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Sample records for acciss study rationale

  1. 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

  2. Rationale and Design of the 'MITOCARE' Study

    DEFF Research Database (Denmark)

    Clemmensen, Peter

    2012-01-01

    40303 targets the mitochondrial permeability transition pore, a promising target for the prevention of reperfusion injury. This multicenter, double-blind study will randomize patients with STEMI to TRO40303 or placebo administered just before balloon inflation or thromboaspiration during PCI...

  3. Design and rationale for the PREVAIL study

    DEFF Research Database (Denmark)

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

    2012-01-01

    Intensive exercise may be an important part of rehabilitation in patients with congenital heart disease (CHD). However, performing regular physical exercise is challenging for many adolescent patients. Consequently, effective exercise encouragements may be needed. Little is known on the effect of e-Health...... encouragements on physical fitness, physical activity, and health-related quality of life in adolescents. This trial is a nationwide interactive e-Health rehabilitation study lasting 1 year, centered on interactive use of mobile phone and Internet technology. We hypothesize that e-Health encouragements......: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. 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...

  5. Latin American Study of Nutrition and Health (ELANS): rationale and study design

    OpenAIRE

    M. Fisberg; Kovalskys, I.; Gómez, G.; Rigotti, A; Cortés, L. Y.; Herrera-Cuenca, M.; Yépez, M. C.; Pareja, R. G.; Guajardo, V.; I.Z. Zimberg; Chiavegatto Filho, A. D. P.; Pratt, M.; Koletzko, B; Tucker, K L; ,

    2016-01-01

    Background Obesity is growing at an alarming rate in Latin America. Lifestyle behaviours such as physical activity and dietary intake have been largely associated with obesity in many countries; however studies that combine nutrition and physical activity assessment in representative samples of Latin American countries are lacking. The aim of this study is to present the design rationale of the Latin American Study of Nutrition and Health/Estudio Latinoamericano de Nutrición y Salud (ELANS) w...

  6. Rationales Shaping International Linkages in Higher Education: A Qualitative Case Study of the ASU-ITESM Strategic Alliance

    Science.gov (United States)

    Camacho Lizarraga, Monica Irene

    2011-01-01

    This qualitative case study examines the rationales of the relationship between Arizona State University (ASU)--an American public research university--and Tecnologico de Monterrey (ITESM), a Mexican private not for profit research university. The focus of the study is to document the different meanings participants attached to the rationales of…

  7. Why look into mathematics classrooms? Rationales for comparative classroom studies in mathematics education

    OpenAIRE

    Jablonka, Eva

    2015-01-01

    International audience Larger comparative studies of mathematics classrooms became most prominent as an appendix of international achievement studies. With the advance of video technology and the potentials it offers for researchers, however, comparative classroom observation studies became attractive and feasible also for smaller scale and low budget projects. This paper intends to provide a basis for discussing rationales for comparative studies of mathematics classrooms. It is suggested...

  8. LucKi Birth Cohort Study: rationale and design

    OpenAIRE

    de Korte-de Boer, Dianne; Mommers, Monique; Creemers, Huub MH; Dompeling, Edward; Feron, Frans JM; Gielkens-Sijstermans, Cindy ML; Jaminon, Mariëlle; Mujakovic, Suhreta; van Schayck, Onno CP; Thijs, Carel; Jansen, Maria

    2015-01-01

    Background Infancy and childhood are characterized by rapid growth and development, which largely determine health status and well-being across the lifespan. Identification of modifiable risk factors and prognostic factors in critical periods of life will contribute to the development of effective prevention and intervention strategies. The LucKi Birth Cohort Study was designed and started in 2006 to follow children from birth into adulthood on a wide range of determinants, disorders, and dis...

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

    Directory of Open Access Journals (Sweden)

    Lu Daru

    2009-07-01

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

  10. Targeting SRC in glioblastoma tumors and brain metastases: rationale and preclinical studies

    OpenAIRE

    Ahluwalia, Manmeet; de Groot, John; Liu, Wei; Gladson, Candece L.

    2010-01-01

    Glioblastoma (GBM) is an extremely aggressive, infiltrative tumor with a poor prognosis. The regulatory approval of bevacizumab for recurrent GBM has confirmed that molecularly targeted agents have potential for GBM treatment. Preclinical data showing that SRC and SRC-family kinases (SFKs) mediate intracellular signaling pathways controlling key biologic/oncogenic processes provide a strong rationale for investigating SRC/SFK inhibitors, eg, dasatinib, in GBM and clinical studies are underway...

  11. Rationale, design and methods of the HEALTHY study behavior intervention component

    OpenAIRE

    Venditti, EM; Elliot, DL; Faith, MS; Firrell, LS; Giles, CM; Goldberg, L.; Marcus, MD; Schneider, M; Solomon, S.; Thompson, D.; Yin, Z.

    2009-01-01

    HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data...

  12. Does Design Rationale Enhance Creativity?

    OpenAIRE

    Jing Wang; Umer Farooq; John M. Carroll

    2010-01-01

    Creativity and rationale are often viewed as two contrasting facets in software design. A lack in recognizing the facilitative relationship between creativity and rationale not only underestimates the benefits designers can obtain from rationale practices, but also confines the approaches that support creativity in software design. Our exploratory study provides empirical evidence of the positive correlation between rationale and creativity. Furthermore, we found that the feasibility of desig...

  13. Does Design Rationale Enhance Creativity?

    Directory of Open Access Journals (Sweden)

    Jing Wang

    2010-01-01

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

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

    OpenAIRE

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

    2012-01-01

    Abstract Background To describe the rationale and design of an observational cohort study analyzing the effects of endoscopic Totally Extraperitoneal (TEP) hernia repair on male fertility (MAIN study). Methods and design The MAIN study is an observational cohort study designed to assess fertility after endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specialized in TEP hernia repair. Male patients of 18-60 years of age, with primary, reducible, bilateral ingu...

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

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    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

  16. 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.

  17. Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

    Directory of Open Access Journals (Sweden)

    Tuvia Peri

    2016-05-01

    Full Text Available Background: Prolonged grief disorder (PGD is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR, originally designed for the treatment of posttraumatic stress disorder (PTSD in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective: In light of findings that cognitive behavior therapy (CBT, including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method: The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results: Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions: This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed.

  18. Rationale, design and methods of the HEALTHY study behavior intervention component.

    Science.gov (United States)

    Venditti, E M; Elliot, D L; Faith, M S; Firrell, L S; Giles, C M; Goldberg, L; Marcus, M D; Schneider, M; Solomon, S; Thompson, D; Yin, Z

    2009-08-01

    HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and

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

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    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

  20. [Venous thromboembolism's risk assessment: rationale, objectives, and methodology--the ARTE study].

    Science.gov (United States)

    França, Ana; De Sousa, Joaquim Abreu; Felicíssimo, Paulo; Ferreira, Daniel

    2011-12-01

    ), haemorrhagic events (major and minor haemorrhages) and death at 6 months after discharge. Each patient will be contacted by telephone at 3 and 6 months after discharge, in order to assess the occurrence of thromboembolic and haemorrhagic events, as well as any readmission. This article describes the ARTE study's rationale, objectives, and methodology. PMID:22849949

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

    Directory of Open Access Journals (Sweden)

    2005-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Prabhat Jha

    2006-02-01

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

  3. The Strathclyde Evaluation of Children's Active Travel (SE-CAT: study rationale and methods

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    McMinn David

    2011-12-01

    Full Text Available Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received the TG intervention increased self-reported distance travelled to school by active modes and reduced the distance travelled by inactive modes. This study was limited by self-reported outcome measures, a small sample, and no follow-up measures. A more robust evaluation of TG is required to address these limitations. This paper describes the rationale and methods for such an evaluation of Travelling Green, and describes the piloting of various active commuting measures in primary school children. Methods/Design Measures of active commuting were piloted in a sample of 26 children (aged 8-9 years over one school week. These measures were subsequently used in an 18-month quasi-experimental design to evaluate the effect of TG on commuting behaviour. Participants were 166 children (60% male aged 8-9 years from 5 primary schools. Two schools (n = 79 children received TG in September/October 2009. Three schools (n = 87 children acted as a comparison group, and subsequently received TG at a later date. Physical activity was measured using Actigraph GT1M accelerometers. Personal and environmental determinants of active commuting were measured via parent and child questionnaires, as were factors related to the Theory of Planned Behaviour and the construct of habit. Measures were taken pre- and post-intervention and at 5 and 12 months follow-up. Discussion The piloted protocol was practical and feasible and piloted measures were reliable and valid. All study data, including

  4. Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

    Science.gov (United States)

    Peri, Tuvia; Hasson-Ohayon, Ilanit; Garber, Sharon; Tuval-Mashiach, Rivka; Boelen, Paul A.

    2016-01-01

    Background Prolonged grief disorder (PGD) is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR), originally designed for the treatment of posttraumatic stress disorder (PTSD) in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective In light of findings that cognitive behavior therapy (CBT), including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed. Highlights of the article Prolonged grief disorder (PGD) affects approximately ten percent of bereaved people. Narrative Reconstruction (NR), an integrative therapy module originally used for PTSD patients, was adapted for PGD. NR consists

  5. 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

  6. POPE study: rationale and methodology of a study to phenotype patients with COPD in Central and Eastern Europe

    Science.gov (United States)

    Zbozinkova, Zuzana; Barczyk, Adam; Tkacova, Ruzena; Valipour, Arschang; Tudoric, Neven; Zykov, Kirill; Somfay, Attila; Miravitlles, Marc; Koblizek, Vladimir

    2016-01-01

    Introduction Chronic obstructive pulmonary disease (COPD) constitutes a major health challenge in Central and Eastern European (CEE) countries. However, clinical phenotypes, symptom load, and treatment habits of patients with COPD in CEE countries remain largely unknown. This paper provides a rationale for phenotyping COPD and describes the methodology of a large study in CEE. Methods/design The POPE study is an international, multicenter, observational cross-sectional survey of patients with COPD in CEE. Participation in the study is offered to all consecutive outpatients with stable COPD in 84 centers across the CEE region if they fulfill the following criteria: age >40 years, smoking history ≥10 pack-years, a confirmed diagnosis of COPD with postbronchodilator FEV1/FVC <0.7, and absence of COPD exacerbation ≥4 weeks. Medical history, risk factors for COPD, comorbidities, lung function parameters, symptoms, and pharmaceutical and nonpharmaceutical treatment are recorded. The POPE project is registered in ClinicalTrials.gov with the identifier NCT02119494. Outcomes The primary aim of the POPE study was to phenotype patients with COPD in a real-life setting within CEE countries using predefined classifications. Secondary aims of the study included analysis of differences in symptoms, and diagnostic and therapeutic behavior in participating CEE countries. Conclusion There is increasing acceptance toward a phenotype-driven therapeutic approach in COPD. The POPE study may contribute to reveal important information regarding phenotypes and therapy in real-life CEE. PMID:27042048

  7. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes.

    Science.gov (United States)

    Mango, Joseph; Cabiling, Eileen; Jones, Loretta; Lucas-Wright, Aziza; Williams, Pluscedia; Wells, Kenneth; Pulido, Esmeralda; Meldrum, Marcia; Ramos, Ana; Chung, Bowen

    2014-02-25

    "Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes" is a 2 minute, 46 second video summarizing the study rationale, study approach, and the 6-month outcomes. The video was produced by four agencies: Healthy African American Families II, a health advocacy organization in South Los Angeles; Behavioral Health Services, the largest substance/alcohol abuse service provider in LA County; UCLA; and RAND Health; contract filmmakers Eileen Cabiling and Joe Mango handled cinematography, editing, and video support. The individuals appearing in the video are key CPIC community and academic partners. The celebratory tone of the video is consistent with a Community Partnered Participatory Research approach, a local variant of participatory action research, where study findings are celebrated by the partners, and dissemination efforts include approaches intended for general audiences, especially from low-income, low-literacy, minority communities, in addition to traditional academic products like peer-reviewed scientific manuscripts. The CPIC video offers a community perspective on the study results to our partners, the general public, other scientists and policy makers. We designed the video to teach community and healthcare partners how to adapt and implement the CPIC depression care model and to offer other community -academic partnerships an example of a non-traditional product developed for dissemination from an NIH-funded research study. PMID:25364622

  8. 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.

  9. Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study

    Directory of Open Access Journals (Sweden)

    Kasenda Benjamin

    2012-08-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials

  10. The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Carlbring Per

    2013-02-01

    Full Text Available Abstract Background Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components. Methods/Design This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1 physical exercise without a clear treatment rationale; (2 physical exercise with treatment rationale; (3 behavioural activation with treatment rationale; or (4 behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period. Discussion The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed. Trial registration ClinicalTrials.gov: NCT01619930

  11. POPE study: rationale and methodology of a study to phenotype patients with COPD in Central and Eastern Europe

    Directory of Open Access Journals (Sweden)

    Zbozinkova Z

    2016-03-01

    Full Text Available Zuzana Zbozinkova,1 Adam Barczyk,2 Ruzena Tkacova,3 Arschang Valipour,4 Neven Tudoric,5 Kirill Zykov,6 Attila Somfay,7 Marc Miravitlles,8 Vladimir Koblizek91Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic; 2Department of Pneumology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland; 3Department of Respiratory Medicine, Faculty of Medicine, P.J. Safarik University, Kosice, Slovakia; 4Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Wien, Austria; 5School of Medicine Zagreb, University Hospital Dubrava, Zagreb, Croatia; 6Laboratory of Pulmonology, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia; 7Department of Pulmonology, University of Szeged, Deszk, Hungary; 8Pneumology Department, Hospital Universitari Vall d’Hebron, CIBER de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 9Department of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech RepublicIntroduction: Chronic obstructive pulmonary disease (COPD constitutes a major health challenge in Central and Eastern European (CEE countries. However, clinical phenotypes, symptom load, and treatment habits of patients with COPD in CEE countries remain largely unknown. This paper provides a rationale for phenotyping COPD and describes the methodology of a large study in CEE.Methods/design: The POPE study is an international, multicenter, observational cross-sectional survey of patients with COPD in CEE. Participation in the study is offered to all consecutive outpatients with stable COPD in 84 centers across the CEE region if they fulfill the following criteria: age >40 years, smoking history ≥10 pack-years, a confirmed diagnosis of COPD with postbronchodilator FEV1/FVC ,0.7, and absence

  12. Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

    Science.gov (United States)

    Bogenschutz, Michael P

    2013-03-01

    Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials. PMID:23627783

  13. Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

    Science.gov (United States)

    Bogenschutz, Michael P

    2013-03-01

    Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

  14. Rationale and Methods of the Substance Use and Psychological Injury Combat Study (SUPIC): A Longitudinal Study of Army Service Members Returning from Deployment in FY2008–2011

    OpenAIRE

    Larson, Mary Jo; Adams, Rachel Sayko; Mohr, Beth A.; Harris, Alex H.S.; Merrick, Elizabeth L.; Funk, Wendy; Hofmann, Keith; Wooten, Nikki R.; Jeffery, Diana D.; Williams, Thomas V.

    2013-01-01

    SUPIC will examine whether early detection and intervention for post-deployment problems among Army Active Duty and National Guard/Reservists returning from Iraq or Afghanistan are associated with improved long-term substance use and psychological outcomes. This paper describes the rationale and significance of SUPIC, and presents demographic and deployment characteristics of the study sample (N=643,205), and self-reported alcohol use and health problems from the subsample with matched post-d...

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

    OpenAIRE

    Cavalcanti, AB; Suzumura, ÉA; Amato, MB; Tallo, FS; Rezende, AC; Telles, MM; Takahashi, LN; Carvalho, VO; Díaz-Quijano, FA; Berwanger, O; Kodama, AA; Ribeiro, GF; Abreu, MO; Oliveira, IM; Guyatt, G

    2012-01-01

    Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter...

  16. Clinicians' perceptions of rationales for rehabilitative exercise in a critical care setting: A cross-sectional study

    OpenAIRE

    Nickels, M.; Aitken, L. M.; Walsham, J.; L. Watson; McPhail, S.

    2016-01-01

    Australian College of Critical Care Nurses Ltd. Background: Rehabilitative exercise for critically ill patients may have many benefits; however, it is unknown what intensive care unit (ICU) clinicians perceive to be important rationale for the implementation of rehabilitative exercise in critical care settings. Objective: To identify which rationales for rehabilitative exercise interventions were perceived by ICU clinicians to be important and determine whether perceptions were consistent acr...

  17. Combined targeting of EGFR-dependent and VEGF-dependent pathways: rationale, preclinical studies and clinical applications.

    Science.gov (United States)

    Tortora, Giampaolo; Ciardiello, Fortunato; Gasparini, Giampietro

    2008-09-01

    Cellular heterogeneity, redundancy of molecular pathways and effects of the microenvironment contribute to the survival, motility and metastasis of cells in solid tumors. It is unlikely that tumors are entirely dependent on only one abnormally activated signaling pathway; consequently, treatment with an agent that interferes with a single target may be insufficient. Combined blockade of functionally linked and relevant multiple targets has become an attractive therapeutic strategy. The EGFR and ERBB2 (HER2) pathways and VEGF-dependent angiogenesis have a pivotal role in cancer pathogenesis and progression. Robust experimental evidence has shown that these pathways are functionally linked and has demonstrated a suggested role for VEGF in the acquired resistance to anti-ERBB drugs when these receptors are pharmacologically blocked. Combined inhibition of ERBB and VEGF signaling interferes with a molecular feedback loop responsible for acquired resistance to anti-ERBB agents and promotes apoptosis while ablating tumor-induced angiogenesis. To this aim, either two agents highly selective against VEGF and ERBB respectively, or, alternatively, a single multitargeted agent, can be used. Preclinical studies have proven the efficacy of both these approaches and early clinical studies have provided encouraging results. This Review discusses the experimental rationale for, preclinical studies of and clinical trials on combined blockade of ERBB and VEGF signaling.

  18. The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods.

    Science.gov (United States)

    Swift, Damon L; Dover, Sara E; Nevels, Tyara R; Solar, Chelsey A; Brophy, Patricia M; Hall, Tyler R; Houmard, Joseph A; Lutes, Lesley D

    2015-11-01

    Recent data has suggested that prolonged sedentary behavior is independent risk factor for cardiovascular and all-cause mortality independent of adequate amounts of moderate to vigorous physical activity. However, few studies have prospectively evaluated if exercise training and increasing non-exercise physical activity leads to greater reduction in cardiometabolic risk compared to aerobic training alone. The purpose of the Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study is to determine whether a physical activity program composed of both aerobic training (consistent with public health recommendations) and increasing non-exercise physical activity (3000 steps above baseline levels) leads to enhanced improvements in waist circumference, oral glucose tolerance, systemic inflammation, body composition, and fitness compared to aerobic training alone in obese adults (N=45). Commercially available accelerometers (Fitbits) will be used to monitor physical activity levels and behavioral coaching will be used to develop strategies of how to increase non-exercise physical activity levels. In this manuscript, we describe the design, rationale, and methodology associated with the I-CAN study. PMID:26542389

  19. Skirting around Critical Feminist Rationales for Teaching Women in Social Studies

    Science.gov (United States)

    Schmeichel, Mardi

    2015-01-01

    Feminist practices can provide firm theoretical grounding for the kind of social studies that scholars promote, especially in relation to efforts to include women in the curriculum. However, in P-12 social studies education, neither women nor feminism receive much attention. The study described in this article was a discourse analysis of 16…

  20. 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

    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...... population differed slightly from the overall cohort but the differences were small for most characteristics and centres. The overall results suggest that, after adjustment for age, dietary intakes estimated from calibration samples can reasonably be interpreted as representative of the main cohorts in most...

  1. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study : rationale and methods

    NARCIS (Netherlands)

    Kaplan, Bonnie J.; Giesbrecht, Gerald F.; Leung, Brenda M. Y.; Field, Catherine J.; Dewey, Deborah; Bell, Rhonda C.; Manca, Donna P.; O'Beirne, Maeve; Johnston, David W.; Pop, Victor J.; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P.; Eliasziw, Misha; McCargar, Linda J.; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M.; Letourneau, Nicole; Martin, Jonathan W.

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their offsp

  2. The Netherlands Study of Depression and Anxiety (NESDA): rationale, objectives and methods

    NARCIS (Netherlands)

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H; Zitman, F.G.; Nolen, W.A.; Spinhoven, P; Cuijpers, P.; De Jong, P.J.; Van Marwijk, H.W.J.; Assendelft, W.J.J.; Van Der Meer, K.; Verhaak, P.; Wensing, M.; de Graaf, R.; Hoogendijk, W.J.; Ormel, J.; Van Dyck, R.

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

  3. The Netherlands Study of Depression and Anxiety (NESDA): rationale, objectives and methods.

    NARCIS (Netherlands)

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H.; Zitman, F.G.; Nolen, W.A.; Spinhoven, P.; Cuijpers, P.; Jong, P.J. de; Marwijk, H.W.J. van; Assendelft, W.J.J.; Meer, K. van der; Verhaak, P.; Wensing, M.; Graaf, R. de; Hoogendijk, W.J.; Ormel, J.; Dyck, R. van

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

  4. The Netherlands Study of Depression and Anxiety (NESDA) : rationale, objectives and methods

    NARCIS (Netherlands)

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H.; Zitman, F.G.; Nolen, W.A.; Spinhoven, P.; Cuijpers, P.; de Jong, P.J.; Van Marwijk, H.W.J.; Assendelft, W.J.J.; van der Meer, K.; Verhaak, P.; Wensing, M.; de Graaf, R.; Hoogendijk, W.J.; Ormel, J.; Van Dyck, R.

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

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

    Science.gov (United States)

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

    2015-03-01

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

  6. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study: rationale and methods.

    Science.gov (United States)

    Kaplan, Bonnie J; Giesbrecht, Gerald F; Leung, Brenda M Y; Field, Catherine J; Dewey, Deborah; Bell, Rhonda C; Manca, Donna P; O'Beirne, Maeve; Johnston, David W; Pop, Victor J; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P; Eliasziw, Misha; McCargar, Linda J; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M; Letourneau, Nicole; Martin, Jonathan W

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their offspring and many of their partners). The primary aims of the APrON study were to determine the relationships between maternal nutrient intake and status, before, during and after gestation, and (1) maternal mood; (2) birth and obstetric outcomes; and (3) infant neurodevelopment. We have collected comprehensive maternal nutrition, anthropometric, biological and mental health data at multiple points in the pregnancy and the post-partum period, as well as obstetrical, birth, health and neurodevelopmental outcomes of these pregnancies. The study continues to follow the infants through to 36 months of age. The current report describes the study design and methods, and findings of some pilot work. The APrON study is a significant resource with opportunities for collaboration.

  7. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

    Directory of Open Access Journals (Sweden)

    Lutschg Meghan Z

    2011-10-01

    Full Text Available Abstract Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control. All participants at the hospital (cluster were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful

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

    Science.gov (United States)

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

    2015-10-01

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

  9. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C;

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90% ...

  10. Learning environments’ activity potential for preschoolers (LEAPP: study rationale and design

    Directory of Open Access Journals (Sweden)

    Patricia Tucker

    2013-09-01

    Full Text Available 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 environments requesting participation from preschoolers aged 2.5-5 years. Data collection included: Actical accelerometers (MiniMitter, Oregon, USA to measure the activity levels of children for five consecutive days (15-second epoch length while in care; the Environment and Policy Assessment and Observation tool to explore the early learning environment’s impact on activity; anthropometric data; the Child Temperament Questionnaire to assess the influence of preschoolers’ temperament on physical activity; and demographic information from parents/guardians and early learning staff. ANOVA and linear regression analyses will be conducted to assess variances in activity levels among preschoolers attending different early learning types and to explore the impact of early learning environments on their activity levels. Independent sample t-tests will be used to examine differences in activity levels based on sex and weight status.Expected impact of the study for public health. This research will provide the first Canadian data to address environmental influences on preschoolers’ activity levels in differing early learning environments. Additionally, this work will highlight the extent to which activity levels vary among preschoolers enrolled in full-day kindergarten, centre-, and home-based childcare.

  11. The Strathclyde Evaluation of Children's Active Travel (SE-CAT): study rationale and methods

    OpenAIRE

    McMinn David; Rowe David A; Murtagh Shemane; Nelson Norah M

    2011-01-01

    Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG) is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received th...

  12. The Cooperative Health Research in South Tyrol (CHRIS) study: rationale, objectives, and preliminary results.

    Science.gov (United States)

    Pattaro, Cristian; Gögele, Martin; Mascalzoni, Deborah; Melotti, Roberto; Schwienbacher, Christine; De Grandi, Alessandro; Foco, Luisa; D'Elia, Yuri; Linder, Barbara; Fuchsberger, Christian; Minelli, Cosetta; Egger, Clemens; Kofink, Lisa S; Zanigni, Stefano; Schäfer, Torsten; Facheris, Maurizio F; Smárason, Sigurður V; Rossini, Alessandra; Hicks, Andrew A; Weiss, Helmuth; Pramstaller, Peter P

    2015-11-05

    The Cooperative Health Research In South Tyrol (CHRIS) study is a population-based study with a longitudinal lookout to investigate the genetic and molecular basis of age-related common chronic conditions and their interaction with life style and environment in the general population. All adults of the middle and upper Vinschgau/Val Venosta are invited, while 10,000 participants are anticipated by mid-2017. Family participation is encouraged for complete pedigree reconstruction and disease inheritance mapping. After a pilot study on the compliance with a paperless assessment mode, computer-assisted interviews have been implemented to screen for conditions of the cardiovascular, endocrine, metabolic, genitourinary, nervous, behavioral, and cognitive system. Fat intake, cardiac health, and tremor are assessed instrumentally. Nutrient intake, physical activity, and life-course smoking are measured semi-quantitatively. Participants are phenotyped for 73 blood and urine parameters and 60 aliquots per participant are biobanked (cryo-preserved urine, DNA, and whole and fractionated blood). Through liquid-chromatography mass-spectrometry analysis, metabolite profiling of the mitochondrial function is assessed. Samples are genotyped on 1 million variants with the Illumina HumanOmniExpressExome array and the first data release including 4570 fully phenotyped and genotyped samples is now available for analysis. Participants' follow-up is foreseen 6 years after the first visit. The target population is characterized by long-term social stability and homogeneous environment which should both favor the identification of enriched genetic variants. The CHRIS cohort is a valuable resource to assess the contribution of genomics, metabolomics, and environmental factors to human health and disease. It is awaited that this will result in the identification of novel molecular targets for disease prevention and treatment.

  13. The health outcomes and physical activity in preschoolers (HOPP study: rationale and design

    Directory of Open Access Journals (Sweden)

    Timmons Brian W

    2012-04-01

    Full Text Available Abstract Background The early years are the period of growth for which we know the least about the impact of physical activity. In contrast, we know that more than 90 % of school-aged Canadian children, for example, are not meeting physical activity recommendations. Such an activity crisis is a major contributor to recent trends in childhood obesity, to which preschoolers are not immune. The World Health Organization estimated that more than 42 million children under the age of 5 years were overweight world-wide in 2010. If an activity crisis exists during the preschool years, we should also be concerned about its broader impact on health. Unfortunately, the relationship between physical activity and health during the early years is poorly understood. The goal of the Health Outcomes and Physical activity in Preschoolers (HOPP study is to describe how the prevalence and patterns of physical activity in preschoolers are associated with indices of health. Methods The HOPP study is a prospective cohort study. We aim to recruit 400 3- to 5-year-old children (equal number of boys and girls and test them once per year for 3 years. Each annual assessment involves 2 laboratory visits and 7 consecutive days of physical activity monitoring with protocols developed in our pilot work. At visit 1, we assess body composition, aerobic fitness, short-term muscle power, motor skills, and have the parents complete a series of questionnaires related to their child’s physical activity, health-related quality of life and general behaviour. Over 7 consecutive days each child wears an accelerometer on his/her waist to objectively monitor physical activity. The accelerometer is programmed to record movement every 3 s, which is needed to accurately capture the intensity of physical activity. At visit 2, we assess vascular structure and function using ultrasound. To assess the associations between physical activity and health outcomes, our primary analysis will involve

  14. Prevalence of Work-Related Asthma in Primary Health Care: Study Rationale and Design

    Science.gov (United States)

    Rabell-Santacana, Ventura; Panadès-Valls, Rafael; Vila-Rigat, Rosa; Hernandez-Huet, Enric; Sivecas-Maristany, Joan; Blanché-Prat, Xavier; Prieto, Gemma; Muñoz, Laura; Torán, Pere

    2015-01-01

    Background : Occupational Asthma (OA) is the most frequent origin of occupational respiratory diseases in industrialized countries and accounts for between 5% and 25% of asthmatic patients. The correct and early diagnosis of OA is of great preventive and socio-economic importance. However, few studies exist on OA’s prevalence in Catalonia and in Spain and those affected are mainly treated by the public health services and not by the occupational health services, which are private. Objective : To determine the prevalence of OA in patients diagnosed with asthma in the Primary Healthcare system and to evaluate the socio-economic impact of OA in the Primary Healthcare system. Methods/Design : We will carry out an observational, transversal and multi-center study in the Primary Healthcare Service in the Barcelona region (Catalonia, Spain), with 385 asthmatic workers aged between 16 and 64 who are currently working or have been working in the past. We will confirm the asthma diagnosis in each patient, and those meeting the inclusion criteria will be asked to answer a questionnaire that aims to link asthma to the patient’s past employment history. The resulting diagnosis will be of either occupational asthma, work-aggravated asthma or common asthma. We will also collect socio-demographic information about the patients, about their smoking status, their exposure outside of the workplace, their work situation at the onset of the symptoms, their employment history, their symptoms of asthma, their present and past medical asthma treatment, and, in order to estimate the economic impact in the Primary Healthcare system, where they have been attended to and treated. Prevalence will link OA or work-aggravated asthma to the total of patients participating in the study with a asthma diagnosis. Discussion : The results will show the prevalence of OA and work-aggravated asthma, and shall provide valuable information to set out and apply the necessary personal and technical

  15. 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

  16. A family smoking index to capture genetic influence in smoking: rationale and two validation studies.

    Science.gov (United States)

    Drobes, David J; Munafò, Marcus R; Leigh, Fiona; Saladin, Michael E

    2005-02-01

    Despite a growing appreciation that genetic factors may impart vulnerability toward smoking behavior, only a modest consensus has been created about the specific genetic mechanisms that may underlie various aspects of smoking. A core feature of genetic contribution toward any complex human behavior is familial resemblance. Most previous attempts to index familial smoking have classified individuals into discrete categories, based on the number of smokers in a family. We discuss the development of a continuous measure of familial smoking, the Family Smoking Index (FSI), which is based on the proportion of smokers in first- and second-degree family members and provides a more precise weighting according to genetic proximity. We present the psychometric characteristics of the FSI as well as initial validation data from two studies. We also describe current and future directions for continued FSI validation and application.

  17. Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design

    DEFF Research Database (Denmark)

    Parving, Hans-Henrik; Brenner, Barry M; McMurray, John J V;

    2009-01-01

    , resuscitated death, myocardial infarction, stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease or doubling of baseline serum creatinine concentration. Secondary endpoints include a composite CV endpoint and a composite renal endpoint. CONCLUSION: ALTITUDE will determine...... the residual renal and cardiovascular risk still remains high. Aliskiren a novel oral direct renin inhibitor that unlike ACEi and ARBs, lowers plasma renin activity, angiotensin I and angiotensin II levels, may thereby provide greater benefit compared to ACEi or ARB alone. METHODS: The primary objective...... of the ALTITUDE trial is to determine whether aliskiren 300 mg once daily, reduces cardiovascular and renal morbidity and mortality compared with placebo when added to conventional treatment (including ACEi or ARB). ALTITUDE is an international, randomized, double-blind, placebo-controlled, parallel-group study...

  18. Rationale and design of South Asian Birth Cohort (START: a Canada-India collaborative study

    Directory of Open Access Journals (Sweden)

    Anand Sonia S

    2013-01-01

    Full Text Available Abstract Background People who originate from the Indian subcontinent (South Asians suffer among the highest rates of type 2 diabetes in the world. Prior evidence suggests that metabolic risk factors develop early in life and are influenced by maternal and paternal behaviors, the intrauterine environment, and genetic factors. The South Asian Birth Cohort Study (START will investigate the environmental and genetic basis of adiposity among 750 South Asian offspring recruited from highly divergent environments, namely, rural and urban India and urban Canada. Methods Detailed information on health behaviors including diet and physical activity, and blood samples for metabolic parameters and DNA are collected from pregnant women of South Asian ancestry who are free of significant chronic disease. They also undergo a provocative test to diagnose impaired glucose tolerance and gestational diabetes. At delivery, cord blood and newborn anthropometric indices (i.e. birth weight, length, head circumference and skin fold thickness are collected. The mother and growing offspring are followed prospectively and information on the growth trajectory, adiposity and health behaviors will be collected annually up to age 3 years. Our aim is to recruit a minimum of 750 mother-infant pairs equally divided between three divergent environments: rural India, urban India, and Canada. Summary The START cohort will increase our understanding of the environmental and genetic determinants of adiposity and related metabolic abnormalities among South Asians living in India and Canada.

  19. PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

    Science.gov (United States)

    Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

    2014-01-01

    Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

  20. Study design, objectives, hypotheses, main findings, health consequences for the population exposed, rationale of future research

    Energy Technology Data Exchange (ETDEWEB)

    Trnovec, T.; Kocan, A. [Slovak Medical Univ., Bratislava (Slovakia); Bencko, V. [Charles Univ., Prague (Czech Republic); Langer, P. [Institute of Experimental Endocrinology SAS, Bratislava (Slovakia); Berg, M. van den [Rijksuniversiteit Utrecht (Netherlands); Bergman, A. [Stockholm Univ. (Sweden); Hustak, M. [Air Force Military Hospital, Kosics (Slovakia)

    2004-09-15

    In Slovakia, the Chemko Chemical Company, based in Strazske, in the Michalovce district, produced PCBs between 1959 and 1984, in the amount of more than 21,000 tons of commercial mixtures (Delor 103, 104, 105, 106, Delotherm DK and DH, Hydelor 137). PCBs were used for similar industrial purposes as in the west. Improper disposal from the Chemko plant via release of effluent directly into the Laborec River resulted in long-term contamination of sediment. As a result eastern Slovakia, the Michalovce district in particular, is recognized as one of the areas all over the world most heavily polluted with PCBs. Historical studies show that blood and adipose PCB levels were higher in Czechoslovakia than elsewhere in the 1970's and 1980's. Current data indicate that persons who eat locally raised food - pork, beef, poultry, eggs - in this district have elevated serum concentrations of PCBs. Environmental exposure to organochlorines in the Michalovce district indicate association with higher rates of certain cancers, but an inverse association with risk of breast cancer. An increased prevalence of thyroid disorders in the polluted area was also reported. This ''experimental setting in nature'' has attracted international scientific teams and two projects in the area are ongoing: Evaluating Human Health Risk from Low-dose and Long-term PCB Exposure, 5{sup th} FP Project QLK4-2000-00488, 2001- 2004; PCBRISK (http://www.pcbrisk.sk/) and Early Childhood Development and PCB Exposures in Slovakia, NCI/NIH, R01-CA96525 University of California, Davis, USA. This paper is serving as an introduction to papers of a session reporting on various health outcomes associated with PCB exposure. The objectives of the PCBRISK project were targeted at an evaluation of the human health risks of low-dose and long-term exposure to a group of persistent organochlorine pollutants, including polychlorinated biphenyls (PCBs) and their metabolites, organochlorine

  1. Danish pain specialists' rationales behind the choice of fentanyl transdermal patches and oral transmucosal systems-A Delphi study

    DEFF Research Database (Denmark)

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2009-01-01

    survey. Response rates were 45% in the brainstorming and 88% in the rating phases, respectively. Statistical analysis with SPSS for Windows 15.00 included descriptive statistics and factor analysis. Results. The most important rationale to choose fentanyl patches was that patients' clinical condition did...

  2. The New Social Studies for the Slow Learner: A Rationale for a Junior High American History Course.

    Science.gov (United States)

    Blackwell, Velvelyn; And Others

    This is a curriculum rationale developed as a preliminary to the development and testing of curricular materials in the slow learner classroom situation. Chapter one disucsses individual characteristics and a definition of a slow learner. The remainder of the report analyzes approaches to teaching, taking into consideration these characteristics.…

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

    Directory of Open Access Journals (Sweden)

    Schouten Nelleke

    2012-05-01

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

  4. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  5. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

    Directory of Open Access Journals (Sweden)

    Berry Diane C

    2012-03-01

    Full Text Available Abstract Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. Methods/Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy. A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I, 9 months of continued monthly contact

  6. Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

    International Nuclear Information System (INIS)

    This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196 refs., 4 figs., 36 tabs

  7. Significance of Haemodynamic and Haemostatic Factors in the Course of Different Manifestations of Cerebral Small Vessel Disease: The SHEF-CSVD Study—Study Rationale and Protocol

    Directory of Open Access Journals (Sweden)

    Jacek Staszewski

    2013-01-01

    Full Text Available Rationale. This paper describes the rationale and design of the SHEF-CSVD Study, which aims to determine the long-term clinical and radiological course of cerebral small vessel disease (CSVD and to evaluate haemostatic and haemodynamic prognostic factors of the condition. Design. This single-centre, prospective, non-interventional cohort study will follow 150 consecutive patients with different clinical manifestations of CSVD (lacunar ischaemic stroke, vascular dementia, vascular parkinsonism or spontaneous deep, intracerebral haemorrhage and 50 age- and sex-matched controls over a period of 24 months. The clinical and radiological course will be evaluated basing on a detailed neurological, neuropsychological and MRI examinations. Haemodynamic (cerebral vasoreactivity, 24 h blood pressure control and haemostatic factors (markers of endothelial and platelet dysfunction, brachial artery flow-mediated dilatation test will be determined. Discussion. The scheduled study will specifically address the issue of haemodynamic and haemostatic prognostic factors and their course over time in various clinical manifestations of CSVD. The findings may aid the development of prophylactic strategies and individualised treatment plans, which are critical during the early stages of the disease.

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

    Directory of Open Access Journals (Sweden)

    Meylaerts Sven AG

    2011-07-01

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

  9. Population-based multicase-control study in common tumors in Spain (MCC-Spain: rationale and study design

    Directory of Open Access Journals (Sweden)

    Gemma Castaño-Vinyals

    2015-07-01

    Discussion: This study, conducted within the Spanish Consortium for Biomedical Research in Epidemiology & Public Health (CIBERESP, is a unique initiative to evaluate etiological factors for common cancers and will promote cancer research and prevention in Spain.

  10. Case study research as bridge builder between science and the society. The rationale behind the ASTRA 2005 winter storm study

    Energy Technology Data Exchange (ETDEWEB)

    Haanpaeae, S.; Peltonen, L.

    2007-07-01

    The challenge of climate change as a complex global issue is that it demands locally grounded solutions that bring together actors from various fields. As a 'wicked' problem climate change adaptation demands deliberation between different subsystems of society, including scientific research. While answering the complex needs of the society, it has to be re-evaluated what 'good' science means. This brings about a need for socially robust knowledge. The need for contextualisation of scientific knowledge is supported by theoretical development in the fields of policy analysis and risk governance. It also entails an epistemic shift away from the 'quest for certainty' towards a pragmatist understanding of knowledge. The underlying request is to integrate expert knowledge with the needs of other stakeholders - to bring in the people to add to the policy formation a notion of emotional knowledge. As a research method, case studies readily contextualise scientific information and therefore offer valuable insights into the underlying social values of the problems at hand. As locally grounded narratives they can offer a shortcut to the formation of a new kind of expertise needed as the demands from the society reform the claims on scientific information. It is argued that developing the science-policy interface and risk communication can both benefit from a contextual research approach using case studies. Such studies have critical and persuasive functions, and they provide a basis for further case-based learning exercises with opportunities for awareness raising, institutional capacity building and practical adaptation measures. (orig.)

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

    Science.gov (United States)

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

    2016-01-01

    Introduction Chronic inguinal pain is a frequently occurring problem in athletes. A diagnosis of inguinal disruption is performed by exclusion of other conditions causing groin pain. Up to now, conservative medical management is considered to be the primary treatment for this condition. Relevant large and prospective clinical studies regarding the treatment of inguinal disruption are limited; however, recent studies have shown the benefits of the totally extraperitoneal patch (TEP) technique. This study provides a complete assessment of the inguinal area in athletes with chronic inguinal pain before and after treatment with the TEP hernia repair technique. Methods and analysis We describe the rationale and design of an observational cohort study for surgical treatment with the endoscopic TEP hernia repair technique in athletes with a painful groin (inguinal disruption). The study is being conducted in a high-volume, single centre hospital with specialty in TEP hernia repair. Patients over 18 years, suffering from inguinal pain for at least 3 months during or after playing sports, and whom have not undergone previous inguinal surgery and have received no benefit from physiotherapy are eligible for inclusion. Patients with any another cause of inguinal pain, proven by physical examination, inguinal ultrasound, X-pelvis/hip or MRI are excluded. Primary outcome is reduction in pain after 3 months. Secondary outcomes are pain reduction, physical functioning, and resumption of sport (in frequency and intensity). Ethics and dissemination An unrestricted research grant for general study purposes was assigned to the Hernia Centre. This study itself is not directly subject to the above mentioned research grant or any other financial sponsorship. We intend to publish the outcome of the study, regardless of the findings. All authors will give final approval of the manuscript version to be published. PMID:26739740

  12. 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

  13. Rationale Management Challenges in Requirements Engineering

    NARCIS (Netherlands)

    Liang, Peng; Avgeriou, Paris; He, Keqing

    2010-01-01

    Rationale and rationale management have been playing an increasingly prominent role in software system development mainly due to the knowledge demand during system evaluation, maintenance, and evolution, especially for large and complex systems. The rationale management for requirements engineering,

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

    Directory of Open Access Journals (Sweden)

    2008-06-01

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

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

    Directory of Open Access Journals (Sweden)

    2012-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Hermans Michel P

    2011-09-01

    Full Text Available Abstract 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

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

    OpenAIRE

    ,

    2008-01-01

    Background Surgeons agree on the benefits of operative treatment of tibial fractures – the most common of long bone fractures – with an intramedullary rod or nail. Rates of re-operation remain high – between 23% and 60% in prior trials – and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better. Methods/Design The objective of this trial was to assess the impac...

  18. A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

    Directory of Open Access Journals (Sweden)

    Malcolm W. Battersby

    2010-03-01

    Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

  19. A framework for design rationale capture and use during geometry design

    OpenAIRE

    Van Schaik, Jeroen Robbert

    2014-01-01

    Despite broad agreement on the utility of design rationale use and capture, a review of the relevant literature shows that industrial usage remains limited, especially during geometry design. An initial field study confirmed low design rationale capture during the geometry design stage. The lack of linking between design rationale and geometry models is identified as a factor holding back design rationale capture. A toolset is presented to link entities in geometry models to design ra...

  20. 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

  1. Rationale and design of the Leipzig (LIFE Heart Study: phenotyping and cardiovascular characteristics of patients with coronary artery disease.

    Directory of Open Access Journals (Sweden)

    Frank Beutner

    Full Text Available OBJECTIVE: We established the Leipzig (LIFE Heart Study, a biobank and database of patients with different stages of coronary artery disease (CAD for studies of clinical, metabolic, cellular and genetic factors of cardiovascular diseases. DESIGN: The Leipzig (LIFE Heart Study (NCT00497887 is an ongoing observational angiographic study including subjects with different entities of CAD. Cohort 1, patients undergoing first-time diagnostic coronary angiography due to suspected stable CAD with previously untreated coronary arteries. Cohort 2, patients with acute myocardial infarction (MI requiring percutaneous revascularization. Cohort 3, patients with known left main coronary artery disease (LMCAD. RESULTS: We present preliminary results of demographics and phenotyping based on a 4-years analysis of a total of 3,165 subjects. Cohort 1 (n=2,274 shows the typical distribution of elective coronary angiography cohorts with 43% cases with obstructive CAD and 37% normal angiograms. Cohorts 2 and 3 consist of 590 and 301 subjects, respectively, adding patients with severe forms of CAD. The suitability of the database and biobank to perform association studies was confirmed by replication of the CAD susceptibility locus on chromosome 9p21 (OR per allele: 1.55 (any CAD, 1.54 (MI, 1.74 (LMCAD, p<10(-6, respectively. A novel finding was that patients with LMCAD had a stronger association with 9p21 than patients with obstructive CAD without LMCAD (OR 1.22, p=0.042. In contrast, 9p21 did not associate with myocardial infarction in excess of stable CAD. CONCLUSION: The Leipzig (LIFE Heart Study provides a basis to identify molecular targets related to atherogenesis and associated metabolic disorders. The study may contribute to an improvement of individual prediction, prevention, and treatment of CAD.

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

    DEFF Research Database (Denmark)

    Støylen, Asbjørn; Conraads, Viviane; Halle, Martin;

    2011-01-01

    interval training at high relative intensity would yield significantly larger effects in terms of left ventricular remodelling compared to moderate continuous exercise training. Study design: In a three-armed randomized multicentre study of stable heart failure patients with left ventricular ejection......)), biomarkers, quality of life, and level of physical activity assessed by questionnaires. In addition, long-term maintenance of effects after the supervised training period will be determined. Assessments will be made at baseline, after the 12-week intervention programme, and at 1-year follow up. A total...

  3. Design and rationale for RE-VERSE AD : A phase 3 study of idarucizumab, a specific reversal agent for dabigatran

    NARCIS (Netherlands)

    Pollack, Charles V.; Reilly, Paul A.; Bernstein, Richard; Dubiel, Robert; Eikelboom, John; Glund, Stephan; Huisman, Menno V.; Hylek, Elaine; Kam, Chak-Wah; Kamphuisen, Pieter W.; Kreuzer, Joerg; Levy, Jerrold H.; Sellke, Frank; Stangier, Joachim; Steiner, Thorsten; Wang, Bushi; Weitz, Jeffrey I.

    2015-01-01

    Idarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD (TM)) is a global phase 3 p

  4. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA

    Directory of Open Access Journals (Sweden)

    Jiménez Francisco

    2010-06-01

    Full Text Available Abstract Background The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Methods/Design Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Discussion Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336.

  5. Markers of achievement for assessing and monitoring gender equity in translational research organisations: a rationale and study protocol

    Science.gov (United States)

    Edmunds, Laurel D; Pololi, Linda H; Greenhalgh, Trisha; Kiparoglou, Vasiliki; Henderson, Lorna R; Williamson, Catherine; Grant, Jonathan; Lord, Graham M; Channon, Keith M; Lechler, Robert I; Buchan, Alastair M

    2016-01-01

    Introduction Translational research organisations (TROs) are a core component of the UK's expanding research base. Equity of career opportunity is key to ensuring a diverse and internationally competitive workforce. The UK now requires TROs to demonstrate how they are supporting gender equity. Yet, the evidence base for documenting such efforts is sparse. This study is designed to inform the acceleration of women's advancement and leadership in two of the UK's leading TROs—the National Institute for Health Research (NIHR) Biomedical Research Centres (BRCs) in Oxford and London—through the development, application and dissemination of a conceptual framework and measurement tool. Methods and analysis A cross-sectional retrospective evaluation. A conceptual framework with markers of achievement and corresponding candidate metrics has been specifically designed for this study based on an adapted balanced scorecard approach. It will be refined with an online stakeholder consultation and semistructured interviews to test the face validity and explore practices and mechanisms that influence gender equity in the given settings. Data will be collected via the relevant administrative databases. A comparison of two funding periods (2007–2012 and 2012–2017) will be carried out. Ethics and dissemination The University of Oxford Clinical Trials and Research Governance Team and the Research and Development Governance Team of Guy's and St Thomas’ National Health Service (NHS) Foundation Trust reviewed the study and deemed it exempt from full ethics review. The results of the study will be used to inform prospective planning and monitoring within the participating NIHR BRCs with a view to accelerating women's advancement and leadership. Both the results of the study and its methodology will be further disseminated to academics and practitioners through the networks of collaborating TROs, relevant conferences and articles in peer-reviewed journals. PMID:26743702

  6. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF)

    DEFF Research Database (Denmark)

    Pitt, Bertram; Anker, Stefan D; Böhm, Michael;

    2015-01-01

    AIMS: To investigate the safety and potential efficacy of the novel non-steroidal mineralocorticoid receptor antagonist finerenone in patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and at high risk of hyperkalaemia and worsening renal...... with eplerenone. Other objectives are to assess the effects of finerenone on a composite clinical endpoint (death from any cause, cardiovascular hospitalizations, or emergency presentations for worsening chronic HF), and on changes in health-related quality of life from baseline. CONCLUSIONS: ARTS-HF is the first...... dysfunction. METHODS AND RESULTS: The MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF; NCT01807221) is a multicentre, randomized, double-blind, active-comparator-controlled, six-parallel-group, phase 2b dose-finding study. In total, 1060 patients with HFrEF and concomitant type...

