Scenarios, personas and user stories: user-centered evidence-based design representations of communicable disease investigations.

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Turner, Anne M; Reeder, Blaine; Ramey, Judith

2013-08-01

Despite years of effort and millions of dollars spent to create unified electronic communicable disease reporting systems, the goal remains elusive. A major barrier has been a lack of understanding by system designers of communicable disease (CD) work and the public health workers who perform this work. This study reports on the application of user-centered design representations, traditionally used for improving interface design, to translate the complex CD work identified through ethnographic studies to guide designers and developers of CD systems. The purpose of this work is to: (1) better understand public health practitioners and their information workflow with respect to CD monitoring and control at a local health agency, and (2) to develop evidence-based design representations that model this CD work to inform the design of future disease surveillance systems. We performed extensive onsite semi-structured interviews, targeted work shadowing and a focus group to characterize local health agency CD workflow. Informed by principles of design ethnography and user-centered design we created persona, scenarios and user stories to accurately represent the user to system designers. We sought to convey to designers the key findings from ethnographic studies: (1) public health CD work is mobile and episodic, in contrast to current CD reporting systems, which are stationary and fixed, (2) health agency efforts are focused on CD investigation and response rather than reporting and (3) current CD information systems must conform to public health workflow to ensure their usefulness. In an effort to illustrate our findings to designers, we developed three contemporary design-support representations: persona, scenario, and user story. Through application of user-centered design principles, we were able to create design representations that illustrate complex public health communicable disease workflow and key user characteristics to inform the design of CD information

Development of a Web-Based Health Care Intervention for Patients With Heart Disease: Lessons Learned From a Participatory Design Study.

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Noergaard, Birgitte; Sandvei, Marianne; Rottmann, Nina; Johannessen, Helle; Wiil, Uffe; Schmidt, Thomas; Pedersen, Susanne S

2017-05-17

The use of telemedicine technologies in health care has increased substantially, together with a growing interest in participatory design methods when developing telemedicine approaches. We present lessons learned from a case study involving patients with heart disease and health care professionals in the development of a personalized Web-based health care intervention. We used a participatory design approach inspired by the method for feasibility studies in software development. We collected qualitative data using multiple methods in 3 workshops and analyzed the data using thematic analysis. Participants were 7 patients with diagnosis of heart disease, 2 nurses, 1 physician, 2 systems architects, 3 moderators, and 3 observers. We present findings in 2 parts. (1) Outcomes of the participatory design process: users gave valuable feedback on ease of use of the platforms' tracking tools, platform design, terminology, and insights into patients' monitoring needs, information and communication technologies skills, and preferences for self-management tools. (2) Experiences from the participatory design process: patients and health care professionals contributed different perspectives, with the patients using an experience-based approach and the health care professionals using a more attitude-based approach. The essential lessons learned concern planning and organization of workshops, including the finding that patients engaged actively and willingly in a participatory design process, whereas it was more challenging to include and engage health care professionals. ©Birgitte Noergaard, Marianne Sandvei, Nina Rottmann, Helle Johannessen, Uffe Wiil, Thomas Schmidt, Susanne S Pedersen. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.05.2017.

An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

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Brinton, John T; Ringham, Brandy M; Glueck, Deborah H

2015-10-13

For studies that compare the diagnostic accuracy of two screening tests, the sample size depends on the prevalence of disease in the study population, and on the variance of the outcome. Both parameters may be unknown during the design stage, which makes finding an accurate sample size difficult. To solve this problem, we propose adapting an internal pilot design. In this adapted design, researchers will accrue some percentage of the planned sample size, then estimate both the disease prevalence and the variances of the screening tests. The updated estimates of the disease prevalence and variance are used to conduct a more accurate power and sample size calculation. We demonstrate that in large samples, the adapted internal pilot design produces no Type I inflation. For small samples (N less than 50), we introduce a novel adjustment of the critical value to control the Type I error rate. We apply the method to two proposed prospective cancer screening studies: 1) a small oral cancer screening study in individuals with Fanconi anemia and 2) a large oral cancer screening trial. Conducting an internal pilot study without adjusting the critical value can cause Type I error rate inflation in small samples, but not in large samples. An internal pilot approach usually achieves goal power and, for most studies with sample size greater than 50, requires no Type I error correction. Further, we have provided a flexible and accurate approach to bound Type I error below a goal level for studies with small sample size.

Parkinson's disease prevalence in Fabry disease: A survey study

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Adina H. Wise

2018-03-01

Full Text Available Recent research has suggested a possible link between Parkinson's disease (PD and Fabry disease. To test this relationship, we administered a self-report and family history questionnaire to determine the prevalence of PD in Fabry disease patients and family members with likely pathogenic alpha-galactosidase A (GLA mutations. A total of 90 Fabry patients (77 from the online survey and 13 from the Icahn School of Medicine at Mount Sinai (ISMMS were included in the analysis. Two of the Fabry disease patients who completed the online survey were diagnosed with PD (2/90, 2.2%. Among probands older than 60, 8.3% (2/24 were diagnosed with PD. Using Kaplan Meier survival analysis, the age-specific risk of PD by age 70 was 11.1%. Family history was available on 72 Fabry families from the online study and 9 Fabry families from ISMMS. Among these 81 families, 6 (7.4% had one first degree relative who fit the criteria for a conservative diagnosis of PD. The results of this study suggest that there may be an increased risk of developing PD in individuals with GLA mutations, but these findings should be interpreted with caution given the limitations of the study design.

Innovative research methods for studying treatments for rare diseases: methodological review.

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Gagne, Joshua J; Thompson, Lauren; O'Keefe, Kelly; Kesselheim, Aaron S

2014-11-24

To examine methods for generating evidence on health outcomes in patients with rare diseases. Methodological review of existing literature. PubMed, Embase, and Academic Search Premier searched for articles describing innovative approaches to randomized trial design and analysis methods and methods for conducting observational research in patients with rare diseases. We assessed information related to the proposed methods, the specific rare disease being studied, and outcomes from the application of the methods. We summarize methods with respect to their advantages in studying health outcomes in rare diseases and provide examples of their application. We identified 46 articles that proposed or described methods for studying patient health outcomes in rare diseases. Articles covered a wide range of rare diseases and most (72%) were published in 2008 or later. We identified 16 research strategies for studying rare disease. Innovative clinical trial methods minimize sample size requirements (n=4) and maximize the proportion of patients who receive active treatment (n=2), strategies crucial to studying small populations of patients with limited treatment choices. No studies describing unique methods for conducting observational studies in patients with rare diseases were identified. Though numerous studies apply unique clinical trial designs and considerations to assess patient health outcomes in rare diseases, less attention has been paid to innovative methods for studying rare diseases using observational data. © Gagne et al 2014.

Cardiovascular disease, risk factors and heart rate variability in the elderly general population: Design and objectives of the CARdiovascular disease, Living and Ageing in Halle (CARLA Study

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Kuss Oliver

2005-11-01

Full Text Available Abstract Background The increasing burden of cardiovascular diseases (CVD in the ageing population of industrialized nations requires an intensive search for means of reducing this epidemic. In order to improve prevention, detection, therapy and prognosis of cardiovascular diseases on the population level in Eastern Germany, it is necessary to examine reasons for the East-West gradient of CVD morbidity and mortality, potential causal mechanisms and prognostic factors in the elderly. Psychosocial and nutritional factors have previously been discussed as possible causes for the unexplained part of the East-West gradient. A reduced heart rate variability appears to be associated with cardiovascular disease as well as with psychosocial and other cardiovascular risk factors and decreases with age. Nevertheless, there is a lack of population-based data to examine the role of heart rate variability and its interaction with psychosocial and nutritional factors regarding the effect on cardiovascular disease in the ageing population. There also is a paucity of epidemiological data describing the health situation in Eastern Germany. Therefore, we conduct a population-based study to examine the distribution of CVD, heart rate variability and CVD risk factors and their associations in an elderly East German population. This paper describes the design and objectives of the CARLA Study. Methods/design For this study, a random sample of 45–80 year-old inhabitants of the city of Halle (Saale in Eastern Germany was drawn from the population registry. By the end of the baseline examination (2002–2005, 1750 study participants will have been examined. A multi-step recruitment strategy aims at achieving a 70 % response rate. Detailed information is collected on own and family medical history, socioeconomic, psychosocial, behavioural and biomedical factors. Medical examinations include anthropometric measures, blood pressure of arm and ankle, a 10-second and a 20

Evaluating disease management programme effectiveness: an introduction to the regression discontinuity design.

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Linden, Ariel; Adams, John L; Roberts, Nancy

2006-04-01

Although disease management (DM) has been in existence for over a decade, there is still much uncertainty as to its effectiveness in improving health status and reducing medical cost. The main reason is that most programme evaluations typically follow weak observational study designs that are subject to bias, most notably selection bias and regression to the mean. The regression discontinuity (RD) design may be the best alternative to randomized studies for evaluating DM programme effectiveness. The most crucial element of the RD design is its use of a 'cut-off' score on a pre-test measure to determine assignment to intervention or control. A valuable feature of this technique is that the pre-test measure does not have to be the same as the outcome measure, thus maximizing the programme's ability to use research-based practice guidelines, survey instruments and other tools to identify those individuals in greatest need of the programme intervention. Similarly, the cut-off score can be based on clinical understanding of the disease process, empirically derived, or resource-based. In the RD design, programme effectiveness is determined by a change in the pre-post relationship at the cut-off point. While the RD design is uniquely suitable for DM programme evaluation, its success will depend, in large part, on fundamental changes being made in the way DM programmes identify and assign individuals to the programme intervention.

Citalopram for agitation in Alzheimer’s disease (CitAD): design and methods

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Drye, Lea T.; Ismail, Zahinoor; Porsteinsson, Anton P.; Rosenberg, Paul B.; Weintraub, Daniel; Marano, Christopher; Pelton, Gregory; Frangakis, Constantine; Rabins, Peter V.; Munro, Cynthia A.; Meinert, Curtis L.; Devanand, D.P.; Yesavage, Jerome; Mintzer, Jacobo E.; Schneider, Lon S.; Pollock, Bruce G.; Lyketsos, Constantine G.

2012-01-01

Background Agitation is one of the most common neuropsychiatric symptoms of Alzheimer’s disease (AD), and is associated with serious adverse consequences for patients and caregivers. Evidence-supported treatment options for agitation are limited. The citalopram for agitation in Alzheimer’s disease (CitAD) study was designed to evaluate the potential of citalopram to ameliorate these symptoms. Methods CitAD is a randomized, double-masked, placebo-controlled multicenter clinical trial with two parallel treatment groups assigned in a 1:1 ratio and randomization stratified by clinical center. The study has eight recruiting clinical centers, a chair’s office and a coordinating center located in university settings in the United States and Canada. 200 people having probable Alzheimer’s disease with clinically significant agitation and without major depression are being recruited. Patients are randomized to receive citalopram (target dose of 30 mg/day) or matching placebo. Caregivers of patients in both treatment groups receive a structured psychosocial therapy. Agitation will be compared between treatment groups using the NeuroBehavioral Rating Scale and the AD Cooperative Study- Clinical Global Impression of Change which are the primary outcomes. Functional performance, cognition, caregiver distress and rates of adverse and serious adverse events will also be measured. Conclusion The authors believe the design elements in CitAD are important features to be included in trials assessing the safety and efficacy of psychotropic medications for clinically significant agitation in Alzheimer’s disease. PMID:22301195

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...

[Rasagiline is not for all Parkinson disease patients: the ADAGIO study].

NARCIS (Netherlands)

Laar, T. van; Boon, A.J.; Bloem, B.R.

2010-01-01

Rasagiline is a MAO-B inhibitor that is currently registered for the symptomatic treatment of Parkinson disease. The ADAGIO trial studied the potential disease-modifying properties of rasagiline in 1100 patients with Parkinson disease, using an innovative 'delayed start' design. Patients were

Design of the NL-ENIGMA study: Exploring the effect of Souvenaid on cerebral glucose metabolism in early Alzheimer's disease.

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Scheltens, Nienke M E; Kuyper, Ingrid S; Boellaard, Ronald; Barkhof, Frederik; Teunissen, Charlotte E; Broersen, Laus M; Lansbergen, Marieke M; van der Flier, Wiesje M; van Berckel, Bart N M; Scheltens, Philip

2016-11-01

Alzheimer's disease is associated with early synaptic loss. Specific nutrients are known to be rate limiting for synapse formation. Studies have shown that administering specific nutrients may improve memory function, possibly by increasing synapse formation. This Dutch study explores the Effect of a specific Nutritional Intervention on cerebral Glucose Metabolism in early Alzheimer's disease (NL-ENIGMA, Dutch Trial Register NTR4718, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4718). The NL-ENIGMA study is designed to test whether the specific multinutrient combination Fortasyn Connect present in the medical food Souvenaid influences cerebral glucose metabolism as a marker for improved synapse function. This study is a double-blind, randomized controlled parallel-group single-center trial. Forty drug-naive patients with mild cognitive impairment or mild dementia with evidence of amyloid deposition are 1:1 randomized to receive either the multinutrient combination or placebo once daily. Main exploratory outcome parameters include absolute quantitative positron emission tomography with 18 F-fluorodeoxyglucose (including arterial sampling) and standard uptake value ratios normalized for the cerebellum or pons after 24 weeks. We expect the NL-ENIGMA study to provide further insight in the potential of this multinutrient combination to improve synapse function.

Design and methods of a strategic outcome study for chronic kidney disease: Frontier of Renal Outcome Modifications in Japan.

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Yamagata, Kunihiro; Makino, Hirofumi; Akizawa, Tadao; Iseki, Kunitoshi; Itoh, Sadayoshi; Kimura, Kenjiro; Koya, Daisuke; Narita, Ichiei; Mitarai, Tetsuya; Miyazaki, Masanobu; Tsubakihara, Yoshiharu; Watanabe, Tsuyoshi; Wada, Takashi; Sakai, Osamu

2010-04-01

The continuous increase in the number of people requiring dialysis is a major clinical and socioeconomical issue in Japan and other countries. This study was designed to encourage chronic kidney disease (CKD) patients to consult a physician, enhance cooperation between nephrologists and general practices, and prevent the progression of kidney disease. Subjects comprise CKD patients aged between 40 and 74 years consulting a general physician, and patients in CKD stage 3 with proteinuria and diabetes or hypertension. This trial is a stratified open cluster-randomized study with two intervention groups: group A (weak intervention) and group B (strong intervention). We have recruited 49 local medical associations (clusters) in 15 different prefectures, which were classified into four regions (strata) based on the level of increase rate of dialysis patients. The patients in group A clusters were instructed initially to undergo treatment in accordance with the current CKD treatment guide, whereas patients in group B clusters were not only instructed in the same fashion but also received support from an information technology (IT)-based system designed to help achieve the goals of CKD treatment, consultation support centers, and consultations by dietitians visiting the local general practice offices. We assessed the rates of continued consultation, collaboration between general practitioners and nephrologists, and progression of CKD (as expressed by CKD stage). Through this study, filling the evidence-practice gap by facilitating effective communication and supporting general physicians and nephrologists, we will establish a CKD care system and decrease the number of advanced-stage CKD patients.

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

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

2014-06-01

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

A cross sectional study of Infectious Bursal Disease and Newcastle Disease in poultry in Narsingdi district of Bangladesh

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Shariful Islam

2016-12-01

Conclusion: IBD and ND are highly prevalent in the study area. Therefore, it is necessary to conduct effective control measures to reduce the prevalence of these diseases. This study can help in designing appropriate control measures considering risk factors of these diseases. [J Adv Vet Anim Res 2016; 3(4.000: 406-412

The role of intervention mapping in designing disease prevention interventions: A systematic review of the literature.

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Garba, Rayyan M; Gadanya, Muktar A

2017-01-01

To assess the role of Intervention Mapping (IM) in designing disease prevention interventions worldwide. Systematic search and review of the relevant literature-peer-reviewed and grey-was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. Only five of the twenty two included studies reviewed were RCTs that compared intervention using IM protocol with placebo intervention, and provided the outcomes in terms of percentage increase in the uptake of disease-prevention programmes, and only one of the five studies provided an effect measure in the form of relative risk (RR = 1.59, 95% CI = 1.08-2.34, p = 0.02). Of the five RCTs, three were rated as strong evidences, one as a medium evidence and one as a weak evidence, and they all reported statistically significant difference between the two study groups, with disease prevention interventions that have used the intervention mapping approach generally reported significant increases in the uptake of disease-prevention interventions, ranging from 9% to 28.5% (0.0001 ≤ p ≤ 0.02), On the other hand, all the 22 studies have successfully identified the determinants of the uptake of disease prevention interventions that is essential to the success of disease prevention programmes. Intervention Mapping has been successfully used to plan, implement and evaluate interventions that showed significant increase in uptake of disease prevention programmes. This study has provided a good understanding of the role of intervention mapping in designing disease prevention interventions, and a good foundation upon which subsequent reviews can be guided.

Prediction of autoimmune diabetes and celiac disease in childhood by genes and perinatal environment: Design and initial aims of the PAGE study

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Lars C. Stene

2014-12-01

Full Text Available Type 1 diabetes and celiac disease result from misdirected immune mediated destruction of host cells, and are among the most common chronic diseases in children. Despite changes in incidence over the past 3 decades, little is known about non-genetic risk factors (except for dietary gluten for celiac disease. Norway is among the countries in the world with the highest incidence of these two diseases. We describe here plans and study design for the PAGE study (Prediction of Autoimmune diabetes and celiac disease in childhood by Genes and perinatal Environment. PAGE is a sub-study within the Norwegian Mother and Child Cohort study, including follow-up of more than 100,000 pregnancies. Children who develop type 1 diabetes or celiac disease are identified via linkage to the Norwegian Patient Register and the Norwegian Childhood Diabetes Registry, with complementing information from questionnaires. The overall aim is to test hypotheses about potential non-genetic risk factors for type 1 diabetes and for celiac disease, with focus on factors operating early in life. In addition to a full cohort analysis of factors registered in questionnaires, we will analyse biomarkers in maternal blood plasma and cord blood plasma. Mothers and children will be genotyped for well-established susceptibility polymorphisms. Biomarkers will be analysed in cases and controls within the cohort. Factors to be tested in the full cohort include infant feeding, diet and dietary supplements in the mother during pregnancy and in the child, and use of antibiotics and non-prescription drugs. Biomarkers to be tested include 25-hydroxyvitamin D, markers of immune activation, and small metabolites (metabolomics. We will also explore the potential role of maternal cells in the fetal circulation (maternal microchimerism in later risk of celiac disease and type 1 diabetes.

Adult asthma disease management: an analysis of studies, approaches, outcomes, and methods.

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Maciejewski, Matthew L; Chen, Shih-Yin; Au, David H

2009-07-01

Disease management has been implemented for patients with asthma in various ways. We describe the approaches to and components of adult asthma disease-management interventions, examine the outcomes evaluated, and assess the quality of published studies. We searched the MEDLINE, EMBASE, CINAHL, PsychInfo, and Cochrane databases for studies published in 1986 through 2008, on adult asthma management. With the studies that met our inclusion criteria, we examined the clinical, process, medication, economic, and patient-reported outcomes reported, and the study designs, provider collaboration during the studies, and statistical methods. Twenty-nine articles describing 27 studies satisfied our inclusion criteria. There was great variation in the content, extent of collaboration between physician and non-physician providers responsible for intervention delivery, and outcomes examined across the 27 studies. Because of limitations in the design of 22 of the 27 studies, the differences in outcomes assessed, and the lack of rigorous statistical adjustment, we could not draw definitive conclusions about the effectiveness or cost-effectiveness of the asthma disease-management programs or which approach was most effective. Few well-designed studies with rigorous evaluations have been conducted to evaluate disease-management interventions for adults with asthma. Current evidence is insufficient to recommend any particular intervention.

Study Design and Interim Outcomes of Guangzhou Institute of Respiratory Disease COPD Biobank.

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Lu, Wenju; Zheng, Zeguang; Chen, Xindong; Tan, Hui; Wang, Jian; Zhang, Zili; Zheng, Jinping; Chen, Rongchang; Zhang, Chenting; Xu, Xiaoming; Chen, Yuqin; Yang, Quan; Xiong, Mingmei; Guo, Meihua; Zhou, Qipeng; Tang, Chun; Wang, Yingfeng; Ye, Jinmei; Li, Defu; Shu, Jiaze; Tan, Shu; Xu, Chuyi; Wang, Yan; Lai, Ning; Yang, Kai; Lu, Jiachun; Ran, Pixin; Zhong, Nanshan

2016-01-01

GIRD COPD Biobank is a multicenter observational study blood-based database with local characteristics, in order to investigate the causes, risk factors, pathogenesis, prevalence patterns and trends of COPD and promote new pathogenic insights in China. We enrolled 855 clinically COPD patients and 660 controls with normal lung function. Extensive data collection has been undertaken with questionnaires, clinical measurements, and collection and storage of blood specimens, following Standard Operating Procedures (SOP). All surveys had similar quality controls, supervisions, and training of the investigator team. Since September 2010, a total of 1515 subjects (1116 [73.7%] males; 855 [56.4%] diagnosed with COPD) were enrolled. Analyses of the design and interim results of the GIRD COPD Biobank Study identified patients with COPD were older, lower educational level, a longer history of pack-year smoking, less in kitchen fan usage, X-ray exposure, and history of disease (P < 0.01 for all); Most of the COPD subjects belonged to moderately severe or worse, stratified according to Global Lung Function Initiative (GLI); COPD patients had relatively more co-morbidities than controls; Environmental hazard exposures might be the main contributors to the reported respiratory symptoms; Cold air, haze, and influenza acted the top three factors to induce respiratory symptoms in both COPD cases and controls. The GIRD COPD Biobank Study has the potential to provide substantial novel insights into the genetics, biomarkers, environmental and lifestyle aspects of COPD. It is expected to provide new insights for pathogenesis and the long-term progression of COPD.

CT study in Alzheimer's disease

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Arai, Heii; Kobayashi, Kazunari; Ikeda, Kenji; Nagao, Yoshiko; Ogihara, Ryuji; Kosaka, Kenji [Tokyo Metropolitan Matsuzawa Hospital (Japan)

1983-01-01

Cerebral atrophy on CT was studied in 18 patients with clinically diagnosed Alzheimer's disease and in 14 healthy age-matched subjects as the control. The patients with Alzheimer's disease were divided into three groups of Stages I, II and III, according to their clinical symptoms. The study of the measurement method disclosed that the computerized measurement involving calculation of the number of pixels contained within the range of the designated CT numbers is liable to produce errors for the determination of the subarachnoid spaces and the ventricles with calcified colloid plexus. Therefore, for the present study was the method adopted, in which the subarachnoid spaces and the ventricles are measured based on the number of pixels contained in the region of interest by tracing them on the display monitor. Then, both Subarachnoid Space Volume Index (SVI) and Ventricle Volume Index (VVI) were calculated as the indices for cortical atrophy and ventricular dilatation in a slice through the level of the foramen interventriculare Monroi and other three successive ones through upper regions. Cerebral atrophy observed on CT in Alzheimer patients is attributable to Alzheimer's disease processes, rather than to physiological aging of the brain. The degree of the atrophy increases in proportion to the clinical stage, and cortical atrophy is apparent even at Stage I, whereas ventricular dilatation becomes pronounced at later stage. CT is one of effective clinical tests for the diagnosis of Alzheimer's disease.

CT study in Alzheimer's disease

International Nuclear Information System (INIS)

Arai, Heii; Kobayashi, Kazunari; Ikeda, Kenji; Nagao, Yoshiko; Ogihara, Ryuji; Kosaka, Kenji

1983-01-01

Cerebral atrophy on CT was studied in 18 patients with clinically diagnosed Alzheimer's disease and in 14 healthy age-matched subjects as the control. The patients with Alzheimer's disease were divided into three groups of Stages I, Ii and III, according to their clinical symptoms. The study of the measurement method disclosed that the computerized measurement involving calculation of the number of pixels contained within the range of the designated CT numbers is liable to produce errors for the determination of the subarachnoid spaces and the ventricles with calcified colloid plexus. Therefor, for the present study was the method adopted, in which the subarachnoid spaces and the ventricles are measured based on the number of pixels contained in the region of interest by tracing them on the display monitor. Then, both Subarachnoid Space Volume Index (SVI) and Ventricle Volume Index (VVI) were calculated as the indices for cortical atrophy and ventricular dilatation in a slice through the level of the foramen interventriculare Monroi and other three successive ones through upper regions. Cerebral atrophy observed on CT in Alzheimer patients is attributable to Alzheimer's disease processes, rather than to physiological aging of the brain. The degree of the atrophy increases in proportion to the clinical stage, and cortical atrophy is apparent even at Stage I, whereas ventricular dilatation becomes pronounced at later stage. CT is one of effective clinical tests for the diagnosis of Alzheimer's disease. (J.P.N.)

In silico studies in drug research against neurodegenerative diseases.

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Makhouri, Farahnaz Rezaei; Ghasemi, Jahan B

2017-08-22

Neurodegenerative diseases such as Alzheimer's disease (AD), progressive neurodegenerative forms of Huntington's disease, Parkinson's disease (PD), amyotrophic lateral sclerosis, spinal cerebellar ataxias, and spinal and bulbar muscular atrophy are described by slow and selective dysfunction and degeneration of neurons and axons in the central nervous system (CNS). Computer-aided or in silico design methods have matured into powerful tools for reducing the number of ligands that should be screened in experimental assays. In the present review, the authors provide a basic background about neurodegenerative diseases and in silico techniques in the drug research. Furthermore, they review the various in silico studies reported against various targets in neurodegenerative diseases, including homology modeling, molecular docking, virtual high-throughput screening, quantitative structure activity relationship (QSAR), hologram quantitative structure activity relationship (HQSAR), 3D pharmacophore mapping, proteochemometrics modeling (PCM), fingerprints, fragment-based drug discovery, Monte Carlo simulation, molecular dynamic (MD) simulation, quantum-mechanical methods for drug design, support vector machines, and machine learning approaches. Neurodegenerative diseases have a multifactorial pathoetiological origin, so scientists have become persuaded that a multi-target therapeutic strategy aimed at the simultaneous targeting of multiple proteins (and therefore etiologies) involved in the development of a disease is recommended in future. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Mockup design of personal health diary app for patients with chronic kidney disease.

Science.gov (United States)

Lin, Hsiu-Wen; Wang, Yu-Jen; Jing, Ling-Fang; Chang, Polun

2014-01-01

Health self-management is important in the care of patients with chronic kidney disease. It is possible to improve the efficiency of patient self-management through the use of mobile technology and related software. This study is divided into three stages: 1. analysis of need: through observation, interview and content analysis of the chronic kidney disease health management manual; 2. design of system prototype: establish interface and system function; 3. prototype evaluation: evaluate whether the prototype designed by this study meets user needs. The system prototype includes: daily record, laboratory examination results, trend graphs, information search, sharing, communications and settings. Prototyping is done with Pencil Project for interface design and linking. The prototype is then exported in PDF format for mock-up simulation. Evaluation results: overall score was 4.01±0.60 leaning towards "agree", the highest score was ease of use (4.25±0.6), followed by easy to learn (4.15±0.68), acceptance (4.01±0.61), reliability (3.87±0.6) and functionality (3.83±0.49). The results show positive attitude towards the system.

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

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Pikhart Hynek

2006-10-01

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

Recommendations for the Design of Serious Games in Neurodegenerative Diseases.

Science.gov (United States)

Ben-Sadoun, Grégory; Manera, Valeria; Alvarez, Julian; Sacco, Guillaume; Robert, Philippe

2018-01-01

The use of Serious Games (SG) in the health domain is expanding. In the field of Neurodegenerative Diseases (ND) such as Alzheimer's Disease, SG are currently employed to provide alternative solutions for patients' treatment, stimulation, and rehabilitation. The design of SG for people with ND implies collaborations between professionals in ND and professionals in SG design. As the field is quite young, professionals specialized in both ND and SG are still rare, and recommendations for the design of SG for people with ND are still missing. This perspective paper aims to provide recommendations in terms of ergonomic choices for the design of SG aiming at stimulating people with ND, starting from the existing SG already tested in this population: "MINWii", "Kitchen and Cooking", and "X-Torp". We propose to rely on nine ergonomic criteria: eight ergonomic criteria inspired by works in the domain of office automation: Compatibility, Guidance, Workload, Adaptability, Consistency, Significance of codes, Explicit control and Error management; and one ergonomic criterion related to videogame: the game rules. Perspectives derived from this proposal are also discussed.

The nursing contribution to chronic disease management: a case of public expectation? Qualitative findings from a multiple case study design in England and Wales.

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Wilson, Patricia Mary; Brooks, Fiona; Procter, Susan; Kendall, Sally

2012-01-01

The global response to the rise in prevalence of chronic disease is a focus on the way services are managed and delivered, in which nurses are seen as central in shaping patient experience. However, there is relatively little known on how patients perceive the changes to service delivery envisaged by chronic care models. The PEARLE project aimed to explore, identify and characterise the origins, processes and outcomes of effective chronic disease management models and the nursing contributions to the models. Design, settings and participants Case study design of seven sites in England and Wales ensuring a range of chronic disease management models. Participants included over ninety patients and family carers ranging in age from children to older people with conditions such as diabetes, respiratory disease, epilepsy, or coronary heart disease. Semi-structured interviews with patients and family carers. Focus groups were conducted with adolescents and children. A whole systems approach guided data collection and data were thematically analysed. Despite nurses' role and skill development and the shift away from the acute care model, the results suggested that patients had a persisting belief in the monopoly of expertise continuing to exist in the acute care setting. Patients were more satisfied if they saw the nurse as diagnostician, prescriber and medical manager of the condition. Patients were less satisfied when they had been transferred from an established doctor-led to nurse-led service. While nurses within the study were highly skilled, patient perception was guided by the familiar rather than most appropriate service delivery. Most patients saw chronic disease management as a medicalised approach and the nursing contribution was most valued when emulating it. Patients' preferences and expectations of chronic disease management were framed by a strongly biomedical discourse. Perceptions of nurse-led chronic disease management were often shaped by what was

Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial.

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Myers, Bronwyn; Lund, Crick; Lombard, Carl; Joska, John; Levitt, Naomi; Butler, Christopher; Cleary, Susan; Naledi, Tracey; Milligan, Peter; Stein, Dan J; Sorsdahl, Katherine

2018-03-16

In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models

Recommendations for the Design of Serious Games in Neurodegenerative Diseases

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Grégory Ben-Sadoun

2018-02-01

Full Text Available The use of Serious Games (SG in the health domain is expanding. In the field of Neurodegenerative Diseases (ND such as Alzheimer’s Disease, SG are currently employed to provide alternative solutions for patients’ treatment, stimulation, and rehabilitation. The design of SG for people with ND implies collaborations between professionals in ND and professionals in SG design. As the field is quite young, professionals specialized in both ND and SG are still rare, and recommendations for the design of SG for people with ND are still missing. This perspective paper aims to provide recommendations in terms of ergonomic choices for the design of SG aiming at stimulating people with ND, starting from the existing SG already tested in this population: “MINWii”, “Kitchen and Cooking”, and “X-Torp”. We propose to rely on nine ergonomic criteria: eight ergonomic criteria inspired by works in the domain of office automation: Compatibility, Guidance, Workload, Adaptability, Consistency, Significance of codes, Explicit control and Error management; and one ergonomic criterion related to videogame: the game rules. Perspectives derived from this proposal are also discussed.

The Harbin Cohort Study on Diet, Nutrition and Chronic Non-communicable Diseases: study design and baseline characteristics.

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Lixin Na

Full Text Available Diet and nutrition have been reported to be associated with many common chronic diseases and blood-based assessment would be vital to investigate the association and mechanism, however, blood-based prospective studies are limited. The Harbin Cohort Study on Diet, Nutrition and Chronic Non-communicable Diseases was set up in 2010. From 2010 to 2012, 9,734 participants completed the baseline survey, including demographic characteristics, dietary intake, lifestyles and physical condition, and anthropometrics. A re-survey on 490 randomly selected participants was done by using the same methods which were employed in the baseline survey. For all participants, the mean age was 50 years and 36% of them were men. Approximately 99.4 % of cohort members donated blood samples. The mean total energy intake was 2671.7 kcal/day in men and 2245.9 kcal/day in women, the mean body mass index was 25.7 kg/m2 in men and 24.6 kg/m2 in women, with 18.4% being obese (≥ 28 kg/m2, 12.7% being diabetic, and 29.5% being hypertensive. A good agreement was obtained for the physical measurements between the baseline survey and re-survey. The resources from the cohort and its fasting and postprandial blood samples collected both at baseline and in each follow-up will be valuable and powerful in investigating relationship between diet, nutrition and chronic diseases and discovering novel blood biomarkers and the metabolism of these biomarkers related to chronic diseases.

Design and characterization of a 32P-patch for the treatment of skin diseases. Studies of its application as a betatherapeutic agent for modulated brachytherapy

International Nuclear Information System (INIS)

Salgueiro, M. J.

2010-01-01

The purpose of this work was to design and evaluate a 32 P-patch for contact brachytherapy of skin diseases. [ 32 P]-chromic phosphate in combination with silicone was employed to produce the designed 32 P patch. Radiopharmaceutical production was carried out in accordance with radiological safety issues. To verify the safety of the 32 P-patch, stability studies in vitro and in vivo were carried out to evaluate the leakage of radioactivity and autoradiographic studies were performed to evaluate the dose homogeneity and shielding. Therapeutic efficacy in animal models of skin cancer as well as in cats with squamous cell carcinoma was evaluated. These results showed that independently of the considered model, tumor growth was arrested and complete regressions were achieved in some other cases. Radiation doses were estimated with equations derived from the MIRD DOSE scheme and compared with Monte Carlo β doses. Some advantages of the designed 32 P-patch allow its use for conformal and modulated radiotherapy such as the possibility of modifying the activity concentration of the patch, the limited range of β- radiation, dose deep distribution and combination with bolus. This 32 P-patch which is easy to prepare and control may be used in the treatment of skin diseases alone or in combination with other treatment modalities. (author)

Improving access to medicines for non-communicable diseases in rural India: a mixed methods study protocol using quasi-experimental design.

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Prashanth, N S; Elias, Maya Annie; Pati, Manoj Kumar; Aivalli, Praveenkumar; Munegowda, C M; Bhanuprakash, Srinath; Sadhana, S M; Criel, Bart; Bigdeli, Maryam; Devadasan, Narayanan

2016-08-22

India has the distinction of financing its healthcare mainly through out-of-pocket expenses by individual families contributing to catastrophic health expenditure and impoverishment. Nearly 70 % of the expenditure is on medicines purchased at private pharmacies. Patients with chronic ailments are especially affected, as they often need lifelong medicines. Over the past years in India, there have been several efforts to improve drug availability at government primary health centres. In this study, we aim to understand health system factors that affect utilisation and access to generic medicines for people with non-communicable diseases. This study aims to understand if (and how) a package of interventions targeting primary health centres and community participation platforms affect utilisation and access to generic medicines for people with non-communicable diseases in the current district context in India. This study will employ a quasi-experimental design and a qualitative theory-driven approach. PHCs will be randomly assigned to one of three arms of the intervention. In one arm, PHCs will receive inputs to optimise service delivery for non-communicable diseases, while the second arm will receive an additional package of interventions to strengthen community participation platforms for improving non-communicable disease care. The third arm will be the control. We will conduct household and facility surveys, before and after the intervention and will estimate the effect of the intervention by difference-in-difference analysis. Sample size for measuring effects was calculated based on obtaining at least 30 households for each primary health centre spread across three distance-based clusters. Primary outcomes include availability and utilisation of medicines at primary health centres and out-of-pocket expenditure for medicines by non-communicable disease households. Focus group discussions with patients and in-depth interviews with health workers will also be

The Natural History of the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Studies: Design and Baseline Characteristics: ProgStar Report No. 1.

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Strauss, Rupert W; Ho, Alex; Muñoz, Beatriz; Cideciyan, Artur V; Sahel, José-Alain; Sunness, Janet S; Birch, David G; Bernstein, Paul S; Michaelides, Michel; Traboulsi, Elias I; Zrenner, Eberhart; Sadda, SriniVas; Ervin, Ann-Margret; West, Sheila; Scholl, Hendrik P N

2016-04-01

To describe the design and baseline characteristics of patients enrolled into 2 natural history studies of Stargardt disease (STGD1). Multicenter retrospective and prospective cohort studies. Three hundred sixty-five unique patients aged 6 years and older at baseline harboring disease-causing variants in the ABCA4 gene and with specified ocular lesions were enrolled from 9 centers in the United States and Europe. In the retrospective study, patients contributed medical record data from at least 2 and up to 4 visits for at least 1 examination modality: fundus autofluorescence (FAF), spectral-domain (SD) optical coherence tomography (SD OCT), and/or microperimetry (MP). The total observational period was at least 2 years and up to 5 years between single visits. Demographic and visual acuity (VA) data also were obtained. In the prospective study, eligible patients were examined at baseline using a standard protocol, with 6-month follow-up visits planned for a 2-year period for serial Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected VA, SD OCT, FAF, and MP. Design and rationale of a multicenter study to determine the progression of STGD1 in 2 large retrospective and prospective international cohorts. Detailed baseline characteristics of both cohorts are presented, including demographics, and structural and functional retinal metrics. Into the retrospective study, 251 patients (458 eyes) were enrolled; mean follow-up ± standard deviation was 3.9±1.6 years. At baseline, 36% had no or mild VA loss, and 47% of the study eyes had areas of definitely decreased autofluorescence (DDAF) with an average lesion area of 2.5±2.9 mm(2) (range, 0.02-16.03 mm(2)). Two hundred fifty-nine patients (489 eyes) were enrolled in the prospective study. At baseline, 20% had no or mild VA loss, and 64% had areas of DDAF with an average lesion area of 4.0±4.4 mm(2) (range, 0.03-24.24 mm(2)). The mean retinal sensitivity with MP was 10.8±5.0 dB. The ProgStar cohorts have

Social media methods for studying rare diseases.

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Schumacher, Kurt R; Stringer, Kathleen A; Donohue, Janet E; Yu, Sunkyung; Shaver, Ashley; Caruthers, Regine L; Zikmund-Fisher, Brian J; Fifer, Carlen; Goldberg, Caren; Russell, Mark W

2014-05-01

For pediatric rare diseases, the number of patients available to support traditional research methods is often inadequate. However, patients who have similar diseases cluster "virtually" online via social media. This study aimed to (1) determine whether patients who have the rare diseases Fontan-associated protein losing enteropathy (PLE) and plastic bronchitis (PB) would participate in online research, and (2) explore response patterns to examine social media's role in participation compared with other referral modalities. A novel, internet-based survey querying details of potential pathogenesis, course, and treatment of PLE and PB was created. The study was available online via web and Facebook portals for 1 year. Apart from 2 study-initiated posts on patient-run Facebook pages at the study initiation, all recruitment was driven by study respondents only. Response patterns and referral sources were tracked. A total of 671 respondents with a Fontan palliation completed a valid survey, including 76 who had PLE and 46 who had PB. Responses over time demonstrated periodic, marked increases as new online populations of Fontan patients were reached. Of the responses, 574 (86%) were from the United States and 97 (14%) were international. The leading referral sources were Facebook, internet forums, and traditional websites. Overall, social media outlets referred 84% of all responses, making it the dominant modality for recruiting the largest reported contemporary cohort of Fontan patients and patients who have PLE and PB. The methodology and response patterns from this study can be used to design research applications for other rare diseases. Copyright © 2014 by the American Academy of Pediatrics.

Retrospective study on cattle and poultry diseases in Uganda

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Joseph Byaruhanga

2017-12-01

Full Text Available Cattle and poultry enterprises are among the major contributors to food security and socioeconomic empowerment of households in Uganda. However, various diseases constrain their productivity. A two-year retrospective study between April 2012 and March 2014 was conducted using records for cattle and poultry diseases diagnosed at the Central Diagnostic Laboratory (CDL to determine prevalent diseases in Uganda. The laboratory received 836 samples from poultry (36.3% and cattle (63.7%. Of the 836 samples, 47.5% had a definitive diagnosis of disease causation. Most of the cattle and poultry diseases diagnosed were protozoan diseases (39.3% followed by bacterial (21.4%, viral (17.1%, helminthiasis (11.1%, nutritional diseases (4% and others (7.1%. For poultry, viral diseases (29.5% and protozoan diseases (27.1% especially newcastle disease (44.3% and coccidiosis (100% respectively, were the most diagnosed. While for cattle, hemo-protozoan parasites (52.1% were the most prevalent, of which 92.9% were east coast fever infection. Bacterial infection (20.5% in cattle were the second most diagnosed diseases and mastitis was the most diagnosed (46.2%. In summary, coccidioisis, collibacillosis, newcastle disease, gumboro disease, and avian helminthiasis were the most prevalent poultry diseases while in cattle, east coast fever, helminthiasis, mastitis, brucellosis and rabies were the most frequently diagnosed diseases. This study has identified the major diseases that hinder poultry and cattle production in Uganda. The data generated by CDL could be used for surveillance, monitoring and designing strategic interventions for control of poultry and cattle diseases in Uganda. Keywords: Coccidiosis, Collibacillosis, East coast fever, Mastitis, Newcastle disease, Rabies

The association between periodontal disease and peritonsillar infection: a prospective study

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Georgalas, Christos; Kanagalingam, Jeeve; Zainal, Azida; Ahmed, Hamid; Singh, Arvind; Patel, Kalpesh S.

2002-01-01

OBJECTIVE: To study the relationship between periodontal status and peritonsillar disease/recurrent tonsillitis. STUDY DESIGN AND SETTING: A total of 158 patients presenting over a 3-year period with peritonsillar abscess (PTA) confirmed by needle aspiration and a control group of 112 patients

Design of robust adaptive controller and feedback error learning for rehabilitation in Parkinson's disease: a simulation study.

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Rouhollahi, Korosh; Emadi Andani, Mehran; Karbassi, Seyed Mahdi; Izadi, Iman

2017-02-01

Deep brain stimulation (DBS) is an efficient therapy to control movement disorders of Parkinson's tremor. Stimulation of one area of basal ganglia (BG) by DBS with no feedback is the prevalent opinion. Reduction of additional stimulatory signal delivered to the brain is the advantage of using feedback. This results in reduction of side effects caused by the excessive stimulation intensity. In fact, the stimulatory intensity of controllers is decreased proportional to reduction of hand tremor. The objective of this study is to design a new controller structure to decrease three indicators: (i) the hand tremor; (ii) the level of delivered stimulation in disease condition; and (iii) the ratio of the level of delivered stimulation in health condition to disease condition. For this purpose, the authors offer a new closed-loop control structure to stimulate two areas of BG simultaneously. One area (STN: subthalamic nucleus) is stimulated by an adaptive controller with feedback error learning. The other area (GPi: globus pallidus internal) is stimulated by a partial state feedback (PSF) controller. Considering the three indicators, the results show that, stimulating two areas simultaneously leads to better performance compared with stimulating one area only. It is shown that both PSF and adaptive controllers are robust regarding system parameter uncertainties. In addition, a method is proposed to update the parameters of the BG model in real time. As a result, the parameters of the controllers can be updated based on the new parameters of the BG model.

The DIAN-TU Next Generation Alzheimer’s prevention trial: adaptive design and disease progression model

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Bateman, Randall J.; Benzinger, Tammie L.; Berry, Scott; Clifford, David B.; Duggan, Cynthia; Fagan, Anne M.; Fanning, Kathleen; Farlow, Martin R.; Hassenstab, Jason; McDade, Eric M.; Mills, Susan; Paumier, Katrina; Quintana, Melanie; Salloway, Stephen P.; Santacruz, Anna; Schneider, Lon S.; Wang, Guoqiao; Xiong, Chengjie

2016-01-01

INTRODUCTION The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) trial is an adaptive platform trial testing multiple drugs to slow or prevent the progression of Alzheimer’s disease in autosomal dominant Alzheimer’s disease (ADAD) families. With completion of enrollment of the first two drug arms, the DIAN-TU now plans to add new drugs to the platform, designated as the Next Generation Prevention Trial (NexGen). METHODS In collaboration with ADAD families, philanthropic organizations, academic leaders, the DIAN-TU Pharma Consortium, the NIH, and regulatory colleagues, the DIAN-TU developed innovative clinical study designs for the DIAN-TU NexGen trial. RESULTS Our expanded trials toolbox consists of a Disease Progression Model for ADAD, primary endpoint DIAN-TU cognitive performance composite, biomarker development, self-administered cognitive assessments, adaptive dose adjustments, and blinded data collection through the last participant completion. CONCLUSION These steps represent elements to improve efficacy of the adaptive platform trial and a continued effort to optimize prevention and treatment trials in ADAD. PMID:27583651

From COPD epidemiology to studies of pathophysiological disease mechanisms: challenges with regard to study design and recruitment process: Respiratory and Cardiovascular Effects in COPD (KOLIN).

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Lindberg, Anne; Linder, Robert; Backman, Helena; Eriksson Ström, Jonas; Frølich, Andreas; Nilsson, Ulf; Rönmark, Eva; Johansson Strandkvist, Viktor; Behndig, Annelie F; Blomberg, Anders

2017-01-01

Background : Chronic obstructive pulmonary disease (COPD) is a largely underdiagnosed disease including several phenotypes. In this report, the design of a study intending to evaluate the pathophysiological mechanism in COPD in relation to the specific phenotypes non-rapid and rapid decline in lung function is described together with the recruitment process of the study population derived from a population based study. Method : The OLIN COPD study includes a population-based COPD cohort and referents without COPD identified in 2002-04 ( n  = 1986), and thereafter followed annually since 2005. Lung function decline was estimated from baseline in 2002-2004 to 2010 (first recruitment phase) or to 2012/2013 (second recruitment phase). Individuals who met the predefined criteria for the following four groups were identified; group A) COPD grade 2-3 with rapid decline in FEV 1 and group B) COPD grade 2-3 without rapid decline in FEV 1 (≥60 and ≤30 ml/year, respectively), group C) ever-smokers, and group D) non-smokers with normal lung function. Groups A-C included ever-smokers with >10 pack years. The intention was to recruit 15 subjects in each of the groups A-D. Results : From the database groups A-D were identified; group A n  = 37, group B n  = 29, group C n  = 41, and group D n  = 55. Fifteen subjects were recruited from groups C and D, while this goal was not reached in the groups A ( n  = 12) and B ( n  = 10). The most common reasons for excluding individuals identified as A or B were comorbidities contraindicating bronchoscopy, or inflammatory diseases/immune suppressive medication expected to affect the outcome. Conclusion : The study is expected to generate important results regarding pathophysiological mechanisms associated with rate of decline in lung function among subjects with COPD and the in-detail described recruitment process, including reasons for non-participation, is a strength when interpreting the results in forthcoming studies.

