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Sample records for monitoring clinical variables

  1. Monitoring Physiological Variables with Membrane Probes

    NASA Technical Reports Server (NTRS)

    Janle, Elsa M.

    1997-01-01

    This project has demonstrated the possibility of using membrane probes in rodents to monitor physiological variables for extended periods of time. The utility of these probes in physiological studies of microgravity has been demonstrated. The feasibility of developing on-line sensors has also been demonstrated and allows for the possibility of developing real-time automated monitoring systems which can be used in ground-base physiological research as well as in research and medical monitoring in space. In addition to space applications these techniques can be extended to medical monitoring in critical care situations on earth as well as facilitating research in many human and animal diseases.

  2. Variability in continuous traffic monitoring data

    SciTech Connect

    Wright, T.; Hu, P.S.; Young, J.

    1996-07-01

    Each state in the United States can be viewed as a universe of road segments. For each road segment in each state, it is desired to know various traffic characteristics based on count data, classification count data, and weigh-in-motion data. These data are absolutely essential for highway design, maintenance, safety, and planning. Given no cost constraints, each road segment would be continuously monitored every day of the year. However, in practice, a few road segments are monitored continuously every day of the year to produce annual characteristics of traffic flow. The remaining road segments are monitored for one or two days each year, and this resulting data are `adjusted` (using factors based on data collected from the continuously monitored road segments) to produce estimates of annual characteristics. With this general approach, each state strives to provide estimates of annual characteristics for each road segment within its jurisdiction. In 1985, the Federal Highway Administration (FHWA) published the Traffic Monitoring Guide to assist states in achieving this end. As with almost any data collection effort, the monitoring data suffers from errors from many sources. In this paper, we report some empirical findings in a research project sponsored by the FHWA. This research project studied the variability in the traffic data from the continuously monitored road segments from state(s) and, the extent to which this variability is transferred to and affects the precision of the data produced from the road segments which are monitored only one or two days each year. The ultimate hope is that states will eventually be able to not only publish an estimate of a characteristic such as Average Annual Daily Traffic (AADT) for each road segment, but also that each estimate will be accompanied by a statement expressing how good the estimate is in terms of its estimated variability or precision, which will likely be expressed as a coefficient of variation.

  3. Monitoring software development through dynamic variables

    NASA Technical Reports Server (NTRS)

    Doerflinger, Carl W.; Basili, Victor R.

    1983-01-01

    Research conducted by the Software Engineering Laboratory (SEL) on the use of dynamic variables as a tool to monitor software development is described. Project independent measures which may be used in a management tool for monitoring software development are identified. Several FORTRAN projects with similar profiles are examined. The staff was experienced in developing these types of projects. The projects developed serve similar functions. Because these projects are similar some underlying relationships exist that are invariant between projects. These relationships, once well defined, may be used to compare the development of different projects to determine whether they are evolving the same way previous projects in this environment evolved.

  4. Monitoring software development through dynamic variables

    NASA Technical Reports Server (NTRS)

    Doerflinger, C. W.; Basili, V. R.

    1985-01-01

    Research conducted by the Software Engineering Laboratory (SEL) on the use of dynamic variables as a tool to monitor software development is described. Project independent measures which may be used in a management tool for monitoring software development are identified. Several FORTRAN projects with similar profiles are examined. The staff was experienced in developing these types of projects. The projects developed serve similar functions. Because these projects are similar some underlying relationships exist that are invariant between the projects. These relationships, once well defined, may be used to compare the development of different projects to determine whether they are evolving the same way previous projects in this environment evolved.

  5. Monitoring software development through dynamic variables

    NASA Technical Reports Server (NTRS)

    Doerflinger, C. W.; Basili, V. R.

    1983-01-01

    Research conducted by the Software Engineering Laboratory (SEL) on the use of dynamic variables as a tool to monitor software development is described. Project independent measures which may be used in a management tool for monitoring software development are identified. Several FORTRAN projects with similar profiles are examined. The staff was experienced in developing these types of projects. The projects developed serve similar functions. Because these projects are similar some underlying relationships exist that are invariant between the projects. These relationships, once well defined, may be used to compare the development of different projects to determine whether they are evolving the same way previous projects in this environment evolved.

  6. Clinical Implications of Glucose Variability: Chronic Complications of Diabetes.

    PubMed

    Jung, Hye Seung

    2015-06-01

    Glucose variability has been identified as a potential risk factor for diabetic complications; oxidative stress is widely regarded as the mechanism by which glycemic variability induces diabetic complications. However, there remains no generally accepted gold standard for assessing glucose variability. Representative indices for measuring intraday variability include calculation of the standard deviation along with the mean amplitude of glycemic excursions (MAGE). MAGE is used to measure major intraday excursions and is easily measured using continuous glucose monitoring systems. Despite a lack of randomized controlled trials, recent clinical data suggest that long-term glycemic variability, as determined by variability in hemoglobin A1c, may contribute to the development of microvascular complications. Intraday glycemic variability is also suggested to accelerate coronary artery disease in high-risk patients.

  7. [Prescribing monitoring in clinical practice: from enlightened empiricism to rational strategies].

    PubMed

    Buclin, Thierry; Herzig, Lilli

    2013-05-15

    Monitoring of a medical condition is the periodic measurement of one or several physiological or biological variables to detect a signal regarding its clinical progression or its response to treatment. We distinguish different medical situations between diagnostic, clinical and therapeutic process to apply monitoring. Many clinical, variables can be used for monitoring, once their intrinsic properties (normal range, critical difference, kinetics, reactivity) and external validity (pathophysiological importance, predictive power for clinical outcomes) are established. A formal conceptualization of monitoring is being developed and should support the rational development of monitoring strategies and their validation through appropriate clinical trials.

  8. What variables can influence clinical reasoning?

    PubMed Central

    Ashoorion, Vahid; Liaghatdar, Mohammad Javad; Adibi, Peyman

    2012-01-01

    Background: Clinical reasoning is one of the most important competencies that a physician should achieve. Many medical schools and licensing bodies try to predict it based on some general measures such as critical thinking, personality, and emotional intelligence. This study aimed at providing a model to design the relationship between the constructs. Materials and Methods: Sixty-nine medical students participated in this study. A battery test devised that consist four parts: Clinical reasoning measures, personality NEO inventory, Bar-On EQ inventory, and California critical thinking questionnaire. All participants completed the tests. Correlation and multiple regression analysis consumed for data analysis. Results: There is low to moderate correlations between clinical reasoning and other variables. Emotional intelligence is the only variable that contributes clinical reasoning construct (r=0.17-0.34) (R2 chnage = 0.46, P Value = 0.000). Conclusion: Although, clinical reasoning can be considered as a kind of thinking, no significant correlation detected between it and other constructs. Emotional intelligence (and its subscales) is the only variable that can be used for clinical reasoning prediction. PMID:23853636

  9. Clinical and acoustical variability in hypokinetic dysarthria

    SciTech Connect

    Metter, E.J.; Hanson, W.R.

    1986-10-01

    Ten male patients with parkinsonism secondary to Parkinson's disease or progressive supranuclear palsy had clinical neurological, speech, and acoustical speech evaluations. In addition, seven of the patients were evaluated by x-ray computed tomography (CT) and (F-18)-fluorodeoxyglucose (FDG) positron emission tomography (PET). Extensive variability of speech features, both clinical and acoustical, were found and seemed to be independent of the severity of any parkinsonian sign, CT, or FDG PET. In addition, little relationship existed between the variability across each measured speech feature. What appeared to be important for the appearance of abnormal acoustic measures was the degree of overall severity of the dysarthria. These observations suggest that a better understanding of hypokinetic dysarthria may result from more extensive examination of the variability between patients. Emphasizing a specific feature such as rapid speaking rate in characterizing hypokinetic dysarthria focuses on a single and inconstant finding in a complex speech pattern.

  10. Esophageal Impedance Monitoring: Clinical Pearls and Pitfalls.

    PubMed

    Ravi, Karthik; Katzka, David A

    2016-09-01

    The development of intraluminal esophageal impedance monitoring has improved our ability to detect and measure gastroesophageal reflux without dependence on acid content. This ability to detect previously unrecognized weak or nonacid reflux episodes has had important clinical implications in the diagnosis and management of gastroesophageal reflux disease (GERD). In addition, with the ability to assess bolus transit within the esophageal lumen, impedance monitoring has enhanced the recognition and characterization of esophageal motility disorders in patients with nonobstructive dysphagia. The assessment of the intraluminal movement of gas and liquid has also been proven to be of diagnostic value in conditions such as rumination syndrome and excessive belching. Further, alternative applications of impedance monitoring, such as the measurement of mucosal impedance, have provided novel insights into assessing esophageal mucosal integrity changes as a consequence of inflammatory change. Future applications for esophageal impedance monitoring also hold promise in esophageal conditions other than GERD. However, despite all of the clinical benefits afforded by esophageal impedance monitoring, important clinical and technical shortcomings limit its diagnostic value and must be considered when interpreting study results. Overinterpretation of studies or application of impedance monitoring in patients can have deleterious clinical implications. This review will highlight the clinical benefits and limitations of esophageal impedance monitoring and provide clinical pearls and pitfalls associated with this technology.

  11. Esophageal Impedance Monitoring: Clinical Pearls and Pitfalls.

    PubMed

    Ravi, Karthik; Katzka, David A

    2016-09-01

    The development of intraluminal esophageal impedance monitoring has improved our ability to detect and measure gastroesophageal reflux without dependence on acid content. This ability to detect previously unrecognized weak or nonacid reflux episodes has had important clinical implications in the diagnosis and management of gastroesophageal reflux disease (GERD). In addition, with the ability to assess bolus transit within the esophageal lumen, impedance monitoring has enhanced the recognition and characterization of esophageal motility disorders in patients with nonobstructive dysphagia. The assessment of the intraluminal movement of gas and liquid has also been proven to be of diagnostic value in conditions such as rumination syndrome and excessive belching. Further, alternative applications of impedance monitoring, such as the measurement of mucosal impedance, have provided novel insights into assessing esophageal mucosal integrity changes as a consequence of inflammatory change. Future applications for esophageal impedance monitoring also hold promise in esophageal conditions other than GERD. However, despite all of the clinical benefits afforded by esophageal impedance monitoring, important clinical and technical shortcomings limit its diagnostic value and must be considered when interpreting study results. Overinterpretation of studies or application of impedance monitoring in patients can have deleterious clinical implications. This review will highlight the clinical benefits and limitations of esophageal impedance monitoring and provide clinical pearls and pitfalls associated with this technology. PMID:27325223

  12. Current clinical applications of heart rate variability.

    PubMed

    Stys, A; Stys, T

    1998-10-01

    Heart rate variability (HRV) has become a popular method for the studies of physiologic mechanisms responsible for the control of heart rate fluctuations, in which the autonomic nervous system appears to play a primary role. Depression of HRV has been observed in many clinical scenarios, including autonomic neuropathy, heart transplantation, congestive heart failure, myocardial infarction (MI), and other cardiac and noncardiac diseases. However, it is important to realize that clinical implication of HRV analysis has been clearly recognized in only two clinical conditions: (1) as a predictor of risk of arrhythmic events or sudden cardiac death after acute MI, and (2) as a clinical marker of evolving diabetic neuropathy. Recently, its role in evaluation and management of heart failure has also been recognized. It is pertinent to recognize the limitations of HRV as far as its clinical utility at present is concerned. The methodology of HRV had remained poorly standardized until the recent publication of the Special Report of the Task Force of ESC/NASPE, and thus has been presenting difficulty in comparing earlier existing data. Also, determination of the exact sensitivity, specificity, and predictive value of HRV, as well as the normal values of standard measures in the general population, still require further investigation before better standards can be set for existing and future clinical applications. This article reviews the major concepts of HRV measurements, their clinical relevance, and the recent advances in this field. PMID:9789691

  13. Data monitoring committees for pragmatic clinical trials.

    PubMed

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  14. Real-Time Clinical Monitoring of Biomolecules

    NASA Astrophysics Data System (ADS)

    Rogers, Michelle L.; Boutelle, Martyn G.

    2013-06-01

    Continuous monitoring of clinical biomarkers offers the exciting possibility of new therapies that use biomarker levels to guide treatment in real time. This review explores recent progress toward this goal. We initially consider measurements in body fluids by a range of analytical methods. We then discuss direct tissue measurements performed by implanted sensors; sampling techniques, including microdialysis and ultrafiltration; and noninvasive methods. A future directions section considers analytical methods at the cusp of clinical use.

  15. All-Sky Monitoring of Variable Sources with Fermi GBM

    NASA Technical Reports Server (NTRS)

    Wilson-Hodge, Colleen A.; Cherry, Michael L.; Case, Gary L.; Camero-Arranz, Ascension; Chaplin, Vandiver; Connaughton, Valerie; Finger, Mark H.; Jenke, Pater; Rodi, James C.; Baumgartner, Wayne H.; Beklen, Elif; Bhat, P. Narayana; Briggs, Michael S.; Gehrels, Neil; Greiner, Jochen; Jahoda, Keith; Kippen, R. Marc; Kouveliotou, Chryssa; Krimm, Hans A.; Kuulkers, Erik; Lund, Niels; Meegan, Charles A.; Natalucci, Lorenzo; Paciesas, William S.; Preece, Robert

    2011-01-01

    This slide presentation reviews the monitoring of variable sources with the Fermi Gamma Ray Burst Monitor (GBM). It reviews the use of the Earth Occultation technique, the observations of the Crab Nebula with the GBM, and the comparison with other satellite's observations. The instruments on board the four satellites indicate a decline in the Crab from 2008-2010.

  16. BioMEMS for multiparameter clinical monitoring

    NASA Astrophysics Data System (ADS)

    Moser, Isabella

    2003-01-01

    For diabetes patients glucose monitoring means an important improvement of their life quality and additionally it is a $3-billion-a-year business. Continuous glucose monitoring provides gapless glucose level control, an early warning of hypoglycemia, and is intended to control insulin pumps. An upgrading to multi-parameter monitoring would not only benefit patients with severe metabolism defects but also the metabolism of diabetes patient could be better controlled by monitoring an additional parameter like lactate. Multi-parameter monitoring devices are not commercially available, one of the complications in the integration of different biosensors using the same detecting molecule for all analytes is chemical cross talk between adjacent amperometric biosensors. Recently some integrated biosensors were published but either they were not mass producible or they were realized in an expensive silicon based technology. In addition to it most of them were not tested under monitoring conditions but their integration principles will be discussed. As an example a low cost multi- parameter microsystem and some applications of it in clinical diagnosis will be presented. Also an overlook of non-invasive methods and (minimal) invasive methods will be given with a focus on microdialysis.

  17. Information-based monitoring of clinical trials.

    PubMed

    Tsiatis, Anastasios A

    2006-10-15

    When designing a clinical trial to compare the effect of different treatments on response, a key issue facing the statistician is to determine how large a study is necessary to detect a clinically important difference with sufficient power. This is the case whether the study will be analysed only once (single-analysis) or whether it will be monitored periodically with the possibility of early stopping (group-sequential). Standard sample size calculations are based on both the magnitude of difference that is considered clinically important as well as values for the nuisance parameters in the statistical model. For planning purposes, best guesses are made for the value of the nuisance parameters and these are used to determine the sample size. However, if these guesses are incorrect this will affect the subsequent power to detect the clinically important difference. It is argued in this paper that statistical precision is directly related to Statistical Information and that the study should continue until the requisite statistical information is obtained. This is referred to as information-based design and analysis of clinical trials. We also argue that this type of methodology is best suited with group-sequential trials which monitor the data periodically and allow for estimation of the statistical information as the study progresses. PMID:16927248

  18. Use of a needle valve variable resistor to improve invasive blood pressure monitoring.

    PubMed

    Abrams, J H; Olson, M L; Marino, J A; Cerra, F B

    1984-11-01

    Inaccurate measurements using in-line systems are partly due to the resonance frequency. A variable acoustic resistor designed to change the damping coefficient of these monitoring systems was evaluated under clinical conditions. The device improved pressure transmission characteristics in measurements on 12 of 13 patients. Use of the device and of the bedside step-impulse test for calibration should improve the reliability of in-line blood pressure monitoring. PMID:6499484

  19. [Current clinical aspects of ambulatory blood pressure monitoring].

    PubMed

    Sauza-Sosa, Julio César; Cuéllar-Álvarez, José; Villegas-Herrera, Karla Montserrat; Sierra-Galán, Lilia Mercedes

    2016-01-01

    Systemic arterial hypertension is the prevalentest disease worldwide that significantly increases cardiovascular risk. An early diagnosis together to achieve goals decreases the risk of complications significatly. Recently have been updated the diagnostic criteria for hypertension and the introduction of ambulatory blood pressure monitoring. The introduction into clinical practice of ambulatory blood pressure monitoring was to assist the diagnosis of «white coat hypertension» and «masked hypertension». Today has also shown that ambulatory blood pressure monitoring is better than the traditional method of recording blood pressure in the office, to the diagnosis and to adequate control and adjustment of drug treatment. Also there have been introduced important new concepts such as isloted nocturnal hypertension, morning blood pressure elevation altered and altered patterns of nocturnal dip in blood pressure; which have been associated with increased cardiovascular risk. Several studies have shown significant prognostic value in some stocks. There are still other concepts on which further study is needed to properly establish their introduction to clinical practice as hypertensive load variability, pulse pressure and arterial stiffness. In addition to setting values according to further clinical studies in populations such as elderly and children. PMID:26794338

  20. [Current clinical aspects of ambulatory blood pressure monitoring].

    PubMed

    Sauza-Sosa, Julio César; Cuéllar-Álvarez, José; Villegas-Herrera, Karla Montserrat; Sierra-Galán, Lilia Mercedes

    2016-01-01

    Systemic arterial hypertension is the prevalentest disease worldwide that significantly increases cardiovascular risk. An early diagnosis together to achieve goals decreases the risk of complications significatly. Recently have been updated the diagnostic criteria for hypertension and the introduction of ambulatory blood pressure monitoring. The introduction into clinical practice of ambulatory blood pressure monitoring was to assist the diagnosis of «white coat hypertension» and «masked hypertension». Today has also shown that ambulatory blood pressure monitoring is better than the traditional method of recording blood pressure in the office, to the diagnosis and to adequate control and adjustment of drug treatment. Also there have been introduced important new concepts such as isloted nocturnal hypertension, morning blood pressure elevation altered and altered patterns of nocturnal dip in blood pressure; which have been associated with increased cardiovascular risk. Several studies have shown significant prognostic value in some stocks. There are still other concepts on which further study is needed to properly establish their introduction to clinical practice as hypertensive load variability, pulse pressure and arterial stiffness. In addition to setting values according to further clinical studies in populations such as elderly and children.

  1. Monitoring D-Region Variability from Lightning Measurements

    NASA Technical Reports Server (NTRS)

    Simoes, Fernando; Berthelier, Jean-Jacques; Pfaff, Robert; Bilitza, Dieter; Klenzing, Jeffery

    2011-01-01

    In situ measurements of ionospheric D-region characteristics are somewhat scarce and rely mostly on sounding rockets. Remote sensing techniques employing Very Low Frequency (VLF) transmitters can provide electron density estimates from subionospheric wave propagation modeling. Here we discuss how lightning waveform measurements, namely sferics and tweeks, can be used for monitoring the D-region variability and day-night transition, and for local electron density estimates. A brief comparison among D-region aeronomy models is also presented.

  2. Variability in traffic monitoring data. Final summary report

    SciTech Connect

    Wright, T.; Hu, P.S.; Young, J.; Lu, A.

    1997-08-01

    For highway maintenance and planning purposes, it is desirable to characterize each road segment by its traffic flow [such as the annual average daily traffic (AADT) and the AADT for each vehicle class], by the weight distribution of vehicles that travel on its roads [such as the annual average daily equivalent single axle loadings (ESAL) and the annual average daily weight per vehicle for each vehicle class]. As with almost any data collection effort, the monitoring data suffer from errors from many sources. This report summarizes results of a two year empirical research effort, which was sponsored by the Federal highway Administration, (i) to study and characterize the variability in the traffic data (volume, classification, and weight) from the continuously monitored road segments, and (ii) to study the extent to which this variability is transferred to, and affects the precision of the data produced form the road segments which are monitored only one or two days each year. The ultimate hope is not only that states will eventually be able to publish an estimate of a characteristic such as AADT for each road segment, but also that each estimate will be accompanied by a statement of how good the estimate is in terms of the estimated variability or precision which will likely be experienced as a coefficient of variation (i.e., the quotient of a standard deviation and a mean). This report provides highlights of research reported in five working papers.

  3. Serial Monitoring of Otoacoustic Emissions in Clinical Trials.

    PubMed

    Konrad-Martin, Dawn; Poling, Gayla L; Dreisbach, Laura E; Reavis, Kelly M; McMillan, Garnett P; Lapsley Miller, Judi A; Marshall, Lynne

    2016-09-01

    The purpose of this report is to provide guidance on the use of otoacoustic emissions (OAEs) as a clinical trial outcome measure for pharmaceutical interventions developed to prevent acquired hearing loss secondary to cochlear insult. OAEs are a rapid, noninvasive measure that can be used to monitor cochlear outer hair cell function. Serial monitoring of OAEs is most clearly established for use in hearing conservation and ototoxicity monitoring programs in which they exhibit more frequent and earlier changes compared with pure-tone audiometry. They also show promise in recent human trials of otoprotectants. Questions remain, however, concerning the most appropriate OAE protocols to use and what constitutes a "significant" OAE response change. Measurement system capabilities are expanding and test efficacy will vary across locations and patient populations. Yet, standardizing minimal measurement criteria and reporting of results is needed including documentation of test-retest variability so that useful comparisons can be made across trials. It is also clear that protocols must be theoretically sound based on known patterns of damage, generate valid results in most individuals tested, be accurate, repeatable, and involve minimal time. Based on the potential value added, OAEs should be included in clinical trials when measurement conditions and time permit. PMID:27518137

  4. Using business intelligence to monitor clinical quality metrics.

    PubMed

    Resetar, Ervina; Noirot, Laura A; Reichley, Richard M; Storey, Patricia; Skiles, Ann M; Traynor, Patrick; Dunagan, W Claiborne; Bailey, Thomas C

    2007-10-11

    BJC HealthCare (BJC) uses a number of industry standard indicators to monitor the quality of services provided by each of its hospitals. By establishing an enterprise data warehouse as a central repository of clinical quality information, BJC is able to monitor clinical quality performance in a timely manner and improve clinical outcomes.

  5. Global biodiversity monitoring: from data sources to essential biodiversity variables

    USGS Publications Warehouse

    Proenca, Vania; Martin, Laura J.; Pereira, Henrique M.; Fernandez, Miguel; McRae, Louise; Belnap, Jayne; Böhm, Monika; Brummitt, Neil; Garcia-Moreno, Jaime; Gregory, Richard D.; Honrado, Joao P; Jürgens, Norbert; Opige, Michael; Schmeller, Dirk S.; Tiago, Patricia; van Sway, Chris A

    2016-01-01

    Essential Biodiversity Variables (EBVs) consolidate information from varied biodiversity observation sources. Here we demonstrate the links between data sources, EBVs and indicators and discuss how different sources of biodiversity observations can be harnessed to inform EBVs. We classify sources of primary observations into four types: extensive and intensive monitoring schemes, ecological field studies and satellite remote sensing. We characterize their geographic, taxonomic and temporal coverage. Ecological field studies and intensive monitoring schemes inform a wide range of EBVs, but the former tend to deliver short-term data, while the geographic coverage of the latter is limited. In contrast, extensive monitoring schemes mostly inform the population abundance EBV, but deliver long-term data across an extensive network of sites. Satellite remote sensing is particularly suited to providing information on ecosystem function and structure EBVs. Biases behind data sources may affect the representativeness of global biodiversity datasets. To improve them, researchers must assess data sources and then develop strategies to compensate for identified gaps. We draw on the population abundance dataset informing the Living Planet Index (LPI) to illustrate the effects of data sources on EBV representativeness. We find that long-term monitoring schemes informing the LPI are still scarce outside of Europe and North America and that ecological field studies play a key role in covering that gap. Achieving representative EBV datasets will depend both on the ability to integrate available data, through data harmonization and modeling efforts, and on the establishment of new monitoring programs to address critical data gaps.

  6. Common variable immunodeficiency leading to spinal subacute combined degeneration monitored by MRI.

    PubMed

    Yousry, T A; Strupp, M; Brüning, R

    1998-05-01

    A patient is reported on with a common variable immunodeficiency syndrome (CVID), in whom chronic gastritis with antibodies against parietal cells and a cytomegalovirus associated enteritis led to vitamin B12 deficiency with consecutive subacute combined degeneration of the spinal cord. The resulting medullary changes, most probably representing demyelination, were visualised with MRI. The effects of treatment were also monitored over three years by MRI and clinical examination. The resolution of the MRI changes correlated with clinical improvement of the patient's signs. In the medical literature only five cases of vitamin B12 related spinal cord changes have been identified by MRI; none was caused by a CVID syndrome.

  7. Monitoring the variability of intrinsic absorption lines in quasar spectra , ,

    SciTech Connect

    Misawa, Toru; Charlton, Jane C.; Eracleous, Michael

    2014-09-01

    We have monitored 12 intrinsic narrow absorption lines (NALs) in five quasars and seven mini-broad absorption lines (mini-BALs) in six quasars for a period of 4-12 yr (1-3.5 yr in the quasar rest-frame). We present the observational data and the conclusions that follow immediately from them, as a prelude to a more detailed analysis. We found clear variability in the equivalent widths (EWs) of the mini-BAL systems but no easily discernible changes in their profiles. We did not detect any variability in the NAL systems or in narrow components that are often located at the center of mini-BAL profiles. Variations in mini-BAL EWs are larger at longer time intervals, reminiscent of the trend seen in variable BALs. If we assume that the observed variations result from changes in the ionization state of the mini-BAL gas, we infer lower limits to the gas density ∼10{sup 3}-10{sup 5} cm{sup –3} and upper limits on the distance of the absorbers from the central engine of the order of a few kiloparsecs. Motivated by the observed variability properties, we suggest that mini-BALs can vary because of fluctuations of the ionizing continuum or changes in partial coverage while NALs can vary primarily because of changes in partial coverage.

  8. Review and classification of variability analysis techniques with clinical applications

    PubMed Central

    2011-01-01

    Analysis of patterns of variation of time-series, termed variability analysis, represents a rapidly evolving discipline with increasing applications in different fields of science. In medicine and in particular critical care, efforts have focussed on evaluating the clinical utility of variability. However, the growth and complexity of techniques applicable to this field have made interpretation and understanding of variability more challenging. Our objective is to provide an updated review of variability analysis techniques suitable for clinical applications. We review more than 70 variability techniques, providing for each technique a brief description of the underlying theory and assumptions, together with a summary of clinical applications. We propose a revised classification for the domains of variability techniques, which include statistical, geometric, energetic, informational, and invariant. We discuss the process of calculation, often necessitating a mathematical transform of the time-series. Our aims are to summarize a broad literature, promote a shared vocabulary that would improve the exchange of ideas, and the analyses of the results between different studies. We conclude with challenges for the evolving science of variability analysis. PMID:21985357

  9. [Measurement of blood pressure variability and the clinical value].

    PubMed

    Kékes, Ede; Kiss, István

    2014-10-19

    Authors have collected and analyzed literature data on blood pressure variability. They present the methods of blood pressure variability measurement, clinical value and relationships with target organ damages and risk of presence of cardiovascular events. They collect data about the prognostic value of blood pressure variability and the effects of different antihypertensive drugs on blood pressure variability. They underline that in addition to reduction of blood pressure to target value, it is essential to influence blood pressure fluctuation and decrease blood pressure variability, because blood pressure fluctuation presents a major threat for the hypertensive subjects. Data from national studies are also presented. They welcome that measurement of blood pressure variability has been included in international guidelines.

  10. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    PubMed

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. PMID:27089522

  11. Impact of Laboratory Practices on Interlaboratory Variability in Therapeutic Drug Monitoring of Immunosuppressive Drugs.

    PubMed

    Christians, Uwe; Vinks, Alexander A; Langman, Loralie J; Clarke, William; Wallemacq, Pierre; van Gelder, Teun; Renjen, Varun; Marquet, Pierre; Meyer, Eric J

    2015-12-01

    The immunosuppressants cyclosporine, tacrolimus, sirolimus, everolimus, and probably also mycophenolic acid require therapeutic drug monitoring (TDM)-guided dosing to ensure that blood concentrations are kept within the target range in transplant patients. Reliable, accurate, and precise test methods are therefore essential to effectively monitor levels and to make proper dose adjustments. Data from proficiency testing programs have shown substantial interlaboratory variability. Only few attempts have been made to study the underlying causes. The aim of this study was to systematically document current practices used for immunosuppressant drug TDM in clinical laboratories and identify methodological and practice differences, which may cause the variability observed among laboratories. Data collection was primarily conducted by a structured Web-based survey. Invitations to participate in the survey were distributed to clinical laboratories providing immunosuppressant drug TDM. Surveys were completed by 76 laboratories in 14 countries. The results of our survey suggest that there are 3 main reasons for interlaboratory variability: (1) lack of standardization of laboratory procedures and workflows starting with sample collection and handling, (2) lack of use of appropriate reference materials (eg, isotope-labeled internal standards for liquid chromatography-tandem mass spectroscopy), and (3) poor compliance with internationally accepted good laboratory practice guidelines (eg, related to quality control, quality assurance, validation, training of personnel). The results of the survey also suggest that interlaboratory variability is a multifactorial problem. Technical-level consensus on laboratory operational procedures, quality systems, and personnel training will be of great importance to improve quality and interlaboratory comparability.

  12. Variability of multifractal parameters in an urban precipitation monitoring network

    NASA Astrophysics Data System (ADS)

    Licznar, Paweł; De Michele, Carlo; Dżugaj, Dagmara; Niesobska, Maria

    2014-05-01

    Precipitation especially over urban areas is considered a highly non-linear process, with wide variability over a broad range of temporal and spatial scales. Despite obvious limitations of rainfall gauges location at urban sites, rainfall monitoring by gauge networks is a standard solution of urban hydrology. Often urban precipitation gauge networks are formed by modern electronic gauges and connected to control units of centralized urban drainage systems. Precipitation data, recorded online through these gauge networks, are used in so called Real-Time-Control (RTC) systems for the development of optimal strategies of urban drainage outflows management. As a matter of fact, the operation of RTC systems is motivated mainly by the urge of reducing the severity of urban floods and combined sewerage overflows, but at the same time, it creates new valuable precipitation data sources. The variability of precipitation process could be achieved by investigating multifractal behavior displayed by the temporal structure of precipitation data. There are multiply scientific communications concerning multifractal properties of point-rainfall data from different worldwide locations. However, very little is known about the close variability of multifractal parameters among closely located gauges, at the distances of single kilometers. Having this in mind, here we assess the variability of multifractal parameters among gauges of the urban precipitation monitoring network in Warsaw, Poland. We base our analysis on the set of 1-minute rainfall time series recorded in the period 2008-2011 by 25 electronic weighing type gauges deployed around the city by the Municipal Water Supply and Sewerage Company in Warsaw as a part of local RTC system. The presence of scale invariance and multifractal properties in the precipitation process was investigated with spectral analysis, functional box counting method and studying the probability distributions and statistical moments of the rainfall

  13. Symbolic dynamics marker of heart rate variability combined with clinical variables enhance obstructive sleep apnea screening.

    PubMed

    Ravelo-García, A G; Saavedra-Santana, P; Juliá-Serdá, G; Navarro-Mesa, J L; Navarro-Esteva, J; Álvarez-López, X; Gapelyuk, A; Penzel, T; Wessel, N

    2014-06-01

    Many sleep centres try to perform a reduced portable test in order to decrease the number of overnight polysomnographies that are expensive, time-consuming, and disturbing. With some limitations, heart rate variability (HRV) has been useful in this task. The aim of this investigation was to evaluate if inclusion of symbolic dynamics variables to a logistic regression model integrating clinical and physical variables, can improve the detection of subjects for further polysomnographies. To our knowledge, this is the first contribution that innovates in that strategy. A group of 133 patients has been referred to the sleep center for suspected sleep apnea. Clinical assessment of the patients consisted of a sleep related questionnaire and a physical examination. The clinical variables related to apnea and selected in the statistical model were age (p < 10(-3)), neck circumference (p < 10(-3)), score on a questionnaire scale intended to quantify daytime sleepiness (p < 10(-3)), and intensity of snoring (p < 10(-3)). The validation of this model demonstrated an increase in classification performance when a variable based on non-linear dynamics of HRV (p < 0.01) was used additionally to the other variables. For diagnostic rule based only on clinical and physical variables, the corresponding area under the receiver operating characteristic (ROC) curve was 0.907 (95% confidence interval (CI) = 0.848, 0.967), (sensitivity 87.10% and specificity 80%). For the model including the average of a symbolic dynamic variable, the area under the ROC curve was increased to 0.941 (95% = 0.897, 0.985), (sensitivity 88.71% and specificity 82.86%). In conclusion, symbolic dynamics, coupled with significant clinical and physical variables can help to prioritize polysomnographies in patients with a high probability of apnea. In addition, the processing of the HRV is a well established low cost and robust technique.

  14. Symbolic dynamics marker of heart rate variability combined with clinical variables enhance obstructive sleep apnea screening

    NASA Astrophysics Data System (ADS)

    Ravelo-García, A. G.; Saavedra-Santana, P.; Juliá-Serdá, G.; Navarro-Mesa, J. L.; Navarro-Esteva, J.; Álvarez-López, X.; Gapelyuk, A.; Penzel, T.; Wessel, N.

    2014-06-01

    Many sleep centres try to perform a reduced portable test in order to decrease the number of overnight polysomnographies that are expensive, time-consuming, and disturbing. With some limitations, heart rate variability (HRV) has been useful in this task. The aim of this investigation was to evaluate if inclusion of symbolic dynamics variables to a logistic regression model integrating clinical and physical variables, can improve the detection of subjects for further polysomnographies. To our knowledge, this is the first contribution that innovates in that strategy. A group of 133 patients has been referred to the sleep center for suspected sleep apnea. Clinical assessment of the patients consisted of a sleep related questionnaire and a physical examination. The clinical variables related to apnea and selected in the statistical model were age (p < 10-3), neck circumference (p < 10-3), score on a questionnaire scale intended to quantify daytime sleepiness (p < 10-3), and intensity of snoring (p < 10-3). The validation of this model demonstrated an increase in classification performance when a variable based on non-linear dynamics of HRV (p < 0.01) was used additionally to the other variables. For diagnostic rule based only on clinical and physical variables, the corresponding area under the receiver operating characteristic (ROC) curve was 0.907 (95% confidence interval (CI) = 0.848, 0.967), (sensitivity 87.10% and specificity 80%). For the model including the average of a symbolic dynamic variable, the area under the ROC curve was increased to 0.941 (95% = 0.897, 0.985), (sensitivity 88.71% and specificity 82.86%). In conclusion, symbolic dynamics, coupled with significant clinical and physical variables can help to prioritize polysomnographies in patients with a high probability of apnea. In addition, the processing of the HRV is a well established low cost and robust technique.

  15. Monitoring the Variability of Intrinsic Absorption Lines in Quasar Spectra

    NASA Astrophysics Data System (ADS)

    Misawa, Toru; Charlton, Jane C.; Eracleous, Michael

    2014-09-01

    We have monitored 12 intrinsic narrow absorption lines (NALs) in five quasars and seven mini-broad absorption lines (mini-BALs) in six quasars for a period of 4-12 yr (1-3.5 yr in the quasar rest-frame). We present the observational data and the conclusions that follow immediately from them, as a prelude to a more detailed analysis. We found clear variability in the equivalent widths (EWs) of the mini-BAL systems but no easily discernible changes in their profiles. We did not detect any variability in the NAL systems or in narrow components that are often located at the center of mini-BAL profiles. Variations in mini-BAL EWs are larger at longer time intervals, reminiscent of the trend seen in variable BALs. If we assume that the observed variations result from changes in the ionization state of the mini-BAL gas, we infer lower limits to the gas density ~103-105 cm-3 and upper limits on the distance of the absorbers from the central engine of the order of a few kiloparsecs. Motivated by the observed variability properties, we suggest that mini-BALs can vary because of fluctuations of the ionizing continuum or changes in partial coverage while NALs can vary primarily because of changes in partial coverage. Based on data collected at Subaru telescope, which is operated by the National Astronomical Observatory of Japan. Based on observations obtained at the European Southern Observatory at La Silla, Chile in programs 65.O-0063(B), 65.O-0474(A), 67.A-0078(A), 68.A-0461(A), 69.A-0204(A), 70.B-0522(A), 072.A-0346(A), 076.A-0860(A), 079.B-0469(A), and 166.A-0106(A).

  16. Earpiece with sensors to measure/monitor multiple physiological variables

    NASA Technical Reports Server (NTRS)

    Schulze, Arthur E. (Inventor); Cooper, Tommy G. (Inventor)

    2003-01-01

    An apparatus and method for positioning sensors relative to one another and anatomic features in a non-invasive device for measuring and monitoring multiple physiological variables from a single site uses an earpiece incorporating a shielded pulse oximetry sensor (POS) having a miniaturized set of LEDs and photosensors configured for pulse oximetry measurements in the reflectance mode and located in the earpiece so as to position the POS against a rear wall of an ear canal. The earpiece also includes a thermopile of no larger than 7 mm. in diameter located on the earpiece to so as to position the thermopile past a second turn of an external auditory meatus so as to view the tympanic membrane. The thermopile includes a reference temperature sensor attached to its base for ambient temperature compensation.

  17. Cataclysmic variables to be monitored for HST observations

    NASA Astrophysics Data System (ADS)

    Waagen, Elizabeth O.

    2012-09-01

    Drs. Boris Gaensicke (Warwick University), Joseph Patterson (Columbia University, Center for Backyard Astrophysics), and Arne Henden (AAVSO), on behalf of a consortium of 16 astronomers, requested the help of AAVSO observers in monitoring the ~40 cataclysmic variables in support of Hubble Space Telescope observations in the coming months. The HST COS (Cosmic Origins Spectrograph) will be carrying out far-ultraviolet spectroscopy of ~40 CVs sequentially, with the aim to measure the temperatures, atmospheric compositions, rotation rates, and eventually masses of their white dwarfs. The primary purpose of the monitoring is to know whether each target is in quiescence immediately prior to the observation window; if it is in outburst it will be too bright for the HST instrumentation. Based on the information supplied by the AAVSO, the HST scheduling team will make the decision (usually) the evening before the scheduled observing time as to whether to go forward with the HST observations. For CCD observers, simultaneous photometry [shortly before, during, and after the HST observations] would be ideal. B filter would be best for a light curve, although for the magnitude estimates, V would be best. Finder charts may be created using the AAVSO Variable Star Plotter (http://www.aavso.org/vsp). Observations should be submitted to the AAVSO International Database. If the target is seen in outburst, please contact the AAVSO immediately and post a message to the Observations and Campaigns & Observations Reports forum (http://www.aavso.org/forum). This campaign will run the better part of a year or longer. See full Alert Notice for more details and list of objects.

  18. Clinical Application of Heart Rate Variability after Acute Myocardial Infarction

    PubMed Central

    Huikuri, Heikki V.; Stein, Phyllis K.

    2012-01-01

    Heart rate (HR) variability has been extensively studied in patients surviving an acute myocardial infarction (AMI). The majority of studies have shown that patients with reduced or abnormal HR variability/turbulence have an increased risk of mortality within few years after an AMI. Various measures of HR dynamics, such as time-domain, spectral, and non-linear measures of HR variability, as well as HR turbulence, have been used in risk stratification of post-AMI patients. The prognostic power of various measures, except of those reflecting rapid R–R interval oscillations, has been almost identical, albeit some non-linear HR variability measures, such as short-term fractal scaling exponent, and HR turbulence, have provided somewhat better prognostic information than the others. Abnormal HR variability predicts both sudden and non-sudden cardiac death after AMI. Because of remodeling of the arrhythmia substrate after AMI, early measurement of HR variability to identify those at high risk should likely be repeated later in order to assess the risk of fatal arrhythmia events. Future randomized trials using HR variability/turbulence as one of the pre-defined inclusion criteria will show whether routine measurement of HR variability/turbulence will become a routine clinical tool for risk stratification of post-AMI patients. PMID:22375128

  19. Clinical review: Respiratory monitoring in the ICU - a consensus of 16

    PubMed Central

    2012-01-01

    Monitoring plays an important role in the current management of patients with acute respiratory failure but sometimes lacks definition regarding which 'signals' and 'derived variables' should be prioritized as well as specifics related to timing (continuous versus intermittent) and modality (static versus dynamic). Many new techniques of respiratory monitoring have been made available for clinical use recently, but their place is not always well defined. Appropriate use of available monitoring techniques and correct interpretation of the data provided can help improve our understanding of the disease processes involved and the effects of clinical interventions. In this consensus paper, we provide an overview of the important parameters that can and should be monitored in the critically ill patient with respiratory failure and discuss how the data provided can impact on clinical management. PMID:22546221

  20. Clozapine Monitoring in Clinical Practice: Beyond the Mandatory Requirement

    PubMed Central

    Kar, Nilamadhab; Barreto, Socorro; Chandavarkar, Rahul

    2016-01-01

    Clozapine is effective in treatment resistant schizophrenia; however, it is underutilised probably because of its side effects. The side effects are also the potential reasons for clozapine discontinuation. A mandatory requirement for its use is regular monitoring of white blood cell count and absolute neutrophil count. However there are many side effects that need monitoring in clinical practice considering their seriousness. This article tries to summarise the clinical concerns surrounding the serious side effects of clozapine some of which are associated with fatalities and presents a comprehensive way to monitor patients on clozapine in clinical practice. It emphasizes the need to broaden the monitoring beyond the mandatory investigations. This may help in improving the safety in clinical practice and increasing clinician confidence for greater and appropriate use of this effective intervention. PMID:27776383

  1. Nevada Monitoring System to Assess Climate Variability and Change

    NASA Astrophysics Data System (ADS)

    Devitt, D. A.; Arnone, J.; Biondi, F.; Fenstermaker, L. F.; Saito, L.; Young, M.; Riddle, B.; Strachan, S. D.; Bird, B.; McCurdy, G.; Lyles, B. F.

    2010-12-01

    The Nevada System of Higher Education (University of Nevada Las Vegas, University of Nevada Reno and the Desert Research Institute) was awarded a multiyear NSF EPSCoR grant to support infrastructure associated with regional climate change research. The overall project is comprised of 5 components: education, cyberinfrastructure, policy, climate modeling and water/ecology. The water and ecology components are using their infrastructure funding for the assessment of climate variability and change on ecosystem function and hydrologic services. A series of 10 m tall towers are under construction and are being equipped with a wide array of sensors to monitor atmospheric, soil and plant parameters over time. The towers are located within the Mojave and Great Basin Deserts in two transects; the Mojave Desert transect is located in the southern Nevada Sheep Mountain Range and the Great Basin transect is located in the east central Nevada Snake Mountain Range. The towers are centrally positioned in well-defined vegetation zones. In southern Nevada these zones are represented by the following plant species: Creosote/Bursage (Creosotebush scrub zone); Blackbrush/Joshua Tree (Blackbrush zone); Pinyon/ Juniper (pygmy conifer zone), Ponderosa Pine (montane zone) and Bristlecone Pine (subalpine zone). The Snake Mountain transect incorporates the eastern and western valleys on both sides of the mountain range. The vegetation zones are represented by: Greasewood and mixed shrub (salt desert zone); Big Sage (sagebrush zone); Pinyon/Juniper (pygmy conifer zone); White/Douglas Fir, Ponderosa Pine and Aspen (montane zone); and Bristlecone/Limber Pine and Engelmann Spruce (subalpine zone). We are currently in the third year of funding with a goal of having the majority of towers fully operational by winter 2010. In close collaboration with our cyberinfrastructure component team, all data acquired from the transect monitoring stations will be made available to other researchers and the

  2. Cadenced IRAC Monitoring of Infrared-Variable AGNs, Part II

    NASA Astrophysics Data System (ADS)

    Ashby, Matthew; Fouesneau, Morgan; Hora, Joseph; Krick, Jessica; Smith, Howard; Surace, Jason

    2008-03-01

    We have analyzed IRAC imaging data from all 97 Spitzer visits to a very well-studied field, the IRAC Dark Calibration Field (IRAC-CF) near the north ecliptic pole. With this extensive dataset we have already identified a unique sample of 30 IR-variable galaxies which we are now working to characterize with respect to variability amplitudes and timescales, panchromatic SEDs, and host morphologies, among other quantities. Unfortunately, the continual change in spacecraft roll angle means that our sources are typically observed for at most six months at a time by each IRAC FOV in succession -- in other words, the visibility windows are exactly out of phase. Thus the existing data, despite the fact that they extend over more than four years, present large, unavoidable gaps that frustrate the time-delay analysis we wish to perform on exactly the timescales known to be common in active galaxies. This has only changed beginning in 2007 July: since that time cadenced IRAC observations have been carried out in synchrony with the IRAC-CF dark-calibration observations as part of our approved Cycle-4 program (PID 40553). Here we are proposing to continue this successful AGN monitoring campaign until the end of the cryogenic mission. The resulting timelines (covering 1500 days thus far and expected to run ultimately to some 2200+ days), will be a unique legacy of the Spitzer mission. This dataset, especially for the sizable, unbiased AGN sample we now have, holds unique promise for measuring the colors and temperatures of IR-varying AGN, and will have much to say about the underlying physical models of the infrared AGN emission. Accordingly we ask for just 8 h to gather IRAC photometry in the temporal gaps that would otherwise accrue in Cycle 5.

  3. Technological advances in perioperative monitoring: Current concepts and clinical perspectives.

    PubMed

    Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

    2015-01-01

    Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any.

  4. Classification of Variable Objects in Massive Sky Monitoring Surveys

    NASA Astrophysics Data System (ADS)

    Woźniak, Przemek; Wyrzykowski, Łukasz; Belokurov, Vasily

    2012-03-01

    The era of great sky surveys is upon us. Over the past decade we have seen rapid progress toward a continuous photometric record of the optical sky. Numerous sky surveys are discovering and monitoring variable objects by hundreds of thousands. Advances in detector, computing, and networking technology are driving applications of all shapes and sizes ranging from small all sky monitors, through networks of robotic telescopes of modest size, to big glass facilities equipped with giga-pixel CCD mosaics. The Large Synoptic Survey Telescope will be the first peta-scale astronomical survey [18]. It will expand the volume of the parameter space available to us by three orders of magnitude and explore the mutable heavens down to an unprecedented level of sensitivity. Proliferation of large, multidimensional astronomical data sets is stimulating the work on new methods and tools to handle the identification and classification challenge [3]. Given exponentially growing data rates, automated classification of variability types is quickly becoming a necessity. Taking humans out of the loop not only eliminates the subjective nature of visual classification, but is also an enabling factor for time-critical applications. Full automation is especially important for studies of explosive phenomena such as γ-ray bursts that require rapid follow-up observations before the event is over. While there is a general consensus that machine learning will provide a viable solution, the available algorithmic toolbox remains underutilized in astronomy by comparison with other fields such as genomics or market research. Part of the problem is the nature of astronomical data sets that tend to be dominated by a variety of irregularities. Not all algorithms can handle gracefully uneven time sampling, missing features, or sparsely populated high-dimensional spaces. More sophisticated algorithms and better tools available in standard software packages are required to facilitate the adoption of

  5. Common variable immunodeficiency leading to spinal subacute combined degeneration monitored by MRI

    PubMed Central

    Yousry, T; Strupp, M; Bruning, R

    1998-01-01

    A patient is reported on with a common variable immunodeficiency syndrome (CVID), in whom chronic gastritis with antibodies against parietal cells and a cytomegalovirus associated enteritis led to vitamin B12 deficiency with consecutive subacute combined degeneration of the spinal cord. The resulting medullary changes, most probably representing demyelination, were visualised with MRI. The effects of treatment were also monitored over three years by MRI and clinical examination. The resolution of the MRI changes correlated with clinical improvement of the patient's signs. In the medical literature only five cases of vitamin B12 related spinal cord changes have been identified by MRI; none was caused by a CVID syndrome.

 PMID:9598686

  6. Ambulatory Blood Pressure Monitoring in Spinal Cord Injury: Clinical Practicability

    PubMed Central

    Hubli, Michèle

    2014-01-01

    Abstract Trauma to the spinal cord often results not only in sensorimotor but also autonomic impairments. The loss of autonomic control over the cardiovascular system can cause profound blood pressure (BP) derangements in subjects with spinal cord injury (SCI) and may therefore lead to increased cardiovascular disease (CVD) risk in this population. The use of ambulatory blood pressure monitoring (ABPM) allows insights into circadian BP profiles, which have been shown to be of good prognostic value for cardiovascular morbidity and mortality in able-bodied subjects. Past studies in SCI subjects using ABPM have shown that alterations in circadian BP patterns are dependent on the spinal lesion level. Tetraplegic subjects with sensorimotor complete lesions have a decreased daytime arterial BP, loss of the physiological nocturnal BP dip, and higher circadian BP variability, including potentially life-threatening hypertensive episodes known as autonomic dysreflexia (AD), compared with paraplegic and able-bodied subjects. The proposed underlying mechanisms of these adverse BP alterations mainly are attributed to a lost or decreased central drive to sympathetic spinal preganglionic neurons controlling the heart and blood vessels. In addition, several maladaptive anatomical changes within the spinal cord and the periphery, as well as the general decrease of physical daily activity in SCI subjects, account for adverse BP changes. ABPM enables the identification of adverse BP profiles and the associated increased risk for CVD in SCI subjects. Concurrently, it also might provide a useful clinical tool to monitor improvements of AD and lost nocturnal dip after appropriate treatments in the SCI population. PMID:24175653

  7. Leveraging network connectivity for quality assurance of clinical display monitors.

    PubMed

    Gersten, Jennifer

    2012-01-01

    The VA Midwest Health Care Network, VISN 23, is one of 21 veteran integrated health service networks (VISN) under the Department of Veterans Affairs. There are approximately 300,000 imaging studies generated per year and currently more than 14,000 picture archiving and communication system (PACS) users in VISN 23. Biomedical Engineering Services within VISN 23 coordinates the provision of medical technology support. One emerging technology leverages network connectivity as a method of calibrating and continuously monitoring clinical display monitors in support of PACS. Utilizing a continuous calibration monitoring system, clinical displays can be identified as out of Digital Imaging and Communications in Medicine (DICOM) compliance through a centralized server. The technical group can receive immediate notification via e-mail and respond proactively. Previously, this problem could go unnoticed until the next scheduled preventive maintenance was performed. This system utilizes simple network management protocols (SNMP) and simple mail transfer protocols (SMTP) across a wide area network for real-time alerts from a centralized location. This central server supports and monitors approximately 320 clinical displays deployed across five states. Over the past three years of implementation in VISN 23, the remote calibration and monitoring capability has allowed for more efficient support of clinical displays and has enhanced patient safety by ensuring a consistent display of images on these clinical displays. PMID:22239357

  8. Considerations for integration of a physiological radar monitoring system with gold standard clinical sleep monitoring systems.

    PubMed

    Singh, Aditya; Baboli, Mehran; Gao, Xiaomeng; Yavari, Ehsan; Padasdao, Bryson; Soll, Bruce; Boric-Lubecke, Olga; Lubecke, Victor

    2013-01-01

    A design for a physiological radar monitoring system (PRMS) that can be integrated with clinical sleep monitoring systems is presented. The PRMS uses two radar systems at 2.45 GHz and 24 GHz to achieve both high sensitivity and high resolution. The system can acquire data, perform digital processing and output appropriate conventional analog outputs with a latency of 130 ms, which can be recorded and displayed by a gold standard sleep monitoring system, along with other standard sensor measurements.

  9. Considerations for integration of a physiological radar monitoring system with gold standard clinical sleep monitoring systems.

    PubMed

    Singh, Aditya; Baboli, Mehran; Gao, Xiaomeng; Yavari, Ehsan; Padasdao, Bryson; Soll, Bruce; Boric-Lubecke, Olga; Lubecke, Victor

    2013-01-01

    A design for a physiological radar monitoring system (PRMS) that can be integrated with clinical sleep monitoring systems is presented. The PRMS uses two radar systems at 2.45 GHz and 24 GHz to achieve both high sensitivity and high resolution. The system can acquire data, perform digital processing and output appropriate conventional analog outputs with a latency of 130 ms, which can be recorded and displayed by a gold standard sleep monitoring system, along with other standard sensor measurements. PMID:24110139

  10. Multiparametric monitoring of tissue vitality in clinical situations

    NASA Astrophysics Data System (ADS)

    Mayevsky, Avraham; Manor, Tamar; Meilin, Sigal; Razon, Nisim; Ouknine, George E.; Ornstein, Eugene

    2001-05-01

    The monitoring of various tissue's physiological and biochemical parameters is one of the tools used by the clinicians to improve diagnosis capacity. As of today, the very few devices developed for real time clinical monitoring of tissue vitality are based on a single parameter measurement. Tissue energy balance could be defined as the ratio between oxygen or energy supply and demand. In order to determine the vitality of the brain, for example, it is necessary to measure at least the following 3 parameters: Energy Demand--potassium ion homeostasis; Energy Supply-- cerebral blood flow; Energy Balance--mitochondrial NADH redox state. For other tissues one can measure various energy demand processes specific to the tested organ. We have developed a unique multiparametric monitoring system tested in various experimental and clinical applications. The multiprobe assembly (MPA) consists of a fiber optic probe for measurement of tissue blood flow and mitochondrial NADH redox state, ion selective electrodes (K+, Ca2+, H+), electrodes for electrical activities (ECoG or ECG and DC potential), temperature probe and for monitoring the brain - Intra Cranial Pressure probe (ICP). The computerized monitoring system was used in the neurological intensive care unit to monitor comatose patients for a period of 24-48 hours. Also, a simplified MPA was used in the neurosurgical operating room or during organ transplantation procedure. It was found that the MPA could be used in clinical situations and that the data collected has a significant diagnosis value for the medical team.

  11. Clinical Management of Multiple Sclerosis Through Home Telehealth Monitoring

    PubMed Central

    Wallin, Mitchell T.; Sloan, Alicia; Maloni, Heidi; Kane, Robert; Martz, Lore; Haselkorn, Jodie K.

    2013-01-01

    This study examined the feasibility of using home telehealth monitoring to improve clinical care and promote symptom self-management among veterans with multiple sclerosis (MS). This was a longitudinal cohort study linking mailed survey data at baseline and 6-month follow-up with information from home telehealth monitors. The study was conducted in two large Department of Veterans Affairs (VA) MS clinics in Seattle, Washington, and Washington, DC, and involved 41 veterans with MS. The measures were demographic information and data from a standardized question set using a home telehealth monitor. Participants reported moderate levels of disability (median Expanded Disability Status Scale [EDSS] score, 6.5) and substantial distance from the nearest VA MS clinic (mean distance, 93.6 miles). Of the participants, 61.0% reported current use of MS disease-modifying treatments. A total of 85.4% of participants provided consistent data from home monitoring. Overall satisfaction with home telehealth monitoring was high, with 87.5% of participants rating their experience as good or better. The most frequently reported symptoms at month 1 were fatigue (95.1%), depression (78.0%), and pain (70.7%). All symptoms were reported less frequently by month 6, with the greatest reduction in depression (change of 23.2 percentage points), although these changes were not statistically significant. Home telehealth monitoring is a promising tool for the management of chronic disease, although substantial practical barriers to efficient implementation remain. PMID:24453757

  12. Holoprosencephaly: examples of clinical variability and etiologic heterogeneity.

    PubMed

    Corsello, G; Buttitta, P; Cammarata, M; Lo Presti, A; Maresi, E; Zumpani, L; Giuffrè, L

    1990-10-01

    Clinical variability and causal heterogeneity of holoprosencephaly is discussed in relation to several newborn infants with cyclopia (cases 4,5,6), cebocephaly (cases 2,3), and premaxillary agenesis (case 1). In subjects with holoprosencephaly, the presence of multiple malformations is an indicator of concomitant chromosome aberrations, as in present case 1 (Down syndrome) and case 3 (trisomy 13). Cases 5 and 6 are two monozygotic twins with the same type of cyclopia and alobar holoprosencephaly recognized by prenatal ultrasonography. The diagnostic importance of ultrasonographic, cytogenetic, and pathological studies is pointed out in view of etiologic evaluation, genetic counseling, and prevention of holoprosencephaly. PMID:2147361

  13. Alterations in clinical, hematological and metabolic variables in bovine neonatal endotoxemia.

    PubMed Central

    Gerros, T C; Semrad, S D; Proctor, R A

    1995-01-01

    Endotoxemia is an important cause of morbidity and mortality in the neonate. Although many models are used to study the problem, none completely simulates the natural disease. To more clearly define a bovine neonatal endotoxemia model we studied the effects of dose of endotoxin on clinical, hematological and biochemical variables. Thirty-four neonatal calves were administered Escherichia coli endotoxin (LPS) at 0 (0.9% saline solution), 0.2, 2.0 or 20 micrograms/kg, by either IV bolus or infusion over 50 minutes. Variables monitored included mean arterial blood pressure (MAP), leukocyte (WBC) count, plasma glucose and lactate concentrations and clinical status. All LPS-treated calves displayed similar clinical signs within one hour. Dose-dependent differences in response to LPS among groups became evident over time. Substantial dose-dependent changes in attitude, appetite, mucous membrane character, capillary refill time, MAP, plasma glucose and lactate concentrations, and WBC count were noted in LPS-treated calves. Higher doses of LPS induced a more prolonged clinical response and significantly (p < 0.05) greater hypotension, lacticemia and hypoglycemia. While dose altered the response to endotoxin, the method of administration had no overall effect on the variables measured. PMID:7704840

  14. Holter Monitoring and Loop Recorders: From Research to Clinical Practice

    PubMed Central

    Ambrosini, Francesco; Lombardi, Federico

    2016-01-01

    Holter monitors are tools of proven efficacy in diagnosing and monitoring cardiac arrhythmias. Despite the fact their use is widely prescribed by general practitioners, little is known about their evolving role in the management of patients with cryptogenic stroke, paroxysmal atrial fibrillation, unexplained recurrent syncope and risk stratification in implantable cardioverter defibrillator or pacemaker candidates. New Holter monitoring technologies and loop recorders allow prolonged monitoring of heart rhythm for periods from a few days to several months, making it possible to detect infrequent arrhythmias in patients of all ages. This review discusses the advances in this area of arrhythmology and how Holter monitors have improved the clinical management of patients with suspected cardiac rhythm diseases.

  15. Holter Monitoring and Loop Recorders: From Research to Clinical Practice

    PubMed Central

    Ambrosini, Francesco; Lombardi, Federico

    2016-01-01

    Holter monitors are tools of proven efficacy in diagnosing and monitoring cardiac arrhythmias. Despite the fact their use is widely prescribed by general practitioners, little is known about their evolving role in the management of patients with cryptogenic stroke, paroxysmal atrial fibrillation, unexplained recurrent syncope and risk stratification in implantable cardioverter defibrillator or pacemaker candidates. New Holter monitoring technologies and loop recorders allow prolonged monitoring of heart rhythm for periods from a few days to several months, making it possible to detect infrequent arrhythmias in patients of all ages. This review discusses the advances in this area of arrhythmology and how Holter monitors have improved the clinical management of patients with suspected cardiac rhythm diseases. PMID:27617093

  16. Holter Monitoring and Loop Recorders: From Research to Clinical Practice.

    PubMed

    Galli, Alessio; Ambrosini, Francesco; Lombardi, Federico

    2016-08-01

    Holter monitors are tools of proven efficacy in diagnosing and monitoring cardiac arrhythmias. Despite the fact their use is widely prescribed by general practitioners, little is known about their evolving role in the management of patients with cryptogenic stroke, paroxysmal atrial fibrillation, unexplained recurrent syncope and risk stratification in implantable cardioverter defibrillator or pacemaker candidates. New Holter monitoring technologies and loop recorders allow prolonged monitoring of heart rhythm for periods from a few days to several months, making it possible to detect infrequent arrhythmias in patients of all ages. This review discusses the advances in this area of arrhythmology and how Holter monitors have improved the clinical management of patients with suspected cardiac rhythm diseases.

  17. Holter Monitoring and Loop Recorders: From Research to Clinical Practice.

    PubMed

    Galli, Alessio; Ambrosini, Francesco; Lombardi, Federico

    2016-08-01

    Holter monitors are tools of proven efficacy in diagnosing and monitoring cardiac arrhythmias. Despite the fact their use is widely prescribed by general practitioners, little is known about their evolving role in the management of patients with cryptogenic stroke, paroxysmal atrial fibrillation, unexplained recurrent syncope and risk stratification in implantable cardioverter defibrillator or pacemaker candidates. New Holter monitoring technologies and loop recorders allow prolonged monitoring of heart rhythm for periods from a few days to several months, making it possible to detect infrequent arrhythmias in patients of all ages. This review discusses the advances in this area of arrhythmology and how Holter monitors have improved the clinical management of patients with suspected cardiac rhythm diseases. PMID:27617093

  18. Ultrasound clinical progress monitoring: Who, where and how?

    PubMed

    Harrison, Gill

    2015-11-01

    Prior to assessment of final ultrasound clinical competency it is important to monitor clinical progress, provide high quality feedback and encourage skills development. The role of the supervisor, mentor and assessor are fundamental to the on-going progress monitoring of ultrasound trainees. This article forms the second part of a larger project which was to elicit ultrasound practitioners' opinions on how progress should be monitored, where and by whom. An on-line questionnaire was used to gain opinions from ultrasound practitioners. Totally, 116 responses were received from professionals with an interest in ultrasound assessment. Results suggested that experienced, qualified ultrasound practitioners should undertake the role of supervisor and assessor, having been prepared for that role by the training centre. Formative monitoring should take place both within the clinical department and possibly the training centre, using a range of methods. Following completion of the training, practitioners should have a preceptorship period to consolidate their knowledge and skills for 3 to 6 months or until further competencies have been demonstrated. Formative progress monitoring should be a recognised part of ultrasound training. Essentially, staff undertaking supervision and assessor roles should be supported and trained to ensure a high quality, consistent learning experience for ultrasound trainees. Additionally, they should provide appropriate feedback to the trainee and education centre.

  19. Plasma level monitoring of antidepressants: theoretical basis and clinical application.

    PubMed

    Gram, L F; Kragh-Sørensen, P; Kristensen, C B; Møller, M; Pedersen, O L; Thayssen, P

    1984-01-01

    For TCAs there is a strong rationale for drug level monitoring in clinical therapy. Therapeutic drug concentration ranges have been established in controlled studies with NT, imipramine, and AT. It has been shown that by appropriate choice of antidepressant and close monitoring of drug levels, treatment with antidepressants in elderly and other risk patients can be carried out effectively and safely, reducing the use of electroconvulsive therapy. Finally, the practical clinical use of antidepressant concentration measurements is now feasible and not expensive, and the analytical procedures can be established in most hospital settings. On the basis of these premises the following can be concluded: Plasma level monitoring should be used as a routine for imipramine, NT, and AT. Further plasma level studies on other antidepressants and in overdose cases should be initiated. Plasma level monitoring is indispensable in clinical research on antidepressants (trials, new drugs, toxicology). Pharmacokinetic considerations may be useful to determine which receptor effects are clinically relevant in therapy and toxicology. PMID:6380231

  20. All-Sky Monitoring of Variable Sources with Fermi GBM

    NASA Technical Reports Server (NTRS)

    Wilson-Hodge, Colleen A.; Finger, Mark; Camero-Arranz, Ascension; Becklen, Elif; Jenke, Peter; Cpe. K/ K/; Steele, Iain; Case, Gary; Cherry, Mike; Rodi, James; Bhat, Narayana

    2011-01-01

    Using the Gamma ray Burst Monitor (GBM) on Fermi, we monitor the transient hard X-ray/soft gamma ray sky. The twelve GBM NaI detectors span 8 keV to 1 MeV, while the two BGO detectors span 150 keV to 40 MeV. We use the Earth occultation technique to monitor a number of sources, including X-ray binaries, AGN, and solar flaring activity. Our monitoring reveals predictable and unpredictable phenomena such as transient outbursts and state changes. With GBM we also track the pulsed flux and spin frequency of accretion powered pulsars using epoch-folding techniques. Searches for quasi-periodic oscillations and X-ray bursts are also possible with GBM all-sky monitoring. Highlights from the Earth Occultation and Pulsar projects will be presented including our recent surprising discovery of variations in the total flux from the Crab. Inclusion of an all-sky monitor is crucial for a successful future X-ray timing mission.

  1. Data-driven risk identification in phase III clinical trials using central statistical monitoring.

    PubMed

    Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

    2016-02-01

    Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not.

  2. Data-driven risk identification in phase III clinical trials using central statistical monitoring.

    PubMed

    Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

    2016-02-01

    Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not. PMID:26233672

  3. SEP Montage Variability Comparison during Intraoperative Neurophysiologic Monitoring

    PubMed Central

    Hanson, Christine; Lolis, Athena Maria; Beric, Aleksandar

    2016-01-01

    Intraoperative monitoring is performed to provide real-time assessment of the neural structures that can be at risk during spinal surgery. Somatosensory evoked potentials (SEPs) are the most commonly used modality for intraoperative monitoring. SEP stability can be affected by many factors during the surgery. This study is a prospective review of SEP recordings obtained during intraoperative monitoring of instrumented spinal surgeries that were performed for chronic underlying neurologic and neuromuscular conditions, such as scoliosis, myelopathy, and spinal stenosis. We analyzed multiple montages at the baseline, and then followed their development throughout the procedure. Our intention was to examine the stability of the SEP recordings throughout the surgical procedure on multiple montages of cortical SEP recordings, with the goal of identifying the appropriate combination of the least number of montages that gives the highest yield of monitorable surgeries. Our study shows that it is necessary to have multiple montages for SEP recordings, as it reduces the number of non-monitorable cases, improves IOM reliability, and therefore could reduce false positives warnings to the surgeons. Out of all the typical montages available for use, our study has shown that the recording montage Cz-C4/Cz-C3 (Cz-Cc) is the most reliable and stable throughout the procedure and should be the preferred montage followed throughout the surgery. PMID:27445969

  4. SEP Montage Variability Comparison during Intraoperative Neurophysiologic Monitoring.

    PubMed

    Hanson, Christine; Lolis, Athena Maria; Beric, Aleksandar

    2016-01-01

    Intraoperative monitoring is performed to provide real-time assessment of the neural structures that can be at risk during spinal surgery. Somatosensory evoked potentials (SEPs) are the most commonly used modality for intraoperative monitoring. SEP stability can be affected by many factors during the surgery. This study is a prospective review of SEP recordings obtained during intraoperative monitoring of instrumented spinal surgeries that were performed for chronic underlying neurologic and neuromuscular conditions, such as scoliosis, myelopathy, and spinal stenosis. We analyzed multiple montages at the baseline, and then followed their development throughout the procedure. Our intention was to examine the stability of the SEP recordings throughout the surgical procedure on multiple montages of cortical SEP recordings, with the goal of identifying the appropriate combination of the least number of montages that gives the highest yield of monitorable surgeries. Our study shows that it is necessary to have multiple montages for SEP recordings, as it reduces the number of non-monitorable cases, improves IOM reliability, and therefore could reduce false positives warnings to the surgeons. Out of all the typical montages available for use, our study has shown that the recording montage Cz-C4/Cz-C3 (Cz-Cc) is the most reliable and stable throughout the procedure and should be the preferred montage followed throughout the surgery. PMID:27445969

  5. Clinical outcomes and adverse effect monitoring in allergic rhinitis.

    PubMed

    Juniper, Elizabeth F; Ståhl, Elisabeth; Doty, Richard L; Simons, F Estelle R; Allen, David B; Howarth, Peter H

    2005-03-01

    The subjective recording in diary cards of symptoms of itch, sneeze, nose running, and blockage, with the use of a rating scale to indicate the level of severity, is usual for clinical trials in allergic rhinitis. The primary outcome measure is usually a composite score that enables a single total symptoms score endpoint. It is appreciated, however, that rhinitis has a greater effect on the individual than is reflected purely by the recording of anterior nasal symptoms. Nasal obstruction is troublesome and may lead to sleep disturbance in addition to impaired daytime concentration and daytime sleepiness. These impairments affect school and work performance. Individuals with rhinitis find it socially embarrassing to be seen sneezing, sniffing, or blowing their nose. To capture these and other aspects of the disease-specific health-related quality of life, questionnaires such as the Rhinoconjunctivitis Quality of Life Questionnaire have been developed and validated for clinical trial use. The adoption of health-related quality of life questionnaires into clinical trials broadens the information obtained regarding the effect of the therapeutic intervention and helps focus on issues relevant to the individual patient. It must be appreciated that it is not only the disease that may adversely affect health-related quality of life; administered therapy, although intended to be beneficial, may also cause health impairment. Adverse-event monitoring is thus essential in clinical trials. The first-generation H 1 -histamines, because of their effect on central H 1 -receptors, are classically associated with central nervous system (CNS) effects such as sedation. Although this is not always perceived by the patient, it is clearly evident with objective performance testing, and positron emission tomography scanning has directly demonstrated the central H 1 -receptor occupancy. The second-generation H 1 -antihistamines have reduced central H 1 -receptor occupancy and considerably

  6. Latent class instrumental variables: a clinical and biostatistical perspective.

    PubMed

    Baker, Stuart G; Kramer, Barnett S; Lindeman, Karen S

    2016-01-15

    In some two-arm randomized trials, some participants receive the treatment assigned to the other arm as a result of technical problems, refusal of a treatment invitation, or a choice of treatment in an encouragement design. In some before-and-after studies, the availability of a new treatment changes from one time period to this next. Under assumptions that are often reasonable, the latent class instrumental variable (IV) method estimates the effect of treatment received in the aforementioned scenarios involving all-or-none compliance and all-or-none availability. Key aspects are four initial latent classes (sometimes called principal strata) based on treatment received if in each randomization group or time period, the exclusion restriction assumption (in which randomization group or time period is an instrumental variable), the monotonicity assumption (which drops an implausible latent class from the analysis), and the estimated effect of receiving treatment in one latent class (sometimes called efficacy, the local average treatment effect, or the complier average causal effect). Since its independent formulations in the biostatistics and econometrics literatures, the latent class IV method (which has no well-established name) has gained increasing popularity. We review the latent class IV method from a clinical and biostatistical perspective, focusing on underlying assumptions, methodological extensions, and applications in our fields of obstetrics and cancer research.

  7. Monitoring cancer stem cells: insights into clinical oncology

    PubMed Central

    Lin, ShuChen; Xu, YingChun; Gan, ZhiHua; Han, Kun; Hu, HaiYan; Yao, Yang; Huang, MingZhu; Min, DaLiu

    2016-01-01

    Cancer stem cells (CSCs) are a small, characteristically distinctive subset of tumor cells responsible for tumor initiation and progression. Several treatment modalities, such as surgery, glycolytic inhibition, driving CSC proliferation, immunotherapy, and hypofractionated radiotherapy, may have the potential to eradicate CSCs. We propose that monitoring CSCs is important in clinical oncology as CSC populations may reflect true treatment response and assist with managing treatment strategies, such as defining optimal chemotherapy cycles, permitting pretreatment cancer surveillance, conducting a comprehensive treatment plan, modifying radiation treatment, and deploying rechallenge chemotherapy. Then, we describe methods for monitoring CSCs. PMID:26929644

  8. Multi-modality neuro-monitoring: conventional clinical trial design.

    PubMed

    Georgiadis, Alexandros L; Palesch, Yuko Y; Zygun, David; Hemphill, J Claude; Robertson, Claudia S; Leroux, Peter D; Suarez, Jose I

    2015-06-01

    Multi-modal monitoring has become an integral part of neurointensive care. However, our approach is at this time neither standardized nor backed by data from randomized controlled trials. The goal of the second Neurocritical Care Research Conference was to discuss research priorities in multi-modal monitoring, what research tools are available, as well as the latest advances in clinical trial design. This section of the meeting was focused on how such a trial should be designed so as to maximize yield and avoid mistakes of the past.

  9. Multi-modality neuro-monitoring: conventional clinical trial design.

    PubMed

    Georgiadis, Alexandros L; Palesch, Yuko Y; Zygun, David; Hemphill, J Claude; Robertson, Claudia S; Leroux, Peter D; Suarez, Jose I

    2015-06-01

    Multi-modal monitoring has become an integral part of neurointensive care. However, our approach is at this time neither standardized nor backed by data from randomized controlled trials. The goal of the second Neurocritical Care Research Conference was to discuss research priorities in multi-modal monitoring, what research tools are available, as well as the latest advances in clinical trial design. This section of the meeting was focused on how such a trial should be designed so as to maximize yield and avoid mistakes of the past. PMID:25832350

  10. Monitoring Variability and Change in Children's Spelling Strategies

    ERIC Educational Resources Information Center

    Farrington-Flint, Lee; Stash, Amanda; Stiller, James

    2008-01-01

    This study examined the role of variability and change in children's strategy performance within the context of spelling. The spelling ability of 34 eight- to nine-year-olds was examined using an experimental spelling task comprising 45 items, which varied with regard to rime unit frequency. The spelling task incorporated a series of consistent,…

  11. Implications of Variability in Clinical Bedside Swallowing Assessment Practices by Speech Language Pathologists.

    PubMed

    McAllister, Sue; Kruger, Samantha; Doeltgen, Sebastian; Tyler-Boltrek, Emma

    2016-10-01

    Speech language pathology (SLP) clinical bedside swallowing assessments (CBSA) are a cornerstone of quality care for patients in acute hospitals who have dysphagia. The CBSA informs clinical diagnosis and decisions regarding further instrumental assessment, and is used to develop a management plan and monitor progress. However, self-report and retrospective research shows that SLPs are highly variable in their use of assessment components considered by experts to be important for quality CBSA, casting doubt on the validity and reliability of CBSA. This prospective study describes the components included by SLPs when designing a standardised evidence based dysphagia assessment protocol for acute care patients and observed patterns of component use. The findings confirm that SLPs use the CBSA for multiple purposes beyond diagnosis of aspiration risk and dysphagia presence/severity. They are highly variable in their use of certain components, but also demonstrate consistent use of a core set. It is apparent that SLPs prioritise the application of clinical reasoning to tailor their CBSA to the patient over following a highly structured item-based protocol. The variability in component use likely reflects a complex clinical reasoning process that draws on a wide variety of information combined with expert knowledge as is also observed in many other medical specialties. Rather than promoting the standardisation of CBSA protocols that constrain SLP practice to strict item-based assessment protocols, consideration should be given to promoting the value and facilitating the clinical reasoning process that supports the utility of the CBSA for diagnosis, patient centred management and treatment planning. PMID:27405423

  12. Defining, monitoring and combining safety information in clinical trials.

    PubMed

    Enas, G G; Goldstein, D J

    Assessment of clinical trial safety data for industry, regulatory agencies, medical practitioners and patients requires definition and measurement, monitoring, and overall analysis. Prospective 'safety' definitions and reliable measurement tools reduce inefficient data collection and improve the validity of resulting analyses. Statistical tools can help investigators monitor safety data from controlled clinical trials and help improve post-marketing surveillance. Also, when evaluating overall safety, one needs to assess all available information by combining information from many trials and other sources. Planning for this combined assessment, incorporating flexibility to assess unanticipated yet important nuances in individual trials, may be more important than the actual statistical analysis method used. A keen awareness of the future needs of consumers of this information is quite important. Some current proposals to combine safety information will be discussed.