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

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

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

  8. 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

  9. British randomised controlled trial of AV and VV optimization (“BRAVO”) study: rationale, design, and endpoints

    OpenAIRE

    Whinnett, Z I; Sohaib, S. M.; Jones, S; Kyriacou, A.; March, K.; Coady, E.; Mayet, J; Hughes, A. D.; Frenneaux, M.; Francis, D. P.; BRAVO Investigators, The

    2014-01-01

    Background Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources. Methods...

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

    Science.gov (United States)

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

    2015-04-27

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

  11. 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.

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

    Science.gov (United States)

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

    2014-01-01

    The ongoing 1000 brains study (1000BRAINS) is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR) Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions and language; examination of motor skills; ratings of personality, life quality, mood and daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla) of the brain. The latter includes (i) 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii) three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fiber tracking and for diffusion kurtosis imaging; (iii) resting-state and task-based functional MRI; and (iv) fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i) comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii) identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates. PMID:25071558

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

    Directory of Open Access Journals (Sweden)

    Cimminiello Claudio

    2010-08-01

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

  14. Late outcomes after acute pulmonary embolism: rationale and design of FOCUS, a prospective observational multicenter cohort study.

    Science.gov (United States)

    Konstantinides, Stavros V; Barco, Stefano; Rosenkranz, Stephan; Lankeit, Mareike; Held, Matthias; Gerhardt, Felix; Bruch, Leonard; Ewert, Ralf; Faehling, Martin; Freise, Julia; Ghofrani, Hossein-Ardeschir; Grünig, Ekkehard; Halank, Michael; Heydenreich, Nadine; Hoeper, Marius M; Leuchte, Hanno H; Mayer, Eckhard; Meyer, F Joachim; Neurohr, Claus; Opitz, Christian; Pinto, Antonio; Seyfarth, Hans-Jürgen; Wachter, Rolf; Zäpf, Bianca; Wilkens, Heinrike; Binder, Harald; Wild, Philipp S

    2016-11-01

    Acute pulmonary embolism (PE) is a frequent cause of death and serious disability. The risk of PE-associated mortality and morbidity extends far beyond the acute phase of the disease. In earlier follow-up studies, as many as 30 % of the patients died during a follow-up period of up to 3 years, and up to 50 % of patients continued to complain of dyspnea and/or poor physical performance 6 months to 3 years after the index event. The most feared 'late sequela' of PE is chronic thromboembolic pulmonary hypertension (CTEPH), the true incidence of which remains obscure due to the large margin of error in the rates reported by mostly small, single-center studies. Moreover, the functional and hemodynamic changes corresponding to early, possibly reversible stages of CTEPH, have not been systematically investigated. The ongoing Follow-Up after acute pulmonary embolism (FOCUS) study will prospectively enroll and systematically follow, over a 2-year period and with a standardized comprehensive program of clinical, echocardiographic, functional and laboratory testing, a large multicenter prospective cohort of 1000 unselected patients (all-comers) with acute symptomatic PE. FOCUS will possess adequate power to provide answers to relevant remaining questions regarding the patients' long-term morbidity and mortality, and the temporal pattern of post-PE abnormalities. It will hopefully provide evidence for future guideline recommendations regarding the selection of patients for long-term follow-up after PE, the modalities which this follow-up should include, and the findings that should be interpreted as indicating progressive functional and hemodynamic post-PE impairment, or the development of CTEPH.

  15. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

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

    Science.gov (United States)

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

    2013-04-01

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

  17. 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

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

    Science.gov (United States)

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

    2013-04-01

    Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation; from a pathophysiological point of view it involves many components, including mucus hypersecretion, oxidative stress and inflammation. N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is controversial; a dose-effect relationship has been demonstrated, but at present it is not known whether a higher dose provides clinical benefits. The PANTHEON Study is a prospective, ICS stratified, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial designed to assess the efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to first exacerbation, as well as quality of life and pulmonary function. The hypothesis, design and methodology are described and baseline characteristics of recruited patients are presented. 1006 COPD patients (444 treated with maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China. Final results of this study will provide objective data on the effects of high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD exacerbations and other outcome variables. PMID:23061828

  19. 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

  20. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery

    Directory of Open Access Journals (Sweden)

    Turpie AG

    2012-06-01

    Full Text Available Alexander GG Turpie,1 André C Schmidt,2 Reinhold Kreutz,3 Michael R Lassen,4 Waheed Jama,1,2 Lorenzo Mantovani,5 Sylvia Haas61Department of Medicine, Hamilton Health Sciences, General Division, Ontario, Canada; 2Bayer Healthcare Pharmaceuticals, Global Development, Berlin, Germany; 3Institut für Klinische Pharmakologie und Toxikologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany; 4Department of Orthopaedics, Spine Clinic, Clinical Trial Unit, Hørsholm Hospital, University of Copenhagen, Hørsholm, Denmark; 5Faculty of Pharmacy, Federico II University of Naples, Naples, Italy; 6Institut für Experimentelle Onkologie und Therapieforschung, TU München, GermanyAbstract: Venous thromboembolism is a frequent and potentially life-threatening complication of orthopedic surgery. Rivaroxaban is an oral direct factor Xa inhibitor, which was shown to be effective for the prevention of venous thromboembolism after elective hip and knee arthroplasty in the RECORD study program. Rivaroxaban has the potential to overcome the limitations of the current standards of care in the prevention of venous thromboembolism. XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopedic surgery of hip or knee is an international, 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 worldwide, with about 7500 patients receiving rivaroxaban and about 7500 standard of care. XAMOS will supplement the clinical data obtained in the Phase III RECORD 1, 2, 3, and 4 trials in which rivaroxaban was shown to be superior for the primary efficacy endpoints, and with a safety profile similar to that of enoxaparin after hip or knee replacement surgery. XAMOS was

  1. Methods and rationale used in a matched cohort study of the incidence of new primary cancers following prostate cancer

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    Cronin-Fenton DP

    2013-10-01

    Full Text Available Deirdre P Cronin-Fenton,1 Sussie Antonsen,1 Karynsa Cetin,2 John Acquavella,2 Andre Daniels,3 Timothy L Lash1,4 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Center for Observational Research, Amgen Incorporated, Thousand Oaks, CA, USA; 3Global Regulatory Affairs and Safety, Amgen Incorporated, Thousand Oaks, CA, USA; 4Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Objectives: We describe several methodological issues that were addressed in conducting a Danish population-based matched cohort study comparing rates of new primary cancers (NPCs in men with and without prostate cancer (PC. Methods: We matched 30,220 men with PC to 151,100 men without PC (comparators on age (±2 years and PC diagnosis/index date. We focused on several methodological issues: 1 to address survival differences between the cohorts we compared rates with and without censoring comparators on the date their matched PC patient died or was censored; 2 to address diagnostic bias, we excluded men with a history of cancer from the comparator cohort; 3 to address prostate cancer immunity, we graphed the hazard of NPC in both cohorts, with and without prostate cancer as an outcome; 4 we used empirical Bayes methods to explore the effect of adjusting for multiple comparisons. Results: After 18 months of follow-up, cumulative person-time was lower in the PC than comparator cohort due to higher mortality among PC patients. Terminating person-time in comparators at the matched PC patient's death or loss to follow-up resulted in comparable person-time up to 30 months of follow-up and lower person-time among comparators thereafter. The hazard of NPC was lower among men with PC than comparators throughout follow-up. There was little difference in rates beyond the first four years of follow-up after removing PC as an outcome. Empirical Bayes adjustment for multiple comparisons had little effect on the

  2. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

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    Chang Anne B

    2012-08-01

    Full Text Available Abstract Background Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Methods We are conducting a bronchiectasis exacerbation study (BEST, which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland. In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily with placebo-azithromycin; azithromycin (5 mg/kg daily with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported. Discussion Effective, evidence-based management

  3. The study of LoSmapimod treatment on inflammation and InfarCtSizE (SOLSTICE): design and rationale.

    Science.gov (United States)

    Melloni, Chiara; Sprecher, Dennis L; Sarov-Blat, Lea; Patel, Manesh R; Heitner, John F; Hamm, Christian W; Aylward, Philip; Tanguay, Jean-Francois; DeWinter, Robbert J; Marber, Michael S; Lerman, Amir; Hasselblad, Vic; Granger, Christopher B; Newby, L Kristin

    2012-11-01

    The p38 mitogen-activated protein kinase (MAPK) is a nexus point in inflammation, sensing, and stimulating cytokine production and driving cell migration and death. In acute coronary syndromes, p38MAPK inhibition could stabilize ruptured atherosclerotic plaques, pacify active plaques, and improve microvascular function, thereby reducing infarct size and risk of subsequent cardiac events. The SOLSTICE trial is randomized, double-blind, placebo-controlled, parallel group, multicenter phase 2a study of 535 patients that evaluates the safety and efficacy of losmapimod (GW856553), a potent oral p38MAPK inhibitor, vs placebo in patients with non-ST-segment elevation myocardial infarction expected to undergo an invasive strategy. The coprimary end points are reduction in high-sensitivity C-reactive protein at 12 weeks and reduction in infarct size as assessed by troponin area under the curve at 72 hours. A key secondary end point is 72-hour and 12-week B-type natriuretic peptide levels as a measure of cardiac remodeling and ventricular strain. The primary safety assessments are serious and nonserious adverse events, results of liver function testing, and major adverse cardiac events. Cardiac magnetic resonance imaging (N = 117) and coronary flow reserve (N = 13) substudies will assess the effects of losmapimod on infarct size, myocardial function, and coronary vasoregulation. Information gained from the SOLSTICE trial will inform further testing of this agent in larger clinical trials. PMID:23137494

  4. The Genetic Response to Short-term Interventions Affecting Cardiovascular Function: Rationale and Design of the HAPI Heart Study

    Science.gov (United States)

    Mitchell, Braxton D.; McArdle, Patrick F.; Shen, Haiqing; Rampersaud, Evadnie; Pollin, Toni I.; Bielak, Lawrence F.; Jaquish, Cashell; Douglas, Julie A.; Roy-Gagnon, Marie-Hélène; Sack, Paul; Naglieri, Rosalie; Hines, Scott; Horenstein, Richard B.; Chang, Yen-Pei C.; Post, Wendy; Ryan, Kathleen A.; Brereton, Nga Hong; Pakyz, Ruth E.; Sorkin, John; Damcott, Coleen M.; O’Connell, Jeffrey R.; Mangano, Charles; Corretti, Mary; Vogel, Robert; Herzog, William; Weir, Matthew R.; Peyser, Patricia A.; Shuldiner, Alan R.

    2008-01-01

    Background The etiology of cardiovascular disease (CVD) is multifactorial. Efforts to identify genes influencing CVD risk have met with limited success to date, likely due to the small effect sizes of common CVD risk alleles and the presence of gene by gene and gene by environment interactions. Methods The Heredity and Phenotype Intervention (HAPI) Heart Study was initiated in 2002 to measure the cardiovascular response to four short-term interventions affecting cardiovascular risk factors and to identify the genetic and environmental determinants of these responses. The measurements included blood pressure responses to the cold pressor stress test and to a high salt diet, triglyceride excursion in response to a high fat challenge, and response in platelet aggregation to aspirin therapy. Results The interventions were carried out in 868 relatively healthy Amish adults from large families. The heritabilities of selected response traits for each intervention ranged from 8–38%, suggesting that some of the variation associated with response to each intervention can be attributed to the additive effects of genes. Conclusions Identifying these response genes may identify new mechanisms influencing CVD and may lead to individualized preventive strategies and improved early detection of high-risk individuals. PMID:18440328

  5. Development of 17alpha-estradiol as a neuroprotective therapeutic agent: rationale and results from a phase I clinical study.

    Science.gov (United States)

    Dykens, James A; Moos, Walter H; Howell, Neil

    2005-06-01

    17alpha-estradiol (17alpha-E2) differs from its isomer, the potent feminizing hormone 17beta-estradiol (17beta-E2), only in the stereochemistry at one carbon, but this is sufficient to render it at least 200-fold less active as a transactivating hormone. Despite its meager hormonal activity, 17alpha-E2 is as potent as 17beta-E2 in protecting a wide variety of cell types, including primary neurons, from a diverse array of lethal and etiologically relevant stressors, including amyloid toxicity, serum withdrawal, oxidative stress, excitotoxicity, and mitochondrial inhibition, among others. Moreover, both estradiol isomers have shown efficacy in animal models of stroke, Alzheimer's disease (AD), and Parkinson's disease (PD). Data from many labs have yielded a mechanistic model in which 17alpha-E2 intercalates into cell membranes, where it terminates lipid peroxidation chain reactions, thereby preserving membrane integrity, and where it in turn is redox cycled by glutathione or by NADPH through enzymatic coupling. Maintaining membrane integrity is critical to mitochondrial function, where loss of impermeability of the inner membrane initiates both necrotic and apoptotic pathways. Thus, by serving as a mitoprotectant, 17alpha-E2 forestalls cell death and could correspondingly provide therapeutic benefit in a host of degenerative diseases, including AD, PD, Friedreich's ataxia, and amyotrophic lateral sclerosis, while at the same time circumventing the common adverse effects elicited by more hormonally active analogues. Positive safety and pharmacokinetic data from a successful phase I clinical study with oral 17alpha-E2 (sodium sulfate conjugate) are presented here, and several options for its future clinical assessment are discussed. PMID:16024755

  6. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    Directory of Open Access Journals (Sweden)

    Okely Anthony D

    2010-10-01

    Full Text Available Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an

  7. Humanities Program: Critique and Rationale.

    Science.gov (United States)

    Pinar, William Frederick

    The psychological impact of schooling is examined within the context of a new school of British psychoanalytic thought. It is concluded that schooling is maddening, in the sense used by Laing, Cooper, and others. A rationale for a sane humanities program is established consisting of two components: the nuclear and the cortical. The nuclear is the…

  8. 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

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

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    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

  10. Space Resource Roundtable Rationale

    Science.gov (United States)

    Duke, Michael

    1999-01-01

    Recent progress in the U.S. Space Program has renewed interest in space resource issues. The Lunar Prospector mission conducted in NASA's Discovery Program has yielded interesting new insights into lunar resource issues, particularly the possibility that water is concentrated in cold traps at the lunar poles. This finding has not yet triggered a new program of lunar exploration or development, however it opens the possibility that new Discovery Missions might be viable. Several asteroid missions are underway or under development and a mission to return samples from the Mars satellite, Phobos, is being developed. These exploration missions are oriented toward scientific analysis, not resource development and utilization, but can provide additional insight into the possibilities for mining asteroids. The Mars Surveyor program now includes experiments on the 2001 lander that are directly applicable to developing propellants from the atmosphere of Mars, and the program has solicited proposals for the 2003/2005 missions in the area of resource utilization. These are aimed at the eventual human exploration of Mars. The beginning of construction of the International Space Station has awakened interest in follow-on programs of human exploration, and NASA is once more studying the human exploration of Moon, Mars and asteroids. Resource utilization will be included as objectives by some of these human exploration programs. At the same time, research and technology development programs in NASA such as the Microgravity Materials Science Program and the Cross-Enterprise Technology Development Program are including resource utilization as a valid area for study. Several major development areas that could utilize space resources, such as space tourism and solar power satellite programs, are actively under study. NASA's interests in space resource development largely are associated with NASA missions rather than the economic development of resources for industrial processes. That

  11. Rationale and Roadmap for Moon Exploration

    Science.gov (United States)

    Foing, B. H.; ILEWG Team

    We discuss the different rationale for Moon exploration. This starts with areas of scientific investigations: clues on the formation and evolution of rocky planets, accretion and bombardment in the inner solar system, comparative planetology processes (tectonic, volcanic, impact cratering, volatile delivery), records astrobiology, survival of organics; past, present and future life. The rationale includes also the advancement of instrumentation: Remote sensing miniaturised instruments; Surface geophysical and geochemistry package; Instrument deployment and robotic arm, nano-rover, sampling, drilling; Sample finder and collector. There are technologies in robotic and human exploration that are a drive for the creativity and economical competitivity of our industries: Mecha-electronics-sensors; Tele control, telepresence, virtual reality; Regional mobility rover; Autonomy and Navigation; Artificially intelligent robots, Complex systems, Man-Machine interface and performances. Moon-Mars Exploration can inspire solutions to global Earth sustained development: In-Situ Utilisation of resources; Establishment of permanent robotic infrastructures, Environmental protection aspects; Life sciences laboratories; Support to human exploration. We also report on the IAA Cosmic Study on Next Steps In Exploring Deep Space, and ongoing IAA Cosmic Studies, ILEWG/IMEWG ongoing activities, and we finally discuss possible roadmaps for robotic and human exploration, starting with the Moon-Mars missions for the coming decade, and building effectively on joint technology developments.

  12. Firms' Rationales for Interaction with Research Universities

    OpenAIRE

    Broström, Anders

    2008-01-01

    R&D managers at 50 firms randomly selected from all firms who have formal relations with two research universities in Stockholm are being interviewed about their rationales for collaboration. Drawing on this material, a distinctive typology of rationales and the therewith associated effects from cooperative relations is presented. As expected, rationales related to innovation, in terms of invented or improved products or processes, are found to be the main drivers for interaction. As regards ...

  13. Rationale, Design and Methods of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men in the Southeastern United States (The MARI Study.

    Directory of Open Access Journals (Sweden)

    DeMarc A Hickson

    Full Text Available This paper describes the rationale, design, and methodology of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men (MSM in the Southeastern United States (U.S.; known locally simply as the MARI Study.Participants are African American MSM aged 18 years and older residing in the deep South.Between 2013 and 2015, 800 African American MSM recruited from two study sites (Jackson, MS and Atlanta, GA will undergo a 1.5-hour examination to obtain anthropometric and blood pressure measures as well as to undergo testing for sexually transmitted infections (STI, including HIV. Intrapersonal, interpersonal, and environmental factors are assessed by audio computer-assisted self-interview survey. Primary outcomes include sexual risk behaviors (e.g., condomless anal sex and prevalent STIs (HIV, syphilis, gonorrhea, and Chlamydia.The MARI Study will typify the HIV environmental 'riskscape' and provide empirical evidence into novel ecological correlates of HIV risk among African American MSM in the deep South, a population most heavily impacted by HIV. The study's anticipated findings will be of interest to a broad audience and lead to more informed prevention efforts, including effective policies and interventions, that achieve the goals of the updated 2020 U.S. National HIV/AIDS Strategy.

  14. When Regional Innovation Policies Meet Policy Rationales and Evidence:

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    of innovation policy rationales, advocating for more specialisation; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic......In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognise their distinctive patterns across...... regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s there has been an important development...

  15. When Regional Innovation Policies meet Policy Rationales and Evidence

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    2016-01-01

    of innovation policy rationales, advocating for more specialization; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic......In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognize their distinctive patterns across...... regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s, there has been an important development...

  16. [The medical rationale category and a new epistemology in health].

    Science.gov (United States)

    do Nascimento, Marilene Cabral; de Barros, Nelson Filice; Nogueira, Maria Inês; Luz, Madel Therezinha

    2013-12-01

    This article is an analytical report on the 20-year trajectory of the 'medical rationale' category that emerged in the early 1990s in the area of Social and Human Sciences in Health in the field of Public Health. Its objective was to study complex and therapeutic medical systems and traditional, complementary and alternative medicines. Based on a critical review of the literature, it presents some aspects of the cultural, political, institutional and social context of its emergence, as well as its main contributions and developments on a theoretical level and on social policies and practices in health. The southern epistemology concept of Boaventura de Sousa Santos is used to reflect upon the contribution of the 'medical rationale' category to the critique of the post-modern scientific rationale and to the creation of a new epistemology in health.

  17. Meeting a Moral Imperative: A Rationale for Teaching the Holocaust

    Science.gov (United States)

    Lindquist, David H.

    2011-01-01

    A primary rationale for studying the Holocaust (Shoah) involves the opportunity to consider the moral implications that can be drawn from examining the event. Studying the Shoah forces students to consider what it means to be human and humane by examining the full continuum of individual behavior, from "ultimate evil" to "ultimate good". This…

  18. 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

    Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusions When a hospital-led study

  19. 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

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

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    Hamish Michael Evans

    2016-03-01

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

  1. Clinical, Functional, and Biological Correlates of Cognitive Dimensions in Major Depressive Disorder - Rationale, Design, and Characteristics of the Cognitive Function and Mood Study (CoFaM-Study).

    Science.gov (United States)

    Baune, Bernhard T; Air, Tracy

    2016-01-01

    Cross-sectional and longitudinal studies exploring clinical, functional, and biological correlates of major depressive disorder are frequent. In this type of research, depression is most commonly defined as a categorical diagnosis based on studies using diagnostic instruments. Given the phenotypic and biological heterogeneity of depression, we chose to focus the phenotypic assessments on three cognitive dimensions of depression including (a) cognitive performance, (b) emotion processing, and (c) social cognitive functioning. Hence, the overall aim of the study is to investigate the long-term clinical course of these cognitive dimensions in depression and its functional (psychosocial) correlates. We also aim to identify biological "genomic" correlates of these three cognitive dimensions of depression. To address the above overall aim, we created the Cognition and Mood Study (CoFaMS) with the key objective to investigate the clinical, functional, and biological correlates of cognitive dimensions of depression by employing a prospective study design and including a healthy control group. The study commenced in April 2015, including patients with a primary diagnosis of a major depressive episode of major depressive disorder or bipolar disorder according to DSM-IV-TR criteria. The assessments cover the three cognitive dimensions of depression (cognitive performance, emotion processing, and social cognition), cognitive function screening instrument, plus functional scales to assess general, work place, and psychosocial function, depression symptom scales, and clinical course of illness. Blood is collected for comprehensive genomic discovery analyses of biological correlates of cognitive dimensions of depression. The CoFaM-Study represents an innovative approach focusing on cognitive dimensions of depression and its functional and biological "genomic" correlates. The CoFaMS team welcomes collaborations with both national and international researchers. PMID:27616997

  2. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: Rationale and study design of a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Klarenbach Scott

    2006-02-01

    Full Text Available Abstract Background Nocturnal hemodialysis (NHD is an alternative to conventional three times per week hemodialysis (CvHD and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV mass, as measured by cardiac magnetic resonance imaging (cMR. Methodology/design All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP to a goal of Discussion To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

  3. 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.; Maupome, 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…

  4. 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

    Full Text Available Abstract Background Bioimpedance analysis (BIA has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. Methods This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. Discussions Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain

  5. Psychological and personality factors in type 2 diabetes mellitus, presenting the rationale and exploratory results from The Maastricht Study: A population-based cohort study

    OpenAIRE

    van Dooren, F.E.P.; Denollet, J; Verhey, F.R.J.; Stehouwer, C.D.; Sep, S.J.S.; Henry, R.M.; Kremers, S. P. J.; Dagnelie, P C; Schaper, N. C.; van der Kallen, C. J. H.; Koster, A.; Pouwer, F.; Schram, M T

    2016-01-01

    Background Strong longitudinal evidence exists that psychological distress is associated with a high morbidity and mortality risk in type 2 diabetes. Little is known about the biological and behavioral mechanisms that may explain this association. Moreover, the role of personality traits in these associations is still unclear. In this paper, we first describe the design of the psychological part of The Maastricht Study that aims to elucidate these mechanisms. Next, we present exploratory resu...

  6. 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

  7. A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design of the ARCTIC Study.

    Science.gov (United States)

    Planchard, David; Yokoi, Takashi; McCleod, Michael J; Fischer, Jürgen R; Kim, Young-Chul; Ballas, Marc; Shi, Kelvin; Soria, Jean-Charles

    2016-05-01

    Anti-programmed cell death-1 and anti-programmed cell death ligand-1 (PD-L1) monotherapies have shown promising clinical activity in advanced, refractory non-small-cell lung cancer (NSCLC), but antitumor activity appears to be greater in patients with PD-L1(+) tumors compared with patients harboring PD-L1(-) tumors. Combining the anti-PD-L1 antibody durvalumab and the anti-cytotoxic T-lymphocyte antigen 4 antibody tremelimumab offers the potential for antitumor activity in patients with advanced NSCLC, regardless of PD-L1 tumor status. ARCTIC (NCT02352948) is a global, phase III, randomized, open-label multicenter study in patients with advanced NSCLC assessing the safety and clinical activity of durvalumab versus standard of care (SoC; erlotinib, gemcitabine, or vinorelbine) in patients with PD-L1(+) tumors (≥25% of tumor cells with membrane staining using VENTANA PD-L1 [SP263] CDx Assay) (Sub-study A) and the combination of durvalumab + tremelimumab or either agent as monotherapy versus SoC in patients with PD-L1(-) tumors (Sub-study B). Eligible patients are those with locally advanced or metastatic NSCLC (Stage IIIB/IV), without epidermal growth factor receptor tyrosine kinase activating mutations or anaplastic lymphoma kinase rearrangements, who have received at least 2 prior systemic regimens, including 1 platinum-based chemotherapy regimen. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include the proportion of patients alive at 12 months, objective response rate, duration of response, progression-free survival at 6 and 12 months, safety and tolerability, pharmacokinetics, immunogenicity, and quality of life. The exploratory endpoints will assess potential biomarkers of treatment response. Recruitment started in January 2015 and is ongoing.

  8. A Rationale for Mixed Methods (Integrative) Research Programmes in Education

    Science.gov (United States)

    Niaz, Mansoor

    2008-01-01

    Recent research shows that research programmes (quantitative, qualitative and mixed) in education are not displaced (as suggested by Kuhn) but rather lead to integration. The objective of this study is to present a rationale for mixed methods (integrative) research programs based on contemporary philosophy of science (Lakatos, Giere, Cartwright,…

  9. Effectiveness of Oral Nutritional Supplementation for Older Women after a Fracture: Rationale, Design and Study of the Feasibility of a Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Lockwood Keri A

    2011-06-01

    Full Text Available Abstract Background Malnutrition is a problem for many older people recovering from a hip and other major fractures. Oral supplementation with high calorie high protein nutrients is a simple intervention that may help older people with fractures to improve their recovery in terms of rehabilitation time, length of hospital stay and mortality. This paper reports a pilot study to test the feasibility of a trial initiated in a hospital setting with an oral supplement to older people with recent fractures. Method A randomized controlled trial with 44 undernourished participants admitted to a hospital following a fracture. The intervention group (n = 23 received a high calorie high protein supplement for forty days in addition to their diet of choice. The control group (n = 21 received high protein milk during their hospital stay in addition to their diet of choice and their usual diet when discharged from hospital. Results All participants were women and their mean age was 85.3 (± 6.1 years. Twenty nine (65% participants had a hip fracture. At baseline no differences were measured between the two groups regarding their nutritional status, their cognitive ability or their abilities in activities of daily living. There were no significant differences between the intervention and control group with reference to nutritional or functional parameters at 40 day and 4 month follow-ups. Median length of stay in hospital was 18.0 days, with 12 participants being readmitted for a median of 7.0 days. Conclusion It is feasible to perform a randomised trial in a hospital and community setting to test the effect of an oral high energy high protein supplement for older people. Due to the limited number of participants and incomplete adherence with use of the supplements no conclusion can be drawn about the efficacy or effectiveness of this intervention.

  10. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy.

    Science.gov (United States)

    Cho, Leslie; Rocco, Michael; Colquhoun, David; Sullivan, David; Rosenson, Robert S; Dent, Ricardo; Xue, Allen; Scott, Rob; Wasserman, Scott M; Stroes, Erik

    2014-03-01

    Statins effectively lower low-density lipoprotein cholesterol (LDL-C), reducing cardiovascular morbidity and mortality. Most patients tolerate statins well, but approximately 10% to 20% experience side effects (primarily muscle-related) contributing to diminished compliance or discontinuation of statin therapy and subsequent increase in cardiovascular risk. Statin-intolerant patients require more effective therapies for lowering LDL-C. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a compelling target for LDL-C-lowering therapy. Evolocumab (AMG 145) is a fully human monoclonal antibody that binds PCSK9, inhibiting its interaction with the LDL receptor to preserve LDL-receptor recycling and reduce LDL-C. Phase 2 studies have demonstrated the safety, tolerability, and preliminary efficacy of subcutaneous evolocumab in diverse populations, including statin-intolerant patients. This article describes the rationale and design of the Goal Achievement After Utilizing an anti-PCSK9 Antibody in Statin-Intolerant Subjects 2 (GAUSS-2) trial, a randomized, double-blind, ezetimibe-controlled, multicenter phase 3 study to evaluate the effects of 12 weeks of evolocumab 140 mg every 2 weeks or 420 mg every month in statin-intolerant patients with hypercholesterolemia. Eligible subjects were unable to tolerate effective doses of ≥2 statins because of myalgia, myopathy, myositis, or rhabdomyolysis that resolved with statin discontinuation. The primary objective of the study is to assess the effects of evolocumab on percentage change from baseline in LDL-C. Secondary objectives include evaluation of safety and tolerability, comparison of the effects of evolocumab vs ezetimibe on absolute change from baseline in LDL-C, and percentage changes from baseline in other lipids. Recruitment of approximately 300 subjects was completed in August 2013.

  11. Rationale and methods of the integrated biomarker and imaging study (IBIS): combining invasive and non-invasive imaging with biomarkers to detect subclinical atherosclerosis and assess coronary lesion biology.

    Science.gov (United States)

    Van Mieghem, Carlos A G; Bruining, Nico; Schaar, Johannes A; McFadden, Eugene; Mollet, Nico; Cademartiri, Filippo; Mastik, Frits; Ligthart, Jurgen M R; Granillo, Gaston A Rodriguez; Valgimigli, Marco; Sianos, Georgios; van der Giessen, Willem J; Backx, Bianca; Morel, Marie-Angele M; Van Es, Gerrit-Anne; Sawyer, Jonathon D; Kaplow, June; Zalewski, Andrew; van der Steen, Anton F W; de Feyter, Pim; Serruys, Patrick W

    2005-08-01

    Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions.

  12. Adoption of managerial innovations: effect of adoption rationales on the adoption process

    OpenAIRE

    Daniel, Elizabeth Mary; Myers, Andrew; Dixon, Keith

    2008-01-01

    The aim of the research is to explore the complex phenomenon of the adoption of managerial innovations by organisations, with an attempt to identify relationships between various elements of this process. Four case studies were compiled using interview data from selected managers. The data provided a means of subjecting the rationales that Sturdy (2004) posited for the adoption of managerial innovations to empirical inquiry. The study also seeks to explore how the identified rationales may...

  13. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation

    DEFF Research Database (Denmark)

    Jons, Christian; Hansen, Peter Steen; Johannessen, Arne;

    2009-01-01

    (MANTRA-PAF) trial is a randomized, controlled, parallel group, multicentre study designed to test whether catheter-based RFA is superior to optimized AAD therapy in suppressing relapse within 24 months of symptomatic and/or asymptomatic AF in patients with paroxysmal AF without prior AAD therapy...... centres in Scandinavia and Germany are participating in the study. Enrolment was started in 2005 and as of November 2008, 260 patients have been enrolled into the study. It is expected that enrolment will end by March 2009, when 300 patients have been included. CONCLUSION: The MANTRA-PAF trial...

  14. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  15. 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.

  16. 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. PMID:25929003

  17. Bridging the gap in heart failure prevention: rationale and design of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study

    DEFF Research Database (Denmark)

    Carrington, Melinda J; Stewart, Simon; de Courten, Barbora

    2010-01-01

    AIMS: The primary objective of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study is to develop a programme of care that cost-effectively prevents the development of chronic heart failure (CHF). Methods NIL-CHF is a randomized controlled trial of a hybrid, home- and clinic-...

  18. Predicting cardiovascular disease morbidity and mortality in chronic kidney disease in Spain. The rationale and design of NEFRONA: a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Roig Jordi

    2010-07-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD. Cardiovascular risk assessment in this population is hampered by the failure of traditional risk factors to fully account for the elevated CVD risk (reverse epidemiology effect and the presence of emerging risk factors specifically related to kidney failure. Therefore, diagnostic tools capable of improving cardiovascular risk assessment beyond traditional risk factors are currently warranted. We present the protocol of a 4-year prospective study aimed to assess the predictive value of non-invasive imaging techniques and biomarkers for CVD events and mortality in patients with CKD. Methods From November 2009 to October 2010, 4137 asymptomatic adult patients with stages 2 to 5 CKD will be recruited from nephrology services and dialysis units throughout Spain. During the same period, 843 participants without CKD (control group will be recruited from lists of primary care physicians, only at baseline. During the follow-up, CVD events and mortality will be recorded from all CKD patients. Clinical and laboratory characteristics will be collected in a medical documentation sheet. Three trained itinerant teams will carry out a carotid ultrasound to assess intima-media thickness and presence of plaques. A composite atherosclerosis score will be constructed based on carotid ultrasound data and measurement of ankle-brachial index. In CKD patients, presence and type of calcifications will be assessed in the wall of carotid, femoral and brachial arteries, and in cardiac valves, by ultrasound. From all participants, blood samples will be collected and stored in a biobank to study novel biomarkers. Conclusions The NEFRONA study is the first large, prospective study to examine the predictive value of several non-invasive imaging techniques and novel biomarkers in CKD patients throughout Spain. Hereby, we present the

  19. 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

  20. 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

  1. Who Should Benefit from REDD+? Rationales and Realities

    Directory of Open Access Journals (Sweden)

    Cecilia Luttrell

    2013-12-01

    Full Text Available Benefit-sharing mechanisms are a central design aspect of REDD+ because they help to create the necessary incentives to reduce carbon emissions. However, if stakeholders do not perceive the benefit sharing as fair, the legitimacy of REDD+, and support for the mechanism, will be weakened. In this paper, drawing on data from CIFOR's Global Comparative Study on REDD+, we analyze national policy processes in 6 countries and incipient benefit-sharing arrangements in 21 REDD+ project sites. Through our analysis of current practices and debates, we identify six rationales that have been put forward to justify how benefits should be distributed and to whom. These rationales encompass a range of perspectives. Some hold that benefit sharing should be related to actual carbon emission reductions or to costs incurred in achieving the reduction of emissions; others emphasize the importance of a legal right to benefit, the need to consider aspects such as poverty reduction or the appropriateness of rewarding those with a history of protecting the forest. Each rationale has implications for the design of benefit-sharing mechanisms and the equity of their outcomes. We point out that, given the wide range of rationales and interests at play, the objectives of REDD+ and benefit sharing must be clearly established and the term "benefit" defined before effective benefit-sharing mechanisms can be designed. For stakeholders to support REDD+, the legitimacy of decision-making institutions, consideration of context, and attention to process are critical. Building legitimacy requires attention not only to fair distributional outcomes but also to consensus on relevant institutions' authority to make decisions and to procedural equity.

  2. Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design

    Science.gov (United States)

    Dokainish, Hisham; Elbarasi, Esam; Masiero, Simona; Van de Heyning, Caroline; Brambatti, Michela; Ghazal, Sami; AL-Maashani, Said; Capucci, Alessandro; Buikema, Lisanne; Leong, Darryl; Shivalkar, Bharati; Saenen, Johan; Miljoen, Hielko; Morillo, Carlos; Divarakarmenon, Syam; Amit, Guy; Ribas, Sebastian; Brautigam, Aaron; Baiocco, Erika; Maolo, Alessandro; Romandini, Andrea; Maffei, Simone; Connolly, Stuart; Healey, Jeff

    2015-01-01

    Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients. PMID:26779517

  3. Primary radiotherapy after tumour excision as an alternative to mastectomy for early breast cancer. Rationale and preliminary results of a prospective study.

    Science.gov (United States)

    Browde, S; Nissenbaum, M M

    1983-09-28

    A conservative approach to the management of breast cancer is gaining acceptance. The evidence from many retrospective and prospective studies indicates that breast-preserving surgery and radiation therapy give results equal to those of mastectomy. Relapse affecting the breast alone has been shown not to be detrimental to survival, while the psychological benefits to the patients have been gratifying. A prospective study of early breast cancer treated by conservative surgery and radiation was commenced at the Johannesburg Hospital in 1980. The results in 57 patients are reported. So far there have been 2 cases of local recurrence. In the majority of cases satisfactory cosmetic results were achieved. It is considered that lumpectomy with axillary dissection to establish nodal status followed by irradiation is the treatment of choice for stage I and II carcinoma of the breast.

  4. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

    Directory of Open Access Journals (Sweden)

    van Dijk Arie PJ

    2008-12-01

    Full Text Available Abstract Background - Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST-elevation myocardial infarction based on proximal lesions of the infarct-related artery. Methods/design - In our multicenter, randomized, placebo controlled clinical trial we will include patients between 18 and 80 years of age with their first ST-elevation myocardial infarction based on a proximal lesion of the infarct-related artery. After receiving a single bolus alteplase 50 mg IV (Actilyse® Boehringer Ingelheim GmbH, a loading dose of aspirin 500 mg, and heparin 5000 IU in the ambulance according to the prehospital thrombolysis protocol, patients, following oral informed consent, are randomized to undergo 15 minutes of pulsatile ultrasound with intravenous administration of ultrasound contrast agent or placebo without ultrasound. Afterwards coronary angiography and, if indicated, percutaneous coronary intervention will take place. A total of 60 patients will be enrolled in approximately 1 year. The primary endpoints are based on the coronary angiogram and consist of TIMI flow, corrected TIMI frame count, and myocardial blush grade. Follow-up includes 12-lead ECG, 2D-echocardiography, cardiac MRI, and enzyme markers to obtain our secondary endpoints, including the infarct size, wall motion abnormalities, and the global left ventricular function. Discussion - The Sonolysis study is the first multicenter, randomized, placebo controlled clinical trial investigating the therapeutic application of ultrasound and microbubbles in acute ST-elevation myocardial infarction patients. A positive finding may stimulate further research and technical innovations to implement the treatment in the ambulance and maybe obtain even more patency at an earlier stage

  5. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial

    DEFF Research Database (Denmark)

    Lilja, Gisela; Nielsen, Niklas; Friberg, Hans;

    2013-01-01

    Mild to moderate cognitive impairment is common amongst long-term survivors of cardiac arrest. In the Target Temperature Management trial (TTM-trial) comatose survivors were randomized to 33°C or 36°C temperature control for 24 hours after cardiac arrest and the effects on survival and neurological...... outcome assessed. This protocol describes a sub-study of the TTM-trial investigating cognitive dysfunction and its consequences for patients' and relatives' daily life....

  6. The China Patient-Centred Evaluative Assessment of Cardiac Events (China PEACE)-Prospective Study of 3-Vessel Disease: rationale and design

    Science.gov (United States)

    Rao, Chenfei; Bongiovanni, Tasce; Li, Xi; Gao, Huawei; Zhang, Heng; Li, Jing; Zhao, Yan; Yuan, Xin; Hua, Kun; Hu, Shengshou; Krumholz, Harlan M; Jiang, Lixin; Zheng, Zhe

    2016-01-01

    Introduction Complex coronary artery disease (left main and three-vessel disease) carries high risks of adverse events and cost burden. However, in China, little is known about which patients are directed toward which treatment strategies and what outcomes are being achieved. Methods and analysis Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, this prospective study of three-Vessel Disease, the China PEACE-3VD study, has a plan to consecutively register over 4000 patients with a diagnosis of 3VD and/or left-main disease by elective coronary angiography at 24 large cardiovascular centres in China. We centrally conducted medical record abstraction and SYNTAX Score calculation for all registered patients. The sites invited patients to the prospective cohort, and conducted 1-year follow-up on major events, including cardiac events, symptoms, secondary prevention and quality of life. The estimated entire sample size of eligible patients of 4000 was determined based on both feasibility and consideration of adequate statistical precision for describing the treatment decisions, guidelines adherence and appropriateness of treatment for patients with complex coronary artery diseases. The study is designed to investigate patient, clinician and hospital factors associated with each treatment strategy (percutaneous coronary intervention, coronary artery bypass grafting or medical therapy) as well as appropriateness of treatment choice, current guideline compliance and patient-reported outcomes for patients with complex coronary artery disease in large cardiovascular centres in China, as a foundation for enhanced knowledge in the field and to assist quality improvement initiatives. Ethics and dissemination The study protocol was approved by the ethics committee at the China National Center for Cardiovascular Diseases. Findings will be shared with participating hospitals, policymakers and the academic community, to promote

  7. Rationale, design and methods for the 22 year follow-up of the Western Australian Pregnancy Cohort (Raine) Study

    OpenAIRE

    Straker, Leon M; Hall, Graham L.; Mountain, Jenny; Howie, Erin K.; White, Elisha; McArdle, Nigel; Eastwood, Peter R.; ,

    2015-01-01

    Background Young adulthood is a critical life period for health and health behaviours. Related measurements collected before and after birth, and during childhood and adolescence can provide a life-course analysis of important factors that contribute to health and behaviour in young adulthood. The Western Australian Pregnancy Cohort (Raine) Study has collected a large number of such measurements during the fetal, perinatal, infancy, childhood and adolescence periods and plans to relate them t...

  8. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    OpenAIRE

    Hedenstierna Göran; Binnekade Jan M; Hollmann Markus W; Tschernko Edda M; Hiesmayr Michael; Wrigge Hermann; Canet Jaume; Jaber Samir; Severgnini Paolo; Hemmes Sabrine NT; Putensen Christian; Abreu Marcelo; Pelosi Paolo; Schultz Marcus J

    2011-01-01

    Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ven...

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

    Directory of Open Access Journals (Sweden)

    Crawford Jeffrey

    2010-04-01

    Full Text Available Abstract Background The Lung Cancer Exercise Training Study (LUNGEVITY is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak, patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC patients. Methods/Design Using a single-center, randomized design, 160 subjects (40 patients/study arm with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1 aerobic training alone, (2 resistance training alone, (3 the combination of aerobic and resistance training, or (4 attention-control (progressive stretching. The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks, social interaction (participants will receive one-on-one instruction, and duration (30-45 mins/session. The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs (e.g., quality of life, fatigue, depression, etc. and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function. All endpoints will be assessed at baseline and postintervention (16 weeks. Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes

  10. Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant in Pakistan

    Directory of Open Access Journals (Sweden)

    Azmat SK

    2014-05-01

    Full Text Available Syed Khurram Azmat,1 Waqas Hameed,1 Anja Lendvay,2 Babar Tasneem Shaikh,3 Ghulam Mustafa,1 Muhammad Ahmed Siddiqui,1 Sajid Brohi,1 Asif Karim,1 Muhammad Ishaque,1 Wajahat Hussain,1 Mohsina Bilgrami,1 Paul J Feldblum2 1Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan; 2FHI 360, Durham, NC, USA; 3Health Services Academy, Islamabad, Pakistan Introduction: The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant in Pakistan during the first year of its use among married women of reproductive age (18–44 years at clinics in two provinces of Pakistan (Sindh and Punjab. Materials and methods: A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Discussion: Over the next 5-year period (2013–2018, 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end

  11. A randomised controlled trial of an enhanced interdisciplinary community based group program for people with Parkinson’s disease: study rationale and protocol

    Directory of Open Access Journals (Sweden)

    Catherine Peters

    2012-03-01

    Full Text Available Parkinson’s disease (PD is a progressive, chronic neurodegenerative disorder for which there is no known cure. Physical exercise programs may be used to assist with the physical management of PD. Several studies have demonstrated that community based physical therapy programs are effective in reducing physical aspects of disability among people with PD. While multidisciplinary therapy interventions may have the potential to reduce disability and improve the quality of life of people with PD, there is very limited clinical trial evidence to support or refute the use of a community based multidisciplinary or interdisciplinary programs for people with PD. A two group randomized trial is being undertaken within a community rehabilitation service in Brisbane, Australia. Community dwelling adults with a diagnosis of Idiopathic Parkinson’s disease are being recruited. Eligible participants are randomly allocated to a standard exercise rehabilitation group program or an intervention group which incorporates physical, cognitive and speech activities in a multi-tasking framework. Outcomes will be measured at 6-week intervals for a period of six months. Primary outcome measures are the Montreal Cognitive Assessment (MoCA and the Timed Up and Go (TUG cognitive test. Secondary outcomes include changes in health related quality of life, communication, social participation, mobility, strength and balance, and carer burden measures. This study will determine the immediate and long-term effectiveness of a unique multifocal, interdisciplinary, dual-tasking approach to the management of PD as compared to an exercise only program. We anticipate that the results of this study will have implications for the development of cost effective evidence based best practice for the treatment of people with PD living in the community.

  12. PRevalence of Abuse and Intimate Partner Violence Surgical Evaluation (P.R.A.I.S.E.: rationale and design of a multi-center cross-sectional study.

    Directory of Open Access Journals (Sweden)

    2010-04-01

    Full Text Available Abstract Background Intimate partner violence (IPV is described by the American Medical Association as "a pattern of coercive behaviors that may include repeated battering and injury, psychological abuse, sexual assault, progressive social isolation, deprivation, and intimidation." The long-term consequences of IPV include health risks, posttraumatic stress disorder, depression, and staggering economic costs for health care of victims. Intimate partner violence is often underreported among women who seek medical attention. The current study seeks to address the issue of possible underreporting of IPV in orthopaedic fracture clinics by establishing prevalence rates of IPV among women seeking treatment for musculoskeletal injuries. Methods/Design We propose a cross-sectional multicenter study wherein 3,600 women will complete a self-reported written questionnaire across clinical sites in North America, Europe, and Australia. Recruitment of participants will take place at orthopaedic fracture clinics at each clinical site. The questionnaire will contain a validated set of questions used to screen for IPV, as well as questions that pertain to the participant's demographic, injury characteristics, and experiences with health care utilization. Female patients presenting to the orthopaedic fracture clinics will complete two validated self-reported written questionnaires (Woman Abuse Screening Tool (WAST and the Partner Violence Screen (PVS to determine the prevalence of IPV in the past 12 months and in their lifetime. The two questionnaires were designed for rapid assessment of IPV status in emergency departments, family practice, and women's health clinics that we believe are similar to our intended setting of an orthopaedic clinic. Discussion If the prevalence of IPV among women attending orthopaedic clinics is greater than the current perceptions of orthopaedic surgeons, this study will serve to advocate for the continued education of medical

  13. Rationale, design and methodology for Intraventricular Pressure Gradients Study: a novel approach for ventricular filling assessment in normal and falling hearts

    Directory of Open Access Journals (Sweden)

    Vouga Luís

    2011-05-01

    Full Text Available Abstract Background Intraventricular pressure gradients have been described between the base and the apex of the left ventricle during early diastolic ventricular filling, as well as, their increase after systolic and diastolic function improvement. Although, systolic gradients have also been observed, data are lacking on their magnitude and modulation during cardiac dysfunction. Furthermore, we know that segmental dysfunction interferes with the normal sequence of regional contraction and might be expected to alter the physiological intraventricular pressure gradients. The study hypothesis is that systolic and diastolic gradients, a marker of normal left ventricular function, may be related to physiological asynchrony between basal and apical myocardial segments and they can be attenuated, lost entirely, or even reversed when ventricular filling/emptying is impaired by regional acute ischemia or severe aortic stenosis. Methods/Design Animal Studies: Six rabbits will be completely instrumented to measuring apex to outflow-tract pressure gradient and apical and basal myocardial segments lengthening changes at basal, afterloaded and ischemic conditions. Afterload increase will be performed by abruptly narrowing or occluding the ascending aorta during the diastole and myocardial ischemia will be induced by left coronary artery ligation, after the first diagonal branch. Patient Studies: Patients between 65-80 years old (n = 12, both genders, with severe aortic stenosis referred for aortic valve replacement will be selected as eligible subjects. A high-fidelity pressure-volume catheter will be positioned through the ascending aorta across the aortic valve to measure apical and outflow-tract pressure before and after aortic valve replacement with a bioprosthesis. Peak and average intraventricular pressure gradients will be recorded as apical minus outflow-tract pressure and calculated during all diastolic and systolic phases of cardiac cycle

  14. 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

  15. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD

    Directory of Open Access Journals (Sweden)

    Hansen Jørgen

    2009-04-01

    Full Text Available Abstract Background The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome. Methods Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures. Discussion This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00140257

  16. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Directory of Open Access Journals (Sweden)

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  17. 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

  18. Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project

    Science.gov (United States)

    Frank, Bernd; Ariza, Liana; Lamparter, Heidrun; Grossmann, Vera; Prochaska, Jürgen H; Ullmann, Alexander; Kindler, Florentina; Weisser, Gerhard; Walter, Ulrich; Lackner, Karl J; Espinola-Klein, Christine; Münzel, Thomas; Konstantinides, Stavros V; Wild, Philipp S

    2015-01-01

    Introduction Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date. Methods and analysis The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three ‘all-comer’ studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings. Ethics and dissemination The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and

  19. 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

  20. Do studies on cortical plasticity provide a rationale for using non invasive brain stimulation as a treatment for Parkinson’s disease patients?

