integrate multi-level, multi-setting health care and public health interventions over a 4-year funding period. Three different communities in California, Massachusetts, and Texas. All CORD demonstration projects targeted 2-12-year-old children whose families are eligible for benefits under Title XXI (CHIP) or Title XIX (Medicaid). The CORD projects were developed independently and consisted of evidence-based interventions that aim to prevent childhood obesity. The interventions promote healthy behaviors in children by applying strategies in 4 key settings (primary care clinics, early care and education centers, public schools, and community institutions). The CORD process evaluation outlined 3 main outcome measures: reach, dose, and fidelity, on 2 levels (researcher to provider, and provider to participant). The plan described here provides insight into the complex nature of process evaluation for consortia of independently designed multi-level, multi-setting intervention studies. The process evaluation results will provide contextual information about intervention implementation and delivery with which to interpret other aspects of the program. Copyright © 2015 Society for Nutrition Education and Behavior. All rights reserved.

  11. Rationale and study design of the Japan environment and children’s study (JECS)

    Science.gov (United States)

    2014-01-01

    Background There is global concern over significant threats from a wide variety of environmental hazards to which children face. Large-scale and long-term birth cohort studies are needed for better environmental management based on sound science. The primary objective of the Japan Environment and Children’s Study (JECS), a nation-wide birth cohort study that started its recruitment in January 2011, is to elucidate environmental factors that affect children’s health and development. Methods/Design Approximately 100,000 expecting mothers who live in designated study areas will be recruited over a 3-year period from January 2011. Participating children will be followed until they reach 13 years of age. Exposure to environmental factors will be assessed by chemical analyses of bio-specimens (blood, cord blood, urine, breast milk, and hair), household environment measurements, and computational simulations using monitoring data (e.g. ambient air quality monitoring) as well as questionnaires. JECS’ priority outcomes include reproduction/pregnancy complications, congenital anomalies, neuropsychiatric disorders, immune system disorders, and metabolic/endocrine system disorders. Genetic factors, socioeconomic status, and lifestyle factors will also be examined as covariates and potential confounders. To maximize representativeness, we adopted provider-mediated community-based recruitment. Discussion Through JECS, chemical substances to which children are exposed during the fetal stage or early childhood will be identified. The JECS results will be translated to better risk assessment and management to provide healthy environment for next generations. PMID:24410977

  12. Cultural Variables Underlying Obesity in Latino Men: Design, Rationale and Participant Characteristics from the Latino Men's Health Initiative.

    Science.gov (United States)

    Sanchez-Johnsen, Lisa; Craven, Meredith; Nava, Magdalena; Alonso, Angelica; Dykema-Engblade, Amanda; Rademaker, Alfred; Xie, Hui

    2017-08-01

    Overweight and obesity are associated with significant health problems and rates of obesity are high among Latino men. This paper describes the design, rationale and participant characteristics of the key demographic variables assessed in an NIH-funded study (R21-CA143636) addressing culture and several obesity-related variables (diet, physical activity, and body image) among Mexican and Puerto Rican men using a community-based participatory research framework. Participants completed objective measures (height, weight, body fat, hip, waist), a health and culture interview, a diet questionnaire, and used an accelerometer to measure their level of physical activity. A total of 203 participants completed the measures and the health and culture interview and 193 completed all study components. Puerto Ricans were older than Mexicans (p health insurance, Body Mass Index, body fat, hip and waist measurements, and the language preference of the interview. Results have implications for the development of a future intervention that incorporates the role of cultural factors into a community participatory obesity intervention for Latino men.

  13. Engendering healthy masculinities to prevent sexual violence: Rationale for and design of the Manhood 2.0 trial.

    Science.gov (United States)

    Abebe, Kaleab Z; Jones, Kelley A; Culyba, Alison J; Feliz, Nayck B; Anderson, Heather; Torres, Irving; Zelazny, Sarah; Bamwine, Patricia; Boateng, Adwoa; Cirba, Benjamin; Detchon, Autumn; Devine, Danielle; Feinstein, Zoe; Macak, Justin; Massof, Michael; Miller-Walfish, Summer; Morrow, Sarah Elizabeth; Mulbah, Paul; Mulwa, Zabi; Paglisotti, Taylor; Ripper, Lisa; Ports, Katie A; Matjasko, Jennifer L; Garg, Aapta; Kato-Wallace, Jane; Pulerwitz, Julie; Miller, Elizabeth

    2018-05-23

    Violence against women and girls is an important global health concern. Numerous health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health prevention strategy. Adapted from an international setting for use in the US, "Manhood 2.0" is a "gender transformative" program that involves challenging harmful gender and sexuality norms that foster violence against women while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce the perpetration of sexual violence (SV) and adolescent relationship abuse (ARA). Manhood 2.0 is being rigorously evaluated in a community-based cluster-randomized trial in 21 lower resource Pittsburgh neighborhoods with 866 adolescent males ages 13-19. The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation. This study will provide urgently needed information about the effectiveness of a gender transformative program, which combines healthy sexuality education, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males. In this manuscript, we outline the rationale for and evaluation design of Manhood 2.0. Clinical Trials #: NCT02427061. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  14. 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

  15. 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

  16. 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 ...

  17. 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

    postoperative rehabilitation (starting six weeks after surgery); (3) early postoperative rehabilitation alone; (4) today's standard care which is postoperative rehabilitation initiated six weeks after surgery. The preoperative rehabilitation program consists of an individually designed, 30-minute home......-based exercise program performed daily. The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling. The primary study endpoint is VO2peak and secondary endpoints...... (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...

  18. Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) 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...... be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new...

  19. 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.

  20. The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics.

    Science.gov (United States)

    Stewart, Tiffany M; Pollard, Tarryn; Hildebrandt, Tom; Beyl, Robbie; Wesley, Nicole; Kilpela, Lisa Smith; Becker, Carolyn Black

    2017-09-01

    Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes. Female collegiate athletes (N=481) aged 17-21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3weeks), and six-, 12-, and 18-month follow-ups. This study achieved 96% (N=481) of target recruitment (N=500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases. Health risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Evaluation of a standard provision versus an autonomy promotive exercise referral programme: rationale and study design

    Directory of Open Access Journals (Sweden)

    Jolly Kate

    2009-06-01

    Full Text Available Abstract Background The National Institute of Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the utility of a Self Determination Theory (SDT-based exercise referral consultation. Methods/Design Design: An exploratory cluster randomised controlled trial comparing standard provision exercise on prescription with a Self Determination Theory-based (SDT exercise on prescription intervention. Participants: 347 people referred to the Birmingham Exercise on Prescription scheme between November 2007 and July 2008. The 13 exercise on prescription sites in Birmingham were randomised to current practice (n = 7 or to the SDT-based intervention (n = 6. Outcomes measured at 3 and 6-months: Minutes of moderate or vigorous physical activity per week assessed using the 7-day Physical Activity Recall; physical health: blood pressure and weight; health status measured using the Dartmouth CO-OP charts; anxiety and depression measured by the Hospital Anxiety and Depression Scale and vitality measured by the subjective vitality score; motivation and processes of change: perceptions of autonomy support from the advisor, satisfaction of the needs for competence, autonomy, and relatedness via physical activity, and motivational regulations for exercise. Discussion This trial will determine whether an exercise referral programme based on Self Determination Theory increases physical activity and other health outcomes compared to a standard programme and will test the underlying SDT-based process model (perceived autonomy support, need satisfaction, motivation regulations, outcomes via structural equation modelling. Trial registration The trial is registered as Current Controlled trials ISRCTN07682833.

  2. Texas Medication Algorithm Project, phase 3 (TMAP-3): rationale and study design.

    Science.gov (United States)

    Rush, A John; Crismon, M Lynn; Kashner, T Michael; Toprac, Marcia G; Carmody, Thomas J; Trivedi, Madhukar H; Suppes, Trisha; Miller, Alexander L; Biggs, Melanie M; Shores-Wilson, Kathy; Witte, Bradley P; Shon, Steven P; Rago, William V; Altshuler, Kenneth Z

    2003-04-01

    . Analyses were based on hierarchical linear models designed to test for initial changes and growth in differences between ALGO and TAU patients over time in this matched clinic design.

  3. A human dietary arachidonic acid supplementation study conducted in a metabolic research unit: rationale and design.

    Science.gov (United States)

    Nelson, G J; Kelley, D S; Emken, E A; Phinney, S D; Kyle, D; Ferretti, A

    1997-04-01

    While there are many reports of studies that fed arachidonic acid (AA) to animals, there are very few reports of AA feeding to humans under controlled conditions. This 130-d study was conceived as a controlled, symmetrical crossover design with healthy, adult male volunteers. They lived in the metabolic research unit (MRU) of the Western Human Nutrition Research (WHNRC) for the entire study. All food was prepared by the WHNRC kitchen. The basal (low-AA) diet consisted of natural foods (30 en% fat, 15 en% protein, and 55 en% carbohydrate), containing 210 mg/d of AA, and met the recommended daily allowance for all nutrients. The high-AA (intervention) diet was similar except that 1.5 g/d of AA in the form of a triglyceride containing 50% AA replaced an equal amount of high-oleic safflower oil in the basal diet. The subjects (ages 20 to 39) were within -10 to +20% of ideal body weight, nonsmoking, and not allowed alcohol in the MRU. Their exercise level was constant, and their body weights were maintained within 2% of entry level. Subjects were initially fed the low-AA diet for 15 d. On day 16, half of the subjects (group A) wee placed on the high-AA diet, and the other group (B) remained on the low-AA diets. On day 65, the two groups switched diets. On day 115, group B returned to the low-AA diet. This design, assuming no carryover effect, allowed us to merge the data from the two groups, with the data comparison days being 65 (low-AA) and 115 (high-AA) for group B and 130 (low-AA) and 65 (high-AA) for group A. The main indices studied were the fatty acid composition of the plasma, red blood cells, platelets, and adipose tissue; in vitro platelet aggregation, bleeding times, clotting factors; immune response as measured by delayed hypersensitivity skin tests, cellular proliferation of peripheral blood mononuclear cells in response to various mitogens and antigens, natural killer cell activity, and response to measles/mumps/rubella and influenza vaccines; the

  4. 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

  5. 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

  6. 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

  7. The Scandinavian baltic pancreatic club (SBPC) database: design, rationale and characterisation of the study cohort.

    Science.gov (United States)

    Olesen, Søren S; Poulsen, Jakob L; Drewes, Asbjørn M; Frøkjær, Jens B; Laukkarinen, Johanna; Parhiala, Mikael; Rix, Iben; Novovic, Srdan; Lindkvist, Björn; Bexander, Louise; Dimcevski, Georg; Engjom, Trond; Erchinger, Friedemann; Haldorsen, Ingfrid S; Pukitis, Aldis; Ozola-Zālīte, Imanta; Haas, Stephan; Vujasinovic, Miroslav; Löhr, J Matthias; Gulbinas, Antanas; Jensen, Nanna M; Jørgensen, Maiken T; Nøjgaard, Camilla

    2017-08-01

    Chronic pancreatitis (CP) is a multifaceted disease associated with several risk factors and a complex clinical presentation. We established the Scandinavian Baltic Pancreatic Club (SBPC) Database to characterise and study the natural history of CP in a Northern European cohort. Here, we describe the design of the database and characteristics of the study cohort. Nine centres from six different countries in the Scandinavian-Baltic region joined the database. Patients with definitive or probable CP (M-ANNHEIM diagnostic criteria) were included. Standardised case report forms were used to collect several assessment variables including disease aetiology, duration of CP, preceding acute pancreatitis, as well as symptoms, complications, and treatments. The clinical stage of CP was characterised according to M-ANNNHEIM. Yearly follow-up is planned for all patients. The study cohort comprised of 910 patients (608 men: 302 women; median age 58 (IQR: 48-67) years with definite 848 (93%) or probable CP 62 (7%). Nicotine (70%) and alcohol (59%) were the most frequent aetiologies and seen in combination in 44% of patients. A history of recurrent acute pancreatitis was seen in 49% prior to the development of CP. Pain (69%) and exocrine pancreatic insufficiency (68%) were the most common complications followed by diabetes (43%). Most patients (30%) were classified as clinical stage II (symptomatic CP with exocrine or endocrine insufficiency). Less than 10% of the patients had undergone pancreatic surgery. The SBPC database provides a mean for future prospective, observational studies of CP in the Northern European continent.

  8. Design and rationale of dabigatran's stroke prevention in real life in Turkey (D-SPIRIT).

    Science.gov (United States)

    Türk, Uğur Önsel; Alioğlu, Emin; Tunçer, Eşref; Özpelit, Mehmet Emre; Pekel, Nihat; Tengiz, İstemihan; Çetin, Nurullah; Dalgıç, Onur; Topaloğlu, Caner; Bilgin, Nazile; Altın, Cihan; Özdemirkıran, Tolga; Tülüce, Kamil; Türkoğlu, Ebru İpek; Özpelit, Ebru

    2016-04-01

    The D-SPIRIT registry is designed to investigate the safety and efficacy of dabigatran etexilate in patients with nonvalvular atrial fibrillation (NVAF) and to collect data on outcomes in clinical practice. The D-SPIRIT is a national, prospective, observational, post-marketing registry involving patients with NVAF who have been taking dabigatran etexilate therapy for stroke prevention for a minimum of 6 months prior to enrollment. The registry will collect and analyze data from routine care, enrolling up to 600 patients in 9 centers. Patients will be followed up for 2 years to evaluate effectiveness and safety. A sample size of 600 subjects is proposed based on the following assumptions; Two-sided significance level of 0.05 (1-sided significance level of 0.025), ischemic stroke incidence rate of 0.768%-1.111%, hemorrhagic stroke incidence rate of 0.109%-0.130%, transient ischemic attack incidence rate of 0.722%-0.623%, therapy discontinuation incidence rate of 40% at day 730, and duration of enrollment period of 12 months with non-uniformed enrollment rate. Ethics approval was given by Dokuz Eylül University Ethics Committee of Clinical Research (2014/54) and approved by the Turkish Ministry of Health. Potential results of D-SPIRIT registry will add data from clinical practice to those from the RE-LY trial to expand knowledge of dabigatran etexilate treatment in patients with NVAF.

  9. Rationale and study design of the Japan environment and children's study (JECS).

    Science.gov (United States)

    Kawamoto, Toshihiro; Nitta, Hiroshi; Murata, Katsuyuki; Toda, Eisaku; Tsukamoto, Naoya; Hasegawa, Manabu; Yamagata, Zentaro; Kayama, Fujio; Kishi, Reiko; Ohya, Yukihiro; Saito, Hirohisa; Sago, Haruhiko; Okuyama, Makiko; Ogata, Tsutomu; Yokoya, Susumu; Koresawa, Yuji; Shibata, Yasuyuki; Nakayama, Shoji; Michikawa, Takehiro; Takeuchi, Ayano; Satoh, Hiroshi

    2014-01-10

    There is global concern over significant threats from a wide variety of environmental hazards to which children face. Large-scale and long-term birth cohort studies are needed for better environmental management based on sound science. The primary objective of the Japan Environment and Children's Study (JECS), a nation-wide birth cohort study that started its recruitment in January 2011, is to elucidate environmental factors that affect children's health and development. Approximately 100,000 expecting mothers who live in designated study areas will be recruited over a 3-year period from January 2011. Participating children will be followed until they reach 13 years of age. Exposure to environmental factors will be assessed by chemical analyses of bio-specimens (blood, cord blood, urine, breast milk, and hair), household environment measurements, and computational simulations using monitoring data (e.g. ambient air quality monitoring) as well as questionnaires. JECS' priority outcomes include reproduction/pregnancy complications, congenital anomalies, neuropsychiatric disorders, immune system disorders, and metabolic/endocrine system disorders. Genetic factors, socioeconomic status, and lifestyle factors will also be examined as covariates and potential confounders. To maximize representativeness, we adopted provider-mediated community-based recruitment. Through JECS, chemical substances to which children are exposed during the fetal stage or early childhood will be identified. The JECS results will be translated to better risk assessment and management to provide healthy environment for next generations.

  10. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry.

    Science.gov (United States)

    Yamamoto, Hideya; Awai, Kazuo; Kuribayashi, Sachio; Kihara, Yasuki

    2014-01-01

    At least two-thirds of cases of acute coronary syndrome are caused by disruption of an atherosclerotic plaque. The natural history of individual plaques is unknown and needs to be established. The Plaque Registration and Evaluation Detected In Computed Tomography (PREDICT) registry is a prospective, multicenter, longitudinal, observational registry. This registry was designed to examine the relationships among coronary CT angiography (CTA) findings and clinical findings, mortality, and morbidity. The relationships among progression of coronary atherosclerosis, including changes in plaque characteristics on coronary CTA, and serum lipid levels and modification of coronary risk factors will also be evaluated. From October 2009 to December 2012, 3015 patients who underwent coronary CTA in 29 centers in Japan were enrolled. These patients were followed for 2 years. The primary end points were considered as all-cause mortality and major cardiac events, including cardiac death, nonfatal myocardial infarction, and unstable angina that required hospitalization. The secondary end points were heart failure that required administration of diuretics, target vessel revascularization, cerebral infarction, peripheral arterial disease, and invasive coronary angiography. Blood pressure, serum lipid, and C-reactive protein levels and all cardiovascular events were recorded at 1 and 2 years. If the initial coronary CTA showed any stenosis or plaques, follow-up coronary CTA was scheduled at 2 years to determine changes in coronary lesions, including changes in plaque characteristics. Analysis of the PREDICT registry data will clarify the relationships between coronary CTA findings and cardiovascular mortality and morbidity in a collaborative multicenter fashion. This trial is registered at www.clinicaltrials.gov as NCT 00991835. Copyright © 2014 Society of Cardiovascular Computed Tomography. All rights reserved.

  11. The population-based Barcelona-Asymptomatic Intracranial Atherosclerosis Study (ASIA: rationale and design

    Directory of Open Access Journals (Sweden)

    Pera Guillem

    2011-02-01

    Full Text Available Abstract Background Large-artery intracranial atherosclerosis may be the most frequent cause of ischemic stroke worldwide. Traditional approaches have attempted to target the disease when it is already symptomatic. However, early detection of intracranial atherosclerosis may allow therapeutic intervention while the disease is still asymptomatic. The prevalence and natural history of asymptomatic intracranial atherosclerosis in Caucasians remain unclear. The aims of the Barcelona-ASymptomatic Intracranial Atherosclerosis (ASIA study are (1 to determine the prevalence of ASIA in a moderate-high vascular risk population, (2 to study its prognostic impact on the risk of suffering future major ischemic events, and (3 to identify predictors of the development, progression and clinical expression of this condition. Methods/Design Cross-over and cohort, population-based study. A randomly selected representative sample of 1,503 subjects with a mild-moderate-high vascular risk (as defined by a REGICOR score ≥ 5% and with neither a history of cerebrovascular nor ischemic heart disease will be studied. At baseline, all individuals will undergo extracranial and transcranial Color-Coded Duplex (TCCD ultrasound examinations to detect presence and severity of extra and intracranial atherosclerosis. Intracranial stenoses will be assessed by magnetic resonance angiography (MRA. Clinical and demographic variables will be recorded and blood samples will be drawn to investigate clinical, biological and genetic factors associated with the presence of ASIA. A long-term clinical and sonographic follow-up will be conducted thereafter to identify predictors of disease progression and of incident vascular events. Discussion The Barcelona-ASIA is a population-based study aiming to evaluate the prevalence and clinical importance of asymptomatic intracranial large-artery atherosclerosis in Caucasians. The ASIA project may provide a unique scientific resource to better

  12. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  13. Rationale and Design Issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) Study

    Science.gov (United States)

    Keren, Ron; Carpenter, Myra A.; Hoberman, Alejandro; Shaikh, Nader; Matoo, Tej K.; Chesney, Russell W.; Matthews, Ranjiv; Gerson, Arlene C.; Greenfield, Saul P.; Fivush, Barbara; McLurie, Gordon A.; Rushton, H. Gil; Canning, Douglas; Nelson, Caleb P.; Greenbaum, Lawrence; Bukowski, Timothy; Primack, William; Sutherland, Richard; Hosking, James; Stewart, Dawn; Elder, Jack; Moxey-Mims, Marva; Nyberg, Leroy

    2010-01-01

    OBJECTIVE Our goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection. DESIGN, PARTICIPANTS, AND METHODS The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring. RESULTS The primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora. CONCLUSIONS The RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae. PMID:19018048

  14. The human early-life exposome (HELIX): project rationale and design.

    Science.gov (United States)

    Vrijheid, Martine; Slama, Rémy; Robinson, Oliver; Chatzi, Leda; Coen, Muireann; van den Hazel, Peter; Thomsen, Cathrine; Wright, John; Athersuch, Toby J; Avellana, Narcis; Basagaña, Xavier; Brochot, Celine; Bucchini, Luca; Bustamante, Mariona; Carracedo, Angel; Casas, Maribel; Estivill, Xavier; Fairley, Lesley; van Gent, Diana; Gonzalez, Juan R; Granum, Berit; Gražulevičienė, Regina; Gutzkow, Kristine B; Julvez, Jordi; Keun, Hector C; Kogevinas, Manolis; McEachan, Rosemary R C; Meltzer, Helle Margrete; Sabidó, Eduard; Schwarze, Per E; Siroux, Valérie; Sunyer, Jordi; Want, Elizabeth J; Zeman, Florence; Nieuwenhuijsen, Mark J

    2014-06-01

    Developmental periods in early life may be particularly vulnerable to impacts of environmental exposures. Human research on this topic has generally focused on single exposure-health effect relationships. The "exposome" concept encompasses the totality of exposures from conception onward, complementing the genome. The Human Early-Life Exposome (HELIX) project is a new collaborative research project that aims to implement novel exposure assessment and biomarker methods to characterize early-life exposure to multiple environmental factors and associate these with omics biomarkers and child health outcomes, thus characterizing the "early-life exposome." Here we describe the general design of the project. In six existing birth cohort studies in Europe, HELIX will estimate prenatal and postnatal exposure to a broad range of chemical and physical exposures. Exposure models will be developed for the full cohorts totaling 32,000 mother-child pairs, and biomarkers will be measured in a subset of 1,200 mother-child pairs. Nested repeat-sampling panel studies (n = 150) will collect data on biomarker variability, use smartphones to assess mobility and physical activity, and perform personal exposure monitoring. Omics techniques will determine molecular profiles (metabolome, proteome, transcriptome, epigenome) associated with exposures. Statistical methods for multiple exposures will provide exposure-response estimates for fetal and child growth, obesity, neurodevelopment, and respiratory outcomes. A health impact assessment exercise will evaluate risks and benefits of combined exposures. HELIX is one of the first attempts to describe the early-life exposome of European populations and unravel its relation to omics markers and health in childhood. As proof of concept, it will form an important first step toward the life-course exposome.

  15. 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.

  16. Living with diabetes: rationale, study design and baseline characteristics for an Australian prospective cohort study

    Directory of Open Access Journals (Sweden)

    Donald Maria

    2012-01-01

    Full Text Available Abstract Background Diabetes mellitus is a major global public health threat. In Australia, as elsewhere, it is responsible for a sizeable portion of the overall burden of disease, and significant costs. The psychological and social impact of diabetes on individuals with the disease can be severe, and if not adequately addressed, can lead to the worsening of the overall disease picture. The Living With Diabetes Study aims to contribute to a holistic understanding of the psychological and social aspects of diabetes mellitus. Methods/Design The Living With Diabetes Study is a 5-year prospective cohort study, based in Queensland, Australia. The first wave of data, which was collected via a mailed self-report survey, was gathered in 2008, with annual collections thereafter. Measurements include: demographic, lifestyle, health and disease characteristics; quality of life (EQ-5D, ADDQoL; emotional well-being (CES-D, LOT-R, ESSI; disease self-management (PAM; and health-care utilisation and patient-assessed quality of care (PACIC. 29% of the 14,439 adults who were invited to participate in the study agreed to do so, yielding a sample size of 3,951 people. Discussion The data collected by the Living With Diabetes Study provides a good representation of Australians with diabetes to follow over time in order to better understand the natural course of the illness. The study has potential to further illuminate, and give a comprehensive picture of the psychosocial implications of living with diabetes. Data collection is ongoing.

  17. The Biomarkers of Exposure and Effect in Agriculture (BEEA) Study: Rationale, Design, Methods, and Participant Characteristics.

    Science.gov (United States)

    Hofmann, Jonathan N; Beane Freeman, Laura E; Lynch, Charles F; Andreotti, Gabriella; Thomas, Kent W; Sandler, Dale P; Savage, Sharon A; Alavanja, Michael C

    2015-01-01

    Agricultural exposures including pesticides, endotoxin, and allergens have been associated with risk of various cancers and other chronic diseases, although the biological mechanisms underlying these associations are generally unclear. To facilitate future molecular epidemiologic investigations, in 2010 the study of Biomarkers of Exposure and Effect in Agriculture (BEEA) was initiated within the Agricultural Health Study, a large prospective cohort in Iowa and North Carolina. Here the design and methodology of BEEA are described and preliminary frequencies for participant characteristics and current agricultural exposures are reported. At least 1,600 male farmers over 50 years of age will be enrolled in the BEEA study. During a home visit, participants are asked to complete a detailed interview about recent agricultural exposures and provide samples of blood, urine, and (since 2013) house dust. As of mid-September 2014, in total, 1,233 participants have enrolled. Most of these participants (83%) were still farming at the time of interview. Among those still farming, the most commonly reported crops were corn (81%) and soybeans (74%), and the most frequently noted animals were beef cattle (35%) and hogs (13%). There were 861 (70%) participants who reported occupational pesticide use in the 12 months prior to interview; among these participants, the most frequently noted herbicides were glyphosate (83%) and 2,4-D (72%), and most commonly reported insecticides were malathion (21%), cyfluthrin (13%), and permethrin (12%). Molecular epidemiologic investigations within BEEA have the potential to yield important new insights into the biological mechanisms through which these or other agricultural exposures influence disease risk.

  18. 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

  19. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  20. 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

  1. The Coordination and Activity Tracking in CHildren (CATCH) study: rationale and design.

    Science.gov (United States)

    Cairney, John; Missiuna, Cheryl; Timmons, Brian W; Rodriguez, Christine; Veldhuizen, Scott; King-Dowling, Sara; Wellman, Sarah; Le, Tuyen

    2015-12-21

    Past studies have found that children with Developmental Coordination Disorder (DCD) engage in less physical activity than typically developing children. This "activity deficit" may result in children with DCD being less physically fit and more likely to be overweight or obese, potentially increasing later risk for poor cardiovascular health. Unfortunately, the majority of DCD research has been limited to cross-sectional designs, leading to questions about the complex relationship among motor ability, inactivity and health-related fitness. Of the few longitudinal studies on the topic, determining precedence amongst these factors is difficult because study cohorts typically focus on mid to late childhood. By this age, both decreased physical fitness and obesity are often established. The Coordination and Activity Tracking in CHildren (CATCH) study will examine the pathways connecting DCD, physical activity, physical fitness, and body composition from early to middle childhood. The CATCH study is a prospective cohort study. We aim to recruit a cohort of 600 children aged 4 to 5 years (300 probable DCD [pDCD] and 300 controls) and test them once a year for 4 years. At Phase 1 of baseline testing, we assess motor skills, cognitive ability (IQ), basic anthropometry, flexibility and lower body muscle strength, while parents complete an interview and questionnaires regarding family demographics, their child's physical activity, and behavioural characteristics. Children who move on to Phase 2 (longitudinal cohort) have their body fat percentage, foot structure, aerobic and anaerobic fitness assessed. An accelerometer to measure physical activity is then given to the child and interested family members. The family also receives an accelerometer logbook and 3-day food dairy. At years 2 to 4, children in the longitudinal cohort will have all baseline assessments repeated (excluding the IQ test), and complete an additional measure of perceived self-efficacy. Parents will

  2. 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

  3. 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.

  4. A Multi-site, Two-Phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, Design, and Methodology

    Science.gov (United States)

    Weiss, Roger D.; Potter, Jennifer Sharpe; Provost, Scott E.; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

    2010-01-01

    The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. PMID:20116457

  5. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

    Science.gov (United States)

    Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd; Gordin, Fred M; Grund, Birgit; Lundgren, Jens D; Neaton, James D; Pett, Sarah L; Phillips, Andrew; Touloumi, Giota; Vjecha, Michael J

    2012-01-01

    Background Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated with an increased risk of serious non-AIDS (SNA) diseases including cardiovascular, renal, and liver diseases and non-AIDS-defining cancers. Although combination antiretroviral treatment (ART) has resulted in a substantial decrease in morbidity and mortality in persons with HIV infection, viral eradication is not feasible with currently available drugs. The optimal time to start ART for asymptomatic HIV infection is controversial and remains one of the key unanswered questions in the clinical management of HIV-infected individuals. Purpose In this article, we outline the rationale and methods of the Strategic Timing of AntiRetroviral Treatment (START) study, an ongoing multicenter international trial designed to assess the risks and benefits of initiating ART earlier than is currently practiced. We also describe some of the challenges encountered in the design and implementation of the study and how these challenges were addressed. Methods A total of 4000 study participants who are HIV type 1 (HIV-1) infected, ART naïve with CD4 count > 500 cells/μL are to be randomly allocated in a 1:1 ratio to start ART immediately (early ART) or defer treatment until CD4 count is AIDS, SNA, or death. The study had a pilot phase to establish feasibility of accrual, which was set as the enrollment of at least 900 participants in the first year. Results Challenges encountered in the design and implementation of the study included the limited amount of data on the risk of a major component of the primary endpoint (SNA) in the study population, changes in treatment guidelines when the pilot phase was well underway, and the complexities of conducting the trial in a geographically wide

  6. 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.

