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Sample records for manually validated human

  1. Validation of Interdisciplinary Cooperative Education Manual.

    ERIC Educational Resources Information Center

    Stone, Sheila D.

    A field test examined the validity of the "Interdisciplinary Cooperative Education Curriculum Manual." (Among those topics covered in the manual are the following: vocational student organizations, leadership, civic responsibility, health and safety, human relations, communications, resource management, consumer skills, consumer law,…

  2. Validation of Agricultural Mechanics Curriculum Manual.

    ERIC Educational Resources Information Center

    Hatcher, Elizabeth; And Others

    This study was concerned with the validation of the Oklahoma Curriculum and Instructional Materials Center's agricultural mechanics curriculum manual and the development of a model whereby future manuals can be validated. Five units in the manual were randomly selected from a list of units to be taught during the second semester of the 1977-78…

  3. CTF Validation and Verification Manual

    SciTech Connect

    Salko, Robert K.; Blyth, Taylor S.; Dances, Christopher A.; Magedanz, Jeffrey W.; Jernigan, Caleb; Kelly, Joeseph; Toptan, Aysenur; Gergar, Marcus; Gosdin, Chris; Avramova, Maria; Palmtag, Scott; Gehin, Jess C.

    2016-05-25

    Coolant-Boiling in Rod Arrays- Two Fluids (COBRA-TF) is a Thermal/Hydraulic (T/H) simulation code designed for Light Water Reactor (LWR) analysis. It uses a two- uid, three- eld (i.e. uid lm, uid drops, and vapor) modeling approach. Both sub-channel and 3D Cartesian forms of nine conservation equations are available for LWR modeling. The code was originally developed by Paci c Northwest Laboratory in 1980 and has been used and modi ed by several institutions over the last several decades. COBRA-TF is also used at the Pennsylvania State University (PSU) by the Reactor Dynamics and Fuel Management Group (RDFMG) and has been improved, updated, and subsequently became the PSU RDFMG version of COBRA- TF (CTF). One part of the improvement process includes validating the methods in CTF. This document seeks to provide a certain level of certainty and con dence in the predictive capabilities of the code for the scenarios it was designed to model|rod bundle geometries with operating conditions that are representative of prototypical Pressurized Water Reactor (PWR)s and Boiling Water Reactor (BWR)s in both normal and accident conditions. This is done by modeling a variety of experiments that simulate these scenarios and then presenting a qualitative and quantitative analysis of the results that demonstrates the accuracy to which CTF is capable of capturing speci c quantities of interest.

  4. Model validation software -- Theory manual

    SciTech Connect

    Dolin, R.M.

    1997-11-04

    Work began in May of 1991 on the initial Independent Spline (IS) technology. The IS technology was based on research by Dolin showing that numerical topology and geometry could be validated through their topography. A unique contribution to this research is that the IS technology has provided a capability to modify one spline`s topology to match another spline`s topography. Work began in May of 1996 to extend the original IS capability to allow solid model topologies to be compared with corresponding two-dimensional topologies. Work began in July, 1996 to extend the IS capability to allow for tool path and inspection data analyses. Tool path analysis involves spline-spline comparisons. Inspection data analysis involves fitting inspection data with some type of analytical curve and then comparing that curve with the original (i.e., nominal) curve topology. There are three types of curves that the inspection data can be fit with. Using all three types of curve fits help engineers understand the As-Built state of whatever it is that is being interrogated. The ability to compute axi-symmetric volumes of revolution for a data set fit with either of the three curves fitting methods described above will be added later. This involves integrating the area under each curve and then revolving the area through 2{pi} radians to get a volume of revolution. The algorithms for doing this will be taken from the IGVIEW software system. The main IS program module parses out the desired activities into four different logical paths: (1) original IS spline modification; (2) two- or three-dimensional topography evaluated against 2D spline; (3) tool path analysis with tool path modifications; and (4) tool path and inspection data comparisons with nominal topography. Users have the option of running the traditional IS application software, comparing 3D ASCII data to a Wilson-Fowler spline interpolation of 2D data, comparing a Wilson-Fowler spline interpolation to analytical topology, or

  5. Manual physical assessment of spinal segmental motion: intent and validity.

    PubMed

    Abbott, J Haxby; Flynn, Timothy W; Fritz, Julie M; Hing, Wayne A; Reid, Duncan; Whitman, Julie M