  13. Spectral Monitoring of NGC 1365: Nucleus and Variable ULX

    NASA Technical Reports Server (NTRS)

    Mushotzky, Richard (Technical Monitor); Fabbiano, G.

    2004-01-01

    A letter has been submitted to ApJ, and is in the final stages of revision on the spectral variability of the nuclear source. We presented multiple Chandra and XMM-Newton observations of the Seyfert Galaxy NGC 1365, which shows the most dramatic X-ray spectral changes observed so far in an AGN: the source switched from reflection dominated to Compton- thin and back in just 6 weeks. During this time the soft thermal component, arising from a 1-kpc region around the center, remained constant. The reflection component is constant at all timescales, and its flux is a fraction of 5% or higher of the direct 2-10 keV emission, implying the presence of thick gas covering a big fraction of the solid angle. The presence of this gas, and the hst variability time scale, suggest that the Compton-thick to Compton thin change is due to variation in the line-of-sight absorber, rather than to extreme intrinsic emission variability. We discuss a structure of the circumnuclear absorbed reflector which can explain the observed X-ray spectral and temporal properties. But these important results come only from scratching the surface of the data, since we did not need any detailed spectral analysis to distinguish between the Compton thick and Compton thin states of the source, the difference in both spectral shape and flux being huge.

  14. [Research on establishment of clinical safety intensive hospital monitoring net of traditional Chinese medicine injection].

    PubMed

    Wang, Lian-Xin; Xie, Yan-Ming; Wang, Zhi-Fei

    2012-09-01

    The establishment of clinical safety monitoring net of traditional Chinese medicine (TCM) injection is the one of the key issues of the monitoring work. The monitoring net is including varieties of types of net, such as clinical monitoring net, multimedia network platform, the net of experts or talents. The paper will introduce the establishing method of clinical safety monitoring net, the establishing of clinical safety monitoring net, and the establishing of network based on the internet, the knowledge network construction of experts, the net construction of talents are all included, to assure the development for clinical safety monitoring work.

  15. Ambulatory Blood Pressure Monitoring in Clinical Practice: A Review

    PubMed Central

    Viera, Anthony J.; Shimbo, Daichi

    2016-01-01

    Ambulatory blood pressure monitoring offers the ability to collect blood pressure readings several times an hour across a 24-hour period. Ambulatory blood pressure monitoring facilitates the identification of white-coat hypertension, the phenomenon whereby certain individuals who are not on antihypertensive medication show elevated blood pressure in a clinical setting but show non-elevated blood pressure averages when assessed by ambulatory blood pressure monitoring. Additionally, readings can be segmented into time windows of particular interest, e.g., mean daytime and nighttime values. During sleep, blood pressure typically decreases, or dips, such that mean sleep blood pressure is lower than mean awake blood pressure. A non-dipping pattern and nocturnal hypertension are strongly associated with increased cardiovascular morbidity and mortality. Approximately 70% of individuals dip ≥10% at night, while 30% have non-dipping patterns, when blood pressure remains similar to daytime average, or occasionally rises above daytime average. The various blood pressure categorizations afforded by ambulatory blood pressure monitoring are valuable for clinical management of high blood pressure since they increase accuracy for diagnosis and the prediction of cardiovascular risk. PMID:25107387

  16. Longterm Optical Monitoring of a Sample of Low Frequency Radio Variables

    NASA Astrophysics Data System (ADS)

    Smith, A. G.; Leacock, R. J.; Pica, A. J.

    A program of long-term optical monitoring of variable extragalactic sources has been carried on at Rosemary Hill Observatory since 1968. The principal instrument used is the 76-cm reflector; the work is done photographically at the f/4 Newtonian focus. Currently about 230 extragalactic sources are monitored. Results for some selected sources are presented.

  17. Use of High Resolution Mobile Monitoring Techniques to Assess Near-Road Air Quality Variability

    EPA Science Inventory

    This presentation provides a description of the techniques used to develop and conduct effective mobile monitoring studies. It also provides a summary of mobile monitoring assessment studies that have been used to assess near-road concentrations and the variability of pollutant l...

  18. Students, Teachers, and Schools as Sources of Variability, Integrity, and Sustainability in Implementing Progress Monitoring

    ERIC Educational Resources Information Center

    Bolt, Daniel M.; Ysseldyke, Jim; Patterson, Michael J.

    2010-01-01

    A three-level variance decomposition analysis was used to examine the sources of variability in implementation of a technology-enhanced progress monitoring system within each year of a 2-year study using a randomized-controlled design. We show that results of technology-enhanced progress monitoring are not necessarily a measure of student…

  19. Use of High Resolution Mobile Monitoring Techniques to Assess Near Road Air Quality Variability

    EPA Science Inventory

    This presentation provides a description of the techniques used to develop and conduct effective mobile monitoring studies. It also provides a summary of mobile monitoring assessment studies that have been used to assess near-road concentrations and the variability of pollutant l...

  20. Monitoring of clinical signs in goats with transmissible spongiform encephalopathies

    PubMed Central

    2010-01-01

    Background As there is limited information about the clinical signs of BSE and scrapie in goats, studies were conducted to describe the clinical progression of scrapie and BSE in goats and to evaluate a short clinical protocol for its use in detecting scrapie-affected goats in two herds with previously confirmed scrapie cases. Clinical assessments were carried out in five goats intracerebrally infected with the BSE agent as well as five reported scrapie suspects and 346 goats subject to cull from the two herds, 24 of which were retained for further monitoring. The brain and selected lymphoid tissue were examined by postmortem tests for disease confirmation. Results The sensitivity and specificity of the short clinical protocol in detecting a scrapie case in the scrapie-affected herds was 3.9% and 99.6%, respectively, based on the presence of tremor, positive scratch test, extensive hair loss, ataxia and absent menace response. All BSE- and scrapie-affected goats displayed abnormalities in sensation (over-reactivity to external stimuli, startle responses, pruritus, absent menace response) and movement (ataxia, tremor, postural deficits) at an advanced clinical stage but the first detectable sign associated with scrapie or BSE could vary between animals. Signs of pruritus were not always present despite similar prion protein genotypes. Clinical signs of scrapie were also displayed by two scrapie cases that presented with detectable disease-associated prion protein only in lymphoid tissues. Conclusions BSE and scrapie may present as pruritic and non-pruritic forms in goats. Signs assessed for the clinical diagnosis of scrapie or BSE in goats should include postural and gait abnormalities, pruritus and visual impairment. However, many scrapie cases will be missed if detection is solely based on the display of clinical signs. PrPd accumulation in the brain appeared to be related to the severity of clinical disease but not to the display of individual neurological signs

  1. Fecal indicator bacteria variability in samples pumped from monitoring wells.

    PubMed

    Kozuskanich, J; Novakowski, K S; Anderson, B C

    2011-01-01

    The detection of microbiological contamination in drinking water from groundwater wells is often made with a limited number of samples that are collected using traditional geochemical sampling protocols. The objective of this study is to examine the variability of fecal indicator bacteria, as observed using discrete samples, due to pumping. Two wells were instrumented as multilevel piezometers in a bedrock aquifer, and bacterial enumeration was conducted on a total of 166 samples (for total coliform, fecal coliform, Escherichia coli, and fecal streptococci) using standard membrane filtration methods. Five tests were conducted using pumping rates ranging from 0.3 to 17 L/min in a variety of purging scenarios, which included constant and variable (incremental increase and decrease) flow. The results clearly show a rapid and reproducible, 1 to 2 log-unit decrease in fecal indicator bacteria at the onset of pumping to stabilized, low-level concentrations prior to the removal of three to five well volumes. The pumping rate was not found to be correlated with the magnitude of observed bacterial counts. Based on the results, we suggest sampling protocols for fecal indicator bacteria that include multiple collections during the course of pumping, including early-time samples, and consider other techniques such as microscopic enumeration when assessing the source of bacteria from the well-aquifer system.

  2. A sequential procedure for monitoring clinical trials against historical controls.

    PubMed

    Xiong, Xiaoping; Tan, Ming; Boyett, James

    2007-03-30

    In this paper, we develop a sequential procedure to monitor clinical trials against historical controls. When there is a strong ethical concern about randomizing patients to existing treatment because biological and medical evidence suggests that the new treatment is potentially superior to the existing one, or when the enrollment is too limited for randomization of subjects into experimental and control groups, one can monitor the trial sequentially against historical controls if the historical data with required quality and sample size are available to form a valid reference for the trial. This design of trial is sometimes the only alternative to a randomized phase III trial design that is intended but not feasible in situations such as above. Monitoring this type of clinical trial leads to a statistical problem of comparing two population means in a situation in which data from one population are sequentially collected and compared with all data from the other population at each interim look. The proposed sequential procedures is based on the sequential conditional probability ratio test (SCPRT) by which the conclusion of the sequential test would be virtually the same as that arrived at by a non-sequential test based on all data at the planned end of the trial. We develop the sequential procedure by proposing a Brownian motion that emulates the test statistic, and then proposing an SCPRT that is adapted to the special properties of the trial. PMID:16900551

  3. Pharmacist monitoring of parenteral nutrition: clinical and cost effectiveness.

    PubMed

    Mutchie, K D; Smith, K A; MacKay, M W; Marsh, C; Juluson, D

    1979-06-01

    The effect of pharmacist involvement in total parenteral nutrient (TPN) therapy on patient outcome and cost of therapy was studied. Data from 26 patients who received standard TPN solutions without pharmacist monitoring (Group 1) were compared with those from 26 patients whose TPN therapy was individualized (by use of a minicomputer) and monitored by a pharmacist (Group 2). Six patients from each group who were 35 days of age or younger and who received TPN as the only caloric source for 8 to 20 days were compared for clinical response. Mean duration of TPN therapy increased form 12.3 +/- 9 days for Group 1 to 14.8 +/- 12 days for Group 2, and the TPN use rate for Group 2 was 31% above that for group 1. The mean daily charge for TPN was greater for Group 1 ($72.00) than for Group 2 ($50.18). The pharmacy's mean cost per course of TPN for Group 2 was $44.10 less than that for Group 1. The mean weight gain in Group 1 was significantly less (4 g/day) than that in Group 2 (17 g/day) (p less than 0.05) (for the six patients per group compared). Pharmacist monitoring of TPN reduced the pharmacy's costs and patient charges for TPN and improved the patients' clinical responses to TPN.

  4. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice

    PubMed Central

    Mosca, M.; Tani, C.; Aringer, M.; Bombardieri, S.; Boumpas, D.; Cervera, R.; Doria, A.; Jayne, D.; Khamashta, M. A.; Kuhn, A.; Gordon, C.; Petri, M.; Schneider, M.; Shoenfeld, Y.; Smolen, J. S.; Talarico, R.; Tincani, A.; Ward, M. M.; Werth, V. P.; Carmona, L.

    2014-01-01

    The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR Recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed. PMID:21224016

  5. Prediction of the Chemoreflex Gain by Common Clinical Variables in Heart Failure

    PubMed Central

    Mirizzi, Gianluca; Giannoni, Alberto; Ripoli, Andrea; Iudice, Giovanni; Bramanti, Francesca; Emdin, Michele; Passino, Claudio

    2016-01-01

    Background Peripheral and central chemoreflex sensitivity, assessed by the hypoxic or hypercapnic ventilatory response (HVR and HCVR, respectively), is enhanced in heart failure (HF) patients, is involved in the pathophysiology of the disease, and is under investigation as a potential therapeutic target. Chemoreflex sensitivity assessment is however demanding and, therefore, not easily applicable in the clinical setting. We aimed at evaluating whether common clinical variables, broadly obtained by routine clinical and instrumental evaluation, could predict increased HVR and HCVR. Methods and results 191 patients with systolic HF (left ventricular ejection fraction—LVEF—<50%) underwent chemoreflex assessment by rebreathing technique to assess HVR and HCVR. All patients underwent clinical and neurohormonal evaluation, comprising: echocardiogram, cardiopulmonary exercise test (CPET), daytime cardiorespiratory monitoring for breathing pattern evaluation. Regarding HVR, multivariate penalized logistic regression, Bayesian Model Averaging (BMA) logistic regression and random forest analysis identified, as predictors, the presence of periodic breathing and increased slope of the relation between ventilation and carbon dioxide production (VE/VCO2) during exercise. Again, the above-mentioned statistical tools identified as HCVR predictors plasma levels of N-terminal fragment of proBNP and VE/VCO2 slope. Conclusions In HF patients, the simple assessment of breathing pattern, alongside with ventilatory efficiency during exercise and natriuretic peptides levels identifies a subset of patients presenting with increased chemoreflex sensitivity to either hypoxia or hypercapnia. PMID:27099934

  6. Spatiotemporal Variability in Potential Evapotranspiration across an Urban Monitoring Network

    NASA Astrophysics Data System (ADS)

    Miller, G. R.; Long, M. R.; Fipps, G.; Swanson, C.; Traore, S.

    2015-12-01

    Evapotranspiration in urban and peri-urban environments is difficult to measure and predict. Barriers to accurate assessment include: the wide range of microclimates caused by urban canyons, heat islands, and park cooling; limited instrument fetch; and the patchwork of native soils, engineered soils, and hardscape. These issues combine to make an accurate assessment of the urban water balance difficult, as evapotranspiration calculations require accurate meteorological data. This study examines nearly three years of data collected by a network of 18 weather stations in Dallas, Texas, designed to measure potential evapotranspiration (ETo) in support of the WaterMyYard conservation program (http://WaterMyYard.org). Variability amongst stations peaked during the summer irrigation months, with a maximum standard deviation of 0.3 mm/hr and 4 mm/d. However, we found a significant degree of information overlap in the network. Most stations had a high correlation (>0.75) with at least one other station in the network, and many had a high correlation with at least 10 others. Correlation strength between station ETo measurements did not necessarily decrease with Euclidean distance, as expected, but was more closely related to differences in station elevation and longitude. Stations that had low correlations with others in the network typically had siting and fetch issues. ETo showed a strong temporal persistence; average station autocorrelation was 0.79 at a 1-hour lag and 0.70 at a 24-hour lag. To supplement the larger-scale network data, we deployed a mobile, vehicle-mounted weather station to quantify deviations present in the atmospheric drivers of evapotranspiration: temperature, humidity, wind, and solar radiation. Data were collected at mid-day during the irrigation season. We found differences in mobile and station ETo predictions up to 0.2 mm/hr, primarily driven by wind speed variations. These results suggest that ETo variation at the neighborhood to municipality

  7. Three-dimensional spatial variability of chemical properties around a monitored waste emplacement tunnel.

    PubMed

    Glassley, William E; Nitao, John J; Grant, Charles W

    2003-01-01

    Regulatory requirements and scientific needs require that the response of the geological system to emplacement of high level radioactive waste be monitored for long time periods. This monitoring activity is intended to establish the extent to which predicted behavior matches the actual response of the geological system to waste emplacement. To accomplish this goal, field measurements must be made at a spatial resolution that will determine whether the changes in parameters that are monitored conform to predicted evolutionary patterns. From the perspective of thermohydrological and geochemical parameters, key measurements will consider pore water compositional evolution and changes in matrix and fracture saturation in the near vicinity of waste emplacement tunnels. A massively parallel high performance computational platform (a 1200 processor IBM SP-2) was used to conduct three-dimensional, high resolution simulations to ascertain the spatial variability to be expected during a monitoring period. The results show that spatial variability in certain chemical parameters below waste emplacement tunnels provides robust targets for monitoring, but will require sampling on the scale of 10 s of centimeters in some locations, in order to rigorously test models. Chemical variability induced by relatively small changes in waste package heat output suggests that designing a monitoring program that will rigorously test model predictions will likely require high resolution, three-dimensional simulations of the "as-built" monitoring tunnels.

  8. An Early Clinical Study of Time-Domain Microwave Radar for Breast Health Monitoring.

    PubMed

    Porter, Emily; Coates, Mark; Popović, Milica

    2016-03-01

    This study reports on monthly scans of healthy patient volunteers with the clinical prototype of a microwave imaging system. The system uses time-domain measurements, and incorporates a multistatic radar approach to imaging. It operates in the 2-4 GHz range and contains 16 wideband sensors embedded in a hemispherical dielectric radome. The system has been previously tested on tissue phantoms in controlled experiments. With this system prototype, we scanned 13 patients (26 breasts) over an eight-month period, collecting a total of 342 breast scans. The goal of the study described in this paper was to investigate how the system measurements are impacted by multiple factors that are unavoidable in monthly monitoring of human subjects. These factors include both biological variability (e.g., tissue variations due to hormonal changes or weight gain) and measurement variability (e.g., inconsistencies in patient positioning, system noise). For each patient breast, we process the results of the monthly scans to assess the variability in both the raw measured signals and in the generated images. The significance of this study is that it quantifies how much variability should be anticipated when conducting microwave breast imaging of a healthy patient over a longer period. This is an important step toward establishing the feasibility of the microwave radar imaging system for frequent monitoring of breast health.

  9. An Early Clinical Study of Time-Domain Microwave Radar for Breast Health Monitoring.

    PubMed

    Porter, Emily; Coates, Mark; Popović, Milica

    2016-03-01

    This study reports on monthly scans of healthy patient volunteers with the clinical prototype of a microwave imaging system. The system uses time-domain measurements, and incorporates a multistatic radar approach to imaging. It operates in the 2-4 GHz range and contains 16 wideband sensors embedded in a hemispherical dielectric radome. The system has been previously tested on tissue phantoms in controlled experiments. With this system prototype, we scanned 13 patients (26 breasts) over an eight-month period, collecting a total of 342 breast scans. The goal of the study described in this paper was to investigate how the system measurements are impacted by multiple factors that are unavoidable in monthly monitoring of human subjects. These factors include both biological variability (e.g., tissue variations due to hormonal changes or weight gain) and measurement variability (e.g., inconsistencies in patient positioning, system noise). For each patient breast, we process the results of the monthly scans to assess the variability in both the raw measured signals and in the generated images. The significance of this study is that it quantifies how much variability should be anticipated when conducting microwave breast imaging of a healthy patient over a longer period. This is an important step toward establishing the feasibility of the microwave radar imaging system for frequent monitoring of breast health. PMID:26259214

  10. Monitoring multiple species: Estimating state variables and exploring the efficacy of a monitoring program

    USGS Publications Warehouse

    Mattfeldt, S.D.; Bailey, L.L.; Grant, E.H.C.

    2009-01-01

    Monitoring programs have the potential to identify population declines and differentiate among the possible cause(s) of these declines. Recent criticisms regarding the design of monitoring programs have highlighted a failure to clearly state objectives and to address detectability and spatial sampling issues. Here, we incorporate these criticisms to design an efficient monitoring program whose goals are to determine environmental factors which influence the current distribution and measure change in distributions over time for a suite of amphibians. In designing the study we (1) specified a priori factors that may relate to occupancy, extinction, and colonization probabilities and (2) used the data collected (incorporating detectability) to address our scientific questions and adjust our sampling protocols. Our results highlight the role of wetland hydroperiod and other local covariates in the probability of amphibian occupancy. There was a change in overall occupancy probabilities for most species over the first three years of monitoring. Most colonization and extinction estimates were constant over time (years) and space (among wetlands), with one notable exception: local extinction probabilities for Rana clamitans were lower for wetlands with longer hydroperiods. We used information from the target system to generate scenarios of population change and gauge the ability of the current sampling to meet monitoring goals. Our results highlight the limitations of the current sampling design, emphasizing the need for long-term efforts, with periodic re-evaluation of the program in a framework that can inform management decisions.

  11. Assessing hospitals' clinical risk management: Development of a monitoring instrument

    PubMed Central

    2010-01-01

    Background Clinical risk management (CRM) plays a crucial role in enabling hospitals to identify, contain, and manage risks related to patient safety. So far, no instruments are available to measure and monitor the level of implementation of CRM. Therefore, our objective was to develop an instrument for assessing CRM in hospitals. Methods The instrument was developed based on a literature review, which identified key elements of CRM. These elements were then discussed with a panel of patient safety experts. A theoretical model was used to describe the level to which CRM elements have been implemented within the organization. Interviews with CRM practitioners and a pilot evaluation were conducted to revise the instrument. The first nationwide application of the instrument (138 participating Swiss hospitals) was complemented by in-depth interviews with 25 CRM practitioners in selected hospitals, for validation purposes. Results The monitoring instrument consists of 28 main questions organized in three sections: 1) Implementation and organizational integration of CRM, 2) Strategic objectives and operational implementation of CRM at hospital level, and 3) Overview of CRM in different services. The instrument is available in four languages (English, German, French, and Italian). It allows hospitals to gather comprehensive and systematic data on their CRM practice and to identify areas for further improvement. Conclusions We have developed an instrument for assessing development stages of CRM in hospitals that should be feasible for a continuous monitoring of developments in this important area of patient safety. PMID:21144039

  12. Variability in biological monitoring of solvent exposure. I. Development of a population physiological model.

    PubMed Central

    Droz, P O; Wu, M M; Cumberland, W G; Berode, M

    1989-01-01

    Biological indicators of exposure to solvents are often characterised by a high variability that may be due either to fluctuations in exposure or individual differences in the workers. To describe and understand this variability better a physiological model for differing workers under variable industrial environments has been developed. Standard statistical distributions are used to simulate variability in exposure concentration, physical workload, body build, liver function, and renal clearance. For groups of workers exposed daily, the model calculates air monitoring indicators and biological monitoring results (expired air, blood, and urine). The results obtained are discussed and compared with measured data, both physiological (body build, cardiac output, alveolar ventilation) and toxicokinetic for six solvents: 1,1,1-trichloroethane, trichloroethylene, tetrachloroethylene, benzene, toluene, styrene, and their main metabolites. Possible applications of this population physiological model are presented. PMID:2765418

  13. Clinical variability and molecular heterogeneity in prostate cancer

    PubMed Central

    Shoag, Jonathan; Barbieri, Christopher E

    2016-01-01

    Prostate cancer is a clinically heterogeneous disease, with some men having indolent disease that can safely be observed, while others have aggressive, lethal disease. Over the past decade, researchers have begun to unravel some of the genomic heterogeneity that contributes to these varying clinical phenotypes. Distinct molecular sub-classes of prostate cancer have been identified, and the uniqueness of these sub-classes has been leveraged to predict clinical outcomes, design novel biomarkers for prostate cancer diagnosis, and develop novel therapeutics. Recent work has also elucidated the temporal and spatial heterogeneity of prostate cancer, helping us understand disease pathogenesis, response to therapy, and progression. New genomic techniques have provided us with a window into the remarkable clinical and genomic heterogeneity of prostate cancer, and this new perspective will increasingly impact patient care. PMID:27080479

  14. Can clinical tests help monitor human papillomavirus vaccine impact?

    PubMed

    Meites, Elissa; Lin, Carol; Unger, Elizabeth R; Steinau, Martin; Patel, Sonya; Markowitz, Lauri E; Hariri, Susan

    2013-09-01

    As immunization programs for human papillomavirus (HPV) are implemented more widely around the world, interest is increasing in measuring their impact. One early measurable impact of HPV vaccine is on the prevalence of specific HPV types in a population. In low-resource settings, a potentially attractive strategy would be to monitor HPV prevalence using clinical cervical cancer screening test results to triage specimens for HPV typing. We assessed this approach in a nationally representative population of U.S. females aged 14-59 years. Using self-collected cervico-vaginal swab specimens from 4,150 women participating in the National Health and Nutrition Examination Survey during 2003-2006, we evaluated type-specific HPV prevalence detected by the Roche linear array (LA) research test on all specimens, compared with type-specific HPV prevalence detected by LA conducted only on specimens positive by the digene hybrid capture 2 (HC-2) clinical test. We calculated weighted prevalence estimates and their 95% confidence intervals (CIs), and examined relative type-specific HPV prevalence according to the two testing approaches. The population prevalence of oncogenic HPV vaccine types 16/18 was 6.2% (CI:5.4-7.1) by LA if all specimens were tested, and 2.4% (CI:1.9-3.0) if restricted to positive HC-2. Relative prevalence of individual HPV types was similar for both approaches. Compared with typing all specimens, a triage approach would require testing fewer specimens, but a greater reduction in HPV prevalence or a larger group of specimens would be needed to detect vaccine impact. Further investigation is warranted to inform type-specific HPV monitoring approaches around the world.

  15. The Gaia spectrophotometric standard stars survey - III. Short-term variability monitoring

    NASA Astrophysics Data System (ADS)

    Marinoni, S.; Pancino, E.; Altavilla, G.; Bellazzini, M.; Galleti, S.; Tessicini, G.; Valentini, G.; Cocozza, G.; Ragaini, S.; Braga, V.; Bragaglia, A.; Federici, L.; Schuster, W. J.; Carrasco, J. M.; Castro, A.; Figueras, F.; Jordi, C.

    2016-11-01

    We present the results of the short-term constancy monitoring of candidate Gaia Spectrophotometric Standard Stars (SPSS). We obtained time series of typically 1.24 h - with sampling periods from 1-3 min to a few hours, depending on the case - to monitor the constancy of our candidate SPSS down to 10 mmag, as required for the calibration of Gaia photometric data. We monitored 162 out of a total of 212 SPSS candidates. The observing campaign started in 2006 and finished in 2015, using 143 observing nights on nine different instruments covering both hemispheres. Using differential photometry techniques, we built light curves with a typical precision of 4 mmag, depending on the data quality. As a result of our constancy assessment, 150 SPSS candidates were validated against short-term variability, and only 12 were rejected because of variability including some widely used flux standards such as BD+174708, SA 105-448, 1740346, and HD 37725.

  16. Continuous intra-arterial blood gas monitoring. A clinical experience.

    PubMed

    Paolillo, G; Tosoni, A; Mariani, M A; Venturino, M

    1994-01-01

    Miniaturized sensors, based upon the principles of optical fluorescence, can measure in vivo the pH, pCO2 value and pO2 value of blood. In this report we studied continuous intra-arterial blood gas monitoring in 27 patients undergoing cardiac surgery (no. 16 coronary artery by-pass grafting, no. 2 valvular surgery) and major vascular surgery (no. 9 abdominal aortic aneurysms). Total duration of continuous intra-arterial blood gas monitoring was 677 hours, with a ratio of 25.0 +/- 14.8 hours/patient (range 4-96 hours). The in vitro values of pH, pCO2 and pO2 were compared to simultaneous records from the fiberoptic sensor for each of the 283 arterial blood gas samples obtained, by means of linear regression and Bland-Altman method, in order to test the correlation and the agreement between the two methods of measuring. For pH average bias was -0.023 and intersensor precision was 0.028, with a strong correlation (R = 0.92; p < 0.001) and agreement. For pCO2 the average bias was 0.91 and the inter-sensor precision was 2.65, with a slight decrease in correlation (R = 0.89; p < 0.001) and agreement. For pO2 average bias was -2.69 and the intersensor precision was 12.16, with a strong correlation (R = 0.97; p < 0.001) and agreement. In addition, we tested the reliability of the system for values of pO2 above 100 mmHg and we found a strong correlation (R = 0.96; p20.001) and agreement even for these clinical conditions, largely out of physiologic parameters. This study demonstrates the feasibility and reliability of continuous intra-arterial three-component PB 3300 (Puritan Bennett) blood gas monitoring. PMID:7800182

  17. Clinical results from a noninvasive blood glucose monitor

    NASA Astrophysics Data System (ADS)

    Blank, Thomas B.; Ruchti, Timothy L.; Lorenz, Alex D.; Monfre, Stephen L.; Makarewicz, M. R.; Mattu, Mutua; Hazen, Kevin

    2002-05-01

    Non-invasive blood glucose monitoring has long been proposed as a means for advancing the management of diabetes through increased measurement and control. The use of a near-infrared, NIR, spectroscopy based methodology for noninvasive monitoring has been pursued by a number of groups. The accuracy of the NIR measurement technology is limited by challenges related to the instrumentation, the heterogeneity and time-variant nature of skin tissue, and the complexity of the calibration methodology. In this work, we discuss results from a clinical study that targeted the evaluation of individual calibrations for each subject based on a series of controlled calibration visits. While the customization of the calibrations to individuals was intended to reduce model complexity, the extensive requirements for each individual set of calibration data were difficult to achieve and required several days of measurement. Through the careful selection of a small subset of data from all samples collected on the 138 study participants in a previous study, we have developed a methodology for applying a single standard calibration to multiple persons. The standard calibrations have been applied to a plurality of individuals and shown to be persistent over periods greater than 24 weeks.

  18. Advanced clinical monitoring: considerations for real-time hemodynamic diagnostics.

    PubMed

    Goldman, J M; Cordova, M J

    1994-01-01

    In an effort to ease staffing burdens and potentially improve patient outcome in an intensive care unit (ICU) environment, we are developing a real-time system to accurately and efficiently diagnose cardiopulmonary emergencies. The system is being designed to utilize all relevant routinely-monitored physiological data in order to automatically diagnose potentially fatal events. The initial stage of this project involved formulating the overall system design and appropriate methods for real-time data acquisition, data storage, data trending, waveform analysis, and implementing diagnostic rules. Initially, we defined a conceptual analysis of the minimum physiologic data set, and the monitoring time-frames (trends) which would be required to diagnose cardiopulmonary emergencies. Following that analysis, we used a fuzzy logic diagnostic engine to analyze physiological data during a simulated arrhythmic cardiac arrest (ACA) in order to assess the validity of our diagnostic methodology. We used rate, trend, and morphologic data extracted from the following signals: expired CO2 time-concentration curve (capnogram), electrocardiogram, and arterial blood pressure. The system performed well: The fuzzy logic engine effectively diagnosed the likelihood of ACA from the subtle hemodynamic trends which preceded the complete arrest. As the clinical picture worsened, the fuzzy logic-based system accurately indicated the change in patient condition. Termination of the simulated arrest was rapidly detected by the diagnostic engine. In view of the effectiveness of this fuzzy logic implementation, we plan to develop additional fuzzy logic modules to diagnose other cardiopulmonary emergencies.

  19. [Orofacial clinical manifestations in adult patients with variable common immunodeficiency].

    PubMed

    Chávez-García, Aurora Alejandra; Moreno-Alba, Miguel Ángel; Elizalde-Monroy, Martín; Segura-Méndez, Nora Hilda; Romero-Flores, Jovita; Cambray-Gutiérrez, Julio César; López-Pérez, Patricia; Del Rivero-Hernández, Leonel Gerardo

    2015-01-01

    Antecedentes: la inmunodeficiencia común variable es la inmunodeficienci primaria más común en adultos. Su prevalencia se estima en 1 por cada 25,000 a 75,000 recién nacidos vivos; existen variaciones por grupos étnicos, se estima en 50 a 70% en pacientes de raza caucásica. Las lesiones de la cavidad oral raramente se describen en pacientes adultos con inmunodeficiencia común variable, en niños con esta enfermedad existen informes de lesiones principalmente de origen infeccioso. Objetivo: describir las lesiones orofaciales (cavidad oral, macizo facial y cuello) en pacientes adultos con inmunodeficiencia común variable. Material y método: estudio transversal, prospectivo, efectuado en todos los adultos con inmunodeficiencia común variable adscritos a la Clínica de inmunodeficiencias primarias, del Hospital de Especialidades, Centro Médico Nacional Siglo XXI, que fueron examinados por un cirujano maxilofacial; se realizó el reporte de hallazgos en lista de cotejo y, posteriormente, el análisis descriptivo de las lesiones. Resultados: se incluyeron 26 pacientes, 16 mujeres y 10 hombres, con edad promedio de 38.6 años. En 18 de 26 pacientes estudiados se observaron lesiones orales, con siete lesiones diferentes y predominio en el sexo femenino 2:1. Las lesiones más frecuentes fueron: hiperplasia de glándulas salivales menores (19/26), petequias (12/26) y úlceras herpetiformes (7/26). En la cara y el cuello se observaron cuatro lesiones distintas, las adenopatías < 2 cm (4/26) fueron las más comunes. Conclusiones: las alteraciones inmunológicas asociadas con la inmunodeficiencia común variable favorecen la aparición de lesiones de origen infeccioso y probablemente autoinmunitario que afectan la cavidad oral, la cara y el cuello.

  20. BR 06-1 CLINICAL APPLICATIONS OF VISIT TO VISIT BLOOD PRESSURE VARIABILITY.

    PubMed

    Shin, Jinho

    2016-09-01

    Since the introduction of visit to visit blood pressure variability (VVBPV) for cardiovascular outcome, it has long been awaited for prospective intervention trial to reduce VVBPV for evidence based medicine. But because of several hurdles, most importantly, pending measure to reduce VVBPV, such trial may not be available in the near future. It means that current understanding on the VVBPV is not casual but related to the cardiovascular outcome.Waiting for more sound evidence, which can be remained in a clinician's mind struggling not to be indifferent for potential benefit? Firstly, the most important potential confounder in spite of the strict statistical analyses to be published may be the mean blood pressure. Secondly, the population candidate for monitoring VVBPV needs to be understood. In general, the higher the risk, the more the value of considering the VVBPV. Thirdly, understanding the biological confounders for VVBPV such as arterial stiffness, low grade systemic inflammation, and sympathetic over-reactivity may inspire the clinician and/or patient the importance of the well-known lifestyle modification such as physical activity. Lastly, therapeutic aspects previously drawing less attention such as the class of drug with less inter-individual blood pressure variability, the relationship between the class of a drug and the volume status, adherence in general, the clinic protocol for the timing of drug intake with or without exercise and office visit, and the general conditions which can affect the volume status and thereby blood pressure level.Even without evidence of direct intervention on VVBPV, by monitoring and understanding VVPBV, a clinician can be developed to a new level of blood pressure management which is not only simply prescribing antihypertensive drugs but also more comprehensive understanding of the patient factors closely related to the blood pressure. PMID:27643152

  1. Ambulatory blood pressure monitoring is a useful clinical tool in nephrology.

    PubMed

    Mansoor, G A; White, W B

    1997-11-01

    Hypertension is a key factor in the genesis and deterioration of many renal diseases and is also a risk factor for death in patients with end-stage renal disease. However, the standard methods of measurement are prone to variability, especially in patients undergoing dialysis. The technique of ambulatory blood pressure monitoring allows a better assessment of overall blood pressure levels and promises to assume a bigger role in the care of renal patients. Ambulatory blood pressure monitoring is widely used in hypertension trials, and the reports of several consensus meetings on the clinical uses of ambulatory blood pressure monitoring have been published. Two similar validation protocols now exist for ambulatory blood pressure monitors, and tables of population-based normal blood pressures for age and gender are available. The available evidence suggests that ambulatory blood pressure compared with blood pressure measured in the physician's office is better correlated to left ventricular mass in subjects with chronic renal disease. Furthermore, studies in subjects with chronic renal disease and those undergoing renal replacement therapy show that blood pressure control is suboptimal in many patients and that nocturnal blood pressure is generally higher than in control subjects. Further insights into overall blood pressure behavior in this population will certainly emerge in the future. PMID:9370174

  2. Monitoring variability in trends of temperature and rainfall in the Apennine Alps (Middle Italy)

    NASA Astrophysics Data System (ADS)

    D'Aprile, Fabrizio; Tapper, Nigel

    2016-04-01

    In 2006 the School of Geography and Environmental Sciences of Monash University in collaboration with the Italian Forest Corps (Corpo Forestale dello Stato), Uffici Territoriali per la Biodiversità di Vallombrosa (Florence) and Pratovecchio (Arezzo)started to monitor the variability in temperature and rainfall in the Tuscan Apennine Alps (Middle Italy). First results showed unexpected variability in trends of both the climate variables and in particular very high variability in similarity of trends among sites even at short distance. Although the time series are ultra-centenary in some sites, trends in temperature and rainfall at the monthly level would show a reduction in temperature and increase in rainfall in the last decade in some cases. This uncertainty poses the question whether the phenomenon was due to some anomaly in the periodical oscillations of 6-7 years of length (spectral Fourier analysis) or the dominant trends in variability of monthly temperature and monthly rainfall are unchanged. Recent analysis of trends would confirm warming and drying of climate in the Apennine Alps in Middle Italy; however, in some sites a relative cooling is shown in the 2000s. In the area, climate warming appears to reach levels that may have relevant implications for forest composition and shift. The relatively fast increase in temperature and reduction in rainfall during the last 3-4 decades further strengthens the importance to continue monitoring climate variability to a deeper level and extend the understanding of its effects at the local level.

  3. MyNewsFlash: A System for Near Real-Time Variable Star Monitoring and Alerts

    NASA Astrophysics Data System (ADS)

    Price, A.; Turner, R.; Malatesta, K.; Simonsen, M. A.

    2004-12-01

    MyNewsFlash is an automated and customizable system for distributing timely variable star data. It supplies near real-time reports to the user of the latest activity of a variable star or class of stars. The stars it monitors, the frequency of report delivery, the delivery format, and more features are all completely customizable so the reader receives only reports of information he or she wants and nothing more or less. In addition, manually-generated alerts called Special MyNewsFlashes are occasionally sent out with additional information on special or abnormal behavior of a variable star. MyNewsFlash evolved from the AAVSO News Flash, an electronic publication dedicated to outbursts of popular cataclysmic variable stars

  4. Variability in Clinical Integration Achieved by Athletic Training Students across Different Clinical Sport Assignments

    ERIC Educational Resources Information Center

    Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.

    2015-01-01

    Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.…

  5. Using Mobile Monitoring to Assess Spatial Variability in Urban Air Pollution Levels: Opportunities and Challenges (Invited)

    NASA Astrophysics Data System (ADS)

    Larson, T.

    2010-12-01

    Measuring air pollution concentrations from a moving platform is not a new idea. Historically, however, most information on the spatial variability of air pollutants have been derived from fixed site networks operating simultaneously over space. While this approach has obvious advantages from a regulatory perspective, with the increasing need to understand ever finer scales of spatial variability in urban pollution levels, the use of mobile monitoring to supplement fixed site networks has received increasing attention. Here we present examples of the use of this approach: 1) to assess existing fixed-site fine particle networks in Seattle, WA, including the establishment of new fixed-site monitoring locations; 2) to assess the effectiveness of a regulatory intervention, a wood stove burning ban, on the reduction of fine particle levels in the greater Puget Sound region; and 3) to assess spatial variability of both wood smoke and mobile source impacts in both Vancouver, B.C. and Tacoma, WA. Deducing spatial information from the inherently spatio-temporal measurements taken from a mobile platform is an area that deserves further attention. We discuss the use of “fuzzy” points to address the fine-scale spatio-temporal variability in the concentration of mobile source pollutants, specifically to deduce the broader distribution and sources of fine particle soot in the summer in Vancouver, B.C. We also discuss the use of principal component analysis to assess the spatial variability in multivariate, source-related features deduced from simultaneous measurements of light scattering, light absorption and particle-bound PAHs in Tacoma, WA. With increasing miniaturization and decreasing power requirements of air monitoring instruments, the number of simultaneous measurements that can easily be made from a mobile platform is rapidly increasing. Hopefully the methods used to design mobile monitoring experiments for differing purposes, and the methods used to interpret those

  6. Stereotypies in autism: a video demonstration of their clinical variability

    PubMed Central

    Goldman, Sylvie; Greene, Paul E.

    2012-01-01

    In autism, stereotypies are frequent and disabling, and whether they correspond to a hyperkinetic movement disorder, a homeostatic response aiming at sensory modulation, or a regulator of arousal remains to be established. So far, it has been challenging to distinguish among these different possibilities, not only because of lack of objective and quantitative means to assess stereotypies, but in our opinion also because of the underappreciated diversity of their clinical presentations. Herein, we illustrate the broad spectrum of stereotypies and demonstrate the usefulness of video-assisted clinical observations of children with autism. The clips presented were extracted from play sessions of 129 children with autism disorder. We conclude that compared to widely used questionnaires and interviews, systematic video observations provide a unique means to classify and score precisely the clinical features of stereotypies. We believe this approach will prove useful to both clinicians and researchers as it offers the level of detail from retrievable images necessary to begin to assess effects of age and treatments on stereotypies, and to embark on the type of investigations required to unravel the physiological basis of motor behaviors in autism. PMID:23316144

  7. Primary Vascular Leiomyosarcoma: Clinical Observations and Molecular Variables

    PubMed Central

    Roland, Christina L.; Boland, Genevieve M.; Demicco, Elizabeth G.; Lusby, Kristelle; Ingram, Davis; May, Caitlin D.; Kivlin, Christine M.; Watson, Kelsey; Al Sannaa, Ghadah A.; Wang, Wei-Lien; Ravi, Vinod; Pollock, Raphael E.; Lev, Dina; Cormier, Janice N.; Hunt, Kelly K.; Feig, Barry W.; Lazar, Alexander J.; Torres, Keila E.

    2016-01-01

    Importance Vascular leiomyosarcomas (vLMS) are a rare subtype of leiomyosarcomas (LMS) most commonly affecting the inferior vena cava and accounting for 5% of all LMS. These tumors are aggressive malignancies for which adjuvant modalities have not shown increased efficacy compared over surgery. Our study evaluates potential molecular markers that should be evaluated in prospective studies to determine their prognostic and therapeutic utility. Objective To evaluate the outcomes of patients with vLMS and associations with immunohistochemical prognostic markers. Design Retrospective chart review Setting Single institution Participants A cohort of 77 patients that presented to MDACC from 1993–2012 was analyzed. All of the cases had a confirmed diagnosis of vascular leiomyosarcoma. Immunohistochemical studies for biomarkers were performed on a tissue microarray that included 26 primary vLMS specimens. Main Outcomes and Measures Demographic, and clinical factors were evaluated to assess clinical course, patterns of recurrence and survival outcomes for patients with primary vLMS. Univariate Cox proportional hazards model was utilized to correlate DSS and time to recurrence with potential prognostic indicators. Results Five year disease-specific survival (DSS) rates after tumor resection was 65%. Median time to local recurrence was 43 months, versus 25 months for distant recurrence versus 15 months for concurrent local and distant recurrences; p=0.04. Strong cytoplasmic β-catenin (p=0.06) and IGF-1R (p=0.04) expression were associated with inferior DSS. Conclusions and Relevance vLMS are aggressive malignancies, with high recurrence rates. Expression of β-catenin and IGF-1R were associated with poor DSS. Prospective studies should evaluate their clinical and therapeutic utility. PMID:26629783

  8. Variability of enzyme markers during clinical regression of atopic dermatitis.

    PubMed

    Tarroux, R; Assalit, M F; Licu, D; Périé, J J; Redoulès, D

    2002-01-01

    Skin surface enzyme activities were found to be significantly different in healthy and in skin with atopic dermatitis and, following appropriate treatment, a close correlation was observed between the clinical staging of the atopic dermatitis and the levels of the assayed marker enzymes. Samples were taken, by stripping with simple adhesive tapes, from a group of subjects on cure in a spa. The corneocytes were recovered from the first layers of the stratum corneum. Aqueous extracts of the strips were tested for their activity on chromophoric substrates which allow fluorescence spectrometry to be used to assay the trypsin-like, acid-phosphatase-like and phospholipase-A2-like activities. We show that the restoration of return to activities close to those of healthy subjects is related to the general condition of the patients, who showed a clearly improved SCORAD. Recovery of the trypsin-like activity and attenuation of the phospholipase-like activity, paralleled the regression of the dermatitis as assessed by a decrease in clinically evaluated parameters of xerosis and inflammation.

  9. Hyperspectral lidar in non-destructive 4D monitoring of climate variables

    NASA Astrophysics Data System (ADS)

    Kaasalainen, S.; Hakala, T.; Nevalainen, O.; Puttonen, E.; Anttila, K.

    2014-09-01

    The first applications of a prototype 8-channel full waveform active hyperspectral lidar (HSL) show a possibility to determine various target 3D characteristics with remote observations. The results open up a prospect for four-dimensional (4D - a three dimensional target representation with time as a fourth dimension) monitoring of important climate variables, such as those related to tree physiology or snow pollution.

  10. Contributions to variability of clinical measures for use as indicators of udder health status in a clinical protocol.

    PubMed

    Fossing, C; Vaarst, M; Houe, H; Enevoldsen, C

    2006-08-22

    A cross-sectional observational study with repeated observations was conducted on 16 Danish dairy farms to quantify the influence of observer, parity, time (stage in lactation) and farm on variables routinely selected for inclusion in clinical protocols, thereby to enable a more valid comparison of udder health between different herds. During 12 months, participating herds were visited 5 times by project technicians, who examined 20 cows and scored the selected clinical variables. The estimates of effect on variables were derived from a random regression model procedure. Statistical analyses revealed that, although estimates for occurrence of several the variables, e.g. degree of oedema, varied significantly between observers, the effects on many of these estimates were similar in size. Almost all estimates for occurrences of variables were significantly affected either parity and lactation stage, or by both e.g. udder tissue consistency. Some variables, e.g. mange, had high estimates for the farm component, and others e.g. teat skin quality had a high individual component. Several of the variables, e.g. wounds on warts, had a high residual component indicating that a there still was a major part of the variation in data, which was unexplained. It was concluded that most of the variables were relevant for implementation in herd health management, but that adjustments need to be made to improve reliability.

  11. Process monitoring using automatic physical measurement based on electrical and physical variability analysis

    NASA Astrophysics Data System (ADS)

    Shauly, Eitan N.; Levi, Shimon; Schwarzband, Ishai; Adan, Ofer; Latinsky, Sergey

    2015-04-01

    A fully automated silicon-based methodology for systematic analysis of electrical features is shown. The system was developed for process monitoring and electrical variability reduction. A mapping step was created by dedicated structures such as static-random-access-memory (SRAM) array or standard cell library, or by using a simple design rule checking run-set. The resulting database was then used as an input for choosing locations for critical dimension scanning electron microscope images and for specific layout parameter extraction then was input to SPICE compact modeling simulation. Based on the experimental data, we identified two items that must be checked and monitored using the method described here: transistor's sensitivity to the distance between the poly end cap and edge of active area (AA) due to AA rounding, and SRAM leakage due to a too close N-well to P-well. Based on this example, for process monitoring and variability analyses, we extensively used this method to analyze transistor gates having different shapes. In addition, analysis for a large area of high density standard cell library was done. Another set of monitoring focused on a high density SRAM array is also presented. These examples provided information on the poly and AA layers, using transistor parameters such as leakage current and drive current. We successfully define "robust" and "less-robust" transistor configurations included in the library and identified unsymmetrical transistors in the SRAM bit-cells. These data were compared to data extracted from the same devices at the end of the line. Another set of analyses was done to samples after Cu M1 etch. Process monitoring information on M1 enclosed contact was extracted based on contact resistance as a feedback. Guidelines for the optimal M1 space for different layout configurations were also extracted. All these data showed the successful in-field implementation of our methodology as a useful process monitoring method.

  12. Decoding Continuous Variables from Neuroimaging Data: Basic and Clinical Applications

    PubMed Central

    Cohen, Jessica R.; Asarnow, Robert F.; Sabb, Fred W.; Bilder, Robert M.; Bookheimer, Susan Y.; Knowlton, Barbara J.; Poldrack, Russell A.

    2011-01-01

    The application of statistical machine learning techniques to neuroimaging data has allowed researchers to decode the cognitive and disease states of participants. The majority of studies using these techniques have focused on pattern classification to decode the type of object a participant is viewing, the type of cognitive task a participant is completing, or the disease state of a participant's brain. However, an emerging body of literature is extending these classification studies to the decoding of values of continuous variables (such as age, cognitive characteristics, or neuropsychological state) using high-dimensional regression methods. This review details the methods used in such analyses and describes recent results. We provide specific examples of studies which have used this approach to answer novel questions about age and cognitive and disease states. We conclude that while there is still much to learn about these methods, they provide useful information about the relationship between neural activity and age, cognitive state, and disease state, which could not have been obtained using traditional univariate analytical methods. PMID:21720520

  13. Monitoring temporal and spatial variability in sandeel (Ammodytes hexapterus) abundance with pigeon guillemot (Cepphus columba) diets

    USGS Publications Warehouse

    Litzow, M.A.; Piatt, J.F.; Abookire, A.A.; Prichard, A.K.; Robards, M.D.

    2000-01-01

    We evaluated pigeon guillemots (Cepphus columba) as monitors of nearshore fish abundance and community composition during 1995-1999 at Kachemak Bay, Alaska. We studied the composition of chick diets at 10 colonies and simultaneously measured fish abundance around colonies with beach seines and bottom trawls. Sandeels (Ammodytes hexapterus) formed the majority of the diet at one group of colonies. Temporal variability in sandeel abundance explained 74% of inter-annual variability in diet composition at these colonies and 93% of seasonal variability. Diets at other colonies were dominated by demersal fish. Among these colonies, 81% of the variability in the proportion of sandeels in diets was explained by spatial differences in sanded abundance. Pigeon guillemots exhibited a non-linear functional response to sandeel abundance in the area where these fish were most abundant. Temporal and spatial variability in demersal fish abundance was not consistently reflected in diets. Spatial differences in the proportion of different demersal fishes in the diet may have been driven by differences in guillemot prey preference. Prey specialization by individual pigeon guillemots was common, and may operate at the colony level. Inter-annual variability in sandeel abundance may have been tracked more accurately because the magnitude of change (11-fold) was greater than that of demersal fish (three-fold). (C) 2000 International Council for the Exploration of the Sea.

  14. Walking function in clinical monitoring of multiple sclerosis by telemedicine.

    PubMed

    Sola-Valls, Núria; Blanco, Yolanda; Sepúlveda, Maria; Llufriu, Sara; Martínez-Lapiscina, Elena H; La Puma, Delon; Graus, Francesc; Villoslada, Pablo; Saiz, Albert

    2015-07-01

    Walking limitation is a key component of disability in patients with multiple sclerosis (MS), but the information on daily walking activity and disability over time is limited. To determine, (1) the agreement between the standard measurements of MS-related disability [expanded disability status scale (EDSS), functional systems (FS) and ambulation index (AI)] obtained by conventional and remote evaluation using a multimedia platform; (2) the usefulness of monitoring 6-min walk test (6MWT) and average daily walking activity (aDWA) to better characterize patients disability. Twenty-five patients (EDSS score 1.0-6.5) were evaluated every 3 months for the first year, and aDWA repeated at year 2. Remote visits included the recording of a video with self-performed neurological examination and specific multimedia questionnaires. aDWA was measured by a triaxial accelerometer. All but two patients completed the study. Modest agreement between conventional and multimedia EDSS was found for EDSS ≤ 4.0 (kappa = 0.2) and good for EDSS ≥ 4.5 (kappa = 0.6). For the overall sample, pyramidal, cerebellar and brainstem FS showed the greatest agreement (kappa = 0.7). SR-AI showed a modest agreement for EDSS ≤ 4.0 and good for EDSS ≥ 4.5 (kappa = 0.3 and 0.6, respectively). There was a strong correlation between conventional and 6MWT measured by accelerometer (r = 0.76). The aDWA correlated strongly with the EDSS (r = -0.86) and a cut-off point of 3279.3 steps/day discriminated patients with ambulatory impairment. There was a significant decline in aDWA over 2 years in patients with ambulatory impairment that were not observed by standard measurements of disability. MS clinical monitoring by telemedicine is feasible, but the observed lower agreement in less disabled patients emphasizes the need to optimize the assessment methodology. Accelerometers capture changes that may indicate deterioration over time. PMID:25957639

  15. Clinical pharmacology in neonates: small size, huge variability.

    PubMed

    Allegaert, Karel; van den Anker, John N

    2014-01-01

    Drug therapy is a powerful tool for improving neonatal outcome. Despite this, neonatologists still routinely prescribe off-label compounds developed for adults and extrapolate doses from those used for children or adults. Knowledge integration through pharmacokinetic modeling is a method that could improve the current situation. Such predictive models may convert neonatal pharmacotherapy from explorative to confirmatory. This can be illustrated by research projects related to the prediction of neonatal renal clearance and neonatal glucuronidation. This type of model will also improve the current knowledge of neonatal (patho)physiology. In the meanwhile, the fields of clinical pharmacology (e.g. pharmacokinetic/pharmacodynamic modeling and pharmacogenetics) and neonatology (e.g. whole-body cooling and the lower limit of viability) have both matured, resulting in new research topics. However, in order for the modeling and the newly emerging topics to become effective tools, they need to be tailored to the specific characteristics of neonates. Consequently, the field of neonatal pharmacotherapy needs dedicated neonatologists who continue to raise the awareness that off-label practices, eminence-based dosing regimens and the absence of neonatal drug formulations all reflect suboptimal care.

  16. Variability in pathogenicity prediction programs: impact on clinical diagnostics

    PubMed Central

    Walters-Sen, Lauren C; Hashimoto, Sayaka; Thrush, Devon Lamb; Reshmi, Shalini; Gastier-Foster, Julie M; Astbury, Caroline; Pyatt, Robert E

    2015-01-01

    Current practice by clinical diagnostic laboratories is to utilize online prediction programs to help determine the significance of novel variants in a given gene sequence. However, these programs vary widely in their methods and ability to correctly predict the pathogenicity of a given sequence change. The performance of 17 publicly available pathogenicity prediction programs was assayed using a dataset consisting of 122 credibly pathogenic and benign variants in genes associated with the RASopathy family of disorders and limb-girdle muscular dystrophy. Performance metrics were compared between the programs to determine the most accurate program for loss-of-function and gain-of-function mechanisms. No one program correctly predicted the pathogenicity of all variants analyzed. A major hindrance to the analysis was the lack of output from a significant portion of the programs. The best performer was MutPred, which had a weighted accuracy of 82.6% in the full dataset. Surprisingly, combining the results of the top three programs did not increase the ability to predict pathogenicity over the top performer alone. As the increasing number of sequence changes in larger datasets will require interpretation, the current study demonstrates that extreme caution must be taken when reporting pathogenicity based on statistical online protein prediction programs in the absence of functional studies. PMID:25802880

  17. The Potential Clinical Utility of Transdermal Alcohol Monitoring Data to Estimate the Number of Alcoholic Drinks Consumed

    PubMed Central

    Dougherty, Donald M.; Hill-Kapturczak, Nathalie; Liang, Yuanyuan; Karns, Tara E.; Lake, Sarah L.; Cates, Sharon E.; Roache, John D.

    2014-01-01

    Objectives Transdermal alcohol monitoring is used extensively in forensic settings to identify whether individuals have violated court-ordered mandates to abstain from drinking. Despite widespread use in that setting, comparatively few studies have explored the clinical utility of transdermal alcohol monitoring. Furthermore, of the few studies conducted, most have relied on the forensically established conservative criteria to identify whether or not a drinking episode has occurred. Here, we explore how transdermal alcohol monitoring data can be used to estimate more clinically meaningful parameters relevant to clinical treatment programs. Methods We developed a procedure to use transdermal data to objectively estimate the number of standardized drinks an individual has consumed. Participants included 46 men and women who consumed 1 to 5 beers within 2 hours in the laboratory on separate days while wearing devices to monitor transdermal alcohol concentrations (TAC). Results A mathematical model was derived to estimate the number of standardized alcohol drinks consumed, which included a number of variables (time-to-peak TAC, area under the TAC curve, and sex). The model was then validated by applying it to data from a separate study. Our results indicate that transdermal alcohol devices can be used to estimate the number of standard drinks consumed. Conclusions Objective methods characterizing both the level of intoxication achieved and the number of drinks consumed, such as transdermal alcohol monitoring, could be useful in both research and treatment settings. PMID:26500459

  18. Nitrate Variability in Groundwater of North Carolina using Monitoring and Private Well Data Models

    PubMed Central

    2015-01-01

    Nitrate (NO3–) is a widespread contaminant of groundwater and surface water across the United States that has deleterious effects to human and ecological health. This study develops a model for predicting point-level groundwater NO3– at a state scale for monitoring wells and private wells of North Carolina. A land use regression (LUR) model selection procedure is developed for determining nonlinear model explanatory variables when they are known to be correlated. Bayesian Maximum Entropy (BME) is used to integrate the LUR model to create a LUR-BME model of spatial/temporal varying groundwater NO3– concentrations. LUR-BME results in a leave-one-out cross-validation r2 of 0.74 and 0.33 for monitoring and private wells, effectively predicting within spatial covariance ranges. Results show significant differences in the spatial distribution of groundwater NO3– contamination in monitoring versus private wells; high NO3– concentrations in the southeastern plains of North Carolina; and wastewater treatment residuals and swine confined animal feeding operations as local sources of NO3– in monitoring wells. Results are of interest to agencies that regulate drinking water sources or monitor health outcomes from ingestion of drinking water. Lastly, LUR-BME model estimates can be integrated into surface water models for more accurate management of nonpoint sources of nitrogen. PMID:25148521

  19. Nitrate variability in groundwater of North Carolina using monitoring and private well data models.

    PubMed

    Messier, Kyle P; Kane, Evan; Bolich, Rick; Serre, Marc L

    2014-09-16

    Nitrate (NO3-) is a widespread contaminant of groundwater and surface water across the United States that has deleterious effects to human and ecological health. This study develops a model for predicting point-level groundwater NO3- at a state scale for monitoring wells and private wells of North Carolina. A land use regression (LUR) model selection procedure is developed for determining nonlinear model explanatory variables when they are known to be correlated. Bayesian Maximum Entropy (BME) is used to integrate the LUR model to create a LUR-BME model of spatial/temporal varying groundwater NO3- concentrations. LUR-BME results in a leave-one-out cross-validation r2 of 0.74 and 0.33 for monitoring and private wells, effectively predicting within spatial covariance ranges. Results show significant differences in the spatial distribution of groundwater NO3- contamination in monitoring versus private wells; high NO3- concentrations in the southeastern plains of North Carolina; and wastewater treatment residuals and swine confined animal feeding operations as local sources of NO3- in monitoring wells. Results are of interest to agencies that regulate drinking water sources or monitor health outcomes from ingestion of drinking water. Lastly, LUR-BME model estimates can be integrated into surface water models for more accurate management of nonpoint sources of nitrogen.

  20. Near-IR spectroscopic monitoring of CLASS I protostars: Variability of accretion and wind indicators

    SciTech Connect

    Connelley, Michael S.; Greene, Thomas P.

    2014-06-01

    We present the results of a program that monitored the near-IR spectroscopic variability of a sample of 19 embedded protostars. Spectra were taken on time intervals from 2 days to 3 yr, over a wavelength range from 0.85 μm to 2.45 μm, for 4-9 epochs of observations per target. We found that the spectra of all targets are variable and that every emission feature observed is also variable (although not for all targets). With one exception, there were no drastic changes in the continua of the spectra, nor did any line completely disappear, nor did any line appear that was not previously apparent. This analysis focuses on understanding the connection between accretion (traced by H Br γ and CO) and the wind (traced by He I, [Fe II], and sometimes H{sub 2}). For both accretion and wind tracers, the median variability was constant versus the time interval between observations; however, the maximum variability that we observed increased with the time interval between observations. Extinction is observed to vary within the minimum sampling time of 2 days, suggesting extinguishing material within a few stellar radii at high disk latitudes. The variability of [Fe II] and H{sub 2} were correlated for most (but not all) of the 7 young stellar objects showing both features, and the amplitude of the variability depends on the veiling. Although the occurrence of CO and Br γ emission are connected, their variability is uncorrelated, suggesting that these emissions originate in separate regions near the protostar (e.g., disk and wind). The variability of Br γ and wind tracers were found to be positively correlated, negatively correlated, or uncorrelated, depending on the target. The variability of Br γ, [Fe II], and H{sub 2} always lies on a plane, although the orientation of the plane in three dimensions depends on the target. While we do not understand all interactions behind the variability that we observed, we have shown that spectroscopic variability is a powerful tool

  1. Optimising survey effort to monitor environmental variables: A case study using New Zealand kiwifruit orchards.

    PubMed

    MacLeod, Catriona J; Green, Peter; Tompkins, Daniel M; Benge, Jayson; Moller, Henrik

    2016-12-01

    Environmental monitoring is increasingly used to assess spatial and temporal trends in agricultural sustainability, and test the effectiveness of farm management policies. However, detecting changes in environmental variables is often technically and logistically challenging. To demonstrate how survey effort for environmental monitoring can be optimised, we applied the new statistical power analysis R package simr to pilot survey data. Specifically, we identified the amount of survey effort required to have an 80% chance of detecting specified trends (-1 to -4% pa) in 13 environmental variables on New Zealand kiwifruit orchards within an 11-year period. The variables assessed were related to soil status, agricultural pests (birds), or ecosystem composition (birds). Analyses were conducted on average values (for each orchard and year combination) to provide a consistent scale for comparison among variables. Survey frequency varied from annual (11 surveys) to every 5 years (3 surveys). Survey size was set at either 30, 60, 150 or 300 orchards. In broad terms, we show the power to detect a specified range of trends over an 11-year period in this sector is much higher for 'soil status' than for 'agricultural pest' or 'ecosystem composition'. Changes in one subset of native bird species (nectar-feeders) requiring a particularly high level of relative survey effort to detect with confidence. Monitoring soil status can thus be smaller and less frequent than those which also want to detect changes in agricultural pests or ecosystem composition (with the latter requiring the most effort) but will depend on the magnitude of changes that is meaningful to detect. This assessment thus allows kiwifruit industry in New Zealand to optimise survey design to the desired information, and provides a template for other industries to do likewise. Power analyses are now more accessible through the provision of the simr package, so deploying and integrating them into design and decision

  2. Optimising survey effort to monitor environmental variables: A case study using New Zealand kiwifruit orchards.

    PubMed

    MacLeod, Catriona J; Green, Peter; Tompkins, Daniel M; Benge, Jayson; Moller, Henrik

    2016-12-01

    Environmental monitoring is increasingly used to assess spatial and temporal trends in agricultural sustainability, and test the effectiveness of farm management policies. However, detecting changes in environmental variables is often technically and logistically challenging. To demonstrate how survey effort for environmental monitoring can be optimised, we applied the new statistical power analysis R package simr to pilot survey data. Specifically, we identified the amount of survey effort required to have an 80% chance of detecting specified trends (-1 to -4% pa) in 13 environmental variables on New Zealand kiwifruit orchards within an 11-year period. The variables assessed were related to soil status, agricultural pests (birds), or ecosystem composition (birds). Analyses were conducted on average values (for each orchard and year combination) to provide a consistent scale for comparison among variables. Survey frequency varied from annual (11 surveys) to every 5 years (3 surveys). Survey size was set at either 30, 60, 150 or 300 orchards. In broad terms, we show the power to detect a specified range of trends over an 11-year period in this sector is much higher for 'soil status' than for 'agricultural pest' or 'ecosystem composition'. Changes in one subset of native bird species (nectar-feeders) requiring a particularly high level of relative survey effort to detect with confidence. Monitoring soil status can thus be smaller and less frequent than those which also want to detect changes in agricultural pests or ecosystem composition (with the latter requiring the most effort) but will depend on the magnitude of changes that is meaningful to detect. This assessment thus allows kiwifruit industry in New Zealand to optimise survey design to the desired information, and provides a template for other industries to do likewise. Power analyses are now more accessible through the provision of the simr package, so deploying and integrating them into design and decision

  3. Distal arthrogryposis with variable clinical expression caused by TNNI2 mutation

    PubMed Central

    Čulić, Vida; Miyake, Noriko; Janković, Sunčana; Petrović, Davor; Šimunović, Marko; Đapić, Tomislav; Shiina, Masaaki; Ogata, Kazuhiro; Matsumoto, Naomichi

    2016-01-01

    Distal arthrogryposis (DA) is a clinically and genetically heterogeneous disorder with multiple joint contractures. We describe a female DA patient with hand and foot deformities, and right-sided torticollis. Using exome sequencing, we identified a novel TNNI2 mutation (c.485>A, p.Arg162Lys) in the patient and her father. The father has no typical DA but hip dysplasia. This may explain the clinical features of DA2B in this family, but with variable clinical expression. PMID:27790376

  4. Clinical Trials With Large Numbers of Variables: Important Advantages of Canonical Analysis.

    PubMed

    Cleophas, Ton J

    2016-01-01

    Canonical analysis assesses the combined effects of a set of predictor variables on a set of outcome variables, but it is little used in clinical trials despite the omnipresence of multiple variables. The aim of this study was to assess the performance of canonical analysis as compared with traditional multivariate methods using multivariate analysis of covariance (MANCOVA). As an example, a simulated data file with 12 gene expression levels and 4 drug efficacy scores was used. The correlation coefficient between the 12 predictor and 4 outcome variables was 0.87 (P = 0.0001) meaning that 76% of the variability in the outcome variables was explained by the 12 covariates. Repeated testing after the removal of 5 unimportant predictor and 1 outcome variable produced virtually the same overall result. The MANCOVA identified identical unimportant variables, but it was unable to provide overall statistics. (1) Canonical analysis is remarkable, because it can handle many more variables than traditional multivariate methods such as MANCOVA can. (2) At the same time, it accounts for the relative importance of the separate variables, their interactions and differences in units. (3) Canonical analysis provides overall statistics of the effects of sets of variables, whereas traditional multivariate methods only provide the statistics of the separate variables. (4) Unlike other methods for combining the effects of multiple variables such as factor analysis/partial least squares, canonical analysis is scientifically entirely rigorous. (5) Limitations include that it is less flexible than factor analysis/partial least squares, because only 2 sets of variables are used and because multiple solutions instead of one is offered. We do hope that this article will stimulate clinical investigators to start using this remarkable method.

  5. 24-h blood pressure monitoring in normal tension glaucoma: night-time blood pressure variability.

    PubMed

    Plange, N; Kaup, M; Daneljan, L; Predel, H G; Remky, A; Arend, O

    2006-02-01

    Systemic arterial hypotension, hypertension and altered ocular blood flow are known risk factors in glaucoma. In this study, 24-h ambulatory blood pressure monitoring was performed in patients with normal tension glaucoma (NTG) and controls to evaluate blood pressure variability. In all, 51 patients with NTG and 28 age-matched controls were included in this prospective study. A 24-h ambulatory blood pressure monitoring (SpaceLabs Medical Inc., Redmond, USA) was performed and systolic, diastolic and mean arterial blood pressures were measured every 30 min during daytime (0800-2000) and night time (0000-0600). To evaluate blood pressure variability a variability index was defined as the s.d. of blood pressure measurements. Night-time blood pressure depression ('dip') was calculated (in percent of the daytime blood pressures). Patients with NTG exhibited higher night-time diastolic (P = 0.01) and mean arterial blood pressure values (P = 0.02) compared to controls, whereas systolic blood pressure data were not significantly different. The variability indices of night-time systolic, diastolic and mean arterial blood pressure measurements were significantly increased in patients with NTG compared to controls (P < 0.05). The night-time blood pressure depression of systolic (P = 0.47), diastolic (P = 0.11) and mean arterial blood pressures (P = 0.28) was not significantly different between patients with NTG and controls. In conclusion, patients with NTG showed increased variability of night-time blood pressure measurements compared to controls. Increased fluctuation of blood pressure may lead to ocular perfusion pressure fluctuation and may cause ischaemic episodes at the optic nerve head. PMID:16239898

  6. THE LICK AGN MONITORING PROJECT: PHOTOMETRIC LIGHT CURVES AND OPTICAL VARIABILITY CHARACTERISTICS

    SciTech Connect

    Walsh, Jonelle L.; Bentz, Misty C.; Barth, Aaron J.; Minezaki, Takeo; Sakata, Yu; Yoshii, Yuzuru; Baliber, Nairn; Bennert, Vardha Nicola; Street, Rachel A.; Treu, Tommaso; Li Weidong; Filippenko, Alexei V.; Stern, Daniel; Brown, Timothy M.; Canalizo, Gabriela; Gates, Elinor L.; Greene, Jenny E.; Malkan, Matthew A.; Woo, Jong-Hak

    2009-11-01

    The Lick AGN Monitoring Project targeted 13 nearby Seyfert 1 galaxies with the intent of measuring the masses of their central black holes using reverberation mapping. The sample includes 12 galaxies selected to have black holes with masses roughly in the range 10{sup 6}-10{sup 7} M {sub sun}, as well as the well-studied active galactic nucleus (AGN) NGC 5548. In conjunction with a spectroscopic monitoring campaign, we obtained broadband B and V images on most nights from 2008 February through 2008 May. The imaging observations were carried out by four telescopes: the 0.76 m Katzman Automatic Imaging Telescope, the 2 m Multicolor Active Galactic Nuclei Monitoring telescope, the Palomar 60 inch (1.5 m) telescope, and the 0.80 m Tenagra II telescope. Having well-sampled light curves over the course of a few months is useful for obtaining the broad-line reverberation lag and black hole mass, and also allows us to examine the characteristics of the continuum variability. In this paper, we discuss the observational methods and the photometric measurements, and present the AGN continuum light curves. We measure various variability characteristics of each of the light curves. We do not detect any evidence for a time lag between the B- and V-band variations, and we do not find significant color variations for the AGNs in our sample.

  7. Monitoring the Far Infrared Variability of Deeply Embedded Protostars with SOFIA/HAWC

    NASA Astrophysics Data System (ADS)

    Johnstone, Doug

    2015-10-01

    Low-mass stars form via gravitational collapse of molecular cloud cores. The evolution of the mass accretion onto a forming protostar depends on the rate at which the interior of the core collapses, the significance of a circumstellar disk as a temporary mass reservoir, and the physics of how the gas is transported through the disk and accretes onto the central star. Despite a clear requirement for time dependency in the accretion rate onto deeply embedded protostars and a large number of theoretical mechanisms for powering variability, our understanding of both the timescale and amplitude of variability is almost entirely unconstrained. The bolometric luminosity of deeply embedded protostars is a direct proxy for the accretion luminosity, modified only by the addition of the stellar luminosity itself. For deeply embedded protostars, the spectral energy distribution peaks in the far infrared, near 100 microns, making this an ideal wavelength for long-term monitoring of accretion variability. We propose to use SOFIA/HAWC at 89 and 154 microns to monitor three star-forming fields (Cepheus, Perseus, and Serpens) as part of a long-term campaign dedicated to uncovering the observational signature of episodic accretion. These observations will aid in our understanding of how stars accumulate their final mass and are neceassry for discriminating between the various theoretical models of episodic accretion onto deeply embedded protostars.

  8. [Clinical and diagnostic value of heart rate variabilities in workers exposed to noise and vibration].

    PubMed

    Serebriakov, P V; Melent'ev, A V; Demina, I D

    2010-01-01

    Noise and vibration cause disorders of vegetative regulation of cardiovascular system. Daily ECG monitoring with heart rate variabilities analysis enables quanitative evaluation of disordered vegetative control over heart rate and diagnosis of cardioneuropathy caused by long occupational exposure to noise and vibration. PMID:20857555

  9. Clinical Development and Implementation of an Institutional Guideline for Prospective EEG Monitoring and Reporting of Delayed Cerebral Ischemia.

    PubMed

    Muniz, Carlos F; Shenoy, Apeksha V; OʼConnor, Kathryn L; Bechek, Sophia C; Boyle, Emily J; Guanci, Mary M; Tehan, Tara M; Zafar, Sahar F; Cole, Andrew J; Patel, Aman B; Westover, Michael B; Rosenthal, Eric S

    2016-06-01

    Delayed cerebral ischemia (DCI) is the most common and disabling complication among patients admitted to the hospital for subarachnoid hemorrhage (SAH). Clinical and radiographic methods often fail to detect DCI early enough to avert irreversible injury. We assessed the clinical feasibility of implementing a continuous EEG (cEEG) ischemia monitoring service for early DCI detection as part of an institutional guideline. An institutional neuromonitoring guideline was designed by an interdisciplinary team of neurocritical care, clinical neurophysiology, and neurosurgery physicians and nursing staff and cEEG technologists. The interdisciplinary team focused on (1) selection criteria of high-risk patients, (2) minimization of safety concerns related to prolonged monitoring, (3) technical selection of quantitative and qualitative neurophysiologic parameters based on expert consensus and review of the literature, (4) a structured interpretation and reporting methodology, prompting direct patient evaluation and iterative neurocritical care, and (5) a two-layered quality assurance process including structured clinician interviews assessing events of neurologic worsening and an adjudicated consensus review of neuroimaging and medical records. The resulting guideline's clinical feasibility was then prospectively evaluated. The institutional SAH monitoring guideline used transcranial Doppler ultrasound and cEEG monitoring for vasospasm and ischemia monitoring in patients with either Fisher group 3 or Hunt-Hess grade IV or V SAH. Safety criteria focused on prevention of skin breakdown and agitation. Technical components included monitoring of transcranial Doppler ultrasound velocities and cEEG features, including quantitative alpha:delta ratio and percent alpha variability, qualitative evidence of new focal slowing, late-onset epileptiform activity, or overall worsening of background. Structured cEEG reports were introduced including verbal communication for findings concerning

  10. Clinical Development and Implementation of an Institutional Guideline for Prospective EEG Monitoring and Reporting of Delayed Cerebral Ischemia.