    Directory of Open Access Journals (Sweden)

    Giacomo eKoch

    2013-11-01

    Full Text Available Animal models of Parkinson’s disease (PD have shown that key mechanisms of cortical plasticity such as long-term potentiation (LTP and long-term depression (LTD can be impaired by the PD pathology. In humans protocols of non-invasive brain stimulation, such as paired associative stimulation (PAS and theta burst stimulation (TBS, can be used to investigate cortical plasticity of the primary motor cortex. Through the amplitude of the motor evoked potential (MEP these transcranial magnetic stimulation methods allow to measure both LTP-like and LTD-like mechanisms of cortical plasticity. So far these protocols have reported some controversial findings when tested in PD patients. While various studies described evidence for reduced LTP- and LTD-like plasticity, others showed different results, demonstrating increased LTP-like and normal LTD-like plasticity. Recent evidence provided support to the hypothesis that these different patterns of cortical plasticity likely depend on the stage of the disease and on the concomitant administration of levo-dopa. However, it still unclear how and if these altered mechanisms of cortical plasticity can be taken as a reliable model to build appropriate protocols aimed at treating PD symptoms b

  1. The Effect of Remote Ischemic Conditioning and Glyceryl Trinitrate on Perioperative Myocardial Injury in Cardiac Bypass Surgery Patients: Rationale and Design of the ERIC-GTN Study.

    Science.gov (United States)

    Hamarneh, Ashraf; Sivaraman, Vivek; Bulluck, Heerajnarain; Shanahan, Hilary; Kyle, Bonnie; Ramlall, Manish; Chung, Robin; Jarvis, Claire; Xenou, Maria; Ariti, Cono; Cordery, Roger; Yellon, Derek M; Hausenloy, Derek J

    2015-11-01

    Remote ischemic conditioning (RIC) using transient limb ischemia/reperfusion has been reported to reduce perioperative myocardial injury in patients undergoing coronary artery bypass grafting and/or valve surgery. The role of intravenous glyceryl trinitrate (GTN) therapy administered during cardiac surgery as a cardioprotective agent and whether it interferes with RIC cardioprotection is not clear and is investigated in the ERIC-GTN trial ( http://www.clinicaltrials.gov: NCT01864252). The ERIC-GTN trial is a single-site, double-blind, randomized, placebo-controlled study. Consenting adult patients (age > 18 years) undergoing elective coronary artery bypass grafting ± valve surgery with blood cardioplegia will be eligible for inclusion. Two hundred sixty patients will be randomized to 1 of 4 treatment groups following anesthetic induction: (1) RIC alone, a RIC protocol comprising three 5-minute cycles of simultaneous upper-arm and thigh cuff inflation/deflation followed by an intravenous (IV) placebo infusion; (2) GTN alone, a simulated sham RIC protocol followed by an IV GTN infusion; (3) RIC + GTN, a RIC protocol followed by an IV GTN infusion; and (4) neither RIC nor GTN, a sham RIC protocol followed by IV placebo infusion. The primary endpoint will be perioperative myocardial injury as quantified by the 72-hour area-under-the-curve serum high-sensitivity troponin T. The ERIC-GTN trial will determine whether intraoperative GTN therapy is cardioprotective during cardiac surgery and whether it affects RIC cardioprotection.

  2. Menaquinone-7 Supplementation to Reduce Vascular Calcification in Patients with Coronary Artery Disease: Rationale and Study Protocol (VitaK-CAC Trial).

    Science.gov (United States)

    Vossen, Liv M; Schurgers, Leon J; van Varik, Bernard J; Kietselaer, Bas L J H; Vermeer, Cees; Meeder, Johannes G; Rahel, Braim M; van Cauteren, Yvonne J M; Hoffland, Ge A; Rennenberg, Roger J M W; Reesink, Koen D; de Leeuw, Peter W; Kroon, Abraham A

    2015-10-28

    Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD). Arterial calcification is caused by an imbalance in calcification regulatory mechanisms. An important inhibitor of calcification is vitamin K-dependent matrix Gla protein (MGP). Both preclinical and clinical studies have shown that inhibition of the vitamin K-cycle by vitamin K antagonists (VKA) results in elevated uncarboxylated MGP (ucMGP) and subsequently in extensive arterial calcification. This led us to hypothesize that vitamin K supplementation may slow down the progression of calcification. To test this, we designed the VitaK-CAC trial which analyses effects of menaquinone-7 (MK-7) supplementation on progression of CAC. The trial is a double-blind, randomized, placebo-controlled trial including patients with coronary artery disease (CAD). Patients with a baseline Agatston CAC-score between 50 and 400 will be randomized to an intervention-group (360 microgram MK-7) or a placebo group. Treatment duration will be 24 months. The primary endpoint is the difference in CAC-score progression between both groups. Secondary endpoints include changes in arterial structure and function, and associations with biomarkers. We hypothesize that treatment with MK-7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD.

  3. Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study.

    Science.gov (United States)

    Funck, Reinhard C; Blanc, Jean-Jacques; Mueller, Hans-Helge; Schade-Brittinger, Carmen; Bailleul, Christophe; Maisch, Bernhard

    2006-08-01

    Despite the deleterious effects of cardiac dyssynchrony and the positive effects of cardiac resynchronization therapy, patients with high-degree atrioventricular block continue to receive desynchronizing right ventricular (RV) pacing systems. Although it is unclear whether the negative effects of RV pacing and left bundle branch block (LBBB) are comparable, and whether they depend on the presence and the degree of structural heart disease, one may hypothesize that RV pacing may have similar effects to LBBB. In the BioPace trial, the long-term effects of RV pacing vs. biventricular pacing will be prospectively compared in 1200 pacemaker patients with high likelihood of mostly paced ventricular events, regardless of whether in sinus rhythm or in atrial fibrillation (AF). After echocardiographic examination of left ventricular (LV) function, patients will be randomly assigned to the implantation of an RV vs. a biventricular pacing system and followed for up to 5 years. Primary study endpoints are survival, quality of life (QoL), and the distance covered in a 6-min hall walk (6-MHW) at 24 months after implantation. Secondary endpoints are QoL and the 6-MHW result at 12 months after implantation, hospitalization rate, LV dimensions, LV ejection fraction, and the development of chronic AF and other adverse events. PMID:16864616

  4. Integrating a family-focused approach into child obesity prevention: Rationale and design for the My Parenting SOS study randomized control trial

    Directory of Open Access Journals (Sweden)

    Campbell Marci

    2011-06-01

    Full Text Available Abstract Background More than 20% of US children ages 2-5 yrs are classified as overweight or obese. Parents greatly influence the behaviors their children adopt, including those which impact weight (e.g., diet and physical activity. Unfortunately, parents often fail to recognize the risk for excess weight gain in young children, and may not be motivated to modify behavior. Research is needed to explore intervention strategies that engage families with young children and motivate parents to adopt behaviors that will foster healthy weight development. Methods This study tests the efficacy of the 35-week My Parenting SOS intervention. The intervention consists of 12 sessions: initial sessions focus on general parenting skills (stress management, effective parenting styles, child behavior management, coparenting, and time management and later sessions apply these skills to promote healthier eating and physical activity habits. The primary outcome is change in child percent body fat. Secondary measures assess parent and child dietary intake (three 24-hr recalls and physical activity (accelerometry, general parenting style and practices, nutrition- and activity-related parenting practices, and parent motivation to adopt healthier practices. Discussion Testing of these new approaches contributes to our understanding of how general and weight-specific parenting practices influence child weight, and whether or not they can be changed to promote healthy weight trajectories. Trial Registration ClinicalTrials.gov: NCT00998348

  5. 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

  6. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses

    Directory of Open Access Journals (Sweden)

    Günther Klaus-Peter

    2009-10-01

    Full Text Available Abstract Background Any metal placed in a biological environment undergoes corrosion. Thus, with their large metallic surfaces, TKA implants are particularly prone to corrosion with subsequent release of metal ions into the human body which may cause local and systemic toxic effects and hypersensitivity reactions, and increase cancer risk. To address this problem, a new 7-layer zirconium coating developed especially for cobalt-chrome orthopaedic implants was tested biomechanically and found to lower metal ion release. The purpose of the proposed clinical trial is to compare the metal ion concentration in patients' plasma before and after implantation of a coated or uncoated TKA implant. Methods/Design In this randomised controlled trial, 120 patients undergoing primary TKA will be recruited at the Department of Orthopaedic Surgery of the University Hospital in Dresden, Germany, and randomised to either the coated or uncoated prosthesis. Outcome assessments will be conducted preoperatively and at 3 months, 12 months and 5 years postoperatively. The primary clinical endpoint will be the chromium ion concentration in the patient's plasma after 1 and 5 years. Secondary outcomes include cobalt, molybdenum and nickel ion concentrations after 1 and 5 years, allergy testing for hypersensitivity against one of these metals, the Knee Society Score to assess clinical and physical function of the knee joint, the self-assessment Oxford Score and the Short Form 36 quality of live questionnaire. Discussion The metal ion concentration in the patient's plasma has been shown to increase after TKA, its eventual adverse effects being widely debated. In the light of this discussion, ways to reduce metal ion release from orthopaedic implants should be studied in detail. The results of this investigation may lead to a new method to achieve this goal. Trials register Clinicaltrials registry NCT00862511

  7. Depression in Primary care: Interpersonal Counseling vs Selective serotonin reuptake inhibitors. The DEPICS Study. A multicenter randomized controlled trial. Rationale and design

    Directory of Open Access Journals (Sweden)

    Scocco Paolo

    2010-11-01

    Full Text Available Abstract Background Depression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs. Psychological interventions are recommended as first-line treatment by the most authoritative international guidelines but few evidences are available on their efficacy and effectiveness for mild depression. Methods/Design This multi-center randomized controlled trial was conducted in 9 Italian centres with the aim to compare the efficacy of Inter-Personal Counseling, a brief structured psychological intervention, to that of Selective Serotonin Reuptake Inhibitors. Patients with depressive symptoms referred by Primary Care Physicians to psychiatric consultation-liaison services were eligible for the study if they met the DSM-IV criteria for major depression, had a score ≥13 on the 21-item Hamilton Depression Rating Scale, and were at their first or second depressive episode. The primary outcome was remission of depressive symptoms at 2-months, defined as a HDRS score ≤ 7. Secondary outcome measures were improvement in global functioning and recurrence of depressive symptoms at 12-months. Patients who did not respond to Inter-Personal Counseling or Selective Serotonin Reuptake Inhibitors at 2-months received augmentation with the other treatment. Discussion This trial addresses some of the shortcomings of existing trials targeting major depression in primary care by evaluating the comparative efficacy of a brief psychological intervention that could be easily disseminated, by including a sample of patients with mild/moderate depression and by using different outcome measures. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000479303

  8. 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.

  9. 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

  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

    . Discussion The pilot study showed the effectiveness of an enhanced low-cost, evidence-based intervention in increased physical activity and improved social support. If successful in demonstrating long-term improvements, this randomised controlled trial will be the first sustainable physical activity intervention based in primary care in our country to demonstrate long-term adherence to physical activity. Trial Registration A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov ID: NCT00714831.

  11. The Effects of Rationales, Differential Reinforcement, and a Guided Compliance Procedure to Increase Compliance among Preschool Children

    Science.gov (United States)

    Wilder, David A.; Myers, Kristin; Nicholson, Katie; Allison, Janelle; Fischetti, Anthony T.

    2012-01-01

    Previous research suggests that rationales, or statements describing why a child should comply with a caregiver-delivered instruction, are ineffective at increasing compliance. In the current study, we compared the effects of rationales to a differential reinforcement procedure and a guided compliance procedure. The results indicated that…

  12. Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome: Optimization of antiplatelet treatment in patients 70years and older-rationale and design of the POPular AGE study

    NARCIS (Netherlands)

    Qaderdan, K.; Ishak, M.; Heestermans, A.A.; Vrey, E. de; Jukema, J.W.; Voskuil, M.; Boer, M.J. de; Hof, A.W.J.; Groenemeijer, B.E.; Vos, G.J.; Janssen, P.W.; Bergmeijer, T.O.; Kelder, J.C.; Deneer, V.H.; Berg, J.M. van den

    2015-01-01

    RATIONALE: Dual antiplatelet therapy with acetylsalicylic acid in combination with a more potent P2Y12- inhibitor (ticagrelor or prasugrel) is recommended in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) to prevent atherothrombotic complications. The evidence on which

  13. Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome : Optimization of antiplatelet treatment in patients 70years and older-rationale and design of the POPular AGE study

    NARCIS (Netherlands)

    Qaderdan, Khalid; Ishak, Maycel; Heestermans, Antonius A C M; de Vrey, Evelyn; Jukema, J Wouter; Voskuil, Michiel; de Boer, Menko-Jan; Van't Hof, Arnoud W J; Groenemeijer, Björn E; Vos, Gerrit-Jan A; Janssen, Paul W A; Bergmeijer, Thomas O; Kelder, Johannes C; Deneer, Vera H M; Ten Berg, Jurriën M

    2015-01-01

    RATIONALE: Dual antiplatelet therapy with acetylsalicylic acid in combination with a more potent P2Y12- inhibitor (ticagrelor or prasugrel) is recommended in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) to prevent atherothrombotic complications. The evidence on which

  14. CYP2C19 genotype-guided antiplatelet therapy in ST-segment elevation myocardial infarction patients-Rationale and design of the Patient Outcome after primary PCI (POPular) Genetics study

    NARCIS (Netherlands)

    Bergmeijer, Thomas O.; Janssen, Paul W.A.; Schipper, Jurjan C.; Qaderdan, Khalid; Ishak, Maycel; Ruitenbeek, Rianne S.; Asselbergs, Folkert W.; van 't Hof, Arnoud W.J.; Dewilde, Willem J.M.; Spanó, Fabrizio; Herrman, Jean-Paul R.; Kelder, Johannes C.; Postma, Maarten J.; de Boer, Anthonius; Deneer, Vera H.M.; ten Berg, Jurriën M.

    2014-01-01

    RATIONALE: In patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (pPCI), the use of dual antiplatelet therapy is essential to prevent atherothrombotic complications. Therefore, patients are treated with acetylsalicylic acid and clo

  15. Study design and rationale for investigating phosphodiesterase type 5 inhibition for the treatment of pulmonary hypertension due to chronic obstructive lung disease: the TADA-PHiLD (TADAlafil for Pulmonary Hypertension associated with chronic obstructive Lung Disease) trial.

    Science.gov (United States)

    Maron, Bradley A; Goldstein, Ronald H; Rounds, Sharon I; Shapiro, Shelley; Jankowich, Matthew; Garshick, Eric; Moy, Marilyn L; Gagnon, David; Choudhary, Gaurav

    2013-12-01

    In patients with chronic obstructive pulmonary disease (COPD), moderate or severe pulmonary hypertension (COPD-PH) is associated with increased rates of morbidity and mortality. Despite this, approaches to treatment and the efficacy of phosphodiesterase type 5 inhibition (PDE-5i) in COPD-PH are unresolved. We present the clinical rationale and study design to assess the effect of oral tadalafil on exercise capacity, cardiopulmonary hemodynamics, and clinical outcome measures in COPD-PH patients. Male and female patients 40-85 years old with GOLD stage 2 COPD or higher and pulmonary hypertension diagnosed on the basis of invasive cardiac hemodynamic assessment (mean pulmonary artery pressure [mPAP] >30 mmHg, pulmonary vascular resistance [PVR] >2.5 Wood units, and pulmonary capillary wedge pressure ≤18 mmHg at rest) will be randomized at a 1∶1 ratio to receive placebo or oral PDE-5i with tadalafil (40 mg daily for 12 months). The primary end point is change from baseline in 6-minute walk distance at 12 months. The secondary end points are change from baseline in PVR and mPAP at 6 months and change from baseline in peak volume of oxygen consumption ([Formula: see text]) during exercise at 12 months. Changes in systemic blood pressure and/or oxyhemoglobin saturation (Sao2) at rest and during exercise will function as safety outcome measures. TADA-PHiLD (TADAlafil for Pulmonary Hypertension assocIated with chronic obstructive Lung Disease) is the first sufficiently powered randomized clinical trial testing the effect of PDE-5i on key clinical and drug safety outcome measures in patients with at least moderate PH due to COPD. PMID:25006405

  16. Rationale and design of XAMOS

    DEFF Research Database (Denmark)

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

    2012-01-01

    worldwide, with about 7500 patients receiving rivaroxaban and about 7500 standard of care. XAMOS will supplement the clinical data obtained in the Phase III RECORD 1, 2, 3, and 4 trials in which rivaroxaban was shown to be superior for the primary efficacy endpoints, and with a safety profile similar......, 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...

  17. Rationale and design of ARTS

    DEFF Research Database (Denmark)

    Pitt, Bertram; Filippatos, Gerasimos; Gheorghiade, Mihai;

    2012-01-01

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

  18. Risk analysis and safety rationale

    International Nuclear Information System (INIS)

    Decision making with respect to safety is becoming more and more complex. The risk involved must be taken into account together with numerous other factors such as the benefits, the uncertainties and the public perception. Can the decision maker be aided by some kind of system, general rules of thumb, or broader perspective on similar decisions? This question has been addressed in a joint Nordic project relating to nuclear power. Modern techniques for risk assessment and management have been studied, and parallels drawn to such areas as offshore safety and management of toxic chemicals in the environment. The report summarises the finding of 5 major technical reports which have been published in the NORD-series. The topics includes developments, uncertainties and limitations in probabilistic safety assessments, negligible risks, risk-cost trade-offs, optimisation of nuclear safety and radiation protection, and the role of risks in the decision making process. (author) 84 refs

  19. 特发性流出道室性心律失常研究:基本原理和设计方案%Idiopathic outflow tract ventricular arrhythmias study (IOTVA Study) :rationale and design

    Institute of Scientific and Technical Information of China (English)

    曹克将; 张澍; 姚焰; 吴书林; 陈明龙; 张凤祥; 杨兵; 李小荣; 魏薇

    2014-01-01

    Background Idiopathic ventricular arrhythmias (IOTVA) in patients without structural heart disease mostly originate from left or right ventricular outflow tract.Data about the epidemiology,nature prognosis and treatment of idiopathic outflow tract premature ventricular complexes/nonsustained ventricular tachycardia (IOTPVC/NSVT),which based on the large sample of clinical trial,are scarce at present.Rationale Some studies have demonstrated that effects on cardiac function of IOTPVC/NSVT are related to its burden.Antiarrhythmic drugs (class IC agents and β-blockers) and catheter ablation are effective for IOTVA.This study will assess effects on cardiac function of IOTPVC burden and compare safety and effectiveness of antiarrhythmic drugs with catheter ablation in patients with IOTPVC/NSVT.Design The IOTVA study will includes the following:①to investigate the proportion of IOTVA to ventricular arrhythmias in outpatients and inpatients at the department of cardiology; ②to inquire the prognosis and its cardiac function in IOTVA patients without any treatment; ③to assess the safety of antiarrhythmic drugs therapy compared with control therapy in IOTVA patients; ④to compare safety and effectiveness of antiarrhythmic drugs with catheter ablation in IOTPVC/NSVT patients with PVCs burden more than 15%.Based on these studies,we would establish the clinical treatment approach for IOTVA.Conclusion IOTVA study will assess effects on cardiac function of IOTPVC burden and evaluate safety and effectiveness of antiarrhythmic drugs and catheter ablation in patients with IOTPVC/NSVT.%背景 发生在无器质性心脏病的室性心律失常又称为特发性室性心律失常(IVA),其中大多数起源于左心室或右心室流出道.目前关于特发性流出道室性早搏(IOTPVC)与非持续性室性心动过速(NSVT)的流行病学调查、预后以及临床干预均缺乏大样本的循证医学证据.基本原理 相关研究表明,不同负荷的IOTPVC/NSVT可

  20. Design and rationale of FOCUS (PX-171-011): A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM)

    International Nuclear Information System (INIS)

    Carfilzomib is a next-generation proteasome inhibitor with single-agent activity in patients with relapsed and refractory multiple myeloma (R/R MM). In PX-171-003-A1, a single-arm phase 2 study of carfilzomib monotherapy in heavily pretreated patients, the overall response rate was 23.7%, 37% of patients achieved ≥ minimal response and median overall survival (OS) was 15.6 months. Based on this study, carfilzomib was recently approved by the US Food and Drug Administration for the treatment of R/R MM. Herein we describe the trial design and rationale for a phase 3 randomized study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study), being conducted to compare OS after treatment with single-agent carfilzomib to best supportive care (BSC) regimen in R/R MM. Patients must have received ≥3 prior regimens, must be responsive to at least 1 line of therapy, and be refractory to their most recent therapy. Eligible patients are randomized 1:1 to receive either carfilzomib (28-day cycles at 20 mg/m2 IV on Days 1–2 of Cycle 1, escalating to 27 mg/m2 IV on Days 8, 9, 15, and 16 and continuing at 27 mg/m2 through Cycle 9 and Days 1, 2, 15, and 16 ≥ Cycle 10) or an active BSC regimen (corticosteroid treatment of prednisolone 30 mg, dexamethasone 6 mg, or equivalent every other day with optional cyclophosphamide 50 mg PO once daily). Patients will continue treatment until disease progression, unacceptable toxicity, or treatment discontinuation and will then enter long-term follow-up for survival. The primary endpoint is OS and secondary endpoints include progression-free survival, overall response rate, and safety. Disease assessments will be determined according to the International Myeloma Working Group Uniform Response Criteria with minimal response per European Blood and Marrow Transplantation Group criteria. This phase 3 trial will provide more rigorous data for carfilzomib, as this is the first carfilzomib study with OS as the primary

  1. Rationale and study design of a cross sectional study documenting the prevalence of Heart Failure amongst the minority ethnic communities in the UK: the E-ECHOES Study (Ethnic - Echocardiographic Heart of England Screening Study)

    OpenAIRE

    Freemantle Nick; Davies Michael; Davis Russell; Gill Paramjit S; Lip Gregory YH

    2009-01-01

    Abstract Background Heart failure is an important cause of cardiovascular morbidity and mortality. Studies to date have not established the prevalence heart failure amongst the minority ethnic community in the UK. T'he aim of the E-ECHOES (Ethnic - Echocardiographic Heart of England Screening Study)is to establish, for the first time, the community prevalence and severity of left ventricular systolic dysfunction (LVSD) and heart failure amongst the South Asian and Black African-Caribbean ethn...

  2. Rationales behind the choice of administration form with fentanyl

    DEFF Research Database (Denmark)

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2010-01-01

    BACKGROUND AND AIM: The aim of this study was to describe the rationale behind the choice of fentanyl administration forms among Danish general practitioners (GPs). METHODS: Thirty-eight Danish GPs were contacted via an Internet survey system to perform a Delphi survey. In the brainstorming phase......, the main reasons for prescribing and not prescribing fentanyl patches, oral transmucosal systems (OTFCs), and nasal sprays were identified. In the second phase, GPs were asked to rate the importance of each reason. RESULTS AND DISCUSSION: Thirty-three GPs responded in the brainstorming phase, and 33 and 31...

  3. Rationale for reduced tornado design bases

    International Nuclear Information System (INIS)

    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

  4. Description and Rationale for the Planning, Monitoring, and Implementation (PMI) Model: Rationale.

    Science.gov (United States)

    Cort, H. Russell

    The rationale for the Planning, Monitoring, and Implementation Model (PMI) is the subject of this paper. The Superintendent of the District of Columbia Public Schools requested a model for systematic evaluation of educational programs to determine their effectiveness. The school system's emphasis on objective-referenced instruction and testing,…

  5. A beginner's guide to writing the nursing conceptual model-based theoretical rationale.

    Science.gov (United States)

    Gigliotti, Eileen; Manister, Nancy N

    2012-10-01

    Writing the theoretical rationale for a study can be a daunting prospect for novice researchers. Nursing's conceptual models provide excellent frameworks for placement of study variables, but moving from the very abstract concepts of the nursing model to the less abstract concepts of the study variables is difficult. Similar to the five-paragraph essay used by writing teachers to assist beginning writers to construct a logical thesis, the authors of this column present guidelines that beginners can follow to construct their theoretical rationale. This guide can be used with any nursing conceptual model but Neuman's model was chosen here as the exemplar.

  6. Placebo versus "standard" hypnosis rationale: attitudes, expectancies, hypnotic responses, and experiences.

    Science.gov (United States)

    Accardi, Michelle; Cleere, Colleen; Lynn, Steven Jay; Kirsch, Irving

    2013-10-01

    In this study participants were provided with either the standard rationale that accompanies the Harvard Group Scale of Hypnotic Susceptibility: A (Shor & Orne, 1962) or a rationale that presented hypnosis as a nondeceptive placebo, consistent with Kirsch's (1994) sociocognitive perspective of hypnosis. The effects of the placebo and standard rationales were highly comparable with respect to hypnotic attitudes; prehypnotic expectancies; objective, subjective, and involuntariness measures of hypnotic responding; as well as a variety of subjective experiences during hypnosis, as measured by the Phenomenology of Consciousness Inventory (Pekala, 1982). Differences among correlations were not evident when measures were compared across groups. However, indices of hypnotic responding were correlated with attitudes in the hypnosis but not the placebo condition, and, generally speaking, the link between subjective experiences during hypnosis and measures of hypnotic responding were more reliable in the placebo than the hypnosis group. Researcher findings are neutral with respect to providing support for altered state versus sociocognitive models of hypnosis.

  7. Looking Forward via Hindsight: A Rationale for Reviewing Our Ideological Roots.

    Science.gov (United States)

    Engels, Dennis W.

    1980-01-01

    Points to a lack of historical studies and posits a rationale for historical study of personalities, events, and ideas in the growth of guidance and counseling. The practice of extending antecedent theory through the development of the history of counseling theory ultimately improves the discipline. (Author)

  8. A dynamic-efficiency rationale for public investment in the health of young

    DEFF Research Database (Denmark)

    Andersen, Torben M.; Bhattacharya, Joydeep

    2014-01-01

    In this paper we assume away standard distributional and static-efficiency arguments for public health and instead seek a dynamic efficiency rationale. We study a lifecycle model wherein young agents make health investments to reduce mortality risk. We identify a welfare rationale for public health...... under dynamic efficiency and exogenous mortality even when private and public investments are perfect substitutes. If health investment reduces mortality risk but individuals do not internalize its effect on the life-annuity interest rate, the “Philipson-Becker effect” emerges; when the young are net...... borrowers, this works together with dynamic efficiency to support a role for public health....

  9. The telmisartan renoprotective study from incipient nephropathy to overt nephropathy--rationale, study design, treatment plan and baseline characteristics of the incipient to overt: angiotensin II receptor blocker, telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION) Study.

    Science.gov (United States)

    Makino, H; Haneda, M; Babazono, T; Moriya, T; Ito, S; Iwamoto, Y; Kawamori, R; Takeuchi, M; Katayama, S

    2005-01-01

    We planned the INNOVATION study to determine whether telmisartan, an angiotensin-2-receptor blocker, delays the progression of renal disease from incipient nephropathy to overt nephropathy in hypertensive or normotensive Japanese patients with type 2 diabetes mellitus. The INNOVATION study is a randomized, double-blind, placebo-controlled trial. Eligible patients must have incipient nephropathy (defined as a urinary albumin to creatinine ratio of 100-300 mg/g creatinine) and a serum creatinine concentration of 300 mg/g creatinine and 30% higher than the baseline on at least two consecutive visits). A total of 1855 patients have been enrolled from 160 study centres. In 527 randomized patients (28.4% of the enrolled patients), mean (SD) urinary albumin to creatinine ratio and serum creatinine concentration at baseline were 173.3 (47.2) mg/g creatinine and 0.78 (0.19) mg/dl. Sixty-eight per cent of the patients had hypertension at baseline. Mean (SD) systolic and diastolic blood pressures at baseline were 137.1 (14.6) and 77.5 (10.3) mmHg. The INNOVATION study will determine whether telmisartan, an angiotensin II receptor blocker, provides clinical benefits in hypertensive or normotensive patients with diabetes mellitus and diabetic nephropathy.

  10. Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study.

    Science.gov (United States)

    Varma, Niraj

    2007-12-01

    Increased implantable cardioverter defibrillator (ICD) implant volumes (and product advisories/recalls) pose management challenges. Most device interrogations at 3- to 6-month routine follow-up visits are "nonactionable," that is, require no clinically significant reprogramming, lead revision, or initiation or up-titration of antiarrhythmic medications. Conversely, implanted devices collect important diagnostic data (eg, atrial fibrillation onset, system integrity) that remain concealed between device interrogations. Remote monitoring may resolve some of these challenges, but has not been studied in a large-scale clinical trial. Home Monitoring (HM) uses automatic (without patient intervention) data and electrogram transmissions with rapid (automatically occur between periodic checks for compromised system integrity (battery, lead parameters, high-voltage circuitry) or arrhythmia occurrence (eg, atrial fibrillation, ventricular arrhythmia). All study patients will have a final office visit 15 months after implant. The results of TRUST may confirm the role of remote monitoring as an intensive surveillance mechanism for device management. PMID:18035071

  11. "Socialized Music": Historical Formations of Community Music through Social Rationales

    Science.gov (United States)

    Yerichuk, Deanna

    2014-01-01

    This article traces the formation of community music through professional and scholarly articles over the last century in North America, and argues that community music has been discursively formed through social rationales, although the specific rationales have shifted. The author employs an archaeological framework inspired by Michel Foucault to…

  12. Study of vitamin D status of rheumatoid arthritis patients Rationale and design of a cross-sectional study by the osteoporosis and metabolic bone diseases study group of the Italian Society of Rheumatology (SIR

    Directory of Open Access Journals (Sweden)

    M. Antonelli

    2011-09-01

    Full Text Available The fundamental role of Vitamin D has been long known in regulating calcium homeostasis and bone metabolism. An increased contribution of Vitamin D was recently described in association with a lower incidence of Rheumatoid Arthritis (RA. This must not be surprising, as the immunomodulating effects of Vitamin D are clear, which have been attributed protective effects in autoimmune disorders such as some chronic inflammatory bowel diseases, multiple sclerosis and type I diabetes. An interaction was suggested between Vitamin D metabolism and inflammation indexes through mediation of TNF-a which is also especially involved in osteoclastic resorption and therefore in bone loss processes. Some preliminary data would indicate an association between seasonal changes of Vitamin D serum levels, latitude and disease activity (DAS28 in RA patients. Consequently, the Osteoporosis and Metabolic Bone Diseases Study Group of SIR believes that there are grounded reasons for assessing the Vitamin D status of RA patients in order to investigate whether this is to be related to physiopathological and clinical aspects of disease other than those of bone involvement. Primary end point of the study will be to assess the levels of 25 OH Vitamin D in RA patients. Secondary endpoints will include correlation with disease activity, densitometry values and bone turnover. The cross-sectional study will enrol patients of both sex genders, age ranging between 30 and 75 years according to the 1988 ACR criteria, onset of symptoms at least 2 years prior to study enrollment. Patients will be excluded suffering from osteometabolic diseases, liver and kidney insufficiency and those administered Vitamin D boli in the previous 12 months. Disease activity will be evaluated with the HAQ. Haematochemical tests and femoral and lumbar bone densitometry will be performed, unless recently undergone by patients. Blood levels of 25 OH C Vitamin D and PHT and of the two bone remodeling markers

  13. Development of regulatory technical rationale for risk monitoring program

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Chang Hyun; Kim, Ju Youl; Kim, Yoon Ik; Yang, Hui Chang; Lee, Yong Suk; Ahn, Kwang Won; Kim, Se Hyung [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In Korea, the risk monitoring program will be developed and applied to each plants till 2003 by the severe accident management plan to enhance the safety functions of the nuclear power plants. Through this plan, the risk monitoring for the full power and low power and shutdown operation will be performed. Therefore the development of consistent risk monitoring system and overall regulatory guides for the risk monitoring program are necessary. The objective of this study is the development of regulatory technical rationales for the nuclear power plant risk monitoring program and the derivation of the requirements need for the development of risk monitoring system. Through this the improvement of regulatory effectiveness to assure the safe operation of nuclear power plant, is expected.

  14. Rationale awareness for quality assurance in iterative human computation processes

    CERN Document Server

    Xiao, Lu

    2012-01-01

    Human computation refers to the outsourcing of computation tasks to human workers. It offers a new direction for solving a variety of problems and calls for innovative ways of managing human computation processes. The majority of human computation tasks take a parallel approach, whereas the potential of an iterative approach, i.e., having workers iteratively build on each other's work, has not been sufficiently explored. This study investigates whether and how human workers' awareness of previous workers' rationales affects the performance of the iterative approach in a brainstorming task and a rating task. Rather than viewing this work as a conclusive piece, the author believes that this research endeavor is just the beginning of a new research focus that examines and supports meta-cognitive processes in crowdsourcing activities.

  15. The rationale for deep brain stimulation in Alzheimer's disease.

    Science.gov (United States)

    Mirzadeh, Zaman; Bari, Ausaf; Lozano, Andres M

    2016-07-01

    Alzheimer's disease is a major worldwide health problem with no effective therapy. Deep brain stimulation (DBS) has emerged as a useful therapy for certain movement disorders and is increasingly being investigated for treatment of other neural circuit disorders. Here we review the rationale for investigating DBS as a therapy for Alzheimer's disease. Phase I clinical trials of DBS targeting memory circuits in Alzheimer's disease patients have shown promising results in clinical assessments of cognitive function, neurophysiological tests of cortical glucose metabolism, and neuroanatomical volumetric measurements showing reduced rates of atrophy. These findings have been supported by animal studies, where electrical stimulation of multiple nodes within the memory circuit have shown neuroplasticity through stimulation-enhanced hippocampal neurogenesis and improved performance in memory tasks. The precise mechanisms by which DBS may enhance memory and cognitive functions in Alzheimer's disease patients and the degree of its clinical efficacy continue to be examined in ongoing clinical trials. PMID:26443701

  16. Vincristine in childhood leukaemia : no pharmacokinetic rationale for dose reduction in adolescents

    NARCIS (Netherlands)

    Frost, BM; Lonnerholm, G; Koopmans, P; Abrahamsson, J; Behrendtz, M; Castor, A; Forestier, E; Uges, DRA

    2003-01-01

    Aim: To investigate whether there is any pharmacokinetic rationale for the common practice of administering vincristine to adolescents at relatively lower doses than those to younger children. Methods: A total of 98 children, aged 1.3-17.3 y, with acute lymphoblastic leukaemia (ALL) were studied on

  17. Netherlands research programme weight gain prevention (NHF-NRG): rationale, objectives and strategies

    NARCIS (Netherlands)

    Kremers, S.P.; Schouten, E.G.; Kok, F.J.; Visscher, T.L.S.; Brug, J.; Kromhout, D.

    2005-01-01

    OBJECTIVE: To outline the rationale, objectives and strategies used in a systematically designed research programmme to study specific weight gain-inducing behaviours, their social-psychological as well as environmental determinants, and the effects of interventions aimed at the prevention of weight

  18. The Importance of Rationales for Internationalization at a Local Level--University and Individual

    Science.gov (United States)

    Willis, Ian; Taylor, John

    2014-01-01

    This study examines rationales for internationalization at a research intensive university in the UK. Internationalization is often described at a macro level without reaching down to explore the individual motivations that may support or constrain internationalization at a particular institution. The article argues that it is important to…

  19. Rationale for Students' Participation in University Governance and Organizational Effectiveness in Ekiti and Ondo States, Nigeria

    Science.gov (United States)

    Akomolafe, C. O.; Ibijola, E. Y.

    2012-01-01

    The study investigated the rationale for students' participation in university governance and organizational effectiveness. A descriptive research of survey design was adopted. The population consisted of all staff and students of Ekiti State University, Ado Ekiti, Ekiti State and Adekunle Ajasin University, Akungba-Akoko, Ondo State. 700 subjects…

  20. Rationale for Antioxidant Supplementation in Hemodialysis Patients

    Directory of Open Access Journals (Sweden)

    Morena Marion

    2001-01-01

    Full Text Available Oxidative stress, which results from an imbalance between reactive oxygen species (ROS production and antioxidant defense mechanisms, is now a well recognized pathogenic process in hemodialysis (HD patients that could be involved in dialysis-related pathologies such as accelerated atherosclerosis, amyloidosis and anemia. This review is aimed at evaluating the rationale for preventive intervention against oxidative damage during HD as well as the putative causal factors implicated in this imbalance. The antioxidant system is severely impaired in uremic patients and impairment increases with the degree of renal failure. HD further worsens this condition mainly by losses of hydrophilic unbound small molecular weight substances such as vitamin C, trace elements and enzyme regulatory compounds. Moreover, inflammatory state due to the hemo-incompatibility of the dialysis system plays a critical role in the production of oxidants contributing further to aggravate the pro-oxidant status of uremic patients. Prevention of ROS overproduction can be achieved by improvement of dialysis biocompatibility, a main component of adequate dialysis, and further complimented by antioxidant supplementation. This could be achieved either orally or via the extracorporeal circuit. Antioxidants such as vitamin E could be bound on dialyzer membranes. Alternatively, hemolipodialysis consisting of loading HD patients with vitamin C or E via an ancillary circuit made of vitamin E-rich liposomes may be used.

  1. Opening Minds in Canada: Background and Rationale

    Science.gov (United States)

    Stuart, Heather; Chen, Shu-Ping; Christie, Romie; Dobson, Keith; Kirsh, Bonnie; Knaak, Stephanie; Koller, Michelle; Krupa, Terry; Lauria-Horner, Bianca; Luong, Dorothy; Modgill, Geeta; Patten, Scott B; Pietrus, Mike; Szeto, Andrew; Whitley, Rob

    2014-01-01

    Objective: To summarize the background and rationale of the approach taken by the Mental Health Commission of Canada’s Opening Minds (OM) Anti-Stigma Initiative. Method: The approach taken by OM incorporates a grassroots, community development philosophy, has clearly defined target groups, uses contact-based education as the central organizing element across interventions, and has a strong evaluative component, so that best practices can be identified, replicated, and disseminated. Contact-based education occurs when people who have experienced a mental illness share their personal story of recovery and hope. Results: OM has acted as a catalyst to develop partnerships between community groups who are undertaking anti-stigma work and an interdisciplinary team of academic researchers in 5 universities who are evaluating the results of these programs. Conclusions: Building partnerships with existing community programs and promoting systematic evaluation using standardized approaches and instruments have contributed to our understanding of best practices in the field of anti-stigma programming. PMID:25565705

  2. The rationale for early intervention in schizophrenia and related disorders

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone;

    2009-01-01

    Abstract Aim: To examine the rationale and evidence supporting an early intervention approach in schizophrenia. Methods: A selective literature review was conducted. Results: During the onset of schizophrenia, there is often a significant delay between the emergence of psychotic symptoms...

  3. Influencing Acceptability of Parent Training Interventions Through Treatment Rationales

    OpenAIRE

    Chase, Trisha

    2015-01-01

    Parent training is an effective intervention for parents of children with a variety of childhood disorders, and parents often view behavioral parent training as acceptable. Explanations and rationales for parent training are commonly provided at the beginning of treatment. However, there is little research regarding how rationales may influence acceptability. There is also limited information on whether fathers and mothers judge the acceptability of parent training differently. The purpose of...

  4. Rationales for Place-based Approaches in Scotland

    OpenAIRE

    Bynner, Claire

    2016-01-01

    The aim of this paper is to remove the confusion surrounding what place-based approaches are, the rationales behind their use, the development of this approach to public service reform in Scotland and the future challenges presented by austerity and welfare reform. Key arguments presented in this paper:  The rationales driving the emergence of new place-based approaches at the neighbourhood level include: o The Civic – in the need for higher quality, more responsive services and for co...

  5. Heart Failure Therapeutics on the Basis of a Biased Ligand of the Angiotensin-2 Type 1 Receptor Rationale and Design of the BLAST-AHF Study (Biased Ligand of the Angiotensin Receptor Study in Acute Heart Failure)

    NARCIS (Netherlands)

    Felker, G. Michael; Butler, Javed; Collins, Sean P.; Cotter, Gad; Davison, Beth A.; Ezekowitz, Justin A.; Filippatos, Gerasimos; Levy, Phillip D.; Metra, Marco; Ponikowski, Piotr; Soergel, David G.; Teerlink, John R.; Violin, Jonathan D.; Voors, Adriaan A.; Pang, Peter S.

    2015-01-01

    The BLAST-AHF (Biased Ligand of the Angiotensin Receptor Study in Acute Heart Failure) study is designed to test the efficacy and safety of TRV027, a novel biased ligand of the angiotensin-2 type 1 receptor, in patients with acute heart failure (AHF). AHF remains a major public health problem, and n

  6. Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE" study: a double-blind randomised controlled multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Lee Myoungsook

    2011-01-01

    Full Text Available Abstract Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT: NCT01031667

  7. A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study

    Science.gov (United States)

    Lubans, David R; Smith, Jordan J; Peralta, Louisa R; Plotnikoff, Ronald C; Okely, Anthony D; Salmon, Jo; Eather, Narelle; Dewar, Deborah L; Kennedy, Sarah; Lonsdale, Chris; Hilland, Toni A; Estabrooks, Paul; Finn, Tara L; Pollock, Emma; Morgan, Philip J

    2016-01-01

    Introduction Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be ‘scaled-up’ and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. Methods and analysis The study will be conducted in two phases. In the first phase (cluster randomised controlled trial), 16 schools will be randomly allocated to the intervention or a usual care control condition. In the second phase, the Reach, Effectiveness, Adoption, Implementation and Maintenance (Re-AIM) framework will be used to guide the design and evaluation of programme dissemination throughout New South Wales (NSW), Australia. In both phases, teachers will be trained to deliver the NEAT and ATLAS programmes, which will include: (1) interactive student seminars; (2) structured physical activity programmes; (3) lunch-time fitness sessions; and (4) web-based smartphone apps. In the cluster RCT, study outcomes will be assessed at baseline, 6 months (primary end point) and 12-months. Muscular fitness will be the primary outcome and secondary outcomes will include: objectively measured body composition, cardiorespiratory fitness, flexibility, resistance training skill competency, physical activity, self-reported recreational screen-time, sleep, sugar-sweetened beverage and junk food snack consumption, self-esteem and well-being. Ethics and dissemination This study has received approval from the University of Newcastle (H-2014-0312) and the NSW Department of Education (SERAP: 2012121) human research ethics committees. This

  8. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

    Science.gov (United States)

    2012-01-01

    Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

  9. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial: study rationale and design

    Directory of Open Access Journals (Sweden)

    Kristensen Peter

    2012-06-01

    Full Text Available Abstract Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE, multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.

  10. Risk and Determinants of Dementia in Patients with Mild Cognitive Impairment and Brain Subcortical Vascular Changes: A Study of Clinical, Neuroimaging, and Biological Markers—The VMCI-Tuscany Study: Rationale, Design, and Methodology

    Directory of Open Access Journals (Sweden)

    Anna Poggesi

    2012-01-01

    Full Text Available Dementia is one of the most disabling conditions. Alzheimer’s disease and vascular dementia (VaD are the most frequent causes. Subcortical VaD is consequent to deep-brain small vessel disease (SVD and is the most frequent form of VaD. Its pathological hallmarks are ischemic white matter changes and lacunar infarcts. Degenerative and vascular changes often coexist, but mechanisms of interaction are incompletely understood. The term mild cognitive impairment defines a transitional state between normal ageing and dementia. Pre-dementia stages of VaD are also acknowledged (vascular mild cognitive impairment, VMCI. Progression relates mostly to the subcortical VaD type, but determinants of such transition are unknown. Variability of phenotypic expression is not fully explained by severity grade of lesions, as depicted by conventional MRI that is not sensitive to microstructural and metabolic alterations. Advanced neuroimaging techniques seem able to achieve this. Beside hypoperfusion, blood-brain-barrier dysfunction has been also demonstrated in subcortical VaD. The aim of the Vascular Mild Cognitive Impairment Tuscany Study is to expand knowledge about determinants of transition from mild cognitive impairment to dementia in patients with cerebral SVD. This paper summarizes the main aims and methodological aspects of this multicenter, ongoing, observational study enrolling patients affected by VMCI with SVD.

  11. Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study)

    International Nuclear Information System (INIS)

    Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV) testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women. VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years), 1000 recent migrant women (aged 26–65 years) and 3000 young women (aged 13–26 years) and 1 control group: 2000 women (aged 26–45 years) attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models will be used to estimate crude and adjusted odds ratios. Cox

  12. Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study

    Directory of Open Access Journals (Sweden)

    Orlando Giovanna

    2012-05-01

    Full Text Available Abstract Background Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women. Methods/design VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years, 1000 recent migrant women (aged 26–65 years and 3000 young women (aged 13–26 years and 1 control group: 2000 women (aged 26–45 years attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models

  13. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

    Science.gov (United States)

    Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

    2016-04-01

    The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

  14. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

    Science.gov (United States)

    Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

    2016-04-01

    The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

  15. Metformin and its effects on myocardial dimension and left ventricular hypertrophy in normotensive patients with coronary heart disease (the MET-REMODEL study): rationale and design of the MET-REMODEL study.

    Science.gov (United States)

    Mohan, Mohapradeep; McSwiggan, Stephen; Baig, Fatima; Rutherford, Lynn; Lang, Chim C

    2015-02-01

    Left ventricular hypertrophy (LVH) is a common and independent risk factor for cardiovascular events in patients with coronary artery disease (CAD). Controlling blood pressure is the standard approach to the management of LVH, but this is only partially effective as LVH also persists in normotensive patients. Apart from blood pressure (BP), other main risk factors associated with LVH are insulin resistance (IR) and central obesity. The diabetic medication, Metformin, reduces IR and aids weight loss and may therefore regress LVH. The MET REMODEL study will investigate the ability of Metformin to regress LVH in 64 patients with CAD. The MET-REMODEL trial is a single-center, phase IV, double blind, randomized, placebo-controlled trial to investigate the efficacy of Metformin in regression of the independent cardiac risk factor of LVH in patients with CAD who are insulin resistant. A minimum of 64 adults with a history of CAD with LVH and IR will be randomized into two groups to receive, either Metformin XL or placebo. The primary endpoint of this trial is to investigate any change in left ventricular mass index. Secondary endpoints include changes to insulin resistance measured using fasting insulin resistance index (FIRI), obesity, LV size, and function and improvement in endothelial function. A positive result will assist clinicians to identify a new mechanism for LVH regression by administering Metformin XL. This may also lead to investigating the mortality benefit of Metformin in patients with CAD and LVH.

  16. Benefits of antioxidant supplements for knee osteoarthritis: rationale and reality.

    Science.gov (United States)

    Grover, Ashok Kumar; Samson, Sue E

    2016-01-01

    Arthritis causes disability due to pain and inflammation in joints. There are many forms of arthritis, one of which is osteoarthritis whose prevalence increases with age. It occurs in various joints including hip, knee and hand with knee osteoarthritis being more prevalent. There is no cure for it. The management strategies include exercise, glucosamine plus chondroitin sulfate and NSAIDs. In vitro and animal studies provide a rationale for the use of antioxidant supplements for its management. This review assesses the reality of the benefits of antioxidant supplements in the management of knee osteoarthritis. Several difficulties were encountered in examining this issue: poorly conducted studies, a lack of uniformity in disease definition and diagnosis, and muddling of conclusions from attempts to isolate the efficacious molecules. The antioxidant supplements with most evidence for benefit for pain relief and function in knee osteoarthritis were based on curcumin and avocado-soya bean unsaponifiables. Boswellia and some herbs used in Ayurvedic and Chinese medicine may also be useful. The benefits of cuisines with the appropriate antioxidants should be assessed because they may be more economical and easier to incorporate into the lifestyle. PMID:26728196

  17. Framing Involvement: Rationale Construction in an Interorganisational Collaboration

    Science.gov (United States)

    Siegel, David J.

    2008-01-01

    An analysis of the different rationales articulated and utilized by partners in an interorganizational collaboration is the focus of this paper. The Leadership Education and Development (LEAD) Program in Business is an initiative involving 12 US universities, nearly 40 multinational corporations, a federal government agency, and a non-profit…

  18. Building "Applied Linguistic Historiography": Rationale, Scope, and Methods

    Science.gov (United States)

    Smith, Richard

    2016-01-01

    In this article I argue for the establishment of "Applied Linguistic Historiography" (ALH), that is, a new domain of enquiry within applied linguistics involving a rigorous, scholarly, and self-reflexive approach to historical research. Considering issues of rationale, scope, and methods in turn, I provide reasons why ALH is needed and…

  19. Karl Popper and Jean Piaget: A Rationale for Constructivism

    Science.gov (United States)

    Harlow, Steve; Cummings, Rhoda; Aberasturi, Suzanne M.