    2009-02-01

    Validity of a clinical test can be defined as the extent to which the test actually assesses what it is intended to assess. In order to investigate the validity of manual physical assessment of the spine, it is therefore essential to establish what physical therapists intend to assess when they are applying these tests. The aims of this study were to (1) establish what manual physical therapists are intending to assess while applying passive intervertebral motion tests; and (2) examine the face validity and content validity for manual physical assessment of the spine. We surveyed 1502 members of the national manual physical therapist organisations of New Zealand and the United States of America using a web-based survey instrument. Sixty-six percent of 466 respondents believed passive accessory intervertebral motion (PAIVM) tests were valid for assessing quantity of segmental motion, and 76% believed passive physiologic intervertebral motion (PPIVM) tests were valid for assessing quantity of segmental motion. Ninety-eight percent of manual physical therapists base treatment decisions at least in part on the results of segmental motion tests. Quality of resistance to passive segmental motion was considered of greater importance than quantity of kinematic motion during PAIVM tests, while the quality of complex kinematic motion was considered of greater importance than quantity of displacement kinematics during PPIVM tests. Manual physical therapists accept the face validity of manual physical assessment of spinal segmental motion to a great extent, however a minority voice scepticism. Content validity is dominated by concepts of segmental kinematics and the force-displacement relationship. Intent of assessment does, however, vary widely between therapists. These data will inform the design of concurrent validity studies. Further work is recommended to increase consistency of intent, methodology and terminology in manual physical assessment of the spine.

  6. Methods in Human Development: Theory Manual.

    ERIC Educational Resources Information Center

    Bessell, Harold

    The manual, developed by psychologists at the Human Development Training Institute, describes techniques for understanding and dealing with the behavior and development of young children. The major objective of the book is to help elementary school teachers improve communication with their pupils. The manual offers conceptual tools for fostering…

  7. Demonstration and Validation Assets: User Manual Development

    SciTech Connect

    2008-06-30

    This report documents the development of a database-supported user manual for DEMVAL assets in the NSTI area of operations and focuses on providing comprehensive user information on DEMVAL assets serving businesses with national security technology applications in southern New Mexico. The DEMVAL asset program is being developed as part of the NSPP, funded by both Department of Energy (DOE) and NNSA. This report describes the development of a comprehensive user manual system for delivering indexed DEMVAL asset information to be used in marketing and visibility materials and to NSTI clients, prospective clients, stakeholders, and any person or organization seeking it. The data about area DEMVAL asset providers are organized in an SQL database with updateable application structure that optimizes ease of access and customizes search ability for the user.

  8. Human Rights: Respecting Our Differences, Teachers' Manual [And] Human Rights: Respecting Our Differences, Students' Manual.

    ERIC Educational Resources Information Center

    McCardle, Elizabeth, Ed.

    This unit on human rights designed for secondary students in Alberta, Canada includes both student and teacher manuals. Eleven chapters in the student manual examine what human rights are, the causes and effects of prejudice and discrimination, relevant laws, and social action. Each chapter includes readings followed by discussion questions and…

  9. Validated foodservice training manual for supervisors with limited experience.

    PubMed

    Sparkman, A F; Briley, M E; Gillham, M B

    1984-12-01

    The objective of this research project was to develop a useful, validated training manual to be used by supervisors in small foodservice operations and government-funded nutrition programs that do not have access to the services of a registered dietitian. The accuracy of the content was critiqued by an expert panel. The pilot phase was conducted at one congregate dining site to assess and revise problems involving evaluation design. The model phase evaluated the trainer's ability to use the manual and the worker's knowledge and performance as a result of training. Foodservice workers' scores after training were significantly higher than scores before training (p less than .01). Performance evaluations 4 weeks after training showed a significant positive change in work behavior (p less than .001) over evaluations before training. At 8 weeks a return to pretraining behavior was observed. The project showed that regular in-service training sessions conducted in short segments that are inexpensive and continuous would be valuable in any foodservice operation with limited access to dietitians. Benefits from such training include improved efficiency of food preparation and service, better quality of products produced, increased cost-effectiveness, and higher employee morale.

  10. Education and Human Resources Sector Assessment Manual.

    ERIC Educational Resources Information Center

    Pigozzi, Mary Joy; Cieutat, Victor J.

    This manual endorses and adopts the sector-assessment approach for planning and managing the allocation of educational resources. Chapter 1 presents the manual's goals. Chapter 2 describes the manual's content and information sources, explains the term "sector assessment," identifies the groups that benefit from recommendations made by…