[Design and implementation of the ELSA-Brasil biobank: a prospective study in a Brazilian population].

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Pereira, Alexandre C; Bensenor, Isabela M; Fedeli, Ligia M; Castilhos, Cristina; Vidigal, Pedro G; Maniero, Viviane; Leite, Claudia M; Pimentel, Robercia A; Duncan, Bruce B; Mill, Jose Geraldo; Lotufo, Paulo A

2013-06-01

The Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) is a multicenter prospective cohort of civil servants designed to assess the determinants of chronic diseases, especially cardiovascular diseases and type 2 diabetes. The present article describes the main design and implementation points of the ELSA-Brasil biobank project. Economic, political, logistical and technological aspects of this study are characterized. Additionally, it discusses the final biorepository protocol and the facilities implemented to achieve this objective. The design and implementation process of the ELSA-Brasil biobank took three years to be performed. Both the central and local biobanks were built according to the best biorepository techniques, using different technological solutions for the distinct needs expected in this study.

The Netherlands Epidemiology of Obesity (NEO) study: study design and data collection.

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de Mutsert, Renée; den Heijer, Martin; Rabelink, Ton Johannes; Smit, Johannes Willem Adriaan; Romijn, Johannes Anthonius; Jukema, Johan Wouter; de Roos, Albert; Cobbaert, Christa Maria; Kloppenburg, Margreet; le Cessie, Saskia; Middeldorp, Saskia; Rosendaal, Frits Richard

2013-06-01

Obesity is a well-established risk factor for many chronic diseases. Incomplete insight exists in the causal pathways responsible for obesity-related disorders and consequently, in the identification of obese individuals at risk of these disorders. The Netherlands Epidemiology of Obesity (NEO) study is designed for extensive phenotyping to investigate pathways that lead to obesity-related diseases. The NEO study is a population-based, prospective cohort study that includes 6,673 individuals aged 45-65 years, with an oversampling of individuals with overweight or obesity. At baseline, data on demography, lifestyle, and medical history have been collected by questionnaires. In addition, samples of 24-h urine, fasting and postprandial blood plasma and serum, and DNA were collected. Participants underwent an extensive physical examination, including anthropometry, electrocardiography, spirometry, and measurement of the carotid artery intima-media thickness by ultrasonography. In random subsamples of participants, magnetic resonance imaging of abdominal fat, pulse wave velocity of the aorta, heart, and brain, magnetic resonance spectroscopy of the liver, indirect calorimetry, dual-energy X-ray absorptiometry, or accelerometry measurements were performed. The collection of data started in September 2008 and completed at the end of September 2012. Participants are followed for the incidence of obesity-related diseases and mortality. The NEO study investigates pathways that lead to obesity-related diseases. A better understanding of the mechanisms underlying the development of disease in obesity may help to identify individuals who are susceptible to the detrimental metabolic, cardiovascular and other consequences of obesity and has implications for the development of prevention and treatment strategies.

Premorbid Personality Characteristics in Alzheimer’s Disease: An Exploratory Case–Control Study

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M. Malinchoc

1997-01-01

Full Text Available Linking data from a case–control study of Alzheimer’s disease with data from a Minnesota Multiphasic Personality Inventory (MMPI outpatient study, we identified 13 Alzheimer's disease cases and 16 controls for case–control comparison. The mean time between personality testing and onset of Alzheimer's disease (or corresponding age for controls was 13 years in cases and 14 years in controls. Alzheimer's disease cases, but not the controls, had scores significantly greater than the normative reference on MMPI scales measuring Social Introversion (p = 0.05, and Pessimism (p = 0.01. When compared to controls, Alzheimer's disease cases had significantly greater scores on the Social Introversion scale (p = 0.03. Despite the small sample size and some design limitations of this exploratory study, our findings may suggest that subjects who score higher on these personality scales have a greater risk of Alzheimer's disease.

A Systematic Review of Longitudinal Studies Which Measure Alzheimer's Disease Biomarkers.

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Lawrence, Emma; Vegvari, Carolin; Ower, Alison; Hadjichrysanthou, Christoforos; De Wolf, Frank; Anderson, Roy M

2017-01-01

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease, with no effective treatment or cure. A gold standard therapy would be treatment to slow or halt disease progression; however, knowledge of causation in the early stages of AD is very limited. In order to determine effective endpoints for possible therapies, a number of quantitative surrogate markers of disease progression have been suggested, including biochemical and imaging biomarkers. The dynamics of these various surrogate markers over time, particularly in relation to disease development, are, however, not well characterized. We reviewed the literature for studies that measured cerebrospinal fluid or plasma amyloid-β and tau, or took magnetic resonance image or fluorodeoxyglucose/Pittsburgh compound B-positron electron tomography scans, in longitudinal cohort studies. We summarized the properties of the major cohort studies in various countries, commonly used diagnosis methods and study designs. We have concluded that additional studies with repeat measures over time in a representative population cohort are needed to address the gap in knowledge of AD progression. Based on our analysis, we suggest directions in which research could move in order to advance our understanding of this complex disease, including repeat biomarker measurements, standardization and increased sample sizes.

Celiac Disease Genomic, Environmental, Microbiome, and Metabolomic (CDGEMM Study Design: Approach to the Future of Personalized Prevention of Celiac Disease

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Maureen M. Leonard

2015-11-01

Full Text Available In the past it was believed that genetic predisposition and exposure to gluten were necessary and sufficient to develop celiac disease (CD. Recent studies however suggest that loss of gluten tolerance can occur at any time in life as a consequence of other environmental stimuli. Many environmental factors known to influence the composition of the intestinal microbiota are also suggested to play a role in the development of CD. These include birthing delivery mode, infant feeding, and antibiotic use. To date no large-scale longitudinal studies have defined if and how gut microbiota composition and metabolomic profiles may influence the loss of gluten tolerance and subsequent onset of CD in genetically-susceptible individuals. Here we describe a prospective, multicenter, longitudinal study of infants at risk for CD which will employ a blend of basic and applied studies to yield fundamental insights into the role of the gut microbiome as an additional factor that may play a key role in early steps involved in the onset of autoimmune disease.

Gene-Lifestyle Interactions in Complex Diseases: Design and Description of the GLACIER and VIKING Studies.

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Kurbasic, Azra; Poveda, Alaitz; Chen, Yan; Agren, Asa; Engberg, Elisabeth; Hu, Frank B; Johansson, Ingegerd; Barroso, Ines; Brändström, Anders; Hallmans, Göran; Renström, Frida; Franks, Paul W

2014-12-01

Most complex diseases have well-established genetic and non-genetic risk factors. In some instances, these risk factors are likely to interact, whereby their joint effects convey a level of risk that is either significantly more or less than the sum of these risks. Characterizing these gene-environment interactions may help elucidate the biology of complex diseases, as well as to guide strategies for their targeted prevention. In most cases, the detection of gene-environment interactions will require sample sizes in excess of those needed to detect the marginal effects of the genetic and environmental risk factors. Although many consortia have been formed, comprising multiple diverse cohorts to detect gene-environment interactions, few robust examples of such interactions have been discovered. This may be because combining data across studies, usually through meta-analysis of summary data from the contributing cohorts, is often a statistically inefficient approach for the detection of gene-environment interactions. Ideally, single, very large and well-genotyped prospective cohorts, with validated measures of environmental risk factor and disease outcomes should be used to study interactions. The presence of strong founder effects within those cohorts might further strengthen the capacity to detect novel genetic effects and gene-environment interactions. Access to accurate genealogical data would also aid in studying the diploid nature of the human genome, such as genomic imprinting (parent-of-origin effects). Here we describe two studies from northern Sweden (the GLACIER and VIKING studies) that fulfill these characteristics.

Design of Knowledge Management System for Diabetic Complication Diseases

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Fiarni, Cut

2017-01-01

This paper examines how to develop a Model for Knowledge Management System (KMS) for diabetes complication diseases. People with diabetes have a higher risk of developing a series of serious health problems. Each patient has different condition that could lead to different disease and health problem. But, with the right information, patient could have early detection so the health risk could be minimized and avoided. Hence, the objective of this research is to propose a conceptual framework that integrates social network model, Knowledge Management activities, and content based reasoning (CBR) for designing such a diabetes health and complication disease KMS. The framework indicates that the critical knowledge management activities are in the process to find similar case and the index table for algorithm to fit the framework for the social media. With this framework, KMS developers can work with healthcare provider to easily identify the suitable IT associated with the CBR process when developing a diabetes KMS.

Current therapeutic molecules and targets in neurodegenerative diseases based on in silico drug design.

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Sehgal, Sheikh Arslan; Hammad, Mirza A; Tahir, Rana Adnan; Akram, Hafiza Nisha; Ahmad, Faheem

2018-03-15

As the number of elderly persons increases, neurodegenerative diseases are becoming ubiquitous. There is currently a great need for knowledge concerning management of old-age neurodegenerative diseases; the most important of which are: Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis, and Huntington's disease. To summarize the potential of computationally predicted molecules and targets against neurodegenerative diseases. Review of literature published since 1997 against neurodegenerative diseases, utilizing as keywords: in silico, Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis ALS, and Huntington's disease. Due to the costs associated with experimentation and current ethical law, performing experiments directly on living organisms has become much more difficult. In this scenario, in silico techniques have been successful and have become powerful tools in the search to cure disease. Researchers use the Computer Aided Drug Design pipeline which: 1) generates 3-dimensional structures of target proteins through homology modeling 2) achieves stabilization through molecular dynamics simulation, and 3) exploits molecular docking through large compound libraries. Next generation sequencing is continually producing enormous amounts of raw sequence data while neuroimaging is producing a multitude of raw image data. To solve such pressing problems, these new tools and algorithms are required. This review elaborates precise in silico tools and techniques for drug targets, active molecules, and molecular docking studies, together with future prospects and challenges concerning possible breakthroughs in Alzheimer's, Parkinson's, Amyotrophic Lateral Sclerosis, and Huntington's disease. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The chronic kidney disease outcomes and practice patterns study Brazil (CKDopps-Brazil: Design, data and methodology

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Rodrigo Bueno de Oliveira

2014-03-01

Full Text Available Introduction: The chronic kidney disease outcomes and practice patterns study (CKDopps is an international observational, prospective, cohort study involving patients with chronic kidney disease (CKD stages 3-5 [estimated glomerular filtration rate (eGFR < 60 ml/min/1.73 m2, with a major focus upon care during the advanced CKD period (eGFR < 30 ml/min/1.73 m2]. During a 1-year enrollment period, each one of the 22 selected clinics will enroll up to 60 advanced CKD patients (eGFR < 30 ml/min/1.73 m2 and not dialysis-dependent and 20 earlier stage CKD patients (eGFR between 30-59 ml/min/1.73 m2. Exclusion criteria: age < 18 years old, patients on chronic dialysis or prior kidney transplant. The study timeline include up to one year for enrollment of patients at each clinic starting in the end of 2013, followed by up to 2-3 years of patient follow-up with collection of detailed longitudinal patient-level data, annual clinic practice-level surveys, and patient surveys. Analyses will apply regression models to evaluate the contribution of patient-level and clinic practice-level factors to study outcomes, and utilize instrumental variable-type techniques when appropriate. Conclusion: Launching in 2013, CKDopps Brazil will study advanced CKD care in a random selection of nephrology clinics across Brazil to gain understanding of variation in care across the country, and as part of a multinational study to identify optimal treatment practices to slow kidney disease progression and improve outcomes during the transition period to end-stage kidney disease.

Education and coronary heart disease: mendelian randomisation study.

Science.gov (United States)

Tillmann, Taavi; Vaucher, Julien; Okbay, Aysu; Pikhart, Hynek; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Tamosiunas, Abdonas; Malyutina, Sofia; Hartwig, Fernando Pires; Fischer, Krista; Veronesi, Giovanni; Palmer, Tom; Bowden, Jack; Davey Smith, George; Bobak, Martin; Holmes, Michael V

2017-08-30

Objective  To determine whether educational attainment is a causal risk factor in the development of coronary heart disease. Design  Mendelian randomisation study, using genetic data as proxies for education to minimise confounding. Setting  The main analysis used genetic data from two large consortia (CARDIoGRAMplusC4D and SSGAC), comprising 112 studies from predominantly high income countries. Findings from mendelian randomisation analyses were then compared against results from traditional observational studies (164 170 participants). Finally, genetic data from six additional consortia were analysed to investigate whether longer education can causally alter the common cardiovascular risk factors. Participants  The main analysis was of 543 733 men and women (from CARDIoGRAMplusC4D and SSGAC), predominantly of European origin. Exposure  A one standard deviation increase in the genetic predisposition towards higher education (3.6 years of additional schooling), measured by 162 genetic variants that have been previously associated with education. Main outcome measure  Combined fatal and non-fatal coronary heart disease (63 746 events in CARDIoGRAMplusC4D). Results  Genetic predisposition towards 3.6 years of additional education was associated with a one third lower risk of coronary heart disease (odds ratio 0.67, 95% confidence interval 0.59 to 0.77; P=3×10 -8 ). This was comparable to findings from traditional observational studies (prevalence odds ratio 0.73, 0.68 to 0.78; incidence odds ratio 0.80, 0.76 to 0.83). Sensitivity analyses were consistent with a causal interpretation in which major bias from genetic pleiotropy was unlikely, although this remains an untestable possibility. Genetic predisposition towards longer education was additionally associated with less smoking, lower body mass index, and a favourable blood lipid profile. Conclusions  This mendelian randomisation study found support for the hypothesis that low education is a causal risk

Reducing selection bias in case-control studies from rare disease registries.

Science.gov (United States)

Cole, J Alexander; Taylor, John S; Hangartner, Thomas N; Weinreb, Neal J; Mistry, Pramod K; Khan, Aneal

2011-09-12

In clinical research of rare diseases, where small patient numbers and disease heterogeneity limit study design options, registries are a valuable resource for demographic and outcome information. However, in contrast to prospective, randomized clinical trials, the observational design of registries is prone to introduce selection bias and negatively impact the validity of data analyses. The objective of the study was to demonstrate the utility of case-control matching and the risk-set method in order to control bias in data from a rare disease registry. Data from the International Collaborative Gaucher Group (ICGG) Gaucher Registry were used as an example. A case-control matching analysis using the risk-set method was conducted to identify two groups of patients with type 1 Gaucher disease in the ICGG Gaucher Registry: patients with avascular osteonecrosis (AVN) and those without AVN. The frequency distributions of gender, decade of birth, treatment status, and splenectomy status were presented for cases and controls before and after matching. Odds ratios (and 95% confidence intervals) were calculated for each variable before and after matching. The application of case-control matching methodology results in cohorts of cases (i.e., patients with AVN) and controls (i.e., patients without AVN) who have comparable distributions for four common parameters used in subject selection: gender, year of birth (age), treatment status, and splenectomy status. Matching resulted in odds ratios of approximately 1.00, indicating no bias. We demonstrated bias in case-control selection in subjects from a prototype rare disease registry and used case-control matching to minimize this bias. Therefore, this approach appears useful to study cohorts of heterogeneous patients in rare disease registries.

Research strategies and the use of nutrient biomarkers in studies of diet and chronic disease.

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Prentice, Ross L; Sugar, Elizabeth; Wang, C Y; Neuhouser, Marian; Patterson, Ruth

2002-12-01

To provide an account of the state of diet and chronic disease research designs and methods; to discuss the role and potential of aggregate and analytical observational studies and randomised controlled intervention trials; and to propose strategies for strengthening each type of study, with particular emphasis on the use of nutrient biomarkers in cohort study settings. Observations from diet and disease studies conducted over the past 25 years are used to identify the strengths and weaknesses of various study designs that have been used to associate nutrient consumption with chronic disease risk. It is argued that a varied research programme, employing multiple study designs, is needed in response to the widely different biases and constraints that attend aggregate and analytical epidemiological studies and controlled intervention trials. Study design modifications are considered that may be able to enhance the reliability of aggregate and analytical nutritional epidemiological studies. Specifically, the potential of nutrient biomarker measurements that provide an objective assessment of nutrient consumption to enhance analytical study reliability is emphasised. A statistical model for combining nutrient biomarker data with self-report nutrient consumption estimates is described, and related ongoing work on odds ratio parameter estimation is outlined briefly. Finally, a recently completed nutritional biomarker study among 102 postmenopausal women in Seattle is mentioned. The statistical model will be applied to biomarker data on energy expenditure, urinary nitrogen, selected blood fatty acid measurements and various blood micronutrient concentrations, and food frequency self-report data, to identify study subject characteristics, such as body mass, age or socio-economic status, that may be associated with the measurement properties of food frequency nutrient consumption estimates. This information will be crucial for the design of a potential larger nutrient

PRELIMINARY REPORT ON NATIONWIDE STUDY OF DRINKING WATER AND CARDIOVASCULAR DISEASES

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This study was designed to further investigate the association(s) of cardiovascular diseases and drinking water constituents. A sample of 4200 adults were randomly selected from 35 geographic areas to represent the civilian noninstitutionalized population of the contiguous United...

A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

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Randall A. Kramer

2014-05-01

Full Text Available The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1 a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2 vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding. The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

A randomized longitudinal factorial design to assess malaria vector control and disease management interventions in rural Tanzania.

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Kramer, Randall A; Mboera, Leonard E G; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H; Paul, Christopher J; Miranda, Marie Lynn

2014-05-16

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

Falls in people with chronic obstructive pulmonary disease: An observational cohort study

DEFF Research Database (Denmark)

Roig, Marc; Eng, Janice J; MacIntyre, Donna L

2011-01-01

STUDY OBJECTIVE: To investigate incidence, risk factors and impact of falls on health related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD). DESIGN: Observational cohort study. METHODS: Patients completed these questionnaires at baseline and at 6-months...

Designing exposure registries for improved tracking of occupational exposure and disease.

Science.gov (United States)

Arrandale, Victoria H; Bornstein, Stephen; King, Andrew; Takaro, Timothy K; Demers, Paul A

2016-06-27

Registries are one strategy for collecting information on occupational exposure and disease in populations. Recently leaders in the Canadian occupational health and safety community have shown an interest in the use of occupational exposure registries. The primary goal of this study was to review a series of Canadian exposure registries to identify their strengths and weaknesses as a tool for tracking occupational exposure and disease in Canada. A secondary goal was to identify the features of an exposure registry needed to specifically contribute to prevention, including the identification of new exposure-disease relationships. A documentary review of five exposure registries from Canada was completed. Strengths and limitations of the registries were compared and key considerations for designing new registries were identified. The goals and structure of the exposure registries varied considerably. Most of the reviewed registries had voluntary registration, which presents challenges for the use of the data for either surveillance or epidemiology. It is recommended that eight key issues be addressed when planning new registries: clear registry goal(s), a definition of exposure, data to be collected (and how it will be used), whether enrolment will be mandatory, as well as ethical, privacy and logistical considerations. When well constructed, an exposure registry can be a valuable tool for surveillance, epidemiology and ultimately the prevention of occupational disease. However, exposure registries also have a number of actual and potential limitations that need to be considered.

Reducing selection bias in case-control studies from rare disease registries

Directory of Open Access Journals (Sweden)

Mistry Pramod K

2011-09-01

Full Text Available Abstract Background In clinical research of rare diseases, where small patient numbers and disease heterogeneity limit study design options, registries are a valuable resource for demographic and outcome information. However, in contrast to prospective, randomized clinical trials, the observational design of registries is prone to introduce selection bias and negatively impact the validity of data analyses. The objective of the study was to demonstrate the utility of case-control matching and the risk-set method in order to control bias in data from a rare disease registry. Data from the International Collaborative Gaucher Group (ICGG Gaucher Registry were used as an example. Methods A case-control matching analysis using the risk-set method was conducted to identify two groups of patients with type 1 Gaucher disease in the ICGG Gaucher Registry: patients with avascular osteonecrosis (AVN and those without AVN. The frequency distributions of gender, decade of birth, treatment status, and splenectomy status were presented for cases and controls before and after matching. Odds ratios (and 95% confidence intervals were calculated for each variable before and after matching. Results The application of case-control matching methodology results in cohorts of cases (i.e., patients with AVN and controls (i.e., patients without AVN who have comparable distributions for four common parameters used in subject selection: gender, year of birth (age, treatment status, and splenectomy status. Matching resulted in odds ratios of approximately 1.00, indicating no bias. Conclusions We demonstrated bias in case-control selection in subjects from a prototype rare disease registry and used case-control matching to minimize this bias. Therefore, this approach appears useful to study cohorts of heterogeneous patients in rare disease registries.

Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention 'ReumaUitgedaagd!' for Adults With a Rheumatic Disease: Results of a Usability Study and Design for a Randomized Control Trail.

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Ammerlaan, Judy W; Mulder, Olga K; de Boer-Nijhof, Nienke C; Maat, Bertha; Kruize, Aike A; van Laar, Jaap; van Os-Medendorp, Harmieke; Geenen, Rinie

2016-06-23

The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization

Towards a European Framework to Monitor Infectious Diseases among Migrant Populations: Design and Applicability

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Flavia Riccardo

2015-09-01

Full Text Available There are limitations in our capacity to interpret point estimates and trends of infectious diseases occurring among diverse migrant populations living in the European Union/European Economic Area (EU/EEA. The aim of this study was to design a data collection framework that could capture information on factors associated with increased risk to infectious diseases in migrant populations in the EU/EEA. The authors defined factors associated with increased risk according to a multi-dimensional framework and performed a systematic literature review in order to identify whether those factors well reflected the reported risk factors for infectious disease in these populations. Following this, the feasibility of applying this framework to relevant available EU/EEA data sources was assessed. The proposed multidimensional framework is well suited to capture the complexity and concurrence of these risk factors and in principle applicable in the EU/EEA. The authors conclude that adopting a multi-dimensional framework to monitor infectious diseases could favor the disaggregated collection and analysis of migrant health data.

The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients.

Science.gov (United States)

Ederer, F; Gaasterland, D E; Sullivan, E K

1994-08-01

Medical therapy has been the standard initial treatment for open-angle glaucoma. When some visual field has been lost and maximum tolerated and effective medical therapy does not succeed in controlling the disease, the patient is considered to have advanced glaucoma, and the first of a potential sequence of surgical treatments is usually indicated. Little is known about the long-term course and prognosis of advanced glaucoma or about the long-term effectiveness of sequential surgical treatments in controlling the disease and preventing vision loss and blindness. The Advanced Glaucoma Intervention Study was designed to study, in advanced glaucoma, the long-term clinical course and prognosis, and, in a randomized trial, the comparative outcomes of two sequences of surgical treatments. Toward these goals, 789 eyes in 591 patients were enrolled at 11 clinical centers between 1988 and 1992. Follow-up will continue until 1996. Eyes were randomly assigned to one of two sequences of surgical treatments. One sequence begins with argon laser trabeculoplasty (ALT), is followed by trabeculectomy, an incisional surgical filtering procedure, should ALT fail to control the disease, and by a second trabeculectomy should the first trabeculectomy fail. The other sequence begins with trabeculectomy, is followed by ALT should the trabeculectomy fail, and by a second trabeculectomy should ALT fail. The main outcome of interest is visual function (visual field and visual acuity). Other important outcomes are intraocular pressure, complications of surgery, time to treatment failure, and extent of need for additional medical therapy. We present in this paper the rationale, objectives, design and methods of the study, and the baseline characteristics of study patients and eyes.

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

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Montoliu-Gaya, Laia; Villegas, Sandra

2015-12-15

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

TOWARDS LANDSCAPE DESIGN GUIDELINES FOR REDUCING LYME DISEASE RISK

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Incidence of Lyme disease in the United States continues to grow. Low-density development is also increasing in endemic regions, raising questions about the relationship between development pattern and disease. This study sought to model Lyme disease incidence rate using quanti...

Risk and protective factors for meningococcal disease in adolescents: matched cohort study

OpenAIRE

Tully, Joanna; Viner, Russell M; Coen, Pietro G; Stuart, James M; Zambon, Maria; Peckham, Catherine; Booth, Clare; Klein, Nigel; Kaczmarski, Ed; Booy, Robert

2006-01-01

Objective: To examine biological and social risk factors for meningococcal disease in adolescents. Design: Prospective, population based, matched cohort study with controls matched for age and sex in 1:1 matching. Controls were sought from the general practitioner. Setting: Six contiguous regions of England, which represent some 65% of the country’s population. Participants: 15-19 year olds with meningococcal disease recruited at hospital admission in six regions (repr...

Association between periodontal diseases and systemic diseases

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Patrícia Weidlich

2008-08-01

Full Text Available Current evidence suggests that periodontal disease may be associated with systemic diseases. This paper reviewed the published data about the relationship between periodontal disease and cardiovascular diseases, adverse pregnancy outcomes, diabetes and respiratory diseases, focusing on studies conducted in the Brazilian population. Only a few studies were found in the literature focusing on Brazilians (3 concerning cardiovascular disease, 7 about pregnancy outcomes, 9 about diabetes and one regarding pneumonia. Although the majority of them observed an association between periodontitis and systemic conditions, a causal relationship still needs to be demonstrated. Further studies, particularly interventional well-designed investigations, with larger sample sizes, need to be conducted in Brazilian populations.

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

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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.

A Review of Study Designs and Statistical Methods for Genomic Epidemiology Studies using Next Generation Sequencing

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Qian eWang

2015-04-01

Full Text Available Results from numerous linkage and association studies have greatly deepened scientists’ understanding of the genetic basis of many human diseases, yet some important questions remain unanswered. For example, although a large number of disease-associated loci have been identified from genome-wide association studies (GWAS in the past 10 years, it is challenging to interpret these results as most disease-associated markers have no clear functional roles in disease etiology, and all the identified genomic factors only explain a small portion of disease heritability. With the help of next-generation sequencing (NGS, diverse types of genomic and epigenetic variations can be detected with high accuracy. More importantly, instead of using linkage disequilibrium to detect association signals based on a set of pre-set probes, NGS allows researchers to directly study all the variants in each individual, therefore promises opportunities for identifying functional variants and a more comprehensive dissection of disease heritability. Although the current scale of NGS studies is still limited due to the high cost, the success of several recent studies suggests the great potential for applying NGS in genomic epidemiology, especially as the cost of sequencing continues to drop. In this review, we discuss several pioneer applications of NGS, summarize scientific discoveries for rare and complex diseases, and compare various study designs including targeted sequencing and whole-genome sequencing using population-based and family-based cohorts. Finally, we highlight recent advancements in statistical methods proposed for sequencing analysis, including group-based association tests, meta-analysis techniques, and annotation tools for variant prioritization.

Cigarette package design: opportunities for disease prevention.

Science.gov (United States)

Difranza, J R; Clark, D M; Pollay, R W

2002-06-15

To learn how cigarette packages are designed and to determine to what extent cigarette packages are designed to target children. A computer search was made of all Internet websites that post tobacco industry documents using the search terms: packaging, package design, package study, box design, logo, trademark and design study. All documents were retrieved electronically and analyzed by the first author for recurrent themes. Cigarette manufacturers devote a great deal of attention and expense to package design because it is central to their efforts to create brand images. Colors, graphic elements, proportioning, texture, materials and typography are tested and used in various combinations to create the desired product and user images. Designs help to create the perceived product attributes and project a personality image of the user with the intent of fulfilling the psychological needs of the targeted type of smoker. The communication of these images and attributes is conducted through conscious and subliminal processes. Extensive testing is conducted using a variety of qualitative and quantitative research techniques. The promotion of tobacco products through appealing imagery cannot be stopped without regulating the package design. The same marketing research techniques used by the tobacco companies can be used to design generic packaging and more effective warning labels targeted at specific consumers.

Designing and implementing an electronic dashboard for disease outbreaks response - Case study of the 2013-2014 Somalia Polio outbreak response dashboard.

Science.gov (United States)

Kamadjeu, Raoul; Gathenji, Caroline

2017-01-01

In April 2013, a case of wild polio virus (WPV) was detected in the Somalia capital Mogadishu. This inaugurated what is now referred to as the 2013-2014 Horn of Africa Polio outbreak with cases reported in Somalia, Kenya and Ethiopia. By the notification of the last polio case in August 2014, 223 cases of WPV had been reported in Somalia, Kenya and Ethiopia of which 199 in Somalia alone. The outbreak response required timely exchange of information between the outbreak response coordination unit (in Nairobi) and local staff located in multiple locations inside the country. The need to track and timely respond to information requests, to satisfy the information/data needs of polio partners and to track key outbreak response performance indicators dictated the need to urgently set up an online dashboard. The Somalia Polio Room dashboard provided a graphical display of the polio outbreak data to track progress and inform decision making. The system was designed using free and open sources components and seamlessly integrated existing polio surveillance data for real time monitoring of key outbreak response performance indicators. In this article, we describe the design and operation of an electronic dashboard for disease surveillance in an outbreak situation and used the lessons learned to propose key design considerations and functional requirements for online electronic dashboards for disease outbreak response.

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

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

2017-08-01

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

THE APPROACHES TO DESIGNING OF NEW GENERATION VACCINES AGAINST THE SHEEP POX DISEASE

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E. F. Yilmaz

2016-12-01

Full Text Available In this review the authors analyzed the sheep pox disease, which occurs outbreaks all over the world particularly in Asia and Africa causing substantial losses in trade of animal and animal products. They categorized the sheep pox disease is one of the prioritized groups of diseases against which the World Organization for Animal Health is fighting. Data concerning a sheep poxes’ history, epidemiology, epizootiology, mortality and economic impact, clinical and pathological signs, features of capripoxvirus that forms the disease are given. Diagnosis treatment and vaccine have been investigated as well. The main conclusion is done according which the designing of new vaccine generation against the sheep pox disease could be as an alternative approach against sheep pox.

Cigarette package design: opportunities for disease prevention

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Pollay RW

2003-01-01

Full Text Available Abstract Objective To learn how cigarette packages are designed and to determine to what extent cigarette packages are designed to target children. Methods A computer search was made of all Internet websites that post tobacco industry documents using the search terms: packaging, package design, package study, box design, logo, trademark and design study. All documents were retrieved electronically and analyzed by the first author for recurrent themes. Data Synthesis Cigarette manufacturers devote a great deal of attention and expense to package design because it is central to their efforts to create brand images. Colors, graphic elements, proportioning, texture, materials and typography are tested and used in various combinations to create the desired product and user images. Designs help to create the perceived product attributes and project a personality image of the user with the intent of fulfilling the psychological needs of the targeted type of smoker. The communication of these images and attributes is conducted through conscious and subliminal processes. Extensive testing is conducted using a variety of qualitative and quantitative research techniques. Conclusion The promotion of tobacco products through appealing imagery cannot be stopped without regulating the package design. The same marketing research techniques used by the tobacco companies can be used to design generic packaging and more effective warning labels targeted at specific consumers.

Peripheral Arterial Disease Study (PERART: Prevalence and predictive values of asymptomatic peripheral arterial occlusive disease related to cardiovascular morbidity and mortality

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Bundó Magda

2007-12-01

Full Text Available Abstract Background The early diagnosis of atherosclerotic disease is essential for developing preventive strategies in populations at high risk and acting when the disease is still asymptomatic. A low ankle-arm index (AAI is a good marker of vascular events and may be diminished without presenting symptomatology (silent peripheral arterial disease. The aim of the PERART study (PERipheral ARTerial disease is to determine the prevalence of peripheral arterial disease (both silent and symptomatic in a general population of both sexes and determine its predictive value related to morbimortality (cohort study. Methods/Design This cross-over, cohort study consists of 2 phases: firstly a descriptive, transversal cross-over study to determine the prevalence of peripheral arterial disease, and secondly, a cohort study to evaluate the predictive value of AAI in relation to cardiovascular morbimortality. From September 2006 to June 2007, a total of 3,010 patients over the age of 50 years will be randomly selected from a population adscribed to 24 healthcare centres in the province of Barcelona (Spain. The diagnostic criteria of peripheral arterial disease will be considered as an AAI Discussion In this study we hope to determine the prevalence of peripheral arterial disease, especially the silent forms, in the general population and establish its relationship with cardiovascular morbimortality. A low AAI may be a better marker of arterial disease than the classical cardiovascular risk factors and may, therefore, contribute to improving the predictive value of the equations of cardiovascular risk and thereby allowing optimisation of multifactorial treatment of atherosclerotic disease.

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

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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

An ambient assisted living approach in designing domiciliary services combined with innovative technologies for patients with Alzheimer's disease: a case study.

Science.gov (United States)

Cavallo, Filippo; Aquilano, Michela; Arvati, Marco

2015-02-01

Alzheimer's disease (AD) is one of the most disabling diseases to affect large numbers of elderly people worldwide. Because of the characteristics of this disease, patients with AD require daily assistance from service providers both in nursing homes and at home. Domiciliary assistance has been demonstrated to be cost effective and efficient in the first phase of the disease, helping to slow down the course of the illness, improve the quality of life and care, and extend independence for patients and caregivers. In this context, the aim of this work is to demonstrate the technical effectiveness and acceptability of an innovative domiciliary smart sensor system for providing domiciliary assistance to patients with AD which has been developed with an Ambient Assisted Living (AAL) approach. The design, development, testing, and evaluation of the innovative technological solution were performed by a multidisciplinary team. In all, 15 sociomedical operators and 14 patients with AD were directly involved in defining the end-users' needs and requirements, identifying design principles with acceptability and usability features and evaluating the technological solutions before and after the real experimentation. A modular technological system was produced to help caregivers continuously monitor the health status, safety, and daily activities of patients with AD. During the experimentation, the acceptability, utility, usability, and efficacy of this system were evaluated as quite positive. The experience described in this article demonstrated that AAL technologies are feasible and effective nowadays and can be actively used in assisting patients with AD in their homes. The extensive involvement of caregivers in the experimentation allowed to assess that there is, through the use of the technological system, a proven improvement in care performance and efficiency of care provision by both formal and informal caregivers and consequently an increase in the quality of life of

Positive deviance study to inform a Chagas disease control program in southern Ecuador.

Science.gov (United States)

Nieto-Sanchez, Claudia; Baus, Esteban G; Guerrero, Darwin; Grijalva, Mario J

2015-05-01

Chagas disease is caused by Trypanosoma cruzi, which is mainly transmitted by the faeces of triatomine insects that find favourable environments in poorly constructed houses. Previous studies have documented persistent triatomine infestation in houses in the province of Loja in southern Ecuador despite repeated insecticide and educational interventions. We aim to develop a sustainable strategy for the interruption of Chagas disease transmission by promoting living environments that are designed to prevent colonisation of rural houses by triatomines. This study used positive deviance to inform the design of an anti-triatomine prototype house by identifying knowledge, attitudes and practices used by families that have remained triatomine-free (2010-2012). Positive deviants reported practices that included maintenance of structural elements of the house, fumigation of dwellings and animal shelters, sweeping with "insect repellent" plants and relocation of domestic animals away from the house, among others. Participants favoured construction materials that do not drastically differ from those currently used (adobe walls and tile roofs). They also expressed their belief in a clear connection between a clean house and health. The family's economic dynamics affect space use and must be considered in the prototype's design. Overall, the results indicate a positive climate for the introduction of housing improvements as a protective measure against Chagas disease in this region.

Evolutionary Meta-Analysis of Association Studies Reveals Ancient Constraints Affecting Disease Marker Discovery

Science.gov (United States)

Dudley, Joel T.; Chen, Rong; Sanderford, Maxwell; Butte, Atul J.; Kumar, Sudhir

2012-01-01

Genome-wide disease association studies contrast genetic variation between disease cohorts and healthy populations to discover single nucleotide polymorphisms (SNPs) and other genetic markers revealing underlying genetic architectures of human diseases. Despite scores of efforts over the past decade, many reproducible genetic variants that explain substantial proportions of the heritable risk of common human diseases remain undiscovered. We have conducted a multispecies genomic analysis of 5,831 putative human risk variants for more than 230 disease phenotypes reported in 2,021 studies. We find that the current approaches show a propensity for discovering disease-associated SNPs (dSNPs) at conserved genomic positions because the effect size (odds ratio) and allelic P value of genetic association of an SNP relates strongly to the evolutionary conservation of their genomic position. We propose a new measure for ranking SNPs that integrates evolutionary conservation scores and the P value (E-rank). Using published data from a large case-control study, we demonstrate that E-rank method prioritizes SNPs with a greater likelihood of bona fide and reproducible genetic disease associations, many of which may explain greater proportions of genetic variance. Therefore, long-term evolutionary histories of genomic positions offer key practical utility in reassessing data from existing disease association studies, and in the design and analysis of future studies aimed at revealing the genetic basis of common human diseases. PMID:22389448

Gleaning Insights from Fecal Microbiota Transplantation and Probiotic Studies for the Rational Design of Combination Microbial Therapies

Science.gov (United States)

Hudson, Lauren E.; Anderson, Sarah E.; Corbett, Anita H.

2016-01-01

SUMMARY Beneficial microorganisms hold promise for the treatment of numerous gastrointestinal diseases. The transfer of whole microbiota via fecal transplantation has already been shown to ameliorate the severity of diseases such as Clostridium difficile infection, inflammatory bowel disease, and others. However, the exact mechanisms of fecal microbiota transplant efficacy and the particular strains conferring this benefit are still unclear. Rationally designed combinations of microbial preparations may enable more efficient and effective treatment approaches tailored to particular diseases. Here we use an infectious disease, C. difficile infection, and an inflammatory disorder, the inflammatory bowel disease ulcerative colitis, as examples to facilitate the discussion of how microbial therapy might be rationally designed for specific gastrointestinal diseases. Fecal microbiota transplantation has already shown some efficacy in the treatment of both these disorders; detailed comparisons of studies evaluating commensal and probiotic organisms in the context of these disparate gastrointestinal diseases may shed light on potential protective mechanisms and elucidate how future microbial therapies can be tailored to particular diseases. PMID:27856521

The KIzSS network, a sentinel surveillance system for infectious diseases in day care centers: study protocol

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Enserink Remko

2012-10-01

Full Text Available Abstract Background Day care-associated infectious diseases are widely recognized as a public health problem but rarely studied. Insights into their dynamics and their association with the day care setting are important for effective decision making in management of infectious disease control. This paper describes the purpose, design and potential of our national multi-center, day care-based sentinel surveillance network for infectious diseases (the KIzSS network. The aim of the KIzSS network is to acquire a long-term insight into the syndromic and microbiological aspects of day care-related infectious diseases and associated disease burden and to model these aspects with day care setting characteristics. Methods/design The KIzSS network applies a prospective cohort design, following day care centers rather than individual children or staff members over time. Data on infectious disease symptoms and related morbidity (children and staff, medical consumption, absenteeism and circulating enteric pathogens (children are collected on a daily, weekly or monthly basis. Every two years, a survey is performed to assess the characteristics of participating day care centers. Discussion The KIzSS network offers a unique potential to study infectious disease dynamics in the day care setting over a sustained period of time. The created (biodatabases will help us to assess day care-related disease burden of infectious diseases among attending children and staff and their relation with the day care setting. This will support the much needed development of evidence-based and pragmatic guidelines for infectious disease control in day care centers.

Sensitivity analysis by experimental design and metamodelling : case study on simulation in national animal disease control

NARCIS (Netherlands)

Vonk Noordegraaf, A.; Nielen, M.; Kleijnen, J.P.C.

2003-01-01

Simulation is a frequently applied tool in the discipline of animal health economics. Application of sensitivity analysis, however, is often limited to changing only one factor at a time (OAT designs). In this study, the statistical techniques of Design of Experiments (DOE) and regression

Designing satisfaction studies

DEFF Research Database (Denmark)

Kristensen, Kai; Eskildsen, Jacob Kjær

2007-01-01

In the effect sampling method, presentation of researcher, the intro text, the order of questions in the questionnaire along with the number of categories in the rating scale is tested in relation to the design of satisfaction studies. Based on the analyses specific recommendations for designing...... satisfaction studies are given....

Visual Design Principles: An Empirical Study of Design Lore

Science.gov (United States)

Kimball, Miles A.

2013-01-01

Many books, designers, and design educators talk about visual design principles such as balance, contrast, and alignment, but with little consistency. This study uses empirical methods to explore the lore surrounding design principles. The study took the form of two stages: a quantitative literature review to determine what design principles are…

The effectiveness of cognitive behavioral therapy on the quality of life of patients with inflammatory bowel disease: multi-center design and study protocol (KL!C- study

Directory of Open Access Journals (Sweden)

Evertsz’ Floor Bennebroek

2012-12-01

Full Text Available Abstract Background Inflammatory Bowel Disease (IBD patients report poorer quality of life (QoL and more anxiety and depressive symptoms than controls from the general population. Cognitive behavioral therapy (CBT is effective for anxiety and depression, but questionable in case of co-morbidity with IBD. Therefore, an adapted new CBT specifically designed for IBD patients was developed. The objective of this study is to evaluate the effectiveness of adapted CBT on QoL. Methods/design IBD patients with a poor level of mental QoL (score less than or equal to 23 on the mental health scale of SF-36 will be randomly assigned to the experimental (n = 40 or waiting-list control condition (n = 40. The experimental condition will then immediately start CBT. The waiting-list control condition will wait 3,5 months before CBT begins with pre- and post assessments. Both conditions will complete a baseline and follow-up assessment following CBT and a mid-treatment assessment. The primary outcome is IBD-specific QoL (IBDQ. Secondary outcomes are generic QoL (SF-36 and anxiety and depression complaints (HADS, CES-D. Additionally, we will examine the working mechanism of the psychological intervention by investigating the impact of the intervention on illness-related cognitions, attitudes, coping styles and their associations with outcome. Data will be analysed on an intention to treat (ITT as well as treatment completer basis (greater than or equal to five sessions followed. Discussion If found effective, this IBD-specific CBT is a first step to enhance poor QoL in IBD patients and possibly, other gastroenterological diseases. By enhancing IBD patients’ QoL, we may also improve their mental and physical health, and lower unnecessary health care consumption. Trial registration number NTR (TC = 1869

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

Science.gov (United States)

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

Mortality due to noncommunicable diseases in Brazil, 1990 to 2015, according to estimates from the Global Burden of Disease study

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Deborah Carvalho Malta

Full Text Available ABSTRACT CONTEXT AND OBJECTIVE: Noncommunicable diseases (NCDs are the leading health problem globally and generate high numbers of premature deaths and loss of quality of life. The aim here was to describe the major groups of causes of death due to NCDs and the ranking of the leading causes of premature death between 1990 and 2015, according to the Global Burden of Disease (GBD 2015 study estimates for Brazil. DESIGN AND SETTING: Cross-sectional study covering Brazil and its 27 federal states. METHODS: This was a descriptive study on rates of mortality due to NCDs, with corrections for garbage codes and underreporting of deaths. RESULTS: This study shows the epidemiological transition in Brazil between 1990 and 2015, with increasing proportional mortality due to NCDs, followed by violence, and decreasing mortality due to communicable, maternal and neonatal causes within the global burden of diseases. NCDs had the highest mortality rates over the whole period, but with reductions in cardiovascular diseases, chronic respiratory diseases and cancer. Diabetes increased over this period. NCDs were the leading causes of premature death (30 to 69 years: ischemic heart diseases and cerebrovascular diseases, followed by interpersonal violence, traffic injuries and HIV/AIDS. CONCLUSION: The decline in mortality due to NCDs confirms that improvements in disease control have been achieved in Brazil. Nonetheless, the high mortality due to violence is a warning sign. Through maintaining the current decline in NCDs, Brazil should meet the target of 25% reduction proposed by the World Health Organization by 2025.

Case-control study on uveal melanoma (RIFA: rational and design

Directory of Open Access Journals (Sweden)

Schmidt-Pokrzywniak Andrea

2004-08-01

Full Text Available Abstract Background Although a rare disease, uveal melanoma is the most common primary intraocular malignancy in adults, with an incidence rate of up to 1.0 per 100,000 persons per year in Europe. Only a few consistent risk factors have been identified for this disease. We present the study design of an ongoing incident case-control study on uveal melanoma (acronym: RIFA study that focuses on radiofrequency radiation as transmitted by radio sets and wireless telephones, occupational risk factors, phenotypical characteristics, and UV radiation. Methods/Design We conduct a case-control study to identify the role of different exposures in the development of uveal melanoma. The cases of uveal melanoma were identified at the Division of Ophthalmology, University of Essen, a referral centre for tumours of the eye. We recruit three control groups: population controls, controls sampled from those ophthalmologists who referred cases to the Division of Ophthalmology, University of Duisburg-Essen, and sibling controls. For each case the controls are matched on sex and age (five year groups, except for sibling controls. The data are collected from the study participants by short self-administered questionnaire and by telephone interview. During and at the end of the field phase, the data are quality-checked. To estimate the effect of exposures on uveal melanoma risk, we will use conditional logistic regression that accounts for the matching factors and allows to control for potential confounding.

Risk and protective factors for Parkinson's disease: a study in Swedish twins.

Science.gov (United States)

Wirdefeldt, Karin; Gatz, Margaret; Pawitan, Yudi; Pedersen, Nancy L

2005-01-01

Many studies have shown a protective effect of cigarette smoking on Parkinson's disease. However, criticism has been raised concerning confounding by genetic factors. We investigated the associations between Parkinson's disease and smoking, alcohol, coffee, area of living, and education in a co-twin control study. Because twins are matched for genetic and familial environmental factors, this design controls for confounding by these factors. We also examined control subjects unrelated to cases. Exposure information was taken from questionnaires answered in the 1960s and 1970s. Parkinson's disease cases were identified through the Swedish Inpatient Discharge Register (IDR) and the Cause of Death Register. In the unrelated control subject comparison, 476 Parkinson's disease cases and 2,380 control subjects were included. In the co-twin control comparison, 415 same-sex twin pairs were included. There was an inverse association between smoking and Parkinson's disease using unrelated control subjects and co-twin control cases. There was no association between Parkinson's disease and alcohol, coffee, or area of living. High educational level was associated with Parkinson's disease in the unrelated control subject comparison but not in the co-twin control comparison. We confirm the protective effect of smoking on Parkinson's disease and establish that the association is only partially explained by genetic and familial environmental factors.