    PubMed

    Muniz, Carlos F; Shenoy, Apeksha V; OʼConnor, Kathryn L; Bechek, Sophia C; Boyle, Emily J; Guanci, Mary M; Tehan, Tara M; Zafar, Sahar F; Cole, Andrew J; Patel, Aman B; Westover, Michael B; Rosenthal, Eric S

    2016-06-01

    Delayed cerebral ischemia (DCI) is the most common and disabling complication among patients admitted to the hospital for subarachnoid hemorrhage (SAH). Clinical and radiographic methods often fail to detect DCI early enough to avert irreversible injury. We assessed the clinical feasibility of implementing a continuous EEG (cEEG) ischemia monitoring service for early DCI detection as part of an institutional guideline. An institutional neuromonitoring guideline was designed by an interdisciplinary team of neurocritical care, clinical neurophysiology, and neurosurgery physicians and nursing staff and cEEG technologists. The interdisciplinary team focused on (1) selection criteria of high-risk patients, (2) minimization of safety concerns related to prolonged monitoring, (3) technical selection of quantitative and qualitative neurophysiologic parameters based on expert consensus and review of the literature, (4) a structured interpretation and reporting methodology, prompting direct patient evaluation and iterative neurocritical care, and (5) a two-layered quality assurance process including structured clinician interviews assessing events of neurologic worsening and an adjudicated consensus review of neuroimaging and medical records. The resulting guideline's clinical feasibility was then prospectively evaluated. The institutional SAH monitoring guideline used transcranial Doppler ultrasound and cEEG monitoring for vasospasm and ischemia monitoring in patients with either Fisher group 3 or Hunt-Hess grade IV or V SAH. Safety criteria focused on prevention of skin breakdown and agitation. Technical components included monitoring of transcranial Doppler ultrasound velocities and cEEG features, including quantitative alpha:delta ratio and percent alpha variability, qualitative evidence of new focal slowing, late-onset epileptiform activity, or overall worsening of background. Structured cEEG reports were introduced including verbal communication for findings concerning

  11. Use of structured decision making to identify monitoring variables and management priorities for salt marsh ecosystems

    USGS Publications Warehouse

    Neckles, Hilary A.; Lyons, James E.; Guntenspergen, Glenn R.; Shriver, W. Gregory; Adamowicz, Susan C.

    2015-01-01

    Most salt marshes in the USA have been degraded by human activities, and coastal managers are faced with complex choices among possible actions to restore or enhance ecosystem integrity. We applied structured decision making (SDM) to guide selection of monitoring variables and management priorities for salt marshes within the National Wildlife Refuge System in the northeastern USA. In general, SDM is a systematic process for decomposing a decision into its essential elements. We first engaged stakeholders in clarifying regional salt marsh decision problems, defining objectives and attributes to evaluate whether objectives are achieved, and developing a pool of alternative management actions for achieving objectives. Through this process, we identified salt marsh attributes that were applicable to monitoring National Wildlife Refuges on a regional scale and that targeted management needs. We then analyzed management decisions within three salt marsh units at Prime Hook National Wildlife Refuge, coastal Delaware, as a case example of prioritizing management alternatives. Values for salt marsh attributes were estimated from 2 years of baseline monitoring data and expert opinion. We used linear value modeling to aggregate multiple attributes into a single performance score for each alternative, constrained optimization to identify alternatives that maximized total management benefits subject to refuge-wide cost constraints, and used graphical analysis to identify the optimal set of alternatives for the refuge. SDM offers an efficient, transparent approach for integrating monitoring into management practice and improving the quality of management decisions.

  12. Photon-monitoring attack on continuous-variable quantum key distribution with source in middle

    NASA Astrophysics Data System (ADS)

    Wang, Yijun; Huang, Peng; Guo, Ying; Huang, Dazu

    2014-12-01

    Motivated by a fact that the non-Gaussian operation may increase entanglement of an entangled system, we suggest a photon-monitoring attack strategy in the entanglement-based (EB) continuous-variable quantum key distribution (CVQKD) using the photon subtraction operations, where the entangled source originates from the center instead of one of the legal participants. It shows that an eavesdropper, Eve, can steal large information from participants after intercepting the partial beams with the photon-monitoring attach strategy. The structure of the proposed CVQKD protocol is useful in simply analyzing how quantum loss in imperfect channels can decrease the performance of the CVQKD protocol. The proposed attack strategy can be implemented under current technology, where a newly developed and versatile no-Gaussian operation can be well employed with the entangled source in middle in order to access to mass information in the EB CVQKD protocol, as well as in the prepare-and-measure (PM) CVQKD protocol.

  13. Sex and Gender: Critical Variables in Pre-Clinical and Clinical Medical Research.

    PubMed

    Morselli, Eugenia; Frank, Aaron P; Santos, Roberta S; Fátima, Luciana A; Palmer, Biff F; Clegg, Deborah J

    2016-08-01

    In this Essay, we discuss the critical need to incorporate sex and gender in pre-clinical and clinical research to enhance our understanding of the mechanisms by which metabolic processes differ by sex and gender. This knowledge will allow for development of personalized medicine which will optimize therapies specific for individuals. PMID:27508869

  14. VizieR Online Data Catalog: Low-Frequency Variable Radio Sources Monitoring (Mitchell+, 1994)

    NASA Astrophysics Data System (ADS)

    Mitchell, K. J.; Dennison, B.; Condon, J. J.; Altschuler, D. R.; Payne, H. E.; O'dell, S. L.

    1994-07-01

    The "lowvar.dat" data set is the result of a detailed multifrequency monitoring program of 34 low-frequency variable radio sources. This consists of flux density measurements at 318, 430, 606, 880, and 1400 MHz over a five-year period. The observations were carried out with the Arecibo 305-m radiotelescope and the Green Bank 91-m radiotelescope. See the documentation by Brian Dennison, either in LaTeX (doc.tex), or in plain ascii (adc.doc) (1 data file).

  15. A method for monitoring the variability in nuclear absorption characteristics of aviation fuels

    NASA Technical Reports Server (NTRS)

    Sprinkle, Danny R.; Shen, Chih-Ping

    1988-01-01

    A technique for monitoring variability in the nuclear absorption characteristics of aviation fuels has been developed. It is based on a highly collimated low energy gamma radiation source and a sodium iodide counter. The source and the counter assembly are separated by a geometrically well-defined test fuel cell. A computer program for determining the mass attenuation coefficient of the test fuel sample, based on the data acquired for a preset counting period, has been developed and tested on several types of aviation fuel.

  16. Method and apparatus for smart battery charging including a plurality of controllers each monitoring input variables

    DOEpatents

    Hammerstrom, Donald J.

    2013-10-15

    A method for managing the charging and discharging of batteries wherein at least one battery is connected to a battery charger, the battery charger is connected to a power supply. A plurality of controllers in communication with one and another are provided, each of the controllers monitoring a subset of input variables. A set of charging constraints may then generated for each controller as a function of the subset of input variables. A set of objectives for each controller may also be generated. A preferred charge rate for each controller is generated as a function of either the set of objectives, the charging constraints, or both, using an algorithm that accounts for each of the preferred charge rates for each of the controllers and/or that does not violate any of the charging constraints. A current flow between the battery and the battery charger is then provided at the actual charge rate.

  17. Automated size-specific CT dose monitoring program: Assessing variability in CT dose

    SciTech Connect

    Christianson, Olav; Li Xiang; Frush, Donald; Samei, Ehsan

    2012-11-15

    Purpose: The potential health risks associated with low levels of ionizing radiation have created a movement in the radiology community to optimize computed tomography (CT) imaging protocols to use the lowest radiation dose possible without compromising the diagnostic usefulness of the images. Despite efforts to use appropriate and consistent radiation doses, studies suggest that a great deal of variability in radiation dose exists both within and between institutions for CT imaging. In this context, the authors have developed an automated size-specific radiation dose monitoring program for CT and used this program to assess variability in size-adjusted effective dose from CT imaging. Methods: The authors radiation dose monitoring program operates on an independent health insurance portability and accountability act compliant dosimetry server. Digital imaging and communication in medicine routing software is used to isolate dose report screen captures and scout images for all incoming CT studies. Effective dose conversion factors (k-factors) are determined based on the protocol and optical character recognition is used to extract the CT dose index and dose-length product. The patient's thickness is obtained by applying an adaptive thresholding algorithm to the scout images and is used to calculate the size-adjusted effective dose (ED{sub adj}). The radiation dose monitoring program was used to collect data on 6351 CT studies from three scanner models (GE Lightspeed Pro 16, GE Lightspeed VCT, and GE Definition CT750 HD) and two institutions over a one-month period and to analyze the variability in ED{sub adj} between scanner models and across institutions. Results: No significant difference was found between computer measurements of patient thickness and observer measurements (p= 0.17), and the average difference between the two methods was less than 4%. Applying the size correction resulted in ED{sub adj} that differed by up to 44% from effective dose estimates

  18. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  19. Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit

    PubMed Central

    2014-01-01

    Background Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners. Methods This paper describes the monitoring methods and procedures that are utilised by a non-commercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks. Results Monitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration. Conclusion We present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk. PMID:24739398

  20. Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors

    PubMed Central

    Reed, Charles Calhoun; Staggers, Nancy

    2016-01-01

    Background Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. Objective This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. Methods At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Results Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. Conclusions The audit log is a function of current capabilities of the physiologic monitoring systems, monitor’s configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices’ log capacity. PMID:27694097

  1. Real-time monitoring for human clinical trials

    SciTech Connect

    Harker, Y.D.

    1995-11-01

    On August 3-4, 1994, an INEL team made measurements related to a real-time monitoring system for use on the epithermal beam facility at the BMRR. BNL has installed two fission chambers in front of the beam collimator, which are to monitor the beam coming from the reactor. These two monitors are located with one just above the 16-cm dia. front aperture and the other is just below. The fission chambers contain depleted uranium, but because of the small amount of U-235 present, they respond to thermal and near thermal neutrons rather than fast neutrons. This feature combined with their relatively small size (0.6 cm dia x 4 cm long) makes them very good monitors in the BMRR epithermal neutron beam. The INEL team worked with H.B. Lui (BNL) in performing initial tests of these monitors and established the settings to achieve stable operation. The main purpose of the measurement studies was to establish a basis for a monitoring method that tracks the dose the patient is receiving rather than the neutron fluence being delivered down the beam line.

  2. A multi-layer monitoring system for clinical management of Congestive Heart Failure

    PubMed Central

    2015-01-01

    Background Congestive Heart Failure (CHF) is a serious cardiac condition that brings high risks of urgent hospitalization and death. Remote monitoring systems are well-suited to managing patients suffering from CHF, and can reduce deaths and re-hospitalizations, as shown by the literature, including multiple systematic reviews. Methods The monitoring system proposed in this paper aims at helping CHF stakeholders make appropriate decisions in managing the disease and preventing cardiac events, such as decompensation, which can lead to hospitalization or death. Monitoring activities are stratified into three layers: scheduled visits to a hospital following up on a cardiac event, home monitoring visits by nurses, and patient's self-monitoring performed at home using specialized equipment. Appropriate hardware, desktop and mobile software applications were developed to enable a patient's monitoring by all stakeholders. For the first two layers, we designed and implemented a Decision Support System (DSS) using machine learning (Random Forest algorithm) to predict the number of decompensations per year and to assess the heart failure severity based on a variety of clinical data. For the third layer, custom-designed sensors (the Blue Scale system) for electrocardiogram (EKG), pulse transit times, bio-impedance and weight allowed frequent collection of CHF-related data in the comfort of the patient's home. We also performed a short-term Heart Rate Variability (HRV) analysis on electrocardiograms self-acquired by 15 healthy volunteers and compared the obtained parameters with those of 15 CHF patients from PhysioNet's PhysioBank archives. Results We report numerical performances of the DSS, calculated as multiclass accuracy, sensitivity and specificity in a 10-fold cross-validation. The obtained average accuracies are: 71.9% in predicting the number of decompensations and 81.3% in severity assessment. The most serious class in severity assessment is detected with good

  3. Journal of Clinical Monitoring and Computing 2015 end of year summary: anesthesia.

    PubMed

    Hendrickx, Jan F A; De Wolf, Andre; Skinner, Stanley

    2016-02-01

    Clinical monitoring is an essential part of the profession of anesthesiology. It would therefore be impossible to review all articles published in the Journal of Clinical Monitoring and Computing that are relevant to anesthesia. Because other reviews will address monitoring of the respiratory and cardiovascular system, the current review will limit itself to topics uniquely related to anesthesia. The topics are organized according to the chronological order in which an anesthetic proceeds: secure the airway; ventilate and deliver anesthetic gases; monitor vital organ function and anesthetic depth; and ensure analgesia during/after emergence from anesthesia (locoregional anesthesia and pain control). PMID:26707866

  4. Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

    PubMed Central

    Zito, Julie M; Derivan, Albert T; Kratochvil, Christopher J; Safer, Daniel J; Fegert, Joerg M; Greenhill, Laurence L

    2008-01-01

    The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring. PMID:18793403

  5. A monitoring campaign for Luhman 16AB. I. Detection of resolved near-infrared spectroscopic variability

    SciTech Connect

    Burgasser, Adam J.; Gillon, Michaël; Jehin, E.; Delrez, L.; Opitom, C.; Faherty, Jacqueline K.; Radigan, Jacqueline; Triaud, Amaury H. M. J.; Plavchan, Peter

    2014-04-10

    We report resolved near-infrared spectroscopic monitoring of the nearby L dwarf/T dwarf binary WISE J104915.57–531906.1AB (Luhman 16AB), as part of a broader campaign to characterize the spectral energy distribution and temporal variability of this system. A continuous 45 minute sequence of low-resolution IRTF/SpeX data spanning 0.8-2.4 μm were obtained, concurrent with combined-light optical photometry with ESO/TRAPPIST. Our spectral observations confirm the flux reversal of this binary, and we detect a wavelength-dependent decline in the relative spectral fluxes of the two components coincident with a decline in the combined-light optical brightness of the system over the course of the observation. These data are successfully modeled as a combination of achromatic (brightness) and chromatic (color) variability in the T0.5 Luhman 16B, consistent with variations in overall cloud opacity; and no significant variability was found in L7.5 Luhman 16A, consistent with recent resolved photometric monitoring. We estimate a peak-to-peak amplitude of 13.5% at 1.25 μm over the full light curve. Using a simple two-spot brightness temperature model for Luhman 16B, we infer an average cold covering fraction of ≈30%-55%, varying by 15%-30% over a rotation period assuming a ≈200-400 K difference between hot and cold regions. We interpret these variations as changes in the covering fraction of a high cloud deck and corresponding 'holes' which expose deeper, hotter cloud layers, although other physical interpretations are possible. A Rhines scale interpretation for the size of the variable features explains an apparent correlation between period and amplitude for Luhman 16B and the variable T dwarfs SIMP 0136+0933 and 2MASS J2139+0220, and predicts relatively fast winds (1-3 km s{sup –1}) for Luhman 16B consistent with light curve evolution on an advective time scale (1-3 rotation periods). The strong variability observed in this flux reversal brown dwarf pair supports

  6. Monitoring meteorological spatial variability in viticulture using a low-cost Wireless Sensor Network

    NASA Astrophysics Data System (ADS)

    Matese, Alessandro; Crisci, Alfonso; Di Gennaro, Filippo; Primicerio, Jacopo; Tomasi, Diego; Guidoni, Silvia

    2014-05-01

    In a long-term perspective, the current global agricultural scenario will be characterize by critical issues in terms of water resource management and environmental protection. The concept of sustainable agriculture would become crucial at reducing waste, optimizing the use of pesticides and fertilizers to crops real needs. This can be achieved through a minimum-scale monitoring of the crop physiologic status and the environmental parameters that characterize the microclimate. Viticulture is often subject to high variability within the same vineyard, thus becomes important to monitor this heterogeneity to allow a site-specific management and maximize the sustainability and quality of production. Meteorological variability expressed both at vineyard scale (mesoclimate) and at single plant level (microclimate) plays an important role during the grape ripening process. The aim of this work was to compare temperature, humidity and solar radiation measurements at different spatial scales. The measurements were assessed for two seasons (2011, 2012) in two vineyards of the Veneto region (North-East Italy), planted with Pinot gris and Cabernet Sauvignon using a specially designed and developed Wireless Sensor Network (WSN). The WSN consists of various levels: the Master/Gateway level coordinates the WSN and performs data aggregation; the Farm/Server level takes care of storing data on a server, data processing and graphic rendering. Nodes level is based on a network of peripheral nodes consisting of a sensor board equipped with sensors and wireless module. The system was able to monitor the agrometeorological parameters in the vineyard: solar radiation, air temperature and air humidity. Different sources of spatial variation were studied, from meso-scale to micro-scale. A widespread investigation was conducted, building a factorial design able to evidence the role played by any factor influencing the physical environment in the vineyard, such as the surrounding climate

  7. [Heart rate variability analysis: a new approach in clinical research methodology for neonatal sepsis].

    PubMed

    Cuestas, Eduardo; Rizzotti, Alina; Agüero, Guillermo

    2011-08-01

    The knowledge on neonatal sepsis has increase significantly, but a clinical or biochemical marker is not available for an early and appropriate diagnosis. This fact results of an inadequate analysis which might be missing important quantum of biological information. A new method of nonlinear analysis have been proposed to investigate time series of physiological data, particularly heart rate variability analysis, that apparently would detect abnormal changes which precedes clinical or biochemical signs of infection by as much as 12-24 hours.

  8. Exposure–Response Modeling of Clinical End Points Using Latent Variable Indirect Response Models

    PubMed Central

    Hu, C

    2014-01-01

    Exposure–response modeling facilitates effective dosing regimen selection in clinical drug development, where the end points are often disease scores and not physiological variables. Appropriate models need to be consistent with pharmacology and identifiable from the time courses of available data. This article describes a general framework of applying mechanism-based models to various types of clinical end points. Placebo and drug model parameterization, interpretation, and assessment are discussed with a focus on the indirect response models. PMID:24897307

  9. Monitoring Urban Water Quality Variability Using Continuous In-Situ Sensors

    NASA Astrophysics Data System (ADS)

    Carey, R. O.; Wollheim, W. M.; Mulukutla, G. K.

    2011-12-01

    Water quality monitoring using continuous in-situ sensors can improve our understanding of biogeochemical variability in urban watersheds. In New Hampshire, the Lamprey River drains an urbanizing watershed and discharges to the nitrogen (N)-impaired Great Bay estuary. Multiple instruments (Satlantic Submersible Ultraviolet Nitrate Analyzer, Turner Designs C6 Multi-Sensor Platform, Hydrolab MS5, and WET Labs Cycle) were deployed continuously for three seasons (April-November, 2011) in the Lamprey River to evaluate water quality relationships under hydrologically variable conditions and across seasons. Parameters monitored at sub-hourly intervals included nitrate-N (NO3-N), chromophoric dissolved organic matter (CDOM), chlorophyll, turbidity, dissolved oxygen (DO), specific conductivity, and pH; dissolved phosphate (PO4-P) was monitored hourly. Grab samples were also collected to assess instrument performance. Preliminary results from deployment through early August 2011 indicate that baseflow was associated with both elevated NO3-N concentrations and specific conductivity, but daily NO3-N fluxes were greater during storms. Greater discharges corresponded to increased values for CDOM, chlorophyll, and DO concentrations. In addition to diurnal cycles for several parameters (i.e., CDOM, chlorophyll, DO, and pH), NO3-N and PO4-P concentrations peaked during the night and day, respectively, suggesting biotic uptake became important at lower flows. Stormwater generally diluted NO3-N concentrations and specific conductivity, indicating groundwater contamination from the predominance of septic waste management and winter road salt application in suburban communities in the watershed. However, greater NO3-N export during storms revealed the importance of stormwater discharges despite the dilution effect. Studies using high-resolution data to evaluate the effects of stormwater discharge and increasing urbanization are crucial to understanding the significance of varying land

  10. Electronic Fetal Monitoring by Microcomputer: A Clinical Application

    PubMed Central

    Lichten, Edward M.

    1981-01-01

    Using recent advances in microcomputer technology, a system for the continuous, direct processing of fetal monitor information is installed in Sinai Hospital. The basic system consists of an Apple IIR microcomputer with accessories readily available at local computer stores. Eight fetal monitors are connected to the computer system by cable. Monitor tracings, similar in quality to the original, are displayed at the central unit and at remote locations throughout the labor and delivery areas. This information can also be transmitted to physicians' homes and reproduced on a multi-copy graphic printer. Two benefits with this system are noted. First, this application of microcomputer technology promotes the rapid dissemination of information to physicians and staff. Second, medical record storage can be improved by the graphic printer's copies.

  11. Marker-based monitoring of seated spinal posture using a calibrated single-variable threshold model.

    PubMed

    Walsh, Pauline; Dunne, Lucy E; Caulfield, Brian; Smyth, Barry

    2006-01-01

    This work, as part of a larger project developing wearable posture monitors for the work environment, seeks to monitor and model seated posture during computer use. A non-wearable marker-based optoelectronic motion capture system was used to monitor seated posture for ten healthy subjects during a calibration exercise and a typing task. Machine learning techniques were used to select overall spinal sagittal flexion as the best indicator of posture from a set of marker and vector variables. Overall flexion data from the calibration exercise were used to define a threshold model designed to classify posture for each subject, which was then applied to the typing task data. Results of the model were analysed visually by qualified physiotherapists with experience in ergonomics and posture analysis to confirm the accuracy of the calibration. The calibration formula was found to be accurate on 100% subjects. This process will be used as a comparative measure in the evaluation of several wearable posture sensors, and to inform the design of the wearable system. PMID:17946301

  12. Monitoring depth of anesthesia using combination of EEG measure and hemodynamic variables.

    PubMed

    Shalbaf, R; Behnam, H; Jelveh Moghadam, H

    2015-02-01

    Monitoring depth of anesthesia (DOA) via vital signs is a major ongoing challenge for anesthetists. A number of electroencephalogram (EEG)-based monitors such as the Bispectral (BIS) index have been proposed. However, anesthesia is related to central and autonomic nervous system functions whereas the EEG signal originates only from the central nervous system. This paper proposes an automated DOA detection system which consists of three steps. Initially, we introduce multiscale modified permutation entropy index which is robust in the characterization of the burst suppression pattern and combine multiscale information. This index quantifies the amount of complexity in EEG data and is computationally efficient, conceptually simple and artifact resistant. Then, autonomic nervous system activity is quantified with heart rate and mean arterial pressure which are easily acquired using routine monitoring machine. Finally, the extracted features are used as input to a linear discriminate analyzer (LDA). The method is validated with data obtained from 25 patients during the cardiac surgery requiring cardiopulmonary bypass. The experimental results indicate that an overall accuracy of 89.4 % can be obtained using combination of EEG measure and hemodynamic variables, together with LDA to classify the vital sign into awake, light, surgical and deep anesthetised states. The results demonstrate that the proposed method can estimate DOA more effectively than the commercial BIS index with a stronger artifact-resistance.

  13. Precipitation variability within an urban monitoring network via microcanonical cascade generators

    NASA Astrophysics Data System (ADS)

    Licznar, P.; De Michele, C.; Adamowski, W.

    2015-01-01

    Understanding the variability of precipitation at small scales is fundamental in urban hydrology. Here we consider the case study of Warsaw, Poland, characterized by a precipitation-monitoring network of 25 gauges and microcanonical cascade models as the instrument of investigation. We address the following issues partially investigated in literature: (1) the calibration of microcanonical cascade model generators in conditions of short time series (i.e., 2.5-5 years), (2) the identification of the probability distribution of breakdown coefficients (BDCs) through ranking criteria and (3) the variability among the gauges of the monitoring network of the empirical distribution of BDCs. In particular, (1) we introduce an overlapping moving window algorithm to determine the histogram of BDCs and compare it with the classic non-overlapping moving window algorithm; (2) we compare the 2N-B distribution, a mixed distribution composed of two normal (N) and one beta (B), with the classic B distribution to represent the BDCs using the Akaike information criterion; and (3) we use the cluster analysis to identify patterns of BDC histograms among gauges and timescales. The scarce representation of the BDCs at large timescales, due to the short period of observation (~ 2.5 years), is solved through the overlapping moving window algorithm. BDC histograms are described by a 2N-B distribution. A clear evolution of this distribution is observed, in all gauges, from 2N-B for small timescales, N-B for intermediate timescales and B distribution for large timescales. The performance of the microcanonical cascades is evaluated for the considered gauges. Synthetic time series are analyzed with respect to the intermittency and the variability of intensity and compared to observed series. BDC histograms for each timescale are compared with the 25 gauges in Warsaw and with other gauges located in Poland and Germany.

  14. HadISDH land surface multi-variable humidity and temperature record for climate monitoring

    NASA Astrophysics Data System (ADS)

    Willett, K. M.; Dunn, R. J. H.; Thorne, P. W.; Bell, S.; de Podesta, M.; Parker, D. E.; Jones, P. D.; Williams, C. N., Jr.

    2014-06-01

    HadISDH.2.0.0 is the first gridded, multi-variable humidity and temperature climate-data product that is homogenised and annually updated. It provides physically consistent estimates for specific humidity, vapour pressure, relative humidity, dew point temperature, wet bulb temperature, dew point depression and temperature. It is a monthly-mean gridded (5° by 5°) product with uncertainty estimates that account for spatio-temporal sampling, climatology calculation, homogenisation and irreducible random measurement effects. It provides a unique tool for the monitoring of a variety of humidity-related variables which have different impacts and implications for society. HadISDH.2.0.0 is shown to be in good agreement both with other estimates where they are available, and with theoretical understanding. The dataset is available from 1973 to the present. The theme common to all variables is of a warming world with more water vapour present in the atmosphere. The largest increases in water vapour are found over the tropics and Mediterranean. Over the tropics and high northern latitudes the surface air over land is becoming more saturated. However, despite increasing water vapour over the mid-latitudes and Mediterranean, the surface air over land is becoming less saturated. These observed features may be due to atmospheric circulation changes, land-sea warming disparities and reduced water availability or changed land surface properties.

  15. HadISDH land surface multi-variable humidity and temperature record for climate monitoring

    NASA Astrophysics Data System (ADS)

    Willett, K. M.; Dunn, R. J. H.; Thorne, P. W.; Bell, S.; de Podesta, M.; Parker, D. E.; Jones, P. D.; Williams, C. N., Jr.

    2014-11-01

    HadISDH.2.0.0 is the first gridded, multi-variable humidity and temperature in situ observations-only climate-data product that is homogenised and annually updated. It provides physically consistent estimates for specific humidity, vapour pressure, relative humidity, dew point temperature, wet bulb temperature, dew point depression and temperature. It is a monthly mean gridded (5° by 5°) product with uncertainty estimates that account for spatio-temporal sampling, climatology calculation, homogenisation and irreducible random measurement effects. It provides a tool for the long-term monitoring of a variety of humidity-related variables which have different impacts and implications for society. It is also useful for climate model evaluation and reanalyses validation. HadISDH.2.0.0 is shown to be in good agreement both with other estimates and with theoretical understanding. The data set is available from 1973 to the present. The theme common to all variables is of a warming world with more water vapour present in the atmosphere. The largest increases in water vapour are found over the tropics and the Mediterranean. Over the tropics and high northern latitudes the surface air over land is becoming more saturated. However, despite increasing water vapour over the mid-latitudes and Mediterranean, the surface air over land is becoming less saturated. These observed features may be due to atmospheric circulation changes, land-sea warming disparities and reduced water availability or changed land surface properties.

  16. Monitoring of early warning indicators for HIV drug resistance in antiretroviral therapy clinics in Zimbabwe.

    PubMed

    Dzangare, J; Gonese, E; Mugurungi, O; Shamu, T; Apollo, T; Bennett, D E; Kelley, K F; Jordan, M R; Chakanyuka, C; Cham, F; Banda, R M

    2012-05-01

    Monitoring human immunodeficiency virus drug resistance (HIVDR) early warning indicators (EWIs) can help national antiretroviral treatment (ART) programs to identify clinic factors associated with HIVDR emergence and provide evidence to support national program and clinic-level adjustments, if necessary. World Health Organization-recommended HIVDR EWIs were monitored in Zimbabwe using routinely available data at selected ART clinics between 2007 and 2009. As Zimbabwe's national ART coverage increases, improved ART information systems are required to strengthen routine national ART monitoring and evaluation and facilitate scale-up of HIVDR EWI monitoring. Attention should be paid to minimizing loss to follow-up, supporting adherence, and ensuring clinic-level drug supply continuity. PMID:22544194

  17. [Phenotypic variability in 47, XXX patients: Clinical report of four new cases].

    PubMed

    Goldschmidt, Ernesto; Márquez, Marisa; Solari, Andrea; Ziembar, María I; Laudicina, Alejandro

    2010-08-01

    The 47, XXX karyotype has a frequency of 1 in 1000 female newborns. However, this karyotype is not usually suspected at birth or childhood. These patients are usually diagnosed during adulthood when they develop premature ovarian failure or infertility, because the early phenotype doesn t have any specific features. The study describes four cases and the clinical variability of the 47, XXX karyotype.

  18. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  19. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  20. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  1. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  2. Using a Web-Based Database to Record and Monitor Athletic Training Students' Clinical Experiences

    ERIC Educational Resources Information Center

    Brown, Kirk W.; Williams, Lisa; Janicki, Thomas

    2008-01-01

    Objective: The purpose of this article is to introduce a documentation recording system employing the Microsoft Structured Query Language (MS-SQL) database used by the Athletic Training Education Program (ATEP) for recording and monitoring of athletic training student (ATS) clinical experiences and hours. Background: Monitoring ATSs clinical…

  3. Changes in Heart Rate Variability after Coronary Artery Bypass Grafting and Clinical Importance of These Findings

    PubMed Central

    Lakusic, Nenad; Mahovic, Darija; Cerkez Habek, Jasna; Novak, Miroslav; Cerovec, Dusko

    2015-01-01

    Heart rate variability is a physiological feature indicating the influence of the autonomic nervous system on the heart rate. Association of the reduced heart rate variability due to myocardial infarction and the increased postinfarction mortality was first described more than thirty years ago. Many studies have unequivocally demonstrated that coronary artery bypass grafting surgery generally leads to significant reduction in heart rate variability, which is even more pronounced than after myocardial infarction. Pathophysiologically, however, the mechanisms of heart rate variability reduction associated with acute myocardial infarction and coronary artery bypass grafting are different. Generally, heart rate variability gradually recovers to the preoperative values within six months of the procedure. Unlike the reduced heart rate variability in patients having sustained myocardial infarction, a finding of reduced heart rate variability after coronary artery bypass surgery is not considered relevant in predicting mortality. Current knowledge about changes in heart rate variability in coronary patients and clinical relevance of such a finding in patients undergoing coronary artery bypass grafting are presented. PMID:26078960

  4. Structural and diffusion imaging versus clinical assessment to monitor amyotrophic lateral sclerosis

    PubMed Central

    Cardenas-Blanco, Arturo; Machts, Judith; Acosta-Cabronero, Julio; Kaufmann, Joern; Abdulla, Susanne; Kollewe, Katja; Petri, Susanne; Schreiber, Stefanie; Heinze, Hans-Jochen; Dengler, Reinhard; Vielhaber, Stefan; Nestor, Peter J.

    2016-01-01

    Amyotrophic lateral sclerosis is a progressive neurodegenerative disease that affects upper and lower motor neurons. Observational and intervention studies can be tracked using clinical measures such as the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) but for a complete understanding of disease progression, objective in vivo biomarkers of both central and peripheral motor pathway pathology are highly desirable. The aim of this study was to determine the utility of structural and diffusion imaging as central nervous system biomarkers compared to the standard clinical measure, ALSFRS-R, to track longitudinal evolution using three time-point measurements. N = 34 patients with ALS were scanned and clinically assessed three times at a mean of three month time intervals. The MRI biomarkers were structural T1-weighted volumes for cortical thickness measurement as well as deep grey matter volumetry, voxel-based morphometry and diffusion tensor imaging (DTI). Cortical thickness focused specifically on the precentral gyrus while quantitative DTI biomarkers focused on the corticospinal tracts. The evolution of imaging biomarkers and ALSFRS-R scores over time were analysed using a mixed effects model that accounted for the scanning interval as a fixed effect variable, and, the initial measurements and time from onset as random variables. The mixed effects model showed a significant decrease in the ALSFRS-R score, (p < 0.0001, and an annual rate of change (AROC) of − 7.3 points). Similarly, fractional anisotropy of the corticospinal tract showed a significant decrease (p = 0.009, AROC = − 0.0066) that, in turn, was driven by a significant increase in radial diffusivity combined with a trend to decrease in axial diffusivity. No significant change in cortical thickness of the precentral gyrus was found (p > 0.5). In addition, deep grey matter volumetry and voxel-based morphometry also identified no significant changes. Furthermore, the

  5. Classification Models for Neurocognitive Impairment in HIV Infection Based on Demographic and Clinical Variables

    PubMed Central

    Muñoz-Moreno, Jose A.; Pérez-Álvarez, Núria; Muñoz-Murillo, Amalia; Prats, Anna; Garolera, Maite; Jurado, M. Àngels; Fumaz, Carmina R.; Negredo, Eugènia; Ferrer, Maria J.; Clotet, Bonaventura

    2014-01-01

    Objective We used demographic and clinical data to design practical classification models for prediction of neurocognitive impairment (NCI) in people with HIV infection. Methods The study population comprised 331 HIV-infected patients with available demographic, clinical, and neurocognitive data collected using a comprehensive battery of neuropsychological tests. Classification and regression trees (CART) were developed to obtain detailed and reliable models to predict NCI. Following a practical clinical approach, NCI was considered the main variable for study outcomes, and analyses were performed separately in treatment-naïve and treatment-experienced patients. Results The study sample comprised 52 treatment-naïve and 279 experienced patients. In the first group, the variables identified as better predictors of NCI were CD4 cell count and age (correct classification [CC]: 79.6%, 3 final nodes). In treatment-experienced patients, the variables most closely related to NCI were years of education, nadir CD4 cell count, central nervous system penetration-effectiveness score, age, employment status, and confounding comorbidities (CC: 82.1%, 7 final nodes). In patients with an undetectable viral load and no comorbidities, we obtained a fairly accurate model in which the main variables were nadir CD4 cell count, current CD4 cell count, time on current treatment, and past highest viral load (CC: 88%, 6 final nodes). Conclusion Practical classification models to predict NCI in HIV infection can be obtained using demographic and clinical variables. An approach based on CART analyses may facilitate screening for HIV-associated neurocognitive disorders and complement clinical information about risk and protective factors for NCI in HIV-infected patients. PMID:25237895

  6. Saliva-based biosensors: noninvasive monitoring tool for clinical diagnostics.

    PubMed

    Malon, Radha S P; Sadir, Sahba; Balakrishnan, Malarvili; Córcoles, Emma P

    2014-01-01

    Saliva is increasingly recognised as an attractive diagnostic fluid. The presence of various disease signalling salivary biomarkers that accurately reflect normal and disease states in humans and the sampling benefits compared to blood sampling are some of the reasons for this recognition. This explains the burgeoning research field in assay developments and technological advancements for the detection of various salivary biomarkers to improve clinical diagnosis, management, and treatment. This paper reviews the significance of salivary biomarkers for clinical diagnosis and therapeutic applications, with focus on the technologies and biosensing platforms that have been reported for screening these biomarkers.

  7. Saliva-Based Biosensors: Noninvasive Monitoring Tool for Clinical Diagnostics

    PubMed Central

    Malon, Radha S. P.; Balakrishnan, Malarvili; Córcoles, Emma P.

    2014-01-01

    Saliva is increasingly recognised as an attractive diagnostic fluid. The presence of various disease signalling salivary biomarkers that accurately reflect normal and disease states in humans and the sampling benefits compared to blood sampling are some of the reasons for this recognition. This explains the burgeoning research field in assay developments and technological advancements for the detection of various salivary biomarkers to improve clinical diagnosis, management, and treatment. This paper reviews the significance of salivary biomarkers for clinical diagnosis and therapeutic applications, with focus on the technologies and biosensing platforms that have been reported for screening these biomarkers. PMID:25276835

  8. Clinical review: A review and analysis of heart rate variability and the diagnosis and prognosis of infection

    PubMed Central

    2009-01-01

    Bacterial infection leading to organ failure is the most common cause of death in critically ill patients. Early diagnosis and expeditious treatment is a cornerstone of therapy. Evaluating the systemic host response to infection as a complex system provides novel insights: however, bedside application with clinical value remains wanting. Providing an integrative measure of an altered host response, the patterns and character of heart rate fluctuations measured over intervals-in-time may be analysed with a panel of mathematical techniques that quantify overall fluctuation, spectral composition, scale-free variation, and degree of irregularity or complexity. Using these techniques, heart rate variability (HRV) has been documented to be both altered in the presence of systemic infection, and correlated with its severity. In this review and analysis, we evaluate the use of HRV monitoring to provide early diagnosis of infection, document the prognostic implications of altered HRV in infection, identify current limitations, highlight future research challenges, and propose improvement strategies. Given existing evidence and potential for further technological advances, we believe that longitudinal, individualized, and comprehensive HRV monitoring in critically ill patients at risk for or with existing infection offers a means to harness the clinical potential of this bedside application of complex systems science. PMID:20017889

  9. Monitoring Crop Yield in USA Using a Satellite-Based Climate-Variability Impact Index

    NASA Technical Reports Server (NTRS)

    Zhang, Ping; Anderson, Bruce; Tan, Bin; Barlow, Mathew; Myneni, Ranga

    2011-01-01

    A quantitative index is applied to monitor crop growth and predict agricultural yield in continental USA. The Climate-Variability Impact Index (CVII), defined as the monthly contribution to overall anomalies in growth during a given year, is derived from 1-km MODIS Leaf Area Index. The growing-season integrated CVII can provide an estimate of the fractional change in overall growth during a given year. In turn these estimates can provide fine-scale and aggregated information on yield for various crops. Trained from historical records of crop production, a statistical model is used to produce crop yield during the growing season based upon the strong positive relationship between crop yield and the CVII. By examining the model prediction as a function of time, it is possible to determine when the in-season predictive capability plateaus and which months provide the greatest predictive capacity.

  10. Clinical validation of software for a versatile variability analyzer: Assessment of autonomic function

    PubMed Central

    Ananthakrishnan, T. S.; Jindal, G. D.; Sinha, Vineet; Jain, Rajesh K.; Kataria, S. K.; Deshpande, Alaka K.

    2007-01-01

    Study of physiological variability is an upcoming area of research having manifold clinical applications. Considerable work has been done on heart rate variability and blood pressure variability during the past four decades. Electronics division, Bhabha Atomic Research Centre, has developed an instrument called medical analyzer, which can be used to study several variabilities simultaneously. This instrument has been used to collect data from control subjects and patients with established diagnosis. The data has been analyzed with the help of a software package developed for this purpose and has been found to be consistent with expected manifestations of the disease on the autonomic nervous system. The description of the software package and results of the study are briefly described in this paper. PMID:21157528

  11. Monitoring pasture variability: optical OptRx(®) crop sensor versus Grassmaster II capacitance probe.

    PubMed

    Serrano, João M; Shahidian, Shakib; Marques da Silva, José Rafael

    2016-02-01

    Estimation of pasture productivity is an important step for the farmer in terms of planning animal stocking, organizing animal lots, and determining supplementary feeding needs throughout the year. The main objective of this work was to evaluate technologies which have potential for monitoring aspects related to spatial and temporal variability of pasture green and dry matter yield (respectively, GM and DM, in kg/ha) and support to decision making for the farmer. Two types of sensors were evaluated: an active optical sensor ("OptRx(®)," which measures the NDVI, "Normalized Difference Vegetation Index") and a capacitance probe ("GrassMaster II" which estimates plant mass). The results showed the potential of NDVI for monitoring the evolution of spatial and temporal patterns of vegetative growth of biodiverse pasture. Higher NDVI values were registered as pasture approached its greatest vegetative vigor, with a significant fall in the measured NDVI at the end of Spring, when the pasture began to dry due to the combination of higher temperatures and lower soil moisture content. This index was also effective for identifying different plant species (grasses/legumes) and variability in pasture yield. Furthermore, it was possible to develop calibration equations between the capacitance and the NDVI (R(2) = 0.757; p < 0.01), between capacitance and GM (R(2) = 0.799; p < 0.01), between capacitance and DM (R(2) =0.630; p < 0.01), between NDVI and GM (R(2) = 0.745; p < 0.01), and between capacitance and DM (R(2) = 0.524; p < 0.01). Finally, a direct relationship was obtained between NDVI and pasture moisture content (PMC, in %) and between capacitance and PMC (respectively, R(2) = 0.615; p < 0.01 and R(2) = 0.561; p < 0.01) in Alentejo dryland farming systems. PMID:26812951

  12. Observing Campaign to Monitor Magnetically-Active Dwarfs for Long-Term Variability

    NASA Astrophysics Data System (ADS)

    Templeton, Matthew R.

    2009-10-01

    Dr. Styliani (Stella) Kafka of the Department of Terrestrial Magnetism, Carnegie Institute of Washington, requests AAVSO observers to perform long-term photometric monitoring on a number of magnetically active dwarf stars, with an observing frequency of one observation every three days taken with one or more filters. When multiple filters are available, the preferred observations are (in order of precedence): Rc, V, Ic, and B. Please observe such that you obtain a signal to noise of at least 50 (100 or higher is preferred). These objects are all nearby dwarfs known or suspected to have magnetic activity, primarily of the UV Ceti (flare star) or BY Draconis subtypes. Long-term photometric monitoring of these objects will be used in conjunction with other multiwavelength observations from ground-based facilities including the Magellan 6.5-meter and DuPont 2.5-meter telescopes in Chile to understand the long-term magnetic activity cycles of these stars. Such a study can reveal information about the physical natures of these stars, but also about their near space environments and habitability for life. These objects are red, and the variability amplitudes are low, often well below 0.1 magnitudes. The long-term variability due to stellar activity cycles may be much lower. Photometric accuracy rather than the number of observations are key to the success of this project. Unaccounted-for atmospheric effects such as extinction will likely overwhelm any long-term signal from these stars. Observers are strongly urged to fully calibrate their systems and to carefully reduce and transform their photometry to standard photometric passbands, including corrections for airmass/atmospheric extinction. Parameters for 40 objects are given. Observations should be submitted to the AAVSO International Database.

  13. Medication Monitoring for People with Dementia in Care Homes: The Feasibility and Clinical Impact of Nurse-Led Monitoring

    PubMed Central

    Jordan, Sue; Gabe, Marie; Newson, Louise; Snelgrove, Sherrill; Panes, Gerwyn; Picek, Aldo; Russell, Ian T.; Dennis, Michael

    2014-01-01

    Objectives. People with dementia are susceptible to adverse effects of medicines. However, they are not always closely monitored. We explored (1) feasibility and (2) clinical impact of nurse-led medication monitoring. Design. Feasibility “before-and-after” intervention study. Setting. Three care homes in Wales. Participants. Eleven service users diagnosed with dementia, taking at least one antipsychotic, antidepressant, or antiepileptic medicine. Intervention. West Wales Adverse Drug Reaction (ADR) Profile for Mental Health Medicines. Outcome Measures. (1) Feasibility: recruitment, retention, and implementation. (2) Clinical impact: previously undocumented problems identified and ameliorated, as recorded in participants' records before and after introduction of the profile, and one month later. Results. Nurses recruited and retained 11 of 29 eligible service users. The profile took 20–25 minutes to implement, caused no harm, and supplemented usual care. Initially, the profile identified previously undocumented problems for all participants (mean 12.7 (SD 4.7)). One month later, some problems had been ameliorated (mean 4.9 (3.6)). Clinical gains included new prescriptions to manage pain (2 participants), psoriasis (1), Parkinsonian symptoms (1), rash (1), dose reduction of benzodiazepines (1), new care plans for oral hygiene, skin problems, and constipation. Conclusions. Participants benefited from structured nurse-led medication monitoring. Clinical trials of our ADR Profile are feasible and necessary. PMID:24707218

  14. Linear variable filter based oil condition monitoring systems for offshore windturbines

    NASA Astrophysics Data System (ADS)

    Wiesent, Benjamin R.; Dorigo, Daniel G.; Şimşek, Özlem; Koch, Alexander W.

    2011-10-01

    A major part of future renewable energy will be generated in offshore wind farms. The used turbines of the 5 MW class and beyond, often feature a planetary gear with 1000 liters lubricating oil or even more. Monitoring the oil aging process provides early indication of necessary maintenance and oil change. Thus maintenance is no longer time-scheduled but becomes wear dependent providing ecological and economical benefits. This paper describes two approaches based on a linear variable filter (LVF) as dispersive element in a setup of a cost effective infrared miniature spectrometer for oil condition monitoring purposes. Spectra and design criteria of a static multi-element detector and a scanning single element detector system are compared and rated. Both LVF miniature spectrometers are appropriately designed for the suggested measurements but have certain restrictions. LVF multi-channel sensors combined with sophisticated multivariate data processing offer the possibility to use the sensor for a broad range of lubricants just by a software update of the calibration set. An all-purpose oil sensor may be obtained.

  15. Photometric Monitoring of a New Sample of Candidate Luminous Blue Variables

    NASA Astrophysics Data System (ADS)

    Mauerhan, Jon; Van Dyk, Schuyler; Wachter, Stefanie

    2012-02-01

    Luminous Blue Variables (LBV) are evolved massive stars in transition from the main-sequence to the Wolf-Rayet phase. They are characterized by extreme luminosities, large photometric variations, and circumstellar nebulae. LBV variability is believed to be linked with the enigmatic processes driving recurrent outbursts of mass which liberate these stars of their hydrogen envelopes. Because of the small sample of 10 Galactic LBVs, progress toward understanding the physics of these processes has been very limited. Fortunately, the Spitzer/MIPSGAL survey revealed a population of ~100 circular nebulae surrounding bright central stars that are heavily obscured in the optical; we have determined that ~50 of them have spectral types similar to active LBVs, such as P Cyg and the Pistol Star. We suspect many of these are LBVs, and that their circumstellar shells are the result of recent mass eruptions. If they are active LBVs, we expect them to exhibit large-amplitude oscillations (~0.5-1 mag) on month-to-year timescales, and/or small eruptions (~1-2 mag) on year-to-decade timescales, like P Cyg and AG Car. Therefore we propose a SMARTS program to identify active LBVs within our sample of 43 candidates by monitoring their IR brightness with CT1.3+ANDICAM. Using an cadence of one month, we will probe for evidence of oscillations. Comparison with 2MASS will probe decade-long changes and potentially reveal evidence for eruptions.

  16. Use of heart rate variability in monitoring stress and recovery in judo athletes.

    PubMed

    Morales, José; Alamo, Juan M; García-Massó, Xavier; Buscà, Bernat; López, Jose L; Serra-Añó, Pilar; González, Luís-Millán

    2014-07-01

    The main objective of this study was to examine the effect of different judo training loads on heart rate variability (HRV) measurements, to determine if they can be used as valid indicators in monitoring stress and recovery in judo athletes. Fourteen male national-standard judo athletes were randomly divided into 2 groups, and each group followed a different type of training, namely, a high training load (HTL) and a moderate training load program (MTL). Data collection included HRV measurements, a Recovery Stress Questionnaire for athletes (RESTQ-SPORT), and strength measurements, 4 weeks before and after the training program. The HTL group had lower square root of the mean squared difference of successive RR intervals, very low frequency, high frequency, short-term variability, short-range scaling exponents, general recovery, sport-specific recovery, general stress, maximum strength, maximum power, and higher low/high frequency ratio at posttest compared with pretest (p ≤ 0.05). The HTL group showed lower short-range and long-range scaling exponents, general recovery, sport-specific recovery, and higher general stress than the MTL group in posttest measurements (p ≤ 0.05). In conclusion, judo athletes enrolled in an HTL program showed an imbalance of the autonomic nervous system with decreased vagal modulation, together with a decrease in strength parameters, higher markers for stress, and a lower perception of recovery.

  17. Atmospheric Parameter Climatologies from AIRS: Monitoring Short-, and Longer-Term Climate Variabilities and 'Trends'

    NASA Technical Reports Server (NTRS)

    Molnar, Gyula; Susskind, Joel

    2008-01-01

    The AIRS instrument is currently the best space-based tool to simultaneously monitor the vertical distribution of key climatically important atmospheric parameters as well as surface properties, and has provided high quality data for more than 5 years. AIRS analysis results produced at the GODDARD/DAAC, based on Versions 4 & 5 of the AIRS retrieval algorithm, are currently available for public use. Here, first we present an assessment of interrelationships of anomalies (proxies of climate variability based on 5 full years, since Sept. 2002) of various climate parameters at different spatial scales. We also present AIRS-retrievals-based global, regional and 1x1 degree grid-scale "trend"-analyses of important atmospheric parameters for this 5-year period. Note that here "trend" simply means the linear fit to the anomaly (relative the mean seasonal cycle) time series of various parameters at the above-mentioned spatial scales, and we present these to illustrate the usefulness of continuing AIRS-based climate observations. Preliminary validation efforts, in terms of intercomparisons of interannual variabilities with other available satellite data analysis results, will also be addressed. For example, we show that the outgoing longwave radiation (OLR) interannual spatial variabilities from the available state-of-the-art CERES measurements and from the AIRS computations are in remarkably good agreement. Version 6 of the AIRS retrieval scheme (currently under development) promises to further improve bias agreements for the absolute values by implementing a more accurate radiative transfer model for the OLR computations and by improving surface emissivity retrievals.

  18. Coordinated Broadband Monitoring of Variable X-Ray Sources in NGC 1313

    NASA Technical Reports Server (NTRS)

    Boettcher, Markus

    2005-01-01

    The nearby (3.7 Mpc) late-type barred spiral galaxy NGC 1313 contains three ultraluminous X-ray sources (ULXs) that are offset from the center of the galaxy. Two of these have been associated with optical ionized nebulae, and their spectral and variability properties indicate that they contain black holes. The third ULX is SN 1978K, which was the second supernova to be detected and recognized as a supernova from its radio emission, and the first from its X-rays. In this project, we have started a long-term program of X-ray (XMM-Newton), optical (VLT), and radio (ATCA) observations of these and other sources in NGC 1313. This program has been continued through Cycle 3. XMM-Newton observations in cycle 2 consisted of eight 10 ksec priority A monitoring observations between 2003 November 25 and 2004 January 16. The data obtained from these observations have been fully analyzed, and the results have been published in Smith et al. (2004). The results included the identification of the optical counterpart of ULX X-2, and firm upper limits for the radio counterparts of ULXs X-1 and X-2. Previously unknown X-ray spectral variability has been detected in ULXs X-1 and X-2. For SNR 1978K, we were able to extend and refine the X-ray decay light curve. In tandem, we developed a semi-analytical model for the spectral variability of microquasar jets, which will be refined and applied to the combined results from our cycle 2 + 3 observations after the cycle-3 data have been fully analyzed.

  19. A systematic review and meta-analysis of clinical variables used in Huntington disease research.

    PubMed

    Franciosi, Sonia; Shim, Yaein; Lau, Margaret; Hayden, Michael R; Leavitt, Blair R

    2013-12-01

    Treatment effect in Huntington disease (HD) clinical trials has relied on primary outcome measures such as total motor score or functional rating scales. However, these measures have limited sensitivity, particularly in pre- to early stages of the disease. We performed a systematic review of HD clinical studies to identify endpoints that correlate with disease severity. Using standard HD keywords and terms, we identified 749 published studies from 1993 to 2011 based on the availability of demographic, biochemical, and clinical measures. The average and variability of each measure was abstracted and stratified according to pre-far, pre-close, early, mild, moderate, and severe HD stages. A fixed-effect meta-analysis on selected variables was conducted at various disease stages. A total of 1,801 different clinical variables and treatment outcomes were identified. Unified Huntington Disease Rating Scale (UHDRS) Motor, UHDRS Independence, and Trail B showed a trend toward separation between HD stages. Other measures, such as UHDRS Apathy, Verbal Fluency, and Symbol Digit, could only distinguish between pre- and early stages of disease and later stages, whereas other measures showed little correlation with increasing HD stages. Using cross-sectional data from published HD clinical trials, we have identified potential endpoints that could be used to track HD disease progression and treatment effect. Longitudinal studies, such as TRACK-HD, are critical for assessing the value of potential markers of disease progression for use in future HD therapeutic trials. A list of variables, references used in this meta-analysis, and database is available at http://www.cmmt.ubc.ca/research/investigators/leavitt/publications.

  20. HIV-1 Genetic Variability in Cuba and Implications for Transmission and Clinical Progression.

    PubMed

    Blanco, Madeline; Machado, Liuber Y; Díaz, Héctor; Ruiz, Nancy; Romay, Dania; Silva, Eladio

    2015-10-01

    INTRODUCTION Serological and molecular HIV-1 studies in Cuba have shown very low prevalence of seropositivity, but an increasing genetic diversity attributable to introduction of many HIV-1 variants from different areas, exchange of such variants among HIV-positive people with several coinciding routes of infection and other epidemiologic risk factors in the seropositive population. The high HIV-1 genetic variability observed in Cuba has possible implications for transmission and clinical progression. OBJECTIVE Study genetic variability for the HIV-1 env, gag and pol structural genes in Cuba; determine the prevalence of B and non-B subtypes according to epidemiologic and behavioral variables and determine whether a relationship exists between genetic variability and transmissibility, and between genetic variability and clinical disease progression in people living with HIV/AIDS. METHODS Using two molecular assays (heteroduplex mobility assay and nucleic acid sequencing), structural genes were characterized in 590 people with HIV-1 (480 men and 110 women), accounting for 3.4% of seropositive individuals in Cuba as of December 31, 2013. Nonrandom sampling, proportional to HIV prevalence by province, was conducted. Relationships between molecular results and viral factors, host characteristics, and patients' clinical, epidemiologic and behavioral variables were studied for molecular epidemiology, transmission, and progression analyses. RESULTS Molecular analysis of the three HIV-1 structural genes classified 297 samples as subtype B (50.3%), 269 as non-B subtypes (45.6%) and 24 were not typeable. Subtype B prevailed overall and in men, mainly in those who have sex with men. Non-B subtypes were prevalent in women and heterosexual men, showing multiple circulating variants and recombinant forms. Sexual transmission was the predominant form of infection for all. B and non-B subtypes were encountered throughout Cuba. No association was found between subtypes and

  1. High-resolution ultrasound imaging and noninvasive optoacoustic monitoring of blood variables in peripheral blood vessels

    NASA Astrophysics Data System (ADS)

    Petrov, Irene Y.; Petrov, Yuriy; Prough, Donald S.; Esenaliev, Rinat O.

    2011-03-01

    Ultrasound imaging is being widely used in clinics to obtain diagnostic information non-invasively and in real time. A high-resolution ultrasound imaging platform, Vevo (VisualSonics, Inc.) provides in vivo, real-time images with exceptional resolution (up to 30 microns) using high-frequency transducers (up to 80 MHz). Recently, we built optoacoustic systems for probing radial artery and peripheral veins that can be used for noninvasive monitoring of total hemoglobin concentration, oxyhemoglobin saturation, and concentration of important endogenous and exogenous chromophores (such as ICG). In this work we used the high-resolution ultrasound imaging system Vevo 770 for visualization of the radial artery and peripheral veins and acquired corresponding optoacoustic signals from them using the optoacoustic systems. Analysis of the optoacoustic data with a specially developed algorithm allowed for measurement of blood oxygenation in the blood vessels as well as for continuous, real-time monitoring of arterial and venous blood oxygenation. Our results indicate that: 1) the optoacoustic technique (unlike pure optical approaches and other noninvasive techniques) is capable of accurate peripheral venous oxygenation measurement; and 2) peripheral venous oxygenation is dependent on skin temperature and local hemodynamics. Moreover, we performed for the first time (to the best of our knowledge) a comparative study of optoacoustic arterial oximetry and a standard pulse oximeter in humans and demonstrated superior performance of the optoacoustic arterial oximeter, in particular at low blood flow.

  2. Professional Continuous Glucose Monitoring in Clinical Practice 2010

    PubMed Central

    Blevins, Thomas C.

    2010-01-01

    Professional continuous glucose monitoring (PCGM) is a 3–5 day test done to evaluate diabetes control. The PCGM test uses interstitial glucose measurements done every 5 min with a glucose-oxidase-impregnated membrane. The PCGM test evaluates glucose control retrospectively with the glucose results being unknown to the patient until the results are downloaded after the testing period. The PCGM test allows the practitioner and patient to evaluate the effect of diet, physical activity, medications, and lifestyle events on glucose control during the 24 h period. Developing a PCGM program at a medical office involves understanding reimbursement issues and having trained staff and a process in place to initiate the test and download and interpret the data. PMID:20307406

  3. Continuous Glucose Monitoring: Evidence and Consensus Statement for Clinical Use

    PubMed Central

    Liebl, Andreas; Henrichs, Helmut R.; Heinemann, Lutz; Freckmann, Guido; Biermann, Eberhard; Thomas, Andreas

    2013-01-01

    Continuous glucose monitoring (CGM) is an essential tool for modern diabetes therapy. Randomized controlled studies have provided evidence that hemoglobin A1c (HbA1c) results can be improved in patients with type 1 diabetes with elevated baseline HbA1c when using CGM frequently enough and that the frequency and duration of hypoglycemic events can be reduced in patients with satisfactory baseline HbA1c. The CGM group within the Working Group Diabetes Technology (AGDT) of the German Diabetes Association (DDG) has defined evidence-based indications for the practical use of CGM in this consensus statement related to hypoglycemia (frequent, severe, or nocturnal) or hypoglycemia unawareness, insufficient metabolic control despite use of all possible therapeutic options and patient compliance, pregnancy associated with inadequate blood glucose results, and the need for more than 10 blood glucose measurements per day. Contraindications and defined preconditions for the successful use of CGM should be considered. PMID:23567009

  4. Intraoperative monitoring of the motor function: experimental and clinical study.

    PubMed

    Kaneko, M; Fukamachi, A; Sasaki, H; Miyazawa, N; Yagishita, T; Nukui, H

    1988-01-01

    Manipulation of the lesions adjacent to the primary motor area or the motor pathway is troublesome for neurosurgeons because they lack an effective method to determine the primary motor area or to monitor motor function in the operative room. It will be of great value to establish a monitoring method of the corticospinal tract under general anaesthesia. We recorded the motor evoked potential (MEP) from direct motor cortex stimulation in cats and showed that it derives almost purely from the corticospinal tract. Then we used this technique during the operation of the resection of tumours near the primary motor area or the motor pathway. 1. Experimental study: Twenty adult cats were used in this study. Recording electrodes were flexible bipolar catheter electrodes inserted into the spinal epidural space. Stimulating electrodes were silver ball electrode on the cortex (anode) and needle electrode in the temporal muscle (cathode). Stimulation of 4-24 V, 5-10 Hz and 0.2 msec in duration were done and evoked potentials signals were averaged 60 to 512 times. MEP with multiple peaks was obtained that had a 112 msec conduction velocity in the spinal cord. We found the same signals from the stimulation of ipsilateral cerebral peduncle. Radiofrequency lesioning of ipsilateral cerebral peduncle produced a loss of MEP. These results show that MEP derives from the corticospinal tract. Significant wave form change, with components of short latency, was noted by the excessively intense stimuli. We supposed that superimposition of the signals from the extrapyramidal pathways, excited in the brain stem, results in this change.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. Clinical monitoring of systemic hemodynamics in critically ill newborns.

    PubMed

    de Boode, Willem-Pieter

    2010-03-01

    Circulatory failure is a major cause of mortality and morbidity in critically ill newborn infants. Since objective measurement of systemic blood flow remains very challenging, neonatal hemodynamics is usually assessed by the interpretation of various clinical and biochemical parameters. An overview is given about the predictive value of the most used indicators of circulatory failure, which are blood pressure, heart rate, urine output, capillary refill time, serum lactate concentration, central-peripheral temperature difference, pH, standard base excess, central venous oxygen saturation and colour.

  6. [Heart rate variability analysis: a new approach in clinical research methodology for neonatal sepsis].

    PubMed

    Cuestas, Eduardo; Rizzotti, Alina; Agüero, Guillermo

    2011-08-01

    The knowledge on neonatal sepsis has increase significantly, but a clinical or biochemical marker is not available for an early and appropriate diagnosis. This fact results of an inadequate analysis which might be missing important quantum of biological information. A new method of nonlinear analysis have been proposed to investigate time series of physiological data, particularly heart rate variability analysis, that apparently would detect abnormal changes which precedes clinical or biochemical signs of infection by as much as 12-24 hours. PMID:21829875

  7. Far Infrared Variability of Sagittarius A*: 25.5 hr of Monitoring with Herschel

    NASA Astrophysics Data System (ADS)

    Stone, Jordan M.; Marrone, D. P.; Dowell, C. D.; Schulz, B.; Heinke, C. O.; Yusef-Zadeh, F.

    2016-07-01

    Variable emission from Sgr A*, the luminous counterpart to the super-massive black hole at the center of our Galaxy, arises from the innermost portions of the accretion flow. Better characterization of the variability is important for constraining models of the low-luminosity accretion mode powering Sgr A*, and could further our ability to use variable emission as a probe of the strong gravitational potential in the vicinity of the 4× {10}6{M}⊙ black hole. We use the Herschel Spectral and Photometric Imaging Receiver (SPIRE) to monitor Sgr A* at wavelengths that are difficult or impossible to observe from the ground. We find highly significant variations at 0.25, 0.35, and 0.5 mm, with temporal structure that is highly correlated across these wavelengths. While the variations correspond to \\lt 1 % changes in the total intensity in the Herschel beam containing Sgr A*, comparison to independent, simultaneous observations at 0.85 mm strongly supports the reality of the variations. The lowest point in the light curves, ˜0.5 Jy below the time-averaged flux density, places a lower bound on the emission of Sgr A* at 0.25 mm, the first such constraint on the THz portion of the spectral energy distribution. The variability on few hour timescales in the SPIRE light curves is similar to that seen in historical 1.3 mm data, where the longest time series is available, but the distribution of variations in the sub-mm do not show a tail of large-amplitude variations seen at 1.3 mm. Simultaneous X-ray photometry from XMM-Newton shows no significant variation within our observing period, which may explain the lack of very large submillimeter variations in our data if X-ray and submillimeter flares are correlated. Herschel is an ESA space observatory with science instruments provided by European-led Principal Investigator consortia and with important participation from NASA.

  8. Far Infrared Variability of Sagittarius A*: 25.5 hr of Monitoring with Herschel

    NASA Astrophysics Data System (ADS)

    Stone, Jordan M.; Marrone, D. P.; Dowell, C. D.; Schulz, B.; Heinke, C. O.; Yusef-Zadeh, F.

    2016-07-01

    Variable emission from Sgr A*, the luminous counterpart to the super-massive black hole at the center of our Galaxy, arises from the innermost portions of the accretion flow. Better characterization of the variability is important for constraining models of the low-luminosity accretion mode powering Sgr A*, and could further our ability to use variable emission as a probe of the strong gravitational potential in the vicinity of the 4× {10}6{M}ȯ black hole. We use the Herschel Spectral and Photometric Imaging Receiver (SPIRE) to monitor Sgr A* at wavelengths that are difficult or impossible to observe from the ground. We find highly significant variations at 0.25, 0.35, and 0.5 mm, with temporal structure that is highly correlated across these wavelengths. While the variations correspond to \\lt 1 % changes in the total intensity in the Herschel beam containing Sgr A*, comparison to independent, simultaneous observations at 0.85 mm strongly supports the reality of the variations. The lowest point in the light curves, ˜0.5 Jy below the time-averaged flux density, places a lower bound on the emission of Sgr A* at 0.25 mm, the first such constraint on the THz portion of the spectral energy distribution. The variability on few hour timescales in the SPIRE light curves is similar to that seen in historical 1.3 mm data, where the longest time series is available, but the distribution of variations in the sub-mm do not show a tail of large-amplitude variations seen at 1.3 mm. Simultaneous X-ray photometry from XMM-Newton shows no significant variation within our observing period, which may explain the lack of very large submillimeter variations in our data if X-ray and submillimeter flares are correlated. Herschel is an ESA space observatory with science instruments provided by European-led Principal Investigator consortia and with important participation from NASA.

  9. Validation of a metered dose inhaler electronic monitoring device: implications for asthma clinical trial use

    PubMed Central

    Pilcher, Janine; Holliday, Mark; Ebmeier, Stefan; McKinstry, Steve; Messaoudi, Fatiha; Weatherall, Mark; Beasley, Richard

    2016-01-01

    Background The SmartTouch Ventolin monitor (Adherium, Auckland, New Zealand) is an electronic monitor for use with a Ventolin metered dose inhaler, which records the date and time of inhaler actuations. This technology has the potential to allow in-depth analysis of patterns of inhaler use in clinical trial settings. The aim of this study was to determine the accuracy of the SmartTouch Ventolin monitor in recording Ventolin actuations. Methods 20 SmartTouch Ventolin monitors were attached to Ventolin metered dose inhalers. Bench testing was performed over a 10-week period, to reflect the potential time frame between visits in a clinical trial. Inhaler actuations were recorded in a paper diary, which was compared with data uploaded from the monitors. Results 2560 actuations were performed during the 10-week study period. Monitor sensitivity for diary-recorded actuations was 99.9% with a lower 97.5% confidence bound of 99.7%. The positive predictive value for diary-recorded actuations was 100% with a 97.5% lower confidence bound of 99.9%. Conclusions The SmartTouch Ventolin monitor is highly accurate in recording and retaining electronic data. It can be recommended for use in clinical trial settings in which training and quality control systems are incorporated into study protocols to ensure accurate data acquisition. PMID:27026805

  10. Nutrition assessment and its effect on various clinical variables among patients undergoing liver transplant

    PubMed Central

    Singh, Kalyani

    2016-01-01

    Background Malnutrition is highly prevalent in patients undergoing liver transplantation and has been associated to various clinical variables and outcome of the surgery. Methods We recruited 54 adult patients undergoing living donor liver transplant (LT) as study sample. Nutrition assessment was performed by body mass index (BMI), BMI for ascites, albumin, subjective global assessment (SGA) and anthropometry [mid upper arm circumference (MUAC), mid arm muscle circumference (MAMC), and triceps skin-fold (TSF)], Hand Grip strength, and phase angle of the body. Prevalence and comparison of malnutrition was performed with various clinical variables: aetiology, Child Turcotte Pugh scores and model for end stage liver disease (ESLD) grades, degree of ascites, blood product usage, blood loss during the surgery, mortality, days [intensive care unit (ICU), Ventilator and Hospital], and Bio-impedance analysis [weight, fat mass, fat free mass (FFM), muscle mass and body fat%]. Results Assessment of nutrition status represents a major challenge because of complications like fluid retention, hypoalbuminemia and hypoproteinemia. Different nutrition assessment tools show great disparity in the level of malnutrition among ESLD patients. In the present study recipient nutrition status evaluation by different nutrition assessment tools used showed malnutrition ranging from 3.7% to 100%. BMI and anthropometric measurements showed lower prevalence of malnutrition than phase angle and SGA whereas hand grip strength showed 100% malnutrition. Agreement among nutrition assessment methods showed moderate agreement (κ=0.444) of SGA with phase angle of the body. Malnutrition by different assessment tools was significantly associated to various clinical variables except MELD and days (ICU, Ventilator and Hospital). SGA was significantly (P<0.05) associated to majority of the clinical variables like aetiology, child Turcotte Pugh grades, degree of ascites, blood product usage, blood loss

  11. Clinical Implications and Economic Impact of Accuracy Differences among Commercially Available Blood Glucose Monitoring Systems

    PubMed Central

    Budiman, Erwin S.; Samant, Navendu; Resch, Ansgar

    2013-01-01

    Background Despite accuracy standards, there are performance differences among commercially available blood glucose monitoring (BGM) systems. The objective of this analysis was to assess the potential clinical and economic impact of accuracy differences of various BGM systems using a modeling approach. Methods We simulated additional risk of hypoglycemia due to blood glucose (BG) measurement errors of five different BGM systems based on results of a real-world accuracy study, while retaining other sources of glycemic variability. Using data from published literature, we estimated an annual additional number of required medical interventions as a result of hypoglycemia. We based our calculations on patients with type 1 diabetes mellitus (T1DM) and T2DM requiring multiple daily injections (MDIs) of insulin in a U.S. health care system. We estimated additional costs attributable to treatment of severe hypoglycemic episodes resulting from BG measurement errors.. Results Results from our model predict an annual difference of approximately 296,000 severe hypoglycemic episodes from BG measurement errors for T1DM (105,000 for T2DM MDI) patients for the estimated U.S. population of 958,800 T1DM and 1,353,600 T2DM MDI patients, using the least accurate BGM system versus patients using the most accurate system in a U.S. health care system. This resulted in additional direct costs of approximately $339 million for T1DM and approximately $121 million for T2DM MDI patients per year. Conclusions Our analysis shows that error patterns over the operating range of BGM meter may lead to relevant clinical and economic outcome differences that may not be reflected in a common accuracy metric or standard. PMID:23566995

  12. Predicting clinical image delivery time by monitoring PACS queue behavior.

    PubMed

    King, Nelson E; Documet, Jorge; Liu, Brent

    2006-01-01

    The expectation of rapid image retrieval from PACS users contributes to increased information technology (IT) infrastructure investments to increase performance as well as continuing demands upon PACS administrators to respond to "slow" system performance. The ability to provide predicted delivery times to a PACS user may curb user expectations for "fastest" response especially during peak hours. This, in turn, could result in a PACS infrastructure tailored to more realistic performance demands. A PACS with a stand-alone architecture under peak load typically holds study requests in a queue until the DICOM C-Move command can take place. We investigate the contents of a stand-alone architecture PACS RetrieveSend queue and identified parameters and behaviors that enable a more accurate prediction of delivery time. A prediction algorithm for studies delayed in a stand-alone PACS queue can be extendible to other potential bottlenecks such as long-term storage archives. Implications of a queue monitor in other PACS architectures are also discussed.

  13. Raman spectroscopy towards clinical application: drug monitoring and pathogen identification.

    PubMed

    Neugebauer, Ute; Rösch, Petra; Popp, Jürgen

    2015-12-01

    Raman spectroscopy is a label-free method that measures quickly and contactlessly, providing detailed information from the sample, and has proved to be an ideal tool for medical and life science research. In this review, recent advances of the technique towards drug monitoring and pathogen identification by the Jena Research Groups are reviewed. Surface-enhanced Raman spectroscopy (SERS) and ultraviolet resonance Raman spectroscopy in hollow-core optical fibres enable the detection of drugs at low concentrations as shown for the metabolites of the immunosuppressive drug 6-mercaptopurine as well as antimalarial agents. Furthermore, Raman spectroscopy can be used to characterise pathogenic bacteria in infectious diseases directly from body fluids, making time-consuming cultivation processes dispensable. Using the example of urinary tract infection, it is shown how bacteria can be identified from patients' urine samples within <1 h. The methods cover both single-cell analysis and dielectrophoretic capturing of bacteria in suspension. The latter method could also be used for fast (<3.5 h) identification of antibiotic resistance as shown exemplarily for vancomycin-resistant enterococci.

  14. Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication

    PubMed Central

    Giesinger, Johannes; Kemmler, Georg; Meraner, Verena; Gamper, Eva-Maria; Oberguggenberger, Anne; Sperner-Unterweger, Barbara; Holzner, Bernhard

    2009-01-01

    Summary Quality of life (QOL) has become a widely used outcome parameter in the evaluation of treatment modalities in clinical oncology research. By now, many of the practical problems associated with measuring QOL in clinical practice can be overcome by the use of computer-based assessment methods. QOL assessment in oncology is dominated by two measurement systems, the FACT scales and the EORTC QLQ-C30 with its modules. The amount of human resources required to implement routine data collection has been reduced significantly by advanced computer technology allowing data collection in busy clinical practice. Monitoring of QOL can contribute to oncologic care by facilitating detection of physical and psychological problems and tracking the course of disease and treatment over time. Furthermore, the integration of screening for psychosocial problems into QOL monitoring contributes to the identification of patients who are in need of psychooncologic interventions. Computer-based QOL monitoring does not replace the direct physician-patient communication but enables to identify specific impairments and symptoms including psychological problems. Beyond clinical practice, QOL data can be used for research purposes and may help health care planners to determine those patient services that should be maintained or ones that should be developed. PMID:20847874

  15. Precipitation variability within an urban monitoring network in terms of microcanonical cascade generators

    NASA Astrophysics Data System (ADS)

    Licznar, P.; De Michele, C.; Adamowski, W.

    2014-05-01

    Understanding the variability of precipitation at small scales is fundamental in urban hydrology. Stochastic models of precipitation are required to feed hydrodynamic models with high resolution data, in order to obtain a probabilistic assessment of urban drainage networks. Microcanonical random cascades are considered here to represent precipitation time series collected in 25 gauges of a monitoring network in Warsaw, Poland. Breakdown coefficients (BDCs) are calculated separately for a hierarchy of subdaily timescales from 5 min (time resolution) to 1280 min, for all gauges. Strong deformations of BDC histograms in form of sharp peaks at small timescales are observed due to the truncation of precipitation depths recorded by gauges. Satisfactory smoothing of empirical BDC histograms is obtained statistically by a slight randomization of nonzero precipitation amounts. The scarce representation of BDCs at large timescales, due to the short period of observation, is solved by the introduction of an algorithm based on overlapping moving windows. BDC histograms are modeled by a 2N-B distribution, which combines two Normal (N) and one Beta (B) distribution. A clear evolution of the distribution from 2N-B at small timescales, to N-B at intermediate timescales, and finally to Beta distribution for large timescales is observed in all gauges. The performance of the microcanonical cascades is evaluated for the considered gauges. Synthetic time series are analyzed with respect to their intermittency and variability of intensity, and compared to observed series. BDC histograms, for each timescale, are compared among the 25 gauges in Warsaw, and with other gauges located in Poland and Germany. The cluster analysis is used to identify patterns of BDC histograms among analyzed set of gauges and timescales, as well as to detect outlier gauges.

  16. Characterizing Non-Linear Dependencies Among Pairs of Clinical Variables and Imaging Data

    PubMed Central

    Caban, Jesus J.; Bagci, Ulas; Mehari, Alem; Alam, Shoaib; Fontana, Joseph R.; Kato, Gregory J.; Mollura, Daniel J.