    2006-01-01

    The current faddish use of the term constructivism has taken on as many different definitions as the number of people attempting to define it. This essay clarifies the meaning of constructivism through an examination of Karl Popper's and Jean Piaget's theories. The authors provide a rationale for the use of Popper's paradigm of "Three Worlds" and…

  20. Introducing ICT in Schools in England: Rationale and Consequences

    Science.gov (United States)

    Hammond, Michael

    2014-01-01

    This paper provides a critical perspective on the attempts to promote the use of information and communication technology (ICT) in teaching and learning in England. It describes the rationale given for the introduction of ICT in terms of its potential to impact on educational standards to contribute to developing a curriculum which has more…

  1. 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…

  2. Rationale for tilted implants: FEA considerations and clinical reports.

    Science.gov (United States)

    DE Vico, G; Bonino, M; Spinelli, D; Schiavetti, R; Sannino, G; Pozzi, A; Ottria, L

    2011-07-01

    The prevalence of the elderly population, as well as life expectancy, increased in the final decades of the 20th century, as described in the World Health Organization 2004 Annual Report. The edentulous condition therefore has a negative impact on the oral health-related quality of life. Patients wearing complete dentures for many years infact, and especially in the mandible, are often unsatisfied because of the instability of the prosthesis during speaking and eating. To date dental implant treatment is well documented as a predictable treatment for partial or complete edentulism. On the other hand the rehabilitation of atrophied edentulous arches with endosseous implants (> 10 mm) in the posterior regions is often associated with anatomic problems such as bone resorption, poor bone quality, mandibular canal, and the presence of maxillary sinuses. Different procedures have been proposed to overcome these anatomic limitations. The use of tilted implants parallel to the anterior wall of the maxillary sinus or the mental foramen/inferior alveolar nerve has been proposed as a conservative solution for the treatment of the atrophic edentulous maxilla. Aim of this study was to describe, through a detailed literature review, the clinical and biomechanical rationale for tilting implants and to evaluate the long-term prognosis of immediately loaded full fixed prostheses for the treatment of edentulous patients (#35) with extreme bone atrophy rehabilited with both axial (#70) and tilted (#70) implants from 2008 to 2010. The results of the present study would suggest that this new surgical technique may reduce patient morbidity and extend the indications for immediate loading full fixed rehabilitations. This improves the predictability of treatment goal, allows for a better risk management, and provides more individual information for the patient. These are the most important aspects of this technology, which may contribute to establish higher-quality standards in

  3. Rationale and design of the AdRem study : Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus

    NARCIS (Netherlands)

    Stolk, Ronald P.; Vingerling, Johannes R.; Cruickshank, J. Kennedy; Hughes, Alun D.; Stanton, Alice; Lu Juming, [No Value; Patel, Anushka; Thom, Simon A. McG.; Grobbee, Diederick E.; Lu, J.M.

    2007-01-01

    The ADVANCE Retinal Measurements (AdRem) Study is a large intervention study evaluating the effects of target driven intensive glucose control and placebo controlled blood pressure lowering on retinal vascular changes. AdRem is a sub-study of the ADVANCE Study (Action in Diabetes and Vascular diseas

  4. Secondary School Students Learning from Reflections on the Rationale behind Self-Made Errors: A Field Experiment

    Science.gov (United States)

    Heemsoth, Tim; Heinze, Aiso

    2016-01-01

    Thus far, it is unclear how students can learn most effectively from their own errors. In this study, reflections on the rationale behind self-made errors are assumed to enhance knowledge acquisition. In a field experiment with pre/post/follow-up design, the authors practiced fractions with 174 seventh- and eighth-grade students who were randomly…

  5. A Model Incorporating the Rationale and Purpose for Conducting Mixed-Methods Research in Special Education and beyond

    Science.gov (United States)

    Collins, Kathleen M. T.; Onwuegbuzie, Anthony J.; Sutton, Ida L.

    2006-01-01

    This article provides a typology of reasons for conducting mixed-methods research in special education. The mixed-methods research process is described along with the role of the rationale and purpose of study. The reasons given in the literature for utilizing mixed-methods research are explicated, and the limitations of these reason frameworks…

  6. Rationales of a Shift towards Knowledge Economy in Jordan from the Viewpoint of Educational Experts and Relationship with Some Variables

    Science.gov (United States)

    Al Zboon, Mohammad Saleem; Al Ahmad, Suliman Diab Ali; Al Zboon, Saleem Odeh

    2009-01-01

    The purpose of the present study was to identify rationales underlying a shift towards knowledge economy in education as perceived by the educational experts in Jordan and relationship with some variables. The random stratum sample (n = 90) consisted of educational experts representing faculty members in the Jordanian universities and top leaders…

  7. Adnectin-targeted inhibitors: rationale and results.

    Science.gov (United States)

    Sachdev, Esha; Gong, Jun; Rimel, Bobbie; Mita, Monica

    2015-08-01

    Adnectins are a family of binding proteins derived from the 10th type III domain of human fibronectin (10Fn3), which is part of the immunoglobulin superfamily and normally binds integrin. The 10Fn3 has the potential for broad therapeutic applications given its structural stability, ability to be manipulated, and its abundance in the human body. The most commonly studied adnectin is CT-322, which is an inhibitor of vascular endothelial growth factor receptor-2. A bispecific adnectin, El-Tandem, has also been developed and binds to epidermal growth factor receptor and insulin-like growth factor-1 receptor simultaneously. Pre-clinical studies have shown promising results in relation to reducing tumor growth, decreasing microvessel density, and promoting normalization of tumor architecture. The phase I trial with CT-322 demonstrates relatively low toxicities. However, the phase II study done with CT-322 in recurrent glioblastoma does not reveal as promising results.

  8. Cannabidiol and epilepsy: Rationale and therapeutic potential.

    Science.gov (United States)

    Leo, Antonio; Russo, Emilio; Elia, Maurizio

    2016-05-01

    Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remains still poor. Unfortunately, besides several advantages, these new AEDs have not satisfactorily reduced the number of refractory patients. Therefore, the need for different other therapeutic options to manage epilepsy is still a current issue. To this purpose, emphasis has been given to phytocannabinoids, which have been medicinally used since ancient time in the treatment of neurological disorders including epilepsy. In particular, the nonpsychoactive compound cannabidiol (CBD) has shown anticonvulsant properties, both in preclinical and clinical studies, with a yet not completely clarified mechanism of action. However, it should be made clear that most phytocannabinoids do not act on the endocannabinoid system as in the case of CBD. In in vivo preclinical studies, CBD has shown significant anticonvulsant effects mainly in acute animal models of seizures, whereas restricted data exist in chronic models of epilepsy as well as in animal models of epileptogenesis. Likewise, clinical evidence seems to indicate that CBD is able to manage epilepsy both in adults and children affected by refractory seizures, with a favourable side effect profile. However, to date, clinical trials are both qualitatively and numerically limited, thus yet inconsistent. Therefore, further preclinical and clinical studies are undoubtedly needed to better evaluate the potential therapeutic profile of CBD in epilepsy, although the actually available data is promising. PMID:26976797

  9. Rationale for the tinnitus retraining therapy trial

    Directory of Open Access Journals (Sweden)

    Craig Formby

    2013-01-01

    Full Text Available The Tinnitus Retraining Therapy Trial (TRTT is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1 directive counseling and sound therapy using conventional sound generators; (2 directive counseling and placebo sound generators; or (3 standard of care as administered in the military. Study centers include a Study Chair′s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant′s life.

  10. Mineralized Collagen: Rationale, Current Status, and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Zhi-Ye Qiu

    2015-07-01

    Full Text Available This paper presents a review of the rationale for the in vitro mineralization process, preparation methods, and clinical applications of mineralized collagen. The rationale for natural mineralized collagen and the related mineralization process has been investigated for decades. Based on the understanding of natural mineralized collagen and its formation process, many attempts have been made to prepare biomimetic materials that resemble natural mineralized collagen in both composition and structure. To date, a number of bone substitute materials have been developed based on the principles of mineralized collagen, and some of them have been commercialized and approved by regulatory agencies. The clinical outcomes of mineralized collagen are of significance to advance the evaluation and improvement of related medical device products. Some representative clinical cases have been reported, and there are more clinical applications and long-term follow-ups that currently being performed by many research groups.

  11. 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.

  12. Scientific rationale of Saturn's in situ exploration

    CERN Document Server

    Mousis, O; Lebreton, J -P; Wurz, P; Cavalié, T; Coustenis, A; Courtin, R; Gautier, D; Helled, R; Irwin, P G J; Morse, A D; Nettelmann, N; Marty, B; Rousselot, P; Venot, O; Atkinson, D H; Waite, J H; Reh, K R; Simon-Miller, A; Atreya, S; André, N; Blanc, M; Daglis, I A; Fischer, G; Geppert, W D; Guillot, T; Hedman, M M; Hueso, R; Lellouch, E; Lunine, J I; Murray, C D; O'Donoghue, J; Rengel, M; Sanchez-Lavega, A; Schmider, F -X; Spiga, A; Spilker, T; Petit, J -M; Tiscareno, M S; Ali-Dib, M; Altwegg, K; Bouquet, A; Briois, C; Fouchet, T; Guerlet, S; Kostiuk, T; Lebleu, D; Moreno, R; Orton, G S; Poncy, J

    2014-01-01

    Remote sensing observations meet some limitations when used to study the bulk atmospheric composition of the giant planets of our solar system. A remarkable example of the superiority of in situ probe measurements is illustrated by the exploration of Jupiter, where key measurements such as the determination of the noble gases abundances and the precise measurement of the helium mixing ratio have only been made available through in situ measurements by the Galileo probe. This paper describes the main scientific goals to be addressed by the future in situ exploration of Saturn placing the Galileo probe exploration of Jupiter in a broader context and before the future probe exploration of the more remote ice giants. In situ exploration of Saturn's atmosphere addresses two broad themes that are discussed throughout this paper: first, the formation history of our solar system and second, the processes at play in planetary atmospheres. In this context, we detail the reasons why measurements of Saturn's bulk element...

  13. Frit valg i ældreplejen - rationaler og udfordringer

    OpenAIRE

    Svendsen, Peter Emil Juhl; Hagmann, Lotte Nygaard; Johansen, Michael Urban

    2004-01-01

    Projektet omhandler de rationaler der ligger bag indførelsen af frit valg i ældreplejen, primært fra Regeringens perspektiv. Den anden store del af projektet er en analyse af fritvalgsordningerne i forhold til om disse nu også er effektive, altså om det kan betale sig at indføre fritvalgsordninger i ældreplejen eller om effektivitet bedre opnås i rent offentligt regi.

  14. Physics rationale for the engineering specifications for ZTH

    International Nuclear Information System (INIS)

    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

  15. Polymorphisms associated with ventricular tachyarrhythmias: rationale, design, and endpoints of the 'diagnostic data influence on disease management and relation of genomics to ventricular tachyarrhythmias in implantable cardioverter/defibrillator patients (DISCOVERY)' study

    DEFF Research Database (Denmark)

    Garcia, Javier; Wieneke, Heinrich; Spencker, Sebastian;

    2010-01-01

    (SNPs) are DNA sequence variations occurring when a single nucleotide in the genome differs among members of a species. A novel concept has emerged being that these common genetic variations might modify the susceptibility of a certain population to specific diseases. Thus, genetic factors may also...... modulate the risk for arrhythmias and sudden cardiac death, and identification of common variants could help to better identify patients at risk. The DISCOVERY study is an interventional, longitudinal, prospective, multi-centre diagnostic study that will enrol 1287 patients in approximately 80 European...... centres. In the genetic part of the DISCOVERY study, candidate gene polymorphisms involved in coding of the G-protein subunits will be correlated with the occurrence of ventricular arrhythmias in patients receiving an ICD for primary prevention. Furthermore, in order to search for additional sequence...

  16. Troublesome Construction: The Rationale and Risks of IIRSA

    Directory of Open Access Journals (Sweden)

    Pitou van Dijck

    2008-10-01

    Full Text Available Latin American countries are involved in implementing a continental-wide infrastructure programme to deepen regional integration and facilitate their insertion in international markets. The IIRSA [Iniciativa para la Integración de la Infraestructura Regional Suramericana] program- me includes ten so called development hubs that may contribute to significant change in the location of economic activities in the continent as well. They may as well have a substantial impact on the environment in regions adjacent to the corridors. This study deals with the rationale and organization of the IIRSA infrastructure programme. Subsequently the study focuses on the spatial impact such corridors may have and the environmental, social and economic implication of these roads. Finally the paper deals with some critical methodological problems involved in the making of of strategic environmental assessment studies of IIRSA-related road infrastructure projects.  Resumen: Una construcción problemática: Razones y riesgos de IIRSALos países latinoamericanos están implementando un programa continental de infraestructura para profundizar la integración regional y facilitar su inserción en los mercados internacionales. El programa de IIRSA [Iniciativa para la Integración de la Infraestructura Regional Surameri cana] incluye diez centros de desarrollo que pueden contribuir a cambios importantes en la ubicación de las actividades económicas en el continente. Estos centros podrían tener un impacto substancial en el medioambiente de las regiones adyacentes a los corredores. Este estudio se ocupa de las razones y organización del programa de infraestructura de IIRSA. Luego nos concentramos en el impacto espacial que pueden tener esos corredores y las implicaciones sociales, económicas y para el medioambiente de esos caminos. Finalmente tratamos en el artículo algunos críticos problemas metodológicos en la elaboración de evaluaciones medioambientales

  17. Piezoelectric hydrogen bonding: computational screening for a design rationale.

    Science.gov (United States)

    Werling, Keith A; Griffin, Maryanne; Hutchison, Geoffrey R; Lambrecht, Daniel S

    2014-09-01

    Organic piezoelectric materials are promising targets in applications such as energy harvesting or mechanical sensors and actuators. In a recent paper (Werling, K. A.; et al. J. Phys. Chem. Lett. 2013, 4, 1365-1370), we have shown that hydrogen bonding gives rise to a significant piezoelectric response. In this article, we aim to find organic hydrogen bonded systems with increased piezo-response by investigating different hydrogen bonding motifs and by tailoring the hydrogen bond strength via functionalization. The largest piezo-coefficient of 23 pm/V is found for the nitrobenzene-aniline dimer. We develop a simple, yet surprisingly accurate rationale to predict piezo-coefficients based on the zero-field compliance matrix and dipole derivatives. This rationale increases the speed of first-principles piezo-coefficient calculations by an order of magnitude. At the same time, it suggests how to understand and further increase the piezo-response. Our rationale also explains the remarkably large piezo-response of 150 pm/V and more for another class of systems, the "molecular springs" (Marvin, C.; et al. J. Phys. Chem. C 2013, 117, 16783-16790.).

  18. Piezoelectric hydrogen bonding: computational screening for a design rationale.

    Science.gov (United States)

    Werling, Keith A; Griffin, Maryanne; Hutchison, Geoffrey R; Lambrecht, Daniel S

    2014-09-01

    Organic piezoelectric materials are promising targets in applications such as energy harvesting or mechanical sensors and actuators. In a recent paper (Werling, K. A.; et al. J. Phys. Chem. Lett. 2013, 4, 1365-1370), we have shown that hydrogen bonding gives rise to a significant piezoelectric response. In this article, we aim to find organic hydrogen bonded systems with increased piezo-response by investigating different hydrogen bonding motifs and by tailoring the hydrogen bond strength via functionalization. The largest piezo-coefficient of 23 pm/V is found for the nitrobenzene-aniline dimer. We develop a simple, yet surprisingly accurate rationale to predict piezo-coefficients based on the zero-field compliance matrix and dipole derivatives. This rationale increases the speed of first-principles piezo-coefficient calculations by an order of magnitude. At the same time, it suggests how to understand and further increase the piezo-response. Our rationale also explains the remarkably large piezo-response of 150 pm/V and more for another class of systems, the "molecular springs" (Marvin, C.; et al. J. Phys. Chem. C 2013, 117, 16783-16790.). PMID:24576213

  19. Rationale, Design, and Baseline Characteristics of ARTS-DN : A Randomized Study to Assess the Safety and Efficacy of Finerenone in Patients with Type 2 Diabetes Mellitus and a Clinical Diagnosis of Diabetic Nephropathy

    NARCIS (Netherlands)

    Ruilope, Luis M.; Agarwal, Rajiv; Chan, Juliana C.; Cooper, Mark E.; Gansevoort, Ron T.; Haller, Hermann; Remuzzi, Giuseppe; Rossing, Peter; Schmieder, Roland E.; Nowack, Christina; Ferreira, Anna C.; Pieper, Alexander; Kimmeskamp-Kirschbaum, Nina; Bakris, George L.

    2014-01-01

    Background/Aims: Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate (stage 2-3) chronic kidney disease. The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN; NCT01874431) is a multicenter, random

  20. Rationale, Design, and Baseline Data of the Insulin Glargine (Lantus) Versus Insulin Detemir (Levemir) Treat-To-Target (L2T3) Study: A Multinational, Randomized Noninferiority Trial of Basal Insulin Initiation in Type 2 Diabetes

    NARCIS (Netherlands)

    S.G.H.A. Swinnen; F.J. Snoek; M.P. Dain; J.H. DeVries; J.B.L. Hoekstra; F. Holleman

    2009-01-01

    Objective: To discuss the design and baseline data of the Lantus (R) (sanofi-aventis, Paris, France) versus Levemir (R) (Novo Nordisk A/S, Bagsvaerd, Denmark) Treat-To-Target (L2T3) study, a multinational, randomized comparison between the basal insulin analogs insulin glargine and insulin detemir.

  1. Detection of coronary microembolization by Doppler ultrasound in patients with stable angina pectoris during percutaneous coronary interventions under an adjunctive antithrombotic therapy with abciximab: design and rationale of the High Intensity Transient Signals ReoPro (HITS-RP study

    Directory of Open Access Journals (Sweden)

    Kretzschmar Daniel

    2012-05-01

    Full Text Available Abstract Background Embolization of atherosclerotic debris from the rupture of a vulnerable atherosclerotic plaque occurs iatrogenically during percutaneous coronary interventions (PCI and can induce myocardial necrosis. These microembolizations are detected as high intensity transient signals (HITS using intracoronary Doppler technology. Presentation of the hypothesis In the presented study we will test if abciximab (ReoPro® infusion reduces high intensity transient signals in patients with stable angina pectoris undergoing PCI in comparison to standard therapy alone. Testing the hypothesis The High Intensity Transient Signals ReoPro® (HITS-RP study will enroll 60 patients. It is a prospective, single center, randomized, double-blinded, controlled trial. The study is designed to compare the efficacy of intravenous abciximab administration for reduction of microembolization during elective PCI. Patients will be randomized in a 1:1 fashion to abciximab or placebo infusion. The primary end point of the HITS-RP-Study is the number of HITS during PCI measured by intracoronary Doppler wire. Secondary endpoints are bleeding complications, elevation of cardiac biomarkers or ECG changes after percutaneous coronary interventions, changes in coronary flow velocity reserve, hs-CRP elevation, any major adverse cardio-vascular event during one month follow-up. Implications of the hypothesis The HITS-RP-Study addresses important questions regarding the efficacy of intravenous abciximab administration in reducing microembolization and periprocedural complications in stable angina pectoris patients undergoing PCI. Trial registration The trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.

  2. Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B12 and folic acid on fracture incidence

    Directory of Open Access Journals (Sweden)

    van Wijngaarden Janneke P

    2011-12-01

    Full Text Available Abstract Background Osteoporosis is a major health problem, and the economic burden is expected to rise due to an increase in life expectancy throughout the world. Current observational evidence suggests that an elevated homocysteine concentration and poor vitamin B12 and folate status are associated with an increased fracture risk. As vitamin B12 and folate intake and status play a large role in homocysteine metabolism, it is hypothesized that supplementation with these B-vitamins will reduce fracture incidence in elderly people with an elevated homocysteine concentration. Methods/Design The B-PROOF (B-Vitamins for the PRevention Of Osteoporotic Fractures study is a randomized double-blind placebo-controlled trial. The intervention comprises a period of two years, and includes 2919 subjects, aged 65 years and older, independently living or institutionalized, with an elevated homocysteine concentration (≥ 12 μmol/L. One group receives daily a tablet with 500 μg vitamin B12 and 400 μg folic acid and the other group receives a placebo tablet. In both tablets 15 μg (600 IU vitamin D is included. The primary outcome of the study is osteoporotic fractures. Measurements are performed at baseline and after two years and cover bone health i.e. bone mineral density and bone turnover markers, physical performance and physical activity including falls, nutritional intake and status, cognitive function, depression, genetics and quality of life. This large multi-center project is carried out by a consortium from the Erasmus MC (Rotterdam, the Netherlands, VUmc (Amsterdam, the Netherlands and Wageningen University, (Wageningen, the Netherlands, the latter acting as coordinator. Discussion To our best knowledge, the B-PROOF study is the first intervention study in which the effect of vitamin B12 and folic acid supplementation on osteoporotic fractures is studied in a general elderly population. We expect the first longitudinal results of the B

  3. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial

    OpenAIRE

    Neuzillet, Cindy; Vergnault, Mathieu; Bonnetain, Franck; Hammel, Pascal

    2015-01-01

    Background Exercise during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). It has been shown to be feasible and efficient in various cancers, including advanced-stage cancers. Effects of physical activity have never been explored in advanced pancreatic ductal adenocarcinoma (PDAC). We aim to evaluate the effects of an exercise intervention in this setting. Methods This randomized, national, multicenter, interventional study will exami...

  4. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  5. Cancer Health Empowerment for Living without Pain (Ca-HELP: study design and rationale for a tailored education and coaching intervention to enhance care of cancer-related pain

    Directory of Open Access Journals (Sweden)

    Slee Christina

    2009-09-01

    Full Text Available Abstract Background Cancer-related pain is common and under-treated. This article describes a study designed to test the effectiveness of a theory-driven, patient-centered coaching intervention to improve cancer pain processes and outcomes. Methods/Design The Cancer Health Empowerment for Living without Pain (Ca-HELP Study is an American Cancer Society sponsored randomized trial conducted in Sacramento, California. A total of 265 cancer patients with at least moderate pain severity (Worst Pain Numerical Analog Score >=4 out of 10 or pain-related impairment (Likert score >= 3 out of 5 were randomly assigned to receive tailored education and coaching (TEC or educationally-enhanced usual care (EUC; 258 received at least one follow-up assessment. The TEC intervention is based on social-cognitive theory and consists of 6 components (assess, correct, teach, prepare, rehearse, portray. Both interventions were delivered over approximately 30 minutes just prior to a scheduled oncology visit. The majority of visits (56% were audio-recorded for later communication coding. Follow-up data including outcomes related to pain severity and impairment, self-efficacy for pain control and for patient-physician communication, functional status and well-being, and anxiety were collected at 2, 6, and 12 weeks. Discussion Building on social cognitive theory and pilot work, this study aims to test the hypothesis that a brief, tailored patient activation intervention will promote better cancer pain care and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity and impairment (primary outcomes; self-efficacy and quality of life (secondary outcomes; and relationships among processes and outcomes of cancer pain care. If this model of coaching by lay health educators proves successful, it could potentially be implemented widely at modest cost. Trial Registration [Clinical Trials Identifier: NCT00283166

  6. The impact of iron supplementation efficiency in female blood donors with a decreased ferritin level and no anaemia. Rationale and design of a randomised controlled trial: a study protocol

    Directory of Open Access Journals (Sweden)

    Tissot Jean-Daniel

    2009-01-01

    Full Text Available Abstract Background There is no recommendation to screen ferritin level in blood donors, even though several studies have noted the high prevalence of iron deficiency after blood donation, particularly among menstruating females. Furthermore, some clinical trials have shown that non-anaemic women with unexplained fatigue may benefit from iron supplementation. Our objective is to determine the clinical effect of iron supplementation on fatigue in female blood donors without anaemia, but with a mean serum ferritin ≤ 30 ng/ml. Methods/Design In a double blind randomised controlled trial, we will measure blood count and ferritin level of women under age 50 yr, who donate blood to the University Hospital of Lausanne Blood Transfusion Department, at the time of the donation and after 1 week. One hundred and forty donors with a ferritin level ≤ 30 ng/ml and haemoglobin level ≥ 120 g/l (non-anaemic a week after the donation will be included in the study and randomised. A one-month course of oral ferrous sulphate (80 mg/day of elemental iron will be introduced vs. placebo. Self-reported fatigue will be measured using a visual analogue scale. Secondary outcomes are: score of fatigue (Fatigue Severity Scale, maximal aerobic power (Chester Step Test, quality of life (SF-12, and mood disorders (Prime-MD. Haemoglobin and ferritin concentration will be monitored before and after the intervention. Discussion Iron deficiency is a potential problem for all blood donors, especially menstruating women. To our knowledge, no other intervention study has yet evaluated the impact of iron supplementation on subjective symptoms after a blood donation. Trial registration NCT00689793

  7. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study

    DEFF Research Database (Denmark)

    NN, NN

    2010-01-01

    in advanced development as an alternative to warfarin for the prevention and treatment of thromboembolic disorders. METHODS: ROCKET AF is a randomized, double-blind, double-dummy, event-driven trial, which aims to establish the noninferiority of rivaroxaban compared with warfarin in patients with nonvalvular...... nonmajor bleeding events. Over 14,000 patients have been randomized at 1,100 sites across 45 countries, and will be followed until 405 primary outcome events are observed. CONCLUSION: The ROCKET AF study will determine the efficacy and safety of rivaroxaban as an alternative to warfarin for the prevention...

  8. Case management for the treatment of patients with major depression in general practices – rationale, design and conduct of a cluster randomized controlled trial – PRoMPT (Primary care Monitoring for depressive Patient's Trial [ISRCTN66386086] – Study protocol

    Directory of Open Access Journals (Sweden)

    Krauth Christian

    2005-10-01

    Full Text Available Abstract Background Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO settings and which might also be effective in other, less structured settings. Methods/Design PRoMPT (PRimary care Monitoring for depressive Patients Trial is a cluster randomised controlled trial with General Practice (GP as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9 from the German version of the Prime MD Patient Health Questionnaire (PHQ-D. Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool, medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline

  9. Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol

    Directory of Open Access Journals (Sweden)

    de la Torre Maria M

    2010-01-01

    Full Text Available Abstract Background Quality of life (QoL decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR, additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. Methods/Design Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP, patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides, muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. Discussion

  10. Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice

    Directory of Open Access Journals (Sweden)

    2010-05-01

    Full Text Available Abstract Background The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Treatment with n-3 polyunsaturated fatty acids improves prognosis after myocardial infarction, but evidence of this benefit is lacking in patients at high cardiovascular risk, but without a history of myocardial infarction. Methods/design Patients were eligible if their general practitioner (GP considered them at high cardiovascular risk because of a cardiovascular disease other than myocardial infarction, or multiple risk factors (at least four major risk factors in non-diabetic patients and one in diabetics. Patients were randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily or placebo in a double-blind study and followed up for five years by their GPs to assess the efficacy of the treatment in preventing cardiovascular mortality (including sudden death and hospitalization for cardiovascular reasons. The secondary, epidemiological, aim of the study is to assess whether it is feasible to adopt current guidelines in everyday clinical practice, with a view to optimizing all the available preventive strategies in people at high cardiovascular risk. A nation-wide network of 860 GPs admitted 12,513 patients to the study between February 2004 and March 2007. The mean age was 64 years and 62% were males. Diabetes mellitus plus one or more cardiovascular risk factors was the main inclusion criterion (47%. About 30% of patients were included because of a history of atherosclerotic cardiovascular disease, 21% for four or more risk factors, and less than 1% for other reasons. Discussion The Rischio and Prevenzione (R&P project provides a feasible model to test the efficacy of n-3 polyunsaturated fatty acid therapy in patients at high

  11. A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491

    Directory of Open Access Journals (Sweden)

    Barbieri Antonella

    2008-11-01

    Full Text Available Abstract Background Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care. Methods Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway or to arm 2 (no intervention, usual care. The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated. Conclusion The management of patients affected by stroke involves the expertise of several professionals, which can

  12. Visceral leishmaniasis in Brazil: rationale and concerns related to reservoir control

    Directory of Open Access Journals (Sweden)

    Guilherme Loureiro Werneck

    2014-10-01

    Full Text Available The control of zoonotic visceral leishmaniasis is a challenge, particularly in Brazil, where the disease has been gradually spreading across the country over the past 30 years. Strategies employed for decreasing the transmission risk are based on the control of vector populations and reservoirs; since humans are considered unnecessary for the maintenance of transmission. Among the adopted strategies in Brazil, the sacrifice of infected dogs is commonly performed and has been the most controversial measure. In the present study, we provide the rationale for the implementation of different control strategies targeted at reservoir populations and highlight the limitations and concerns associated with each of these strategies.

  13. Review of platinum complex biochemistry suggests a rationale for combined platinum-radiotherapy

    International Nuclear Information System (INIS)

    A review of the biochemistry of platinum coordination complexes represented by the parent complex cis-dichlorodiammineplatinum II, (cis-DDP), indicates that this family of chemotherapeutic agents binds to DNA affording the potential for interactions with other therapeutic modalities. Results of relatively recent studies in bacteria, mammalian cell cultures and in animal tumor systems suggest that these platinum complexes interact with irradiation, thereby producing cell kill that may be greater than additive. A rationale is provided for the combination of cis-DDP and other platinum complexes with radiotherapy in the treatment of cancer

  14. Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).

    Science.gov (United States)

    Crawford, Jeffrey; Prado, Carla M M; Johnston, Mary Ann; Gralla, Richard J; Taylor, Ryan P; Hancock, Michael L; Dalton, James T

    2016-06-01

    subject must have ≥10 % improvement in physical function compared to baseline. To meet the definition of response on LBM, a subject must have demonstrated no loss of LBM compared with baseline. Secondary endpoints include durability of response assessed at day 147 in those responding at day 84. A combined overall survival analysis for both studies is considered a key secondary safety endpoint. The POWER trials design was established with extensive clinical input and collaboration with regulatory agencies. The efficacy endpoints are a result of this feedback and discussion of the threshold for clinical benefit in patients at risk for muscle wasting. Full results from these studies will soon be published and will further guide the development of future anabolic trials. Clinical Trial ID: NCT01355484. https://clinicaltrials.gov/ct2/show/NCT01355484 , NCT01355497. https://clinicaltrials.gov/ct2/show/NCT01355497?term=g300505&rank=1 .

  15. Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial.

    Science.gov (United States)

    Klausen, Susanne Hwiid; Mikkelsen, Ulla Ramer; Hirth, Asle; Wetterslev, Jørn; Kjærgaard, Hanne; Søndergaard, Lars; Andersen, Lars Louis

    2012-04-01

    Intensive exercise may be an important part of rehabilitation in patients with congenital heart disease (CHD). However, performing regular physical exercise is challenging for many adolescent patients. Consequently, effective exercise encouragements may be needed. Little is known on the effect of e-Health encouragements on physical fitness, physical activity, and health-related quality of life in adolescents. This trial is a nationwide interactive e-Health rehabilitation study lasting 1 year, centered on interactive use of mobile phone and Internet technology. We hypothesize that e-Health encouragements and interactive monitoring of intensive exercise for 1 year can improve physical fitness, physical activity, and health-related quality of life. Two hundred sixteen adolescents (age, 13-16 years) with surgically corrected complex CHD but without significant hemodynamic residual defects and no restrictions 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 inspires the behavioral theoretical background. The e-Health intervention and the Godfrey cycle ergometer protocol have been feasibility tested and seem applicable to adolescents with CHD. The trial is expected to contribute with new knowledge regarding how physical activity in adolescents with CHD can be increased and, possibly, comorbidity be reduced. PMID:22520519

  16. The Irritable Bowel Syndrome Outcome Study (IBSOS): rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome.

    Science.gov (United States)

    Lackner, Jeffrey M; Keefer, Laurie; Jaccard, James; Firth, Rebecca; Brenner, Darren; Bratten, Jason; Dunlap, Laura J; Ma, Changxing; Byroads, Mark

    2012-11-01

    Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc.) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines.

  17. The Irritable Bowel Syndrome Outcome Study (IBSOS): rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome.

    Science.gov (United States)

    Lackner, Jeffrey M; Keefer, Laurie; Jaccard, James; Firth, Rebecca; Brenner, Darren; Bratten, Jason; Dunlap, Laura J; Ma, Changxing; Byroads, Mark

    2012-11-01

    Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc.) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines. PMID:22846389

  18. Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities

    Directory of Open Access Journals (Sweden)

    Lubans David R

    2012-06-01

    and active. The findings from the study may be used to guide teacher pre-service education, professional learning and school policy in primary schools. Trial registration Australian New Zealand Clinical Trials Registry No: ACTRN12611001080910

  19. Communication style and exercise compliance in physiotherapy (CONNECT. A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Lonsdale Chris

    2012-06-01

    Full Text Available Abstract Background Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations. The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations. Methods/Design This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12 in Dublin, Ireland (population = 1.25 million will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics will not receive this training. Participants (N = 292 with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as

  20. An ecological dynamics rationale to explain home advantage in professional football

    Science.gov (United States)

    Gama, José; Dias, Gonçalo; Couceiro, Micael; Passos, Pedro; Davids, Keith; Ribeiro, João

    2016-03-01

    Despite clear findings, research on home advantage in team sports lacks a comprehensive theoretical rationale for understanding why this phenomenon is so compelling. The aim of this study was to provide an explanatory theoretical rationale in ecological dynamics for the influence of home advantage observed in research on professional football. We recorded 30 competitive matches and analyzed 13958 passes, from one highly successful team in the Portuguese Premier League, during season 2010/2011. Performance data were analyzed using the Match Analysis Software—Amisco® (version 3.3.7.25), allowing us to characterize team activity profiles. Results were interpreted from an ecological dynamics perspective, explaining how task and environmental constraints of a competitive football setting required performers to continuously co-adapt to teammate behaviors. Despite slight differences in percentage of ball possession when playing home or away, the number of passes achieved by the team, while in possession of the ball, was quite different between home or away venues. When playing at home, the number of passes performed by the team was considerably higher than when playing away. The explanation proposed in this study for a home advantage effect can be understood from studying interpersonal coordination tendencies of team sports players as agents in a complex adaptive system.

  1. The International Takotsubo Registry: Rationale, Design, Objectives, and First Results.

    Science.gov (United States)

    Ghadri, Jelena-R; Cammann, Victoria L; Templin, Christian

    2016-10-01

    Takotsubo syndrome (TTS) was first described in Japan in 1990. The clinical presentation is similar to that of acute coronary syndrome (ACS). Cardiac enzymes are commonly elevated. A global initiative was launched and the InterTAK Registry was established to provide a systematic database. The major goals of the International Takotsubo Registry (InterTAK Registry) are to provide a comprehensive clinical characterization on natural history, treatment, and outcomes. We linked a biorepository to identify biomarkers for the diagnosis and prognosis and to investigate the genetic basis as well as disease-related factors. We focus on the rationale, objectives, design, and first results of the InterTAK Registry. PMID:27638029

  2. Critique of rationale for transmutation of nuclear waste

    International Nuclear Information System (INIS)

    It has been suggested that nuclear transmutation could be used in the elimination or reduction of hazards from radioactive wastes. The rationale for this suggestion is the subject of this paper. The objectives of partitioning-transmutation are described. The benefits are evaluated. The author concludes that transmutation would appear at best to offer the opportunity of reducing an already low risk. This would not seem to be justifiable considering the cost. If non-radiological risks are considered, there is a negative total benefit

  3. Plato's Cosmic Theology: A Rationale for a Polytheistic Astrology?

    Science.gov (United States)

    Henriques, André

    2015-05-01

    Plato's cosmology influenced classical astronomy and religion, but was in turn influenced by the polytheistic context of its time. Throughout his texts, including the cosmological treatise Timaeus, and the discussions on the soul in the Phaedrus, Plato (c.428-c.348 BC) established what can be generalised as Platonic cosmological thought. An understanding of the philosophical and mythical levels of Platonic thought can provide a rationale for polytheistic and astrological worldviews, pointing to some cosmological continuity, alongside major shifts, from ancient Greek religion to the astrological thought of ancient astronomers such as Claudius Ptolemy.

  4. Providing a Rationale for Promoting Argument-Based Inquiry Approach to Science Education: A Deweyan Pragmatist Aesthetics Perspective

    OpenAIRE

    Şevket Benhür Oral

    2012-01-01

    Argumentation in science education is a well-established and successful research programme. Key theoretical underpinnings of this approach come from situated cognition perspective, the theory of communicative action and the sociocultural perspective, language studies and social semiotics, philosophy of science studies, and developmental psychology. In this paper, it will be argued that all these theoretical frameworks that aim to provide a rationale for promoting argument-based inquiry approa...

  5. New Knowledge Network Evaluation Method for Design Rationale Management

    Institute of Scientific and Technical Information of China (English)

    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.

  6. Glucocorticoid augmentation of prolonged exposure therapy: rationale and case report

    Directory of Open Access Journals (Sweden)

    Laura Pratchett

    2010-12-01

    Full Text Available Rationale: Prolonged exposure (PE therapy has been found to reduce symptoms of posttraumatic stress disorder (PTSD; however, it is difficult for many patients to engage fully in the obligatory retelling of their traumatic experiences. This problem is compounded by the fact that habituation and cognitive restructuring – the main mechanisms through which PE is hypothesized to work – are not instantaneous processes, and often require several weeks before the distress associated with imaginal exposure abates. Case reports: Two cases are described that respectively illustrate the use of hydrocortisone and placebo, in combination with PE, for the treatment of combat-related PTSD. Based on known effects of glucocorticoids on learning and memory performance, we hypothesized that augmentation with hydrocortisone would improve the therapeutic effects of PE by hastening “new” learning and facilitating decreases in the emotional impact of fear memories during the course of treatment. The veteran receiving hydrocortisone augmentation of PE displayed an accelerated and ultimately greater decline in PTSD symptoms than the veteran receiving placebo. Conclusions: While no general conclusion can be derived from comparison of two patients, the findings are consistent with the rationale for augmentation. These case reports support the potential for an appropriately designed and powered clinical trial to examine the efficacy of glucocorticoids in augmenting the effects of psychotherapy for PTSD.

  7. Commercially-driven human interplanetary propulsion systems: Rationale, concept, technology, and performance requirements

    International Nuclear Information System (INIS)

    Previous studies of human interplanetary missions are largely characterized by long trip times, limited performance capabilities, and enormous costs. Until these missions become dramatically more open-quote open-quote commercial-friendly close-quote close-quote, their funding source and rationale will be restricted to national governments and their political/scientific interests respectively. A rationale is discussed for human interplanetary space exploration predicated on the private sector. Space propulsion system requirements are identified for interplanetary transfer times of no more than a few weeks/months to and between the major outer planets. Nuclear fusion is identified as the minimum requisite space propulsion technology. A conceptual design is described and evolutionary catalyzed-DD to DHe3 fuel cycles are proposed. Magnetic nozzles for direct thrust generation and quantifying the operational aspects of the energy exchange mechanisms between high energy reaction products and neutral propellants are identified as two of the many key supporting technologies essential to satisfying system performance requirements. Government support of focused, breakthrough technologies is recommended at funding levels appropriate to other ongoing federal research. copyright 1996 American Institute of Physics

  8. Agglomeration and Specialisation Patterns of Finnish Biotechnology. On the Search for an Economic Rationale of a Dispersed Industry Structure

    OpenAIRE

    Tahvanainen, Antti-Jussi; Hermans, Raine

    2008-01-01

    This study sets out to inspect empirically whether existing theory in Geographical Economics (GE) is able to provide a rationale for the controversial and much debated structure of the highly knowledge- and research-intensive biotechnology industry in Finland. In addition to providing evidence of GE in action, we integrate the effects that active public technology policy might have on geographic structures of industries into our analysis as a novel discourse. The results provide evidence of a...

  9. Large Deployable Reflector Science and Technology Workshop. Volume 2: Scientific Rationale and Technology Requirements

    Science.gov (United States)

    Hollenbach, D. (Editor)

    1983-01-01

    The scientific rationale for the large deployable reflector (LDR) and the overall technological requirements are discussed. The main scientific objectives include studies of the origins of planets, stars and galaxies, and of the ultimate fate of the universe. The envisioned studies require a telescope with a diameter of at least 20 m, diffraction-limited to wavelengths as short as 30-50 micron. In addition, light-bucket operation with 1 arcsec spatial resolution in the 2-4 microns wavelength region would be useful in studies of high-redshifted galaxies. Such a telescope would provide a large increase in spectroscopic sensitivity and spatial resolving power compared with existing or planned infrared telescopes.

  10. Ethical Rationale for the Ebola "Ring Vaccination" Trial Design.

    Science.gov (United States)

    Rid, Annette; Miller, Franklin G

    2016-03-01

    The 2014 Ebola virus epidemic is the largest and most severe ever recorded. With no approved vaccines or specific treatments for Ebola, clinical trials were launched within months of the epidemic in an unprecedented show of global partnership. One of these trials used a highly innovative "ring vaccination" design. The design was chosen for operational, scientific, and ethical reasons--in particular, it was regarded as ethically superior to individually randomized placebo-controlled trials. We scrutinize the ethical rationale for the ring vaccination design. We argue that the ring vaccination design is ethical but fundamentally equivalent to placebo-controlled designs with respect to withholding a potentially effective intervention from the control group. We discuss the implications for the ongoing ring vaccination trial and future research.

  11. RATIONALE AND PROCEDURES IN THE TEACHING OF INTENSIVE READING

    Institute of Scientific and Technical Information of China (English)

    Xiong; Jincai

    1999-01-01

    This paper is a product of intensive reading teaching reform practice held in Shantou Universityin 1998,under the instruction of Mr.Black(professor of New York City University).It summarises therational and procedures we used in the teaching practice of intensive reading.Modes of top-down and bot-tom-up processing are introduced,procedures such as skimming,scanning,careful reading,writing,role-playing,presentation and practice are described,particular importance is attached to group work orpair work.The rationale and procedures we put forward in this paper are not revolutionary but a combi-nation of traditional Chinese teacher-centred mode with contemporary western student-centred approachin the teaching of intensive reading in China.However,they have been proved highly efficient and prac-tical,which makes this paper worth reading.

  12. Advanced control room evaluation: General approach and rationale

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M. (Brookhaven National Lab., Upton, NY (USA)); Wachtel, J. (Nuclear Regulatory Commission, Washington, DC (USA))

    1991-01-01

    Advanced control rooms (ACRs) for future nuclear power plants (NPPs) are being designed utilizing computer-based technologies. The US Nuclear Regulatory Commission reviews the human engineering aspects of such control rooms to ensure that they are designed to good human factors engineering principles and that operator performance and reliability are appropriately supported in order to protect public health and safety. This paper describes the rationale and general approach to the development of a human factors review guideline for ACRs. The factors influencing the guideline development are discussed, including the review environment, the types of advanced technologies being addressed, the human factors issues associated with advanced technology, and the current state-of-the-art of human factors guidelines for advanced human-system interfaces (HSIs). The proposed approach to ACR review would track the design and implementation process through the application of review guidelines reflecting four review modules: planning, design process analysis, human factors engineering review, and dynamic performance evaluation. 21 refs.

  13. Rationale for hedging initiatives: Empirical evidence from the energy industry

    Science.gov (United States)

    Dhanarajata, Srirajata

    Theory offers different rationales for hedging including (i) financial distress and bankruptcy cost, (ii) capacity to capture attractive investment opportunities, (iii) information asymmetry, (iv) economy of scale, (v) substitution for hedging, (vi) managerial risk aversion, and (vii) convexity of tax schedule. The purpose of this dissertation is to empirically test the explanatory power of the first five theoretical rationales on hedging done by oil and gas exploration and production (E&P) companies. The level of hedging is measured by the percentage of production effectively hedged, calculated based on the concept of delta and delta-gamma hedging. I employ Tobit regression, principal components, and panel data analysis on dependent and raw independent variables. Tobit regression is applied due to the fact that the dependent variable used in the analysis is non-negative. Principal component analysis helps to reduce the dimension of explanatory variables while panel data analysis combines/pools the data that is a combination of time-series and cross-sectional. Based on the empirical results, leverage level is consistently found to be a significant factor on hedging activities, either due to an attempt to avoid financial distress by the firm, or an attempt to control agency cost by debtholders, or both. The effect of capital expenditures and discretionary cash flows are both indeterminable due possibly to a potential mismatch in timing of realized cash flow items and hedging decision. Firm size is found to be positively related to hedging supporting economy of scale hypothesis, which is introduced in past literature, as well as the argument that large firm usually are more sophisticated and should be more willing and more comfortable to use hedge instruments than smaller firms.

  14. Organ Donation in the 50+ Age Demographic: Survey Results on Decision Rationale and Information Preferences.

    Science.gov (United States)

    Tartaglia, Alexander; Dodd-McCue, Diane; Myer, Kevin A; Mullins, Andrew

    2016-09-01

    The rate of organ donation by older potential donors is significantly declining even though recent studies show positive clinical outcomes with organs transplanted from older donors. This study examined the 50+ age demographic to identify the rationale for donation decisions, preferred media methods of donation information delivery, and responsiveness to an age-tailored donation message. Results from 579 surveys, 87% from the 50+ age demographic, found respondents prone to self-select themselves as medically ineligible based on current medication and health status, even though they might be medically suitable donors. Their incentive to pursue additional information on donation is limited except when motivated by personal accounts within their families and communities. In addition, even when computer literate, they continue to favor the printed or spoken word for donation information delivery. The results suggest an opportunity for those working with older adults to develop more personalized, localized donation education programs targeting this age demographic. PMID:24752758

  15. Complementary and alternative medicine for autism spectrum disorders: rationale, safety and efficacy.

    Science.gov (United States)

    Whitehouse, Andrew J O

    2013-09-01

    Complementary and alternative medicine is widely used for children with autism spectrum disorder, despite uncertainty regarding efficacy. This review describes complementary and alternative practices commonly used among this population, the rationale for the use of each practice, as well as the side-effect profile and evidence for efficacy. The existing evidence base indicates that melatonin can be recommended as a treatment for sleeping disturbances associated with autism spectrum disorder, while secretin can be rejected as an efficacious treatment for broader autistic symptoms. There is insufficient evidence to draw conclusions on the efficacy of modified diets, hyperbaric oxygen therapy, immune therapy, and vitamin and fatty acid supplementation. There is a clear need for methodologically rigorous studies to provide evidence-based guidance to families and clinicians regarding complementary and alternative practices for individuals with autism spectrum disorders. PMID:23682728

  16. Cognitive Defusion versus Thought Distraction: A Clinical Rationale, Training, and Experiential Exercise in Altering Psychological Impacts of Negative Self-Referential Thoughts

    Science.gov (United States)

    Masuda, Akihiko; Feinstein, Amanda B.; Wendell, Johanna W.; Sheehan, Shawn T.

    2010-01-01

    Using two modes of intervention delivery, the present study compared the effects of a cognitive defusion strategy with a thought distraction strategy on the emotional discomfort and believability of negative self-referential thoughts. One mode of intervention delivery consisted of a clinical rationale and training (i.e., Partial condition). The…

  17. Novel pharmaceutical rationale against human lymphatic fi-larial parasite:An oxidative premise

    Institute of Scientific and Technical Information of China (English)

    R.D.Sharma; P.B.Janardhana; D.Gajalakshmi; M.V.R.Reddy; K.Goswami

    2009-01-01

    Objective:Mandate from WHO has boosted up anti-filarial drug research.Diethylcarbamazine citrate (DEC) was not known for any direct effect on filarial parasites.However,recent report proposed its direct apoptotic effect.Oxidative stress has been implicated in apoptotic impact.A study was designed to explore the possibili-ty of oxidative rationale to be operative in the direct anti-filarial effect of DEC.Methods:Various doses of DEC and potent oxidant H2 O2 alone were used in vitro to check for the effects on B.malayi microfilariae,fol-lowed by the use of DEC in combination with H2 O2 .Reversal of the oxidative impact of the drug was tested u-sing the antioxidant,vitamin C and also lipid peroxidation levels in the post incubation culture supernatants were assayed.Result:As expected,DEC alone failed to record any anti-filarial effect.H2 O2 alone also failed to show any significant effect until a very high dose was used.However,in combination significant anti-filarial effect was noticed,which allowed even 44% reduction in the dose of H2 O2 .Any significant lipid peroxidation was not found.Vitamin C demonstrated 30 % inhibitory effect.Conclusion:DEC and H2 O2 combination be-ing able to educe synergistic anti-filarial effect and inhibition of the same by vitamin C hinted towards covert oxidative component in the mechanism of DEC.Further implication of non-significant lipid peroxidation was addressed in the perspective of subtle oxidative nexus that seems to be operative in observed anti-filarial effect. Exploration of such rationale might lead to novel drug development.