  11. Testing manual dexterity using a virtual reality simulator: reliability and validity.

    PubMed

    Ben-Gal, G; Weiss, E I; Gafni, N; Ziv, A

    2013-08-01

    Virtual reality dental training simulators, unlike traditional human-based assessment, have the potential to enable consistent and reliable assessment. The purpose of this study was to determine whether a haptic simulator (IDEA Dental(®) ) could provide a reliable and valid assessment of manual dexterity. A total of 106 participants were divided into three groups differing in dental manual dexterity experience: (i) 63 dental students, (ii) 28 dentists, (iii) 14 non-dentists. The groups, which were expected to display various performance levels, were required to perform virtual drilling tasks in different geometric shapes. The following task parameters were registered: (i) Time to completion (ii) accuracy (iii) number of trials to successful completion and (iv) score provided by the simulator. The reliability of the tasks was calculated for each parameter. The simulator and its scoring algorithm showed high reliability in all the parameters measured. The simulator was able to differentiate between non-professionals and dental students or non-professionals and dentists. Our study suggests that for improved construct validity, shorter working times and more difficult tasks should be introduced. The device should also be designed to provide greater sensitivity in measuring the accuracy of the task. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Training Manual for Human Service Risk Managers. Final Report.

    ERIC Educational Resources Information Center

    Davis, Frank W.; And Others

    This manual is designed to educate human service agency management personnel involved in transportation about basic risk management principles and insurance issues. Chapter I illustrates the liability factors that create the insurance and risk management needs. Both legal and humanitarian obligations of human service agencies involved in…

  13. Computer aided manual validation of mass spectrometry-based proteomic data.

    PubMed

    Curran, Timothy G; Bryson, Bryan D; Reigelhaupt, Michael; Johnson, Hannah; White, Forest M

    2013-06-15

    Advances in mass spectrometry-based proteomic technologies have increased the speed of analysis and the depth provided by a single analysis. Computational tools to evaluate the accuracy of peptide identifications from these high-throughput analyses have not kept pace with technological advances; currently the most common quality evaluation methods are based on statistical analysis of the likelihood of false positive identifications in large-scale data sets. While helpful, these calculations do not consider the accuracy of each identification, thus creating a precarious situation for biologists relying on the data to inform experimental design. Manual validation is the gold standard approach to confirm accuracy of database identifications, but is extremely time-intensive. To palliate the increasing time required to manually validate large proteomic datasets, we provide computer aided manual validation software (CAMV) to expedite the process. Relevant spectra are collected, catalogued, and pre-labeled, allowing users to efficiently judge the quality of each identification and summarize applicable quantitative information. CAMV significantly reduces the burden associated with manual validation and will hopefully encourage broader adoption of manual validation in mass spectrometry-based proteomics.

  14. Computer Aided Manual Validation of Mass Spectrometry-based Proteomic Data

    PubMed Central

    Curran, Timothy G.; Bryson, Bryan D.; Reigelhaupt, Michael; Johnson, Hannah; White, Forest M.

    2013-01-01

    Advances in mass spectrometry-based proteomic technologies have increased the speed of analysis and the depth provided by a single analysis. Computational tools to evaluate the accuracy of peptide identifications from these high-throughput analyses have not kept pace with technological advances; currently the most common quality evaluation methods are based on statistical analysis of the likelihood of false positive identifications in large-scale data sets. While helpful, these calculations do not consider the accuracy of each identification, thus creating a precarious situation for biologists relying on the data to inform experimental design. Manual validation is the gold standard approach to confirm accuracy of database identifications, but is extremely time-intensive. To palliate the increasing time required to manually validate large proteomic datasets, we provide computer aided manual validation software (CAMV) to expedite the process. Relevant spectra are collected, catalogued, and pre-labeled, allowing users to efficiently judge the quality of each identification and summarize applicable quantitative information. CAMV significantly reduces the burden associated with manual validation and will hopefully encourage broader adoption of manual validation in mass spectrometry-based proteomics. PMID:23500044

  15. Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-01-01

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

  16. Validation of Placebo in a Manual Therapy Randomized Controlled Trial.

    PubMed

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-07-06

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment ("yes" or "no") and how strongly they believed that active treatment was received (numeric rating scale 0-10). The outcome measures included the rate of successful blinding and the certitude of the participants' beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months.

  17. Content validity of manual spinal palpatory exams - A systematic review

    PubMed Central

    Najm, Wadie I; Seffinger, Michael A; Mishra, Shiraz I; Dickerson, Vivian M; Adams, Alan; Reinsch, Sibylle; Murphy, Linda S; Goodman, Arnold F