    2012-01-01

    Advances in computer-aided diagnosis (CAD) systems have shown the benefits of using computer-based techniques to obtain quantitative image measurements of the extent of a particular disease. Such measurements provide more accurate information that can be used to better study the associations between anatomical changes and clinical findings. Unfortunately, even with the use of quantitative image features, the correlations between anatomical changes and clinical findings are often not apparent and definite conclusions are difficult to reach. This paper uses nonparametric exploration techniques to demonstrate that even when the associations between two-variables seems weak, advanced properties of the associations can be studied and used to better understand the relationships between individual measurements. This paper uses quantitative imaging findings and clinical measurements of 85 patients with pulmonary fibrosis to demonstrate the advantages of non-linear dependency analysis. Results show that even when the correlation coefficients between imaging and clinical findings seem small, statistical measurements such as the maximum asymmetry score (MAS) and maximum edge value (MEV) can be used to better understand the hidden associations between the variables. PMID:23366482

  17. CYP2C19 Polymorphisms and Therapeutic Drug Monitoring of Voriconazole: Are We Ready for Clinical Implementation of Pharmacogenomics?

    PubMed Central

    Obeng, Aniwaa Owusu; Egelund, Eric F.; Alsultan, Abdullah; Peloquin, Charles A.; Johnson, Julie A.

    2014-01-01

    Since its approval by the United States Food and Drug Administration in 2002, voriconazole has become a key component in the successful treatment of many invasive fungal infections, including the most common, aspergillosis and candidiasis. Despite voriconazole’s widespread use, optimizing its treatment in an individual can be challenging due to significant interpatient variability in plasma concentrations of the drug. Variability is due to nonlinear pharmacokinetics and the influence of patient characteristics such as age, sex, weight, liver disease, and genetic polymorphisms in the cytochrome P450 2C19 gene (CYP2C19) encoding for the CYP2C19 enzyme, the primary enzyme responsible for metabolism of voriconazole. CYP2C19 polymorphisms account for the largest portion of variability in voriconazole exposure, posing significant difficulty to clinicians in targeting therapeutic concentrations. In this review, we discuss the role of CYP2C19 polymorphisms and their influence on voriconazole’s pharmacokinetics, adverse effects, and clinical efficacy. Given the association between CYP2C19 genotype and voriconazole concentrations, as well as the association between voriconazole concentrations and clinical outcomes, particularly efficacy, it seems reasonable to suggest a potential role for CYP2C19 genotype to guide initial voriconazole dose selection followed by therapeutic drug monitoring to increase the probability of achieving efficacy while avoiding toxicity. PMID:24510446

  18. Variable selection for covariate-adjusted semiparametric inference in randomized clinical trials

    PubMed Central

    Yuan, Shuai; Zhang, Hao Helen; Davidian, Marie

    2013-01-01

    Extensive baseline covariate information is routinely collected on participants in randomized clinical trials, and it is well-recognized that a proper covariate-adjusted analysis can improve the efficiency of inference on the treatment effect. However, such covariate adjustment has engendered considerable controversy, as post hoc selection of covariates may involve subjectivity and lead to biased inference, while prior specification of the adjustment may exclude important variables from consideration. Accordingly, how to select covariates objectively to gain maximal efficiency is of broad interest. We propose and study the use of modern variable selection methods for this purpose in the context of a semiparametric framework, under which variable selection in modeling the relationship between outcome and covariates is separated from estimation of the treatment effect, circumventing the potential for selection bias associated with standard analysis of covariance methods. We demonstrate that such objective variable selection techniques combined with this framework can identify key variables and lead to unbiased and efficient inference on the treatment effect. A critical issue in finite samples is validity of estimators of uncertainty, such as standard errors and confidence intervals for the treatment effect. We propose an approach to estimation of sampling variation of estimated treatment effect and show its superior performance relative to that of existing methods. PMID:22733628

  19. Reducing Clinical Trial Monitoring Resource Allocation and Costs Through Remote Access to Electronic Medical Records

    PubMed Central

    Uren, Shannon C.; Kirkman, Mitchell B.; Dalton, Brad S.; Zalcberg, John R.

    2013-01-01

    Purpose: With electronic medical records (eMRs), the option now exists for clinical trial monitors to perform source data verification (SDV) remotely. We report on a feasibility study of remote access to eMRs for SDV and the potential advantages of such a process in terms of resource allocation and cost. Methods: The Clinical Trials Unit at the Peter MacCallum Cancer Centre, in collaboration with Novartis Pharmaceuticals Australia, conducted a 6-month feasibility study of remote SDV. A Novartis monitor was granted dedicated software and restricted remote access to the eMR portal of the cancer center, thereby providing an avenue through which perform SDV. Results: Six monitoring visits were conducted during the study period, four of which were performed remotely. The ability to conduct two thirds of the monitoring visits remotely in this complex phase III study resulted in an overall cost saving to Novartis. Similarly, remote monitoring eased the strain on internal resources, particularly monitoring space and hospital computer terminal access, at the cancer center. Conclusion: Remote access to patient eMRs for SDV is feasible and is potentially an avenue through which resources can be more efficiently used. Although this feasibility study involved limited numbers, there is no limit to scaling these processes to any number of patients enrolled onto large clinical trials. PMID:23633977

  20. Heart Rate Variability Monitoring during Sleep Based on Capacitively Coupled Textile Electrodes on a Bed

    PubMed Central

    Lee, Hong Ji; Hwang, Su Hwan; Yoon, Hee Nam; Lee, Won Kyu; Park, Kwang Suk

    2015-01-01

    In this study, we developed and tested a capacitively coupled electrocardiogram (ECG) measurement system using conductive textiles on a bed, for long-term healthcare monitoring. The system, which was designed to measure ECG in a bed with no constraints of sleep position and posture, included a foam layer to increase the contact region with the curvature of the body and a cover to ensure durability and easy installation. Nine healthy subjects participated in the experiment during polysomnography (PSG), and the heart rate (HR) coverage and heart rate variability (HRV) parameters were analyzed to evaluate the system. The experimental results showed that the mean of R-peak coverage was 98.0% (95.5%–99.7%), and the normalized errors of HRV time and spectral measures between the Ag/AgCl system and our system ranged from 0.15% to 4.20%. The root mean square errors for inter-beat (RR) intervals and HR were 1.36 ms and 0.09 bpm, respectively. We also showed the potential of our developed system for rapid eye movement (REM) sleep and wake detection as well as for recording of abnormal states. PMID:26007716

  1. Heart Rate Variability Monitoring during Sleep Based on Capacitively Coupled Textile Electrodes on a Bed.

    PubMed

    Lee, Hong Ji; Hwang, Su Hwan; Yoon, Hee Nam; Lee, Won Kyu; Park, Kwang Suk

    2015-05-14

    In this study, we developed and tested a capacitively coupled electrocardiogram (ECG) measurement system using conductive textiles on a bed, for long-term healthcare monitoring. The system, which was designed to measure ECG in a bed with no constraints of sleep position and posture, included a foam layer to increase the contact region with the curvature of the body and a cover to ensure durability and easy installation. Nine healthy subjects participated in the experiment during polysomnography (PSG), and the heart rate (HR) coverage and heart rate variability (HRV) parameters were analyzed to evaluate the system. The experimental results showed that the mean of R-peak coverage was 98.0% (95.5%-99.7%), and the normalized errors of HRV time and spectral measures between the Ag/AgCl system and our system ranged from 0.15% to 4.20%. The root mean square errors for inter-beat (RR) intervals and HR were 1.36 ms and 0.09 bpm, respectively. We also showed the potential of our developed system for rapid eye movement (REM) sleep and wake detection as well as for recording of abnormal states.

  2. Coherence of heart rate variability and local physical fields in monitoring studies

    NASA Astrophysics Data System (ADS)

    Tuzhilkin, D. A.; Borodin, A. S.

    2015-11-01

    Technological advances have led to a substantial modification of the physical fields of the environment, which could affect the status of living organisms under their constant exposure. In this study, the activity of human cardiovascular system under the influence of a complex natural physical environmental factors investigated. The study was conducted on a representative homogeneous sample (44 persons aged 19 to 22 years) by simultaneous monitoring of electrocardiograms and natural physical fields in Tomsk (geomagnetic field, meteorological parameters - temperature, pressure and humidity, surface wind speed, the parameters of the Schumann resonance - amplitude, frequency and quality factor of the first four modes in the range of 6 to 32 Hz, the power spectral density infrasonic background in the range of from 0,5 to 32 Hz). It was shown that among the set of parameters of physical fields present field that can resonate in the functioning of the human organism. The greatest coherence with heart rate variability detect variations eastern component of the geomagnetic field.

  3. Monitoring design for assessing compliance with numeric nutrient standards for rivers and streams using geospatial variables.

    PubMed

    Williams, Rachel E; Arabi, Mazdak; Loftis, Jim; Elmund, G Keith

    2014-09-01

    Implementation of numeric nutrient standards in Colorado has prompted a need for greater understanding of human impacts on ambient nutrient levels. This study explored the variability of annual nutrient concentrations due to upstream anthropogenic influences and developed a mathematical expression for the number of samples required to estimate median concentrations for standard compliance. A procedure grounded in statistical hypothesis testing was developed to estimate the number of annual samples required at monitoring locations while taking into account the difference between the median concentrations and the water quality standard for a lognormal population. For the Cache La Poudre River in northern Colorado, the relationship between the median and standard deviation of total N (TN) and total P (TP) concentrations and the upstream point and nonpoint concentrations and general hydrologic descriptors was explored using multiple linear regression models. Very strong relationships were evident between the upstream anthropogenic influences and annual medians for TN and TP ( > 0.85, < 0.001) and corresponding standard deviations ( > 0.7, < 0.001). Sample sizes required to demonstrate (non)compliance with the standard depend on the measured water quality conditions. When the median concentration differs from the standard by >20%, few samples are needed to reach a 95% confidence level. When the median is within 20% of the corresponding water quality standard, however, the required sample size increases rapidly, and hundreds of samples may be required. PMID:25603257

  4. Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry.

    PubMed

    Enas, G G; Dornseif, B E; Sampson, C B; Rockhold, F W; Wuu, J

    1989-03-01

    The definitions of "interim analysis" and "monitoring" of clinical trials are often ambiguous in the current literature. The resulting confusion can lead to erroneous conclusions and misguided decisions, especially when activities that are operational or observational are evaluated in a probabilistic sense as inferential. The authors seek to define "interim analysis" and "monitoring" in a mutually exclusive fashion. These definitions will then provide the opportunity to review and categorize existing clinical trial practices and procedures. This will clarify such issues as "when to look" and "when to pay a price" (e.g., test size and power) and characterize such issues in the context of pharmaceutical industry drug development. PMID:2702837

  5. Factor analysis of the interrelationships between clinical variables in horses with colic.

    PubMed

    Thoefner, M B; Ersbøll, A K; Jensen, A L; Hesselholt, M

    2001-02-16

    A prospective survey of horses with colic referred to the Large Animal Hospital at the Royal Veterinary and Agricultural University of Copenhagen, Denmark, was undertaken between August 1994 and December 1997. The interrelationships between 17 clinical variables were analysed using factor analysis. Factor analysis uncovers the structure of the variability in data and therefore detects multicollinearity. A total of 528 horses were admitted in the study period. Of these, 16 were excluded from the analysis as a result of miscellaneous conditions. Only 205 horses had observations for all 17 variables. Because no major change occurred in the main diagnostic categories, this population was considered as a representative subset. Factor analysis confirmed the clinical impression of correlation between variables, but the multicollinearity turned out not to be strong. Four factors were extracted, and these accounted for 51% of the total variance. The retained factors were interpreted by integrating previously reported clinical research. The first factor, which was interpreted as endotoxaemia, had high loadings on capillary refill time, mucous-membrane colour, degree of pain, heart rate, packed-cell volume and abdominal sounds. In the second factor, cecal decompression, admission month and gastric reflux had the predominant influence, and this factor was explained as cecal tympany. The third factor was simply interpreted as age because it had high loadings on gender, age and temperature. In the fourth factor, the interpretation was not straightforward, although breed had the greatest influence in the formation of this factor. Subsequently, the extracted factors were used in a logistic-regression analysis to determine their association with outcome (survival/death). The two factors interpreted as endotoxaemia and age were related to the outcome.

  6. Influence of clinical and demographic variables on quality of life in patients with Parkinson's disease

    PubMed Central

    Karlsen, K. H.; Larsen, J.; Tandberg, E.; Maland, J.

    1999-01-01

    OBJECTIVES—To identify the clinical and demographic factors that are associated with a poor quality of life in patients with Parkinson's disease.
METHODS—233 of a total of 245 patients identified in a community based study in a Norwegian county participated in the study. Quality of life was measured by the Nottingham Health Profile (NHP). The results were compared with those in 100 healthy elderly people. Clinical and demographic variables were determined during a semistructured interview and by clinical examination by a neurologist. Multiple regression analyses were used to determine which variables were associated with higher distress scores.
RESULTS—Patients with Parkinson's disease had higher distress scores than the healthy elderly people for all the NHP dimensions. The variables that most strongly predicted a high total NHP score were depressive symptoms, self reported insomnia, and a low degree of independence, measured by the Schwab and England scale. Severity of parkinsonism contributed, but to a lesser extent. Nearly half the patients with Parkinson's disease reported lack of energy, compared with a fifth of the control group. Severity of depressive symptoms and a higher score on the UPDRS motor subscale only partly accounted for this finding. Only 30% of the variation in NHP energy score was explained by the predictive variables identified in this study.
CONCLUSIONS—Parkinson's disease has a substantial impact on health related quality of life. Depressive symptoms and sleep disorders correlated strongly with high distress scores. Patients with Parkinson's disease should be examined for both conditions, which require treatment. Low energy was commonly reported and may be a separate entity of Parkinson's disease.

 PMID:10201412

  7. A disposable flexible skin patch for clinical optical perfusion monitoring at multiple depths

    NASA Astrophysics Data System (ADS)

    Farkas, Dana L.; Kolodziejski, Noah J.; Stapels, Christopher J.; McAdams, Daniel R.; Fernandez, Daniel E.; Podolsky, Matthew J.; Christian, James F.; Ward, Brent B.; Vartarian, Mark; Feinberg, Stephen E.; Lee, Seung Yup; Parikh, Urmi; Mycek, Mary-Ann; Joyner, Michael J.; Johnson, Christopher P.; Paradis, Norman A.

    2016-03-01

    Stable, relative localization of source and detection fibers is necessary for clinical implementation of quantitative optical perfusion monitoring methods such as diffuse correlation spectroscopy (DCS) and diffuse reflectance spectroscopy (DRS). A flexible and compact device design is presented as a platform for simultaneous monitoring of perfusion at a range of depths, enabled by precise location of optical fibers in a robust and secure adhesive patch. We will discuss preliminary data collected on human subjects in a lower body negative pressure model for hypovolemic shock. These data indicate that this method facilitates simple and stable simultaneous monitoring of perfusion at multiple depths and within multiple physiological compartments.

  8. The influence of toothbrush wear on the variables of plaque and gingivitis in clinical trials.

    PubMed

    Galgut, P N

    2001-01-01

    Although toothbrush wear has been shown not to be critical in ensuring optimal plaque removal, the degree of toothbrush wear occurring in a clinical trial may influence the results of the trial. The aim of this study was to determine the effects of toothbrush wear on the clinical variables of dental plaque and gingivitis. There were 107 subjects who participated in this six-month clinical trial in which plaque and gingivitis scores were assessed in relation to toothbrush wear at 2, 4, 12 and 24 weekly intervals. At each appointment, the toothbrushes being used were assessed for wear and replaced if necessary. It was found that 58% of the group were "rapid," and 42% were "slow" wearers. Of the group, 18.6% required replacement toothbrushes within two weeks from baseline with 50.9% of replacement toothbrushes being issued within four weeks of the start of the trial. Two subjects required as many as 10 replacement toothbrushes over the six-month trial period. "Slow" wearers had significantly lower plaque scores than "rapid" wearers at weeks 4 and 12, whereas the "rapid" wearers had significantly lower gingivitis scores than "slow" wearers at weeks 2 and 4. Clinical results show that significant toothbrush wear patterns of individuals participating in clinical trials should be taken into account when designing clinical trials assessing plaque and gingivitis scores. It may be necessary to exclude "rapid" toothbrush wearers from clinical trials that assess plaque and its removal. As the rate of toothbrush wear varied considerably among subjects, the simple classification of subjects into "rapid" and "slow" wearers may require further subgrouping. The surprising result that "rapid" wearers achieved lower levels of gingivitis requires further study to determine if this observation is valid in clinical trials designed for this purpose.

  9. Higher Blood Pressure Variability in White Coat Hypertension; from the Korean Ambulatory Blood Pressure Monitoring Registry

    PubMed Central

    Kang, In Sook; Shin, Jinho; Ihm, Sang-Hyun; Kim, Ju Han; Park, Sungha; Kim, Kwang-Il; Kim, Woo-Shik; Kim, Soon Gil; Shin, Gil Ja

    2016-01-01

    Background and Objectives Blood pressure variability (BPV) was recently shown to be a risk factor of stroke. White coat hypertension (WCH) used to be regarded as innocuous, but one long-term follow-up study reported that WCH increased stroke rate compared to normotension (NT). In this study, we aimed to evaluate the relationship between WCH and BPV. Subjects and Methods We analyzed 1398 subjects from the Korean Ambulatory Blood Pressure Registry, who were divided into NT (n=364), masked hypertension (n=122), white coat hypertension (n=254), and sustained hypertension (n=658) groups. Results Baseline characteristics were similar among groups. The average real variability (ARV), a highly sensitive BPV parameter, was highest in the WCH group, followed by the sustained hypertension, masked hypertension, and NT groups. The results persisted after being adjusted for covariates. The WCH vs. sustained hypertension results (adjusted mean±standard error) were as follows: 24-h systolic ARV, 22.9±0.8 vs. 19.4±0.6; 24-h diastolic ARV, 16.8±0.6 vs. 14.3±0.5; daytime systolic ARV, 21.8±0.8 vs. 16.8±0.6; and daytime diastolic ARV, 16.2±0.6 vs. 13.4±0.5 (p<0.001 for all comparisons). Conclusion From the registry data, we found that subjects with WCH or masked hypertension had higher BPV than NT. However, long-term follow-up data assessing the clinical influences of WCH on stroke are needed. PMID:27275173

  10. Transient forces generated by projectiles on variable quality mouthguards monitored by instrumented impact testing

    PubMed Central

    Warnet, L; Greasley, A

    2001-01-01

    Objectives—(a) To determine the force-time trace that occurs when a spring mounted simulated upper jaw is impacted; (b) to examine if mouthguards of variable quality have significant influence on such force-time traces; (c) to attempt to relate physical events to the profile of the force-time traces recorded. Methods—A simulated jaw, consisting of ceramic teeth inserted into a hard rubber arch reinforced with a composite jawbone, was fitted with various mouthguards as part of a previous round robin study. A clinical assessment distinguished good, bad, and poor mouthguards, and these were each fitted to the jaw, which was then submitted to instrumental impact tests under conditions expected to produce tooth fractures. The force-time trace was recorded for such impact events. Results—The spring mounting method caused two distinct peaks in the force-time trace. The initial one was related to inertia effects and showed an increase in magnitude with impactor velocity as expected. The second peak showed features that were related to the differences in the mouthguards selected. Conclusions—The use of a force washer within a conical ended impactor enabled force-time traces to be recorded during the impact of a spring mounted simulated jaw fitted with mouthguards of variable quality. The spring mounting system causes an initial inertial peak followed by a second peak once the spring mount has fully compressed. Good fitting guards, which keep most teeth intact, result in high stiffness targets that in turn generate high reaction forces in the impactor. If the spring mounting is omitted, the two peaks are combined to give even higher reaction forces. The force-time trace offers some potential for assessing both overall mouthguard performance and individual events during the impact sequence. Mouthguards with good retention to the jaw remained attached during the impact event and helped to preserve the structural integrity of the target. This in turn developed high

  11. Episiotomy and its relationship to various clinical variables that influence its performance

    PubMed Central

    Ballesteros-Meseguer, Carmen; Carrillo-García, César; Meseguer-de-Pedro, Mariano; Canteras-Jordana, Manuel; Martínez-Roche, Mª Emilia

    2016-01-01

    Objective: to understand the episiotomy rate and its relationship with various clinical variables. Method: a descriptive, cross-sectional, analytic study of 12,093 births in a tertiary hospital. Variables: Parity, gestational age, start of labor, use of epidural analgesia, oxytocin usage, position during fetal explusion, weight of neonate, and completion of birth. The analysis was performed with SPSS 19.0. Results: the global percentage of episiotomies was 50%. The clinical variables that presented a significant association were primiparity (RR=2.98), gestational age >41 weeks (RR=1.2), augmented or induced labor (RR=1.33), epidural analgesia use (RR=1,95), oxytocin use (RR=1.58), lithotomy position during fetal expulsion (RR=6.4), and instrumentation (RR=1.84). Furthermore, maternal age ≥35 years (RR=0.85) and neonatal weight <2500 g (RR=0.8) were associated with a lower incidence of episiotomy. Conclusions: episiotomy is dependent on obstetric interventions performed during labor. If we wish to reduce the episiotomy rate, it will be necessary to bear in mind these risk factors when establishing policies for reducing this procedure. PMID:27224064

  12. Predictive monitoring of mobile patients by combining clinical observations with data from wearable sensors.

    PubMed

    Clifton, Lei; Clifton, David A; Pimentel, Marco A F; Watkinson, Peter J; Tarassenko, Lionel

    2014-05-01

    The majority of patients in the hospital are ambulatory and would benefit significantly from predictive and personalized monitoring systems. Such patients are well suited to having their physiological condition monitored using low-power, minimally intrusive wearable sensors. Despite data-collection systems now being manufactured commercially, allowing physiological data to be acquired from mobile patients, little work has been undertaken on the use of the resultant data in a principled manner for robust patient care, including predictive monitoring. Most current devices generate so many false-positive alerts that devices cannot be used for routine clinical practice. This paper explores principled machine learning approaches to interpreting large quantities of continuously acquired, multivariate physiological data, using wearable patient monitors, where the goal is to provide early warning of serious physiological determination, such that a degree of predictive care may be provided. We adopt a one-class support vector machine formulation, proposing a formulation for determining the free parameters of the model using partial area under the ROC curve, a method arising from the unique requirements of performing online analysis with data from patient-worn sensors. There are few clinical evaluations of machine learning techniques in the literature, so we present results from a study at the Oxford University Hospitals NHS Trust devised to investigate the large-scale clinical use of patient-worn sensors for predictive monitoring in a ward with a high incidence of patient mortality. We show that our system can combine routine manual observations made by clinical staff with the continuous data acquired from wearable sensors. Practical considerations and recommendations based on our experiences of this clinical study are discussed, in the context of a framework for personalized monitoring.

  13. IL8 gene as modifier of cystic fibrosis: unraveling the factors which influence clinical variability.

    PubMed

    Furlan, Larissa Lazzarini; Marson, Fernando Augusto Lima; Ribeiro, José Dirceu; Bertuzzo, Carmen Sílvia; Salomão Junior, João Batista; Souza, Dorotéia Rossi Silva

    2016-08-01

    The severity of cystic fibrosis (CF) is associated with classes of mutations in the CFTR gene (cystic fibrosis transmembrane regulator), physical environment and modifier genes interaction. The IL8 gene (interleukin 8), according to its respective polymorphisms, influences inflammatory responses. This study analyzed IL8 gene polymorphisms (rs4073, rs2227306 and rs2227307), by means of PCR/RFLP, and their association with pulmonary function markers and clinical severity scores in 186 patients with CF, considering the CFTR genotype. There was an association between rs2227307 and precocity of the disease. The severity of lung disease was associated with the following markers: transcutaneous arterial hemoglobin oxygen saturation (SaO2) (regardless of CFTR genotype, for the polymorphisms rs4073, rs2227306 and rs2227307); mucoid Pseudomonas aeruginosa (regardless of CFTR genotype, for the polymorphisms rs2227306 and rs2227307). Pulmonary function markers (SaO2 and spirometric variables) and clinical severity scores were also associated with IL8 gene polymorphisms. This study identified the IL8 gene, represented by rs4073 and rs2227306 polymorphisms, and particularly the rs2227307 polymorphism, as potentiating factors for the degree of variability in the severity of CF, especially in pulmonary clinical manifestation correlated with increased morbidity and mortality. PMID:27209008

  14. Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

    PubMed Central

    Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

    2007-01-01

    Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

  15. Longterm optical monitoring of bright BL Lacertae objects with ATOM: Spectral variability and multiwavelength correlations

    NASA Astrophysics Data System (ADS)

    Wierzcholska, Alicja; Ostrowski, Michał; Stawarz, Łukasz; Wagner, Stefan; Hauser, Marcus

    2015-01-01

    Context. Blazars are the established sources of an intense and variable non-thermal radiation extending from radio wavelengths up to high and very high-energy γ-rays. Understanding the spectral evolution of blazars in selected frequency ranges, as well as multifrequency correlations in various types of blazar sources, is of a primary importance for constraining blazar physics. Aims: We present the results of a long-term optical monitoring of a sample of 30 blazars of the BL Lac type, most of which are the confirmed TeV emitters. We study the optical color-magnitude correlation patterns emerging in the analyzed sample and compare the optical properties of the targets with the high-energy γ-ray and high-frequency radio data. Methods: The optical observations were carried out in R and B filters using the Automatic Telescope for Optical Monitoring (ATOM) located at the site of the H.E.S.S. Array. Each object in the sample was observed during at least 20 nights in the period 2007 to 2012. Results: We find significant overall color-magnitude correlations (meaning bluer-when-brighter spectral evolution) in 40% of the sample. The sources that do not display any clear chromatism in the full datasets often do exhibit bluer-when-brighter behavior but only in isolated shorter time intervals. We also discovered spectral state transitions at optical wavelengths in several of the analyzed sources. Finally, we find that the radio, optical, and γ-ray luminosities of the sources in the sample obey almost linear correlations, which seem induced, at least partly, by the redshift dependence and may also be affected by the non-simultaneity of the analyzed multifrequency dataset. Conclusions: We argue that the observed bluer-when-brighter behavior is intrinsic to the jet-emission regions, at least for some of these blazars, rather than resulting from the contamination of the measured flux by the starlight of host galaxies. We also conclude that the significance of color

  16. Exploring AGNs in the Local Universe through High Angular Resolution Spectroscopy and Optical Variability Monitoring

    NASA Astrophysics Data System (ADS)

    Walsh, Jonelle L.

    This dissertation presents the results of several observational projects designed to explore AGNs, on scales of about 100 pc and smaller, in nearby galaxies. High angular resolution spectroscopy acquired from HST STIS and Keck LGS AO OSIRIS observations are used to study the kinematic structure of gas disks and stars on scales comparable to the gravitational sphere of influence of the supermassive black hole. Specifically, I use multi-slit STIS data of low-luminosity AGNs to map out the emission-line kinematics, and to look for regularly rotating velocity fields suitable for future gas dynamical black hole mass measurements. The HST data is further useful for searching for electron-density gradients and for examining how the emission-line velocity dispersion varies as a function of aperture size. In another project, I aim to resolve a discrepancy between two previous gas dynamical measurements of the black hole in the elliptical galaxy M84. I perform new measurements of the gas kinematics from archival multi-slit STIS data, and carry out a more comprehensive dynamical model of the emission-line disk than had been previously attempted. With the most recent project, I measure high-resolution stellar kinematics from LGS AO OSIRIS data and large-scale kinematics from long-slit LRIS data of the S0 galaxy NGC 3998. Using triaxial orbit-based stellar dynamical models, I determine the black hole mass. The stellar dynamical value is then compared to a previous gas dynamical determination in order to test the consistency between these two main mass measurement methods. In addition to using high spatial resolution spectroscopy, AGN variability can be used to probe the inner regions of AGNs. The Lick AGN Monitoring Project targeted 12 galaxies expected to harbor low-mass black holes. Through reverberation mapping, the collaboration measured the masses of nine black holes, and learned about the geometry and kinematics of the broad-line region in several of the objects. I

  17. [Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Song, Nian-bin

    2015-12-01

    This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety. PMID:27245017

  18. Dealing with incomplete and variable detectability in multi-year, multi-site monitoring of ecological populations

    USGS Publications Warehouse

    Converse, Sarah J.; Royle, J. Andrew; Gitzen, Robert A.; Millspaugh, Joshua J.; Cooper, Andrew B.; Licht, Daniel S.

    2012-01-01

    An ecological monitoring program should be viewed as a component of a larger framework designed to advance science and/or management, rather than as a stand-alone activity. Monitoring targets (the ecological variables of interest; e.g. abundance or occurrence of a species) should be set based on the needs of that framework (Nichols and Williams 2006; e.g. Chapters 2–4). Once such monitoring targets are set, the subsequent step in monitoring design involves consideration of the field and analytical methods that will be used to measure monitoring targets with adequate accuracy and precision. Long-term monitoring programs will involve replication of measurements over time, and possibly over space; that is, one location or each of multiple locations will be monitored multiple times, producing a collection of site visits (replicates). Clearly this replication is important for addressing spatial and temporal variability in the ecological resources of interest (Chapters 7–10), but it is worth considering how this replication can further be exploited to increase the effectiveness of monitoring. In particular, defensible monitoring of the majority of animal, and to a lesser degree plant, populations and communities will generally require investigators to account for imperfect detection (Chapters 4, 18). Raw indices of population state variables, such as abundance or occupancy (sensu MacKenzie et al. 2002), are rarely defensible when detection probabilities are < 1, because in those cases detection may vary over time and space in unpredictable ways. Myriad authors have discussed the risks inherent in making inference from monitoring data while failing to correct for differences in detection, resulting in indices that have an unknown relationship to the parameters of interest (e.g. Nichols 1992, Anderson 2001, MacKenzie et al. 2002, Williams et al. 2002, Anderson 2003, White 2005, Kéry and Schmidt 2008). While others have argued that indices may be preferable in some

  19. Therapeutic drug monitoring of racemic venlafaxine and its main metabolites in an everyday clinical setting.

    PubMed

    Reis, Margareta; Lundmark, Jöns; Björk, Henrik; Bengtsson, Finn

    2002-08-01

    When Efexor (venlafaxine) became available in Sweden, a therapeutic drug monitoring (TDM) service was developed in the authors' laboratory. This analytical service was available to all physicians in the country. From March 1996, to November 1997, 797 serum concentration analyses of venlafaxine (VEN) and its main metabolites, O-desmethylvenlafaxine (ODV), N-desmethylvenlafaxine (NDV), and N,O-didesmethylvenlafaxine (DDV) were requested. These samples, each of which was accompanied by clinical information on a specially designed request form, represented 635 inpatients or outpatients, comprising all ages, treated in a naturalistic setting. The first sample per patient, drawn as a trough value in steady state and with documented concomitant medication, was further evaluated pharmacokinetically (n = 187). The doses prescribed were from 37.5 mg/d to 412.5 mg/d. There was a wide interindividual variability of serum concentrations on each dose level, and the mean coefficient of variation of the dose-corrected concentrations (C/D) was 166% for C/D VEN, 60% for C/D ODV, 151% for C/D NDV, and 59% for C/D DDV. The corresponding CV for the ratio ODV/VEN was 110%. However, within patients over time, the C/D VEN and ODV/VEN variation was low, indicating stability in individual metabolizing capacity. Patients over 65 years of age had significantly higher concentrations of C/D VEN and C/D ODV than the younger patients. Women had higher C/D NDV and C/D DDV, and a higher NDV/VEN ratio than men, and smokers showed lower C/D ODV and C/D DDV than nonsmokers. A number of polycombinations of drugs were assessed for interaction screening, and a trend for lowered ODV/VEN ratio was found, predominantly with concomitant medication with CNS-active drug(s) known to inhibit CYP2D6.

  20. Clinical applications of esophageal impedance monitoring and high-resolution manometry.

    PubMed

    Kessing, Boudewijn F; Smout, André J P M; Bredenoord, Albert J

    2012-06-01

    Esophageal impedance monitoring and high-resolution manometry (HRM) are useful tools in the diagnostic work-up of patients with upper gastrointestinal complaints. Impedance monitoring increases the diagnostic yield for gastroesophageal reflux disease in adults and children and has become the gold standard in the diagnostic work-up of reflux symptoms. Its role in the work-up for belching disorders and rumination seems promising. HRM is superior to other diagnostic tools for the evaluation of achalasia and contributes to a more specific classification of esophageal disorders in patients with non-obstructive dysphagia. The role of HRM in patients with dysphagia after laparoscopic placement of an adjustable gastric band seems promising. Future studies will further determine the clinical implications of the new insights which have been acquired with these techniques. This review aims to describe the clinical applications of impedance monitoring and HRM. PMID:22350944

  1. From genotype to phenotype; clinical variability in Lesch-Nyhan disease. The role of epigenetics.

    PubMed

    Trigueros Genao, M; Torres, R J

    2014-11-01

    Lesch-Nyhan disease is a rare genetic disease characterized by a deficiency in the function of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT). Patients affected by this disease experience hyperuricemia, motor disorders, mental retardation and, in the most severe cases, self-mutilation. Its clinical manifestations depend on the enzymatic activity of HGPRT, which is classically linked to the type of alteration in the HGPRT gene. More than 400 mutations of this gene have been found. At present, one of the controversial aspects of the disease is the relationship between the genotype and phenotype; cases have been described lacking a mutation, such as the patient presented in this article, as well as families who despite sharing the same genetic defect show disorders with differing severity. Epigenetic processes, which modify the genetic expression without changing the sequence of the deoxyribonucleic acid (DNA), could explain the clinical variability observed in this disease.

  2. Use of generalised additive models to categorise continuous variables in clinical prediction

    PubMed Central

    2013-01-01

    Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

  3. [Examination of the genetic variability among biofilm-forming Candida albicans clinical isolates].

    PubMed

    Durán, Estela Liliana; Mujica, Maria Teresa; Jewtuchowicz, Virginia Marta; Finquelievich, Jorge Luis; Pinoni, Maria Victoria; Iovannitti, Cristina Adela

    2007-12-31

    Biofilms are microbial communities encased in a self-produced polymeric matrix and represent a common mode of microbial growth. Candida albicans is able to colonize the surface of catheters, prostheses, and epithelia, forming biofilms that are highly resistant to antimicrobial drugs. The objective of this study was the genotypic characterization of biofilm-forming C. albicans clinical isolates using RAPD (Random Amplified Polymorphic DNA). We have studied 25 clinical isolates of C. albicans from oral cavities, blood, skin, nail, stool, oesophagus biopsy and vaginal fluids from patients suffering from candidiasis. For each strain biofilm formation was analysed by measuring the ability to adhere to and grow on polystyrene plastic surfaces using XTT [2,3-bis(2-methoxi-4nitro-5sulfophenil)-2H tetrazolium-5carboxanilide] reduction assay. The similarity coefficients generated by RAPD using four different primers varied from 49 to 91%, indicating a high degree of genetic variability between the clinical isolates. The dendrogram clustered the isolates in four related groups, all groups included strains with very different abilities to form biofilms. The isolates with similar genotypes often showed very different biofilm formation abilities. Strains were grouped into clusters independently of their clinical sources. Our results suggested that a direct correlation does not exist between the biofilm-forming ability of natural populations of C. albicans and the genotype as determined by RAPD.

  4. Learning neuroendoscopy with an exoscope system (video telescopic operating monitor): Early clinical results

    PubMed Central

    Parihar, Vijay; Yadav, Y. R.; Kher, Yatin; Ratre, Shailendra; Sethi, Ashish; Sharma, Dhananjaya

    2016-01-01

    Context: Steep learning curve is found initially in pure endoscopic procedures. Video telescopic operating monitor (VITOM) is an advance in rigid-lens telescope systems provides an alternative method for learning basics of neuroendoscopy with the help of the familiar principle of microneurosurgery. Aims: The aim was to evaluate the clinical utility of VITOM as a learning tool for neuroendoscopy. Materials and Methods: Video telescopic operating monitor was used 39 cranial and spinal procedures and its utility as a tool for minimally invasive neurosurgery and neuroendoscopy for initial learning curve was studied. Results: Video telescopic operating monitor was used in 25 cranial and 14 spinal procedures. Image quality is comparable to endoscope and microscope. Surgeons comfort improved with VITOM. Frequent repositioning of scope holder and lack of stereopsis is initial limiting factor was compensated for with repeated procedures. Conclusions: Video telescopic operating monitor is found useful to reduce initial learning curve of neuroendoscopy. PMID:27695549

  5. Learning neuroendoscopy with an exoscope system (video telescopic operating monitor): Early clinical results

    PubMed Central

    Parihar, Vijay; Yadav, Y. R.; Kher, Yatin; Ratre, Shailendra; Sethi, Ashish; Sharma, Dhananjaya

    2016-01-01

    Context: Steep learning curve is found initially in pure endoscopic procedures. Video telescopic operating monitor (VITOM) is an advance in rigid-lens telescope systems provides an alternative method for learning basics of neuroendoscopy with the help of the familiar principle of microneurosurgery. Aims: The aim was to evaluate the clinical utility of VITOM as a learning tool for neuroendoscopy. Materials and Methods: Video telescopic operating monitor was used 39 cranial and spinal procedures and its utility as a tool for minimally invasive neurosurgery and neuroendoscopy for initial learning curve was studied. Results: Video telescopic operating monitor was used in 25 cranial and 14 spinal procedures. Image quality is comparable to endoscope and microscope. Surgeons comfort improved with VITOM. Frequent repositioning of scope holder and lack of stereopsis is initial limiting factor was compensated for with repeated procedures. Conclusions: Video telescopic operating monitor is found useful to reduce initial learning curve of neuroendoscopy.

  6. Clinical variables associated with suicide attempts in schizophrenia before and after the first episode.

    PubMed

    Togay, Bilge; Noyan, Handan; Tasdelen, Rumeysa; Ucok, Alp

    2015-09-30

    The aim of this study was to investigate variables associated with suicide attempts in schizophrenia before and after the first episode. We evaluated history of past sucide attempts, clinical symptoms, level of functioning and cognitive performances of 172 patients with first-episode schizophrenia at first admission. Information was collected regarding clinical symptom severity, treatment compliance, and suicide attempts during the follow-up. We found that 16.5% of the patients attempted suicide before admission, and 6.2% of them attempted suicide during the follow-up. The patients who had attempted suicide before admission were mostly women, and more likely to be hospitalized in first year of follow up. BPRS-depression subscale score at admission and alcohol/substance use appeared as independent variables that found associated with suicide attempts prior to admission in logistic regression analysis. The patients who attempted suicide during the follow-up had significantly higher BPRS-depression subcale scores at sixth months of follow-up. Treatment compliance during the first 6 months and duration of remission was lower in this group. Our findings suggest that longer duration of first hospital treatment, the presence of depressive symptoms, and nonadherence to treatment in early phases of follow up after FES are predictors of suicide attempts. On the other hand, keeping remission during the follow-up protects against suicide attempts. PMID:26210651

  7. Variability of flashes and background luminances of clinical electroretinography stimuli across 14 UK centres

    NASA Astrophysics Data System (ADS)

    Hamilton, R.; Abdlseaed, A. Al; Healey, J.; Neveu, M. M.; Brown, L.; Keating, D.; McBain, V. A.; Sculfor, D.; Thompson, D. A.

    2013-08-01

    Three different flash strengths (dim, 0.01 cd s m-2; strong, 3 cd s m-2; strongest, 10 or 30 cd s m-2) and one adapting field luminance (30 cd m-2) are used for clinical electroretinograms (ERGs). To quantify their variability for local, LED-flash protocols, and for an ISCEV-specified, xenon-flash protocol, photometric measurements were made at 14 ERG centres across the UK. For local protocols, flashes were within a median of 0.01 log units of nominal, target levels and six, nine, eight and eight of 14 centres were within ISCEV tolerance (±0.05 log units) for dim, strong, strongest flashes and backgrounds, respectively. For the ISCEV-specified protocol, flashes were within a median of 0.02, 0.001 and 0.01 log units of ISCEV target dim, strong and strongest flashes, and fewer (5/12, 7/13, 3/13 and 11/13) centres were within ISCEV tolerance for dim, strong and strongest flashes and backgrounds, respectively. Paired LED-xenon comparison for a subset of centres showed close agreement. Variability of flashes was less for LED than xenon flashtube sources for strong and strongest flashes; for the strongest flash, LED flashes were closer to target values than xenon flashes. These data support a recommendation of LED use for clinical electroretinography.

  8. Clinical and hematologic variables in ponies with experimentally induced equine ehrlichial colitis (Potomac horse fever).

    PubMed

    Ziemer, E L; Whitlock, R H; Palmer, J E; Spencer, P A

    1987-01-01

    The clinical and hematologic variables of 10 ponies with experimentally induced equine ehrlichial colitis (EEC; syn: Potomac horse fever) were studied for a 30-day period (6 ponies) or until death (4 ponies). The earliest clinical sign indicative of EEC was fever (rectal temperature exceeding 39 C). All ponies became depressed (CNS) at various times during the disease, and 90% of the ponies developed diarrhea between 9 and 15 days after infection was induced. The most significant hematologic change was an increase in plasma protein concentration after the onset of fever (P less than 0.05). The PCV in all ponies became increased above base line during the diarrheic phase of EEC. Forty percent of the ponies developed anemia (PCV less than or equal to 23%) during the study. White blood cell counts were highly variable, with 80% of the ponies developing leukopenia (WBC less than 5,000/microliters) during the illness and 60% of the ponies developing leukocytosis (WBC greater than 14,000/microliters) after leukopenia was observed. Differential WBC changes varied widely and included neutropenia with a left shift, lymphopenia, and eosinopenia. Serial thrombocyte counts, which were done for only 1 pony, identified the development of marked thrombocytopenia. Some hematologic changes in ponies with EEC were similar to those reported in canine monocytic and equine granulocytic ehrlichioses. These data are discussed in the context of the pathogenesis and differential diagnosis of EEC.

  9. [Variability in the autonomous communities of the clinical recommendations in the service portfolios in primary care].

    PubMed

    Miguel-García, Félix; Hernández-Rubio, María de los Santos Ichaso; Quintana, Ana Isabel Fernández; Latorre, Mercedes Alfaro

    2011-10-01

    The quality guidelines established in Primary Care Service Portfolios of Autonomous Communities were analysed. It was observed that there were similarities in the number and content of the controls in children over 2 years-old, time intervals of cardiovascular risk and breast cancer mammography screening. Variability was observed in the number of controls (from 2 to 8) recommended for infants less than 2 years old, in the time intervals of monitoring parameters of patients with risk factors (for example, glycosylated haemoglobin in the diabetic every 2, 6, or 12 months), in the time intervals in cervical cytology (every 3 or 5 years) and in the age periods of performing the cytology (from 15, 20, 25, or 30 years up to 55 or 60 years) or mammography (from 45 or 50 years up to 60 or 65 years). PMID:21737182

  10. State-of-the-Art Sensor Technology in Spain: Invasive and Non-Invasive Techniques for Monitoring Respiratory Variables

    PubMed Central

    Domingo, Christian; Blanch, Lluis; Murias, Gaston; Luján, Manel

    2010-01-01

    The interest in measuring physiological parameters (especially arterial blood gases) has grown progressively in parallel to the development of new technologies. Physiological parameters were first measured invasively and at discrete time points; however, it was clearly desirable to measure them continuously and non-invasively. The development of intensive care units promoted the use of ventilators via oral intubation ventilators via oral intubation and mechanical respiratory variables were progressively studied. Later, the knowledge gained in the hospital was applied to out-of-hospital management. In the present paper we review the invasive and non-invasive techniques for monitoring respiratory variables. PMID:22399898

  11. Quality assurance for the clinical implementation of kilovoltage intrafraction monitoring for prostate cancer VMAT

    SciTech Connect

    Ng, J. A.; Booth, J. T.; O’Brien, R. T.; Huang, C.-Y.; Keall, P. J.; Colvill, E.; Poulsen, P. R.

    2014-11-01

    Purpose: Kilovoltage intrafraction monitoring (KIM) is a real-time 3D tumor monitoring system for cancer radiotherapy. KIM uses the commonly available gantry-mounted x-ray imager as input, making this method potentially more widely available than dedicated real-time 3D tumor monitoring systems. KIM is being piloted in a clinical trial for prostate cancer patients treated with VMAT (NCT01742403). The purpose of this work was to develop clinical process and quality assurance (QA) practices for the clinical implementation of KIM. Methods: Informed by and adapting existing guideline documents from other real-time monitoring systems, KIM-specific QA practices were developed. The following five KIM-specific QA tests were included: (1) static localization accuracy, (2) dynamic localization accuracy, (3) treatment interruption accuracy, (4) latency measurement, and (5) clinical conditions accuracy. Tests (1)–(4) were performed using KIM to measure static and representative patient-derived prostate motion trajectories using a 3D programmable motion stage supporting an anthropomorphic phantom with implanted gold markers to represent the clinical treatment scenario. The threshold for system tolerable latency is <1 s. The tolerances for all other tests are that both the mean and standard deviation of the difference between the programmed trajectory and the measured data are <1 mm. The (5) clinical conditions accuracy test compared the KIM measured positions with those measured by kV/megavoltage (MV) triangulation from five treatment fractions acquired in a previous pilot study. Results: For the (1) static localization, (2) dynamic localization, and (3) treatment interruption accuracy tests, the mean and standard deviation of the difference are <1.0 mm. (4) The measured latency is 350 ms. (5) For the tests with previously acquired patient data, the mean and standard deviation of the difference between KIM and kV/MV triangulation are <1.0 mm. Conclusions: Clinical process and

  12. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 3: Design considerations.

    PubMed

    Ball, Greg; Silverman, Michael H

    2011-09-01

    Ongoing safety monitoring of clinical trials of investigational treatments must operate at levels that range from the minute and detailed - namely, mathematical treatment of trial data - to the philosophical and societal - namely, ethical concerns for individuals and populations. Between those two poles lies a realm of environmental and pragmatic considerations that reflect the goals, biases, risk-tolerance, and constraints of study sponsors and organizers. These factors, while more difficult to quantify or, at times, to justify, also have a meaningful impact on the approach to safety monitoring and the resulting actions and outcomes. This paper considers the influence and interaction of two such factors, study design and statistical framework, on continuous safety monitoring procedures. Group sequential designs have been generally preferred for clinical trials over continuous sequential designs because of practical considerations. The group means and greater time for deliberation when using a group sequential procedure, as opposed to a continuous sequential procedure, can improve the quality of the analyses with minimal loss in sensitivity. However, undertaking any sequential analysis within a frequentist framework provokes considerable theoretical and practical difficulties. Continuous monitoring with a likelihood based method, on the other hand, has the advantages that all available information, including new data, can be used; sample sizes need not be fixed; and decisions can be made at any time without statistical penalty, irrespective of trial design. Such responsive statistical rules are needed to provide guidance to the human beings charged with trial monitoring.

  13. Is it me? Verbal self-monitoring neural network and clinical insight in schizophrenia.

    PubMed

    Sapara, Adegboyega; Ffytche, Dominic H; Cooke, Michael A; Williams, Steven C R; Kumari, Veena

    2015-12-30

    Self-monitoring, defined as the ability to distinguish between self-generated stimuli from other-generated ones, is known to be impaired in schizophrenia. This impairment has been theorised as the basis for many of the core psychotic symptoms, in particular, poor clinical insight. This study aimed to investigate verbal self-monitoring related neural substrates of preserved and poor clinical insight in schizophrenia. It involved 40 stable schizophrenia outpatients, 20 with preserved and 20 with poor insight, and 20 healthy participants. All participants underwent functional magnetic resonance imaging with brain coverage covering key areas in the self-monitoring network during a verbal self-monitoring task. Healthy participants showed higher performance accuracy and greater thalamic activity than both preserved and poor insight patient groups. Preserved insight patients showed higher activity in the putamen extending into the caudate, insula and inferior frontal gyrus, compared to poor insight patients, and in the anterior cingulate and medial frontal gyrus, compared to healthy participants. Poor insight patients did not show greater activity in any brain area compared to preserved insight patients or healthy participants. Future studies may pursue therapeutic avenues, such as meta-cognitive therapies to promote self-monitoring or targeted stimulation of relevant brain areas, as means of enhancing insight in schizophrenia. PMID:26549744

  14. Is it me? Verbal self-monitoring neural network and clinical insight in schizophrenia

    PubMed Central

    Sapara, Adegboyega; ffytche, Dominic H.; Cooke, Michael A.; Williams, Steven C.R.; Kumari, Veena

    2015-01-01

    Self-monitoring, defined as the ability to distinguish between self-generated stimuli from other-generated ones, is known to be impaired in schizophrenia. This impairment has been theorised as the basis for many of the core psychotic symptoms, in particular, poor clinical insight. This study aimed to investigate verbal self-monitoring related neural substrates of preserved and poor clinical insight in schizophrenia. It involved 40 stable schizophrenia outpatients, 20 with preserved and 20 with poor insight, and 20 healthy participants. All participants underwent functional magnetic resonance imaging with brain coverage covering key areas in the self-monitoring network during a verbal self-monitoring task. Healthy participants showed higher performance accuracy and greater thalamic activity than both preserved and poor insight patient groups. Preserved insight patients showed higher activity in the putamen extending into the caudate, insula and inferior frontal gyrus, compared to poor insight patients, and in the anterior cingulate and medial frontal gyrus, compared to healthy participants. Poor insight patients did not show greater activity in any brain area compared to preserved insight patients or healthy participants. Future studies may pursue therapeutic avenues, such as meta-cognitive therapies to promote self-monitoring or targeted stimulation of relevant brain areas, as means of enhancing insight in schizophrenia. PMID:26549744

  15. Variability of wavefront aberration measurements in small pupil sizes using a clinical Shack-Hartmann aberrometer

    PubMed Central

    Ginis, Harilaos S; Plainis, Sotiris; Pallikaris, Aristophanis

    2004-01-01

    Background Recently, instruments for the measurement of wavefront aberration in the living human eye have been widely available for clinical applications. Despite the extensive background experience on wavefront sensing for research purposes, the information derived from such instrumentation in a clinical setting should not be considered a priori precise. We report on the variability of such an instrument at two different pupil sizes. Methods A clinical aberrometer (COAS Wavefront Scienses, Ltd) based on the Shack-Hartmann principle was employed in this study. Fifty consecutive measurements were perfomed on each right eye of four subjects. We compared the variance of individual Zernike expansion coefficients as determined by the aberrometer with the variance of coefficients calculated using a mathematical method for scaling the expansion coefficients to reconstruct wavefront aberration for a reduced-size pupil. Results Wavefront aberration exhibits a marked variance of the order of 0.45 microns near the edge of the pupil whereas the central part appears to be measured more consistently. Dispersion of Zernike expansion coefficients was lower when calculated by the scaling method for a pupil diameter of 3 mm as compared to the one introduced when only the central 3 mm of the Shack – Hartmann image was evaluated. Signal-to-noise ratio was lower for higher order aberrations than for low order coefficients corresponding to the sphero-cylindrical error. For each subject a number of Zernike expansion coefficients was below noise level and should not be considered trustworthy. Conclusion Wavefront aberration data used in clinical care should not be extracted from a single measurement, which represents only a static snapshot of a dynamically changing aberration pattern. This observation must be taken into account in order to prevent ambiguous conclusions in clinical practice and especially in refractive surgery. PMID:15018630

  16. [Is MRI monitoring useful in clinical practice in patients with multiple sclerosis? No].

    PubMed

    Edan, G

    2013-11-01

    Is regular MRI monitoring useful in clinical practice in multiple sclerosis patients treated with disease modifying therapy (DMT) drugs? My answer is no. Tacking a DMT drug is not by itself a pertinent criterion for requiring a systematic MRI monitoring in MS patients. Five clinical criteria should be taken into consideration before prescribing regular MRI examinations. The clinical form of the disease: MRI monitoring in DMT treated patients, has been demonstrated as useful only in pure relapsing-remitting MS patients. Up to now, there is no convincing demonstration of therapeutic efficacy with any DMT drug, neither first-line nor second-line drugs in patients with primary or secondary progressive MS disease. The duration of the disease, epidemiological data leading to the concept of a two-stage disability progression in MS, emphasizes the importance of treating as early as possible RRMS patients in order to stop accumulation of new focal MRI CNS lesions. In this regard, an annual monitoring for the 5 first years of the disease looks reasonable in order to better personalize the treatment choice among the few approved DMT drugs. The duration of the treatment: a first MRI assessment at month 6 after initiating a new DMT drug is adequate in order to better distinguish responder versus no responder. The persistence of Gado+lesions at 6 months is a strong indication for considering alternative treatment. The disease activity: both criteria, clinical and MRI, are needed to recognized very active or aggressive relapsing MS patients, leading to decide a rapid use of second-line treatment therapy. The treatment choice: in JC positive MS patients treated with natalizumab, the risk of PML is as high as more than 1 % in those JC+MS patients that are treated continuously more than 24 months. A regular MRI monitoring (3 or 6months) is recommended in order to detect as early as possible MRI abnormalities suggesting PML.

  17. [Clinical assessment of a monitor "MedStorm" (Norway) of galvanic skin response correlates with preoperative stress].

    PubMed

    2011-01-01

    Clinical trials were performed by Russian anesthesiologists of pain monitor based on measuring galvanic skin response (skin conductance). 5 pations were studied the monitor showed lower sensitivity to assess the level of analgesia during combined anesthesia which allows to not recommend it for use in clinical practice. PMID:22379919

  18. Variability in the microcanonical cascades parameters among gauges of urban precipitation monitoring network

    NASA Astrophysics Data System (ADS)

    Licznar, Paweł; Rupp, David; Adamowski, Witold

    2013-04-01

    In the fall of 2008, Municipal Water Supply and Sewerage Company (MWSSC) in Warsaw began operating the first large precipitation monitoring network dedicated to urban hydrology in Poland. The process of establishing the network as well as the preliminary phase of its operation, raised a number of questions concerning optimal gauge location and density and revealed the urgent need for new data processing techniques. When considering the full-field precipitation as input to hydrodynamic models of stormwater and combined sewage systems, standard processing techniques developed previously for single gauges and concentrating mainly on the analysis of maximum rainfall rates and intensity-duration-frequency (IDF) curves development were found inadequate. We used a multifractal rainfall modeling framework based on microcanonical multiplicative random cascades to analyze properties of Warsaw precipitation. We calculated breakdown coefficients (BDC) for the hierarchy of timescales from λ=1 (5-min) up to λ=128 (1280-min) for all 25 gauges in the network. At small timescales histograms of BDCs were strongly deformed due to the recording precision of rainfall amounts. A randomization procedure statistically removed the artifacts due to precision errors in the original series. At large timescales BDC values were sparse due to relatively short period of observations (2008-2011). An algorithm with a moving window was proposed to increase the number of BDC values at large timescales and to smooth their histograms. The resulting empirical BDC histograms were modeled by a theoretical "2N-B" distribution, which combined 2 separate normal (N) distributions and one beta (B) distribution. A clear evolution of BDC histograms from a 2N-B distribution for small timescales to a N-B distributions for intermediate timescales and finally to a single beta distributions for large timescales was observed for all gauges. Cluster analysis revealed close patterns of BDC distributions among almost

  19. [The clinical immunology laboratory in diagnosis and monitoring of systemic lupus erythematosus and connective tissue diseases].

    PubMed

    Sinico, R A; Radice, A

    2005-01-01

    The laboratory and particularly clinical immunology laboratories have an essential role in diagnosing and monitoring systemic lupus erythematosus (SLE), as well as other connective tissue diseases. The role of the clinical immunology laboratory in these diseases is to confirm or exclude diagnosis, to monitor disease activity, and to identify subgroup of patients. To obtain the best results in terms of diagnostic performance and clinical usefulness, the following recommendations should be fulfilled: anti-nuclear antibodies (ANA) determination by indirect immunofluorescence on Hep-2 cells is an effective screening assay in patients with clinical features of SLE. A negative ANA test makes the diagnosis of SLE unlikely. Anti-dsDNA antibodies are highly specific for SLE and are associated with renal involvement. The method of choice for anti-dsDNA is the Farr assay; however, the necessity of using radioactive materials reduces its applicability. As an alternative, immunofluorescence on Crithidia Luciliae can be used in the diagnostic phase due to its high specificity. The detection of antibodies to extractable nuclear antigens (ENA) and to phospholipids (lupus anticoagulant and anti-cardiolipin antibodies) is useful in identifying subgroups of patients at risk for some clinical manifestations. Anti-dsDNA measurement with a quantitative assay (the Farr assay or ELISA) is currently the best method to monitor disease activity along with complement levels. New assays (anti-C1q and anti-nucleosome antibodies) have been recently proposed for the diagnosis (anti-nucleosome) and monitoring of SLE patients (anti-C1q and anti-nucleosome antibodies), with promising results.

  20. The Impact of the Perceived Purpose of Electronic Performance Monitoring on an Array of Attitudinal Variables

    ERIC Educational Resources Information Center

    Wells, Deborah L.; Moorman, Robert H.; Werner, Jon M.

    2007-01-01

    As a form of performance monitoring, electronic performance monitoring (EPM) offers the opportunity for unobtrusive and continuous performance data gathering. These strengths can also make EPM stressful and threatening. Many features of performance evaluation systems, including the organizational purposes for which they are used, can affect…

  1. Clinical Utility of Routine Cardiac Monitoring in Breast Cancer Patients Receiving Trastuzumab

    PubMed Central

    Davis, Christine C.; Zelnak, Amelia; Eley, J. William; Goldstein, Daniel A.; Switchenko, Jeffrey M.; McKibbin, Trevor

    2016-01-01

    Background Trastuzumab targets the human epidermal growth factor receptor-2 (HER2). Cardiotoxicity is a potential adverse effect, manifesting as either an asymptomatic decline in left-ventricular ejection fraction or infrequently as largely reversible symptomatic heart failure (HF). Monitoring recommendations differ between product labeling and 2012 guidelines, and the clinical utility of serial cardiac monitoring in patients with metastatic breast cancer remains controversial. Objective The objectives of this study were to describe the frequency of monitoring, incidence of symptomatic or asymptomatic HF, overall effect on treatment, and cost of monitoring for cardiotoxicity. Methods We preformed an institutional review board–approved retrospective chart review of breast cancer patients receiving trastuzumab from January 1, 2009, through January 1, 2014, at an academic medical center. Results Out of 154 treatments, 72% were adjuvant, and 28% were metastatic. In the adjuvant setting, a mean of 4.5 (interquartile range [IQR] = 4–5) echocardiograms (echos) over a mean of 11.5 (IQR = 11–12) months were performed. In the metastatic setting, a mean of 3.1 (IQR = 1–5) echos over a mean of 20.2 (IQR = 9–31) months were performed. Symptomatic HF events occurred in 4 adjuvant (3.6%) and 2 metastatic patients (6.5%); 10 patients (6.5%) had a treatment interruption, with 9 (90%) tolerating restart of trastuzumab. Two patients (1.3%) changed treatment as a result of cardiotoxicity. Using population incidence of HER2-positive breast cancer, $13 million could be saved if monitoring were reduced by 1 echo per patient. Conclusions Given the low incidence of clinically significant HF and cost of monitoring, less frequent monitoring may be justified. PMID:27307412

  2. Association of socioeconomic and clinical variables with the state of frailty among older inpatients1

    PubMed Central

    Tavares, Darlene Mara dos Santos; Nader, Isabella Danielle; de Paiva, Mariana Mapelli; Dias, Flavia Aparecida; Pegorari, Maycon Sousa

    2015-01-01

    Objectives: to identify the prevalence of frailty among inpatient older adults in a clinical hospital and check the association of the socioeconomic and clinical characteristics with the state of frailty. Method: observational, cross-sectional and analytical study, conducted with 255 hospitalized patients. Materials used: structured instrument for the economical and clinical data and frailty phenotype of Fried. Descriptive and bivariate statistical analysis was carried out and, by means of chi-square tests and ANOVA One-way (p<0.05). Results: the prevalence of frailty corresponded to 26.3%, while pre-frailty represented 53.3%. The highest proportion of frail seniors was identified for 80 years or older (p = 0.004), widowed (p = 0.035) and with the highest average length of stay (p = 0.006). Conclusion: inpatient older adults presented high percentages of frail states associated with socioeconomic variables and hospitalization period. The identification of the health conditions related to pre-frailty and frailty can foster the planning and implementation of the assistance to older adults in this context. PMID:26626004

  3. Clinical predictors and impact of ambulatory blood pressure monitoring in pediatric hypertension referrals.

    PubMed

    Davis, Marguerite L; Ferguson, Michael A; Zachariah, Justin P

    2014-09-01

    Elevated blood pressure (BP) is rising in children. Significant proportions of children have reactive hypertension or masked hypertension, making ambulatory BP monitoring (ABPM) a valuable tool, although with potential economic implications. In youth referred for elevated BP, we sought clinic BP combinations that obviated the need for ABPM and to specify the economic role of ABPM. In a retrospective pediatric referral cohort (N = 170), we examine clinic systolic BP (SBP) predictors of components of ABPM hypertension and their combination. In economic analyses, we compared effectiveness and charges of three diagnostic pathways: (1) clinic BP alone; (2) abnormal clinic BP prompting ABPM; or (3) universal ABPM. ABPM hypertension occurred in 55 (32.4%) and reactive hypertension in 37 (21.8%), average automated (β = 0.208; 95% confidence interval, 0.027, 0.389; P = .03) and maximum auscultatory clinic SBP (β = 0.160; 95% confidence interval 0.022, 0.299; P = .02) were associated with ABPM SBP mean, but none predicted SBP load. No clinic SBP combination was associated with ABPM hypertension. Universal ABPM accrued the lowest average charge per hypertensive youth identified ($10,948). We did not identify a clinic SBP combination that predicted ABPM hypertension in youth referred for elevated BP. Universal ABPM, in this context, may be the most economically and clinically efficient diagnostic strategy. PMID:25065681

  4. Clinical predictors and impact of ambulatory blood pressure monitoring in pediatric hypertension referrals.

    PubMed

    Davis, Marguerite L; Ferguson, Michael A; Zachariah, Justin P

    2014-09-01

    Elevated blood pressure (BP) is rising in children. Significant proportions of children have reactive hypertension or masked hypertension, making ambulatory BP monitoring (ABPM) a valuable tool, although with potential economic implications. In youth referred for elevated BP, we sought clinic BP combinations that obviated the need for ABPM and to specify the economic role of ABPM. In a retrospective pediatric referral cohort (N = 170), we examine clinic systolic BP (SBP) predictors of components of ABPM hypertension and their combination. In economic analyses, we compared effectiveness and charges of three diagnostic pathways: (1) clinic BP alone; (2) abnormal clinic BP prompting ABPM; or (3) universal ABPM. ABPM hypertension occurred in 55 (32.4%) and reactive hypertension in 37 (21.8%), average automated (β = 0.208; 95% confidence interval, 0.027, 0.389; P = .03) and maximum auscultatory clinic SBP (β = 0.160; 95% confidence interval 0.022, 0.299; P = .02) were associated with ABPM SBP mean, but none predicted SBP load. No clinic SBP combination was associated with ABPM hypertension. Universal ABPM accrued the lowest average charge per hypertensive youth identified ($10,948). We did not identify a clinic SBP combination that predicted ABPM hypertension in youth referred for elevated BP. Universal ABPM, in this context, may be the most economically and clinically efficient diagnostic strategy.

  5. Relationship of psychological and physiological variables in long-term self-monitored data during work ability rehabilitation program.

    PubMed

    Pärkkä, Juha; Merilahti, Juho; Mattila, Elina M; Malm, Esko; Antila, Kari; Tuomisto, Martti T; Saarinen, Ari Viljam; van Gils, Mark; Korhonen, Ilkka

    2009-03-01

    Individual wellness comprises both psychological and physiological wellbeing, which are interrelated. In long-term monitoring of wellness, both components should be included. Work-related stress and burnout are persistent problems in industrial countries. Early identification of work-related stress symptoms and early intervention could reduce individual suffering and improve the working productivity and creativity. The goal of this study was to explore the relationship between physiological and psychological variables measured at home by the users themselves or automatically. In all, 17 (3 males and 14 females, age 40-62) people participating in a work ability rehabilitation program (due to work overload) were monitored for three months. Physiological and behavioral variables (activity, bed occupancy, heart rate (HR) and respiration during night, HR during day, blood pressure, steps, weight, room illumination, and temperature) were measured with different unobtrusive wireless sensors. Daily self-assessment of stress, mood, and behaviors (exercise, sleep) were collected using a mobile phone diary. The daily self-assessment of stress and the Derogatis stress profile questionnaire were used as reference for stress status. Results show modest, but significant pooled overall correlations between self-assessed stress level, and physiological and behavioral variables (e.g., sleep length measured with wrist-worn activity monitor: rho = -0.22, p < 0.001, and variance of nightly bedroom illumination: rho = 0.13, p < 0.001). Strong, but sometimes conflicting correlations can be found at individual level, suggesting individual reactions to stress in daily life.

  6. Self-monitoring in clinical practice: a challenge for medical educators.

    PubMed

    Epstein, Ronald M; Siegel, Daniel J; Silberman, Jordan

    2008-01-01

    Recent literature has described how the capacity for concurrent self-assessment-ongoing moment-to-moment self-monitoring-is an important component of the professional competence of physicians. Self-monitoring refers to the ability to notice our own actions, curiosity to examine the effects of those actions, and willingness to use those observations to improve behavior and thinking in the future. Self-monitoring allows for the early recognition of cognitive biases, technical errors, and emotional reactions and may facilitate self-correction and development of therapeutic relationships. Cognitive neuroscience has begun to explore the brain functions associated with self-monitoring, and the structural and functional changes that occur during mental training to improve attentiveness, curiosity, and presence. This training involves cultivating habits of mind such as experiencing information as novel, thinking of "facts" as conditional, seeing situations from multiple perspectives, suspending categorization and judgment, and engaging in self-questioning. The resulting awareness is referred to as mindfulness and the associated moment-to-moment self-monitoring as mindful practice-in contrast to being on "automatic pilot" or "mindless" in one's behavior. This article is a preliminary exploration into the intersection of educational assessment, cognitive neuroscience, and mindful practice, with the hope of promoting ways of improving clinicians' capacity to self-monitor during clinical practice, and, by extension, improve the quality of care that they deliver.

  7. Immune Monitoring in Cancer Vaccine Clinical Trials: Critical Issues of Functional Flow Cytometry-Based Assays

    PubMed Central

    Urbani, Francesca; Proietti, Enrico

    2013-01-01

    The development of immune monitoring assays is essential to determine the immune responses against tumor-specific antigens (TSAs) and tumor-associated antigens (TAAs) and their possible correlation with clinical outcome in cancer patients receiving immunotherapies. Despite the wide range of techniques used, to date these assays have not shown consistent results among clinical trials and failed to define surrogate markers of clinical efficacy to antitumor vaccines. Multiparameter flow cytometry- (FCM-) based assays combining different phenotypic and functional markers have been developed in the past decade for informative and longitudinal analysis of polyfunctional T-cells. These technologies were designed to address the complexity and functional heterogeneity of cancer biology and cellular immunity and to define biomarkers predicting clinical response to anticancer treatment. So far, there is still a lack of standardization of some of these immunological tests. The aim of this review is to overview the latest technologies for immune monitoring and to highlight critical steps involved in some of the FCM-based cellular immune assays. In particular, our laboratory is focused on melanoma vaccine research and thus our main goal was the validation of a functional multiparameter test (FMT) combining different functional and lineage markers to be applied in clinical trials involving patients with melanoma. PMID:24195078

  8. Relationship between Sevoflurane Plasma Concentration, Clinical Variables and Bispectral Index Values during Cardiopulmonary Bypass

    PubMed Central

    Nitzschke, Rainer; Wilgusch, Joana; Kersten, Jan Felix; Goepfert, Matthias Sebastian

    2015-01-01

    Background Anesthetic administration is increasingly guided by electroencephalography (EEG)-based monitoring, such as the bispectral index (BIS). However, during cardiopulmonary bypass (CPB), factors other than the administered hypnotic agents may influence EEG signals, and their effects on BIS values are unknown. Methods This report is a secondary analysis of data from a prospective, controlled interventional study comparing the effect of sevoflurane administration guided by BIS monitoring (group SevoBIS) and constant administration of sevoflurane (group Sevo1.8Vol%) during CPB. Sevoflurane plasma concentration (SPC) was measured using gas chromatography. The relationships of BIS to SPC, CPB pump flow, arterial pressure, hematocrit, temperature, time on CPB, and patient characteristics were analysed. Results No association was observed between BIS values and SPC in group SevoBIS. In group Sevo1.8Vol%, a 40 μg ml-1 increase in SPC, which encompassed the entire range of observed values of the SPC in this analysis, was associated with a decrease of 3.6 (95% confidence interval (CI): 1.1–6.1) in BIS values (p = 0.005). Each increase in CPB time of 10 minutes was associated with an increase in BIS values of 0.25 (95%CI: 0.11–0.39, p<0.001). Path analysis revealed that the BIS values of SevoBIS patients were 5.3 (95%CI: 3.2–7.5) units higher than those of Sevo1.8Vol% patients (p<0.001), which was the strongest effect on BIS values. Path analysis revealed a slope of 0.5 (95%CI: 0.3–0.7) BIS units per 1°C body temperature (p<0.001). Conclusion BIS monitoring is insensitive to clinically relevant changes in SPC in individual patients during CPB. PMID:26312484

  9. [A new neuromuscular transmission monitor (TOF Guard): the rationale behind the method and its clinical usefulness].

    PubMed

    Ueda, N; Masuda, Y; Muteki, T; Tsuda, H; Hiraki, T; Harada, H; Tobata, H

    1994-01-01

    TOF Guard is one of the latest developments in the field of neuromuscular monitoring equipment. This system uses a miniature acceleration transducer (a piezo-electric ceramic wafer is used), simply fastened to the thumb with tape. The rationale behind the method is Newton's second law, stating that the acceleration is directly proportional to the force. In this study, authors assessed the accuracy of this system in clinical use, comparing with the force transducer method (Myograph 2000). The result showed that there was a very close positive correlation between the values of T1, TOF ratio and posttetanic count simultaneously measured by both methods. The coefficient of correlation was 0.96, and its significance level was P < 0.001. From the clinical view point, it is concluded that TOF Guard is very useful because of its accuracy and because the equipment is easy to handle, compact and of low price as a neuromuscular monitoring system for routine anesthesia.

  10. Clinical Utility and Limitations of Intraoperative Monitoring of Visual Evoked Potentials

    PubMed Central

    Luo, Yeda; Regli, Luca; Bozinov, Oliver; Sarnthein, Johannes

    2015-01-01

    Objectives During surgeries that put the visual pathway at risk of injury, continuous monitoring of the visual function is desirable. However, the intraoperative monitoring of the visual evoked potential (VEP) is not yet widely used. We evaluate here the clinical utility of intraoperative VEP monitoring. Methods We analyzed retrospectively 46 consecutive surgeries in 2011-2013. High luminance stimulating devices delivered flash stimuli on the closed eyelid during intravenous anesthesia. We monitored VEP features N75 and P100 and took patients' preoperative and postoperative visual function from patient charts. Postoperative ophthalmologic workup was performed in 25 (54%) patients and preoperatively in 28 (61%) patients. Results VEP recordings were feasible in 62 of 85 eyes (73%) in 46 patients. All 23 eyes without VEP had impaired vision. During surgery, VEPs remained stable throughout surgery in 50 eyes. In 44 of these, visual function did not deteriorate and three patients (6 eyes) developed hemianopia. VEP decreased transiently in 10 eyes and visual function of all was preserved. VEPs were lost permanently in 2 eyes in two patients without new postoperative visual impairment. Conclusions Satisfactory intraoperative VEP monitoring was feasible in all patients except in those with severe visual impairment. Preservation of VEPs predicted preserved visual function. During resection of lesions in the visual cortex, VEP monitoring could not detect new major visual field defects due to injury in the posterior visual pathway. Intraoperative VEPs were sensitive enough to detect vascular damage during aneurysm clipping and mechanical manipulation of the anterior visual pathway in an early reversible stage. Intraoperative VEP monitoring influenced surgical decisions in selected patients and proved to be a useful supplement to the toolbox of intraoperative neurophysiological monitoring. PMID:25803287

  11. [Muscle relaxants and neuromuscular monitoring - Introduction for a safe clinical application].

    PubMed

    Döcker, Dennis; Walther, Andreas

    2012-05-01

    The use of muscle relaxants facilitates endotracheal intubation and ameliorates the conditions of surgery. But, their use should be controlled - otherwise there will be postoperative residual curarisation which can lead to patient discomfort up to severe medical complications. Therefore, an appropriate surveillance via objective neuromuscular monitoring is essential. This article gives a review of the basic principles of muscle relaxants, their clinical application and the surveillance of their effects and degradation.

  12. The laboratory of clinical virology in monitoring patients undergoing monoclonal antibody therapy.

    PubMed

    Cavallo, R

    2011-12-01

    The relevant efficacy of monoclonal antibodies (mAbs) has resulted in the successful treatment of several diseases, although susceptibility to infections remains a major problem. This review summarizes aspects of the literature regarding viral infections and mAbs, specifically addressing the risk of infection/reactivation, the measures that can reduce this risk, and the role played by the laboratory of clinical virology in monitoring patients undergoing mAb therapy.

  13. [Muscle relaxants and neuromuscular monitoring - Introduction for a safe clinical application].