Testing the Developmental Origins of Health and Disease Hypothesis for Psychopathology Using Family-Based Quasi-Experimental Designs

Science.gov (United States)

D’Onofrio, Brian M.; Class, Quetzal A.; Lahey, Benjamin B.; Larsson, Henrik

2014-01-01

The Developmental Origin of Health and Disease (DOHaD) hypothesis is a broad theoretical framework that emphasizes how early risk factors have a causal influence on psychopathology. Researchers have raised concerns about the causal interpretation of statistical associations between early risk factors and later psychopathology because most existing studies have been unable to rule out the possibility of environmental and genetic confounding. In this paper we illustrate how family-based quasi-experimental designs can test the DOHaD hypothesis by ruling out alternative hypotheses. We review the logic underlying sibling-comparison, co-twin control, offspring of siblings/twins, adoption, and in vitro fertilization designs. We then present results from studies using these designs focused on broad indices of fetal development (low birth weight and gestational age) and a particular teratogen, smoking during pregnancy. The results provide mixed support for the DOHaD hypothesis for psychopathology, illustrating the critical need to use design features that rule out unmeasured confounding. PMID:25364377

Positive deviance study to inform a Chagas disease control program in southern Ecuador

Directory of Open Access Journals (Sweden)

Claudia Nieto-Sanchez

2015-05-01

Full Text Available Chagas disease is caused by Trypanosoma cruzi, which is mainly transmitted by the faeces of triatomine insects that find favourable environments in poorly constructed houses. Previous studies have documented persistent triatomine infestation in houses in the province of Loja in southern Ecuador despite repeated insecticide and educational interventions. We aim to develop a sustainable strategy for the interruption of Chagas disease transmission by promoting living environments that are designed to prevent colonisation of rural houses by triatomines. This study used positive deviance to inform the design of an anti-triatomine prototype house by identifying knowledge, attitudes and practices used by families that have remained triatomine-free (2010-2012. Positive deviants reported practices that included maintenance of structural elements of the house, fumigation of dwellings and animal shelters, sweeping with "insect repellent" plants and relocation of domestic animals away from the house, among others. Participants favoured construction materials that do not drastically differ from those currently used (adobe walls and tile roofs. They also expressed their belief in a clear connection between a clean house and health. The family's economic dynamics affect space use and must be considered in the prototype's design. Overall, the results indicate a positive climate for the introduction of housing improvements as a protective measure against Chagas disease in this region.

Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM – a Pan Canadian cohort study

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Sonia S. Anand

2016-07-01

Full Text Available Abstract Background The Canadian Alliance for Healthy Hearts and Minds (CAHHM is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Methods/Design Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity, cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. Discussion CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

Using mixed methods to investigate factors influencing reporting of livestock diseases: a case study among smallholders in Bolivia.

Science.gov (United States)

Limon, Georgina; Lewis, Elisa G; Chang, Yu-Mei; Ruiz, Hugo; Balanza, Maria Elba; Guitian, Javier

2014-02-01

Livestock disease surveillance is particularly challenging in resource-scarce settings, where disease events are often unreported. Surveillance performance is determined as much by the quantifiable biological attributes of the disease, as it is by motivations and barriers perceived by livestock keepers for disease reporting. Mixed methods designs, which integrate the collection, analysis and interpretation of qualitative and quantitative data in a single study, are increasingly used across different disciplines. These designs allow for a deeper exploration of the topic under investigation, than can be achieved by either approach alone. In this study a mixed methods design was used in order to gain a greater understanding of the factors that influence reporting of livestock diseases in Bolivia. There is a need to strengthen passive surveillance in this country, among other reasons as part of an eradication programme for Foot and Mouth Disease (FMD). Findings revealed livestock keepers in the study area were extremely unlikely to report the occurrence of livestock health events to the Official Veterinary Services (OVS). Communication outside the local community occurs more often through alternative routes and this is positively correlated with disease awareness. The main barriers to disease reporting identified were a lack of institutional credibility and the conflicting priorities of the OVS and livestock keepers. As for other animal and human diseases across the developing world, passive surveillance of livestock diseases in Bolivia should be enhanced; this is urgent in view of the current FMD eradication programme. Increasing timeliness and smallholders' participation requires a detailed understanding of their likely actions and perceived barriers towards disease reporting. These insights are most likely to be developed through a holistic mixed methods approach of quantitative and qualitative analyses. Copyright © 2013 The Authors. Published by Elsevier B.V. All

Design and development of a mobile app for Ménière disease patients

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Jorge REY-MARTÍNEZ

2018-01-01

Full Text Available Introduction and objective: The application of information and communication technologies to health care is contributing to a real revolution in health care field. Current medicine is benefiting from the rapid and extraordinary technological development of "smart" mobile phones and tablets. The mobile medicine (mHealth allows, among other advantages, a better monitoring and tracking of the symptomatology of the patients. This fact not only facilitates the clinical follow-up, improving care, but also helps patients to be jointly responsible for their own health, contributing to improve their quality of life. Computer applications designed specifically for these devices (apps are especially useful for monitoring chronic diseases, such as Ménière's disease. Method: In this work, the process of design, development and publication of an app called "Ménière" is detailed, this app is designed to help patients and their doctors to track and follow this disease. Results: The app was developed for the iOS operating system using the Xcode software development kit, using Swift and Objective-C as programming languages. Special attention was paid to privacy, security, usability, veracity and transparency. Conclusions: This application provides the patient with a complete and versatile tool to monitor their symptoms.

Study designs to enhance identification of genetic factors in healthy aging.

Science.gov (United States)

Manolio, Teri A

2007-12-01

The sequencing of the human genome and the growing understanding of its function are providing powerful new research tools for identifying genetic variants that are associated with complex diseases and traits. Somewhat less emphasis has been given to genes related to healthy aging, although the approaches for studying health-related traits are analogous to those used for disease-related studies. A critical step prior to the design of such studies is to define a healthy aging phenotype, which should be standardized to permit comparisons across studies and should involve more than simple longevity. Phenotypes of particular value for genetic research are those with high heritability and close relationships to gene products or pathways, preferably with minimal or at least measurable environmental influences. Appropriate study designs to identify genotype-phenotype associations include family-based linkage studies, candidate gene association analyses, and genome-wide association studies. Advances in genotyping and sequencing technologies, and the generation of the human haplotype map database, now permit the cost-effective investigation of the very large sample sizes needed for genome-wide association studies in unrelated individuals. Challenges in interpretation and translation of such studies include assessing the potential for bias and confounding, as well as determining the clinical validity and utility of findings proposed for wider application. Many such studies are currently supported or being planned across the National Institutes of Health (NIH), and lend themselves to the kind of coordinated clinical research envisioned in programs such as the NIH Roadmap.

Engaging Teens with Asthma in Designing a Patient-Centered Mobile App to Aid Disease Self-Management.

Science.gov (United States)

Schneider, Tali; Panzera, Anthony D; Couluris, Marisa; Lindenberger, James; McDermott, Robert; Bryant, Carol A

2015-08-10

Despite the growing market of e-health disease self-management tools, few studies have reported the presence of teen patients in all phases of product design. While rates of American teens using mobile Internet grow, an opportunity to deliver disease self-management targeted for teen patients exists. Building on findings from previous investigations with teens with asthma, we explored teens' insights on the development of a patient-centered asthma management application (app). Two existing asthma apps were used by 16 teen asthmatics for 7-10 days. At the end of the trial period, in-depth interviews were conducted with each participant to gather insights about the user experience. Participants requested more asthma-related content that educates them about their condition. Suggested improvements to currently available apps included a longer list of selectable symptoms to track, medication tracking, and more compelling interface features. Participants showed interest in using apps for managing their asthma, yet recommended improvements on current design. Whereas national figures point to a more ubiquitous mobile device environment, implementation efforts must respond to participants' recommendations while minding lingering digital divides. Currently available apps lack appealing components that teens seek or desire. Subsequent development should include teens' participation in component design insights.

A Metabolome-Wide Study of Dry Eye Disease Reveals Serum Androgens as Biomarkers

NARCIS (Netherlands)

Vehof, Jelle; Hysi, Pirro G.; Hammond, Christopher J.

Purpose: To test the association between serum metabolites and dry eye disease (DED) using a hypothesisfree metabolomics approach. Design: Cross-sectional association study. Participants: A total of 2819 subjects from the population-representative TwinsUK cohort in the United Kingdom, with a mean

Climate Change Impacts on Waterborne Diseases: Moving Toward Designing Interventions.

Science.gov (United States)

Levy, Karen; Smith, Shanon M; Carlton, Elizabeth J

2018-06-01

Climate change threatens progress achieved in global reductions of infectious disease rates over recent decades. This review summarizes literature on potential impacts of climate change on waterborne diseases, organized around a framework of questions that can be addressed depending on available data. A growing body of evidence suggests that climate change may alter the incidence of waterborne diseases, and diarrheal diseases in particular. Much of the existing work examines historical relationships between weather and diarrhea incidence, with a limited number of studies projecting future disease rates. Some studies take social and ecological factors into account in considerations of historical relationships, but few have done so in projecting future conditions. The field is at a point of transition, toward incorporating social and ecological factors into understanding the relationships between climatic factors and diarrheal diseases and using this information for future projections. The integration of these components helps identify vulnerable populations and prioritize adaptation strategies.

Repository design sensitivity study: Engineering study report

International Nuclear Information System (INIS)

1987-01-01

A preliminary sensitivity study of the salt repository design has been performed to identify critical site and design parameters to help guide future site characterization and design optimization activities. The study considered the SCP-conceptual design at the Deaf Smith County site in Texas with the horizontal waste package emplacement mode as the base case. Relative to this base case, parameter variations were compared. Limited studies were performed which considered the vertical emplacement mode geometry. The report presents the reference data base and design parameters on which the study was based (including the range of parameters that might be expected). Detailed descriptions of the numerical modeling methods and assumptions are included for the thermal, thermomechanical and hydrogeological analyses. The impacts of parameter variations on the sensitivity of the rock mass response are discussed. Recommendations are provided to help guide site characterization activities and advanced conceptual design optimization activities. 47 refs., 119 refs., 22 tabs

Simultaneous Mutation Detection in 90 Retinal Disease Genes in Multiple Patients Using a Custom-designed 300-kb Retinal Resequencing Chip

NARCIS (Netherlands)

Booij, Judith C.; Bakker, Arne 1; Kulumbetova, Jamilia; Moutaoukil, Youssef; Smeets, Bert; Verheij, Joke; Kroes, Hester Y.; Klaver, Caroline C. W.; van Schooneveld, Mary; Bergen, Arthur A. B.; Florijn, Ralph J.

Purpose: To develop a high-throughput, cost-effective diagnostic strategy for the identification of known and new mutations in 90 retinal disease genes. Design: Evidence-based study. Participants: Sixty patients with a variety of retinal disorders, including Leber's congenital amaurosis, ocular

Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases.

Science.gov (United States)

Sawata, Hiroshi; Ueshima, Kenji; Tsutani, Kiichiro

2011-04-14

Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP) study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1) to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2) to find ways to improve the environment surrounding clinical trials in Japan more generally. We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization), websites of related medical societies, the University Hospital Medical Information Network (UMIN) Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs). Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5%) was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not disclosed. To improve the quality of clinical

Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases

Directory of Open Access Journals (Sweden)

Tsutani Kiichiro

2011-04-01

Full Text Available Abstract Background Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1 to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2 to find ways to improve the environment surrounding clinical trials in Japan more generally. Methods We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization, websites of related medical societies, the University Hospital Medical Information Network (UMIN Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. Results We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs. Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5% was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not

Parkinson's disease as community health problem: study in Norwegian nursing homes. The Norwegian Study Group of Parkinson's Disease in the Elderly.

OpenAIRE

Larsen, J P

1991-01-01

OBJECTIVE--To examine the extent of under-diagnosis and overdiagnosis of Parkinson's disease and to determine quality of treatment in a defined population. DESIGN--Clinical evaluation of an elderly population. SETTING--40 Norwegian nursing homes. SUBJECTS--3322 residents of nursing homes, of whom 500 were selected by nursing staff for evaluation on the basis of a structured information programme on Parkinson's disease and 269 were examined in detail by neurologists. MAIN OUTCOME MEASURES--Pat...

Design and Co-design of Project-organized Studies

DEFF Research Database (Denmark)

Nielsen, Jørgen Lerche; Andreasen, Lars Birch

2014-01-01

The chapter contributes to discussions on design processes in relation to education, presenting different notions of design research and demonstrating how professors and students are involved together in designing innovative and constructive study processes that can help foster students' engagement...

Rheumatic heart disease- a study of surgically excised cardiac valves and biopsies

International Nuclear Information System (INIS)

Khalil Ullah; Badsha, S.; Khan, A.; Kiani, M.R.; Ahmed, S.A.

2002-01-01

Objective: To examine the prevalence, age, sex and topographical distribution of the rheumatic heart diseases and its morphology. Design: A cross sectional descriptive study. Place and Duration of Study: Pathology Department, Army Medical College, Rawalpindi between 1981-1990. Patients and Methods: Five hundred and twenty six surgically excised cardiac valves and biopsies were studied in the laboratory in the light of clinical data. Results: Carditis constituted 87.4 % of the cardiac valvular disease with 23.5% active and 71% healed rheumatic lesions. About 5.5% had morphological appearances consistent with RHD. The lesions affected mitral valves (37.0%), aortic valve (22.1%), mitral and aortic valves together (21.0%) and atrial appendages (19.0%). Presentation was mostly as mitral stenosis either isolated (49.2% ) or combined (31.0%), aortic stenosis (11.7% ) and aortic incompetence with regurgitation (7.3%). Conclusion: Rheumatic carditis constitutes a significant proportion of cardiac valvular disease and affects comparatively younger age, with slight male preponderance and primarily affects mitral valve. (author)

A study on periodontal disease and systemic disease relationship a hospital based study in Bangalore

Directory of Open Access Journals (Sweden)

Sukhvinder Singh Oberoi

2013-01-01

Full Text Available Background: Periodontal deterioration has been reported to be associated with various systemic conditions like Cardiovascular disease, Diabetes, Respiratory disease, Liver cirrhosis, Bacterial Pneumonia, Nutritional deficiencies and adverse pregnancy outcomes. Aim: To assess the periodontal disease among patients with systemic disease/conditions. Materials and Method: A total of 500 patients with systemic disease/conditions (Diabetes, Cardiovascular disease, Respiratory disease and Renal disease and 500-age and gender matched controls without systemic disease/conditions were selected from the Government Hospitals in Bangalore City. The medical conditions were recorded and the periodontal status of the study population was assessed using the CPITN index. Results: The prevalence of CPITN Code 4 was found to be more among the patients with systemic disease/conditions (46.2%. The mean number of sextants with CPITN code 3 and 4 were more among the patients with systemic disease/conditions. The prevalence of CPITN code was found to be more among the patients with Respiratory disease whereas the mean number of sextants was found to be more among the patients with Diabetes, Cardiovascular and Renal disease. Conclusion: It may be concluded that the systemic diseases/conditions are associated with higher severity of periodontal disease.

Analogue patients’ self-reported engagement and psychophysiological arousal in a video-vignettes design : Patients versus disease-naïve individuals

NARCIS (Netherlands)

Visser, L.N.C.; Tollenaar, M.S.; Bosch, J.A.; van Doornen, L.J.P.; de Haes, H.C.J.M.; Smets, E.M.A.

2016-01-01

Objectives The ecological validity of video-vignettes design investigating patient-provider communication hinges on the engagement of analogue patients (APs) with the vignette. The present study aimed to compare engagement in two commonly utilized groups of APs, patients and disease-naïve

Analogue patients' self-reported engagement and psychophysiological arousal in a video-vignettes design: Patients versus disease-naïve individuals

NARCIS (Netherlands)

Visser, Leonie N. C.; Tollenaar, Marieke S.; Bosch, Jos A.; van Doornen, Lorenz J. P.; de Haes, Hanneke C. J. M.; Smets, Ellen M. A.

2016-01-01

The ecological validity of video-vignettes design investigating patient-provider communication hinges on the engagement of analogue patients (APs) with the vignette. The present study aimed to compare engagement in two commonly utilized groups of APs, patients and disease-naïve individuals.

A comparison of Cox and logistic regression for use in genome-wide association studies of cohort and case-cohort design.

Science.gov (United States)

Staley, James R; Jones, Edmund; Kaptoge, Stephen; Butterworth, Adam S; Sweeting, Michael J; Wood, Angela M; Howson, Joanna M M

2017-06-01

Logistic regression is often used instead of Cox regression to analyse genome-wide association studies (GWAS) of single-nucleotide polymorphisms (SNPs) and disease outcomes with cohort and case-cohort designs, as it is less computationally expensive. Although Cox and logistic regression models have been compared previously in cohort studies, this work does not completely cover the GWAS setting nor extend to the case-cohort study design. Here, we evaluated Cox and logistic regression applied to cohort and case-cohort genetic association studies using simulated data and genetic data from the EPIC-CVD study. In the cohort setting, there was a modest improvement in power to detect SNP-disease associations using Cox regression compared with logistic regression, which increased as the disease incidence increased. In contrast, logistic regression had more power than (Prentice weighted) Cox regression in the case-cohort setting. Logistic regression yielded inflated effect estimates (assuming the hazard ratio is the underlying measure of association) for both study designs, especially for SNPs with greater effect on disease. Given logistic regression is substantially more computationally efficient than Cox regression in both settings, we propose a two-step approach to GWAS in cohort and case-cohort studies. First to analyse all SNPs with logistic regression to identify associated variants below a pre-defined P-value threshold, and second to fit Cox regression (appropriately weighted in case-cohort studies) to those identified SNPs to ensure accurate estimation of association with disease.

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

Science.gov (United States)

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

2017-04-05

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

Systematic review of general burden of disease studies using disability-adjusted life years

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Polinder Suzanne

2012-11-01

Full Text Available Abstract Objective To systematically review the methodology of general burden of disease studies. Three key questions were addressed: 1 what was the quality of the data, 2 which methodological choices were made to calculate disability adjusted life years (DALYs, and 3 were uncertainty and risk factor analyses performed? Furthermore, DALY outcomes of the included studies were compared. Methods Burden of disease studies (1990 to 2011 in international peer-reviewed journals and in grey literature were identified with main inclusion criteria being multiple-cause studies that quantified the burden of disease as the sum of the burden of all distinct diseases expressed in DALYs. Electronic database searches included Medline (PubMed, EMBASE, and Web of Science. Studies were collated by study population, design, methods used to measure mortality and morbidity, risk factor analyses, and evaluation of results. Results Thirty-one studies met the inclusion criteria of our review. Overall, studies followed the Global Burden of Disease (GBD approach. However, considerable variation existed in disability weights, discounting, age-weighting, and adjustments for uncertainty. Few studies reported whether mortality data were corrected for missing data or underreporting. Comparison with the GBD DALY outcomes by country revealed that for some studies DALY estimates were of similar magnitude; others reported DALY estimates that were two times higher or lower. Conclusions Overcoming “error” variation due to the use of different methodologies and low-quality data is a critical priority for advancing burden of disease studies. This can enlarge the detection of true variation in DALY outcomes between populations or over time.

Plant Disease Severity Assessment-How Rater Bias, Assessment Method, and Experimental Design Affect Hypothesis Testing and Resource Use Efficiency.

Science.gov (United States)

Chiang, Kuo-Szu; Bock, Clive H; Lee, I-Hsuan; El Jarroudi, Moussa; Delfosse, Philippe

2016-12-01

The effect of rater bias and assessment method on hypothesis testing was studied for representative experimental designs for plant disease assessment using balanced and unbalanced data sets. Data sets with the same number of replicate estimates for each of two treatments are termed "balanced" and those with unequal numbers of replicate estimates are termed "unbalanced". The three assessment methods considered were nearest percent estimates (NPEs), an amended 10% incremental scale, and the Horsfall-Barratt (H-B) scale. Estimates of severity of Septoria leaf blotch on leaves of winter wheat were used to develop distributions for a simulation model. The experimental designs are presented here in the context of simulation experiments which consider the optimal design for the number of specimens (individual units sampled) and the number of replicate estimates per specimen for a fixed total number of observations (total sample size for the treatments being compared). The criterion used to gauge each method was the power of the hypothesis test. As expected, at a given fixed number of observations, the balanced experimental designs invariably resulted in a higher power compared with the unbalanced designs at different disease severity means, mean differences, and variances. Based on these results, with unbiased estimates using NPE, the recommended number of replicate estimates taken per specimen is 2 (from a sample of specimens of at least 30), because this conserves resources. Furthermore, for biased estimates, an apparent difference in the power of the hypothesis test was observed between assessment methods and between experimental designs. Results indicated that, regardless of experimental design or rater bias, an amended 10% incremental scale has slightly less power compared with NPEs, and that the H-B scale is more likely than the others to cause a type II error. These results suggest that choice of assessment method, optimizing sample number and number of replicate

RISK OF INFERTILITY IN PATIENTS WITH CELIAC DISEASE: a meta-analysis of observational studies

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Juan Sebastian LASA

2014-04-01

Full Text Available Context Celiac disease is an autoimmune disorder of the small intestine associated with several extra-intestinal features, such as reproductive disorders. The relationship between celiac disease and infertility has been previously assessed, with conflicting results. Objectives We seek to determine the relationship between celiac disease and infertility. Methods Data was extracted from case-control or cohort design studies from 1966 to December 2013 using the MEDLINE-Pubmed, EMBASE, LILACS and Cochrane Library databases. We analyzed two kinds of trials: those assessing the risk of infertility in subjects with already diagnosed celiac disease, and those evaluating the prevalence of undiagnosed celiac disease in subjects with a diagnosis of infertility. Results The search yielded 413 potentially relevant studies for revision, 12 of which were finally included for analysis. A significant association was found between women with a diagnosis of infertility and undiagnosed celiac disease [OR 3.09 (95% CI 1.74-5.49]. When considering those studies assessing the occurrence of infertility in subjects with already-diagnosed celiac disease, no difference was found between celiac disease patients and control subjects [OR 0.99 (0.86-1.13]. Conclusions Undiagnosed celiac disease is a risk factor for infertility. Women seeking medical advice for this particular condition should be screened for celiac disease. Adoption of a gluten-free diet could have a positive impact on fertility in this group of patients.

Improving the analysis of designed studies by combining statistical modelling with study design information

NARCIS (Netherlands)

Thissen, U.; Wopereis, S.; Berg, S.A.A. van den; Bobeldijk, I.; Kleemann, R.; Kooistra, T.; Dijk, K.W. van; Ommen, B. van; Smilde, A.K.

2009-01-01

Background: In the fields of life sciences, so-called designed studies are used for studying complex biological systems. The data derived from these studies comply with a study design aimed at generating relevant information while diminishing unwanted variation (noise). Knowledge about the study

PMD: designing a portable medicine dispenser for persons suffering from Alzheimer’s disease

NARCIS (Netherlands)

de Beer, Roel C.J.M.; Keijers, R.; Shahid, S.; Al Mahmud, A.; Mubin, O.

2010-01-01

In this paper we present the user-centred design of a medicine dispenser for persons suffering from Alzheimer’s disease. The prototype was evaluated in two phases with two caregivers and two Alzheimer’s patients. Caregivers evaluated the device positively. The Alzheimer’s patients faced usability

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

International Nuclear Information System (INIS)

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

2010-01-01

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

Designed multiple ligands in metabolic disease research: from concept to platform.

Science.gov (United States)

Gattrell, W; Johnstone, C; Patel, S; Smith, C Sambrook; Scheel, A; Schindler, M

2013-08-01

Type 2 diabetes mellitus (T2DM) is a multifactorial disease, and drug monotherapy typically results in unsatisfactory treatment outcomes for patients. Even when used in combination, existing therapies lack efficacy in the long term. Designed multiple ligands (DMLs) are compounds developed to modulate multiple targets relevant to a disease. DMLs offer the potential to yield greater efficacy over monotherapies, either by modulating different biological pathways, or by boosting a single one. However, examples of DMLs progressing into clinical trials, or onto the market are rare; DML drug discovery is challenging, and perceived by some to be almost impossible. Nevertheless, with the judicious selection of biological targets, both from a biological and chemical perspective, it is possible to develop drug-like DMLs. Copyright © 2013 Elsevier Ltd. All rights reserved.

Central Pain Processing in Early-Stage Parkinson's Disease: A Laser Pain fMRI Study.

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Christine Petschow

Full Text Available Pain is a common non-motor symptom in Parkinson's disease. As dopaminergic dysfunction is suggested to affect intrinsic nociceptive processing, this study was designed to characterize laser-induced pain processing in early-stage Parkinson's disease patients in the dopaminergic OFF state, using a multimodal experimental approach at behavioral, autonomic, imaging levels.13 right-handed early-stage Parkinson's disease patients without cognitive or sensory impairment were investigated OFF medication, along with 13 age-matched healthy control subjects. Measurements included warmth perception thresholds, heat pain thresholds, and central pain processing with event-related functional magnetic resonance imaging (erfMRI during laser-induced pain stimulation at lower (E = 440 mJ and higher (E = 640 mJ target energies. Additionally, electrodermal activity was characterized during delivery of 60 randomized pain stimuli ranging from 440 mJ to 640 mJ, along with evaluation of subjective pain ratings on a visual analogue scale.No significant differences in warmth perception thresholds, heat pain thresholds, electrodermal activity and subjective pain ratings were found between Parkinson's disease patients and controls, and erfMRI revealed a generally comparable activation pattern induced by laser-pain stimuli in brain areas belonging to the central pain matrix. However, relatively reduced deactivation was found in Parkinson's disease patients in posterior regions of the default mode network, notably the precuneus and the posterior cingulate cortex.Our data during pain processing extend previous findings suggesting default mode network dysfunction in Parkinson's disease. On the other hand, they argue against a genuine pain-specific processing abnormality in early-stage Parkinson's disease. Future studies are now required using similar multimodal experimental designs to examine pain processing in more advanced stages of Parkinson's disease.

Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

Science.gov (United States)

Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

2017-08-17

A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial.

Science.gov (United States)

Bekelman, David B; Plomondon, Mary E; Sullivan, Mark D; Nelson, Karin; Hattler, Brack; McBryde, Connor; Lehmann, Kenneth G; Potfay, Jonathan; Heidenreich, Paul; Rumsfeld, John S

2013-07-09

Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an 'effectiveness trial' to support broader implementation in the healthcare system if it is successful. Unique identifier: NCT00461513.

Periodontal disease and risk of chronic obstructive pulmonary disease: a meta-analysis of observational studies.

Directory of Open Access Journals (Sweden)

Xian-Tao Zeng

Full Text Available BACKGROUND: Many epidemiological studies have found a positive association between periodontal disease (PD and risk of chronic obstructive pulmonary disease (COPD, but this association is varied and even contradictory among studies. We performed a meta-analysis to ascertain the relationship between PD and COPD. METHODS: PubMed and Embase database were searched up to January 10, 2012, for relevant observational studies on the association between PD and risk of COPD. Data from the studies selected were extracted and analyzed independently by two authors. The meta-analysis was performed using the Comprehensive Meta-Analysis software. RESULTS: Fourteen observational studies (one nested case-control, eight case-control, and five cross-sectional involving 3,988 COPD patients were yielded. Based on random-effects meta-analysis, a significant association between PD and COPD was identified (odds ratio = 2.08, 95% confidence interval = 1.48-2.91; P<0.001, with sensitivity analysis showing that the result was robust. Subgroups analyses according to study design, ethnicity, assessment of PD/COPD, and adjusted/unadjusted odds ratios also revealed a significant association. Publication bias was detected. CONCLUSIONS: Based on current evidence, PD is a significant and independent risk factor of COPD. However, whether a causal relationships exists remains unclear. Morever, we suggest performing randomized controlled trails to explore whether periodontal interventions are beneficial in regulating COPD pathogenesis and progression.

Prospective study of alcohol drinking patterns and coronary heart disease in women and men

DEFF Research Database (Denmark)

Tolstrup, Janne; Jensen, Majken K; Tjønneland, Anne

2006-01-01

OBJECTIVE: To determine the association between alcohol drinking patterns and risk of coronary heart disease in women and men. DESIGN: Population based cohort study. SETTING: Denmark, 1993-2002. PARTICIPANTS: 28 448 women and 25 052 men aged 50-65 years, who were free of cardiovascular disease...... at entry to the study. MAIN OUTCOME MEASURES: Incidence of coronary heart disease occurring during a median follow-up period of 5.7 years. RESULTS: 749 and 1283 coronary heart disease events occurred among women and men. Women who drank alcohol on at least one day a week had a lower risk of coronary heart...... disease than women who drank alcohol on less than one day a week. Little difference was found, however, between drinking frequency: one day a week (hazard ratio 0.64, 95% confidence interval 0.51 to 0.81), 2-4 days a week (0.63, 0.52 to 0.77), five or six days a week (0.79, 0.61 to 1.03), and seven days...

Wayfinding in ageing and Alzheimer's disease within a virtual senior residence: study protocol.

Science.gov (United States)

Davis, Rebecca; Ohman, Jennifer

2016-07-01

To report a study protocol that examines the impact of adding salient cues in a virtual reality simulation of a senior residential building on wayfinding for older adults with and without Alzheimer's disease. An early symptom of Alzheimer's disease is the inability to find one's way (wayfinding). Senior residential environments are especially difficult for wayfinding. Salient cues may be able to help persons with Alzheimer's disease find their way more effectively so they can maintain independence. A repeated measures, within and between subjects design. This study was funded by the National Institutes of Health (August 2012). Older adults (N = 40) with normal cognition and older adults with early stage Alzheimer's disease/mild cognitive impairment (N = 40) will try to find their way to a location repeatedly in a virtual reality simulation of senior residence. There are two environments: standard (no cues) and salient (multiple cues). Outcome measures include how often and how quickly participants find the target location in each cue condition. The results of this study have the potential to provide evidence for ways to make the environment more supportive for wayfinding for older adults with Alzheimer's disease. This study is registered at Trialmatch.alz.org (Identifier 260425-5). © 2016 John Wiley & Sons Ltd.

Genetic Expression in Cystic Fibrosis Related Bone Disease. An Observational, Transversal, Cross-Sectional Study.

Science.gov (United States)

Ciuca, Ioana M; Pop, Liviu L; Rogobete, Alexandru F; Onet, Dan I; Guta-Almajan, Bogdan; Popa, Zoran; Horhat, Florin G

2016-09-01

Cystic fibrosis (CF) is the most frequent monogenic genetic disease with autosomal recessive transmission and characterized by important clinical polymorphism and significant lethal prospective. CF related bone disease occurs frequently in adults with CF. Childhood is the period of bone formation, and therefore, children are more susceptible to low bone density. Several factors like pancreatic insufficiency, hormone imbalance, and physical inactivity contribute to CF bone disease development. Revealing this would be important for prophylactic treatment against bone disease occurrence. The study was observational, transversal, with a cross-sectional design. The study included 68 children with cystic fibrosis, genotyped and monitored in the National CF Centre. At the annual assessment, besides clinical examination, biochemical evaluation for pancreatic insufficiency, and diabetes, they were evaluated for bone mineral density using dual energy X-ray absorptiometry (DXA). Twenty-six patients, aged over 10 years were diagnosed with CF bone disease, without significant gender gap. Bone disease was frequent in patients aged over 10 years with exocrine pancreatic insufficiency, carriers of severe mutations, and CF liver disease. CF carriers of a severe genotype which associates pancreatic insufficiency and CF liver disease, are more likely predisposed to low bone mineral density. Further studies should discover other significant influences in order to prevent the development of CF bone disease and an improved quality of life in cystic fibrosis children.

An Approach Towards Structure Based Antimicrobial Peptide Design for Use in Development of Transgenic Plants: A Strategy for Plant Disease Management.

Science.gov (United States)

Ilyas, Humaira; Datta, Aritreyee; Bhunia, Anirban

2017-01-01

Antimicrobial peptides (AMPs), also known as host defense peptides (HDPs), are ubiquitous and vital components of innate defense response that present themselves as potential candidates for drug design, and aim to control plant and animal diseases. Though their application for plant disease management has long been studied with natural AMPs, cytotoxicity and stability related shortcomings for the development of transgenic plants limit their usage. Newer technologies like molecular modelling, NMR spectroscopy and combinatorial chemistry allow screening for potent candidates and provide new avenues for the generation of rationally designed synthetic AMPs with multiple biological functions. Such AMPs can be used for the control of plant diseases that lead to huge yield losses of agriculturally important crop plants, via generation of transgenic plants. Such approaches have gained significant attention in the past decade as a consequence of increasing antibiotic resistance amongst plant pathogens, and the shortcomings of existing strategies that include environmental contamination and human/animal health hazards amongst others. This review summarizes the recent trends and approaches used for employing AMPs, emphasizing on designed/modified ones, and their applications toward agriculture and food technology. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Understanding complex clinical reasoning in infectious diseases for improving clinical decision support design.

Science.gov (United States)

Islam, Roosan; Weir, Charlene R; Jones, Makoto; Del Fiol, Guilherme; Samore, Matthew H

2015-11-30

Clinical experts' cognitive mechanisms for managing complexity have implications for the design of future innovative healthcare systems. The purpose of the study is to examine the constituents of decision complexity and explore the cognitive strategies clinicians use to control and adapt to their information environment. We used Cognitive Task Analysis (CTA) methods to interview 10 Infectious Disease (ID) experts at the University of Utah and Salt Lake City Veterans Administration Medical Center. Participants were asked to recall a complex, critical and vivid antibiotic-prescribing incident using the Critical Decision Method (CDM), a type of Cognitive Task Analysis (CTA). Using the four iterations of the Critical Decision Method, questions were posed to fully explore the incident, focusing in depth on the clinical components underlying the complexity. Probes were included to assess cognitive and decision strategies used by participants. The following three themes emerged as the constituents of decision complexity experienced by the Infectious Diseases experts: 1) the overall clinical picture does not match the pattern, 2) a lack of comprehension of the situation and 3) dealing with social and emotional pressures such as fear and anxiety. All these factors contribute to decision complexity. These factors almost always occurred together, creating unexpected events and uncertainty in clinical reasoning. Five themes emerged in the analyses of how experts deal with the complexity. Expert clinicians frequently used 1) watchful waiting instead of over- prescribing antibiotics, engaged in 2) theory of mind to project and simulate other practitioners' perspectives, reduced very complex cases into simple 3) heuristics, employed 4) anticipatory thinking to plan and re-plan events and consulted with peers to share knowledge, solicit opinions and 5) seek help on patient cases. The cognitive strategies to deal with decision complexity found in this study have important

Delayed-Start Analyses in the Phase 3 Solanezumab EXPEDITION3 Study in Mild Alzheimer's Disease.

Science.gov (United States)

Liu-Seifert, H; Case, M G; Andersen, S W; Holdridge, K C; Aisen, P S; Kollack-Walker, S; Siemers, E

2018-01-01

A delayed-start design has been proposed to assess a potential disease-modifying effect in investigational drugs for Alzheimer's disease that target the underlying disease process. We extended this methodology to recently obtained data from the EXPEDITION3. EXPEDITION3 was a Phase 3, double-blind study with participants randomized to solanezumab (400 mg) or placebo every 4 weeks for 80 weeks, with an optional extension of active treatment. The delayed-start analysis was designed to determine if a statistically significant treatment difference established during the placebo-controlled period is maintained (at predefined level) during the delayed-start period, which would suggest the active drug has a disease-modifying effect. The delayed-start analysis was assessed across multiple efficacy measures, and includes data from baseline in the placebo-controlled period and up to 9 months in the delayed-start period. No significant difference was observed between the placebo and solanezumab treatment groups at the end of the placebo-controlled period for the Alzheimer's Disease Assessment Scale-Cognitive 14-item subscale. A significant treatment difference was observed at the end of the placebo-controlled period for the Alzheimer's Disease Cooperative Study-Activities of Daily Living instrumental items, an effect also seen at 6 months in the delayed-start period, and the noninferiority criterion was met. No other efficacy measures met these criteria. Delayed-start statistical methodology was used to understand the longitudinal outcomes in EXPEDITION3 and its extension. The small treatment differences observed at the end of the placebo-controlled phase prevented adequate assessment of any putative disease modifying effect.

Cardiovascular disease in patients with osteogenesis imperfecta — a nationwide, register-based cohort study

OpenAIRE

Folkestad, Lars; Hald, Jannie Dahl; Gram, Jeppe; Langdahl, Bente L.; Hermann, Anne Pernille; Diederichsen, Axel CP; Abrahamsen, Bo; Brixen, Kim

2016-01-01

BACKGROUND: Osteogenesis imperfecta (OI) is a hereditary connective tissue disease often due to mutations in genes coding for type 1 collagen. Collagen type 1 is important in the development of the heart and vasculature. Little is known about the risk of cardiovascular disease (CVD) in OI.OBJECTIVE: To investigate the risk of symptomatic CVD in OI.DESIGN: A Danish nationwide, population-based and register-based longitudinal open cohort study.PARTICIPANTS: All patients registered with the diag...

Thigh circumference and risk of heart disease and premature death: prospective cohort study

DEFF Research Database (Denmark)

Heitmann, Berit; Frederiksen, Peder

2009-01-01

OBJECTIVE: To examine associations between thigh circumference and incident cardiovascular disease and coronary heart disease and total mortality. DESIGN: Prospective observational cohort study with Cox proportional hazards model and restricted cubic splines. SETTING: Random subset of adults...... in Denmark. PARTICIPANTS: 1436 men and 1380 women participating in the Danish MONICA project, examined in 1987-8 for height, weight, and thigh, hip, and waist circumference, and body composition by impedance. MAIN OUTCOME MEASURES: 10 year incidence of cardiovascular and coronary heart disease and 12.5 years...... of follow-up for total death. RESULTS: A small thigh circumference was associated with an increased risk of cardiovascular and coronary heart diseases and total mortality in both men and women. A threshold effect for thigh circumference was evident, with greatly increased risk of premature death below...

Quantifying the benefits of achieving or maintaining long-term low risk profile for cardiovascular disease : The doetinchem cohort study

NARCIS (Netherlands)

Hulsegge, Gerben; Smit, Henriëtte A.; Van Der Schouw, Yvonne T.; Daviglus, Martha L.; Verschuren, W. M Monique

2015-01-01

Background: Studies investigating the relation between risk profiles and cardiovascular disease have measured risk at baseline only. We investigated maintenance and changes of risk profiles over time and their potential impact on incident cardiovascular disease. Design: Population-based cohort

Quantifying the benefits of achieving or maintaining long-term low risk profile for cardiovascular disease: The Doetinchem Cohort Study

NARCIS (Netherlands)

Hulsegge, G.; Smit, H.A.; van der Schouw, Y.T.; Daviglus, M.L.; Verschuren, W.M.

2015-01-01

Background: Studies investigating the relation between risk profiles and cardiovascular disease have measured risk at baseline only. We investigated maintenance and changes of risk profiles over time and their potential impact on incident cardiovascular disease. Design: Population-based cohort

Digital dashboard design using multiple data streams for disease surveillance with influenza surveillance as an example.

Science.gov (United States)

Cheng, Calvin K Y; Ip, Dennis K M; Cowling, Benjamin J; Ho, Lai Ming; Leung, Gabriel M; Lau, Eric H Y

2011-10-14

Great strides have been made exploring and exploiting new and different sources of disease surveillance data and developing robust statistical methods for analyzing the collected data. However, there has been less research in the area of dissemination. Proper dissemination of surveillance data can facilitate the end user's taking of appropriate actions, thus maximizing the utility of effort taken from upstream of the surveillance-to-action loop. The aims of the study were to develop a generic framework for a digital dashboard incorporating features of efficient dashboard design and to demonstrate this framework by specific application to influenza surveillance in Hong Kong. Based on the merits of the national websites and principles of efficient dashboard design, we designed an automated influenza surveillance digital dashboard as a demonstration of efficient dissemination of surveillance data. We developed the system to synthesize and display multiple sources of influenza surveillance data streams in the dashboard. Different algorithms can be implemented in the dashboard for incorporating all surveillance data streams to describe the overall influenza activity. We designed and implemented an influenza surveillance dashboard that utilized self-explanatory figures to display multiple surveillance data streams in panels. Indicators for individual data streams as well as for overall influenza activity were summarized in the main page, which can be read at a glance. Data retrieval function was also incorporated to allow data sharing in standard format. The influenza surveillance dashboard serves as a template to illustrate the efficient synthesization and dissemination of multiple-source surveillance data, which may also be applied to other diseases. Surveillance data from multiple sources can be disseminated efficiently using a dashboard design that facilitates the translation of surveillance information to public health actions.

Study design of PANGAEA 2.0, a non-interventional study on RRMS patients to be switched to fingolimod.

Science.gov (United States)

Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

2016-08-08

The therapeutic options for patients with Multiple Sclerosis (MS) have steadily increased due to the approval of new substances that now supplement traditional first-line agents, demanding a paradigm shift in the assessment of disease activity and treatment response in clinical routine. Here, we report the study design of PANGAEA 2.0 (Post-Authorization Non-interventional GermAn treatment benefit study of GilEnyA in MS patients), a non-interventional study in patients with relapsing-remitting MS (RRMS) identify patients with disease activity and monitor their disease course after treatment switch to fingolimod (Gilenya®), an oral medication approved for patients with highly active RRMS. In the first phase of the PANGAEA 2.0 study the disease activity status of patients receiving a disease-modifying therapy (DMT) is evaluated in order to identify patients at risk of disease progression. This evaluation is based on outcome parameters for both clinical disease activity and magnetic resonance imaging (MRI), and subclinical measures, describing disease activity from the physician's and the patient's perspective. In the second phase of the study, 1500 RRMS patients identified as being non-responders and switched to fingolimod (oral, 0.5 mg/daily) are followed-up for 3 years. Data on relapse activity, disability progression, MRI lesions, and brain volume loss will be assessed in accordance to 'no evidence of disease activity-4' (NEDA-4). The modified Rio score, currently validated for the evaluation of treatment response to interferons, will be used to evaluate the treatment response to fingolimod. The MS management software MSDS3D will guide physicians through the complex processes of diagnosis and treatment. A sub-study further analyzes the benefits of a standardized quantitative evaluation of routine MRI scans by a central reading facility. PANGAEA 2.0 is being conducted between June 2015 and December 2019 in 350 neurological practices and centers in Germany

Low LDL cholesterol, PCSK9 and HMGCR genetic variation, and risk of Alzheimer's disease and Parkinson's disease: Mendelian randomisation study.

Science.gov (United States)

Benn, Marianne; Nordestgaard, Børge G; Frikke-Schmidt, Ruth; Tybjærg-Hansen, Anne

2017-04-24

Objective  To test the hypothesis that low density lipoprotein (LDL) cholesterol due to genetic variation in the genes responsible for LDL cholesterol metabolism and biosynthesis( PCSK9 and 3-hydroxy-3-methylglutaryl-CoA reductase ( HMGCR ), respectively) is associated with a high risk of Alzheimer's disease, vascular dementia, any dementia, and Parkinson's disease in the general population. Design  Mendelian randomisation study. Setting  Copenhagen General Population Study and Copenhagen City Heart Study. Participants  111 194 individuals from the Danish general population. Main outcome measures  Risk of Alzheimer's disease, vascular dementia, all dementia, and Parkinson's disease. Results  In observational analyses, the multifactorially adjusted hazard ratio for Parkinson's disease in participants with an LDL cholesterol level LDL cholesterol level. In genetic, causal analyses adjusted for age, sex, and year of birth, the risk ratios for a lifelong 1 mmol/L lower LDL cholesterol level were 0.57 (0.27 to 1.17) for Alzheimer's disease, 0.81 (0.34 to 1.89) for vascular dementia, 0.66 (0.34 to 1.26) for any dementia, and 1.02 (0.26 to 4.00) for Parkinson's disease. Summary level data from the International Genomics of Alzheimer's Project using Egger Mendelian randomisation analysis gave a risk ratio for Alzheimer's disease of 0.24 (0.02 to 2.79) for 26 PCSK9 and HMGCR variants, and of 0.64 (0.52 to 0.79) for 380 variants of LDL cholesterol level lowering. Conclusion  Low LDL cholesterol levels due to PCSK9 and HMGCR variants had no causal effect on high risk of Alzheimer's disease, vascular dementia, any dementia, or Parkinson's disease; however, low LDL cholesterol levels may have a causal effect in reducing the risk of Alzheimer's disease. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Macular function and morphological features in juvenile Stargardt disease: Longitudinal study

Science.gov (United States)

Testa, Francesco; Melillo, Paolo; Iorio, Valentina Di; Orrico, Ada; Attanasio, Marcella; Rossi, Settimio; Simonelli, Francesca

2014-01-01

Purpose to evaluate disease progression in a cohort of patients with clinical and genetic diagnosis of Stargardt disease. Design longitudinal cohort study. Subjects 56 selected patients with a clinical and molecular diagnosis of Stargardt disease, an early age of onset and a median follow-up length of two years. Methods patients underwent routine examination including full-field electroretinography, microperimetry and optical coherence tomography. Main Outcome Measures best corrected visual acuity, mean retinal sensitivity, fixation stability, preferred retinal locus, inner-outer segment (IS/OS) junction loss, atrophic lesion area. Results 56 patients with a mean age of disease onset of 15.3 years (range: 3 - 28 years), a mean disease length of 12.1 years and a mean age at baseline of 27.4 years were analyzed. The median best corrected visual acuity was 20/200 in both eyes. Optical coherence tomography parameters (IS/OS alteration and retinal pigment epithelium lesion area) were obtained in 49 patients because signal quality was poor in the remaining 7 patients. Optical coherence tomography revealed a mean retinal pigment epithelium lesion area of 2.6 mm2, preserved foveal IS/OS in 4.1% of patients, loss of foveal IS/OS in 59.2%, and extensive loss of macular IS/OS in 36.7%. Microperimetric findings showed a reduced macular sensitivity (mean 10 dB) and an unstable fixation in half of the patient cohort. The longitudinal analysis showed a significant progressive reduction of best corrected visual acuity and macular sensitivity (at an estimated rate of 0.04 decimals and 1.19 dB per year, respectively) associated with a significant enlargement of retinal pigment epithelium lesion area (0.282 mm2 per year). No significant changes in ophthalmoscopic findings and electroretinographic responses were detected. Conclusions this study highlights the importance of microperimetry and optical coherence tomography in monitoring Stargardt patients. In fact, quantifying the

Taming Human Genetic Variability: Transcriptomic Meta-Analysis Guides the Experimental Design and Interpretation of iPSC-Based Disease Modeling

Directory of Open Access Journals (Sweden)

Pierre-Luc Germain

2017-06-01

Full Text Available Both the promises and pitfalls of the cell reprogramming research platform rest on human genetic variation, making the measurement of its impact one of the most urgent issues in the field. Harnessing large transcriptomics datasets of induced pluripotent stem cells (iPSC, we investigate the implications of this variability for iPSC-based disease modeling. In particular, we show that the widespread use of more than one clone per individual in combination with current analytical practices is detrimental to the robustness of the findings. We then proceed to identify methods to address this challenge and leverage multiple clones per individual. Finally, we evaluate the specificity and sensitivity of different sample sizes and experimental designs, presenting computational tools for power analysis. These findings and tools reframe the nature of replicates used in disease modeling and provide important resources for the design, analysis, and interpretation of iPSC-based studies.