  7. 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.

  8. Small sustainable monetary incentives versus charitable donations to promote exercise: Rationale, design, and baseline data from a randomized pilot study.

    Science.gov (United States)

    Williams, David M; Lee, Harold H; Connell, Lauren; Boyle, Holly; Emerson, Jessica; Strohacker, Kelley; Galárraga, Omar

    2018-03-01

    Regular physical activity (PA) enhances weight-loss and reduces risk of chronic disease. However, as few as 10% of U.S. adults engage in regular PA. Incentive programs to promote PA have shown some promise, but have typically used incentives that are too large to sustain over time and have not demonstrated habit formation or been tested in community settings. This report presents the rationale and design of a randomized pilot study testing the feasibility and preliminary efficacy of small monetary incentives for PA (n=25) versus charitable donations in the same amount (n=25) versus control (n=25) over 12months among 75 low-active but otherwise healthy adults at a local YMCA. Incentives are based on YMCA attendance, which is verified by electronic swipe card data and is the primary study outcome, with self-reported minutes/week of PA assessed as a secondary outcome. Incentives are intentionally small enough-$1/session, maximum of $5/week-such that they could be indefinitely sustained by community organizations, privately-owned health clubs, healthcare organizations, or employers (e.g., employer fitness facilities). Costs of the incentive program for the sponsoring organization may be partially offset by increases in membership resulting from the appeal of the program. Moreover, if efficacious, the charitable donation incentive program may have the added benefit of building social capital for the sponsoring organization and potentially serving as a tax write-off, thus further offsetting the cost of the incentives. Findings will also have implications for the use of financially sustainable community-based incentive programs for other health-related behaviors (e.g., weight loss, smoking). Copyright © 2018 Elsevier Inc. All rights reserved.

  9. 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.

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

    OpenAIRE

    Anna-Carlotta Zarski; Anna-Carlotta Zarski; Matthias Berking; David Daniel Ebert

    2018-01-01

    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 In...

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

    OpenAIRE

    Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

    2018-01-01

    Introduction Genito-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. Aim This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an...

  12. [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 (Pmanufacture custom trays by three-dimensional printing method, there is no need to pour preliminary cast after taking the primary impression, therefore, it can save the impression material and model material. As to completing denture restoration, manufacturing custom trays using FSD system is worth being

  13. 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.

  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. 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

  16. CAD/CAM Helps Build Better Bots: High-Tech Design and Manufacture Draws Engineering-Oriented Students

    Science.gov (United States)

    Van Name, Barry

    2012-01-01

    There is a battlefield where no quarter is given, no mercy shown, but not a single drop of blood is spilled. It is an arena that witnesses the bringing together of high-tech design and manufacture with the outpouring of brute force, under the remotely accessed command of some of today's brightest students. This is the world of battling robots, or…

  17. 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

  18. 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.

  19. Overcoming Limitations in Previous Research on Exercise as a Smoking Cessation Treatment: Rationale and Design of the “Quit for Health” Trial

    Science.gov (United States)

    Williams, David M.; Ussher, Michael; Dunsiger, Shira; Miranda, Robert; Gwaltney, Chad J.; Monti, Peter M.; Emerson, Jessica

    2013-01-01

    Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)—an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants’ natural environments. PMID:24246818

  20. Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection.

    Science.gov (United States)

    Huang, David T; Angus, Derek C; Chang, Chung-Chou H; Doi, Yohei; Fine, Michael J; Kellum, John A; Peck-Palmer, Octavia M; Pike, Francis; Weissfeld, Lisa A; Yabes, Jonathan; Yealy, Donald M

    2017-08-29

    Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated in bacterial, but not viral infection. Multiple European trials found procalcitonin-guided care reduced antibiotic use in lower respiratory tract infection, with no apparent harm. However, applicability to US practice is limited due to trial design features impractical in the US, between-country differences, and residual safety concerns. The Procalcitonin Antibiotic Consensus Trial (ProACT) is a multicenter randomized trial to determine the impact of a procalcitonin antibiotic prescribing guideline, implemented with basic reproducible strategies, in US patients with lower respiratory tract infection. We describe the trial methods using the Consolidated Standards of Reporting Trials (CONSORT) framework, and the rationale for key design decisions, including choice of eligibility criteria, choice of control arm, and approach to guideline implementation. ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.

  1. Reasons for continuing use of Complementary and Alternative Medicine (CAM) in students: a consumer commitment model.

    Science.gov (United States)

    Sirois, Fuschia M; Salamonsen, Anita; Kristoffersen, Agnete E

    2016-02-24

    Research on continued CAM use has been largely atheoretical and has not considered the broader range of psychological and behavioral factors that may be involved. The purpose of this study was to test a new conceptual model of commitment to CAM use that implicates utilitarian (trust in CAM) and symbolic (perceived fit with CAM) in psychological and behavioral dimensions of CAM commitment. A student sample of CAM consumers, (N = 159) completed a survey about their CAM use, CAM-related values, intentions for future CAM use, CAM word-of-mouth behavior, and perceptions of being an ongoing CAM consumer. Analysis revealed that the utilitarian, symbolic, and CAM commitment variables were significantly related, with r's ranging from .54 to .73. A series hierarchical regression analyses controlling for relevant demographic variables found that the utilitarian and symbolic values uniquely accounted for significant and substantial proportion of the variance in each of the three CAM commitment indicators (R(2) from .37 to .57). The findings provide preliminary support for the new model that posits that CAM commitment is a multi-dimensional psychological state with behavioral indicators. Further research with large-scale samples and longitudinal designs is warranted to understand the potential value of the new model.

  2. 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.

  3. 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.

  4. 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......INTRODUCTION: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance...... over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim...

  5. An Innovative Radiation Hardened CAM Architecture

    CERN Document Server

    Shojaii, Seyed Ruhollah; The ATLAS collaboration

    2018-01-01

    This article describes an innovative Content Addressable Memory (CAM) cell with radiation hardened (RH) architecture. The RH-CAM is designed in a commercial 28 nm CMOS technology. The circuit has been simulated in worst-case conditions, and the effects due to single particles have been analyzed by injecting a current pulse into a circuit node. The proposed architecture is suitable for on-time pattern recognition tasks in harsh environments, such as front-end electronics in hadron colliders and in space applications.

  6. 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

  7. 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

  8. Trend and application of CAD/CAM system

    International Nuclear Information System (INIS)

    Kang, Man Ok

    1984-09-01

    This report is about trend and application of CAD/CAM system, giving descriptions of computer aided design which helps construction, engineering and drafting tasks. It also tells of computer aided manufacturing related general design of manufactures, which includes process design, production management, decision of work technology, processing. The need and application of CAD/CAM system is increasing more and more for industry each area.

  9. Incorporation of CAD/CAM Restoration Into Navy Dentistry

    Science.gov (United States)

    2017-09-26

    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...this time by allowing for rapid scanning, designing , development, and production of dental restorations. Using this technology gives dentists the

  10. 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.

  11. 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

  12. Overcoming limitations in previous research on exercise as a smoking cessation treatment: rationale and design of the "Quit for Health" trial.

    Science.gov (United States)

    Williams, David M; Ussher, Michael; Dunsiger, Shira; Miranda, Robert; Gwaltney, Chad J; Monti, Peter M; Emerson, Jessica

    2014-01-01

    Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)--an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants' natural environments. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. 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

    2014-03-01

    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. 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. 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 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

  14. Working Inside for Smoking Elimination (Project W.I.S.E. study design and rationale to prevent return to smoking after release from a smoke free prison

    Directory of Open Access Journals (Sweden)

    Mello Jennifer

    2011-10-01

    Full Text Available Abstract Background Incarcerated individuals suffer disproportionately from the health effects of tobacco smoking due to the high smoking prevalence in this population. In addition there is an over-representation of ethnic and racial minorities, impoverished individuals, and those with mental health and drug addictions in prisons. Increasingly, prisons across the U.S. are becoming smoke free. However, relapse to smoking is common upon release from prison, approaching 90% within a few weeks. No evidence based treatments currently exist to assist individuals to remain abstinent after a period of prolonged, forced abstinence. Methods/Design This paper describes the design and rationale of a randomized clinical trial to enhance smoking abstinence rates among individuals following release from a tobacco free prison. The intervention is six weekly sessions of motivational interviewing and cognitive behavioral therapy initiated approximately six weeks prior to release from prison. The control group views six time matched videos weekly starting about six weeks prior to release. Assessments take place in-person 3 weeks after release and then for non-smokers every 3 months up to 12 months. Smoking status is confirmed by urine cotinine. Discussion Effective interventions are greatly needed to assist these individuals to remain smoke free and reduce health disparities among this socially and economically challenged group. Trial Registration NCT01122589

  15. 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

  16. HEALTHY study rationale, design and methods: Moderating risk of type 2 diabetes in multi-ethnic middle school students

    Science.gov (United States)

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and gly...

  17. 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 ...

  18. Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

    Science.gov (United States)

    Felker, G Michael; Ahmad, Tariq; Anstrom, Kevin J; Adams, Kirkwood F; Cooper, Lawton S; Ezekowitz, Justin A; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L; Leifer, Eric S; Mark, Daniel B; Desvigne-Nickens, Patrice; Paynter, Gayle; Piña, Ileana L; Whellan, David J; O'Connor, Christopher M

    2014-10-01

    The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840). Copyright © 2014 American College of Cardiology Foundation

  19. 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

  20. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students

    OpenAIRE

    2009-01-01

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and glycemic dysregulation: body mass index ≥85th percentile, fasting glucose ≥5.55 mmol l-1 (100 mg per 100 ml) and fasting insulin ≥180 pmol l-1 (30 μU ml-1). A series of pilot studies established the f...

  1. 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

  2. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

    Science.gov (United States)

    Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

    2015-05-01

    Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Rationale, design, and results of the first screening round of a comprehensive, register-based, Chlamydia screening implementation programme in the Netherlands

    Directory of Open Access Journals (Sweden)

    Koekenbier Rik H

    2010-10-01

    Full Text Available Abstract Background Implementing Chlamydia trachomatis screening in the Netherlands has been a point of debate for several years. The National Health Council advised against implementing nationwide screening until additional data collected from a pilot project in 2003 suggested that screening by risk profiles could be effective. A continuous increase in infections recorded in the national surveillance database affirmed the need for a more active approach. Here, we describe the rationale, design, and implementation of a Chlamydia screening demonstration programme. Methods A systematic, selective, internet-based Chlamydia screening programme started in April 2008. Letters are sent annually to all 16 to 29-year-old residents of Amsterdam, Rotterdam, and selected municipalities of South Limburg. The letters invite sexually active persons to login to http://www.chlamydiatest.nl with a personal code and to request a test kit. In the lower prevalence area of South Limburg, test kits can only be requested if the internet-based risk assessment exceeds a predefined value. Results We sent invitations to 261,025 people in the first round. One-fifth of the invitees requested a test kit, of whom 80% sent in a sample for testing. The overall positivity rate was 4.2%. Conclusions This programme advances Chlamydia control activities in the Netherlands. Insight into the feasibility, effectiveness, cost-effectiveness, and impact of this large-scale screening programme will determine whether the programme will be implemented nationally.

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

    Directory of Open Access Journals (Sweden)

    Mark W. Vander Weg

    2018-03-01

    Full Text Available 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.

  5. The "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study: Rationale, design and methods.

    Science.gov (United States)

    Calvani, Riccardo; Picca, Anna; Marini, Federico; Biancolillo, Alessandra; Cesari, Matteo; Pesce, Vito; Lezza, Angela Maria Serena; Bossola, Maurizio; Leeuwenburgh, Christiaan; Bernabei, Roberto; Landi, Francesco; Marzetti, Emanuele

    2018-05-10

    Sarcopenia, the progressive and generalised loss of muscle mass and strength/function, is a major health issue in older adults given its high prevalence and burdensome clinical implications. Over the years, this condition has been endorsed as a marker for discriminating biological from chronological age. However, the absence of a unified operational definition has hampered its full appreciation by healthcare providers, researchers and policy-makers. In addition to this unsolved debate, the complexity of musculoskeletal ageing represents a major challenge to the identification of clinically meaningful biomarkers. Here, we illustrate the advantages of biomarker discovery procedures in muscle ageing based on multivariate methodologies as an alternative approach to traditional single-marker strategies. The rationale, design and methods of the "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study are described as an application of a multi-marker strategy for the development of biomarkers for the newly operationalised Physical Frailty & Sarcopenia condition. Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. 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. 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).

  8. The Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) Registry: Rationale and Design.

    Science.gov (United States)

    Stewart, Elizabeth A; Lytle, Barbara L; Thomas, Laine; Wegienka, Ganesa R; Jacoby, Vanessa; Diamond, Michael P; Nicholson, Wanda K; Anchan, Raymond M; Venable, Sateria; Wallace, Kedra; Marsh, Erica E; Maxwell, George L; Borah, Bijan J; Catherino, William H; Myers, Evan R

    2018-05-08

    To design and establish a uterine fibroid (UF) registry based in the United States (US) to provide comparative effectiveness data regarding UF treatment. We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality (AHRQ) in collaboration with the-Patient-Centered Outcomes Research Institute (PCORI). COMPARE-UF is designed to help answer critical questions about treatment options for women with symptomatic UF. Women undergoing a procedure for UF (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance guided focused ultrasound or progestin-releasing intrauterine device insertion) at one of the COMPARE-UF sites are invited to participate in a prospective registry with three years follow-up for post-procedural outcomes. Enrolled participants provide annual follow-up through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. We built a network of nine clinical sites across the US with expertise in the care of women with UF to capture geographic, racial, ethnic and procedural diversity. Of the initial 2031 women enrolled in COMPARE-UF, 42% are self-identified as Black or African-American and 40% are age 40 years or younger with 16% of participants under age 35. Women undergoing myomectomy comprise the largest treatment group at 46% of all procedures with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all

  9. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial

    DEFF Research Database (Denmark)

    Hasenfuss, Gerd; Gustafsson, Finn; Kaye, David

    2015-01-01

    OBJECTIVE: Heart failure with preserved ejection fraction (HFpEF) is characterized by elevated left atrial pressure during rest and/or exercise. The Reduce LAP-HF (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) trial will evaluate the safety and performance of the Interatrial...... Shunt Device (IASD) System II, designed to directly reduce elevated left atrial pressure, in patients with HFpEF. METHODS: The Reduce LAP-HF Trial is a prospective, nonrandomized, open-label trial to evaluate a novel device that creates a small permanent shunt at the level of the atria. A minimum of 60...... patients with ejection fraction ≥40% and New York Heart Association functional class III or IV heart failure with a pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg at rest or ≥25 mm Hg during supine bike exercise will be implanted with an IASD System II, and followed for 6 months to assess the primary...

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

    Science.gov (United States)

    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.

    2015-01-01

    Background 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. Procedure 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. Results 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. Conclusions 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. Pediatr Blood Cancer © 2015 Wiley Periodicals, Inc. PMID:26275071

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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

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

    Directory of Open Access Journals (Sweden)

    Qiao You-Lin

    2011-05-01

    Full Text Available 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 outcomes across real-world clinical practice, has recently been expanded as a national study in China, allowing a detailed analysis of hepatocellular carcinoma in this important country. Methods/Design The global HCC BRIDGE study is a multiregional longitudinal cohort trial including patients newly diagnosed with hepatocellular carcinoma between January 1, 2005, and June 30, 2011, who are receiving treatment for hepatocellular carcinoma via sites in the Asia-Pacific, European, and North American regions. The HCC BRIDGE China national study comprises the portion of the global HCC BRIDGE study conducted within mainland China. Patients will be followed from time of diagnosis of hepatocellular carcinoma (post-January 1, 2005 to time of death or December 31, 2011, whichever comes first. Data will be collected on demographic/clinical characteristics, relevant laboratory values, hepatocellular carcinoma/underlying liver disease treatment, tumor response, adverse events, hospitalizations, and overall survival. The primary study end point is overall survival; secondary end points are disease progression, treatment-limiting adverse events, and treatment failure. Results At the time of writing, 15 sites have selected for participation across all 7 traditional regions of China (North, North-East, East, South, South-West, North-West, and Central. The anticipated study population from the China national study is approximately 9000 patients. Discussion Findings from the

  20. 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.

  1. Enhancing inhibitory learning to reduce overeating: Design and rationale of a cue exposure therapy trial in overweight and obese women.

    Science.gov (United States)

    van den Akker, Karolien; Schyns, Ghislaine; Jansen, Anita

    2016-07-01

    The prevalence of overweight and obesity has increased substantially over the last decades. Weight loss attempts in overweight individuals are common, though they seldom result in successful long-term weight loss. One very promising treatment is food cue exposure therapy, during which overweight individuals are repeatedly exposed to food-associated cues (e.g., the sight, smell and taste of high-calorie foods, overeating environments) without eating in order to extinguish cue-elicited appetitive responses to food cues. However, only few studies have tested the effectiveness of cue exposure, especially with regards to weight loss. For exposure treatment of anxiety disorders, it has been proposed that inhibitory learning is critical for exposure to be effective. In this RCT, we translated techniques proposed by Craske et al. (2014) to the appetitive domain and developed a novel cue exposure therapy for overeating aimed at maximizing inhibitory learning. The current RCT tested the effectiveness of this 8-session cue exposure intervention relative to a control intervention in 45 overweight adult (aged 18-60) females at post-treatment and 3-month follow-up, of which 39 participants completed the study. Weight loss, eating psychopathology, food cue reactivity, and snacking behaviour were studied as main treatment outcomes, and mediators and moderators of treatment effects were studied. The presented study design represents an innovative effort to provide valuable clinical recommendations for the treatment of overeating and obesity. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. 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.

  3. Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM) - a Pan Canadian cohort study.

    Science.gov (United States)

    Anand, Sonia S; Tu, Jack V; Awadalla, Philip; Black, Sandra; Boileau, Catherine; Busseuil, David; Desai, Dipika; Després, Jean-Pierre; de Souza, Russell J; Dummer, Trevor; Jacquemont, Sébastien; Knoppers, Bartha; Larose, Eric; Lear, Scott A; Marcotte, Francois; Moody, Alan R; Parker, Louise; Poirier, Paul; Robson, Paula J; Smith, Eric E; Spinelli, John J; Tardif, Jean-Claude; Teo, Koon K; Tusevljak, Natasa; Friedrich, Matthias G

    2016-07-27

    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. 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. 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. 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.

  5. 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

  6. Barriers to successful implementation of care in home haemodialysis (BASIC-HHD):1. Study design, methods and rationale.

    Science.gov (United States)

    Jayanti, Anuradha; Wearden, Alison J; Morris, Julie; Brenchley, Paul; Abma, Inger; Bayer, Steffen; Barlow, James; Mitra, Sandip

    2013-09-17

    Ten years on from the National Institute of Health and Clinical Excellence' technology appraisal guideline on haemodialysis in 2002; the clinical community is yet to rise to the challenge of providing home haemodialysis (HHD) to 10-15% of the dialysis cohort. The renal registry report, suggests underutilization of a treatment type that has had a lot of research interest and several publications worldwide on its apparent benefit for both physical and mental health of patients. An understanding of the drivers to introducing and sustaining the modality, from organizational, economic, clinical and patient perspectives is fundamental to realizing the full benefits of the therapy with the potential to provide evidence base for effective care models. Through the BASIC-HHD study, we seek to understand the clinical, patient and carer related psychosocial, economic and organisational determinants of successful uptake and maintenance of home haemodialysis and thereby, engage all major stakeholders in the process. We have adopted an integrated mixed methodology (convergent, parallel design) for this study. The study arms include a. patient; b. organization; c. carer and d. economic evaluation. The three patient study cohorts (n = 500) include pre-dialysis patients (200), hospital haemodialysis (200) and home haemodialysis patients (100) from geographically distinct NHS sites, across the country and with variable prevalence of home haemodialysis. The pre-dialysis patients will also be prospectively followed up for a period of 12 months from study entry to understand their journey to renal replacement therapy and subsequently, before and after studies will be carried out for a select few who do commence dialysis in the study period. The process will entail quantitative methods and ethnographic interviews of all groups in the study. Data collection will involve clinical and biomarkers, psychosocial quantitative assessments and neuropsychometric tests in patients. Organizational

  7. Rationale and design of the Cardiovascular Inflammation Reduction Trial: a test of the inflammatory hypothesis of atherothrombosis.

    Science.gov (United States)

    Everett, Brendan M; Pradhan, Aruna D; Solomon, Daniel H; Paynter, Nina; Macfadyen, Jean; Zaharris, Elaine; Gupta, Milan; Clearfield, Michael; Libby, Peter; Hasan, Ahmed A K; Glynn, Robert J; Ridker, Paul M

    2013-08-01

    Inflammation plays a fundamental role in atherothrombosis. Yet, whether direct inhibition of inflammation will reduce the occurrence of adverse cardiovascular outcomes is not known. The Cardiovascular Inflammation Reduction Trial (CIRT) (ClinicalTrials.govNCT01594333) will randomly allocate 7,000 patients with prior myocardial infarction (MI) and either type 2 diabetes or the metabolic syndrome to low-dose methotrexate (target dose 15-20 mg/wk) or placebo over an average follow-up period of 3 to 5 years. Low-dose methotrexate is a commonly used anti-inflammatory regimen for the treatment of rheumatoid arthritis and lacks significant effects on lipid levels, blood pressure, or platelet function. Both observational and mechanistic studies suggest that low-dose methotrexate has clinically relevant antiatherothrombotic effects. The CIRT primary end point is a composite of nonfatal MI, nonfatal stroke, and cardiovascular death. Secondary end points are all-cause mortality, coronary revascularization plus the primary end point, hospitalization for congestive heart failure plus the primary end point, all-cause mortality plus coronary revascularization plus congestive heart failure plus the primary end point, incident type 2 diabetes, and net clinical benefit or harm. CIRT will use standardized central methodology designed to ensure consistent performance of all dose adjustments and safety interventions at each clinical site in a manner that protects the blinding to treatment but maintains safety for enrolled participants. CIRT aims to test the inflammatory hypothesis of atherothrombosis in patients with prior MI and either type 2 diabetes or metabolic syndrome, conditions associated with persistent inflammation. If low-dose methotrexate reduces cardiovascular events, CIRT would provide a novel therapeutic approach for the secondary prevention of heart attack, stroke, and cardiovascular death. Copyright © 2013 Mosby, Inc. All rights reserved.

  8. The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

    Science.gov (United States)

    Ritter, Philippe; Duray, Gabor Z; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight

    2015-05-01

    Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  9. The Korean Study of Women’s Health-Related Issues (K-Stori: Rationale and Study Design

    Directory of Open Access Journals (Sweden)

    Ha Na Cho

    2017-06-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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.

  10. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial.

    Science.gov (United States)

    Sullivan, D K; Goetz, J R; Gibson, C A; Mayo, M S; Washburn, R A; Lee, Y; Ptomey, L T; Donnelly, J E

    2016-01-01

    Despite the plethora of weight loss programs available in the US, the prevalence of overweight and obesity (BMI≥25kg/m(2)) among US adults continues to rise at least, in part, due to the high probability of weight regain following weight loss. Thus, the development and evaluation of novel interventions designed to improve weight maintenance are clearly needed. Virtual reality environments offer a promising platform for delivering weight maintenance interventions as they provide rapid feedback, learner experimentation, real-time personalized task selection and exploration. Utilizing virtual reality during weight maintenance allows individuals to engage in repeated experiential learning, practice skills, and participate in real-life scenarios without real-life repercussions, which may diminish weight regain. We will conduct an 18-month effectiveness trial (6 months weight loss, 12 months weight maintenance) in 202 overweight/obese adults (BMI 25-44.9kg/m(2)). Participants who achieve ≥5% weight loss following a 6month weight loss intervention delivered by phone conference call will be randomized to weight maintenance interventions delivered by conference call or conducted in a virtual environment (Second Life®). The primary aim of the study is to compare weight change during maintenance between the phone conference call and virtual groups. Secondarily, potential mediators of weight change including energy and macronutrient intake, physical activity, consumption of fruits and vegetables, self-efficacy for both physical activity and diet, and attendance and completion of experiential learning assignments will also be assessed. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. 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.

  12. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students.

    Science.gov (United States)

    Hirst, Kathryn; Baranowski, Tom; DeBar, Lynn; Foster, Gary D; Kaufman, Francine; Kennel, Phyllis; Linder, Barbara; Schneider, Margaret; Venditti, Elizabeth M; Yin, Zenong

    2009-08-01

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and glycemic dysregulation: body mass index > or =85th percentile, fasting glucose > or =5.55 mmol l(-1) (100 mg per 100 ml) and fasting insulin > or =180 pmol l(-1) (30 microU ml(-1)). A series of pilot studies established the feasibility of performing data collection procedures and tested the development of an intervention consisting of four integrated components: (1) changes in the quantity and nutritional quality of food and beverage offerings throughout the total school food environment; (2) physical education class lesson plans and accompanying equipment to increase both participation and number of minutes spent in moderate-to-vigorous physical activity; (3) brief classroom activities and family outreach vehicles to increase knowledge, enhance decision-making skills and support and reinforce youth in accomplishing goals; and (4) communications and social marketing strategies to enhance and promote changes through messages, images, events and activities. Expert study staff provided training, assistance, materials and guidance for school faculty and staff to implement the intervention components. A cohort of students were enrolled in sixth grade and followed to end of eighth grade. They attended a health screening data collection at baseline and end of study that involved measurement of height, weight, blood pressure, waist circumference and a fasting blood draw. Height and weight were also collected at the end of the seventh grade. The study was conducted in 42 middle schools, six at each of seven locations across the country, with 21 schools randomized to receive the intervention and 21 to act as controls (data collection activities only). Middle school was the unit of

  13. 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.

  14. Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18month randomized trial.

    Science.gov (United States)

    Donnelly, J E; Ptomey, L T; Goetz, J R; Sullivan, D K; Gibson, C A; Greene, J L; Lee, R H; Mayo, M S; Honas, J J; Washburn, R A

    2016-11-01

    Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated. Therefore, we will conduct an 18month trial to compare weight loss (6months) and maintenance (7-18months) in 123 overweight/obese adolescents with mild to moderate IDD, and a parent, randomized to a weight management intervention delivered remotely using FaceTime™ on an iPad using either a conventional meal plan diet (RD/CD) or a Stop Light diet enhanced with PCMs (RD/eSLD), or conventional diet delivered during face-to-face home visits (FTF/CD). This design will provide an adequately powered comparison of both diet (CD vs. eSLD) and delivery strategy (FTF vs. RD). Exploratory analyses will examine the influence of behavioral session attendance, compliance with recommendations for diet (energy intake), physical activity (min/day), self-monitoring of diet and physical activity, medications, and parental variables including diet quality, physical activity, baseline weight, weight change, and beliefs and attitudes regarding diet and physical activity on both weight loss and maintenance. We will also complete a cost and contingent valuation analysis to compare costs between RD and FTF delivery. Copyright © 2016. Published by Elsevier Inc.

  15. 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.

  16. 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.

  17. Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial.

    Science.gov (United States)

    Ahmed Ali, Usama; Issa, Yama; Bruno, Marco J; van Goor, Harry; van Santvoort, Hjalmar; Busch, Olivier R C; Dejong, Cornelis H C; Nieuwenhuijs, Vincent B; van Eijck, Casper H; van Dullemen, Hendrik M; Fockens, Paul; Siersema, Peter D; Gouma, Dirk J; van Hooft, Jeanin E; Keulemans, Yolande; Poley, Jan W; Timmer, Robin; Besselink, Marc G; Vleggaar, Frank P; Wilder-Smith, Oliver H; Gooszen, Hein G; Dijkgraaf, Marcel G W; Boermeester, Marja A

    2013-03-18

    In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis. The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least

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

    Science.gov (United States)

    Manniën, Judith; Klomp, Trudy; Wiegers, Therese; Pereboom, Monique; Brug, Johannes; de Jonge, Ank; van der Meijde, Margreeth; Hutton, Eileen; Schellevis, Francois; Spelten, Evelien

    2012-03-20

    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. 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. In total, 7685 clients completed at least one questionnaire, 136 midwives and

  19. 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.