    PubMed

    Döcker, Dennis; Walther, Andreas

    2012-05-01

    The use of muscle relaxants facilitates endotracheal intubation and ameliorates the conditions of surgery. But, their use should be controlled - otherwise there will be postoperative residual curarisation which can lead to patient discomfort up to severe medical complications. Therefore, an appropriate surveillance via objective neuromuscular monitoring is essential. This article gives a review of the basic principles of muscle relaxants, their clinical application and the surveillance of their effects and degradation. PMID:22628025

  14. CLINICAL VARIABILITY IN TWO SISTERS WITH KEUTEL SYNDROME DUE TO A HOMOZYGOUS MUTATION IN MGP GENE.

    PubMed

    Tüysüz, B; Cinar, B; Laçiner, S; Onay, H; Mittaz-Crettol, L

    2015-01-01

    Keutel syndrome (KS) is an autosomal recessive disease characterised by abnormal cartilage calcification, brachytelephalangism, peripheral pulmonary artery stenosis, hearing loss and midface retrusion. KS is caused by homozygous mutations in MGP, a gene encoding Matrix Gla protein which acts as a calcification inhibitor in extracellular matrix. We present two Turkish sisters (22 and 13 years old) who had abnormal cartilage calcification, brachytelephalangism, congenital heart defect and chronic asthmatic bronchitis. The patients were homozygous for c.62-2A>G (IVS1-2 A>G) mutation in MGP gene. Abnormal cartilage calcification, brachytelephalangism and midfacial retrusion are the hallmarks of KS. It was observed that the younger sister had striking cartilaginous calcifications, midfacial retrusion and severe brachytelephalangism while her older sister had mild costal cartilaginous calcifications and brachytelephalangism without any midfacial retrusion. Intrafamiliar clinical variability for KS has not been described previously. PMID:26349188

  15. Variability of Creatinine Measurements in Clinical Laboratories: Results from the CRIC Study

    PubMed Central

    Joffe, Marshall; Hsu, Chi-yuan; Feldman, Harold I.; Weir, Matthew; Landis, J.R.; Hamm, L. Lee

    2010-01-01

    Objectives Estimating equations using serum creatinine (SCr) are often used to assess glomerular filtration rate (GFR). Such creatinine (Cr)-based formulae may produce biased estimates of GFR when using Cr measurements that have not been calibrated to reference laboratories. In this paper, we sought to examine the degree of this variation in Cr assays in several laboratories associated with academic medical centers affiliated with the Chronic Renal Insufficiency Cohort (CRIC) Study; to consider how best to correct for this variation, and to quantify the impact of such corrections on eligibility for participation in CRIC. Variability of Cr is of particular concern in the conduct of CRIC, a large multicenter study of subjects with chronic renal disease, because eligibility for the study depends on Cr-based assessment of GFR. Methods A library of 5 large volume plasma specimens from apheresis patients was assembled, representing levels of plasma Cr from 0.8 to 2.4 mg/dl. Samples from this library were used for measurement of Cr at each of the 14 CRIC laboratories repetitively over time. We used graphical displays and linear regression methods to examine the variability in Cr, and used linear regression to develop calibration equations. We also examined the impact of the various calibration equations on the proportion of subjects screened as potential participants who were actually eligible for the study. Results There was substantial variability in Cr assays across laboratories and over time. We developed calibration equations for each laboratory; these equations varied substantially among laboratories and somewhat over time in some laboratories. The laboratory site contributed the most to variability (51% of the variance unexplained by the specimen) and variation with time accounted for another 15%. In some laboratories, calibration equations resulted in differences in eligibility for CRIC of as much as 20%. Conclusions The substantial variability in SCr assays

  16. Three-month validation of a turbuhaler electronic monitoring device: implications for asthma clinical trial use

    PubMed Central

    Pilcher, Janine; Shirtcliffe, Philippa; Patel, Mitesh; McKinstry, Steve; Cripps, Terrianne; Weatherall, Mark; Beasley, Richard

    2015-01-01

    Background Electronic monitoring of inhaled asthma therapy is suggested as the ‘gold standard’ for measuring patterns of medication use in clinical trials. The SmartTurbo (Adherium (NZ) Ltd, Auckland, New Zealand) is an electronic monitor for use with a turbuhaler device (AstraZeneca, UK). The aim of this study was to determine the accuracy of the SmartTurbo in recording Symbicort actuations over a 12-week period of use. Methods Twenty SmartTurbo monitors were attached to the base of 20 Symbicort turbuhalers. Bench testing in a research facility was undertaken on days 0, 5, 6, 7, 8, 9, 14, 21, 28, 56 and 84. Patterns of ‘low-use’ (2 sets of 2 actuations on the same day) and ‘high-use’ (2 sets of 8 actuations on the same day) were performed. The date and time of actuations were recorded in a paper diary and compared with data uploaded from the SmartTurbo monitors. Results 2800 actuations were performed. Monitor sensitivity was 99.9% with a lower 97.5% confidence bound of 99.6%. The positive predictive value was 99.9% with a 97.5% lower confidence bound of 99.7%. Accuracy was not affected by whether the pattern of inhaler use was low or high, or whether there was a delay in uploading the actuation data. Conclusions The SmartTurbo monitor is highly accurate in recording and retaining electronic data in this 12-week bench study. It can be recommended for use in clinical trial settings, in which quality control systems are incorporated into study protocols to ensure accurate data acquisition. PMID:26629345

  17. Design and Clinical Feasibility of Personal Wearable Monitor for Measurement of Activity and Environmental Exposure

    PubMed Central

    Ribón Fletcher, Richard; Oreskovic, Nicolas M.; Robinson, Alyssa I.

    2015-01-01

    Human exposure to specific environmental factors (e.g. air quality, lighting, and sound) is known to play an important role in the pathogenesis of many chronic diseases (e.g. asthma) and mental health disorders (e.g. anxiety). However, conventional fixed environmental monitoring stations are sparsely located and, despite environmental models, cannot adequately assess individual exposure levels. New forms of low-cost portable monitors have begun to emerge that enable the collection of higher spatial density “crowd sourced” data; however, the first generation of these low-cost environmental monitors have generally not been suitable for clinical environmental health studies due to practical challenges such as calibration, reproducibility, form factor, and battery life. In this paper, we present a wearable environmental monitor that overcomes these challenges and can be used in clinical studies The new device, called “Eco-Mini,” can be used without a smart phone and is capable of locally sampling and recording a variety of environmental parameters (Ozone, Sulfur Dioxide, Volatile Organic Compounds, humidity, temperature, ambient light color balance, and sound level) as well as individual activity (3-axis accelerometer) and location (GPS). In this paper, we also report findings and discuss lessons learned from a feasibility study conducted for one week with pediatric patients as part of an ongoing asthma research study. PMID:25570098

  18. Design and clinical feasibility of personal wearable monitor for measurement of activity and environmental exposure.

    PubMed

    Fletcher, Richard Ribón; Oreskovic, Nicolas M; Robinson, Alyssa I

    2014-01-01

    Human exposure to specific environmental factors (e.g. air quality, lighting, and sound) is known to play an important role in the pathogenesis of many chronic diseases (e.g. asthma) and mental health disorders (e.g. anxiety). However, conventional fixed environmental monitoring stations are sparsely located and, despite environmental models, cannot adequately assess individual exposure levels. New forms of low-cost portable monitors have begun to emerge that enable the collection of higher spatial density "crowd sourced" data; however, the first generation of these low-cost environmental monitors have generally not been suitable for clinical environmental health studies due to practical challenges such as calibration, reproducibility, form factor, and battery life. In this paper, we present a wearable environmental monitor that overcomes these challenges and can be used in clinical studies The new device, called "Eco-Mini," can be used without a smart phone and is capable of locally sampling and recording a variety of environmental parameters (Ozone, Sulfur Dioxide, Volatile Organic Compounds, humidity, temperature, ambient light color balance, and sound level) as well as individual activity (3-axis accelerometer) and location (GPS). In this paper, we also report findings and discuss lessons learned from a feasibility study conducted for one week with pediatric patients as part of an ongoing asthma research study. PMID:25570098

  19. A hybrid approach to achieving both marginal and conditional balances for stratification variables in sequential clinical trials.

    PubMed

    Lin, Yunzhi; Su, Zheng

    2013-01-01

    Various methods exist in the literature for achieving marginal balance for baseline stratification variables in sequential clinical trials. One major limitation with balancing on the margins of the stratification variables is that there is an efficiency loss when the primary analysis is stratified. To preserve the efficiency of a stratified analysis one recently proposed approach balances on the crossing of the stratification variables included in the analysis, which achieves conditional balance for the variables. A hybrid approach to achieving both marginal and conditional balances in sequential clinical trials is proposed, which is applicable to both continuous and categorical stratification variables. Numerical results based on extensive simulation studies and a real dataset show that the proposed approach outperforms the existing ones and is particularly useful when both additive and stratified models are planned for a trial.

  20. Psychological Variables Potentially Implicated in Opioid-Related Mortality as Observed in Clinical Practice

    PubMed Central

    Passik, Steven D.; Lowery, Amy

    2014-01-01

    Opioid-related deaths in the United States have become a public health problem, with accidental and unintended overdoses being especially troubling. Screening for psychological risk factors is an important first step in safeguarding against nonadherence practices and identifying patients who may be vulnerable to the risks associated with opioid therapy. Validated screening instruments can aid in this attempt as a complementary tool to clinicians’ assessments. A structured screening is imperative as part of an assessment, as clinician judgment is not the most reliable method of identifying nonadherence. As a complement to formal screening, we present for discussion and possible future study certain psychological variables observed during years of clinical practice that may be linked to medication nonadherence and accidental overdose. These variables include catastrophizing, fear, impulsivity, attention deficit disorders, existential distress, and certain personality disorders. In our experience, chronic pain patients with dual diagnoses may become “chemical copers” as a way of coping with their negative emotion. For these patients, times of stress could lead to accidental overdose. Behavioral, cognitive-behavioral (acceptance and commitment, dialectical behavior), existential (meaning-centered, dignity), and psychotropic therapies have been effective in treating these high-risk comorbidities, while managing expectations of pain relief appears key to preventing accidental overdose. PMID:21668755

  1. Variable number of tandem repeats in clinical strains of Haemophilus influenzae.

    PubMed Central

    van Belkum, A; Scherer, S; van Leeuwen, W; Willemse, D; van Alphen, L; Verbrugh, H

    1997-01-01

    An algorithm capable of identifying short repeat motifs was developed and used to screen the whole genome sequence available for Haemophilus influenzae, since some of these repeats have been shown to affect bacterial virulence. Various di- to hexanucleotide repeats were identified, confirming and extending previous findings on the existence of variable-number-of-tandem-repeat loci (VNTRs). Repeats with units of 7 or 8 nucleotides were not encountered. For all of the 3- to 6-nucleotide repeats in the H. influenzae chromosome, PCR tests capable of detecting allelic polymorphisms were designed. Fourteen of 18 of the potential VNTRs were indeed highly polymorphic when different strains were screened. Two of the potential VNTRs appeared to be short and homogeneous in length; another one may be specific for the H. influenzae Rd strain only. One of the primer sets generated fingerprint-type DNA banding patterns. The various repeat types differed with respect to intrinsic stability as well. It was noted for separate colonies derived from a single clinical specimen or strains passaged for several weeks on chocolate agar plates that the lengths of the VNTRs did not change. When several strains from different patients infected during an outbreak of lung disease were analyzed, increased but limited variation was encountered in all VNTR sites analyzed. One of the 5-nucleotide VNTRs proved to be hypervariable. This variability may reflect the molecular basis of a mechanism used by H. influenzae bacteria to successfully colonize and infect different human individuals. PMID:9393791

  2. Quality Assessment for Therapeutic Drug Monitoring in AIDS Clinical Trials Group (ACTG 5146): A Multicenter Clinical Trial

    PubMed Central

    DiFrancesco, Robin; Rosenkranz, Susan; Mukherjee, A. Lisa; Demeter, Lisa M.; Jiang, Hongyu; DiCenzo, Robert; Dykes, Carrie; Rinehart, Alex; Albrecht, Mary; Morse, Gene D.

    2010-01-01

    In a randomized trial, AIDS Clinical Trials Group (ACTG) protocol 5146 (A5146) investigated the use of TDM to adjust doses of HIV-1 protease inhibitors (PIs) in patients with prior virologic failure on PI-based therapy who were starting a new PI-based regimen. The overall percentage of “PI trough repeats”, such as rescheduled visits or redrawn PI trough specimens, increased from 2% to 5% to 10% as the process progressed from the clinical sites, the PSL, and the study team, respectively. Cumulatively, this represents a 17% rate of failure to obtain adequate PI trough sample. While targeting a turn-around of ≤ 7 days from sample receipt to a drug concentration report, 12% of the received specimens required a longer period to report concentrations. The implementation of dosing changes in the TDM arm were achieved within ≤7 days for 56% of the dose change events, and within ≤14 days for 77% of dose change events. This quality assurance analysis provides a valuable summary of the specific points in the TDM process that could be improved during a multicenter clinical trial including: [1] shortening the timeline of sample shipment from clinical site to the lab, [2] performing the collection of PI trough specimen within the targeted sampling window by careful monitoring of the last dose times and collection times by the clinicians [3] increasing patient adherence counseling to reduce the number of samples that are redrawn due to suspecting inconsistent adherence, and [4] decreasing the time to successful TDM-based dose adjustment. The application of some of these findings may also be relevant to single center studies or clinical TDM programs within a hospital. PMID:20592644

  3. Clinical variability of type 1 neurofibromatosis: is there a neurofibromatosis-Noonan syndrome?

    PubMed Central

    Stern, H J; Saal, H M; Lee, J S; Fain, P R; Goldgar, D E; Rosenbaum, K N; Barker, D F

    1992-01-01

    Detailed clinical, ophthalmological, and molecular studies were performed on a multigeneration family in which there were many subjects with type 1 neurofibromatosis, a common autosomal dominant disorder. Affected family members displayed a wide range of clinical findings including, in two subjects, features seen in Noonan syndrome (triangular facies, downward slanting palpebral fissures, micrognathia, short stature, and learning disability). Subjects have been described previously whose features have overlapped with neurofibromatosis and Noonan syndrome, and it has been suggested that these persons might represent a separate condition. DNA haplotype analysis showed linkage of the neurofibromatosis phenotype seen in this family to the proximal long arm of chromosome 17 in the region where the type 1 neurofibromatosis gene has been mapped. These results imply that the Noonan phenotype seen in some patients with type 1 neurofibromatosis might be the result of variable or variant expression of the neurofibromatosis gene on chromosome 17. The possible role of non-specific factors, such as fetal hypotonia, in producing the neurofibromatosis-Noonan phenotype needs further investigation. The availability of closely linked and intragenic molecular markers for neurofibromatosis could potentially be useful in the diagnosis and characterisation of patients and families with atypical forms of neurofibromatosis. Images PMID:1348094

  4. Myocardial architecture and patient variability in clinical patterns of atrial fibrillation

    PubMed Central

    Manani, Kishan A.; Christensen, Kim; Peters, Nicholas S.

    2016-01-01

    Atrial fibrillation (AF) increases the risk of stroke by a factor of 4–5 and is the most common abnormal heart rhythm. The progression of AF with age, from short self-terminating episodes to persistence, varies between individuals and is poorly understood. An inability to understand and predict variation in AF progression has resulted in less patient-specific therapy. Likewise, it has been a challenge to relate the microstructural features of heart muscle tissue (myocardial architecture) with the emergent temporal clinical patterns of AF. We use a simple model of activation wave-front propagation on an anisotropic structure, mimicking heart muscle tissue, to show how variation in AF behavior arises naturally from microstructural differences between individuals. We show that the stochastic nature of progressive transversal uncoupling of muscle strands (e.g., due to fibrosis or gap junctional remodeling), as occurs with age, results in variability in AF episode onset time, frequency, duration, burden, and progression between individuals. This is consistent with clinical observations. The uncoupling of muscle strands can cause critical architectural patterns in the myocardium. These critical patterns anchor microreentrant wave fronts and thereby trigger AF. It is the number of local critical patterns of uncoupling as opposed to global uncoupling that determines AF progression. This insight may eventually lead to patient-specific therapy when it becomes possible to observe the cellular structure of a patient’s heart. PMID:27766317

  5. Myocardial architecture and patient variability in clinical patterns of atrial fibrillation

    NASA Astrophysics Data System (ADS)

    Manani, Kishan A.; Christensen, Kim; Peters, Nicholas S.

    2016-10-01

    Atrial fibrillation (AF) increases the risk of stroke by a factor of 4-5 and is the most common abnormal heart rhythm. The progression of AF with age, from short self-terminating episodes to persistence, varies between individuals and is poorly understood. An inability to understand and predict variation in AF progression has resulted in less patient-specific therapy. Likewise, it has been a challenge to relate the microstructural features of heart muscle tissue (myocardial architecture) with the emergent temporal clinical patterns of AF. We use a simple model of activation wave-front propagation on an anisotropic structure, mimicking heart muscle tissue, to show how variation in AF behavior arises naturally from microstructural differences between individuals. We show that the stochastic nature of progressive transversal uncoupling of muscle strands (e.g., due to fibrosis or gap junctional remodeling), as occurs with age, results in variability in AF episode onset time, frequency, duration, burden, and progression between individuals. This is consistent with clinical observations. The uncoupling of muscle strands can cause critical architectural patterns in the myocardium. These critical patterns anchor microreentrant wave fronts and thereby trigger AF. It is the number of local critical patterns of uncoupling as opposed to global uncoupling that determines AF progression. This insight may eventually lead to patient-specific therapy when it becomes possible to observe the cellular structure of a patient's heart.

  6. [Variable clinical expression of familial Incontinentia Pigmenti syndrome - presentation of three cases].

    PubMed

    Kutkowska-Kaźmierczak, Anna; Obersztyn, Ewa; Bonnefont, Jean-Paul; Rosińska-Borkowska, Danuta; Mazurczak, Tomasz; Sobczyńska-Tomaszewska, Agnieszka; Mazurczak, Tadeusz

    2008-01-01

    Incontinentia Pigmenti (IP, Bloch-Sulzberger syndrome, OMIM 308300) is a rare X-linked dominant genodermatosis, usually lethal in males in the prenatal period. Wide spectrum of clinical expression consists of skin hyperpigmented lines and swirling patterns, dysplastic teeth and nails, and in 30% central nervous system abnormalities including seizures, microcephaly and intellectual disability (10% of cases). In 80% of IP cases, the disease is caused by a large-scale deletion of exons 4 to 10 of the NEMO gene. Three cases of variable expression of Incontinentia Pigmenti are presented. In a one-year-old girl, her mother and grandmother molecular analysis revealed the same typical deletion of the NEMO gene. In the proband, characteristic skin lesions were detected located over the trunk and lower limbs. Characteristic evolution of the changes was observed. In the mother, expression of the disease was much milder, whereas in the grandmother lesions were restricted to the fingernails. Clinical characteristics and pedigree data are described. PMID:19305025

  7. Influence of M. tuberculosis Lineage Variability within a Clinical Trial for Pulmonary Tuberculosis

    PubMed Central

    Nahid, Payam; Bliven, Erin E.; Kim, Elizabeth Y.; Mac Kenzie, William R.; Stout, Jason E.; Diem, Lois; Johnson, John L.; Gagneux, Sebastien; Hopewell, Philip C.; Kato-Maeda, Midori

    2010-01-01

    Recent studies suggest that M. tuberculosis lineage and host genetics interact to impact how active tuberculosis presents clinically. We determined the phylogenetic lineages of M. tuberculosis isolates from participants enrolled in the Tuberculosis Trials Consortium Study 28, conducted in Brazil, Canada, South Africa, Spain, Uganda and the United States, and secondarily explored the relationship between lineage, clinical presentation and response to treatment. Large sequence polymorphisms and single nucleotide polymorphisms were analyzed to determine lineage and sublineage of isolates. Of 306 isolates genotyped, 246 (80.4%) belonged to the Euro-American lineage, with sublineage 724 predominating at African sites (99/192, 51.5%), and the Euro-American strains other than 724 predominating at non-African sites (89/114, 78.1%). Uneven distribution of lineages across regions limited our ability to discern significant associations, nonetheless, in univariate analyses, Euro-American sublineage 724 was associated with more severe disease at baseline, and along with the East Asian lineage was associated with lower bacteriologic conversion after 8 weeks of treatment. Disease presentation and response to drug treatment varied by lineage, but these associations were no longer statistically significant after adjustment for other variables associated with week-8 culture status. PMID:20505778

  8. Influence of M. tuberculosis lineage variability within a clinical trial for pulmonary tuberculosis.

    PubMed

    Nahid, Payam; Bliven, Erin E; Kim, Elizabeth Y; Mac Kenzie, William R; Stout, Jason E; Diem, Lois; Johnson, John L; Gagneux, Sebastien; Hopewell, Philip C; Kato-Maeda, Midori

    2010-05-20

    Recent studies suggest that M. tuberculosis lineage and host genetics interact to impact how active tuberculosis presents clinically. We determined the phylogenetic lineages of M. tuberculosis isolates from participants enrolled in the Tuberculosis Trials Consortium Study 28, conducted in Brazil, Canada, South Africa, Spain, Uganda and the United States, and secondarily explored the relationship between lineage, clinical presentation and response to treatment. Large sequence polymorphisms and single nucleotide polymorphisms were analyzed to determine lineage and sublineage of isolates. Of 306 isolates genotyped, 246 (80.4%) belonged to the Euro-American lineage, with sublineage 724 predominating at African sites (99/192, 51.5%), and the Euro-American strains other than 724 predominating at non-African sites (89/114, 78.1%). Uneven distribution of lineages across regions limited our ability to discern significant associations, nonetheless, in univariate analyses, Euro-American sublineage 724 was associated with more severe disease at baseline, and along with the East Asian lineage was associated with lower bacteriologic conversion after 8 weeks of treatment. Disease presentation and response to drug treatment varied by lineage, but these associations were no longer statistically significant after adjustment for other variables associated with week-8 culture status.

  9. Clinical significance of automatic warning function of cardiac remote monitoring systems in preventing acute cardiac episodes

    PubMed Central

    Chen, Shou-Qiang; Xing, Shan-Shan; Gao, Hai-Qing

    2014-01-01

    Objective: In addition to ambulatory Holter electrocardiographic recording and transtelephonic electrocardiographic monitoring (TTM), a cardiac remote monitoring system can provide an automatic warning function through the general packet radio service (GPRS) network, enabling earlier diagnosis, treatment and improved outcome of cardiac diseases. The purpose of this study was to estimate its clinical significance in preventing acute cardiac episodes. Methods: Using 2 leads (V1 and V5 leads) and the automatic warning mode, 7160 patients were tested with a cardiac remote monitoring system from October 2004 to September 2007. If malignant arrhythmias or obvious ST-T changes appeared in the electrocardiogram records was automatically transferred to the monitoring center, the patient and his family members were informed, and the corresponding precautionary or therapeutic measures were implemented immediately. Results: In our study, 274 cases of malignant arrhythmia, including sinus standstill and ventricular tachycardia, and 43 cases of obvious ST-segment elevation were detected and treated. Because of early detection, there was no death or deformity. Conclusions: A cardiac remote monitoring system providing an automatic warning function can play an important role in preventing acute cardiac episodes. PMID:25674124

  10. Demographic variables, clinical aspects, and medicolegal implications in a population of patients with adjustment disorder

    PubMed Central

    Anastasia, Annalisa; Colletti, Chiara; Cuoco, Valentina; Quartini, Adele; Urso, Stefania; Rinaldi, Raffaella; Bersani, Giuseppe

    2016-01-01

    Introduction Although adjustment disorder (AD) is considered as residual diagnosis and receives little attention in research, it plays an important role in clinical practice and also assumes an increasingly important role in the field of legal medicine, where the majority of diagnostic frameworks (eg, mobbing) often refer to AD. Our study aimed to look for specific stressor differences among demographic and clinical variables in a naturalistic setting of patients with AD. Methods A restrospective statistical analysis of the data of patients diagnosed with AD from November 2009 to September 2012, identified via manual search from the archive of the outpatient setting at the University Unit of Psychiatry “A. Fiorini” Hospital, Terracina (Latina, Italy), was performed. Results The sample consisted of 93 patients (46 males and 47 females), aged between 26 and 85, with medium–high educational level who were mainly employed. In most cases (54.80%), a diagnosis of AD with mixed anxiety and depressed mood was made. In all, 72% of the sample reported a negative family history for psychiatric disorders. In 22.60%, a previous history of psychopathology, especially mood disorders (76.19%), was reported. The main stressors linked to the development of AD were represented by working problems (32.30%), family problems (23.70%), and/or somatic disease (22.60%) with significant differences with respect to age and sex. Half of the patients were subjected to a single first examination; 24.47% requested a copy of medical records. Conclusion Confirming previous data from previous reports, our results suggest that AD may have a distinct profile in demographic and clinical terms. Increased scientific attention is hoped, particularly focused on addressing a better definition of diagnostic criteria, whose correctness and accuracy are critical, especially in situations with medicolegal implications. PMID:27099504

  11. PRECISION PHOTOMETRIC MONITORING OF VERY LOW MASS {sigma} ORIONIS CLUSTER MEMBERS: VARIABILITY AND ROTATION AT A FEW Myr

    SciTech Connect

    Cody, Ann Marie; Hillenbrand, Lynne A.

    2010-12-15

    We present high-precision photometry on 107 variable low-mass stars and brown dwarfs in the {approx}3 Myr {sigma} Orionis open cluster. We have carried out I-band photometric monitoring within two fields, encompassing 153 confirmed or candidate members of the low-mass cluster population, from 0.02 to 0.5 M {sub sun}. We are sensitive to brightness changes on timescales from 10 minutes to two weeks with amplitudes as low as 0.004 mag, and find variability on these timescales in nearly 70% of cluster members. We identify both periodic and aperiodic modes of variability, as well as semi-periodic rapid fading events that are not accounted for by the standard explanations of rotational modulation of surface features or accretion. We have incorporated both optical and infrared color data to uncover trends in variability with mass and circumstellar disks. While the data confirm that the lowest-mass objects (M < 0.2 M {sub sun}) rotate more rapidly than the 0.2-0.5 M {sub sun} members, they do not support a direct connection between rotation rate and the presence of a disk. Finally, we speculate on the origin of irregular variability in cluster members with no evidence for disks or accretion.

  12. Undertaking clinical audit, with reference to a Prescribing Observatory for Mental Health audit of lithium monitoring.

    PubMed

    Paton, Carol; Barnes, Thomas R E

    2014-06-01

    Audit is an important tool for quality improvement. The collection of data on clinical performance against evidence-based and clinically relevant standards, which are considered by clinicians to be realistic in routine practice, can usefully prompt reflective practice and the implementation of change. Evidence of participation in clinical audit is required to achieve intended learning outcomes for trainees in psychiatry and revalidation for those who are members of the Royal College of Psychiatrists. This article addresses some of the practical steps involved in conducting an audit project, and, to illustrate key points, draws on lessons learnt from a national, audit-based, quality improvement programme of lithium prescribing and monitoring conducted through the Prescribing Observatory for Mental Health.

  13. Combination of process and vibration data for improved condition monitoring of industrial systems working under variable operating conditions

    NASA Astrophysics Data System (ADS)

    Ruiz-Cárcel, C.; Jaramillo, V. H.; Mba, D.; Ottewill, J. R.; Cao, Y.

    2016-01-01

    The detection and diagnosis of faults in industrial processes is a very active field of research due to the reduction in maintenance costs achieved by the implementation of process monitoring algorithms such as Principal Component Analysis, Partial Least Squares or more recently Canonical Variate Analysis (CVA). Typically the condition of rotating machinery is monitored separately using vibration analysis or other specific techniques. Conventional vibration-based condition monitoring techniques are based on the tracking of key features observed in the measured signal. Typically steady-state loading conditions are required to ensure consistency between measurements. In this paper, a technique based on merging process and vibration data is proposed with the objective of improving the detection of mechanical faults in industrial systems working under variable operating conditions. The capabilities of CVA for detection and diagnosis of faults were tested using experimental data acquired from a compressor test rig where different process faults were introduced. Results suggest that the combination of process and vibration data can effectively improve the detectability of mechanical faults in systems working under variable operating conditions.

  14. Design and Evaluation of an Intelligent Remote Tidal Volume Variability Monitoring System in E-Health Applications.

    PubMed

    Fekr, Atena Roshan; Radecka, Katarzyna; Zilic, Zeljko

    2015-09-01

    A reliable long-term monitoring and diagnosis of breath disorders at an early stage provides an improvement of medical act, life expectancy, and quality of life while decreasing the costs of treatment and medical services. Therefore, a real-time unobtrusive monitoring of respiration patterns, as well as breath parameters, is a critical need in medical applications. In this paper, we propose an intelligent system for patient home care, capable of measuring respiration rate and tidal volume variability via a wearable sensing technology. The proposed system is designed particularly for the goal of diagnosis and treatment in patients with pathological breathing, e.g., respiratory complications after surgery or sleep disorders. The complete system was comprised of wearable calibrated accelerometer sensor, Bluetooth low energy, and cloud database. The experiments are conducted with eight subjects and the overall error in respiration rate calculation is obtained 0.29%±0.33% considering SPR-BTA spirometer as the reference. We also introduce a method for tidal volume variability estimation while validated using Pearson correlation. Furthermore, since it is essential to detect the critical events resulted from sudden rise or fall in per breath tidal volume of the patients, we provide a technique to automatically find the accurate threshold values based on each individual breath characteristics. Therefore, the system is able to detect the major changes, precisely by more than 98%, and provide immediate feedback such as sound alarm for round-the-clock respiration monitoring. PMID:26087508

  15. Monitoring fluvial water chemistry for trend detection: hydrological variability masks trends in datasets covering fewer than 12 years.

    PubMed

    Howden, Nicholas J K; Burt, Tim P; Worrall, Fred; Whelan, Michael J

    2011-03-01

    This paper sub-samples four 35 year water quality time series to consider the potential influence of short-term hydrological variability on process inference derived from short-term monitoring data. The data comprise two time series for nitrate (NO(3)-N) and two for DOC (using water colour as a surrogate). The four catchments were selected not only because of their long records, but also because the four catchments are very different: upland and lowland, agricultural and non-agricultural. Multiple linear regression is used to identify the trend and effects of rainfall and hydrological 'memory effects' over the full 35 years, and then a moving-window technique is used to subsample the series, using window widths of between 6 and 20 years. The results suggest that analyses of periods between six and eleven years are more influenced by local hydrological variability and therefore provide misleading results about long-term trends, whereas periods of longer than twelve years tend to be more representative of underlying system behaviour. This is significant: if such methods for analysing monitoring data were used to validate changes in catchment management, a monitoring period of less than 12 years might be insufficient to demonstrate change in the underlying system.

  16. Design and Evaluation of an Intelligent Remote Tidal Volume Variability Monitoring System in E-Health Applications.

    PubMed

    Fekr, Atena Roshan; Radecka, Katarzyna; Zilic, Zeljko

    2015-09-01

    A reliable long-term monitoring and diagnosis of breath disorders at an early stage provides an improvement of medical act, life expectancy, and quality of life while decreasing the costs of treatment and medical services. Therefore, a real-time unobtrusive monitoring of respiration patterns, as well as breath parameters, is a critical need in medical applications. In this paper, we propose an intelligent system for patient home care, capable of measuring respiration rate and tidal volume variability via a wearable sensing technology. The proposed system is designed particularly for the goal of diagnosis and treatment in patients with pathological breathing, e.g., respiratory complications after surgery or sleep disorders. The complete system was comprised of wearable calibrated accelerometer sensor, Bluetooth low energy, and cloud database. The experiments are conducted with eight subjects and the overall error in respiration rate calculation is obtained 0.29%±0.33% considering SPR-BTA spirometer as the reference. We also introduce a method for tidal volume variability estimation while validated using Pearson correlation. Furthermore, since it is essential to detect the critical events resulted from sudden rise or fall in per breath tidal volume of the patients, we provide a technique to automatically find the accurate threshold values based on each individual breath characteristics. Therefore, the system is able to detect the major changes, precisely by more than 98%, and provide immediate feedback such as sound alarm for round-the-clock respiration monitoring.

  17. Use of artificial stomach-duodenum model for investigation of dosing fluid effect on clinical trial variability.

    PubMed

    Polster, Christopher S; Atassi, Faraj; Wu, Sy-Juen; Sperry, David C

    2010-10-01

    Lilly Compound X (LCX) is an oncology drug that was tested in a phase I clinical study using starch blend capsules. The drug was given to a small patient population (4 patients) and showed large inter- and intra-patient variability. In order to evaluate the possible effect of stomach pH on exposure and ways to mitigate the variability issue, artificial stomach-duodenum (ASD) experiments were conducted to investigate the hypothesis that carefully selected dosing fluids would have an impact in minimizing exposure variability caused by the formulation, which could lead to more consistent evaluation of drug absorption in patients. The ASD data corroborates the observed variability, and was a good tool to investigate the effect of stomach pH and potential dosing solutions on duodenal concentrations. Administering capsules co-formulated with Captisol (10% drug load) along with Sprite was shown by the ASD to be an effective way to increase duodenal concentrations as well as to reduce the difference between duodenal concentrations for different gastric pH. The reduction in variability of duodenum AUC (in ASD) is expected to correlate well with a reduction of variability in patient exposure. The dosing regimen of Sprite/Captisol is therefore suggested for future clinical trials involving LCX. Furthermore, for design of early phase clinical trials, ASD technology can be used to assist in choosing the proper dosing solution to mitigate absorption and exposure variability issues. PMID:20669969

  18. Strategies for monitoring and updating clinical practice guidelines: a systematic review

    PubMed Central

    2012-01-01

    Background Scientific knowledge is in constant change. The flow of new information requires a frequent re-evaluation of the available research results. Clinical practice guidelines (CPGs) are not exempted from this phenomenon and need to be kept updated to maintain the validity of their recommendations. The objective of our review is to systematically identify, describe and assess strategies for monitoring and updating CPGs. Study design and setting We conducted a systematic review of studies evaluating one or more methods of updating (with or without monitoring) CPGs or recommendations. We searched MEDLINE (PubMed) and The Cochrane Methodology Register (The Cochrane Library) from 1966 to June 2012. Additionally, we hand-searched reference lists of the included studies and the Guidelines International Network book of abstracts. If necessary, we contacted study authors to obtain additional information. Results We included a total of eight studies. Four evaluated if CPGs were out of date, three updated CPGs, and one continuously monitored and updated CPGs. The most detailed reported phase of the process was the identification of new evidence. As opposed to studies updating guidelines, studies evaluating if CPGs were out of date applied restricted searches. Only one study compared a restricted versus an exhaustive search suggesting that a restricted search is sufficient to assess recommendations’ Validity. One study analyzed the survival time of CPGs and suggested that these should be reassessed every three years. Conclusions There is limited evidence about the optimal strategies for monitoring and updating clinical practice guidelines. A restricted search is likely to be sufficient to monitor new evidence and assess the need to update, however, more information is needed about the timing and type of search. Only the exhaustive search strategy has been assessed for the update of CPGs. The development and evaluation of more efficient strategies is needed to improve

  19. Variability in young very low mass stars: two surprises from spectrophotometric monitoring

    NASA Astrophysics Data System (ADS)

    Bozhinova, I.; Scholz, A.; Eislöffel, J.

    2016-05-01

    We present simultaneous photometric and spectroscopic observations of seven young and highly variable M dwarfs in star-forming regions in Orion, conducted in four observing nights with FOcal Reducer and low dispersion Spectrograph2 at European Southern Observatory/VLT. All seven targets show significant photometric variability in the I band, with amplitudes between 0.1-0.8 mag, The spectra, however, remain remarkably constant, with spectral type changes less than 0.5 subtypes. Thus, the brightness changes are not caused by veiling that `fills in' absorption features. Three objects in the σ Ori cluster (age ˜3 Myr) exhibit strong Hα emission and Hα variability, in addition to the continuum variations. Their behaviour is mostly consistent with the presence of spots with temperature of ˜300 K above the photosphere and filling factors between 0.2-0.4, in contrast to typical hotspots observed in more massive stars. The remaining targets near ɛ Ori, likely to be older, show eclipse-like light curves, no significant Hα activity and are better represented by variable extinction due to circumstellar material. Interestingly, two of them show no evidence of infrared excess emission. Our study shows that high-amplitude variability in young very low mass stars can be caused by different phenomena than in more massive T Tauri stars and can persist when the disc has disappeared and accretion has ceased.

  20. Turbidity-based sediment monitoring in northern Thailand: Hysteresis, variability, and uncertainty

    EPA Science Inventory

    Annual total suspended solid (TSS) loads in the Mae Sa Catchment in northern Thailand, determined with an automated, turbidity-based monitoring approach, were approximately 62,000, 33,000, and 14,000 Mg during the three years of observation. These loads were equivalent to basin y...

  1. Quantification of reef benthos communities and variability inherent to the monitoring using video transect method.

    PubMed

    Ramos, Carla Alecrim Colaço; Amaral, Fernanda Duarte; de Kikuchi, Ruy Kenji Papa; Chaves, Eduardo Marocci; de Melo, Gabriel Rivas

    2010-03-01

    Long-term monitoring program of organisms is the most recommended for understanding changing processes on reefs. The video transect method presents advantages for that. Specialists state that it is important to make sure that the recorded coverage is always the same between campaigns, so that differences in results may be entirely attributed to environmental changes. This study aimed to test the capability of implementing this requirement through tracking simulation and its validity for monitoring the benthic communities of reefs using the video transect method. Ten transects 20 m long were established in Todos os Santos Bay coral reefs. Subsequent to the first transect capture, a second diver repeated the same track, simulating two different monitoring campaigns. Data were transformed and a matrix of similarity was generated using Bray-Curtis' Index. ANOSIM analysis was performed to test the similarity of the ten transects and its repetitions. The result, R = 0.08 (P = 0.928), shows that reef monitoring using video transect, the way it is described in the literature, is appropriate, but it is important to consider some premises discussed in this work. PMID:19234751

  2. Finding Stellar Variability: Monitoring Algol with On-Line Night Sky Live Data

    NASA Astrophysics Data System (ADS)

    Muzzin, V.; Shamir, L.; Nemiroff, R. J.; Night Sky Live Collaboration

    2004-12-01

    Advanced undergraduates now have the opportunity to track the brightness and variability of famous variable stars all over the sky with no more than a web browser and a spreadsheet. The opportunity arises from the Night Sky Live global network of fisheye CONtinuous CAMeras (CONCAMs) which generate public domain, on-line data, freely available at http://NightSkyLive.net . Here we use the deep eclipses of Beta Perseus (Algol) to demonstrate the use of the automatically generated photometry tables. Useful educational concepts in statistics and practical astronomy are clearly demonstrated.

  3. Real-Time Continuous Glucose Monitoring in the Clinical Setting: The Good, the Bad, and the Practical

    PubMed Central

    Mamkin, Irene; Ten, Svetlana; Bhandari, Sonal; Ramchandani, Neesha

    2008-01-01

    Real-time continuous glucose monitoring (RT-CGM) is the latest technological breakthrough in diabetes care. Despite its limitations of lag time between sensor and blood glucose, the need for calibration, false detection of and failure to detect hypoglycemia, and mild discomfort or skin irritation reported in some users, RT-CGM is a highly beneficial tool that can be used to detect nocturnal or unrecognized hypoglycemia and glycemic variability. This, in turn, can lead to better treatment decisions, which may improve metabolic control and decrease the incidence and progression of diabetes complications. The RT-CGM devices are fairly accurate and easy to use. It is not difficult to establish a clinical RT-CGM program in the office. However, it requires persistence and an understanding of the patient's perspective of using RT-CGM so it can be presented and taught appropriately. This article discusses the benefits and limitations of RT-CGM and establishment of a RT-CGM program in the clinical setting. PMID:19885273

  4. Variability of the human heart rate as a diagnostic instrument obtained by mean of a wireless monitor

    NASA Astrophysics Data System (ADS)

    Barajas Mauricio, Sánchez; Hernández González, Martha Alicia; Figueroa Vega, Nicte; Malacara Hernández, Juan Manuel; Fraga Teodoro, Córdova

    2014-11-01

    Introduction: Heart rate variability (HRV) is the cyclic measurement of RR intervals between normal beats. Aim: To determine the VFC via a wireless Polar monitor. Material and methods: 100 symptomatic menopausal women were studied for measurements of HRV were I post a Polar RS400 Watch four hrs. Results: Obtained through the fast Fourier transform, the frequency domain HRV low frequency (LF) 0.04-0.15 Hz, high frequency (HF) 0.15-0.4Hz and the ratio LF / HF. Conclusion: obtaining HRV is important for cardiovascular autonomic assessment in menopausal women.

  5. Results of a five-year program of multifrequency monitoring of low-frequency variable radio sources

    NASA Technical Reports Server (NTRS)

    Mitchell, K. J.; Dennison, Brian; Condon, J. J.; Altschuler, Daniel R.; Payne, H. E.; O'Dell, S. L.; Broderick, J. J.

    1994-01-01

    We present the results of a detailed multifrequency monitoring program of low-frequency variable radio sources. This consists of light curves at 318, 430, 606, 880, and 1400 MHz over a 5 year period. The observations were carried out with the Arecibo 305 m radiotelescope and the Green Bank 91 m radio telescope. The spectral characteristics of the variations confirm the general picture that at least two mechanisms are responsible. The first is clearly intrinsic evolution of synchrotron-emitting components as it is manifested by variations that appear first and most strongly at high frequencies, subsequently drifting to lower frequencies with diminished amplitude. The more common type of low-frequency variability, however, dominates at frequencies below approximately 800 MHz, while the variations near 1 GHz are often quite weak. This spectral property is strong evidence that these variations are interstellar refractive scintillation.

  6. Temporal and spatial variability of phytoplankton monitored by a combination of monitoring buoys, pigment analysis and fast screening microscopy in the Fehmarn Belt Estuary.

    PubMed

    Schlüter, Louise; Møhlenberg, Flemming; Kaas, Hanne

    2014-08-01

    For 2 years, a baseline investigation was carried out to collect reference information of the present environmental status in the Fehmarn Belt and adjacent area. The temporal and spatial variability of phytoplankton was monitored by a combination of monitoring buoys, pigment analysis and fast screening microscopy. The overall phytoplankton succession in the Fehmarn Belt area was found to be influenced primarily by the seasonal changes, where various diatoms dominated the spring and autumn blooms and flagellates like Chrysochromulina sp., Dictyocha speculum and various dinoflagellates were occasionally abundant in late spring and summer. The phytoplankton groups were remarkably uniform horizontally in the investigation area while large differences in both biomasses and composition of individual phytoplankton groups were seen vertically in the water column, especially in the summer periods, in which the two-layer exchange flow between the North Sea and the Baltic Sea is showing a particularly strong stratification in the Fehmarn Belt. The chlorophyll a concentrations ranged continuously from 1 to 3 μg/L at the three permanent buoy stations during the 2 years of monitoring, except for the spring and autumn blooms where chlorophyll a increased up to 18 μg/L in the spring of 2010 and up to 8 μg/L in the autumn of 2009. Recurrent blooms of filamentous cyanobacteria are common during the summer period in the Baltic Sea and adjacent areas, but excessive blooms of cyanobacteria did not occur in 2009 and 2010 in the Fehmarn Belt area. The combination of the HPLC pigment analysis method and monitoring buoys continuously measuring fluorescence at selected stations with fast screening of samples in the microscope proved advantageous for obtaining information on both the phytoplankton succession and dynamic and, at the same time, getting information on duration and intensity of the blooms as well as specific information on the dominant species present both temporally and

  7. Methodology and technology for peripheral and central blood pressure and blood pressure variability measurement: current status and future directions - Position statement of the European Society of Hypertension Working Group on blood pressure monitoring and cardiovascular variability.

    PubMed

    Stergiou, George S; Parati, Gianfranco; Vlachopoulos, Charalambos; Achimastos, Apostolos; Andreadis, Emanouel; Asmar, Roland; Avolio, Alberto; Benetos, Athanase; Bilo, Grzegorz; Boubouchairopoulou, Nadia; Boutouyrie, Pierre; Castiglioni, Paolo; de la Sierra, Alejandro; Dolan, Eamon; Head, Geoffrey; Imai, Yutaka; Kario, Kazuomi; Kollias, Anastasios; Kotsis, Vasilis; Manios, Efstathios; McManus, Richard; Mengden, Thomas; Mihailidou, Anastasia; Myers, Martin; Niiranen, Teemu; Ochoa, Juan Eugenio; Ohkubo, Takayoshi; Omboni, Stefano; Padfield, Paul; Palatini, Paolo; Papaioannou, Theodore; Protogerou, Athanasios; Redon, Josep; Verdecchia, Paolo; Wang, Jiguang; Zanchetti, Alberto; Mancia, Giuseppe; O'Brien, Eoin

    2016-09-01

    Office blood pressure measurement has been the basis for hypertension evaluation for almost a century. However, the evaluation of blood pressure out of the office using ambulatory or self-home monitoring is now strongly recommended for the accurate diagnosis in many, if not all, cases with suspected hypertension. Moreover, there is evidence that the variability of blood pressure might offer prognostic information that is independent of the average blood pressure level. Recently, advancement in technology has provided noninvasive evaluation of central (aortic) blood pressure, which might have attributes that are additive to the conventional brachial blood pressure measurement. This position statement, developed by international experts, deals with key research and practical issues in regard to peripheral blood pressure measurement (office, home, and ambulatory), blood pressure variability, and central blood pressure measurement. The objective is to present current achievements, identify gaps in knowledge and issues concerning clinical application, and present relevant research questions and directions to investigators and manufacturers for future research and development (primary goal).

  8. Methodology and technology for peripheral and central blood pressure and blood pressure variability measurement: current status and future directions - Position statement of the European Society of Hypertension Working Group on blood pressure monitoring and cardiovascular variability.

    PubMed

    Stergiou, George S; Parati, Gianfranco; Vlachopoulos, Charalambos; Achimastos, Apostolos; Andreadis, Emanouel; Asmar, Roland; Avolio, Alberto; Benetos, Athanase; Bilo, Grzegorz; Boubouchairopoulou, Nadia; Boutouyrie, Pierre; Castiglioni, Paolo; de la Sierra, Alejandro; Dolan, Eamon; Head, Geoffrey; Imai, Yutaka; Kario, Kazuomi; Kollias, Anastasios; Kotsis, Vasilis; Manios, Efstathios; McManus, Richard; Mengden, Thomas; Mihailidou, Anastasia; Myers, Martin; Niiranen, Teemu; Ochoa, Juan Eugenio; Ohkubo, Takayoshi; Omboni, Stefano; Padfield, Paul; Palatini, Paolo; Papaioannou, Theodore; Protogerou, Athanasios; Redon, Josep; Verdecchia, Paolo; Wang, Jiguang; Zanchetti, Alberto; Mancia, Giuseppe; O'Brien, Eoin

    2016-09-01

    Office blood pressure measurement has been the basis for hypertension evaluation for almost a century. However, the evaluation of blood pressure out of the office using ambulatory or self-home monitoring is now strongly recommended for the accurate diagnosis in many, if not all, cases with suspected hypertension. Moreover, there is evidence that the variability of blood pressure might offer prognostic information that is independent of the average blood pressure level. Recently, advancement in technology has provided noninvasive evaluation of central (aortic) blood pressure, which might have attributes that are additive to the conventional brachial blood pressure measurement. This position statement, developed by international experts, deals with key research and practical issues in regard to peripheral blood pressure measurement (office, home, and ambulatory), blood pressure variability, and central blood pressure measurement. The objective is to present current achievements, identify gaps in knowledge and issues concerning clinical application, and present relevant research questions and directions to investigators and manufacturers for future research and development (primary goal). PMID:27214089

  9. Green light for liver function monitoring using indocyanine green? An overview of current clinical applications.

    PubMed

    Vos, J J; Wietasch, J K G; Absalom, A R; Hendriks, H G D; Scheeren, T W L

    2014-12-01

    The dye indocyanine green is familiar to anaesthetists, and has been studied for more than half a century for cardiovascular and hepatic function monitoring. It is still, however, not yet in routine clinical use in anaesthesia and critical care, at least in Europe. This review is intended to provide a critical analysis of the available evidence concerning the indications for clinical measurement of indocyanine green elimination as a diagnostic and prognostic tool in two areas: its role in peri-operative liver function monitoring during major hepatic resection and liver transplantation; and its role in critically ill patients on the intensive care unit, where it is used for prediction of mortality, and for assessment of the severity of acute liver failure or that of intra-abdominal hypertension. Although numerous studies have demonstrated that indocyanine green elimination measurements in these patient populations can provide diagnostic or prognostic information to the clinician, 'hard' evidence - i.e. high-quality prospective randomised controlled trials - is lacking, and therefore it is not yet time to give a green light for use of indocyanine green in routine clinical practice.

  10. New oral anticoagulants: clinical indications, monitoring and treatment of acute bleeding complications.

    PubMed

    Fenger-Eriksen, C; Münster, A-M; Grove, E L

    2014-07-01

    New oral anticoagulants like the direct thrombin inhibitor, dabigatran (Pradaxa®), and factor Xa-inhibitors, rivaroxaban (Xarelto®) and apixaban (Eliquis®) are available for prophylaxis and treatment of thromboembolic disease. They are emerging alternatives to warfarin and provide equal or better clinical outcome together with reduced need for routine monitoring. Methods for measuring drug concentrations are available, although a correlation between plasma drug concentrations and the risk of bleeding has not been firmly established. Standard laboratory measures like prothrombin time and activated partial thromboplastin time are not sensitive enough to detect thrombin or factor Xa inhibition provided by new oral anticoagulants. Thus, these standard tests may only be used as a crude estimation of the actual anticoagulation status. Further challenges regarding patients receiving new oral anticoagulants who presents with major bleeding or need for emergency surgery pose a unique problem. No established agents are clinically available to reverse the anticoagulant effect, although preclinical data report prothrombin complex concentrate as more efficient than fresh frozen plasma or other prohaemostatic agents. This review summaries current knowledge on approved new oral anticoagulants and discusses clinical aspects of monitoring, with particular focus on the management of the bleeding patient.

  11. Ambulatory blood pressure monitoring-derived short-term blood pressure variability is increased in Cushing's syndrome.

    PubMed

    Rebellato, Andrea; Grillo, Andrea; Dassie, Francesca; Sonino, Nicoletta; Maffei, Pietro; Martini, Chiara; Paoletta, Agostino; Fabris, Bruno; Carretta, Renzo; Fallo, Francesco

    2014-11-01

    Cushing's syndrome is associated with high cardiovascular morbility and mortality. Blood pressure (BP) variability within a 24-h period is increasingly recognized as an independent predictor of cardiovascular risk. The aim of our study was to investigate the short-term BP variability indices in Cushing's syndrome. Twenty-five patients with Cushing's syndrome (mean age 49 ± 13 years, 4 males; 21 Cushing's disease and 4 adrenal adenoma patients) underwent 24-h ambulatory BP monitoring (ABPM) and evaluation of cardiovascular risk factors. Cushing patients were divided into 8 normotensive (NOR-CUSH) and 17 hypertensive (HYP-CUSH) patients and were compared with 20 normotensive (NOR-CTR) and 20 hypertensive (HYP-CTR) age-, sex-, and BMI-matched control subjects. Short-term BP variability was derived from ABPM and calculated as the following: (1) standard deviation (SD) of 24-h, daytime, and nighttime BP; (2) 24-h weighted SD of BP; and (3) average real variability (ARV), i.e., the average of the absolute differences between consecutive BP measurements over 24 h. In comparison with controls, patients with Cushing's syndrome, either normotensive or hypertensive, had higher 24-h and daytime SD of BP, as well as higher 24-h weighted SD and ARV of BP (P = 0.03 to P < 0.0001). No difference in metabolic parameters was observed between NOR-CTR and NOR-CUSH or between HYP-CTR and HYP-CUSH subgroups. ABPM-derived short-term BP variability is increased in Cushing's syndrome, independent of BP elevation. It may represent an additional cardiovascular risk factor in this disease. The role of excess cortisol in BP variability has to be further clarified.

  12. Phenotypic characterization of X-linked retinoschisis: Clinical, electroretinography, and optical coherence tomography variables

    PubMed Central

    Neriyanuri, Srividya; Dhandayuthapani, Sudha; Arunachalam, Jayamuruga Pandian; Raman, Rajiv

    2016-01-01

    Aims: To study the phenotypic characteristics of X-linked retinoschisis (XLRS) and report the clinical, electroretinogram (ERG), and optical coherence tomography (OCT) variables in Indian eyes. Design: A retrospective study. Materials and Methods: Medical records of 21 patients with retinoschisis who were genetically confirmed to have RS1 mutation were reviewed. The phenotype characterization included the age of onset, best-corrected visual acuity, refractive error, fundus findings, OCT, and ERG. Statistical Analysis Used: Data from both the eyes were used for analysis. A P < 0.05 was set as statistical significance. Data were not normally distributed (P < 0.05, Shapiro wilk); hence, nonparametric tests were used for statistical analysis. Results: All were males whose mean age of presentation was 9 years. Visual acuity was moderately impaired (median 0.6 logMAR, interquartile range: 0.47, 1) in these eyes with a hyperopic refractive error of median +1.75 Ds (interquartile range: +0.50 Ds, +4.25 Ds). About 54.7% of the eyes had both foveal and peripheral schisis, isolated foveal schisis was seen in 28.5% of the eyes, and schisis with retinal detachment was seen in 16.6% of the eyes. The inner nuclear layer was found to be commonly involved in the schisis, followed by outer nuclear and plexiform layers as evident on OCT. On ERG, a- and b-wave amplitudes were significantly reduced in eyes with foveal and peripheral schisis when compared to the eyes with only foveal schisis (P < 0.05). Conclusions: XLRS has phenotypic heterogeneity as evident on OCT, ERG, and clinical findings. PMID:27609164

  13. Bayesian sequential monitoring design for two-arm randomized clinical trials with noncompliance

    PubMed Central

    Shen, Weining; Ning, Jing; Yuan, Ying

    2015-01-01

    In early-phase clinical trials, interim monitoring is commonly conducted based on the estimated intent-to-treat effect, which is subject to bias in the presence of noncompliance. To address this issue, we propose a Bayesian sequential monitoring trial design based on the estimation of the causal effect using a principal stratification approach. The proposed design simultaneously considers efficacy and toxicity outcomes, and utilizes covariates to predict a patient’s potential compliance behavior and identify the causal effects. Based on accumulating data, we continuously update the posterior estimates of the causal treatment effects, and adaptively make the go/no-go decision for the trial. Numerical results show that the proposed method has desirable operating characteristics and addresses the issue of noncompliance. PMID:25756852

  14. Post-Marketing Health Technology Monitoring. The Analysis of an Experience from a Clinical Perspective

    PubMed Central

    Ibargoyen-Roteta, Nora; Cabriada-Nuño, Jose Luis; Gutiérrez-Ibarluzea, Iñaki; Hernández-Ramírez, Vicent; Clofent-Vilaplana, Juan; Domènech-Morral, Eugeni; Ginard-Vicens, Daniel; Oliva-Oliva, Gloria; Queiro-Verdes, Teresa

    2011-01-01

    Introduction: A system for monitoring the use of aphaeresis in the treatment of ulcerative colitis (UC), named system for monitoring aphaeresis in ulcerative colitis (SiMAC), was designed in 2006 in the Basque Country. In the present study, the opinion of the clinicians who participated in SiMAC was evaluated, in order to identify the barriers and gather suggestions that could improve implementation of this kind of system. Methods: A mixed questionnaire was designed, in order to gather clinicians’ assessments of the SiMAC monitoring system. Results: The response rate was 73.9% (17/23). The data from 40.96% (159/388) of patients with UC treated with aphaeresis was recorded. The main reasons for not including the data from all treated patients were a lack of required data or not meeting the study inclusion criteria. Positive aspects of the SiMAC were identified, as the simplicity of data collection and its systematic, multi-center approach. The negative aspects mentioned were the use of a local computer application and the lack of time for health professionals to enter data. Discussion: The use of monitoring systems helps to formalize the introduction of technologies of little-known effectiveness; involve clinicians and medical societies in coming to agreement and obtaining information about the safety, effectiveness or efficiency of new technologies; and provide relevant information to healthcare administrations for making decisions about the introduction of new technologies into healthcare practice. In order for a monitoring system to work, the process must be straightforward. A minimum set of key variables that are easy to collect must be selected, and an effort made to involve a range of stakeholders, especially institutions and scientific societies, to support the work group. PMID:21863141

  15. The effect of clozapine on premature mortality: an assessment of clinical monitoring and other potential confounders.

    PubMed

    Hayes, Richard D; Downs, Johnny; Chang, Chin-Kuo; Jackson, Richard G; Shetty, Hitesh; Broadbent, Matthew; Hotopf, Matthew; Stewart, Robert

    2015-05-01

    Clozapine can cause severe adverse effects yet it is associated with reduced mortality risk. We test the hypothesis this association is due to increased clinical monitoring and investigate risk of premature mortality from natural causes. We identified 14 754 individuals (879 deaths) with serious mental illness (SMI) including schizophrenia, schizoaffective and bipolar disorders aged ≥ 15 years in a large specialist mental healthcare case register linked to national mortality tracing. In this cohort study we modeled the effect of clozapine on mortality over a 5-year period (2007-2011) using Cox regression. Individuals prescribed clozapine had more severe psychopathology and poorer functional status. Many of the exposures associated with clozapine use were themselves risk factors for increased mortality. However, we identified a strong association between being prescribed clozapine and lower mortality which persisted after controlling for a broad range of potential confounders including clinical monitoring and markers of disease severity (adjusted hazard ratio 0.4; 95% CI 0.2-0.7; p = .001). This association remained after restricting the sample to those with a diagnosis of schizophrenia or those taking antipsychotics and after using propensity scores to reduce the impact of confounding by indication. Among individuals with SMI, those prescribed clozapine had a reduced risk of mortality due to both natural and unnatural causes. We found no evidence to indicate that lower mortality associated with clozapine in SMI was due to increased clinical monitoring or confounding factors. This is the first study to report an association between clozapine and reduced risk of mortality from natural causes. PMID:25154620

  16. The Effect of Clozapine on Premature Mortality: An Assessment of Clinical Monitoring and Other Potential Confounders

    PubMed Central

    Hayes, Richard D.; Downs, Johnny; Chang, Chin-Kuo; Jackson, Richard G.; Shetty, Hitesh; Broadbent, Matthew; Hotopf, Matthew; Stewart, Robert

    2015-01-01

    Clozapine can cause severe adverse effects yet it is associated with reduced mortality risk. We test the hypothesis this association is due to increased clinical monitoring and investigate risk of premature mortality from natural causes. We identified 14 754 individuals (879 deaths) with serious mental illness (SMI) including schizophrenia, schizoaffective and bipolar disorders aged ≥ 15 years in a large specialist mental healthcare case register linked to national mortality tracing. In this cohort study we modeled the effect of clozapine on mortality over a 5-year period (2007–2011) using Cox regression. Individuals prescribed clozapine had more severe psychopathology and poorer functional status. Many of the exposures associated with clozapine use were themselves risk factors for increased mortality. However, we identified a strong association between being prescribed clozapine and lower mortality which persisted after controlling for a broad range of potential confounders including clinical monitoring and markers of disease severity (adjusted hazard ratio 0.4; 95% CI 0.2–0.7; p = .001). This association remained after restricting the sample to those with a diagnosis of schizophrenia or those taking antipsychotics and after using propensity scores to reduce the impact of confounding by indication. Among individuals with SMI, those prescribed clozapine had a reduced risk of mortality due to both natural and unnatural causes. We found no evidence to indicate that lower mortality associated with clozapine in SMI was due to increased clinical monitoring or confounding factors. This is the first study to report an association between clozapine and reduced risk of mortality from natural causes. PMID:25154620

  17. A question-based approach to adopting pharmacogenetics to understand risk for clinical variability in pharmacokinetics in early drug development.

    PubMed

    Evers, R; Blanchard, R L; Warner, A W; Cutler, D; Agrawal, N G B; Shaw, P M

    2014-09-01

    Understanding genetic variations that influence pharmacokinetics (PK) in humans is important for optimal clinical use of drugs. Guidances for making decisions on when to conduct pharmacogenetic research during drug development have been proposed by regulatory agencies, but their uniform adoption presents problems due to an inherent lack of flexibility. A questions-based approach (QBA) was developed to enable drug development teams at Merck to iteratively and flexibly evaluate the potential impact of pharmacogenetics (PGx) on clinical pharmacokinetic variability. PMID:25141952

  18. Variability amongst radiographers in the categorization of clinical acceptability for digital trauma radiography

    NASA Astrophysics Data System (ADS)

    Decoster, Robin; Toomey, Rachel; Smits, Dirk; Mol, Harrie; Verhelle, Filip; Butler, Marie-Louise

    2016-03-01

    Introduction: Radiographers evaluate anatomical structures to judge clinical acceptability of a radiograph. Whether a radiograph is deemed acceptable for diagnosis or not depends on the individual decision of the radiographer. Individual decisions cause variation in the accepted image quality. To minimise these variations definitions of acceptability, such as in RadLex, were developed. On which criteria radiographers attribute a RadLex categories to radiographs is unknown. Insight into these criteria helps to further optimise definitions and reduce variability in acceptance between radiographers. Therefore, this work aims the evaluation of the correlation between the RadLex classification and the evaluation of anatomical structures, using a Visual Grading Analysis (VGA) Methods: Four radiographers evaluated the visibility of five anatomical structures of 25 lateral cervical spine radiographs on a secondary class display with a VGA. They judged clinical acceptability of each radiograph using RadLex. Relations between VGAS and RadLex category were analysed with Kendall's Tau correlation and Nagelkerke pseudo-R². Results: The overall VGA score (VGAS) and the RadLex score correlate (rτ= 0.62, p<0.01, R2=0.72) strongly. The observers' evaluation of contrast between bone, air (trachea) and soft tissue has low value in predicting (rτ=0.55, p<0.01, R2=0.03) the RadLex score. The reproduction of spinous processes (rτ=0.67, p<0.01, R2=0.31) and the evaluation of the exposure (rτ=0.65, p<0.01, R2=0.56) have a strong correlation with high predictive value for the RadLex score. Conclusion: RadLex scores and VGAS correlate positively, strongly and significantly. The predictive value of bony structures may support the use of these in the judgement of clinical acceptability. Considerable inter-observer variations in the VGAS within a certain RadLex category, suggest that observers use of observer specific cut

  19. Suitability of modelled and remotely sensed essential climate variables for monitoring Euro-Mediterranean droughts

    NASA Astrophysics Data System (ADS)

    Szczypta, C.; Calvet, J.-C.; Maignan, F.; Dorigo, W.; Baret, F.; Ciais, P.

    2013-11-01

    Two new remotely sensed Leaf Area Index (LAI) and Surface Soil Moisture (SSM) satellite products are compared with two sets of simulations of the ORCHIDEE and ISBA-A-gs land surface models to investigate how recent droughts affected vegetation over the Euro-Mediterranean area. We analyze the interannual variability over the period 1991-2008. The leaf onset and the Length of the vegetation Growing Period (LGP) are derived from the satellite-derived LAI and from the modelled LAI. The LGP values produced by the photosynthesis-driven phenology model of ISBA-A-gs are closer to the satellite-derived LAI LGP than those produced by ORCHIDEE. In the latter, the phenology is based on a growing degree-day model for leaf onset, and on both climatic conditions and leaf life span for senescence. Further, the interannual variability of LAI is better captured by ISBA-A-gs than by ORCHIDEE. The summer 2003 drought case study shows a relatively good agreement of the modelled LAI anomalies with the observations, but the two models underestimate plant regrowth in the autumn. A better representation of the root-zone soil moisture profile could improve the simulations of both models. The satellite-derived SSM is compared with SSM simulations of ISBA-A-gs, only, as ORCHIDEE has no explicit representation of SSM. Overall, the ISBA-A-gs simulations of SSM agree well with the satellite-derived SSM and are used to detect regions where the satellite product could be improved. Finally, a correspondence is found between the interannual variability of detrended SSM and LAI. The predictability of LAI is less pronounced using remote sensing observations than using simulated variables. However, consistent results are found in July for the croplands of Ukraine and southern Russia.

  20. Suitability of modelled and remotely sensed essential climate variables for monitoring Euro-Mediterranean droughts

    NASA Astrophysics Data System (ADS)

    Szczypta, C.; Calvet, J.-C.; Maignan, F.; Dorigo, W.; Baret, F.; Ciais, P.

    2014-05-01

    Two new remotely sensed leaf area index (LAI) and surface soil moisture (SSM) satellite-derived products are compared with two sets of simulations of the ORganizing Carbon and Hydrology In Dynamic EcosystEms (ORCHIDEE) and Interactions between Soil, Biosphere and Atmosphere, CO2-reactive (ISBA-A-gs) land surface models. We analyse the interannual variability over the period 1991-2008. The leaf onset and the length of the vegetation growing period (LGP) are derived from both the satellite-derived LAI and modelled LAI. The LGP values produced by the photosynthesis-driven phenology model of ISBA-A-gs are closer to the satellite-derived LAI and LGP than those produced by ORCHIDEE. In the latter, the phenology is based on a growing degree day model for leaf onset, and on both climatic conditions and leaf life span for senescence. Further, the interannual variability of LAI is better captured by ISBA-A-gs than by ORCHIDEE. In order to investigate how recent droughts affected vegetation over the Euro-Mediterranean area, a case study addressing the summer 2003 drought is presented. It shows a relatively good agreement of the modelled LAI anomalies with the observations, but the two models underestimate plant regrowth in the autumn. A better representation of the root-zone soil moisture profile could improve the simulations of both models. The satellite-derived SSM is compared with SSM simulations of ISBA-A-gs only, as ORCHIDEE has no explicit representation of SSM. Overall, the ISBA-A-gs simulations of SSM agree well with the satellite-derived SSM and are used to detect regions where the satellite-derived product could be improved. Finally, a correspondence is found between the interannual variability of detrended SSM and LAI. The predictability of LAI is less pronounced using remote sensing observations than using simulated variables. However, consistent results are found in July for the croplands of the Ukraine and southern Russia.

  1. Identification of novel TFG mutation in HMSN-P pedigree: Emphasis on variable clinical presentations.

    PubMed

    Khani, Marzieh; Shamshiri, Hosein; Alavi, Afagh; Nafissi, Shahriar; Elahi, Elahe

    2016-10-15

    We aimed to identify the genetic cause of neurological disease in an Iranian pedigree whose manifestations suggested hereditary motor and sensory neuropathy with proximal predominance (HMSN-P). Identification of a p.Gly269Val mutation in TFG, the known HMSN-P causative gene, provided supportive evidence. Subjective, biochemical, electrodiagnostic, and imaging data were compared with previously reported HMSN-P patients, including patients of an earlier described Iranian pedigree. Although notable clinical variability was found, comparable involvement of proximal and distal muscles was observed in both Iranian pedigrees. Interestingly, the same p.Gly269Val mutation was recently reported as cause of Charcot-Marie-Tooth disease type 2 in a Taiwanese pedigree. The likelihood that the two pedigrees with the p.Gly269Val mutation are not affected with different diseases is discussed. Identification of a second Iranian HMSN-P pedigree further confirms that HMSN-P is not confined to the Far East. Furthermore, p.Pro285Leu that has been the only TFG mutation thus far reported in HMSN-P patients is not the only mutation that can cause the disease. It is emphasized HMSN-P is a neuronopathy. PMID:27653917

  2. Identification of novel TFG mutation in HMSN-P pedigree: Emphasis on variable clinical presentations.

    PubMed

    Khani, Marzieh; Shamshiri, Hosein; Alavi, Afagh; Nafissi, Shahriar; Elahi, Elahe

    2016-10-15

    We aimed to identify the genetic cause of neurological disease in an Iranian pedigree whose manifestations suggested hereditary motor and sensory neuropathy with proximal predominance (HMSN-P). Identification of a p.Gly269Val mutation in TFG, the known HMSN-P causative gene, provided supportive evidence. Subjective, biochemical, electrodiagnostic, and imaging data were compared with previously reported HMSN-P patients, including patients of an earlier described Iranian pedigree. Although notable clinical variability was found, comparable involvement of proximal and distal muscles was observed in both Iranian pedigrees. Interestingly, the same p.Gly269Val mutation was recently reported as cause of Charcot-Marie-Tooth disease type 2 in a Taiwanese pedigree. The likelihood that the two pedigrees with the p.Gly269Val mutation are not affected with different diseases is discussed. Identification of a second Iranian HMSN-P pedigree further confirms that HMSN-P is not confined to the Far East. Furthermore, p.Pro285Leu that has been the only TFG mutation thus far reported in HMSN-P patients is not the only mutation that can cause the disease. It is emphasized HMSN-P is a neuronopathy.

  3. Staphylococcus agnetis sp. nov., a coagulase-variable species from bovine subclinical and mild clinical mastitis.

    PubMed

    Taponen, Suvi; Supré, Karlien; Piessens, Veerle; Van Coillie, Els; De Vliegher, Sarne; Koort, Joanna M K

    2012-01-01

    Thirteen Gram-positive-staining coagulase-variable staphylococci were isolated from subclinical and mild clinical mastitic bovine milk (n=12) and a teat apex (n=1). The results of sequence analysis of the 16S rRNA gene and two housekeeping genes, rpoB and tuf, and DNA fingerprinting with amplified fragment length polymorphism (AFLP) analysis showed that the isolates formed a separate branch within the genus Staphylococcus. The phylogenetically most closely related species were Staphylococcus hyicus and Staphylococcus chromogenes. DNA-DNA hybridization with S. hyicus DSM 20459(T) and S. chromogenes DSM 20674(T) confirmed that the isolates belonged to a separate species. The predominant fatty acids were i-C(15:0), ai-C(15:0), i-C(17:0) and C(20:0) and the peptidoglycan type was A3α L-Lys-Gly(5). Based on the results of genotypic and phenotypic analyses, it is proposed that the thirteen isolates represent a novel species, for which the name Staphylococcus agnetis sp. nov. is proposed. Strain 6-4(T) (=DSM 23656(T)=CCUG 59809(T)) is the type strain. PMID:21335502

  4. Computer-based patient monitoring systems. Use in research and clinical practice.

    PubMed

    Zimmet, P; Lang, A; Mazze, R S; Endersbee, R

    1988-01-01

    The use of new technologies, such as computers, in the management of diabetes has changed dramatically over the past decade. The development of the memory-based reflectance meter, telephone modems for the transmission of self-monitored blood glucose, and computer programs to aggregate and analyze data have significantly altered approaches to diabetes care. The clinical application of these systems is just now being evaluated. Initial data suggest that these systems enhance treatment, improve patient performance, assist in collection and representation of accurate and reliable data, and may be associated with improved metabolic control.

  5. ECa-Directed Soil Sampling for Characterizing Spatial Variability: Monitoring Management- Induced Change

    NASA Astrophysics Data System (ADS)

    Corwin, D. L.

    2006-05-01

    Characterizing spatial variability is an important consideration of any landscape-scale soil-related problem. Geospatial measurements of apparent soil electrical conductivity (ECa) are useful for characterizing spatial variability by directing soil sampling. The objective of this presentation is to discuss equipment, protocols, sampling designs, and a case study of an ECa survey to characterize spatial variability. Specifically, a preliminary spatio-temporal study of management-induced changes to soil quality will be demonstrated for a drainage water reuse study site. The spatio-temporal study used electromagnetic induction ECa data and a response surface sampling design to select 40 sites that reflected the spatial variability of soil properties (i.e., salinity, Na levels, Mo, and B) impacting the intended agricultural use of a saline-sodic field in California's San Joaquin Valley. Soil samples were collected in August 1999 and April 2002. Data from 1999 indicate the presence of high salinity, which increased with depth, high sodium adsorption ratio (SAR), which also increased with depth, and moderate to high B and Mo, which showed no specific trends with depth. The application of drainage water for 32 months resulted in leaching of B from the top 0.3 of soil, leaching of salinity from the top 0.6 m of soil, and leaching of Na and Mo from the top 1.2 m of soil. The leaching fraction over the time period from 1999-2002 was estimated to be 0.10. The level of salinity in the reused drainage water (i.e., 3-5 dS/m) allowed infiltration and leaching to occur even though high sodium and high expanding-lattice clay levels posed potential water flow problems. The leaching of salinity, Na, Mo, and B has resulted in increased forage yield and improved quality of those yields. Preliminary spatio-temporal analyses indicate at least short-term feasibility of drainage water reuse from the perspective of soil quality when the goal is forage production for grazing livestock. The

  6. Correlation between genetic variability and virulence factors in clinical strains of Malassezia pachydermatis of animal origin.

    PubMed

    Buommino, Elisabetta; Nocera, Francesca Paola; Parisi, Annamaria; Rizzo, Antonietta; Donnarumma, Giovanna; Mallardo, Karina; Fiorito, Filomena; Baroni, Adone; De Martino, Luisa

    2016-09-01

    Malassezia pachydermatis is a yeast belonging to the microbiota of the skin and mucous membranes of dog and cat, but it can also act as pathogen, causing dermatitis. The aim of this work was to evaluate the genetic variability of M. pachydermatis strains isolated from symptomatic dogs and cats and determine a correlation between genotype and phenotype. For this purpose eleven strains of M. pachydermatis were molecularly classified by nested-polymerase chain reaction (nested-PCR) based on ITS-1 and ITS-2 regions, specific for fungal rRNA genes. Furthermore, random amplification of polymorphic DNA (RAPD) was applied for genetic typing of M. pachydermatis isolates identifying four different genotypes. Strains belonging to genotype 1 produced the highest amount of biofilm and phospholipase activity. The inflammatory response induced by M. pachydermatis strains in immortalized human keratinocytes (HaCat cells) was significantly different when we compared the results obtained from each strain. In particular, HaCat cells infected with the strains belonging to genotypes 1 and 2 triggered the highest levels of increase in TLR-2, IL-1β, IL-6, IL-8, COX-2 and MMP-9 expression. By contrast, cells infected with the strains of genotype 3 and those of genotype 4 did not significantly induce TLR-2 and cytokines. The results obtained might suggest a possible association between genotype and virulence factors expressed by M. pachydermatis strains. This highlights the need for a more accurate identification of the yeast to improve the therapeutic approach and to monitor the onset of human infections caused by this emergent zoonotic pathogen. PMID:27602421

  7. Optic Nerve Sheath Diameter: Translating a Terrestrial Focused Technique into a Clinical Monitoring Tool for Spaceflight

    NASA Technical Reports Server (NTRS)

    Mason, Sara; Foy, Millennia; Sargsyan, Ashot; Garcia, Kathleen; Wear, Mary L.; Bedi, Deepak; Ernst, Randy; Van Baalen, Mary

    2015-01-01

    Ultrasonography is increasingly used to quickly measure optic nerve sheath diameter (ONSD) when increased intracranial pressure (ICP) is suspected. NASA Space and Clinical Operations Division has been using ground and on-orbit ultrasound since 2009 as a proxy for ICP in non-acute monitoring for space medicine purposes. In the terrestrial emergency room population, an ONSD greater than 0.59 cm is considered highly predictive of elevated intracranial pressure. However, this cut-off limit is not applicable to the spaceflight setting since over 50% of US Operating Segment (USOS) astronauts have an ONSD greater than 0.60 cm even before launch. Crew Surgeon clinical decision-making is complicated by the fact that many astronauts have history of previous spaceflights. Our data characterize the distribution of baseline ONSD in the astronaut corps, its longitudinal trends in long-duration spaceflight, and the predictive power of this measure related to increased ICP outcomes.