Research Design

DEFF Research Database (Denmark)

2019-01-01

Gunnar Scott Reinbacher (editor) Antology.  Research Design : Validation in Social Sciences. Gunnar Scott Reinbacher: Introduction. Research design and validity. 15p Ole Riis: Creative Research design. 16 p Lennart Nørreklit: Validity in Research Design. 24p Gitte Sommer Harrits: Praxeological...... Scott Reinbacher: Multidisciplinary Research Designs in Problem Based Research. The case of an european project on chronical diseases, the Tandem project (Training Alternmative Networking Skills in Diabetes Management). 15p Niels Nørgaard Kristensen: A qualitative bottom up approach to post modern...... knowledge: An integrated strategy for combining "explaining" and "understanding". 22p Heidi Houlberg Salomonsen & Viola Burau: Comparative research designs. 40p Rasmus Antoft & Heidi Houlberg Salomonsen: Studying organizations by a Pragmatic Research Design: the case of qualitative case study  designs. 31p...

Melanocortin-1 receptor, skin cancer and phenotypic characteristics (M-SKIP project: study design and methods for pooling results of genetic epidemiological studies

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Raimondi Sara

2012-08-01

Full Text Available Abstract Background For complex diseases like cancer, pooled-analysis of individual data represents a powerful tool to investigate the joint contribution of genetic, phenotypic and environmental factors to the development of a disease. Pooled-analysis of epidemiological studies has many advantages over meta-analysis, and preliminary results may be obtained faster and with lower costs than with prospective consortia. Design and methods Based on our experience with the study design of the Melanocortin-1 receptor (MC1R gene, SKin cancer and Phenotypic characteristics (M-SKIP project, we describe the most important steps in planning and conducting a pooled-analysis of genetic epidemiological studies. We then present the statistical analysis plan that we are going to apply, giving particular attention to methods of analysis recently proposed to account for between-study heterogeneity and to explore the joint contribution of genetic, phenotypic and environmental factors in the development of a disease. Within the M-SKIP project, data on 10,959 skin cancer cases and 14,785 controls from 31 international investigators were checked for quality and recoded for standardization. We first proposed to fit the aggregated data with random-effects logistic regression models. However, for the M-SKIP project, a two-stage analysis will be preferred to overcome the problem regarding the availability of different study covariates. The joint contribution of MC1R variants and phenotypic characteristics to skin cancer development will be studied via logic regression modeling. Discussion Methodological guidelines to correctly design and conduct pooled-analyses are needed to facilitate application of such methods, thus providing a better summary of the actual findings on specific fields.

Melanocortin-1 receptor, skin cancer and phenotypic characteristics (M-SKIP) project: study design and methods for pooling results of genetic epidemiological studies

Science.gov (United States)

2012-01-01

Background For complex diseases like cancer, pooled-analysis of individual data represents a powerful tool to investigate the joint contribution of genetic, phenotypic and environmental factors to the development of a disease. Pooled-analysis of epidemiological studies has many advantages over meta-analysis, and preliminary results may be obtained faster and with lower costs than with prospective consortia. Design and methods Based on our experience with the study design of the Melanocortin-1 receptor (MC1R) gene, SKin cancer and Phenotypic characteristics (M-SKIP) project, we describe the most important steps in planning and conducting a pooled-analysis of genetic epidemiological studies. We then present the statistical analysis plan that we are going to apply, giving particular attention to methods of analysis recently proposed to account for between-study heterogeneity and to explore the joint contribution of genetic, phenotypic and environmental factors in the development of a disease. Within the M-SKIP project, data on 10,959 skin cancer cases and 14,785 controls from 31 international investigators were checked for quality and recoded for standardization. We first proposed to fit the aggregated data with random-effects logistic regression models. However, for the M-SKIP project, a two-stage analysis will be preferred to overcome the problem regarding the availability of different study covariates. The joint contribution of MC1R variants and phenotypic characteristics to skin cancer development will be studied via logic regression modeling. Discussion Methodological guidelines to correctly design and conduct pooled-analyses are needed to facilitate application of such methods, thus providing a better summary of the actual findings on specific fields. PMID:22862891

Prosthetic valves in adult patients with congenital heart disease : Rationale and design of the Dutch PROSTAVA study

NARCIS (Netherlands)

Freling, H. G.; van Slooten, Y. J.; van Melle, J. P.; Mulder, B. J. M.; van Dijk, A. P. J.; Hillege, H. L.; Post, M. C.; Sieswerda, G. Tj; Jongbloed, M. R. M.; Willems, T. P.; Pieper, P. G.

2012-01-01

Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. The primary objective

Radionuclide therapy of skin cancers and Bowen's disease using specially designed skin patch: A pilot study in an animal model and clinical trial

International Nuclear Information System (INIS)

Lee, J. D.; Park, K. K.; Lee, M. G.; Lee, J. T.; Yoo, H. S.; Kim, E. H.; Rhim, K. J.; Kim, Y. M.; Park, K. B.; Kim, J. R.

1997-01-01

Skin cancer is the most common malignant tumors in human. Therapeutic modalities of the skin cancers are local destruction, radiotherapy and surgery. External radiation therapy leads to good results, however, overall 5-6 weeks of treatment period is needed to deliver optimal radiation dose to tumors. In this study, β-emitting radionuclide, Ho-166, impregnated in a specially designed patch was utilized to superficial skin cancers and Bowen's disease for local irradiation. Methods; Animal study was employed in 10 mice with chemically induced skin tumors. Five- mm size patches containing 22.2 -72.15 MBq(0.6 - 1.95 mCi) of Ho-166 were applied to the tumor surface for 1 -2 hr. In clinical trial, patients with squamous carcinoma(n=3), basal cell carcinoma(n=1), and Bowen's disease(n=1) were treated with patches containing 273.8 - 999 MBq (7.4 - 27 mCi) of Ho-166 for 30 minutes to 1 hour. Pathologic examination was performed 4 - 7 weeks after the treatment in animal model. Skin biopsy was performed 8 weeks post-treatment in four patients. Results; Tumor destruction was seen 1 week post the treatment, however, radiation dermatitis or ulceration developed at the site of radionuclide application. Those reactions healed gradually with fibrosis or epithelialization, which was confirmed pathologically. No significant adverse reaction to radiation except subcutaneous fibrosis was found. Conclusion; Superficial skin tumors could be successfully treated by topical application of β-emitting radionuclides. (author)

Eurythmy therapy in chronic disease: a four-year prospective cohort study

Directory of Open Access Journals (Sweden)

Willich Stefan N

2007-04-01

exercises had long-term improvement of chronic disease symptoms and quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that eurythmy therapy can be useful for patients motivated for this therapy.

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)

Orlando, Giovanna; Tanzi, Elisabetta; Chatenoud, Liliane; Gramegna, Maria; Rizzardini, Giuliano

2012-01-01

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

Identifying patterns in signs and symptoms preceding the clinical diagnosis of Alzheimer's disease: Retrospective medical record review study and a nested case -control design.

Science.gov (United States)

Bature, Fidelia; Pang, Dong; Robinson, Anthea; Polson, Norma; Pappas, Yannis; Guinn, Barbara

2018-04-04

Evidence suggests that individuals with Alzheimer's disease (AD) are often diagnosed in the later stages of their disease with a poor prognosis. This study aimed to identify patterns in signs and symptoms preceding the clinical diagnosis of AD to suggest a predictive model for earlier diagnosis of the disease in the primary care. A retrospective medical record review; nested case control design. Participants included one hundred and nine patients from three general practice (GP) surgeries in Milton Keynes and Luton Clinical Commissioning groups (CCG) (37 cases with AD and 72 controls without AD). A retrospective analysis using the logistic regression of the presence of signs and symptoms before the diagnosis of AD was attained. Identification of the timing and sequence of appearance of these presentations as first reported before the clinical diagnosis was measured. Episodic memory with an odds ratio of 1.85 was the most frequent presentation, documented in 1.38% of the controls and 75.6% in cases. Auditory disturbance with an odds ratio of 3.03, which has not previously been noted except in the form of auditory hallucination, could have a diagnostic value. Auditory disturbance, which occurred mostly in the Caucasian females, could discriminate individuals with AD from those without. The symptom, which presented up to 14.5 (mean time) years prior to clinical diagnosis, was identified in Caucasians and mixed race individuals only. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Evolution of patency rates of self-expandable bare metal stents for endovascular treatment of femoro-popliteal arterial occlusive disease: Does stent design matter?

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Treitl, Karla Maria; Woerner, Benedikt; Schinner, Regina; Czihal, Michael; Notohamiprodjo, Susan; Hoffmann, Ulrich; Treitl, Marcus

2017-09-01

To analyse the patency rates of femoro-popliteal stenting with different self-expandable Nitinol stent-designs. Two hundred and twenty-two patients (142 (64%) male; age 72.4 ± 11.6 years) with symptomatic femoro-popliteal peripheral arterial occlusive disease (PAOD) underwent percutaneous transluminal angioplasty (PTA) and stenting with three different Nitinol stents (interwoven IW: n = 70; closed-cell CC: n = 85; open-cell OC: n = 67). One-year post-procedural target lesion revascularization (TLR_12M) rates were investigated with regard to co-morbidities: diabetes (DBM), hyperlipidaemia (HLP), hypertension (RR), coronary artery disease (CAD) and degree of calcification. Twelve-month follow-up data were available for 60, 69 and 50 patients in the IW, OC and CC groups (179 patients in total). The cumulative patency (IW: 52 (86.7%); OC: 50 (72.5%); CC: 23 (46.0%); P stent and the highest TLR_12M for the CC stent. The interwoven stent-design was superior to the standard open- and closed-cell stent-designs in endovascular treatment of femoro-popliteal PAOD in a follow-up period of 12 months. • Results of femoro-popliteal stenting are still unsatisfactory. • Comparative studies for currently available different Nitinol stent-designs are lacking. • This is a first comparative study on long-term patency of different Nitinol stent-designs. • Interwoven stent-design leads to improved long-term patency. • Interwoven stent-design leads to lower TLR than other stent-designs.

Diabetic retinopathy is associated with mortality and cardiovascular disease incidence: the EURODIAB prospective complications study

NARCIS (Netherlands)

van Hecke, M.V.; Dekker, J.M.; Stehouwer, C.D.A.; Polak, B.C.P.; Fuller, J.H.; Sjolie, A.K.; Kofinis, A.; Rottiers, R.; Porta, M.; Chaturvedi, N.

2005-01-01

OBJECTIVE - To study the relationship of nonproliferative and proliferative retinopathy with all-cause mortality and cardiovascular disease (CVD) incidence in type 1 diabetic patients and, additionally, the role of cardiovascular risk factors in these associations. RESEARCH DESIGN AND METHODS - This

Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

Science.gov (United States)

Narita, Zui; Yokoi, Yuma

2017-06-19

Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

Design, construction and evaluation of multi-epitope antigens for diagnosis of Lyme disease.

Science.gov (United States)

Schreterova, Eva; Bhide, Mangesh; Potocnakova, Lenka; Borszekova Pulzova, Lucia

2017-12-23

Introduction and objective. Lyme disease (LD) is the most common vector-borne disease in the temperate zone of the Northern Hemisphere. Diagnosis of LD is mainly based on clinical symptoms supported with serology (detection of anti-Borrelia antibodies) and is often misdiagnosed in areas of endemicity. In this study, the chimeric proteins (A/C-2, A/C-4 and A/C-7.1) consisting of B-cell epitopes of outer surface proteins OspA and OspC from Borrelia genospecies prevalent in Eastern Slovakia, were designed, over-expressed in E. coli, and used to detect specific anti-Borrelia antibodies in serologically characterized sera from patients with Lyme-like symptoms to evaluate their diagnostic potential. Results showed that chimeras vary in their immuno-reactivity when tested with human sera. Compared with the results obtained from a two-tier test, the application of recombinant multi-epitope chimeric proteins as diagnosis antigens, produced fair agreement in the case of A/C-2 (0.20<κ<0.40) and good agreement (0.60<κ<0.80) when A/C-7.1 was used as capture antigen. Chimera A/C-4 were excluded from further study due to loss of reactivity with OspA-specific antibodies. The combination of specific B-cell epitopes from OspA and OspC proteins may improve the diagnostic accuracy of serologic assays, but further studies are required to address this hypothesis.

Neurological diseases and bullous pemphigoid: A case-control study in Iranian patients.

Science.gov (United States)

Daneshpazhooh, Maryam; Khorassani, Javad; Balighi, Kamran; Ghandi, Narges; Mahmoudi, Hamidreza; Tohidinik, Hamidreza; Hamzelou, Shahin; Chams-Davatchi, Cheyda

2017-01-01

Neurological diseases are important co-morbidities found in association with bullous pemphigoid. Various neurological conditions (stroke, Parkinson's disease, dementia, epilepsy and multiple sclerosis) have been reported as associations of this bullous disease; whether these are significant has not been definitely proved. However, the presence of neurological conditions is a predictor of poorer prognosis. Our aim was to examine the association of bullous pemphigoid and neurological diseases in Iranian bullous pemphigoid patients. The medical records of one hundred and sixty consecutive bullous pemphigoid patients who presented to the Autoimmune Bullous Diseases Research Center, Tehran, Iran, from 2006 to 2011 were examined for evidence of any neurological disease. The control group comprised of 317 age- and sex-matched subjects. Neurological diseases were seen in 42 (26.4%) patients with bullous pemphigoid and in 29 (9.1%) controls (odds ratio: 3.53 (2.1-5.9), P< 0.001). Comparing cases to controls, stroke was seen in 17.5% versus 4.1%, odds ratio 4.96 (2.49-9.88); dementia in 5.6% versus 1.9%, odds ratio 3.09 (1.08-8.84); Parkinson's disease in 2.5% versus 2.2%, odds ratio 1.14 (0.33-3.94); epilepsy in 2.5% versus 0.6%, odds ratio 4.04 (0.73-22.3); and multiple sclerosis in 0 versus 0.3% odds ratio 1.00 (0.98-1.01). The main limitations of our study were referral bias, retrospective design and a rather low sample size. Neurological diseases in general, and stroke and dementia in particular, were significantly associated with bullous pemphigoid in our study.

Design of comprehensive Alzheimer's disease centers to address unmet national needs.

Science.gov (United States)

Trojanowski, John Q; Arnold, Steven E; Karlawish, Jason H; Brunden, Kurt; Cary, Mark; Davatzikos, Christos; Detre, John; Gaulton, Glen; Grossman, Murray; Hurtig, Howard; Jedrziewski, Kathryn; McCluskey, Leo; Naylor, Mary; Polsky, Daniel; Schellenberg, Gerard D; Siderowf, Andrew; Shaw, Leslie M; Van Deerlin, Vivianna; Wang, Li-San; Werner, Rachel; Xie, Sharon X; Lee, Virginia M-Y

2010-03-01

The problem of Alzheimer's disease (AD) exemplifies the challenges of dealing with a broad range of aging-related chronic disorders that require long-term, labor-intensive, and expensive care. As the baby boom generation ages and brain diseases become more prevalent, the need to confront the pending health care crisis is more urgent than ever before. Indeed, there is now a critical need to expand significantly the national effort to solve the problem of AD, with special focus on prevention. The Campaign to Prevent Alzheimer's Disease by 2020 (PAD2020) aims to create a new paradigm for planning and supporting the organization of worldwide cooperative research networks to develop new technologies for early detection and treatments of aging-related memory and motor impairments. PAD 2020 is developing an implementation plan to justify (1) increasing the federal budget for research, (2) developing novel national resources to discover new interventions for memory and motor disorders, and (3) creating innovative and streamlined decision-making processes for selecting and supporting new ideas. Since 1978 the National Institute on Aging or National Institute of Health (NIH) established an extensive national network of AD research facilities at academic institutions including AD Centers (ADCs), Consortium to Establish a Registry for AD, AD Cooperative Study (ADCS), AD Drug Discovery Program, National Alzheimer's Coordinating Center, National Cell Repository for AD, and AD Neuroimaging Initiative. However, despite the success of these programs and their critical contributions, they are no longer adequate to meet the challenges presented by AD. PAD 2020 is designed to address these changes by improving the efficiency and effectiveness of these programs. For example, the ADCs (P30s and P50s) can be enhanced by converting some into Comprehensive Alzheimer's Disease Centers (CADCs) to support not only research, but also by being demonstration projects on care/treatment, clinical

Education for patients with chronic kidney disease in Taiwan: a prospective repeated measures study.

Science.gov (United States)

Yen, Miaofen; Huang, Jeng-Jong; Teng, Hsiu-Lan

2008-11-01

To investigate the physical, knowledge and quality of life outcomes of an educational intervention for patients with early stage chronic kidney disease. A comprehensive predialysis education care team can be effective in slowing the progression of chronic kidney disease. A single group repeated measures design was used to evaluate the effects of the intervention. Participants were recruited through health department community health screen data banks. A predialysis, team-delivered educational intervention covering renal function health care, dietary management of renal function and the effects of Chinese herb medication on renal function was designed and implemented. Data were collected at baseline, six and 12 months. Study outcomes included physical indicators, knowledge (renal function protection, use of Chinese herbs and renal function and diet) and quality of life. Data were analysed using repeated measure anova to test for change over time in outcome variables. Sixty-six persons participated in this study. The predialysis educational intervention showed significant differences at the three time points in overall knowledge scores, waist-hip ratio, body mass index and global health status. Knowledge measures increased at month 6 and decreased at month 12. The primary indicator of renal function, glomerular filtration rate, remained stable throughout the 12 months of follow-up, despite the relatively older mean age of study participants. A predialysis education care team can provide effective disease-specific knowledge and may help retard deterioration of renal function in persons with early-stage chronic kidney disease. The intervention dose may need to be repeated every six months to maintain knowledge effects. A predialysis educational program with disease-specific knowledge and information is feasible and may provide positive outcomes for patients. Topics on the uses of Chinese herbs should be included for people who are likely to use alternative therapies.

Association between falls in elderly women and chronic diseases and drug use: cross sectional study

OpenAIRE

Lawlor, Debbie A; Patel, Rita; Ebrahim, Shah

2003-01-01

OBJECTIVE: To assess the associations between having had a fall and chronic diseases and drug use in elderly women. DESIGN: Cross sectional survey, using data from the British women's heart and health study. SETTING: General practices in 23 towns in Great Britain. PARTICIPANTS: 4050 women aged 60-79 years. MAIN OUTCOME MEASURE: Whether women had had falls in the previous 12 months. RESULTS: The prevalence of falling increased with increasing numbers of simultaneously occurring chronic disease...

An evaluation of different target enrichment methods in pooled sequencing designs for complex disease association studies.

Directory of Open Access Journals (Sweden)

Aaron G Day-Williams

Full Text Available Pooled sequencing can be a cost-effective approach to disease variant discovery, but its applicability in association studies remains unclear. We compare sequence enrichment methods coupled to next-generation sequencing in non-indexed pools of 1, 2, 10, 20 and 50 individuals and assess their ability to discover variants and to estimate their allele frequencies. We find that pooled resequencing is most usefully applied as a variant discovery tool due to limitations in estimating allele frequency with high enough accuracy for association studies, and that in-solution hybrid-capture performs best among the enrichment methods examined regardless of pool size.

International Network of Chronic Kidney Disease cohort studies (iNET-CKD): a global network of chronic kidney disease cohorts.

Science.gov (United States)

Dienemann, Thomas; Fujii, Naohiko; Orlandi, Paula; Nessel, Lisa; Furth, Susan L; Hoy, Wendy E; Matsuo, Seiichi; Mayer, Gert; Methven, Shona; Schaefer, Franz; Schaeffner, Elke S; Solá, Laura; Stengel, Bénédicte; Wanner, Christoph; Zhang, Luxia; Levin, Adeera; Eckardt, Kai-Uwe; Feldman, Harold I

2016-09-02

Chronic kidney disease (CKD) is a global health burden, yet it is still underrepresented within public health agendas in many countries. Studies focusing on the natural history of CKD are challenging to design and conduct, because of the long time-course of disease progression, a wide variation in etiologies, and a large amount of clinical variability among individuals with CKD. With the difference in health-related behaviors, healthcare delivery, genetics, and environmental exposures, this variability is greater across countries than within one locale and may not be captured effectively in a single study. Studies were invited to join the network. Prerequisites for membership included: 1) observational designs with a priori hypotheses and defined study objectives, patient-level information, prospective data acquisition and collection of bio-samples, all focused on predialysis CKD patients; 2) target sample sizes of 1,000 patients for adult cohorts and 300 for pediatric cohorts; and 3) minimum follow-up of three years. Participating studies were surveyed regarding design, data, and biosample resources. Twelve prospective cohort studies and two registries covering 21 countries were included. Participants age ranges from >2 to >70 years at inclusion, CKD severity ranges from stage 2 to stage 5. Patient data and biosamples (not available in the registry studies) are measured yearly or biennially. Many studies included multiple ethnicities; cohort size ranges from 400 to more than 13,000 participants. Studies' areas of emphasis all include but are not limited to renal outcomes, such as progression to ESRD and death. iNET-CKD (International Network of CKD cohort studies) was established, to promote collaborative research, foster exchange of expertise, and create opportunities for research training. Participating studies have many commonalities that will facilitate comparative research; however, we also observed substantial differences. The diversity we observed across

The COLOFOL trial: study design and comparison of the study population with the source cancer population

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Hansdotter Andersson P

2016-01-01

Full Text Available Pernilla Hansdotter Andersson,1 Peer Wille-Jørgensen,2 Erzsébet Horváth-Puhó,3 Sune Høirup Petersen,2 Anna Martling,4 Henrik Toft Sørensen,3 Ingvar Syk1 On behalf of the COLOFOL Study Group 1Department of Surgery, Skåne University Hospital, Malmö, Sweden; 2Abdominal Disease Center K, Bispebjerg University Hospital, Copenhagen, Denmark; 3Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 4Department of Molecular Medicine and Surgery, Karolinska Institutet, Solna, Sweden Introduction: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. Materials and methods: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. Results: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate. A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56% were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized

Prehospital antiplatelet use and functional status on admission of patients with non-haemorrhagic moyamoya disease: a nationwide retrospective cohort study (J-ASPECT study)

OpenAIRE

Onozuka, Daisuke; Hagihara, Akihito; Nishimura, Kunihiro; Kada, Akiko; Nakagawara, Jyoji; Ogasawara, Kuniaki; Ono, Junichi; Shiokawa, Yoshiaki; Aruga, Toru; Miyachi, Shigeru; Nagata, Izumi; Toyoda, Kazunori; Matsuda, Shinya; Suzuki, Akifumi; Kataoka, Hiroharu

2016-01-01

Objectives To elucidate the association between antiplatelet use in patients with non-haemorrhagic moyamoya disease before hospital admission and good functional status on admission in Japan. Design Retrospective, multicentre, non-randomised, observational study. Setting Nationwide registry data in Japan. Participants A total of 1925 patients with non-haemorrhagic moyamoya disease admitted between 1 April 2012 and 31 March 2014 in Japan. Main outcome measure We performed propensity score-matc...

Design of therapeutic vaccines as a novel antibody therapy for cardiovascular diseases.

Science.gov (United States)

Nakagami, Hironori

2017-09-01

Vaccines are primarily used worldwide as a preventive medicine for infectious diseases and have recently been applied to cancer. We and others have developed therapeutic vaccines designed for cardiovascular diseases that are notably different from previous vaccines. In the case of cancer vaccines, a specific protein in cancer cells is a target antigen, and the activation of cytotoxic T cells (CTL) is required to kill and remove the antigen-presenting cancer cells. Our therapeutic vaccines work against hypertension by targeting angiotensin II (Ang II) as the antigen, which is an endogenous hormone. Therapeutic vaccines must avoid CTL activation and induce the blocking antibodies for Ang II. The goal of our therapeutic vaccine for cardiovascular diseases is to induce the specific antibody response toward the target protein without inducing T-cell or antibody-mediated inflammation through the careful selection of the target antigen, carrier protein and adjuvants. The goal of our therapeutic vaccine is similar to that of antibody therapy. Recently, multiple antibody-based drugs have been developed for cancer, immune-related diseases, and dyslipidemia, which are efficient but expensive. If the effect of a therapeutic vaccine is nearly equivalent to antibody therapy as an alternative approach, the lower medical cost and improvement in drug adherence can be advantages of therapeutic vaccines. In this review, we will describe our concept of therapeutic vaccines for cardiovascular diseases and the future directions of therapeutic vaccines as novel antibody therapies. Copyright © 2017. Published by Elsevier Ltd.

Untimed Design Fluency in Aging and Alzheimer's Disease: Psychometrics and Normative Data.

Science.gov (United States)

Sunderaraman, Preeti; Sokolov, Elisaveta; Cines, Sarah; Sullo, Elizabeth; Orly, Aidan; Lerer, Bianca; Karlawish, Jason; Huey, Edward; Cosentino, Stephanie

2015-01-01

Design fluency tests, commonly used in both clinical and research contexts to evaluate nonverbal concept generation, have the potential to offer useful information in the differentiation of healthy versus pathological aging. Although normative data for older adults (OAs) are available for multiple timed versions of this test, similar data have been unavailable for a previously published untimed test, the Graphic Pattern Generation Test (GPG). Time constraints common to almost all of the available design fluency tests may cloud interpretation of higher-level executive abilities-for example, in individuals with slow processing speed. The current study examined the psychometric properties of the GPG and presents normative data in a sample of 167 healthy OAs and 110 individuals diagnosed with Alzheimer's disease (AD). Results suggest that a brief version of the GPG can be administered reliably and that this short form has high test-retest and interrater reliability. Number of perseverations was higher in individuals with AD as compared with OAs. A cutoff score of 4 or more perseverations showed a moderate degree of sensitivity (76%) and specificity (37%) in distinguishing individuals with AD and OAs. Finally, perseverations were associated with nonmemory indexes, thereby underscoring the nonverbal nature of this error in OAs and individuals with AD.

PET-Studies in parkinson's disease

International Nuclear Information System (INIS)

Schwarz, J.

2002-01-01

Positron-emission-tomography (PET) has enabled to study the metabolism and blood flow in specific brain areas. Besides, there is a variety of radiotracers that allow quantification of the function of distinct molecules. In respect to Parkinson's disease, PET allowed for the first time to assess the number of dopaminergic neurons in vivo. Thus, helping confirming a dopaminergic deficit, measuring disease progression and also help to determine the function of dopaminergic grafts. Current research has shifted to determine the role of related neurotransmitter systems in the pathophysiology of Parkinson's disease. (orig.) [de

Radioisotopic studies of bone diseases

International Nuclear Information System (INIS)

Ell, P.J.

1976-01-01

Consideration is given to the study of bone diseases. The most used radionuclides in the skeletal investigation are analysed and a table of radiopharmaceuticals of localization in the skeleton is showed. Emphasis is given to the use of Strontium 85 and 87m, fluorine 18 and technetium 99m. The phosphate compounds labelled with Technetium 99m are studied in detail and the structures of these organic and inorganic compounds are given. A table with values of the blood clearance of those compounds is presented. The skeletal distribution of the phosphate compounds-sup(99m)Tc, as well as the abnormal scintigraphy of skeleton by means of them, are analysed. Referring to bone diseases, the benign and malignant ones are studied: a table is given of bone diseases with positive imaging to the skeleton scintigraphy in the former case and the main applications of this scintigraphy in the latter one. Emphasis is given, in all the cases, to the clinical applications of the method, with recommendations in each one. Scintigraphic imagings are presented referring to each item studied [pt

Optimal vaccine stockpile design for an eradicated disease: application to polio.

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Tebbens, Radboud J Duintjer; Pallansch, Mark A; Alexander, James P; Thompson, Kimberly M

2010-06-11

Eradication of a disease promises significant health and financial benefits. Preserving those benefits, hopefully in perpetuity, requires preparing for the possibility that the causal agent could re-emerge (unintentionally or intentionally). In the case of a vaccine-preventable disease, creation and planning for the use of a vaccine stockpile becomes a primary concern. Doing so requires consideration of the dynamics at different levels, including the stockpile supply chain and transmission of the causal agent. This paper develops a mathematical framework for determining the optimal management of a vaccine stockpile over time. We apply the framework to the polio vaccine stockpile for the post-eradication era and present examples of solutions to one possible framing of the optimization problem. We use the framework to discuss issues relevant to the development and use of the polio vaccine stockpile, including capacity constraints, production and filling delays, risks associated with the stockpile, dynamics and uncertainty of vaccine needs, issues of funding, location, and serotype dependent behavior, and the implications of likely changes over time that might occur. This framework serves as a helpful context for discussions and analyses related to the process of designing and maintaining a stockpile for an eradicated disease. (c) 2010 Elsevier Ltd. All rights reserved.

The effect of long working hours on cerebrovascular and cardiovascular disease; A case-crossover study.

Science.gov (United States)

Shin, Kyong-Sok; Chung, Yun Kyung; Kwon, Young-Jun; Son, Jun-Seok; Lee, Se-Hoon

2017-09-01

This study investigated the relationship between weekly working hours and the occurrence of cerebro-cardiovascular diseases using a case-crossover study design. We investigated average working hours during the 7 days before the onset of illness (hazard period) and average weekly working hours between 8 days and 3 months before the onset of cerebro-cardiovascular diseases (control period) for 1,042 cases from the workers' compensation database for 2009. Among all subjects, the odds ratio by conditional logistic regression for the risk of cerebro-cardiovascular diseases with a 10 hr increase in average weekly working hours was 1.45 (95% confidence interval [CI]: 1.22-1.72), a significant association. An increase in average weekly working hours may trigger the onset of cerebro-cardiovascular disease. Am. J. Ind. Med. 60:753-761, 2017. © 2017. Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Blood pressure in young adults with and without a paternal history of premature coronary heart disease in Europe: the EARS study. [European arteriosclerosis study

NARCIS (Netherlands)

Masana, L.; Farinaro, E.; Henauw, S. de; Nicaud, V.

1996-01-01

Objective : The European Arteriosclerosis Study (EARS) was designed to identify variables which discriminate subjects with a paternal history of premature coronary heart disease (CHD) from controls and to study the distribution of these variables across Europe. In this article we report on the blood

Statistical guidance for experimental design and data analysis of mutation detection in rare monogenic mendelian diseases by exome sequencing.

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Degui Zhi

Full Text Available Recently, whole-genome sequencing, especially exome sequencing, has successfully led to the identification of causal mutations for rare monogenic Mendelian diseases. However, it is unclear whether this approach can be generalized and effectively applied to other Mendelian diseases with high locus heterogeneity. Moreover, the current exome sequencing approach has limitations such as false positive and false negative rates of mutation detection due to sequencing errors and other artifacts, but the impact of these limitations on experimental design has not been systematically analyzed. To address these questions, we present a statistical modeling framework to calculate the power, the probability of identifying truly disease-causing genes, under various inheritance models and experimental conditions, providing guidance for both proper experimental design and data analysis. Based on our model, we found that the exome sequencing approach is well-powered for mutation detection in recessive, but not dominant, Mendelian diseases with high locus heterogeneity. A disease gene responsible for as low as 5% of the disease population can be readily identified by sequencing just 200 unrelated patients. Based on these results, for identifying rare Mendelian disease genes, we propose that a viable approach is to combine, sequence, and analyze patients with the same disease together, leveraging the statistical framework presented in this work.

Histological outcome of duodenal biopsies in patients with clinically suspected celiac disease - a study of 100 cases

International Nuclear Information System (INIS)

Sarfraz, T.; Khan, S.A.; Tariq, H.

2018-01-01

To see the histological outcome of duodenal biopsies done in patients clinically suspected of celiac disease. Study Design: Prospective descriptive study. Place and Duration of Study: Histopathology Department, Army Medical College Rawalpindi, from 1 Jan 2017 to 30 Jun 2017. Material and Methods: One hundred (100) cases were included in the study. Duodenal biopsies done in patients clinically suspected of celiac disease were included in the study. Inadequate biopsies were excluded from the study. All the normal and abnormal histological features were noted to make the diagnosis. Data was entered and analyzed by using SPSS version 17. Results: Duodenal biopsies of 100 patients, done in clinically suspected cases of celiac disease were analyzed histologically. Out of these 100 cases, 46 cases (46%) showed histological features consistent with celiac disease, while 38 cases (38%) revealed chronic non specific duodenitis, 2 cases (2%) were of giardiasis, while 14 biopsies (14%) were unremarkable with no significant pathology. Conclusion: A significant number of cases clinically suspected of celiac disease may not be showing histological features consistent with celiac disease on duodenal biopsies. Due to the changing presentation of disease, as well as the recognition of a number of potential clinical and histopathological mimics, communication between pathologists and gastroenterologists is essential for appropriate interpretation of duodenal biopsy specimens. (author)

Studying the role of dystrophin-associated proteins in influencing Becker muscular dystrophy disease severity.

Science.gov (United States)

van den Bergen, J C; Wokke, B H A; Hulsker, M A; Verschuuren, J J G M; Aartsma-Rus, A M

2015-03-01

Becker muscular dystrophy is characterized by a variable disease course. Many factors have been implicated to contribute to this diversity, among which the expression of several components of the dystrophin associated glycoprotein complex. Together with dystrophin, most of these proteins anchor the muscle fiber cytoskeleton to the extracellular matrix, thus protecting the muscle from contraction induced injury, while nNOS is primarily involved in inducing vasodilation during muscle contraction, enabling adequate muscle oxygenation. In the current study, we investigated the role of three components of the dystrophin associated glycoprotein complex (beta-dystroglycan, gamma-sarcoglycan and nNOS) and the dystrophin homologue utrophin on disease severity in Becker patients. Strength measurements, data about disease course and fresh muscle biopsies of the anterior tibial muscle were obtained from 24 Becker patients aged 19 to 66. The designation of Becker muscular dystrophy in this study was based on the mutation and not on the clinical severity. Contrary to previous studies, we were unable to find a relationship between expression of nNOS, beta-dystroglycan and gamma-sarcoglycan at the sarcolemma and disease severity, as measured by muscle strength in five muscle groups and age at reaching several disease milestones. Unexpectedly, we found an inverse correlation between utrophin expression at the sarcolemma and age at reaching disease milestones. Copyright © 2015 Elsevier B.V. All rights reserved.

Strengthening the delivery of asthma and chronic obstructive pulmonary disease care at primary health-care facilities: study design of a cluster randomized controlled trial in Pakistan

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Muhammad Amir Khan

2015-11-01

Full Text Available Background: Respiratory diseases, namely asthma and chronic obstructive pulmonary disease (COPD, account for one-fourth of the patients at the primary health-care (PHC facilities in Pakistan. Standard care practices to manage these diseases are necessary to reduce the morbidity and mortality rate associated with non-communicable diseases in developing countries. Objective: To develop and measure the effectiveness of operational guidelines and implementation materials, with sound scientific evidence, for expanding lung health care, especially asthma and COPD through PHC facilities already strengthened for tuberculosis (TB care in Pakistan. Design: A cluster randomized controlled trial with two arms (intervention and control, with qualitative and costing study components, is being conducted in 34 clusters; 17 clusters per arm (428 asthma and 306 COPD patients, in three districts in Pakistan from October 2014 to December 2016. The intervention consists of enhanced case management of asthma and COPD patients through strengthening of PHC facilities. The main outcomes to be measured are asthma and COPD control among the registered cases at 6 months. Cluster- and individual-level analyses will be done according to intention to treat. Residual confounding will be addressed by multivariable logistic and linear regression models for asthma and COPD control, respectively. The trial is registered with ISRCTN registry (ISRCTN 17409338. Conclusions: Currently, only about 20% of the estimated prevalent asthma and COPD cases are being identified and reported through the respective PHC network. Lung health care and prevention has not been effectively integrated into the core PHC package, although a very well-functioning TB program exists at the PHC level. Inclusion of these diseases in the already existent TB program is expected to increase detection rates and care for asthma and COPD.

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

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Gevers Tom JG

2012-04-01

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

Comparative evaluation of serum antioxidant levels in periodontally diseased patients: An interventional study

Science.gov (United States)

Thomas, Biju; Madani, Shabeer Mohamed; Prasad, B. Rajendra; Kumari, Suchetha

2014-01-01

Background: Periodontal disease is an immune-inflammatory disease characterized by connective tissue breakdown, loss of attachment and alveolar bone resorption. In normal physiology, there is a dynamic equilibrium between reactive oxygen species activity and antioxidant defense capacity and when that equilibrium shifts in favor of reactive oxygen species, oxidative stress results. Oxidative stress is thought to play a causative role in the pathogenesis of periodontal diseases. Catalase (CAT) protects cells from hydrogen peroxide generated within them. Even though, CAT is not essential for some cell types under normal conditions, it plays an important role countering the effects of oxidative stress on the cell. Aim: This study was designed to estimate and compare the CAT and total antioxidant capacity (TAOC) levels in the serum of periodontitis, gingivitis, and healthy individuals before and after nonsurgical periodontal therapy. Materials and Methods: This study was conducted in the Department of Periodontics, A. B. Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore. The study was designed as a single blinded interventional study comprising of 75 subjects, inclusive of both sexes and divided into three groups of 25 patients each. Patients were categorized into chronic periodontitis, gingivitis and healthy. The severity of inflammation was assessed by using gingival index and pocket probing depth. Biochemical analysis was done to estimate the TAOC and CAT levels before and after nonsurgical periodontal therapy. Results obtained were then statistically analyzed using ANOVA test and paired t-test. Results: The results showed a higher level of serum TAOC and CAT in the healthy group compared with the other groups. The difference was found to be statistically significant (P periodontitis group. PMID:25191070

Periodontal disease in pregnant patients with rheumatic valvular disease: clinical and microbiological study.

Science.gov (United States)

Avila, Walkiria Samuel; Timerman, Lilia; Romito, Giuseppe Alexandre; Marcelino, Sílvia Linard; Neves, Itamara Lúcia Itagiba; Zugaib, Marcelo; Grinberg, Max

2011-04-01

The periodontal disease during pregnancy of women with rheumatic valve disease imply infective endocarditis risks and higher rate of preterm birth and low birth weight. To study the periodontal disease rate of women with rheumatic valve disease during pregnancy. We studied 140 pregnant women who included 70 patients with rheumatic valve disease and 70 healthy women. The periodontal examination included: 1) periodontal clinical exam regard the follow variables: a) probing depth; b) gingival margin; c) clinical attachment level; d) bleeding on probing; e) plaque index and f) gingival index; and 2) microbiological test was performed in samples serum and gingival crevicular fluid and considered positive controls to Porphyromonas gingivalis, Tannerella forsithia e Aggregobacter actinomycetemcomitans. Age and parity were similar between groups; as single or combined the mitral valve disease was prevalent among the rheumatic valve lesion in 45 (32.1%) e 20 (28.5%) cases, respectively. Among the periodontal variables gingival margin (p=0.01) and plaque index (p=0.04) were different between groups. The periodontal disease was identified in 20 (14,3%) pregnant women, seven (10%) of them were patients with valve rheumatic disease and the remain 13 (18,6%) were healthy women, its percentual was not different between groups (p=0,147). Microbiological analyses of oral samples showed higher percentual of P. gingivalis in healthy pregnant women (p=0.004). The clinical and microbiological study during pregnancy showed comparable incidence of periodontal disease between women with rheumatic valve disease and healthy women.

A double-blind study of the efficacy of apomorphine and its assessment in "off-periods in Parkinson's disease

NARCIS (Netherlands)

van Laar, T.; Jansen, E.N.H.; Essink, A.W.G.; Neef, C.; Oosterloo, Sebe J.

1993-01-01

Five patients with idiopathic Parkinson's disease with severe response fluctuations were selected for a randomized double-blind placebo-controlled study, concerning the clinical effects of subcutaneous apomorphine and its assessment in `off¿-periods. The study was designed as five n = 1 studies, in

A cross-sectional survey to study the relationship of periodontal disease with cardiovascular disease, respiratory disease, and diabetes mellitus.

Science.gov (United States)

Oberoi, Sukhvinder Singh; Harish, Yashoda; Hiremath, Shivalingaswamy; Puranik, Manjunath

2016-01-01

Periodontal deterioration has been reported to be associated with systemic diseases such as cardiovascular disease (CVD), diabetes mellitus, respiratory disease, liver cirrhosis, bacterial pneumonia, nutritional deficiencies, and adverse pregnancy outcomes. The present study assessed the periodontal disease among patients with systemic conditions such as diabetes, CVD, and respiratory disease. The study population consisted of 220 patients each of CVD, respiratory disease, and diabetes mellitus, making a total of 660 patients in the systemic disease group. A control group of 340 subjects were also included in the study for comparison purpose. The periodontal status of the patients with these confirmed medical conditions was assessed using the community periodontal index of treatment needs (CPITNs) index. The prevalence of CPITN code 4 was found to be greater among the patients with respiratory disease whereas the mean number of sextants with score 4 was found to be greater among the patients with diabetes mellitus and CVD. The treatment need 0 was found to be more among the controls (1.18%) whereas the treatment need 1, 2, and 3 were more among the patients with respiratory disease (100%, 97.73%, and 54.8%), diabetes mellitus (100%, 100% and 46.4%), and CVD (100%, 97.73%, and 38.1%), in comparison to the controls (6.18%). From the findings of the present study, it can be concluded that diabetes mellitus, CVD, and respiratory disease are associated with a higher severity of periodontal disease.

A cross-sectional survey to study the relationship of periodontal disease with cardiovascular disease, respiratory disease, and diabetes mellitus

Directory of Open Access Journals (Sweden)

Sukhvinder Singh Oberoi

2016-01-01

Full Text Available Background: Periodontal deterioration has been reported to be associated with systemic diseases such as cardiovascular disease (CVD, diabetes mellitus, respiratory disease, liver cirrhosis, bacterial pneumonia, nutritional deficiencies, and adverse pregnancy outcomes. Aim: The present study assessed the periodontal disease among patients with systemic conditions such as diabetes, CVD, and respiratory disease. Materials and Methods: The study population consisted of 220 patients each of CVD, respiratory disease, and diabetes mellitus, making a total of 660 patients in the systemic disease group. A control group of 340 subjects were also included in the study for comparison purpose. The periodontal status of the patients with these confirmed medical conditions was assessed using the community periodontal index of treatment needs (CPITNs index. Results: The prevalence of CPITN code 4 was found to be greater among the patients with respiratory disease whereas the mean number of sextants with score 4 was found to be greater among the patients with diabetes mellitus and CVD. The treatment need 0 was found to be more among the controls (1.18% whereas the treatment need 1, 2, and 3 were more among the patients with respiratory disease (100%, 97.73%, and 54.8%, diabetes mellitus (100%, 100% and 46.4%, and CVD (100%, 97.73%, and 38.1%, in comparison to the controls (6.18%. Conclusion: From the findings of the present study, it can be concluded that diabetes mellitus, CVD, and respiratory disease are associated with a higher severity of periodontal disease.

A Metabolic Study of Huntington's Disease.

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Rajasree Nambron

Full Text Available Huntington's disease patients have a number of peripheral manifestations suggestive of metabolic and endocrine abnormalities. We, therefore, investigated a number of metabolic factors in a 24-hour study of Huntington's disease gene carriers (premanifest and moderate stage II/III and controls.Control (n = 15, premanifest (n = 14 and stage II/III (n = 13 participants were studied with blood sampling over a 24-hour period. A battery of clinical tests including neurological rating and function scales were performed. Visceral and subcutaneous adipose distribution was measured using magnetic resonance imaging. We quantified fasting baseline concentrations of glucose, insulin, cholesterol, triglycerides, lipoprotein (a, fatty acids, amino acids, lactate and osteokines. Leptin and ghrelin were quantified in fasting samples and after a standardised meal. We assessed glucose, insulin, growth hormone and cortisol concentrations during a prolonged oral glucose tolerance test.We found no highly significant differences in carbohydrate, protein or lipid metabolism markers between healthy controls, premanifest and stage II/III Huntington's disease subjects. For some markers (osteoprotegerin, tyrosine, lysine, phenylalanine and arginine there is a suggestion (p values between 0.02 and 0.05 that levels are higher in patients with premanifest HD, but not moderate HD. However, given the large number of statistical tests performed interpretation of these findings must be cautious.Contrary to previous studies that showed altered levels of metabolic markers in patients with Huntington's disease, our study did not demonstrate convincing evidence of abnormalities in any of the markers examined. Our analyses were restricted to Huntington's disease patients not taking neuroleptics, anti-depressants or other medication affecting metabolic pathways. Even with the modest sample sizes studied, the lack of highly significant results, despite many being tested, suggests that

Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

Science.gov (United States)

Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

2016-03-22

attainment, carers' perception of patients' goal attainment and patients' and carers' health status and psychosocial well-being, measured at the same time points. Cost-effectiveness will be examined to explore the design of a larger cost-effectiveness analysis alongside a full trial. This pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson's disease dementia and dementia with Lewy bodies. The results of the study will inform the design of a fully powered randomised controlled trial. ISRCTN16584442 DOI 10.1186/ISRCTN16584442 13 April 2015.

Design of a consumer health record for supporting the patient-centered management of chronic diseases.

NARCIS (Netherlands)

de Clerq, P.A.; Hasman, A.; Wolffenbuttel, B.H.R.