  20. 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).

  1. 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

  2. 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

  3. 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

    2015-01-01

    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. PMID:26621218

  4. Translation of the Care of Persons with Dementia in their Environments (COPE) intervention in a publicly-funded home care context: Rationale and research design.

    Science.gov (United States)

    Fortinsky, Richard H; Gitlin, Laura N; Pizzi, Laura T; Piersol, Catherine Verrier; Grady, James; Robison, Julie T; Molony, Sheila

    2016-07-01

    Dementia is the leading cause of loss of independence in older adults worldwide. In the U.S., approximately 15 million family members provide care to relatives with dementia. This paper presents the rationale and design for a translational study in which an evidence-based, non-pharmacologic intervention for older adults with dementia and family caregivers (CGs) is incorporated into a publicly-funded home care program for older adults at risk for nursing home admission. The 4-month Care of Persons with Dementia in their Environments (COPE) intervention is designed to optimize older adults' functional independence, and to improve CG dementia management skills and health-related outcomes. COPE features 10 in-home occupational therapy visits, and 1 in-home visit and 1 telephone contact by an advanced practice nurse. COPE was deemed efficacious in a published randomized clinical trial. In the present study, older adults with dementia enrolled in the Connecticut Home Care Program for Elders (CHCPE) and their CGs are randomly assigned to receive COPE plus their ongoing CHCPE services, or to continue receiving CHCPE services only. The primary outcome for older adults with dementia is functional independence; secondary outcomes are activity engagement, quality of life, and prevention or alleviation of neuropsychiatric symptoms. CG outcomes include perceived well-being and confidence in using activities to manage dementia symptoms. Translational outcomes include net financial benefit of COPE, and feasibility and acceptability of COPE implementation into the CHCPE. COPE has the potential to improve health-related outcomes while saving Medicaid waiver and state revenue-funded home care program costs nationwide. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. 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

  6. 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...

  7. 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...

  8. Rationale and design of ARTS

    DEFF Research Database (Denmark)

    Pitt, Bertram; Filippatos, Gerasimos; Gheorghiade, Mihai

    2012-01-01

    . 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...

  9. Early markers of airways inflammation and occupational asthma: Rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices

    Directory of Open Access Journals (Sweden)

    Hannhart Bernard

    2009-04-01

    Full Text Available Abstract Background Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. Methods and design This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii evaluate whether, and how, constitutional (e.g. atopy and behavioural (e.g. smoking risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Discussion Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

  10. The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

    Science.gov (United States)

    Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

    2016-01-01

    The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

  11. 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.

  12. 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.

  13. 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

  14. A workplace email-linked website intervention for modifying cancer-related dietary and lifestyle risk factors: rationale, design and baseline findings.

    Science.gov (United States)

    Ang, Y K; Mirnalini, K; Zalilah, M S

    2013-04-01

    The use of email and website as channels for workplace health information delivery is not fully explored. This study aims to describe the rationale, design, and baseline findings of an email-linked website intervention to improve modifiable cancer risk factors. Employees of a Malaysian public university were recruited by systematic random sampling and randomised into an intervention (n = 174) or control group (n = 165). A website was developed for the intervention and educational modules were uploaded onto the website. The intervention group received ten consecutive weekly emails with hypertext links to the website for downloading the modules and two individual phone calls as motivational support whilst the control group received none. Diet, lifestyle, anthropometric measurements, psychosocial factors and stages of change related to dietary fat, fruit and vegetable intake, and physical activity were assessed. Participants were predominantly female and in non-academic positions. Obesity was prevalent in 15% and 37% were at risk of co-morbidities. Mean intake of fats was 31%, fruit was -1 serving/day and vegetable was < 1 serving/day. Less than 20% smoked and drank alcohol and about 40% were physically inactive. The majority of the participants fell into the Preparation stage for decreasing fat intake, eating more fruit and vegetables, and increasing physical activity. Self-efficacy and perceived benefits were lowest among participants in the Precontemplation/Contemplation stage compared to the Preparation and Action/Maintenance stages. Baseline data show that dietary and lifestyle practices among the employees did not meet the international guidelines for cancer prevention. Hence the findings warrant the intervention planned.

  15. 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.

  16. 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.

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

    Science.gov (United States)

    Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

    2017-01-01

    Genito-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. This 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. Two 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. The 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. Given 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. German Register of Clinical Studies (DRKS): DRKS00010228.

  18. 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.

  19. 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.

  20. 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.

  1. CAD/CAM-assisted breast reconstruction

    International Nuclear Information System (INIS)

    Melchels, Ferry; Hutmacher, Dietmar Werner; Wiggenhauser, Paul Severin; Schantz, Jan-Thorsten; Warne, David; Barry, Mark; Ong, Fook Rhu; Chong, Woon Shin

    2011-01-01

    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.

  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. 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

  4. 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

  5. Understanding dental CAD/CAM for restorations--the digital workflow from a mechanical engineering viewpoint.

    Science.gov (United States)

    Tapie, L; Lebon, N; Mawussi, B; Fron Chabouis, H; Duret, F; Attal, J-P

    2015-01-01

    As digital technology infiltrates every area of daily life, including the field of medicine, so it is increasingly being introduced into dental practice. Apart from chairside practice, computer-aided design/computer-aided manufacturing (CAD/CAM) solutions are available for creating inlays, crowns, fixed partial dentures (FPDs), implant abutments, and other dental prostheses. CAD/CAM dental solutions can be considered a chain of digital devices and software for the almost automatic design and creation of dental restorations. However, dentists who want to use the technology often do not have the time or knowledge to understand it. A basic knowledge of the CAD/CAM digital workflow for dental restorations can help dentists to grasp the technology and purchase a CAM/CAM system that meets the needs of their office. This article provides a computer-science and mechanical-engineering approach to the CAD/CAM digital workflow to help dentists understand the technology.

  6. Camønoen

    DEFF Research Database (Denmark)

    Gyimóthy, Szilvia; Widtfeld Meged, Jane

    2016-01-01

    Coastal communities in Denmark have experienced a steady socioeconomic decline, which has further been aggravated by a stagnating tourism and agricultural sector. Within this context, coastal regions are attempting to harness the potentials of the emerging collaborative economy and its communitar......Coastal communities in Denmark have experienced a steady socioeconomic decline, which has further been aggravated by a stagnating tourism and agricultural sector. Within this context, coastal regions are attempting to harness the potentials of the emerging collaborative economy and its...... 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...

  7. Introduction of effect and consideration of the introduction of CAD/CAM system

    International Nuclear Information System (INIS)

    Kang, Man Ok

    1984-12-01

    This reports introduction of effect and consideration of the introduction of computer-aided design and computer aided manufacturing system. It includes outline of CAD/CAM system like definition, classification, system kinds, and development process of CAD/CAM system, technology, market trend development prospect, and value on introduction of this system, and current application of CAD/CAM system in major application area, development countries and Korea.

  8. CAM therapies among primary care patients using opioid therapy for chronic pain

    OpenAIRE

    Fleming, Sara; Rabago, David P; Mundt, Marlon P; Fleming, Michael F

    2007-01-01

    Abstract Background Complementary and alternative medicine (CAM) is an increasingly common therapy used to treat chronic pain syndromes. However; there is limited information on the utilization and efficacy of CAM therapy in primary care patients receiving long-term opioid therapy. Method A survey of CAM therapy was conducted with a systematic sample of 908 primary care patients receiving opioids as a primary treatment method for chronic pain. Subjects completed a questionnaire designed to as...

  9. 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 ...

  10. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

    Science.gov (United States)

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-09-11

    Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

  11. Randomized controlled trial to evaluate the effect of canola oil on blood vessel function in peripheral arterial disease: rationale and design of the Canola-PAD Study

    Directory of Open Access Journals (Sweden)

    Enns JE

    2014-10-01

    Full Text Available Jennifer E Enns,1,2 Peter Zahradka,1–3 Randolph P Guzman,4,5 Alanna Baldwin,1 Brendon Foot,1 Carla G Taylor1–31Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Research Centre, Winnipeg, Canada; 2Department of Physiology, University of Manitoba, Winnipeg, Manitoba, Canada; 3Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada; 4IH Asper Clinical Research Institute, St Boniface Hospital, Winnipeg, Canada; 5Section of Vascular Surgery, Department of Surgery, St Boniface Hospital, Winnipeg, CanadaBackground: Individuals with peripheral arterial disease (PAD are at high risk for cardiac events due to atherosclerosis. Dietary fatty acid composition has been shown to modulate blood vessel properties, but whether a diet enriched in conventional canola oil can improve clinical endpoints in PAD is not known.Purpose: To describe the rationale and design of a clinical trial testing the effect of canola oil consumption on vascular function and cardiovascular risk factors in an 8-week dietary intervention in individuals with PAD.Methods: The Canola-PAD Study was a single center, prospective, double-blind, randomized controlled trial in 50 patients over 40 years old with PAD. Participants were randomized into two groups and consumed food items containing either conventional canola oil (25 g/day or an oil mixture representing the Western diet (25 g/day for 8 weeks as part of their usual diet. The primary outcome was vascular function (ankle-brachial index, arterial stiffness, endothelial dysfunction, walking capacity, and cognitive function. Secondary measurements included anthropometrics, serum lipid profile and fatty acid composition, markers of inflammation and glycemic control, and serum metabolite profile.Discussion: The Canola-PAD Study uses an innovative and noninvasive approach to evaluate the effect of canola oil on clinically relevant outcomes in individuals with PAD, including

  12. 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

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

    Science.gov (United States)

    Wideman, Laurie; Calkins, Susan D; Janssen, James A; Lovelady, Cheryl A; Dollar, Jessica M; Keane, Susan P; Perrin, Eliana M; Shanahan, Lilly

    2016-06-01

    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. 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 cytokines. Individuals also completed extensive self

  14. Thyroid Disease and Complementary and Alternative Medicine (CAM)

    Science.gov (United States)

    ... Alternative Medicine in Thyroid Disease Complementary and Alternative Medicine in Thyroid Disease (CAM) WHAT IS COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM)? Complementary and Alternative Medicine (CAM) is defined ...

  15. 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.

  16. 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

  17. 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.

  18. IPAD II (Integrated Programs for Aerospace-Vehicle Design) Advances in Distributed Data Base Management for CAD/CAM (Computer-Aided Design and Manufacturing Technology). Proceedings of a National Symposium Held in Denver, Colorado, April 17-19, 1984.

    Science.gov (United States)

    1984-01-01

    et al. "DATANET/HERMES: Un Sistema Per La Gestione Di Basi Di Dati Distribuite", Annual Conference, A.I. C. A., Pavia, (September 1981). [9] Neuhold...to move to more sophisticated integrated CAD/CAM applications. A geometrically complete three-dimensional des - cription is required for such purposes...definitions and semantic constructs for these types of applications have achieved a de facto degree of standardization and normalization (a common and

  19. 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.

  20. Different CAD/CAM-processing routes for zirconia restorations: influence on fitting accuracy.

    Science.gov (United States)

    Kohorst, Philipp; Junghanns, Janet; Dittmer, Marc P; Borchers, Lothar; Stiesch, Meike

    2011-08-01

    The aim of the present in vitro study was to evaluate the influence of different processing routes on the fitting accuracy of four-unit zirconia fixed dental prostheses (FDPs) fabricated by computer-aided design/computer-aided manufacturing (CAD/CAM). Three groups of zirconia frameworks with ten specimens each were fabricated. Frameworks of one group (CerconCAM) were produced by means of a laboratory CAM-only system. The other frameworks were made with different CAD/CAM systems; on the one hand by in-laboratory production (CerconCAD/CAM) and on the other hand by centralized production in a milling center (Compartis) after forwarding geometrical data. Frameworks were then veneered with the recommended ceramics, and marginal accuracy was determined using a replica technique. Horizontal marginal discrepancy, vertical marginal discrepancy, absolute marginal discrepancy, and marginal gap were evaluated. Statistical analyses were performed by one-way analysis of variance (ANOVA), with the level of significance chosen at 0.05. Mean horizontal discrepancies ranged between 22 μm (CerconCAM) and 58 μm (Compartis), vertical discrepancies ranged between 63 μm (CerconCAD/CAM) and 162 μm (CerconCAM), and absolute marginal discrepancies ranged between 94 μm (CerconCAD/CAM) and 181 μm (CerconCAM). The marginal gap varied between 72 μm (CerconCAD/CAM) and 112 μm (CerconCAM, Compartis). Statistical analysis revealed that, with all measurements, the marginal accuracy of the zirconia FDPs was significantly influenced by the processing route used (p manufacture of four-unit FDPs.

  1. CO2 Acquisition Membrane (CAM)

    Science.gov (United States)

    Mason, Larry W.; Way, J. Douglas; Vlasse, Marcus

    2003-01-01

    The objective of CAM is to develop, test, and analyze thin film membrane materials for separation and purification of carbon dioxide (CO2) from mixtures of gases, such as those found in the Martian atmosphere. The membranes are targeted toward In Situ Resource Utilization (ISRU) applications that will operate in extraterrestrial environments and support future unmanned and human space missions. A primary application is the Sabatier Electrolysis process that uses Mars atmosphere CO2 as raw material for producing water, oxygen, and methane for rocket fuel and habitat support. Other applications include use as an inlet filter to collect and concentrate Mars atmospheric argon and nitrogen gases for habitat pressurization, and to remove CO2 from breathing gases in Closed Environment Life Support Systems (CELSS). CAM membrane materials include crystalline faujasite (FAU) zeolite and rubbery polymers such as silicone rubber (PDMS) that have been shown in the literature and via molecular simulation to favor adsorption and permeation of CO2 over nitrogen and argon. Pure gas permeation tests using commercial PDMS membranes have shown that both CO2 permeance and the separation factor relative to other gases increase as the temperature decreases, and low (Delta)P(Sub CO2) favors higher separation factors. The ideal CO2/N2 separation factor increases from 7.5 to 17.5 as temperature decreases from 22 C to -30 C. For gas mixtures containing CO2, N2, and Ar, plasticization decreased the separation factors from 4.5 to 6 over the same temperature range. We currently synthesize and test our own Na(+) FAU zeolite membranes using standard formulations and secondary growth methods on porous alumina. Preliminary tests with a Na(+) FAU membrane at 22 C show a He/SF6 ideal separation factor of 62, exceeding the Knudsen diffusion selectivity by an order of magnitude. This shows that the membrane is relatively free from large defects and associated non-selective (viscous flow) transport

  2. Fabricating Complete Dentures with CAD/CAM and RP Technologies.

    Science.gov (United States)

    Bilgin, Mehmet Selim; Erdem, Ali; Aglarci, Osman Sami; Dilber, Erhan

    2015-06-01

    Two techological approaches for fabricating dentures; computer-aided design and computer-aided manufacturing (CAD/CAM) and rapid prototyping (RP), are combined with the conventional techniques of impression and jaw relation recording to determine their feasibility and applicability. Maxillary and mandibular edentulous jaw models were produced using silicone molds. After obtaining a gypsum working model, acrylic bases were crafted, and occlusal rims for each model were fabricated with previously determined standard vertical and centric relationships. The maxillary and mandibular relationships were recorded with guides. The occlusal rims were then scanned with a digital scanner. The alignment of the maxillary and mandibular teeth was verified. The teeth in each arch were fabricated in one piece, or set, either by CAM or RP. Conventional waxing and flasking was then performed for both methods. These techniques obviate a practitioner's need for technicians during design and provide the patient with an opportunity to participate in esthetic design with the dentist. In addition, CAD/CAM and RP reduce chair time; however, the materials and techniques need further improvements. Both CAD/CAM and RP techniques seem promising for reducing chair time and allowing the patient to participate in esthetics design. Furthermore, the one-set aligned artificial tooth design may increase the acrylic's durability. © 2015 by the American College of Prosthodontists.

  3. Schools (Students) Exchanging CAD/CAM Files over the Internet.

    Science.gov (United States)

    Mahoney, Gary S.; Smallwood, James E.

    This document discusses how students and schools can benefit from exchanging computer-aided design/computer-aided manufacturing (CAD/CAM) files over the Internet, explains how files are exchanged, and examines the problem of selected hardware/software incompatibility. Key terms associated with information search services are defined, and several…

  4. 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.

  5. Using Rationale To Assist Student Cognitive And Intellectual Development

    Directory of Open Access Journals (Sweden)

    Janet E. Burge

    2010-01-01

    Full Text Available One of the questions posed at the National Science Foundation (NSF-sponsored workshop on Creativity and Rationale in Software Design was on the role of rationale in supporting idea generation in the classroom. College students often struggle with problems where more than one possible solution exists. Part of the difficulty lies in the need for students to progress through different levels of development cognitively and intellectually before they can tackle creative problem solving. Argumentation-based rationale provides a natural mechanism for representing problems, candidate solutions, criteria, and arguments relating those criteria to the candidate solutions. Explicitly expressing rationale for their work encourages students to reflect on why they made their choices, and to actively consider multiple alternatives. We report on an experiment performed during a Data Structures course where students captured rationale.

  6. Facultative crassulacean acid metabolism (CAM) plants: powerful tools for unravelling the functional elements of CAM photosynthesis.

    Science.gov (United States)

    Winter, Klaus; Holtum, Joseph A M

    2014-07-01

    Facultative crassulacean acid metabolism (CAM) describes the optional use of CAM photosynthesis, typically under conditions of drought stress, in plants that otherwise employ C3 or C4 photosynthesis. In its cleanest form, the upregulation of CAM is fully reversible upon removal of stress. Reversibility distinguishes facultative CAM from ontogenetically programmed unidirectional C3-to-CAM shifts inherent in constitutive CAM plants. Using mainly measurements of 24h CO2 exchange, defining features of facultative CAM are highlighted in five terrestrial species, Clusia pratensis, Calandrinia polyandra, Mesembryanthemum crystallinum, Portulaca oleracea and Talinum triangulare. For these, we provide detailed chronologies of the shifts between photosynthetic modes and comment on their usefulness as experimental systems. Photosynthetic flexibility is also reviewed in an aquatic CAM plant, Isoetes howellii. Through comparisons of C3 and CAM states in facultative CAM species, many fundamental biochemical principles of the CAM pathway have been uncovered. Facultative CAM species will be of even greater relevance now that new sequencing technologies facilitate the mapping of genomes and tracking of the expression patterns of multiple genes. These technologies and facultative CAM systems, when joined, are expected to contribute in a major way towards our goal of understanding the essence of CAM. © The Author 2014. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. The use of CAM and conventional treatments among primary care consulters with chronic musculoskeletal pain

    Directory of Open Access Journals (Sweden)

    Lewis Martyn

    2007-05-01

    Full Text Available Abstract Background Chronic musculoskeletal pain is the single most cited reason for use of complementary and alternative medicine (CAM. Primary care is the most frequent conventional medical service used by patients with pain in the UK. We are unaware, however, of a direct evidence of the extent of CAM use by primary care patients, and how successful they perceive it to be. Methods Aims and objectives To determine CAM use among patients with chronic musculoskeletal pain who have consulted about their pain in primary care. Study design Face-to-face interview-based survey. Setting Three general practices in North Staffordshire. Participants Respondents to a population pain survey who had reported having musculoskeletal pain in the survey and who had consulted about their pain in primary care in the previous 12 months as well as consenting to further research and agreeing to an interview. Information was gathered about their pain and the use of all treatments for pain, including CAM, in the previous year. Results 138 interviews were completed. 116 participants (84% had used at least one CAM treatment for pain in the previous year. 65% were current users of CAM. The ratio of over-the-counter CAM use to care from a CAM provider was 3:2. 111 participants (80% had used conventional treatment. 95 (69% were using a combination of CAM and conventional treatment. Glucosamine and fish oil were the most commonly used CAM treatments (38%, 35% respectively. Most CAM treatments were scored on average as being helpful, and users indicated that they intended to use again 87% of the CAM treatments they had already used. Conclusion We provide direct evidence that most primary care consulters with chronic musculoskeletal pain have used CAM in the previous year, usually in combination with conventional treatments. The high prevalence and wide range of users experiences of benefit and harm from CAM strengthen the argument for more research into this type of medicine

  8. 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

    utilization. Methods: The Registry is an observational, nonrandomized, standard of care evaluation to be conducted at approximately 50 investigational centers in Europe and New Zealand where the S-ICD is approved for use and distribution. Clinical Registry endpoints include perioperative (30 days postimplant......Background: Leads in and on the heart of the transvenous implantable cardioverter defibrillator (ICD) form the Achilles' heel of this system due to potential for peri- and postimplant complications. The S-ICD is a newer generation of the ICD that does not require leads on the heart...... 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...

  9. Prevalence of cam hip shape morphology: a systematic review.

    Science.gov (United States)

    Dickenson, E; Wall, P D H; Robinson, B; Fernandez, M; Parsons, H; Buchbinder, R; Griffin, D R

    2016-06-01

    Cam hip shape morphology is a recognised cause of femoroacetabular impingement (FAI) and is associated with hip osteoarthritis. Our aim was to systematically review the available epidemiological evidence assessing the prevalence of cam hip shape morphology in the general population and any studied subgroups including subjects with and without hip pain. All studies that reported the prevalence of cam morphology, measured by alpha angles, in subjects aged 18 and over, irrespective of study population or presence of hip symptoms were considered for inclusion. We searched AMED, MEDLINE, EMBASE, CINAHL and CENTRAL in October 2015. Two authors independently identified eligible studies and assessed risk of bias. We planned to pool data of studies considered clinically homogenous. Thirty studies met inclusion criteria. None of the included studies were truly population-based: three included non-representative subgroups of the general population, 19 included differing clinical populations, while eight included professional athletes. All studies were judged to be at high risk of bias. Due to substantial clinical heterogeneity meta analysis was not possible. Across all studies, the prevalence estimates of cam morphology ranged from 5 to 75% of participants affected. We were unable to demonstrate a higher prevalence in selected subgroups such as athletes or those with hip pain. There is currently insufficient high quality data to determine the true prevalence of cam morphology in the general population or selected subgroups. Well-designed population-based epidemiological studies that use homogenous case definitions are required to determine the prevalence of cam morphology and its relationship to hip pain. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  10. DOE LLW classification rationale

    International Nuclear Information System (INIS)

    Flores, A.Y.

    1991-01-01

    This report was about the rationale which the US Department of Energy had with low-level radioactive waste (LLW) classification. It is based on the Nuclear Regulatory Commission's classification system. DOE site operators met to review the qualifications and characteristics of the classification systems. They evaluated performance objectives, developed waste classification tables, and compiled dose limits on the waste. A goal of the LLW classification system was to allow each disposal site the freedom to develop limits to radionuclide inventories and concentrations according to its own site-specific characteristics. This goal was achieved with the adoption of a performance objectives system based on a performance assessment, with site-specific environmental conditions and engineered disposal systems

  11. 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.

  12. Marginal adaptation and CAD-CAM technology: A systematic review of restorative material and fabrication techniques.

    Science.gov (United States)

    Papadiochou, Sofia; Pissiotis, Argirios L

    2018-04-01

    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

  13. Experimental Study on Revetec Engine Cam Performance

    International Nuclear Information System (INIS)

    Gasim, Maisara Mohyeldin; Chui, Lee Giok; Anwar, Khirul Azhar bin

    2012-01-01

    In Revetec engine (three-lobed) cam replaces the crankshaft to convert the reciprocating motion of the engine piston, to a rotating motion in the drive line. Since the cam controls the piston movement, the cam profile has a great effect on engine performance. In this paper an experimental study was done to a (three- lobed) cam with Cycloidal motion profile but with different ratios between the base circle radius of the cam and the radius of the roller follower. DEWESoft was used to find the displacement and the vibration of the piston, and compare the actual results from the test with the theoretical results from the cam profile equation. The results showed that there is a periods of miss contact between the follower and the cam when the ratio between the base circle radius of the cam and the radius of the roller follower is less than a certain value, and also increasing of vibration. The suggested ratio between the cam and follower radius is to be more than 2:1.

  14. 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.

  15. Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

    Science.gov (United States)

    Kanzler, Kathryn E; Robinson, Patricia J; McGeary, Donald D; Mintz, Jim; Potter, Jennifer Sharpe; Muñante, Mariana; Lopez, Eliot J; Dougherty, Donald M; Hale, Willie J; Velligan, Dawn I

    2018-03-01

    Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach. Copyright © 2018 Elsevier Inc. All rights reserved.

  16. Early markers of airways inflammation and occupational asthma: rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices.

    Science.gov (United States)

    Tossa, Paul; Bohadana, Abraham; Demange, Valérie; Wild, Pascal; Michaely, Jean-Pierre; Hannhart, Bernard; Paris, Christophe; Zmirou-Navier, Denis

    2009-04-23

    Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i) examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii) evaluate whether, and how, constitutional (e.g. atopy) and behavioural (e.g. smoking) risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

  17. Radiosensitizers: rationale and potential

    International Nuclear Information System (INIS)

    Brown, J.M.

    1981-01-01

    This paper briefly reviews agents that are capable of sensitizing hypoxic cells to radiation and chemotherapeutic agents. The first part is a synopsis of the development of hypoxic radiosensitizers, which concludes that misonidazole can be effective against human tumors. Unfortunately, neurotoxicity limits its effectiveness in humans because the dose that can be given in conjunction with daily fractionated radiation is five to ten times lower than is required for full radiosensitization of the hypoxic cells. The second part covers our recent efforts to develop a drug that does not produce such limiting neurotoxicity. The primary rationale of our program was to synthesize a drug with a short plasma half-life that was too hydrophilic to cross the blood-brain barrier but was able to penetrate tumors and radiosensitize hypoxic cells. From this program, a new drug, SR-2508, has been found that is as efficient as misonidazole in its radiosensitizing ability, but is four to ten times less toxic. Finally, the potential of radiosensitizers not only as agents that can sensitize tumor cells to radiation, but also as agents that can specifically sensitize tumors to chemotherapeutic agents, is discussed. In addition, these drugs may be potential cytotoxic agents that produce toxicity only in solid tumors

  18. Ecophysiology of Crassulacean Acid Metabolism (CAM).

    Science.gov (United States)

    Lüttge, Ulrich

    2004-06-01

    Crassulacean Acid Metabolism (CAM) as an ecophysiological modification of photosynthetic carbon acquisition has been reviewed extensively before. Cell biology, enzymology and the flow of carbon along various pathways and through various cellular compartments have been well documented and discussed. The present attempt at reviewing CAM once again tries to use a different approach, considering a wide range of inputs, receivers and outputs. Input is given by a network of environmental parameters. Six major ones, CO(2), H(2)O, light, temperature, nutrients and salinity, are considered in detail, which allows discussion of the effects of these factors, and combinations thereof, at the individual plant level ('physiological aut-ecology'). Receivers of the environmental cues are the plant types genotypes and phenotypes, the latter including morphotypes and physiotypes. CAM genotypes largely remain 'black boxes', and research endeavours of genomics, producing mutants and following molecular phylogeny, are just beginning. There is no special development of CAM morphotypes except for a strong tendency for leaf or stem succulence with large cells with big vacuoles and often, but not always, special water storage tissues. Various CAM physiotypes with differing degrees of CAM expression are well characterized. Output is the shaping of habitats, ecosystems and communities by CAM. A number of systems are briefly surveyed, namely aquatic systems, deserts, salinas, savannas, restingas, various types of forests, inselbergs and paramós. While quantitative census data for CAM diversity and biomass are largely missing, intuition suggests that the larger CAM domains are those systems which are governed by a network of interacting stress factors requiring versatile responses and not systems where a single stress factor strongly prevails. CAM is noted to be a strategy for variable, flexible and plastic niche occupation rather than lush productivity. 'Physiological syn-ecology' reveals

  19. 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.

  20. 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.

  1. 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.

  2. The CUPCIG (CAM-Use in Primary Care in Germany) Study:Part I-Pain. Study Protocol of a Pilot-trial to Assess Feasibility, Acceptability and Perceived Effectiveness of CAM in Pain Disorders in Primary Care.

    Science.gov (United States)

    Schencking, Martin; Sönnichsen, Andreas; Bassüner, Susanne; Redaelli, Marcus

    2015-01-01

    There is limited valid data available on CAM procedures for chronic joint and neuropathic pain in primary care in Germany. Indiviual CAM qualifications of the general practitioners (GPs) and the potential of cost reduction through CAM treatment are almost unknown. The aim of this pilot trial preceding the main study is to examine the survey mode, to estimate the response rate by GPs with or without an additional qualification for CAM, and to identify the status quo in therapeutic approaches for chronic pain disorders in primary care. This is a cross-sectional study with an ex post facto design among German GPs consisting of 2 parts: In a first step, a pilot trial precedes the main study targeting 200 GPs with and 200 GPs without additional qualification in CAM in a selected region. The results of the CUPCIG study comprise the distribution of pain types treated in primary care practices, the GPs' attitude toward complementary pain therapy, pharmacological or CAM treatment, the estimate of cost reduction through CAM treatment of pain, the application of diverse CAM procedures, and biographical data. The CUPCIG study serves to compile pain therapy approaches in primary care in Germany with respect to the individual CAM expertise of the GPs. © 2015 S. Karger GmbH, Freiburg.