  8. Predicted Interval Plots (PIPS): A Graphical Tool for Data Monitoring of Clinical Trials

    PubMed Central

    Li, Lingling; Evans, Scott R.; Uno, Hajime; Wei, L.J.

    2011-01-01

    Group sequential designs are often used in clinical trials to evaluate efficacy and/or futility. Many methods have been developed for different types of endpoints and scenarios. However, few of these methods convey information regarding effect sizes (e.g., treatment differences) and none uses prediction to convey information regarding potential effect size estimates and associated precision, with trial continuation. To address these limitations, Evans et al. (2007) proposed to use prediction and predicted intervals as a flexible and practical tool for quantitative monitoring of clinical trials. In this article, we reaffirm the importance and usefulness of this innovative approach and introduce a graphical summary, predicted interval plots (PIPS), to display the information obtained in the prediction process in a straightforward yet comprehensive manner. We outline the construction of PIPS and apply this method in two examples. The results and the interpretations of the PIPS are discussed. PMID:21423789

  9. Of the interest of monitoring complementary parameters to better understand nutrient and pesticides variability in groundwater

    NASA Astrophysics Data System (ADS)

    Gourcy, Laurence; Baran, Nicole

    2014-05-01

    Pesticides and nutrients (as NO3, NO2, NH4) are the parameters degrading most of the groundwater bodies in France. The surveillance-monitoring network described under the Water Framework Directive (2000/60/EC) has for main goal the evaluation of the groundwater chemical status and the assessment of long-term trends in natural conditions and in pollutant concentrations resulting from human activity. The operational monitoring network allows to better assessing the groundwater bodies « at risk ». For management purposes, and particularly to identify the programme of measures needed to reduce the impact of diffuse contaminant on groundwater, the monitoring mentioned under WFD is not sufficient. A better comprehension of water and solute transfer is therefore necessary. Since 2008, high resolution monitoring of nutrient and pesticides in groundwater were performed for a limited period at five sites of various lithological contexts in France. Based on the geological and hydrogeological understanding complementary parameters were selected to be analysed in addition to the main contaminants. In volcanic and mountainous context, Martinique and La Reunion Islands, stable isotopes (δ18O, δ2H) and age dating were analysed as in lowland context, alterites of granite formations in Brittany and sedimentary glacial-fluvial deposits in Rhone-Alpes region, age dating was complementing the analyses of major ions including NO2, NH4 and NO3 and selected pesticides and metabolites. At all studied sites, the pattern of monthly variation of nutrients and dissolved ions is quite different from pesticides time evolution. In the described case studies, apparent age (or CFC and SF6 concentrations) and δ18O and δ2H (and calculated d-excess) are quite stable from one month to another even during intensive rainfall episodes and pesticide concentrations may vary at the same time to a large extend. A seasonal trend is observed for chemical data when water level is significantly changes

  10. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm.

    PubMed

    Bailey, Timothy S; Chang, Anna; Christiansen, Mark

    2015-03-01

    We assessed the performance of a modified Dexcom G4 Platinum system with an advanced algorithm, in comparison with frequent venous samples measured on a laboratory reference (YSI) during a clinic session and in comparison to self-monitored blood glucose (SMBG) during home use. Fifty-one subjects with diabetes were enrolled in a prospective multicenter study. Subjects wore 1 sensor for 7-day use and participated in one 12-hour in-clinic session on day 1, 4, or 7 to collect YSI reference venous glucose every 15 minutes and capillary SMBG test every 30 minutes. Carbohydrate consumption and insulin dosing and timing were manipulated to obtain data in low and high glucose ranges. In comparison with the laboratory reference method (n = 2,263) the system provided a mean and median absolute relative differences (ARD) of 9.0% and 7.0%, respectively. The mean absolute difference for CGM was 6.4 mg/dL when the YSIs were within hypoglycemia ranges (≤ 70 mg/dL). The percentage in the clinically accurate Clarke error grid A zone was 92.4% and in the benign error B zone was 7.1%. Majority of the sensors (73%) had an aggregated MARD in reference to YSI ≤ 10%. The MARD of CGM-SMBG for home use was 11.3%. The study showed that the point and rate accuracy, clinical accuracy, reliability, and consistency over the duration of wear and across glycemic ranges were superior to current commercial real-time CGM systems. The performance of this CGM is reaching that of a self-monitoring blood glucose meter in real use environment. PMID:25370149

  11. Clinical Accuracy of a Continuous Glucose Monitoring System With an Advanced Algorithm

    PubMed Central

    Bailey, Timothy S.; Chang, Anna; Christiansen, Mark

    2014-01-01

    Background: We assessed the performance of a modified Dexcom G4 Platinum system with an advanced algorithm, in comparison with frequent venous samples measured on a laboratory reference (YSI) during a clinic session and in comparison to self-monitored blood glucose (SMBG) during home use. Methods: Fifty-one subjects with diabetes were enrolled in a prospective multicenter study. Subjects wore 1 sensor for 7-day use and participated in one 12-hour in-clinic session on day 1, 4, or 7 to collect YSI reference venous glucose every 15 minutes and capillary SMBG test every 30 minutes. Carbohydrate consumption and insulin dosing and timing were manipulated to obtain data in low and high glucose ranges. Results: In comparison with the laboratory reference method (n = 2,263) the system provided a mean and median absolute relative differences (ARD) of 9.0% and 7.0%, respectively. The mean absolute difference for CGM was 6.4 mg/dL when the YSIs were within hypoglycemia ranges (≤ 70 mg/dL). The percentage in the clinically accurate Clarke error grid A zone was 92.4% and in the benign error B zone was 7.1%. Majority of the sensors (73%) had an aggregated MARD in reference to YSI ≤ 10%. The MARD of CGM-SMBG for home use was 11.3%. Conclusions: The study showed that the point and rate accuracy, clinical accuracy, reliability, and consistency over the duration of wear and across glycemic ranges were superior to current commercial real-time CGM systems. The performance of this CGM is reaching that of a self-monitoring blood glucose meter in real use environment. PMID:25370149

  12. Variability of concentrations of polybrominated diphenyl ethers and polychlorinated biphenyls in air: implications for monitoring, modeling and control

    NASA Astrophysics Data System (ADS)

    Gouin, T.; Harner, T.; Daly, G. L.; Wania, F.; Mackay, D.; Jones, K. C.

    Monitoring data indicate that organic compounds with high octanol-air partition coefficients ( KOA), such as polybrominated diphenyl ethers (PBDEs) and polychlorinated biphenyls (PCBs) exhibit seasonally variable air concentrations, especially during early spring, shortly after snow melt and before bud-burst when levels are elevated. This variability can complicate the interpretation of monitoring data designed to assess year-to-year changes. It is suggested that relatively simple dynamic multimedia mass balance models can assist interpretation by "factoring out" variability attributable to temperature and other seasonal effects as well as identifying likely contaminant sources. To illustrate this approach, high-volume air samples were collected from January to June, 2002 at a rural location in southern Ontario. Gas-phase concentrations for both ΣPBDE and ΣPCB rose from below the detection limit during the winter to 19 and 110 pg m -3, respectively, in early spring, only to decrease again following bud-burst. Passive air samples (PAS), deployed at seven urban, rural and remote sites for two one-month periods prior and following bud-burst, indicate a strong urban-rural gradient for both the PBDEs and PCBs. Calculated air concentrations from the PAS are shown to agree favorably with the high-volume air sampling data, with concentrations ranging 6-85 pg m -3 and 6-360 pg m -3 for ΣPBDE and ΣPCB, respectively. Concentrations in urban areas are typically 5 times greater than in rural locations. These data were interpreted using simulation results from a fate model including a seasonally variable forest canopy and snow pack, suggesting that the primary source is urban and that the "spring pulse" is the result of several interacting factors. Such contaminants are believed to be efficiently deposited in winter, accumulate in the snow pack and are released to terrestrial surfaces upon snow melt in spring. Warmer temperatures cause volatilization and a rise in air

  13. Using Essential Biodiversity Variables (EBVs) As a Framework for Coordination Between Research and Monitoring Networks: A Case Study with Phenology

    NASA Astrophysics Data System (ADS)

    Weltzin, J. F.; Jones, K. D.; Brown, J. F.; Elmendorf, S.; Enquist, C.; Rosemartin, A.; Thorpe, A.; Wee, B.

    2014-12-01

    The United Nations Convention on Biological Diversity (CBD) was organized to encourage countries to take action to address issues of declining biodiversity. In2010, the CBD identified specific goals for 2011-2020 (the "Aichi Targets") and a tiered system of indicators necessary to achieve those targets. Essential biodiversity variables (EBVs) are the standardized measurements and observations at the base of this system; they are the basic level of information that is necessary to calculate these indicators. By providing a list of pre-defined EBVs, existing research and research planned for the future can align measurements to address common questions. We assessed the applicability of phenology EBVs for standardizing measurements across observation networks within the US as a test case for use of the standardized used of EBVs. Phenology products from the USA National Phenology Network, a citizen science observer based program, NEON, a multi-scale ecological observatory, and remotely sensed data from USGS EROS were considered for this purpose. Essential Biodiversity Variables currently defined for phenology are insufficient to support consistent measurement across monitoring networks. Specifically, phenology which is a field of study, is currently listed as a single EBV within the general category of 'species traits'. With the only guidance provided to future observation networks being that of measuring 'phenology,' there would likely be as many approaches to achieving this goal as networks participating. We propose more narrowly defined variables which may be more appropriate for standardization and demonstrate how these measurements satisfy the basic characteristics of an EBV in that they are relevant, sensitive to change, biological and generalizable, scalable, feasible, stable and, represent state variables. We map these variables to the tiered indicators identified by the CBD and, finally, to Aichi Targets to which they contribute. EBVs may be used not only to

  14. Monitoring the variability of active galactic nuclei from a space-based platform

    NASA Technical Reports Server (NTRS)

    Peterson, Bradley M.; Atwood, Bruce; Byard, Paul L.

    1994-01-01

    Detailed monitoring of AGN's with FRESIP can provide well-sampled light curves for a large number of AGN's. Such data are completely unprecedented in this field, and will provide powerful new constraints on the origin of the UV/optical continuum in AGN's. The FRESIP baseline design will allow 1 percent photometry on sources brighter than V approximately equals 19.6 mag, and we estimate that over 300 sources can be studied. We point out that digitization effects will have a significant negative impact on the faint limit and the number of detectable sources will decrease dramatically if a fixed gain setting (estimated to be nominally 25 e(-) per ADU) is used for all read-outs. We note that the primary limitation to studying AGN's is background (sky and read-out noise) rather than source/background contrast with a focused telescope and by longer integrations. While we believe that it may be possible to achieve the AGN-monitoring science goals with a more compact and much less expensive telescope, the proposed FRESIP satellite affords an excellent opportunity to attain the required data at essentially zero cost as a secondary goal of a more complex mission.

  15. A Wearable Patch to Enable Long-Term Monitoring of Environmental, Activity and Hemodynamics Variables.

    PubMed

    Etemadi, Mozziyar; Inan, Omer T; Heller, J Alex; Hersek, Sinan; Klein, Liviu; Roy, Shuvo

    2016-04-01

    We present a low power multi-modal patch designed for measuring activity, altitude (based on high-resolution barometric pressure), a single-lead electrocardiogram, and a tri-axial seismocardiogram (SCG). Enabled by a novel embedded systems design methodology, this patch offers a powerful means of monitoring the physiology for both patients with chronic cardiovascular diseases, and the general population interested in personal health and fitness measures. Specifically, to the best of our knowledge, this patch represents the first demonstration of combined activity, environmental context, and hemodynamics monitoring, all on the same hardware, capable of operating for longer than 48 hours at a time with continuous recording. The three-channels of SCG and one-lead ECG are all sampled at 500 Hz with high signal-to-noise ratio, the pressure sensor is sampled at 10 Hz, and all signals are stored to a microSD card with an average current consumption of less than 2 mA from a 3.7 V coin cell (LIR2450) battery. In addition to electronic characterization, proof-of-concept exercise recovery studies were performed with this patch, suggesting the ability to discriminate between hemodynamic and electrophysiology response to light, moderate, and heavy exercise. PMID:25974943

  16. Standardized principal components for vegetation variability monitoring across space and time

    NASA Astrophysics Data System (ADS)

    Mathew, T. R.; Vohora, V. K.

    2016-08-01

    Vegetation at any given location changes through time and in space. In what quantity it changes, where and when can help us in identifying sources of ecosystem stress, which is very useful for understanding changes in biodiversity and its effect on climate change. Such changes known for a region are important in prioritizing management. The present study considers the dynamics of savanna vegetation in Kruger National Park (KNP) through the use of temporal satellite remote sensing images. Spatial variability of vegetation is a key characteristic of savanna landscapes and its importance to biodiversity has been demonstrated by field-based studies. The data used for the study were sourced from the U.S. Agency for International Development where AVHRR derived Normalized Difference Vegetation Index (NDVI) images available at spatial resolutions of 8 km and at dekadal scales. The study area was extracted from these images for the time-period 1984-2002. Maximum value composites were derived for individual months resulting in an image dataset of 216 NDVI images. Vegetation dynamics across spatio-temporal domains were analyzed using standardized principal components analysis (SPCA) on the NDVI time-series. Each individual image variability in the time-series is considered. The outcome of this study demonstrated promising results - the variability of vegetation change in the area across space and time, and also indicated changes in landscape on 6 individual principal components (PCs) showing differences not only in magnitude, but also in pattern, of different selected eco-zones with constantly changing and evolving ecosystem.

  17. Highly accurate moving object detection in variable bit rate video-based traffic monitoring systems.

    PubMed

    Huang, Shih-Chia; Chen, Bo-Hao

    2013-12-01

    Automated motion detection, which segments moving objects from video streams, is the key technology of intelligent transportation systems for traffic management. Traffic surveillance systems use video communication over real-world networks with limited bandwidth, which frequently suffers because of either network congestion or unstable bandwidth. Evidence supporting these problems abounds in publications about wireless video communication. Thus, to effectively perform the arduous task of motion detection over a network with unstable bandwidth, a process by which bit-rate is allocated to match the available network bandwidth is necessitated. This process is accomplished by the rate control scheme. This paper presents a new motion detection approach that is based on the cerebellar-model-articulation-controller (CMAC) through artificial neural networks to completely and accurately detect moving objects in both high and low bit-rate video streams. The proposed approach is consisted of a probabilistic background generation (PBG) module and a moving object detection (MOD) module. To ensure that the properties of variable bit-rate video streams are accommodated, the proposed PBG module effectively produces a probabilistic background model through an unsupervised learning process over variable bit-rate video streams. Next, the MOD module, which is based on the CMAC network, completely and accurately detects moving objects in both low and high bit-rate video streams by implementing two procedures: 1) a block selection procedure and 2) an object detection procedure. The detection results show that our proposed approach is capable of performing with higher efficacy when compared with the results produced by other state-of-the-art approaches in variable bit-rate video streams over real-world limited bandwidth networks. Both qualitative and quantitative evaluations support this claim; for instance, the proposed approach achieves Similarity and F1 accuracy rates that are 76

  18. Highly accurate moving object detection in variable bit rate video-based traffic monitoring systems.

    PubMed

    Huang, Shih-Chia; Chen, Bo-Hao

    2013-12-01

    Automated motion detection, which segments moving objects from video streams, is the key technology of intelligent transportation systems for traffic management. Traffic surveillance systems use video communication over real-world networks with limited bandwidth, which frequently suffers because of either network congestion or unstable bandwidth. Evidence supporting these problems abounds in publications about wireless video communication. Thus, to effectively perform the arduous task of motion detection over a network with unstable bandwidth, a process by which bit-rate is allocated to match the available network bandwidth is necessitated. This process is accomplished by the rate control scheme. This paper presents a new motion detection approach that is based on the cerebellar-model-articulation-controller (CMAC) through artificial neural networks to completely and accurately detect moving objects in both high and low bit-rate video streams. The proposed approach is consisted of a probabilistic background generation (PBG) module and a moving object detection (MOD) module. To ensure that the properties of variable bit-rate video streams are accommodated, the proposed PBG module effectively produces a probabilistic background model through an unsupervised learning process over variable bit-rate video streams. Next, the MOD module, which is based on the CMAC network, completely and accurately detects moving objects in both low and high bit-rate video streams by implementing two procedures: 1) a block selection procedure and 2) an object detection procedure. The detection results show that our proposed approach is capable of performing with higher efficacy when compared with the results produced by other state-of-the-art approaches in variable bit-rate video streams over real-world limited bandwidth networks. Both qualitative and quantitative evaluations support this claim; for instance, the proposed approach achieves Similarity and F1 accuracy rates that are 76

  19. Clinical Use of Anti-Xa Monitoring in Malignancy-Associated Thrombosis.

    PubMed

    Yentz, Sarah; Onwuemene, Oluwatoyosi A; Stein, Brady L; Cull, Elizabeth H; McMahon, Brandon

    2015-01-01

    Introduction. Low molecular weight heparin (LMWH) is preferred for malignancy-associated venous thromboembolism (VTE). Many providers monitor LMWH with anti-Xa levels, despite little validation on correspondence with patient outcome. Methods. This is a retrospective, single institution study of anti-Xa measurement in malignancy-associated thrombosis. Cases were identified using the Electronic Data Warehouse, and inclusion was confirmed by two independent reviewers. Malignancy type, thrombotic history, measurement rationale and accuracy, clinical context, and management changes were evaluated. Results. 167 cases met inclusion criteria. There was no clear rationale for anti-Xa testing in 56%. Impaired renal function (10%), documented or suspected recurrent thrombosis despite anticoagulation (9%), and bleeding (6%) were the most common reasons for testing. Incorrect measurement occurred in 44%. Renal impairment was not a significant impetus for testing, as 70% had a GFR > 60. BMI > 30 was present in 40%, and 28% had a BMI < 25. Clinical impact was low, as only 11% of patients had management changes. Conclusions. Provider education in accuracy and rationale for anti-Xa testing is needed. Our study illustrates uncertainty of interpretation and clinical impact of routine anti-Xa testing, as management was affected in few patients. It is not yet clear in which clinical context providers should send anti-Xa levels. PMID:26543644

  20. Clinical Use of Anti-Xa Monitoring in Malignancy-Associated Thrombosis

    PubMed Central

    Yentz, Sarah; Onwuemene, Oluwatoyosi A.; Stein, Brady L.; Cull, Elizabeth H.; McMahon, Brandon

    2015-01-01

    Introduction. Low molecular weight heparin (LMWH) is preferred for malignancy-associated venous thromboembolism (VTE). Many providers monitor LMWH with anti-Xa levels, despite little validation on correspondence with patient outcome. Methods. This is a retrospective, single institution study of anti-Xa measurement in malignancy-associated thrombosis. Cases were identified using the Electronic Data Warehouse, and inclusion was confirmed by two independent reviewers. Malignancy type, thrombotic history, measurement rationale and accuracy, clinical context, and management changes were evaluated. Results. 167 cases met inclusion criteria. There was no clear rationale for anti-Xa testing in 56%. Impaired renal function (10%), documented or suspected recurrent thrombosis despite anticoagulation (9%), and bleeding (6%) were the most common reasons for testing. Incorrect measurement occurred in 44%. Renal impairment was not a significant impetus for testing, as 70% had a GFR > 60. BMI > 30 was present in 40%, and 28% had a BMI < 25. Clinical impact was low, as only 11% of patients had management changes. Conclusions. Provider education in accuracy and rationale for anti-Xa testing is needed. Our study illustrates uncertainty of interpretation and clinical impact of routine anti-Xa testing, as management was affected in few patients. It is not yet clear in which clinical context providers should send anti-Xa levels. PMID:26543644

  1. Future clinical uses of neurophysiological biomarkers to predict and monitor treatment response for schizophrenia.

    PubMed

    Light, Gregory A; Swerdlow, Neal R

    2015-05-01

    Advances in psychiatric neuroscience have transformed our understanding of impaired and spared brain functions in psychotic illnesses. Despite substantial progress, few (if any) laboratory tests have graduated to clinics to inform diagnoses, guide treatments, and monitor treatment response. Providers must rely on careful behavioral observation and interview techniques to make inferences about patients' inner experiences and then secondary deductions about impacted neural systems. Development of more effective treatments has also been hindered by a lack of translational quantitative biomarkers that can span the brain-behavior treatment knowledge gap. Here, we describe an example of a simple, low-cost, and translatable electroencephalography (EEG) measure that offers promise for improving our understanding and treatment of psychotic illnesses: mismatch negativity (MMN). MMN is sensitive to and/or predicts response to some pharmacologic and nonpharmacologic interventions and accounts for substantial portions of variance in clinical, cognitive, and psychosocial functioning in schizophrenia (SZ). This measure has recently been validated for use in large-scale multisite clinical studies of SZ. Finally, MMN greatly improves our ability to forecast which individuals at high clinical risk actually develop a psychotic illness. These attributes suggest that MMN can contribute to personalized biomarker-guided treatment strategies aimed at ameliorating or even preventing the onset of psychosis. PMID:25752648

  2. Correlation of delta high-resolution computed tomography (HRCT) score with delta clinical variables in early systemic sclerosis (SSc) patients

    PubMed Central

    Euathrongchit, Juntima; Wattanawittawas, Pittaporn; Kasitanon, Nuntana

    2016-01-01

    Background The correlation of changes (delta: Δ) of high-resolution computed tomography (HRCT) score with the Δ of other clinical variables has not been well studied. The purpose of this study was to determine the correlation of Δ HRCT score with Δ percent predicted forced vital capacity (%pFVC), Δ modified Rodnan Skin Score (mRSS), Δ erythrocyte sedimentation rate (ESR), and Δ percent of oxygen saturation at room air (%SpO2) in patients with early systemic sclerosis (SSc). Methods We used an inception cohort of early-SSc patients seen at the Rheumatology Clinic, Chiang Mai University, Thailand, between January 2010 and June 2014. All patients underwent HRCT at study entry and every 12 months thereafter. Thirty-one SSc patients who underwent pulmonary function test (PFT) within 12 weeks of their corresponding HRCT at baseline and last visit were identified. The extent of ground glass (GG), lung fibrosis (Fib), bronchiectasis (B), and honeycombing (HC) was scored, and then aggregated to produce a total (t) HRCT score. Results Mean ± SD age and disease duration from non-Raynaud’s phenomenon (NRP) to undergo HRCT at baseline were 52.2±8.8 years and 11.7±7.1 months, respectively. Seventeen (54.8%) patients were female and 20 (64.5%) were classified as dcSSc. The mean ± SD interval between the two HRCT tests was 16.0±7.2 months. The Δ HRCT scores [total fibrosis scores (t-Fib), total bronchiectasis scores (t-B), and total HRCT score (t-HRCT) scores] and Δ mRSS, but not Δ %pFVC, showed significant change over the observation period. We found significant correlation of Δ total honeycombing scores (t-HC) with Δ ESR (r=−0.44, P<0.05), and Δ t-Fib with Δ %SpO2 (r=−0.38, P<0.05). However, no significant correlation of any Δ HRCT scores with Δ %pFVC and Δ mRSS were observed. Conclusions In this study, the changes in the HRCT scores were greater than %pFVC; this, along with their correlations with the changes in ESR and %SpO2, suggest that HRCT

  3. On the use of ultrasonic fatigue testing technique--variable amplitude loadings and crack growth monitoring.

    PubMed

    Müller, T; Sander, M

    2013-12-01

    In the very high cycle fatigue regime high-frequency testing techniques are required. Using the ultrasonic fatigue technique, testing time could be reduced significantly in comparison to conventional servo-hydraulic machines. An ultrasonic fatigue testing system developed by the BOKU Vienna with load frequencies of about 20kHz is used for variable amplitude loading investigations in the VHCF regime. Therefore, the amplitude level during fatigue tests is controlled by a PC using an own developed software. Additionally, an in situ reconstruction of a damage equivalent load spectrum based on a load time history is introduced schematically. To optimize the experimental procedure a temperature-controlled pulse-pause adaption has been developed and implemented into the software. For quantifying the influence of variable amplitude loadings on the fatigue life, e.g. load interaction effects, the crack growth is measured by using the potential drop technique that is adapted to the ultrasonic fatigue testing system. Finally, the results of two-step-block loading tests are presented. PMID:23597637

  4. Clinical expert panel on monitoring potential lung toxicity of inhaled oligonucleotides: consensus points and recommendations.

    PubMed

    Alton, Eric W; Boushey, Homer A; Garn, Holger; Green, Francis H; Hodges, Michael; Martin, Richard J; Murdoch, Robert D; Renz, Harald; Shrewsbury, Stephen B; Seguin, Rosanne; Johnson, Graham; Parry, Joel D; Tepper, Jeff; Renzi, Paolo; Cavagnaro, Joy; Ferrari, Nicolay

    2012-08-01

    Oligonucleotides (ONs) are an emerging class of drugs being developed for the treatment of a wide variety of diseases including the treatment of respiratory diseases by the inhalation route. As a class, their toxicity on human lungs has not been fully characterized, and predictive toxicity biomarkers have not been identified. To that end, identification of sensitive methods and biomarkers that can detect toxicity in humans before any long term and/or irreversible side effects occur would be helpful. In light of the public's greater interests, the Inhalation Subcommittee of the Oligonucleotide Safety Working Group (OSWG) held expert panel discussions focusing on the potential toxicity of inhaled ONs and assessing the strengths and weaknesses of different monitoring techniques for use during the clinical evaluation of inhaled ON candidates. This white paper summarizes the key discussions and captures the panelists' perspectives and recommendations which, we propose, could be used as a framework to guide both industry and regulatory scientists in future clinical research to characterize and monitor the short and long term lung response to inhaled ONs.

  5. An approach to 'dynamic--DDD (defined daily dose) monitoring' to reduce adverse clinical outcomes and increase patient safety: information repositories and event triggers in clinical practice.

    PubMed

    Eryilmaz, Esat N

    2011-01-01

    The goal of every effort and actions/interventions in almost all healthcare settings throughout the world's health systems -primary care, inpatient, outpatient encounters, diagnostic and therapeutic interventions, peri-operative settings- is and has been to achieve a well defined outcome (a kind of improvement in health status of the patient under consideration, an observable and significant change(s) in selected set(s) of clinical parameters confirmed by laboratory results and pathology findings, improvements in clinical outcomes). Clinical inefficiencies, in this context, should be addressed very systematically and scientifically. This is achieved through a continuously monitoring approach to adverse drug events based on information repositories and evidence-based rule sets. For monitoring drug-related outcomes and clinical outcomes in general, the concept of DDD (Defined Daily Dose) compliance is explained in this article to eliminate and avoid adverse clinical outcomes.

  6. Noninvasive cerebral blood oxygenation monitoring: clinical test of multiwavelength optoacoustic system

    NASA Astrophysics Data System (ADS)

    Petrov, Y. Y.; Prough, D. S.; Petrova, I.; Patrikeev, I. A.; Cicenaite, I.; Esenaliev, R. O.

    2007-02-01

    Continuous monitoring of cerebral blood oxygenation is critically important for treatment of patients with life-threatening conditions like severe brain injury or during cardiac surgery. We designed and built a novel multiwavelength optoacoustic system for noninvasive, continuous, and accurate monitoring of cerebral blood oxygenation. We use an Optical Parametric Oscillator as a light source. We successfully tested the system in vitro as well as in vivo in large animals (sheep) through thick tissues overlying blood vessels which drain venous blood out of the brain (e.g., superior sagittal sinus or jugular vein). Here we present the results of clinical tests of the system for continuous noninvasive cerebral blood oxygenation monitoring in the internal jugular vein of healthy volunteers. We applied our custom-built optoacoustic probe (which incorporated a wide-band acoustic transducer and an optical fiber) to the neck area overlying the internal jugular vein. We performed measurements with volunteers at 18 wavelengths in the near-infrared spectral range. Despite a thick layer of overlying connective tissue and low energy used in the experiments, we recorded signals with high signal-to-noise ratios for all volunteers. We found that the temporal (independent of signal amplitude) parameters of recorded profiles for different levels of blood oxygenation correlated well with the spectrum of effective attenuation coefficients of blood.

  7. Use of Continuous Electronic Fetal Monitoring in a Preterm Fetus: Clinical Dilemmas and Recommendations for Practice

    PubMed Central

    Afors, Karolina; Chandraharan, Edwin

    2011-01-01

    The aim of intrapartum continuous electronic fetal monitoring using a cardiotocograph (CTG) is to identify a fetus exposed to intrapartum hypoxic insults so that timely and appropriate action could be instituted to improve perinatal outcome. Features observed on a CTG trace reflect the functioning of somatic and autonomic nervous systems and the fetal response to hypoxic or mechanical insults during labour. Although, National Guidelines on electronic fetal monitoring exist for term fetuses, there is paucity of recommendations based on scientific evidence for monitoring preterm fetuses during labour. Lack of evidence-based recommendations may pose a clinical dilemma as preterm births account for nearly 8% (1 in 13) live births in England and Wales. 93% of these preterm births occur after 28 weeks, 6% between 22–27 weeks, and 1% before 22 weeks. Physiological control of fetal heart rate and the resultant features observed on the CTG trace differs in the preterm fetus as compared to a fetus at term making interpretation difficult. This review describes the features of normal fetal heart rate patterns at different gestations and the physiological responses of a preterm fetus compared to a fetus at term. We have proposed an algorithm “ACUTE” to aid management. PMID:21922045

  8. National Variability in Intracranial Pressure Monitoring and Craniotomy for Children With Moderate to Severe Traumatic Brain Injury

    PubMed Central

    Van Cleve, William; Kernic, Mary A.; Ellenbogen, Richard G.; Wang, Jin; Zatzick, Douglas F.; Bell, Michael J.; Wainwright, Mark S.; Groner, Jonathan I.; Mink, Richard B.; Giza, Christopher C.; Boyle, Linda Ng; Mitchell, Pamela H.; Rivara, Frederick P.; Vavilala, Monica S.

    2014-01-01

    BACKGROUND Traumatic brain injury (TBI) is a significant cause of mortality and disability in children. Intracranial pressure monitoring (ICPM) and craniotomy/craniectomy (CRANI) may affect outcomes. Sources of variability in the use of these interventions remain incompletely understood. OBJECTIVE To analyze sources of variability in the use of ICPM and CRANI. METHODS Retrospective cross-sectional study of patients with moderate/severe pediatric TBI with the use of data submitted to the American College of Surgeons National Trauma Databank. RESULTS We analyzed data from 7140 children at 156 US hospitals during 7 continuous years. Of the children, 27.4% had ICPM, whereas 11.7% had a CRANI. Infants had lower rates of ICPM and CRANI than older children. A lower rate of ICPM was observed among children hospitalized at combined pediatric/adult trauma centers than among children treated at adult-only trauma centers (relative risk = 0.80; 95% confidence interval 0.66-0.97). For ICPM and CRANI, 18.5% and 11.6%, respectively, of residual model variance was explained by between-hospital variation in care delivery, but almost no correlation was observed between within-hospital tendency toward performing these procedures. CONCLUSION Infants received less ICPM than older children, and children hospitalized at pediatric trauma centers received less ICPM than children at adult-only trauma centers. In addition, significant between-hospital variability existed in the delivery of ICPM and CRANI to children with moderate-severe TBI. PMID:23863766

  9. Chronotypes in patients with nonseasonal depressive disorder: Distribution, stability and association with clinical variables.

    PubMed

    Müller, Matthias Johannes; Cabanel, Nicole; Olschinski, Christiane; Jochim, Dorothee; Kundermann, Bernd

    2015-01-01

    The individual's chronotype is regarded as rather stable trait with substantial heritability and normal distribution of the "morningness-eveningness" dimension in the general population. Eveningness has been related to the risk of developing affective, particularly depressive, disorders. However, age and other sociobiological factors may influence chronotypes. The present study investigated the distribution, stability, and clinical correlates of chronotype and morningness-eveningness in hospitalized patients with affective disorder. Chronotype was assessed with the morningness-eveningness questionnaire (MEQ) in 93 patients with nonseasonal depressive syndrome (85% major depression; 15% depressive adjustment disorder) after admission, and in 19 patients again before discharge. Distribution, stability and correlations of MEQ scores with clinical variables were calculated. Additionally, a literature analysis of chronotype distributions in samples of nondepressed persons and patients with nonseasonal depression was carried out. MEQ scores (mean 49 ± 11, range 23-75, higher scores indicate morningness) in 93 acutely depressed inpatients (age 41 ± 14 years, range 18-75 years; 63% women; hospitalization 48 ± 22 days; BDI-II 32 ± 11) were normally distributed (Shapiro-Wilk test; W = 0.993, p = 0.920) with 59.1% intermediate types, 19.4% evening types, and 21.5% morning types. MEQ change scores from admission to discharge were nonsignificant (-1.3 ± 5.0; paired t-test, t18 = -1.09; p = 0.29) despite significantly improved depression scores (-19.4 ± 7.6; paired t-test, t18 = 11.2, p < 0.001). Age (r = 0.24), and depression scores (r = -0.21) correlated significantly (p < 0.05) with MEQ scores; associations with sex and hospitalization duration were nonsignificant. The present study and literature findings revealed that the frequency of evening types is not clearly elevated in depression, but morning types are

  10. Effects of CD4 monitoring frequency on clinical endpoints in clinically stable HIV-infected patients with viral suppression

    PubMed Central

    Ahn, Jin Young; Boettiger, David; Law, Matthew; Kumarasamy, Nagalingeswaran; Yunihastuti, Evy; Chaiwarith, Romanee; Lee, Man Po; Sim, Benedict LH; Oka, Shinichi; Wong, Wingwai; Kamarulzaman, Adeeba; Kantipong, Pacharee; Phanuphak, Praphan; Ng, Oon Tek; Kiertiburanakul, Sasisopin; Zhang, Fujie; Pujari, Sanjay; Ditangco, Rossana; Ratanasuwan, Winai; Merati, Tuti Parwati; Saphonn, Vonthanak; Sohn, Annette H.; Choi, Jun Yong

    2015-01-01

    Background Current treatment guidelines for HIV infection recommend routine CD4+ lymphocyte (CD4) count monitoring in patients with viral suppression. This may have a limited impact on influencing care as clinically meaningful CD4 decline rarely occurs during viral suppression. Methods In a regional HIV observational cohort in the Asia-Pacific, patients with viral suppression (2 consecutive viral loads <400 copies/mL) and a CD4 count ≥200 cells/μL who had CD4 testing 6 monthly were analyzed. Main study endpoints were occurrence of one CD4 count <200 cells/μL (single CD4<200) and two CD4 counts <200 cells/μL within a 6-month period (confirmed CD4<200). A comparison of time to single and confirmed CD4<200 with biannual or annual CD4 assessment was performed by generating a hypothetical group comprised of the same patients with annual CD4 testing by removing every second CD4 count. Results Among 1538 patients, the rate of single CD4<200 was 3.45/100 patient-years, and of confirmed CD4<200 was 0.77/100 patient-years. During 5 years of viral suppression, patients with baseline CD4 200-249 cells/μL were significantly more likely to experience confirmed CD4<200 compared with patients with higher baseline CD4 (hazard ratio 55.47 [95% confidence interval 7.36–418.20], p<0.001 versus baseline CD4 ≥500 cells/μL). Cumulative probabilities of confirmed CD4<200 was also higher in patients with baseline CD4 200-249 cells/μL compared with patients with higher baseline CD4. There was no significant difference in time to confirmed CD4<200 between biannual and annual CD4 measurement (p=0.336). Conclusions Annual CD4 monitoring in virally suppressed HIV patients with a baseline CD4 ≥250 cells/μL may be sufficient for clinical management. PMID:25850606

  11. Multiwaveband Monitoring of the Bright, Violently Variable Quasar 3C454.3

    NASA Technical Reports Server (NTRS)

    Marscher, Alan P.

    1997-01-01

    The RXTE (Rossi X Ray Timing Explorer) data of the quasar 3C 454.3 were analyzed by the PI (Principle Investigator) and his graduate students. The resulting light curve is shown. Substantial variations are seen. These, however, are not correlated with variations at either optical or radio wavelengths. For this reason, the PI decided that more observations were needed and that the project should be continued. These observations have taken place or are scheduled for Cycles 2 and 3 of RXTE. Because the project is continuing, no publications have yet resulted. The PI plans to submit a paper to the Astrophysical Journal at the conclusion of the multi-year monitoring project.

  12. Anti Xa monitoring during treatment with low molecular weight heparin or danaparoid: inter-assay variability.

    PubMed

    Kitchen, S; Iampietro, R; Woolley, A M; Preston, F E

    1999-10-01

    If laboratory monitoring of low molecular weight heparin (LMWH) therapy is required the test of choice is the anti Xa activity assay. The relationship between anti Xa results obtained using different techniques is unknown. The aim of the present study was to compare anti Xa results obtained with eight different commercially available anti Xa activity assays (five chromogenic and three clotting based assays) in samples from patients receiving either therapeutic or prophylactic LMWH (enoxaparin or dalteparin) or danaparoid. We have demonstrated that highly significant differences exist between results obtained using different techniques. The mean anti Xa activity in patients receiving treatment or prophylaxis with enoxaparin ranged from 0.28 to 0.64 iu/ml. A similar relationship was present in samples from patients treated with dalteparin, mean anti Xa results ranging from 0.43 to 0.69 iu/ml. The Heptest clotting assay as used here in combination with the Automated Coagulation Laboratory instrument, was associated with lower results than other clotting or chromogenic techniques. In patients receiving danaparoid for heparin induced thrombocytopaenia (HIT) mean results with three clotting based assays were 0.30 to 0.36 u/ml, compared to mean results of 0.47 to 0.65 u/ml for chromogenic assays. Our data clearly indicate that the selection of anti Xa assay method could influence patient management since the dose required to achieve the therapeutic range would differ according to the assay employed. This is particularly important since the frequency of haemorrhagic side effects has been shown by others to be dose dependent, irrespective of the concomitant anti Xa activity results. In danaparoid therapy the clotting assays studied here should not be employed for monitoring without a modified target range, unless it can be demonstrated that the higher doses required to achieve the therapeutic range are safe. PMID:10544915

  13. Variability in colony attendance of crevice-nesting horned puffins: Implications for population monitoring

    USGS Publications Warehouse

    Harding, A.M.A.; Piatt, J.F.; Byrd, G.V.; Hatch, Shyla A.; Konyukhov, N.B.; Golubova, E.U.; Williams, J.C.

    2005-01-01

    It is difficult to survey crevice-nesting seabirds because nest-sites are hard to identify and count, and the number of adult birds attending a colony can be extremely variable within and between days. There is no standardized method for surveying crevice-nesting horned puffins (Fratercula corniculata), and consequently little is known about abundance or changes in their numbers. We examined the variability in colony attendance of horned puffins at 5 breeding colonies in the North Pacific to assess whether variation in count data can be reduced to a level that would allow us to detect changes in the number of birds attending a colony. We used within-year measures of variation in attendance to examine the power to detect a change in numbers between 2 years, and we used measures of among-year variation to examine the power to detect trends over multiple years. Diurnal patterns of attendance differed among colonies, and among-day variation in attendance was generally lowest from mid- to late-incubation to early chick rearing. Within-year variation in water counts was lower than in land counts, and variation was lower using a daily index based on 5 counts per day than it was using 1 count per day. Measures of among-year variation in attendance also were higher for land-based than water-based counts, and they were higher when we used a 10-day survey period than when we used a 30-day period. The use of either 1 or 5 counts a day during the colony-specific diurnal peak of attendance had little influence on levels of among-year variation. Overall, our study suggests that variation in count data may be reduced to a level that allows detection of trends in numbers. However, more studies of interannual variability in horned puffin attendance are needed. Further, the relationship between count data and breeding population size needs more study before the number of birds present at the colony can be used with confidence as an index of population trend.

  14. Epidemiological Profile of Facial Fractures and Their Relationship With Clinical-Epidemiological Variables.

    PubMed

    de Lucena, Amanda Lira Rufino; da Silva Filho, Gabriel Freire; de Almeida Pinto Sarmento, Tássia Cristina; de Carvalho, Sérgio Henrique Gonçalves; Fonseca, Fátima Roneiva Alves; de Santana Sarmento, Dmitry José

    2016-03-01

    The objective of this study was to identify the epidemiological profile of facial fractures and to associate with clinical-epidemiological variables. An epidemiological survey was conducted in which data retrieved from the records of patients with facial fractures were analyzed. Pearson χ(2) test, Student t-test, one-way analysis of variance, Bonferroni post-hoc test, and logistic regression were used for statistical analysis, adopting a level of significance of 5%. The sample consisted of 718 patients ranging in age from 21 to 30 years (56.4%), including 480 (66.9%) men. Traffic accidents were the main etiological agent (62.7%) and the nasal bones were the most affected (41.8%). An association was observed between age and etiology (P < 0.001), fractured bone (P < 0.001), type of treatment (P < 0.001), hospital length of stay (P < 0.001), and complications (P = 0.001). Patients with traffic accident [odds ratio (OR) = 3.08, P < 0.001] and fall (OR = 2.50, P = 0.049) as etiology had more risk of complications. The type of fractured bone was associated with etiology (P < 0.001), type of treatment (P < 0.001), hospital length of stay (P < 0.001), and complications (maxilla--OR = 1.90, P = 0.004). In conclusion, facial fractures predominantly affect men aged 21 to 30 years. Traffic accidents are the main etiology and the nasal bone is the site most affected. It was observed that the older the patient, the greater the susceptibility to falls, surgical treatment, hospital stay, and complications. Patients with maxillary or mandibular fractures remain hospitalized for longer periods of time. Fractures by traffic accident and fall had more risk of complications. The risk of complications was also higher in patients with maxilla fracture. PMID:26967072

  15. Yoga for Heart Rate Variability: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

    PubMed

    Posadzki, Paul; Kuzdzal, Adrian; Lee, Myeong Soo; Ernst, Edzard

    2015-09-01

    The objective of this systematic review is to summarize and critically assess the effects of yoga on heart rate variability (HRV). Nine databases were searched from their inceptions to June 2014. We included randomized clinical trials (RCTs) comparing yoga against any type of control intervention in healthy individuals or patients with any medical condition. Risk of bias was assessed using the Cochrane criteria. Two reviewers performed the selection of studies, data extraction, and quality assessments independent of one another. Fourteen trials met the inclusion criteria. Only two of them were of acceptable methodological quality. Ten RCTs reported favourable effects of yoga on various domains of HRV, whereas nine of them failed to do so. One RCT did not report between-group comparisons. The meta-analysis (MA) of two trials did not show favourable effects of yoga compared to usual care on E:I ratio (n = 61, SMDs = 0.63; 95% CIs [-0.72 to 1.99], p = 0.36; heterogeneity: r(2) = 0.79, χ(2) = 5.48, df = 1, (p = 0.02); I(2) = 82%). The MA also failed to show statistically significant differences between the groups regarding the 30:15 ratio (n = 61, SMDs = 0.20; 95% CIs [-0.43 to 0.84], p = 0.53; heterogeneity: r(2) = 0.07, χ(2) = 1.45, df = 1, (p = 0.23); I(2) = 31%). The data from the remaining RCTs were too heterogeneous for pooling. These results provide no convincing evidence for the effectiveness of yoga in modulating HRV in patients or healthy subjects. Future investigations in this area should overcome the multiple methodological weaknesses of the previous research.

  16. Instantaneous monitoring of sleep fragmentation by point process heart rate variability and respiratory dynamics.

    PubMed

    Citi, Luca; Bianchi, Matt T; Klerman, Elizabeth B; Barbieri, Riccardo

    2011-01-01

    We present a novel, automatic point-process approach that is able to provide continuous, instantaneous estimates of heart rate variability (HRV) and respiratory sinus arrhythmia (RSA) in long duration data recordings such as those during an entire night of sleep. We analyze subjects with and without sleep apnea who underwent diagnostic polysomnography. The proposed algorithm is able to quantify multi-scale high time resolution autonomic signatures of sleep fragmentation, such as arousals and stage transitions, throughout an entire night. Results demonstrate the ability of our methods to track fast dynamic transitions from sleep to wake and between REM sleep and other sleep stages, providing resolution details not available in sleep scoring summaries. An automatic threshold-based procedure is further able to detect brief arousals, with the instantaneous indices characterizing specific arousal dynamic signatures.

  17. Review of information and communication technology devices for monitoring functional and cognitive decline in Alzheimer's disease clinical trials.

    PubMed

    Pillai, Jagan A; Bonner-Jackson, Aaron

    2015-01-01

    Detecting and monitoring early cognitive impairment in Alzheimer's disease (AD) is a significant need in the field of AD therapeutics. Successful AD clinical trial designs have to overcome challenges related to the subtle nature of early cognitive changes. Continuous unobtrusive assessments using Information and Communication Technology (ICT) devices to capture markers of intra-individual change over time to assess cognitive and functional disability therefore offers significant benefits. We review the literature and provide an overview on randomized clinical trials in AD that use intelligent systems to monitor functional decline, as well as strengths, weaknesses, and future directions for the use of ICTs in a new generation of AD clinical trials. PMID:25708378

  18. Bioluminescence-based neuraminidase inhibition assay for monitoring influenza virus drug susceptibility in clinical specimens.

    PubMed

    Marjuki, Henju; Mishin, Vasiliy P; Sleeman, Katrina; Okomo-Adhiambo, Margaret; Sheu, Tiffany G; Guo, Lizheng; Xu, Xiyan; Gubareva, Larisa V

    2013-11-01

    The QFlu prototype bioluminescence-based neuraminidase (NA) inhibition (NI) assay kit was designed to detect NA inhibitor (NAI)-resistant influenza viruses at point of care. Here, we evaluated its suitability for drug susceptibility assessment at a surveillance laboratory. A comprehensive panel of reference viruses (n = 14) and a set of 90 seasonal influenza virus A and B isolates were included for testing with oseltamivir and/or zanamivir in the QFlu assay using the manufacturer-recommended protocol and a modified version attuned to surveillance requirements. The 50% inhibitory concentrations (IC50s) generated were compared with those of NI assays currently used for monitoring influenza drug susceptibility, the fluorescent (FL) and chemiluminescent (CL) assays. To provide proof of principle, clinical specimens (n = 235) confirmed by real-time reverse transcription (RT)-PCR to contain influenza virus A(H1N1)pdm09 and prescreened for the oseltamivir resistance marker H275Y using pyrosequencing were subsequently tested in the QFlu assay. All three NI assays were able to discriminate the reference NA variants and their matching wild-type viruses based on the difference in their IC50s. Unless the antigenic types were first identified, certain NA variants (e.g., H3N2 with E119V) could be detected among seasonal viruses using the FL assays only. Notably, the QFlu assay identified oseltamivir-resistant A(H1N1)pdm09 viruses carrying the H275Y marker directly in clinical specimens, which is not feasible with the other two phenotypic assays, which required prior virus culturing in cells. Furthermore, The QFlu assay allows detection of the influenza virus A and B isolates carrying established and potential NA inhibitor resistance markers and may become a useful tool for monitoring drug resistance in clinical specimens. PMID:23917311

  19. VERITAS 2008-2009 MONITORING OF THE VARIABLE GAMMA-RAY SOURCE M 87

    SciTech Connect

    Acciari, V. A.; Benbow, W.; Aliu, E.; Arlen, T.; Chow, Y. C.; Aune, T.; Beilicke, M.; Buckley, J. H.; Bugaev, V.; Dickherber, R.; Boltuch, D.; Bradbury, S. M.; Byrum, K.; Cannon, A.; Cesarini, A.; Ciupik, L.; Cogan, P.; Cui, W.; Finley, J. P.; Duke, C.

    2010-06-10

    M 87 is a nearby radio galaxy that is detected at energies ranging from radio to very high energy (VHE) gamma rays. Its proximity and its jet, misaligned from our line of sight, enable detailed morphological studies and extensive modeling at radio, optical, and X-ray energies. Flaring activity was observed at all energies, and multi-wavelength correlations would help clarify the origin of the VHE emission. In this paper, we describe a detailed temporal and spectral analysis of the VERITAS VHE gamma-ray observations of M 87 in 2008 and 2009. In the 2008 observing season, VERITAS detected an excess with a statistical significance of 7.2 standard deviations ({sigma}) from M 87 during a joint multi-wavelength monitoring campaign conducted by three major VHE experiments along with the Chandra X-ray Observatory. In 2008 February, VERITAS observed a VHE flare from M 87 occurring over a 4 day timespan. The peak nightly flux above 250 GeV was (1.14 {+-} 0.26) x 10{sup -11} cm{sup -2} s{sup -1}, which corresponded to 7.7% of the Crab Nebula flux. M 87 was marginally detected before this 4 day flare period, and was not detected afterward. Spectral analysis of the VERITAS observations showed no significant change in the photon index between the flare and pre-flare states. Shortly after the VHE flare seen by VERITAS, the Chandra X-ray Observatory detected the flux from the core of M 87 at a historical maximum, while the flux from the nearby knot HST-1 remained quiescent. Acciari et al. presented the 2008 contemporaneous VHE gamma-ray, Chandra X-ray, and Very Long Baseline Array radio observations which suggest the core as the most likely source of VHE emission, in contrast to the 2005 VHE flare that was simultaneous with an X-ray flare in the HST-1 knot. In 2009, VERITAS continued its monitoring of M 87 and marginally detected a 4.2{sigma} excess corresponding to a flux of {approx}1% of the Crab Nebula. No VHE flaring activity was observed in 2009.

  20. Monitoring electron donor metabolism under variable electron acceptor conditions using 13C-labeled lactate

    NASA Astrophysics Data System (ADS)

    Bill, M.; Conrad, M. E.; Yang, L.; Beller, H. R.; Brodie, E. L.

    2010-12-01

    Three sets of flow-through columns constructed with aquifer sediment from Hanford (WA) were used to study reduction of Cr(VI) to poorly soluble Cr(III) under denitrifying, sulfate-reducing/fermentative, and iron-reducing conditions with lactate as the electron donor. In order to understand the relationship between electron donors and biomarkers, and to determine the differences in carbon isotope fractionation resulting from different microbial metabolic processes, we monitored the variation in carbon isotopes in dissolved inorganic carbon (DIC), in total organic carbon (TOC), and in lactate, acetate and propionate. The greatest enrichment in 13C in columns was observed under denitrifying conditions. The δ13C of DIC increased by ~1750 to ~2000‰ fifteen days after supplementation of natural abundance lactate with a 13C-labeled lactate tracer (for an influent δ13C of ~2250‰ for the lactate) indicating almost complete oxidation of the electron donor. The denitrifying columns were among the most active columns and had the highest cell counts and the denitrification rate was highly correlated with Cr(VI) reduction rate. δ13C values of DIC ranged from ~540 to ~1170‰ for iron-reducing conditions. The lower enrichment in iron columns was related to the lower biological activity observed with lower yields of RNA and cell numbers in the column effluents. The carbon isotope shift in the sulfate-reducing ~198 to ~1960‰ for sulfate-reducing conditions reflecting the lower levels of the lactate in these columns. Additionally, in two of the sulfate columns, almost complete fermentation of the lactate occurred, producing acetate and propionate with the labeled carbon signature, but relatively smaller amounts of inorganic carbon. For all electron-accepting conditions, TOC yielded similar δ13C values as lactate stock solutions. Differences in C use efficiency, metabolic rate or metabolic pathway contributed to the differing TOC δ13C to DIC δ13C ratios between treatments

  1. Using performance indicators to monitor attendance at the Broken Hill blood lead screening clinic.

    PubMed

    Boreland, Frances; Lyle, David

    2009-04-01

    Although the average blood lead level of 1-4-year-old children in Broken Hill has halved since 1991, about 1 in 5 still have blood lead levels higher than the national target (<10 microg/dL). The estimated proportion of children attending the Lead Clinic has declined, to approximately 42% in 2006, raising concern that some children with elevated blood lead levels may not be presenting, thus missing out on appropriate treatment and advice. The aim of this study was to describe patterns of attendance at the clinic as a first step to understanding what factors contribute to clinic attendance and non-attendance. Routinely collected data from the Lead Clinic database were used to describe the impact of factors such as child age, the lead-risk area in which they live, seasonal influences and specific promotional activities on clinic attendance rates from 1999 to June 2007. Estimates of the number of children living in each of the five lead-risk areas were derived from 2001 and 2006 census data and estimates of the number of children born to mothers resident in Broken Hill were derived from the Midwives Data Collection. Attendance rates declined by approximately one-third during the study period. Younger children, and those living closer to the central mining area, were more likely to attend for blood lead screening. Cohort analysis indicated cumulative attendance has declined, with children born in 2005 having a cumulative incidence at 18 months of age 5-10% lower than that for previous birth cohorts. The majority (54%) of children who developed a notifiable blood lead level (15 microg/dL) were first detected at 2 years of age or older, a number of whom (40%) had no recorded tests before the age of 2 years. The analysis has demonstrated the benefits of using an expanded set of performance indicators to monitor the blood lead screening programme. It provides valuable additional information about the reach of the programme. Next steps include seeking additional feedback

  2. Consensus Report of the Coalition for Clinical Research—Self-Monitoring of Blood Glucose

    PubMed Central

    Klonoff, David C.; Bergenstal, Richard; Blonde, Lawrence; Boren, Suzanne Austin; Church, Timothy S.; Gaffaney, Jenifer; Jovanovič, Lois; Kendall, David M.; Kollman, Craig; Kovatchev, Boris P.; Leippert, Claudia; DDG, Diabetesberaterin; Owens, David R.; Polonsky, William H.; Reach, Gérard; Renard, Eric; Riddell, Michael C.; Rubin, Richard R.; Schnell, Oliver; Siminiero, Linda M.; Vigersky, Robert A.; Wilson, Darrell M.; Wollitzer, Alison Okada

    2008-01-01

    The Coalition for Clinical Research—Self-Monitoring of Blood Glucose Scientific Board, a group of nine academic clinicians and scientists from the United States and Europe, convened in San Francisco, California, on June 11–12, 2008, to discuss the appropriate uses of self-monitoring of blood glucose (SMBG) and the measures necessary to accurately assess the potential benefit of this practice in noninsulin-treated type 2 diabetes mellitus (T2DM). Thirteen consultants from the United States, Europe, and Canada from academia, practice, and government also participated and contributed based on their fields of expertise. These experts represent a range of disciplines that include adult endocrinology, pediatric endocrinology, health education, mathematics, statistics, psychology, nutrition, exercise physiology, and nursing. This coalition was organized by Diabetes Technology Management, Inc. Among the participants, there was consensus that: protocols assessing the performance of SMBG in noninsulin treated T2DM must provide the SMBG intervention subjects with blood glucose (BG) goals and instructions on how to respond to BG data in randomized controlled trials (RCTs);intervention subjects in clinical trials of SMBG-driven interventions must aggressively titrate their therapeutic responses or lifestyle changes in response to hyperglycemia;control subjects in clinical trials of SMBG must be isolated from SMBG-driven interventions and not be contaminated by physician experience with study subjects receiving a SMBG intervention;the best endpoints to measure in a clinical trial of SMBG in T2DM include delta Hemoglobin A1c levels, hyperglycemic events, hypoglycemic events, time to titrate noninsulin therapy to a maximum necessary dosage, and quality of life indices;either individual randomization or cluster randomization may be appropriate methods for separating control subjects from SMBG intervention subjects, provided that precautions are taken to avoid bias and that the

  3. Variability of selected nutrients and contaminants monitored in rodent diets: A 6-year study

    SciTech Connect

    Oller, W.L.; Kendall, D.C.; Greenman, D.L. )

    1989-01-01

    The results are given from monitoring a commercial closed-formula cereal-based rodent diet (Purina 5010), two open-formula cereal-based diets (NIH-31 and NIH-07), and one purified diet (AIN-76) for selected nutrients and contaminants. The observed concentrations of nutrients (protein, fat, vitamin A, and thiamine) approximated the manufacturer specifications for closed-formula cereal diet, while the average concentrations of nutrients found in the open-formula cereal diets were well above the nominal concentrations. Nominal concentrations for these open-formula diets tended to be close to the minimum values that were observed. Except for protein levels, greater variation in nutrient concentrations was found in the purified diet than in the cereal diets. Contaminants were generally much lower in the purified diet than in the cereal diets, but the variation of contaminants was about equal in the two types of diets. Open- and closed-formula cereal diets appear to be very similar to each other in the degree of variation of nutrients and contaminants. Cadmium, lead, and selenium are the constituents of greatest concern in assuring the quality of the rodent diets that were evaluated.

  4. Monitoring of In-Field Variability for Site Specific Crop Management Through Open Geospatial Information

    NASA Astrophysics Data System (ADS)

    Řezník, T.; Lukas, V.; Charvát, K.; Charvát, K., Jr.; Horáková, Š.; Křivánek, Z.; Herman, L.

    2016-06-01

    The agricultural sector is in a unique position due to its strategic importance around the world. It is crucial for both citizens (consumers) and the economy (both regional and global), which, ideally, should ensure that the whole sector is a network of interacting organisations. It is important to develop new tools, management methods, and applications to improve the management and logistic operations of agricultural producers (farms) and agricultural service providers. From a geospatial perspective, this involves identifying cost optimization pathways, reducing transport, reducing environmental loads, and improving the energy balance, while maintaining production levels, etc. This paper describes the benefits of, and open issues arising from, the development of the Open Farm Management Information System. Emphasis is placed on descriptions of available remote sensing and other geospatial data, and their harmonization, processing, and presentation to users. At the same time, the FOODIE platform also offers a novel approach of yield potential estimations. Validation for one farm demonstrated 70% successful rate when comparing yield results at a farm counting 1'284 hectares on one hand and results of a theoretical model of yield potential on the other hand. The presented Open Farm Management Information System has already been successfully registered under Phase 8 of the Global Earth Observation System of Systems (GEOSS) Architecture Implementation Pilot in order to support the wide variety of demands that are primarily aimed at agriculture and water pollution monitoring by means of remote sensing.

  5. Wide variability in the sensitivity of APTT reagents for monitoring of heparin dosage.

    PubMed Central

    Kitchen, S; Jennings, I; Woods, T A; Preston, F E

    1996-01-01

    AIM: To assess the sensitivity of activated partial thromboplastin time (APTT) reagents for monitoring heparin dosage using data from the UK National External Quality Assessment Scheme (NEQAS) for blood coagulation. METHODS: Data were reviewed from four surveys using samples prepared by addition of heparin to normal plasma in vitro and from two surveys in which samples were prepared using plasma from patients receiving heparin therapy (ex vivo samples). RESULTS: For both in vitro and ex vivo samples, notable differences between APTT reagents with respect to heparin sensitivity were noted. This indicates that a uniform therapeutic range of 1.5-2.5 calculated by the APTT ratio may not be appropriate for all reagents. Reagent sensitivity in ex vivo samples was substantially different to that in in vitro samples. CONCLUSIONS: The results of this large series of laboratories clearly indicate that reagent specific therapeutic ranges may be necessary, and that samples prepared by the addition of heparin to normal plasma in vitro can be misleading and should not be used. PMID:8666677

  6. Installation of a variable-angle spectrometer system for monitoring diffuse and global solar radiation

    NASA Astrophysics Data System (ADS)

    Ormachea, O.; Abrahamse, A.; Tolavi, N.; Romero, F.; Urquidi, O.; Pearce, J. M.; Andrews, R.

    2013-11-01

    We report on the design and installation of a spectrometer system for monitoring solar radiation in Cochabamba, Bolivia. Both the light intensity and the spectral distribution affect the power produced by a photovoltaic device. Local variations in the solar spectrum (especially compared to the AM1.5 standard) may have important implications for device optimization and energy yield estimation. The spectrometer system, based on an Ocean Optics USB4000 (300-900nm) spectrometer, was designed to increase functionality. Typically systems only record the global horizontal radiation. Our system moves a fiber-optic cable 0-90 degrees and takes measurements in 9 degree increments. Additionally, a shadow band allows measurement of the diffuse component of the radiation at each position. The electronic controls utilize an Arduino UNO microcontroller to synchronizes the movement of two PAP bipolar (stepper) motors with the activation of the spectrometer via an external trigger. The spectrometer was factory calibrated for wavelength and calibrated for absolute irradiance using a Sellarnet SL1-Cal light source. We present preliminary results from data taken March-June, 2013, and comment on implications for PV devices in Cochabamba.

  7. Optical system design with variable working distance for monitoring of environmental contamination in infrared region

    NASA Astrophysics Data System (ADS)

    Romanova, G. E.; Zaitceva, A. S.

    2016-04-01

    The project is dedicated to a research and development of a compact optical system for an identification of dangerous substances in a surrounding environment using a spectrum of scattered laser radiation. There is a whole class of tasks for diagnostics of environments and substances which are solved by mobile systems on distances of 0.5 - 10 m from the object. The key feature of an optical system in this case is having the highest functionality, to meet this demands it should be able to work on variable distances and provide the minimal light spot. The purpose of the work is a research of the best possible initial system parameters and its components, designing of an optical system with minimum possible number of elements providing acceptable quality of the image in the required dimensions. An image quality criterion for such systems is the size of the light spot, which defines an operation speed of the system. Using the beam diameter and allowable system dimensions as initial parameters of the two components system, relations were found which helps to define optimal component parameters for future design. To provide the possibility of working on various distances the thickness between the components can be varied. An example of a two component system consisted of three lenses with spherical surfaces is presented. The system works with a laser with the wavelength of 0.785 μm and provides the light spot less than 2.3 mm for all working distances within the range of 2 - 5 m.

  8. Developing a multipoint titration method with a variable dose implementation for anaerobic digestion monitoring.

    PubMed

    Salonen, K; Leisola, M; Eerikäinen, T

    2009-01-01

    Determination of metabolites from an anaerobic digester with an acid base titration is considered as superior method for many reasons. This paper describes a practical at line compatible multipoint titration method. The titration procedure was improved by speed and data quality. A simple and novel control algorithm for estimating a variable titrant dose was derived for this purpose. This non-linear PI-controller like algorithm does not require any preliminary information from sample. Performance of this controller is superior compared to traditional linear PI-controllers. In addition, simplification for presenting polyprotic acids as a sum of multiple monoprotic acids is introduced along with a mathematical error examination. A method for inclusion of the ionic strength effect with stepwise iteration is shown. The titration model is presented with matrix notations enabling simple computation of all concentration estimates. All methods and algorithms are illustrated in the experimental part. A linear correlation better than 0.999 was obtained for both acetate and phosphate used as model compounds with slopes of 0.98 and 1.00 and average standard deviations of 0.6% and 0.8%, respectively. Furthermore, insensitivity of the presented method for overlapping buffer capacity curves was shown.

  9. Can Gait Signatures Provide Quantitative Measures for Aiding Clinical Decision-Making? A Systematic Meta-Analysis of Gait Variability Behavior in Patients with Parkinson's Disease.

    PubMed

    König, Niklas; Singh, Navrag B; Baumann, Christian R; Taylor, William R

    2016-01-01

    A disturbed, inconsistent walking pattern is a common feature of patients with Parkinson's disease (PwPD). Such extreme variability in both temporal and spatial parameters of gait has been associated with unstable walking and an elevated prevalence of falls. However, despite their ability to discretise healthy from pathological function, normative variability values for key gait parameters are still missing. Furthermore, an understanding of each parameter's response to pathology, as well as the inter-parameter relationships, has received little attention. The aim of this systematic literature review and meta-analysis was therefore to define threshold levels for pathological gait variability as well as to investigate whether all gait parameters are equally perturbed in PwPD. Based on a broader systematic literature search that included 13'195 titles, 34 studies addressed Parkinson's disease, presenting 800 PwPD and 854 healthy subjects. Eight gait parameters were compared, of which six showed increased levels of variability during walking in PwPD. The most commonly reported parameter, coefficient of variation of stride time, revealed an upper threshold of 2.4% to discriminate the two groups. Variability of step width, however, was consistently lower in PwPD compared to healthy subjects, and therefore suggests an explicit sensory motor system control mechanism to prioritize balance during walking. The results provide a clear functional threshold for monitoring treatment efficacy in patients with Parkinson's disease. More importantly, however, quantification of specific functional deficits could well provide a basis for locating the source and extent of the neurological damage, and therefore aid clinical decision-making for individualizing therapies. PMID:27445759

  10. Can Gait Signatures Provide Quantitative Measures for Aiding Clinical Decision-Making? A Systematic Meta-Analysis of Gait Variability Behavior in Patients with Parkinson's Disease

    PubMed Central

    König, Niklas; Singh, Navrag B.; Baumann, Christian R.; Taylor, William R.

    2016-01-01

    A disturbed, inconsistent walking pattern is a common feature of patients with Parkinson's disease (PwPD). Such extreme variability in both temporal and spatial parameters of gait has been associated with unstable walking and an elevated prevalence of falls. However, despite their ability to discretise healthy from pathological function, normative variability values for key gait parameters are still missing. Furthermore, an understanding of each parameter's response to pathology, as well as the inter-parameter relationships, has received little attention. The aim of this systematic literature review and meta-analysis was therefore to define threshold levels for pathological gait variability as well as to investigate whether all gait parameters are equally perturbed in PwPD. Based on a broader systematic literature search that included 13′195 titles, 34 studies addressed Parkinson's disease, presenting 800 PwPD and 854 healthy subjects. Eight gait parameters were compared, of which six showed increased levels of variability during walking in PwPD. The most commonly reported parameter, coefficient of variation of stride time, revealed an upper threshold of 2.4% to discriminate the two groups. Variability of step width, however, was consistently lower in PwPD compared to healthy subjects, and therefore suggests an explicit sensory motor system control mechanism to prioritize balance during walking. The results provide a clear functional threshold for monitoring treatment efficacy in patients with Parkinson's disease. More importantly, however, quantification of specific functional deficits could well provide a basis for locating the source and extent of the neurological damage, and therefore aid clinical decision-making for individualizing therapies. PMID:27445759

  11. Spatial and Temporal Variability in Pesticide Exposure Downstream of a Heavily Irrigated Cropping Area: Application of Different Monitoring Techniques.

    PubMed

    O'Brien, Dominique; Lewis, Stephen; Davis, Aaron; Gallen, Christie; Smith, Rachael; Turner, Ryan; Warne, Michael; Turner, Scott; Caswell, Stewart; Mueller, Jochen F; Brodie, Jon

    2016-05-25

    Pesticide exposure threatens many freshwater and estuarine ecosystems around the world. This study examined the temporal and spatial trends of pesticide concentrations in a waterway within an agriculturally developed dry-tropics catchment using a combination of grab and passive sampling methods over a continuous two-year monitoring program. A total of 43 pesticide residues were detected with 7 pesticides exceeding ecologically relevant water quality guidelines/trigger values during the study period and 4 (ametryn, atrazine, diuron, and metolachlor) of these exceeding guidelines for several months. The presence and concentration of the pesticides in the stream coincided with seasonal variability in rainfall, harvest timing/cropping cycle, and management changes. The sampling approach used demonstrates that the application of these complementary sampling techniques (both grab and passive sampling methods) was effective in establishing pesticide usage patterns in upstream locations where application data are unavailable.

  12. Spatial and Temporal Variability in Pesticide Exposure Downstream of a Heavily Irrigated Cropping Area: Application of Different Monitoring Techniques.

    PubMed

    O'Brien, Dominique; Lewis, Stephen; Davis, Aaron; Gallen, Christie; Smith, Rachael; Turner, Ryan; Warne, Michael; Turner, Scott; Caswell, Stewart; Mueller, Jochen F; Brodie, Jon

    2016-05-25

    Pesticide exposure threatens many freshwater and estuarine ecosystems around the world. This study examined the temporal and spatial trends of pesticide concentrations in a waterway within an agriculturally developed dry-tropics catchment using a combination of grab and passive sampling methods over a continuous two-year monitoring program. A total of 43 pesticide residues were detected with 7 pesticides exceeding ecologically relevant water quality guidelines/trigger values during the study period and 4 (ametryn, atrazine, diuron, and metolachlor) of these exceeding guidelines for several months. The presence and concentration of the pesticides in the stream coincided with seasonal variability in rainfall, harvest timing/cropping cycle, and management changes. The sampling approach used demonstrates that the application of these complementary sampling techniques (both grab and passive sampling methods) was effective in establishing pesticide usage patterns in upstream locations where application data are unavailable. PMID:26755130

  13. Predictive variables for the occurrence of early clinical mastitis in primiparous Holstein cows under field conditions in France.

    PubMed Central

    Barnouin, J; Chassagne, M

    2001-01-01

    Holstein heifers from 47 dairy herds in France were enrolled in a field study to determine predictors for clinical mastitis within the first month of lactation. Precalving and calving variables (biochemical, hematological, hygienic, and disease indicators) were collected. Early clinical mastitis (ECM) predictive variables were analyzed by using a multiple logistic regression model (99 cows with ECM vs. 571 without clinical mastitis throughout the first lactation). Two variables were associated with a higher risk of ECM: a) difficult calving and b) medium and high white blood cell (WBC) counts in late gestation. Two prepartum indicators were associated with a lower ECM risk: a) medium and high serum concentrations of immunoglobulin G1 (IgG1) and b) high percentage of eosinophils among white blood cells. Calving difficulty and certain biological blood parameters (IgG1, eosinophils) could represent predictors that would merit further experimental studies, with the aim of designing programs for reducing the risk of clinical mastitis in the first lactation. PMID:11195522

  14. The “Laboratory” Effect: Comparing Radiologists' Performance and Variability during Prospective Clinical and Laboratory Mammography Interpretations1

    PubMed Central

    Gur, David; Bandos, Andriy I.; Cohen, Cathy S.; Hakim, Christiane M.; Hardesty, Lara A.; Ganott, Marie A.; Perrin, Ronald L.; Poller, William R.; Shah, Ratan; Sumkin, Jules H.; Wallace, Luisa P.; Rockette, Howard E.

    2008-01-01

    Purpose: To compare radiologists' performance during interpretation of screening mammograms in the clinic with their performance when reading the same mammograms in a retrospective laboratory study. Materials and Methods: This study was conducted under an institutional review board–approved, HIPAA-compliant protocol; the need for informed consent was waived. Nine experienced radiologists rated an enriched set of mammograms that they had personally read in the clinic (the “reader-specific” set) mixed with an enriched “common” set of mammograms that none of the participants had previously read in the clinic by using a screening Breast Imaging Reporting and Data System (BI-RADS) rating scale. The original clinical recommendations to recall the women for a diagnostic work-up, for both reader-specific and common sets, were compared with their recommendations during the retrospective experiment. The results are presented in terms of reader-specific and group-averaged sensitivity and specificity levels and the dispersion (spread) of reader-specific performance estimates. Results: On average, the radiologists' performance was significantly better in the clinic than in the laboratory (P = .035). Interreader dispersion of the computed performance levels was significantly lower during the clinical interpretations (P < .01). Conclusion: Retrospective laboratory experiments may not represent either expected performance levels or interreader variability during clinical interpretations of the same set of mammograms in the clinical environment well. © RSNA, 2008 PMID:18682584

  15. Testing the PROMIS® Depression measures for monitoring depression in a clinical sample outside the US.

    PubMed

    Vilagut, G; Forero, C G; Adroher, N D; Olariu, E; Cella, D; Alonso, J

    2015-09-01

    The Patient Reported Outcomes Measurement Information System (PROMIS) was devised to facilitate assessment of patient self-reported health status, taking advantage of Item Response Theory. We aimed to assess measurement properties of the PROMIS Depression item bank and an 8-item static short form in a Spanish clinical sample. A three-month follow-up study of patients with active mood/anxiety symptoms (n = 218) was carried out. We assessed model unidimensionality (Confirmatory Item Factor Analysis), reliability (internal consistency and Item Information Curves), and validity (convergent-discriminant with correlations; known-groups with comparison of means and effect sizes; and criterion validity with Receiver operating Characteristics (ROC) analysis). We also assessed 3-month responsiveness to change (Cohen's effect sizes (d) in stable and recovered patients). The unidimensional model showed adequate fit (CFI = 0.97, RMSEA = 0.08). Information Curves had reliabilities over 0.90 throughout most of the score continuum. As expected, we observed high correlations with external self-reported depression, and moderate with self-reported anxiety and clinical measures. The item bank showed an increasing severity gradient from no disorder (mean = 48, SE = 0.6) to depression with comorbid anxiety (mean = 55.8, SE = 0.4). PROMIS detected depression disorder with great accuracy according to the area under the curve (AUC = 0.89). Both formats, item bank and short form, were highly responsive to change in recovered patients (d > 0.7) and had small changes in stable patients (d < 0.2). The good metric properties of the Spanish PROMIS Depression measures provide further evidence of their adequacy for monitoring depression levels of patients in clinical settings. This double check of quality (within countries and populations) supports the ability of PROMIS measures for guaranteeing fair comparisons across languages and countries in specific clinical populations. PMID:26228413

  16. Spatio-temporal variability of abient seismic noise repeatedly monitored above a geothermal reservoir

    NASA Astrophysics Data System (ADS)

    Woith, H.; Parolai, S.; Picozzi, M.; Boxberger, T.; Milkereit, C.; Zschau, J.

    2011-12-01

    shall be investigated by repeated array measurements scheduled for September 2011. At this stage, we have no clear indications for the postulated source effect as a DHI mechanism. To test the last remaining DHI candidate, namely that the fluid reservoir modifies/amplifies incoming seismic waves (site-effect), we intend to continuously monitor the seismic noise on and off the reservoir and compare the response of the reservoir site to earthquakes with the signal at the reference site outside the reservoir.