2001-01-01

: Medinfo 2001;10(Pt 2):1445-9 Related Articles, Books, LinkOut Design of a consumer health record for supporting the patient-centered management of chronic diseases. de Clercq PA, Hasman A, Wolffenbuttel BH. Department of Medical Informatics, University of Maastricht, Maastricht, The Netherlands.

Echocardiographic study of cardiac dysfunction in patients of chronic kidney disease on hemodialysis

International Nuclear Information System (INIS)

Arshi, S.; Butt, G.U.D.; Mian, F.A.

2016-01-01

Objective: The objective of this study was to see echocardiographic findings of cardiac dysfunction in patients of chronic kidney disease (CKD) on hemodialysis. Study Design: Comparative cross sectional study. Place and Duration of Study: Department of nephrology, Pakistan Institute of Medical Sciences. Islamabad from September 2014 to February 2015. Patients and Methods: One hundred patients of either gender were included in this study. Fifty patients of chronic kidney disease stage V on hemodialysis were taken for echocardiography and fifty were normal. Echocardiography was done for cardiac dysfunction. Systolic function was measured by ejection fraction (EF) and fractional shortening (FS). Diastolic function was measured by E/A ratio. Results: Out of 100 patients included in the study, 50 patients were on hemodialysis and 50 were control. Left ventricular end systolic and end diastolic volumes were higher in patients on hemodialysis than controls as well as left atrial enlargement and inter ventricular septum which was statistically significant. Ejection fraction, although normal and fractional shortening decreased in patients on hemodialysis (p<0.05). Diastolic dysfunction was present in 36 patients on hemodialysis, while absent in the control group. Conclusion: Patients with chronic kidney disease on hemodialysis have higher prevalence of cardiac dysfunction. (author)

Toxoplasma gondii exposure and Parkinson's disease: a case–control study

Science.gov (United States)

Alvarado-Esquivel, Cosme; Méndez-Hernández, Edna Madai; Salas-Pacheco, José Manuel; Ruano-Calderón, Luis Ángel; Hernández-Tinoco, Jesús; Arias-Carrión, Oscar; Sánchez-Anguiano, Luis Francisco; Castellanos-Juárez, Francisco Xavier; Sandoval-Carrillo, Ada Agustina; Liesenfeld, Oliver; Ramos-Nevárez, Agar

2017-01-01

Objectives To determine the association between Toxoplasma gondii infection and Parkinson's disease and to investigate whether T. gondii seropositivity is associated with the general characteristics of patients with Parkinson's disease. Design Case–control study. Setting Cases and controls were enrolled in Durango City, Mexico. Participants 65 patients with Parkinson's disease and 195 age- and gender-matched control subjects without Parkinson's disease. Primary and secondary outcome measures Serum samples of participants were analysed for anti-T. gondii IgG and IgM antibodies by commercially available enzyme-linked immunoassays. Prevalence of T. gondii DNA was determined in seropositive subjects using PCR. The association between clinical data and infection was examined by bivariate analysis. Results Anti-T. gondii IgG antibodies were found in 6/65 cases (9.2%) and in 21/195 controls (10.8%) (OR 0.84; 95% CI 0.32 to 2.18; p=0.81). The frequency of high (>150 IU/mL) antibody levels was similar among cases and controls (p=0.34). None of the anti-T. gondii IgG positive cases and four of the anti-T. gondii IgG positive controls had anti-T. gondii IgM antibodies (p=0.54). The prevalence of T. gondii DNA was comparable in seropositive cases and controls (16.7% and 25%, respectively; p=1.0). Seroprevalence of T. gondii infection was associated with a young age onset of disease (p=0.03), high Unified Parkinson Disease Rating Scale scores (p=0.04) and depression (p=0.02). Seropositivity to T. gondii infection was lower in patients treated with pramipexole than in patients without this treatment (p=0.01). However, none of the associations remained significant after Bonferroni correction. Conclusions The results do not support an association between T. gondii infection and Parkinson's disease. However, T. gondii infection might have an influence on certain symptoms of Parkinson's disease. Further research to elucidate the role of T. gondii exposure on Parkinson's disease

Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study.

Science.gov (United States)

Steensma, David P; Abedi, Medrdad; Bejar, Rafael; Cogle, Christopher R; Foucar, Kathryn; Garcia-Manero, Guillermo; George, Tracy I; Grinblatt, David; Komrokji, Rami; Ma, Xiaomei; Maciejewski, Jaroslaw; Pollyea, Daniel A; Savona, Michael R; Scott, Bart; Sekeres, Mikkael A; Thompson, Michael A; Swern, Arlene S; Nifenecker, Melissa; Sugrue, Mary M; Erba, Harry

2016-08-19

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are myeloid neoplasms in which outgrowth of neoplastic clones disrupts normal hematopoiesis. Some patients with unexplained persistent cytopenias may not meet minimal diagnostic criteria for MDS but an alternate diagnosis is not apparent; the term idiopathic cytopenia of undetermined significance (ICUS) has been used to describe this state. MDS and AML occur primarily in older patients who are often treated outside the clinical trial setting. Consequently, our understanding of the patterns of diagnostic evaluation, management, and outcomes of these patients is limited. Furthermore, there are few natural history studies of ICUS. To better understand how patients who have MDS, ICUS, or AML are managed in the routine clinical setting, the Connect MDS/AML Disease Registry, a multicenter, prospective, observational cohort study of patients newly diagnosed with these conditions has been initiated. The Connect MDS/AML Disease Registry will capture diagnosis, risk assessment, treatment, and outcomes data for approximately 1500 newly diagnosed patients from approximately 150 community and academic sites in the United States in 4 cohorts: (1) lower-risk MDS (International Prognostic Scoring System [IPSS] low and intermediate-1 risk), with and without del(5q); (2) higher-risk MDS (IPSS intermediate-2 and high risk); (3) ICUS; and (4) AML in patients aged ≥ 55 years (excluding acute promyelocytic leukemia). Diagnosis will be confirmed by central review. Baseline patient characteristics, diagnostic patterns, treatment patterns, clinical outcomes, health economics outcomes, and patient-reported health-related quality of life will be entered into an electronic data capture system at enrollment and quarterly for 8 years. A tissue substudy to explore the relationship between karyotypes, molecular markers, and clinical outcomes will be conducted, and is optional for patients. The Connect MDS/AML Disease

Bacteriophage-based synthetic biology for the study of infectious diseases

Science.gov (United States)

Lu, Timothy K.

2014-01-01

Since their discovery, bacteriophages have contributed enormously to our understanding of molecular biology as model systems. Furthermore, bacteriophages have provided many tools that have advanced the fields of genetic engineering and synthetic biology. Here, we discuss bacteriophage-based technologies and their application to the study of infectious diseases. New strategies for engineering genomes have the potential to accelerate the design of novel phages as therapies, diagnostics, and tools. Though almost a century has elapsed since their discovery, bacteriophages continue to have a major impact on modern biological sciences, especially with the growth of multidrug-resistant bacteria and interest in the microbiome. PMID:24997401

Myocardial perfusion studies in coronary diseases

International Nuclear Information System (INIS)

Mut, Fernando

1994-01-01

For detecting in precocious form a coronary disease is necessary to apply a diagnostic techniques. The main considerations to be indicated in the present work are: physiological considerations, myocardial perfusion studies with radiotracers such as Talio 201, 99mTc, MIBI, 99mTc-Teboroxima, 99mTc-Fosfinas, instrumentation for obtain good images,proceedings protocols, studies interpretation, standards, SPECT, anomalies standards, coronary diseases

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

Science.gov (United States)

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

2016-07-27

The Canadian Alliance for Healthy Hearts and Minds (CAHHM) is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services) with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity), cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI) of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

Prospective study on dietary intakes of folate, betaine, and choline and cardiovascular disease risk in women.

NARCIS (Netherlands)

Dalmeijer, G.W.; Olthof, M.R.; Verhoef, P.; Bots, M.L.; van der Schouw, Y.T.

2008-01-01

Objective: To investigate the association between dietary intakes of folate, betaine and choline and the risk of cardiovascular disease (CVD). Design: Prospective cohort study. Subjects: A total of 16165 women aged 49-70 years without prior CVD. Subjects were breast cancer screening participants in

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

Science.gov (United States)

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

2016-01-01

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

Coronary artery disease in patients with cerebrovascular disease: a prospective study

International Nuclear Information System (INIS)

Rokey, R.; Rolak, L.A.; Harati, Y.; Kutka, N.; Verani, M.S.

1984-01-01

Coronary artery disease is the cause of death in most patients who have transient ischemic attacks or stroke. Evaluation for this condition is not routinely performed in such patients, and no prospective studies have been reported. We prospectively examined 50 consecutive patients with transient ischemic attacks or mild stroke to determine the prevalence and importance of coronary artery disease. All patients were examined by a cardiologist and underwent both exercise thallium-201 scintigraphy and exercise radionuclide ventriculography. Sixteen patients were suspected to have coronary artery disease on the basis of clinical evaluation. In 15 of these the was confirmed by the nuclear scans. The remaining 34 patients had no clinical evidence of heart disease, yet 14 had abnormal cardiac scans. Twenty of 22 patients with abnormal scans who underwent cardiac catheterization had significant coronary artery disease or a cardiomyopathy. The discovery of heart disease altered clinical management in 13 patients. Overall, 29 of 50 patients had significant coronary artery disease, compared with a 7% prevalence of the condition in other patients of similar age at the same institution

Control of deaths from diarrheal disease in rural communities. I. Design of an intervention study and effects on child mortality.

Science.gov (United States)

Kielmann, A A; Mobarak, A B; Hammamy, M T; Gomaa, A I; Abou-el-Saad, S; Lotfi, R K; Mazen, I; Nagaty, A

1985-12-01

From May through October 1980, the "Strengthening Rural Health Delivery" project (SRHD) under the Rural Health Department of the Ministry of Health of Egypt had conducted an investigation into prevention of child mortality from diarrheal disease through testing various modules of Oral Rehydration Therapy delivery mechanisms. In a six-cell design counting a total of almost 29,000 children, ORT was provided both as hypotonic sucrose/salt solution prepared and administered by mothers and normotonic, balanced electrolyte solution in the hands of both mothers and health care providers and the effects on child mortality during the peak season of diarrheal incidence were measured. In addition, utilization and effects of ORT when made readily available through commercial channels was similarly examined. A cost-benefit analysis was performed on the cost of the services as well as on the outcome for each of five study cells using the sixth, the control, as reference. Results showed that early rehydration with a sucrose/salt solution in the hands of mothers, backed by balanced oral rehydration solution in the hands of health care providers proved the most cost-effective means of reducing diarrhea-specific mortality as well as being as safe as prepackaged commercial preparations.

Comparative evaluation of serum antioxidant levels in periodontally diseased patients: An interventional study

Directory of Open Access Journals (Sweden)

Biju Thomas

2014-01-01

Full Text Available Background: Periodontal disease is an immune-inflammatory disease characterized by connective tissue breakdown, loss of attachment and alveolar bone resorption. In normal physiology, there is a dynamic equilibrium between reactive oxygen species activity and antioxidant defense capacity and when that equilibrium shifts in favor of reactive oxygen species, oxidative stress results. Oxidative stress is thought to play a causative role in the pathogenesis of periodontal diseases. Catalase (CAT protects cells from hydrogen peroxide generated within them. Even though, CAT is not essential for some cell types under normal conditions, it plays an important role countering the effects of oxidative stress on the cell. Aim: This study was designed to estimate and compare the CAT and total antioxidant capacity (TAOC levels in the serum of periodontitis, gingivitis, and healthy individuals before and after nonsurgical periodontal therapy. Materials and Methods: This study was conducted in the Department of Periodontics, A. B. Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore. The study was designed as a single blinded interventional study comprising of 75 subjects, inclusive of both sexes and divided into three groups of 25 patients each. Patients were categorized into chronic periodontitis, gingivitis and healthy. The severity of inflammation was assessed by using gingival index and pocket probing depth. Biochemical analysis was done to estimate the TAOC and CAT levels before and after nonsurgical periodontal therapy. Results obtained were then statistically analyzed using ANOVA test and paired t-test. Results: The results showed a higher level of serum TAOC and CAT in the healthy group compared with the other groups. The difference was found to be statistically significant (P < 0.0001. The posttreatment levels of TAOC were statistically higher than the pretreatment levels in periodontitis group.

Design and application of the emergency response mobile phone-based information system for infectious disease reporting in the Wenchuan earthquake zone.

Science.gov (United States)

Ma, Jiaqi; Zhou, Maigeng; Li, Yanfei; Guo, Yan; Su, Xuemei; Qi, Xiaopeng; Ge, Hui

2009-05-01

To describe the design and application of an emergency response mobile phone-based information system for infectious disease reporting. Software engineering and business modeling were used to design and develop the emergency response mobile phone-based information system for infectious disease reporting. Seven days after the initiation of the reporting system, the reporting rate in the earthquake zone reached the level of the same period in 2007, using the mobile phone-based information system. Surveillance of the weekly report on morbidity in the earthquake zone after the initiation of the mobile phone reporting system showed the same trend as the previous three years. The emergency response mobile phone-based information system for infectious disease reporting was an effective solution to transmit urgently needed reports and manage communicable disease surveillance information. This assured the consistency of disease surveillance and facilitated sensitive, accurate, and timely disease surveillance. It is an important backup for the internet-based direct reporting system for communicable disease. © 2009 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy

Directory of Open Access Journals (Sweden)

Deepak P

2016-11-01

Full Text Available Parakkal Deepak, Edward V Loftus Jr Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA Abstract: Crohn’s disease is characterized by a dysregulation of both innate and adaptive immunity responses. Interleukin-12/23 (IL-12/23 pathway has been found to be a major driver of inflammation in adaptive immune responses. Ustekinumab is a fully human immunoglobulin G1 kappa monoclonal antibody that blocks the p40 subunit of IL-12 and IL-23 and prevents their interaction with their cell surface receptor and further cytokine activation. It is currently approved in the management of plaque psoriasis and psoriatic arthritis. Very promising data have emerged through phase II and phase III trials (UNITI-1, UNITI-2, and IM-UNITI for both induction and maintenance of clinical response and remission in moderate-to-severe Crohn’s disease, resulting in approval by the Food and Drug Administration for this condition. This article reviews the immunology of the IL-12/23 pathway, available data regarding the initial designing of ustekinumab, drug development through clinical trials including pharmacokinetics, efficacy, and safety, and its potential place in the treatment of Crohn’s disease.Keywords: ustekinumab, Crohn’s disease, inflammatory bowel disease, interleukin-12/23 monoclonal antibody, interleukin-12, interleukin-23

Preventing Airborne Disease Transmission: Review of Methods for Ventilation Design in Health Care Facilities

Science.gov (United States)

Aliabadi, Amir A.; Rogak, Steven N.; Bartlett, Karen H.; Green, Sheldon I.

2011-01-01

Health care facility ventilation design greatly affects disease transmission by aerosols. The desire to control infection in hospitals and at the same time to reduce their carbon footprint motivates the use of unconventional solutions for building design and associated control measures. This paper considers indoor sources and types of infectious aerosols, and pathogen viability and infectivity behaviors in response to environmental conditions. Aerosol dispersion, heat and mass transfer, deposition in the respiratory tract, and infection mechanisms are discussed, with an emphasis on experimental and modeling approaches. Key building design parameters are described that include types of ventilation systems (mixing, displacement, natural and hybrid), air exchange rate, temperature and relative humidity, air flow distribution structure, occupancy, engineered disinfection of air (filtration and UV radiation), and architectural programming (source and activity management) for health care facilities. The paper describes major findings and suggests future research needs in methods for ventilation design of health care facilities to prevent airborne infection risk. PMID:22162813

Prevalence and clinical features of celiac disease in patients with autoimmune thyroiditis: cross-sectional study

Directory of Open Access Journals (Sweden)

Aline Ventura

Full Text Available CONTEXT AND OBJECTIVE: Celiac disease is an autoimmune disorder with an average prevalence of 1% in Europe and the United States. Because of strong European ancestry in southern Brazil, this study aimed to evaluate the seroprevalence of celiac disease among autoimmune thyroiditis patients.DESIGN AND SETTING: Cross-sectional study in a public university hospital.METHODS: This cross-sectional prevalence study included autoimmune thyroiditis patients who were tested for anti-endomysial and anti-transglutaminase antibodies between August 2010 and July 2011.RESULTS: Fifty-three patients with autoimmune thyroiditis were included; 92.5% were women, with mean age of 49.0 ± 13.5 years. Five patients (9.3% were serologically positive for celiac disease: three of them (5.6% were reactive for anti-endomysial antibodies and two (3.7% for anti-transglutaminase. None of them exhibited anemia and one presented diarrhea. Endoscopy was performed on two patients: one with normal histology and the other with lymphocytic infiltrate and villous atrophy.CONCLUSION: The prevalence of celiac disease among patients with autoimmune thyroid disease was 9.3%; one patient complained of diarrhea and none presented anemia. Among at-risk populations, like autoimmune thyroiditis patients, the presence of diarrhea or anemia should not be used as a criterion for indicating celiac disease investigation. This must be done for all autoimmune thyroiditis patients because of its high prevalence.

Design of a Bayesian adaptive phase 2 proof-of-concept trial for BAN2401, a putative disease-modifying monoclonal antibody for the treatment of Alzheimer's disease.

Science.gov (United States)

Satlin, Andrew; Wang, Jinping; Logovinsky, Veronika; Berry, Scott; Swanson, Chad; Dhadda, Shobha; Berry, Donald A

2016-01-01

Recent failures in phase 3 clinical trials in Alzheimer's disease (AD) suggest that novel approaches to drug development are urgently needed. Phase 3 risk can be mitigated by ensuring that clinical efficacy is established before initiating confirmatory trials, but traditional phase 2 trials in AD can be lengthy and costly. We designed a Bayesian adaptive phase 2, proof-of-concept trial with a clinical endpoint to evaluate BAN2401, a monoclonal antibody targeting amyloid protofibrils. The study design used dose response and longitudinal modeling. Simulations were used to refine study design features to achieve optimal operating characteristics. The study design includes five active treatment arms plus placebo, a clinical outcome, 12-month primary endpoint, and a maximum sample size of 800. The average overall probability of success is ≥80% when at least one dose shows a treatment effect that would be considered clinically meaningful. Using frequent interim analyses, the randomization ratios are adapted based on the clinical endpoint, and the trial can be stopped for success or futility before full enrollment. Bayesian statistics can enhance the efficiency of analyzing the study data. The adaptive randomization generates more data on doses that appear to be more efficacious, which can improve dose selection for phase 3. The interim analyses permit stopping as soon as a predefined signal is detected, which can accelerate decision making. Both features can reduce the size and duration of the trial. This study design can mitigate some of the risks associated with advancing to phase 3 in the absence of data demonstrating clinical efficacy. Limitations to the approach are discussed.

The South Asian heart lifestyle intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: Design and methods

OpenAIRE

Kandula, Namratha R.; Patel, Yasin; Dave, Swapna; Seguil, Paola; Kumar, Santosh; Baker, David W.; Spring, Bonnie; Siddique, Juned

2013-01-01

Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian heart lifestyle intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved...

The LIFE child study: a life course approach to disease and health

Science.gov (United States)

2012-01-01

Background Profound knowledge about child growth, development, health, and disease in contemporary children and adolescents is still rare. Epidemiological studies together with new powerful research technologies present exciting opportunities to the elucidation of risk factor-outcome associations with potentially major consequences for prevention, diagnosis and treatment. Aim To conduct a unique prospective longitudinal cohort study in order to assess how environmental, metabolic and genetic factors affect growth, development and health from fetal life to adulthood. Methods The ‘Leipzig Research Centre for Civilization Diseases (LIFE) Child Study’ focuses on two main research objectives: (1) monitoring of normal growth, development and health; (2) non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems. Detailed assessments will be conducted alongside long-term storage of biological samples in 2,000 pregnant women and more than 10,000 children and their families. Results Close coordination and engagement of a multidisciplinary team in the LIFE Child study successfully established procedures and systems for balancing many competing study and ethical needs. Full participant recruitment and complete data collection started in July 2011. Early data indicate a high acceptance rate of the study program, successful recruitment strategies and the establishment of a representative cohort for the population of Leipzig. A series of subprojects are ongoing, and analyses and publications are on their way. Discussion This paper addresses key elements in the design and implementation of the new prospective longitudinal cohort study LIFE Child. Given the recognized need for long-term data on adverse effects on health and protective factors, our study data collection should provide magnificent opportunities to examine complex interactions that govern the emergence of non-communicable diseases. PMID:23181778

The LIFE child study: a life course approach to disease and health

Directory of Open Access Journals (Sweden)

Quante Mirja

2012-11-01

Full Text Available Abstract Background Profound knowledge about child growth, development, health, and disease in contemporary children and adolescents is still rare. Epidemiological studies together with new powerful research technologies present exciting opportunities to the elucidation of risk factor-outcome associations with potentially major consequences for prevention, diagnosis and treatment. Aim To conduct a unique prospective longitudinal cohort study in order to assess how environmental, metabolic and genetic factors affect growth, development and health from fetal life to adulthood. Methods The ‘Leipzig Research Centre for Civilization Diseases (LIFE Child Study’ focuses on two main research objectives: (1 monitoring of normal growth, development and health; (2 non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems. Detailed assessments will be conducted alongside long-term storage of biological samples in 2,000 pregnant women and more than 10,000 children and their families. Results Close coordination and engagement of a multidisciplinary team in the LIFE Child study successfully established procedures and systems for balancing many competing study and ethical needs. Full participant recruitment and complete data collection started in July 2011. Early data indicate a high acceptance rate of the study program, successful recruitment strategies and the establishment of a representative cohort for the population of Leipzig. A series of subprojects are ongoing, and analyses and publications are on their way. Discussion This paper addresses key elements in the design and implementation of the new prospective longitudinal cohort study LIFE Child. Given the recognized need for long-term data on adverse effects on health and protective factors, our study data collection should provide magnificent opportunities to examine complex interactions that govern the emergence of non-communicable diseases.

SPFC bus design studies

Energy Technology Data Exchange (ETDEWEB)

Potter, L.; Reinkingh, J.

1999-07-01

This report presents the results of a study assessing the design options for a solid polymer fuel cell bus. Commercial and operation requirements, environmental and market drivers, and fuel processor modeling are examined. Power train specifications and detailed system design are investigated covering fuel cell system dynamic response, hybrid system size, fuel cell system start-up time, system specifications, and hybrid bus component dimensions and costs. (UK)

Surveillance study for creating the national clinical database relating to ECG-gated myocardial perfusion SPECT of asymptomatic ischemic heart disease in patients with type-2 diabetes mellitus. J-ACCESS 2 study design

International Nuclear Information System (INIS)

Kusuoka, Hideo; Yamasaki, Yoshimitsu; Izumi, Tohru; Kashiwagi, Atsunori; Kawamori, Ryuzo; Shimamoto, Kazuaki; Yamada, Nobuhiro; Nishimura, Tsunehiko

2008-01-01

used by the largest number (83.2%), followed by hypotensive (66.7%), hypolipidemic (40.7%), and antiplatelet drugs (27.7%), vasodilators (5.5%), and antioxidants and others (2.3%). This study was designed to clarify the correlation between coronary artery disease and diabetes mellitus as its risk factor based on the clinical and imaging findings. Patient enrollment was closed on September 30, 2005, and follow-up is now under way. (author)

Novel Vector Design and Hexosaminidase Variant Enabling Self-Complementary Adeno-Associated Virus for the Treatment of Tay-Sachs Disease.

Science.gov (United States)

Karumuthil-Melethil, Subha; Nagabhushan Kalburgi, Sahana; Thompson, Patrick; Tropak, Michael; Kaytor, Michael D; Keimel, John G; Mark, Brian L; Mahuran, Don; Walia, Jagdeep S; Gray, Steven J

2016-07-01

GM2 gangliosidosis is a family of three genetic neurodegenerative disorders caused by the accumulation of GM2 ganglioside (GM2) in neuronal tissue. Two of these are due to the deficiency of the heterodimeric (α-β), "A" isoenzyme of lysosomal β-hexosaminidase (HexA). Mutations in the α-subunit (encoded by HEXA) lead to Tay-Sachs disease (TSD), whereas mutations in the β-subunit (encoded by HEXB) lead to Sandhoff disease (SD). The third form results from a deficiency of the GM2 activator protein (GM2AP), a substrate-specific cofactor for HexA. In their infantile, acute forms, these diseases rapidly progress with mental and psychomotor deterioration resulting in death by approximately 4 years of age. After gene transfer that overexpresses one of the deficient subunits, the amount of HexA heterodimer formed would empirically be limited by the availability of the other endogenous Hex subunit. The present study used a new variant of the human HexA α-subunit, μ, incorporating critical sequences from the β-subunit that produce a stable homodimer (HexM) and promote functional interactions with the GM2AP- GM2 complex. We report the design of a compact adeno-associated viral (AAV) genome using a synthetic promoter-intron combination to allow self-complementary (sc) packaging of the HEXM gene. Also, a previously published capsid mutant, AAV9.47, was used to deliver the gene to brain and spinal cord while having restricted biodistribution to the liver. The novel capsid and cassette design combination was characterized in vivo in TSD mice for its ability to efficiently transduce cells in the central nervous system when delivered intravenously in both adult and neonatal mice. This study demonstrates that the modified HexM is capable of degrading long-standing GM2 storage in mice, and it further demonstrates the potential of this novel scAAV vector design to facilitate widespread distribution of the HEXM gene or potentially other similar-sized genes to the nervous system.

A Novel Combination Therapy for Patients With Dry Eye Disease: A Pilot Study.

Science.gov (United States)

Smith, Will; McMahon, David; Nymark, Maria

2018-05-01

Context • Approximately 25% of the US population suffers from dry eyes or some abnormality of the exposed ocular surface. Investigation of effective modalities for their management is needed. Objective • The study intended to examine the efficacy of a proprietary, daily, Dry Eye Protocol consisting of daily use of a moist, heated, ocular compress and intake of an omega-3 dietary supplement in treatment of ocular surface disease. Design • The research team designed a 4-wk, clinically based, open-label, multicenter cohort study. Setting • The study took place at 6 private eye care practices throughout the United States: Beverly Hills, CA, USA; San Diego, CA, USA; Sunnyvale, CA, USA; Park City, UT, USA; Tarpon Spring, FL, USA; and Kennewick, WA, USA. Participants • Participants were adults between 18 and 75 y of age who had established ocular surface disease based on clinical findings and the results of testing using the ocular surface disease index (OSDI). Intervention • For period of 30 d, participants used a combined daily protocol that included (1) application of a moist, heated, eye compress and (2) a nutritional therapy via an omega-3 supplement in an oral triglyceride form. Outcome Measures • Measures included the OSDI and a test of tear break-up time (TBUT). Results • Of the original 35 participants, 33 completed the 4-wk protocol. The participants using the proprietary Dry Eye Protocol showed significant improvements from baseline, demonstrated by a 49% decrease in OSDI scores (P = .0015); and 46% of participants reported becoming asymptomatic of dry eye symptoms. A significant improvement was also observed in TBUT, increasing from 3.0 to 5.4 s. Conclusions • Daily use of the proprietary Dry Eye Protocol that included a high dosage of triglyceride omega-3 and use of a moist, heated, compress daily showed significant improvement for participants in OSDI and TBUT and should be considered to be a first-line therapy for patients with dry eye

Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

Directory of Open Access Journals (Sweden)

Kevin Sweet

2014-01-01

Full Text Available We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF or hypertension (HTN, managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC. Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®. OSUWMC patient participants with chronic disease (CD receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1 change in risk perception; (2 knowledge retention; (3 perceived personal control; (4 health behavior change; and, for the active arm (5, overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.

Prevalence of silent breast cancer in autopsy specimens, as studied by the disease being held by image-guided biopsies: The pilot study and literature review

Science.gov (United States)

Sidiropoulou, Zacharoula; Vasconcelos, Ana Paula; Couceiro, Cristiana; Dos Santos, Carlos; Araújo, Ana Virginia; Alegre, Inês; Santos, Claudia; Costa, Filipa; Henriques, Vanessa; Neves, Carlos; Cardoso, Fátima; Gascon, Pere

2017-01-01

Breast cancer epidemiological patterns vary in European countries, which present different incidence rates. Data have suggested that the reduction in breast cancer mortality is not only due to the early detection of the disease, but is, in almost equal part, due to screening and to the advances that have been made in molecular medicine and the development of novel therapies. The aim of the present study is to quantify the actual number of cases of breast cancer present in both of the sexes by calculating the prevalence of silent breast cancer in corpses. To achieve this quantification, bilateral subcutaneous radical mastectomies are performed in corpses of either sex above 40 years of age that lacked any clinical manifestation of the disease, and where the breast cancer or its complications was not the cause of death. Only five publications exist in the international literature based on medico-legal autopsies that were designed to define the ‘natural reservoir’ of the disease. To the best of our knowledge, the present study is the first one to appraise breast tissue via imaging by means of orienting the biopsy incision. In conclusion, to the best of our knowledge, the design of the present study is the first of its type, where image-guided biopsies are used to define the prevalence of silent breast cancer. The study aims to demonstrate that the ‘disease reservoir’ is, in reality, higher than was originally considered to be so. Furthermore, the study aims to contribute towards an improved definition of the disease by determining which tumour profiles potentially do not benefit from aggressive treatments (for example, in case where a high prevalence of low-grade ductal carcinoma in situ is to be detected). According to our pilot study, this analysis represents a feasible protocol. PMID:28781784

Collective design in 3D printing: A large scale empirical study of designs, designers and evolution

DEFF Research Database (Denmark)

Özkil, Ali Gürcan

2017-01-01

This paper provides an empirical study of a collective design platform (Thingiverse); with the aim of understanding the phenomenon and investigating how designs concurrently evolve through the large and complex network of designers. The case study is based on the meta-data collected from 158 489 ...

Self administered cognitive screening test (TYM) for detection of Alzheimer’s disease: cross sectional study

Science.gov (United States)

Pengas, George; Dawson, Kate; Clatworthy, Philip

2009-01-01

Objective To evaluate a cognitive test, the TYM (“test your memory”), in the detection of Alzheimer’s disease. Design Cross sectional study. Setting Outpatient departments in three hospitals, including a memory clinic. Participants 540 control participants aged 18-95 and 139 patients attending a memory clinic with dementia/amnestic mild cognitive impairment. Intervention Cognitive test designed to use minimal operator time and to be suitable for non-specialist use. Main outcome measures Performance of normal controls on the TYM. Performance of patients with Alzheimer’s disease on the TYM compared with age matched controls. Validation of the TYM with two standard tests (the mini-mental state examination (MMSE) and the Addenbrooke’s cognitive examination-revised (ACE-R)). Sensitivity and specificity of the TYM in the detection of Alzheimer’s disease. Results Control participants completed the TYM with an average score of 47/50. Patients with Alzheimer’s disease scored an average of 33/50. The TYM score shows excellent correlation with the two standard tests. A score of ≤42/50 had a sensitivity of 93% and specificity of 86% in the diagnosis of Alzheimer’s disease. The TYM was more sensitive in detection of Alzheimer’s disease than the mini-mental examination, detecting 93% of patients compared with 52% for the mini-mental state exxamination. The negative and positive predictive values of the TYM with the cut off of ≤42 were 99% and 42% with a prevalence of Alzheimer’s disease of 10%. Thirty one patients with non-Alzheimer dementias scored an average of 39/50. Conclusions The TYM can be completed quickly and accurately by normal controls. It is a powerful and valid screening test for the detection of Alzheimer’s disease. PMID:19509424

Disease-modifying anti-rheumatic drug use in pregnant women with rheumatic diseases: a systematic review of the risk of congenital malformations.

Science.gov (United States)

Baldwin, Corisande; Avina-Zubieta, Antonio; Rai, Sharan K; Carruthers, Erin; De Vera, Mary A

2016-01-01

Despite the high incidence of rheumatic diseases during the reproductive years, little is known about the impact of disease-modifying anti-rheumatic drug (DMARD) use during pregnancy. Our objective was to systematically review and appraise evidence in women with rheumatic disease on the use of traditional and biologic DMARDs during pregnancy and the risk of congenital malformation outcomes. We conducted a systematic search of MEDLINE, EMBASE, and INTERNATIONAL PHARMACEUTICAL ABSTRACTS databases. Inclusion criteria were: 1) study sample including women with rheumatic disease; 2) use of traditional and/or biologic DMARDs during pregnancy; and 3) congenital malformation outcome(s) reported. We extracted information on study design, data source, number of exposed pregnancies, type of DMARD, number of live births, and number of congenital malformations. Altogether, we included 79 studies; the majority were based on designs that did not involve a comparison group, including 26 case reports, 17 case series, 20 cross-sectional studies, and 4 surveys. Studies that had a comparator group included 1 case control, 10 cohort studies, and 1 controlled trial. Hydroxychloroquine and azathioprine represent the most studied traditional DMARD exposures and, among biologics, most of the reports were on infliximab and etanercept. This is the first systematic review on the use of both traditional and biologic DMARDs during pregnancy among women with rheumatic diseases and congenital malformation outcomes, with a focus on study design and quality. Findings confirm the limited number of studies, as well as the need to improve study designs.

What components of chronic care organisation relate to better primary care for coronary heart disease patients? An observational study.

NARCIS (Netherlands)

Lieshout, J. van; Frigola Capell, E.; Ludt, S.; Grol, R.P.T.M.; Wensing, M.J.P.

2012-01-01

OBJECTIVES: Cardiovascular risk management (CVRM) received by patients shows large variation across countries. In this study we explored the aspects of primary care organisation associated with key components of CVRM in coronary heart disease (CHD) patients. DESIGN: Observational study. SETTING: 273

How system designers think: a study of design thinking in human factors engineering.

Science.gov (United States)

Papantonopoulos, Sotiris

2004-11-01

The paper presents a descriptive study of design thinking in human factors engineering. The objective of the study is to analyse the role of interpretation in design thinking and the role of design practice in guiding interpretation. The study involved 10 system designers undertaking the allocation of cognitive functions in three production planning and control task scenarios. Allocation decisions were recorded and verbal protocols of the design process were collected to elicit the subjects' thought processes. Verbal protocol analysis showed that subjects carried out the design of cognitive task allocation as a problem of applying a selected automation technology from their initial design deliberations. This design strategy stands in contrast to the predominant view of system design that stipulates that user requirements should be thoroughly analysed prior to making any decisions about technology. Theoretical frameworks from design research and ontological design showed that the system design process may be better understood by recognizing the role of design hypotheses in system design, as well as the diverse interactions between interpretation and practice, means and ends, and design practice and the designer's pre-understanding which shape the design process. Ways to balance the bias exerted on the design process were discussed.

Global Burden Of Disease Studies: Implications For Mental And Substance Use Disorders.

Science.gov (United States)

Whiteford, Harvey; Ferrari, Alize; Degenhardt, Louisa

2016-06-01

Global Burden of Disease studies have highlighted mental and substance use disorders as the leading cause of disability globally. Using the studies' findings for policy and planning requires an understanding of how estimates are generated, the required epidemiological data are gathered, disability and premature mortality are defined and counted, and comparative risk assessment for risk-factor analysis is undertaken. The high burden of mental and substance use disorders has increased their priority on the global health agenda, but not enough to prompt concerted action by governments and international agencies. Using Global Burden of Disease estimates in health policy and planning requires combining them with other information such as evidence on the cost-effectiveness of interventions designed to reduce the disorders' burden. Concerted action is required by mental health advocates and policy makers to assemble this evidence, taking into account the health, social, and economic challenges facing each country. Project HOPE—The People-to-People Health Foundation, Inc.

The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives

DEFF Research Database (Denmark)

Muntendam, Pieter; McCall, Carol; Sanz, Javier

2010-01-01

characteristics on file with Humana Inc, a total of 7,687 men 55 to 80 years of age and women 60 to 80 years of age without evidence of atherothrombotic disease but presumed to be at risk for near-term atherothrombotic events were enrolled between January 2008 and June 2009. Those who met the prespecified......Image Study will help identify those patients with subclinical atherosclerosis who are at risk for near-term atherothrombotic events and enable a more personalized management of care....

A case study examination of structure and function in a state health department chronic disease unit.

Science.gov (United States)

Alongi, Jeanne

2015-04-01

I explored the structural and operational practices of the chronic disease prevention and control unit of a state health department and proposed a conceptual model of structure, function, and effectiveness for future study. My exploratory case study examined 7 elements of organizational structure and practice. My interviews with staff and external stakeholders of a single chronic disease unit yielded quantitative and qualitative data that I coded by perspective, process, relationship, and activity. I analyzed these for patterns and emerging themes. Chi-square analysis revealed significant correlations among collaboration with goal ambiguity, political support, and responsiveness, and evidence-based decisions with goal ambiguity and responsiveness. Although my study design did not permit conclusions about causality, my findings suggested that some elements of the model might facilitate effectiveness for chronic disease units and should be studied further. My findings might have important implications for identifying levers around which capacity can be built that may strengthen effectiveness.

Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study.

Science.gov (United States)

Diamantidis, Clarissa Jonas; Fink, Wanda; Yang, Shiming; Zuckerman, Marni R; Ginsberg, Jennifer; Hu, Peter; Xiao, Yan; Fink, Jeffrey C

2013-11-15

Health information technology has become common in the care of patients with chronic diseases; however, there are few such applications employed in kidney disease. The aim of the study was to evaluate the use of a website providing disease-specific safety information by patients with predialysis chronic kidney disease. As part of the Safe Kidney Care (SKC) study, an educational website was designed to provide information on safety concerns in chronic kidney disease. Phase I study participants were provided a medical alert accessory with a unique ID number, the Safe Kidney Care website, and an in-person tutorial on the use of the Internet and accessing the SKC website at baseline. Participants were asked to visit the website and enter their unique ID as frequently as they desired over the next 365 days or until their annual follow-up visit, whichever occurred first. Participants' visits and dwell times on specific safety modules were tracked using embedded webpage PHP scripts linked to a MySQL database, enabling the collection of website usage statistics. Of 108 Phase I participants, 28.7% (31/108) visited the website from 1-6 times during the observation period (median follow-up 365 days). Median access time was 7 minutes per visit (range <1-46) and 13 minutes per person (range <1-123). The three most frequently visited pages were "Renal function calculator", "Pills to avoid", and "Foods to avoid". High school education and frequent Internet use were significantly associated with website entry (P=.02 and P=.03, respectively). Preliminary results show general interest in a Web-based platform designed to improve patient safety in chronic kidney disease. Clinicaltrials.gov NCT01407367; http://clinicaltrials.gov/show/NCT01407367 (Archived by WebCite at http://www.webcitation.org/6KvxFKA6M).

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

Directory of Open Access Journals (Sweden)

Pera Guillem

2011-02-01

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

Contact Heat Evoked Potentials (CHEPs) in Patients with Mild-Moderate Alzheimer's Disease and Matched Control-A Pilot Study

DEFF Research Database (Denmark)

Jensen-Dahm, Christina; Madsen, Caspar Skau; Waldemar, Gunhild

2016-01-01

OBJECTIVE: Clinical studies have found that patients with Alzheimer's disease report pain of less intensity and with a lower affective response, which has been thought to be due to altered pain processing. The authors wished to examine the cerebral processing of non-painful and painful stimuli...... threshold and heat pain threshold. Somatosensory evoked potentials, amplitude, and latency were within normal range and similar for the two groups. CONCLUSIONS: The findings suggest that the processing of non-painful and painful stimuli is preserved in patients with mild to moderate Alzheimer's disease....... using somatosensory evoked potentials and contact heat evoked potentials in patients with Alzheimer's disease and in healthy elderly controls. DESIGN: Case-control study SETTING AND SUBJECTS: Twenty outpatients with mild-moderate Alzheimer's disease and in 17 age- and gender-matched healthy controls...

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

DEFF Research Database (Denmark)

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

2002-01-01

The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer......, a calibration approach was developed. This approach involved an additional dietary assessment common across study populations to re-express individual dietary intakes according to the same reference scale. A single 24-hour diet recall was therefore collected, as the EPIC reference calibration method, from...... in a large multi-centre European study. These studies showed that, despite certain inherent methodological and logistic constraints, a study design such as this one works relatively well in practice. The average response in the calibration study was 78.3% and ranged from 46.5% to 92.5%. The calibration...

A web-based program for informal caregivers of persons with Alzheimer's disease: an iterative user-centered design.

Science.gov (United States)

Cristancho-Lacroix, Victoria; Moulin, Florence; Wrobel, Jérémy; Batrancourt, Bénédicte; Plichart, Matthieu; De Rotrou, Jocelyne; Cantegreil-Kallen, Inge; Rigaud, Anne-Sophie

2014-09-15

Web-based programs have been developed for informal caregivers of people with Alzheimer's disease (PWAD). However, these programs can prove difficult to adopt, especially for older people, who are less familiar with the Internet than other populations. Despite the fundamental role of usability testing in promoting caregivers' correct use and adoption of these programs, to our knowledge, this is the first study describing this process before evaluating a program for caregivers of PWAD in a randomized clinical trial. The objective of the study was to describe the development process of a fully automated Web-based program for caregivers of PWAD, aiming to reduce caregivers' stress, and based on the user-centered design approach. There were 49 participants (12 health care professionals, 6 caregivers, and 31 healthy older adults) that were involved in a double iterative design allowing for the adaptation of program content and for the enhancement of website usability. This process included three component parts: (1) project team workshops, (2) a proof of concept, and (3) two usability tests. The usability tests were based on a mixed methodology using behavioral analysis, semistructured interviews, and a usability questionnaire. The user-centered design approach provided valuable guidelines to adapt the content and design of the program, and to improve website usability. The professionals, caregivers (mainly spouses), and older adults considered that our project met the needs of isolated caregivers. Participants underlined that contact between caregivers would be desirable. During usability observations, the mistakes of users were also due to ergonomics issues from Internet browsers and computer interfaces. Moreover, negative self-stereotyping was evidenced, when comparing interviews and results of behavioral analysis. Face-to-face psycho-educational programs may be used as a basis for Web-based programs. Nevertheless, a user-centered design approach involving targeted

FFAG Designs for the International Design Study for the Neutrino Factory

Energy Technology Data Exchange (ETDEWEB)

Berg, J.S.; Machida, S.

2009-05-04

The International Design Study for the Neutrino Factory (IDS-NF) aims to produce a design report for a neutrino factory. One component of that design is a linear nonscaling fixed-field alternating gradient accelerator (FFAG) that will accelerate to the final energy of 25 GeV. An FFAG is used to reduce the machine cost by maximizing the number of passes made through the RF cavities. We present some design options for this FFAG, individually optimized for cost. We study the addition of nonlinear magnets to the lattice to improve the performance of the lattice and consider the negative effects of doing so.

A participatory approach to design monitoring indicators of production diseases in organic dairy farms.

Science.gov (United States)

Duval, J E; Fourichon, C; Madouasse, A; Sjöström, K; Emanuelson, U; Bareille, N

2016-06-01

Production diseases have an important negative effect on the health and welfare of dairy cows. Although organic animal production systems aim for high animal health levels, compliance with European organic farming regulations does not guarantee that this is achieved. Herd health and production management (HHPM) programs aim at optimizing herd health by preventing disease and production problems, but as yet they have not been consistently implemented by farmers. We hypothesize that one reason is the mismatch between what scientists propose as indicators for herd health monitoring and what farmers would like to use. Herd health monitoring is a key element in HHPM programs as it permits a regular assessment of the functioning of the different components of the production process. Planned observations or measurements of these components are indispensable for this monitoring. In this study, a participatory approach was used to create an environment in which farmers could adapt the indicators proposed by scientists for monitoring the five main production diseases on dairy cattle farms. The adaptations of the indicators were characterized and the farmers' explanations for the changes made were described. The study was conducted in France and Sweden, which differ in terms of their national organic regulations and existing advisory services. In both countries, twenty certified organic dairy farmers and their animal health management advisors participated in the study. All of the farmers adapted the initial monitoring plan proposed by scientists to specific production and animal health situation on their farm. This resulted in forty unique and farm-specific combinations of indicators for herd health monitoring. All but three farmers intended to monitor five health topics simultaneously using the constructed indicators. The qualitative analysis of the explanations given by farmers for their choices enabled an understanding of farmers' reasons for selecting and adapting

FED/INTOR reactor design studies

International Nuclear Information System (INIS)

Brown, T.G.; Cramer, B.A.; Davisson, J.P.; Kunselman, M.H.; Reiersen, W.T.; Sager, P.H.; Strickler, D.J.

1982-03-01

Upon completing the design studies identified in this report, an overall assessment of the design options is made that will form the bases to define the configuration of the next major Tokamak device. The TF coil size will be defined, along with the vacuum boundary, the PF coil arrangement, and the torus configuration. After the configuration is established, an overall performance and cost re-assessment should be made to finally trade off device performance with machine capital and operating costs to establish a reactor design point for a given set of design requirements

Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls.

Science.gov (United States)

Verani, Jennifer R; Baqui, Abdullah H; Broome, Claire V; Cherian, Thomas; Cohen, Cheryl; Farrar, Jennifer L; Feikin, Daniel R; Groome, Michelle J; Hajjeh, Rana A; Johnson, Hope L; Madhi, Shabir A; Mulholland, Kim; O'Brien, Katherine L; Parashar, Umesh D; Patel, Manish M; Rodrigues, Laura C; Santosham, Mathuram; Scott, J Anthony; Smith, Peter G; Sommerfelt, Halvor; Tate, Jacqueline E; Victor, J Chris; Whitney, Cynthia G; Zaidi, Anita K; Zell, Elizabeth R

2017-06-05

Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under 'real world' conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential. Published by Elsevier Ltd.

Genetic design of pigs as experimental models in the combat between chronic diseases and healthy aging

DEFF Research Database (Denmark)

Bolund, Lars

2012-01-01

with and without intervention. The genome of different pig breeds have been sequenced, revealing that the pig is genetically more similar to man than conventional laboratory animals - in agreement with the similarities in organ development, physiology and metabolism. Genetically designed minipigs (Göttingen...... pigs. We can also produce clones of pigs, some disease prone and some fluorescing, to perform experiments in regenerative medicine where the fate of healthy fluorescent cells can be followed in the, basically identical, disease prone animals. It is also our hope that our pig models can contribute...

Sodium phenylbutyrate in Huntington's disease: a dose-finding study.