    2003-01-01

    Background Many health care professionals use spinal palpatory exams as a primary and well-accepted part of the evaluation of spinal pathology. However, few studies have explored the validity of spinal palpatory exams. To evaluate the status of the current scientific evidence, we conducted a systematic review to assess the content validity of spinal palpatory tests used to identify spinal neuro-musculoskeletal dysfunction. Methods Review of eleven databases and a hand search of peer-reviewed literature, published between 1965–2002, was undertaken. Two blinded reviewers abstracted pertinent data from the retrieved papers, using a specially developed quality-scoring instrument. Five papers met the inclusion/exclusion criteria. Results Three of the five papers included in the review explored the content validity of motion tests. Two of these papers focused on identifying the level of fixation (decreased mobility) and one focused on range of motion. All three studies used a mechanical model as a reference standard. Two of the five papers included in the review explored the validity of pain assessment using the visual analogue scale or the subjects' own report as reference standards. Overall the sensitivity of studies looking at range of motion tests and pain varied greatly. Poor sensitivity was reported for range of motion studies regardless of the examiner's experience. A slightly better sensitivity (82%) was reported in one study that examined cervical pain. Conclusions The lack of acceptable reference standards may have contributed to the weak sensitivity findings. Given the importance of spinal palpatory tests as part of the spinal evaluation and treatment plan, effort is required by all involved disciplines to create well-designed and implemented studies in this area. PMID:12734016

  18. Effects of Retinal Eccentricity on Human Manual Control

    NASA Technical Reports Server (NTRS)

    Popovici, Alexandru; Zaal, Peter M. T.

    2017-01-01

    This study investigated the effects of viewing a primary flight display at different retinal eccentricities on human manual control behavior and performance. Ten participants performed a pitch tracking task while looking at a simplified primary flight display at different horizontal and vertical retinal eccentricities, and with two different controlled dynamics. Tracking performance declined at higher eccentricity angles and participants behaved more nonlinearly. The visual error rate gain increased with eccentricity for single-integrator-like controlled dynamics, but decreased for double-integrator-like dynamics. Participants' visual time delay was up to 100 ms higher at the highest horizontal eccentricity compared to foveal viewing. Overall, vertical eccentricity had a larger impact than horizontal eccentricity on most of the human manual control parameters and performance. Results might be useful in the design of displays and procedures for critical flight conditions such as in an aerodynamic stall.

  19. Nearly automated analysis of coronary Doppler flow velocity from transthoracic ultrasound images: validation with manual tracings.

    PubMed

    Magagnin, V; Delfino, L; Cerutti, S; Turiel, M; Caiani, E G

    2007-05-01

    Coronary flow velocity reserve is obtained by manual tracings of transthoracic coronary Doppler flow velocity profiles as the ratio of stress versus baseline diastolic peak velocities. This approach introduces subjectivity in the measurements and limits the information which could be exploited from the Doppler velocity profile. Accordingly, our goals were to develop a technique for nearly automated detection of Doppler coronary flow velocity profile, and automatically compute both conventional and additional amplitude, derivative and temporal parameters, and validate it with manual tracings. A total of 100 patients (17 normals, 15 patients with severe coronary stenosis, 41 with connective tissue disease and 27 with diabetes mellitus) were studied. Linear correlation and Bland-Altman analyses showed that the proposed method was highly accurate and repeatable compared to the manual measurements. Comparison between groups evidenced significant differences in some of the automated parameters, thus representing potentially additional indices useful for the noninvasive diagnosis of microcirculatory or coronary artery disease.

  20. The development and preliminary validation of the Taiwanese Manual Ability Measure for Burns.

    PubMed

    Lin, Szu-Yen; Chen, Christine C; Mao, Hui-Fen; Hsiao, Fong-Yi; Tu, Vita Yu-Hsien

    2013-09-01

    To develop and validate the Taiwanese Manual Ability Measure for Burns (T-MAM for Burns), a task-oriented functional evaluation tool to assess self-reported manual ability in burn patients. A longitudinal study. A sample of 45 burn patients from burn rehabilitation centers with varying degrees of hand involvement. The preliminary testing version was formed by adding burn specific items to the Taiwanese version of the Manual Ability Measure. A field test was then conducted for item reduction and psychometric properties testing. Out of 55 initial items, 20 were selected into the final version of the T-MAM for Burns. Psychometric analyses indicated that it was reliable (test-retest ICC=.99), with adequate concurrent validity with various other hand function tests (r=-.79 with the short form Disabilities of the Arm, Shoulder, and Hand, or, the QuickDASH) and discriminative validity (significant difference (t=2.99, P=.005) between groups with unilateral vs. bilateral hand burns), and responsive (ES=.24 and .44 at one- and 3-month evaluations). This study shows that the T-MAM for Burns has great potential to be a functional outcome measure for burn rehabilitation. Additional research with a larger sample should be conducted to further confirm its validity and reliability. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  1. Validation of the ABILHAND questionnaire as a measure of manual ability in patients with rheumatoid arthritis

    PubMed Central

    Durez, Patrick; Fraselle, Virginie; Houssiau, Frédéric; Thonnard, Jean‐Louis; Nielens, Henri; Penta, Massimo