  17. Non-participation in a randomized controlled trial: the effect on clinical and non-clinical variables.

    PubMed

    Vermaire, J H; van Loveren, C; Poorterman, J H G; Hoogstraten, J

    2011-01-01

    Studies reporting clinical and non-clinical parameters of participants and non-participants of clinical trials are scarce. In the available studies non-participants were likely to show less favourable outcomes than participants on both socioeconomic parameters as well as on caries experience. However, the impact of non-participation on the total sample of the research population is not established. In the present study, as part of baseline data collection for a randomized controlled trial on caries-preventive strategies, 346 parents of children 6.0 years (± 3 months) of age were approached to let their child participate. Sixty parents refused, but 56 of them were willing to fill out the same set of questionnaires and to allow their child to be clinically examined once. Parents from participating children had higher socioeconomic status, were more often of autochthonous origin and scored better on knowledge questions than parents of non-participating children. Furthermore, parents of participating children reported a higher willingness to invest, were more likely to hold on to regular meals and their child had lower levels of plaque compared to non-participating children. Surprisingly, the participating children had higher dmfs scores than the non-participating children. Their care index (fs/ds + fs) was higher than that of non-participating children. Based on the findings of this study, the presumption that non-participating children will show less favourable clinical outcomes cannot be supported. Although participants differed from non-participants, they did not differ from the total population. It is suggested that the external validity of a randomized controlled trial on caries-preventive strategies is not necessarily affected by non-participation bias. PMID:21576959

  18. Guidelines for the diagnosis, treatment and clinical monitoring of patients with juvenile and adult Pompe disease.

    PubMed

    Llerena Junior, Juan Clinton; Nascimento, Osvaldo Jm; Oliveira, Acary Souza B; Dourado Junior, Mario Emilio T; Marrone, Carlo D; Siqueira, Heloise Helena; Sobreira, Cláudia F R; Dias-Tosta, Elza; Werneck, Lineu Cesar

    2016-02-01

    Pompe disease (PD) is a potentially lethal illness involving irreversible muscle damage resulting from glycogen storage in muscle fiber and activation of autophagic pathways. A promising therapeutic perspective for PD is enzyme replacement therapy (ERT) with the human recombinant enzyme acid alpha-glucosidase (Myozyme®). The need to organize a diagnostic flowchart, systematize clinical follow-up, and establish new therapeutic recommendations has become vital, as ERT ensures greater patient longevity. A task force of experienced clinicians outlined a protocol for diagnosis, monitoring, treatment, genetic counseling, and rehabilitation for PD patients. The study was conducted under the coordination of REBREPOM, the Brazilian Network for Studies of PD. The meeting of these experts took place in October 2013, at L'Hotel Port Bay in São Paulo, Brazil. In August 2014, the text was reassessed and updated. Given the rarity of PD and limited high-impact publications, experts submitted their views. PMID:26690841

  19. Transitional cardiovascular physiology and comprehensive hemodynamic monitoring in the neonate: relevance to research and clinical care.

    PubMed

    Azhibekov, Timur; Noori, Shahab; Soleymani, Sadaf; Seri, Istvan

    2014-02-01

    A thorough understanding of developmental cardiovascular physiology is essential for early recognition of cardiovascular compromise, selective screening of at-risk groups of neonates, and individualized management using pathophysiology-targeted interventions. Although we have gained a better understanding of the physiology and pathophysiology of postnatal cardiovascular transition over the past decade with the use of sophisticated methods to study neonatal hemodynamics, most aspects of neonatal hemodynamics remain incompletely understood. In addition, targeted therapeutic interventions of neonatal hemodynamic compromise have not been shown to improve mortality and clinically relevant outcomes. However, the recent development of comprehensive hemodynamic monitoring systems capable of non-invasive, continuous and simultaneous bedside assessment of cardiac output, organ blood flow, microcirculation, and tissue oxygen delivery has made sophisticated analysis of the obtained physiologic data possible and has created new research opportunities with the potential of direct implications to patient care.

  20. Hydroacoustic monitoring of sorted bedforms west of Sylt (SE North Sea) - Interannual variabilities during five years

    NASA Astrophysics Data System (ADS)

    Mielck, Finn; Hass, H. Christian

    2014-05-01

    Sorted bedforms can be found in coastal shelf seas worldwide. These spatially-grain-size-sorted bedforms with lengths of up to several kilometers are consisting of small rippled medium-to-coarse sand and can remain stable for decades. However, the knowledge about their development is still fragmentary. For this study, a shallow investigation area with water depth <15 m located west of the island of Sylt (SE North Sea, Germany) was annually surveyed with high-resolution hydroacoustic means (i.e. sidescan sonar, multibeam echo sounder, and sub-bottom profiler) within a time frame of five years. Aim was to detected short-time variances regarding the stability of the prevailing bedforms in an area which is strongly influenced by distinct tidal and wind-driven currents as well as storm surges. The measurements show sinuous stripes of rippled medium sand which are surrounded by smooth fine-sand areas. These sorted bedforms are basically linked to the morphology characterized by ridges and channels and could be identified as flow-transverse features that are maintained by ebb and flood currents of almost equal strengths. The bidirectional flow field generates sharp boundaries between the coarse- and fine-sand domains in both current directions. Further to the north, where unidirectional flow field conditions prevail, asymmetric bedforms could be detected with only one sharp boundary aligned counter to the current direction. While comparing the data sets of the different years, no significant changes regarding the morphology and distribution of the sorted bedforms were detectable. However, the boundaries to the fine-sand domains reveal small-scale variabilities. New minor bedforms and small rippled excavation marks developed and disappeared during the measure campaign. We suppose that these processes mainly occur during periodically recurring storm surges: Fine-sand layers are winnowed away and the shapes of the bedforms changes. Intensity and direction of these storms are

  1. Monitoring of Bright Giant Variables requested in support of ground-based spectroscopy and for long-term study

    NASA Astrophysics Data System (ADS)

    Rector, Travis; Price, Aaron; Templeton, Matthew R.

    2011-05-01

    Dr. Steve Howell (NASA) and Dr. Travis Rector (University of Alaska, Anchorage) have requested AAVSO observations of several bright giant variable stars of diverse classes in support of spectroscopic observations to be made at Kitt Peak National Observatory between 2011 May 30 and 2011 June 01. Long-term monitoring of these objects is also encouraged. The goal of the project is to determine if the surface temperatures and radii of these stars change in a recognizable pattern over long timescales. Priority targets are Z UMa, R CrB, SX Her, TT Oph, TX Oph, AC Her, and R Sct. Additional targets are R Vir, Y CVn, g Her, UU Her, UZ Oph, V453 Oph, XX Oph, TZ Oph, V564 Oph, T Lyr, AD Aql, AR Sgr, V5569 Sgr, EP Lyr, and EU Del. Finder charts with sequence may be created using the AAVSO Variable Star Plotter (http://www.aavso.org/vsp). Observations should be submitted to the AAVSO International Database. See full Alert Notice for more details.

  2. Radiopharmaceuticals in Preclinical and Clinical Development for Monitoring of Therapy with PET

    PubMed Central

    Dunphy, Mark PS.; Lewis, Jason S.

    2010-01-01

    This review article discusses PET agents, other than 18F-FDG, with the potential to monitor the response to therapy before, during, or after therapeutic intervention. This review deals primarily with non–18F-FDG PET tracers that are in the final stages of preclinical development or in the early stages of clinical application for monitoring the therapeutic response. Four sections related to the nature of the tracers are included: radiotracers of DNA synthesis, such as the 2 most promising agents, the thymidine analogs 3′-18F-fluoro-3′-deoxythymidine and 18F-1-(2′-deoxy-2′-fluoro-β-d-arabinofuranosyl)thymine; agents for PET imaging of hypoxia within tumors, such as 60/62/64Cu-labeled diacetyl-bis(N4-methylthiosemicarbazone) and 18F-fluoromisonidazole; amino acids for PET imaging, including the most popular such agent, l-[methyl-11C]methionine; and agents for the imaging of tumor expression of androgen and estrogen receptors, such as 16β-18F-fluoro-5α-dihydrotestosterone and 16α-18F-fluoro-17β-estradiol, respectively. PMID:19380404

  3. Experimental and clinical tests of the oxyconsumeter: a new oxygen uptake monitor.

    PubMed

    Wuenscher, V; Lueder, M; Bensow, C

    1989-12-01

    The prototype of a microprocessor controlled oxygen uptake monitor oxyconsumeter developed by Draegerwerk AG, Luebeck, FRG, has been tested. The measuring accuracy of this device was assessed with laboratory bench experiments utilizing both the nitrogen dilution technique and the hydrogen combustion technique to simulate oxygen uptake (VO2). The correlation coefficient between the simulated and the measured VO2 values was 0.9989 (p less than 0.05, n = 115). The average relative error of the VO2 values was -3.32% +/- 3.88% when breathing 21 vol% oxygen and -5.58% +/- 4.53% for 70 vol% oxygen (percent of reading). This was within the range given by the manufacturer (+/- 5% for 21 vol% to less than 40 vol%, +/- 10% for 40 vol% to less than 70 vol%) with few exceptions. Furthermore the oxyconsumeter was used in clinical experiments to determine oxygen uptake during general anaesthesia. Oxygen uptake was monitored using a non-rebreathing system with an externally triggered expiratory valve. The difference between preanaesthetic reference values and values determined during anaesthesia averaged -24.8 +/- 20.1 ml/min/m2 oxygen. This average relative change of -16.0 +/- 11.5% was statistically significant in 11 of 15 cases (p less than 0.05). PMID:2628511

  4. Clinical monitoring of early caries lesions using cross polarization optical coherence tomography

    NASA Astrophysics Data System (ADS)

    Fried, Daniel; Staninec, Michal; Darling, Cynthia L.; Chan, Kenneth H.; Pelzner, Roger B.

    New methods are needed for the nondestructive measurement of tooth demineralization and remineralization and to monitor the progression of incipient caries lesions (tooth decay) for effective nonsurgical intervention and to evaluate the performance of anti-caries treatments such as chemical treatments or laser irradiation. Studies have shown that optical coherence tomography (OCT) has great potential to fulfill this role, since it can be used to measure the depth and severity of early lesions with an axial resolution exceeding 10-μm. It is easy to apply in vivo and it can be used to image the convoluted topography of tooth occlusal surfaces. In this paper we present early results from two clinical studies underway to measure the effect of fluoride intervention on early lesions. CP-OCT was used to monitor early lesions on enamel and root surfaces before and after intervention with fluoride varnish. The lesion depth and internal structure were resolved for all the lesions examined and some lesions had well defined surface zones of lower reflectivity that may be indicative of arrested lesions. Changes were also noted in the structure of some of the lesions after fluoride intervention.

  5. Variable clinical manifestations of a glycine to glutamic acid substitution of the COL3A1 gene at residue 736

    SciTech Connect

    Pope, F.M.; Narcisi, P.; Richards, A.J.

    1994-09-01

    Glycine substitutions at the 3{prime} end of the COL3A1 gene generally produce a characteristic clinical phenotype including acrogeria and severe vascular fragility. Here we report a three generation British family in which the propositus presented with aneurysms of the groins. He, his mother, sister and elder daughter all had the external clinical phenotype of vascular EDS IV whilst another daughter and nephew were clinically normal. Cultured skin fibroblasts from the propositus and his clinically affected relatives poorly secreted normal and overmodified collagen III species. Normal components of secreted proteins predominated whilst overmodified molecules were prominent in intracellular material. Surprisingly the normal children also secreted less collagen type III than expected (though more than their clinically abnormal relatives). cDNA from bases 2671 to 3714 were amplified as four overlapping PCR fragments and analysed by DGGE. The region between 2671 and 3015 was heterozygous. Sequencing showed a mutation of glycine to glutamic acid at residue 736. This mutation created an extra Apa 1 restriction site which was suitable for family studies. These showed inheritance of the mutant gene by both vascular and non-vascular clinical phenotypes. This family therefore illustrates that replacement of glycine to glutamic acid at position 736 produces variable clinical and biochemical phenotypes ranging from easily recognizable vascular EDS IV with very poor collagen secretion to an EDS III-like picture and with less severe protein disturbance. The reasons for these differences are at present unexplained.

  6. Use of near infrared spectroscopy for the clinical monitoring of adult brain

    NASA Astrophysics Data System (ADS)

    Kirkpatrick, Peter J.; Smielewski, P.; Lam, J. M.; Al-Rawi, P.

    1996-10-01

    Adult near infrared spectroscopy (NIRS) is a potential method for noninvasively assessing changes in cerebral oxygenation. Unlike neonatal NIRS, access of light to the adult rain requires penetration through thick extracranial tissues, and hence detection of changed in cerebral chromophore concentration can only be achieved by using NIRS in the reflectance mode. This adds variables that are difficult to control. They include the effects of a different intraoptode distance, intersubject anatomical variation, and the influence of a pathological extra- to intracranial collateral blood supply. Although studies showing movements of oxyhemoglobin concentration following specific cerebral stimuli have been published, the separation of changes occurring in the extracranial and intracranial compartments remains a challenge. Experience with NIRS in the three adult clinical scenarios of carotid endarterectomy, head injury, and carbon dioxide stress testing is presented. The influence of extracranial contamination is demonstrated, as are the methods adopted to help control for extracranial blood flow changes. Provisional experience with spatially responded spectroscopy technology is also discussed.

  7. Comparison of adherence monitoring tools and correlation to virologic failure in a pediatric HIV clinical trial.

    PubMed

    Intasan, Jintana; Bunupuradah, Torsak; Vonthanak, Saphonn; Kosalaraksa, Pope; Hansudewechakul, Rawiwan; Kanjanavanit, Suparat; Ngampiyaskul, Chaiwat; Wongsawat, Jurai; Luesomboon, Wicharn; Apornpong, Tanakorn; Kerr, Stephen; Ananworanich, Jintanat; Puthanakit, Thanyawee

    2014-06-01

    There is no consensus on a gold standard for monitoring adherence to antiretroviral therapy (ART). We compared different adherence monitoring tools in predicting virologic failure as part of a clinical trial. HIV-infected Thai and Cambodian children aged 1-12 years (N=207) were randomized to immediate-ART or deferred-ART until CD4% <15%. Virologic failure (VF) was defined as HIV-RNA >1000 copies/mL after ≥6 months of ART. Adherence monitoring tools were: (1) announced pill count, (2) PACTG adherence questionnaire (form completed by caregivers), and (3) child self-report (self-reporting from children or caregivers to direct questioning by investigators during the clinic visit) of any missed doses in the last 3 days and in the period since the last visit. The Kappa statistic was used to describe agreement between each tool. The median age at ART initiation was 7 years with median CD4% 17% and HIV-RNA 5.0 log(10)copies/mL and 92% received zidovudine/lamivudine/nevirapine. Over 144 weeks, 13% had VF. Mean adherence by announced pill count before VF in VF children was 92% compared to 98% in children without VF (p=0.03). Kappa statistics indicated slight to fair agreement between tools. In multivariate analysis adjusting for gender, treatment arm ethnicity and caregiver education, significant predictors of VF were poor adherence by announced pill count (OR 4.56; 95%CI 1.78-11.69), reporting any barrier to adherence in the PACTG adherence questionnaire (OR 7.08; 95%CI 2.42-20.73), and reporting a missed dose in the 24 weeks since the last HIV-RNA assessment (OR 8.64; 95%CI 1.96-38.04). In conclusion, we recommend the child self-report of any missed doses since last visit for use in HIV research and in routine care settings, because it is easy and quick to administer and a strong association with development of VF. PMID:24901463

  8. A computational platform for continuous seizure anticipation, monitoring and clinical evaluation.

    PubMed

    Giannakakis, Giorgos; Pediaditis, Matthew; Stavrinidis, George; Konstantinidis, George; Kritsotakis, Vangelis; Tsakanikas, Vasilis; Ligerakis, Michael; Sakkalis, Vangelis; Vorgia, Pelagia; Tsiknakis, Manolis

    2016-01-01

    The development of platforms that are able to continuously monitor and handle epileptic seizures in a non invasive manner is of great importance as they would improve the quality of life of drug resistant epileptic patients. In this work, a device and a computational platform is presented for acquiring low noise electroencephalographic signals, for the detection/prediction of epileptic seizures and the storage of ictal activity in an electronic personal health record. In order to develop this platform, a systematic clinical protocol was established including a number of drug resistant children from the University Hospital of Heraklion. Dry electrodes with innovative micro-spike design were proposed in order to increase the signal to noise ratio of the recorded EEG signals. A wearable low cost platform and its corresponding wireless communication protocol was developed focus on minimizing the interference with the patient's body. A computational subsystem with advanced algorithms provides detection/anticipation of upcoming seizure activity and aims to protect the patient from an accident due to a seizure or to improve his/her social life. Finally, the seizure activity information is stored in an electronic health record for further clinical evaluation. PMID:27225563

  9. Managing and monitoring chronic non-communicable diseases in a primary health care clinic, Lilongwe, Malawi

    PubMed Central

    Manjomo, R. C.; Mwagomba, B.; Ade, S.; Ali, E.; Ben-Smith, A.; Khomani, P.; Bondwe, P.; Nkhoma, D.; Douglas, G. P.; Tayler-Smith, K.; Chikosi, L.; Gadabu, O. J.

    2016-01-01

    Setting: Patients with chronic non-communicable diseases attending a primary health care centre, Lilongwe, Malawi. Objective: Using an electronic medical record monitoring system, to describe the quarterly and cumulative disease burden, management and outcomes of patients registered between March 2014 and June 2015. Design: A cross-sectional study. Results: Of 1135 patients, with new registrations increasing each quarter, 66% were female, 21% were aged ⩾65 years, 20% were obese, 53% had hypertension alone, 18% had diabetes alone, 12% had asthma, 10% had epilepsy and 7% had both hypertension and diabetes. In every quarter, about 30% of patients did not attend the clinic and 19% were registered as lost to follow-up (not seen for ⩾1 year) in the last quarter. Of those attending, over 90% were prescribed medication, and 80–90% with hypertension and/or diabetes had blood pressure/blood glucose measured. Over 85% of those with epilepsy had no seizures and 60–75% with asthma had no severe attacks. Control of blood pressure (41–51%) and diabetes (15–38%) was poor. Conclusion: It is feasible to manage patients with non-communicable diseases in a primary health care setting in Malawi, although more attention is needed to improve clinic attendance and the control of hypertension and diabetes. PMID:27358797

  10. Monitoring of pulmonary endothelial enzyme function: an animal model for a simplified clinically applicable procedure

    SciTech Connect

    Toivonen, H.J.; Makari, N.; Catravas, J.D.

    1988-01-01

    The authors present a simple and clinically applicable method for the serial monitoring of pulmonary microvascular enzyme function in vivo. This method requires the intravenous injection of trace amounts of a radiolabelled substrate and the collection of a single arterial blood sample. Simultaneous measurement of pulmonary blood flow, (e.g., by dye- or thermo-dilution) and the determination of blood hematocrit are also needed for the calculations. This method was compared to the multiple blood sample indicator dilution method in normal anesthesized rabbits. Both methods gave identical results for the metabolism of the synthetic, hemodynamically inactive tripeptide, /sup 3/H-benzoyl-Phe-Ala-Pro (/sup 3/H-BPAP), by pulmonary microvascular endothelial angiotensin converting enzyme. The parameters measured were: 1) substrate utilization, expressed linearly and logarithmically, and 2) the apparent first order reaction constant. The new method was also used for the simultaneous measurement of single pass, transpulmonary metabolism of /sup 3/H-BPAP by angiotensin converting enzyme and of 5'-adenosine monophosphate by 5'-nucleotidase in rabbits in vivo. The authors propose that similar enzyme kinetic measurements could be used in clinical studies to test their usefulness as an aid in the early diagnosis of incipient pulmonary endothelial dysfunction, e.g., adult respiratory distress syndrome.

  11. Clinical Malaria Transmission Trends and Its Association with Climatic Variables in Tubu Village, Botswana: A Retrospective Analysis.

    PubMed

    Chirebvu, Elijah; Chimbari, Moses John; Ngwenya, Barbara Ntombi; Sartorius, Benn

    2016-01-01

    Good knowledge on the interactions between climatic variables and malaria can be very useful for predicting outbreaks and preparedness interventions. We investigated clinical malaria transmission patterns and its temporal relationship with climatic variables in Tubu village, Botswana. A 5-year retrospective time series data analysis was conducted to determine the transmission patterns of clinical malaria cases at Tubu Health Post and its relationship with rainfall, flood discharge, flood extent, mean minimum, maximum and average temperatures. Data was obtained from clinical records and respective institutions for the period July 2005 to June 2010, presented graphically and analysed using the Univariate ANOVA and Pearson cross-correlation coefficient tests. Peak malaria season occurred between October and May with the highest cumulative incidence of clinical malaria cases being recorded in February. Most of the cases were individuals aged >5 years. Associations between the incidence of clinical malaria cases and several factors were strong at lag periods of 1 month; rainfall (r = 0.417), mean minimum temperature (r = 0.537), mean average temperature (r = 0.493); and at lag period of 6 months for flood extent (r = 0.467) and zero month for flood discharge (r = 0.497). The effect of mean maximum temperature was strongest at 2-month lag period (r = 0.328). Although malaria transmission patterns varied from year to year the trends were similar to those observed in sub-Saharan Africa. Age group >5 years experienced the greatest burden of clinical malaria probably due to the effects of the national malaria elimination programme. Rainfall, flood discharge and extent, mean minimum and mean average temperatures showed some correlation with the incidence of clinical malaria cases. PMID:26983035

  12. Clinical Malaria Transmission Trends and Its Association with Climatic Variables in Tubu Village, Botswana: A Retrospective Analysis

    PubMed Central

    Chimbari, Moses John; Ngwenya, Barbara Ntombi; Sartorius, Benn

    2016-01-01

    Good knowledge on the interactions between climatic variables and malaria can be very useful for predicting outbreaks and preparedness interventions. We investigated clinical malaria transmission patterns and its temporal relationship with climatic variables in Tubu village, Botswana. A 5-year retrospective time series data analysis was conducted to determine the transmission patterns of clinical malaria cases at Tubu Health Post and its relationship with rainfall, flood discharge, flood extent, mean minimum, maximum and average temperatures. Data was obtained from clinical records and respective institutions for the period July 2005 to June 2010, presented graphically and analysed using the Univariate ANOVA and Pearson cross-correlation coefficient tests. Peak malaria season occurred between October and May with the highest cumulative incidence of clinical malaria cases being recorded in February. Most of the cases were individuals aged >5 years. Associations between the incidence of clinical malaria cases and several factors were strong at lag periods of 1 month; rainfall (r = 0.417), mean minimum temperature (r = 0.537), mean average temperature (r = 0.493); and at lag period of 6 months for flood extent (r = 0.467) and zero month for flood discharge (r = 0.497). The effect of mean maximum temperature was strongest at 2-month lag period (r = 0.328). Although malaria transmission patterns varied from year to year the trends were similar to those observed in sub-Saharan Africa. Age group >5 years experienced the greatest burden of clinical malaria probably due to the effects of the national malaria elimination programme. Rainfall, flood discharge and extent, mean minimum and mean average temperatures showed some correlation with the incidence of clinical malaria cases. PMID:26983035

  13. Genetic variability among isolates of Listeria monocytogenes from food products, clinical samples and processing environments, estimated by RAPD typing.

    PubMed

    Martinez, Iciar; Rørvik, Liv Marit; Brox, Vigdis; Lassen, Jørgen; Seppola, Marit; Gram, Lone; Fonnesbech-Vogel, Birte

    2003-08-01

    RAPD analysis with four primers was used to examine the genetic relationship among 432 strains of Listeria monocytogenes isolated from clinical and veterinarian cases of listeriosis, dairy, vegetable, meat- and fish-based food items, environmental samples and samples collected from one transport terminal, one poultry-processing company and four Atlantic salmon-processing plants. The purpose of the study was to determine whether clinical isolates belonged to a specific genetic group, whether links could be made between food groups and clinical cases and whether specific genetic groups were associated with specific food products or processing units. There was great genetic variability among the isolates, which produced a total of 141 RAPD composites based on the RAPD analysis with four primers. The RAPD composites divided in two major clusters and clinical isolates were evenly distributed in both of them. None of the isolates from food products had the same RAPD composite as isolates from human patients, thus, no particular food commodity could be linked to clinical cases. Each food-processing environment was contaminated with more than one RAPD composite and the genetic variability found within each company was, in most cases, of approximately the same magnitude as the variability found when considering all the samples. In each plant, one or a few types persisted over time, indicating the presence of an established in-house flora. Our results indicate that most of the analysed cases of listeriosis were sporadic and, further, that these cases cannot be traced to a few specific food sources. We also found that no particular RAPD composite was better suited for survival in specific food types or food-processing environments, indicating that although differences may be found in virulence properties of individual strains, all L. monocytogenes must be treated as potentially harmful. PMID:12810292

  14. Joint impact of clinical and behavioral variables on the risk of unplanned readmission and death after a heart failure hospitalization.

    PubMed

    Padhukasahasram, Badri; Reddy, Chandan K; Li, Yan; Lanfear, David E

    2015-01-01

    Most current methods for modeling rehospitalization events in heart failure patients make use of only clinical and medications data that is available in the electronic health records. However, information about patient-reported functional limitations, behavioral variables and socio-economic background of patients may also play an important role in predicting the risk of readmission in heart failure patients. We developed methods for predicting the risk of rehospitalization in heart failure patients using models that integrate clinical characteristics with patient-reported functional limitations, behavioral and socio-economic characteristics. Our goal was to estimate the predictive accuracy of the joint model and compare it with models that make use of clinical data alone or behavioral and socio-economic characteristics alone, using real patient data. We collected data about the occurrence of hospital readmissions from a cohort of 789 heart failure patients for whom a range of clinical and behavioral characteristics data is also available. We applied the Cox model, four different variants of the Cox proportional hazards framework as well as an alternative non-parametric approach and determined the predictive accuracy for different categories of variables. The concordance index obtained from the joint prediction model including all types of variables was significantly higher than the accuracy obtained from using only clinical factors or using only behavioral, socioeconomic background and functional limitations in patients as predictors. Collecting information on behavior, patient-reported estimates of physical limitations and frailty and socio-economic data has significant value in the predicting the risk of readmissions with regards to heart failure events and can lead to substantially more accurate events prediction models.

  15. Kilovoltage Intrafraction Monitoring for Prostate Intensity Modulated Arc Therapy: First Clinical Results

    SciTech Connect

    Ng, Jin Aun; Booth, Jeremy T.; Poulsen, Per R.; Fledelius, Walther; Worm, Esben Schjodt; Eade, Thomas; Hegi, Fiona; Kneebone, Andrew; Kuncic, Zdenka; Keall, Paul J.

    2012-12-01

    Purpose: Most linear accelerators purchased today are equipped with a gantry-mounted kilovoltage X-ray imager which is typically used for patient imaging prior to therapy. A novel application of the X-ray system is kilovoltage intrafraction monitoring (KIM), in which the 3-dimensional (3D) tumor position is determined during treatment. In this paper, we report on the first use of KIM in a prospective clinical study of prostate cancer patients undergoing intensity modulated arc therapy (IMAT). Methods and Materials: Ten prostate cancer patients with implanted fiducial markers undergoing conventionally fractionated IMAT (RapidArc) were enrolled in an ethics-approved study of KIM. KIM involves acquiring kV images as the gantry rotates around the patient during treatment. Post-treatment, markers in these images were segmented to obtain 2D positions. From the 2D positions, a maximum likelihood estimation of a probability density function was used to obtain 3D prostate trajectories. The trajectories were analyzed to determine the motion type and the percentage of time the prostate was displaced {>=}3, 5, 7, and 10 mm. Independent verification of KIM positional accuracy was performed using kV/MV triangulation. Results: KIM was performed for 268 fractions. Various prostate trajectories were observed (ie, continuous target drift, transient excursion, stable target position, persistent excursion, high-frequency excursions, and erratic behavior). For all patients, 3D displacements of {>=}3, 5, 7, and 10 mm were observed 5.6%, 2.2%, 0.7% and 0.4% of the time, respectively. The average systematic accuracy of KIM was measured at 0.46 mm. Conclusions: KIM for prostate IMAT was successfully implemented clinically for the first time. Key advantages of this method are (1) submillimeter accuracy, (2) widespread applicability, and (3) a low barrier to clinical implementation. A disadvantage is that KIM delivers additional imaging dose to the patient.

  16. In Vivo Monitoring of Hemodynamic Changes during Clogging and Unclogging of Blood Supply for the Application of Clinical Shock Detection

    NASA Astrophysics Data System (ADS)

    Kanawade, Rajesh; Stelzle, Florian; Schmidt, Michael

    This paper presents a novel methodology in early detection of clinical shock by monitoring hemodynamic changes using diffuse reflectance measurement technique. Detailed prototype of the reflectance measurement system and data analysis technique of hemodynamic monitoring was carried out in our laboratory. The real time in-vivo measurements were done from the index finger. This study demonstrates preliminary results of real time monitoring of reduced/- oxyhemoglobin changes during clogging and unclogging of blood flow in the finger tip. The obtained results were verified with pulse-oximeter values, connected to the tip of the same index finger.

  17. Intra-Gene DNA Methylation Variability Is a Clinically Independent Prognostic Marker in Women’s Cancers

    PubMed Central

    Bartlett, Thomas E.; Jones, Allison; Goode, Ellen L.; Fridley, Brooke L.; Cunningham, Julie M.; Berns, Els M. J. J.; Wik, Elisabeth; Salvesen, Helga B.; Davidson, Ben; Trope, Claes G.; Lambrechts, Sandrina; Vergote, Ignace; Widschwendter, Martin

    2015-01-01

    We introduce a novel per-gene measure of intra-gene DNA methylation variability (IGV) based on the Illumina Infinium HumanMethylation450 platform, which is prognostic independently of well-known predictors of clinical outcome. Using IGV, we derive a robust gene-panel prognostic signature for ovarian cancer (OC, n = 221), which validates in two independent data sets from Mayo Clinic (n = 198) and TCGA (n = 358), with significance of p = 0.004 in both sets. The OC prognostic signature gene-panel is comprised of four gene groups, which represent distinct biological processes. We show the IGV measurements of these gene groups are most likely a reflection of a mixture of intra-tumour heterogeneity and transcription factor (TF) binding/activity. IGV can be used to predict clinical outcome in patients individually, providing a surrogate read-out of hard-to-measure disease processes. PMID:26629914

  18. [Analysis Methods of Short-term Non-linear Heart Rate Variability and Their Application in Clinical Medicine].

    PubMed

    Chi, Xianglin; Zhou, Jianhua; Shi, Ping; Liu, Chengyu

    2016-02-01

    The linear analysis for heart rate variability (HRV), including time domain method, frequency domain method and time-frequency analysis, has reached a lot of consensus. The non-linear analysis has also been widely applied in biomedical and clinical researches. However, for non-linear HRV analysis, especially for short-term non-linear HRV analysis, controversy still exists, and a unified standard and conclusion has not been formed. This paper reviews and discusses three short-term non-linear HRV analysis methods (fractal dimension, entropy and complexity) and their principles, progresses and problems in clinical application in detail, in order to provide a reference for accurate application in clinical medicine.

  19. Monitoring

    DOEpatents

    Orr, Christopher Henry; Luff, Craig Janson; Dockray, Thomas; Macarthur, Duncan Whittemore

    2004-11-23

    The invention provides apparatus and methods which facilitate movement of an instrument relative to an item or location being monitored and/or the item or location relative to the instrument, whilst successfully excluding extraneous ions from the detection location. Thus, ions generated by emissions from the item or location can successfully be monitored during movement. The technique employs sealing to exclude such ions, for instance, through an electro-field which attracts and discharges the ions prior to their entering the detecting location and/or using a magnetic field configured to repel the ions away from the detecting location.

  20. PCR Based Detection of Phase Variable Genes in Pakistani Based Clinical Helicobacter pylori Strains

    PubMed Central

    Ahmad, Sajjad; Ahmad, Faisal; Rahman, Faiz ur; Khan, Salman; Murad, Waheed; Mughal, Imran; ur Rahman, Amjad; Muhammad Khan, Fida; Khan, Imad; Ahmad, Hajra

    2016-01-01

    Background The distribution pattern of phase-variable genes varies from strain to strain and from region to region. The present study was carried out to investigate the distribution pattern of phase-variable genes within Pakistan-based Helicobacter pylori strains and to analyze and compare them with strains prevalent in other parts of the world. Objectives To determine the distribution pattern of phase-variable genes in H. pylori strains circulating in Pakistan. Patients and Methods Biopsy samples were collected from 85 symptomatic patients suffering from various upper gastrointestinal tract symptoms. The biopsy specimens were chopped, then inoculated on H. pylori-specific media and incubated in a Campylobacter Gas Generating kit. Positive isolates were further confirmed via staining and biochemical procedures. Primers were designed for five phase-variable genes using OligoCalc, an oligonucleotide properties calculator (version 3.26) according to parameters stipulated in the literature. Polymerase chain reaction (PCR) was performed on all positive isolates to determine the presence or absence of phase-variable genes. Results On culturing, the prevalence of H. pylori infections in the samples was 44.7%. The prevalence was higher in females than in males, and it increased with age. PCR amplification revealed that the hsdR gene was present in 79% of samples, while the mod and β-subunit genes were present in 16% and 30% of samples, respectively. The streptococcal M protein gene was found in 79%, while the fliP gene was prevalent in 56%. Conclusions The distribution patterns of phase-variable genes in Pakistani H. pylori strains were found to be somewhat different. The dominant prevalence of the hsdR gene was an interesting finding, considering its role in bacterial defense in both micro- and macroenvironments.

  1. Passive Acoustic Monitoring of the Temporal Variability of Odontocete Tonal Sounds from a Long-Term Marine Observatory

    PubMed Central

    Lin, Tzu-Hao; Yu, Hsin-Yi; Chen, Chi-Fang; Chou, Lien-Siang

    2015-01-01

    The developments of marine observatories and automatic sound detection algorithms have facilitated the long-term monitoring of multiple species of odontocetes. Although classification remains difficult, information on tonal sound in odontocetes (i.e., toothed whales, including dolphins and porpoises) can provide insights into the species composition and group behavior of these species. However, the approach to measure whistle contour parameters for detecting the variability of odontocete vocal behavior may be biased when the signal-to-noise ratio is low. Thus, methods for analyzing the whistle usage of an entire group are necessary. In this study, a local-max detector was used to detect burst pulses and representative frequencies of whistles within 4.5–48 kHz. Whistle contours were extracted and classified using an unsupervised method. Whistle characteristics and usage pattern were quantified based on the distribution of representative frequencies and the composition of whistle repertoires. Based on the one year recordings collected from the Marine Cable Hosted Observatory off northeastern Taiwan, odontocete burst pulses and whistles were primarily detected during the nighttime, especially after sunset. Whistle usage during the nighttime was more complex, and whistles with higher frequency were mainly detected during summer and fall. According to the multivariate analysis, the diurnal variation of whistle usage was primarily related to the change of mode frequency, diversity of representative frequency, and sequence complexity. The seasonal variation of whistle usage involved the previous three parameters, in addition to the diversity of whistle clusters. Our results indicated that the species and behavioral composition of the local odontocete community may vary among seasonal and diurnal cycles. The current monitoring platform facilitates the evaluation of whistle usage based on group behavior and provides feature vectors for species and behavioral

  2. Passive acoustic monitoring of the temporal variability of odontocete tonal sounds from a long-term marine observatory.

    PubMed

    Lin, Tzu-Hao; Yu, Hsin-Yi; Chen, Chi-Fang; Chou, Lien-Siang

    2015-01-01

    The developments of marine observatories and automatic sound detection algorithms have facilitated the long-term monitoring of multiple species of odontocetes. Although classification remains difficult, information on tonal sound in odontocetes (i.e., toothed whales, including dolphins and porpoises) can provide insights into the species composition and group behavior of these species. However, the approach to measure whistle contour parameters for detecting the variability of odontocete vocal behavior may be biased when the signal-to-noise ratio is low. Thus, methods for analyzing the whistle usage of an entire group are necessary. In this study, a local-max detector was used to detect burst pulses and representative frequencies of whistles within 4.5-48 kHz. Whistle contours were extracted and classified using an unsupervised method. Whistle characteristics and usage pattern were quantified based on the distribution of representative frequencies and the composition of whistle repertoires. Based on the one year recordings collected from the Marine Cable Hosted Observatory off northeastern Taiwan, odontocete burst pulses and whistles were primarily detected during the nighttime, especially after sunset. Whistle usage during the nighttime was more complex, and whistles with higher frequency were mainly detected during summer and fall. According to the multivariate analysis, the diurnal variation of whistle usage was primarily related to the change of mode frequency, diversity of representative frequency, and sequence complexity. The seasonal variation of whistle usage involved the previous three parameters, in addition to the diversity of whistle clusters. Our results indicated that the species and behavioral composition of the local odontocete community may vary among seasonal and diurnal cycles. The current monitoring platform facilitates the evaluation of whistle usage based on group behavior and provides feature vectors for species and behavioral classification

  3. Clinical significance of dynamic monitoring by transcranial doppler ultrasound and intracranial pressure monitor after surgery of hypertensive intracerebral hemorrhage.

    PubMed

    Liu, Zaiming; Chen, Qianxue; Tian, Daofeng; Wang, Long; Liu, Baohui; Zhang, Shenqi

    2015-01-01

    The aim of this study was to investigate the surgical method of hypertensive intracerebral hemorrhage (HIH) and how to control the postoperative blood pressure. 96 HIH patients were performed the craniotomic hematoma dissection (CHD) and the hematoma-cavity drilling drainage (HCDD), respectively. Meanwhile, the intracranial pressure and mean arterial pressure of each patient were continuously monitored for 7 days, the postoperative 1(st), 3(rd), 7(th) and 14(th)-day average flow velocities and pulsatility indexes of the bilateral middle cerebral arteries were monitored. CHD exhibited the significant difference in the long-term quality of life (ADL classification 6 months later) of patients with hematoma >50 ml than HCDD; furthermore, the postoperative 1(st), 3(rd), 7(th) and 14(th)-day TCD parameter analysis revealed that CHD exhibited better results in relieving the intracranial pressure and improving the cerebral blood flow than HCDD, and the postoperative ICP and MAP monitoring towards all patients could effectively control the blood pressure and prevent the further bleeding. The patients with hematoma >50 ml should choose CHD, and all HIH patients should be routinely performed the ICP and MAP monitoring.

  4. Determining the climatic drivers of speleothem proxy variability: coupling modern cave monitoring with a multicomponent reactive transport model

    NASA Astrophysics Data System (ADS)

    Covey, A. K.; Oster, J. L.; Druhan, J. L.; Lawrence, C. R.

    2015-12-01

    Speleothem isotopic and geochemical proxy records can illuminate changes in climate patterns, soils, vegetation, and the amount of seepage water flow into a cave. However, the number of potential chemical and transport mechanisms that influence drip water composition can complicate speleothem records. A thorough understanding of processes affecting isotopic and geochemical compositions of modern cave waters is essential for interpreting proxies in a climate context. We couple a reactive transport model, CrunchTope, with modern measurements from Blue Spring Cave, Tennessee to understand the factors controlling proxy variability. For 2 years we have monitored surface and soil temperature, precipitation and soil moisture, cave temperature and pCO2, drip rate, and drip water chemistry, δ18O, and δ13C of dissolved inorganic carbon (DIC). The range of variability in drip water δ18O indicates some drips are fed by fracture flow from the surface, while others are fed by more diffuse flow paths. For both drip types, δ13CDIC is inversely correlated with monthly rainfall. Cave air pCO2 suggests seasonal ventilation driven by surface air temperature change. Drip water Sr/Ca and Mg/Ca indicate prior carbonate precipitation (PCP) occurs in the epikarst, but do not appear to reflect cave ventilation. To improve interpretations of drip water geochemical variation, we parameterize CrunchTope with horizons representing soil, epikarst and karst. We use this model to simulate water chemistry changes due to coupled fluid transport and water-mineral interactions in the soils and bedrock. Initial model runs reproduce mean drip water [Sr] and [Mg]. Accurate simulation of drip water [Ca] requires inclusion of a low pCO2 layer that drives PCP. With the inclusion of isotope systematics, a baseline model calibrated with modern data will be available to simulate the effects of long-term climate change on cave waters, thus enhancing the quantitative interpretation of speleothem proxy

  5. Polyvinylidene fluoride film based nasal sensor to monitor human respiration pattern: an initial clinical study.

    PubMed

    Roopa Manjunatha, G; Rajanna, K; Mahapatra, D Roy; Nayak, M M; Krishnaswamy, Uma Maheswari; Srinivasa, R

    2013-12-01

    Design and development of a piezoelectric polyvinylidene fluoride (PVDF) thin film based nasal sensor to monitor human respiration pattern (RP) from each nostril simultaneously is presented in this paper. Thin film based PVDF nasal sensor is designed in a cantilever beam configuration. Two cantilevers are mounted on a spectacle frame in such a way that the air flow from each nostril impinges on this sensor causing bending of the cantilever beams. Voltage signal produced due to air flow induced dynamic piezoelectric effect produce a respective RP. A group of 23 healthy awake human subjects are studied. The RP in terms of respiratory rate (RR) and Respiratory air-flow changes/alterations obtained from the developed PVDF nasal sensor are compared with RP obtained from respiratory inductance plethysmograph (RIP) device. The mean RR of the developed nasal sensor (19.65 ± 4.1) and the RIP (19.57 ± 4.1) are found to be almost same (difference not significant, p > 0.05) with the correlation coefficient 0.96, p < 0.0001. It was observed that any change/alterations in the pattern of RIP is followed by same amount of change/alterations in the pattern of PVDF nasal sensor with k = 0.815 indicating strong agreement between the PVDF nasal sensor and RIP respiratory air-flow pattern. The developed sensor is simple in design, non-invasive, patient friendly and hence shows promising routine clinical usage. The preliminary result shows that this new method can have various applications in respiratory monitoring and diagnosis. PMID:23771706

  6. Monitoring of the Environment at the Transplant Unit—Hemato-Oncology Clinic

    PubMed Central

    Matoušková, Ivanka; Holy, Ondřej

    2014-01-01

    Aims: Aim of this study was to monitor the environment at the Transplant Unit—Hemato-Oncology Clinic, University Hospital Olomouc (Olomouc, Czech Republic) and identify risks for the patients. Methods and Results: Microorganisms were cultivated under standard aerobic conditions. Strains were biochemically identified using the BD Phoenix™ PID Panel (USA). Legionella pneumophila was identified by DNA sequencing. From the air, the most frequently isolated strains were coagulase-negative staphylococci (94.3%), Micrococcus spp. and Bacillus spp. No Gram-negative strains were isolated from the air. From the surfaces, the most frequently isolated Gram-positive strains were coagulase-negative staphylococci (67.4%), Bacillus spp., enterococci (5.5%), Staphylococcus aureus (2.3%) and Micrococcus spp. (1.7%). From the surfaces, the most frequently isolated Gram-negative strains were from genera Pseudomonas (28%), Enterobacter (28%), E. coli (6%), and Klebsiella spp. (5%). From the personnel, the most frequently isolated Gram-positive strains were coagulase-negative staphylococci (59.6%), Bacillus spp. (24.1%) and Staphylococcus aureus (9.8%). From the personnel, the most frequently isolated Gram-negative strains were Enterobacter spp. (61%), Klebsiella oxytoca (18%), and E. coli (11%). Microscopic filamentous fungi were isolated in 13 cases (2.71%). Isolated strains were Aspergillus spp. (4), Trichoderma spp. (2), Penicillium spp. (2), one case of the strains Paecilomyces spp., Eurotium spp., Monilia spp. Conclusions: The study found no significant deviations in the microbial contamination of the cleanroom air. The personnel entrance of the Transplant Unit represent a high risk area, an extreme value (7270 CFU/m3) was recorded. Regime measures are fully effective, no other deficiencies were found. Significance and Impact of the Study: This epidemiological study, which was held for the duration of one year at the Transplant Unit—Hemato-Oncology Clinic, University

  7. Sentence Comprehension in Agrammatic Aphasia: History and Variability to Clinical Implications

    ERIC Educational Resources Information Center

    Johnson, Danielle; Cannizzaro, Michael S.

    2009-01-01

    Individuals with Broca's aphasia often present with deficits in their ability to comprehend non-canonical sentences. This has been contrastingly characterized as a systematic loss of specific grammatical abilities or as individual variability in the dynamics between processing load and resource availability. The present study investigated sentence…

  8. Flexible designs for phase II comparative clinical trials involving two response variables.

    PubMed

    Bersimis, S; Sachlas, A; Papaioannou, T

    2015-01-30

    The aim of phase II clinical trials is to determine whether an experimental treatment is sufficiently promising and safe to justify further testing. The need for reduced sample size arises naturally in phase II clinical trials owing to both technical and ethical reasons, motivating a significant part of research in the field during recent years, while another significant part of the research effort is aimed at more complex therapeutic schemes that demand the consideration of multiple endpoints to make decisions. In this paper, our attention is restricted to phase II clinical trials in which two treatments are compared with respect to two dependent dichotomous responses proposing some flexible designs. These designs permit the researcher to terminate the clinical trial when high rates of favorable or unfavorable outcomes are observed early enough requiring in this way a small number of patients. From the mathematical point of view, the proposed designs are defined on bivariate sequences of multi-state trials, and the corresponding stopping rules are based on various distributions related to the waiting time until a certain number of events appear in these sequences. The exact distributions of interest, under a unified framework, are studied using the Markov chain embedding technique, which appears to be very useful in clinical trials for the sample size determination. Tables of expected sample size and power are presented. The numerical illustration showed a very good performance for these new designs.

  9. AN INDEPENDENT ANALYSIS OF THE BROWN DWARF ATMOSPHERE MONITORING (BAM) DATA: LARGE-AMPLITUDE VARIABILITY IS RARE OUTSIDE THE L/T TRANSITION

    SciTech Connect

    Radigan, Jacqueline

    2014-12-20

    Observations of variability can provide valuable information about the processes of cloud formation and dissipation in brown dwarf atmospheres. Here we report the results of an independent analysis of archival data from the Brown dwarf Atmosphere Monitoring (BAM) program. Time series data for 14 L and T dwarfs reported to be significantly variable over timescales of hours were analyzed. We confirm large-amplitude variability (amplitudes >2%) for 4 out of 13 targets and place upper limits of 0.7%-1.6% on variability in the remaining sample. For two targets we find evidence of weak variability at amplitudes of 1.3% and 1.6%. Based on our revised classification of variable objects in the BAM study, we find strong variability outside the L/T transition to be rare at near infrared wavelengths. From a combined sample of 81 L0-T9 dwarfs from the revised BAM sample and the variability survey of Radigan et al., we infer an overall observed frequency for large-amplitude variability outside the L/T transition of 3.2{sub −1.8}{sup +2.8}%, in contrast to 24{sub −9}{sup +11}% for L9-T3.5 spectral types. We conclude that while strong variability is not limited to the L/T transition, it occurs more frequently in this spectral type range, indicative of larger or more highly contrasting cloud features at these spectral types.

  10. Riboflavin as an oral tracer for monitoring compliance in clinical research.

    PubMed

    Ramanujam, V M Sadagopa; Anderson, Karl E; Grady, James J; Nayeem, Fatima; Lu, Lee-Jane W

    2011-01-01

    We studied urinary riboflavin as an objective biomarker of compliance in clinical research using a simplified method amenable to high throughput analysis. Six healthy women not taking vitamin supplements ingested a study pill containing riboflavin (32 mg) as an inactive tracer and the soy isoflavones daidzin (0.243 mmole) and genistin (0.222 mmole) as active ingredients once daily for four days. Riboflavin and metabolites of the isoflavones were measured in urine samples obtained before and after each pill. Urinary excretion of riboflavin and metabolites of both isoflavones peaked within 8 hrs and remained higher than baseline for 24 hrs. Urinary excretion of riboflavin was also measured in 152 additional women with unrestricted dietary supplement intakes. Mean and median urinary riboflavin concentrations in these women were 0.42 and 0.31 μg/mL, respectively, compared to 0.2 μg/mL during a riboflavin-restricted diet. Receiver operating characteristics (ROC) curves indicated that urinary riboflavin within 24 hrs after a 32 mg dose would perform well as a measure of compliance (all areas under the ROC curves ≥0.84. Samples collected during the initial 8 hrs after pill ingestion performed better as a compliance measure than later collections. In summary, compliance in a clinical study can be monitored in real time by incorporating 32 mg of riboflavin into study pills, with compliance indicated by urinary riboflavin levels increasing over individual baselines or to ≥1.0 μg/mL, with a false positive rate of being classified as compliant at <5%. PMID:21949554

  11. 78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Investigations--A Risk-Based Approach to Monitoring; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Oversight of Clinical Investigations--A Risk-Based Approach to...

  12. Clinical Studies of Real-Time Monitoring of Lithotripter Performance Using Passive Acoustic Sensors

    NASA Astrophysics Data System (ADS)

    Leighton, T. G.; Fedele, F.; Coleman, A. J.; McCarthy, C.; Ryves, S.; Hurrell, A. M.; De Stefano, A.; White, P. R.

    2008-09-01

    This paper describes the development and clinical testing of a passive device which monitors the passive acoustic emissions generated within the patient's body during Extracorporeal Shock Wave Lithotripsy (ESWL). Designed and clinically tested so that it can be operated by a nurse, the device analyses the echoes generated in the body in response to each ESWL shock, and so gives real time shock-by-shock feedback on whether the stone was at the focus of the lithotripter, and if so whether the previous shock contributed to stone fragmentation when that shock reached the focus. A shock is defined as being `effective' if these two conditions are satisfied. Not only can the device provide real-time feedback to the operator, but the trends in shock `effectiveness' can inform treatment. In particular, at any time during the treatment (once a statistically significant number of shocks have been delivered), the percentage of shocks which were `effective' provides a treatment score TS(t) which reflects the effectiveness of the treatment up to that point. The TS(t) figure is automatically delivered by the device without user intervention. Two clinical studies of the device were conducted, the ethics guidelines permitting only use of the value of TS(t) obtained at the end of treatment (this value is termed the treatment score TS0). The acoustically-derived treatment score was compared with the treatment score CTS2 given by the consultant urologist at the three-week patient's follow-up appointment. In the first clinical study (phase 1), records could be compared for 30 out of the 118 patients originally recruited, and the results of phase 1 were used to refine the parameter values (the `rules') with which the acoustic device provides its treatment score. These rules were tested in phase 2, for which records were compared for 49 of the 85 patients recruited. Considering just the phase 2 results (since the phase 1 data were used to draw up the `rules' under which phase 2 operated

  13. Soft X-ray irradiance measured by the Solar Aspect Monitor on the Solar Dynamic Observatory Extreme ultraviolet Variability Experiment

    NASA Astrophysics Data System (ADS)

    Lin, C. Y.; Bailey, S. M.; Jones, A.; Woodraska, D.; Caspi, A.; Woods, T. N.; Eparvier, F. G.; Wieman, S. R.; Didkovsky, L. V.

    2016-04-01

    The Solar Aspect Monitor (SAM) is a pinhole camera on the Extreme ultraviolet Variability Experiment (EVE) aboard the Solar Dynamics Observatory. SAM projects the solar disk onto the CCD through a metallic filter designed to allow only solar photons shortward of 7 nm to pass. Contamination from energetic particles and out-of-band irradiance is, however, significant in the SAM observations. We present a technique for isolating the 0.01-7 nm integrated irradiance from the SAM signal to produce the first results of broadband irradiance for the time period from May 2010 to May 2014. The results of this analysis agree with a similar data product from EVE's EUV SpectroPhotometer to within 25%. We compare our results with measurements from the Student Nitric Oxide Explorer Solar X-ray Photometer and the Thermosphere Ionosphere Mesosphere Energetics and Dynamics Solar EUV Experiment at similar levels of solar activity. We show that the full-disk SAM broadband results compared well to the other measurements of the 0.01-7 nm irradiance. We also explore SAM's capability toward resolving spatial contribution from regions of solar disk in irradiance and demonstrate this feature with a case study of several strong flares that erupted from active regions on 11 March 2011.

  14. Neurobiological and clinical variables associated with alcohol abuse in bulimia nervosa.

    PubMed

    Vaz-Leal, Francisco J; Ramos-Fuentes, María I; Rodríguez-Santos, Laura; Flores-Mateos, Isabel S; Franco-Zambrano, Andrés; Rojo-Moreno, Luis; Beato-Fernández, Luis

    2015-05-01

    The study was aimed at analysing the reciprocal relationships of several clinical and neurobiological items in order to predict alcohol misuse in patients with bulimia nervosa (BN). Seventy BN patients and 70 healthy controls were assessed for depression, impulsivity, borderline personality traits and self-defeating behaviours using specific scales; serum cortisol and 24-hour urinary excretion of serotonin and 5-hydroxiindolacetic acid were also assessed. The study confirmed the implications of these clinical factors for alcohol misuse in BN patients, but the results suggested that depressive symptoms and hypercortisolism could lie behind these relationships.

  15. Neurobiological and clinical variables associated with alcohol abuse in bulimia nervosa.

    PubMed

    Vaz-Leal, Francisco J; Ramos-Fuentes, María I; Rodríguez-Santos, Laura; Flores-Mateos, Isabel S; Franco-Zambrano, Andrés; Rojo-Moreno, Luis; Beato-Fernández, Luis

    2015-05-01

    The study was aimed at analysing the reciprocal relationships of several clinical and neurobiological items in order to predict alcohol misuse in patients with bulimia nervosa (BN). Seventy BN patients and 70 healthy controls were assessed for depression, impulsivity, borderline personality traits and self-defeating behaviours using specific scales; serum cortisol and 24-hour urinary excretion of serotonin and 5-hydroxiindolacetic acid were also assessed. The study confirmed the implications of these clinical factors for alcohol misuse in BN patients, but the results suggested that depressive symptoms and hypercortisolism could lie behind these relationships. PMID:25766414

  16. Improvement in latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint in rheumatoid arthritis.

    PubMed

    Hu, Chuanpu; Zhou, Honghui

    2016-02-01

    Improving the quality of exposure-response modeling is important in clinical drug development. The general joint modeling of multiple endpoints is made possible in part by recent progress on the latent variable indirect response (IDR) modeling for ordered categorical endpoints. This manuscript aims to investigate, when modeling a continuous and a categorical clinical endpoint, the level of improvement achievable by joint modeling in the latent variable IDR modeling framework through the sharing of model parameters for the individual endpoints, guided by the appropriate representation of drug and placebo mechanism. This was illustrated with data from two phase III clinical trials of intravenously administered mAb X for the treatment of rheumatoid arthritis, with the 28-joint disease activity score (DAS28) and 20, 50, and 70% improvement in the American College of Rheumatology (ACR20, ACR50, and ACR70) disease severity criteria were used as efficacy endpoints. The joint modeling framework led to a parsimonious final model with reasonable performance, evaluated by visual predictive check. The results showed that, compared with the more common approach of separately modeling the endpoints, it is possible for the joint model to be more parsimonious and yet better describe the individual endpoints. In particular, the joint model may better describe one endpoint through subject-specific random effects that would not have been estimable from data of this endpoint alone.

  17. Handgrip strength test as a complementary tool in monitoring asthma in daily clinical practice in children.

    PubMed

    Latorre-Román, Pedro Ángel; Navarro-Martínez, Ana Vanesa; Mañas-Bastidas, Alfonso; García-Pinillos, Felipe

    2014-12-01

    The aim of this study was to demonstrate that handgrip strength test can discriminate the presence/absence of asthma and between intermittent and moderate persistent asthma in children. 140 children (70 healthy and 70 with asthma) completed the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and performed the handgrip strength test. Forty-eight hours later, subjects performed spirometry. The results showed Handgrip strength was significantly lower (p<0.001) in children with asthma compared with healthy ones. There were also significant differences (p= 0.024) according to the severity of the disease; children with moderate persistent asthma performed worse than children with intermittent asthma. Binary logistic regression analysis and ROC curve analysis revealed that the result in handgrip strength test was a predictive factor for asthma (cut-off at 16.84 kg) and for severity of pathology (cut-off at 15.06 kg). Handgrip strength was reduced in children with asthma. Handgrip strength was positively associated with lung capacity and quality of life. The fact that the handgrip strength test was able to discriminate between presence/absence of asthma and between intermittent and moderate persistent asthma in children suggested that this test could be used as a complementary tool in the monitoring of asthma in daily clinical practice.

  18. The first clinical treatment with kilovoltage intrafraction monitoring (KIM): A real-time image guidance method

    SciTech Connect

    Keall, Paul J. O’Brien, Ricky; Huang, Chen-Yu; Aun Ng, Jin; Colvill, Emma; Rugaard Poulsen, Per; Fledelius, Walther; Juneja, Prabhjot; Booth, Jeremy T.; Simpson, Emma; Bell, Linda; Alfieri, Florencia; Eade, Thomas; Kneebone, Andrew

    2015-01-15

    Purpose: Kilovoltage intrafraction monitoring (KIM) is a real-time image guidance method that uses widely available radiotherapy technology, i.e., a gantry-mounted x-ray imager. The authors report on the geometric and dosimetric results of the first patient treatment using KIM which occurred on September 16, 2014. Methods: KIM uses current and prior 2D x-ray images to estimate the 3D target position during cancer radiotherapy treatment delivery. KIM software was written to process kilovoltage (kV) images streamed from a standard C-arm linear accelerator with a gantry-mounted kV x-ray imaging system. A 120° pretreatment kV imaging arc was acquired to build the patient-specific 2D to 3D motion correlation. The kV imager was activated during the megavoltage (MV) treatment, a dual arc VMAT prostate treatment, to estimate the 3D prostate position in real-time. All necessary ethics, legal, and regulatory requirements were met for this clinical study. The quality assurance processes were completed and peer reviewed. Results: During treatment, a prostate position offset of nearly 3 mm in the posterior direction was observed with KIM. This position offset did not trigger a gating event. After the treatment, the prostate motion was independently measured using kV/MV triangulation, resulting in a mean difference of less than 0.6 mm and standard deviation of less than 0.6 mm in each direction. The accuracy of the marker segmentation was visually assessed during and after treatment and found to be performing well. During treatment, there were no interruptions due to performance of the KIM software. Conclusions: For the first time, KIM has been used for real-time image guidance during cancer radiotherapy. The measured accuracy and precision were both submillimeter for the first treatment fraction. This clinical translational research milestone paves the way for the broad implementation of real-time image guidance to facilitate the detection and correction of geometric and

  19. Correlation between the Lactate Dehydrogenase Levels with Laboratory Variables in the Clinical Severity of Sickle Cell Anemia in Congolese Patients

    PubMed Central

    Mikobi, Tite Minga; Lukusa Tshilobo, Prosper; Aloni, Michel Ntetani; Mvumbi Lelo, Georges; Akilimali, Pierre Zalagile; Muyembe-Tamfum, Jean Jacques; Race, Valérie; Matthijs, Gert; Mbuyi Mwamba, Jean Marie

    2015-01-01

    Background Sickle cell anemia is an inflammatory disease and is characterized by chronic hemolysis. We sought to evaluate the association of lactate dehydrogenase levels with specific clinical phenotypes and laboratory variables in patients with sickle cell anemia. Methods The present cross-sectional study was conducted in Sickle Cell Centre of Yolo in Kinshasa, the Democratic Republic of Congo. Two hundred and eleven patients with Sickle Cell Anemia in steady state were recruited. Seventy-four participants with normal Hb (Hb-AA) were selected as a control group. Results The average rates of hemoglobin, hematocrit, and red blood cells tended to be significantly lower in subjects with Hb-SS (p<0.001). The average rates of white blood cells, platelets, reticulocytes and serum LDH were significantly higher in subjects with Hb-SS (p<0.001). The average rates of Hb, HbF, hematocrit and red blood cells of Hb-SS patients with asymptomatic clinical phenotype were significantly higher than those of the two other phenotypes. However, the average rates of white blood cells, platelets, reticulocytes, and LDH of Hb-SS patients with the severe clinical phenotype are higher than those of two other clinical phenotypes. Significant correlations were observed between Hb and white blood cell in severe clinical phenotype (r3 = -0.37 *) between Hb and red blood cells in the three phenotypes (r1 = 0.69 * r2 * = 0.69, r3 = 0.83 *), and finally between Hb and reticulocytes in the asymptomatic clinical phenotype and severe clinical phenotype (r1 = -0.50 * r3 = 0.45 *). A significant increase in LDH was observed in patients with leg ulcer, cholelithiasis and aseptic necrosis of the femoral head. Conclusion The increase in serum LDH is accompanied by changes in hematological parameters. In our midst, serum LDH may be considered as an indicator of the severity of the disease. PMID:25946088

  20. Molecular method for the characterization of Coxiella burnetii from clinical and environmental samples: variability of genotypes in Spain

    PubMed Central

    2012-01-01

    Background Coxiella burnetii is a highly clonal microorganism which is difficult to culture, requiring BSL3 conditions for its propagation. This leads to a scarce availability of isolates worldwide. On the other hand, published methods of characterization have delineated up to 8 different genomic groups and 36 genotypes. However, all these methodologies, with the exception of one that exhibited limited discriminatory power (3 genotypes), rely on performing between 10 and 20 PCR amplifications or sequencing long fragments of DNA, which make their direct application to clinical samples impracticable and leads to a scarce accessibility of data on the circulation of C. burnetii genotypes. Results To assess the variability of this organism in Spain, we have developed a novel method that consists of a multiplex (8 targets) PCR and hybridization with specific probes that reproduce the previous classification of this organism into 8 genomic groups, and up to 16 genotypes. It allows for a direct characterization from clinical and environmental samples in a single run, which will help in the study of the different genotypes circulating in wild and domestic cycles as well as from sporadic human cases and outbreaks. The method has been validated with reference isolates. A high variability of C. burnetii has been found in Spain among 90 samples tested, detecting 10 different genotypes, being those adaA negative associated with acute Q fever cases presenting as fever of intermediate duration with liver involvement and with chronic cases. Genotypes infecting humans are also found in sheep, goats, rats, wild boar and ticks, and the only genotype found in cattle has never been found among our clinical samples. Conclusions This newly developed methodology has permitted to demonstrate that C. burnetii is highly variable in Spain. With the data presented here, cattle seem not to participate in the transmission of C. burnetii to humans in the samples studied, while sheep, goats, wild

  1. Time-Dependent Prediction and Evaluation of Variable Importance Using SuperLearning in High Dimensional Clinical Data

    PubMed Central

    Hubbard, Alan; Munoz, Ivan Diaz; Decker, Anna; Holcomb, John B; Schreiber, Martin A; Bulger, Eileen M; Brasel, Karen J; Fox, Erin E; del Junco, Deborah J; Wade, Charles E; Rahbar, Mohammad H; Cotton, Bryan A; Phelan, Herb A; Myers, John G; Alarcon, Louis H; Muskat, Peter; Cohen, Mitchell J

    2013-01-01

    Background Prediction of outcome after injury is fraught with uncertainty and statistically beset by misspecified models. Single-time point regression only gives prediction and inference at one time, of dubious value for continuous prediction of ongoing bleeding. New statistical, machine learning techniques such as SuperLearner exist to make superior prediction at iterative time-points while also evaluating the changing relative importance of each measured variable on an outcome. This then can provide continuously changing prediction of outcome and evaluation of which clinical variables likely drive a particular outcome. Methods PROMMTT data was evaluated utilizing both naïve (standard stepwise logistic regression) and SuperLearner techniques to develop a time-dependent prediction of future mortality, within discrete time intervals. We avoided both under- and over-fitting using cross-validation to select an optimal combination of predictors among candidate predictors/machine learning algorithms. SuperLearner was also used to produce interval-specific robust measures of variable importance measures (VIM resulting in an ordered list of variables, by time-point) that have the strongest impact on future mortality. Results 980 patients had complete clinical and outcome data and were included in the analysis. The prediction of ongoing transfusion with SuperLearner was superior to the naïve approach for all time intervals (correlations of cross-validated predictions with the outcome were 0.819, 0.789, 0.792 for time intervals 30–90, 90–180, 180–360, >360 minutes. The estimated VIM of mortality also changed significantly at each time point Conclusions The SuperLeaner technique for prediction of outcome from a complex dynamic multivariate dataset is superior at each time interval to standard models. Additionally, the SuperLearner VIM at each time point provides insight into the time-specific drivers of future outcome, patient trajectory and targets for clinical

  2. Variable expression and incomplete penetrance of developmental dysplasia of the hip: clinical challenge in a 71-member multigeneration family.

    PubMed

    Feldman, George J; Peters, Christopher L; Erickson, Jill A; Hozack, Bryan A; Jaraha, Ranna; Parvizi, Javad

    2012-04-01

    Developmental dysplasia of the hip is a crippling condition that affects children and adults. Identical twin studies support a strong causative genetic component. Although clinical tests for newborns can detect gross malformations, it is the subtle malformations that are often not detected, resulting in early onset osteoarthritis of the hip in adults. As a first step in identifying the causative mutation, we have recruited the largest documented affected family with 71 members spanning generations. Clinical and radiographic signs of developmental dysplasia of the hip are described, and the diagnostic challenge of identifying affected family members is discussed.Variable expression of disease allele is evident in several members of the family and greatly contributes to the diagnostic challenge facing clinicians. PMID:22177793

  3. [Ultrasonic aspirator with controllable suction system--variable action suction adapter and clinical experience with it].

    PubMed

    Nagasawa, S; Shimano, H; Kuroiwa, T

    2000-12-01

    While the ultrasonic aspirator (UA) has been widely used as one of the indispensable tools in the field of neurosurgery, a potential risk when using the present UA is injury to the neurovascular structures due to ultrasonic pulverization and constant forceful suction power. We have devised a small variable action suction adapter that can be used in a similar manner to conventional surgical suction tubes. The UA control unit and the handpiece used in this study were the Sonopet UST-2000 and HA-01, respectively (M & M Corporation Tokyo, Japan). The handpiece is slim, with the mid-portion diameter of 13 mm, and it weighs 100 grams. A variable action suction adapter was made from polycarbonate of 15 x 12 x 13 mm in size. The adapter was connected to the suction tube using a Y-shaped connector (Fig. 2 A), which was integrated into the handpiece. The suction power is regulated by variably closing the oval-shaped hole. The adapter can be variously placed on and rotated around the handpiece (Fig. 2 B and C) so that either the right or left hand handles it in a similar fashion to conventional suction tubes. We used this UA in surgery for 8 patients with large brain tumors (meningioma in 5 cases, metastatic brain tumor in 2 cases and glioma in one case). It reduced the risk of suction-related injury to the neurovascular structures and was handled in a similar manner to conventional suction tubes. This adapter ensures the complete control of suction power, which will reduce the risk of suction injury.

  4. Measurement variability and sincerity of effort: clinical utility of isokinetic strength coefficient of variation scores.

    PubMed

    Birmingham, T B; Kramer, J F; Speechley, M; Chesworth, B M; MacDermid, J

    1998-06-01

    Although the use of measures of strength variability as a means of judging sincerity of effort is becoming common practice, the accuracy of doing so has been questioned. Coefficient of variation (CV) cut-off points, indicating the upper limit of variability for repeated maximal efforts, are routinely used to identify workers providing submaximal efforts during various strength tests. However, the stability of the CV itself has not been considered when comparing an individual's observed CV score to these cut-off points. The purpose of the present study was to examine the day-to-day variability of the CV calculated from maximal isokinetic knee extension efforts, and to describe how this measurement error affects the accuracy of the CV as a distinguishing criterion between maximal and submaximal efforts. Thirty-one healthy males (mean age 25 +/- 4.5 years) completed three maximal and three submaximal isokinetic knee extension efforts on two separate occasions. Although submaximal CVs were significantly greater than maximal CVs (15.6 versus 3.7%; p < 0.01), there was considerable overlap between submaximal and maximal CV frequency distributions. More importantly, an individual observed CV could vary +/- 3.1% as a result of day-to-day variation or measurement error. This range in possible CV scores should be considered when comparing an individual's score to proposed cut-off points. Since individual CVs vary considerably from day-to-day, and since precise cut-off values distinguishing between maximal and submaximal conditions cannot be identified, CV scores must be interpreted cautiously, and the potential errors in relying extensively on this approach to identifying insincere efforts should be recognised.

  5. Identifying Signs of Tinea Pedis: A Key to Understanding Clinical Variables.

    PubMed

    Canavan, Theresa N; Elewski, Boni E

    2015-10-01

    Tinea pedis is a frequently encountered dermatophytosis affecting the superficial skin of the feet, primarily of adults. The prevalence of tinea pedis has increased over the last several decades due to an increase in multiple risk factors. Infection from dermatophytes is most common, but infection from other fungi can also result in tinea pedis. Four distinct clinical presentations occur: interdigital, moccasin, vesicular, and acute ulcerative types. A variety of physical exam findings can help the clinician identify patients with tinea pedis.

  6. Relationship of Clinical and Microbiological Variables in Patients with Type 1 Diabetes Mellitus and Periodontitis

    PubMed Central

    Sakalauskiene, Jurgina; Kubilius, Ricardas; Gleiznys, Alvydas; Vitkauskiene, Astra; Ivanauskiene, Egle; Šaferis, Viktoras

    2014-01-01

    Background The aim of the study was to analyze how metabolic control of type 1 diabetes is related to clinical and microbiological periodontal parameters. Material/Methods The study involved 56 subjects aged from 19 to 50 years divided into 2 groups: healthy subjects (the H group), and diabetic (type 1 diabetes) patients with chronic untreated generalized periodontitis (the DM group). The glycosylated hemoglobin value (HbA1c) was determined using the UniCel DxC 800 SYNCHRON System (Beckman Coulter, USA), and the concentration in blood was measured by the turbidimetric immunoinhibition method. A molecular genetic assay (Micro-IDent plus, Germany) was used to detect periodontopathogenic bacteria in plaque samples. Periodontitis was confirmed by clinical and radiological examination. Results Fusobacterium nucleatum, Capnocytophaga species, and Eikenella corrodens were the most frequently found bacteria in dental plaque samples (77.8%, 66.7%, and 33.4%, respectively), whereas Aggregatibacter actinomycetemcomitans was identified 40.7% less frequently in the DM group than in the H group. The strongest relationship was observed between the presence of 2 periodontal pathogens – F. nucleatum and Capnocytophaga spp. – and poorer metabolic control in type 1 diabetes patients (HbA1c) and all clinical parameters of periodontal pathology. Conclusions Periodontal disease was more evident in type 1 diabetic patients, and the prevalence of periodontitis was greatly increased in subjects with poorer metabolic control. PMID:25294115

  7. Artificial neural network modeling using clinical and knowledge independent variables predicts salt intake reduction behavior

    PubMed Central

    Isma’eel, Hussain A.; Sakr, George E.; Almedawar, Mohamad M.; Fathallah, Jihan; Garabedian, Torkom; Eddine, Savo Bou Zein

    2015-01-01

    Background High dietary salt intake is directly linked to hypertension and cardiovascular diseases (CVDs). Predicting behaviors regarding salt intake habits is vital to guide interventions and increase their effectiveness. We aim to compare the accuracy of an artificial neural network (ANN) based tool that predicts behavior from key knowledge questions along with clinical data in a high cardiovascular risk cohort relative to the least square models (LSM) method. Methods We collected knowledge, attitude and behavior data on 115 patients. A behavior score was calculated to classify patients’ behavior towards reducing salt intake. Accuracy comparison between ANN and regression analysis was calculated using the bootstrap technique with 200 iterations. Results Starting from a 69-item questionnaire, a reduced model was developed and included eight knowledge items found to result in the highest accuracy of 62% CI (58-67%). The best prediction accuracy in the full and reduced models was attained by ANN at 66% and 62%, respectively, compared to full and reduced LSM at 40% and 34%, respectively. The average relative increase in accuracy over all in the full and reduced models is 82% and 102%, respectively. Conclusions Using ANN modeling, we can predict salt reduction behaviors with 66% accuracy. The statistical model has been implemented in an online calculator and can be used in clinics to estimate the patient’s behavior. This will help implementation in future research to further prove clinical utility of this tool to guide therapeutic salt reduction interventions in high cardiovascular risk individuals. PMID:26090333

  8. Biallelic Mutations in TMEM126B Cause Severe Complex I Deficiency with a Variable Clinical Phenotype.

    PubMed

    Alston, Charlotte L; Compton, Alison G; Formosa, Luke E; Strecker, Valentina; Oláhová, Monika; Haack, Tobias B; Smet, Joél; Stouffs, Katrien; Diakumis, Peter; Ciara, Elżbieta; Cassiman, David; Romain, Nadine; Yarham, John W; He, Langping; De Paepe, Boel; Vanlander, Arnaud V; Seneca, Sara; Feichtinger, René G; Płoski, Rafal; Rokicki, Dariusz; Pronicka, Ewa; Haller, Ronald G; Van Hove, Johan L K; Bahlo, Melanie; Mayr, Johannes A; Van Coster, Rudy; Prokisch, Holger; Wittig, Ilka; Ryan, Michael T; Thorburn, David R; Taylor, Robert W

    2016-07-01

    Complex I deficiency is the most common biochemical phenotype observed in individuals with mitochondrial disease. With 44 structural subunits and over 10 assembly factors, it is unsurprising that complex I deficiency is associated with clinical and genetic heterogeneity. Massively parallel sequencing (MPS) technologies including custom, targeted gene panels or unbiased whole-exome sequencing (WES) are hugely powerful in identifying the underlying genetic defect in a clinical diagnostic setting, yet many individuals remain without a genetic diagnosis. These individuals might harbor mutations in poorly understood or uncharacterized genes, and their diagnosis relies upon characterization of these orphan genes. Complexome profiling recently identified TMEM126B as a component of the mitochondrial complex I assembly complex alongside proteins ACAD9, ECSIT, NDUFAF1, and TIMMDC1. Here, we describe the clinical, biochemical, and molecular findings in six cases of mitochondrial disease from four unrelated families affected by biallelic (c.635G>T [p.Gly212Val] and/or c.401delA [p.Asn134Ilefs(∗)2]) TMEM126B variants. We provide functional evidence to support the pathogenicity of these TMEM126B variants, including evidence of founder effects for both variants, and establish defects within this gene as a cause of complex I deficiency in association with either pure myopathy in adulthood or, in one individual, a severe multisystem presentation (chronic renal failure and cardiomyopathy) in infancy. Functional experimentation including viral rescue and complexome profiling of subject cell lines has confirmed TMEM126B as the tenth complex I assembly factor associated with human disease and validates the importance of both genome-wide sequencing and proteomic approaches in characterizing disease-associated genes whose physiological roles have been previously undetermined. PMID:27374774

  9. Biallelic Mutations in TMEM126B Cause Severe Complex I Deficiency with a Variable Clinical Phenotype.

    PubMed

    Alston, Charlotte L; Compton, Alison G; Formosa, Luke E; Strecker, Valentina; Oláhová, Monika; Haack, Tobias B; Smet, Joél; Stouffs, Katrien; Diakumis, Peter; Ciara, Elżbieta; Cassiman, David; Romain, Nadine; Yarham, John W; He, Langping; De Paepe, Boel; Vanlander, Arnaud V; Seneca, Sara; Feichtinger, René G; Płoski, Rafal; Rokicki, Dariusz; Pronicka, Ewa; Haller, Ronald G; Van Hove, Johan L K; Bahlo, Melanie; Mayr, Johannes A; Van Coster, Rudy; Prokisch, Holger; Wittig, Ilka; Ryan, Michael T; Thorburn, David R; Taylor, Robert W

    2016-07-01

    Complex I deficiency is the most common biochemical phenotype observed in individuals with mitochondrial disease. With 44 structural subunits and over 10 assembly factors, it is unsurprising that complex I deficiency is associated with clinical and genetic heterogeneity. Massively parallel sequencing (MPS) technologies including custom, targeted gene panels or unbiased whole-exome sequencing (WES) are hugely powerful in identifying the underlying genetic defect in a clinical diagnostic setting, yet many individuals remain without a genetic diagnosis. These individuals might harbor mutations in poorly understood or uncharacterized genes, and their diagnosis relies upon characterization of these orphan genes. Complexome profiling recently identified TMEM126B as a component of the mitochondrial complex I assembly complex alongside proteins ACAD9, ECSIT, NDUFAF1, and TIMMDC1. Here, we describe the clinical, biochemical, and molecular findings in six cases of mitochondrial disease from four unrelated families affected by biallelic (c.635G>T [p.Gly212Val] and/or c.401delA [p.Asn134Ilefs(∗)2]) TMEM126B variants. We provide functional evidence to support the pathogenicity of these TMEM126B variants, including evidence of founder effects for both variants, and establish defects within this gene as a cause of complex I deficiency in association with either pure myopathy in adulthood or, in one individual, a severe multisystem presentation (chronic renal failure and cardiomyopathy) in infancy. Functional experimentation including viral rescue and complexome profiling of subject cell lines has confirmed TMEM126B as the tenth complex I assembly factor associated with human disease and validates the importance of both genome-wide sequencing and proteomic approaches in characterizing disease-associated genes whose physiological roles have been previously undetermined.