  18. 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.

  19. 心房颤动发生机制及干预方法学研究:基本原理和设计方案%Study of mechanism of atrial fibrillation and comparison of ablation and pharmacological therapy (SMAF-CAPT) :rationale and design

    Institute of Scientific and Technical Information of China (English)

    黄从新; 张澍; 马长生; 江洪; 黄鹤; 吴钢; 李红良; 唐艳红; 杨波

    2014-01-01

    Background Mechanism of atrial fibrillation (AF) is still unclear,its related genes and upstream regulatory mechanisms should be studied.The major treatments of AF include pharmacological therapy (PT) and catheter ablation (CA),and it has been proved that CA is more suitable than PT,but our own clinical data remain unknown.The purpose of SMAF-CAPT is to explore the mechanism of AF and its suitable treatments strategy.The study consists of two parts:①study of mechanism of atrial fibrillation (SMAF),②comparison of ablation and pharmacological therapy (CAPA).Rationale ①SMAF study:Cardiac electrophysiology can be upstream regulated in many aspects and links,such as neurotransmitters,protein kinases,G proteins,the relation between them and arrhythmia has been increasingly taken seriously.Our previous studies have demonstrated that regulator of G protein signaling 5 (RGS5) is closely related by cardiac hypertrophy and arrhythmias.Furthermore,it also finds that micro RNA (miRNA) is closely associated with arrhythmia,which provides a new direction for upstream regulation of arrhythmia.In recent years,it has been proved patients with refractory hypertension can get benefits from renal sympathetic denervation (RDN),which can change the autonomic nervous system and thus may affect the occurrence and maintenance of AF.However,the exact effect and mechanism are unclear,and the influence to RDN on atrium matrix remodeling also needs attention.Screen AF-related genes by genetic engineering technique,and then establish animals models of specific genes modification,SMAF aims to explore the feasibility and targets of upstream regulation to AF.And to study the impact and mechanisms of RDN on trigger and maintenance of AF.②CAPA Study:Pharmacological treatment (PT) can partly maintain the sinus rhythm,or improve the symptoms of patients with chronic heart failure,but its long-term effects seem poor.The strategy of ventricular rate control has no significant benefit on the

  20. China’s electric vehicle subsidy scheme: Rationale and impacts

    International Nuclear Information System (INIS)

    To promote the market penetration of electric vehicles (EV), China launched the Electric Vehicle Subsidy Scheme (EVSS) in Jan 2009, followed by an update in Sep 2013, which we named phase I and phase II EVSS, respectively. In this paper, we presented the rationale of China’s two-phase EVSS and estimated their impacts on EV market penetration, with a focus on the ownership cost analysis of battery electric passenger vehicles (BEPV). Based on the ownership cost comparison of five defining BEPV models and their counterpart conventional passenger vehicle (CPV) models, we concluded that in the short term, especially before 2015, China’s EVSS is very necessary for BEPVs to be cost competitive compared with CPVs. The transition from phase I to phase II EVSS will generally reduce subsidy intensity, thus resulting in temporary rise of BEPV ownership cost. However, with the decrease of BEPV manufacturing cost, the ownership cost of BEPV is projected to decrease despite of the phase-out mechanism under phase II EVSS. In the mid term of around 2015–2020, BEPV could become less or not reliant on subsidy to maintain cost competitiveness. However, given the performance disadvantages of BEPV, especially the limited electric range, China’s current EVSS is not sufficient for the BEPV market to take off. Technology improvement associated with battery cost reduction has to play an essential role in starting up China’s BEPV market. - Highlights: • China’s phase I and phase II electric vehicle subsidy schemes were reviewed. • Major electric vehicle models in China’s vehicle market were reviewed. • The ownership costs of five defining electric passenger vehicle models were compared. • Policies to promote electric vehicle deployment in China were discussed

  1. A Thematic Review of Interactive Whiteboard Use in Science Education: Rationales, Purposes, Methods and General Knowledge

    Science.gov (United States)

    Ormanci, Ummuhan; Cepni, Salih; Deveci, Isa; Aydin, Ozhan

    2015-10-01

    In Turkey and many other countries, the importance of the interactive whiteboard (IWB) is increasing, and as a result, projects and studies are being conducted regarding the use of the IWB in classrooms. Accordingly, in these countries, many issues are being researched, such as the IWB's contribution to the education process, its use in classroom settings and problems that occur when using the IWB. In this context, the research and analysis of studies regarding the use of the IWB have important implications for educators, researchers and teachers. This study aims to review and analyze studies conducted regarding the use of the IWB in the field of science. Accordingly, as a thematic review of the research was deemed appropriate, extant articles available in the literature were analyzed using a matrix that consisted of general features (type of journal, year and demographic properties) and content features (rationales, aims, research methods, samples, data collections, results and suggestions). According to the findings, it was concluded that the studies regarding the use of IWBs were conducted due to deficiencies in the current literature. However, there are rare studies in which the reasons for the research were associated with the nature of science education. There were also studies that focused on the effects of the IWB on student academic success and learning outcomes. Within this context, it is evident that there is a need for further research concerning the use of IWBs in science education and for studies regarding the effect of IWBs on students' skills.

  2. Using Automated Processes to Generate Test Items And Their Associated Solutions and Rationales to Support Formative Feedback

    Directory of Open Access Journals (Sweden)

    Mark Gierl

    2015-08-01

    Full Text Available Automatic item generation is the process of using item models to produce assessment tasks using computer technology. An item model is similar to a template that highlights the elements in the task that must be manipulated to produce new items. The purpose of our study is to describe an innovative method for generating large numbers of diverse and heterogeneous items along with their solutions and associated rationales to support formative feedback. We demonstrate the method by generating items in two diverse content areas, mathematics and nonverbal reasoning

  3. Rationale for using Peltophorum africanum (Fabaceae extracts in veterinary medicine

    Directory of Open Access Journals (Sweden)

    S.E. Bizimenyera

    2005-06-01

    . aureus and 0.16 mg/mℓ for P. aeruginosa. There is therefore a rationale for the traditional use of root and bark of P. africanum in treating bacterial infection related diseases.

  4. The place of the clock in pediatric advice: rationales, cultural themes, and impediments to breastfeeding.

    Science.gov (United States)

    Millard, A V

    1990-01-01

    This analysis treats the U.S. medical literature as evidence concerning the formal system of knowledge in allopathic medicine. An examination of pediatric advice on breastfeeding reveals the logic of medical reasoning, the use of scientific rationales, and the intrusion of specific cultural themes. The corpus of data includes works of 18 authors published in 36 volumes from 1897 to 1987, 27 volumes being editions of two major pediatric textbooks. All sources advocate breastfeeding but the detailed advice on how to carry out the process actually tends to undermine it. Moreover, the clock has provided the main frame of reference, creating regimentation reminiscent of factory work, segmenting breastfeeding into a series of steps, and emphasizing efficiency in time and motion. Feeding schedules were advocated in former decades as a matter of discipline for the infant, but nowadays they are viewed as biologically innate to normal infants and to breast milk production. The literature manifests responses over the century to behavioral, biochemical and physiological studies; however, except possibly for one textbook, no thorough rethinking has occurred. Sources of the 1980s continue to focus on the tempo of feeding as a major concern. Cultural themes besides the factory model of breastfeeding include the extension of professional advice to family matters, the subordination of lay women to professional expertise, mistrust of women's bodily signals including the let-down reflex in determining the timing of feedings, mistrust of signals from infants as well, and a professional ideal of flexible advice coupled with rigid limits concerning schedules. The literature interweaves the cultural themes with rationales based on physiological studies in support of specific regimens in breastfeeding, and the relegation of control in breastfeeding to medical experts denies the validity of mutual bodily and emotional responses within the mother-infant dyad. Pediatric authorities thus

  5. The Rationale of Crisis Management – On the Handling of Coincidence in Economic Situation

    Directory of Open Access Journals (Sweden)

    Peter Bendixen

    2010-07-01

    Full Text Available The subject of this essay is too complex a problem as to cover all details in depth and, thus, draws its attention only to core aspects of the handling of coincidence leaving out sophisticated studies and analytic findings as well as detailed reference to economic literature though there is not very much. On the other hand, for a lot of actual as well as general reasons, the subject is too important a matter as to ignore the serious methodological problems of crisis management, which are rooted in some politically still active bias hidden in orthodox neo-classical economics (Stiglitz 2010. If crisis management continues to follow traditional rationales, it will fail realizing the increasing dynamic of crises within the globalising economies of the world. No existing economy can be considered as an isolated system of its own embedded in a stable composition of societal surroundings. Obviously, many a critical situation has its origin in the sphere of civilization, of political discrepancies, and of administrative inflexibilities. On the other hand, any grave amplitude of markets would touch the entire social surrounding. The belief in the markets’ strength of self-regulation is a dangerous construction of orthodox economics (Bendixen 2009b, 2010. The view on crises suggested here is that of a holistic approach to understand a critical situation. Any interpretation of a situation includes empirical dates and figures based on analytic research, but solving a problem is not an act of logical derivation from findings, as if a solution can be excavated in the mud of reality by empirical studies only. Empirical figures report events of the past; the future does not reveal any empiricism. This would be a contradiction in itself. The end of a crisis as well as the search for solutions to fight the problems revealed is unavoidably a view into the future. Therefore, the rationale of crisis management cannot be made of pure empiricism but should include a

  6. Preliminary scientific rationale for a voyage to a thousand astronomical units

    Science.gov (United States)

    Etchegaray, M. I. (Compiler)

    1987-01-01

    A proposed mission to 1000 astronomical units (TAU) is under study by the Jet Propulsion Laboratory. Launch date for a TAU mission is likely to be well into the first decade of the 21st century. Study of TAU has focused on the technologies required to carry out this ambitious mission and the identification of preliminary scientific rationale for such a deep space flight. A 1-MW nuclear-powered electric propulsion (NEP) system forms the baseline method for achieving the high velocities required. A solar system escape velocity of 106 km/s is needed to propel the TAU vehicle to 1000 AU in 50 years. The NEP system must accelerate the vehicle for about ten years before this velocity is attained because of the extremely low thrust nature of the xenon-fueled ion engines. At the end of the thrusting phase the NEP system is jettisoned to allow the TAU spacecraft and science experiments to coast out to 1000 AU. Another important technology for TAU is advanced optical communication systems, which are envisioned for transmitting science data to Earth. A 1-m optical telescope combined with a 10-W laser transponder can transmit 20 kbps to a 10-m Earth-orbit-based telescope from 1000 AU.

  7. Not just another multi-professional course! Part 1. Rationale for a transformative curriculum.

    Science.gov (United States)

    Duncan, Madeleine; Alperstein, Melanie; Mayers, Pat; Olckers, Lorna; Gibbs, Trevor

    2006-02-01

    Undergraduate inter- and multi-professional education has traditionally aimed to develop health professionals who are able to collaborate effectively in comprehensive healthcare delivery. The respective professions learn from and about each other through comparisons of roles, responsibilities, powers, duties and perspectives in order to promote integrated service. Described here is the educational rationale of a multi-professional course with a difference; one that injects value to undergraduate health professional education through the development of critical cross-field knowledge, skills and attitudes that unite rather than differentiate professions. The aim of this course, offered at the Faculty of Health Sciences, University of Cape Town, is to lay an integrated, pan-professional foundation for the advancement of collective commitment to and understanding of national health and social development objectives such as primary health care, human rights and professionalism. Pan-professional refers to curriculum content that is core and of critical relevance to all participating professions. What is learned, how it is learned, how learning is facilitated and how it is applied, has been co-constructed by a multi-professional design team representing a range of health professions (audiology, medicine, occupational therapy, nursing, physiotherapy and speech therapy) and academic disciplines (anthropology, sociology, psychology, history, African studies and social development, information technology and language literacy). Education specialists facilitate the ongoing design process ensuring that the structure and content of the curriculum complies with contemporary adult learning principles and national higher education imperatives. Designing the original curriculum required the deconstruction of intra-professional and disciplinary canons of knowledge and ways of 'doing things' in order to identify and develop shared interpretations of critical epistemology and axiology

  8. The rationale and potential for the reduction of oral malodour using Streptococcus salivarius probiotics.

    Science.gov (United States)

    Burton, J P; Chilcott, C N; Tagg, J R

    2005-01-01

    The primary treatment for oral malodour is the reduction of bacterial populations, especially those present on the tongue, by use of a variety of antimicrobial agents or mechanical devices. However, shortly after treatment the problematic bacteria quickly repopulate the tongue and the malodour returns. In our studies, we have used a broadly-active antimicrobial (chlorhexidine) to effect temporary depletion of the oral microbiota and then have attempted to repopulate the tongue surface with Streptococcus salivarius K12, a benign commensal probiotic. The objective of this is to prevent re-establishment of non-desirable bacterial populations and thus help limit the re-occurrence of oral malodour over a prolonged period. In this paper, we discuss why contemporary probiotics are inadequate for treatment of oral malodour and examine the rationale for selection of particular bacterial species for future use in the treatment of this condition. In our preliminary trials of the use of a chlorhexidine rinse followed by strain K12 lozenges, the majority (8/13) of subjects with confirmed halitosis maintained reduced breath levels of volatile sulphur compounds for at least 2 weeks. We conclude that probiotic bacterial strains originally sourced from the indigenous oral microbiotas of healthy humans may have potential application as adjuncts for the prevention and treatment of halitosis. PMID:15752094

  9. Rationale and Description of Right Ventricle-Protective Ventilation in ARDS.

    Science.gov (United States)

    Paternot, Alexis; Repessé, Xavier; Vieillard-Baron, Antoine

    2016-10-01

    Pulmonary vascular dysfunction is associated with ARDS and leads to increased right-ventricular afterload and eventually right-ventricular failure, also called acute cor pulmonale. Interest in acute cor pulmonale and its negative impact on outcome in patients with ARDS has grown in recent years. Right-ventricular function in these patients should be closely monitored, and this is helped by the widespread use of echocardiography in intensive care units. Because mechanical ventilation may worsen right-ventricular failure, the interaction between the lungs and the right ventricle appears to be a key factor in the ventilation strategy. In this review, a rationale for a right ventricle-protective ventilation approach is provided, and such a strategy is described, including the reduction of lung stress (ie, the limitation of plateau pressure and driving pressure), the reduction of PaCO2 , and the improvement of oxygenation. Prone positioning seems to be a crucial part of this strategy by protecting both the lungs and the right ventricle, resulting in increased survival of patients with ARDS. Further studies are required to validate the positive impact on prognosis of right ventricle-protective mechanical ventilation.

  10. National G6PD neonatal screening program in Gaza Strip of Palestine: rationale, challenges and recommendations.

    Science.gov (United States)

    Sirdah, M M; Al-Kahlout, M S; Reading, N S

    2016-09-01

    Congenital genetic disorders affecting neonates or young children can have serious clinical consequences if undiagnosed and left untreated. Early detection and an accurate diagnosis are, therefore, of major importance for preventing negative patient outcomes. Even though the occurrence of each specific metabolic disorder may be rare, their collective impact of preventable complications may be of considerable importance to the public health. Our previous studies showed that glucose-6-phosphate dehydrogenase (G6PD) deficiency is a problem of public health importance that has been shown to be a predominant cause of acute hemolytic anemia requiring hospitalization in Palestinian young children in Gaza Strip. Intriguingly, the majority of these children had one of the three variants, Mediterranean(c.) (563T) , African G6PD A-(c.) (202A) (/c.) (376G) and heretofore unrecognized as a common G6PD-deficient variant G6PD Cairo(c.) (404C) . The high prevalence of G6PD deficiency, as well as dietary factors in the region that precipitate anemia, argues for a need to protect the Palestinian children from a treatable and manageable genetic and metabolic disorder. This work reviews and discusses rationales and challenges of G6PD screening program in Gaza Strip. We advocate adopting a national neonatal G6PD screening program in Gaza Strip to identify children at risk and promote wellness and health for Palestine. PMID:27064064

  11. Practices and rationales of community engagement with wind farms: awareness raising, consultation, empowerment

    DEFF Research Database (Denmark)

    Aitken, Mhairi; Haggett, Claire; Rudolph, David Philipp

    2016-01-01

    In light of the growing emphasis on community engagement in the literature on renewable energy planning, and given the acknowledgement of the complexity of community engagement as a concept, we conducted an empirical review of practice relating to community engagement with onshore wind farms...... in the UK, exploring what is actually happening in terms of community engagement relating to onshore wind farms, and examining the rationales underpinning approaches to community engagement. We found that a wide range of engagement methods are being used in relation to onshore wind farms across the UK......-hierarchical classification of community engagement approaches: awareness raising; consultation and empowerment. This provides a useful tool for reflecting on practices and rationales of community engagement. By considering the three approaches non-hierarchically, this model allows for an examination of how such rationales...

  12. Development of a Publicly Available, Comprehensive Database of Fiber and Health Outcomes: Rationale and Methods.

    Directory of Open Access Journals (Sweden)

    Kara A Livingston

    Full Text Available Dietary fiber is a broad category of compounds historically defined as partially or completely indigestible plant-based carbohydrates and lignin with, more recently, the additional criteria that fibers incorporated into foods as additives should demonstrate functional human health outcomes to receive a fiber classification. Thousands of research studies have been published examining fibers and health outcomes.(1 Develop a database listing studies testing fiber and physiological health outcomes identified by experts at the Ninth Vahouny Conference; (2 Use evidence mapping methodology to summarize this body of literature. This paper summarizes the rationale, methodology, and resulting database. The database will help both scientists and policy-makers to evaluate evidence linking specific fibers with physiological health outcomes, and identify missing information.To build this database, we conducted a systematic literature search for human intervention studies published in English from 1946 to May 2015. Our search strategy included a broad definition of fiber search terms, as well as search terms for nine physiological health outcomes identified at the Ninth Vahouny Fiber Symposium. Abstracts were screened using a priori defined eligibility criteria and a low threshold for inclusion to minimize the likelihood of rejecting articles of interest. Publications then were reviewed in full text, applying additional a priori defined exclusion criteria. The database was built and published on the Systematic Review Data Repository (SRDR™, a web-based, publicly available application.A fiber database was created. This resource will reduce the unnecessary replication of effort in conducting systematic reviews by serving as both a central database archiving PICO (population, intervention, comparator, outcome data on published studies and as a searchable tool through which this data can be extracted and updated.

  13. The SCOUT-O3 Darwin Aircraft Campaign: rationale and meteorology

    Directory of Open Access Journals (Sweden)

    D. Brunner

    2009-01-01

    Full Text Available An aircraft measurement campaign involving the Russian high-altitude aircraft M55 Geophysica and the German DLR Falcon was conducted in Darwin, Australia in November and December 2005 as part of the European integrated project SCOUT-O3. The overall objectives of the campaign were to study the transport of trace gases through the tropical tropopause layer (TTL, mechanisms of dehydration close to the tropopause, and the role of deep convection in these processes. In this paper a detailed roadmap of the campaign is presented, including rationales for each flight, and an analysis of the local and large-scale meteorological context in which they were embedded. The campaign took place during the pre-monsoon season which is characterized by a pronounced diurnal evolution of deep convection including a mesoscale system over the Tiwi Islands north of Darwin known as "Hector". This allowed studying in detail the role of deep convection in structuring the tropical tropopause region, in situ sampling convective overshoots above storm anvils, and probing the structure of anvils and cirrus clouds by Lidar and a suite of in situ instruments onboard the two aircraft. The large-scale flow during the first half of the campaign was such that local flights, away from convection, sampled air masses downstream of the "cold trap" region over Indonesia. Abundant cirrus clouds enabled the study of active dehydration, in particular during two TTL survey flights. The campaign period also encompassed a Rossby wave breaking event transporting stratospheric air to the tropical middle troposphere and an equatorial Kelvin wave modulating tropopause temperatures and hence the conditions for dehydration.

  14. The SCOUT-O3 Darwin Aircraft Campaign: rationale and meteorology

    Directory of Open Access Journals (Sweden)

    D. Brunner

    2008-09-01

    Full Text Available An aircraft measurement campaign involving the Russian high-altitude aircraft M55 Geophysica and the German DLR Falcon was conducted in Darwin, Australia in November and December 2005 as part of the European integrated project SCOUT-O3. The overall objectives of the campaign were to study the transport of trace gases through the tropical tropopause layer (TTL, mechanisms of dehydration close to the tropopause, and the role of deep convection in these processes. In this paper a detailed roadmap of the campaign is presented, including rationales for each flight, and an analysis of the local and large-scale meteorological context in which they were embedded. The campaign took place during the pre-monsoon season which is characterized by a pronounced diurnal evolution of deep convection including a mesoscale system over the Tiwi Islands north of Darwin known as "Hector". This allowed studying in detail the role of deep convection in structuring the tropical tropopause region, in situ sampling convective overshoots above storm anvils, and probing the structure of anvils and cirrus clouds by Lidar and a suite of in situ instruments onboard the two aircraft. The large-scale flow during the first half of the campaign was such that local flights, away from convection, sampled air masses downstream of the "cold trap" region over Indonesia. Abundant cirrus clouds enabled the study of active dehydration, in particular during two TTL survey flights. The campaign period also encompassed a Rossby wave breaking event transporting stratospheric air to the tropical middle troposphere and an equatorial Kelvin wave modulating tropopause temperatures and hence the conditions for dehydration.

  15. Usage of U7 small nuclear ribonucleic acid in gene therapy of hemoglobin D Punjab disorder: Rationale?

    Directory of Open Access Journals (Sweden)

    Viroj Wiwanitkit

    2013-01-01

    Full Text Available Background: Hemoglobin (Hb D Punjab disorder is a congenital hemoglobinopathy described in India. It is a disorder due to defect in beta-globin gene. Materials and Methods: Here, the author assesses the possibility of U7.623 gene therapy for Hb D Punjab disorder. A standard bioinformatic analysis to study the effect of co-expression between nucleic acid sequence for human Hb D Punjab beta-globin chain and U7.623 was performed. Result: It can be seen that fully recovery of Hb function and biological process can be derived via gene ontology study. Conclusion: Here, there is a rationale to use U7 small nuclear ribonucleic acid as a possible tool for gene therapy in Hb D Punjab disorder.

  16. Drug delivery for in vitro fertilization: rationale, current strategies and challenges.

    Science.gov (United States)

    Janát-Amsbury, Margit M; Gupta, Kavita M; Kablitz, Caroline D; Peterson, C Matthew

    2009-08-10

    In vitro fertilization has experienced phenomenal progress in the last thirty years and awaits the additional refinement and enhancement of medication delivery systems. Opportunity exists for the novel delivery of gonadotropins, progesterone and other adjuvants. This review highlights the rationale for various medications, present delivery methods and introduces the status of novel ideas and possibilities.

  17. Sequence, Program Words, and Sequence Rationale for the 1971 Revised First-Grade Spelling Program.

    Science.gov (United States)

    Berdiansky, Betty

    Pupils participating in the 1971-1972 tryout of the Southwest Regional Laboratory (SWRL) First Grade Spelling Program were taught to combine consonants and consonant clusters with word elements to form program words. This paper presents the sequence of instruction for these elements and the rationale used in deriving this sequence. In addition, it…

  18. Coercion or Compulsion?: Rationales behind Informal Payments for Education in Azerbaijan

    Science.gov (United States)

    Lepisto, Eric; Kazimzade, Elmina

    2009-01-01

    Although informal payments are necessary for education systems in many countries, they prohibit education accessibility and equity in Eastern Europe and neighboring states. Exploring the rationales and the relationships is a promising approach for understanding corruption in education and ensuring educational equity. In this article, rationales…

  19. Rationale for Students Preparation and Entrepreneurship Education in the Face of Global Economic Crisis in Nigeria

    Science.gov (United States)

    Onuma, Nwite

    2016-01-01

    The rationale for students preparation in job creation through entrepreneurship education was examined. Problems of unemployment among Nigerian university graduates and challenges to entrepreneurship in the face of global economic crisis were also highlighted. The persistent problem of unemployment among University graduates and its attendant…

  20. Establishing Assessment Scales Using a Novel Disciplinary Rationale for Scientific Reasoning

    Science.gov (United States)

    Kind, Per Morten

    2013-01-01

    The article argues that science assessment should change from an item-driven to a construct-driven practice and pay more attention to disciplinary scientific reasoning. It investigates assessment scales developed from a novel theoretical rationale, describing scientific reasoning as three fundamental practices (hypothesizing, experimenting, and…

  1. Physics Education Research in the United States: A Summary of Its Rationale and Main Findings.

    Science.gov (United States)

    Gonzales-Espada, Wilson J.

    2003-01-01

    Recognizes how difficult it is for secondary and post-secondary students to make connections between physics and everyday phenomena, rationalize the use of a particular formula for a given problem, and go beyond algebraic substitutions to really make sense of physics in a meaningful way. Provides a rationale for physicists to become involved in…

  2. Connecting agents and artifacts in CSCL: Towards a rationale of mutual shaping

    NARCIS (Netherlands)

    Overdijk, Maarten; Van Diggelen, Wouter; Kirschner, Paul A.; Baker, Michael

    2012-01-01

    Overdijk, M., Van Diggelen, W., Kirschner, P. A., & Baker, M. (2012). Connecting agents and artifacts in CSCL: Towards a rationale of mutual shaping. International Journal of Computer-Supported Collaborative Learning, 7, 193-210. doi:10.1007/s11412-012-9143-2

  3. Five Big, Big Five Issues : Rationale, Content, Structure, Status, and Crosscultural Assessment

    NARCIS (Netherlands)

    De Raad, Boele

    1998-01-01

    This article discusses the rationale, content, structure, status, and crosscultural assessment of the Big Five trait factors, focusing on topics of dispute and misunderstanding. Taxonomic restrictions of the original Big Five forerunner, the "Norman Five," are discussed, and criticisms regarding the

  4. Children's Choices for Recreational Reading: A Three-Part Investigation of Selection Preferences, Rationales, and Processes

    Science.gov (United States)

    Mohr, Kathleen A. J.

    2006-01-01

    This report delineates a three-part investigation into first graders' preferences, selection rationales, and processes when choosing a picture book to own. One-hundred ninety first graders were invited to select their favorite book from among nine high-quality, well-illustrated picture books representing a variety of topics, media, and genres. In…

  5. Advanced water-cooled reactor technologies. Rationale, state of progress and outlook

    International Nuclear Information System (INIS)

    Eighty per cent of the world's power reactors are water cooled and moderated. Many improvements in their design and operation have been implemented since the first such reactor started commercial operation in 1957. This report addresses the safety, environmental and economic rationales for further improvements, as well as their relevance to currently operating water reactors

  6. Integrating the Beliefs of Dewey, Lewin, and Rogers into a Rationale for Effective Group Leadership.

    Science.gov (United States)

    Grove, Richard W.

    1992-01-01

    Presents a rationale for effective group leadership grounded in John Withall's articulation of selected beliefs of John Dewey, Kurt Lewin, and Carl Rogers. Teachers and administrators need more and better preparation in collaborative inquiry. Knowledge and skills in collaborative inquiry should undergird the successful functioning of groups of…

  7. Rationale and methods of discovering hormetins as drugs for healthy ageing

    DEFF Research Database (Denmark)

    Rattan, Suresh I S

    2012-01-01

    Introduction: Mild stress-induced hormesis is becoming increasingly attractive as an aging interventional strategy, and is leading to the discovery of hormesis-inducing compounds called homretins. This review gives the background, rationale and approaches for screening, testing and developing nov...

  8. From "Refuge" to "Polis": Shifting the Rationale for Religiosity in Schools

    Science.gov (United States)

    Dippo, Don

    2010-01-01

    This article responds to Bruce Collet's article "From Refuge to Polis: Shifting the Rationale for Religiosity in Schools." In this rejoinder my intention is to shift the discussion from school-as-refuge to school-as-polis and to ask whether the integration interests of recent immigrants and refugees might not be better served by a more inclusive…

  9. Combating 'inflammaging' through a Mediterranean whole diet approach: the NU-AGE project rationale

    NARCIS (Netherlands)

    Santoro, A.; Pini, E.; Scurti, M.; Palmas, G.; Berendsen, A.; Brzozowska, A.M.; The NU-AGE Consortium, A.; Groot, de C.P.G.M.; Feskens, E.J.M.; Fairweather-Tait, S.; Salvioli, S.; Capri, M.

    2013-01-01

    The development of a chronic, low grade, inflammatory status named "inflammaging" is a major characteristic of aging which plays a critical role in the pathogenesis of age-related diseases. The NU-AGE rationale is that a one year Mediterranean whole diet (considered by UNESCO a heritage of humanity)

  10. Health promotion – The rationale and the obstacles in workplaces with different employment and financial soundness

    Directory of Open Access Journals (Sweden)

    Krzysztof Puchalski

    2013-12-01

    Full Text Available Background: This paper presents the prevalence of health promotion in workplaces in Poland. It characterises the undertaken actions, their rationale and perceived obstacles. It analyses the diversity of these phenomena in the companies of different financial soundness and level of employment. Material and Methods: The study was conducted with the use of Computer Assisted Telephone Interview in 2010 on the representative national sample of 1002 workplaces hiring more than 50 employees. The data was compared with the results of the survey conducted in 2006, with the use of a Paper and Pencil interview on 611 similar companies. Results: Both studies have shown that 40% of the companies are concerned about their employees' health to a greater extent than they are obliged to by the law. At the same time, more than 80% of the companies have been introducing various modifications and health-oriented actions without definite health intentions. Most companies improve their physical working environment, organise/sponsor medical services, sports activities and try to reduce stress and smoking. Managers have increased their awareness of business benefits received from health promotion. They have displayed more personal involvement in health promotion implementation. The most often mentioned obstacles have included limited financial resources and little interest of employees regarding health issues. Conclusions: The larger and wealthier the company is, the more often health promotion in the company is performed. Such a company is more convinced about an increase in its activities and has more reasons to care about health. Unequal access to health promotion of workers in different companies may contribute to an increase in health inequalities in the working population. Med Pr 2013;64(6:743–754

  11. Combining GLP-1 receptor agonists with insulin: therapeutic rationales and clinical findings.

    Science.gov (United States)

    Holst, J J; Vilsbøll, T

    2013-01-01

    Due to the increasing prevalence of type 2 diabetes mellitus (T2DM), the emergent trend towards diagnosis in younger patients and the progressive nature of this disease, many more patients than before now require insulin to maintain glycaemic control. However, there is a degree of inertia among physicians and patients regarding the initiation and intensification of insulin therapy, in part due to concerns about the associated weight gain and increased risk of hypoglycaemia. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) increase insulin release and suppress glucagon secretion in a glucose-dependent manner, thus conferring glycaemic control with a low incidence of hypoglycaemia. GLP-1RAs also promote weight loss, and have beneficial effects on markers of β cell function, lipid levels, blood pressure and cardiovascular risk markers. However, the durability of their effectiveness is unknown and, compared with insulin, the antihyperglycaemic efficacy of GLP-1RAs is limited. The combination of a GLP-1RA and insulin might thus be highly effective for optimal glucose control, ameliorating the adverse effects typically associated with insulin. Data from clinical studies support the therapeutic potential of GLP-1RA-insulin combination therapy, typically showing beneficial effects on glycaemic control and body weight, with a low incidence of hypoglycaemia and, in established insulin therapy, facilitating reductions in insulin dose. In this review, the physiological and pharmacological rationale for using GLP-1RA and insulin therapies in combination is discussed, and data from clinical studies that have assessed the efficacy and safety of this treatment strategy are outlined. PMID:22646532

  12. Environmental benefits and economic rationale of expanding the Italian natural gas private car fleet

    International Nuclear Information System (INIS)

    There are several concerns which bring to consider natural gas as a viable alternative to liquid fuels in transport. First, natural gas allows the curbing of global pollution in this steadily growing industry. Indeed, decoupling greenhouse gas emissions from transport growth has become a major issue in tackling climate change. Second, a more extensive use of natural gas would relieve city air quality, which is presently at levels harmful of human health. Nonetheless, this is just one side of the coin. The other side entails building a refuelling station network, and this carries financial requirements. The financing fraction holds a pivotal role in deciding whether natural gas for automotive purposes is an efficient solution. The final aim of this work is, therefore, to compare the natural gas advantages, stemming from avoided global and local emission, with the economic rationale of engaging in supplementary model network investments. A system dynamics model underlies this study's economic reasoning and is taken as reference for quantitative assertions. The model, named CH4CleanerAir, contains data referring to two scenarios: a Business As Usual Scenario and an Expansion Scenario. Simulation runs in Expansion Scenario serve to understand how gaseous pollution diminishes and network investments rise when the natural gas-fuelled fleet, as share of the total fleet, increases. Are new infrastructures needs compatible with existing refuelling facilities? What is the extent by which the natural gas-fuelled fleet can actually reduce global and local emission? The scenarios' gap analysis lead to the work's final considerations. The sounder reductions of gaseous pollutants in the last years of the considered time lag make the overall assessment lean towards a positive evaluation of natural gas employment in this industry. The beneficial effects of increasing the natural gas-fuel-led fleet take some time to unfold, but they eventually prevail. This study shows how natural

  13. A Content Assist based Approach for Providing Rationale of Method Change for Object Oriented Programming

    Directory of Open Access Journals (Sweden)

    Amit S. Ami

    2015-01-01

    Full Text Available Software engineering requires modification of code during development and maintenance phase. During modification, a difficult task is to understand rationale of changed code. Present Integrated Development Environments (IDEs attempt to help this by providing features integrated with different types of repositories. However, these features still consume developer's time as he has to switch from editor to another window for this purpose. Moreover, these features focus on elements available in present version of code, thus increasing the difficulty of finding rationale of an element removed or modified earlier. Leveraging different sources for providing information through code completion menus has been shown to be valuable, even when compared to standalone counterparts offering similar functionalities in literature. Literature also shows that it is one of the most used features for consuming information within IDE. Based on that, we prepare an Eclipse plug-in and a framework that allows providing reason of code change, at method granularity, across versions through a new code completion menu in IDE. These allow a software engineer to gain insight about rationale of removed or modified methods which are otherwise not available in present version of code. Professional software engineers participated in our empirical evaluation process and we observed that more than 80% participants considered this to be a useful approach for saving time and effort to understand rationale of method change. Later, based on their feedback, the plug-in and framework is modified to incorporate chronological factors. We perform quasi experimental evaluation with professional software engineers. It is found that time required to find rationale of method change is reduced to at least half compared to usual amount of time required for all the software engineers who participated in the quantitative evaluation.

  14. Ethical implications of co-benefits rationale within climate change mitigation strategy

    Directory of Open Access Journals (Sweden)

    Rita Vasconcellos Oliveira

    2016-10-01

    Full Text Available Climate change mitigation effort is being translated into several actions and discourses that make collateral benefits and their rationale increasingly relevant for sustainability, in such a way that they are now a constant part of the political agenda. Taking a border and consensual perspective, co-benefits are considered here to be emerging advantages of the implementation of measures regarding the lowering of greenhouse gases.Departing from the analysis of policy documents referring to two European urban transportation strategies, the emergent co-benefits are problematized and discussed to better understand their moral aspect. Further ethical reflection is conducted after an analysis of some unintended consequences of co-benefits rationale coming from the mentioned examples. The focus is primarily on the challenges of an integrative moral justification for co-benefits and also for their role in the climate change mitigation effort. We also discuss the limitations of the current normative models that frame co-benefits rationale, from a moral viewpoint and in relation to the overall climate change mitigation strategy.In this article, we propose the concepts of well-being and freedom, as portrayed by Capabilities Approach, as possible guiding notions for the moral and social evaluation of goodness of these emergent benefits and their rationale too. Additionally, some preliminary conclusions are drawn regarding the potential of the presented concepts to favour the climate change mitigation action. Finally, a scenario is drawn where Capabilities Approach is the moral guideline for co-benefits rationale showing this way its potential in terms of enhancing climate change mitigation strategy.

  15. The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®

    Directory of Open Access Journals (Sweden)

    Höybye C

    2013-04-01

    Full Text Available Charlotte Höybye,1 Lars Sävendahl,2 Henrik Thybo Christesen,3 Peter Lee,4 Birgitte Tønnes Pedersen,5 Michael Schlumpf,6 John Germak,7 Judith Ross8 1Department of Molecular Medicine and Surgery, Karolinska Institute and Department of Endocrinology, Metabolism and Diabetes, 2Department of Women’s and Children’s Health, Karolinska Institute and Division of Pediatrics, Karolinska University Hospital, Stockholm, Sweden; 3Hans Christian Andersen Children’s Hospital, Odense University Hospital, Odense, Denmark; 4Department of Pediatrics, Penn State College of Medicine, Hershey, PA, USA; 5Global Development, Novo Nordisk A/S, Søborg, Denmark; 6Global Medical Affairs Biopharm, Novo Nordisk Health Care AG, Zurich, Switzerland; 7Clinical Development and Medical Affairs, Novo Nordisk Inc, Princeton, NJ, USA; 8Department of Pediatrics, Thomas Jefferson University, Philadelphia, PA, USA Objective: Randomized controlled trials have shown that growth hormone (GH therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. Design: The NordiNet® International Outcome Study (IOS and the American Norditropin® Studies: Web Enabled Research (ANSWER Program® are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. Patients: The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. Measurements: The studies gather long-term data on the safety and effectiveness of real-life treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of

  16. CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: A clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients.

    Science.gov (United States)

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena M; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-07-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having Mediterranean diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study. PMID:27297848

  17. CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: A clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients.

    Science.gov (United States)

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena M; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-07-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study.

  18. Is there a rationale for short cardioplegia re-dosing intervals?

    Institute of Scientific and Technical Information of China (English)

    Yves; D; Durandy

    2015-01-01

    While cardioplegia has been used on millions of patients during the last decades, the debate over the best technique is still going on. Cardioplegia is not only meant to provide a non-contracting heart and a field without blood, thus avoiding the risk of gas emboli, but also used for myocardial protection. Its electromechanical effect is easily confirmed through direct vision of the heart and continuous electrocardiogram monitoring, but there is no consensus on the best way to assess the quality of myocardial protection. The optimal approach is thus far from clear and the considerable amount of literature on the subject fails to provide a definite answer. Cardioplegia composition(crystalloid vs blood, with or without various substrate enhancement), temperature and site(s) of injection have been extensively researched. While less frequently studied, re-dosing interval is also an important factor. A common and intuitive idea is that shorter redosing intervals lead to improved myocardial protection. A vast majority of surgeons use re-dosing intervals of 20-30 min, or even less, during coronary artery bypass graft and multidose cardioplegia has been the "gold standard" for decades. However, one-shot cardioplegia is becoming more commonly used and is likely to be a valuable alternative. Some surgeons prefer the comfort of single-shot cardioplegia while others feel more confident with shorter re-dosing intervals. There is no guarantee that a single strategy can be safely applied to all patients, irrespective of their age, comorbidities or cardiopathy. The goal of this review is to discuss the rationale for short re-dosing intervals.

  19. Prostatic Artery Embolization (PAE) for Symptomatic Benign Prostatic Hyperplasia (BPH): Part 2, Insights into the Technical Rationale

    Energy Technology Data Exchange (ETDEWEB)

    Sun, Fei, E-mail: feisun@ccmijesususon.com; Crisóstomo, Verónica, E-mail: crisosto@ccmijesususon.com; Báez-Díaz, Claudia, E-mail: cbaez@ccmijesususon.com; Sánchez, Francisco M., E-mail: msanchez@ccmijesususon.com [Jesús Usón Minimally Invasive Surgery Centre (Spain)

    2016-02-15

    Rationale of prostatic artery embolization (PAE) in the treatment of symptomatic benign prostatic hyperplasia is conventionally believed to include two parts: shrinkage of the enlarged prostate gland as a result of PAE-induced ischemic infarction and potential effects to relax the increased prostatic smooth muscle tone by reducing the number and density of α{sub 1}-adrenergic receptor in the prostate stroma. This review describes new insights into the likely mechanisms behind PAE, such as ischemia-induced apoptosis, apoptosis enhanced by blockage of androgens circulation to the embolized prostate, secondary denervation following PAE, and potential effect of nitric oxide pathway immediately after embolization. Studies on therapeutic mechanisms in PAE may shed light on potentially new treatment strategies and development of novel techniques.

  20. Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with Fosinopril and Pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT])

    NARCIS (Netherlands)

    Diercks, GFH; Janssen, WMT; van Boven, AJ; Bak, AAA; de Jong, PE; Crijns, HJGM; van Gilst, WH

    2000-01-01

    This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/day will prevent cardiovascular and renal disease in nonhypertensive (RR 10 mg/L once in an early morning spot urine and 15 to 300 mg/

  1. Glycemic control in cardiac surgery: Rationale and current evidence

    Directory of Open Access Journals (Sweden)

    G Girish

    2014-01-01

    Full Text Available Studies in cardiac surgical patients have shown an association of hyperglycemia with increased incidences of sepsis, mediastinitis, prolonged mechanical ventilation, cardiac arrhythmias and longer intensive care and hospital stay. There is considerable controversy regarding appropriate glycemic management in these patients and in the definition of hyperglycemia and hypoglycemia or the blood sugar levels at which therapy should be initiated. There is also dilemma regarding the usage of "tight glycemic control" with studies showing conflicting evidences. Part of the controversy can be explained by the differing designs of these studies and the variable definitions of hyperglycemia and hypoglycemia.

  2. Verifying causes of death in Thailand: rationale and methods for empirical investigation

    Directory of Open Access Journals (Sweden)

    Polprasert Warangkana

    2010-05-01

    Full Text Available Abstract Background Cause-specific mortality statistics by age and sex are primary evidence for epidemiological research and health policy. Annual mortality statistics from vital registration systems in Thailand are of limited utility because about 40% of deaths are registered with unknown or nonspecific causes. This paper reports the rationale, methods, and broad results from a comprehensive study to verify registered causes in Thailand. Methods A nationally representative sample of 11,984 deaths was selected using a multistage stratified cluster sampling approach, distributed across 28 districts located in nine provinces of Thailand. Registered causes were verified through medical record review for deaths in hospitals and standard verbal autopsy procedures for deaths outside hospitals, the results of which were used to measure validity and reliability of registration data. Study findings were used to develop descriptive estimates of cause-specific mortality by age and sex in Thailand. Results Causes of death were verified for a total of 9,644 deaths in the study sample, comprised of 3,316 deaths in hospitals and 6,328 deaths outside hospitals. Field studies yielded specific diagnoses in almost all deaths in the sample originally assigned an ill-defined cause of death at registration. Study findings suggest that the leading causes of death in Thailand among males are stroke (9.4%; transport accidents (8.1%; HIV/AIDS (7.9%; ischemic heart diseases (6.4%; and chronic obstructive lung diseases (5.7%. Among females, the leading causes are stroke (11.3%; diabetes (8%; ischemic heart disease (7.5%; HIV/AIDS (5.7%; and renal diseases (4%. Conclusions Empirical investigation of registered causes of death in the study sample yielded adequate information to enable estimation of cause-specific mortality patterns in Thailand. These findings will inform burden of disease estimation and economic evaluation of health policy choices in the country. The

  3. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer

    International Nuclear Information System (INIS)

    To improve the efficacy of first-line therapy for advanced non-small cell lung cancer (NSCLC), additional maintenance chemotherapy may be given after initial induction chemotherapy in patients who did not progress during the initial treatment, rather than waiting for disease progression to administer second-line treatment. Maintenance therapy may consist of an agent that either was or was not present in the induction regimen. The antifolate pemetrexed is efficacious in combination with cisplatin for first-line treatment of advanced NSCLC and has shown efficacy as a maintenance agent in studies in which it was not included in the induction regimen. We designed a phase III study to determine if pemetrexed maintenance therapy improves progression-free survival (PFS) and overall survival (OS) after cisplatin/pemetrexed induction therapy in patients with advanced nonsquamous NSCLC. Furthermore, since evidence suggests expression levels of thymidylate synthase, the primary target of pemetrexed, may be associated with responsiveness to pemetrexed, translational research will address whether thymidylate synthase expression correlates with efficacy outcomes of pemetrexed. Approximately 900 patients will receive four cycles of induction chemotherapy consisting of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day 1 of a 21-day cycle. Patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 who have not progressed during induction therapy will randomly receive (in a 2:1 ratio) one of two double-blind maintenance regimens: pemetrexed (500 mg/m2 on day 1 of a 21-day cycle) plus best supportive care (BSC) or placebo plus BSC. The primary objective is to compare PFS between treatment arms. Secondary objectives include a fully powered analysis of OS, objective tumor response rate, patient-reported outcomes, resource utilization, and toxicity. Tumor specimens for translational research will be obtained from consenting patients before induction treatment

  4. 中国人群孕前队列研究先兆子痫:原理、研究方法和基线结果%A pre-conception cohort to study preeclampsia in China:Rationale, study design, and preliminary results

    Institute of Scientific and Technical Information of China (English)

    文师吾; 谭红专; 谢日华; Graeme N. Smith; Mark Walker

    2012-01-01

    目的:目前尚不清楚先兆子痫是由孕前因素还是妊娠因素所引起.本研究通过在中国湖南地区建立孕前队列以阐明先兆子痫的病因.方法:本研究拟在湖南浏阳地区招募5000对半年内有怀孕打算的未孕夫妇,并追踪研究对象的怀孕、分娩及产后情况.结果:目前本孕前队列共招募了1915对未孕夫妇.与孕前相比较,产妇的收缩压和舒张压在孕中早期有所下降,然而在孕后期有所上升.结论:孕前队列的建立将对孕期先兆子痫及产后心血管疾病的预防发挥重要的理论和实际意义.%Objective: It is uncertain whether preeclampsia (PE) is caused by pre-existing factors or by pregnancy itself. We want to answer this important question in public health by conducting a large pre-conception cohort in China.Methods: A prospective and pre-conception cohort study with a target recruitment of 5000 couples who plan to have a baby within 6 months was performed and their conception, delivery, and postpartum were followed up in Liuyang county, Hunan Province of P. R. China. Results: A total of 1915 young couples have been recruited into this unique pre-conception cohort till now. In general, both systolic blood pressure and diastolic blood pressure decreased in early second trimester from pre-conception level but increased in third trimester and at delivery. Conclusion: The proposed pre-conception cohort study will have important theoretical and practical implications on the prevention of PE and its associated cardiovascular disease risks.

  5. Zero Tolerance Policy in Schools: Rationale, Consequences, and Alternatives.

    Science.gov (United States)

    Casella, Ronnie

    2003-01-01

    Discusses theory/policies supporting zero tolerance policy in schools, including rational choice theory in criminology and national crime policies based on deterrence. Potential consequences of zero tolerance policy implementation are described and shown to involve outcomes similar to those identified by researchers studying national crime policy.…

  6. Phenomenological Analysis of Rationale for School Transfer Credit Policies

    Science.gov (United States)

    Melton, Amye M.

    2012-01-01

    Students face challenges when attempting to transfer college credits; sometimes, the process results in having to retake classes already completed at another institution. A qualitative phenomenological study, grounded in an advocacy/participatory worldview, was used to explore how leaders of higher learning institutions determined reasons academic…

  7. Short-Form Philadelphia Naming Test: Rationale and Empirical Evaluation

    Science.gov (United States)

    Walker, Grant M.; Schwartz, Myrna F.