Science.gov (United States)

Hogarth, Penelope; Lovrecic, Luca; Krainc, Dimitri

2007-10-15

Transcriptional dysregulation in Huntington's disease (HD) is mediated in part by aberrant patterns of histone acetylation. We performed a dose-finding study in human HD of sodium phenylbutyrate (SPB), a histone deacetylase inhibitor that ameliorates the HD phenotype in animal models. We used a dose-escalation/de-escalation design, using prespecified toxicity criteria and standard clinical and laboratory safety measures. The maximum tolerated dose was 15 g/day. At higher doses, toxicity included vomiting, lightheadedness, confusion, and gait instability. We saw no significant laboratory or electrocardiographic abnormalities. Gene expression changes in blood suggested an inverse dose-response. In conclusion, SPB at 12 to 15 g/day appears to be safe and well-tolerated in human HD. 2007 Movement Disorder Society

Computer-Aided Drug Design Approaches to Study Key Therapeutic Targets in Alzheimer’s Disease

NARCIS (Netherlands)

Lemos, A.; Melo, Rita; de Sousa Moreira, I.; Cordeiro, Maria Natália D S

2017-01-01

Alzheimer’s Disease (AD) is one of the most common and complex age-related neurodegenerative disorders in elderly people. Currently there is no cure for AD, and available therapeutic alternatives only improve both cognitive and behavioral functions. For that reason, the search for anti-AD

Study design and patient recruitment for the Japan Polyp Study

Directory of Open Access Journals (Sweden)

Sano Y

2014-05-01

, Japan Background: The Japan Polyp Study (JPS Workgroup was established in 2000 to evaluate colonoscopic follow-up surveillance strategies. The JPS was a multicenter randomized controlled trial designed to evaluate follow-up surveillance strategies in patients who had undergone two complete colonoscopies for control of colorectal cancer, with removal of all detected polyps. The aim of the present analysis was to assess the patient recruitment and whether the clinical characteristics were adequate for enrollment at the participating centers. Materials and methods: Among referrals for colonoscopy at the eleven participating centers, all patients who were 40–69 years old, without a family or personal history of familial polyposis, Lynch syndrome, inflammatory bowel disease, or a personal history of polypectomy with unknown histology, and had no invasive colorectal cancer or colectomy, were considered for inclusion from February 2003. Results: Among 4,752 referrals, a total of 3,926 patients with a mean age of 57.3 (range 40–69 years, including 2,440 (62% males, were included in the JPS. The participation rate was 83%. Among them, a total of 2,757 patients who had undergone two complete colonoscopies with removal of all detected polyps were eligible, giving an eligibility rate of 70% (2,757 of 3,926. Among the eligible patients, 2,166 were assigned to randomized groups, and 591 patients to a nonrandomized group. The last steps of data lock, analysis, and complete histopathological assessment based on a pathology review are ongoing. Conclusion: Eligible patients recruited for the JPS were successfully assigned on the basis of the expected sample-size calculation. Keywords: colonoscopy, follow-up surveillance strategies, Japan Polyp Study (JPS, study design, multicenter randomized controlled trial

Aorto-iliac occlusive disease in the different population groups ...

African Journals Online (AJOL)

Background. It has previously been accepted that atherosclerotic disease is uncommon among blacks worldv.ride; however, recent studies have increasingly reported atherosclerotic disease in this group. Study design. Prospective study of hospital patients with aorta-iliac occlusive disease presenting to the vascUlar ...

Adventures in Infectious Diseases

Energy Technology Data Exchange (ETDEWEB)

Fisher-Hoch, Susan [University of Texas School of Public Health

2011-11-01

Dr. Susan Fisher-Hoch, Virologist and Epidemiologist, will discuss her research and travels associated with viral hemorrhagic fevers. From the Ebola outbreak in Reston, Virginia to outbreaks of Crimean Congo Hemorrhagic Fever in South Africa, Senegal, and Saudi Arabia, Dr. Fisher-Hoch has studied and tracked the pathophysiology of these viral diseases. These studies have led her from the Center for Disease Control in the United States, to Lyon, France where she was instrumental in designing, constructing, and rendering operational a laboratory capable of containing some of the world's most dangerous diseases.

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

e-Vita: design of an innovative approach to COPD disease management in primary care through eHealth application.

Science.gov (United States)

Talboom-Kamp, E P W A; Verdijk, N A; Blom, C M G; Harmans, L M; Talboom, I J S H; Numans, M E; Chavannes, N H

2016-08-16

COPD is a highly complex disease to manage as patients show great variation in symptoms and limitations in daily life. In the last decade self-management support of COPD has been introduced as an effective method to improve quality and efficiency of care, and to reduce healthcare costs. Despite the urge to change the organisation of health care and the potential of eHealth to support this, large-scale implementation in daily practice remains behind, especially in the Netherlands. We designed a multilevel study, called e-Vita, to investigate different organisational implementation methods of a self-management web portal to support and empower patients with COPD in three different primary care settings. Using a parallel cohort design, the clinical effects of the web portal will be assessed using an interrupted times series (ITS) study design and measured according to changes in health status with the Clinical COPD Questionnaire (CCQ). The different implementations and net benefits of self-management through eHealth on clinical outcomes will be evaluated from human, organisational, and technical perspectives. To our knowledge this is the first study to combine different study designs that enable simultaneous investigation of clinical effects, as well as effects of different organisational implementation methods whilst controlling for confounding effects of the organisational characteristics. We hypothesize that an implementation with higher levels of personal assistance, and integrated in an existing care program will result in increased use of and satisfaction with the platform, thereby increasing health status and diminishing exacerbation and hospitalisation. NTR4098 (31-07-2013).

Polysomnographic Findings and Clinical Correlates in Huntington Disease: A Cross-Sectional Cohort Study

Science.gov (United States)

Piano, Carla; Losurdo, Anna; Della Marca, Giacomo; Solito, Marcella; Calandra-Buonaura, Giovanna; Provini, Federica; Bentivoglio, Anna Rita; Cortelli, Pietro

2015-01-01

Study Objectives: To evaluate the sleep pattern and the motor activity during sleep in a cohort of patients affected by Huntington disease (HD). Design: Cross-sectional cohort study. Setting: Sleep laboratory. Patients: Thirty HD patients, 16 women and 14 men (mean age 57.3 ± 12.2 y); 30 matched healthy controls (mean age 56.5 ± 11.8 y). Interventions: Subjective sleep evaluation: Epworth Sleepiness Scale (ESS); Berlin's Questionnaire, interview for restless legs syndrome (RLS), questionnaire for REM sleep behavior disorder (RBD). Clinical evaluation: disease duration, clinical severity (unified Huntington disease motor rating scale [UHDMRS]), genetic tests. Laboratory-based full-night attended video-polysomnography (V-PSG). Measurements and Results: The duration of the disease was 9.4 ± 4.4 y, UHMDRS score was 55.5 ± 23.4, CAG repeats were 44.3 ± 4.1. Body mass index was 21.9 ± 4.0 kg/m2. No patients or caregivers reported poor sleep quality. Two patients reported symptoms of RLS. Eight patients had an ESS score ≥ 9. Eight patients had high risk of obstructive sleep apnea. At the RBD questionnaire, two patients had a pathological score. HD patients, compared to controls, showed shorter sleep, reduced sleep efficiency index, and increased arousals and awakenings. Four patients presented with sleep disordered breathing (SDB). Periodic limb movements (PLMs) during wake and sleep were observed in all patients. No episode of RBD was observed in the V-PSG recordings, and no patients showed rapid eye movement (REM) sleep without atonia. The disease duration correlated with ESS score (P Marca G, Solito M, Calandra-Buonaura G, Provini F, Bentivoglio AR, Cortelli P. Polysomnographic findings and clinical correlates in Huntington disease: a cross-sectional cohort study. SLEEP 2015;38(9):1489–1495. PMID:25845698

Co-Designing a Collaborative Chronic Care Network (C3N) for Inflammatory Bowel Disease: Development of Methods

Science.gov (United States)

Dellal, George; Peterson, Laura E; Provost, Lloyd; Gloor, Peter A; Fore, David Livingstone; Margolis, Peter A

2018-01-01

Background Our health care system fails to deliver necessary results, and incremental system improvements will not deliver needed change. Learning health systems (LHSs) are seen as a means to accelerate outcomes, improve care delivery, and further clinical research; yet, few such systems exist. We describe the process of codesigning, with all relevant stakeholders, an approach for creating a collaborative chronic care network (C3N), a peer-produced networked LHS. Objective The objective of this study was to report the methods used, with a diverse group of stakeholders, to translate the idea of a C3N to a set of actionable next steps. Methods The setting was ImproveCareNow, an improvement network for pediatric inflammatory bowel disease. In collaboration with patients and families, clinicians, researchers, social scientists, technologists, and designers, C3N leaders used a modified idealized design process to develop a design for a C3N. Results Over 100 people participated in the design process that resulted in (1) an overall concept design for the ImproveCareNow C3N, (2) a logic model for bringing about this system, and (3) 13 potential innovations likely to increase awareness and agency, make it easier to collect and share information, and to enhance collaboration that could be tested collectively to bring about the C3N. Conclusions We demonstrate methods that resulted in a design that has the potential to transform the chronic care system into an LHS. PMID:29472173

Longitudinal Study of the Transition From Healthy Aging to Alzheimer Disease

Science.gov (United States)

Johnson, David K.; Storandt, Martha; Morris, John C.; Galvin, James E.

2009-01-01

Background Detection of the earliest cognitive changes signifying Alzheimer disease is difficult. Objective To model the cognitive decline in preclinical Alzheimer disease. Design Longitudinal archival study comparing individuals who became demented during follow-up and people who remained nondemented on each of 4 cognitive factors: global, verbal memory, visuospatial, and working memory. Setting Alzheimer Disease Research Center, Washington University School of Medicine, St Louis, Missouri. Participants One hundred thirty-four individuals who became demented during follow-up and 310 who remained nondemented. Main Outcome Measures Inflection point in longitudinal cognitive performance. Results The best-fitting model for each of the 4 factors in the stable group was linear, with a very slight downward trend on all but the Visuospatial factor. In contrast, a piecewise model with accelerated slope after a sharp inflection point provided the best fit for the group that progressed. The optimal inflection point for all 4 factors was prior to diagnosis of dementia: Global, 2 years; Verbal and Working Memory, 1 year; and Visuospatial, 3 years. These results were also obtained when data were limited to the subset (n=44) with autopsy-confirmed Alzheimer disease. Conclusions There is a sharp inflection point followed by accelerating decline in multiple domains of cognition, not just memory, in the preclinical period in Alzheimer disease when there is insufficient cognitive decline to warrant clinical diagnosis using conventional criteria. Early change was seen in tests of visuospatial ability, most of which were speeded. Research into early detection of cognitive disorders using only episodic memory tasks may not be sensitive to all of the early manifestations of disease. PMID:19822781

Case-Control Studies - An Efficient Observational Study Design

NARCIS (Netherlands)

van Stralen, Karlijn J.; Dekker, Friedo W.; Zoccali, Carmine; Jager, Kitty J.

2010-01-01

Case-control studies are an efficient research method for investigating risk factors of a disease. The method involves the comparison of the odds of exposure in a patient group with that of the odds of exposure in a control group. As only a minority of the population is included in the study, less

An Evaluation of the Training Program: "The Alzheimer's Disease Afflicted: Understanding the Disease and the Resident."

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Miah, M. Mizanur Rahman

This study was undertaken to evaluate a training program on understanding Alzheimer's disease for nursing home caregivers of those with the disease. A pretest/posttest design control group methodology was used to evaluate 81 staff members. Results of the study showed that: (1) staff satisfaction with working with mentally impaired and demented…

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

Science.gov (United States)

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

2012-01-01

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

The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses

Science.gov (United States)

2014-01-01

Background Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. Methods/Design The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Discussion Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks. PMID:24475944

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

Techniques for Conducting Effective Concept Design and Design-to-Cost Trade Studies

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Di Pietro, David A.

2015-01-01

Concept design plays a central role in project success as its product effectively locks the majority of system life cycle cost. Such extraordinary leverage presents a business case for conducting concept design in a credible fashion, particularly for first-of-a-kind systems that advance the state of the art and that have high design uncertainty. A key challenge, however, is to know when credible design convergence has been achieved in such systems. Using a space system example, this paper characterizes the level of convergence needed for concept design in the context of technical and programmatic resource margins available in preliminary design and highlights the importance of design and cost evaluation learning curves in determining credible convergence. It also provides techniques for selecting trade study cases that promote objective concept evaluation, help reveal unknowns, and expedite convergence within the trade space and conveys general practices for conducting effective concept design-to-cost studies.

Inflammatory bowel disease increases the risk of Parkinson's disease

DEFF Research Database (Denmark)

Villumsen, Marie; Aznar, Susana; Pakkenberg, Bente

2018-01-01

OBJECTIVE: Intestinal inflammation has been suggested to play a role in development of Parkinson's disease (PD) and multiple system atrophy (MSA). To test the hypothesis that IBD is associated with risk of PD and MSA, we performed a nationwide population-based cohort study. DESIGN: The cohort...... patients with UC (HR=1.35; 95% CI 1.20 to 1.52) and not significantly different among patients with Crohn's disease (HR=1.12; 95% CI 0.89 to 1.40). CONCLUSIONS: This nationwide, unselected, cohort study shows a significant association between IBD and later occurrence of PD, which is consistent with recent...

Macular function and morphologic features in juvenile stargardt disease: longitudinal study.

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Testa, Francesco; Melillo, Paolo; Di Iorio, Valentina; Orrico, Ada; Attanasio, Marcella; Rossi, Settimio; Simonelli, Francesca

2014-12-01

To evaluate disease progression in a cohort of patients with a clinical and genetic diagnosis of Stargardt disease. Longitudinal cohort study. A total of 56 selected patients with a clinical and molecular diagnosis of Stargardt disease, an early age of onset, and a median follow-up length of 2 years. Patients underwent routine examination, including full-field electroretinography, microperimetry, and optical coherence tomography. Best-corrected visual acuity (BCVA), mean retinal sensitivity, fixation stability, preferred retinal locus, inner segment/outer segment (IS/OS) junction loss, and atrophic lesion area. A total of 56 patients with a mean age at disease onset of 15.3 years (range, 3-28 years), a mean disease duration of 12.1 years, and a mean age at baseline of 27.4 years were analyzed. The median BCVA was 20/200 in both eyes. Optical coherence tomography parameters (IS/OS alteration and retinal pigment epithelium lesion area) were obtained in only 49 patients because the signal quality was poor in the remaining 7 patients. Optical coherence tomography revealed a mean retinal pigment epithelium lesion area of 2.6 mm(2), preserved foveal IS/OS in 4.1% of patients, loss of foveal IS/OS in 59.2% of patients, and extensive loss of macular IS/OS in 36.7% of patients. Microperimetric findings showed a reduced macular sensitivity (mean, 10 decibels [dB]) and an unstable fixation in half of the patient cohort. The longitudinal analysis showed a significant progressive reduction of BCVA and macular sensitivity (at an estimated rate of 0.04 decimals and 1.19 dB/year, respectively) associated with a significant enlargement of retinal pigment epithelium lesion area (0.282 mm(2)/year). No significant changes in ophthalmoscopic findings and electroretinographic responses were detected. This study highlights the importance of microperimetry and optical coherence tomography in monitoring patients with Stargardt disease. Quantifying the decline of visual functionality and

Some design aspects of transuranic field studies

International Nuclear Information System (INIS)

Gilbert, R.O.; Eberhardt, L.L.

1977-01-01

In this paper, we discuss some design aspects of transuranic field studies. Some of the principal steps in the design of such studies are given and illustrated using examples. This is followed by a review of sampling designs that have been used at nuclear detonation and safety-shot sites on the Nevada Test Site and elsewhere for estimating spatial pattern and total amounts in soil. Some design aspects of ecosystem-type transuranic studies for estimating total amounts as well as movement of transuranics between ecosystem components are also discussed. Acceptance sampling using either attributes or measurements is considered as a possible approach for deciding whether to clean up a contaminated site. Three general guidelines for the design of efficient transuranic studies are presented

Identifying asthma and chronic obstructive pulmonary disease in patients with persistent cough presenting to general practitioners : descriptive study

NARCIS (Netherlands)

Thiadens, HA; de Bock, GH; Deker, FW; Huysman, JAN; Springer, MP; Postma, DS

1998-01-01

Objective: To determine the prevalence of asthma and chronic obstructive pulmonary disease in patients not known to have these disorders, who present in general practice with persistent cough, and to ascertain criteria to help general practitioners in diagnosis. Design: Descriptive study. Setting:

DISEASE MANAGEMENT INFORMATION SYSTEM

OpenAIRE

Bens Pardamean; Anindito; Anjela Djoeang; Nana Tobing

2013-01-01

The study designed an information system model for Disease Management (DisMan) that met the specifications and needs of a consumer electronics manufacturer. The diseases monitored by this study were diabetes, hypertension and tuberculosis. Data were collected through interviews with the companyâs human resources department and occupational health provider. As for the model, literature and online research were conducted to collect health standards and information system standards on existing D...

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

A qualitative descriptive study of risk reduction for coronary disease among the Hong Kong Chinese.

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Chan, Choi Wan; Lopez, Violeta

2014-01-01

Achieving optimal control and reduction in coronary heart disease (CHD) risks in Hong Kong (HK) remains significant and requires exploring. This article addresses the ability to reduce CHD risks among the HK Chinese. Through secondary analysis, a qualitative descriptive design using focus group interviews and content analysis were adopted. Older and younger adults were invited for the study. An interview schedule was used to guide discussions during focus group interviews. Four categories emerged from the data: planning of health actions, control of risk-reducing behavior, perceived opportunities for understanding CHD, and chest pain appraisal. Local culture and population needs play a central role in disease perception and prevention. The findings are essential to target strategies for initiating health acts for younger adults and establish public education resources that underscore understanding of CHD risk, symptom recognition, and disease management, particularly among those middle-aged and older people at high risk and with the diseased populations. © 2013 Wiley Periodicals, Inc.

Designer exosomes produced by implanted cells intracerebrally deliver therapeutic cargo for Parkinson's disease treatment.

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Kojima, Ryosuke; Bojar, Daniel; Rizzi, Giorgio; Hamri, Ghislaine Charpin-El; El-Baba, Marie Daoud; Saxena, Pratik; Ausländer, Simon; Tan, Kelly R; Fussenegger, Martin

2018-04-03

Exosomes are cell-derived nanovesicles (50-150 nm), which mediate intercellular communication, and are candidate therapeutic agents. However, inefficiency of exosomal message transfer, such as mRNA, and lack of methods to create designer exosomes have hampered their development into therapeutic interventions. Here, we report a set of EXOsomal transfer into cells (EXOtic) devices that enable efficient, customizable production of designer exosomes in engineered mammalian cells. These genetically encoded devices in exosome producer cells enhance exosome production, specific mRNA packaging, and delivery of the mRNA into the cytosol of target cells, enabling efficient cell-to-cell communication without the need to concentrate exosomes. Further, engineered producer cells implanted in living mice could consistently deliver cargo mRNA to the brain. Therapeutic catalase mRNA delivery by designer exosomes attenuated neurotoxicity and neuroinflammation in in vitro and in vivo models of Parkinson's disease, indicating the potential usefulness of the EXOtic devices for RNA delivery-based therapeutic applications.

Designing a Language Study.

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Brown, James Dean

Some issues in the design of classroom research on second language teaching are discussed, with the intention of helping the researcher avoid conceptual pitfalls that may cripple the study later in the process. This begins with an examination of concerns in sampling, including definition of a population to be studied, alternative sampling…

Comparative evaluation of serum superoxide dismutase and glutathione levels in periodontally diseased patients: An interventional study

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Thomas Biju

2014-01-01

Full Text Available Background: Periodontal disease is an immune-inflammatory disease characterized by connective tissue breakdown, loss of attachment, and alveolar bone resorption. Under normal physiological conditions, a dynamic equilibrium is maintained between the reactive oxygen species (ROS and antioxidant defense capacity. Oxidative stress occurs when this equilibrium shifts in favor of ROS. Oxidative stress is thought to play a causative role in the pathogenesis of periodontal diseases. Aim: The present study was designed to estimate and compare the superoxide dismutase (SOD and glutathione (GSH levels in the serum of periodontitis, gingivitis, and healthy individuals before and after nonsurgical periodontal therapy. Materials and Methods: The present study was conducted in the Department of Periodontics, A. B. Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore. The study was designed as a single blinded interventional study comprising 75 subjects, inclusive of both sexes and divided into three groups of 25 patients each. Patients were categorized into chronic periodontitis, gingivitis, and healthy. The severity of inflammation was assessed using gingival index and pocket probing depth. Biochemical analysis was done to estimate the SOD and GSH levels before and after nonsurgical periodontal therapy. Results obtained were then statistically analyzed using ANOVA test and paired t-test. Results: The results showed a higher level of serum SOD and GSH in the healthy group compared to the other groups. The difference was found to be statistically significant (P < 0.0001. The post-treatment levels of SOD were statistically higher than the pre-treatment levels in periodontitis and gingivitis group.

The Study on the Thyroid Disease

International Nuclear Information System (INIS)

Lee, Mun Ho

1982-01-01

Several recent advances in our knowledge of thyroid physiology have broad application to the diagnosis and management of thyroid disorders. For in the thyroid, more than other end-ocrine organs, pathophysiology can be translated directly into the diagnosis and management of thyroid disease. Graves' disease is a syndrome including goiter with hyperthyroidism, exophthalmos and dermatopathy. The pathogenesis of Graves' disease is not yet clearly identified, but various autoantibodies to the thyroid gland and immunapathalogic studied indicate that autoimmune processes are involved in the pathogenesis of the disease. The diagnosis and management of Graves' disease are largely dependent on radionuclide technique as radioimmunoassay, radioactive iodine therapy and so on. Several laboratory tests are also developed to determine the remission of this disease including TRH stimulation test, T 3 , suppression test and detection of thyroid stimulating immunoglobulins. Autoimmune thyroiditis is almost certainly a primary immunologic disease and the incidence tends to increase recently, mainly due to the application of biopsy technique is thyroid diseases. Thyroid nodules have been a great challenge to physicians because of the possibility of malignancy. But recently, cytologic examination of thyroid aspirate provides a very simple and also reliable diagnostic method in patients with thyroid nodules. In 163 patients with thyroid nodules, only 19.3% was revealed to be malignant. Therefore cytologic examination of thyroid aspirate and thyroid biopsy should be included in the diagnosis of nodular patients prior to surgical intervention. In this paper, a comprehensive review is presented on the pathogenesis, clinical features, laboratory findings and therapeutic modalities of various thyroid diseases on the basis of over 80 researches performed during the past 20 years at radioisotope clinic, Seoul National University Hospital.

Laughter Yoga, Adults Living With Parkinson׳s Disease, and Caregivers: A Pilot Study.

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DeCaro, Debra Swedberg; Constantine Brown, Jodi L

2016-01-01

This study explored outcomes of Laughter Yoga in adults with Parkinson׳s disease (PD) and their caregivers. Laughter has been shown to generally improve mood in physically healthy adults, and specifically in adults with heart disease or cancer, but little research exists regarding the impact of laughter in adults with Parkinson׳s disease. Low mood is frequently a co-morbid condition for adults with Parkinson׳s disease, and can negatively affect their caregivers. Pre-experimental (O1 × O2) pretest-posttest design. Data collection occurred at six unique PD support groups in Southern California. Participants (N = 85) comprised a convenience sample of adults diagnosed with Parkinson׳s disease (n = 47) and accompanying caregivers (n = 38). Subjects participated in a 45-min Laughter Yoga (LY) session conducted by a Certified Laughter Yoga Teacher. This study utilized the Laughter Yoga "How Do You Feel?" (HDYF) form. The form consists of a series of 10 scales labeled "well-being" measures including enthusiasm, energy level, mood, optimism, stress level, level of friendship with group members, level of awareness about breathing, level of muscle relaxation, level of mental relaxation, and ability to laugh without a reason. Paired sample t-tests reveal statistically significant improvements in well-being for adults with PD and their caregivers after attending an LY session. Therapists and other clinicians should consider utilizing this unique technique with adults with PD to address co-morbid low-mood conditions and include caregivers in the LY sessions for support and their own benefit. Copyright © 2016 Elsevier Inc. All rights reserved.

Epidemiology and the control of disease in China, with emphasis on the Chinese Biobank Study.

Science.gov (United States)

Li, L; Guo, Y; Chen, Z; Chen, J; Peto, R

2012-03-01

Similar to many other developing countries, China is facing a double burden of disease as a result of epidemiological transition. Non-communicable diseases (NCDs) represent a major challenge, having an adverse effect on the health of the Chinese population and increasing the economic burden of health care. In today's era of evidence-based medicine and decision making, China, as a developing country, has a lack of local scientific evidence which will affect the effectiveness of NCD prevention and control. As such, and on the basis of decades of cooperation and trust with the University of Oxford, the Chinese Biobank Study [Kadoorie Study of Chronic Disease in China (KSCDC)] was commenced in 2004. KSCDC, an international prospective project, aims to establish the basis of a blood-based health database, using genetic, environmental and lifestyle aspects to investigate and understand the causes, risk factors, pathogenesis, prevalence patterns and trends of major chronic diseases in China (such as stroke, coronary heart disease, cancer, diabetes, hypertension, chronic obstructive pulmonary disease etc.). This study has a duration of 15-20 years, and will provide scientific evidence for strategic planning of NCD prevention and control, and development of new treatment and intervention approaches. In total, approximately 510,000 adults aged 30-79 years have been recruited from the general population in 10 geographically defined regions (five rural and five urban) of China, with differing disease profiles and differing risk exposures. Extensive data collection has been undertaken with questionnaires, physical measurements, and collection and storage of blood samples. KSCDC is a multi-factor, multi-disease, multi-disciplinary large-scale chronic disease epidemiological study, and is also one of the largest long-term blood-based population cohort studies ever conducted in the world. It is worth mentioning that all gene specimens are kept in China, and all associated

Heart Disease, Hypertension, Gestational Diabetes Mellitus, and Preeclampsia/Eclampsia in Mothers With Juvenile Arthritis: A Nested Case-Control Study.

Science.gov (United States)

Feldman, Debbie E; Vinet, Évelyne; Bérard, Anick; Duffy, Ciarán; Hazel, Beth; Meshefedjian, Garbis; Sylvestre, Marie-Pierre; Bernatsky, Sasha

2017-02-01

To determine whether women with a history of juvenile arthritis are at higher risk for heart disease and hypertension and for developing adverse maternal outcomes: gestational diabetes mellitus, maternal hypertension, and preeclampsia/eclampsia. We designed a nested case-control study from a cohort of first-time mothers with prior physician billing codes suggesting juvenile arthritis, and a matched comparison group without juvenile arthritis. For the nested case-control design, we selected 3 controls for each case for the outcomes of heart disease (n = 403), prepregnancy hypertension (n = 66), gestational diabetes mellitus (n = 285), maternal hypertension (n = 561), and preeclampsia/eclampsia (n = 236). We used conditional logistic regression, adjusting for maternal age and education. Having juvenile arthritis was associated with heart disease (odds ratio [OR] 2.44 [95% confidence interval (95% CI) 1.15-5.15]) but not with gestational hypertension, diabetes mellitus, or preeclampsia/eclampsia. All 66 cases of prepregnancy hypertension had juvenile arthritis. Having prepregnancy hypertension was strongly associated with preeclampsia/eclampsia (OR 8.05 [95% CI 2.69-24.07]). Women with a history of juvenile arthritis had a higher risk of heart disease. This risk signals the potential importance of cardiac prevention strategies in juvenile arthritis. As this was a retrospective study, it was not possible to correct for some relevant potential confounders. Further studies should assess the impact of medications, disease severity, and other factors (e.g., obesity) on cardiac outcomes in juvenile arthritis. © 2016, American College of Rheumatology.

Exploratory Shaft Facility design basis study report

International Nuclear Information System (INIS)

Langstaff, A.L.

1987-01-01

The Design Basis Study is a scoping/sizing study that evaluated the items concerning the Exploratory Shaft Facility Design including design basis values for water and methane inflow; flexibility of the design to support potential changes in program direction; cost and schedule impacts that could result if the design were changed to comply with gassy mine regulations; and cost, schedule, advantages and disadvantages of a larger second shaft. Recommendations are proposed concerning water and methane inflow values, facility layout, second shaft size, ventilation, and gassy mine requirements. 75 refs., 3 figs., 7 tabs

Usability Study of a Computer-Based Self-Management System for Older Adults with Chronic Diseases

Science.gov (United States)

Tao, Da

2012-01-01

Background Usability can influence patients’ acceptance and adoption of a health information technology. However, little research has been conducted to study the usability of a self-management health care system, especially one geared toward elderly patients. Objective This usability study evaluated a new computer-based self-management system interface for older adults with chronic diseases, using a paper prototype approach. Methods Fifty older adults with different chronic diseases participated. Two usability evaluation methods were involved: (1) a heuristics evaluation and (2) end-user testing with a think-aloud testing method, audio recording, videotaping, and interviewing. A set of usability metrics was employed to determine the overall system usability, including task incompletion rate, task completion time, frequency of error, frequency of help, satisfaction, perceived usefulness, and perceived ease of use. Interviews were used to elicit participants’ comments on the system design. The quantitative data were analyzed using descriptive statistics and the qualitative data were analyzed for content. Results The participants were able to perform the predesigned self-management tasks with the current system design and they expressed mostly positive responses about the perceived usability measures regarding the system interface. However, the heuristics evaluation, performance measures, and interviews revealed a number of usability problems related to system navigation, information search and interpretation, information presentation, and readability. Design recommendations for further system interface modifications were discussed. Conclusions This study verified the usability of the self-management system developed for older adults with chronic diseases. Also, we demonstrated that our usability evaluation approach could be used to quickly and effectively identify usability problems in a health care information system at an early stage of the system development

Beyond disease susceptibility-Leveraging genome-wide association studies for new insights into complex disease biology.

Science.gov (United States)

Lee, J C

2017-12-01

Genetic studies in complex diseases have been highly successful, but have also been largely one-dimensional: predominantly focusing on the genetic contribution to disease susceptibility. While this is undoubtedly important-indeed it is a pre-requisite for understanding the mechanisms underlying disease development-there are many other important aspects of disease biology that have received comparatively little attention. In this review, I will discuss how existing genetic data can be leveraged to provide new insights into other aspects of disease biology, why such insights could change the way we think about complex disease, and how this could provide opportunities for better therapies and/or facilitate personalised medicine. To do this, I will use the example of Crohn's disease-a chronic form of inflammatory bowel disease that has been one of the main success stories in complex disease genetics. Indeed, thanks to genetic studies, we now have a much more detailed understanding of the processes involved in Crohn's disease development, but still know relatively little about what determines the subsequent disease course (prognosis) and why this differs so considerably between individuals. I will discuss how we came to realise that genetic variation plays an important role in determining disease prognosis and how this has changed the way we think about Crohn's disease genetics. This will illustrate how phenotypic data can be used to leverage new insights from genetic data and will provide a broadly applicable framework that could yield new insights into the biology of multiple diseases. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Discrepancy between self- and proxy-rated pain in Alzheimer's disease: results from the danish Alzheimer intervention study

DEFF Research Database (Denmark)

Jensen-Dahm, C.; Vogel, A.; Waldorff, F.B.

2012-01-01

OBJECTIVES: To investigate the prevalence of self- and proxy-reported pain in a cohort with Alzheimer's disease (AD) and to identify characteristics of individuals with AD reporting pain. DESIGN: Data were collected at the baseline visit of the Danish Alzheimer Intervention Study. SETTING......: Community. PARTICIPANTS: Three hundred twenty-one community-living individuals with AD (MMSE >/= 20) and their primary caregivers. MEASUREMENTS: Pain was assessed as part of the EuroQol EQ-5D (caregiver- and self-rated). The Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease...

The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

Science.gov (United States)

Grubbs, Vanessa; Garcia, Faviola; Jue, Bonnie L; Vittinghoff, Eric; Ryder, Mark; Lovett, David; Carrillo, Jacqueline; Offenbacher, Steven; Ganz, Peter; Bibbins-Domingo, Kirsten; Powe, Neil R

2017-02-01

Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials. Copyright © 2016. Published by Elsevier Inc.

Extracellular RNAs: development as biomarkers of human disease

Directory of Open Access Journals (Sweden)

Joseph F. Quinn

2015-08-01

Full Text Available Ten ongoing studies designed to test the possibility that extracellular RNAs may serve as biomarkers in human disease are described. These studies, funded by the NIH Common Fund Extracellular RNA Communication Program, examine diverse extracellular body fluids, including plasma, serum, urine and cerebrospinal fluid. The disorders studied include hepatic and gastric cancer, cardiovascular disease, chronic kidney disease, neurodegenerative disease, brain tumours, intracranial haemorrhage, multiple sclerosis and placental disorders. Progress to date and the plans for future studies are outlined.

Dynamics of the connectome in Huntington's disease: A longitudinal diffusion MRI study

OpenAIRE

Odish, Omar F.F.; Caeyenberghs, Karen; Hosseini, Hadi; van den Bogaard, Simon J.A.; Roos, Raymund A.C.; Leemans, Alexander

2015-01-01

Abstract Objectives To longitudinally investigate the connectome in different stages of Huntington's disease (HD) by applying graph theoretical analysis to diffusion MRI data. Experimental design We constructed weighted structural networks and calculated their topological properties. Twenty-two premanifest (preHD), 10 early manifest HD and 24 healthy controls completed baseline and 2 year follow-up scans. We stratified the preHD group based on their predicted years to disease onset into a far...

Using protein design algorithms to understand the molecular basis of disease caused by protein-DNA interactions: the Pax6 example

DEFF Research Database (Denmark)

Alibes, A.; Nadra, A.; De Masi, Federico

2010-01-01

diseases such as aniridia. The validity of FoldX to deal with protein-DNA interactions was demonstrated by showing that high levels of accuracy can be achieved for mutations affecting these interactions. Also we showed that protein-design algorithms can accurately reproduce experimental DNA-binding logos......Quite often a single or a combination of protein mutations is linked to specific diseases. However, distinguishing from sequence information which mutations have real effects in the protein's function is not trivial. Protein design tools are commonly used to explain mutations that affect protein...... stability, or protein-protein interaction, but not for mutations that could affect protein-DNA binding. Here, we used the protein design algorithm FoldX to model all known missense mutations in the paired box domain of Pax6, a highly conserved transcription factor involved in eye development and in several...

A systematic review of protocol studies on conceptual design cognition: design as search and exploration

OpenAIRE

Hay, Laura; Duffy, Alex H.B.; McTeague, Chris; Pidgeon, Laura M.; Vuletic, Tijana; Grealy, Madeleine

2017-01-01

This paper reports findings from the first systematic review of protocol studies focusing specifically on conceptual design cognition, aiming to answer the following research question: What is our current understanding of the cognitive processes involved in conceptual design tasks carried out by individual designers? We reviewed 47 studies on architectural design, engineering design and product design engineering. This paper reports 24 cognitive processes investigated in a subset of 33 studie...

Gastroesophageal Reflux Disease: A Population Based Study

OpenAIRE

Nwokediuko, Sylvester

2009-01-01

Background The prevalence of gastroesophageal reflux disease varies in different parts of the world. There are no population based studies in Nigeria. The main objectives of this study were to determine the prevalence and risk factors for gastroesophageal reflux disease in a population of Nigerian medical students. Methods The Carlsson-Dent questionnaire was administered to medical students in the clinical phase of their training at the University of Nigeria, Enugu Campus. Some putative risk ...

Design Thinking for mHealth Application Co-Design to Support Heart Failure Self-Management.

Science.gov (United States)

Woods, Leanna; Cummings, Elizabeth; Duff, Jed; Walker, Kim

2017-01-01

Heart failure is a prevalent, progressive chronic disease costing in excess of $1billion per year in Australia alone. Disease self-management has positive implications for the patient and decreases healthcare usage. However, adherence to recommended guidelines is challenging and existing literature reports sub-optimal adherence. mHealth applications in chronic disease education have the potential to facilitate patient enablement for disease self-management. To the best of our knowledge no heart failure self-management application is available for safe use by our patients. In this paper, we present the process established to co-design a mHealth application in support of heart-failure self-management. For this development, an interdisciplinary team systematically proceeds through the phases of Stanford University's Design Thinking process; empathise, define, ideate, prototype and test with a user-centred philosophy. Using this clinician-led heart failure app research as a case study, we describe a sequence of procedures to engage with local patients, carers, software developers, eHealth experts and clinical colleagues to foster rigorously developed and locally relevant patient-facing mHealth solutions. Importantly, patients are engaged in each stage with ethnographic interviews, a series of workshops and multiple re-design iterations.

Mitochondrial disease patient motivations and barriers to participate in clinical trials.

Directory of Open Access Journals (Sweden)

Zarazuela Zolkipli-Cunningham

Full Text Available Clinical treatment trials are increasingly being designed in primary mitochondrial disease (PMD, a phenotypically and genetically heterogeneous collection of inherited multi- system energy deficiency disorders that lack effective therapy. We sought to identify motivating factors and barriers to clinical trial participation in PMD.A survey study was conducted in two independent mitochondrial disease subject cohorts. A discovery cohort invited subjects with well-defined biochemical or molecularly- confirmed PMD followed at a single medical center (CHOP, n = 30/67 (45% respondents. A replication cohort included self-identified PMD subjects in the Rare Disease Clinical Research Network (RDCRN national contact registry (n = 290/1119 (26% respondents. Five-point Likert scale responses were analyzed using descriptive and quantitative statistics. Experienced and prioritized symptoms for trial participation, and patient attitudes toward detailed aspects of clinical trial drug features and study design.PMD subjects experienced an average of 16 symptoms. Muscle weakness, chronic fatigue, and exercise intolerance were the lead symptoms encouraging trial participation. Motivating trial design factors included a self-administered study drug; vitamin, antioxidant, natural or plant-derivative; pills; daily treatment; guaranteed treatment access during and after study; short travel distances; and late-stage (phase 3 participation. Relative trial participation barriers included a new study drug; discontinuation of current medications; disease progression; daily phlebotomy; and requiring participant payment. Treatment trial type or design preferences were not influenced by population age (pediatric versus adult, prior research trial experience, or disease severity.These data are the first to convey clear PMD subject preferences and priorities to enable improved clinical treatment trial design that cuts across the complex diversity of disease. Partnering with rare

Prevention of congenital Chagas disease by Benznidazole treatment in reproductive-age women. An observational study.

Science.gov (United States)

Álvarez, María G; Vigliano, Carlos; Lococo, Bruno; Bertocchi, Graciela; Viotti, Rodolfo

2017-10-01

Since the decline in new cases of infection by insect/vector, congenital Chagas disease has become more relevant in the transmission of Chagas disease. Treatment with benznidazole significantly reduces the parasitemia, which constitutes an important factor linked to vertical transmission. The objective of this study was to evaluate whether treatment with benznidazole previously administered to women of childbearing age can prevent or reduce the incidence of new cases of congenital Chagas disease. An historical cohort study that included all women in reproductive age (15-45 years) assisted in our center was designed. We included 67 mothers with chronic Chagas disease; 35 women had not been treated prior to pregnancy, 15 had been treated prior to pregnancy and 17 gave birth prior and after treatment with benznidazole. Eight mothers gave birth to 16 children with congenital Chagas disease (8/67, 12%). The prevalence of congenital Chagas was 16/114 (14%) children born to untreated mothers and 0/42 (0%) children born to benznidazole- treated mothers, p=0.01. No significant differences were observed in clinical, serologic, epidemiological or socioeconomic baseline variables between mothers with and without children born with congenital Chagas. A 32% conversion rate to negative serology was observed in benznidazole-treated women after long-term follow up. Antiparasitic treatment administered to women in reproductive age can prevent the occurrence of congenital Chagas disease. Copyright © 2017 Elsevier B.V. All rights reserved.

Study on clinical symptoms in canine cardiac diseases

Directory of Open Access Journals (Sweden)

F. Karlette Anne

Full Text Available Cardiac diseases in canines are an extensively studied phenomenon all over the world but meagre information has been reported in India. Certain problems, including historical, physical, and laboratory abnormalities, are associated with cardiovascular or pulmonary disease. In India however, the recognition of canine cardiac diseases has been delayed, and ignored on account of lack of awareness and knowledge by the owner and inadequate diagnostic facility to a field veterinarian. Considering the above facts, the present study was undertaken in Gujarat to survey the prevalence of common cardiac diseases in hospital population of dogs along with the clinical symptoms which often goes undetected due to lack of proper diagnostic techniques to be implied and the most forms of heart disease may be present for many years before any evidence of failure develops. In the present study most of the clinical cases of cardiac diseases were presented with a history of nocturnal coughing (seven cases; 2.55%, exercise intolerance (five cases; 1.82%, partial or complete anorexia (five cases; 1.82%, swelling in abdominal area (four cases; 1.45%, dullness and depression (two cases; 0.72%, cachexia and hepatojugular pulsation (one case each; 0.36% each at times. [Vet World 2009; 2(8.000: 307-309

Design study on advanced nuclear fuel recycle system. Conceptual design study of recycle system using molten salt

International Nuclear Information System (INIS)

Kasai, Y.; Kakehi, I.; Moro, T.; Higashi, T.; Tobe, K.; Kawamura, F.; Yonezawa, S.; Yoshiuji, T.

1998-10-01

Advanced recycle system engineering group of OEC (Oarai Engineering Center) has being carried out a design study of the advanced nuclear fuel recycle system using molten salt (electro-metallurgical process). This system is aiming for improvements of fuel cycle economy and reduction of environmental burden (MA recycles, Minimum of radioactive waste disposal), and also improvement of safety and nuclear non-proliferation. This report describes results of the design study that has been continued since December 1996. (1) A design concept of the advanced nuclear fuel recycle system, that is a module type recycles system of pyrochemical reprocessing and fuel re-fabrication was studied. The module system has advantage in balance of Pu recycle where modules are constructed in coincidence with the construction plan of nuclear power plants, and also has flexibility for technology progress. A demonstration system, minimum size of the above module, was studies. This system has capacity of 10 tHM/y and is able to demonstrate recycle technology of MOX fuel, metal fuel and nitride fuel. (2) Each process of the system, which are pyrochemical electrorefining system, cathode processor, de-cladding system, waste disposal system, etc., were studied. In this study, capacity of an electrorefiner was discussed, and vitrification experiment of molten salt using lead-boric acid glass was conducted. (3) A hot cell system and material handling system of the demonstration system was studied. A robot driven by linear motor was studied for the handling system, and an arrangement plan of the cell system was made. Criticality analysis in the cell system and investigation of material accountancy system of the recycle plant were also made. This design study will be continued in coincidence with design study of reactor and fuel, aiming to establish the concept of FBR recycle system. (author)

Crystallization and preliminary crystallographic studies of the copper-binding domain of the amyloid precursor protein of Alzheimer’s disease

Energy Technology Data Exchange (ETDEWEB)

Kong, Geoffrey K.-W. [Biota Structural Biology Laboratory, St Vincent’s Institute, 9 Princes Street, Fitzroy, Victoria 3065 (Australia); Department of Pathology, The University of Melbourne, Victoria 3010 (Australia); Galatis, Denise; Barnham, Kevin J. [Department of Pathology, The University of Melbourne, Victoria 3010 (Australia); The Mental Health Research Institute of Victoria, Parkville, Victoria 3052 (Australia); Polekhina, Galina; Adams, Julian J. [Biota Structural Biology Laboratory, St Vincent’s Institute, 9 Princes Street, Fitzroy, Victoria 3065 (Australia); Masters, Colin L. [Department of Pathology, The University of Melbourne, Victoria 3010 (Australia); The Mental Health Research Institute of Victoria, Parkville, Victoria 3052 (Australia); Cappai, Roberto [Department of Pathology, The University of Melbourne, Victoria 3010 (Australia); The Mental Health Research Institute of Victoria, Parkville, Victoria 3052 (Australia); Centre for Neuroscience, The University of Melbourne, Victoria 3010 (Australia); Parker, Michael W.; McKinstry, William J., E-mail: wmckinstry@svi.edu.au [Biota Structural Biology Laboratory, St Vincent’s Institute, 9 Princes Street, Fitzroy, Victoria 3065 (Australia)

2005-01-01

The binding of Cu{sup 2+} ions to the copper-binding domain of the amyloid precursor protein of Alzheimer’s disease reduces the production of the amyloid β peptide, which is centrally involved in Alzheimer’s disease. Structural studies of the copper-binding domain will provide a basis for structure-based drug design that might prove useful in treating this devastating disease. Alzheimer’s disease is thought to be triggered by production of the amyloid β (Aβ) peptide through proteolytic cleavage of the amyloid precursor protein (APP). The binding of Cu{sup 2+} to the copper-binding domain (CuBD) of APP reduces the production of Aβ in cell-culture and animal studies. It is expected that structural studies of the CuBD will lead to a better understanding of how copper binding causes Aβ depletion and will define a potential drug target. The crystallization of CuBD in two different forms suitable for structure determination is reported here.

Hourly differences in air pollution and risk of respiratory disease in the elderly: a time-stratified case-crossover study.

Science.gov (United States)

Yorifuji, Takashi; Suzuki, Etsuji; Kashima, Saori

2014-08-13

Epidemiological studies have shown adverse effects of short-term exposure to air pollution on respiratory disease outcomes; however, few studies examined this association on an hourly time scale. We evaluated the associations between hourly changes in air pollution and the risk of respiratory disease in the elderly, using the time of the emergency call as the disease onset for each case. We used a time-stratified case-crossover design. Study participants were 6,925 residents of the city of Okayama, Japan, aged 65 or above who were taken to hospital emergency rooms between January 2006 and December 2010 for onset of respiratory disease. We calculated city-representative hourly average concentrations of air pollutants from several monitoring stations. By using conditional logistic regression models, we estimated odds ratios per interquartile-range increase in each pollutant by exposure period prior to emergency call, adjusting for hourly ambient temperature, hourly relative humidity, and weekly numbers of reported influenza cases aged ≥60. Suspended particulate matter (SPM) exposure 24 to respiratory disease. For example, following one interquartile-range increase, odds ratios were 1.05 (95% confidence interval: 1.01, 1.09) for SPM exposure 24 to respiratory disease of SPM or ozone. Overall, the effect estimates for chronic obstructive pulmonary disease and allied conditions were equivocal. This study provides further evidence that hourly changes in air pollution exposure increase the risks of respiratory disease, and that SO2 may be related with more immediate onset of the disease than other pollutants.