  10. Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards’ Responses

    PubMed Central

    Lutz, Nadine; Bürger, Friederike; Luntz, Steffen; Hinderhofer, Katrin; Bendszus, Martin; Hoffmann, Georg F.; Ries, Markus

    2015-01-01

    Background Children and patients with cognitive deficits may find it difficult to understand the implication of research. In the European Union (EU), clinical studies outside the EU directives concerning medicinal products or medical devices, i.e., “miscellaneous clinical studies”, have no legally mandated timelines for institutional review boards’ (IRB) decisions. Goal To evaluate the review process of IRBs for two different “miscellaneous” multicenter clinical research protocols involving vulnerable subjects (children and adult stroke patients). Methods Descriptive and comparative statistics. Protocol 1 is a prospective, multicenter, cross-sectional screening study of a symptomatic pediatric population at risk for Fabry disease involving genetic testing (NCT02152189). Protocol 2 is a prospective, multicenter, randomized, controlled, open-label, blinded endpoint post-market study to evaluate the effectiveness of stent retrievers (NCT02135926). After having obtained positive initial IRB votes at the main study site, both protocols were subsequently submitted to the remaining IRBs. Results Protocol 1 was submitted to 19 IRBs. No IRB objected to the study. Median time-to-final vote was 34 (IQR 10–65; range 0 to 130) days. Two IRBs accepted the coordinating center’s IRB votes without re-evaluation. Changes to the informed consent documents were asked by 7/19 IRBs, amendments to the protocol by 2. Protocol 2 was submitted to 16 IRBs. Fifteen decisions were made. No IRB objected to the study. Median time-to final vote was 59 (IQR 10 to 65; range 0 to 128) days, which was not statistically significantly different compared with protocol 1 (Wilcoxon test). Two IRBs accepted a previous IRB decision and did not conduct an independent review. Eight/16 IRBs required changes to the informed consent documents; two IRBs recommended an amendment of the protocol. Conclusion Both clinical research protocols involving vulnerable populations were well accepted. IRB

  11. Smith-Lemli-Opitz syndrome: a variable clinical and biochemical phenotype.

    PubMed Central

    Ryan, A K; Bartlett, K; Clayton, P; Eaton, S; Mills, L; Donnai, D; Winter, R M; Burn, J

    1998-01-01

    We have reviewed all known UK cases of Smith-Lemli-Opitz syndrome. Among 49 cases with proven 7-dehydrocholesterol reductase deficiency, half had been terminated or had died in infancy. The minimum incidence is 1 in 60,000. The frequent occurrence of hypospadias may account for 71% of recognised cases being male. Important common features which emerged include short thumbs, severe photosensitivity, aggressive behaviour, and atrioventricular septal defect. The typical facial appearance becomes less obvious with age and 20% of cases did not have 2/3 toe syndactyly. Biochemical measurements of serum 7-dehydrocholesterol did not correlate with clinical severity. Images PMID:9678700

  12. Anxiety Disorders in Caucasian and African American Children: A Comparison of Clinical Characteristics, Treatment Process Variables, and Treatment Outcomes

    PubMed Central

    Gordon-Hollingsworth, Arlene T.; Becker, Emily M.; Keeton, Courtney; Compton, Scott N.; Birmaher, Boris B.; Sakolsky, Dara J.; Piacentini, John; Albano, Anne M.; Kendall, Philip C.; Suveg, Cynthia M.; March, John S.

    2014-01-01

    This study examined racial differences in anxious youth using data from the Child/Adolescent Anxiety Multimodal Study (CAMS) [1]. Specifically, the study aims addressed whether African American (n = 44) versus Caucasian (n = 359) children varied on (1) baseline clinical characteristics, (2) treatment process variables, and (3) treatment outcomes. Participants were ages 7–17 and met DSM-IV-TR criteria for generalized anxiety disorder, social phobia, and/or separation anxiety disorder. Baseline data, as well as outcome data at 12 and 24 weeks, were obtained by independent evaluators. Weekly treatment process variables were collected by therapists. Results indicated no racial differences on baseline clinical characteristics. However, African American participants attended fewer psychotherapy and pharmacotherapy sessions, and were rated by therapists as less involved and compliant, in addition to showing lower mastery of CBT. Once these and other demographic factors were accounted for, race was not a significant predictor of response, remission, or relapse. Implications of these findings suggest African American and Caucasian youth are more similar than different with respect to the manifestations of anxiety and differences in outcomes are likely due to treatment barriers to session attendance and therapist engagement. PMID:25293650

  13. Factors influencing the outcome of intrauterine insemination (IUI): age, clinical variables and significant thresholds.

    PubMed

    Speyer, B E; Abramov, B; Saab, W; Doshi, A; Sarna, U; Harper, J C; Serhal, P

    2013-10-01

    The aim was to investigate the influence of various biological factors upon the outcome of intrauterine insemination (IUI). The total IUI history (856 cycles) of 352 couples was studied. Live-birth showed a strong negative correlation with female age but no correlation with male age. Antimüllerian hormone (AMH) and antral follicle count (AFC) correlated negatively with female age, and follicle stimulating hormone (FSH) correlated positively. Significant thresholds were found for all three variables, and also for total motile count (TMC) in the prepared sperm. Calculating pregnancy losses per positive pregnancy showed a strong correlation with increasing female age. This was highly significant for biochemical losses but not for fetal heart miscarriages. Male age had no effect on rate of pregnancy loss. In conclusion, female age, FSH, AMH and TMC are good predictive factors for live-birth and therefore relate to essential in vivo steps in the reproductive process. PMID:24127958

  14. Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe

    PubMed Central

    Medina Lara, Antonieta; Kigozi, Jesse; Amurwon, Jovita; Muchabaiwa, Lazarus; Nyanzi Wakaholi, Barbara; Mujica Mota, Ruben E.; Walker, A. Sarah; Kasirye, Ronnie; Ssali, Francis; Reid, Andrew; Grosskurth, Heiner; Babiker, Abdel G.; Kityo, Cissy; Katabira, Elly; Munderi, Paula; Mugyenyi, Peter; Hakim, James; Darbyshire, Janet; Gibb, Diana M.; Gilks, Charles F.

    2012-01-01

    Background Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART) have rarely been evaluated. Methods Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM) or laboratory and clinical monitoring (LCM); individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial. Results 3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults (median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm3) were followed for median 4.9 years. LCM had a mean 0.112 year (41 days) survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks). CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term. Conclusions There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African

  15. Phenotypic variability in gap junction syndromic skin disorders: experience from KID and Clouston syndromes' clinical diagnostics.

    PubMed

    Kutkowska-Kaźmierczak, Anna; Niepokój, Katarzyna; Wertheim-Tysarowska, Katarzyna; Giza, Aleksandra; Mordasewicz-Goliszewska, Maria; Bal, Jerzy; Obersztyn, Ewa

    2015-08-01

    Connexins belong to the family of gap junction proteins which enable direct cell-to-cell communication by forming channels in adjacent cells. Mutations in connexin genes cause a variety of human diseases and, in a few cases, result in skin disorders. There are significant differences in the clinical picture of two rare autosomal dominant syndromes: keratitis-ichthyosis-deafness (KID) syndrome and hidrotic ectodermal dysplasia (Clouston syndrome), which are caused by GJB2 and GJB6 mutations, respectively. This is despite the fact that, in both cases, malfunctioning of the same family proteins and some overlapping clinical features (nail dystrophy, hair loss, and palmoplantar keratoderma) is observed. KID syndrome is characterized by progressive vascularizing keratitis, ichthyosiform erythrokeratoderma, and neurosensory hearing loss, whereas Clouston syndrome is characterized by nail dystrophy, hypotrichosis, and palmoplantar keratoderma. The present paper presents a Polish patient with sporadic KID syndrome caused by the mutation of p.Asp50Asn in GJB2. The patient encountered difficulties in obtaining a correct diagnosis. The other case presented is that of a family with Clouston syndrome (caused by p.Gly11Arg mutation in GJB6), who are the first reported patients of Polish origin suffering from this disorder. Phenotype diversity among patients with the same genotypes reported to date is also summarized. The conclusion is that proper diagnosis of these syndromes is still challenging and should always be followed by molecular verification. PMID:25575739

  16. Batch-to-batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial.

    PubMed

    Burmeister Getz, E; Carroll, K J; Jones, B; Benet, L Z

    2016-09-01

    Current pharmacokinetic (PK) bioequivalence guidelines do not account for batch-to-batch variability in study design or analysis. Here we evaluate the magnitude of batch-to-batch PK variability for Advair Diskus 100/50. Single doses of fluticasone propionate and salmeterol combinations were administered by oral inhalation to healthy subjects in a randomized clinical crossover study comparing three different batches purchased from the market, with one batch replicated across two treatment periods. All pairwise comparisons between different batches failed the PK bioequivalence statistical test, demonstrating substantial PK differences between batches that were large enough to demonstrate bio-inequivalence in some cases. In contrast, between-replicate PK bioequivalence was demonstrated for the replicated batch. Between-batch variance was ∼40-70% of the estimated residual error. This large additional source of variability necessitates re-evaluation of bioequivalence assessment criteria to yield a result that is both generalizable and consistent with the principles of type I and type II error rate control.

  17. Intra-host viral variability in children clinically infected with H1N1 (2009) pandemic influenza.

    PubMed

    Bourret, Vincent; Croville, Guillaume; Mansuy, Jean-Michel; Mengelle, Catherine; Mariette, Jérôme; Klopp, Christophe; Genthon, Clémence; Izopet, Jacques; Guérin, Jean-Luc

    2015-07-01

    Recent in-depth genetic analyses of influenza A virus samples have revealed patterns of intra-host viral genetic variability in a variety of relevant systems. These have included laboratory infected poultry, horses, pigs, chicken eggs and swine respiratory cells, as well as naturally infected poultry and horses. In humans, next generation sequencing techniques have enabled the study of genetic variability at specific positions of the viral genome. The present study investigated how 454 pyrosequencing could help unravel intra-host genetic diversity patterns on the full-length viral hæmagglutinin and neuraminidase genes from human H1N1 (2009) pandemic influenza clinical cases. This approach revealed unexpected patterns of co-infection in a 3-week old toddler, arising from rapid and complex reassortment phenomena on a local epidemiological scale. It also suggested the possible existence of very low frequency mutants resistant to neuraminidase inhibitors in two untreated patients. As well as revealing patterns of intra-host viral variability, this report highlights technical challenges in the appraisal of scientifically and medically relevant topics such as the natural occurrence of homologous recombination or very low frequency drug-resistant variants in influenza virus populations.

  18. Chemometrics and in-line near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell culture: prediction of multiple cultivation variables.

    PubMed

    Clavaud, Matthieu; Roggo, Yves; Von Daeniken, Ralph; Liebler, André; Schwabe, Jan-Oliver

    2013-07-15

    In the present study near infrared (NIR) spectroscopy was used to monitor the cultivation of mammalian Chinese hamster ovary (CHO) cells producing a monoclonal antibody in a fed-batch cell culture process. A temperature shift was applied during the cultivation. The cells were incubated at 37 °C and 33 °C. The Fourier transform near infrared (FT-NIR) multiplex process analyzer spectroscopy was investigated to monitor cultivation variables of the CHO cell culture from 10 independent batches using two channels of the FT-NIR. The measurements were performed on production scale bioreactors of 12,500 L. The cell cultures were analyzed with the spectrometer coupled to a transflection sterilizable fiber optic probe inserted into the bioreactors. Multivariate data analysis (MVDA) employing unsupervised principal component analysis (PCA) and partial least squares regression methods (PLS) were applied. PCA demonstrated that 96% of the observed variability was explained by the process trajectory and the inter-batch variability. PCA was found to be a significant tool in identifying batch homogeneity between lots and in detecting abnormal fermentation runs. Seven different cell culture parameters such as osmolality, glucose concentration, product titer, packed cell volume (PCV), integrated viable packed cell volume (ivPCV), viable cell density (VCD), and integrated viable cell count (iVCC) were monitored inline and predicted by NIR. NIR spectra and reference analytics data were computed using control charts to evaluate the monitoring abilities. Control charts of each media component were under control by NIR spectroscopy. The PLS calibration plots offered accurate predictive capabilities for each media. This paper underlines the capability for inline prediction of multiple cultivation variables during bioprocess monitoring.

  19. Tau PET patterns mirror clinical and neuroanatomical variability in Alzheimer's disease.

    PubMed

    Ossenkoppele, Rik; Schonhaut, Daniel R; Schöll, Michael; Lockhart, Samuel N; Ayakta, Nagehan; Baker, Suzanne L; O'Neil, James P; Janabi, Mustafa; Lazaris, Andreas; Cantwell, Averill; Vogel, Jacob; Santos, Miguel; Miller, Zachary A; Bettcher, Brianne M; Vossel, Keith A; Kramer, Joel H; Gorno-Tempini, Maria L; Miller, Bruce L; Jagust, William J; Rabinovici, Gil D

    2016-05-01

    SEE SARAZIN ET AL DOI101093/BRAIN/AWW041 FOR A SCIENTIFIC COMMENTARY ON THIS ARTICLE: The advent of the positron emission tomography tracer (18)F-AV1451 provides the unique opportunity to visualize the regional distribution of tau pathology in the living human brain. In this study, we tested the hypothesis that tau pathology is closely linked to symptomatology and patterns of glucose hypometabolism in Alzheimer's disease, in contrast to the more diffuse distribution of amyloid-β pathology. We included 20 patients meeting criteria for probable Alzheimer's disease dementia or mild cognitive impairment due to Alzheimer's disease, presenting with a variety of clinical phenotypes, and 15 amyloid-β-negative cognitively normal individuals, who underwent (18)F-AV1451 (tau), (11)C-PiB (amyloid-β) and (18)F-FDG (glucose metabolism) positron emission tomography, apolipoprotein E (APOE) genotyping and neuropsychological testing. Voxel-wise contrasts against controls (at P < 0.05 family-wise error corrected) showed that (18)F-AV1451 and (18)F-FDG patterns in patients with posterior cortical atrophy ('visual variant of Alzheimer's disease', n = 7) specifically targeted the clinically affected posterior brain regions, while (11)C-PiB bound diffusely throughout the neocortex. Patients with an amnestic-predominant presentation (n = 5) showed highest (18)F-AV1451 retention in medial temporal and lateral temporoparietal regions. Patients with logopenic variant primary progressive aphasia ('language variant of Alzheimer's disease', n = 5) demonstrated asymmetric left greater than right hemisphere (18)F-AV1451 uptake in three of five patients. Across 30 FreeSurfer-defined regions of interest in 16 Alzheimer's disease patients with all three positron emission tomography scans available, there was a strong negative association between (18)F-AV1451 and (18)F-FDG uptake (Pearson's r = -0.49 ± 0.07, P < 0.001) and less pronounced positive associations between (11)C-PiB and (18)F

  20. Tau PET patterns mirror clinical and neuroanatomical variability in Alzheimer's disease.

    PubMed

    Ossenkoppele, Rik; Schonhaut, Daniel R; Schöll, Michael; Lockhart, Samuel N; Ayakta, Nagehan; Baker, Suzanne L; O'Neil, James P; Janabi, Mustafa; Lazaris, Andreas; Cantwell, Averill; Vogel, Jacob; Santos, Miguel; Miller, Zachary A; Bettcher, Brianne M; Vossel, Keith A; Kramer, Joel H; Gorno-Tempini, Maria L; Miller, Bruce L; Jagust, William J; Rabinovici, Gil D

    2016-05-01

    SEE SARAZIN ET AL DOI101093/BRAIN/AWW041 FOR A SCIENTIFIC COMMENTARY ON THIS ARTICLE: The advent of the positron emission tomography tracer (18)F-AV1451 provides the unique opportunity to visualize the regional distribution of tau pathology in the living human brain. In this study, we tested the hypothesis that tau pathology is closely linked to symptomatology and patterns of glucose hypometabolism in Alzheimer's disease, in contrast to the more diffuse distribution of amyloid-β pathology. We included 20 patients meeting criteria for probable Alzheimer's disease dementia or mild cognitive impairment due to Alzheimer's disease, presenting with a variety of clinical phenotypes, and 15 amyloid-β-negative cognitively normal individuals, who underwent (18)F-AV1451 (tau), (11)C-PiB (amyloid-β) and (18)F-FDG (glucose metabolism) positron emission tomography, apolipoprotein E (APOE) genotyping and neuropsychological testing. Voxel-wise contrasts against controls (at P < 0.05 family-wise error corrected) showed that (18)F-AV1451 and (18)F-FDG patterns in patients with posterior cortical atrophy ('visual variant of Alzheimer's disease', n = 7) specifically targeted the clinically affected posterior brain regions, while (11)C-PiB bound diffusely throughout the neocortex. Patients with an amnestic-predominant presentation (n = 5) showed highest (18)F-AV1451 retention in medial temporal and lateral temporoparietal regions. Patients with logopenic variant primary progressive aphasia ('language variant of Alzheimer's disease', n = 5) demonstrated asymmetric left greater than right hemisphere (18)F-AV1451 uptake in three of five patients. Across 30 FreeSurfer-defined regions of interest in 16 Alzheimer's disease patients with all three positron emission tomography scans available, there was a strong negative association between (18)F-AV1451 and (18)F-FDG uptake (Pearson's r = -0.49 ± 0.07, P < 0.001) and less pronounced positive associations between (11)C-PiB and (18)F

  1. Characterization and genetic variability of feed-borne and clinical animal/human Aspergillus fumigatus strains using molecular markers.

    PubMed

    Pena, Gabriela A; Coelho, Irene; Reynoso, María M; Soleiro, Carla; Cavaglieri, Lilia R

    2015-09-01

    Aspergillus fumigatus, the major etiological agent of human and animal aspergillosis, is a toxigenic fungus largely regarded as a single species by macroscopic and microscopic features. However, molecular studies have demonstrated that several morphologically identified A. fumigatus strains might be genetically distinct. This work was aimed to apply PCR-restriction length fragment polymorphisms (PCR-RFLP) and random amplification of polymorphic DNA (RAPD) molecular markers to characterize a set of feed-borne and clinical A. fumigatus sensu lato strains isolated from Argentina and Brazil and to determine and compare their genetic variability. All A. fumigatus strains had the same band profile and those typical of A. fumigatus sensu stricto positive controls by PCR-RFLP. Moreover, all Argentinian and Brazilian strains typified by RAPD showed similar band patterns to each other and to A. fumigatus sensu stricto reference strains regardless of their isolation source (animal feeds or human/animal clinical cases) and geographic origin. Genetic similarity coefficients ranged from 0.61 to 1.00, but almost all isolates showed 78% of genetic similarly suggesting that genetic variability was found at intraspecific level. Finally, benA sequencing confirmed its identification as A. fumigatus sensu stricto species. These results suggest that A. fumigatus sensu stricto is a predominant species into Aspergillus section Fumigati found in animal environments as well as in human/animal clinical cases, while other species may be rarely isolated. The strains involved in human and animal aspergillosis could come from the environment where this fungus is frequently found. Rural workers and animals would be constantly exposed.

  2. Conventional clinical and prognostic variables in 150 oral squamous cell carcinoma cases from the indigenous population of Karachi

    PubMed Central

    Alamgir, Muhammad Mohiuddin; Jamal, Qamar; Mirza, Talat

    2016-01-01

    Objective: To analyze clinical and prognostic variables of Oral Squamous Cell Carcinoma (OSCC) cases from the indigenous population of Karachi and to correlate with the common risk factor of tobacco habit. Methods: The study was conducted at Ziauddin University, Karachi. One hundred fifty OSCC cases were collected from the Oncology Department of Ziauddin University Hospital, North Nazimabad, Karachi and Otolaryngology ward of Civil Hospital, Karachi, during 2011 and 2015. The reporting included demographic details and variables like intra-oral subsites, clinical stage and histological grade. Recurrence of tumor after initial resection was also documented. Results: The patient’s population comprised of 98 males and 52 females. The mean age was 47.1± 12.22 (range:20-78 years). Maximum numbers were seen in the 41–50 years age group. Urdu-speaking community was the most affected ethnic group (n=75). Clinico-pathological analysis revealed that majority of cases were moderately differentiated (59%) and were either clinical stage II (35%) or IV (29%) tumors. The most common intra-oral subsite came out to be buccal mucosa of cheeks (56%) followed by lateral borders of tongue (21%), lips (13%), alveolar (6%), palate (2.6%) floor of mouth (1.3%), etc. Recurrence was observed in 08 out of 150 cases. All patients underwent primary resection±neck dissection and reconstruction where possible. Conclusions: Overall experience with oral squamous cell carcinoma shows that it has a high tendency for local invasion as well as dissemination to regional lymph nodes, i.e. cervical lymph nodes, both are associated with a poor prognosis. Preventable risk factor of tobacco chewing has been observed in majority of these cases. PMID:27375712

  3. Clinical NECR in 18F-FDG PET scans: optimization of injected activity and variable acquisition time. Relationship with SNR

    NASA Astrophysics Data System (ADS)

    Carlier, T.; Ferrer, L.; Necib, H.; Bodet-Milin, C.; Rousseau, C.; Kraeber-Bodéré, F.

    2014-10-01

    The injected activity and the acquisition time per bed position for 18F-FDG PET scans are usually optimized by using metrics obtained from phantom experiments. However, optimal activity and time duration can significantly vary from a phantom set-up and from patient to patient. An approach using a patient-specific noise equivalent count rate (NECR) modelling has been previously proposed for optimizing clinical scanning protocols. We propose using the clinical NECR on a large population as a function of the body mass index (BMI) for deriving the optimal injected activity and acquisition duration per bed position. The relationship between the NEC and the signal-to-noise ratio (SNR) was assessed both in a phantom and in a clinical setting. 491 consecutive patients were retrospectively evaluated and divided into 4 BMI subgroups. Two criteria were used to optimize the injected activity and the time per bed position was adjusted using the NECR value while keeping the total acquisition time constant. Finally, the relationship between NEC and SNR was investigated using an anthropomorphic phantom and a population of 507 other patients. While the first dose regimen suggested a unique injected activity (665 MBq) regardless of the BMI, the second dose regimen proposed a variable activity and a total acquisition time according to the BMI. The NEC improvement was around 35% as compared with the local current injection rule. Variable time per bed position was derived according to BMI and anatomical region. NEC and number of true events were found to be highly correlated with SNR for the phantom set-up and partially confirmed in the patient study for the BMI subgroup under 28 kg m-2 suggesting that for the scanner, the nonlinear reconstruction algorithm used in this study and BMI < 28 kg m-2, NEC, or the number of true events linearly correlated with SNR2.

  4. [Individual variability in the structure and topography of the celiac plexus and its clinical significance].

    PubMed

    Vlasova, M I

    2000-01-01

    Using anatomical and histological methods individual variability of structure and topography of coeliac plexus 94 preparations of adults of both sexes were studied. In 32% coeliac plexus was presented as a multitude of small ganglia connected by a network of nerve fibres remote from visceral branches of aorta. In 38% the plexus was composed of middle sized ganglia concentrated into groups at the level of coeliac trunk from the left and at the level of the source of superior mesenteric artery without contacts wit lig.arcuatum from right, histologically ganglia had lobular structure with low amount of connective tissue (29%-50%). In 30% it was comprised of 2-4 large conglomerates of ganglia attached to lig.arcuatum from the bottom forming a dense circle around the vessel, decline in neuron relative number was discovered histologically. Single neurons surrounded by rough fibrous tissue were observed instead of lobules (42-94%). Correlation between structure and topography of the plexus and skeletotopy of coeliac trunk, aorta and lig.arcuatum were established which can be used to reveal "risk" groups involving neuroganglionic component in extravasal compression of coeliac trunk.

  5. Epidermal growth factor receptor mutation in adenocarcinoma lung in a North Indian population: Prevalence and relation with different clinical variables

    PubMed Central

    Kasana, Basharat Ahmad; Dar, Waseem Raja; Aziz, Sheikh Aijaz; Lone, Abdul Rashid; Sofi, Najeeb Ullah; Dar, Imtiyaz Ahmad; Latief, Muzamil; Arshad, Faheem; Hussain, Moomin; Hussain, Mir

    2016-01-01

    Introduction: Lung cancer is one of the most common causes of cancer deaths worldwide. Adenocarcinoma is taking over squamous cell lung cancer as the predominant histological subtype. Several cytotoxic drugs are available for the treatment of lung cancer, but side effects limit their use. Recently, targeted therapies for cancers have come into clinical practice. Aims and Objectives: To determine the prevalence of epidermal growth factor receptor (EGFR) mutation in adenocarcinoma lung in a North Indian population and its relation with different clinical variables. Materials and Methods: A total of 57 patients who met inclusion criteria were recruited into the study. Relevant history, clinical examination and investigations were done. EGFR mutation was done in all patients. Results: A total of twenty patients tested positive for EGFR mutation. EGFR was more frequently detected in female patients (53.8%), while as only 19.4% of the male patients expressed EGFR mutation, which was statistically very significant (P = 0.007). EGFR mutation was more frequently detected in nonsmokers (52%) as compared to smokers (21.9%) which also was statistically significant (P value of 0.018). EGFR mutation was more common in Stage III and IV adenocarcinomas (48%) as compared to Stage I and II (21.4%) which was statistically significant (P value 0.034). Conclusion: EGFR mutation should be routinely done in all patients of adenocarcinoma lung particularly non-smoker females with Stage III and IV disease. PMID:27688613

  6. Risk estimates for hip fracture from clinical and densitometric variables and impact of database selection in Lebanese subjects.

    PubMed

    Badra, Mohammad; Mehio-Sibai, Abla; Zeki Al-Hazzouri, Adina; Abou Naja, Hala; Baliki, Ghassan; Salamoun, Mariana; Afeiche, Nadim; Baddoura, Omar; Bulos, Suhayl; Haidar, Rachid; Lakkis, Suhayl; Musharrafieh, Ramzi; Nsouli, Afif; Taha, Assaad; Tayim, Ahmad; El-Hajj Fuleihan, Ghada

    2009-01-01

    Bone mineral density (BMD) and fracture incidence vary greatly worldwide. The data, if any, on clinical and densitometric characteristics of patients with hip fractures from the Middle East are scarce. The objective of the study was to define risk estimates from clinical and densitometric variables and the impact of database selection on such estimates. Clinical and densitometric information were obtained in 60 hip fracture patients and 90 controls. Hip fracture subjects were 74 yr (9.4) old, were significantly taller, lighter, and more likely to be taking anxiolytics and sleeping pills than controls. National Health and Nutrition Examination Survey (NHANES) database selection resulted in a higher sensitivity and almost equal specificity in identifying patients with a hip fracture compared with the Lebanese database. The odds ratio (OR) and its confidence interval (CI) for hip fracture per standard deviation (SD) decrease in total hip BMD was 2.1 (1.45-3.05) with the NHANES database, and 2.11 (1.36-2.37) when adjusted for age and body mass index (BMI). Risk estimates were higher in male compared with female subjects. In Lebanese subjects, BMD- and BMI-derived hip fracture risk estimates are comparable to western standards. The study validates the universal use of the NHANES database, and the applicability of BMD- and BMI-derived risk fracture estimates in the World Health Organization (WHO) global fracture risk model, to the Lebanese. PMID:19246223

  7. Novel method for early signs of clinical shock detection by monitoring blood capillary/vessel spatial pattern.

    PubMed

    Kanawade, Rajesh; Klämpfl, Florian; Riemann, Max; Knipfer, Christian; Tangermann-Gerk, Katja; Schmidt, Michael; Stelzle, Florian

    2014-10-01

    The ability to monitor capillary/vessel spatial patterns and local blood volume fractions is critical in clinical shock detection and its prevention in Intensive Care Units (ICU). Although the causes of shock might be different, the basic abnormalities in pathophysiological changes are the same. To detect these changes, we have developed a novel method based on both spectrally and spatially resolved diffuse reflectance spectra. The preliminary study has shown that this method can monitor the spatial distribution of capillary/vessel spatial patterns through local blood volume fractions of reduced hemoglobin and oxyhemoglobin. This method can be used as a real-time and non-invasive tool for the monitoring of shock development and feedback on the therapeutic intervention.

  8. Self-Monitoring in Clinical Practice: A Challenge for Medical Educators

    ERIC Educational Resources Information Center

    Epstein, Ronald M.; Siegel, Daniel J.; Silberman, Jordan

    2008-01-01

    Recent literature has described how the capacity for concurrent self-assessment--ongoing moment-to-moment self-monitoring--is an important component of the professional competence of physicians. Self-monitoring refers to the ability to notice our own actions, curiosity to examine the effects of those actions, and willingness to use those…

  9. Understanding Spatial and Temporal Variability in Ozone Levels within a Remote-sensing Scale Grid Cell using Data Collected with Low-cost, Next Generation Monitoring Systems

    NASA Astrophysics Data System (ADS)

    Collier, A. M.; Hannigan, M.; Masson, N.; Piedrahita, R.; Gordon, J. L.; Russel, M.

    2014-12-01

    For the past several years, our research group has been developing low-cost (for reference, each unit costs under $1000) next generation air quality monitors, which utilize metal-oxide semiconductor sensors and non-dispersive infrared sensors to collect data on various gaseous pollutants. The pollutants of focus for this deployment were CO2, O3, and NO2. Additional data collected by the monitors includes temperature, humidity, wind speed and direction, and some information on hydrocarbon levels. A main focus of our research has been sensor characterization and exploring research applications of the technology. During summer 2014, the DISCOVER-AQ and FRAPPE sampling campaigns provided our group with the opportunity to deploy twenty monitors throughout the sampling region with the Boulder Atmospheric Observatory Tower in Erie CO at the center of our monitoring area. Thirteen of these monitors were located at ground-level within an approximately 10 by 10 km grid cell, and the rest were outside of this area at various distances. This placement was intended to provide information on pollutant variability, specifically ozone, within a remote-sensing sized grid cell. Additionally, the availability of reference monitors in the field provided opportunities for co-location during the deployment and hence, opportunities to quantify monitor performance. Analysis will include both an evaluation of low-cost sensor performance and a look at temporal and spatial variability. For example, land-use regression modeling will be used to explore population density, distance to roadways, and distance to oil and gas activity as covariates. Additionally, we will explore how the spatial distribution varies with time and look for temporal patterns.

  10. A temperature-based variable for monitoring outdoor coil airflow in an air-source heat pump during frost-forming conditions

    SciTech Connect

    Payne, W.V. II; O`Neal, D.L.

    1994-12-31

    Frost-buildup tests were conducted on a 3-ton (10.6kW) nominal cooling capacity air-source heat pump with an orifice expansion device. This study was conducted to determine if a simple temperature-based control variable could be used to determine the amount of degradation in the outdoor airflow (and heating capacity) of the unit. Refrigerant pressures and temperatures were monitored through-out the system in addition to power requirements and airflow rates. A temperature-based variable was developed that could be used to predict airflow degradation across the outdoor heat exchanger. This variable was defined using the difference between ambient air temperature and a measured refrigerant temperature. Eight refrigerant temperatures in the system were recorded and evaluated. Plots of airflow as a function of this temperature variable, along with plots of the absolute value percent changes of this temperature variable and airflow, were evaluated to determine which refrigerant temperatures could best be used in the variable to predict degradation in airflow. The best fit between the temperature-based variable and airflow degradation occurred with the inclusion of the refrigerant temperature at the outlet from the evaporator. Calculations of percent changes based on values sampled after a defrost showed a polynomial or linear relationship between airflow and the temperature-based variable. Data from two previously tested heat pumps were also used to compare changes in the outdoor airflow to changes in the temperature-based variable. The base-case heat pump and another heat pump both used an orifice as the expansion device in the heating mode. A third heat pump, which used a thermostatic expansion valve (TXV) as the expansion device in the heating mode, failed to show the same goodness of fit between airflow and the temperature-based variable.

  11. Variability in response to nonsteroidal anti-inflammatory analgesics: evidence from controlled clinical therapeutic trial of flurbiprofen in rheumatoid arthritis.

    PubMed Central

    Preston, S J; Arnold, M H; Beller, E M; Brooks, P M; Buchanan, W W

    1988-01-01

    1. A clinical trial was conducted with flurbiprofen 100 mg three times a day by mouth in rheumatoid arthritis to determine variability in response. 2. Forty patients entered the study, but only 32 completed it. Patients were treated with flurbiprofen on two occasions at a month's interval, each being preceded by a 3 day wash out period. Pain relief and a Ritchie articular index of joint tenderness was assessed at the beginning and end of each treatment period. 3. Flurbiprofen produced significant improvement in both pain relief and articular tenderness. No significant differences were observed between the two trial periods in the mean of these outcome measures. 4. No evidence was found to support the concept of responders and non-responders. PMID:3242581

  12. Investigation of horizontal and vertical variability of sediment pollution in groyne fields of the Middle Elbe (Germany) in a perspective of sediment monitoring

    NASA Astrophysics Data System (ADS)

    Büttner, Olaf; Baborowski, Martina; Morgenstern, Peter; Jancke, Thomas; Westrich, Bernhard

    2013-04-01

    High spatial heterogeneity of physical and chemical sediment properties was observed in horizontal and vertical direction of the deposits in a groyne field of the middle Elbe. The respective sediment cores were less polluted on the top as compared to consolidated deeper layers, indicating a decreasing trend of contamination in the river basin. In contrast to water quality monitoring, the impact of the large Elbe flood in 2002 was still visible in the deeper layers of the groyne field sediments six years after the event. Because environmental risk increases with erosion potential of discharge and contamination level of sediments, monitoring for environmental risk must capture not only surface sediments but also deeper layers up to an anticipated erosion depth [1]. Reference [1] Baborowski M, Büttner O, Morgenstern P, Jancke T, Westrich B (2012) Spatial variability of metal pollution in groyne fields of the Middle Elbe - Implications for sediment monitoring. Environmental Pollution 167(0): 115-123

  13. Feasibility of Using Clinical Element Models (CEM) to Standardize Phenotype Variables in the Database of Genotypes and Phenotypes (dbGaP)

    PubMed Central

    Lin, Ko-Wei; Tharp, Melissa; Conway, Mike; Hsieh, Alexander; Ross, Mindy; Kim, Jihoon; Kim, Hyeon-Eui

    2013-01-01

    The database of Genotypes and Phenotypes (dbGaP) contains various types of data generated from genome-wide association studies (GWAS). These data can be used to facilitate novel scientific discoveries and to reduce cost and time for exploratory research. However, idiosyncrasies and inconsistencies in phenotype variable names are a major barrier to reusing these data. We addressed these challenges in standardizing phenotype variables by formalizing their descriptions using Clinical Element Models (CEM). Designed to represent clinical data, CEMs were highly expressive and thus were able to represent a majority (77.5%) of the 215 phenotype variable descriptions. However, their high expressivity also made it difficult to directly apply them to research data such as phenotype variables in dbGaP. Our study suggested that simplification of the template models makes it more straightforward to formally represent the key semantics of phenotype variables. PMID:24058713

  14. Human papillomavirus and host variables as predictors of clinical course in patients with juvenile-onset recurrent respiratory papillomatosis.

    PubMed Central

    Gabbott, M; Cossart, Y E; Kan, A; Konopka, M; Chan, R; Rose, B R

    1997-01-01

    This study provides the first systematic evaluation of papillomavirus type and viral mutation occurring during the course of juvenile-onset recurrent respiratory papillomatosis. One hundred ninety-nine consecutive papillomas excised from 47 children between 1981 and 1996 at The New Children's Hospital in Sydney, Australia, were tested for human papillomavirus (HPV) DNA by PCR. PCR products from the viral upstream regulatory region (URR) enhancer were sequenced, and variation was related to clinical variables. Forty-four of the 47 children had HPV-induced papillomas, with type 11 accounting for 24 (55%) and type 6 accounting for 19 (43%); one (2%) was positive for either type 6 or 11. Overall, 183 (98%) of the 186 samples with amplifiable DNA were HPV positive. There was no change in HPV type over time and no statistically significant association between HPV type and disease aggressiveness. One novel, large-scale URR duplication was identified in an HPV type 11 isolate in the last of a series of six papillomas examined and the first from the bronchus. However, the duplication was not found in HPV type 11 isolates from the associated pulmonary carcinoma and its metastases in other organs. Three of 14 URR point mutations coincided with transcription factor binding sites, but there were no obvious associations with clinical course. Chi-square and multiple linear regression analyses of clinicopathological variables revealed early age at diagnosis (less than 4 years) as an independent predictor of aggressive disease (P < 0.001). A bimodal distribution of the age at diagnosis was noted, with peaks at 2 and 11 years of age. PMID:9399501

  15. Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

    PubMed Central

    Kalali, Amir; West, Mark; Walling, David; Hilt, Dana; Engelhardt, Nina; Alphs, Larry; Loebel, Antony; Vanover, Kim; Atkinson, Sarah; Opler, Mark; Sachs, Gary; Nations, Kari; Brady, Chris

    2016-01-01

    This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed. PMID:27413584

  16. Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders.

    PubMed

    Daniel, David; Kalali, Amir; West, Mark; Walling, David; Hilt, Dana; Engelhardt, Nina; Alphs, Larry; Loebel, Antony; Vanover, Kim; Atkinson, Sarah; Opler, Mark; Sachs, Gary; Nations, Kari; Brady, Chris

    2016-01-01

    This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed.

  17. Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation

    PubMed Central

    2016-01-01

    Background Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3–12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. Objective The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a “real world” context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. Methods A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. Results In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM

  18. Fuzzy-Arden-Syntax-based, Vendor-agnostic, Scalable Clinical Decision Support and Monitoring Platform.

    PubMed

    Adlassnig, Klaus-Peter; Fehre, Karsten; Rappelsberger, Andrea

    2015-01-01

    This study's objective is to develop and use a scalable genuine technology platform for clinical decision support based on Arden Syntax, which was extended by fuzzy set theory and fuzzy logic. Arden Syntax is a widely recognized formal language for representing clinical and scientific knowledge in an executable format, and is maintained by Health Level Seven (HL7) International and approved by the American National Standards Institute (ANSI). Fuzzy set theory and logic permit the representation of knowledge and automated reasoning under linguistic and propositional uncertainty. These forms of uncertainty are a common feature of patients' medical data, the body of medical knowledge, and deductive clinical reasoning.

  19. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2016 OUTPATIENT GLUCOSE MONITORING CONSENSUS STATEMENT.

    PubMed

    Bailey, Timothy S; Grunberger, George; Bode, Bruce W; Handelsman, Yehuda; Hirsch, Irl B; Jovanovič, Lois; Roberts, Victor Lawrence; Rodbard, David; Tamborlane, William V; Walsh, John

    2016-02-01

    This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician. PMID:26848630

  20. [CLINICAL GUIDELINES FOR DIAGNOSIS, TREATMENT AND MONITORING OF PATIENTS WITH INVASIVE BREAST CANCER--CROATIAN ONCOLOGY SOCIETY].

    PubMed

    Šeparović, Robert; Ban, Marija; Silovska, Tajana; Oresković, Lidija Beketić; Soldić, Željko; Podolski, Paula; Pleština, Stjepko; Gugić, Damir; Petković, Marija; Jakić-Razumović, Jasminka; Vojnović, Zeljko; Miše, Branka Petrić; Tomić, Snježana; Stanec, Zdenko; Vrdoljak, Danko Velemir; Drinković, Ivan; Brkljačić, Boris; Mustać, Elvira; Utrobičić, Ivan; Vrdoljak, Eduard

    2015-01-01

    Breast cancer is the most common cancer in women. It can be diagnosed in early stage through screening, early detection and educational programs, and when diagnosed early it can be efficiently treated. Treatment modalities include surgery, chemotherapy, radiotherapy, hormonal therapy and targeted biologic therapy, according to the stage of the disease and patient condition. Treatment decisions should be made after multidisciplinary team discussion. Due to the significance of this disease it is important to define and implement standardized approach for diagnostic, treatment and monitoring algorithm as well. The following text presents the clinical guidelines in order to standardize the procedures and criteria for diagnosis, management, treatment and monitoring of patients with breast cancer in the Republic of Croatia. PMID:26380471

  1. Evaluating the Clinical Accuracy of GlucoMen®Day: A Novel Microdialysis-based Continuous Glucose Monitor

    PubMed Central

    Valgimigli, Francesco; Lucarelli, Fausto; Scuffi, Cosimo; Morandi, Sara; Sposato, Iolanda

    2010-01-01

    Background The objective of this work was to determine the clinical accuracy of GlucoMen®Day, a new microdialysis-based continuous glucose monitoring system (CGMS) from A. Menarini Diagnostics (Florence, Italy). Accuracy evaluation was performed using continuous glucose-error grid analysis (CG-EGA), as recommended by the Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline (POCT05-A). Methods Two independent clinical trials were carried out on patients with types 1 and 2 diabetes mellitus, the glycemic levels of whom were monitored in an in-home setting for 100-hour periods. A new multiparametric algorithm was developed and used to compensate in real-time the GlucoMen®Day signal. The time lag between continuous glucose monitoring (CGM) and reference data was first estimated using the Poincaré plot method. The entire set of CGM/reference data pairs was then evaluated following the CG-EGA criteria, which allowed an estimation of the combined point and rate accuracy stratified by glycemic ranges. Results With an estimated time lag of 11 minutes, the linear regression analysis of the CGM/reference glucose values yielded r = 0.92. The mean absolute error (MAE) was 11.4 mg/dl. The calculated mean absolute rate deviation (MARD) was 0.63 mg/dl/min. The data points falling within the A+B zones of CG-EGA were 100% in hypoglycemia, 95.7% in euglycemia, and 95.2% in hyperglycemia. Conclusions The GlucoMen®Day system provided reliable, real-time measurement of subcutaneous glucose levels in patients with diabetes for up to 100 hours. The device showed the ability to follow rapid glycemic excursions and detect severe hypoglycemic events accurately. Its accuracy parameters fitted the criteria of the state-of-the-art consensus guideline for CGMS, with highly consistent results from two independent studies. PMID:20920438

  2. Monitoring and root cause analysis of clinical biochemistry turn around time at an academic hospital.

    PubMed

    Chauhan, Kiran P; Trivedi, Amit P; Patel, Dharmik; Gami, Bhakti; Haridas, N

    2014-10-01

    Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7-8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction. PMID:25298634

  3. Verification of monitor unit calculations for non-IMRT clinical radiotherapy: Report of AAPM Task Group 114

    SciTech Connect

    Stern, Robin L.; Heaton, Robert; Fraser, Martin W.; and others

    2011-01-15

    The requirement of an independent verification of the monitor units (MU) or time calculated to deliver the prescribed dose to a patient has been a mainstay of radiation oncology quality assurance. The need for and value of such a verification was obvious when calculations were performed by hand using look-up tables, and the verification was achieved by a second person independently repeating the calculation. However, in a modern clinic using CT/MR/PET simulation, computerized 3D treatment planning, heterogeneity corrections, and complex calculation algorithms such as convolution/superposition and Monte Carlo, the purpose of and methodology for the MU verification have come into question. In addition, since the verification is often performed using a simpler geometrical model and calculation algorithm than the primary calculation, exact or almost exact agreement between the two can no longer be expected. Guidelines are needed to help the physicist set clinically reasonable action levels for agreement. This report addresses the following charges of the task group: (1) To re-evaluate the purpose and methods of the ''independent second check'' for monitor unit calculations for non-IMRT radiation treatment in light of the complexities of modern-day treatment planning. (2) To present recommendations on how to perform verification of monitor unit calculations in a modern clinic. (3) To provide recommendations on establishing action levels for agreement between primary calculations and verification, and to provide guidance in addressing discrepancies outside the action levels. These recommendations are to be used as guidelines only and shall not be interpreted as requirements.

  4. Verification of monitor unit calculations for non-IMRT clinical radiotherapy: report of AAPM Task Group 114.

    PubMed

    Stern, Robin L; Heaton, Robert; Fraser, Martin W; Goddu, S Murty; Kirby, Thomas H; Lam, Kwok Leung; Molineu, Andrea; Zhu, Timothy C

    2011-01-01

    The requirement of an independent verification of the monitor units (MU) or time calculated to deliver the prescribed dose to a patient has been a mainstay of radiation oncology quality assurance. The need for and value of such a verification was obvious when calculations were performed by hand using look-up tables, and the verification was achieved by a second person independently repeating the calculation. However, in a modern clinic using CT/MR/PET simulation, computerized 3D treatment planning, heterogeneity corrections, and complex calculation algorithms such as convolution/superposition and Monte Carlo, the purpose of and methodology for the MU verification have come into question. In addition, since the verification is often performed using a simpler geometrical model and calculation algorithm than the primary calculation, exact or almost exact agreement between the two can no longer be expected. Guidelines are needed to help the physicist set clinically reasonable action levels for agreement. This report addresses the following charges of the task group: (1) To re-evaluate the purpose and methods of the "independent second check" for monitor unit calculations for non-IMRT radiation treatment in light of the complexities of modern-day treatment planning. (2) To present recommendations on how to perform verification of monitor unit calculations in a modern clinic. (3) To provide recommendations on establishing action levels for agreement between primary calculations and verification, and to provide guidance in addressing discrepancies outside the action levels. These recommendations are to be used as guidelines only and shall not be interpreted as requirements.

  5. A pilot clinical trial on a Variable Automated Speed and Sensing Treadmill (VASST) for hemiparetic gait rehabilitation in stroke patients

    PubMed Central

    Chua, Karen S. G.; Chee, Johnny; Wong, Chin J.; Lim, Pang H.; Lim, Wei S.; Hoo, Chuan M.; Ong, Wai S.; Shen, Mira L.; Yu, Wei S.

    2015-01-01

    Introduction: Impairments in walking speed and capacity are common problems after stroke which may benefit from treadmill training. However, standard treadmills, are unable to adapt to the slower walking speeds of stroke survivors and are unable to automate training progression. This study tests a Variable Automated Speed and Sensing Treadmill (VASST) using a standard clinical protocol. VASST is a semi-automated treadmill with multiple sensors and micro controllers, including wireless control to reposition a fall-prevention harness, variable pre-programmed exercise parameters and laser beam foot sensors positioned on the belt to detect subject's foot positions. Materials and Methods: An open-label study with assessor blinding was conducted in 10 community-dwelling chronic hemiplegic patients who could ambulate at least 0.1 m/s. Interventions included physiotherapist-supervised training on VASST for 60 min three times per week for 4 weeks (total 12 h). Outcome measures of gait speed, quantity, balance, and adverse events were assessed at baseline, 2, 4, and 8 weeks. Results: Ten subjects (8 males, mean age 55.5 years, 2.1 years post stroke) completed VASST training. Mean 10-m walk test speed was 0.69 m/s (SD = 0.29) and mean 6-min walk test distance was 178.3 m (84.0). After 4 weeks of training, 70% had significant positive gains in gait speed (0.06 m/s, SD = 0.08 m/s, P = 0.037); and 90% improved in walking distance. (54.3 m, SD = 30.9 m, P = 0.005). There were no adverse events. Discussion and Conclusion: This preliminary study demonstrates the initial feasibility and short-term efficacy of VASST for walking speed and distance for people with chronic post-stroke hemiplegia. PMID:26217170

  6. WEATHER ON THE NEAREST BROWN DWARFS: RESOLVED SIMULTANEOUS MULTI-WAVELENGTH VARIABILITY MONITORING OF WISE J104915.57–531906.1AB

    SciTech Connect

    Biller, Beth A.; Crossfield, Ian J. M.; Mancini, Luigi; Ciceri, Simona; Kopytova, Taisiya G.; Bonnefoy, Mickaël; Deacon, Niall R.; Schlieder, Joshua E.; Buenzli, Esther; Brandner, Wolfgang; Bailer-Jones, Coryn A. L.; Henning, Thomas; Goldman, Bertrand; Southworth, John; Allard, France; Homeier, Derek; Freytag, Bernd; Greiner, Jochen

    2013-11-20

    We present two epochs of MPG/ESO 2.2 m GROND simultaneous six-band (r'i'z' JHK) photometric monitoring of the closest known L/T transition brown dwarf binary WISE J104915.57–531906.1AB. We report here the first resolved variability monitoring of both the T0.5 and L7.5 components. We obtained 4 hr of focused observations on the night of 2013 April 22 (UT), as well as 4 hr of defocused (unresolved) observations on the night of 2013 April 16 (UT). We note a number of robust trends in our light curves. The r' and i' light curves appear to be anti-correlated with z' and H for the T0.5 component and in the unresolved light curve. In the defocused dataset, J appears correlated with z' and H and anti-correlated with r' and i', while in the focused dataset we measure no variability for J at the level of our photometric precision, likely due to evolving weather phenomena. In our focused T0.5 component light curve, the K band light curve displays a significant phase offset relative to both H and z'. We argue that the measured phase offsets are correlated with atmospheric pressure probed at each band, as estimated from one-dimensional atmospheric models. We also report low-amplitude variability in i' and z' intrinsic to the L7.5 component.

  7. A new definition of pharmaceutical quality: assembly of a risk simulation platform to investigate the impact of manufacturing/product variability on clinical performance.

    PubMed

    Short, Steven M; Cogdill, Robert P; D'Amico, Frank; Drennen, James K; Anderson, Carl A

    2010-12-01

    The absence of a unanimous, industry-specific definition of quality is, to a certain degree, impeding the progress of ongoing efforts to "modernize" the pharmaceutical industry. This work was predicated on requests by Dr. Woodcock (FDA) to re-define pharmaceutical quality in terms of risk by linking production characteristics to clinical attributes. A risk simulation platform that integrates population statistics, drug delivery system characteristics, dosing guidelines, patient compliance estimates, production metrics, and pharmacokinetic, pharmacodynamic, and in vitro-in vivo correlation models to investigate the impact of manufacturing variability on clinical performance of a model extended-release theophylline solid oral dosage system was developed. Manufacturing was characterized by inter- and intra-batch content uniformity and dissolution variability metrics, while clinical performance was described by a probabilistic pharmacodynamic model that expressed the probability of inefficacy and toxicity as a function of plasma concentrations. Least-squares regression revealed that both patient compliance variables, percent of doses taken and dosing time variability, significantly impacted efficacy and toxicity. Additionally, intra-batch content uniformity variability elicited a significant change in risk scores for the two adverse events and, therefore, was identified as a critical quality attribute. The proposed methodology demonstrates that pharmaceutical quality can be recast to explicitly reflect clinical performance.

  8. Monitoring colony phenology using within-day variability in continuous weight and temperature of honey bee hives

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Continuous weight and temperature data were collected for honey bee hives in two locations in Arizona, and those data were evaluated with respect to separate measurements of hive phenology to develop methods for monitoring hives non-invasively. Both the weight and temperature data were divided into ...

  9. Detection of beta-class variability in Black Hole source GRS 1915+105 by Astrosat Scanning Sky Monitor

    NASA Astrophysics Data System (ADS)

    Ramadevi, M. C.; Ravishankar, B. T.; Nandi, Anuj; Girish, V.; Singh, Brajpal; Jain, Anand; Agrawal, Vivek Kumar; Agarwal, Anil; Bhattacharya, Dipankar; Seetha, S.; Sharma, M. Ramakrishna; Sharan, Vaishali; Babu, V. C.; Yadav, Reena; Meena, G.; Murthy, N. Sitarama; Kumar; Ashoka, B. N.; Kulkarni, Ravi; Iyer, Nirmal; Radhika, D.; Kushwaha, Ankur; Balaji, K.; Nagesh, G.; Kumar, Manoj; Gaan, Dhruti Ranjan; Kulshresta, Prashanth; Agarwal, Pankaj; Sebastin, Matthew; Rajarajan, A.; Rao, S. V. S. Subba; Pandiyan; R.; Rao, K. Subba; Rao, Chaitra; Sarma, K. Suryanarayana

    2015-10-01

    The Scanning Sky Monitor (SSM) on board ASTROSAT was made operational on October 12th, 2015, the 15th day after launch (September 28th, 2015). After initial observations of the Crab Nebula, on October 14th 2015, the SSM was maneuvered for a stare at the galactic Black Hole source GRS 1915+105.

  10. FDG PET/CT response in diffuse large B-cell lymphoma: Reader variability and association with clinical outcome.

    PubMed

    Han, Eun Ji; O, Joo Hyun; Yoon, Hyukjin; Jung, Seung Eun; Park, Gyeongsin; Choi, Byung Ock; Cho, Seok-Goo

    2016-09-01

    F-18-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) is essential for monitoring response to treatment in patients with diffuse large B-cell lymphoma (DLBCL) and qualitative interpretation is commonly applied in clinical practice. We aimed to evaluate the interobserver agreements of qualitative PET/CT response in patients with DLBCL and the predictive value of PET/CT results for clinical outcome.PET/CT images were obtained for patients with DLBCL 3 times: at baseline, after 3 cycles of first-line chemotherapy (interim), and after completion of chemotherapy. Two nuclear medicine physicians (with 3 and 8 years of experience with PET/CT) retrospectively assessed response to chemotherapy blinded to the clinical outcome using International Harmonization Project (IHP) criteria and Deauville 5-point score. The associations between PET/CT results and progression-free survival (PFS) and overall survival (OS) were assessed using Cox regression analysis.A total of 112 PET/CT images were included from 59 patients with DLBCL (36 male, 23 female; mean age 53 ± 14 years). Using the IHP criteria, interobserver agreement was substantial (Cohen κ = 0.76) with absolute agreement consistency of 89%. Using the Deauville score, interobserver agreement was moderate (Cohen weighted κ = 0.54) and absolute consistency was 62%. The most common cause of disagreements was discordant interpretation of residual tumor uptake. With median follow-up period of 60 months, estimated 5-year PFS and OS were 81% and 92%, respectively. Neither interim nor posttreatment PET/CT results by both readers were significantly associated with PFS. Interim PET/CT result by the more experienced reader using Deauville score was a significant factor for OS (P = 0.019).Moderate-to-substantial interobserver agreement was observed for response assessments according to qualitative PET/CT criteria, and interim PET/CT result could predict OS in patients with DLBCL. Further

  11. Development and clinical evaluation of noninvasive near-infrared monitoring of cerebral oxygenation

    NASA Astrophysics Data System (ADS)

    Wickramasinghe, Yappa A.; Rolfe, Peter J.; Palmer, Keith; Watkins, S.; Spencer, S. A.; Doyle, M.; O'Brien, S.; Walker, A.; Rice, C.; Smallpeice, C.

    1994-02-01

    Near infrared spectroscopy (NIRS) is a relatively new method which is suitable for monitoring oxygenation in blood and tissue in the brain of the fetus and the neonate. The technique involves in-vivo determination of the absorption of light in the wavelength range 775 to 900 nm through such tissue and converting such changes in absorbance to provide information about the changes in the concentration of oxygenated and de-oxygenated haemoglobin (HbO2 and Hb). Recent developments of the methodology now enable the calculation of changes in cerebral blood volume (CBV) as well as absolute CBV and cerebral blood flow (CBF). The attraction of this method is its applicability to monitor cerebral function in a wide variety of patient groups. Although primarily developed for neonatal use it is today applied on the fetus to investigate fetal hypoxia and on adults undergoing surgery.

  12. Monitoring of anti-cancer treatment with (18)F-FDG and (18)F-FLT PET: a comprehensive review of pre-clinical studies.

    PubMed

    Jensen, Mette Munk; Kjaer, Andreas

    2015-01-01

    Functional imaging of solid tumors with positron emission tomography (PET) imaging is an evolving field with continuous development of new PET tracers and discovery of new applications for already implemented PET tracers. During treatment of cancer patients, a general challenge is to measure treatment effect early in a treatment course and by that to stratify patients into responders and non-responders. With 2-deoxy-2-[(18)F]fluoro-D-glucose ((18)F-FDG) and 3'-deoxy-3'-[(18)F]fluorothymidine((18)F-FLT) two of the cancer hallmarks, altered energy metabolism and increased cell proliferation, can be visualized and quantified non-invasively by PET. With (18)F-FDG and (18)F-FLT PET changes in energy metabolism and cell proliferation can thereby be determined after initiation of cancer treatment in both clinical and pre-clinical studies in order to predict, at an early time-point, treatment response. It is hypothesized that decreases in glycolysis and cell proliferation may occur in tumors that are sensitive to the applied cancer therapeutics and that tumors that are resistant to treatment will show unchanged glucose metabolism and cell proliferation. Whether (18)F-FDG and/or (18)F-FLT PET can be used for prediction of treatment response has been analyzed in many studies both following treatment with conventional chemotherapeutic agents but also following treatment with different targeted therapies, e.g. monoclonal antibodies and small molecules inhibitors. The results from these studies have been most variable; in some studies early changes in (18)F-FDG and (18)F-FLT uptake predicted later tumor regression whereas in other studies no change in tracer uptake was observed despite the treatment being effective. The present review gives an overview of pre-clinical studies that have used (18)F-FDG and/or (18)F-FLT PET for response monitoring of cancer therapeutics.

  13. Monitoring of anti-cancer treatment with 18F-FDG and 18F-FLT PET: a comprehensive review of pre-clinical studies

    PubMed Central

    Jensen, Mette Munk; Kjaer, Andreas

    2015-01-01

    Functional imaging of solid tumors with positron emission tomography (PET) imaging is an evolving field with continuous development of new PET tracers and discovery of new applications for already implemented PET tracers. During treatment of cancer patients, a general challenge is to measure treatment effect early in a treatment course and by that to stratify patients into responders and non-responders. With 2-deoxy-2-[18F]fluoro-D-glucose (18F-FDG) and 3’-deoxy-3’-[18F]fluorothymidine(18F-FLT) two of the cancer hallmarks, altered energy metabolism and increased cell proliferation, can be visualized and quantified non-invasively by PET. With 18F-FDG and 18F-FLT PET changes in energy metabolism and cell proliferation can thereby be determined after initiation of cancer treatment in both clinical and pre-clinical studies in order to predict, at an early time-point, treatment response. It is hypothesized that decreases in glycolysis and cell proliferation may occur in tumors that are sensitive to the applied cancer therapeutics and that tumors that are resistant to treatment will show unchanged glucose metabolism and cell proliferation. Whether 18F-FDG and/or 18F-FLT PET can be used for prediction of treatment response has been analyzed in many studies both following treatment with conventional chemotherapeutic agents but also following treatment with different targeted therapies, e.g. monoclonal antibodies and small molecules inhibitors. The results from these studies have been most variable; in some studies early changes in 18F-FDG and 18F-FLT uptake predicted later tumor regression whereas in other studies no change in tracer uptake was observed despite the treatment being effective. The present review gives an overview of pre-clinical studies that have used 18F-FDG and/or 18F-FLT PET for response monitoring of cancer therapeutics. PMID:26550536

  14. In-situ monitoring of California's drought: Impacts on key hydrologic variables in the Southern Sierra Nevada

    NASA Astrophysics Data System (ADS)

    Oroza, C.; Zheng, Z.; Zhang, Z.; Glaser, S. D.; Bales, R. C.; Conklin, M. H.

    2015-12-01

    Like many semi-arid regions, California relies on seasonal snowmelt from the Sierra Nevada mountain range to provide freshwater allocations for multiple stakeholders throughout the year. The magnitude and timing of runoff from these regions is being altered by consecutive years of drought, affecting downstream ecosystems, hydropower operations, and deliveries to agriculture and urban water users. Understanding the long-term effect of drought on the montane water balance requires temporally continuous, in-situ measurements of key hydrologic variables across large spatial domains. We discuss a seven-year dataset from the Southern Sierra Critical Zone Observatory, which includes co-located measurements of snowpack, soil moisture, and soil temperature in the Kings River watershed. We investigate how these key hydrologic variables are affected as the region transitions from winters that have nearly continuous snow cover (2008-2011) to winters with extended snow-on, snow-off periods (2012-2014). For water year 2014, we observe a 93% decline in average snowpack, a 35% decline in average soil moisture, and a 25% increase in average soil temperature compared to a wet-year index of each variable. We discuss the effect of physiographic features, including slope, aspect, elevation, and canopy coverage on the changes observed in each variable. Finally, we use sparse inverse covariance estimation to investigate the changing conditional relationships throughout the observatory in wet and dry years.

  15. Variable tellurite resistance profiles of clinically-relevant Shiga toxin-producing Escherichia coli (STEC) influence their recovery from foodstuffs.

    PubMed

    Kerangart, Stéphane; Douëllou, Thomas; Delannoy, Sabine; Fach, Patrick; Beutin, Lothar; Sergentet-Thévenot, Delphine; Cournoyer, Benoit; Loukiadis, Estelle

    2016-10-01

    Tellurite (Tel)-amended selective media and resistance (Tel-R) are widely used for detecting Shiga toxin-producing Escherichia coli (STEC) from foodstuffs. Tel-R of 81 O157 and non-O157 STEC strains isolated from animal, food and human was thus investigated. Variations of STEC tellurite minimal inhibitory concentration (MIC) values have been observed and suggest a multifactorial and variable tellurite resistome between strains. Some clinically-relevant STEC were found highly susceptible and could not be recovered using a tellurite-based detection scheme. The ter operon was highly prevalent among highly Tel-R STEC but was not always detected among intermediately-resistant strains. Many STEC serogroup strains were found to harbor sublines showing a gradient of MIC values. These Tel-R sublines showed statistically significant log negative correlations with increasing tellurite concentration. Whatever the tellurite concentration, the highest number of resistant sublines was observed for STEC belonging to the O26 serogroup. Variations in the number of these Tel-R sublines could explain the poor recovery of some STEC serogroups on tellurite-amended media especially from food products with low levels of contamination. Comparison of tellurite MIC values and distribution of virulence-related genes showed Tel-R and virulence to be related. PMID:27375242

  16. Variable tellurite resistance profiles of clinically-relevant Shiga toxin-producing Escherichia coli (STEC) influence their recovery from foodstuffs.

    PubMed

    Kerangart, Stéphane; Douëllou, Thomas; Delannoy, Sabine; Fach, Patrick; Beutin, Lothar; Sergentet-Thévenot, Delphine; Cournoyer, Benoit; Loukiadis, Estelle

    2016-10-01

    Tellurite (Tel)-amended selective media and resistance (Tel-R) are widely used for detecting Shiga toxin-producing Escherichia coli (STEC) from foodstuffs. Tel-R of 81 O157 and non-O157 STEC strains isolated from animal, food and human was thus investigated. Variations of STEC tellurite minimal inhibitory concentration (MIC) values have been observed and suggest a multifactorial and variable tellurite resistome between strains. Some clinically-relevant STEC were found highly susceptible and could not be recovered using a tellurite-based detection scheme. The ter operon was highly prevalent among highly Tel-R STEC but was not always detected among intermediately-resistant strains. Many STEC serogroup strains were found to harbor sublines showing a gradient of MIC values. These Tel-R sublines showed statistically significant log negative correlations with increasing tellurite concentration. Whatever the tellurite concentration, the highest number of resistant sublines was observed for STEC belonging to the O26 serogroup. Variations in the number of these Tel-R sublines could explain the poor recovery of some STEC serogroups on tellurite-amended media especially from food products with low levels of contamination. Comparison of tellurite MIC values and distribution of virulence-related genes showed Tel-R and virulence to be related.

  17. Implementation of Out-of-Office Blood Pressure Monitoring in the Netherlands: From Clinical Guidelines to Patients' Adoption of Innovation.

    PubMed

    Carrera, Pricivel M; Lambooij, Mattijs S

    2015-10-01

    Out-of-office blood pressure monitoring is promoted by various clinical guidelines toward properly diagnosing and effectively managing hypertension and engaging the patient in their care process. In the Netherlands, however, the Dutch cardiovascular risk management (CVRM) guidelines do not explicitly prescribe 24-hour ambulatory blood pressure measurement (ABPM) and home BP measurement (HBPM). The aim of this descriptive study was to develop an understanding of patients' and physicians' acceptance and use of out-of-office BP monitoring in the Netherlands given the CVRM recommendations.Three small focus group discussions (FGDs) with patients and 1 FGD with physicians were conducted to explore the mechanisms behind the acceptance and use of out-of-office BP monitoring and reveal real-world challenges that limit the implementation of out-of-office BP monitoring methods. To facilitate the FGDs, an analytical framework based on the technology acceptance model (TAM), the theory of planned behavior and the model of personal computing utilization was developed to guide the FGDs and analysis of the transcriptions of each FGD.ABPM was the out-of-office BP monitoring method prescribed by physicians and used by patients. HBPM was not offered to patients even with patients' feedback of poor tolerance of ABPM. Even as there was little awareness about HBPM among patients, there were a few patients who owned and used sphygmomanometers. Patients professed and seemed to exhibit self-efficacy, whereas physicians had reservations about (all of their) patients' self-efficacy in properly using ABPM. Since negative experience with ABPM impacted patients' acceptance of ABPM, the interaction of factors that determined acceptance and use was found to be dynamic among patients but not for physicians.In reference to the CVRM guidelines, physicians implemented out-of-office BP monitoring but showed a strong preference for ABPM even where there is poor tolerance of the method. We found that

  18. Simultaneous Radio to (Sub-) Mm-Monitoring of Variability and Spectral Shape Evolution of Potential GLAST Blazars

    SciTech Connect

    Fuhrmann, L.; Zensus, J.A.; Krichbaum, T.P.; Angelakis, E.; Readhead, A.C.S.; /Caltech

    2011-11-29

    The Large Area Telescope (LAT) instrument onboard GLAST offers a tremendous opportunity for future blazar studies. In order to fully benefit from its capabilities and to maximize the scientific return from the LAT, it is of great importance to conduct dedicated multi-frequency monitoring campaigns that will result comprehensive observations. Consequently, we initiated an effort to conduct a GLAST-dedicated, quasi-simultaneous, broad-band flux-density (and polarization) monitoring of potential GLAST blazars with the Effelsberg and OVRO radio telescopes (11 cm to 7mm wavelength). Here, we present a short overview of these activities which will complement the multi-wavelengths activities of the GLAST/LAT collaboration towards the 'low-energy' radio bands. Further we will give a brief outlook including the extension of this coordinated campaign towards higher frequencies and future scientific aims.

  19. Spatial variability of metal pollution in groyne fields of the Middle Elbe--implications for sediment monitoring.

    PubMed

    Baborowski, M; Büttner, O; Morgenstern, P; Jancke, T; Westrich, B

    2012-08-01

    High spatial heterogeneity of physical and chemical sediment properties was observed in both horizontal and vertical directions of deposits in a groyne field of the Middle Elbe. The respective sediment cores were less polluted on the top compared to consolidated deeper layers, indicating a decreasing trend of contamination in the river basin. In contrast to water quality monitoring, the impact of the large Elbe flood in 2002 was still visible in the deeper layers (5-30 cm) of the groyne field sediments six years after the event. Due to the fact that the environmental risk increases with erosion potential of discharge and contamination level of sediments, monitoring for environmental risk must capture not only surface sediments but also deeper layers up to an anticipated erosion depth.

  20. Adjustment on the Type I Error Rate for a Clinical Trial Monitoring for both Intermediate and Primary Endpoints

    PubMed Central

    Halabi, Susan

    2013-01-01

    In many clinical trials, a single endpoint is used to answer the primary question and forms the basis for monitoring the experimental therapy. Many trials are lengthy in duration and investigators are interested in using an intermediate endpoint for an accelerated approval, but will rely on the primary endpoint (such as, overall survival) for the full approval of the drug by the Food and Drug Administration. We have designed a clinical trial where both intermediate (progression-free survival, (PFS)) and primary endpoints (overall survival, (OS)) are used for monitoring the trial so the overall type I error rate is preserved at the pre-specified alpha level of 0.05. A two-stage procedure is used. In the first stage, the Bonferroni correction was used where the global type I error rate was allocated to each of the endpoints. In the next stage, the O’Brien-Fleming approach was used to design the boundary for the interim and final analysis for each endpoint. Data were generated assuming several parametric copulas with exponential marginals. Different degrees of dependence, as measured by Kendall’s τ, between OS and PFS were assumed: 0 (independence) 0.3, 0.5 and 0.70. This approach is applied to an example in a prostate cancer trial. PMID:24466469

  1. A thermal monitoring sheet with low influence from adjacent waterbolus for tissue surface thermometry during clinical hyperthermia.

    PubMed

    Arunachalam, Kavitha; Maccarini, Paolo F; Stauffer, Paul R

    2008-10-01

    This paper presents a complete thermal analysis of a novel conformal surface thermometer design with directional sensitivity for real-time temperature monitoring during hyperthermia treatments of large superficial cancer. The thermal monitoring sheet (TMS) discussed in this paper consists of a 2-D array of fiberoptic sensors embedded between two layers of flexible, low-loss, and thermally conductive printed circuit board (PCB) film. Heat transfer across all interfaces from the tissue surface through multiple layers of insulating dielectrics surrounding the small buried temperature sensor and into an adjacent temperature-regulated water coupling bolus was studied using 3-D thermal simulation software. Theoretical analyses were carried out to identify the most effective differential TMS probe configuration possible with commercially available flexible PCB materials and to compare their thermal responses with omnidirectional probes commonly used in clinical hyperthermia. A TMS sensor design that employs 0.0508-mm Kapton MTB and 0.2032-mm Kapton HN flexible polyimide films is proposed for tissue surface thermometry with low influence from the adjacent waterbolus. Comparison of the thermal simulations with clinical probes indicates the new differential TMS probe design to outperform in terms of both transient response and steady-state accuracy in selectively reading the tissue surface temperature, while decreasing the overall thermal barrier of the probe between the coupling waterbolus and tissue surface.

  2. A Thermal Monitoring Sheet with Low Influence from Adjacent Waterbolus for Tissue Surface Thermometry during Clinical Hyperthermia

    PubMed Central

    Arunachalam, K.; Maccarini, P.F.; Stauffer, P. R.

    2009-01-01

    This paper presents a complete thermal analysis of a novel conformal surface thermometer design with directional sensitivity for real time temperature monitoring during hyperthermia treatments of large superficial cancer. The thermal monitoring sheet (TMS) discussed in this paper consists of a two-dimensional array of fiberoptic sensors embedded between two layers of flexible, low loss and thermally conductive printed circuit board (PCB) film. Heat transfer across all interfaces from the tissue surface through multiple layers of insulating dielectrics surrounding the small buried temperature sensor and into an adjacent temperature regulated water coupling bolus was studied using 3D thermal simulation software. Theoretical analyses were carried out to identify the most effective differential TMS probe configuration possible with commercially available flexible PCB materials, and to compare their thermal responses with omni-directional probes commonly used in clinical hyperthermia. A TMS sensor design that employs 0.0508m Kapton MTB® and 0.2032 mm Kapton HN® flexible polyimide films is proposed for tissue surface thermometry with low influence from the adjacent waterbolus. Comparison of the thermal simulations with clinical probes indicate the new differential TMS probe design to outperform in terms of both transient response and steady state accuracy in selectively reading the tissue surface temperature, while decreasing the overall thermal barrier of the probe between the coupling waterbolus and tissue surface. PMID:18838365

  3. First Clinical Evaluation of a New Percutaneous Optical Fiber Glucose Sensor for Continuous Glucose Monitoring in Diabetes

    PubMed Central

    Müller, Achim Josef; Knuth, Monika; Nikolaus, Katharina Sibylle; Krivánek, Roland; Küster, Frank; Hasslacher, Christoph

    2013-01-01

    Background This article describes a new fiber-coupled, percutaneous fluorescent continuous glucose monitoring (CGM) system that has shown 14 days of functionality in a human clinical trial. Method The new optical CGM system (FiberSense) consists of a transdermal polymer optical fiber containing a biochemical glucose sensor and a small fluorescence photometer optically coupled to the fiber. The glucose-sensitive optical fiber was implanted in abdominal and upper-arm subcutaneous tissue of six diabetes patients and remained there for up to 14 days. The performance of the system was monitored during six visits to the study center during the trial. Blood glucose changes were induced by oral carbohydrate intake and insulin injections, and capillary blood glucose samples were obtained from the finger tip. The data were analyzed using linear regression and the consensus error grid analysis. Results The FiberSense worn at the upper arm exhibited excellen