    2012-01-01

    Purpose: To create two matched short forms of the Philadelphia Naming Test (PNT; Roach, Schwartz, Martin, Grewal, & Brecher, 1996) that yield similar results to the PNT for measuring anomia. Method: In Study 1, archived naming data from 94 individuals with aphasia were used to identify which PNT items should be included in the short forms. The 2…

  8. Brivaracetam: Rationale for discovery and preclinical profile of a selective SV2A ligand for epilepsy treatment.

    Science.gov (United States)

    Klitgaard, Henrik; Matagne, Alain; Nicolas, Jean-Marie; Gillard, Michel; Lamberty, Yves; De Ryck, Marc; Kaminski, Rafal M; Leclercq, Karine; Niespodziany, Isabelle; Wolff, Christian; Wood, Martyn; Hannestad, Jonas; Kervyn, Sophie; Kenda, Benoit

    2016-04-01

    Despite availability of effective antiepileptic drugs (AEDs), many patients with epilepsy continue to experience refractory seizures and adverse events. Achievement of better seizure control and fewer side effects is key to improving quality of life. This review describes the rationale for the discovery and preclinical profile of brivaracetam (BRV), currently under regulatory review as adjunctive therapy for adults with partial-onset seizures. The discovery of BRV was triggered by the novel mechanism of action and atypical properties of levetiracetam (LEV) in preclinical seizure and epilepsy models. LEV is associated with several mechanisms that may contribute to its antiepileptic properties and adverse effect profile. Early findings observed a moderate affinity for a unique brain-specific LEV binding site (LBS) that correlated with anticonvulsant effects in animal models of epilepsy. This provided a promising molecular target and rationale for identifying selective, high-affinity ligands for LBS with potential for improved antiepileptic properties. The later discovery that synaptic vesicle protein 2A (SV2A) was the molecular correlate of LBS confirmed the novelty of the target. A drug discovery program resulted in the identification of anticonvulsants, comprising two distinct families of high-affinity SV2A ligands possessing different pharmacologic properties. Among these, BRV differed significantly from LEV by its selective, high affinity and differential interaction with SV2A as well as a higher lipophilicity, correlating with more potent and complete seizure suppression, as well as a more rapid brain penetration in preclinical models. Initial studies in animal models also revealed BRV had a greater antiepileptogenic potential than LEV. These properties of BRV highlight its promising potential as an AED that might provide broad-spectrum efficacy, associated with a promising tolerability profile and a fast onset of action. BRV represents the first selective SV2A

  9. Mission objectives and scientific rationale for the magnetometer mission.

    Science.gov (United States)

    Langel, R. A.

    1991-12-01

    Based on a review of the characteristics of the geomagnetic field, objectives for the magnetic portion of the ARISTOTELES mission are: (1) To derive a description of the main magnetic field and its secular variation. (2) To investigate the correlation between the geomagnetic field and variations in the length of day. (3) To study properties of the fluid core. (4) To study the conductivity of the mantle. (5) To model the state and evolution of the crust and upper lithosphere. (6) To measure and characterize field aligned currents and ionospheric currents and to understand their generation mechanisms and their role in energy coupling in the interplanetary-magnetospheric-ionospheric systems. Procedures for these investigations are outlined.

  10. Behavioral Couples Therapy for Substance Abuse: Rationale, Methods, and Findings

    OpenAIRE

    Fals-Stewart, William; O’Farrell, Timothy J.; Birchler, Gary R.

    2004-01-01

    Behavioral couples therapy (BCT), a treatment approach for married or cohabiting drug abusers and their partners, attempts to reduce substance abuse directly and through restructuring the dysfunctional couple interactions that frequently help sustain it. In multiple studies with diverse populations, patients who engage in BCT have consistently reported greater reductions in substance use than have patients who receive only individual counseling. Couples receiving BCT also have reported higher...

  11. The rationale for early intervention in schizophrenia and related disorders

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone;

    2009-01-01

    and this relationship holds even after controlling for the potential confounding variable of premorbid functioning. In Norway, the early Treatment and Intervention in PSychosis study demonstrated that duration of untreated psychosis is amenable to intervention with the combination of educational campaigns......, adherence to treatment, comorbid drug abuse, relapse and readmission. Some benefits persist after cessation of the intervention. Conclusions: Early intervention in schizophrenia is justified to reduce the negative personal and social impact of prolonged periods of untreated symptoms. Furthermore, phase...

  12. Strength Training for Arthritis Trial (START): design and rationale

    OpenAIRE

    Messier, Stephen P.; Mihalko, Shannon L.; Beavers, Daniel P.; Nicklas, Barbara J.; DeVita, Paul; Carr, J. Jeffery; Hunter, David J.; Williamson, Jeff D.; Kim L Bennell; Guermazi, Ali; Lyles, Mary; Richard F Loeser

    2013-01-01

    Background Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with knee osteoarthritis (OA), and thigh muscle weakness is an independent and modifiable risk factor for it. However, while all published treatment guidelines recommend muscle strengthening exercise to combat loss of muscle mass and strength in knee OA patients, previous strength training studies either used intensities or loads below recommended levels for healthy adults or were generally short,...

  13. Hospital without dyspnea: rationale and design of a multidisciplinary intervention.

    Science.gov (United States)

    Vicent, Lourdes; Olarte, Juan Manuel Nuñez; Puente-Maestu, Luis; Artajona, Esther; Fernández-Avilés, Francisco; Martínez-Sellés, Manuel

    2016-07-01

    Dyspnea is a common and disabling symptom of respiratory and heart diseases, which is growing in incidence. During hospital admission, breathlessness is under-diagnosed and under-treated, although there are treatments available for controlling the symptom. We have developed a tailored implementation strategy directed to medical staff to promote the application of these pharmacological and non-pharmacological tools in dealing with dyspnea. The primary aim is to decrease the rate of patients that do not receive an adequate relief of dyspnea. This is a four-stage quasi-experimental study. The intervention consists in two teaching talks that will be taught in Cardiology and Respiratory Medicine Departments. The contents will be prepared by Palliative Care specialists, based on available tools for management of dyspnea and patients' needs. A cross-sectional study of dyspnea in hospitalized patients will be performed before and after the intervention to ascertain an improvement in dyspnea intensity due to changes in medical practices. The last phase consists in the creation of consensus protocols for dyspnea management based in our experience. The results of this study are expected to be of great value and may change clinical practice in the near future and promote a changing for the better of dyspnea care. PMID:27605944

  14. Rationale and Design of the Access Specification Language RASP

    Directory of Open Access Journals (Sweden)

    Mark Evered

    2014-05-01

    Full Text Available In this paper we describe the formal specification language RASP for expressing fine-grained access control constraints in information systems. The design of the language is motivated by a number of IS case studies which demonstrate the complexity of the access constraints which arise if minimal (need-to-know access is to be strictly enforced. RASP supports modularity, parameterization, role acquisition, constraint expressions and a symmetrical approach to role transitions and attribute transitions. No existing access control specification language supports all of these complex, realistic requirements.

  15. Rationale simplified hardening training and recreational complexes future teachers

    Directory of Open Access Journals (Sweden)

    Verbludov I.B.

    2010-02-01

    Full Text Available Distribution in the modern world epidemiological diseases are influenza and acute respiratory viral infections requires a search for simplified, effective preventive means. The main direction of prevention of these diseases is to strengthen and enhance the activities of the immune system. Strengthening the protective systems of the body is directly related to the constant holding of different types of hardening. This study illustrates the possibility of using quenching air and water in the independent exercise training and recreational facilities in all conditions of students.

  16. Chemical rationale for selection of isolates for genome sequencing

    DEFF Research Database (Denmark)

    Rank, Christian; Larsen, Thomas Ostenfeld; Frisvad, Jens Christian

    The advances in gene sequencing will in the near future enable researchers to affordably acquire the full genomes of handpicked isolates. We here present a method to evaluate the chemical potential of an entire species and select representatives for genome sequencing. The selection criteria for new...... strains to be sequenced can be manifold, but for studying the functional phenotype, using a metabolome based approach offers a cheap and rapid assessment of critical strains to cover the chemical diversity. We have applied this methodology on the complex A. flavus/A. oryzae group. Though these two species...

  17. The confusion technique untangled: its theoretical rationale and preliminary classification.

    Science.gov (United States)

    Otani, A

    1989-01-01

    This article examines the historical development of Milton H. Erickson's theoretical approach to hypnosis using confusion. Review of the literature suggests that the Confusion Technique, in principle, consists of a two-stage "confusion-restructuring" process. The article also attempts to categorize several examples of confusion suggestions by seven linguistic characteristics: (1) antonyms, (2) homonyms, (3) synonyms, (4) elaboration, (5) interruption, (6) echoing, and (7) uncommon words. The Confusion Technique is an important yet little studied strategy developed by Erickson. More work is urged to investigate its nature and properties.

  18. [Anatomical rationale for lingual nerve injury prevention during mandibular block].

    Science.gov (United States)

    Semkin, V A; Dydikin, S S; Kuzin, A V; Sogacheva, V V

    2015-01-01

    The topographic and anatomical study of lingual nerve structural features was done. It was revealed that during mandibular anesthesia possible lingual nerve injury can occur if puncture needle is lower than 1 cm. of molars occlusal surface level. The position of the lingual nerve varies withmandible movements. At the maximum open mouth lingual nerve is not mobile and is pressed against the inner surface of the mandibular ramus by the medial pterygoid muscle and the temporal muscle tendon. When closing the mouth to 1.25±0.2 cmfrom the physiological maximum, lingual nerve is displaced posteriorly from the internal oblique line of the mandible and gets mobile. On the basis of topographic and anatomic features of the lingual nervestructure the authors recommend the re-do of inferior alveolar nerve block, a semi-closed mouth position or the use the "high block techniques" (Torus anesthesia, Gow-Gates, Vazirani-Akinozi). PMID:26271698

  19. Rationale for wind-borne missile criteria for DOE facilities

    Energy Technology Data Exchange (ETDEWEB)

    McDonald, J R; Murray, R

    1999-09-01

    High winds tend to pick up and transport various objects and debris, which are referred to as wind-borne missiles or tornado missiles, depending on the type of storm. Missiles cause damage by perforating the building envelope or by collapsing structural elements such as walls, columns or frames. The primary objectives of this study are as follows: (1) to provide a basis for wind-borne or tornado missile criteria for the design and evaluation of DOE facilities, and (2) to provide guidelines for the design and evaluation of impact-resistant missile barriers for DOE facilities The first objective is accomplished through a synthesis of information from windstorm damage documentation experience and computer simulation of missile trajectories. The second objective is accomplished by reviewing the literature, which describes various missile impact tests, and by conducting a series of impact tests at a Texas Tech University facility to fill in missing information.

  20. A review of the scientific rationale and methods used in the search for other planetary systems

    Science.gov (United States)

    Black, D. C.

    1985-01-01

    Planetary systems appear to be one of the crucial links in the chain leading from simple molecules to living systems, particularly complex (intelligent?) living systems. Although there is currently no observational proof of the existence of any planetary system other than our own, techniques are now being developed which will permit a comprehensive search for other planetary systems. The scientific rationale for and methods used in such a search effort are reviewed here.

  1. Rationale for human modelling in human in the loop systems design

    OpenAIRE

    Fass, Didier; Lieber, Romain

    2009-01-01

    Human modelling in human-in-the-loop systems (HITLS) design can be a complex and dynamic endeavour. Thereby it needs a theoretical framework for grounding methods and models on verified principals and an integrative approach that takes into consideration the specificity of biological organization of living systems, according to the principles of physics, and a coherent way to organize and integrate structural and functional artificial elements. This paper focuses on the rationale of human mod...

  2. Establishing assessment scales using a novel disciplinary rationale for scientific reasoning.

    OpenAIRE

    Kind, P.

    2013-01-01

    The article argues that science assessment should change from an item-driven to a construct-driven practice and pay more attention to disciplinary scientific reasoning. It investigates assessment scales developed from a novel theoretical rationale, describing scientific reasoning as three fundamental practices (hypothesizing, experimenting, and evidence evaluation) and building on three types of knowledge (science content knowledge, procedural knowledge, and epistemic knowledge). The scale de...

  3. Sildenafil in heart failure with reactive pulmonary hypertension (Sildenafil HF) clinical trial (rationale and design)

    OpenAIRE

    Guglin, Maya; Rajagopalan, Navin; Anaya, Paul; Charnigo, Richard

    2016-01-01

    In this article, we present the rationale and design of the Sildenafil HF trial (ClinicalTrials.gov identifier: NCT02304705). We will randomize patients with heart failure and reactive pulmonary hypertension (pulmonary capillary wedge pressure > 15 mmHg, pulmonary vascular resistance > 3 Wood units) into two groups: the treatment group receiving sildenafil 20 mg 3 times a day and a matching placebo group. The duration of intervention will be 3 months. The primary outcome is 6-minute walk dist...

  4. Corporate Real Estate Unit Formation: Rationale, Industry, and Type of Unit

    OpenAIRE

    Ronald C. Rutherford; Stone, Robert W.

    1989-01-01

    This research investigates relationships between a corporation's rationale for forming a Corporate Real Estate Unit (CREU), its industry, and the type of CREU formed. Four conclusions are offered. First, there is no significant relationship between industry and the type of CREU formed. Second, relationships exist between the formation motives and the corporation's industry. Third, CREU formation by wholly owned subsidiaries is likely to be motivated by development and profits, while centraliz...

  5. Individual savings accounts for social insurance:rationale and alternative designs

    OpenAIRE

    Bovenberg, A.L.; Hansen, M.; Sorensen, P.B.

    2008-01-01

    Using Danish data, we find that about three-fourths of the taxes levied to finance public transfers actually finance benefits that redistribute income over the life cycle of individual taxpayers rather than redistribute resources across people. This finding and similar results for other countries provide a rationale for financing part of social insurance via mandatory individual savings accounts. We discuss the advantages and disadvantages of mandatory individual savings accounts for social i...

  6. A Rationale for Tying Merchants' Membership of Platforms Serving Independent Markets

    OpenAIRE

    King, Michael

    2011-01-01

    A Rationale for Tying Merchants' Membership of Platforms Serving Independent Markets. This thesis was submitted to the University of Manchester for the degree of Doctor of Social Sciences in the Faculty of Humanities by Michael King during September 2010. I analyses the effect of tying sellers' membership of a monopoly platform to membership of another platform, which operates in an otherwise competitive market. Visa's contentious use of the honour-all-cards rule to tie their debit and cr...

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

    OpenAIRE

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

    2014-01-01

    Background 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. Methods/Design LCoMotion was designed as a cluster-randomize...

  8. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial

    DEFF Research Database (Denmark)

    Sandø, Andreas; Schultz, Martin; Eugen-Olsen, Jesper;

    2016-01-01

    complications or deaths. Our aim is to determine whether measurement of the blood level of the biomarker soluble urokinase plasminogen activator receptor (suPAR) can enhance early risk stratification leading to reduced mortality, lower rate of complications, and improved patient flow in acutely admitted adult......) 2016 and ends June 6(th) 2016. The study aims to include 10.000 patients in both the interventional and control arm. The results will be presented in 2017. DISCUSSION: The present article aims to describe the design and rationale of the TRIAGE III study that will investigate whether the availability...

  9. Measurement of adolescent smoking behavior: rationale and methods.

    Science.gov (United States)

    Pechacek, T F; Murray, D M; Luepker, R V; Mittelmark, M B; Johnson, C A; Shutz, J M

    1984-03-01

    The initiation of cigarette smoking among adolescents is a health problem which has been the subject of discussion and study for many years. The evaluation of strategies to deter the adoption of smoking has long been hampered by the problems of measuring adolescent smoking behavior. Recently, interest has increased in biochemical measures of smoking under the assumption that they are more objective measures. The validity of this assumption is addressed for several ages of adolescents. This paper presents saliva thiocyanate levels, expired air carbon monoxide levels, and smoking self-reports from a sample of 2200 junior and senior high-school students. Interrelationships among the biochemical and behavioral measures are strong among the total population, ranging from 0.48 to 0.95 (Pearson r) but are much weaker at the younger age levels. Normative levels of carbon monoxide and saliva thiocyanate are presented by age (11-13, 14-15, and 16-17 years old). These data indicate that habitual smoking appears to develop in a gradual fashion and that several years may pass between initial experimentation and adult levels of smoking. Younger students consistently display lower levels of thiocyanate and carbon monoxide than older students of the same self-reported levels of smoking, suggesting that inhalation patterns may vary as a function of age or years smoking.

  10. Synergy as a rationale for phage therapy using phage cocktails

    Directory of Open Access Journals (Sweden)

    Matthew Schmerer

    2014-09-01

    Full Text Available Where phages are used to treat bacterial contaminations and infections, multiple phages are typically applied at once as a cocktail. When two or more phages in the cocktail attack the same bacterium, the combination may produce better killing than any single phage (synergy or the combination may be worse than the best single phage (interference. Synergy is of obvious utility, especially if it can be predicted a priori, but it remains poorly documented with few examples known. This study addresses synergy in which one phage improves adsorption by a second phage. It first presents evidence of synergy from an experimental system of two phages and a mucoid E. coli host. The synergy likely stems from a tailspike enzyme produced by one of the phages. We then offer mathematical models and simulations to understand the dynamics of synergy and the enhanced magnitude of bacterial control possible. The models and observations complement each other and suggest that synergy may be of widespread utility and may be predictable from easily observed phenotypes.

  11. Rationale for anti-OX40 cancer immunotherapy.

    Science.gov (United States)

    Aspeslagh, Sandrine; Postel-Vinay, Sophie; Rusakiewicz, Sylvie; Soria, Jean-Charles; Zitvogel, Laurence; Marabelle, Aurélien

    2016-01-01

    Immune checkpoint blockade with antagonistic monoclonal antibodies (mAbs) targeting B7 immunoglobulin superfamily molecules (CTLA-4, PD-1, and PD-L1) generate long lasting anti-tumour immune responses translating into clinical benefit across many cancer types. However, many patients are primarily resistant to immune checkpoint blockade -based monotherapy and many others will eventually relapse. Therefore, new immunostimulatory targets are needed to overcome primary and secondary resistance to immunotherapy. Besides the B7 co-inhibitory receptors, the tumour necrosis factor receptor superfamily contains many other immune checkpoints, which could become the next generation immunomodulators. Among them stands OX40 (CD134), a co-stimulatory molecule that can be expressed by activated immune cells. Several anti-OX40 agonistic monoclonal antibodies are currently tested in early phase cancer clinical trials. Accumulating preclinical evidence supports their clinical development. However, conflicting results and controversies between in vitro and in vivo data point to the need for comprehensive ancillary studies to be performed in upcoming clinical trials to better understand the mechanism of action of anti-OX40 mAbs-based therapy. PMID:26645943

  12. A Rationale for Age-Adapted Immunosuppression in Organ Transplantation.

    Science.gov (United States)

    Krenzien, Felix; ElKhal, Abdallah; Quante, Markus; Rodriguez Cetina Biefer, Hector; Hirofumi, Uehara; Gabardi, Steven; Tullius, Stefan G

    2015-11-01

    Demographic changes are associated with a steady increase of older patients with end-stage organ failure in need for transplantation. As a result, the majority of transplant recipients are currently older than 50 years, and organs from elderly donors are more frequently used. Nevertheless, the benefit of transplantation in older patients is well recognized, whereas the most frequent causes of death among older recipients are potentially linked to side effects of their immunosuppressants.Immunosenescence is a physiological part of aging linked to higher rates of diabetes, bacterial infections, and malignancies representing the major causes of death in older patients. These age-related changes impact older transplant candidates and may have significant implications for an age-adapted immunosuppression. For instance, immunosenescence is linked to lower rates of acute rejections in older recipients, whereas the engraftment of older organs has been associated with higher rejection rates. Moreover, new-onset diabetes mellitus after transplantation is more frequent in the elderly, potentially related to corticosteroids, calcineurin inhibitors, and mechanistic target of rapamycin inhibitors.This review presents current knowledge for an age-adapted immunosuppression based on both, experimental and clinical studies in and beyond transplantation. Recommendations of maintenance and induction therapy may help to improve graft function and to design future clinical trials in the elderly.

  13. The DAE{\\delta}ALUS Project: Rationale and Beam Requirements

    CERN Document Server

    Alonso, Jose R

    2010-01-01

    Neutrino physics focuses on huge detectors deep underground. The Sanford Lab in South Dakota will build a 300 kiloton water-Cherenkov detector 1500 meters deep for muon neutrino oscillation studies of the mass hierarchy and CP violation. This will be used by the Long Baseline experiment (LBNE) detecting few GeV neutrinos from Fermilab, 1300 km away. The DAE{\\delta}ALUS Collaboration also plans several neutrino-production sites at closer distances up to 20 km from the 300 kT detector, producing muon antineutrinos from stopped pions. The complementarity with LBNE greatly enhances results, and enthusiasm is mounting to do both experiments. DAE{\\delta}ALUS needs 0.8-1 GeV accelerators with mA proton beams. Three sites at 1.5, 8 and 20 km from the 300 kT detector require several accelerators. The cost per machine must be below 1/10 of existing megawatt-class proton machines. Beyond high power and energy, beam parameters are modest. Challenges are reliability, control of beam loss and minimizing activation. Options...

  14. Rationale and clinical data supporting nutritional intervention in Alzheimer's disease.

    Science.gov (United States)

    Engelborghs, S; Gilles, C; Ivanoiu, A; Vandewoude, M

    2014-01-01

    Adequate nutrition plays an important role in the maintenance of cognitive function, particularly during aging. Malnutrition is amongst the risk factors for developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Epidemiological studies have associated deficiencies in some nutrients with a higher risk of cognitive dysfunction and/or AD. Cognitive decline in AD is correlated with synaptic loss and many of the components required to maintain optimal synaptic function are derived from dietary sources. As synapses are part of the neuronal membrane and are continuously being remodelled, the availability of sufficient levels of nutritional precursors (mainly uridine monophosphate, choline and omega-3 fatty acids) to make the phospholipids required to build neuronal membranes may have beneficial effects on synaptic degeneration in AD. In addition, B-vitamins, phospholipids and other micronutrients act as cofactors to enhance the supply of precursors required to make neuronal membranes and synapses. Despite this, no randomized controlled trial has hitherto provided evidence that any single nutrient has a beneficial effect on cognition or lowers the risk for AD. However, a multi-target approach using combinations of (micro)nutrients might have beneficial effects on cognitive function in neurodegenerative brain disorders like AD leading to synaptic degeneration. Here we review the clinical evidence for supplementation, based on a multi-target approach with a focus on key nutrients with a proposed role in synaptic dysfunction. Based on preclinical evidence, a nutrient mixture, Souvenaid(®) (Nutricia N.V., Zoetermeer, The Netherlands) was developed. Clinical trials with Souvenaid(®) have shown improved memory performance in patients with mild AD. Further clinical trials to evaluate the effects of nutritional intervention in MCI and early dementia due to AD are on-going. PMID:24635394

  15. Performance enhancement with supplements: incongruence between rationale and practice

    Directory of Open Access Journals (Sweden)

    Mazanov Jason

    2007-11-01

    Full Text Available Abstract Background Athletes are expected to consider multiple factors when making informed decision about nutritional supplement use. Besides rules, regulations and potential health hazards, the efficacy of different nutritional supplements in performance enhancement is a key issue. The aim of this paper was to find evidence for informed decision making by investigating the relationship between specific performance-related reasons for supplement use and the reported use of nutritional supplements. Methods The 'UK Sport 2005 Drug Free Survey' data (n = 874 were re-analysed using association [χ2] and 'strength of association' tests [ϕ] to show the proportion of informed choices and to unveil incongruencies between self-reported supplement use and the underlying motives. Results Participants (n = 520 reported supplement use in the pattern of: vitamin C (70.4%, creatine (36.1%, whey protein (30.6%, iron (29.8%, caffeine (23.8%, and ginseng (8.3% for the following reasons: strength maintenance (38.1%, doctors' advice (24.2%, enhancing endurance (20.0%, ability to train longer (13.3%, and provided by the governing body (3.8%. Of thirty possible associations between the above supplements and reasons, 11 were predictable from literature precedents and only 8 were evidenced and these were not strong (ϕ 2 = 49.14, p 2 = 97.08, p 2 = 97.82, p Conclusion This study provided a platform for assessing congruence between athletes' reasons for supplement use and their actual use. These results suggest that a lack of understanding exists in supplement use. There is an urgent need to provide accurate information which will help athletes make informed choices about the use of supplements.

  16. Midcarpal hemiarthroplasty for wrist arthritis: rationale and early results.

    Science.gov (United States)

    Vance, Michael C; Packer, Greg; Tan, David; Crisco, J J Trey; Wolfe, Scott W

    2012-08-01

    Midcarpal hemiarthroplasty is a novel motion-preserving treatment for radiocarpal arthritis and is an alternative to current procedures that provide pain relief at the expense of wrist biomechanics and natural motion. It is indicated primarily in active patients with a well-preserved distal row and debilitating arthritic symptoms. By resurfacing the proximal carpal row, midcarpal arthroplasty relieves pain while preserving the midcarpal articulation and the anatomic center of wrist rotation. This technique has theoretical advantages when compared with current treatment options (i.e., arthrodesis and total wrist arthroplasty) since it provides coupled wrist motion, preserves radial length, is technically simple, and avoids the inherent risks of nonunion and distal component failure. The KinematX midcarpal hemiarthroplasty has an anatomic design and does not disrupt the integrity of the wrist ligaments. We have implanted this prosthesis in nine patients with promising early results. The indications for surgery were as follows: scapholunate advanced collapse wrist (three), posttraumatic osteoarthritis (three), inflammatory arthritis (two), and Keinböck disease (one). Prospective data has been collected and the results are preliminary given the infancy of the procedure. The mean follow-up was 30.9 weeks (range: 16 to 56 weeks). The mean Mayo wrist score increased from 31.9 preoperatively to 58.8 (p manipulation for wrist stiffness. There was no evidence of prosthetic loosening or capitolunate narrowing. The procedure is simple (average surgical time was 49 minutes) and maintains coupled wrist motion through preservation of the midcarpal articulation. The preliminary data show that it appears safe but considerably longer follow-up is required before conclusions can be drawn as to its durability, reliability, and overall success. The level of evidence for this study is therapeutic level IV (case series).

  17. Rationale and design: telepsychology service delivery for depressed elderly veterans

    Directory of Open Access Journals (Sweden)

    Richardson Lisa K

    2009-04-01

    Full Text Available Abstract Background Older adults who live in rural areas experience significant disparities in health status and access to mental health care. "Telepsychology," (also referred to as "telepsychiatry," or "telemental health" represents a potential strategy towards addressing this longstanding problem. Older adults may benefit from telepsychology due to its: (1 utility to address existing problematic access to care for rural residents; (2 capacity to reduce stigma associated with traditional mental health care; and (3 utility to overcome significant age-related problems in ambulation and transportation. Moreover, preliminary evidence indicates that telepsychiatry programs are often less expensive for patients, and reduce travel time, travel costs, and time off from work. Thus, telepsychology may provide a cost-efficient solution to access-to-care problems in rural areas. Methods We describe an ongoing four-year prospective, randomized clinical trial comparing the effectiveness of an empirically supported treatment for major depressive disorder, Behavioral Activation, delivered either via in-home videoconferencing technology ("Telepsychology" or traditional face-to-face services ("Same-Room". Our hypothesis is that in-homeTelepsychology service delivery will be equally effective as the traditional mode (Same-Room. Two-hundred twenty-four (224 male and female elderly participants will be administered protocol-driven individual Behavioral Activation therapy for depression over an 8-week period; and subjects will be followed for 12-months to ascertain longer-term effects of the treatment on three outcomes domains: (1 clinical outcomes (symptom severity, social functioning; (2 process variables (patient satisfaction, treatment credibility, attendance, adherence, dropout; and (3 economic outcomes (cost and resource use. Discussion Results from the proposed study will provide important insight into whether telepsychology service delivery is as effective

  18. Enhancing measurement in science education research through Rasch analysis: Rationale and properties

    Directory of Open Access Journals (Sweden)

    Jørgen Sjaastad

    2014-10-01

    Full Text Available This article presents the basic rationale of Rasch theory and seven core properties of Rasch modeling; analyses of test targeting, person separation, person fit, item fit, differential item functioning, functioning of response categories and tests of unidimensionality. Illustrative examples are provided consecutively, drawing on Rasch analysis of data from a survey where students in the 9th grade responded to questions regarding their mathematics competence. The relationship between Rasch theory and classical test theory is commented on. Rasch theory provides science and mathematics education researchers with valuable tools to evaluate the psychometric quality of tests and questionnaires and support the development of these.

  19. Theoretical Rationale of Heating Block for Testing Bench of Aerospace Crafts Thermal Protection Elements

    Directory of Open Access Journals (Sweden)

    Petrova Anna A.

    2016-01-01

    Full Text Available The theoretical rationale for the structural layout of a testing bench with zirconium dioxide heating elements on the basis of modelling radiative-conductive heat transfer are presented. The numerical simulation of radiative-conductive heat transfer for the two-dimensional scaled model of the testing segment with the finite-element analysis software package Ansys 15.0 are performed. The simulation results showed that for the selected layout of the heaters the temperature non-uniformity along the length of the sample over time will not exceed 3 % even at a temperature of 2000 K.

  20. Theoretical Rationale of Heating Block for Testing Bench of Aerospace Crafts Thermal Protection Elements

    Science.gov (United States)

    Petrova, Anna A.; Reznik, Sergey V.

    2016-02-01

    The theoretical rationale for the structural layout of a testing bench with zirconium dioxide heating elements on the basis of modelling radiative-conductive heat transfer are presented. The numerical simulation of radiative-conductive heat transfer for the two-dimensional scaled model of the testing segment with the finite-element analysis software package Ansys 15.0 are performed. The simulation results showed that for the selected layout of the heaters the temperature non-uniformity along the length of the sample over time will not exceed 3 % even at a temperature of 2000 K.

  1. [PCR rationale for use of oral cephalosporins by oral surgery procedures].

    Science.gov (United States)

    Tsarev, V N; Chuvilkin, V I; Akhmedov, G D; Chuvilkina, E I; Gadzhiev, F N; Nikitin, I V

    2014-01-01

    The article presents the experience of PCR detection of DNA of pathogenic germs inducing odontogenic inflammation. Pus samples of 48 patients aged 18 to 68 years undergoing oral surgery because of apical periodontal lesions and pericoronitis. The results showed microorganisms associations revealed by PCR are sensitive to III generation cephalosporins. Effective oral regimen included 400 mg Ceftibuten once daily. The PCR results thus served as a rationale for use of oral cephalosporins by oral surgery procedures proved by clinical and immunological data in postoperative period.

  2. Preliminary design specification for Department of Energy standardized spent nuclear fuel canisters. Volume 2: Rationale document

    International Nuclear Information System (INIS)

    This document (Volume 2) is a companion document to a preliminary design specification for the design of canisters to be used during the handling, storage, transportation, and repository disposal of Department of Energy (DOE) spent nuclear fuel (SNF). This document contains no procurement information, such as the number of canisters to be fabricated, explicit timeframes for deliverables, etc. However, this rationale document does provide background information and design philosophy in order to help engineers better understand the established design criteria (contained in Volume 1 respectively) necessary to correctly design and fabricate these DOE SNF canisters

  3. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized tr

    OpenAIRE

    Howard, Andrea A; Hirsch-Moverman, Yael; Frederix, Koen; Daftary, Amrita; Saito, Suzue; Gross, Tal; Wu, Yingfeng; Maama, Llang Bridget

    2016-01-01

    Background: Initiating antiretroviral therapy (ART) early during tuberculosis (TB) treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap.Objective: The Start TB Patients on ART and Retain on Treatment (START) Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package...

  4. Providing a Rationale for Promoting Argument-Based Inquiry Approach to Science Education: A Deweyan Pragmatist Aesthetics Perspective

    Directory of Open Access Journals (Sweden)

    Şevket Benhür Oral

    2012-12-01

    Full Text Available Argumentation in science education is a well-established and successful research programme. Key theoretical underpinnings of this approach come from situated cognition perspective, the theory of communicative action and the sociocultural perspective, language studies and social semiotics, philosophy of science studies, and developmental psychology. In this paper, it will be argued that all these theoretical frameworks that aim to provide a rationale for promoting argument-based inquiry approach to science education stand to benefit if their unique insights can be brought together within the theory of Deweyan pragmatist aesthetics. It is my contention that learners first need to experience the most fundamental human situation, namely, the problematic as the ontological condition of experiencing the world as a human, in carefully calibrated pedagogically appropriate settings to get the process of collaborative inquiry going. One such setting is provided by the Science Writing Heuristic (SWH, an argument-based collaborative inquiry approach to experience negotiation of meaning in relation to science content in school. It will be claimed that the SWH approach, which is an immersion-oriented argument intervention model, is successful to the extent that it enacts a learning situation whereby the process of collaborative inquiry as understood by Dewey unfolds and provides a consummatory experience for the learners as well as the teachers.

  5. History, rationale, and lessons learned: Thresholds of potential concern in Kruger National Park river adaptive management

    Directory of Open Access Journals (Sweden)

    Craig A. McLoughlin

    2011-05-01

    Full Text Available The Kruger National Park’s (KNP adopted system of management, called Strategic Adaptive Management (SAM, originated during the Kruger National Park Rivers Research Programme (KNPRRP of the 1990s. An important concept in SAM is the thresholds of potential concern (TPCs, representing end-points in a continuum of change. TPCs within the KNP SAM system guide management if or when reached, ‘red-flagging’ possible negative biodiversity impacts and catalysing consideration of management options. TPC-related monitoring generates the strategic information for ongoing evaluation, learning and adaptation within SAM. Post- KNPRRP, although river flow and water quality TPCs have been implemented partly, those designed to detect undesirable changes in biodiversity have not been implemented, until recently. This paper describes the history, rationale, application and ongoing developments associated with the KNP river TPCs over the last decade, providing some key lessons for organisations utilising SAM. The paper concludes with an overview of new thinking and future directions envisaged for the KNP river TPCs, as part of the KNP SAM system. Conservation implications: This paper documents important concepts of strategic adaptive management associated with the KNP river systems. Understanding, related to the rationale and justification for use and development or refinement of the thresholds of potential concern, lays an important foundation for ongoing work in managing these rivers adaptively.

  6. Direct renin inhibition in addition to or as an alternative to angiotensin converting enzyme inhibition in patients with chronic systolic heart failure: rationale and design of the Aliskiren Trial to Minimize OutcomeS in Patients with HEart failuRE (ATMOSPHERE) study

    DEFF Research Database (Denmark)

    Krum, Henry; Massie, Barry; Abraham, William T;

    2011-01-01

    S for Patients with HEart failuRE (ATMOSPHERE) study is to evaluate the effect of both aliskiren and enalapril monotherapy and aliskiren/enalapril combination therapy on cardiovascular death and HF hospitalization in patients with chronic systolic HF, NYHA functional class II-IV symptoms, and elevated plasma...... monotherapy, or the combination. The primary endpoints of ATMOSPHERE are (i) whether the aliskiren/enalapril combination is superior to enalapril monotherapy in delaying time to first occurrence of cardiovascular death or HF hospitalization and (ii) whether aliskiren monotherapy is superior or at least non......-inferior to enalapril monotherapy on this endpoint. Perspective The ATMOSPHERE study will definitively determine the role of a DRI strategy additional to or as an alternative to conventional RAAS blockade in patients with chronic systolic HF....

  7. Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population

    OpenAIRE

    Post, Janisse M.; Ali, Shozab S.; Roberson, Lara L.; Ehimen C Aneni; Shaharyar, Sameer; Younus, Adnan; Jamal, Omar; Ahmad, Rameez; Aziz, Muhammad A.; Malik, Rehan; Spatz, Erica S.; Feldman, Theodore; Fialkow, Jonathan; Veledar, Emir; Ricardo C Cury

    2016-01-01

    Background Metabolic syndrome (MetS) and diabetes confer a high risk for developing subsequent cardiovascular disease (CVD). Persons with MetS constitute 24–34 % of the employee population at Baptist Health South Florida (BHSF), a self-insured healthcare organization. The Baptist Employee Healthy Heart Study (BEHHS) aims to assess the addition of a personalized, interactive, web-based, nutrition-management and lifestyle-management program to the existing health-expertise web platform availabl...

  8. A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study.

    Science.gov (United States)

    Thomson, Cynthia A; Crane, Tracy E; Miller, Austin; Garcia, David O; Basen-Engquist, Karen; Alberts, David S

    2016-07-01

    Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors. PMID:27394382

  9. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX – RAdiation Dose study (RAD-MATRIX)

    Energy Technology Data Exchange (ETDEWEB)

    Sciahbasi, Alessandro, E-mail: alessandro.sciahbasi@fastwebnet.it [Interventional Cardiology, Sandro Pertini Hospital – ASL RMB, Rome (Italy); Calabrò, Paolo [Division of Cardiology - Department of Cardio-Thoracic Sciences - Second University of Naples (Italy); Sarandrea, Alessandro [HSE Management, Rome (Italy); Rigattieri, Stefano [Interventional Cardiology, Sandro Pertini Hospital – ASL RMB, Rome (Italy); Tomassini, Francesco [Department of Cardiology, Infermi Hospital, Rivoli (Italy); Sardella, Gennaro [La Sapienza University, Rome (Italy); Zavalloni, Dennis [UO Emodinamica e Cardiologia Invasiva, IRCCS, Istituto Clinico Humanitas, Rozzano (Italy); Cortese, Bernardo [Interventional Cardiology, Fatebenefratelli Hospital, Milan (Italy); Limbruno, Ugo [Cardiology Unit, Misericordia Hospital, Grosseto (Italy); Tebaldi, Matteo [Cardiology Department, University of Ferrara, Department of Cardiology (Italy); Gagnor, Andrea [Department of Cardiology, Infermi Hospital, Rivoli (Italy); Rubartelli, Paolo [Villa Scassi Hospital, Genova (Italy); Zingarelli, Antonio [San Martino Hospital, Genova (Italy); Valgimigli, Marco [Thoraxcenter, Rotterdam (Netherlands)

    2014-06-15

    Background: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. Methods: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. Conclusions: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

  10. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized trial

    Science.gov (United States)

    Howard, Andrea A.; Hirsch-Moverman, Yael; Frederix, Koen; Daftary, Amrita; Saito, Suzue; Gross, Tal; Wu, Yingfeng; Maama, Llang Bridget

    2016-01-01

    Background Initiating antiretroviral therapy (ART) early during tuberculosis (TB) treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective The Start TB Patients on ART and Retain on Treatment (START) Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP) to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho. Design Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center). The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW) for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months). Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete. Discussion The START

  11. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Andrea A. Howard

    2016-06-01

    Full Text Available Background: Initiating antiretroviral therapy (ART early during tuberculosis (TB treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective: The Start TB Patients on ART and Retain on Treatment (START Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho. Design: Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center. The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months. Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete

  12. Healthy eating for life: rationale and development of an English as a second language (ESL) curriculum for promoting healthy nutrition.

    Science.gov (United States)

    Martinez, Josefa L; Rivers, Susan E; Duncan, Lindsay R; Bertoli, Michelle; Domingo, Samantha; Latimer-Cheung, Amy E; Salovey, Peter

    2013-12-01

    Low health literacy contributes significantly to cancer health disparities disadvantaging minorities and the medically underserved. Immigrants to the United States constitute a particularly vulnerable subgroup of the medically underserved, and because many are non-native English speakers, they are pre-disposed to encounter language and literacy barriers across the cancer continuum. Healthy Eating for Life (HE4L) is an English as a second language (ESL) curriculum designed to teach English language and health literacy while promoting fruit and vegetable consumption for cancer prevention. This article describes the rationale, design, and content of HE4L. HE4L is a content-based adult ESL curriculum grounded in the health action process approach to behavior change. The curriculum package includes a soap opera-like storyline, an interactive student workbook, a teacher's manual, and audio files. HE4L is the first teacher-administered, multimedia nutrition-education curriculum designed to reduce cancer risk among beginning-level ESL students. HE4L is unique because it combines adult ESL principles, health education content, and behavioral theory. HE4L provides a case study of how evidence-based, health promotion practices can be implemented into real-life settings and serves as a timely, useful, and accessible nutrition-education resource for health educators.

  13. Economic and Risk Analyses for SMEs Internationalization Projects. A Preliminary Insight on the Rationale of Business Consulting Firms

    Directory of Open Access Journals (Sweden)

    Elena - Madalina VĂTĂMĂNESCU

    2014-06-01

    Full Text Available The present study is meant to be a first step towards the investigation of two current issues: the organization’s demand for highly professional services and the business consulting firms’ response as a challenge for the ethic imperatives. The main question raised is whether the national business consulting firms are liable to provide the economic and risk analyses required by the ambitious internationalization projects of small and medium enterprises (SMEs, and if not, what should be the firms’ ethical approach. In this respect, preliminary conclusions were made after testing the deliverables of several business consulting firms which were contracted to elaborate intricate economic and risk analyses of an internationalization project developed by a medium enterprise. The proven level of expertise of the contracted firms did not confirm their claims and assurances that they were fit for the job. This is why the rationale of today’s business consulting firms should be taken into account for further consideration while the exigency for increased savvy should become a priority.

  14. A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success.

    Science.gov (United States)

    Nwaru, Bright I; Parkkali, Saara; Abacassamo, Fatima; Salomé, Graca; Chilundo, Baltazar; Augusto, Orvalho; Cliff, Julie; Dgedge, Martinho; Regushevskaya, Elena; Nikula, Minna; Hemminki, Elina

    2015-04-01

    The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 μg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well. PMID:23020829

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    or in the vasculature. We present the rationale and study design of the Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (EFFORTLESS S-ICD) Registry which was designed to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource...

  16. Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults.

    Science.gov (United States)

    Gold, Diane R; Litonjua, Augusto A; Carey, Vincent J; Manson, JoAnn E; Buring, Julie E; Lee, I-Min; Gordon, David; Walter, Joseph; Friedenberg, Georgina; Hankinson, John L; Copeland, Trisha; Luttmann-Gibson, Heike

    2016-03-01

    Laboratory and observational research studies suggest that vitamin D and marine omega-3 fatty acids may reduce risk for pneumonia, acute exacerbations of respiratory diseases including chronic obstructive lung disease (COPD) or asthma, and decline of lung function, but prevention trials with adequate dosing, adequate power, and adequate time to follow-up are lacking. The ongoing Lung VITAL study is taking advantage of a large clinical trial-the VITamin D and OmegA-3 TriaL (VITAL)--to conduct the first major evaluation of the influences of vitamin D and marine omega-3 fatty acid supplementation on pneumonia risk, respiratory exacerbation episodes, asthma control and lung function in adults. VITAL is a 5-year U.S.-wide randomized, double-blind, placebo-controlled, 2 × 2 factorial trial of supplementation with vitamin D3 ([cholecalciferol], 2000 IU/day) and marine omega-3 FA (Omacor® fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) for primary prevention of CVD and cancer among men and women, at baseline aged ≥50 and ≥55, respectively, with 5107 African Americans. In a subset of 1973 participants from 11 urban U.S. centers, lung function is measured before and two years after randomization. Yearly follow-up questionnaires assess incident pneumonia in the entire randomized population, and exacerbations of respiratory disease, asthma control and dyspnea in a subpopulation of 4314 randomized participants enriched, as shown in presentation of baseline characteristics, for respiratory disease, respiratory symptoms, and history of cigarette smoking. Self-reported pneumonia hospitalization will be confirmed by medical record review, and exacerbations will be confirmed by Center for Medicare and Medicaid Services data review.

  17. Rationale and Design of the Dual Energy Computed Tomography for Ischemia Determination Compared to “Gold Standard” Non-invasive and Invasive Techniques (DECIDE-Gold): A Multicenter International Efficacy Diagnostic Study of Rest-Stress Dual-Energy Computed Tomography Angiography with Perfusion

    Science.gov (United States)

    Truong, Quynh A.; Knaapen, Paul; Pontone, Gianluca; Andreini, Daniele; Leipsic, Jonathon; Carrascosa, Patricia; Lu, Bin; Branch, Kelley; Raman, Subha; Bloom, Stephen; Min, James K.

    2014-01-01

    BACKGROUND Dual-energy CT (DECT) has potential to improve myocardial perfusion for physiologic assessment of coronary artery disease (CAD). Diagnostic performance of rest-stress DECT perfusion (DECTP) is unknown. OBJECTIVE DECIDE-Gold is a prospective multicenter study to evaluate the accuracy of DECT to detect hemodynamic (HD) significant CAD, as compared to fractional flow reserve (FFR) as a reference standard. METHODS Eligible participants are subjects with symptoms of CAD referred for invasive coronary angiography (ICA). Participants will undergo DECTP, which will be performed by pharmacological stress, and participants will subsequently proceed to ICA and FFR. HD-significant CAD will be defined as FFR ≥ 0.80. In those undergoing myocardial stress imaging (MPI) by positron emission tomography (PET), single photon emission computed tomography (SPECT) or cardiac magnetic resonance (CMR) imaging, ischemia will be graded by % ischemic myocardium. Blinded core laboratory interpretation will be performed for CCTA, DECTP, MPI, ICA and FFR. RESULTS Primary endpoint is accuracy of DECTP to detect ≥ 1 HD-significant stenosis at the subject-level when compared to FFR. Secondary and tertiary endpoints are accuracies of combinations of DECTP at the subject and vessel levels compared to FFR and MPI. CONCLUSION DECIDE-Gold will determine the performance of DECTP for diagnosing ischemia. PMID:25549826

  18. Tyler’s Curriculum Rationale and the Reconceptualists. Interview with Ralph W. Tyler (1902-1994

    Directory of Open Access Journals (Sweden)

    Graciela Cordero Arroyo

    2004-11-01

    Full Text Available Ralph W. Tyler was considered one of the most influential of US educators during the last century. The purpose of this paper is to present an interview granted by Tyler to the first author of this paper in 1990. Tyler’s interview is preceded by a brief analysis of his work, in the hope of shedding light on some misconceptions that Tyler’s work has suffered since early 70s. The present interview may have been the only one given to an Ibero-American academician, and one of the very few in which Tyler spoke openly about what he thought of the fierce criticism launched by reconceptualists against his curriculum rationale.

  19. 'Letting go': rationale and strategies for student-centred approaches to clinical teaching.

    Science.gov (United States)

    Rideout, E M

    1994-04-01

    To date the clinical practice portion of nursing education has tended to emphasise patient problems related to specific disease processes and the technical interventions needed to deal with those problems. Teacher-centred methods of education that place control of the process and content of learning with the teacher have seemed appropriate. However, the role and function of nursing is changing. Autonomy, independence and decision-making are more highly valued. In order that nurses develop these skills and abilities, a shift in focus in nursing education is required. This paper presents a rationale for more student-centred approaches to education. Strategies for clinical teaching will be described that emphasise collaboration between student and teacher. Suggestions designed to facilitate change in the roles of teachers and students will be offered. PMID:8177186

  20. 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...

  1. The anti-interleukin-1 in type 1 diabetes action trial--background and rationale

    DEFF Research Database (Denmark)

    Pickersgill, Linda M S; Mandrup-Poulsen, Thomas R

    2009-01-01

    Type 1 diabetes (T1D) is caused by an inflammatory destruction of pancreatic beta-cells. Pro-inflammatory cytokines, in particular interleukin-1 (IL-1), have been suggested to be effector molecules based on the observations that pro-inflammatory cytokines cause beta-cell apoptosis in vitro...... and aggravate diabetes in vivo, and that inhibition of the action of these cytokines reduce diabetes incidence in animal models of type 1 diabetes and islet graft destruction. This review presents the rationale for and design of a recently launched double-blind, multicenter, randomized clinical trial...... that investigates the effect of interleukin-1 antagonism on beta-cell function in subjects with T1D of recent-onset....

  2. Rationale for the use of radiolabelled peptides in diagnosis and therapy

    Energy Technology Data Exchange (ETDEWEB)

    Koopmans, K.P. [Martini Hospital, Department of Radiology and Nuclear Medicine, Groningen (Netherlands); Glaudemans, A.W.J.M. [University of Groningen, Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen (Netherlands)

    2012-02-15

    Nuclear medicine techniques are becoming more important in imaging oncological and infectious diseases. For metabolic imaging of these diseases, antibody and peptide imaging are currently used. In recent years peptide imaging has become important, therefore the rationale for the use of peptide imaging is described in this article. Criteria for a successful peptide tracer are a high target specificity, a high binding affinity, a long metabolic stability and a high target-to-background ratio. Tracer internalization is also beneficial. For oncological imaging, many tracers are available, most originating from regulatory peptides, but penetrating peptides are also being developed. Peptides for imaging inflammatory and infectious diseases include regulatory peptides, antimicrobial peptides and others. In conclusion, for the imaging of oncological, inflammatory and infectious diseases, many promising peptides are being developed. The ideal peptide probe is characterized by rapid and specific target localization and binding with a high tumour-to-background ratio. (orig.)

  3. The CfAO's Astronomy Course in COSMOS: Curriculum Design, Rationale, and Application

    CERN Document Server

    Cooksey, Kathy L; Porter, Jason; Raschke, Lynne; Severson, Scott; Hinkley, Sasha

    2010-01-01

    From 2001 to 2007, COSMOS provided a teaching and outreach venue for the Center for Adaptive Optics Professional Development Program (CfAO PDP). COSMOS is a four-week residential mathematics and science summer program for high-school students organized by the University of California on four of its campuses. Two topical science courses comprised each COSMOS cluster. An astronomy course has always formed a basis for the CfAO PDP-affiliated cluster. The course included a variety of pedagogical techniques to address a diversity of learners and goals. We outline the astronomy course---lectures, activities, etc.---and provide the rationale for what was taught, how it was aught, and when it was taught.