    2007-01-01

    Objective: Hand and upper limb involvement is common in patients with rheumatoid arthritis (RA). However, its impact on manual activities of daily life has not been fully evaluated. A measure of manual ability was developed, through the Rasch measurement model, by adapting and validating the ABILHAND questionnaire, which measures the patient's perceived difficulty in performing everyday manual activities. Methods 112 patients with RA were evaluated. The following tests were performed: the ABILHAND questionnaire, the Health Assessment Questionnaire (HAQ), the Jamar grip and key pinch strength tests, the Box and Block dexterity test and the Purdue pegboard dexterity test. In total, 35 patients were reassessed to determine the test–retest reliability of the ABILHAND, and 6 patients were studied before and after therapy with tumour necrosis factor (TNF) blockers to address sensitivity to change. Results The Rasch refinement of the ABILHAND led to a selection of 27 items rated on a 3‐point scale. The resulting ability scale was targeted to the ability of the patients. The item‐difficulty hierarchy was stable across demographic and clinical subgroups and over time. Grip and key pinch strength and manual and digital dexterity on both hands were significantly, though moderately, correlated with the ABILHAND measures. Manual ability was also significantly related to the number of affected hands, disease duration, tender and swollen joint counts on upper limbs, disease activity and the HAQ. Sensitivity to change was demonstrated in patients treated with TNF blockers, commensurate with their clinical improvement. Conclusion The ABILHAND questionnaire is a clinically valid person‐centred measure of manual ability that could be useful in longitudinal RA studies. PMID:17170054

  2. The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance: evidence of validity.

    PubMed

    Frisoni, Giovanni B; Jack, Clifford R; Bocchetta, Martina; Bauer, Corinna; Frederiksen, Kristian S; Liu, Yawu; Preboske, Gregory; Swihart, Tim; Blair, Melanie; Cavedo, Enrica; Grothe, Michel J; Lanfredi, Mariangela; Martinez, Oliver; Nishikawa, Masami; Portegies, Marileen; Stoub, Travis; Ward, Chadwich; Apostolova, Liana G; Ganzola, Rossana; Wolf, Dominik; Barkhof, Frederik; Bartzokis, George; DeCarli, Charles; Csernansky, John G; deToledo-Morrell, Leyla; Geerlings, Mirjam I; Kaye, Jeffrey; Killiany, Ronald J; Lehéricy, Stephane; Matsuda, Hiroshi; O'Brien, John; Silbert, Lisa C; Scheltens, Philip; Soininen, Hilkka; Teipel, Stefan; Waldemar, Gunhild; Fellgiebel, Andreas; Barnes, Josephine; Firbank, Michael; Gerritsen, Lotte; Henneman, Wouter; Malykhin, Nikolai; Pruessner, Jens C; Wang, Lei; Watson, Craig; Wolf, Henrike; deLeon, Mony; Pantel, Johannes; Ferrari, Clarissa; Bosco, Paolo; Pasqualetti, Patrizio; Duchesne, Simon; Duvernoy, Henri; Boccardi, Marina

    2015-02-01

    An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. Fourteen tracers segmented 10 Alzheimer's Disease Neuroimaging Initiative (ADNI) cases scanned at 1.5 T and 3T following local protocols, qualified for segmentation based on the HarP through a standard web-platform and resegmented following the HarP. The five most accurate tracers followed the HarP to segment 15 ADNI cases acquired at three time points on both 1.5 T and 3T. The agreement among tracers was relatively low with the local protocols (absolute left/right ICC 0.44/0.43) and much higher with the HarP (absolute left/right ICC 0.88/0.89). On the larger set of 15 cases, the HarP agreement within (left/right ICC range: 0.94/0.95 to 0.99/0.99) and among tracers (left/right ICC range: 0.89/0.90) was very high. The volume variance due to different tracers was 0.9% of the total, comparing favorably to variance due to scanner manufacturer (1.2), atrophy rates (3.5), hemispheric asymmetry (3.7), field strength (4.4), and significantly smaller than the variance due to atrophy (33.5%, P < .001), and physiological variability (49.2%, P < .001). The HarP has high measurement stability compared with local segmentation protocols, and good reproducibility within and among human tracers. Hippocampi segmented with the HarP can be used as a reference for the qualification of human tracers and automated segmentation algorithms. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  3. The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance: Evidence of validity