  3. 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.

  4. Comparative evaluation of RetCam vs. gonioscopy images in congenital glaucoma

    OpenAIRE

    Azad, Raj V; Chandra, Parijat; Chandra, Anuradha; Gupta, Aparna; Gupta, Viney; Sihota, Ramanjit

    2014-01-01

    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 a...

  5. CAM therapies among primary care patients using opioid therapy for chronic pain

    Directory of Open Access Journals (Sweden)

    Mundt Marlon P

    2007-05-01

    Full Text Available Abstract Background Complementary and alternative medicine (CAM is an increasingly common therapy used to treat chronic pain syndromes. However; there is limited information on the utilization and efficacy of CAM therapy in primary care patients receiving long-term opioid therapy. Method A survey of CAM therapy was conducted with a systematic sample of 908 primary care patients receiving opioids as a primary treatment method for chronic pain. Subjects completed a questionnaire designed to assess utilization, efficacy and costs of CAM therapies in this population. Results Patients were treated for a variety of pain problems including low back pain (38.4%, headaches (9.9%, and knee pain (6.5%; the average duration of pain was 16 years. The median morphine equivalent opioid dose was 41 mg/day, and the mean dose was 92 mg/day. Forty-four percent of the sample reported CAM therapy use in the past 12 months. Therapies utilized included massage therapy (27.3%, n = 248, chiropractic treatment (17.8%, n = 162, acupuncture (7.6%, n = 69, yoga (6.1%, n = 55, herbs and supplements (6.8%, n = 62, and prolotherapy (5.9%, n = 54. CAM utilization was significantly related to age female gender, pain severity income pain diagnosis of neck and upper back pain, and illicit drug use. Medical insurance covered chiropractic treatment (81.8% and prolotherapy (87.7%, whereas patients primarily paid for other CAM therapies. Over half the sample reported that one or more of the CAM therapies were helpful. Conclusion This study suggests CAM therapy is widely used by patients receiving opioids for chronic pain. Whether opioids can be reduced by introducing such therapies remains to be studied.

  6. CAM therapies among primary care patients using opioid therapy for chronic pain.

    Science.gov (United States)

    Fleming, Sara; Rabago, David P; Mundt, Marlon P; Fleming, Michael F

    2007-05-16

    Complementary and alternative medicine (CAM) is an increasingly common therapy used to treat chronic pain syndromes. However; there is limited information on the utilization and efficacy of CAM therapy in primary care patients receiving long-term opioid therapy. A survey of CAM therapy was conducted with a systematic sample of 908 primary care patients receiving opioids as a primary treatment method for chronic pain. Subjects completed a questionnaire designed to assess utilization, efficacy and costs of CAM therapies in this population. Patients were treated for a variety of pain problems including low back pain (38.4%), headaches (9.9%), and knee pain (6.5%); the average duration of pain was 16 years. The median morphine equivalent opioid dose was 41 mg/day, and the mean dose was 92 mg/day. Forty-four percent of the sample reported CAM therapy use in the past 12 months. Therapies utilized included massage therapy (27.3%, n = 248), chiropractic treatment (17.8%, n = 162), acupuncture (7.6%, n = 69), yoga (6.1%, n = 55), herbs and supplements (6.8%, n = 62), and prolotherapy (5.9%, n = 54). CAM utilization was significantly related to age female gender, pain severity income pain diagnosis of neck and upper back pain, and illicit drug use. Medical insurance covered chiropractic treatment (81.8%) and prolotherapy (87.7%), whereas patients primarily paid for other CAM therapies. Over half the sample reported that one or more of the CAM therapies were helpful. This study suggests CAM therapy is widely used by patients receiving opioids for chronic pain. Whether opioids can be reduced by introducing such therapies remains to be studied.

  7. Motion laws synthesis for cam mechanisms with multiple follower displacement

    Science.gov (United States)

    Podgornyj, Yu I.; Skeeba, V. Yu; Kirillov, A. V.; Martynova, T. G.; Skeeba, P. Yu

    2018-03-01

    The research discusses the cam mechanisms design. The analysis of specialized literature indicates that the synthesis of the cam mechanisms laws of motion is currently done mainly by a standard set of acceleration curves. In some cases, the designer needs to synthesize a new acceleration law which should be task-specific and enforce a certain production step. The values of the technological loads and inertia forces loads generated by the mechanism are calculated to analyze the slay mechanism behavior in the production of closely woven fabrics. Mathematical packages MathCad and SolidWorks are used in calculations. As a result of the research, the authors propose the methodology for synthesizing the slay mechanism with multiple follower displacements for the point of contact between the reed and the fabric edge. Theoretical studies have been tested on a specific machine model (STB loom). The authors have synthesized the motion law of the filling threads beat-up mechanism for the production of strong fabrics. New basic and closing cam profiles are proposed. The results are designed to enhance the possibilities of the looms and to recommend the most efficient equipment operation modes for the producers.

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. Camshaft bearing arrangement for overhead cam engine

    Energy Technology Data Exchange (ETDEWEB)

    Yoshikawa, M.

    1985-01-01

    In an assembly for an internal combustion engine comprising a cylinder block, a cylinder head detachably affixed to the cylinder block by a plurality of threaded fastening means, a plurality of poppet valves supported for reciprocation in the cylinder head and a camshaft for operating the poppet valves, the improvement is described comprising a cam carrier detachably affixed to the cylinder head and overlying the threaded fastening means, and a bearing cap affixed to the cam carrier. The cam carrier and the bearing cap have bearing surfaces for journaling the camshaft.

  15. 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.

  16. A Space Cam Mechanism for Power Transmission of an Opposite-cylinder Piston Engine

    Directory of Open Access Journals (Sweden)

    Zhang Haoyue

    2015-01-01

    Full Text Available For the purpose of improving the engine’s power density, we put forward a new type of power transmission mechanism which is used for opposed-cylinder engine. The gas pressure acts on the cam through the piston and push rod, and the spindle rotation of external is driven by the cam. The design of spatial cam work surface is completed by using the enveloping theory of a family of space curves, the force between roller and cam is analyzed using dynamic analysis software. Under the condition of equal number, size and stroke of piston, the new one with larger power density is more compact in structure than the traditional power transmission mechanism, and the reaction force on either side of the main shaft and the acting force between pistons and cylinders are smaller than those in traditional one, which prolongs the service life of the pistons.

  17. Digital Dentistry — Digital Impression and CAD/CAM System Applications

    Directory of Open Access Journals (Sweden)

    Gabor Alin-Gabriel

    2017-03-01

    Full Text Available Digital imprint and computer-aided design/computer-aided manufacture (CAD/CAM systems offer several benefits compared to traditional techniques. The use of a CAD/CAM system to scan preparations and generate restorations in-office, removes a second appointment for the patient. The existence of precision benefits in using complete systems and chairside scanning systems, has been proven. CAD/CAM restorations have a good longevity and meet the accepted clinical parameters. New digital impression methods are presently accessible, and before long, the long-awaited goal of sparing patients of one the most unpleasant practices in clinical dentistry, acquiring dental impressions, will be exchanged by intraoral digital scanning. CAD/CAM systems existing nowadays, can feed data through accurate digital scans created from plaster models, straight to manufacturing systems that can shape ceramic or resin restorations with no requirement of a physical copy of the prepared, adjacent, and antagonist teeth.

  18. Rationale and design of the worldwide prospective multicenter registry on radiation dose estimates of cardiac CT angiography in daily practice in 2017 (PROTECTION VI)

    DEFF Research Database (Denmark)

    Stocker, Thomas J; Deseive, Simon; Chen, Marcus

    2018-01-01

    -randomized and randomized studies have been performed to reduce the associated radiation exposure. Currently, it is unclear if the advances in technology and knowledge about radiation reduction translated into reduced levels of cardiac CTA radiation dose in daily clinical practice as well as a wide utilization of dose......-saving strategies. METHODS: The PROTECTION VI study is a multicenter, prospective, worldwide registry designed to evaluate radiation dose exposure, utilization of dose-saving strategies and diagnostic image quality during cardiac CTA in current daily practice. Assessment of image quality will be addressed...... median radiation dose levels, image quality, frequency of use and efficacy of algorithms for dose reduction, and patient and study-related predictors associated with radiation dose. CONCLUSIONS: The PROTECTION VI study is designed to provide a reliable estimate of current radiation dose for cardiac CTA...

  19. 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

  20. Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

    Directory of Open Access Journals (Sweden)

    Lynch Wesley C

    2012-04-01

    Full Text Available Abstract Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program or a “best-practices” (Healthy Living Information control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587

  1. 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...... for cancer related symptoms and side effects, but as a spiritual practice as well. For some individuals this may be true to an even higher extent than in established religious institutions....

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. Angiotensin receptor blockade in acute stroke. The Scandinavian Candesartan Acute Stroke Trial: rationale, methods and design of a multicentre, randomised- and placebo-controlled clinical trial (NCT00120003)

    DEFF Research Database (Denmark)

    Sandset, Else Charlotte; Murray, Gordon; Boysen, Gudrun Margrethe

    2010-01-01

    AND DESIGN: The Scandinavian Candesartan Acute Stroke Trial is an international randomised, placebo-controlled, double-blind trial of candesartan in acute stroke. We plan to recruit 2500 patients presenting within 30 h of stroke (ischaemic or haemorrhagic) and with systolic blood pressure =140 mm......Hg. The recruited patients are randomly assigned to candesartan or placebo for 7-days (doses increasing from 4 to 16 mg once daily). Randomisation is performed centrally via a secure web interface. The follow-up period is 6-months. Patients are included from the following nine North-European countries: Norway...

  7. Rationale and design of the RESOLVE trial: lanreotide as a volume reducing treatment for polycystic livers in patients with autosomal dominant polycystic kidney disease

    Directory of Open Access Journals (Sweden)

    Gevers Tom JG

    2012-04-01

    Full Text Available Abstract Background A large proportion of patients with autosomal dominant polycystic kidney disease (ADPKD suffers from polycystic liver disease. Symptoms arise when liver volume increases. The somatostatin analogue lanreotide has proven to reduce liver volume in patients with polycystic liver disease. However, this study also included patients with isolated polycystic liver disease (PCLD. The RESOLVE trial aims to assess the efficacy of lanreotide treatment in ADPKD patients with symptomatic polycystic livers. In this study we present the design of the RESOLVE trial. Methods/design This open-label clinical trial evaluates the effect of 6 months of lanreotide in ADPKD patients with symptomatic polycystic livers. Primary outcome is change in liver volume determined by computerised tomography-volumetry. Secondary outcomes are changes in total kidney volume, kidney intermediate volume and renal function. Furthermore, urinary (NGAL, α1-microglobulin, KIM-1, H-FABP, MCP-1 and serum (fibroblast growth factor 23 biomarkers associated with ADPKD disease severity are assessed to investigate whether these biomarkers predict treatment responses to lanreotide. Moreover, safety and tolerability of the drug in ADPKD patients will be assessed. Discussion We anticipate that lanreotide is an effective therapeutic option for ADPKD patients with symptomatic polycystic livers and that this trial aids in the identification of patient related factors that predict treatment response. Trial registration number Clinical trials.gov NCT01354405

  8. 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.

  9. Comparing focused ultrasound and uterine artery embolization for uterine fibroids – Rationale and Design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

    Science.gov (United States)

    Bouwsma, Esther V.A.; Hesley, Gina K.; Woodrum, David A.; Weaver, Amy L.; Leppert, Phyllis C.; Peterson, Lisa G.; Stewart, Elizabeth A.

    2011-01-01

    Objective To present the rational, design and methodology of the FIRSTT study (Fibroid Interventions: Reducing Symptoms Today and Tomorrow, NCT00995878, clinicaltrials.gov). Design Randomized Clinical Trial (RCT) Setting Two Academic Medical Centers Patient(s) Premenopausal women with symptomatic uterine fibroids. Intervention(s) Participants are randomized to two FDA-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization (UAE) and MRI guided focused ultrasound (MRgFUS). Main Outcome Measure(s) The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health related quality of life, impairment of ovarian reserve, treatment complications and the economic impact of these issues. Results The trial is currently in the phase of active recruitment. Conclusions This RCT will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. PMID:21794858

  10. A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS study

    Science.gov (United States)

    Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; Jobe, Jared B.; Maupomé, Gerardo; Ritenbaugh, Cheryl

    2012-01-01

    Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches. PMID:23001689

  11. Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.

    Science.gov (United States)

    Harrison, Robert W; Radhakrishnan, Vaishnavi; Lam, Peter S; Allocco, Dominic J; Brar, Sandeep; Fahy, Martin; Fisher, Rebecca; Ikeno, Fumiaki; Généreux, Philippe; Kimura, Takeshi; Liu, Minglei; Lye, Weng Kit; Mintz, Gary S; Nagai, Hirofumi; Suzuki, Yuka; White, Roseann; Allen, John C; Krucoff, Mitchell W

    2016-12-01

    The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, whereas understanding their comparability across geographic populations could enhance global DES evaluation. The East-West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss, as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8-13 months of follow-up. Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow-up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements. Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow-up for novel stent designs. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. AFSC/FMA/CAMS Data Objects

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CAMS system consists of a set of tables and packages that provide authentication services to all other North Pacific Groundfish and Halibut Observing Program...

  13. CAMS: OLAPing Multidimensional Data Streams Efficiently

    Science.gov (United States)

    Cuzzocrea, Alfredo

    In the context of data stream research, taming the multidimensionality of real-life data streams in order to efficiently support OLAP analysis/mining tasks is a critical challenge. Inspired by this fundamental motivation, in this paper we introduce CAMS (C ube-based A cquisition model for M ultidimensional S treams), a model for efficiently OLAPing multidimensional data streams. CAMS combines a set of data stream processing methodologies, namely (i) the OLAP dimension flattening process, which allows us to obtain dimensionality reduction of multidimensional data streams, and (ii) the OLAP stream aggregation scheme, which aggregates data stream readings according to an OLAP-hierarchy-based membership approach. We complete our analytical contribution by means of experimental assessment and analysis of both the efficiency and the scalability of OLAPing capabilities of CAMS on synthetic multidimensional data streams. Both analytical and experimental results clearly connote CAMS as an enabling component for next-generation Data Stream Management Systems.

  14. Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): design and rationale of a randomized controlled trial.

    Science.gov (United States)

    Wiggers, Jimme K; Coelen, Robert J S; Rauws, Erik A J; van Delden, Otto M; van Eijck, Casper H J; de Jonge, Jeroen; Porte, Robert J; Buis, Carlijn I; Dejong, Cornelis H C; Molenaar, I Quintus; Besselink, Marc G H; Busch, Olivier R C; Dijkgraaf, Marcel G W; van Gulik, Thomas M

    2015-02-14

    Liver surgery in perihilar cholangiocarcinoma (PHC) is associated with high postoperative morbidity because the tumor typically causes biliary obstruction. Preoperative biliary drainage is used to create a safer environment prior to liver surgery, but biliary drainage may be harmful when severe drainage-related complications deteriorate the patients' condition or increase the risk of postoperative morbidity. Biliary drainage can cause cholangitis/cholecystitis, pancreatitis, hemorrhage, portal vein thrombosis, bowel wall perforation, or dehydration. Two methods of preoperative biliary drainage are mostly applied: endoscopic biliary drainage, which is currently used in most regional centers before referring patients for surgical treatment, and percutaneous transhepatic biliary drainage. Both methods are associated with severe drainage-related complications, but two small retrospective series found a lower incidence in the number of preoperative complications after percutaneous drainage compared to endoscopic drainage (18-25% versus 38-60%, respectively). The present study randomizes patients with potentially resectable PHC and biliary obstruction between preoperative endoscopic or percutaneous transhepatic biliary drainage. The study is a multi-center trial with an "all-comers" design, randomizing patients between endoscopic or percutaneous transhepatic biliary drainage. All patients selected to potentially undergo a major liver resection for presumed PHC are eligible for inclusion in the study provided that the biliary system in the future liver remnant is obstructed (even if they underwent previous inadequate endoscopic drainage). Primary outcome measure is the total number of severe preoperative complications between randomization and exploratory laparotomy. The study is designed to detect superiority of percutaneous drainage: a provisional sample size of 106 patients is required to detect a relative decrease of 50% in the number of severe preoperative

  15. Children's Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity.

    Science.gov (United States)

    Wilken, Lynne R; Novotny, Rachel; Fialkowski, Marie K; Boushey, Carol J; Nigg, Claudio; Paulino, Yvette; Leon Guerrero, Rachael; Bersamin, Andrea; Vargo, Don; Kim, Jang; Deenik, Jonathan

    2013-10-09

    Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children's Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. The Children's Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children's Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The Children

  16. 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

  17. Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design.

    Science.gov (United States)

    Lal, Rohit; Bourayou, Nawel; Hillerdal, Gunnar; Nicolson, Marianne; Vikstrom, Anders; Lorenzo, Maria; D'yachkova, Yulia; Barriga, Susana; Visseren-Grul, Carla

    2013-10-03

    Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m(2) every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients' quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design

  18. Rationale, design, and method of the Diabetes & Women's Health study – a study of long-term health implications of glucose intolerance in pregnancy and their determinants

    DEFF Research Database (Denmark)

    Zhang, Cuilin; Hu, Frank B; Olsen, Sjurdur F

    2014-01-01

    or public health interventions in relation to the transition of gestational diabetes mellitus to type 2 diabetes mellitus. To achieve the goal efficiently, we are applying a hybrid design enrolling and collecting data longitudinally from approximately 4000 women with a medical history of gestational...... in determining the transition from gestational diabetes mellitus to overt type 2 diabetes mellitus. These critical data gaps served as the impetus for this Diabetes & Women's Health study with the overall goal of investigating genetic factors and their interactions with risk factors amenable to clinical...... diabetes mellitus in two existing prospective cohorts, the Nurses' Health Study II and the Danish National Birth Cohort. Women who had a medical history of gestational diabetes mellitus in one or more of their pregnancies are eligible for the present study. After enrollment, we follow study participants...

  19. 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.

  20. 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

  1. 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

  2. Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial.

    Science.gov (United States)

    Kilburn, Tina R; Sørensen, Merete Juul; Thastum, Mikael; Rapee, Ronald M; Rask, Charlotte Ulrikka; Arendt, Kristian Bech; Thomsen, Per Hove

    2018-04-02

    Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD. This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre-post assessment) mixed between-within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child's level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child's behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention. This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general. https://ClinicalTrials.gov ( NCT02908321 ). Registered 19th of September 2016.

  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)

    Thompson, Debbe; Bhatt, Riddhi; Lazarus, Melanie; Cullen, Karen; Baranowski, Janice; Baranowski, Tom

    2012-11-21

    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. 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. 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. To our knowledge, this is the first research to explore the effect of implementation intentions on child fruit and vegetable goal attainment and consumption. This intervention will contribute valuable information regarding whether implementation intentions are effective with elementary age children. ClinicalTrials.gov NCT01004094.

  4. 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

  5. Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thromboembolic infrainguinal disease (DUET: design and rationale

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    Fioole Bram

    2011-01-01

    Full Text Available Abstract Background The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis. Methods/design Sixty adult patients with recently (between 1 and 7 weeks thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A or US-accelerated thrombolysis (group B. Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery. Discussion The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications. Trial registration Current Controlled Trials ISRCTN72676102

  6. Determinants of cardiovascular disease and other non-communicable diseases in Central and Eastern Europe: Rationale and design of the HAPIEE study

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    Pikhart Hynek

    2006-10-01

    Full Text Available Abstract Background Over the last five decades, a wide gap in mortality opened between western and eastern Europe; this gap increased further after the dramatic fluctuations in mortality in the former Soviet Union (FSU in the 1990s. Recent rapid increases in mortality among lower socioeconomic groups in eastern Europe suggests that socioeconomic factors are powerful determinants of mortality in these populations but the more proximal factors linking the social conditions with health remain unclear. The HAPIEE (Health, Alcohol and Psychosocial factors In Eastern Europe study is a prospective cohort study designed to investigate the effect of classical and non-conventional risk factors and social and psychosocial factors on cardiovascular and other non-communicable diseases in eastern Europe and the FSU. The main hypotheses of the HAPIEE study relate to the role of alcohol, nutrition and psychosocial factors. Methods and design The HAPIEE study comprises four cohorts in Russia, Poland, the Czech Republic and Lithuania; each consists of a random sample of men and women aged 45–69 years old at baseline, stratified by gender and 5 year age groups, and selected from population registers. The total planned sample size is 36,500 individuals. Baseline information from the Czech Republic, Russia and Poland was collected in 2002–2005 and includes data on health, lifestyle, diet (food frequency, socioeconomic circumstances and psychosocial factors. A short examination included measurement of anthropometric parameters, blood pressure, lung function and cognitive function, and a fasting venous blood sample. Re-examination of the cohorts in 2006–2008 focuses on healthy ageing and economic well-being using face-to-face computer assisted personal interviews. Recruitment of the Lithuanian cohort is ongoing, with baseline and re-examination data being collected simultaneously. All cohorts are being followed up for mortality and non-fatal cardiovascular

  7. 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

  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. 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

  10. 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

  11. The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design

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    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

  12. 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

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    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

  13. Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    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 on treatment of depression

  14. 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

  15. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation

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    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

  16. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

    Science.gov (United States)

    Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

    2017-04-12

    Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

  17. Immunomodulation of Autoimmune Arthritis by Herbal CAM

    Directory of Open Access Journals (Sweden)

    Shivaprasad H. Venkatesha

    2011-01-01

    Full Text Available Rheumatoid arthritis (RA is a debilitating autoimmune disease of global prevalence. The disease is characterized by synovial inflammation leading to cartilage and bone damage. Most of the conventional drugs used for the treatment of RA have severe adverse reactions and are quite expensive. Over the years, increasing proportion of patients with RA and other immune disorders are resorting to complementary and alternative medicine (CAM for their health needs. Natural plant products comprise one of the most popular CAM for inflammatory and immune disorders. These herbal CAM belong to diverse traditional systems of medicine, including traditional Chinese medicine, Kampo, and Ayurvedic medicine. In this paper, we have outlined the major immunological pathways involved in the induction and regulation of autoimmune arthritis and described various herbal CAM that can effectively modulate these immune pathways. Most of the information about the mechanisms of action of herbal products in the experimental models of RA is relevant to arthritis patients as well. The study of immunological pathways coupled with the emerging application of genomics and proteomics in CAM research is likely to provide novel insights into the mechanisms of action of different CAM modalities.

  18. Chiropractic and CAM Utilization: A Descriptive Review

    Directory of Open Access Journals (Sweden)

    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.

  19. Genomic analyses of the CAM plant pineapple.

    Science.gov (United States)

    Zhang, Jisen; Liu, Juan; Ming, Ray

    2014-07-01

    The innovation of crassulacean acid metabolism (CAM) photosynthesis in arid and/or low CO2 conditions is a remarkable case of adaptation in flowering plants. As the most important crop that utilizes CAM photosynthesis, the genetic and genomic resources of pineapple have been developed over many years. Genetic diversity studies using various types of DNA markers led to the reclassification of the two genera Ananas and Pseudananas and nine species into one genus Ananas and two species, A. comosus and A. macrodontes with five botanical varieties in A. comosus. Five genetic maps have been constructed using F1 or F2 populations, and high-density genetic maps generated by genotype sequencing are essential resources for sequencing and assembling the pineapple genome and for marker-assisted selection. There are abundant expression sequence tag resources but limited genomic sequences in pineapple. Genes involved in the CAM pathway has been analysed in several CAM plants but only a few of them are from pineapple. A reference genome of pineapple is being generated and will accelerate genetic and genomic research in this major CAM crop. This reference genome of pineapple provides the foundation for studying the origin and regulatory mechanism of CAM photosynthesis, and the opportunity to evaluate the classification of Ananas species and botanical cultivars. © The Author 2014. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  20. Chiropractic and CAM utilization: a descriptive review.

    Science.gov (United States)

    Lawrence, Dana J; Meeker, William C

    2007-01-22

    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 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. A total of 137 papers were selected, based upon including information about chiropractic utilization, CAM utilization and low back pain and other conditions. Information was extracted from each paper addressing use of chiropractic and CAM, and is summarized in tabular form. 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. 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.

  1. Rationale and design of the Karolinska-Rennes (KaRen) prospective study of dyssynchrony in heart failure with preserved ejection fraction.

    Science.gov (United States)

    Donal, Erwan; Lund, Lars H; Linde, Cecilia; Edner, Magnus; Lafitte, Stéphane; Persson, Hans; Bauer, Fabrice; Ohrvik, John; Ennezat, Pierre-Vladimir; Hage, Camilla; Löfman, Ida; Juilliere, Yves; Logeart, Damien; Derumeaux, Geneviève; Gueret, Pascal; Daubert, Jean-Claude

    2009-02-01

    Heart failure with preserved ejection fraction (HFPEF) is common but not well understood. Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF. We have designed a prospective, multicenter, international, observational study to characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects prognosis. Patients presenting with acute heart failure (HF) will be screened so as to identify 400 patients with HFPEF. Inclusion criteria will be: acute presentation with Framingham criteria for HF, left ventricular ejection fraction>or=45%, brain natriuretic peptide (BNP)>100 pg/mL or NT-proBNP>300 pg/mL. Once stabilized, 4-8 weeks after the index presentation, patients will return and undergo questionnaires, serology, ECG, and Doppler echocardiography. Thereafter, patients will be followed for mortality and HF hospitalization every 6 months for at least 18 months. Sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography, cardiopulmonary exercise testing, and serological markers. KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in HFPEF. The results might improve our understanding of HFPEF and generate answers to the question whether dyssynchrony could be a target for therapy in HFPEF.

  2. Incorporating prosocial behavior to promote physical activity in older adults: rationale and design of the Program for Active Aging and Community Engagement (PACE).

    Science.gov (United States)

    Foy, Capri G; Vitolins, Mara Z; Case, L Douglas; Harris, Susan J; Massa-Fanale, Carol; Hopley, Richard J; Gardner, Leah; Rudiger, Nicole; Yamamoto, Kathryn; Swain, Brittany; Goff, David C; Danhauer, Suzanne C; Booth, Deborah; Gaspari, Jamie

    2013-09-01

    Despite the benefits of regular physical activity among older adults, physical activity rates are low in this population. The Program for Active Aging and Community Engagement (PACE) is an ongoing randomized controlled trial designed to compare the effects of two interventions on physical activity at 12 months among older adults. A total of 300 men and women aged 55 years or older will be randomized into either a healthy aging (HA) control intervention (n = 150), which is largely based upon educational sessions, or a prosocial behavior physical activity (PBPA) intervention (n = 150), which incorporates structured physical activity sessions, cognitive-behavioral counseling, and opportunities to earn food for donation to a regional food bank based on weekly physical activity and volunteering. The PBPA intervention is delivered at a local YMCA, and a regional grocery store chain donates the food to the food bank. Data will be collected at baseline, 3, 6, and 12 months. The primary outcome is physical activity as assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire at 12 months. Secondary outcomes include physical function and health-related quality of life. If successful, the PACE study will demonstrate that prosocial behavior and volunteerism may be efficaciously incorporated into interventions and will provide evidence for a novel motivating factor for physical activity. © 2013.

  3. The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study.

    Science.gov (United States)

    Gordin, Daniel; Fadl Elmula, Fadl Elmula M; Andersson, Bert; Gottsäter, Anders; Elf, Johan; Kahan, Thomas; Christensen, Kent Lodberg; Vikatmaa, Pirkka; Vikatmaa, Leena; Bastholm Olesen, Thomas; Groop, Per-Henrik; Olsen, Michael Hecht; Tikkanen, Ilkka

    2017-10-01

    To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension. This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of  ≥145 mm Hg, and/or a daytime diastolic ABPM of  ≥95 mm Hg after witnessed drug intake (including  ≥3 antihypertensive drugs, preferably including a diuretic). The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety. This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.

  4. Managed ventricular pacing vs. conventional dual-chamber pacing for elective replacements: the PreFER MVP study: clinical background, rationale, and design.