A generalized model to estimate the statistical power in mitochondrial disease studies involving 2×k tables.

Directory of Open Access Journals (Sweden)

Jacobo Pardo-Seco

Full Text Available BACKGROUND: Mitochondrial DNA (mtDNA variation (i.e. haplogroups has been analyzed in regards to a number of multifactorial diseases. The statistical power of a case-control study determines the a priori probability to reject the null hypothesis of homogeneity between cases and controls. METHODS/PRINCIPAL FINDINGS: We critically review previous approaches to the estimation of the statistical power based on the restricted scenario where the number of cases equals the number of controls, and propose a methodology that broadens procedures to more general situations. We developed statistical procedures that consider different disease scenarios, variable sample sizes in cases and controls, and variable number of haplogroups and effect sizes. The results indicate that the statistical power of a particular study can improve substantially by increasing the number of controls with respect to cases. In the opposite direction, the power decreases substantially when testing a growing number of haplogroups. We developed mitPower (http://bioinformatics.cesga.es/mitpower/, a web-based interface that implements the new statistical procedures and allows for the computation of the a priori statistical power in variable scenarios of case-control study designs, or e.g. the number of controls needed to reach fixed effect sizes. CONCLUSIONS/SIGNIFICANCE: The present study provides with statistical procedures for the computation of statistical power in common as well as complex case-control study designs involving 2×k tables, with special application (but not exclusive to mtDNA studies. In order to reach a wide range of researchers, we also provide a friendly web-based tool--mitPower--that can be used in both retrospective and prospective case-control disease studies.

The Impact of Diagnostic Code Misclassification on Optimizing the Experimental Design of Genetic Association Studies

Directory of Open Access Journals (Sweden)

Steven J. Schrodi

2017-01-01

Full Text Available Diagnostic codes within electronic health record systems can vary widely in accuracy. It has been noted that the number of instances of a particular diagnostic code monotonically increases with the accuracy of disease phenotype classification. As a growing number of health system databases become linked with genomic data, it is critically important to understand the effect of this misclassification on the power of genetic association studies. Here, I investigate the impact of this diagnostic code misclassification on the power of genetic association studies with the aim to better inform experimental designs using health informatics data. The trade-off between (i reduced misclassification rates from utilizing additional instances of a diagnostic code per individual and (ii the resulting smaller sample size is explored, and general rules are presented to improve experimental designs.

Impact of Fatigue in Rheumatic Diseases in the Work Environment: A Qualitative Study.

LENUS (Irish Health Repository)

Connolly, Deirdre

2015-10-28

Fatigue is a symptom of arthritis that causes difficulty at work. An improved understanding of this symptom could assist its management in the work environment. The aim of this study was to explore people with rheumatic diseases\\' experiences of fatigue in work. A qualitative descriptive design was used with semi-structured interviews and a constant comparative method of data analysis. There were 18 participants, the majority of them female with Rheumatoid Arthritis (RA) and working full-time. Three themes were identified: "Impact of fatigue on work performance" with cognition, mood and physical abilities being the main difficulties reported. In the second theme "Disclosure at Work" participants discussed disclosing their disease to employers but reported a lack of understanding of fatigue from colleagues. The final theme "work-based fatigue management strategies" included cognitive strategies and energy management techniques, which were mainly self-taught. In this study, fatigue was reported to impact on many areas of work performance with limited understanding from colleagues and employers. Interventions from health professionals to assist with development of work-related self-management skills are required to assist with symptom management in the work place. Such interventions should include education to employers and colleagues on the nature of fatigue in Rheumatic diseases.

Screening Fabry's disease in chronic kidney disease patients not on dialysis: a multicenter study.

Science.gov (United States)

Yeniçerioğlu, Yavuz; Akdam, Hakan; Dursun, Belda; Alp, Alper; Sağlam Eyiler, Funda; Akın, Davut; Gün, Yelda; Hüddam, Bülent; Batmazoğlu, Mehmet; Gibyeli Genek, Dilek; Pirinççi, Serhat; Ersoy, İsmail Rıfkı; Üzüm, Atilla; Soypaçacı, Zeki; Tanrısev, Mehmet; Çolak, Hülya; Demiral Sezer, Sibel; Bozkurt, Gökay; Akyıldız, Utku Oğan; Akyüz Ünsal, Ayşe İpek; Ünübol, Mustafa; Uslu, Meltem; Eryılmaz, Ufuk; Günel, Ceren; Meteoğlu, İbrahim; Yavaşoğlu, İrfan; Ünsal, Alparslan; Akar, Harun; Okyay, Pınar

2017-11-01

Fabry's disease is an X-linked inherited, rare, progressive, lysosomal storage disorder, affecting multiple organs due to the deficient activity of α-galactosidase A (α-Gal A) enzyme. The prevalence has been reported to be 0.15-1% in hemodialysis patients; however, the information on the prevalence in chronic kidney disease not on dialysis is lacking. This study aimed to determine the prevalence of Fabry's disease in chronic kidney disease. The patients older than 18 years, enclosing KDIGO 2012 chronic kidney disease definitions, not on dialysis, were enrolled. Dried blood spots on Guthrie papers were used to analyze α-Gal A enzyme and genetic analysis was performed in individuals with enzyme activity ≤1.2 μmol/L/h. A total of 1453 chronic kidney disease patients not on dialysis from seven clinics in Turkey were screened. The mean age of the study population was 59.3 ± 15.9 years. 45.6% of patients were female. The creatinine clearance of 77.3% of patients was below 60 mL/min/1.73 m 2 , 8.4% had proteinuria, and 2.5% had isolated microscopic hematuria. The mean value of patients' α-Gal A enzyme was detected as 2.93 ± 1.92 μmol/L/h. 152 patients had low levels of α-Gal A enzyme activity (≤1.2 μmol/L/h). In mutation analysis, A143T and D313Y variants were disclosed in three male patients. The prevalence of Fabry's disease in chronic kidney disease not on dialysis was found to be 0.2% (0.4% in male, 0.0% in female). Fabry's disease should be considered in the differential diagnosis of chronic kidney disease with unknown etiology even in the absence of symptoms and signs suggestive of Fabry's disease.

Associations between subjective happiness and dry eye disease: a new perspective from the Osaka study.

Science.gov (United States)

Kawashima, Motoko; Uchino, Miki; Yokoi, Norihiko; Uchino, Yuichi; Dogru, Murat; Komuro, Aoi; Sonomura, Yukiko; Kato, Hiroaki; Kinoshita, Shigeru; Mimura, Masaru; Tsubota, Kazuo

2015-01-01

Dry eye disease has become an important health problem. A lack of concordance between self-reported symptoms and the outcome of dry eye examinations has raised questions about dry eye disease. To explore the association between subjective happiness and objective and subjective symptoms of dry eye disease. The study adopted a cross-sectional design. All the employees of a company in Osaka, Japan. 672 Japanese office workers using Visual Display Terminals (age range: 26-64 years). The dry eye measurement tools included the Schirmer test, conjunctivocorneal staining, the tear film break-up time, as well as the administration of a dry eye symptoms questionnaire. Happiness was measured by the Subjective Happiness Scale. Dry eye examination parameters, dry eye symptoms questionnaires, and the Subjective Happiness Scale score. Of the 672 workers, 561 (83.5%) completed the questionnaires and examinations. The mean Subjective Happiness Scale score was 4.91 (SD = 1.01). This score was inversely correlated with the dry eye symptom score (r = -0.188, p happiness was the lowest in the group without objective results, but reported subjective symptoms of dry eyes (p happiness and self-reported symptoms of dry eyes. Findings of this study revealed a new perspective on dry eye disease, including the potential for innovative treatments of a specific population with dry eye disease.

Retrospective Study of Epidermal Parasitic Skin Diseases amongst ...

African Journals Online (AJOL)

ADOWIE PERE

ABSTRACT: A ten year retrospective study (1997-2006) was undertaken to determine the prevalence of. Epidermal Parasitic Skin Diseases (EPSD) among out-patients from the skin diseases hospital in Maiduguri, Borno state. Out of 10,000 out-patients examined during the study period, 3527(35.27%) where infected with ...

Effects of interactive metronome training on postural stability and upper extremity function in Parkinson's disease: a case study.

Science.gov (United States)

Kim, Arim; Lee, Hye-Sun; Song, Chiang-Soon

2017-01-01

[Purpose] The purpose of this study was to examine the effects of interactive metronome training on the postural stability and upper extremity function of an individual with Parkinson's disease. [Subject and Methods] The participant of this case study was a 75-year-old female with Parkinson's disease diagnosed 7 years prior. This study was a single-subject research with an A-B-A design. She received IM training during the treatment phase (B phase) for 40 minutes per session. She was assessed pretest and posttest using the Berg balance scale and Wolf motor function test, and at baseline and the treatment phase using the measured box-and-block test and a Tetrax system. [Results] After training, the patient's static and dynamic balance, functional activity, and performance time of the upper extremity improved. Interactive metronome therapy improved the manual dexterity of both hands. Interactive metronome therapy also improved the limit of stability of the Parkinson's disease. [Conclusion] Though a case study, the results of this study suggest that IM therapy is effective at restoring the postural stability and upper extremity function of patients with Parkinson's disease.

Design studies of Tokamak power reactor in JAERI

International Nuclear Information System (INIS)

Tone, T.; Nishikawa, M.; Tanaka, Y.

1985-01-01

Recent design studies of tokamak power reactor and related activities conducted in JAERI are presented. A design study of the SPTR (Swimming-Pool Type Reactor) concept was carried out in FY81 and FY82. The reactor design studies in the last two years focus on nuclear components, heat transport and energy conversion systems. In parallel of design studies, tokamak systems analysis code is under development to evaluate reactor performances, cost and net energy balance

Prevalence of periodontal disease in children with leukemia disease and thalassemia

Directory of Open Access Journals (Sweden)

Hardianti Maulidita

2016-06-01

Full Text Available Various periodontal disease can occur in children and adolescents. Some can take place quickly and periodontal tissue damage. Several previous studies indicate that systemic diseases associated with periodontal disease in children. This study aims to determine the prevalence of periodontal disease in children with leukemia and thalassemia. The design study is a cross-sectional approach. Periodontal pocket depth measurements performed using the WHO standard of measurement. The samples in this study were drawn from the entire population using accidental sampling method. Sampled population was pediatric patients with leukemia and thalassemia. These patients were undergoing treatment in hospital Wahidin Sudirohusodo Hospital Makassar. During the study, children with leukemia as many as 18 patients and children with thalassemia by 8 patients. Distribution of pediatric patients suffering from leukemia by CPITN score; score of 2 as many as 10 patients (55.6%, a score of 1 as 6 patients (33.3%, and  score of 0 as many as 2 patients (11.1%. CPITN score in children with thalassemia; scores 2 in 1 patient (12.5%, a score of 1 as 6 patients (75%, and score of 0 by 1 patient (12.5%. Children who have leukemia and thalassemia, showed the rate of occurrence of different periodontal disease. Children with leukemia shows the level of periodontal disease is higher than in children with thalassemia disease.

Analysis of Swine Movements in a Province in Northern Vietnam and Application in the Design of Surveillance Strategies for Infectious Diseases.

Science.gov (United States)

Baudon, E; Fournié, G; Hiep, D T; Pham, T T H; Duboz, R; Gély, M; Peiris, M; Cowling, B J; Ton, V D; Peyre, M

2017-04-01

While swine production is rapidly growing in South-East Asia, the structure of the swine industry and the dynamic of pig movements have not been well-studied. However, this knowledge is a prerequisite for understanding the dynamic of disease transmission in swine populations and designing cost-effective surveillance strategies for infectious diseases. In this study, we assessed the farming and trading practices in the Vietnamese swine familial farming sector, which accounts for most pigs in Vietnam, and for which disease surveillance is a major challenge. Farmers from two communes of a Red River Delta Province (northern Vietnam) were interviewed, along with traders involved in pig transactions. Major differences in the trade structure were observed between the two communes. One commune had mainly transversal trades, that is between farms of equivalent sizes, whereas the other had pyramidal trades, that is from larger to smaller farms. Companies and large familial farrow-to-finish farms were likely to act as major sources of disease spread through pig sales, demonstrating their importance for disease control. Familial fattening farms with high pig purchases were at greater risk of disease introduction and should be targeted for disease detection as part of a risk-based surveillance. In contrast, many other familial farms were isolated or weakly connected to the swine trade network limiting their relevance for surveillance activities. However, some of these farms used boar hiring for breeding, increasing the risk of disease spread. Most familial farms were slaughtering pigs at the farm or in small local slaughterhouses, making the surveillance at the slaughterhouse inefficient. In terms of spatial distribution of the trades, the results suggested that northern provinces were highly connected and showed some connection with central and southern provinces. These results are useful to develop risk-based surveillance protocols for disease detection in the swine familial

Infusing Technology Driven Design Thinking in Industrial Design Education: A Case Study

Science.gov (United States)

Mubin, Omar; Novoa, Mauricio; Al Mahmud, Abdullah

2017-01-01

Purpose: This paper narrates a case study on design thinking-based education work in an industrial design honours program. Student projects were developed in a multi-disciplinary setting across a Computing and Engineering faculty that allowed promoting technologically and user-driven innovation strategies. Design/methodology/approach: A renewed…

Designing and delivering facilitated storytelling interventions for chronic disease self-management: a scoping review.

Science.gov (United States)

Gucciardi, Enza; Jean-Pierre, Nicole; Karam, Grace; Sidani, Souraya

2016-07-11

Little is known about how to develop and deliver storytelling as an intervention to support those managing chronic illnesses. This scoping review aims to describe the core elements of storytelling interventions in order to help facilitate its implementation. A scoping review was conducted in seven databases for articles published up to May 2014 to identify interventions that describe in detail how storytelling was used to support people in disease self-management interventions. Ten articles met all inclusion criteria. Core elements consistently observed across the storytelling interventions were: reflection and interactive meaning-making of experiences; principles of informality and spontaneity; non-directional and non-hierarchical facilitation; development of group norms and conduct to create a community among participants; and both an individual and collective role for participants. Differences were also observed across interventions, such as: the conceptual frameworks that directed the design of the intervention; the type and training of facilitators; intervention duration; and how session topics were selected and stories delivered. Furthermore, evaluation of the intervention and outcome assessment varied greatly across studies. The use of storytelling can be a novel intervention to enhance chronic disease self-management. The core elements identified in the review inform the development of the intervention to be more patient-centred by guiding participants to take ownership of and lead the intervention, which differs significantly from traditional support groups. Storytelling has the potential to provide patients with a more active role in their health care by identifying their specific needs as well as gaps in knowledge and skills, while allowing them to form strong bonds with peers who share similar disease-related experiences. However, measures of impact differed across interventions given the variation in chronic conditions. Our findings can guide future

Argonne Tau-charm factory collider design study

International Nuclear Information System (INIS)

Teng, L.C.; Crosbie, E.A.; Norem, J.

1995-01-01

The design approach and design principles for a Tau-charm Factory at Argonne were studied. These studies led to a set of preliminary parameters and tentative component features as presented in this paper

The Emerging Risk Factors Collaboration: analysis of individual data on lipid, inflammatory and other markers in over 1.1 million participants in 104 prospective studies of cardiovascular diseases

DEFF Research Database (Denmark)

Danesh, J; Erqou, S; Walker, M

2007-01-01

Many long-term prospective studies have reported on associations of cardiovascular diseases with circulating lipid markers and/or inflammatory markers. Studies have not, however, generally been designed to provide reliable estimates under different circumstances and to correct for within-person v......Many long-term prospective studies have reported on associations of cardiovascular diseases with circulating lipid markers and/or inflammatory markers. Studies have not, however, generally been designed to provide reliable estimates under different circumstances and to correct for within....... This initiative will characterize more precisely and in greater detail than has previously been possible the shape and strength of the age- and sex-specific associations of several lipid and inflammatory markers with incident coronary heart disease outcomes (and, secondarily, with other incident cardiovascular...

Mirror Advanced Reactor Study interim design report

Energy Technology Data Exchange (ETDEWEB)

1983-04-01

The status of the design of a tenth-of-a-kind commercial tandem-mirror fusion reactor is described at the midpoint of a two-year study. When completed, the design is to serve as a strategic goal for the mirror fusion program. The main objectives of the Mirror Advanced Reactor Study (MARS) are: (1) to design an attractive tandem-mirror fusion reactor producing electricity and synfuels (in alternate versions), (2) to identify key development and technology needs, and (3) to exploit the potential of fusion for safety, low activation, and simple disposal of radioactive waste. In the first year we have emphasized physics and engineering of the central cell and physics of the end cell. Design optimization and trade studies are continuing, and we expect additional modifications in the end cells to further improve the performance of the final design.

Mirror Advanced Reactor Study interim design report

International Nuclear Information System (INIS)

1983-04-01

The status of the design of a tenth-of-a-kind commercial tandem-mirror fusion reactor is described at the midpoint of a two-year study. When completed, the design is to serve as a strategic goal for the mirror fusion program. The main objectives of the Mirror Advanced Reactor Study (MARS) are: (1) to design an attractive tandem-mirror fusion reactor producing electricity and synfuels (in alternate versions), (2) to identify key development and technology needs, and (3) to exploit the potential of fusion for safety, low activation, and simple disposal of radioactive waste. In the first year we have emphasized physics and engineering of the central cell and physics of the end cell. Design optimization and trade studies are continuing, and we expect additional modifications in the end cells to further improve the performance of the final design

Comprehensive genetic study of fatty acids helps explain the role of noncoding inflammatory bowel disease associated SNPs and fatty acid metabolism in disease pathogenesis.

Science.gov (United States)

Jezernik, Gregor; Potočnik, Uroš

2018-03-01

Fatty acids and their derivatives play an important role in inflammation. Diet and genetics influence fatty acid profiles. Abnormalities of fatty acid profiles have been observed in inflammatory bowel diseases (IBD), a group of complex diseases defined by chronic gastrointestinal inflammation. IBD associated fatty acid profile abnormalities were observed independently of nutritional status or disease activity, suggesting a common genetic background. However, no study so far has attempted to look for overlap between IBD loci and fatty acid associated loci or investigate the genetics of fatty acid profiles in IBD. To this end, we conducted a comprehensive genetic study of fatty acid profiles in IBD using iCHIP, a custom microarray platform designed for deep sequencing of immune-mediated disease associated loci. This study identifies 10 loci associated with fatty acid profiles in IBD. The most significant associations were a locus near CBS (p = 7.62 × 10 -8 ) and a locus in LRRK2 (p = 1.4 × 10 -7 ). Of note, this study replicates the FADS gene cluster locus, previously associated with both fatty acid profiles and IBD pathogenesis. Furthermore, we identify 18 carbon chain trans-fatty acids (p = 1.12 × 10 -3 ), total trans-fatty acids (p = 4.49 × 10 -3 ), palmitic acid (p = 5.85 × 10 -3 ) and arachidonic acid (p = 8.58 × 10 -3 ) as significantly associated with IBD pathogenesis. Copyright © 2018 Elsevier Ltd. All rights reserved.

Role of cytokines in development of pre-eclampsia associated with periodontal disease - Cohort Study.

Science.gov (United States)

Kumar, Ashok; Begum, Nargis; Prasad, Sudha; Lamba, Arundeep K; Verma, Mahesh; Agarwal, Sarita; Sharma, Shashi

2014-04-01

The present study was designed to find any association of cytokines in women with periodontal disease and development of pre-eclampsia in North Indian population. A total of 504 consecutively registered primigravida with a single live pregnancy were recruited at 14-18 weeks of gestation from antenatal clinic of Maulana Azad Medical College & associated Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences, New Delhi. One periodontist performed oral health examination of all patients at inclusion into study. Blood samples were collected to measure the level of cytokines IL-4, IL-10, TNF-α and IFN-γ. The profile of blood levels of cytokines from women with periodontal disease was observed. The log serum levels of TNF-α & IL-4 at 16-18 weeks of gestation were significantly higher in women with periodontal disease (4.13 ± 2.06; 0.47 ± 1.56 pg/ml respectively) than in women with healthy gums (2.16 ± 1.51; 0.02 ± 1.84 pg/ml respectively, p Periodontal disease is associated with log serum TNF-α levels at cut-off ≥14.43 pg/ml at sensitivity 71.2% and specificity 62% (OR = 4.04; 95%CI = 2.77-5.87). Woman with periodontal disease who later developed pre-eclampsia had lower levels of TNF-α (3.72 ± 1.33 pg/ml) than those with periodontal disease who did not develop pre-eclampsia (4.20 ± 2.15 pg/ml, p ≥ 0.05). Reduced TNF-α level secretion in the early second trimester in women with periodontal disease appears to be associated with the development of pre-eclampsia. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Carotenoids: 2. Diseases and supplementation studies].

Science.gov (United States)

Faure, H; Fayol, V; Galabert, C; Grolier, P; Moël, G L; Stephens, J; Nabet, F

1999-05-01

Inverse correlations have been found in most studies on the relationship between dietary intake and plasma concentrations of carotenoids on one side and degenerative diseases such as cancer and cardiovascular diseases on the other side. Protective effects of carotenoids have been found for pathologies of the retina and the skin. Concentrations of these molecules in blood are lower in digestive pathologies and HIV. Short- and long-term toxicity of carotenoids was found to be low. In combination with the beneficial effects found for diets rich in carotenoids, this has initiated trials with relatively high doses of carotenoid supplements. In the study in Linxian (China) in a rural population with poor nutritional status, supplementation with beta-carotene, zinc, selenium and vitamin E lowered total mortality and mortality from stomach cancer. Other studies (ATBC, Caret.) on well-fed subjects did not show beneficial effects on mortality from cancer and cardiovascular diseases. On the contrary, higher mortality and lung cancer incidence was found in supplemented subjects that were also exposed to asbestos and cigarette smoke. In these studies, doses of supplemental beta-carotene were high and varied from 20 to 50 mg/day. One still ongoing study, called Suvimax, doses subjects for eight years with a cocktail of vitamins and minerals including 6 mg per day of beta-carotene. This supplementation with physiologically seen more "normal" doses might give clarity on the question if beta-carotene is the protective factor in fruits and vegetables.

Design of a Novel Servo-motorized Laser Device for Visual Pathways Diseases Therapy

Directory of Open Access Journals (Sweden)

Carlos Ignacio Sarmiento

2015-12-01

Full Text Available We discuss a novel servo-motorized laser device and a research protocol for visual pathways diseases therapies. The proposed servo-mechanized laser device can be used for potential rehabilitation of patients with hemianopia, quadrantanopia, scotoma, and some types of cortical damages. The device uses a semi spherical structure where the visual stimulus will be shown inside, according to a previous stimuli therapy designed by an ophthalmologist or neurologist. The device uses a pair of servomotors (with torque=1.5kg, which controls the laser stimuli position for the internal therapy and another pair for external therapy. Using electronic tools such as microcontrollers along with miscellaneous electronic materials, combined with LabVIEW based interface, a control mechanism is developed for the new device. The proposed device is well suited to run various visual stimuli therapies. We outline the major design principles including the physical dimensions, laser device’s kinematical analysis and the corresponding software development.

Lycopene and risk of cardiovascular diseases: A meta-analysis of observational studies.

Science.gov (United States)

Song, Bo; Liu, Kai; Gao, Yuan; Zhao, Lu; Fang, Hui; Li, Yusheng; Pei, Lulu; Xu, Yuming

2017-09-01

The aim of current meta-analysis was to investigate the relation between lycopene and risk of cardiovascular diseases (CVD). Studies concerning about the association between lycopene and risk of CVD were searched on Pubmed, Embase, and Web of Science from inception to October 2016. A total of 14 eligible studies were identified. A significantly inverse association with a pooled risk ratio (RR) of 0.83 (95% CI: 0.76-0.90) was shown between lycopene exposure and risk of CVD. Findings were similar restricting to dietary studies (RR = 0.87, 95% CI = 0.79-0.96) and biomarker studies (RR = 0.74, 95% CI = 0. 62-0.87).Dietary lycopene intake was statistically significant for coronary heart disease (CHD) (RR: 0.87; 95% CI: 0.76-0.98) and stroke (RR: 0.83; 95% CI: 0.69-0.96).The pooled risk estimate was generally similar for lycopene biomarker concentrations, but the association was only statistically significant for stroke (RR: 0.65; 95% CI: 0.42-0.87). Subgroup analyses showed that retrospective and low quality studies were statistically significant sources of heterogeneity. Higher lycopene exposure is inversely associated with a lower risk of CVD. Further well-designed randomized clinical trials are required to assess the role of lycopene on CVD. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Designing a software for systematic registration of oral and maxillofacial diseases based on the latest update of the World Health Organization ICD-10 classification system in 2010

Directory of Open Access Journals (Sweden)

Arash Mansorian

2014-04-01

Full Text Available   Background and Aims: Classification is a fundamental issue in quantitative studies of any phenomenon and has been known as a necessity for the advancement of science. Using a standard record system for diseases is critical for research purposes and also could improve the quality of medical health services. In this study, after evaluating current codding systems in oral medicine, we designed a software for systematic coding and registration of Oral and Maxillofacial diseases based on the latest update of the World Health Organization ICD-10 classification system in 2010.   Materials and Methods: Based on the latest WHO ICD-10 update in 2010 and by using software s as: vb.net, net framework, SQL Server and Microsoft Visual Studio, standard coding software for recording patient's data at the department of Oral Medicine, School of Dentistry, Tehran University of Medical Sciences was designed. Data from all patients were codded by standard ICD-10 codes and registered by the software. Also an online portal for recording patient's data which could be used nationwide was designed. By d esigning this software the process of forming and registering patient's records, and their treatment process is facilitated . An archive of patient data was also stablished .   Conclusion: As a result , this software in addition to maintaining patient data , facilitate studies and research projects greatly. It’s recommended that the Iranian Ministry of Health and Medical Education as the concessioner of this software, improves codding and registration systems of oral diseases at the dental schools by developing this software.

The clinical efficacy of reminiscence therapy in patients with mild-to-moderate Alzheimer disease: Study protocol for a randomized parallel-design controlled trial.

Science.gov (United States)

Li, Mo; Lyu, Ji-Hui; Zhang, Yi; Gao, Mao-Long; Li, Wen-Jie; Ma, Xin

2017-12-01

Alzheimer disease (AD) is one of the most common diseases among the older adults. Currently, various nonpharmacological interventions are used for the treatment of AD. Such as reminiscence therapy is being widely used in Western countries. However, it is often used as an empirical application in China; the evidence-based efficacy of reminiscence therapy in AD patients remains to be determined. Therefore, the aim of this research is to assess the effectives of reminiscence therapy for Chinese elderly. This is a randomized parallel-design controlled trial. Mild and moderate AD patients who are in the Beijing Geriatric Hospital, China will be randomized into control and intervention groups (n = 45 for each group). For the intervention group, along with conventional drug therapy, participants will be exposed to a reminiscence therapy of 35 to 45 minutes, 2 times/wk for 12 consecutive weeks. Patients in the control group will undergo conventional drug therapy only. The primary outcome measure will be the differences in Alzheimer disease Assessment Scale-Cognitive Section Score. The secondary outcome measures will be the differences in the Cornell scale for depression in dementia, Neuropsychiatric Inventory score, and Barthel Index scores at baseline, at 4 and 12 weeks of treatment, and 12 weeks after treatment. The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval no. 2015-010). Findings will be disseminated through presentation at scientific conferences and in academic journals. Chinese Clinical Trial Registry identifier ChiCTR-INR-16009505. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

A Twin Study of Perthes Disease

DEFF Research Database (Denmark)

Metcalfe, David; Van Dijck, Stephanie; Parsons, Nicolas

2016-01-01

BACKGROUND: Legg-Calvé-Perthes disease (LCPD) is an idiopathic avascular necrosis of the femoral head. Its etiology is poorly understood, although previous studies have implicated low birth weight and possible genetic determinants. The aim of this study was to identify potential birth weight...

Prevalence of Periodontal Disease in Children with Leukemia and Thalassemia

OpenAIRE

Marhamah; Maulidita, Hardianti

2014-01-01

Background. Various periodontal disease can occur in children and adolescents. Some can take place quickly and periodontal tissue damage. Several previous studies indicate that systemic diseases associated with periodontal disease in children. Objectives. This study aims to determine the prevalence of periodontal disease in children with leukemia and thalassemia. Methods. The design study is a cross-sectional approach. Periodontal pocket depth measurements performed using the WHO standa...

Treatment of Crohn's disease with cannabis: an observational study.

Science.gov (United States)

Naftali, Timna; Lev, Lihi Bar; Yablecovitch, Doron; Yablekovitz, Doron; Half, Elisabeth; Konikoff, Fred M

2011-08-01

The marijuana plant cannabis is known to have therapeutic effects, including improvement of inflammatory processes. However, no report of patients using cannabis for Crohn's disease (CD) was ever published. To describe the effects of cannabis use in patients suffering from CD. In this retrospective observational study we examined disease activity, use of medication, need for surgery, and hospitalization before and after cannabis use in 30 patients (26 males) with CD. Disease activity was assessed by the Harvey Bradshaw index for Crohn's disease. Of the 30 patients 21 improved significantly after treatment with cannabis. The average Harvey Bradshaw index improved from 14 +/- 6.7 to 7 +/- 4.7 (P disease in humans. The results indicate that cannabis may have a positive effect on disease activity, as reflected by reduction in disease activity index and in the need for other drugs and surgery. Prospective placebo-controlled studies are warranted to fully evaluate the efficacy and side effects of cannabis in CD.

Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

Science.gov (United States)

Irish, Ashley; Dogra, Gursharan; Mori, Trevor; Beller, Elaine; Heritier, Stephane; Hawley, Carmel; Kerr, Peter; Robertson, Amanda; Rosman, Johan; Paul-Brent, Peta-Anne; Starfield, Melissa; Polkinghorne, Kevan; Cass, Alan

2009-01-21

Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20-54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding. This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that

Argonne Tau-charm Factory collider design study

International Nuclear Information System (INIS)

Teng, L.C.; Crosbie, E.A.; Norem, J.; Repond, J.

1996-01-01

The design approach and design principles for a Tau-charm Factory at Argonne were studied. These studies led to a set of preliminary parameters and tentative component features as presented in this paper. copyright 1996 American Institute of Physics

Designing for Nomadic Play: A case study of participatory design with children

DEFF Research Database (Denmark)

Brynskov, Martin; Christensen, Bent Guldbjerg; Ludvigsen, Martin

This poster presents the results from an empirical probe study trying to engage children creatively in the design process of systems and artifacts that support nomadic life-style. Based on observational studies and interviews with children of different ages (5-15 years), we conducted a participat......This poster presents the results from an empirical probe study trying to engage children creatively in the design process of systems and artifacts that support nomadic life-style. Based on observational studies and interviews with children of different ages (5-15 years), we conducted...... a participatory design workshop cycle where children were encouraged to envision and virtually play with not-yet-invented future technology. Findings include qualitative characterizations of children’s activities (e.g. ‘play’ culture, use of digital media, age and gender differences, relation to space...

How air pollution influences clinical management of respiratory diseases. A case-crossover study in Milan

OpenAIRE

Santus Pierachille; Russo Antonio; Madonini Enzo; Allegra Luigi; Blasi Francesco; Centanni Stefano; Miadonna Antonio; Schiraldi Gianfranco; Amaducci Sandro

2012-01-01

Abstract Background Environmental pollution is a known risk factor for multiple diseases and furthermore increases rate of hospitalisations. We investigated the correlation between emergency room admissions (ERAs) of the general population for respiratory diseases and the environmental pollutant levels in Milan, a metropolis in northern Italy. Methods We collected data from 45770 ERAs for respiratory diseases. A time-stratified case-crossover design was used to investigate the association bet...

COMPREHENSIVE STUDY OF HYDATID DISEASE OF LIVER AND MANAGEMENT AT PERIPHERAL TERTIARY CARE HOSPITAL

Directory of Open Access Journals (Sweden)

Karunaharan Thomas

2017-04-01

Full Text Available BACKGROUND Hydatid Disease (HD is a zoonotic disease caused by the larvae of Echinococcosis granulosus, now become a rare clinical entity in teaching medical college hospitals. This is due to the public education about the disease, mode of spread and treatment available. The aim of the study is to review the epidemiology, clinical presentation, diagnostic methods available, organs affected and treatment available in the tertiary hospitals and outcome. MATERIALS AND METHODS Data Collection- Patients with upper right abdominal pain with radiological and ultrasound findings are included in the study. About twenty patients are taken for this study. Medical managements, surgical procedure done and outcomes are recorded, tabulated and analysed. Research Design- Prospective Study, Research Setting- KAPV Govt. Medical College and Mahatma Gandhi Memorial Govt. Hospital, Trichy, Tamilnadu. Duration- 7 yrs. (2009 to 2016 Sample Size- Twenty. Inclusion CriteriaPatients between 12 to 70 years of age of both sexes. Patient having right upper abdomen or epigastric pain with positive radiological and ultrasound findings. Patient willing to participate in the study. Exclusion Criteria- Patients more than 70 years not willing to participate in the study patients absconded in between the management. RESULTS Liver is a commonest solid organ affected by the hydatid disease. Most of the diagnosis are made accidentally when the patients are investigated for some other diseases. The commonest clinical presentation is right abdominal or epigastric pain with hepatomegaly. The average age group is 45 years. X-ray abdomen, ultrasound abdomen are the most useful investigations. Asymptomatic uncomplicated small cyst less than 5 cms are managed with medical treatment. Symptomatic large cysts are submitted for surgical intervention. CONCLUSION The main source of income in majority of rural population is agriculture and sheep and cattle grazing. WHO is working towards the

The dry eye assessment and management (DREAM©) study: Study design and baseline characteristics.

Science.gov (United States)

Asbell, Penny A; Maguire, Maureen G; Peskin, Ellen; Bunya, Vatinee Y; Kuklinski, Eric J

2018-06-05

Describe trial design and baseline characteristics of participants in the DRy Eye Assessment and Management (DREAM©) Study. Prospective, multi-center, randomized, double-masked "real-world" clinical trial assessing efficacy and safety of oral omega-3 (ω3) supplementation for the treatment of dry eye disease (DED). RESULTS: Mean age of participants was 58.0 ± 13.2 years. Mean OSDI score at baseline was 44.4 ± 14.2. Mean conjunctival staining score (scale 0-6) was 3.0 ± 1.4, corneal staining score (scale 0-15) was 3.9 ± 2.7, tear break-up time was 3.1 ± 1.5 s, and Schirmer test was 9.6 ± 6.5 mm/5 min. DREAM© participants mirror real world patients who seek intervention for their DED-related symptoms despite their current treatments. Results regarding the efficacy of omega-3 supplementation will be helpful to clinicians and patients with moderate to severe DED who are considering omega-3 as a treatment. This trial design may be a model for future RCT's on nutritional supplements and DED treatments seeking to provide useful information for clinical practice. ClinicalTrials.gov number NCT02128763. Copyright © 2017. Published by Elsevier Inc.

[The methods within the evaluation of disease management programmes in control-group designs using the example of diabetes mellitus - a systematic literature review].

Science.gov (United States)

Drabik, A; Sawicki, P T; Müller, D; Passon, A; Stock, S

2012-08-01

Disease management programmes (DMPs) were implemented in Germany in 2002. Their evaluation is required by law. Beyond the mandatory evaluation, a growing number of published studies evaluate the DMP for diabetes mellitus type 2 in a control-group design. As patients opt into the programme on a voluntary basis it is necessary to adjust the inherent selection bias between groups. The aim of this study is to review published studies which evaluate the diabetes DMP using a control-group design with respect to the methods used. A systematic literature review of electronic databases (PUBMED, Cochrane Library, EMBASE, MEDPILOT) and a hand search of reference lists of the relevant publications was conducted to identify studies evaluating the DMP diabetes mellitus in a control-group design. 8 studies were included in the systematic literature review. 4 studies gathered retrospective claims data from sickness funds, one from physician's records, one study used prospective data from ambulatory care, and 2 studies were based on one patient survey. Methods used for adjustment of selection bias included exact matching, matching using propensity score methods, age-adjusted and sex-separated analysis, and adjustment in a regression model/analysis of covariance. One study did not apply adjustment methods. The intervention period ranged from 1 day to 4 years. Considered outcomes of studies (surrogate parameter, diabetes complications, mortality, quality of life, and claim data) depended on the database. In the evaluation of the DMP diabetes mellitus based on a control-group design neither the database nor the methods used for selection bias adjustment were consistent in the available studies. Effectiveness of DMPs cannot be judged based on this review due to heterogeneity of study designs. To allow for a comprehensive programme evaluation standardised minimum requirements for the evaluation of DMPs in the control group design are required. © Georg Thieme Verlag KG Stuttgart · New

The impact of renal insufficiency and anaemia on survival in patients with cardiovascular disease: a cohort study.

LENUS (Irish Health Repository)

Anderson, Jocelyn

2009-01-01

BACKGROUND: The simultaneous occurrence of cardiovascular disease (CVD), kidney disease, and anaemia is associated with increased morbidity and mortality. In the community setting, little data exists about the risk associated with milder levels of anaemia when it is present concurrently with CVD and chronic kidney disease (CKD). The aim of this study was to establish the prevalence of CKD and anaemia in patients with CVD in the community and to examine whether the presence of anaemia was associated with increased morbidity and mortality. METHODS: This study was designed as a retrospective cohort study and involved a random sample of 35 general practices in the West of Ireland. A practice-based sample of 1,609 patients with established cardiovascular disease was generated in 2000\\/2001 and followed for five years. The primary endpoint was death from any cause. Statistical analysis involved using one-way ANOVA and Chi-squared tests for baseline data and Cox proportional-hazards models for mortality data. RESULTS: Of the study sample of 617 patients with blood results, 33% (n = 203) had CKD while 6% (n = 37) had CKD and anaemia. The estimated risk of death from any cause, when compared to patients with cardiovascular disease only, was almost double (HR = 1.98, 95% CI 0.99 to 3.98) for patients with both CVD and CKD and was over 4 times greater (HR = 4.33, 95% CI 1.76 to 10.68) for patients with CVD, CKD and anaemia. CONCLUSION: In patients with cardiovascular disease in the community, chronic kidney disease and anaemia occur commonly. The presence of chronic kidney disease carries an increased mortality risk which increases in an additive way with the addition of anaemia. These results suggest that early primary care diagnosis and management of this high risk group may be worthwhile.

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

NARCIS (Netherlands)

Apers, Silke; Kovacs, Adrienne H.; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C.; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M.; Jackson, Jamie L.; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A.; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip; Maisuls, Héctor; Cabrera, Marcelo; Eaton, Sarah; Larion, Ruth; FengWang, Qi; van Deyk, Kristien; Goossens, Eva; Rassart, Jessica; Mackie, Andrew; Ballantyne, Ross; Rankin, Kathryn; Norris, Colleen; Taylor, Dylan; Vondermuhll, Isabelle; Windram, Jonathan; Heggie, Pamela; Lasiuk, Gerri; Proietti, Anna; Dore, Annie; Mercier, Lise-Andrée; Mongeon, François-Pierre; Marcotte, François; Mulder, Barbara

2015-01-01

Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research

Tissue-type plasminogen activator and C-reactive protein in acute coronary heart disease. A nested case-control study

DEFF Research Database (Denmark)

Gram, J; Bladbjerg, E-M; Møller, L

2000-01-01

OBJECTIVES: To study the importance of inflammation and fibrinolysis for evolution of ischaemic heart disease in a cohort of initially healthy subjects. DESIGN: Nested case-control study. Follow-up periods 7-15 years. SUBJECTS: Included in the study were 133 cases with coronary heart disease...... and 258 controls. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Subjects with ischaemic heart disease identified in 1991 by the Danish National Hospital Register. Protein concentration of C-reactive protein (CRP) and tissue-type plasminogen activator (t-PA) were measured with ELISA methods in stored serum.......005) and it was present in both the 7-9 years follow-up cohort (CRP: P = 0.014; t-PA: P = 0.001) and the 15 years follow-up cohort (CRP: P = 0.027; t-PA: P = 0.012). The best predictor of CRP was t-PA, whilst the best predictor of t-PA was triglycerides. In a logistic regression analysis model, t-PA still came out...

Small mammal populations in zoonotic disease and toxicological studies

International Nuclear Information System (INIS)

Muul, I.

1978-01-01

Examples of zoonotic diseases are discussed in relation to their distribution in mammalian hosts. Various ecological factors influence disease distribution patterns so that only a certain portion of the mammalian populations are subject to infections. Emphasis was placed on some of these ecological factors in studying the mainstream of infections in endemic hosts and vectors. This approach might be called medical ecology and would be supplemental to epidemiological studies which characteristically emphasize human involvement in zoonotic disease transmission. For example, occurrence in certain habitats and vertical distribution within forest habitats predisposed various mammalian species to infections. Arboreal species did not have scrub typhus infections while terrestrial species had high infection rates. Malaria parasites were common in arboreal mammals but uncommon in terrestrial species. Additionally, disease surveys in the absence of population data pertaining to potential host species sometimes yield misleading results, especially if age structure within populations changes through time. In field studies use of sentinel animals of known immunological history provide valuable supplemental information to surveys of free living animals which may have been infected at some unknown time in the past. As many different species should be studied as is practical since some species may not be susceptible to certain diseases under study. In laboratory studies, inclusion of non-standard mammals may provide opportunities to culture disease organisms which do not proliferate in standard laboratory species, or to replace diminishing resources of such species as primates

Cryostat design case studies, principles and engineering

CERN Document Server

2016-01-01

This book enables the reader to learn the fundamental and applied aspects of practical cryostat design by examining previous design choices and resulting cryostat performance. Through a series of extended case studies the book presents an overview of existing cryostat design covering a wide range of cryostat types and applications, including the magnet cryostats that comprise the majority of the Large Hadron Collider at CERN, space-borne cryostats containing sensors operating below 1 K, and large cryogenic liquid storage vessels. It starts with an introductory section on the principles of cryostat design including practical data and equations. This section is followed by a series of case studies on existing cryostats, describing the specific requirements of the cryostat, the challenges involved and the design choices made along with the resulting performance of the cryostat. The cryostat examples used in the studies are chosen to cover a broad range of cryostat applications and the authors of each case are ...

Prediction of disease and phenotype associations from genome-wide association studies.

Directory of Open Access Journals (Sweden)

Stephanie N Lewis

Full Text Available Genome wide association studies (GWAS have proven useful as a method for identifying genetic variations associated with diseases. In this study, we analyzed GWAS data for 61 diseases and phenotypes to elucidate common associations based on single nucleotide polymorphisms (SNP. The study was an expansion on a previous study on identifying disease associations via data from a single GWAS on seven diseases.Adjustments to the originally reported study included expansion of the SNP dataset using Linkage Disequilibrium (LD and refinement of the four levels of analysis to encompass SNP, SNP block, gene, and pathway level comparisons. A pair-wise comparison between diseases and phenotypes was performed at each level and the Jaccard similarity index was used to measure the degree of association between two diseases/phenotypes. Disease relatedness networks (DRNs were used to visualize our results. We saw predominant relatedness between Multiple Sclerosis, type 1 diabetes, and rheumatoid arthritis for the first three levels of analysis. Expected relatedness was also seen between lipid- and blood-related traits.The predominant associations between Multiple Sclerosis, type 1 diabetes, and rheumatoid arthritis can be validated by clinical studies. The diseases have been proposed to share a systemic inflammation phenotype that can result in progression of additional diseases in patients with one of these three diseases. We also noticed unexpected relationships between metabolic and neurological diseases at the pathway comparison level. The less significant relationships found between diseases require a more detailed literature review to determine validity of the predictions. The results from this study serve as a first step towards a better understanding of seemingly unrelated diseases and phenotypes with similar symptoms or modes of treatment.

Epigenetic Epidemiology of Complex Diseases Using Twins

DEFF Research Database (Denmark)

Tan, Qihua

2013-01-01

through multiple epigenetic mechanisms. This paper reviews the new developments in using twins to study disease-related epigenetic alterations, links them to lifetime environmental exposure with a focus on the discordant twin design and proposes novel data-analytical approaches with the aim of promoting...... a more efficient use of twins in epigenetic studies of complex human diseases....

Designs for mechanical circulatory support device studies.

Science.gov (United States)

Neaton, James D; Normand, Sharon-Lise; Gelijns, Annetine; Starling, Randall C; Mann, Douglas L; Konstam, Marvin A

2007-02-01

There is increased interest in mechanical circulatory support devices (MCSDs), such as implantable left ventricular assist devices (LVADs), as "destination" therapy for patients with advanced heart failure. Because patient availability to evaluate these devices is limited and randomized trials have been slow in enrolling patients, a workshop was convened to consider designs for MCSD development including alternatives to randomized trials. A workshop was jointly planned by the Heart Failure Society of America and the US Food and Drug Administration and was convened in March 2006. One of the panels was asked to review different designs for evaluating new MCSDs. Randomized trials have many advantages over studies with no controls or with nonrandomized concurrent or historical controls. These advantages include the elimination of bias in the assignment of treatments and the balancing, on average, of known and unknown baseline covariates that influence response. These advantages of randomization are particularly important for studies in which the treatments may not differ from one another by a large amount (eg, a head-to-head study of an approved LVAD with a new LVAD). However, researchers have found it difficult to recruit patients to randomized studies because the number of clinical sites that can carry out the studies is not large. Also, there is a reluctance to randomize patients when the control device is considered technologically inferior. Thus ways of improving the design of randomized trials were discussed, and the advantages and disadvantages of alternative designs were considered. The panel concluded that designs should include a randomized component. Randomized designs might be improved by allowing the control device to be chosen before randomization, by first conducting smaller vanguard studies, and by allowing crossovers in trials with optimal medical management controls. With use of data from completed trials, other databases, and registries, alternative

Evaluation of a clinical decision support tool for osteoporosis disease management: protocol for an interrupted time series design.