    PubMed Central

    Frisoni, Giovanni B.; Jack, Clifford R.; Bocchetta, Martina; Bauer, Corinna; Frederiksen, Kristian S.; Liu, Yawu; Preboske, Gregory; Swihart, Tim; Blair, Melanie; Cavedo, Enrica; Grothe, Michel J.; Lanfredi, Mariangela; Martinez, Oliver; Nishikawa, Masami; Portegies, Marileen; Stoub, Travis; Ward, Chadwich; Apostolova, Liana G.; Ganzola, Rossana; Wolf, Dominik; Barkhof, Frederik; Bartzokis, George; DeCarli, Charles; Csernansky, John G.; deToledo-Morrell, Leyla; Geerlings, Mirjam I.; Kaye, Jeffrey; Killiany, Ronald J.; Lehéricy, Stephane; Matsuda, Hiroshi; O'Brien, John; Silbert, Lisa C.; Scheltens, Philip; Soininen, Hilkka; Teipel, Stefan; Waldemar, Gunhild; Fellgiebel, Andreas; Barnes, Josephine; Firbank, Michael; Gerritsen, Lotte; Henneman, Wouter; Malykhin, Nikolai; Pruessner, Jens C.; Wang, Lei; Watson, Craig; Wolf, Henrike; deLeon, Mony; Pantel, Johannes; Ferrari, Clarissa; Bosco, Paolo; Pasqualetti, Patrizio; Duchesne, Simon; Duvernoy, Henri; Boccardi, Marina

    2015-01-01

    Background An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. Methods Fourteen tracers segmented 10 Alzheimer's Disease Neuroimaging Initiative (ADNI) cases scanned at 1.5 T and 3T following local protocols, qualified for segmentation based on the HarP through a standard web-platform and resegmented following the HarP. The five most accurate tracers followed the HarP to segment 15 ADNI cases acquired at three time points on both 1.5 T and 3T. Results The agreement among tracers was relatively low with the local protocols (absolute left/right ICC 0.44/0.43) and much higher with the HarP (absolute left/right ICC 0.88/0.89). On the larger set of 15 cases, the HarP agreement within (left/right ICC range: 0.94/0.95 to 0.99/0.99) and among tracers (left/right ICC range: 0.89/0.90) was very high. The volume variance due to different tracers was 0.9% of the total, comparing favorably to variance due to scanner manufacturer (1.2), atrophy rates (3.5), hemispheric asymmetry (3.7), field strength (4.4), and significantly smaller than the variance due to atrophy (33.5%, P < .001), and physiological variability (49.2%, P < .001). Conclusions The HarP has high measurement stability compared with local segmentation protocols, and good reproducibility within and among human tracers. Hippocampi segmented with the HarP can be used as a reference for the qualification of human tracers and automated segmentation algorithms. PMID:25267715

  4. Reliability and validity of self-reported assessment of exposure and outcome variables for manual lifting tasks: a preliminary investigation.

    PubMed

    Yeung, Simon S; Genaidy, Ash M; Karwowski, Waldemar; Leung, P C

    2002-09-01

    The reliability and validity of self-reported assessment of exposure and outcome variables were examined for manual lifting activities among ten physiotherapists. In this study, the participants evaluated the effects of five lifting variables on perceived effort, twice separated by a one-week period. One hundred and sixty-two lifting conditions were evaluated by each subject. The exposure and outcome lifting variables were described in linguistic terms. Intra-class correlation coefficient (ICC(1,1)) analysis revealed a mean value of 0.62 for all lifting activities. The self-reported assessment was cross-validated with the NIOSH lifting index by mapping the linguistic variables into numerical ranges. Moderate correlations (r = 0.54 and 0.53, p<0.01) were obtained between perceived physical exertion/perceived risk and lifting index. The findings of this study provide preliminary indications that human-based methodologies may be further explored on experienced workers.

  5. Reliability of a new supination resistance measurement device and validation of the manual supination resistance test.

    PubMed

    Griffiths, Ian B; McEwan, Islay M

    2012-01-01

    Kinematic observations are inconsistent in predicting lower-extremity injury risk, and research suggests that kinetic variables may be more important in this regard. Before kinetics can be prospectively investigated, we need reliable ways of measuring them clinically. A measurement instrument was manufactured that closely mirrors a manual test used to clinically estimate supination resistance force. The reliability of the instrument and the validity of the clinical test were investigated. The left feet of 26 healthy individuals (17 men and 9 women; mean ± SD age, 25.9 ± 9.2 years; mean ± SD weight, 77.7 ± 13.3 kg) were assessed. Foot Posture Index (FPI-6), manual supination resistance, and machine supination resistance were measured. Intrarater and interrater reliability of all of the measurements were calculated. Correlations of the supination resistance measured by the device with FPI-6, the manual supination resistance test, and body weight were investigated. Interrater reliability of all of the measurements was generally poor. The supination resistance machine correlated highly with the manual supination test for the rater experienced with its use. Supination resistance measurements correlated poorly with the FPI-6 and weakly with body weight. The supination resistance machine was shown to have sufficient limits of agreement for the study, but improvements need to be made for more meaningful research going forward. In this study, the force required to supinate a foot was independent of its posture, and approximately 12% of it was explained by body weight. Further work is required with a much larger sample size to build regression models that sufficiently predict supination resistance force and that will be of clinical use. The manual supination test is a valid clinical test for clinicians experienced in its use.