    Science.gov (United States)

    Quesada, Aurelio; Botto, Gianluca; Erdogan, Ali; Kozak, Milan; Lercher, Peter; Nielsen, Jens Cosedis; Piot, Olivier; Ricci, Renato; Weiss, Christian; Becker, Daniel; Wetzels, Gwenn; De Roy, Luc

    2008-03-01

    Several clinical studies have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can be detrimental. The managed ventricular pacing (MVP) algorithm is designed to give preference to spontaneous AV conduction, thus minimizing RV pacing. The clinical outcomes of MVP are being studied in several ongoing trials in patients undergoing a first device implantation, but it is unknown to what extent MVP is beneficial in patients with a history of ventricular pacing. The purpose of the Prefer for Elective Replacement MVP (PreFER MVP) study is to assess the superiority of the MVP algorithm to conventional pacemaker and implantable cardioverter-defibrillator programming in terms of freedom from hospitalization for cardiovascular causes in a population of patients exposed to long periods of ventricular pacing. PreFER MVP is a prospective, 1:1 parallel, randomized (MVP ON/MVP OFF), single-blinded multi-centre trial. The study population consists of patients with more than 40% ventricular pacing documented with their previous device. Approximately, 600 patients will be randomized and followed for at least 24 months. The primary endpoint comprises cardiovascular hospitalization. The PreFER MVP trial is the first large prospective randomized clinical trial evaluating the effect of MVP in patients with a history of RV pacing.

  5. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

    Science.gov (United States)

    Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

    2016-03-15

    Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

  6. Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients.

    Science.gov (United States)

    Casella, Michela; Dello Russo, Antonio; Pelargonio, Gemma; Bongiorni, Maria Grazia; Del Greco, Maurizio; Piacenti, Marcello; Andreassi, Maria Grazia; Santangeli, Pasquale; Bartoletti, Stefano; Moltrasio, Massimo; Fassini, Gaetano; Marini, Massimiliano; Di Cori, Andrea; Di Biase, Luigi; Fiorentini, Cesare; Zecchi, Paolo; Natale, Andrea; Picano, Eugenio; Tondo, Claudio

    2012-10-01

    Radiofrequency catheter ablation is the mainstay of therapy for supraventricular tachyarrhythmias. Conventional radiofrequency catheter ablation requires the use of fluoroscopy, thus exposing patients to ionising radiation. The feasibility and safety of non-fluoroscopic radiofrequency catheter ablation has been recently reported in a wide range of supraventricular tachyarrhythmias using the EnSite NavX™ mapping system. The NO-PARTY is a multi-centre, randomised controlled trial designed to test the hypothesis that catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system results in a clinically significant reduction in exposure to ionising radiation compared with conventional catheter ablation. The study will randomise 210 patients undergoing catheter ablation of supraventricular tachyarrhythmias to either a conventional ablation technique or one guided by the EnSite NavX™ mapping system. The primary end-point is the reduction of the radiation dose to the patient. Secondary end-points include procedural success, reduction of the radiation dose to the operator, and a cost-effectiveness analysis. In a subgroup of patients, we will also evaluate the radiobiological effectiveness of dose reduction by assessing acute chromosomal DNA damage in peripheral blood lymphocytes. NO-PARTY will determine whether radiofrequency catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction in ionising radiation exposure for both patient and operator.

  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. 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 [ISRCTN38327949

    Science.gov (United States)

    Besselink, Marc GH; van Santvoort, Hjalmar C; Nieuwenhuijs, Vincent B; Boermeester, Marja A; Bollen, Thomas L; Buskens, Erik; Dejong, Cornelis HC; van Eijck, Casper HJ; van Goor, Harry; Hofker, Sijbrand S; Lameris, Johan S; van Leeuwen, Maarten S; Ploeg, Rutger J; van Ramshorst, Bert; Schaapherder, Alexander FM; Cuesta, Miguel A; Consten, Esther CJ; Gouma, Dirk J; van der Harst, Erwin; Hesselink, Eric J; Houdijk, Lex PJ; Karsten, Tom M; van Laarhoven, Cees JHM; Pierie, Jean-Pierre EN; Rosman, Camiel; Bilgen, Ernst Jan Spillenaar; Timmer, Robin; van der Tweel, Ingeborg; de Wit, Ralph J; Witteman, Ben JM; Gooszen, Hein G

    2006-01-01

    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. PMID:16606471

  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. 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.

  11. The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.

    Science.gov (United States)

    Rash, Joshua A; Lavoie, Kim L; Sigal, Ronald J; Campbell, David J T; Manns, Braden J; Tonelli, Marcello; Campbell, Tavis S

    2016-07-01

    Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication. Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. 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

    2017-01-01

    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. PMID:28315481

  13. A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

    Science.gov (United States)

    Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

    2018-04-04

    Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

  14. An intervention strategy for improving residential environment and positive mental health among public housing tenants: rationale, design and methods of Flash on my neighborhood!

    Science.gov (United States)

    Houle, Janie; Coulombe, Simon; Radziszewski, Stephanie; Leloup, Xavier; Saïas, Thomas; Torres, Juan; Morin, Paul

    2017-09-25

    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. 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). 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.

  15. The rationale/design of the Guimarães/Vizela study: a multimodal population-based cohort study to determine global cardiovascular risk and disease.

    Science.gov (United States)

    Cunha, Pedro Guimarães; Cotter, Jorge; Oliveira, Pedro; Vila, Isabel; Sousa, Nuno

    2014-06-01

    Cardiovascular disease and dementia are growing medical and social problems in aging societies. Appropriate knowledge of cardiovascular disease and cognitive decline risk factors (RFs) are critical for global CVR health preventive intervention. Many epidemiological studies use case definition based on data collected/measured in a single visit, a fact that can overestimate prevalence rates and distant from clinical practice demanding criteria. Portugal displays an elevated stroke mortality rate. However, population's global CV risk characterization is limited, namely, considering traditional/nontraditional RF and new intermediate phenotypes of CV and renal disease. Association of hemodynamic variables (pulse wave velocity and central blood pressure) with global CVR stratification, cognitive performance, and kidney disease are practically inexistent at a dwelling population level. After reviewing published data, we designed a population-based cohort study to analyze the prevalence of these cardiovascular RFs and intermediate phenotypes, using random sampling of adult dwellers living in 2 adjacent cities. Strict definition of phenotypes was planned: subjects were observed twice, and several hemodynamic and other biological variables measured at least 3 months apart. Three thousand thirty-eight subjects were enrolled, and extensive data collection (including central and peripheral blood pressure, pulse wave velocity), sample processing, and biobank edification were carried out. One thousand forty-seven cognitive evaluations were performed. Seeking for CV risk reclassification, early identification of subjects at risk, and evidence of early vascular aging and cognitive and renal function decline, using the strict daily clinical practice criteria, will lead to better resource allocation in preventive measures at a population level.

  16. Rationale, Design, and Methodological Aspects of the BUDAPEST-GLOBAL Study (Burden of Atherosclerotic Plaques Study in Twins-Genetic Loci and the Burden of Atherosclerotic Lesions).

    Science.gov (United States)

    Maurovich-Horvat, Pál; Tárnoki, Dávid L; Tárnoki, Ádám D; Horváth, Tamás; Jermendy, Ádám L; Kolossváry, Márton; Szilveszter, Bálint; Voros, Viktor; Kovács, Attila; Molnár, Andrea Á; Littvay, Levente; Lamb, Hildo J; Voros, Szilard; Jermendy, György; Merkely, Béla

    2015-12-01

    The heritability of coronary atherosclerotic plaque burden, coronary geometry, and phenotypes associated with increased cardiometabolic risk are largely unknown. The primary aim of the Burden of Atherosclerotic Plaques Study in Twins-Genetic Loci and the Burden of Atherosclerotic Lesions (BUDAPEST-GLOBAL) study is to evaluate the influence of genetic and environmental factors on the burden of coronary artery disease. By design this is a prospective, single-center, classical twin study. In total, 202 twins (61 monozygotic pairs, 40 dizygotic same-sex pairs) were enrolled from the Hungarian Twin Registry database. All twins underwent non-contrast-enhanced computed tomography (CT) for the detection and quantification of coronary artery calcium and for the measurement of epicardial fat volumes. In addition, a single non-contrast-enhanced image slice was acquired at the level of L3-L4 to assess abdominal fat distribution. Coronary CT angiography was used for the detection and quantification of plaque, stenosis, and overall coronary artery disease burden. For the primary analysis, we will assess the presence and volume of atherosclerotic plaques. Furthermore, the 3-dimensional coronary geometry will be assessed based on the coronary CT angiography datasets. Additional phenotypic analyses will include per-patient epicardial and abdominal fat quantity measurements. Measurements obtained from monozygotic and dizygotic twin pairs will be compared to evaluate the genetic or environmental effects of the given phenotype. The BUDAPEST-GLOBAL study provides a unique framework to shed some light on the genetic and environmental influences of cardiometabolic disorders. © 2015 Wiley Periodicals, Inc.

  17. Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster randomized pragmatic trial

    Science.gov (United States)

    Choudhry, Niteesh K.; Isaac, Thomas; Lauffenburger, Julie C.; Gopalakrishnan, Chandrasekar; Khan, Nazleen F.; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L.; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M.; Naseem, Samrah; Gagne, Joshua J.; Jackevicius, Cynthia A.; Fischer, Michael A.; Solomon, Daniel H.; Sequist, Thomas D.

    2016-01-01

    Background Approximately half of patients with chronic cardiometabolic conditions are non-adherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may or may not need adherence assistance. Objective To evaluate the effect of a multi-component, behaviorally-tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. Trial design The STIC2IT (Study of a Tele-pharmacy Intervention for Chronic diseases To Improve Treatment adherence) trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multi-component intervention that uses behavioral interviewing, text messaging, mailed progress reports and video visits. Targeted patients are those who are non-adherent to glucose-lowering, anti-hypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients’ individual health barriers and their level of health activation. We cluster randomized 14 practice sites of a large multi-specialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients to be followed for 12 months after randomization. The trial’s primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and healthcare resource utilization. Conclusion This trial will determine whether a technologically-enabled, behaviorally-targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. PMID:27659887

  18. Comparison of home fortification with two iron formulations among Kenyan children: Rationale and design of a placebo-controlled non-inferiority trial

    Directory of Open Access Journals (Sweden)

    Emily M. Teshome

    2017-09-01

    Full Text Available Introduction: Home fortification powders containing iron and other micronutrients have been recommended by World Health Organisation to prevent iron deficiency anaemia in areas of high prevalence. There is evidence, however, that home fortification at this iron dose may cause gastrointestinal adverse events including diarrhoea. Providing a low dose of highly absorbable iron (3 mg iron as NaFeEDTA may be safer because the decreased amount of iron in the gut lumen can possibly reduce the burden of these adverse effects whilst resulting in similar or higher amounts of absorbed iron. Objective: To show non-inferiority of home fortification with 3 mg iron as NaFeEDTA compared with 12.5 mg iron as encapsulated ferrous fumarate, with haemoglobin response as the primary outcome. Design: 338 Kenyan children aged 12–36 months will be randomly allocated to daily home fortification with either: a 3 mg iron as NaFeEDTA (experimental treatment, b 12.5 mg iron as encapsulated ferrous fumarate (reference, or c placebo. At baseline, after 30 days of intervention and within 100 days post-intervention, blood samples will be assessed for primary outcome (haemoglobin concentration, iron status markers, Plasmodium parasitaemia and inflammation markers. Urine and stool samples will be assessed for hepcidin concentrations and inflammation, respectively. Adherence will be assessed by self-reporting, sachet counts and by an electronic monitoring device. Conclusion: If daily home fortification with a low dose of iron (3 mg NaFeEDTA has similar or superior efficacy to a high dose (12.5 mg ferrous fumarate then it would be the preferred choice for treatment of iron deficiency anaemia in children. Keywords: Adherence, Anaemia, Child, Preschool, Dietary supplements, Iron, Non-inferiority, Fortification

  19. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes

    Directory of Open Access Journals (Sweden)

    Wilmot Emma G

    2011-12-01

    Full Text Available Abstract Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a aged 18-40 years with a BMI in the obese range; b 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89 or control (n = 89 arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409.

  20. 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.

  1. 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.

  2. Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial.

    Science.gov (United States)

    Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre; Staessen, Jan A

    2014-06-01

    The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. ClinicalTrials.gov Identifier: NCT 01505010.

  3. Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

    Science.gov (United States)

    Blake, Kathryn; Holbrook, Janet T; Antal, Holly; Shade, David; Bunnell, H Timothy; McCahan, Suzanne M; Wise, Robert A; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

    2015-05-01

    Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. 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.

  5. Rationale and design of MUSIC OS-EU: an international observational study of the treatment of postmenopausal women for osteoporosis in Europe and Canada.

    Science.gov (United States)

    Modi, Ankita; Sen, Shuvayu; Adachi, Jonathan D; Adami, Silvano; Cortet, Bernard; Cooper, Alun L; Geusens, Piet; Mellström, Dan; Weaver, Jessica P; van den Bergh, Joop P; Nguyen, Allison M; Keown, Paul A; Leung, Albert T; Sajjan, Shiva

    2015-01-01

    The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS-EU) was designed to better understand the rate and burden of gastrointestinal (GI) events on clinical and health care outcomes among postmenopausal women with osteoporosis. MUSIC OS-EU is a prospective, multinational, observational cohort study of postmenopausal women ≥50 years of age diagnosed with osteoporosis and enrolled in physician clinics in six countries: France, Italy, the Netherlands, Sweden, the United Kingdom, and Canada. The MUSIC OS-EU study has three components: (i) a physician survey to describe their management of osteoporotic patients with GI events; (ii) a retrospective chart survey to describe the receipt and type of osteoporosis medication prescribed; and (iii) a prospective cohort study including untreated and treated patients diagnosed with osteoporosis to investigate the rate of GI events and association with osteoporosis medication use patterns, health-related quality of life, treatment satisfaction and resource utilisation among postmenopausal women with osteoporosis. Physicians at 97 sites completed the physician questionnaire and data for 716 patients were abstracted for the retrospective chart review. Enrolment and the baseline data collection for the prospective cohort study were conducted between March 2012 and June 2013 for 292 untreated and 2,959 treated patients, of whom 684 were new users and 2,275 were experienced users of oral osteoporosis medications. The results of MUSIC OS-EU will illuminate the association of GI events with the management of osteoporosis and with patient-reported outcomes among postmenopausal women with osteoporosis in Europe and Canada.

  6. 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.

  7. Rationale and design of the CAPAMIS study: Effectiveness of pneumococcal vaccination against community-acquired pneumonia, acute myocardial infarction and stroke

    Directory of Open Access Journals (Sweden)

    Salsench Elisabet

    2010-01-01

    Full Text Available Abstract Background The 23-valent polysaccharide pneumococcal vaccine (PPV-23 is recommended for elderly and high-risk people, although its effectiveness is controversial. Some studies have reported an increasing risk of acute vascular events among patients with pneumonia, and a recent case-control study has reported a reduction in the risk of myocardial infarction among patients vaccinated with PPV-23. Given that animal experiments have shown that pneumococcal vaccination reduces the extent of atherosclerotic lesions, it has been hypothesized that PPV-23 could protect against acute vascular events by an indirect effect preventing pneumonia or by a direct effect on oxidized low-density lipoproteins. The main objective of this study is to evaluate the clinical effectiveness of PPV-23 in reducing the risk of pneumonia and acute vascular events (related or nonrelated with prior pneumonia in the general population over 60 years. Methods/Design Cohort study including 27,000 individuals 60 years or older assigned to nine Primary Care Centers in the region of Tarragona, Spain. According to the reception of PPV-23 before the start of the study, the study population will be divided into vaccinated and nonvaccinated groups, which will be followed during a consecutive 30-month period. Primary Care and Hospitals discharge databases will initially be used to identify study events (community-acquired pneumonia, hospitalisation for acute myocardial infarction and stroke, but all cases will be further validated by checking clinical records. Multivariable Cox regression analyses estimating hazard ratios (adjusted for age, sex and comorbidities will be used to estimate vaccine effectiveness. Discussion The results of the study will contribute to clarify the controversial effect of the PPV-23 in preventing community-acquired pneumonia and they will be critical in determining the posible role of pneumococcal vaccination in cardiovascular prevention.

  8. Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

    Science.gov (United States)

    Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

    2018-03-01

    Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. 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.

  10. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

    Science.gov (United States)

    Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

    2015-11-01

    Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease

    Directory of Open Access Journals (Sweden)

    Hussain Shazia T

    2012-09-01

    Full Text Available Abstract Background In patients with stable coronary artery disease (CAD, decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR have shown improved event free survival. Cardiovascular magnetic resonance (CMR perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation. Trial design The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1 The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2 The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation at one year. Clinical trials.gov identifier NCT01236807. Conclusion MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.

  12. Fracture strength testing of crowns made of CAD/CAM composite resins.

    Science.gov (United States)

    Okada, Ryota; Asakura, Masaki; Ando, Akihiro; Kumano, Hirokazu; Ban, Seiji; Kawai, Tatsushi; Takebe, Jun

    2018-03-28

    The purpose of this study was to ascertain whether computer aided design/computer aided manufacturing (CAD/CAM) composite resin crowns have sufficient strength to withstand the bite force of the molar teeth. The null hypothesis was that the fracture strength of CAD/CAM composite resin crowns is lower than the average maximum bite force of the molar tooth. The crowns, which shape is the right maxillary first molar, were fabricated using four CAD/CAM blanks made of composite resins (Block HC: HC, KZR-CAD HR: HR, KZR-CAD HR2: HR2, Avencia Block: AVE) and one CAD/CAM blank made of lithium disilicate glass-ceramic (IPS e.max CAD: IPS), which was used as a control. Fracture strength of fabricated crowns bonded to metal abutment and biaxial flexural strength of the materials were evaluated. The results of fracture strength test and biaxial flexural strength test showed different tendencies. The fracture strength of CAD/CAM composite resin crowns except HC ranged from 3.3kN to 3.9kN, and was similar to that of IPS (3.3kN). In contrast, biaxial flexural strength of CAD/CAM composite resins ranged from 175MPa to 247MPa, and was significantly lower than that of IPS (360MPa). All CAD/CAM composite resin crowns studied presented about 3-4 times higher fracture strength than the average maximum bite force of the molar tooth (700-900N), which result leads to the conclusion that CAD/CAM composite resin crowns would have sufficient strength to withstand the bite force of the molar teeth. Copyright © 2017 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  13. Do CAD/CAM dentures really release less monomer than conventional dentures?

    Science.gov (United States)

    Steinmassl, Patricia-Anca; Wiedemair, Verena; Huck, Christian; Klaunzer, Florian; Steinmassl, Otto; Grunert, Ingrid; Dumfahrt, Herbert

    2017-06-01

    Computer-aided design (CAD)/computer-aided manufacturing (CAM) dentures are assumed to have more favourable material properties than conventionally fabricated dentures, among them a lower methacrylate monomer release. The aim of this study was to test this hypothesis. CAD/CAM dentures were generated from ten different master casts by using four different CAD/CAM systems. Conventional, heat-polymerised dentures served as control group. Denture weight and volume were measured; the density was calculated, and the denture surface area was assessed digitally. The monomer release after 7 days of water storage was measured by high-performance liquid chromatography. Whole You Nexteeth and Wieland Digital Dentures had significantly lower mean volume and weight than conventional dentures. Baltic Denture System and Whole You Nexteeth had a significantly increased density. Baltic Denture System had a significantly smaller surface area. None of the CAD/CAM dentures released significantly less monomer than the control group. All tested dentures released very low amounts of methacrylate monomer, but not significantly less than conventional dentures. A statistically significant difference might nevertheless exist in comparison to other, less recommendable denture base materials, such as the frequently used autopolymerising resins. CAD/CAM denture fabrication has numerous advantages. It enables the fabrication of dentures with lower resin volume and lower denture weight. Both could increase the patient comfort. Dentures with higher density might exhibit more favourable mechanical properties. The hypothesis that CAD/CAM dentures release less monomer than conventional dentures could, however, not be verified.

  14. Integration of CAM and CNC operation through code editing and manipulation

    International Nuclear Information System (INIS)

    Rosli Darmawan; Shalina Sheik Muhammad

    2004-01-01

    The IT technology for engineering design and manufacturing has gone through significant advancement for the last 30 years. It is widely acknowledged that IT would provide competitive advantage for engineering company in term of production cycle, productivity and efficiency. The recent development in this area is on the total system integration. While standard off-shelf CAD/CAM/CNC software and hardware packages would provide solution for system integration, more often than not users will stumble upon compatibility problems. Moreover, most of the integration deals with CAD and CAM systems. CNC integration has not been fully developed. Users always found problems in the integration of CAM and CNC machine due to the different level of technological development. CNC codes have not fundamentally progressed in the last 50 years, while CAD/CAM software packages have undergone massive evolution and improvement. This paper discusses a practical solution of CAM and CNC integration through code editing and manipulation within the CAM system in order to comply with the CNC machine requirements. (Author)

  15. Rate of cardiac arrhythmias and silent brain lesions in experienced marathon runners: rationale, design and baseline data of the Berlin Beat of Running study

    Directory of Open Access Journals (Sweden)

    Haeusler Karl

    2012-08-01

    Full Text Available Abstract Background Regular exercise is beneficial for cardiovascular health but a recent meta-analysis indicated a relationship between extensive endurance sport and a higher risk of atrial fibrillation, an independent risk factor for stroke. However, data on the frequency of cardiac arrhythmias or (clinically silent brain lesions during and after marathon running are missing. Methods/ Design In the prospective observational “Berlin Beat of Running” study experienced endurance athletes underwent clinical examination (CE, 3 Tesla brain magnetic resonance imaging (MRI, carotid ultrasound imaging (CUI and serial blood sampling (BS within 2-3 days prior (CE, MRI, CUI, BS, directly after (CE, BS and within 2 days after (CE, MRI, BS the 38th BMW BERLIN-MARATHON 2011. All participants wore a portable electrocardiogram (ECG-recorder throughout the 4 to 5 days baseline study period. Participants with pathological MRI findings after the marathon, troponin elevations or detected cardiac arrhythmias will be asked to undergo cardiac MRI to rule out structural abnormalities. A follow-up is scheduled after one year. Results Here we report the baseline data of the enrolled 110 athletes aged 36-61 years. Their mean age was 48.8 ± 6.0 years, 24.5% were female, 8.2% had hypertension and 2.7% had hyperlipidaemia. Participants have attended a mean of 7.5 ± 6.6 marathon races within the last 5 years and a mean of 16 ± 36 marathon races in total. Their weekly running distance prior to the 38th BMW BERLIN-MARATHON was 65 ± 17 km. Finally, 108 (98.2% Berlin Beat-Study participants successfully completed the 38th BMW BERLIN-MARATHON 2011. Discussion Findings from the “Berlin Beats of Running” study will help to balance the benefits and risks of extensive endurance sport. ECG-recording during the marathon might contribute to identify athletes at risk for cardiovascular events. MRI results will give new insights into the link

  16. Estimation of the optimum dose of vitamin D for disease prevention in older people: rationale, design and baseline characteristics of the BEST-D trial.

    Science.gov (United States)

    Clarke, Robert; Newman, Connie; Tomson, Joseph; Hin, Harold; Kurien, Rijo; Cox, Jolyon; Lay, Michael; Sayer, Jenny; Hill, Michael; Emberson, Jonathan; Armitage, Jane

    2015-04-01

    Previous large trials of vitamin D for prevention of fractures and other disease outcomes have reported conflicting results, possibly because the doses tested were insufficient to maintain optimum blood levels of vitamin D (25[OH]D) predicted by the observational studies. This report describes the design and baseline characteristics of the BEST-D (Biochemical Efficacy and Safety Trial of vitamin D) trial which aims to establish the best dose of vitamin D to assess in a future large outcome trial. The BEST-D trial will compare the biochemical and other effects of daily dietary supplementation with 100 μg or 50 μg vitamin D3 or placebo, when administered for 12 months, in 305 ambulant community-dwelling older people living in Oxfordshire, England. The primary analyses will compare 12-month mean plasma concentrations of 25(OH)D as well as the proportion of participants with a 12-month concentration >90 nmol/L between participants allocated 100 μg and participants allocated 50 μg daily. Secondary analyses will compare the two active doses (both separately and when combined) with placebo. Additional end-points include biochemical assessments of safety, blood pressure, arterial stiffness, falls, fractures, heel and wrist bone density, grip strength and physical performance and echocardiographic assessments of cardiac function in a random sample of participants. About one-third of eligible participants agreed to participate in the trial. The mean age was 72 (SD 6) years with equal numbers of men and women. About one third reported a prior history of fracture or hypertension, one-fifth reported a prior cardiovascular event, and one tenth reported diabetes or a fall in the previous 6 months. The results of this trial will help determine the optimum dose of vitamin D to test in a larger trial investigating whether vitamin D supplementation can reduce the risk of fractures, cardiovascular disease or cancer. Crown Copyright © 2015. Published by Elsevier Ireland Ltd. All

  17. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods.

    Science.gov (United States)

    Gillison, Fiona; Standage, Martyn; Verplanken, Bas

    2014-03-04

    Physical inactivity and a poor diet predict lifestyle diseases such as diabetes, cardiovascular disease, and certain types of cancer. Marked declines in physical activity occur during late adolescence, coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours. The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning. As actively engaging young people in initiatives based on health messages is challenging, we also tested the efficacy of financial incentives in promoting initial engagement with the programme. A three-arm cluster-randomised design was used. Participants were school pupils from Year 11 and 13 (i.e., in their final year of study), aged 16-18 years. To reduce contamination effects, the unit of randomisation was school. Participants were randomly allocated to receive (i) a 12-week behavioural support intervention consisting of six appointments, (ii) a behavioural support intervention plus incentives (totalling £40), or (iii) an information-only control group. Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician. Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process. Consistent with self-determination theory, all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation. The primary outcome was objectively assessed physical activity (via GT1M accelerometers). Secondary outcome measures were diet, motivation and habit strength. Data were collected at baseline, post

  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, Dermot; Russell, Darren; Guy, Rebecca J

    2015-12-10

    Gay and bisexual men (GBM) are a major risk group for HIV acquisition, yet the majority of higher-risk GBM test for HIV less often than recommended (3-6 monthly). HIV self-testing has the potential to increase testing frequency and improve awareness of personal HIV status. HIV self-tests have been approved in some countries, however there are concerns whether self-testing would increase HIV testing frequency enough to compensate for the reduced sensitivity of self-tests in early infection. We describe here a randomised controlled trial to assess the effectiveness of self-testing in increasing HIV testing frequency among higher-risk GBM, and its acceptability. Participants are higher-risk HIV negative GBM (>5 partners or condomless anal intercourse in previous 3 months; n = 350), including 50 GBM who tested for HIV over two years ago or never tested before ('infrequent-testers'). Participants are recruited from sexual health clinics and community-based organisations, and randomised 1:1 to either self-testing or standard-care (routine clinic-based testing) arms. The trial employs a wait-list control design: participants in the standard-care arm switch to self-testing arm in the second year, and gain access to self-test kits. Participants in the self-testing arm receive four oral-fluid self-test kits at enrolment, with additional kits provided on request. Demographics, sexual behaviour and HIV testing preferences are collected at baseline, and the frequency and pattern of HIV and sexually transmissible infection (STI) testing is collected via online 3-monthly questionnaires. The acceptability of self-testing is assessed at 12 months via an online questionnaire and in-depth interviews. A 24-h telephone support is provided, with expedited follow-up of those with reactive self-test results. The primary outcome is HIV testing frequency (mean number of HIV tests per person) over 12 months, and the secondary outcomes are: mean number of STI tests (chlamydia

  19. 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.