  4. The role of Amazonian anthropogenic soils in shifting cultivation: learning from farmers' rationales

    Directory of Open Access Journals (Sweden)

    André B. Junqueira

    2016-03-01

    Full Text Available We evaluated farmers' rationales to understand their decision making in relation to the use of fertile anthropogenic soils, i.e., Amazonian dark earths (ADE, and for dealing with changes in shifting cultivation in Central Amazonia. We analyzed qualitative information from 196 interviews with farmers in 21 riverine villages along the Madeira River. In order to decide about crop management options to attain their livelihood objectives, farmers rely on an integrated and dynamic understanding of their biophysical and social environment. Farmers associate fallow development with higher crop yields and lower weed pressure, but ADE is always associated with high yields and high weeding requirements. Amazonian dark earths are also seen as an opportunity to grow different crops and/or grow crops in more intensified management systems. However, farmers often maintain simultaneously intensive swiddens on ADE and extensive swiddens on nonanthropogenic soils. Farmers acknowledge numerous changes in their socioeconomic environment that affect their shifting cultivation systems, particularly their growing interaction with market economies and the incorporation of modern agricultural practices. Farmers considered that shifting cultivation systems on ADE tend to be more prone to changes leading to intensification, and we identified cases, e.g., swiddens used for watermelon cultivation, in which market demand led to overintensification and resulted in ADE degradation. This shows that increasing intensification can be a potential threat to ADE and can undermine the importance of these soils for agricultural production, for the conservation of agrobiodiversity, and for local livelihoods. Given that farmers have an integrated knowledge of their context and respond to socioeconomic and agro-ecological changes in their environment, we argue that understanding farmers' knowledge and rationales is crucial to identify sustainable pathways for the future of ADE and of

  5. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C;

    2010-01-01

    years). A questionnaire (cases and controls) is used to acquire information on known and proposed risk factors for stroke. Cardiovascular (e.g. blood pressure) and anthropometric (e.g. waist-to-hip ratio) measurements are obtained at the time of interview. Nonfasting blood samples and random urine...

  6. SOFTWARE FEASIBILITY STUDY TO TRANSFORM COMPLEX SCIENTIFIC WRITTEN KNOWLEDGE TO A CLEAR, RATIONALE AND SIMPLE LANGUAGE

    Directory of Open Access Journals (Sweden)

    Manoj Khandelwal

    2015-08-01

    Full Text Available Ali Akbar Dehkhoda, the prominent lexicographer, describes a person who has difficulty in grasping knowledge as someone who “Cannot understand something without knowing all its details.” If the knowledge required by somebody is in a language other than the person’s mother tongue, access to this knowledge will surely meet special difficulties resulting from the person’s lack of mastery over the second language. Any project that can monitor knowledge sources written in English and change them into the user’s language by employing a simple understandable model is capable of being a knowledge-based project with a world view regarding text simplification. This article creates a knowledge system, investigates some algorithms for analyzing contents of complex texts, and presents solutions for changing such texts simple and understandable ones. Texts are automatically analyzed and their ambiguous points are identified by software, but it is the author or the human agent who makes decisions concerning omission of the ambiguities or correction of the texts.

  7. Internationalization Rationales, Obstacles and Drivers: A Multiple Case Study of Spanish Higher Education Institutions

    Science.gov (United States)

    Grasset, Cristina

    2013-01-01

    This research examined the cases of three diverse Spanish universities, making inferences about the factors influencing the internationalization processes of higher education institutions in response to the broader forces of globalization. Data were collected from a panel of experts and multiple public and institutional sources utilizing a mixed…

  8. Listening to Audiences: A Brief Rationale and History of Audience Research in Popular Media Studies

    Science.gov (United States)

    Schiappa, Edward; Wessels, Emanuelle

    2007-01-01

    Popular media may be described as television, film, radio, and print media primarily offered for the purpose of entertainment. Such popular media have been the object of critical analysis for decades, both for academic scholars and popular pundits. Our focus is not on quantitative or experimental research concerning popular media effects, but…

  9. Rationale and design of the Measuring Athlete's Risk of Cardiovascular events (MARC) study

    NARCIS (Netherlands)

    Braber, T. L.; Mosterd, A.; Prakken, N. H. J.; Doevendans, P. A. F. M.; Mali, W. P. Th. M.; Backx, F. J. G.; Grobbee, D. E.; Rienks, R.; Nathoe, H. M.; Bots, M. L.; Velthuis, B. K.

    2015-01-01

    Background More than 90 % of exercise-related cardiac arrests occur in men, predominantly those aged 45 years and older with coronary artery disease (CAD) as the main cause. The current sports medical evaluation (SME) of middle-aged recreational athletes consists of a medical history, physical exami

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

    DEFF Research Database (Denmark)

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

    2009-01-01

    unknown whether a combination of metformin and insulin analogues is superior to insulin analogues alone. Nor is it known which insulin analogue regimen is the optimal. OBJECTIVE: The primary objective of this trial is to evaluate the effect of an 18-month treatment with metformin vs. placebo...... in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients. DESIGN: A randomized, stratified, multicentre trial having a 2 x 3 factorial design. The metformin part is double masked and placebo controlled. The insulin......-acting insulin analogue. RANDOMIZATION: Central randomization stratified for age (above 65 years), previous insulin treatment and treatment centre. INTERVENTIONS: Metformin 1 g x two times daily vs. placebo (approximately 475 patients vs. 475 patients) in combination with insulin detemir before bedtime...

  11. Rationale and clinical utility of the darunavir-cobicistat combination in the treatment of HIV/AIDS.

    Science.gov (United States)

    Putcharoen, Opass; Do, Tanya; Avihingsanon, Anchalee; Ruxrungtham, Kiat

    2015-01-01

    This article is to provide an update overview of cobicistat (COBI)-boosted darunavir in response to its recent approval by the US Food and Drug Administration, and inclusion as an alternative first-line regime in the 2015 treatment guidelines in the US. COBI is a relatively new non-antiretroviral cytochrome P450 3A inhibitor or pharmacoenhancer. The rationale behind COBI development was to provide an alternative to ritonavir (RTV) as a protease inhibitor pharmacoenhancer, due to associated adverse events with short- and long-term RTV use, such as gastrointestinal intolerability, drug-drug interactions, insulin resistance, lipodystrophy, and hyperlipidemia. Although in vitro studies suggest that COBI may result in a lower incidence of undesired drug-drug interactions and lipid-associated disorders than RTV, not all Phase III studies have well addressed these issues, and the data are limited. However, Phase III studies have demonstrated tolerability, noninferiority, and bioequivalence of COBI compared to RTV. Two main advantages of COBI over RTV-containing regimes have been noted as follows: 1) COBI has no anti-HIV activity; therefore, resistance to COBI as a booster in addition to protease inhibitor resistance is of little concern, allowing for COBI-containing regimes in future. 2) COBI's solubility and dissolution rate allow for co-formulated/fixed-dose combination products. Nonetheless, prior to initiating COBI-containing treatment regimens, the following should be considered: 1) COBI may increase serum creatinine levels and reduce estimated glomerular filtration rate (GFR) without affecting actual GFR; 2) potential drug-drug interaction data are insufficient, warranting caution when initiating COBI in conjunction with concomitant medication or in individuals with multiple comorbidities; 3) food plays a pivotal role in boosting darunavir exposure, warranting caution and patient education on the importance of taking COBI-containing regimens with appropriate amounts

  12. Rationale and Specifications for a Prototype, Group-Administered End-of-Unit Assessment Instrument for the SWRL Reading Program.

    Science.gov (United States)

    Okada, Masahito; Besel, Ronald

    This document describes the purposes, rationale, and specifications of a prototype group-administered criterion exercise to be used with blocks 1-8 of the Southwest Regional Laboratory (SWRL) Reading Program. A description of the sampling domains, sampling procedures, and the methods employed in the construction of test items is presented. Also…

  13. The Rationale for Subsidy of Higher Education in Hong Kong: A Sensible Decision from an Economic Viewpoint

    Science.gov (United States)

    Chan, Shing Yin Amy

    2010-01-01

    This paper is an attempt to draw the statistical data from reports and documents to reveal the rationale for subsidizing the higher education in Hong Kong. There is a discussion made with reference to educational planning interacting with personal choice. The notion of economics has been noted with consideration of allocation of scarce resources…

  14. The Effects of an Aversive Stimulus, a Rationale, and Sex of Child on Punishment Effectiveness and Generalization

    Science.gov (United States)

    LaVoie, Joseph C.

    1973-01-01

    Punisher effectiveness and generalization of an aversive stimulus, a rationale, and a combination of the two were investigated in a laboratory analog designed for punishment research, with 80 first and second grade subjects. Significantly greater suppression of deviant behavior and punishment generalization occurred when the punisher consisted of…

  15. Subsidizing Early Childhood Education and Care for Parents on Low Income: Moving beyond the Individualized Economic Rationale of Neoliberalism

    Science.gov (United States)

    Simpson, Donald; Envy, Rose

    2015-01-01

    Neoliberalism and an associated "new politics of parenting" adopts a predominantly economic rationale which discursively positions early childhood education and care (ECEC) as essential to tackling several social ills by allowing individual parents (particularly young mothers) to improve their labour force participation, thus boosting…

  16. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    Directory of Open Access Journals (Sweden)

    Burke Kylie

    2010-08-01

    Full Text Available Abstract Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a

  17. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

    Directory of Open Access Journals (Sweden)

    Matos Margarida G

    2008-07-01

    Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self

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

    Science.gov (United States)

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

    2015-01-01

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

  19. The rationale behind small food store interventions in low-income urban neighborhoods: insights from New Orleans.

    Science.gov (United States)

    Bodor, J Nicholas; Ulmer, Vanessa M; Dunaway, Lauren Futrell; Farley, Thomas A; Rose, Donald

    2010-06-01

    Environmental approaches to the obesity problem in the US have garnered favor due to growing evidence that changes to the environment are at the root of the epidemic. Low-income urban neighborhoods, where obesity rates are disproportionately high, typically lack supermarkets yet have a high density of small food stores. This may increase the risk for unhealthy diets and obesity for neighborhood residents, because small stores carry mostly energy-dense foods and few fruits and vegetables. This paper pulls together various studies and pilot work conducted in New Orleans to explore the rationale behind small store interventions. Many low-income residents in New Orleans live within walking distance of small food stores and shop at them frequently. Marketing research has documented that changes to in-store shelf space and displays of specific foods affect the sales of these foods. Initiatives in New Orleans and elsewhere have demonstrated some success with improving healthy food availability in small stores, and an intercept survey of customers at small stores suggests that customers would purchase more fruits and vegetables if available. Efforts to encourage small store operators to offer a healthier mix of foods may, in the end, depend on the profitability of such changes. Evidence from a typical small store in New Orleans indicates that a greater percentage of gross profits come from snack foods and beverages than from fruits and vegetables. More research is needed to better understand the financial operations of small food stores and whether altering the mix of foods is economically feasible. PMID:20410086

  20. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    NARCIS (Netherlands)

    Norden, A.G.W. van; Laat, K.F. de; Gons, R.A.R.; Uden, I.W.M. van; Dijk, E.J. van; Oudheusden, L.J. van; Esselink, R.A.J.; Bloem, B.R.; Engelen, B.G. van; Zwarts, M.J.; Tendolkar, I.; Olde-Rikkert, M.G.M.; Vlugt, M.J. van der; Zwiers, M.P.; Norris, D.G.; Leeuw, F.E. de

    2011-01-01

    BACKGROUND: Cerebral small vessel disease (SVD) is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects wit

  1. 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

  2. Analysis and evaluation of the rationales for single-sex schooling.

    Science.gov (United States)

    Bigler, Rebecca S; Hayes, Amy Roberson; Liben, Lynn S

    2014-01-01

    Amendments passed as part of the No Child Left Behind Act in 2006 made some forms of single-sex (SS) public education legal in the United States. Proponents offer a host of arguments in favor of such schooling. This chapter identifies and evaluates five broad rationales for SS schooling. We conclude that empirical evidence fails to support proponents' claims but nonetheless suggests ways in which to improve coeducation. Specifically, we (a) show that the purported benefits of SS schooling arise from factors confounded with, but not causally linked to, single-sex composition; (b) challenge claims that biological sex is an effective marker of differences relevant to instruction; (c) argue that sexism on the part of teachers and peers persists in SS contexts; and (d) critique the notion that gender per se "disappears" in SS contexts. We also address societal implications of the use of sex-segregated education and conclude that factors found to be beneficial for students should be implemented within coeducational schools. PMID:25344998

  3. Analysis and evaluation of the rationales for single-sex schooling.

    Science.gov (United States)

    Bigler, Rebecca S; Hayes, Amy Roberson; Liben, Lynn S

    2014-01-01

    Amendments passed as part of the No Child Left Behind Act in 2006 made some forms of single-sex (SS) public education legal in the United States. Proponents offer a host of arguments in favor of such schooling. This chapter identifies and evaluates five broad rationales for SS schooling. We conclude that empirical evidence fails to support proponents' claims but nonetheless suggests ways in which to improve coeducation. Specifically, we (a) show that the purported benefits of SS schooling arise from factors confounded with, but not causally linked to, single-sex composition; (b) challenge claims that biological sex is an effective marker of differences relevant to instruction; (c) argue that sexism on the part of teachers and peers persists in SS contexts; and (d) critique the notion that gender per se "disappears" in SS contexts. We also address societal implications of the use of sex-segregated education and conclude that factors found to be beneficial for students should be implemented within coeducational schools.

  4. Mindfulness-based stress reduction for veterans exposed to military sexual trauma: rationale and implementation considerations.

    Science.gov (United States)

    Gallegos, Autumn M; Cross, Wendi; Pigeon, Wilfred R

    2015-06-01

    Military sexual trauma (MST) represents a significant public health concern among military personnel and Veterans and is associated with considerable morbidity and suicide risk. It is estimated that 22% of Veteran women and 1% of Veteran men experienced sexual assault or repeated, threatening sexual harassment during their military service. Exposure to traumatic stress has detrimental effects on emotion regulation, which refers to a set of strategies used to modulate different components of emotion at different points on the trajectory of an emotional response. Mindfulness-based interventions offer approaches to health that focus on mind and body practices that can help regulate the experience and expression of difficult emotions. Mindfulness-based stress reduction (MBSR) is an evidence-based therapy shown to be effective for depression, anxiety, and post-traumatic stress disorder. This article discusses the rationale for providing MBSR to Veterans who have been exposed to MST. The article also discusses ways to facilitate implementation of this practice in the U.S. Department of Veterans Affairs health care system. We address potential barriers to care and ways to facilitate implementation at the patient, provider, organization/local, and policy levels. MBSR is likely to be an important component of a comprehensive approach to care for Veterans exposed to MST. PMID:26032384

  5. The rationale for simple approaches for sustainability assessment and management in contaminated land practice.

    Science.gov (United States)

    Bardos, R Paul; Bone, Brian D; Boyle, Richard; Evans, Frank; Harries, Nicola D; Howard, Trevor; Smith, Jonathan W N

    2016-09-01

    The scale of land-contamination problems, and of the responses to them, makes achieving sustainability in contaminated land remediation an important objective. The Sustainable Remediation Forum in the UK (SuRF-UK) was established in 2007 to support more sustainable remediation practice in the UK. The current international interest in 'sustainable remediation' has achieved a fairly rapid consensus on concepts, descriptions and definitions for sustainable remediation, which are now being incorporated into an ISO standard. However the sustainability assessment methods being used remain diverse with a range of (mainly) semi-quantitative and quantitative approaches and tools developed, or in development. Sustainability assessment is site specific and subjective. It depends on the inclusion of a wide range of considerations across different stakeholder perspectives. Taking a tiered approach to sustainability assessment offers important advantages, starting from a qualitative assessment and moving through to semi-quantitative and quantitative assessments on an 'as required' basis only. It is also clear that there are a number of 'easy wins' that could improve performance against sustainability criteria right across the site management process. SuRF-UK has provided a checklist of 'sustainable management practices' that describes some of these. This paper provides the rationale for, and an outline of, and recently published SuRF-UK guidance on preparing for and framing sustainability assessments; carrying out qualitative sustainability assessment; and simple good management practices to improve sustainability across contaminated land management activities. PMID:26765509

  6. Point: The rationale for universal lipid screening and treatment in children.

    Science.gov (United States)

    Benuck, Irwin

    2015-01-01

    Screening a healthy population for future harmful diseases has the potential of reducing the risk of later morbidity and mortality with early identification and intervention. However, it is important that the screening meets acceptable standards, and the benefits of the screening outweigh risks. The recently published "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents" (National Heart Lung Blood Institute Guidelines) carefully examined the multiple risk factors for coronary artery disease that begins in childhood but may not become problematic until years later. The evidence-based guidelines give many recommendations that are focused on identification, prevention, and intervention. Included in the guidelines are useful suggestions for improving lifestyle and food choices. In the section on lipids and lipoprotein, careful consideration was given to universal screening of children between 9 and 11 years of age with no known cardiac risk factors and again, if needed, between 17 and 21 years of age. Children with cardiac risk factors may be screened earlier. The section continues with rationale for medical management of children who are refractory to other interventions. The purpose of this article is to discuss the benefits of screening for dyslipidemia in the pediatric population and when necessary, medical management to reduce the risk for coronary artery disease. Both universal screening and early intervention in the pediatric population will identify individuals not previously recognized at risk for premature coronary artery disease and stroke and reduce the incidence of later morbidity and mortality. PMID:26343217

  7. Residents' Yard Choices and Rationales in a Desert City: Social Priorities, Ecological Impacts, and Decision Tradeoffs

    Science.gov (United States)

    Larson, Kelli L.; Casagrande, David; Harlan, Sharon L.; Yabiku, Scott T.

    2009-11-01

    As a dominant land use in urban ecosystems, residential yards impact water and other environmental resources. Converting thirsty lawns into alternative landscapes is one approach to water conservation, yet barriers such as cultural norms reinforce the traditional lawn. Meanwhile, the complex social and ecological implications of yard choices complicate programs aimed at changing grass and other yard features for particular purposes. In order to better understand individual landscape decisions, we qualitatively examined residents’ rationales for their preferred yard types in the desert metropolis of Phoenix, Arizona. After briefly presenting landscape choices across two survey samples, the dominant reasons for preferences are discussed: appearance, maintenance, environment, recreation, microclimate, familiarity, and health/safety. Three broader analytical themes emerged from these descriptive codes: (1) residents’ desires for attractive, comfortable landscapes of leisure encompassing pluralistic tastes, lifestyles, and perceptions; (2) the association of environmental benefits and impacts with different landscape types involving complex social and ecological tradeoffs; and (3) the cultural legacies evident in modern landscape choices, especially in terms of a dichotomous human-nature worldview among long-time residents of the Phoenix oasis. Given these findings, programs aimed at landscape change must recognize diverse preferences and rationalization processes, along with the perceived versus actual impacts and tradeoffs of varying yard alternatives.

  8. Intraperitoneal Gemcitabine Chemotherapy Treatment for Patients with Resected Pancreatic Cancer: Rationale and Report of Early Data

    Directory of Open Access Journals (Sweden)

    Paul H. Sugarbaker

    2011-01-01

    Full Text Available Currently, the surgical management of pancreas cancer is recognized around the world as inadequate. Despite a potentially curative R0 resection, long-term survival is rare. There is a strong rationale for the use of chemotherapy in the operating room to reduce local-regional of recurrent/progressive disease. Gemcitabine monotherapy administered by an intraperitoneal route in the operating room with hyperthermia and then for long-term treatment postoperatively has a pharmacologic basis in that the exposure of peritoneal surfaces to intraperitoneal gemcitabine is approximately 200–500 times the exposure that occurs within the plasma. A standardized treatment with intraoperative and long-term chemotherapy that is well tolerated would greatly facilitate further improvements in pancreas cancer treatment and may lead the way to an evolution of more successful treatment strategies of this dread disease. The aim of this paper is to present the early data on a protocol in progress in patients with resected pancreatic cancer.

  9. Employment self-disclosure of postsecondary graduates with learning disabilities: rates and rationales.

    Science.gov (United States)

    Madaus, Joseph W; Foley, Teresa E; McGuire, Joan M; Ruban, Lilia M

    2002-01-01

    One hundred thirty-two graduates with learning disabilities (LD) of a large, public, competitive postsecondary institution were surveyed to determine if they had self-disclosed their LD to their current employer and to provide the reasons for choosing to self-disclose or not to self-disclose. Based on a response rate of 67.4% (n = 89), the results indicated that 86.5% of the respondents were employed full time. Although nearly 90% of the respondents stated that their LD affected their work in some way, only 30.3% self-disclosed to their employer. Of those who had not self-disclosed, the majority reported that there was no reason or need to self-disclose. However, 46.1% reported not self-disclosing due to fear of a potentially negative impact in the workplace or due to a concern for job security. Specific rationales for disclosure and information related to the use of self-reported accommodations and strategies are presented.

  10. Rationale for the Use of CAD/CAM Technology in Implant Prosthodontics

    Science.gov (United States)

    Abduo, Jaafar; Lyons, Karl

    2013-01-01

    Despite the predictable longevity of implant prosthesis, there is an ongoing interest to continue to improve implant prosthodontic treatment and outcomes. One of the developments is the application of computer-aided design and computer-aided manufacturing (CAD/CAM) to produce implant abutments and frameworks from metal or ceramic materials. The aim of this narrative review is to critically evaluate the rationale of CAD/CAM utilization for implant prosthodontics. To date, CAD/CAM allows simplified production of precise and durable implant components. The precision of fit has been proven in several laboratory experiments and has been attributed to the design of implants. Milling also facilitates component fabrication from durable and aesthetic materials. With further development, it is expected that the CAD/CAM protocol will be further simplified. Although compelling clinical evidence supporting the superiority of CAD/CAM implant restorations is still lacking, it is envisioned that CAD/CAM may become the main stream for implant component fabrication. PMID:23690778

  11. Rationale for the Use of CAD/CAM Technology in Implant Prosthodontics

    Directory of Open Access Journals (Sweden)

    Jaafar Abduo

    2013-01-01

    Full Text Available Despite the predictable longevity of implant prosthesis, there is an ongoing interest to continue to improve implant prosthodontic treatment and outcomes. One of the developments is the application of computer-aided design and computer-aided manufacturing (CAD/CAM to produce implant abutments and frameworks from metal or ceramic materials. The aim of this narrative review is to critically evaluate the rationale of CAD/CAM utilization for implant prosthodontics. To date, CAD/CAM allows simplified production of precise and durable implant components. The precision of fit has been proven in several laboratory experiments and has been attributed to the design of implants. Milling also facilitates component fabrication from durable and aesthetic materials. With further development, it is expected that the CAD/CAM protocol will be further simplified. Although compelling clinical evidence supporting the superiority of CAD/CAM implant restorations is still lacking, it is envisioned that CAD/CAM may become the main stream for implant component fabrication.

  12. The Rationale for a Teaching Innovation About the Interrelationship Between Science and Technology

    Science.gov (United States)

    Hadjilouca, R.; Constantinou, C. P.; Papadouris, N.

    2011-10-01

    This paper refers to the development of a teaching innovation for the nature of science (NOS), for students aged 11-15, which specifically focuses on the interrelationship between science and technology. The development of the teaching and learning materials relied on inputs from three sources: the history and philosophy of science and technology, existing knowledge concerning the teaching and learning about the NOS, empirical data on students' initial ideas and difficulties about this topic. The first served to provide an account for the various forms of interaction between science and technology, which, in turn, guided the formulation of epistemologically coherent learning objectives. The second provided the pedagogical grounds on which to base the design of the activities. The third facilitated the design of activities that build on students' productive initial ideas, while providing them with guidance to resolve the difficulties they tend to encounter. In this paper, we describe the rationale underlying the teaching and learning materials and we describe the activity sequence they embody.

  13. NESC Peer-Review of the Flight Rationale for Expected Debris Report. Version 1.0

    Science.gov (United States)

    Harris, Charles E.; Raju, Ivatury S.; Stadler, John H.; Piascik, Robert S.; Kramer-White, Julie A.; Labbe, Steve G.; Ungar, Eugene K.; Rotter, Hank A.; Rogers, James H.; Null, Cynthia H.

    2005-01-01

    Since the loss of Columbia on February 1, 2003, the Space Shuttle Program (SSP) has significantly improved the understanding of launch and ascent debris, implemented hardware modifications to reduce debris, and conducted tests and analyses to understand the risks associated with expected debris. The STS-114 flight rationale for expected debris relies on a combination of all three of these factors. A number of design improvements have been implemented to reduce debris at the source. The External Tank (ET) thermal protection system (TPS) foam has been redesigned and/or process improvements have been implemented in the following locations: the bipod closeout, the first ten feet of the liquid hydrogen (LH2) tank protuberance air load (PAL) ramp, and the LH2 tank-to-intertank flange closeout. In addition, the forward bipod ramp has been eliminated and heaters have been installed on the bipod fittings and the liquid oxygen (LO2) feedline forward bellows to prevent ice formation. The Solid Rocket Booster (SRB) bolt catcher has been redesigned. The Orbiter reaction control system (RCS) thruster cover "butcher paper" has been replaced with a material that sheds at a low velocity. Finally, the pad area has been cleaned to reduce debris during lift-off.

  14. The rationale for simple approaches for sustainability assessment and management in contaminated land practice.

    Science.gov (United States)

    Bardos, R Paul; Bone, Brian D; Boyle, Richard; Evans, Frank; Harries, Nicola D; Howard, Trevor; Smith, Jonathan W N

    2016-09-01

    The scale of land-contamination problems, and of the responses to them, makes achieving sustainability in contaminated land remediation an important objective. The Sustainable Remediation Forum in the UK (SuRF-UK) was established in 2007 to support more sustainable remediation practice in the UK. The current international interest in 'sustainable remediation' has achieved a fairly rapid consensus on concepts, descriptions and definitions for sustainable remediation, which are now being incorporated into an ISO standard. However the sustainability assessment methods being used remain diverse with a range of (mainly) semi-quantitative and quantitative approaches and tools developed, or in development. Sustainability assessment is site specific and subjective. It depends on the inclusion of a wide range of considerations across different stakeholder perspectives. Taking a tiered approach to sustainability assessment offers important advantages, starting from a qualitative assessment and moving through to semi-quantitative and quantitative assessments on an 'as required' basis only. It is also clear that there are a number of 'easy wins' that could improve performance against sustainability criteria right across the site management process. SuRF-UK has provided a checklist of 'sustainable management practices' that describes some of these. This paper provides the rationale for, and an outline of, and recently published SuRF-UK guidance on preparing for and framing sustainability assessments; carrying out qualitative sustainability assessment; and simple good management practices to improve sustainability across contaminated land management activities.

  15. The Danish Alzheimer intervention study

    DEFF Research Database (Denmark)

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

    2011-01-01

    Background: 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 characteri......Background: 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...

  16. Money Laundering, Corruption and Growth: An Empirical Rationale for a Global Convergence on Anti-Money Laundering Regulation

    OpenAIRE

    Cavalcante Veiga, Luiz Humberto; de Andrade, Joaquim Pinto

    2006-01-01

    This paper provides empirical evidence on the impact of anti-money laundering regulations on growth and, it examines the rationale for a global adoption of these rules. The empirical results have led us to confirm a positive relation between low corruption levels and high investment and growth. We approached the impact on growth of money laundering prevention (MLP) initiatives in two ways: first, by verifying that the existence of these initiatives affects the perception of corruption. Second...

  17. Mesopancreas: A boundless structure, namely the rationale for dissection of the paraaortic area in pancreaticoduodenectomy for pancreatic head carcinoma

    OpenAIRE

    Peparini, Nadia

    2015-01-01

    This review highlights the rationale for dissection of the 16a2 and 16b1 paraaortic area during pancreaticoduodenectomy (PD) for carcinoma of the head of the pancreas. Recent advances in surgical anatomy of the mesopancreas indicate that the retropancreatic area is not a single entity with well defined boundaries but an anatomical site of embryological fusion of peritoneal layers, and that continuity exists between the neuro lymphovascular adipose tissues of the retropancreatic and paraaortic...

  18. Rationale and clinical utility of the darunavir–cobicistat combination in the treatment of HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Putcharoen O

    2015-10-01

    Full Text Available Opass Putcharoen,1 Tanya Do,2 Anchalee Avihingsanon,2 Kiat Ruxrungtham1,2 1Department of Medicine, Faculty of Medicine, Chulalongkorn University, 2The HIV Netherlands Australia Thailand (HIV-NAT Research Collaboration, The Thai Red Cross AIDS Research Center, Bangkok, Thailand Abstract: This article is to provide an update overview of cobicistat (COBI-boosted darunavir in response to its recent approval by the US Food and Drug Administration, and inclusion as an alternative first-line regime in the 2015 treatment guidelines in the US. COBI is a relatively new non-antiretroviral cytochrome P450 3A inhibitor or pharmacoenhancer. The rationale behind COBI development was to provide an alternative to ritonavir (RTV as a protease inhibitor pharmacoenhancer, due to associated adverse events with short- and long-term RTV use, such as gastrointestinal intolerability, drug–drug interactions, insulin resistance, lipodystrophy, and hyperlipidemia. Although in vitro studies suggest that COBI may result in a lower incidence of undesired drug–drug interactions and lipid-associated disorders than RTV, not all Phase III studies have well addressed these issues, and the data are limited. However, Phase III studies have demonstrated tolerability, noninferiority, and bioequivalence of COBI compared to RTV. Two main advantages of COBI over RTV-containing regimes have been noted as follows: 1 COBI has no anti-HIV activity; therefore, resistance to COBI as a booster in addition to protease inhibitor resistance is of little concern, allowing for COBI-containing regimes in future. 2 COBI’s solubility and dissolution rate allow for co-formulated/fixed-dose combination products. Nonetheless, prior to initiating COBI-containing treatment regimens, the following should be considered: 1 COBI may increase serum creatinine levels and reduce estimated glomerular filtration rate (GFR without affecting actual GFR; 2 potential drug–drug interaction data are insufficient

  19. The Survey of the Health of Wisconsin (SHOW, a novel infrastructure for population health research: rationale and methods

    Directory of Open Access Journals (Sweden)

    Friedman Elliot M

    2010-12-01

    Full Text Available Abstract Background Evidence-based public health requires the existence of reliable information systems for priority setting and evaluation of interventions. Existing data systems in the United States are either too crude (e.g., vital statistics, rely on administrative data (e.g., Medicare or, because of their national scope (e.g., NHANES, lack the discriminatory power to assess specific needs and to evaluate community health activities at the state and local level. This manuscript describes the rationale and methods of the Survey of the Health of Wisconsin (SHOW, a novel infrastructure for population health research. Methods/Design The program consists of a series of independent annual surveys gathering health-related data on representative samples of state residents and communities. Two-stage cluster sampling is used to select households and recruit approximately 800-1,000 adult participants (21-74 years old each year. Recruitment and initial interviews are done at the household; additional interviews and physical exams are conducted at permanent or mobile examination centers. Individual survey data include physical, mental, and oral health history, health literacy, demographics, behavioral, lifestyle, occupational, and household characteristics as well as health care access and utilization. The physical exam includes blood pressure, anthropometry, bioimpedance, spirometry, urine collection and blood draws. Serum, plasma, and buffy coats (for DNA extraction are stored in a biorepository for future studies. Every household is geocoded for linkage with existing contextual data including community level measures of the social and physical environment; local neighborhood characteristics are also recorded using an audit tool. Participants are re-contacted bi-annually by phone for health history updates. Discussion SHOW generates data to assess health disparities across state communities as well as trends on prevalence of health outcomes and

  20. The relevance of WHO injury surveillance guidelines for evaluation: learning from the aboriginal community-centered injury surveillance system (ACCISS) and two institution-based systems

    OpenAIRE

    Auer Anna M; Dobmeier Teresa M; Haglund Bo JA; Tillgren Per

    2011-01-01

    Abstract Background Over the past three decades, the capacity to develop and implement injury surveillance systems (ISS) has grown worldwide and is reflected by the diversity of data gathering environments in which ISS operate. The capacity to evaluate ISS, however, is less advanced and existing evaluation guidelines are ambiguous. Furthermore, the applied relevance of these guidelines to evaluate ISS operating in various settings is unclear. The aim of this paper was to examine how the World...

  1. Rationale, design, methodology and hospital characteristics of the first gulf acute heart failure registry (gulf care

    Directory of Open Access Journals (Sweden)

    Kadhim J Sulaiman

    2014-01-01

    Full Text Available Background: There is paucity of data on heart failure (HF in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE. Materials and Methods: Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF. The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. Results: A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain participated in the project. The majority of hospitals were community hospitals (46%; 22/47 followed by non-University teaching (32%; 15/47 and University hospitals (17%. Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47 with 59% (28/47 having catheterization laboratory facilities. However, only 29% (14/47 had a dedicated HF clinic facility. Most patients (71% were cared for by a cardiologist. Conclusions: Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden

  2. The analysis and rationale behind the upgrading of existing standard definition thermal imagers to high definition

    Science.gov (United States)

    Goss, Tristan M.

    2016-05-01

    With 640x512 pixel format IR detector arrays having been on the market for the past decade, Standard Definition (SD) thermal imaging sensors have been developed and deployed across the world. Now with 1280x1024 pixel format IR detector arrays becoming readily available designers of thermal imager systems face new challenges as pixel sizes reduce and the demand and applications for High Definition (HD) thermal imaging sensors increases. In many instances the upgrading of existing under-sampled SD thermal imaging sensors into more optimally sampled or oversampled HD thermal imaging sensors provides a more cost effective and reduced time to market option than to design and develop a completely new sensor. This paper presents the analysis and rationale behind the selection of the best suited HD pixel format MWIR detector for the upgrade of an existing SD thermal imaging sensor to a higher performing HD thermal imaging sensor. Several commercially available and "soon to be" commercially available HD small pixel IR detector options are included as part of the analysis and are considered for this upgrade. The impact the proposed detectors have on the sensor's overall sensitivity, noise and resolution is analyzed, and the improved range performance is predicted. Furthermore with reduced dark currents due to the smaller pixel sizes, the candidate HD MWIR detectors are operated at higher temperatures when compared to their SD predecessors. Therefore, as an additional constraint and as a design goal, the feasibility of achieving upgraded performance without any increase in the size, weight and power consumption of the thermal imager is discussed herein.

  3. A rationale for maintaining the double containment requirement for plutonium shipments

    Energy Technology Data Exchange (ETDEWEB)

    Channell, James K. [Environmental Evaluation Group, Albuquerque, NM (US); Anastas, George [Environmental Evaluation Group, Albuquerque, NM (US)

    2003-12-31

    Current U.S. Nuclear Regulatory Commission (NRC) transportation regulations (10 CFR 71.63 (b)) require that all shipments containing more than 20 curies of plutonium must be transported in packages that provide double containment. On April 30, 2002 the NRC issued a proposed rule that would eliminate §71.63(b) and the double containment requirement. NRC’s reasons for proposing elimination of §71.63(b) are: (1) compatibility with International Atomic Energy Agency Transportation Safety Standards (which do not have the requirement); (2) the current rule is inconsistent with the A1/A2 system since it applies only to plutonium; (3) double containment causes a heavier package and results in higher transportation costs; (4) the separate inner containment results in additional radiation exposure; and (5) while there would be additional protection from a separate inner container in an accident; this type of approach is not “risk informed nor performance based.” The Environmental Evaluation Group (EEG) has been a proponent of the double containment requirement for the Waste Isolation Pilot Plant (WIPP) shipments for twenty years. This requirement affects shipments to WIPP much more than any other current or planned shipping campaign because reactor fuel elements, metal or metal alloy, and vitrified high-level waste are exempt from §71.63(b). EEG submitted comments on the Proposed Rule on July 26, 2002 (Appendix C). This report is an update and expansion of the July 26, 2002 comments. Actual WIPP experience with shipments in the double contained TRUPACT-II package is used to respond to NRC arguments for deletion of §71.63(b) and offers a rationale for maintaining the current requirement.

  4. Rationale and operational plan to upgrade the U.S. gravity database

    Science.gov (United States)

    Hildenbrand, Thomas G.; Briesacher, Allen; Flanagan, Guy; Hinze, William J.; Hittelman, A.M.; Keller, Gordon R.; Kucks, R.P.; Plouff, Donald; Roest, Walter; Seeley, John; Stith, David A.; Webring, Mike

    2002-01-01

    A concerted effort is underway to prepare a substantially upgraded digital gravity anomaly database for the United States and to make this data set and associated usage tools available on the internet. This joint effort, spearheaded by the geophysics groups at the National Imagery and Mapping Agency (NIMA), University of Texas at El Paso (UTEP), U.S. Geological Survey (USGS), and National Oceanic and Atmospheric Administration (NOAA), is an outgrowth of the new geoscientific community initiative called Geoinformatics (www.geoinformaticsnetwork.org). This dominantly geospatial initiative reflects the realization by Earth scientists that existing information systems and techniques are inadequate to address the many complex scientific and societal issues. Currently, inadequate standardization and chaotic distribution of geoscience data, inadequate accompanying documentation, and the lack of easy-to-use access tools and computer codes for analysis are major obstacles for scientists, government agencies, and educators. An example of the type of activities envisioned, within the context of Geoinformatics, is the construction, maintenance, and growth of a public domain gravity database and development of the software tools needed to access, implement, and expand it. This product is far more than a high quality database; it is a complete data system for a specific type of geophysical measurement that includes, for example, tools to manipulate the data and tutorials to understand and properly utilize the data. On August 9, 2002, twenty-one scientists from the federal, private and academic sectors met at a workshop to discuss the rationale for upgrading both the United States and North American gravity databases (including offshore regions) and, more importantly, to begin developing an operational plan to effectively create a new gravity data system. We encourage anyone interested in contributing data or participating in this effort to contact G.R. Keller or T.G. Hildenbrand

  5. The Practicum in Preservice Teacher Education: A Review of Empirical Studies

    Science.gov (United States)

    Cohen, Esther; Hoz, Ron; Kaplan, Haya

    2013-01-01

    This literature review presents a systematic analysis of 113 empirical studies conducted between 1996 and 2009, portraying a picture of the rationales, goals, activities, roles, and outcomes in the different practicum settings in teacher education programs. The review shows that the rationale, goals, and activities in the different practicum…

  6. Identification of potentially safe promising fungal cell factories for the production of polyketide natural food colorants using chemotaxonomic rationale

    DEFF Research Database (Denmark)

    Mapari, Sameer Shamsuddin; Meyer, Anne S.; Thrane, Ulf;

    2009-01-01

    Background: Colorants derived from natural sources look set to overtake synthetic colorants in market value as manufacturers continue to meet the rising demand for clean label ingredients-particularly in food applications. Many ascomycetous fungi naturally synthesize and secrete pigments and thus...... chemical diversity and biodiversity of ascomycetous fungi. This rationale could be very handy for the selection of potentially safe fungal cell factories not only for polyketide pigments but also for the other industrially important polyketides; the molecular and genetic basis for the biosynthesis of which...

  7. [Phosphate binders in renal patients: a point estimate from rationale, through evidences to the real world setting].

    Science.gov (United States)

    Galassi, Andrea; Giovenzana, Maria Enrica; Galbiati, Eleonora; Auricchio, Sara; Colzani, Sara; Scanziani, Renzo

    2016-01-01

    Phosphate binders represent a common intervention in renal patients affected by chronic kidney disease and mineral bone disorder (CKD-MBD). Although counteracting P overload through binders adoption is argued by a physiology-driven approach, the efficacy of this intervention on hard endpoints remains poorly evident. The inconsistencies between rationale and methodological weakness, concerning the clinical relevance of P binding in chronic kidney disease, will be herein discussed with special focus on the need of a multi-factorial treatment against CKD-MBD, which is currently more achievable due to the variety of P binders and the rapid evolution of nutritional therapy, dialysis techniques and nursing science. PMID:27545626

  8. Planning for countering nuclear terrorism. Chapter 1. Motivation and redirection: rationale and achievements in the russian closed nuclear cities

    International Nuclear Information System (INIS)

    The non-proliferation rationale and achievements of the collaboration between the UK and Russia for a personnel redirection programme in the Closed Nuclear Cities is described. A framework for the interaction between demand and supply dimensions of proliferation threats is developed to show how redirection programmes to enable WMD (weapons of mass destruction) specialists move into civilian activities reduce these same threats. Early results from the UK-Russia Closed Nuclear Cities Partnership are presented and compared with the parallel US funded Nuclear Cities Initiative and similar local economic development measures

  9. 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.

  10. Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: the Weight-Wise II Program.

    Science.gov (United States)

    Samuel-Hodge, Carmen D; Garcia, Beverly A; Johnston, Larry F; Kraschnewski, Jennifer L; Gustafson, Alison A; Norwood, Arnita F; Glasgow, Russell E; Gold, Alison D; Graham, John W; Evenson, Kelly R; Stearns, Sally C; Gizlice, Ziya; Keyserling, Thomas C

    2012-01-01

    Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes of translation using the RE-AIM framework, use of an evidence-based weight loss intervention, a detailed description of participant recruitment and representativeness, and a practical randomized trial designed to assess the effectiveness of the intervention. Of 81 health departments invited to participate, 30 (37%) were eligible and willing, and 6 were selected at random to deliver the intervention. Of 432 potential participants screened by phone, 213 (49%) were eligible and of these, 189 (89%) completed baseline measures and were randomized to receive a 5-month weight loss intervention or a delayed intervention. The mean age was 51, mean BMI 37 kg/m(2), 53% were African American, and 43% had no health insurance. The results of this study should be informative to key stakeholders interested in real world weight loss interventions for low-income mid-life women.

  11. Rationale for the development of IMC-3G3, a fully human immunoglobulin G subclass 1 monoclonal antibody targeting the platelet-derived growth factor receptor alpha.

    Science.gov (United States)

    Shah, Gaurav D; Loizos, Nick; Youssoufian, Hagop; Schwartz, Jonathan D; Rowinsky, Eric K

    2010-02-15

    A large body of evidence suggests that the platelet-derived growth factor (PDGF) family and associated receptors are potential targets in oncology therapeutic development because of their critical roles in the proliferation and survival of various cancers and in the regulation and growth of the tumor stroma and blood vessels. Several small molecules that nonspecifically target the PDGF signaling axis are in current use or development as anticancer therapies. However, for the majority of these agents, PDGF and its receptors are neither the primary targets nor the principal mediators of anticancer activity. IMC-3G3, a fully human monoclonal antibody of the immunoglobulin G subclass 1, specifically binds to the human PDGF receptor alpha (PDGFRalpha) with high affinity and blocks PDGF ligand binding and PDGFRalpha activation. The results of preclinical studies and the frequent expression of PDGFRalpha in many types of cancer and in cancer-associated stroma support a rationale for the clinical development of IMC-3G3. Currently, IMC-3G3 is being evaluated in early clinical development for patients with several types of solid malignancies.

  12. Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM).

    Science.gov (United States)

    Sciagrà, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J; Slart, Riemer H J A; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Übleis, Christopher; Hacker, Marcus

    2016-07-01

    Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice.

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

    Science.gov (United States)

    Yao, Wei; Childs, Peter R N

    2013-07-01

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

  14. The metabolic rationale for a lack of cross-reactivity between sulfonamide antimicrobials and other sulfonamide-containing drugs.

    Science.gov (United States)

    Lehmann, David F

    2012-06-01

    Sulfonamide antimicrobials (sulfamethoxazole) contain an arylamine group, oxidized by CYP2C9 to the hydroxylamine with subsequent auto-oxidation to a highly reactive [-nitroso-] intermediate is a necessary (if not sufficient) cause of drug hypersensitivity. Accordingly, xenobiotics that do not contain an arylamine cannot generate this reactive intermediate and do not cross react with sulfonamide antimicrobials. Despite this well-attested observation, product labeling and direct-to-consumer advertising for non-arylamine therapeutic classes of drugs containing the sulfonamido- functional group persist with a warning of the potential for cross-reactivity. It is hoped that by offering an explicit rationale for the lack of cross-reactivity will provide medical practitioners with a level comfort to proceed with prescribing medications such as thiazide diuretics and celecoxib for patients with a history of hypersensitivity to sulfonamide antimicrobials. PMID:23157194

  15. Rationale and Development of a Security Assurance Index with Application toward the Development of a World Risk Index

    Energy Technology Data Exchange (ETDEWEB)

    M. M. Plum; G. A. Beitel, PhD

    2006-06-01

    Assurance categories were previously developed to support the Department of Homeland Security’s efforts in the mitigation of Cyber Control System events. Defined according to the risk of life and economic loss, the minimum range is designated by policy, whereas the maximum limit seems to be constrained only by limits and interdependencies of the event. Use of this life / assets scale has proven to be helpful in managing risk due to the scale's ease of use, communication, and understanding. Suggestions have been made that this scale could be applied to all events of terror, disaster, and calamity of an international scale, with equally good results. This paper presents the history of some existing scales of disaster and assurance, the rationale behind the development of the original Security Assurance Index, and our proposed scale of disaster and calamity as a World Risk Index.

  16. Pre-attentive processing and schizophrenia: animal studies.

    NARCIS (Netherlands)

    Ellenbroek, B.A.

    2004-01-01

    RATIONALE: Schizophrenia is characterized by a large variety of cognitive symptoms, among which information processing deficits have been extensively studied. So far, these aspects have been found to be remarkably stable and effective treatment is still lacking. Traditionally, information processing

  17. An objective rationale for the choice of regularisation parameter with application to global multiple-frequency S-wave tomography

    Directory of Open Access Journals (Sweden)

    C. Zaroli

    2013-06-01

    Full Text Available In a linear ill-posed inverse problem, the regularisation parameter (damping controls the balance between minimising both the residual data misfit and the model norm. Poor knowledge of data uncertainties often makes the selection of damping rather arbitrary. To go beyond that subjectivity, an objective rationale for the choice of damping is presented, which is based on the coherency of delay-time estimates in different frequency bands. Our method is tailored to the problem of global Multiple-Frequency Tomography (MFT, using a data set of 287 078 S-wave delay-times measured in five frequency bands (10, 15, 22, 34, 51 s central periods. Whereas for each ray path the delay-time estimates should vary coherently from one period to the other, the noise most likely is not coherent. Thus, the lack of coherency of the information in different frequency bands is exploited, using an analogy with the cross-validation method, to identify models dominated by noise. In addition, a sharp change of behaviour of the model ℓ∞-norm, as the damping becomes lower than a threshold value, is interpreted as the signature of data noise starting to significantly pollute at least one model component. Models with damping larger than this threshold are diagnosed as being constructed with poor data exploitation. Finally, a preferred model is selected from the remaining range of permitted model solutions. This choice is quasi-objective in terms of model interpretation, as the selected model shows a high degree of similarity with almost all other permitted models (correlation superior to 98% up to spherical harmonic degree 80. The obtained tomographic model is displayed in mid lower-mantle (660–1910 km depth, and is shown to be compatible with three other recent global shear-velocity models. A wider application of the presented rationale should permit us to converge towards more objective seismic imaging of the Earth's mantle.

  18. Understanding the Rationale for Preschool Physical Education: Implications for Practitioners' and Children's Embodied Practices and Subjectivity Formation

    Science.gov (United States)

    McEvilly, Nollaig; Atencio, Matthew; Verheul, Martine; Jess, Mike

    2013-01-01

    This paper provides an overview of selected academic research literature that underpins contemporary preschool physical education. We highlight and interrogate diverse rationales and beliefs that serve to influence and structure preschool physical education in various forms. We speculate as to how preschool practitioners and children might engage…

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

    NARCIS (Netherlands)

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

    2015-01-01

    OBJECTIVE: 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). MATERIALS A

  20. Design Rationale Behind the Serious Self-Regulation Game Intervention “Balance-It”: Overweight Prevention Among Secondary Vocational Education Students in the Netherlands

    NARCIS (Netherlands)

    Spook, J.E.; Paulussen, T.G.W.M.; Paulissen, R.T; Visschedijk, G.C.; Kok, G.; Empelen, P. van

    2015-01-01

    Objective: 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). Materials a

  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. Combining Computational and Biochemical Studies for a Rationale on the Anti-Aromatase Activity of Natural Polyphenols

    OpenAIRE

    Neves, Marco A. C.; Dinis, Teresa C. P.; Colombo, Giorgio; Melo, M. Luísa Sá e

    2007-01-01

    Aromatase, an enzyme of the cytochrome P450 family, is a very important pharmacological target, particularly for the treatment of breast cancer. The anti-aromatase activity of a set of natural polyphenolic compounds was evaluated in vitro. Strong aromatase inhibitors including flavones, flavanones, resveratrol, and oleuropein, with activities comparable to that of the reference anti-aromatase drug aminoglutethimide, were identified. Through the application of molecular modeling techniques bas...