  6. On the reliability and validity of manual muscle testing: a literature review.

    PubMed

    Cuthbert, Scott C; Goodheart, George J

    2007-03-06

    A body of basic science and clinical research has been generated on the manual muscle test (MMT) since its first peer-reviewed publication in 1915. The aim of this report is to provide an historical overview, literature review, description, synthesis and critique of the reliability and validity of MMT in the evaluation of the musculoskeletal and nervous systems. Online resources were searched including Pubmed and CINAHL (each from inception to June 2006). The search terms manual muscle testing or manual muscle test were used. Relevant peer-reviewed studies, commentaries, and reviews were selected. The two reviewers assessed data quality independently, with selection standards based on predefined methodologic criteria. Studies of MMT were categorized by research content type: inter- and intraexaminer reliability studies, and construct, content, concurrent and predictive validity studies. Each study was reviewed in terms of its quality and contribution to knowledge regarding MMT, and its findings presented. More than 100 studies related to MMT and the applied kinesiology chiropractic technique (AK) that employs MMT in its methodology were reviewed, including studies on the clinical efficacy of MMT in the diagnosis of patients with symptomatology. With regard to analysis there is evidence for good reliability and validity in the use of MMT for patients with neuromusculoskeletal dysfunction. The observational cohort studies demonstrated good external and internal validity, and the 12 randomized controlled trials (RCTs) that were reviewed show that MMT findings were not dependent upon examiner bias. The MMT employed by chiropractors, physical therapists, and neurologists was shown to be a clinically useful tool, but its ultimate scientific validation and application requires testing that employs sophisticated research models in the areas of neurophysiology, biomechanics, RCTs, and statistical analysis.

  7. Time Series Modeling of Human Operator Dynamics in Manual Control Tasks

    NASA Technical Reports Server (NTRS)

    Biezad, D. J.; Schmidt, D. K.

    1984-01-01

    A time-series technique is presented for identifying the dynamic characteristics of the human operator in manual control tasks from relatively short records of experimental data. Control of system excitation signals used in the identification is not required. The approach is a multi-channel identification technique for modeling multi-input/multi-output situations. The method presented includes statistical tests for validity, is designed for digital computation, and yields estimates for the frequency response of the human operator. A comprehensive relative power analysis may also be performed for validated models. This method is applied to several sets of experimental data; the results are discussed and shown to compare favorably with previous research findings. New results are also presented for a multi-input task that was previously modeled to demonstrate the strengths of the method.

  8. Time series modeling of human operator dynamics in manual control tasks

    NASA Technical Reports Server (NTRS)

    Biezad, D. J.; Schmidt, D. K.

    1984-01-01

    A time-series technique is presented for identifying the dynamic characteristics of the human operator in manual control tasks from relatively short records of experimental data. Control of system excitation signals used in the identification is not required. The approach is a multi-channel identification technique for modeling multi-input/multi-output situations. The method presented includes statistical tests for validity, is designed for digital computation, and yields estimates for the frequency responses of the human operator. A comprehensive relative power analysis may also be performed for validated models. This method is applied to several sets of experimental data; the results are discussed and shown to compare favorably with previous research findings. New results are also presented for a multi-input task that has not been previously modeled to demonstrate the strengths of the method.

  9. Reliability and validity of the Microsoft Kinect for assessment of manual wheelchair propulsion.

    PubMed

    Milgrom, Rachel; Foreman, Matthew; Standeven, John; Engsberg, Jack R; Morgan, Kerri A

    2016-01-01

    Concurrent validity and test-retest reliability of the Microsoft Kinect in quantification of manual wheelchair propulsion were examined. Data were collected from five manual wheelchair users on a roller system. Three Kinect sensors were used to assess test-retest reliability with a still pose. Three systems were used to assess concurrent validity of the Kinect to measure propulsion kinematics (joint angles, push loop characteristics): Kinect, Motion Analysis, and Dartfish ProSuite (Dartfish joint angles were limited to shoulder and elbow flexion). Intraclass correlation coefficients revealed good reliability (0.87-0.99) between five of the six joint angles (neck flexion, shoulder flexion, shoulder abduction, elbow flexion, wrist flexion). ICCs suggested good concurrent validity for elbow flexion between the Kinect and Dartfish and between the Kinect and Motion Analysis. Good concurrent validity was revealed for maximum height, hand-axle relationship, and maximum area (0.92-0.95) between the Kinect and Dartfish and maximum height and hand-axle relationship (0.89-0.96) between the Kinect and Motion Analysis. Analysis of variance revealed significant differences (p < 0.05) in maximum length between Dartfish (mean 58.76 cm) and the Kinect (40.16 cm). Results pose promising research and clinical implications for propulsion assessment and overuse injury prevention with the application of current findings to future technology.