  20. Effectiveness and cost-effectiveness of 'BeweegKuur', a combined lifestyle intervention in the Netherlands: Rationale, design and methods of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kremers Stef PJ

    2011-10-01

    Full Text Available Abstract Background Improving the lifestyle of overweight and obese adults is of increasing interest in view of its role in several chronic diseases. Interventions aiming at overweight or weight-related chronic diseases suffer from high drop-out rates. It has been suggested that Motivational Interviewing and more frequent and more patient-specific coaching could decrease the drop-out rate. 'BeweegKuur' is a multidisciplinary lifestyle intervention which offers three programmes for overweight persons. The effectiveness and the cost-effectiveness of intensively guided programmes, such as the 'supervised exercise programme' of 'BeweegKuur', for patients with high weight-related health risk, remain to be assessed. Our randomized controlled trial compares the expenses and effects of the 'supervised exercise programme' with those of the less intensively supervised 'start-up exercise programme'. Methods/Design The one-year intervention period involves coaching by a lifestyle advisor, a physiotherapist and a dietician, coordinated by general practitioners (GPs. The participating GP practices have been allocated to the interventions, which differ only in terms of the amount of coaching offered by the physiotherapist. Whereas the 'start-up exercise programme' includes several consultations with physiotherapists to identify barriers hampering independent exercising, the 'supervised exercise programme' includes more sessions with a physiotherapist, involving exercise under supervision. The main goal is transfer to local exercise facilities. The main outcome of the study will be the participants' physical activity at the end of the one-year intervention period and after one year of follow-up. Secondary outcomes are dietary habits, health risk, physical fitness and functional capacity. The economic evaluation will consist of a cost-effectiveness analysis and a cost-utility analysis. The primary outcome measures for the economic evaluation will be the physical

  1. Psychological risk factors of micro- and macrovascular outcomes in primary care patients with type 2 diabetes: rationale and design of the DiaDDZoB Study

    Directory of Open Access Journals (Sweden)

    Pop Victor JM

    2010-07-01

    Full Text Available Abstract Background Depression is a common psychiatric complication of diabetes, but little is known about the natural course and the consequences of depressive symptoms in primary care patients with type 2 diabetes. While depression has been related to poor glycemic control and increased risk for macrovascular disease, its association with microvascular complications remains understudied. The predictive role of other psychological risk factors such as Type D (distressed personality and the mechanisms that possibly link depression and Type D personality with poor vascular outcomes are also still unclear. Methods/Design This prospective cohort study will examine: (1 the course of depressive symptoms in primary care patients with type 2 diabetes; (2 whether depressive symptoms and Type D personality are associated with the development of microvascular and/or macrovascular complications and with the risk of all-cause or vascular mortality; and (3 the behavioral and physiological mechanisms that may mediate these associations. The DiaDDZoB Study is embedded within the larger DIAZOB Primary Care Diabetes study, which covers a comprehensive cohort of type 2 diabetes patients treated by over 200 primary care physicians in South-East Brabant, The Netherlands. These patients will be followed during their lifetime and are assessed annually for demographic, clinical, lifestyle and psychosocial factors. Measurements include an interviewer-administered and self-report questionnaire, regular care laboratory tests and physical examinations, and pharmacy medication records. The DiaDDZoB Study uses data that have been collected during the original baseline assessment in 2005 (M0; N = 2,460 and the 2007 (M1; N = 2,225 and 2008 (M2; N = 2,032 follow-up assessments. Discussion The DiaDDZoB Study is expected to contribute to the current understanding of the course of depression in primary care patients with type 2 diabetes and will also test whether depressed

  2. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Krüger Matthias

    2011-02-01

    Full Text Available Abstract Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for

  3. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Hall Amanda M

    2009-05-01

    Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

  4. A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design

    Directory of Open Access Journals (Sweden)

    Lambert Sylvie D

    2012-09-01

    Full Text Available Abstract Background Although it is known both patients’ and partners’ reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients’ partners’ reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples’ illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD. Methods/design In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1 Coping-Together or 2 a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping will be assessed at baseline (before receiving study material and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted. Discussion As partners’ distress rates exceed not only population

  5. Three-dimensional mapping of mechanical activation patterns, contractile dyssynchrony and dyscoordination by two-dimensional strain echocardiography: Rationale and design of a novel software toolbox

    Directory of Open Access Journals (Sweden)

    Cramer Maarten J

    2008-05-01

    Full Text Available Abstract Background Dyssynchrony of myocardial deformation is usually described in terms of variability only (e.g. standard deviations SD's. A description in terms of the spatio-temporal distribution pattern (vector-analysis of dyssynchrony or by indices estimating its impact by expressing dyscoordination of shortening in relation to the global ventricular shortening may be preferential. Strain echocardiography by speckle tracking is a new non-invasive, albeit 2-D imaging modality to study myocardial deformation. Methods A post-processing toolbox was designed to incorporate local, speckle tracking-derived deformation data into a 36 segment 3-D model of the left ventricle. Global left ventricular shortening, standard deviations and vectors of timing of shortening were calculated. The impact of dyssynchrony was estimated by comparing the end-systolic values with either early peak values only (early shortening reserve ESR or with all peak values (virtual shortening reserve VSR, and by the internal strain fraction (ISF expressing dyscoordination as the fraction of deformation lost internally due to simultaneous shortening and stretching. These dyssynchrony parameters were compared in 8 volunteers (NL, 8 patients with Wolff-Parkinson-White syndrome (WPW, and 7 patients before (LBBB and after cardiac resynchronization therapy (CRT. Results Dyssynchrony indices merely based on variability failed to detect differences between WPW and NL and failed to demonstrate the effect of CRT. Only the 3-D vector of onset of shortening could distinguish WPW from NL, while at peak shortening and by VSR, ESR and ISF no differences were found. All tested dyssynchrony parameters yielded higher values in LBBB compared to both NL and WPW. CRT reduced the spatial divergence of shortening (both vector magnitude and direction, and improved global ventricular shortening along with reductions in ESR and dyscoordination of shortening expressed by ISF. Conclusion Incorporation

  6. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design.

    Science.gov (United States)

    Denost, Quentin; Saillour, Florence; Masya, Lindy; Martinaud, Helene Maillou; Guillon, Stephanie; Kret, Marion; Rullier, Eric; Quintard, Bruno; Solomon, Michael

    2016-04-04

    Among patients with rectal cancer, 5-10% have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10% recur locally following primary surgery (LRRC). In both cases, patients 'care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients' care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients. The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end points will

  7. Rationale and design for SHAREHD: a quality improvement collaborative to scale up Shared Haemodialysis Care for patients on centre based haemodialysis.

    Science.gov (United States)

    Fotheringham, James; Barnes, Tania; Dunn, Louese; Lee, Sonia; Ariss, Steven; Young, Tracey; Walters, Stephen J; Laboi, Paul; Henwood, Andy; Gair, Rachel; Wilkie, Martin

    2017-11-24

    The study objective is to assess the effectiveness and economic impact of a structured programme to support patient involvement in centre-based haemodialysis and to understand what works for whom in what circumstances and why. It implements a program of Shared Haemodialysis Care (SHC) that aims to improve experience and outcomes for those who are treated with centre-based haemodialysis, and give more patients the confidence to dialyse independently both at centres and at home. The 24 month mixed methods cohort evaluation of 600 prevalent centre based HD patients is nested within a 30 month quality improvement program that aims to scale up SHC at 12 dialysis centres across England. SHC describes an intervention where patients who receive centre-based haemodialysis are given the opportunity to learn, engage with and undertake tasks associated with their treatment. Following a 6-month set up period, a phased implementation programme is initiated across 12 dialysis units using a randomised stepped wedge design with 6 centres participating in each of 2 steps, each lasting 6 months. The intervention utilises quality improvement methodologies involving rapid tests of change to determine the most appropriate mechanisms for implementation in the context of a learning collaborative. Running parallel with the stepped wedge intervention is a mixed methods cohort evaluation that employs patient questionnaires and interviews, and will link with routinely collected data at the end of the study period. The primary outcome measure is the number of patients performing at least 5 dialysis-related tasks collected using 3 monthly questionnaires. Secondary outcomes measures include: the number of people choosing to perform home haemodialysis or dialyse independently in-centre by the end of the study period; end-user recommendation; home dialysis establishment delay; staff impact and confidence; hospitalisation; infection and health economics. The results from this study will provide

  8. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design

    International Nuclear Information System (INIS)

    Denost, Quentin; Saillour, Florence; Masya, Lindy; Martinaud, Helene Maillou; Guillon, Stephanie; Kret, Marion; Rullier, Eric; Quintard, Bruno; Solomon, Michael

    2016-01-01

    Among patients with rectal cancer, 5–10 % have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10 % recur locally following primary surgery (LRRC). In both cases, patients ‘care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients’ care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients. The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end

  9. 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

    International Nuclear Information System (INIS)

    Thorsen, Lene; Nilsen, Tormod S; Raastad, Truls; Courneya, Kerry S; Skovlund, Eva; Fosså, Sophie D

    2012-01-01

    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. 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 are measured on muscle cross sections and

  10. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

    Directory of Open Access Journals (Sweden)

    Puig-Ribera Anna

    2009-01-01

    Full Text Available Abstract Background Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care. Method and design Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ, self-employed and from 9 Primary Healthcare Centres (PHC. They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session. Participants from each PHC will be randomly allocated to an intervention (IG and control group (CG. The following parameters will be assessed pre and post intervention in both groups: (1 health-related quality of life (SF-12, (2 physical activity stage of change (Prochaska's stages of change, (3 level of physical activity (IPAQ-short version, (4 change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA, (5 level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS, and (6 control based on analysis (HDL, LDL and glycated haemoglobin. Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages

  11. 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.

  12. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study: rationales and study design

    Directory of Open Access Journals (Sweden)

    Liu Li

    2012-09-01

    that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis. Trial registration Current Controlled Trials NCT01509937

  13. The Alberta population-based prospective evaluation of the quality of life outcomes and economic impact of bariatric surgery (APPLES study: background, design and rationale

    Directory of Open Access Journals (Sweden)

    McCargar Linda

    2010-10-01

    Full Text Available Abstract Background Extreme obesity affects nearly 8% of Canadians, and is debilitating, costly and ultimately lethal. Bariatric surgery is currently the most effective treatment available; is associated with reductions in morbidity/mortality, improvements in quality of life; and appears cost-effective. However, current demand for surgery in Canada outstrips capacity by at least 1000-fold, causing exponential increases in already protracted, multi-year wait-times. The objectives and hypotheses of this study were as follows: 1. To serially assess the clinical, economic and humanistic outcomes in patients wait-listed for bariatric care over a 2-year period. We hypothesize deterioration in these outcomes over time; 2. To determine the clinical effectiveness and changes in quality of life associated with modern bariatric procedures compared with medically treated and wait-listed controls over 2 years. We hypothesize that surgery will markedly reduce weight, decrease the need for unplanned medical care, and increase quality of life; 3. To conduct a 3-year (1 year retrospective and 2 year prospective economic assessment of bariatric surgery compared to medical and wait-listed controls from the societal, public payor, and health-care payor perspectives. We hypothesize that lower indirect, out of pocket and productivity costs will offset increased direct health-care costs resulting in lower total costs for bariatric surgery. Methods/design Population-based prospective cohort study of 500 consecutive, consenting adults, including 150 surgically treated patients, 200 medically treated patients and 150 wait-listed patients. Subjects will be enrolled from the Edmonton Weight Wise Regional Obesity Program (Edmonton, Alberta, Canada, with prospective bi-annual follow-up for 2 years. Mixed methods data collection, linking primary data to provincial administrative databases will be employed. Major outcomes include generic, obesity-specific and preference

  14. A cluster-randomized, controlled trial of nutritional supplementation and promotion of responsive parenting in Madagascar: the MAHAY study design and rationale

    Directory of Open Access Journals (Sweden)

    Lia C. H. Fernald

    2016-06-01

    Full Text Available Abstract Background Over half of the world’s children suffer from poor nutrition, and as a consequence they experience delays in physical and mental health, and cognitive development. There is little data evaluating the effects of delivery of lipid-based, nutrition supplementation on growth and development during pregnancy and early childhood within the context of a scaled-up program. Furthermore, there is limited evidence on effects of scaled-up, home-visiting programs that focus on the promotion of child development within the context of an existing, national nutrition program. Methods/Design The MAHAY ("smart" in Malagasy study uses a multi-arm randomized-controlled trial (RCT to test the effects and cost-effectiveness of combined interventions to address chronic malnutrition and poor child development. The arms of the trial are: (T0 existing program with monthly growth monitoring and nutritional/hygiene education; (T1 is T0 + home visits for intensive nutrition counseling within a behavior change framework; (T2 is T1 + lipid-based supplementation (LNS for children 6–18 months old; (T3 is T2 + LNS supplementation of pregnant/lactating women; and (T4 is T1 + intensive home visiting program to support child development. There are anticipated to be n = 25 communities in each arm (n = 1250 pregnant women, n = 1250 children 0–6 months old, and n = 1250 children 6–18 months old. Primary outcomes include growth (length/height-for-age z-scores and child development (mental, motor and social development. Secondary outcomes include care-giver reported child morbidity, household food security and diet diversity, micro-nutrient status, maternal knowledge of child care and feeding practices, and home stimulation practices. We will estimate unadjusted and adjusted intention-to-treat effects. Study protocols have been reviewed and approved by the Malagasy Ethics Committee at the Ministry of Health in Madagascar and by

  15. Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the diagest 3-GP motivation study

    Directory of Open Access Journals (Sweden)

    Berkhout Christophe

    2012-06-01

    explores issues in primary care, its design must anticipate GP participation early in the trial. Based on our questionnaire response rates, we found that one in two GPs were willing to participate in our hospital-led study, regardless of their initial attitudes.

  16. Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the Diagest 3-GP motivation study.

    Science.gov (United States)

    Berkhout, Christophe; Vandaele-Bétancourt, Marie; Robert, Stéphane; Lespinasse, Solène; Mitha, Gamil; Bradier, Quentin; Vambergue, Anne; Fontaine, Pierre

    2012-06-21

    Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3 years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs) were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs' attitudes towards hospital-based studies, and to develop strategies to enhance their involvement and reduce subject drop-out rates. We used a three-step process: step one used a phenomenological approach exploring the beliefs, attitudes, motivations and environmental factors contributing to the GPs' level of interest in the study. Data were collected in face-to-face interviews and coded by hand and with hermeneutic software to develop distinct GP profiles. Step two was a cross-sectional survey by questionnaire to determine the distribution of the profiles in the GP study population and whether completion of an attached case report form (CRF) was associated with a particular GP profile. In step three, we assessed the impact of the motivation study on participation rates in the main study. Fifteen interviews were conducted to achieve data saturation. Theorisation led to the definition of 4 distinct GP profiles. The response rate to the questionnaire was 73%, but dropped to 52% when a CRF was attached. The link between GP profiles and the rate of CRF completion remains to be verified. The GPs provided data on the CRF that was of comparable quality to those collected in the main trial. Our analysis showed that the motivation study increased overall participation in the main study by 23%, accounting for 16% (24/152) of all final visits for 536 patients who were initially enrolled in the Diagest 3 study. When a hospital-led study explores issues in primary care, its design must anticipate GP

  17. Comparison of denture tooth movement between CAD-CAM and conventional fabrication techniques.

    Science.gov (United States)

    Goodacre, Brian J; Goodacre, Charles J; Baba, Nadim Z; Kattadiyil, Mathew T

    2018-01-01

    Data comparing the denture tooth movement of computer-aided design and computer-aided manufacturing (CAD-CAM) and conventional denture processing techniques are lacking. The purpose of this in vitro study was to compare the denture tooth movement of pack-and-press, fluid resin, injection, CAD-CAM-bonded, and CAD-CAM monolithic techniques for fabricating dentures to determine which process produces the most accurate and reproducible prosthesis. A total of 50 dentures were evaluated, 10 for each of the 5 groups. A master denture was fabricated and milled from prepolymerized poly(methyl methacrylate). For the conventional processing techniques (pack-and-press, fluid resin, and injection) a polyvinyl siloxane putty mold of the master denture was made in which denture teeth were placed and molten wax injected. The cameo surface of each wax-festooned denture was laser scanned, resulting in a standard tessellation language (STL) format file. The CAD-CAM dentures included 2 subgroups: CAD-CAM-bonded teeth in which the denture teeth were bonded into the milled denture base and CAD-CAM monolithic teeth in which the denture teeth were milled as part of the denture base. After all specimens had been fabricated, they were hydrated for 24 hours, and the cameo surface laser scanned. The preprocessing and postprocessing scan files of each denture were superimposed using surface-matching software. Measurements were made at 64 locations, allowing evaluation of denture tooth movement in a buccal, lingual, mesial-distal, and occlusal direction. The use of median and interquartile range values was used to assess accuracy and reproducibility. Levene and Kruskal-Wallis analyses of variance were used to evaluate differences between processing techniques (α=.05). The CAD-CAM monolithic technique was the most accurate, followed by fluid resin, CAD-CAM-bonded, pack-and-press, and injection. CAD-CAM monolithic technique was the most reproducible, followed by pack-and-press, CAD-CAM

  18. 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.

  19. Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

    Science.gov (United States)

    Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

    2015-01-01

    Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

  20. 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.

  1. Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.

    Science.gov (United States)

    Winer, Rachel L; Tiro, Jasmin A; Miglioretti, Diana L; Thayer, Chris; Beatty, Tara; Lin, John; Gao, Hongyuan; Kimbel, Kilian; Buist, Diana S M

    2018-01-01

    Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Rationales for Commonly "Challenged" Taught Books.

    Science.gov (United States)

    Shugert, Diane P., Ed.; And Others

    1983-01-01

    Intended for teachers, this focused journal issue contains separate rationales for teaching books that have been challenged as appropriate instructional materials. Following a discussion of the purpose for rationales and suggestions for using them, the journal presents rationales for teaching the following books: "To Kill a Mockingbird,""The Diary…

  3. Design and rationale for the PREVAIL study

    DEFF Research Database (Denmark)

    Klausen, Susanne Hwiid; Mikkelsen, Ulla Ramer; Hirth, Asle

    2012-01-01

    to participate in physical activity are in the process of being enrolled by invitation after informed consent. Physical fitness is measured as the maximal oxygen uptake (Vo(2)) at baseline and after 12 months by an assessor blinded to the randomization group. After baseline testing, the patients are 1......:1 randomized to an intervention group or a control group. Individually fully automated tailored e-Health encouragements--SMS, Internet, and mobile applications--aimed at increasing physical activity are delivered to the participants in the intervention group once a week. The Bandura's Social Cognitive Theory...

  4. Rationale and Design of the 'MITOCARE' Study

    DEFF Research Database (Denmark)

    Clemmensen, Peter

    2012-01-01

    resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better...

  5. Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial.

    Science.gov (United States)

    Lechtzin, N; West, N; Allgood, S; Wilhelm, E; Khan, U; Mayer-Hamblett, N; Aitken, M L; Ramsey, B W; Boyle, M P; Mogayzel, P J; Goss, C H

    2013-11-01

    Acute pulmonary exacerbations are central events in the lives of individuals with cystic fibrosis (CF). Pulmonary exacerbations lead to impaired lung function, worse quality of life, and shorter survival. We hypothesized that aggressive early treatment of acute pulmonary exacerbation may improve clinical outcomes. Describe the rationale of an ongoing trial designed to determine the efficacy of home monitoring of both lung function measurements and symptoms for early detection and subsequent early treatment of acute CF pulmonary exacerbations. A randomized, non-blinded, multi-center trial in 320 individuals with CF aged 14 years and older. The study compares usual care to a twice a week assessment of home spirometry and CF respiratory symptoms using an electronic device with data transmission to the research personnel to identify and trigger early treatment of CF pulmonary exacerbation. Participants will be enrolled in the study for 12 months. The primary endpoint is change in FEV1 (L) from baseline to 12 months determined by a linear mixed effects model incorporating all quarterly FEV1 measurements. Secondary endpoints include time to first acute protocol-defined pulmonary exacerbation, number of acute pulmonary exacerbations, number of hospitalization days for acute pulmonary exacerbation, time from the end of acute pulmonary exacerbation to onset of subsequent pulmonary exacerbation, change in health related quality of life, change in treatment burden, change in CF respiratory symptoms, and adherence to the study protocol. This study is a first step in establishing alternative approaches to the care of CF pulmonary exacerbations. We hypothesize that early treatment of pulmonary exacerbations has the potential to slow lung function decline, reduce respiratory symptoms and improve the quality of life for individuals with CF. © 2013.

  6. Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669).

    Science.gov (United States)

    Bishop, Annette; Wynne-Jones, Gwenllian; Lawton, Sarah A; van der Windt, Danielle; Main, Chris; Sowden, Gail; Burton, A Kim; Lewis, Martyn; Jowett, Sue; Sanders, Tom; Hay, Elaine M; Foster, Nadine E

    2014-07-10

    Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. Current Controlled Trials ISRCTN52269669.

  7. Rationale, design, and baseline findings from HIPP: A randomized controlled trial testing a home-based, individually-tailored physical activity print intervention for African American women in the Deep South.

    Science.gov (United States)

    Pekmezi, Dori; Ainsworth, Cole; Joseph, Rodney; Bray, Molly S; Kvale, Elizabeth; Isaac, Shiney; Desmond, Renee; Meneses, Karen; Marcus, Bess; Demark-Wahnefried, Wendy

    2016-03-01

    African American women report high rates of physical inactivity and related health disparities. In our previous formative research, we conducted a series of qualitative assessments to examine physical activity barriers and intervention preferences among African American women in the Deep South. These data were used to inform a 12-month Home-based, Individually-tailored Physical activity Print (HIPP) intervention, which is currently being evaluated against a wellness contact control condition among 84 post-menopausal African American women residing in the metropolitan area of Birmingham, Alabama. This paper reports the rationale, design and baseline findings of the HIPP trial. The accrued participants had an average age of 57 (SD=4.7), a BMI of 32.1 kg/m(2) (SD=5.16) with more than half (55%) having a college education and an annual household income under $50,000 (53.6%). At baseline, participants reported an average of 41.5 min/week (SD=49.7) of moderate intensity physical activity, and 94.1% were in the contemplation or preparation stages of readiness for physical activity. While social support for exercise from friends and family was low, baseline levels of self-efficacy, cognitive and behavioral processes of change, decisional balance, outcome expectations, and enjoyment appeared promising. Baseline data indicated high rates of obesity and low levels of physical activity, providing strong evidence of need for intervention. Moreover, scores on psychosocial measures suggested that such efforts may be well received. This line of research in technology-based approaches for promoting physical activity in African American women in the Deep South has great potential to address health disparities and impact public health. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Characterization of SynCAM surface trafficking using a SynCAM derived ligand with high homophilic binding affinity

    International Nuclear Information System (INIS)

    Breillat, Christelle; Thoumine, Olivier; Choquet, Daniel

    2007-01-01

    In order to better probe SynCAM function in neurons, we produced a fusion protein between the extracellular domain of SynCAM1 and the constant fragment of human IgG (SynCAM-Fc). Whether in soluble form or immobilized on latex microspheres, the chimera bound specifically to the surface of hippocampal neurons and recruited endogenous SynCAM molecules. SynCAM-Fc was also used in combination with Quantum Dots to follow the mobility of transfected SynCAM receptors at the neuronal surface. Both immobile and highly mobile SynCAM were found. Thus, SynCAM-Fc behaves as a high affinity ligand that can be used to study the function of SynCAM at the neuronal membrane

  9. Blood irradiation: Rationale and technique

    International Nuclear Information System (INIS)

    Lewis, M.C.

    1990-01-01

    Upon request by the local American Red Cross, the Savannah Regional Center for Cancer Care irradiates whole blood or blood components to prevent post-transfusion graft-versus-host reaction in patients who have severely depressed immune systems. The rationale for blood irradiation, the total absorbed dose, the type of patients who require irradiated blood, and the regulations that apply to irradiated blood are presented. A method of irradiating blood using a linear accelerator is described

  10. Advances in computer-aided engineering : CAD/CAM-research at Delft University of Technology. Report of the VF-project CAD/CAM 1989-1994

    NARCIS (Netherlands)

    Undetermined, U.

    1994-01-01

    This book contains a collection of articles describing on-going CAD/CAM-research at several engineering faculties at Delft University of Technology. Two main themes covered in this book are 'Conceptual design of complex products' and 'Product modelling and product data exchange'.

  11. Rationale of Early Adopters of Fossil Fuel Divestment

    Science.gov (United States)

    Beer, Christopher Todd

    2016-01-01

    Purpose: This research uses the social science perspectives of institutions, ecological modernization and social movements to analyze the rationale used by the early-adopting universities of fossil fuel divestment in the USA. Design/methodology/approach: Through analysis of qualitative data from interviews with key actors at the universities that…

  12. Oral Health Promotion in Schools: Rationale and Evaluation

    Science.gov (United States)

    Kizito, Alex; Caitlin, Meredith; Wang, Yili; Kasangaki, Arabat; Macnab, Andrew J.

    2014-01-01

    Purpose: The purpose of this paper is to explain the rationale and potential for the WHO health promoting schools (HPS) to improve children's oral health, and describe validated quantitative methodologies and qualitative approaches to measure program impact. Design/Methodology/Approach: Critical discussion of the impact of poor oral health and…

  13. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Glastonbury Briony

    2008-08-01

    Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

  14. Effectiveness of CAM therapy: understanding the evidence.

    Science.gov (United States)

    Staud, Roland

    2011-02-01

    By definition, complementary and alternative medicine (CAM) attempts to diagnose and treat illnesses in unconventional ways. CAM has been classified as: (1) alternative medical systems (eg, traditional Chinese medicine [including acupuncture], naturopathic medicine, ayurvedic medicine, and homeopathy); (2) biologic-based therapies (eg, herbal, special dietary, and individual biologic treatments); (3) energy therapies (eg, Reiki, therapeutic touch, magnet therapy, Qi Gong, and intercessory prayer); (4) manipulative and body-based systems (eg, chiropractic, osteopathy, and massage); and (5) mind-body interventions (eg, meditation, biofeedback, hypnotherapy, and the relaxation response). This review focuses on how to assess the effectiveness of CAM therapies for chronic musculoskeletal pains, emphasizing the role of specific and nonspecific analgesic mechanisms, including placebo. Copyright © 2011 Elsevier Inc. All rights reserved.

  15. Status of the NectarCAM camera project

    International Nuclear Information System (INIS)

    Glicenstein, J.F.; Delagnes, E.; Fesquet, M.; Louis, F.; Moudden, Y.; Moulin, E.; Nunio, F.; Sizun, P.

    2014-01-01

    NectarCAM is a camera designed for the medium-sized telescopes of the Cherenkov Telescope Array (CTA) covering the central energy range 100 GeV to 30 TeV. It has a modular design based on the NECTAr chip, at the heart of which is a GHz sampling Switched Capacitor Array and 12-bit Analog to Digital converter. The camera will be equipped with 265 7-photomultiplier modules, covering a field of view of 7 to 8 degrees. Each module includes the photomultiplier bases, High Voltage supply, pre-amplifier, trigger, readout and Thernet transceiver. Events recorded last between a few nanoseconds and tens of nanoseconds. A flexible trigger scheme allows to read out very long events. NectarCAM can sustain a data rate of 10 kHz. The camera concept, the design and tests of the various sub-components and results of thermal and electrical prototypes are presented. The design includes the mechanical structure, the cooling of electronics, read-out, clock distribution, slow control, data-acquisition, trigger, monitoring and services. A 133-pixel prototype with full scale mechanics, cooling, data acquisition and slow control will be built at the end of 2014. (authors)

  16. PreCam: A Precursor Observational Campaign for Calibration of the Dark Energy Survey

    Energy Technology Data Exchange (ETDEWEB)

    Kuehn, K.; Kuhlmann, S.; Allam, S.; Annis, J. T.; Bailey, T.; Balbinot, E.; Bernstein, J. P.; Biesiadzinski, T.; Burke, D. L.; Butner, M.; Camargo, J. I. B.; da Costa, L. A. N.; DePoy, D.; Diehl, H. T.; Dietrich, J. P.; Estrada, J.; Fausti, A.; Gerke, B.; Guarino, V.; Head, H. H.; Kessler, R.; Lin, H.; Lorenzon, W.; Maia, M. A. G.; Maki, L.; Marshall, J.; Nord, B.; Neilsen, E.; Ogando, R. L. C.; Park, D.; Peoples, J.; Rastawicki, D.; Rheault, J. -P.; Santiago, B.; Schubnell, M.; Seitzer, P.; Smith, J. A.; Spinka, H.; Sypniewski, A.; Tarle, G.; Tucker, D. L.; Walker, A. R.; Wester, W.

    2013-04-01

    PreCam, a precursor observational campaign supporting the Dark Energy Survey (DES), is designed to produce a photometric and astrometric catalog of nearly a hundred thousand standard stars within the DES footprint, while the PreCam instrument also serves as a prototype testbed for the Dark Energy Camera's hardware and software. This catalog represents a potential 100-fold increase in Southern Hemisphere photometric standard stars, and therefore will be an important component in the calibration of the Dark Energy Survey. We provide details on the PreCam instrument's design, construction, and testing, as well as results from a subset of the 51 nights of PreCam survey observations on the University of Michigan Department of Astronomy's Curtis-Schmidt telescope at Cerro Tololo Inter-American Observatory (CTIO). We briefly describe the preliminary data processing pipeline that has been developed for PreCam data and the preliminary results of the instrument performance, as well as astrometry and photometry of a sample of stars previously included in other southern sky surveys.

  17. Paper-Less CAD/CAM For Accelerator Components

    International Nuclear Information System (INIS)

    Franks, R M; Alford, O; Bertolini, L R

    2001-01-01

    Computer-aided design and manufacture (CAD/CAM) have enabled advances in the design and manufacture of many accelerator components, though government procurement rules tend to inhibit its use. We developed and executed a method that provides adequate documentation for the procurement process, industrial vendor manufacturing processes, and laboratory installation activities. We detail our experiences in the design and manufacture of 60 separate and unique PEP-II Low Energy Ring Interaction Region vacuum chambers totaling ∼ 140m in length as an example of how we used this technique, reducing design effort and manufacturing risk while streamlining the production process. We provide ''lessons learned'' to better implement and execute the process in subsequent iterations. We present our study to determine the estimated savings in the design and production of the Spallation Neutron Source room temperature linac if this process were utilized

  18. Educational Rationale Metadata for Learning Objects

    Directory of Open Access Journals (Sweden)

    Tom Carey

    2002-10-01

    Full Text Available Instructors searching for learning objects in online repositories will be guided in their choices by the content of the object, the characteristics of the learners addressed, and the learning process embodied in the object. We report here on a feasibility study for metadata to record process-oriented information about instructional approaches for learning objects, though a set of Educational Rationale [ER] tags which would allow authors to describe the critical elements in their design intent. The prototype ER tags describe activities which have been demonstrated to be of value in learning, and authors select the activities whose support was critical in their design decisions. The prototype ER tag set consists descriptors of the instructional approach used in the design, plus optional sub-elements for Comments, Importance and Features which implement the design intent. The tag set was tested by creators of four learning object modules, three intended for post-secondary learners and one for K-12 students and their families. In each case the creators reported that the ER tag set allowed them to express succinctly the key instructional approaches embedded in their designs. These results confirmed the overall feasibility of the ER tag approach as a means of capturing design intent from creators of learning objects. Much work remains to be done before a usable ER tag set could be specified, including evaluating the impact of ER tags during design to improve instructional quality of learning objects.