  3. Synthesis and biological evaluation of novel s-triazine based aryl/heteroaryl entities: Design, rationale and comparative study

    Directory of Open Access Journals (Sweden)

    Nirali S. Mewada

    2016-06-01

    Full Text Available The urgent need in search of new biological entities to fight back with recent drug-resistant microbial flora, has led us report a library of s-triazine derivatives. The intermediate 4-((4-chloro-6-methoxy-1,3,5-triazin-2-ylaminobenzonitrile 3 was substituted with various thiophenol, phenol, aniline and piperazine/piperidine/morpholine moieties to furnish the final 35 target compounds i.e. (4a–j, (5a–j, (6a–g and (7a–h, respectively. These compounds were screened for in vitro antibacterial evaluation against bacteria (Staphylococcus aureus MTCC 96, Bacillus cereus MTCC 619, Escherichia coli MTCC 739, and Pseudomonas aeruginosa MTCC 741 and antifungal activity against fungi (Candida albicans MTCC 183, Aspergillus niger MTCC 282, and Aspergillus clavatus MTCC 1323. The title compounds were further subjected for antituberculosis activity against Mycobacterium tuberculosis H37Rv strain using the BACTEC MGIT method. In this biological evaluation, thiophenol derivatives were found to be more active than the rest (i.e. -Thiophenol > -piperazine > -Aniline > -phenol. The final compounds were characterized by FT-IR, 1H NMR, 13C NMR, mass spectroscopy and elemental analysis.

  4. Limited agreement exists between rationale and practice in athletes' supplement use for maintenance of health: a retrospective study

    Directory of Open Access Journals (Sweden)

    Mazanov Jason

    2007-10-01

    Full Text Available Abstract Background The widespread use of nutritional supplements among athletes is poorly understood. The prevalence of supplement intake and users' knowledge have been researched independently leading to useful, but disconnected, information on supplement use. Methods The 'UK Sport 2005 Drug Free Survey' data (n = 874 were re-analysed using association [χ2] and 'strength of association' tests [φ], to discover observed incongruencies between self-reported supplement use and the underlying motives. Results are given for test pairs between 'motive for use' [doctor's advice, avoiding sickness, overcoming injuries and enhancement of diet] and each supplement used and these were categorized as strong (φ > .7, intermediate (7 φ > .3 and weak (φ Results The use of selected supplements varied widely as follows: multivitamin (72.7%, vitamin C (70.4%, echinacea (30.8%, iron (29.8%, magnesium (11.0% and ginseng (8.3%. Associations with motive were found in 8 of the 10 test pairs which were expected from literature precedents, however only weak associations exist. Of these, four were associated with avoidance of sickness [iron (χ2 = 11.94, p χ2 = 6.43, p φ = .11, p = .011, vitamin C (χ2 = 54.67, p φ = .32, p χ2 = 40.34, p φ = .28, p χ2 = 7.64, p = .006; φ = .12, p = .006 and multivitamin (χ2 = 9.103, p = .003; φ = .13, p = .003; overcoming injuries with magnesium (χ2 = 6.99, p = .008; φ = .11, p = .008; doctors' advice and iron (χ2 = 35.00, p φ = .25, p = .001. Conclusion These results suggest a lack of understanding regarding supplements and health maintenance, except for vitamin C and echinacea. Furthermore, supplement use is apparently independent of physicians/dieticians' advice, except for iron. This may suggest a widespread circumvention of expert advice in the growing area of supplement use and therefore should be addressed to underscore potential health risks.

  5. Targeting Body Image Schema for Smoking Cessation among College Females: Rationale, Program Description, and Pilot Study Results

    Science.gov (United States)

    Napolitano, Melissa A.; Lloyd-Richardson, Elizabeth E.; Fava, Joseph L.; Marcus, Bess H.

    2011-01-01

    Smoking among young adults is a significant public health problem. Despite the negative health effects, many young women smoke for weight and body image reasons. Understanding the factors that prompt young women to initiate and continue smoking is important for designing smoking cessation interventions. The aim of the current article is to outline…

  6. Study on burnup credit evaluation method at JAERI towards securing criticality safety rationale for management of spent fuel

    International Nuclear Information System (INIS)

    A higher initial 235U enrichment is currently required in the nuclear fuel fabrication specification to realize higher fuel burnup. Traditionally, in the criticality safety design of spent fuel (SF) storage and transportation (S/T) casks or facilities, the fuel is usually assumed to be at its full initial enrichment (so called fresh fuel assumption) to provide a large safety allowance, which is sometimes excessively given, for example requiring unnecessarily large space between fuel assemblies. The burnup credit taken for criticality safety design is firstly implemented to the SF Storage Rack of Rokkasho Reprocessing Facility, which is completed and expected for operation soon. Except for that, no burnup credit has been taken in criticality safety design for SF S/T casks or intermediate storage facilities in Japan. Since in the near future it is considered inevitable to handle spent fuel massively, it is desired to implement the rational S/T design saving safety and economy by taking into account the fuel burnup in the criticality safety control. Computer codes and data which are vital to assess criticality safety in the design stage of nuclear fuel cycle facility have been developed and prepared to constitute a Japanese criticality safety handbook at JAERI

  7. Optimizing senior’s surgical care - Elder-friendly Approaches to the Surgical Environment (EASE) study: rationale and objectives

    OpenAIRE

    Khadaroo, Rachel G.; Padwal, Raj S.; Adrian S. Wagg; Clement, Fiona; Warkentin, Lindsey M.; Holroyd-Leduc, Jayna

    2015-01-01

    Background It is estimated that seniors (≥65 years old) account for >50 % of acute inpatient hospital days and are presenting for surgical evaluation of acute illness in increasing numbers. Unfortunately, conventional acute care models rarely take into account needs of the elderly population. The failure to consider these special needs have resulted in poor outcomes, longer lengths of hospital stay and have likely increased the need for institutional care. Acute Care for the Elderly models on...

  8. Rationale for the prevention of oral diseases in primary health care: an international collaborative study in oral health education.

    Science.gov (United States)

    Bourgeois, Denis M; Phantumvanit, Prathip; Llodra, Juan Carlos; Horn, Virginie; Carlile, Monica; Eiselé, Jean-Luc

    2014-10-01

    Ensuring that members of society are healthy and reaching their full potential requires the prevention of oral diseases through the promotion of oral health and well-being. The present article identifies the best policy conditions of effective public health and primary care integration and the actors who promote and sustain these efforts. In this review, arguments and recommendations are provided to introduce an oral health collaborative promotion programme called Live.Learn.Laugh. phase 2, arising from an unique partnership between FDI World Dental Federation, the global company Unilever plc and an international network of National Dental Associations, health-care centres, schools and educators populations. PMID:25209645

  9. A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: Rationale and design of study

    Science.gov (United States)

    Early and rapid growth in infants is strongly associated with early development and persistence of obesity in young children. Substantial research has linked child obesity/overweight to increased risks for serious health outcomes, which include adverse physical, psychological, behavioral, or social ...

  10. The gulf implantable cardioverter-defibrillator registry: Rationale, methodology, and implementation

    Directory of Open Access Journals (Sweden)

    Alawi A Alsheikh-Ali

    2015-01-01

    Conclusions: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region.

  11. Rats are the smart choice: Rationale for a renewed focus on rats in behavioral genetics.

    Science.gov (United States)

    Parker, Clarissa C; Chen, Hao; Flagel, Shelly B; Geurts, Aron M; Richards, Jerry B; Robinson, Terry E; Solberg Woods, Leah C; Palmer, Abraham A

    2014-01-01

    Due in part to their rich behavioral repertoire rats have been widely used in behavioral studies of drug abuse-related traits for decades. However, the mouse became the model of choice for researchers exploring the genetic underpinnings of addiction after the first mouse study was published demonstrating the capability of engineering the mouse genome through embryonic stem cell technology. The sequencing of the mouse genome and more recent re-sequencing of numerous inbred mouse strains have further cemented the status of mice as the premier mammalian organism for genetic studies. As a result, many of the behavioral paradigms initially developed and optimized for rats have been adapted to mice. However, numerous complex and interesting drug abuse-related behaviors that can be studied in rats are very difficult or impossible to adapt for use in mice, impeding the genetic dissection of those traits. Now, technological advances have removed many of the historical limitations of genetic studies in rats. For instance, the rat genome has been sequenced and many inbred rat strains are now being re-sequenced and outbred rat stocks are being used to fine-map QTLs. In addition, it is now possible to create "knockout" rats using zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALENs) and related techniques. Thus, rats can now be used to perform quantitative genetic studies of sophisticated behaviors that have been difficult or impossible to study in mice. This article is part of a Special Issue entitled 'NIDA 40th Anniversary Issue'.

  12. Active Fantasy Sports: Rationale and Feasibility of Leveraging Online Fantasy Sports to Promote Physical Activity

    Science.gov (United States)

    Majewski, Sara; Standish, Melanie; Agarwal, Pooja; Podowski, Aleksandra; Carson, Rebecca; Eyesus, Biruk; Shah, Aakash; Schneider, Kristin L

    2014-01-01

    Background The popularity of active video games (AVGs) has skyrocketed over the last decade. However, research suggests that the most popular AVGs, which rely on synchronous integration between players’ activity and game features, fail to promote physical activity outside of the game or for extended periods of engagement. This limitation has led researchers to consider AVGs that involve asynchronous integration of players’ ongoing physical activity with game features. Rather than build an AVG de novo, we selected an established sedentary video game uniquely well suited for the incorporation of asynchronous activity: online fantasy sports. Objective The primary aim of this study was to explore the feasibility of a new asynchronous AVG—active fantasy sports—designed to promote physical activity. Methods We conducted two pilot studies of an active fantasy sports game designed to promote physical activity. Participants wore a low cost triaxial accelerometer and participated in an online fantasy baseball (Study 1, n=9, 13-weeks) or fantasy basketball (Study 2, n=10, 17-weeks) league. Privileges within the game were made contingent on meeting weekly physical activity goals (eg, averaging 10,000 steps/day). Results Across the two studies, the feasibility of integrating physical activity contingent features and privileges into online fantasy sports games was supported. Participants found the active fantasy sports game enjoyable, as or more enjoyable than traditional (sedentary) online fantasy sports (Study 1: t 8=4.43, P<.01; Study 2: t 9=2.09, P=.07). Participants in Study 1 increased their average steps/day, t 8=2.63, P<.05, while participants in Study 2 maintained (ie, did not change) their activity, t 9=1.57, P=.15). In postassessment interviews, social support within the game was cited as a key motivating factor for increasing physical activity. Conclusions Preliminary evidence supports potential for the active fantasy sports system as a sustainable and

  13. Ferrocyanide Safety Program rationale for removing six tanks from the safety watch list

    Energy Technology Data Exchange (ETDEWEB)

    Borsheim, G.L.

    1993-09-01

    This report documents an in-depth study of single-shell tanks containing ferrocyanide wastes. Topics include: safety assessments, tank histories, supportive documentation about interim stabilization and planned remedial activities.

  14. Advanced fuel cycles: a rationale and strategy for adopting the low-enriched-uranium fuel cycle

    International Nuclear Information System (INIS)

    A two-year study of alternatives to the natural uranium fuel cycle in CANDU reactors is summarized. The possible advanced cycles are briefly described. Selection criteria for choosing a cycle for development include resource utilization, economics, ease of implementaton, and social acceptability. It is recommended that a detailed study should be made with a view to the early implementation of the low-enriched uranium cycle. (LL)

  15. Probiotics for the Treatment of Symptomatic Uncomplicated Diverticular Disease: Rationale and Current Evidence.

    Science.gov (United States)

    Scarpignato, Carmelo; Bertelé, Anna; Tursi, Antonio

    2016-10-01

    Changes in the colonic microbiota are critical to the pathogenesis of diverticular complications such as diverticulitis and peridiverticular abscesses. However, more subtle changes in microbiota composition may well be important to the more chronic manifestations of diverticulosis. Some studies have shown the presence of bacterial overgrowth in subgroups of patients with diverticular disease and recent studies, using molecular biology techniques, found an increase of proteobacteria and actinobacteria in patients with symptomatic uncomplicated diverticular disease (SUDD), compared with healthy controls. The use of probiotics to modulate intestinal microecology in SUDD appears therefore rational. Although several investigations evaluating the clinical efficacy of probiotics have been performed, no definitive results have yet been achieved, mainly due to the heterogeneity of the available studies. Most of the studies used probiotics in combination with poorly absorbed antimicrobials or anti-inflammatory drugs. In only 4 studies, there was a harm using probiotics alone, but only 1 was a placebo-controlled, double-blind trial. The analysis of the available evidence reveals a poor quality of the published studies, whose design was heterogeneous, with only 2 out of 11 trials being double-blind and randomized. Therefore, available data can only suggest a benefit of probiotics in SUDD, but do not allow any evidence-based definite conclusion. As a consequence, current guidelines state that there is insufficient evidence to recommend probiotics for symptom relief in patients with diverticular disease. PMID:27622371

  16. Exploring the Rationales Expressed for Including a CSR Position to the Top Management Team

    DEFF Research Database (Denmark)

    Strand, Robert

    Recently, a number of positions with corporate social responsibility (CSR) in the position title have been introduced to the top management teams (TMTs) of some of the world’s largest corporations. I explore this phenomenon. I revisit 10 such positions identified in a previous study to add a...

  17. A Rationale for Developing Communication Training Programs: Issues and Resources for Curriculum Development.

    Science.gov (United States)

    Curtis, Dan B.; Beebe, Steven A.

    A number of studies consistently identify the importance of communication skills, both oral and written, as vital to employability. Speech communication departments, however, have been slow either in responding to industry's needs or in informing students of the high correlation between communication skills and employability. Some of the possible…

  18. "Water Is Life"--Farmer Rationales and Water Saving in Khorezm, Uzbekistan: A Lifeworld Analysis

    Science.gov (United States)

    Oberkircher, Lisa; Hornidge, Anna-Katharina

    2011-01-01

    Khorezm Province is located in the Amu Darya lowlands of Uzbekistan, where unsustainable use of irrigation water has led to the Aral Sea crisis. This study deals with the question of how farmers in Khorezm perceive water and its management and how this facilitates or prevents water conservation, or "water saving," in irrigated agriculture. To…

  19. A Thematic Review of Interactive Whiteboard Use in Science Education: Rationales, Purposes, Methods and General Knowledge

    Science.gov (United States)

    Ormanci, Ummuhan; Cepni, Salih; Deveci, Isa; Aydin, Ozhan

    2015-01-01

    In Turkey and many other countries, the importance of the interactive whiteboard (IWB) is increasing, and as a result, projects and studies are being conducted regarding the use of the IWB in classrooms. Accordingly, in these countries, many issues are being researched, such as the IWB's contribution to the education process, its use in classroom…

  20. Is there a rationale for treatment of chronic liver disease with antithrombotic therapy?

    NARCIS (Netherlands)

    Hugenholtz, Greg C. G.; Northup, Patrick G.; Porte, Robert J.; Lisman, Ton

    2015-01-01

    Recent advances in the understanding of the coagulopathy in chronic liver disease have provided a strong support for anticoagulation as a new therapeutic paradigm for patients with cirrhosis. Laboratory studies indicate that the net effect of changes in hemostasis in many patients with chronic liver

  1. Rationales for Support That African American Grandmothers Provide to Their Children Who Are Parenting Adolescents

    Science.gov (United States)

    Sumo, Jen'nea; Dancy, Barbara; Julion, Wrenetha; Wilbur, JoEllen

    2015-01-01

    African American grandmothers are known to be a major source of support for their children who are parenting adolescents, but little is known about why they provide support. The purpose of this study was to describe the kinds of support provided by African American maternal and paternal grandmothers to their parenting adolescents and the reasons…

  2. Faculty Member Engagement in Canadian University Internationalization: A Consideration of Understanding, Motivations and Rationales

    Science.gov (United States)

    Friesen, Rhonda

    2013-01-01

    Faculty members are key agents in the institutional internationalization process within Canadian higher education. In the growing volumes of literature on internationalization, however, few authors consider how faculty members perceive their role in this process. In this study I take a phenomenological research approach to explore the…

  3. New regulations for medical devices: Rationale, advances and impact on research and patient care.

    Science.gov (United States)

    Labek, Gerold; Schöffl, Harald; Stoica, Christian Ioan

    2016-03-18

    A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts - such as age, comorbidities, the patients' risk profiles or the hospital profile - are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.

  4. Diagnosis and Management of Iron Deficiency in CKD: A Summary of the NICE Guideline Recommendations and Their Rationale.

    Science.gov (United States)

    Ratcliffe, Laura E K; Thomas, Wayne; Glen, Jessica; Padhi, Smita; Pordes, Ben A J; Wonderling, David; Connell, Roy; Stephens, Suzanne; Mikhail, Ashraf I; Fogarty, Damian G; Cooper, Jan K; Dring, Belinda; Devonald, Mark A J; Brown, Chris; Thomas, Mark E

    2016-04-01

    The UK-based National Institute for Health and Care Excellence (NICE) has updated its guidance on iron deficiency and anemia management in chronic kidney disease. This report outlines the recommendations regarding iron deficiency and their rationale. Serum ferritin alone or transferrin saturation alone are no longer recommended as diagnostic tests to assess iron deficiency. Red blood cell markers (percentage hypochromic red blood cells, reticulocyte hemoglobin content, or reticulocyte hemoglobin equivalent) are better than ferritin level alone at predicting responsiveness to intravenous iron. When red blood cell markers are not available, a combination of transferrin saturation iron status testing and treatment strategies, using percentage hypochromic red blood cells > 6% was the most cost-effective strategy for both hemodialysis and nonhemodialysis patients. A trial of oral iron replacement is recommended in people not receiving an erythropoiesis-stimulating agent (ESA) and not on hemodialysis therapy. For children receiving ESAs, but not treated by hemodialysis, oral iron should be considered. In adults and children receiving ESAs and/or on hemodialysis therapy, intravenous iron should be offered. When giving intravenous iron, high-dose low-frequency administration is recommended. For all children and for adults receiving in-center hemodialysis, low-dose high-frequency administration may be more appropriate.

  5. Technical rationale and sampling procedures for assessing the effects of subsurface volatile organic contaminants on indoor air quality

    Energy Technology Data Exchange (ETDEWEB)

    Wong, T.T.; Agar, J.G. [O' Connor Associates Environmental Inc., Calgary, AB (Canada); Gregoire, M.Y. [O' Connor Associates Environmental Inc., Winnipeg, MB (Canada)

    2003-07-01

    Volatile organic compounds (VOC) can affect indoor air quality through vapours released indoors by cigarette smoke, building materials, and common household solvents and cleaners. Therefore, the level of VOC contaminants might be a reliable indicator of the impact due to subsurface contamination. The following method of indirect assessment has been accepted by Canadian and American environmental regulatory bodies. This accepted method involves soil gas sampling close to the basement or ground floor slab of a building and VOC vapour transport modeling in order to estimate soil gas flow rates and VOC flux into a building. VOC flux concentration can be used to evaluate the potential human exposure to soil or groundwater derived VOCs, and to estimate the associated human health risks. This paper describes the shallow vapour sampler and sampling procedure specifically designed for collecting representative soil gas samples in the zone adjacent to a building basement or a ground floor slab, which was developed by O'Connor Associates. The results of numerical modeling, and the technical rationale behind the design of a soil gas sampling program for different soil types were presented. Soil type, depth to groundwater, and sampling well construction and their respective influence were discussed with reference to soil gas sampling programs and human health risk evaluations. 12 refs., 5 tabs., 6 figs.

  6. Comparison of the rationale used in setting occupational exposure standards for ionizing radiation and hazardous chemical substances

    International Nuclear Information System (INIS)

    Ten chemicals which create significant occupational hazard are reviewed. They are toluene diisocyanate, hydrogen fluoride, n-hexane, carbon disulphide, cadmium, inorganic mercury, cobalt, nitroglycerol, silica and vinyl chloride. Each is discussed under the headings of physiological intake and elimination in humans, characteristics of acute and chronic toxicity, sites of occupational exposure and rationale for limits of such exposure. Since radioactive substances yield ionizing radiation as the common hazard the treatment of the current permissible levels of exposure is somewhat simpler. Having set out industrial standards for exposure to hazardous substances and radionuclides, a detailed comparison is made. Exposure limits to ioninzing radiation are sufficiently low to remove the appearance of directly related injury. It is expected however that low level exposure may have a stochastic effect, that is, there is the possibility of a slightly increased incidence of neoplasms in a large exposed population, but numbers will be too small to be able to attribute any particular case to the exposure. TLVs on the other hand, depending on the particular chemical, may be high enough in the workplace to permit some directly related signs or symptoms in the exposed individual. 244 refs

  7. Structural rationale for the recognition of arginine at P₃ in PEXEL motif containing proteins of Plasmodium falciparum by plasmepsin V.

    Science.gov (United States)

    Guruprasad, Lalitha; Tanneeru, Karunakar; Guruprasad, Kunchur

    2011-06-01

    The virulent form of malaria is caused by Plasmodium falciparum that infects red blood cells. In order to survive inside the host, the parasite remodels the infected erythrocytes by exporting more than 300 effector proteins outside the parasitophorous vacuole membrane into the cytosol. The main feature of all the export proteins is the presence of a pentapeptide sequence motif; RxLxE/Q/D. This sequence motif is hydrolysed between L-x and the proteins with the acetylated new N-terminus xE/Q/D are exported. The enzyme responsible for this hydrolysis is plasmepsin V which is one of the ten aspartic proteases in P. falciparum. In order to understand the structural rationale for the specificity of this protease towards cleavage of the above motif, we generated three-dimensional models of seven plasmepsins (I, V to X) for which experimental structures are not available and compared these along with the crystal structures of three P. falciparum plasmepsins (II to IV). The structure comparisons revealed the importance of Tyr13, Glu77 and Ala117 specific to plasmepsin V that facilitates the accommodation of arginine at P₃ in the RxLxE/Q/D motif. Our analysis correlates the structure-function relationship of plasmepsin V.

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

    Directory of Open Access Journals (Sweden)

    Bramlage Peter

    2008-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Bossuyt Patrick MM

    2007-08-01

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

  10. 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......BACKGROUND: The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise. METHODS: Using a 2x2 factorial design with continuous effect endpoint...

  11. B-Cell Depletion Therapy in Systemic Sclerosis: Experimental Rationale and Update on Clinical Evidence

    Directory of Open Access Journals (Sweden)

    Dimitrios Daoussis

    2011-01-01

    Full Text Available Systemic sclerosis (SSc is a systemic rheumatic disease with poor prognosis since therapeutic options are limited. Recent evidence from animal models suggests that B-cells may be actively involved in the fibrotic process. B-cells from tight skin mice, an animal model of scleroderma, display a “hyperresponsive” phenotype; treatment with rituximab (RTX significantly attenuates skin fibrosis in this animal model. In humans, B-cell infiltration is a prominent finding in most lung biopsies obtained from patients with SSc-associated interstitial lung disease. Several open label studies have assessed the clinical efficacy of RTX in SSc. In most patients skin fibrosis improved; lung function either improved or remained stable. Definite conclusions regarding the clinical efficacy of RTX in SSc cannot be drawn but further exploration with a multicenter, randomized study is warranted.

  12. International Financial Reporting Standard’s (IFRS Adoption in Ghana: Rationale, Benefits and Challenges

    Directory of Open Access Journals (Sweden)

    Adwoa Acheampomaa Boateng

    2014-10-01

    Full Text Available The International Financial Reporting Standards (IFRS was adopted by Ghana in 2007. The study assessed eighteen (18 professional accountants from listed firms on the Ghana Stock Exchange (GSE, to measure the benefits and challenges of IFRS. The study revealed that IFRS improved the access of local companies to international markets. It was also observed that the local firms gained more credibility, transparency, acceptance and consolidation following its adoption. However, most respondents believed that decreasing information cost, competitive leading edge, and integration of accounting Information Technology system were not major benefits as proposed by literature. Nonetheless, some of these local companies after the migration faced challenges like coping with the sophistication of the new standard, lack of qualified personnel, and additional operational cost. Nevertheless, most of the respondents disagreed with the proposition that IFRS had a negative impact on their firms’ balance of retained earnings.

  13. Rationale and design of the Pan-African Sudden Cardiac Death survey

    DEFF Research Database (Denmark)

    Bonny, Aimé; Ngantcha, Marcus; Amougou, Sylvie Ndongo;

    2014-01-01

    of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). We will also analyse the employment of resuscitation attempts during the time frame of sudden cardiac arrest (SCA) in various patient populations throughout African countries. CONCLUSION......: This study will provide comprehensive, contemporary data on the epidemiology of SCD in Africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world....

  14. Underdiagnosis of Chronic Obstructive Pulmonary Disease: A Rationale for Spirometry as a Screening Tool

    OpenAIRE

    R Andrew McIvor; Tashkin, Donald P.

    2001-01-01

    Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity and mortality. It is the fourth leading cause of death in the United States, and its impact on quality of life can be severe. The debate on spirometry as a screening tool has been raised and dropped on various occasions over the past 30 years. This paper readdresses the debate in the light of recent evidence from population studies. Spirometry is an underused, easy to perform office-based procedure that has ...

  15. Ascorbic Acid and the Brain: Rationale for the Use against Cognitive Decline

    OpenAIRE

    Harrison, Fiona E.; Bowman, Gene L.; Maria Cristina Polidori

    2014-01-01

    This review is focused upon the role of ascorbic acid (AA, vitamin C) in the promotion of healthy brain aging. Particular attention is attributed to the biochemistry and neuronal metabolism interface, transport across tissues, animal models that are useful for this area of research, and the human studies that implicate AA in the continuum between normal cognitive aging and age-related cognitive decline up to Alzheimer’s disease. Vascular risk factors and comorbidity relationships with cogniti...

  16. A rationale to target the SWI/SNF complex for cancer therapy

    OpenAIRE

    Hohmann, Anja F.; Vakoc, Christopher R.

    2014-01-01

    SWI/SNF is a multi-subunit chromatin remodeling complex that performs fundamental roles in gene regulation, cell lineage specification, and organismal development. Mutations that inactivate SWI/SNF subunits are found in nearly 20% of human cancers, which indicates that the proper functioning of this complex is necessary to prevent tumor formation in diverse tissues. Recent studies show that SWI/SNF-mutant cancers depend on residual SWI/SNF complexes for their aberrant growth, thus revealing s...

  17. The Rationale/Benefits of Nuclear Thermal Rocket Propulsion for NASA's Lunar Space Transportation System

    Science.gov (United States)

    Borowski, Stanley K.

    1994-01-01

    The solid core nuclear thermal rocket (NTR) represents the next major evolutionary step in propulsion technology. With its attractive operating characteristics, which include high specific impulse (approximately 850-1000 s) and engine thrust-to-weight (approximately 4-20), the NTR can form the basis for an efficient lunar space transportation system (LTS) capable of supporting both piloted and cargo missions. Studies conducted at the NASA Lewis Research Center indicate that an NTR-based LTS could transport a fully-fueled, cargo-laden, lunar excursion vehicle to the Moon, and return it to low Earth orbit (LEO) after mission completion, for less initial mass in LEO than an aerobraked chemical system of the type studied by NASA during its '90-Day Study.' The all-propulsive NTR-powered LTS would also be 'fully reusable' and would have a 'return payload' mass fraction of approximately 23 percent--twice that of the 'partially reusable' aerobraked chemical system. Two NTR technology options are examined--one derived from the graphite-moderated reactor concept developed by NASA and the AEC under the Rover/NERVA (Nuclear Engine for Rocket Vehicle Application) programs, and a second concept, the Particle Bed Reactor (PBR). The paper also summarizes NASA's lunar outpost scenario, compares relative performance provided by different LTS concepts, and discusses important operational issues (e.g., reusability, engine 'end-of life' disposal, etc.) associated with using this important propulsion technology.

  18. Radiobiological research for improving cancer therapy in India: rationale, problems and prospects

    International Nuclear Information System (INIS)

    Cancer is emerging as a very important health hazard in India. According to recent studies by the Indian Council of Medical Research, about 2.25 million patients are presently suffering from different types of cancer in India. Approximately one million new cases are diagnosed, and nearly 0.3 million deaths occur every year on account of this disease. About 2/3rd of the cancers are at an advanced stage at the time of diagnosis. However, the allocation of funds for healthcare in India to support the research efforts for developing more potent radio-chemotherapy protocols for cancer treatment is too little. Studies by the W.H.O. have estimated that less developed countries including India use less than 5% of world resources destined for cancer control. It follows from the above discussions that it is imperative to further encourage and diversify the radiobiological research in India. This can be achieved by creating radiobiological research facilities, mainly in all the cancer centers and post graduate medical institutions, and further expanding the upcoming laboratories in the universities such as Bikaner. Collaborative research programs between laboratories at different centers could facilitate systematic evaluation of various pharmacological agents and neutraceuticals for potential application for treatment of different cancers. Our studies on combination of radiation with temozolomide and certain adjuvants with selective effects on brain tumour cells will be very briefly discussed in this presentation. Finally the possible administrative set up and multi dimensional collaborations for cost effective utilization of existing resources to further augment radiation biology research will also be discussed

  19. The Personalized Reminder Information and Social Management System (PRISM) Trial: Rationale, Methods and Baseline Characteristics

    Science.gov (United States)

    Czaja, Sara J.; Boot, Walter R.; Charness, Neil; Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D.; Lee, Chin Chin; Nair, Sankaran N.

    2014-01-01

    Technology holds promise in terms of providing support to older adults. To date there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65 – 98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol. PMID:25460342

  20. Controlled air incinerator for radioactive waste. Volume I. Rationale, process, equipment, performance, and recommendations

    International Nuclear Information System (INIS)

    This two-volume report is a detailed design and operating documentation of the Los Alamos National Laboratory Controlled Air Incinerator (CAI) and is an aid to technology transfer to other Department of Energy contractor sites and the commercial sector. Volume I describes the CAI process, equipment, and performance, and it recommends modifications based on Los Alamos experience. It provides the necessary information for conceptual design and feasibility studies. Volume II provides descriptive engineering information such as drawings specifications, calculations, and costs. It aids duplication of the process at other facilities

  1. Los Alamos Controlled Air Incinerator for radioactive waste. Volume I. Rationale, process, equipment, performance, and recommendations

    International Nuclear Information System (INIS)

    This two-volume report is a detailed design and operating documentation of the Los Alamos National Laboratory Controlled Air Incinerator (CAI) and is an aid to technology transfer to other Department of Energy contractor sites and the commercial sector. Volume I describes the CAI process, equipment, and performance, and it recommends modifications based on Los Alamos experience. It provides the necessary information for conceptual design and feasibility studies. Volume II provides descriptive engineering information such as drawing, specifications, calculations, and costs. It aids duplication of the process at other facilities

  2. Los Alamos Controlled Air Incinerator for radioactive waste. Volume I. Rationale, process, equipment, performance, and recommendations

    Energy Technology Data Exchange (ETDEWEB)

    Neuls, A.S.; Draper, W.E.; Koenig, R.A.; Newmyer, J.M.; Warner, C.L.

    1982-08-01

    This two-volume report is a detailed design and operating documentation of the Los Alamos National Laboratory Controlled Air Incinerator (CAI) and is an aid to technology transfer to other Department of Energy contractor sites and the commercial sector. Volume I describes the CAI process, equipment, and performance, and it recommends modifications based on Los Alamos experience. It provides the necessary information for conceptual design and feasibility studies. Volume II provides descriptive engineering information such as drawing, specifications, calculations, and costs. It aids duplication of the process at other facilities.

  3. The rationale for preventing cancer cachexia: targeting excessive fatty acid oxidation.

    Science.gov (United States)

    Qian, Chao-Nan

    2016-07-21

    Cachexia commonly occurs at the terminal stage of cancer and has largely unclear molecular mechanisms. A recent study published in Nature Medicine, entitled "Excessive fatty acid oxidation induces muscle atrophy in cancer cachexia," reveals that cachectic cancer cells can secrete multiple cytokines that induce excessive fatty acid oxidation, which is responsible for muscle loss in cancer cachexia. Inhibition of fatty acid oxidation using etomoxir can increase muscle mass and body weight in cancer cachexia animal models. The usage of stable cachexia animal models is also discussed in this research highlight.

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

    Directory of Open Access Journals (Sweden)

    Fischer Mary

    2010-03-01

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

  5. Ascorbic Acid and the Brain: Rationale for the Use against Cognitive Decline

    Directory of Open Access Journals (Sweden)

    Fiona E. Harrison

    2014-04-01

    Full Text Available This review is focused upon the role of ascorbic acid (AA, vitamin C in the promotion of healthy brain aging. Particular attention is attributed to the biochemistry and neuronal metabolism interface, transport across tissues, animal models that are useful for this area of research, and the human studies that implicate AA in the continuum between normal cognitive aging and age-related cognitive decline up to Alzheimer’s disease. Vascular risk factors and comorbidity relationships with cognitive decline and AA are discussed to facilitate strategies for advancing AA research in the area of brain health and neurodegeneration.

  6. A rationale method for evaluating unscrewing torque values of prosthetic screws in dental implants

    Directory of Open Access Journals (Sweden)

    Felipe Miguel Saliba

    2011-02-01

    Full Text Available OBJECTIVES: Previous studies that evaluated the torque needed for removing dental implant screws have not considered the manner of transfer of the occlusal loads in clinical settings. Instead, the torque used for removal was applied directly to the screw, and most of them omitted the possibility that the hexagon could limit the action of the occlusal load in the loosening of the screws. The present study proposes a method for evaluating the screw removal torque in an anti-rotational device independent way, creating an unscrewing load transfer to the entire assembly, not only to the screw. MATERIAL AND METHODS: Twenty hexagonal abutments without the hexagon in their bases were fixed with a screw to 20 dental implants. They were divided into two groups: Group 1 used titanium screws and Group 2 used titanium screws covered with a solid lubricant. A torque of 32 Ncm was applied to the screw and then a custom-made wrench was used for rotating the abutment counterclockwise, to loosen the screw. A digital torque meter recorded the torque required to loosen the abutment. RESULTS: There was a significant difference between the means of Group 1 (38.62±6.43 Ncm and Group 2 (48.47±5.04 Ncm, with p=0.001. CONCLUSION: This methodology was effective in comparing unscrewing torque values of the implant-abutment junction even with a limited sample size. It confirmed a previously shown significant difference between two types of screws.

  7. Structural Basis of Binding and Rationale for the Potent Urease Inhibitory Activity of Biscoumarins

    Directory of Open Access Journals (Sweden)

    Muhammad Arif Lodhi

    2014-01-01

    Full Text Available Urease belongs to a family of highly conserved urea-hydrolyzing enzymes. A common feature of these enzymes is the presence of two Lewis acid nickel ions and reactive cysteine residue in the active sites. In the current study we examined a series of biscoumarins 1–10 for their mechanisms of inhibition with the nickel containing active sites of Jack bean and Bacillus pasteurii ureases. All these compounds competitively inhibited Jack bean urease through interaction with the nickel metallocentre, as deduced from Michaelis-Menten kinetics, UV-visible absorbance spectroscopic, and molecular docking simulation studies. Some of the compounds behaved differently in case of Bacillus pasteurii urease. We conducted the enzyme kinetics, UV-visible spectroscopy, and molecular docking results in terms of the known protein structure of the enzyme. We also evaluated possible molecular interpretations for the site of biscoumarins binding and found that phenyl ring is the major active pharmacophore. The excellent in vitro potency and selectivity profile of the several compounds described combined with their nontoxicity against the human cells and plants suggest that these compounds may represent a viable lead series for the treatment of urease associated problems.

  8. Acute diverticulitis in younger patients: Any rationale for a different approach?

    Institute of Scientific and Technical Information of China (English)

    Gil R Faria; Ana B Almeida; Herculano Moreira; Jo(a)o Pinto-de-Sousa; Pedro Correia-da-Silva; Amadeu P Pimenta

    2011-01-01

    AIM: To compare the natural history and course of acute diverticulitis in a younger age group with an older population and to evaluate whether younger patients should be managed differently.METHODS: This study was a retrospective review of 157 patients treated with acute diverticulitis between January 1, 2004 and December 31, 2007. Diverticulitis was stratified according to the Hinchey classification.Patients were divided into 2 populations: group A ≤50 years (n = 31); group B > 50 years (n = 126). Mean patient follow-up was 15 mo.RESULTS: The median age was 60 years. A significantly higher proportion of patients in group B presented with complicated diverticulitis (36.5% vs 12.9%,P = 0.01). Recurrence was more frequent in group A (25.8% vs 11.1%, P = 0.03) and the mean time-torecurrence was shorter (12 mo vs 28 mo, P = 0.26).The most severe recurrent episodes of acute diverticulitis were classified as Hinchey stage Ⅰ and none of the patients required emergency surgery. In multivariate analysis, only age (P = 0.024) was identified as an independent prognostic factor for recurrence.CONCLUSION: Based on the results of this study, we recommend that diverticulitis management should be based on the severity of the disease and not on the age of the patient.

  9. The role and rationale of nuclear medicine procedures in the differential diagnosis of renovascular hypertension

    International Nuclear Information System (INIS)

    The use of radionuclides in the differential diagnosis of renovascular hypertension has gone through many periods of enthusiasm and of disappointment. Regardless of the problems with the routine renogram, the availability of gamma camera renal evaluation makes possible meaningful preintervention of screening. The use of the test as a follow-up procedure is an extremely important but often overlooked application of radionuclides in the evaluation of renovascular hypertension. The radionuclide technique is a sensitive and accurate method of evaluating the results of percutaneous angioplasty or surgery or renal function in the affected kidney of patients with renovascular disease. A major change in our approach to the nuclear medicine diagnosis of renovascular hypertension has been the introduction of captopril renography. Although there is still a great deal of work to be done and many investigators are actively studying captopril renography, the potential of the test is clear. Captopril renography should include a baseline renogram, followed by the administration of 25 mg of captopril and a repeat study. Specificity and sensitivity data on this test probably will not be available for several years, but preliminary results are encouraging enough to justify routine use at this time in clinics in which screening for renovascular hypertension is carried out. (author)

  10. Leukotriene D4 nasal provocation test: Rationale, methodology and diagnostic value

    Science.gov (United States)

    ZHU, ZHENG; XIE, YANQING; GUAN, WEIJIE; GAO, YI; XIA, SHU; LIANG, JIANXIN; ZHENG, JINPING

    2016-01-01

    Cysteinyl leukotrienes (LT) play a vital role in the pathogenesis of allergic rhinitis (AR), but few studies have investigated the nasal mucosal physiological response to LTs in AR patients. The aim of the present study was to establish the methodology and investigate the diagnostic value and safety of a leukotriene D4 (LTD4) nasal provocation test. LTD4 nasal provocation tests were performed in 26 AR patients and 16 normal control subjects. Nasal airway responsiveness was assessed by calculating the concentration of LTD4 required to cause a 60% increase in nasal airway resistance (PC60NAR-LTD4), which was measured using rhinomanometry and a composite symptom score. Receiver operating characteristic (ROC) curve was applied to evaluate the diagnostic value of LTD4 nasal provocation test, and adverse events were recorded. The study protocol was registered with the U.S. National Institutes of Health (https://clinicaltrials.gov/ct2/show/NCT01963741). PC60NAR-LTD4 in AR was significantly lower compared with that of normal controls [8.36 (IQR, 10.00) vs. 17.00 (IQR, 0.00) µg/ml, P=0.005]. Composite symptom score was higher in AR as compared with normal controls (1.19±0.94 vs. 0.12±0.50, P<0.001). The symptom scores included sneezing (0.12±0.34 vs. 0.00±0.00, P=0.149), rhinorrhea (0.79±0.66 vs. 0.06±0.25, P<0.001) and chemosis or itching of the eyes (0.06±0.25 vs. 0.21±0.42, P=0.216). High diagnostic value was indicated by the ROC [AUC: 0.822, 95%CI (0.665, 0.961)]. No serious adverse events were observed. Thus, the present results indicate that AR patients exhibited nasal hyperactivity to LTD4, and the established procedure of LTD4 nasal provocation testing is effective and safe for use in the diagnosis of AR. PMID:27347089

  11. Return of talent programs: rationale and evaluation criteria for programs to ameliorate a 'brain drain'.

    Science.gov (United States)

    Keely, C B

    1986-03-01

    The term, brain drain, describes the loss of skilled professionals and the nonreturn of students from advanced study abroad. It is now used almost exclusively in reference to mobility from less developed countries to more developed countries. Controversy centers on whether needed skills are being drawn off unfairly at subsidized rates from developing to developed countries or whether excess capability is being utilized in developed countries rather than underemployed or wasted at home. Some causes of high level personnel migration include: 1) wage differentials between sending and receiving countries; 2) absence of opportunities for career development or mobility for reasons other than merit or accomplishment; 3) lack of high quality facilities, equipment, time, and other costly supports in developing countries; 4) employer's lack of knowledge of employee work and the resulting wages; and 5) political disagreement or persecution. Prospects for closing wage gaps and upgrading working conditions on a large scale in developing countries are dim. Growth of the labor force coupled with national needs that are not congruent with professions requiring costly facilities, supplies, and equipment make this a slim possibility. Increasing career mobility possibilities seems to be a more promising route to reducing brain drain. One form of preventive measure is offering study abroad which requires service at the end of the study period; a variation is to guarantee employment for university graduates or for certain sectors, such as scientists. Restructuring decisions on hiring and promotion would have a positive effect, as would developing a better evaluation of expected productivity by type of training. Successful return of talent programs will be relatively modest in terms of the number of people returning and should be thought of as a part of human capital investment. Programs that are concerned with filling positions rather than with luring talent home are more likely to be

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

    Directory of Open Access Journals (Sweden)

    Nieuwenhuis Edward ES

    2011-10-01

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

  13. Archaeology in Social Studies: An Integrated Approach. Theme: Archaeology in the Classroom.

    Science.gov (United States)

    Devine, Heather

    1989-01-01

    Provides a rationale for integrating archaeology into the social studies classroom, suggesting archaeology topics that satisfy knowledge goals in the curriculum. Describes field trip, excavation, and experimental archaeology activities. Includes lists of archaeological agencies and teacher references. (LS)

  14. RATIONALE FOR A SPECIFIC THERAPY OF CYTOMEGALOVIRUS INFECTION IN CHILDREN WITH BRONCHIAL ASTHMA

    Directory of Open Access Journals (Sweden)

    E. N. Suprun

    2013-01-01

    Full Text Available Abstract. We propose a protocol of treatment in cases of bronchial asthma with cytomegalovirus (CMV persistence. This basic therapy is administered depending on the disease severity, according to the National Programme 2009. The treatment includes administration of human immunoglobulin, with dosage according on CMV antibodies titers. The study has revealed that such regimen of antibody administration based on the content of anti-CMV antibodies in bronchial asthma treatment stops active CMV replication in bronchial mucous membrane, alleviates clinical course of the disease, diminishes changes of immune system typical to children suffering from bronchial asthma and CMV reactivation, thus allowing to reduce the volume of basic therapy, along with maintaining control of asthma control.

  15. Application of Autofluorescence Endoscopy for Colorectal Cancer Screening: Rationale and an Update

    Directory of Open Access Journals (Sweden)

    Hiroyuki Aihara

    2012-01-01

    Full Text Available As the result of basic researches, several intravital fluorophores have been determined so far in human colorectal tissue. Autofluorescence endoscopy (AFE can detect slight alterations in their distribution and concentration during the colorectal carcinogenesis process and, thus facilitate noninvasive screening colonoscopies without the need for fluorescent substances or staining reagents to be administered. While detecting faint autofluorescence intensity by conventional fiberoptic endoscopy remains challenging, the latest AFE system with high-resolution videoendoscope capabilities enables such detection by using a false-color display algorithm. To this end, the diagnostic benefits of AFE have been reported in several multicenter randomized controlled studies of colorectal cancer (CRC screening and differential diagnosis. CRC screening using the latest AFE technology could, therefore, lead to future reductions in CRC mortality.

  16. Regionalization in local public health systems: variation in rationale, implementation, and impact on public health preparedness.

    Science.gov (United States)

    Stoto, Michael A

    2008-01-01

    Comparative case studies found that regionalization originated from a crisis or perceived need for a coordinated response, a need to build local public health capacity, or an effort to use federal preparedness funds more efficiently. Regions vary in terms of their congruence with regional structures for partner agencies, such as emergency management agencies, as well as hospital and health services markets and organizational structure. Some focus on building formal organizational relationships to coordinate and sometimes standardize preparedness and response activities or build regional capacity, while others focus on building informal professional networks. Whatever the approach, strong leadership and trust are required for effective planning, emergency response, and sustainability. This article suggests that regionalization improves emergency preparedness by allowing for more efficient use of resources and better coordination and demonstrated progress in terms of planning and coordination; regional capacity-building, training, and exercises; and development of professional networks.

  17. Getting the Mix Right Again: An Updated and Theoretical Rationale for Interaction

    Directory of Open Access Journals (Sweden)

    Terry Anderson, Canada Research Chair in Distance Education

    2003-10-01

    Full Text Available No topic raises more contentious debate among educators than the role of interaction as a crucial component of the education process. This debate is fueled by surface problems of definition and vested interests of professional educators, but is more deeply marked by epistemological assumptions relative to the role of humans and human interaction in education and learning. The seminal article by Daniel and Marquis (1979 challenged distance educators to get the mixture right between independent study and interactive learning strategies and activities. They quite rightly pointed out that these two primary forms of education have differing economic, pedagogical, and social characteristics, and that we are unlikely to find a “perfect” mix that meets all learner and institutional needs across all curricula and content. Nonetheless, hard decisions have to be made.

  18. Rationale for Haze Formation after Carboxymethyl Cellulose (CMC) Addition to Red Wine.

    Science.gov (United States)

    Sommer, Stephan; Dickescheid, Christian; Harbertson, James F; Fischer, Ulrich; Cohen, Seth D

    2016-09-14

    The aim of this study was to identify the source of haze formation in red wine after the addition of carboxymethyl cellulose (CMC) and to characterize the dynamics of precipitation. Ninety commercial wines representing eight grape varieties were collected, tested with two commercial CMC products, and analyzed for susceptibility to haze formation. Seventy-four of these wines showed a precipitation within 14 days independent of the CMC product used. The precipitates of four representative samples were further analyzed for elemental composition (CHNS analysis) and solubility under different conditions to determine the nature of the solids. All of the precipitates were composed of approximately 50% proteins and 50% CMC and polyphenols. It was determined that the interactions between CMC and bovine serum albumin are pH dependent in wine-like model solution. Furthermore, it was found that the color loss associated with CMC additions required the presence of proteins and cannot be observed with CMC and anthocyanins alone. PMID:27571332

  19. Complexity and dynamism from an urban health perspective: a rationale for a system dynamics approach.

    Science.gov (United States)

    Tozan, Yesim; Ompad, Danielle C

    2015-06-01

    In a variety of urban health frameworks, cities are conceptualized as complex and dynamic yet commonly used epidemiological methods have failed to address this complexity and dynamism head on due to their narrow problem definitions and linear analytical representations. Scholars from a variety of disciplines have also long conceptualized cities as systems, but few have modeled urban health issues as problems within a system. Systems thinking in general and system dynamics in particular are relatively new approaches in public health, but ones that hold immense promise as methodologies to model and analyze the complexity underlying urban processes to effectively inform policy actions in dynamic environments. This conceptual essay reviews the utility of applying the concepts, principles, and methods of systems thinking to the study of complex urban health phenomena as a complementary approach to standard epidemiological methods using specific examples and provides recommendations on how to better incorporate systems thinking methods in urban health research and practice. PMID:25952137

  20. Media richness and social information processing: rationale for multifocal continuing medical education activities.

    Science.gov (United States)

    Gilman, S C; Turner, J W

    2001-01-01

    Academic business communication has studied the results of media selection in organizations. Little of this work has been discussed in the context of continuing medical education (CME); however, it may apply to improving the design of educational activities. This article reviews literature on media richness and social information processing theories. The concept of media richness suggests that media choice results from a match between the objective characteristics of the medium and the content requirements of a message. In this context, media include face-to-face conversation and print and electronic media. Social information processing theory suggests that media selection is also based on participants' social norms for how information is communicated in their environment and the participants' familiarity with specific media types. Appraisal of CME with respect to these theories suggests that the complex relationship of CME content and CME participant environments invites the most effective strategies of multiple media experienced over time in what might be called multifocal continuing medical education.