Science.gov (United States)

Kastner, Monika; Sawka, Anna; Thorpe, Kevin; Chignel, Mark; Marquez, Christine; Newton, David; Straus, Sharon E

2011-07-22

Osteoporosis affects over 200 million people worldwide at a high cost to healthcare systems. Although guidelines on assessing and managing osteoporosis are available, many patients are not receiving appropriate diagnostic testing or treatment. Findings from a systematic review of osteoporosis interventions, a series of mixed-methods studies, and advice from experts in osteoporosis and human-factors engineering were used collectively to develop a multicomponent tool (targeted to family physicians and patients at risk for osteoporosis) that may support clinical decision making in osteoporosis disease management at the point of care. A three-phased approach will be used to evaluate the osteoporosis tool. In phase 1, the tool will be implemented in three family practices. It will involve ensuring optimal functioning of the tool while minimizing disruption to usual practice. In phase 2, the tool will be pilot tested in a quasi-experimental interrupted time series (ITS) design to determine if it can improve osteoporosis disease management at the point of care. Phase 3 will involve conducting a qualitative postintervention follow-up study to better understand participants' experiences and perceived utility of the tool and readiness to adopt the tool at the point of care. The osteoporosis tool has the potential to make several contributions to the development and evaluation of complex, chronic disease interventions, such as the inclusion of an implementation strategy prior to conducting an evaluation study. Anticipated benefits of the tool may be to increase awareness for patients about osteoporosis and its associated risks and provide an opportunity to discuss a management plan with their physician, which may all facilitate patient self-management.

Alternative Design Study Report: WindPACT Advanced Wind Turbine Drive Train Designs Study; November 1, 2000 -- February 28, 2002

Energy Technology Data Exchange (ETDEWEB)

Poore, R.; Lettenmaier, T.

2003-08-01

This report presents the Phase I results of the National Renewable Energy Laboratory's (NREL's) WindPACT (Wind Partnership for Advanced Component Technologies) Advanced Wind Turbine Drive Train Designs Study. Global Energy Concepts, LLC performed this work under a subcontract with NREL. The purpose of the WindPACT project is to identify technology improvements that will enable the cost of energy (COE) from wind turbines to be reduced. Other parts of the WindPACT project have examined blade and logistics scaling, balance-of-station costs, and rotor design. This study was designed to investigate innovative drive train designs.

Effects of interactive metronome training on postural stability and upper extremity function in Parkinson’s disease: a case study

Science.gov (United States)

Kim, Arim; Lee, Hye-Sun; Song, Chiang-Soon

2017-01-01

[Purpose] The purpose of this study was to examine the effects of interactive metronome training on the postural stability and upper extremity function of an individual with Parkinson’s disease. [Subject and Methods] The participant of this case study was a 75-year-old female with Parkinson’s disease diagnosed 7 years prior. This study was a single-subject research with an A-B-A design. She received IM training during the treatment phase (B phase) for 40 minutes per session. She was assessed pretest and posttest using the Berg balance scale and Wolf motor function test, and at baseline and the treatment phase using the measured box-and-block test and a Tetrax system. [Results] After training, the patient’s static and dynamic balance, functional activity, and performance time of the upper extremity improved. Interactive metronome therapy improved the manual dexterity of both hands. Interactive metronome therapy also improved the limit of stability of the Parkinson’s disease. [Conclusion] Though a case study, the results of this study suggest that IM therapy is effective at restoring the postural stability and upper extremity function of patients with Parkinson’s disease. PMID:28210066

Coronary heart disease mortality after irradiation for Hodgkin's disease

International Nuclear Information System (INIS)

Boivin, J.F.; Hutchison, G.B.

1982-01-01

The authors conducted a study designed to evaluate the hypothesis that irradiation to the heart in the treatment for Hodgkin's disease (HD) is associated with increased coronary heart disease (CHD) mortality. This report describes 957 patients diagnosed with HD in 1942-75 and analyzes follow-up findings through December 1977. Twenty-five coronary heart disease deaths have been observed, and 4258.2 person-years of experience at risk have been accrued. The relative death rate (RDR), defined as the CHD mortality for heart-irradiated subjects divided by the mortality for nonirradiated subjects, was estimated. After adjustment for the effect of interval of observation, age, stage, and class, the RDR estimate is 1.5 but does not differ significantly from unit

280 GHz Gyro-BWO design study: Final report

International Nuclear Information System (INIS)

1988-07-01

This report summarizes the results of a design study of a 280 GHz Gyro-BWO tunable source. The purpose of this study is to identify and propose viable design alternatives for any significant technological risk associated with building an operational BWO system. The tunable Gyro-BWO system will have three major components: a Gyro-BWO microwave tube, a superconducting magnet, and a power supply/modulator. The design tasks for this study in order of decreasing importance are: design and specification of the superconducting magnet; preliminary design and layout of a Gyro-BWO microwave tube; and specification for the power supply/modulator. 2 refs., 4 figs

A quantitative analysis of statistical power identifies obesity end points for improved in vivo preclinical study design.

Science.gov (United States)

Selimkhanov, J; Thompson, W C; Guo, J; Hall, K D; Musante, C J

2017-08-01

The design of well-powered in vivo preclinical studies is a key element in building the knowledge of disease physiology for the purpose of identifying and effectively testing potential antiobesity drug targets. However, as a result of the complexity of the obese phenotype, there is limited understanding of the variability within and between study animals of macroscopic end points such as food intake and body composition. This, combined with limitations inherent in the measurement of certain end points, presents challenges to study design that can have significant consequences for an antiobesity program. Here, we analyze a large, longitudinal study of mouse food intake and body composition during diet perturbation to quantify the variability and interaction of the key metabolic end points. To demonstrate how conclusions can change as a function of study size, we show that a simulated preclinical study properly powered for one end point may lead to false conclusions based on secondary end points. We then propose the guidelines for end point selection and study size estimation under different conditions to facilitate proper power calculation for a more successful in vivo study design.

Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings

Directory of Open Access Journals (Sweden)

Willich Stefan N

2009-06-01

Full Text Available Abstract Background Many children with chronic disease use complementary therapies. Anthroposophic treatment for paediatric chronic disease is provided by physicians and differs from conventional treatment in the use of special therapies (art therapy, eurythmy movement exercises, rhythmical massage therapy and special medications. We studied clinical outcomes in children with chronic diseases under anthroposophic treatment in routine outpatient settings. Methods In conjunction with a health benefit program, consecutive outpatients starting anthroposophic treatment for any chronic disease participated in a prospective cohort study. Main outcome was disease severity (Disease and Symptom Scores, physicians' and caregivers' assessment on numerical rating scales 0–10. Disease Score was documented after 0, 6, and 12 months, Symptom Score after 0, 3, 6, 12, 18, and 24 months. Results A total of 435 patients were included. Mean age was 8.2 years (standard deviation 3.3, range 1.0–16.9 years. Most common indications were mental disorders (46.2% of patients; primarily hyperkinetic, emotional, and developmental disorders, respiratory disorders (14.0%, and neurological disorders (5.7%. Median disease duration at baseline was 3.0 years (interquartile range 1.0–5.0 years. The anthroposophic treatment modalities used were medications (69.2% of patients, eurythmy therapy (54.7%, art therapy (11.3%, and rhythmical massage therapy (6.7%. Median number of eurythmy/art/massage therapy sessions was 12 (interquartile range 10–20, median therapy duration was 118 days (interquartile range 78–189 days. From baseline to six-month follow-up, Disease Score improved by average 3.00 points (95% confidence interval 2.76–3.24 points, p Conclusion Children under anthroposophic treatment had long-term improvement of chronic disease symptoms. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study

Computed tomography study of Alzheimer's disease

Energy Technology Data Exchange (ETDEWEB)

Arai, H; Kobayashi, K; Ikeda, Y; Nagao, Y; Ogihara, R; Kosaka, K

1983-01-01

Computed tomography (CT) was used to study cerebral atrophy in 18 patients with clinically diagnosed Alzheimer's disease of presenile type and in 14 healthy age-matched subjects as controls. Using the computerized planimetric method, Subarachnoid Space Volume Index and Ventricle Volume Index were calculated as the measure of cortical atrophy and ventricular dilatation respectively. From the results the following conclusions were drawn: 1. The cerebral atrophy in Alzheimer patients could be attributable to the disease processes rather than to physiological aging of the brain. 2. The degree of atrophy increases in parallel with the progress of the clinical stage, and the cortical atrophy is already apparent at an early stage, whereas the ventricular dilatation becomes pronounced at later stages. 3. CT could be one of the most useful clinical tests available for the diagnosis of Alzheimer's disease.

A framework for investigating geographical variation in diseases, based on a study of Legionnaires' disease.

Science.gov (United States)

Bhopal, R S

1991-11-01

Demonstration of geographical variations in disease can yield powerful insight into the disease pathway, particularly for environmentally acquired conditions, but only if the many problems of data interpretation can be solved. This paper presents the framework, methods and principles guiding a study of the geographical epidemiology of Legionnaires' Disease in Scotland. A case-list was constructed and disease incidence rates were calculated by geographical area; these showed variation. Five categories of explanation for the variation were identified: short-term fluctuations of incidence in time masquerading as differences by place; artefact; and differences in host-susceptibility, agent virulence, or environment. The methods used to study these explanations, excepting agent virulence, are described, with an emphasis on the use of previously existing data to test hypotheses. Examples include the use of mortality, census and hospital morbidity data to assess the artefact and host-susceptibility explanations; and the use of ratios of serology tests to disease to examine the differential testing hypothesis. The reasoning and process by which the environmental focus of the study was narrowed and the technique for relating the geographical pattern of disease to the putative source are outlined. This framework allows the researcher to plan for the parallel collection of the data necessary both to demonstrate geographical variation and to point to the likely explanation.

Common Periodontal Diseases of Children and Adolescents

OpenAIRE

Hayat Al-Ghutaimel; Hisham Riba; Salem Al-Kahtani; Saad Al-Duhaimi

2014-01-01

Background. Since 2000, studies, experiments, and clinical observations revealed high prevalence of periodontal diseases among children and adolescents. Therefore, this paper was designed to provide an update for dental practitioners on epidemiology, microbiology, pathology, prevention, diagnosis, and treatment of periodontal diseases in children and adolescents. Methods. This paper reviews the current literature concerning periodontal diseases in pediatric dentistry. It includes MEDLINE data...

The oral-systemic disease connection: a retrospective study.

Science.gov (United States)

Joseph, Bobby K; Kullman, Leif; Sharma, Prem N

2016-11-01

The study aimed at determining the association between oral disease and systemic health based on panoramic radiographs and general health of patients treated at Kuwait University Dental Center. The objective was to determine whether individuals exhibiting good oral health have lower propensity to systemic diseases. A total of 1000 adult patients treated at Kuwait University Dental Center were randomly selected from the patient's records. The general health of patients was assessed from the medical history of each patient recorded during their visit to the clinic. The number of reported diseases and serious symptoms were used to develop a medical index. The oral health of these patients was assessed from panoramic radiographs to create an oral index by evaluating such parameters as caries, periodontitis, periapical lesions, pericoronitis, and tooth loss. In a total of 887 patients, 43.8 % had an oral index between 3 and 8, of which significantly higher (62.1 %) patients were with medical conditions compared to those without (33.2 %; p relationship when the diagnosis of oral disease was based primarily on radiographic findings. Future research needs to include prospective clinical and interventional studies. The significance of the oral-systemic disease connection highlights the importance of preventing and treating oral disease which have profound medical implications on general health.

Schematic representation of case study research designs.

Science.gov (United States)

Rosenberg, John P; Yates, Patsy M

2007-11-01

The paper is a report of a study to demonstrate how the use of schematics can provide procedural clarity and promote rigour in the conduct of case study research. Case study research is a methodologically flexible approach to research design that focuses on a particular case - whether an individual, a collective or a phenomenon of interest. It is known as the 'study of the particular' for its thorough investigation of particular, real-life situations and is gaining increased attention in nursing and social research. However, the methodological flexibility it offers can leave the novice researcher uncertain of suitable procedural steps required to ensure methodological rigour. This article provides a real example of a case study research design that utilizes schematic representation drawn from a doctoral study of the integration of health promotion principles and practices into a palliative care organization. The issues discussed are: (1) the definition and application of case study research design; (2) the application of schematics in research; (3) the procedural steps and their contribution to the maintenance of rigour; and (4) the benefits and risks of schematics in case study research. The inclusion of visual representations of design with accompanying explanatory text is recommended in reporting case study research methods.

Tobacco use among designated air pollution victims and its association with lung function and respiratory symptoms: a retrospective cross-sectional study

OpenAIRE

Kotaki, Kenji; Senjyu, Hideaki; Tanaka, Takako; Yano, Yudai; Miyamoto, Naomi; Nishinakagawa, Tsuyoshi; Yanagita, Yorihide; Asai, Masaharu; Kozu, Ryo; Tabusadani, Mitsuru; Sawai, Terumitsu; Honda, Sumihisa

2014-01-01

Objectives: We sought to elucidate the long-term association of tobacco use and respiratory health in designated pollution victims with and without obstructive pulmonary defects. Design: A retrospective cross-sectional study. Setting: The register of pollution victims in Kurashiki, Japan. Participants: 730 individuals over 65 years of age previously diagnosed with pollution-related respiratory disease. Patients were classified into four groups according to their smoking status and whether the...

Nuclear-Powered GPS Spacecraft Design Study

Energy Technology Data Exchange (ETDEWEB)

Raab, Bernard

1977-05-01

This is the final report of a study to investigate the potential benefits of a nuclear (radioisotope) - powered satellite for advanced phases of the Global Positioning System (GPS) program. The critical parameters were: power to user; mean mission duration; orbital predictability; thermal control of on-board frequency standards; and vulnerability. The reference design approach is described, and input data are given for two power systems that are under development: an organic Rankine system and a Brayton cycle system. Reference design details are provided and structural design and analysis are discussed, as well as thermal design and analysis. A higher altitude version is also considered.

Mobile Variable Depth Sampling System Design Study

International Nuclear Information System (INIS)

BOGER, R.M.

2000-01-01

A design study is presented for a mobile, variable depth sampling system (MVDSS) that will support the treatment and immobilization of Hanford LAW and HLW. The sampler can be deployed in a 4-inch tank riser and has a design that is based on requirements identified in the Level 2 Specification (latest revision). The waste feed sequence for the MVDSS is based on Phase 1, Case 3S6 waste feed sequence. Technical information is also presented that supports the design study

Mobile Variable Depth Sampling System Design Study

Energy Technology Data Exchange (ETDEWEB)

BOGER, R.M.

2000-08-25

A design study is presented for a mobile, variable depth sampling system (MVDSS) that will support the treatment and immobilization of Hanford LAW and HLW. The sampler can be deployed in a 4-inch tank riser and has a design that is based on requirements identified in the Level 2 Specification (latest revision). The waste feed sequence for the MVDSS is based on Phase 1, Case 3S6 waste feed sequence. Technical information is also presented that supports the design study.

The nutritional geometry of liver disease including non-alcoholic fatty liver disease.

Science.gov (United States)

Simpson, Stephen J; Raubenheimer, David; Cogger, Victoria C; Macia, Laurence; Solon-Biet, Samantha M; Le Couteur, David G; George, Jacob

2018-02-01

Nutrition has a profound effect on chronic liver disease, especially non-alcoholic fatty liver disease (NAFLD). Most observational studies and clinical trials have focussed on the effects of total energy intake, or the intake of individual macronutrients and certain micronutrients, such as vitamin D, on liver disease. Although these studies have shown the importance of nutrition on hepatic outcomes, there is not yet any unifying framework for understanding the relationship between diet and liver disease. The Geometric Framework for Nutrition (GFN) is an innovative model for designing nutritional experiments or interpreting nutritional data that can determine the effects of nutrients and their interactions on animal behaviour and phenotypes. Recently the GFN has provided insights into the relationship between dietary energy and macronutrients on obesity and ageing in mammals including humans. Mouse studies using the GFN have disentangled the effects of macronutrients on fatty liver and the gut microbiome. The GFN is likely to play a significant role in disentangling the effects of nutrients on liver disease, especially NAFLD, in humans. Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Clinic-cytologic study of conjunctivochalasis and its relation to thyroid autoimmune diseases: prospective cohort study.

Science.gov (United States)

de Almeida, Sandra Flavia Fiorentini; de Sousa, Luciene B; Vieira, Luis A; Chiamollera, Maria I; Barros, Jeison de N

2006-08-01

To determine the prevalence of conjunctivochalasis in patients with immune thyroid diseases, to determine whether there is any association between the 2 diseases, and to determine cytologic study of conjunctivochalasis through the cytology impression test. A clinical prospective cohort study carried out by the External Diseases Department in the Ophthalmology Sector and the Thyroid Department in the Endocrinology Sector at Federal University of Sao Paulo (UNIFESP). The patients included were divided into 2 groups following these inclusion criteria: a control group of 25 patients without thyroid diseases, confirmed after clinical and laboratory examinations (thyroid hormones), or any other ocular diseases. The study group consisted of 31 patients with thyroid diseases, the diagnosis of which was confirmed by the Endocrinology Sector. The thyroidopathies included were autoimmune diseases but excluded nonautoimmune diseases. A protocol endorsed by the UNIFESP was followed, using clinical and ophthalmological history, biomicroscopy, and impression cytology. Fifty-two percent of patients without thyroid diseases and 88% of patients with thyroid diseases presented with conjunctivochalasis. The risk ratio was 1.705 (Pr > chi(2) = 0.0038), indicating that there is an association between them. For the impression cytology in inferior bulbar conjunctiva, there was an association between the result of the impression cytology and conjunctivochalasis (Pearson chi(2) = 10.1190 Pr = 0.006). The prevalence of conjunctivochalasis in patients with autoimmune thyroid diseases was 88%. Patients with autoimmune thyroidopathy presented higher percentages of conjunctivochalasis than the control group, confirming the association between them. The cytologic study showed the highest prevalence of abnormal surface features in eyes with conjunctivochalasis.

Lyme disease in children in southeastern Connecticut. Pediatric Lyme Disease Study Group.

Science.gov (United States)

Gerber, M A; Shapiro, E D; Burke, G S; Parcells, V J; Bell, G L

1996-10-24

Although the incidence of Lyme disease is highest in children, there are few prospective data on the clinical manifestations and outcomes in children. We conducted a prospective, longitudinal, community-based cohort study of children with newly diagnosed Lyme disease in an area of Connecticut in which the disease is highly endemic. We obtained clinical and demographic information and performed serial antibody tests and follow-up evaluations. Over a period of 20 months, 201 consecutive patients were enrolled; their median age was 7 years (range, 1 to 21). The initial clinical manifestations of Lyme disease were a single erythema migrans lesion in 66 percent, multiple erythema migrans lesions in 23 percent, arthritis in 6 percent, facial-nerve palsy in 3 percent, aseptic meningitis in 2 percent, and carditis in 0.5 percent. At presentation, 37 percent of the patients with a single erythema migrans lesion and 89 percent of those with multiple erythema migrans lesions had antibodies against Borrelia burgdorferi. All but 3 of the 201 patients were treated for two to four weeks with conventional antimicrobial therapy, which was administered orally in 96 percent. All had prompt clinical responses. After four weeks, 94 percent were completely asymptomatic (including the two patients whose parents had refused to allow antimicrobial treatment). At follow-up a mean of 25.4 months later, none of the patients had evidence of either chronic or recurrent Lyme disease. Six patients subsequently had a new episode of erythema migrans. About 90 percent of children with Lyme disease present with erythema migrans, which is an early stage of the disease. The prognosis is excellent for those with early Lyme disease who are treated promptly with conventional courses of antimicrobial agents.

Prognostic factors of pemphigus vulgaris disease: a study on 119 patients

Directory of Open Access Journals (Sweden)

Halaji Z

2009-03-01

Full Text Available "nBackground: Since the systemic steroids are introduced in Pemphigus Vulgaris treatment, the prognosis of disease improved significantly. This study was designed to evaluate determining factors in the prognosis of pemphigus vulgaris in Iranian patients. "nMethods: In this study, 119 patients with documented pemphigus vulgaris who had presented to Razi Hospital from 2001 until 2003 were included. These patients had presented for the first time and treated with prednisolone and Azathioprine. Morality rate, minor and major relapses and duration of first remission had been defined as prognostic criteria and correlation between them and other demographic variables and disease characteristics were investigated. "nResults: The majority of patients (84.1% were followed for more than one year. The major recurrence and minor recurrence occurred in 28(23.5% and 65(54.6% of patients respectively, no case of mortality was observed. In patients who received treatment six months or less after onset of disease the frequency of major recurrence was less than the others. 18(17.8% vs. 12(41.4%, (p=0.009. Duration of primary remission more than one year was detected in most of the patients (64.7%. In patients with less than 10 initial cutaneous lesions, period of primary remission was longer than the other patients. (p=0.009. Shorter duration of primary remission were noted in older patients (age>50 in comparison with younger patients (age≤50, p=0.04. "nConclusions: Male gender, old age, interval more than 6 months between onsets of symptoms to initial treatment and more than 10 skin lesions on admission, are associated with poor prognosis of pemphigus vulgaris.

Design Study for A Low-Cost LH2 Turbopump

Science.gov (United States)

Japikse, David; Baines, Nicholas; Platt, Michael J.

2000-01-01

A preliminary design study, focusing on potential component selections and design for manufacturing and assembly (DFMAR1) analysis, is presented in this study. The investigation focused on a nominal cost liquid hydrogen turbopump suitable for a private launch class vehicle. Utilizing a "turbocharger-like" design philosophy, preliminary feasibility studies of the basic pump design class, the rotordynamic design class, and the turbine design class were conducted with associated DFMA evaluations. Reasonable cost levels and sensible levels of product assurance have been established.

The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design.

Science.gov (United States)

Talboom-Kamp, Esther Pwa; Verdijk, Noortje A; Kasteleyn, Marise J; Harmans, Lara M; Talboom, Irvin Jsh; Looijmans-van den Akker, Ingrid; van Geloven, Nan; Numans, Mattijs E; Chavannes, Niels H

2017-08-16

Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes. The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ). The parallel cohort design includes 3 levels of integration in IDM (groups 1, 2, 3) and randomization of 2 levels of personal assistance for patients (group A, high assistance, group B, low assistance). Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data. Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (-0.47% per month) and after the intervention (-0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945). The e-Vita eHealth-supported COPD

A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease

DEFF Research Database (Denmark)

Hjermind, Lena Elisabeth

2013-01-01

BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect of latrepir......BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect...... of latrepirdine on cognition and global function in patients with mild to moderate Huntington disease. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Sixty-four research centers in Australia, Europe, and North America. PATIENTS Four hundred three patients with mild to moderate Huntington...... between those randomized to latrepirdine (68.5%) and placebo (68.0%). CONCLUSION In patients with mild to moderate Huntington disease and cognitive impairment, treatment with latrepirdine for 6 months was safe and well tolerated but did not improve cognition or global function relative to placebo. TRIAL...

Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study

DEFF Research Database (Denmark)

Friis-Møller, Nina; Weber, Rainer; Reiss, Peter

2003-01-01

OBJECTIVE: To determine the prevalence of risk factors for cardiovascular disease (CVD) among HIV-infected persons, and to investigate any association between such risk factors, stage of HIV disease, and use of antiretroviral therapies. DESIGN: Baseline data from 17,852 subjects enrolled in DAD, ...

The Evonik-Mainz-Eye-Care-Study (EMECS: design and execution of the screening investigation.

Directory of Open Access Journals (Sweden)

Lorenz Barleon

Full Text Available To determine if screening for major ophthalmological diseases is feasible within the frame of routine occupational medicine examinations in a large working population.13037 employees of Evonik Industries aged 40 to 65 years were invited to be screened for major ophthalmological diseases (glaucoma, age related macular degeneration and diabetic retinopathy between June 2007 and March 2008 within an extended setting of occupational medicine. Ophthalmological examinations consisted of visual acuity, objective refraction, pachymetry, tonometry, perimetry (frequency doubling technology, confocal scanning laser ophthalmoscopy and digital fundus photography. Participants responded to a questionnaire addressing history of ocular and general diseases and social history.4183 participants (961 female and 3222 male were examined at 13 different sites. Response rates for eligible persons at those sites ranged from 17.9 to 60.5% but were in part limited by availability of examination slots. Average age of participants was 48.4 ± 5.4 years (mean ± SD. 4147 out of 4183 subjects (99.1% had a visual acuity ≥ 0.5 in the better eye and 3665 out of 4183 (87.6% subjects had a visual acuity ≥ 0.8 in the better eye. 1629 participants (38.9% had previously not been seen by an ophthalmologist at all or not within the last three years.This article describes the study design and basic characteristics of study participants within a large occupational medicine based screening study for ophthalmological diseases. Response rates exceeded expectations and were limiting examination capacity. Meaningful data could be obtained for almost all participants. We reached participants who previously had not received ophthalmic care. Thus, ophthalmological screening appears to be feasible within the frame of routine occupational medicine examinations.

Disease activity in pregnant women with Crohn's disease and birth outcomes: a regional Danish cohort study

DEFF Research Database (Denmark)

Nørgård, Bente; Hundborg, Heidi H; Jacobsen, Bent Ascanius

2007-01-01

OBJECTIVES: CD is associated with increased risk of adverse birth outcomes, but existing studies have not assessed the impact of disease activity during pregnancy. We examined the impact of disease activity on birth outcomes: LBW, preterm birth, LBW at term, and CAs. METHODS: All births by CD wom...... disease activity). Further research is needed to assess the critical impact of disease activity in larger cohorts of CD women....

Conceptual Design of Haptic-Feedback Navigation Device for Individuals with Alzheimer's Disease.

Science.gov (United States)

Che Me, Rosalam; Biamonti, Alessandro; Mohd Saad, Mohd Rashid

2015-01-01

Wayfinding ability in older adults with Alzheimer's disease (AD) is progressively impaired due to ageing and deterioration of cognitive domains. Usually, the sense of direction is deteriorated as visuospatial and spatial cognition are associated with the sensory acuity. Therefore, navigation systems that support only visual interactions may not be appropriate in case of AD. This paper presents a concept of wearable navigation device that integrates the haptic-feedback technology to facilitate the wayfinding of individuals with AD. The system provides the simplest instructions; left/right using haptic signals, as to avoid users' distraction during navigation. The advantages of haptic/tactile modality for wayfinding purpose based on several significant studies are presented. As preliminary assessment, a survey is conducted to understand the potential of this design concept in terms of (1) acceptability, (2) practicality, (3) wearability, and (4) environmental settings. Results indicate that the concept is highly acceptable and commercially implementable. A working prototype will be developed based on the results of the preliminary assessment. Introducing a new method of navigation should be followed by continuous practices for familiarization purpose. Improved navigability allows the good performance of activities of daily living (ADLs) hence maintain the good quality of life in older adults with AD.

Preventing and controlling foodborne disease in commercial and institutional food service settings: a systematic review of published intervention studies.

Science.gov (United States)

Viator, Catherine; Blitstein, Jonathan; Brophy, Jenna E; Fraser, Angela

2015-02-01

This study reviews the current literature on behavioral and environmental food safety interventions conducted in commercial and institutional food service settings. A systematic search of the published literature yielded 268 candidate articles, from which a set of 23 articles reporting intervention outcomes was retained for evaluation. A categorization of measured outcomes is reported; studies addressed multiple outcomes ranging from knowledge, attitudes, and behavior of personal hygiene and food safety to management practices and disease rates and outbreaks. This study also investigates the quality of reported research methods used to evaluate the effectiveness of the interventions, using a nine-point quality index adapted by the authors. The observed scores suggest that there are opportunities to improve the design and reporting of research in the field of foodborne disease prevention as it applies to food safety interventions that target the food service industry. The aim is to aid researchers in this area to design higher quality studies and to produce clearer and more useful reports of their research. In turn, this can help to create a more complete evidence base that can be used to continually improve interventions in this domain.

Strategies for glucose control in a study population with diabetes, renal disease and anemia (Treat study).

Science.gov (United States)

Weinrauch, Larry A; D'Elia, John A; Finn, Peter; Lewis, Eldrin F; Desai, Akshay S; Claggett, Brian L; Cooper, Mark E; McGill, Janet B

2016-03-01

Glucose lowering medication use among patients with type 2 diabetes and advanced renal disease (eGFRrenal disease advances, most of the oral anti-diabetic agents requiring renal clearance must be reduced or discontinued. The potential for prolonged hypoglycemia, fluid/volume overload and congestive heart failure may complicate medication choices. In order to evaluate patterns of glycemia management we describe glucose lowering medication use among patients with advanced renal disease and type 2 diabetes in a large multinational outcome trial designed to focus on patients with eGFRrenal function when compared with standard populations with normal kidney function. The use of multiple oral agents, or oral agents plus insulin was quite common. While gender did not appear to play a role in medication choices, there were significant regional variations. For example, oral agents were used more in North America compared with other regions (Latin America, Australia/Western Europe, Russia/Eastern Europe). Patients enrolled at more advanced ages were less likely to be on a regimen of rapid-acting insulin alone consistent with recommendations that suggest a preference for longer-acting preparations in the geriatric population (1). Higher degrees of obesity were associated more complex treatment regimens. Despite this population being at high risk for cardiovascular events, the use of beta blockers (50%), statins (64%) and aspirin (48%) were relatively low, especially in the group that did not require medications to achieve adequate glycemic control. Current attempts to compare strategies for diabetes therapy must control for baseline demographic group differences influencing treatment choice. Future recommendations for glycemic control in patients with Grade 3 or higher chronic kidney disease require additional studies, with matched populations. We suggest that evaluation of studies similar to TREAT will assist in determining the optimal therapeutic regimens for populations

Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study

DEFF Research Database (Denmark)

Friis-Møller, Nina; Weber, Rainer; Reiss, Peter

2003-01-01

, a prospective multinational cohort study initiated in 1999. METHODS: Cross-sectional analyses of CVD risk factors at baseline. The data collected includes data on demographic variables, cigarette smoking, diabetes mellitus, hypertension, dyslipidaemia, body mass index, stage of HIV infection, antiretroviral......OBJECTIVE: To determine the prevalence of risk factors for cardiovascular disease (CVD) among HIV-infected persons, and to investigate any association between such risk factors, stage of HIV disease, and use of antiretroviral therapies. DESIGN: Baseline data from 17,852 subjects enrolled in DAD...... therapy. RESULTS: Almost 25% of the study population were at an age where there is an appreciable risk of CVD, with those receiving a protease inhibitor (PI) and/or non-nucleoside reverse transcriptase inhibitor (NNRTI) tending to be older. 1.4% had a previous history of CVD and 51.5% were cigarette...

Heart diseases and long-term risk of dementia and Alzheimer's disease: a population-based CAIDE study.

Science.gov (United States)

Rusanen, Minna; Kivipelto, Miia; Levälahti, Esko; Laatikainen, Tiina; Tuomilehto, Jaakko; Soininen, Hilkka; Ngandu, Tiia

2014-01-01

Many cardiovascular risk factors are shown to increase the risk of dementia and Alzheimer's disease (AD), but the impact of heart disease on later development of dementia is still unclear. The aim of the study was to investigate the long-term risk of dementia and Alzheimer's disease (AD) related to midlife and late-life atrial fibrillation (AF), heart failure (HF), and coronary artery disease (CAD) in a population-based study with a follow-up of over 25 years. Cardiovascular Risk Factors, Aging and Dementia (CAIDE) study includes 2000 participants who were randomly selected from four separate, population-based samples originally studied in midlife (1972, 1977, 1982, or 1987). Re-examinations were carried out in 1998 and 2005-2008. Altogether 1,510 (75.5%) persons participated in at least one re-examination, and 127 (8.4%) persons were diagnosed with dementia (of which 102 had AD). AF in late-life was an independent risk factor for dementia (HR 2.61, 95% CI 1.05-6.47; p = 0.039) and AD (HR 2.54, 95% CI 1.04-6.16; p = 0.040) in the fully adjusted analyses. The association was even stronger among the apolipoprotein E (APOE) ε4 non-carriers. Late-life HF, but not CAD, tended to increase the risks as well. Heart diseases diagnosed at midlife did not increase the risk of later dementia and AD. Late-life heart diseases increase the subsequent risk of dementia and AD. Prevention and effective treatment of heart diseases may be important also from the perspective of brain health and cognitive functioning.

A national prospective study on childhood celiac disease in the Netherlands 1993-2000: an increasing recognition and a changing clinical picture

NARCIS (Netherlands)

Steens, R.F.; Csizmadia, C.G.; George, E.K.; Ninaber, M.K.; Hira Sing, R.A.; Mearin, M.L.

2005-01-01

OBJECTIVES: To investigate prospectively whether the incidence of diagnosed celiac disease (CD) is increasing in the Netherlands and whether the clinical presentation is changing. STUDY DESIGN: All newly diagnosed cases of CD throughout the Netherlands were registered prospectively from 1993 to

Large-scale identification of clinical and genetic predictors of motor progression in patients with newly diagnosed Parkinson's disease: a longitudinal cohort study and validation.

Science.gov (United States)

Latourelle, Jeanne C; Beste, Michael T; Hadzi, Tiffany C; Miller, Robert E; Oppenheim, Jacob N; Valko, Matthew P; Wuest, Diane M; Church, Bruce W; Khalil, Iya G; Hayete, Boris; Venuto, Charles S

2017-11-01

Better understanding and prediction of progression of Parkinson's disease could improve disease management and clinical trial design. We aimed to use longitudinal clinical, molecular, and genetic data to develop predictive models, compare potential biomarkers, and identify novel predictors for motor progression in Parkinson's disease. We also sought to assess the use of these models in the design of treatment trials in Parkinson's disease. A Bayesian multivariate predictive inference platform was applied to data from the Parkinson's Progression Markers Initiative (PPMI) study (NCT01141023). We used genetic data and baseline molecular and clinical variables from patients with Parkinson's disease and healthy controls to construct an ensemble of models to predict the annual rate of change in combined scores from the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II and III. We tested our overall explanatory power, as assessed by the coefficient of determination (R 2 ), and replicated novel findings in an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson's disease (LABS-PD; NCT00605163). The potential utility of these models for clinical trial design was quantified by comparing simulated randomised placebo-controlled trials within the out-of-sample LABS-PD cohort. 117 healthy controls and 312 patients with Parkinson's disease from the PPMI study were available for analysis, and 317 patients with Parkinson's disease from LABS-PD were available for validation. Our model ensemble showed strong performance within the PPMI cohort (five-fold cross-validated R 2 41%, 95% CI 35-47) and significant-albeit reduced-performance in the LABS-PD cohort (R 2 9%, 95% CI 4-16). Individual predictive features identified from PPMI data were confirmed in the LABS-PD cohort. These included significant replication of higher baseline MDS-UPDRS motor score, male sex, and increased age, as well as a novel Parkinson's disease

Designing Mobile Health Technology for Bipolar Disorder

DEFF Research Database (Denmark)

Bardram, JE; Frost, Mads; Szántó, Károly

2013-01-01

usefulness of the system was high. Based on this study, the paper discusses three HCI questions related to the design of personal health technologies; how to design for disease awareness and self-treatment, how to ensure adherence to personal health technologies, and the roles of different types...

Stressors of School-age Children With Allergic Diseases: A Qualitative Study.

Science.gov (United States)

Iio, Misa; Hamaguchi, Mana; Nagata, Mayumi; Yoshida, Koichi

2018-05-08

Most studies of stress in children with chronic diseases have been geared toward parents and caregivers have not considered allergic diseases together. This study aimed to identify the stressors associated with allergic diseases in Japanese school-age children. Stressors associated with allergic diseases of 11 school-age children (seven boys and four girls; age range: 9-12 years) were investigated using semi-structured interviews. In the qualitative thematic analysis of stressors about allergic diseases, two themes: allergic disease-specific stressors and common stressors in chronic diseases, and 12 categories were identified. A thematic map was applied to four domains of stressor: physiological factors, psychological factors, social factors, and environmental factors. The results showed that school-age children with allergic diseases have a variety of stressors. Future studies should aim to develop an allergic disease-specific stress management program with school-age children. In children with allergic diseases, not only is stress management in daily life important, but also stress management for disease-specific matters to control the symptoms and maintain mental health. Stress management should be supported for school-age children with allergic diseases. Copyright © 2018 Elsevier Inc. All rights reserved.

Paired split-plot designs of multireader multicase studies.

Science.gov (United States)

Chen, Weijie; Gong, Qi; Gallas, Brandon D

2018-07-01

The widely used multireader multicase ROC study design for comparing imaging modalities is the fully crossed (FC) design: every reader reads every case of both modalities. We investigate paired split-plot (PSP) designs that may allow for reduced cost and increased flexibility compared with the FC design. In the PSP design, case images from two modalities are read by the same readers, thereby the readings are paired across modalities. However, within each modality, not every reader reads every case. Instead, both the readers and the cases are partitioned into a fixed number of groups and each group of readers reads its own group of cases-a split-plot design. Using a [Formula: see text]-statistic based variance analysis for AUC (i.e., area under the ROC curve), we show analytically that precision can be gained by the PSP design as compared with the FC design with the same number of readers and readings. Equivalently, we show that the PSP design can achieve the same statistical power as the FC design with a reduced number of readings. The trade-off for the increased precision in the PSP design is the cost of collecting a larger number of truth-verified patient cases than the FC design. This means that one can trade-off between different sources of cost and choose a least burdensome design. We provide a validation study to show the iMRMC software can be reliably used for analyzing data from both FC and PSP designs. Finally, we demonstrate the advantages of the PSP design with a reader study comparing full-field digital mammography with screen-film mammography.

Bayesian methods for the design and interpretation of clinical trials in very rare diseases

Science.gov (United States)

Hampson, Lisa V; Whitehead, John; Eleftheriou, Despina; Brogan, Paul

2014-01-01

This paper considers the design and interpretation of clinical trials comparing treatments for conditions so rare that worldwide recruitment efforts are likely to yield total sample sizes of 50 or fewer, even when patients are recruited over several years. For such studies, the sample size needed to meet a conventional frequentist power requirement is clearly infeasible. Rather, the expectation of any such trial has to be limited to the generation of an improved understanding of treatment options. We propose a Bayesian approach for the conduct of rare-disease trials comparing an experimental treatment with a control where patient responses are classified as a success or failure. A systematic elicitation from clinicians of their beliefs concerning treatment efficacy is used to establish Bayesian priors for unknown model parameters. The process of determining the prior is described, including the possibility of formally considering results from related trials. As sample sizes are small, it is possible to compute all possible posterior distributions of the two success rates. A number of allocation ratios between the two treatment groups can be considered with a view to maximising the prior probability that the trial concludes recommending the new treatment when in fact it is non-inferior to control. Consideration of the extent to which opinion can be changed, even by data from the best feasible design, can help to determine whether such a trial is worthwhile. © 2014 The Authors. Statistics in Medicine published by John Wiley & Sons, Ltd. PMID:24957522

The emerging paradigm of network medicine in the study of human disease.

Science.gov (United States)

Chan, Stephen Y; Loscalzo, Joseph

2012-07-20

The molecular pathways that govern human disease consist of molecular circuits that coalesce into complex, overlapping networks. These network pathways are presumably regulated in a coordinated fashion, but such regulation has been difficult to decipher using only reductionistic principles. The emerging paradigm of "network medicine" proposes to utilize insights garnered from network topology (eg, the static position of molecules in relation to their neighbors) as well as network dynamics (eg, the unique flux of information through the network) to understand better the pathogenic behavior of complex molecular interconnections that traditional methods fail to recognize. As methodologies evolve, network medicine has the potential to capture the molecular complexity of human disease while offering computational methods to discern how such complexity controls disease manifestations, prognosis, and therapy. This review introduces the fundamental concepts of network medicine and explores the feasibility and potential impact of network-based methods for predicting individual manifestations of human disease and designing rational therapies. Wherever possible, we emphasize the application of these principles to cardiovascular disease.

Using case-control designs for genome-wide screening for associations between genetic markers and disease susceptibility loci.

Science.gov (United States)

Yang, Q; Khoury, M J; Atkinson, M; Sun, F; Cheng, R; Flanders, W D

1999-01-01

We used a case-control design to scan the genome for any associations between genetic markers and disease susceptibility loci using the first two replicates of the Mycenaean population from the GAW11 (Problem 2) data. Using a case-control approach, we constructed a series of 2-by-3 tables for each allele of every marker on all six chromosomes. Odds ratios (ORs) and 95% confidence intervals (95% CI) were estimated for all alleles of every marker. We selected the one allele for which the estimated OR had the minimum p-value to plot in the graph. Among these selected ORs, we calculated 95% CI for those that had a p-value Mycenaean population, the case-control design identified allele number 1 of marker 24 on chromosome 1 to be associated with a disease susceptibility gene, OR = 2.10 (95% CI 1.66-2.62). Our approach failed to show any other significant association between case-control status and genetic markers. Stratified analysis on the environmental risk factor (E1) provided no further evidence of significant association other than allele 1 of marker 24 on chromosome 1. These data indicate the absence of linkage disequilibrium for markers flanking loci A, B, and C. Finally, we examined the effect of gene x environment (G x E) interaction for the identified allele. Our results provided no evidence of G x E interaction, but suggested that the environmental exposure alone was a risk factor for the disease.

Hamstring tightness and Scheuermann's disease a pilot study.

Science.gov (United States)

Fisk, J W; Baigent, M L

1981-06-01

The lateral radiographs of the dorsal spines of 20 patients presenting with mainly low back pain are studied. These patients had clinically evident loss of flexion in the low dorsal spine and very tight hamstring muscles. 85% of them showed definite evidence of previous Scheuermann's Disease. The possibility that tight hamstrings may be an important factor in the aetiology of this disease is discussed, and a further large scale study is proposed.

Community participation in disease control.

Science.gov (United States)

Bermejo, A; Bekui, A

1993-05-01

The main determinants of community participation in disease control programmes are identified and a framework with eleven variables is developed. Attention is drawn to the political background, community characteristics, the managerial capacity of the provider and the epidemiology of the disease. The framework is designed to guide health professionals in the systematic assessment and monitoring of participation in disease control programmes. Analysis of the Ghanaian Guinea Worm Eradication Programme and the Nicaraguan Tuberculosis Control Programme are presented as case studies. They show that political support does not guarantee community participation in disease control programmes and stress the importance of other determinants such as commitment to PHC, intersectoral coordination, the project approach and human resources. The relevance of the epidemiology of the disease in determining what degree of community participation will be most effective is highlighted by the case studies.

Comparing Clinical Profiles in Alzheimer's Disease and Parkinson's Disease Dementia

Directory of Open Access Journals (Sweden)

Martin R. Farlow

2013-09-01

Full Text Available Background: Greater understanding of differences in baseline impairment and disease progression in patients with Alzheimer's disease (AD and Parkinson's disease dementia (PDD may improve the interpretation of drug effects and the design of future studies. Methods: This was a retrospective analysis of three randomized, double-blind rivastigmine databases (one in PDD, two in AD. Impairment on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog, Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL scale, 10-item Neuropsychiatric Inventory (NPI-10 and the ADCS-Clinical Global Impression of Change (CGIC was compared [standardized difference (Cohen's d, similar if Results: Patients with AD or PDD had similar levels of impairment on the ADAS-cog and NPI-10. Scores on the ADCS-ADL scale (standardized difference = 0.47 and the ADAS-cog memory domain (total, 0.33; items, 0.10-0.58 were higher in AD; PDD patients were more impaired in the language (0.23 and praxis (0.34 domains. AD patients receiving placebo showed greater deterioration on the ADAS-cog (0.14 and improvement on the NPI-10 (0.11 compared with patients with PDD. Conclusion: Differing patterns of impairment occur in AD and PDD.

Comparing clinical profiles in Alzheimer's disease and Parkinson's disease dementia.

Science.gov (United States)

Farlow, Martin R; Schmitt, Frederick; Aarsland, Dag; Grossberg, George T; Somogyi, Monique; Meng, Xiangyi

2013-01-01

Greater understanding of differences in baseline impairment and disease progression in patients with Alzheimer's disease (AD) and Parkinson's disease dementia (PDD) may improve the interpretation of drug effects and the design of future studies. This was a retrospective analysis of three randomized, double-blind rivastigmine databases (one in PDD, two in AD). Impairment on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, 10-item Neuropsychiatric Inventory (NPI-10) and the ADCS-Clinical Global Impression of Change (CGIC) was compared [standardized difference (Cohen's d), similar if <0.1]. Patients with AD or PDD had similar levels of impairment on the ADAS-cog and NPI-10. Scores on the ADCS-ADL scale (standardized difference = 0.47) and the ADAS-cog memory domain (total, 0.33; items, 0.10-0.58) were higher in AD; PDD patients were more impaired in the language (0.23) and praxis (0.34) domains. AD patients receiving placebo showed greater deterioration on the ADAS-cog (0.14) and improvement on the NPI-10 (0.11) compared with patients with PDD. Differing patterns of impairment occur in AD and PDD.

Controlled air incinerator conceptual design study

International Nuclear Information System (INIS)

1982-01-01

This report presents a conceptual design study for a controlled air incinerator facility for incineration of low level combustible waste at Three Mile Island Unit 2 (TMI-2). The facility design is based on the use of a Helix Process Systems controlled air incinerator. Cost estimates and associated engineering, procurement, and construction schedules are also provided. The cost estimates and schedules are presented for two incinerator facility designs, one with provisions for waste ash solidification, the other with provisions for packaging the waste ash for transport to an undefined location

Flavonoids and Reduction of Cardiovascular Disease (CVD) in Chronic Obstructive Pulmonary Disease (COPD).

Science.gov (United States)

Russo, Patrizia; Prinzi, Giulia; Lamonaca, Palma; Cardaci, Vittorio; Fini, Massimo

2018-05-13

Chronic obstructive pulmonary disease (COPD) and cardiovascular diseases (CV) often coexist. COPD and CVD are complex diseases characterized by a strict interaction between environment and genetic. The mechanisms linking these two diseases are complex, multifactorial and not entirely understood, influencing the therapeutic approach. COPD is characterized by several comorbidities, it is hypothesizable that treatment of cardiovascular co-morbidities may reduce morbidity and mortality. Flavonoids are an important class of plant low molecular weight secondary metabolites (SMs). Convincing data from laboratory, epidemiological, and human clinical studies point to an important effects on CVD risk prevention. This review aims to provide up-to-date information on the ability of Flavonoids to reduce the CVD risk. Current studies support the potential of Flavonoids to prevent the risk of CVD. Well-designed clinical studies are suggested to evaluate advantages and limits of Flavonoids for managing CVD comorbidity in COPD. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.