  19. The 'Walking for Wellbeing in the West' randomised controlled trial of a pedometer-based walking programme in combination with physical activity consultation with 12 month follow-up: rationale and study design

    Directory of Open Access Journals (Sweden)

    Ogilvie David

    2008-07-01

    Full Text Available Abstract Background Scotland has a policy aimed at increasing physical activity levels in the population, but evidence on how to achieve this is still developing. Studies that focus on encouraging real world participants to start physical activity in their settings are needed. The Walking for Well-being in the West study was designed to assess the effectiveness of a pedometer-based walking programme in combination with physical activity consultation. The study was multi-disciplinary and based in the community. Walking for Well-being in the West investigated whether Scottish men and women, who were not achieving the current physical activity recommendation, increased and maintained walking behaviour over a 12 month period. This paper outlines the rationale and design of this innovative and pragmatic study. Methods Participants were randomised into two groups: Group 1: Intervention (pedometer-based walking programme combined with a series of physical activity consultations; Group 2: Waiting list control for 12 weeks (followed by minimal pedometer-based intervention. Physical activity (primary outcome was measured using pedometer step counts (7 day and the International Physical Activity Questionnaire (long version. Psychological processes were measured using questionnaires relating to the Transtheoretical Model of Behaviour Change, mood (Positive and Negative Affect Schedule and quality of life (Euroqol EQ-5D instrument. Physiological measures included anthropometric and metabolic outcomes. Environmental influences were assessed subjectively (Neighbourhood Quality of Life Survey and objectively (neighbourhood audit tool and GIS mapping. The qualitative evaluation employed observation, semi-structured interviews and focus groups. A supplementary study undertook an economic evaluation. Discussion Data analysis is on-going. Walking for Well-being in the West will demonstrate if a pedometer based walking programme, in combination with physical

  20. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting - rationale, design and baseline characteristics.

    Science.gov (United States)

    Laurence, Caroline; Gialamas, Angela; Yelland, Lisa; Bubner, Tanya; Ryan, Philip; Willson, Kristyn; Glastonbury, Briony; Gill, Janice; Shephard, Mark; Beilby, Justin

    2008-08-06

    Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT. The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding

  1. Zambian Peer Educators for HIV Self-Testing (ZEST) study: rationale and design of a cluster randomised trial of HIV self-testing among female sex workers in Zambia.

    Science.gov (United States)

    Oldenburg, Catherine E; Ortblad, Katrina F; Chanda, Michael M; Mwanda, Kalasa; Nicodemus, Wendy; Sikaundi, Rebecca; Fullem, Andrew; Barresi, Leah G; Harling, Guy; Bärnighausen, Till

    2017-04-20

    HIV testing and knowledge of status are starting points for HIV treatment and prevention interventions. Among female sex workers (FSWs), HIV testing and status knowledge remain far from universal. HIV self-testing (HIVST) is an alternative to existing testing services for FSWs, but little evidence exists how it can be effectively and safely implemented. Here, we describe the rationale and design of a cluster randomised trial designed to inform implementation and scale-up of HIVST programmes for FSWs in Zambia. The Zambian Peer Educators for HIV Self-Testing (ZEST) study is a 3-arm cluster randomised trial taking place in 3 towns in Zambia. Participants (N=900) are eligible if they are women who have exchanged sex for money or goods in the previous 1 month, are HIV negative or status unknown, have not tested for HIV in the previous 3 months, and are at least 18 years old. Participants are recruited by peer educators working in their communities. Participants are randomised to 1 of 3 arms: (1) direct distribution (in which they receive an HIVST from the peer educator directly); (2) fixed distribution (in which they receive a coupon with which to collect the HIVST from a drug store or health post) or (3) standard of care (referral to existing HIV testing services only, without any offer of HIVST). Participants are followed at 1 and 4 months following distribution of the first HIVST. The primary end point is HIV testing in the past month measured at the 1-month and 4-month visits. This study was approved by the Institutional Review Boards at the Harvard T.H. Chan School of Public Health in Boston, USA and ERES Converge in Lusaka, Zambia. The findings of this trial will be presented at local, regional and international meetings and submitted to peer-reviewed journals for publication. Pre-results; NCT02827240. 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. Comparison of Flexural Strength of Different CAD/CAM PMMA-Based Polymers.

    Science.gov (United States)

    Alp, Gülce; Murat, Sema; Yilmaz, Burak

    2018-01-28

    To compare the flexural strength of different computer-aided design/computer-aided manufacturing (CAD/CAM) poly(methyl methacrylate)-based (PMMA) polymers and conventional interim resin materials after thermocycling. Rectangular-shaped specimens (n = 15, for each material) (25 × 2 × 2 mm 3 ) were fabricated from 3 CAD/CAM PMMA-based polymers (Telio CAD [T]; M-PM-Disc [M]; Polident-PMMA [P]), 1 bis-acrylate composite resin (Protemp 4 [PT]), and 1 conventional PMMA (ArtConcept Artegral Dentine [C]) according to ISO 10477:2004 Standards (Dentistry-Polymer-Based Crown and Bridge Materials). The specimens were subjected to 10,000 thermocycles (5 to 55°C). Three-point flexural strength of the specimens was tested in a universal testing machine at a 1.0 mm/min crosshead speed, and the flexural strength data (σ) were calculated (MPa). The flexural strength values were statistically analyzed using 1-way ANOVA, and Tukey HSD post-hoc test for multiple comparisons (α = 0.05). Flexural strength values ranged between 66.1 ± 13.1 and 131.9 ± 19.8 MPa. There were significant differences among the flexural strengths of tested materials, except for between T and P CAD/CAM PMMA-based polymers (p > 0.05). CAD/CAM PMMA-based polymer M had the highest flexural strength and conventional PMMA had the lowest (p CAD/CAM PMMA-based T and P polymers had significantly higher flexural strength than the bis-acrylate composite resin (p CAD/CAM PMMA-based M (p CAD/CAM PMMA-based polymers was greater than the flexural strength of bis-acrylate composite resin, which had a greater flexural strength compared to conventional PMMA resin. © 2018 by the American College of Prosthodontists.

  3. Modified FlowCAM procedure for quantifying size distribution of zooplankton with sample recycling capacity.

    Directory of Open Access Journals (Sweden)

    Esther Wong

    Full Text Available We have developed a modified FlowCAM procedure for efficiently quantifying the size distribution of zooplankton. The modified method offers the following new features: 1 prevents animals from settling and clogging with constant bubbling in the sample container; 2 prevents damage to sample animals and facilitates recycling by replacing the built-in peristaltic pump with an external syringe pump, in order to generate negative pressure, creates a steady flow by drawing air from the receiving conical flask (i.e. vacuum pump, and transfers plankton from the sample container toward the main flowcell of the imaging system and finally into the receiving flask; 3 aligns samples in advance of imaging and prevents clogging with an additional flowcell placed ahead of the main flowcell. These modifications were designed to overcome the difficulties applying the standard FlowCAM procedure to studies where the number of individuals per sample is small, and since the FlowCAM can only image a subset of a sample. Our effective recycling procedure allows users to pass the same sample through the FlowCAM many times (i.e. bootstrapping the sample in order to generate a good size distribution. Although more advanced FlowCAM models are equipped with syringe pump and Field of View (FOV flowcells which can image all particles passing through the flow field; we note that these advanced setups are very expensive, offer limited syringe and flowcell sizes, and do not guarantee recycling. In contrast, our modifications are inexpensive and flexible. Finally, we compared the biovolumes estimated by automated FlowCAM image analysis versus conventional manual measurements, and found that the size of an individual zooplankter can be estimated by the FlowCAM image system after ground truthing.

  4. Information management and complementary alternative medicine: the anatomy of information about CAMs through PubMed.

    Science.gov (United States)

    Corrao, Salvatore; Argano, Christiano; Colomba, Daniela; Ippolito, Calogero; Gargano, Vincenzo; Arcoraci, Vincenzo; Licata, Giuseppe

    2013-10-01

    In recent years, there has been a growing interest about complementary and alternative medicine (CAM), and the use of CAM interventions has become more common among people. For these reasons, health professionals must be able to effectively manage information in this field of knowledge according to an evidence-based point of view. This study assessed the anatomy of the available information about CAMs using PubMed, to give practical instructions to manage information in this field. We also analyzed the anatomy of information according to each alternative medicine branch, narrow and broad search methods, subset filters for indexed-for-Medline and non-indexed citations, and different publication types including randomized controlled trials (RCTs) and meta-analyses. Our results demonstrated that the use of CAMs subset (supplied by PubMed search engine) leads to a great number of citations determining an information overload. Our data reveal that it would be more useful to search for the CAM separately, identifying specific items and study design. Moreover, we found the largest number of randomized clinical trials and meta-analyses related to herbal medicine and acupuncture, neither RCTs nor meta-analyses were available for bach and flower remedies, auriculoacupuncture, iridology, and pranotherapy. For the first time, our study gives a comprehensive view of the anatomy of information regarding CAMs and each branch of them. We suggest a methodological approach to face with searching information about this emerging issue from an evidence-based point of view. Finally, our data pointed out some "grey zones" since neither RCTs nor meta-analyses were available for some CAMs.

  5. Patients’ views of CAM as spiritual practice

    DEFF Research Database (Denmark)

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

    2011-01-01

    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...

  6. performance characteristics of a cam turning attachment

    African Journals Online (AJOL)

    Dr Obe

    ABSTRACT. A modification of a cylindrical turning unit has been done to give a non- cylindrical turning attachment for production of irregular shapes, like cams on the lathe machine. To assess the performance of the attachment, cutting forces have been measured using a 'Sigma' Cutting Tool. Dynamometer. Furthermore ...

  7. [Tailored cranioplasty using CAD-CAM technology].

    Science.gov (United States)

    Vitanovics, Dusán; Major, Ottó; Lovas, László; Banczerowski, Péter

    2014-11-30

    The majority of cranial defects are results of surgical intervention. The defect must be covered within resonable period of time usually after 4-6 week given the fact that the replacement of bone improve the brain circulation. Number of surgical techniques and materials are available to perform cranioplasty. Due to favorable properties we chosed ultra high molecular weight polyethylene as material. In this paper the authors show a procedure which allows tailored artificial bone replacement using state of art medical and engineering techniques. between 2004 and 2012, 19 patients were operated on cranial bone defect and a total of 22 3D custom-designed implants were implanted. The average age of patients was 35.4 years. In 12 patients we performed primary cranioplasty, while seven patients had the replacement at least once. Later the implants had to be removed due to infection or other causes (bone necrosis, fracture). All patients had native and bone-windowed 1 mm resolution CT. The 3D design was made using the original CT images and with design program. Computer controlled lathe was used to prepare a precise-fitting model. During surgery, the defect was exposed and the implant was fixed to normal bone using mini titanium plates and screws. All of our patients had control CT at 3, 6 and 12 months after surgery and at the same time neurological examination. Twenty-one polyethylene and one titanium implants were inserted. The average follow-up of the patients was 21.5 months, ranged from two to 96 months. We follow 12 patients (63.15%) more than one year. No intraoperative implant modifications had to be made. Each of the 22 implant exactly matched the bone defect proved by CT scan. No one of our patients reported aesthetic problems and we did not notice any kind of aesthetic complication. We had short term complication in three cases due to cranioplasty, subdural, epidural haemorrhage and skin defect. Polyethylene is in all respects suitable for primary and secondary

  8. Physics rationale for the engineering specifications for ZTH

    International Nuclear Information System (INIS)

    Dimarco, J.N.

    1987-01-01

    This report presents the physics rationale that established the engineering design of ZTH. The physics criteria are given and the implications regarding the engineering design are presented. Experimental and theoretical background evidence is given in support of the criteria but the justification is left to other reports and peer reviews. The physics criteria discussed here are limited to the ones deemed to be of highest engineering priority. 32 refs., 9 figs

  9. Complementary and alternative medicine use of women with breast cancer : Self-help CAM attracts other women than guided CAM therapies

    NARCIS (Netherlands)

    Lo-Fo-Wong, Deborah N. N.; Ranchor, Adelita V.; de Haes, Hanneke C. J. M.; Sprangers, Mirjam A. G.; Henselmans, Inge

    2012-01-01

    Objective: Examine stability of use of complementary and alternative medicine (CAM) of breast cancer patients, reasons for CAM use, and sociodemographic, clinical, and psychological predictors of CAM use. Methods: CAM use was assessed after adjuvant therapy and six months later. Following the CAM

  10. Complementary and alternative medicine use of women with breast cancer: Self-help CAM attracts other women than guided CAM therapies

    NARCIS (Netherlands)

    Lo-Fo-Wong, Deborah N. N.; Ranchor, Adelita V.; de Haes, Hanneke C. J. M.; Sprangers, Mirjam A. G.; Henselmans, Inge

    2012-01-01

    Objective: Examine stability of use of complementary and alternative medicine (CAM) of breast cancer patients, reasons for CAM use, and sociodemographic, clinical, and psychological predictors of CAM use. Methods: CAM use was assessed after adjuvant therapy and six months later. Following the CAM

  11. AffectCam : arousal- augmented sensecam for richer recall of episodic memories

    OpenAIRE

    Sas, Corina; Fratczak, Thomasz; Rees, Matthew; Gellersen, Hans; Kalnikaitė, Vaiva; Coman, Alina; Höök, Kristina

    2013-01-01

    This paper describes the design and evaluation of AffectCam, a wearable system integrating SenseCam and BodyMedia SenseWear for capturing galvanic skin response as a measure of bodily arousal. AffectCam’s algorithms use arousal as a filtering mechanism for selecting the most personally relevant photos captured during people’s ordinary daily life, i.e. high arousal photos. We discuss initial findings showing that emotional arousal does improve the quality of memory recall associated with emoti...

  12. Application of CAD/CAE/CAM in forging process: a review

    International Nuclear Information System (INIS)

    Ahmad Baharuddin Abdullah; Hamouda, A.M.S.

    2005-01-01

    Forging can be described as the process in which metal is plastically deformed with application of huge pressure. The process not only changes the shape but also improves the properties of the forged parts due to grain size refinement. Conventionally, the empirical trial and error method has been applied, but recently there are various tools are employed to improved product quality and economic of the process. For example, Computer Aided Design (CAD) is widely used in modeling of the process, while Computer Aided Engineering (CAE) tools have been utilized in analyzing the process. To physically demonstrate the process, Computer Aided Manufacturing (CAM) such as CNC machine has been exploited. In order to improve forging process efficiency, an integrated system that combines all advantages of CAD, CAM and CAE need to be developed. This paper presents an overview of computer aided simulation such as CAD, CAE and CAM application in forging process. (Author)

  13. INTEGRASI SOFTWARE CAD-CAM DALAM SISTEM OPERASI MESIN BUBUT CNC

    Directory of Open Access Journals (Sweden)

    Yuris Setyoadi

    2015-12-01

    Full Text Available Computer Aided Manufacturing (CAM adalah sebuah teknologi aplikasi yang menggunakan perangkat lunak komputer dan mesin untuk memfasilitasi dan mengotomatisasi proses manufaktur. Computer Aided Manufacturing (CAM adalah penerus dari Computer Aided Engineering (CAE dan sering digunakan bersama dengan Computer-Aided Design (CAD. Bidang manufaktur, perangkat komputer telah dipergunakan untuk mengontrol mesin-mesin produksi otomatis dengan ketepatan tinggi, misalnya mesin CNC. ?é?áArtikel ini membahas tentang penggunaan software CAD-CAM (SOLIDWorks dan CAMWorks yang terintegrasi kemudian diaplikasikan ke mesin bubut CNC yang menggunakan software Mach3, Mach3 adalah software yang bisa mengubah komputer dekstop menjadi sebuah piranti kontroller mesin CNC. Software SOLIDWorks, CAMWorks dan Mach3 diintegrasikan ke dalam sistem operasi mesin bubut CNC sehingga proses koreksi dan modifikasi format perintah gerakan dalam G/M code dapat dilakukan dalam software tersebut.

  14. Fabricating CAD/CAM Implant-Retained Mandibular Bar Overdentures: A Clinical and Technical Overview

    Directory of Open Access Journals (Sweden)

    Chui Ling Goo

    2017-01-01

    Full Text Available This report describes the clinical and technical aspects in the oral rehabilitation of an edentulous patient with knife-edge ridge at the mandibular anterior edentulous region, using implant-retained overdentures. The application of computer-aided design and computer-aided manufacturing (CAD/CAM in the fabrication of the overdenture framework simplifies the laboratory process of the implant prostheses. The Nobel Procera CAD/CAM System was utilised to produce a lightweight titanium overdenture bar with locator attachments. It is proposed that the digital workflow of CAD/CAM milled implant overdenture bar allows us to avoid numerous technical steps and possibility of casting errors involved in the conventional casting of such bars.

  15. 21 CFR 872.3661 - Optical Impression Systems for CAD/CAM.

    Science.gov (United States)

    2010-04-01

    ... of sensor and a computer with software. (b) Classification. Class II (Special Controls). The device... entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted.../CAM. (a) Identification. An optical impression system for computer assisted design and manufacturing...

  16. De CAD/CAM-brug vervaardigd met behulp van een composiet mock-up

    NARCIS (Netherlands)

    Denissen, H.; Đozic, A.

    2010-01-01

    Het esthetische aspect van een brugconstructie in het front is niet altijd voorspelbaar. Dit geldt voor zowel conventionele bruggen als bruggen die computerondersteund worden ontworpen (computer-aided design, cad ) en geproduceerd (computer-aided manufacturing, cam ). Een cruciale factor is het

  17. Knowledge and training needs among Danish nurses about CAM

    DEFF Research Database (Denmark)

    Lunde, Anita

    2010-01-01

    to explore nurses’ knowledge about CAM and their needs for training. Methods: Similar to international investigations a Danish “CAM-knowledge” questionnaire was developed that included multiple choice, yes/no and 5 points scale answers. Validity was established through initial pilot testing. Contacts...... to a randomized sample of 2500 nurses were established through the Danish Nurses Foundation. The questionnaires were mailed by post with the possibility of anonymous return. The data material was analyzed using non-parametic methods. Results: The response rate was 67 % and 1458 completed questionnaires were...... of CAM also tend to have a theoretical background of CAM. Around 75 % of the nurses agree or partly agree that it is important for nurses to receive education about CAM and that nurses have knowledge about CAM that enables them to advise patients. Training needs concerning CAM were indicated by 52...

  18. Sleep-time ambulatory blood pressure as a prognostic marker of vascular and other risks and therapeutic target for prevention by hypertension chronotherapy: Rationale and design of the Hygia Project.

    Science.gov (United States)

    Hermida, Ramón C

    2016-01-01

    This article describes the rationale, objectives, design and conduct of the ambulatory blood pressure monitoring (ABPM)-based Hygia Project. Given the substantial evidence of the significantly better prognostic value of ABPM compared to clinic BP measurements, several international guidelines now propose ABPM as a requirement to confirm the office diagnosis of hypertension. Nonetheless, all previous ABPM outcome investigations, except the Monitorización Ambulatoria para Predicción de Eventos Cardiovasculares study (MAPEC) study, relied upon only a single, low-reproducible 24 h ABPM assessment per participant done at study inclusion, thus precluding the opportunity to explore the potential reduction in cardiovascular disease (CVD) risk associated with modification of prognostic ABPM-derived parameters by hypertension therapy. The findings of the single-center MAPEC study, based upon periodic systematic 48 h ABPM evaluation of all participants during a median follow-up of 5.6 years, constitute the first proof-of-concept evidence that the progressive reduction of the asleep systolic blood pressure (SBP) mean and correction of the sleep-time relative SBP decline toward the normal dipper BP profile, most efficiently accomplished by a bedtime hypertension treatment strategy, best attenuates the risk of CVD, stroke and development of new-onset diabetes. The Hygia Project, primarily designed to extend the use of ABPM in primary care as a requirement for diagnosis of hypertension, evaluation of response to treatment and individualized assessment of CVD and other risks, is a research network presently composed of 40 clinical sites and 292 investigators. Its main objectives are to (i) investigate whether specific treatment-induced changes in ABPM-derived parameters reduce risk of CVD events, stroke, new-onset diabetes and/or development of chronic kidney disease (CKD); and (ii) test the hypothesis that bedtime chronotherapy entailing the entire daily dose of ≥1

  19. Rationale and methods of the EFCOSUM project

    NARCIS (Netherlands)

    Brussaard, J.H.; Johansson, L.; Kearney, J.

    2002-01-01

    Objective: To describe the rationale and methods for a European project (EFCOSUM) to develop a method for a European food consumption survey that delivers internationally comparable data on a set of policy-relevant nutritional indicators. Rationale and methods: Currently Member States are collecting

  20. Rational redesign of the biodegradative enzyme cytochrome P450 cam:

    International Nuclear Information System (INIS)

    Ornstein, R.; Paulsen, M.; Bass, M.; Arnold, G.

    1991-03-01

    Cytochromes P450, a superfamily of monooxygenase enzymes present in all kingdoms of living organisms, are very versatile with respect to substrate range and catalytic functionality. Many recalcitrant halogenated hydrocarbons, on DOE sites and throughout the nation, result in serious environmental impact. Cytochromes P450 have been shown to be catalytically capable of, at least partial, dehalogenation of some such compounds. Clearly, however, their active site stereochemistry and related functional components are not well suited for this role because the rates of dehalogenation are generally rather modest. The evolution of modified active site and access channel structures may proceed very slowly if multiple genetic changes are simultaneously required for enzyme adaptation. Since each mutational event is by itself a rare event, a basic premise of our research is that designing multiple changes into an enzyme may be more timely than waiting for them to occur biologically either via natural selection or under laboratory-controlled conditions. Starting with available high-resolution x-ray crystal structures, molecular modeling and molecular dynamics simulations have been used to probe the basic structure/function principles and conformational fluctuations of the biodegradative enzyme, cytochrome P450cam (camphor hydroxylase from Pseudomonas putida) and active site mutants, to provide the fundamental understanding necessary for rational engineering of the enzyme for modified substrate specificity. In the present paper, we review our progress to data, in the area of molecular dynamics simulations and active site redesign of P450cam. 36 refs., 2 figs

  1. Search for rapid variability of 53 Cam

    International Nuclear Information System (INIS)

    Zverko, J.

    1982-01-01

    Photoelectric observations of magnetic Ap star 53 Cam made at the Skalnate Pleso Observatory in 1978 and 1979 are analyzed from the point of view of rapid variability. The observations were made with an intermediate passband filter, effective wavelength 526 nm. Besides the differences msub(53Cam)-msub(Comp), the behaviour was also investigated of the deflections for the comparison star during the observation runs. A strong correlation between the behaviour of the comparison and variable star light curve was found and the appearance differs from night to night depending on atmospheric conditions. Each observation run is analyzed in detail and it was concluded that all observed variations are only apparent and due to the variability of atmospheric extinction above the observation site. (author)

  2. CAM and Post-Traumatic Stress Disorder

    Directory of Open Access Journals (Sweden)

    Alex Hankey

    2007-01-01

    Full Text Available In the form of the Transcendental Meditation program CAM offers a method of eliminating deep-rooted stress, the efficacy of which has been demonstrated in several related studies. Any discussion of CAM and post-traumatic stress disorder should include a study of its application to Vietnam War Veterans in which improvements were observed on all variables, and several participants were able to return to work after several years of being unable to hold a job. The intervention has been studied for its impact on brain and autonomic nervous system function. It has been found to be highly effective against other stress-related conditions such as hypertension, and to improve brain coherence—a measure of effective brain function. It should be considered a possible ‘new and improved mode of treatment’ for PTSD, and further studies of its application made.

  3. Screening for retinopathy of prematurity-a comparison between binocular indirect ophthalmoscopy and RetCam 120

    Directory of Open Access Journals (Sweden)

    Shah Parag

    2006-01-01

    Full Text Available Aim: To compare the photographic screening for retinopathy of prematurity (ROP using RetCam 120 with binocular indirect ophthalmoscope (BIO, which is the current gold standard. Setting and Design: Prospective, comparative study. Materials and Methods: A total of 87 RetCam examinations were performed on 27 premature babies. They were stored in a separate file after deleting the identifying information. At the same visit using the BIO with scleral depression, an experienced vitreoretinal surgeon evaluated the fundus in detail. A masked examiner then evaluated the RetCam photographs for presence or absence of ROP, the stage and zone of the disease, and the presence or absence of plus disease. These data were then compared with the BIO findings to determine the sensitivity, specificity, and the positive and negative predictive values of the method. Results: ROP was detected in 63 of 87 examinations by BIO and in 56 of 87 RetCam examinations. Nine RetCam examinations were false-negative and two were false-positive. Sensitivity of RetCam was 85.71% (54/63 and specificity was 91.66% (22/24. The positive and negative predictive values were 96.43% and 70.97% respectively. Conclusion: Nine cases having ROP were missed by the RetCam. All these cases were either in zone 3 or the outer part of zone 2, which later regressed. These were missed mostly because of the restricted mobility of the camera head caused by its size and the barrier caused by the lid speculum arms. No case of threshold ROP was missed. RetCam may replace BIO for screening of ROP.

  4. Camões e a cosmogonia

    Science.gov (United States)

    Costa, J. M.

    2003-08-01

    Os Lusíadas, escrito por Luis de Camões em 1572, é um poema épico renascentista e a visão Cosmogônica do autor é apresentada, principalmente, no último canto do poema, quando Tétis mostra ao Gama a Máquina do Mundo. A Cosmogonia de Camões neste poema reflete uma visão de uma época de transição, que ainda não incorporou os elementos da revolução Copernicana. É uma visão Grego- Ptolomaica e também medieval. O poeta guia-se pela tradução e notas feita por Pedro Nunes, inventor do Nonio, do Tratado da Esfera "De Sphaera" do Astrônomo Inglês John Holywood, mais conhecido pelo nome latinizado de Johannes Sacrobosco. Outra provável fonte de Camões, de acordo com Luciano Antonio Pereira da Silva em Astronomia de os Lusíadas, é o "Theoricae novae Planetarum" (1460) do astrólogo Alemão Jorge Purbáquio (1423 - 1461). A Astronomia de Os Lusíadas representa a ciência do tempo de Camões. Camões nunca emprega a palavra constelação e seu catálogo é bastante completo. A Máquina do Mundo tem a Terra no centro. Em redor, em círculos concêntricos, a lua (Diana), Mercúrio, Vênus, o Sol (Febo), Marte, Júpiter e Saturno. Envolvendo estes astros tem o firmamento seguido pelo "Céu Áqueo" ou cristalino, depois o 1o Móbil, esfera que arrasta todas as outras consigo. Este trabalho, multidisciplinar, serve tanto para ensinar aos alunos da Física como das Ciências Humanas, a concepção de mundo do renascimento de uma forma belamente poética em versos decassílabos Este trabalho também ajuda na apreciação do maior clássico da língua portuguesa e mostra como as Ciências e as artes, em geral, estão correlacionadas e refletem a visão de mundo da época em que foi produzida.

  5. Workflow of CAD / CAM Scoliosis Brace Adjustment in Preparation Using 3D Printing.

    Science.gov (United States)

    Weiss, Hans-Rudolf; Tournavitis, Nicos; Nan, Xiaofeng; Borysov, Maksym; Paul, Lothar

    2017-01-01

    High correction bracing is the most effective conservative treatment for patients with scoliosis during growth. Still today braces for the treatment of scoliosis are made by casting patients while computer aided design (CAD) and computer aided manufacturing (CAM) is available with all possibilities to standardize pattern specific brace treatment and improve wearing comfort. CAD / CAM brace production mainly relies on carving a polyurethane foam model which is the basis for vacuuming a polyethylene (PE) or polypropylene (PP) brace. Purpose of this short communication is to describe the workflow currently used and to outline future requirements with respect to 3D printing technology. Description of the steps of virtual brace adjustment as available today are content of this paper as well as an outline of the great potential there is for the future 3D printing technology. For 3D printing of scoliosis braces it is necessary to establish easy to use software plug-ins in order to allow adding 3D printing technology to the current workflow of virtual CAD / CAM brace adjustment. Textures and structures can be added to the brace models at certain well defined locations offering the potential of more wearing comfort without losing in-brace correction. Advances have to be made in the field of CAD / CAM software tools with respect to design and generation of individually structured brace models based on currently well established and standardized scoliosis brace libraries.

  6. Unique CAD/CAM three-quarter crown restoration of a central incisor: a case report.

    Science.gov (United States)

    Goldberg, Marvin B; Siegel, Sharon C; Rezakani, Niloufar

    2013-07-01

    Computer-aided design and computer-aided manufacturing (CAD/CAM) dentistry has been in use for more than 2 decades. Recent improvements in this technology have made CAD/CAM restorations a viable alternative for routine dental care. This technology is being taught in dental schools to prepare students for contemporary dental practice and is particularly useful in unique restorative situations that allow conservation of tooth structure. This case report describes the restoration of a central incisor that was previously restored with an unesthetic three-quarter gold crown. The tooth exhibited recurrent caries and an unaffected labial wall of supported enamel. A CAD/CAM three-quarter crown was planned to conserve tooth structure. After preparation, the tooth was scanned for a CAD/CAM crown in order to fabricate a ceramic restoration, which was then milled and bonded, producing an esthetic result. Typically, in cases of esthetic enhancement, a labial laminate restoration is fabricated, but in this situation, a different approach was necessary to make a design for the lingual surface of an anterior tooth.

  7. The influence of polishing techniques on pre-polymerized CAD\\CAM acrylic resin denture bases.

    Science.gov (United States)

    Alammari, Manal Rahma

    2017-10-01

    Lately, computer-aided design and computer-aided manufacturing (CAD/CAM) has broadly been successfully employed in dentistry. The CAD/CAM systems have recently become commercially available for fabrication of complete dentures, and are considered as an alternative technique to conventionally processed acrylic resin bases. However, they have not yet been fully investigated. The purpose of this study was to inspect the effects of mechanical polishing and chemical polishing on the surface roughness (Ra) and contact angle (wettability) of heat-cured, auto-cured and CAD/CAM denture base acrylic resins. This study was conducted at the Advanced Dental Research Laboratory Center of King Abdulaziz University from March to June 2017. Three denture base materials were selected: heat cure poly-methylmethacrylate resin, thermoplastic (polyamide resin) and (CAD\\CAM) denture base resin. Sixty specimens were prepared and divided into three groups, twenty in each. Each group was divided according to the polishing techniques into (Mech P) and (Chem P), ten specimens in each; surface roughness and wettability were investigated. Data were analyzed by SPSS version 22, using one-way ANOVA and Pearson coefficient. One-way analysis of variance (ANOVA) and post hoc tests were used for comparing the surface roughness values between three groups which revealed a statistical significant difference between them (p 1 CAD\\CAM denture base material (group III) showed the least mean values (1.08±0.23, 1.39±0.31, Mech P and Chem P respectively). CAD/CAM showed the least contact angle in both polishing methods, which were statistically significant at 5% level (p=0.034 and pCAD\\CAM denture base resin with superior smooth surface compared to chemical polishing. Mechanical polishing is considered the best effective polishing technique. CAD/CAM denture base material should be considered as the material of choice for complete denture construction in the near future, especially for older dental

  8. Effectiveness and efficiency of a CAD/CAM orthodontic bracket system.

    Science.gov (United States)

    Brown, Matthew W; Koroluk, Lorne; Ko, Ching-Chang; Zhang, Kai; Chen, Mengqi; Nguyen, Tung

    2015-12-01

    The first straight-wire appliance was introduced over 40 years ago to increase the consistency and efficiency of orthodontic treatment. More recently, computer-aided design and computer-aided manufacturing (CAD/CAM) technology has been used to create individualized orthodontic appliances. The purpose of this study was to investigate the clinical effectiveness and efficiency of CAD/CAM customized orthodontic appliances compared with direct and indirect bonded stock orthodontic brackets. This retrospective study included 3 treatment groups: group 1 patients were direct bonded with self-ligating appliances, group 2 patients were indirect bonded with self-ligating appliances, and group 3 patients were indirect bonded with CAD/CAM self-ligating appliances. Complete pretreatment and posttreatment records were obtained for all patients. The American Board of Orthodontics (ABO) Discrepancy Index was used to evaluate the pretreatment records, and the posttreatment outcomes were analyzed using the ABO Cast-Radiograph Evaluation. All data collection and analysis were completed by 1 evaluator. There were no statistically significant differences in the ABO Discrepancy Index or the ABO Cast-Radiograph Evaluation among the groups. Treatment times for the 3 groups were significantly different; the CAD/CAM group was the shortest at 13.8 ± 3.4 months, compared with 21.9 ± 5.0 and 16.9 ± 4.1 months for the direct bonded and indirect bonded groups, respectively. The number of treatment appointments for the CAD/CAM group was significantly fewer than for the direct bonded group. The CAD/CAM orthodontic bracket system evaluated in this study was as effective in treatment outcome measures as were standard brackets bonded both directly and indirectly. The CAD/CAM appliance was more efficient in regard to treatment duration, although the decrease in total archwire appointments was minimal. Further investigation is needed to better quantify the clinical benefits of CAD/CAM orthodontic

  9. Availability Analysis of the Ventilation Stack CAM Interlock System

    International Nuclear Information System (INIS)

    YOUNG, J.

    2000-01-01

    Ventilation Stack Continuous Air Monitor (CAM) Interlock System failure modes, failure frequencies and system availability have been evaluated for the RPP. The evaluation concludes that CAM availability is as high as assumed in the safety analysis and that the current routine system surveillance is adequate to maintain this availability. Further, requiring an alarm to actuate upon CAM failure is not necessary to maintain the availability credited in the safety analysis, nor is such an arrangement predicted to significantly improve system availability. However, if CAM failures were only detected by the 92-day functional tests required in the Authorization Basis (AB), CAM availability would be much less than that credited in the safety analysis. Therefore it is recommended that the current surveillance practice of daily simple system checks, 30-day source checks and 92-day functional tests be continued in order to maintain CAM availability

  10. APPLICATION OF 3D DIGITAL SCANNING AND CAD/CAM SYSTEMS FOR ZIRCONIA INDIRECT RESTORATIONS

    Directory of Open Access Journals (Sweden)

    Mariela Tsanova

    2016-09-01

    Full Text Available Object: To study the CAD/CAM systems’ possibilities for manufacturing Zirconia indirect restorations for restoring vital, vastly devastated teeth. Material and methods: Five patients with vital, heavily destroyed molars were included in the clinical study. The teeth were prepared according to requirements for Zirconia restorations. The impressions were taken with 3D intraoral scanner. The acquired data is transmitted electronically for designing the future restoration by the CAD software. After designing, the restoration is milled by the CAM module and sintered, according to a specially projected programme in accordance with the manufacturing demands. After clinical check-up, the restorations are glazed, air-blasted and cemented. Results: Setting up an individual protocol for working with CAD/CAM systems for restoring vital, severely devastated teeth with Zirconia indirect restorations. A research is made on 3D digital scanning, occlusal and proximal modeling, virtual articulation, analyzing the incline of the cavity walls, the thickness of the restoration and the possibilities for restoring the anatomy of the tooth according to patient’s individual characteristics of the teeth’s arch. Conclusion: The scanning and design process should be evaluated with the same quality control as when using traditional methods. The CAD software requires excellent preparation of the tooth cavity and digital scanning. This is the reason why these systems require a thorough understanding of CAD/CAM calibration and parameters of the product to be clinically acceptable. Once understood, CAD/CAM dentistry can create detailed and accurate restorations that function and perform with great success and longevity.

  11. Laia de Camões — O épico

    Directory of Open Access Journals (Sweden)

    Lygia Alvares Correa

    1951-06-01

    Full Text Available CIDADE ('liernatii. Laia de Camões — O épico, Revista da Faculdade  de Letras. Tomo XVI. 2.°' série. ns. I e 2. Universidade de Lisboa  1950. (Primeiro Parágrafo do Artigo Este segundo volume que a respeito de Camões escreve o Prof. Cidade surge 14 anos após, "Luiz de Camões".

  12. Test plan for FY-91 alpha CAM evaluation

    International Nuclear Information System (INIS)

    Winberg, M.R.

    1991-03-01

    This report describes the test plan for evaluating the Merlin Gerin, Inc., Edgar alpha continuous air monitor (CAM) and associated analysis system to be conducted by Idaho National Engineering Laboratory (INEL) for the Department of Energy. INEL has evaluated other commercial alpha CAM systems to detect transuranic contaminants during waste handling and retrieval operations. This test plan outlines experimental methods, sampling methods, sampling and analysis techniques, and equipment needed and safety and quality requirements to test the commercial CAM. 8 refs., 3 figs

  13. Treatment Preferences for CAM in Children with Chronic Pain

    OpenAIRE

    Tsao, Jennie C. I.; Meldrum, Marcia; Kim, Su C.; Jacob, Margaret C.; Zeltzer, Lonnie K.

    2006-01-01

    CAM therapies have become increasingly popular in pediatric populations. Yet, little is known about children's preferences for CAM. This study examined treatment preferences in chronic pediatric pain patients offered a choice of CAM therapies for their pain. Participants were 129 children (94 girls) (mean age = 14.5 years ± 2.4; range = 8–18 years) presenting at a multidisciplinary, tertiary clinic specializing in pediatric chronic pain. Bivariate and multivariate analyses were used to examin...

  14. "Step by Step". A feasibility study of a lunchtime walking intervention designed to increase walking, improve mental well-being and work performance in sedentary employees: Rationale and study design

    Directory of Open Access Journals (Sweden)

    Fox Kenneth R

    2010-09-01

    Full Text Available Abstract Background Following an extensive recruitment campaign, a 16-week lunchtime intervention to increase walking was implemented with insufficiently physically active University employees to examine programme feasibility and the effects of the programme in increasing walking behaviour, and in improving well-being and work performance. Methods/design A feasibility study in which participants were randomised to an immediate treatment or a delayed treatment control (to start at 10 weeks group. For the first ten weeks of the intervention, participants took part in three facilitator-led group walks per week each of thirty minutes duration and were challenged to accumulate another sixty minutes of walking during the weekends. In the second phase of the intervention, the organised group walks ceased to be offered and participants were encouraged to self-organise their walks. Motivational principles were employed using contemporary motivational theory. Outcome measures (including self-reported walking, step counts, cardiovascular fitness, general and work-related well-being and work performance were assessed at baseline, at the end of the 16-week intervention and (for some four months after the end of the intervention. Process and outcome assessments were also taken throughout, and following, the intervention. Discussion The results of the intervention will determine the feasibility of implementing a lunchtime walking programme to increase walking behaviour, well-being and performance in sedentary employees. If successful, there is scope to implement definitive trials across a range of worksites with the aim of improving both employee and organisational health. Trial registration Current Controlled Trials ISRCTN81504663.

  15. Accuracy of CAD-CAM-fabricated removable partial dentures.

    Science.gov (United States)

    Arnold, Christin; Hey, Jeremias; Schweyen, Ramona; Setz, Jürgen M

    2018-04-01

    The conventional fabrication of removable partial dentures (RPDs) is a complex, error-prone, time-consuming, and expensive process. The use of computer-aided design and computer-aided manufacturing (CAD-CAM) techniques, especially rapid prototyping, promises a more effective method for fabricating RPD frameworks. The purpose of this in vitro study was to evaluate the fit of RPD clasps fabricated by means of 4 different CAD-CAM-systems and to compare those fittings with that of the conventional lost-wax casting technique (LWT). A master model of a partially edentulous maxilla with the canines and second molars as the remaining teeth was fabricated. After the model was optically scanned, we designed a quadrangularly supported RPD with 4 clasps and a palatal strap major connector. A standard tessellation language data set was used to fabricate 12 identical RPDs by using 4 different CAD-CAM techniques: indirect rapid prototyping (wax inject printing combined with LWT), direct rapid prototyping (selective laser melting), indirect milling (wax milling with LWT), and direct milling (resin milling [polyetheretherketone]). Three conventionally cast RPDs (LWT) served as the control group. The fit accuracy of the clasps (n=12 for each group) was determined in both the horizontal and vertical dimensions by using light microscopy. Indirectly milled RPDs (117 ±34 μm horizontal and 45 ±21 μm vertical) and directly milled RPDs (43 ±23 μm horizontal, and 38 ±21 μm vertical) showed significantly better (P<.05) fit than did conventionally fabricated LWT RPDs (133 ±59 μm horizontal; 73 ±25 μm vertical). The worst fit was found for RPDs fabricated using indirect rapid prototyping (323 ±188 μm horizontal and 112 ±60 μm vertical) or direct rapid prototyping (365 ±205 μm horizontal and 363 ±133 μm vertical), which were unstable on the master model, making them unsuitable for clinical use. Most RPDs exhibited smaller vertical measuring distances. Compared with the LWT

  16. QUANTIFICATION OF ANGIOGENESIS IN THE CHICKEN CHORIOALLANTOIC MEMBRANE (CAM

    Directory of Open Access Journals (Sweden)

    Silvia Blacher

    2011-05-01

    Full Text Available The chick chorioallantoic membrane (CAM provides a suitable in vivo model to study angiogenesis and evaluate several pro- and anti-angiogenic factors and compounds. In the present work, new developments in image analysis are used to quantify CAM angiogenic response from optical microscopic observations, covering all vascular components, from the large supplying and feeding vessels down to the capillary plexus. To validate our methodology angiogenesis is quantified during two phases of CAM development (day 7 and 13 and after treatment with an antiangiogenic modulator of the angiogenesis. Our morphometric analysis emphasizes that an accurate quantification of the CAM vasculature needs to be performed at various scales.

  17. Lacie phase 1 Classification and Mensuration Subsystem (CAMS) rework experiment

    Science.gov (United States)

    Chhikara, R. S.; Hsu, E. M.; Liszcz, C. J.

    1976-01-01

    An experiment was designed to test the ability of the Classification and Mensuration Subsystem rework operations to improve wheat proportion estimates for segments that had been processed previously. Sites selected for the experiment included three in Kansas and three in Texas, with the remaining five distributed in Montana and North and South Dakota. The acquisition dates were selected to be representative of imagery available in actual operations. No more than one acquisition per biophase were used, and biophases were determined by actual crop calendars. All sites were worked by each of four Analyst-Interpreter/Data Processing Analyst Teams who reviewed the initial processing of each segment and accepted or reworked it for an estimate of the proportion of small grains in the segment. Classification results, acquisitions and classification errors and performance results between CAMS regular and ITS rework are tabulated.

  18. Bioethics: A Rationale and a Model

    Science.gov (United States)

    Barman, Charles R.; Rusch, John J.

    1978-01-01

    Discusses the rationale for and development of an undergraduate bioethics course. Based on experiences with the course, general suggestions are offered to instructors planning to add bioethics to existing curricula. (MA)

  19. Expression, crystallization and preliminary diffraction studies of the Pseudomonas putida cytochrome P450cam operon repressor CamR

    International Nuclear Information System (INIS)

    Maenaka, Katsumi; Fukushi, Kouji; Aramaki, Hironori; Shirakihara, Yasuo

    2005-01-01

    The P. putida cytochrome P450cam operon repressor CamR has been expressed in E. coli and crystallized in space group P2 1 2 1 2. The Pseudomonas putida cam repressor (CamR) is a homodimeric protein that binds to the camO DNA operator to inhibit the transcription of the cytochrome P450cam operon camDCAB. CamR has two functional domains: a regulatory domain and a DNA-binding domain. The binding of the inducer d-camphor to the regulatory domain renders the DNA-binding domain unable to bind camO. Native CamR and its selenomethionyl derivative have been overproduced in Escherichia coli and purified. Native CamR was crystallized under the following conditions: (i) 12–14% PEG 4000, 50 mM Na PIPES, 0.1 M KCl, 1% glycerol pH 7.3 at 288 K with and without camphor and (ii) 1.6 M P i , 50 mM Na PIPES, 2 mM camphor pH 6.7 at 278 K. The selenomethionyl derivative CamR did not crystallize under either of these conditions, but did crystallize using 12.5% PEG MME 550, 25 mM Na PIPES, 2.5 mM MgCl 2 pH 7.3 at 298 K. Preliminary X-ray diffraction studies revealed the space group to be orthorhombic (P2 1 2 1 2), with unit-cell parameters a = 48.0, b = 73.3, c = 105.7 Å. Native and selenomethionyl derivative data sets were collected to 3 Å resolution at SPring-8 and the Photon Factory

  20. *Abstracts - 7th IN-CAM Research Symposium, Evaluating CAM Practices: Effectiveness, Integration, Economics & Safety - November 2012.

    Science.gov (United States)

    Boon, Heather; Verhoef, Marja J

    2012-10-23

    Abstract The following are abstracts of oral and poster presentations given at the 7th IN-CAM Research Symposium - Evaluating CAM Practices: Effectiveness, Integration, Economics & Safety, and the 4th HomeoNet Research Forum, a pre-Symposium event. The IN-CAM Research Symposium was held November 2 to 4, 2012 at the Leslie Dan Faculty of Pharmacy, University of Toronto, in Toronto, Ontario, Canada. For more information, please visit: www.incamresearch.ca.

  1. New Content Addressable Memory (CAM) Technologies for Big Data and Intelligent Electronics Enabled by Magneto-Electric Ternary CAM

    Science.gov (United States)

    2017-12-11

    AFRL-RY-WP-TR-2017-0198 NEW CONTENT ADDRESSABLE MEMORY (CAM) TECHNOLOGIES FOR BIG DATA AND INTELLIGENT ELECTRONICS ENABLED BY MAGNETO-ELECTRIC...MEMORY (CAM) TECHNOLOGIES FOR BIG DATA AND INTELLIGENT ELECTRONICS ENABLED BY MAGNETO-ELECTRIC TERNARY CAM 5a. CONTRACT NUMBER FA8650-16-1-7655 5b... electronic applications, such as internet of things, big data, wireless sensors, and mobile devices, have begun to focus on the importance of energy

  2. New Rationales for Women on Boards

    OpenAIRE

    Choudhury, B.

    2014-01-01

    Should measures promoting women to corporate boards be solely justified in terms of economic arguments? Traditionally, such measures have tended to rely on utilitarian arguments, despite the fact that the most prominent of these arguments—the relationship between women’s presence on boards and firm financial performance—is equivocal. Conversely, this article argues that rationales for increasing women on boards should be based on both equality and economics grounds. An equality rationale is n...

  3. THE FOURIER SERIES USED IN ANALYSE OF THE CAM MECHANISMS FOR THE SHOEMAKING MACHINES (PART I

    Directory of Open Access Journals (Sweden)

    IOVAN-DRAGOMIR Alina

    2016-05-01

    Full Text Available A computer assisted procedure for the cinematic analysis of the mechanism of a cam is essential in making a certain type of research operations. They mainly refer to the optimization of operations running on specific machinery, or to the re-design of the mechanism, in order to make the mechanism digital. This analysis seems even more important, when we consider the fact that most of the machines used in shoe industry nowadays use a cam mechanism. The paper is devided in two parts. In first part, it is elaborated a method of finding of a function G(x, belonging to a Fourier series, which approximates the numerical values {xi, yi}, with the biggest accuracy. Finding the function that approximates the most accurately the data set, for the position parameters of the follower S(ω, ( will lead to a complete kinematic and dynamic analysis of the cam mechanism. These values repeat with T = 2π period. In second part, the method is tasted using MatCAD work sessions which allow a numerical and graphical analysis of the mathematical relations involved, in order to test the reability of the method. The set of experimental data are resulted after measuring a cam mechanism of a machine used in shoemaking.

  4. A Review of CAM for Procedural Pain in Infancy: Part II. Other Interventions

    Directory of Open Access Journals (Sweden)

    Jennie C. I. Tsao

    2008-01-01

    Full Text Available This article is the second in a two-part series reviewing the empirical evidence for complementary and alternative medicine (CAM approaches for the management of pain related to medical procedures in infants up to 6 weeks of age. Part I of this series investigated the effects of sucrose with or without non-nutritive sucking (NNS. The present article examines other CAM interventions for procedural pain including music-based interventions, olfactory stimulation, kangaroo care and swaddling. Computerized databases were searched for relevant studies including prior reviews and primary trials. Preliminary support was revealed for the analgesic effects of the CAM modalities reviewed. However, the overall quality of the evidence for these approaches remains relatively weak. Additional well-designed trials incorporating rigorous methodology are required. Such investigations will assist in the development of evidence-based guidelines on the use of CAM interventions either alone or in concert with conventional approaches to provide safe, reliable analgesia for infant procedural pain.

  5. Motorized CPM/CAM physiotherapy device with sliding-mode Fuzzy Neural Network control loop.

    Science.gov (United States)

    Ho, Hung-Jung; Chen, Tien-Chi

    2009-11-01

    Continuous passive motion (CPM) and controllable active motion (CAM) physiotherapy devices promote rehabilitation of damaged joints. This paper presents a computerized CPM/CAM system that obviates the need for mechanical resistance devices such as springs. The system is controlled by a computer which performs sliding-mode Fuzzy Neural Network (FNN) calculations online. CAM-type resistance force is generated by the active performance of an electric motor which is controlled so as to oppose the motion of the patient's leg. A force sensor under the patient's foot on the device pedal provides data for feedback in a sliding-mode FNN control loop built around the motor. Via an active impedance control feedback system, the controller drives the motor to behave similarly to a damped spring by generating and controlling the amplitude and direction of the pedal force in relation to the patient's leg. Experiments demonstrate the high sensitivity and speed of the device. The PC-based feedback nature of the control loop means that sophisticated auto-adaptable CPM/CAM custom-designed physiotherapy becomes possible. The computer base also allows extensive data recording, data analysis and network-connected remote patient monitoring.

  6. Edge strength of CAD/CAM materials.

    Science.gov (United States)

    Pfeilschifter, Maria; Preis, Verena; Behr, Michael; Rosentritt, Martin

    2018-05-16

    To investigate the edge force of CAD/CAM materials as a function of (a) material, (b) thickness, and (c) distance from the margin. Materials intended for processing with CAD/CAM were investigated: eight resin composites, one resin-infiltrated ceramic, and a clinically proven lithiumdisilicate ceramic (reference). To measure edge force (that is, load to failure/crack), plates (d = 1 mm) were fixed and loaded with a Vickers diamond indenter (1 mm/min, Zwick 1446) at a distance of 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1.0 mm from the edge. Edge force was defined as a loading force at a distance of 0.5 mm. The type of failure was determined. To investigate the influence of the thickness, all data were determined on 1-mm and 2-mm plates. To test the influence of bonding and an underlying dentin, individual 1-mm plates were bonded to a 1-mm-thick dentin-like (concerning modulus of elasticity) resin composite. For the 1-mm plates, edge force varied between 64.4 ± 24.2 N (Shofu Block HC) and 183.2 ± 63.3 N (ceramic reference), with significant (p ≤ 0.001) differences between the materials. For the 2-mm plates, values between 129.2 ± 32.5 N (Lava Ultimate) and 230.3 ± 67.5 N (Cerasmart) were found. Statistical comparison revealed no significant differences (p > 0.109) between the materials. Brilliant Crios (p = 0.023), Enamic (p = 0.000), Shofu Blocks HC (p = 0.009), and Grandio Bloc (p = 0.002) showed significantly different edge force between the 1-mm- and 2-mm-thick plates. The failure pattern was either cracking, (severe) chipping, or fracture. Material, material thickness, and distance from the edge impact the edge force of CAD/CAM materials. CAD/CAM materials should be carefully selected on the basis of their individual edge force and performance during milling. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. Cam-driven monochromator for QEXAFS

    Energy Technology Data Exchange (ETDEWEB)

    Caliebe, W.A. [National Synchrotron Light Source, Brookhaven National Laboratory, Upton, NY 11973 (United States); So, I. [National Synchrotron Light Source, Brookhaven National Laboratory, Upton, NY 11973 (United States); Lenhard, A. [National Synchrotron Light Source, Brookhaven National Laboratory, Upton, NY 11973 (United States); Siddons, D.P. [National Synchrotron Light Source, Brookhaven National Laboratory, Upton, NY 11973 (United States)

    2006-11-15

    We have developed a cam-drive for quickly tuning the energy of an X-ray monochromator through an X-ray absorption edge for quick extended X-ray absorption spectroscopy (QEXAFS). The data are collected using a 4-channel, 12-bit multiplexed VME analog to digital converter and a VME angle encoder. The VME crate controller runs a real-time operating system. This system is capable of collecting 2 EXAFS-scans in 1 s with an energy stability of better than 1 eV. Additional improvements to increase the speed and the energy stability are under way.

  8. Cam-driven monochromator for QEXAFS

    Science.gov (United States)

    Caliebe, W. A.; So, I.; Lenhard, A.; Siddons, D. P.

    2006-11-01

    We have developed a cam-drive for quickly tuning the energy of an X-ray monochromator through an X-ray absorption edge for quick extended X-ray absorption spectroscopy (QEXAFS). The data are collected using a 4-channel, 12-bit multiplexed VME analog to digital converter and a VME angle encoder. The VME crate controller runs a real-time operating system. This system is capable of collecting 2 EXAFS-scans in 1 s with an energy stability of better than 1 eV. Additional improvements to increase the speed and the energy stability are under way.

  9. Cam-driven monochromator for QEXAFS

    International Nuclear Information System (INIS)

    Caliebe, W.A.; So, I.; Lenhard, A.; Siddons, D.P.

    2006-01-01

    We have developed a cam-drive for quickly tuning the energy of an X-ray monochromator through an X-ray absorption edge for quick extended X-ray absorption spectroscopy (QEXAFS). The data are collected using a 4-channel, 12-bit multiplexed VME analog to digital converter and a VME angle encoder. The VME crate controller runs a real-time operating system. This system is capable of collecting 2 EXAFS-scans in 1 s with an energy stability of better than 1 eV. Additional improvements to increase the speed and the energy stability are under way

  10. The rationale for energy efficiency policy: Assessing the recognition of the multiple benefits of energy efficiency retrofit policy

    International Nuclear Information System (INIS)

    Kerr, Niall; Gouldson, Andy; Barrett, John

    2017-01-01

    The rationale for energy efficiency policy can be framed in terms of a variety of different benefits. This paper considers how different benefits have been used within the overall rationale for energy efficient retrofit policy in different contexts. We posit that different rationales may be used for the same policy response, and that the form of rationale used may affect the design, delivery or the level of policy support, with different rationales making it easier to account for different results. Considering retrofit policy in the contexts of the UK, Germany, New Zealand and Ireland, we characterise policy rationale in each case, assessing what the key perceived benefits have been, and whether they have changed over time. The analysis identifies some marked differences between cases with the recognition of benefits and the ensuing policy rationale resulting from a complex mix of political, social and economic influences. We find that recognition of multiple benefits may not equate with multiplied policy support, and instead it is more likely that different rationales will have relevance at different times, for different audiences. The findings highlight that, alongside evidence for policy, it is important to also consider how the overall rationale for policy is eventually framed. - Highlights: • Energy efficiency as a policy issue with perceived multiple benefits. • Assessment of the influence of different benefits on rationale for energy efficient retrofit policy. • How does the rationale for retrofit policy differ in different national policy contexts. • To what extent are the perceived multiple benefits of policy recognised. • What influence does eventual rationale for policy have on the policy implemented.

  11. Model-Based Engineering and Manufacturing CAD/CAM Benchmark

    International Nuclear Information System (INIS)

    Domm, T.D.; Underwood, R.S.

    1999-01-01

    than a single computer-aided manufacturing (CAM) system. The Inteznet was a technology that all companies were considering to either transport information more easily throughout the corporation or as a conduit for business, as the small firm was doing Successfully. Because PrdEngineer is the de facto CAD standard fbr the NWC, the Benchmark Team targeted companies using Parametric Technology Corporation (PTC) software tools. Most of the companies used Pm'Engineer for design to some degree, but found the PTC CAM product, PdManufacture lacking as compared to alternate CAM solutions. All of the companies visited found the data exchange between CAD/CAM systems problematic. It was apparent that these companies were trying to consolidate their software tools to reduce translation but had not been able to do so because no single solution had all the needed capabilities. In regard to organizational structure and human resources, two companies were found to be using product or program teams. These teams consisted of the technical staff capable of completing the entire task and were xmintained throughout the project. This same strategy was evident at another of the companies but with more mobility of members. For all companies visited except the small work structure breakdown and responsibility were essentially the same as Y-12's at this time. The functions of numerical control (NC), desi and process planning were separate and distinct. The team made numerous recommendations that are detailed in the report

  12. mHealth to Improve the Diet Among Low-Income Populations Enrolled in an Established U.S. Nutrition Program: Design and Rationale of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Heather Noel Fedesco

    2015-10-01

    the limitations with current SMS interventions is that most have relied on providing reminder texts at the conclusion of an education/counseling sessi