  10. Quick-Eye: Examination of Human Performance Characteristics Using Eye Tracking and Manual-Based Control Systems for Monitoring Multiple Displays

    DTIC Science & Technology

    2013-03-01

    by using eye-tracking input instead of manual controls to switch control among multiple displays. 15. SUBJECT TERMS Eye tracking human - computer interaction interface...tracking has become an increasingly viable means of human - computer interaction . Specifically, those APPROVED FOR PUBLIC RELEASE; DISTRIBUTION IS...control methods; validate system performance against predictive models of human - computer interaction performance b. Relationship between response

  11. Validation of three viable-cell counting methods: Manual, semi-automated, and automated.

    PubMed

    Cadena-Herrera, Daniela; Esparza-De Lara, Joshua E; Ramírez-Ibañez, Nancy D; López-Morales, Carlos A; Pérez, Néstor O; Flores-Ortiz, Luis F; Medina-Rivero, Emilio

    2015-09-01

    A viable cell count is essential to evaluate the kinetics of cell growth. Since the hemocytometer was first used for counting blood cells, several variants of the methodology have been developed towards reducing the time of analysis and improving accuracy through automation of both sample preparation and counting. The successful implementation of automated techniques relies in the adjustment of cell staining, image display parameters and cell morphology to obtain equivalent precision, accuracy and linearity with respect to the hemocytometer. In this study we conducted the validation of three trypan blue exclusion-based methods: manual, semi-automated, and fully automated; which were used for the estimation of density and viability of cells employed for the biosynthesis and bioassays of recombinant proteins. Our results showed that the evaluated attributes remained within the same range for the automated methods with respect to the manual, providing an efficient alternative for analyzing a huge number of samples.

  12. User's Manual for Data for Validating Models for PV Module Performance

    SciTech Connect

    Marion, W.; Anderberg, A.; Deline, C.; Glick, S.; Muller, M.; Perrin, G.; Rodriguez, J.; Rummel, S.; Terwilliger, K.; Silverman, T. J.

    2014-04-01

    This user's manual describes performance data measured for flat-plate photovoltaic (PV) modules installed in Cocoa, Florida, Eugene, Oregon, and Golden, Colorado. The data include PV module current-voltage curves and associated meteorological data for approximately one-year periods. These publicly available data are intended to facilitate the validation of existing models for predicting the performance of PV modules, and for the development of new and improved models. For comparing different modeling approaches, using these public data will provide transparency and more meaningful comparisons of the relative benefits.

  13. Validation of an educative manual for patients with head and neck cancer submitted to radiation therapy.

    PubMed

    Cruz, Flávia Oliveira de Almeida Marques da; Ferreira, Elaine Barros; Vasques, Christiane Inocêncio; Mata, Luciana Regina Ferreira da; Reis, Paula Elaine Diniz Dos

    2016-06-14

    develop the content and face validation of an educative manual for patients with head and neck cancer submitted to radiation therapy. descriptive methodological research. The Theory of Psychometrics was used for the validation process, developed by 15 experts in the theme area of the educative manual and by two language and publicity professionals. A minimum agreement level of 80% was considered to guarantee the validity of the material. the items addressed in the assessment tool of the educative manual were divided in three blocks: objectives, structure and format, and relevance. Only one item, related to the sociocultural level of the target public, obtained an agreement rate <80%, and was reformulated based on the participants' suggestions. All other items were considered appropriate and/or complete appropriate in the three blocks proposed: objectives - 92.38%, structure and form - 89.74%, and relevance - 94.44%. the face and content validation of the educative manual proposed were attended to. This can contribute to the understanding of the therapeutic process the head and neck cancer patient is submitted to during the radiation therapy, besides supporting clinical practice through the nursing consultation. validar o conteúdo e a aparência de manual educativo direcionado aos pacientes com câncer de cabeça e pescoço, submetidos à radioterapia. pesquisa metodológica, de caráter descritivo. Utilizou-se a Teoria da Psicometria para o processo de validação, o qual foi realizado por 15 peritos na área temática do manual educativo e por dois profissionais de letras e publicidade. Foi considerado o índice de concordância de, no mínimo, 80% para se garantir a validação do material. os itens abordados no instrumento de avaliação do manual educativo foram divididos em três blocos: objetivos, estrutura e apresentação, e relevância. Apenas um item, relacionado ao nível sociocultural do público-alvo, obteve índice de concordância <80%, tendo sido

  14. Human Factors Approach to Comparative Usability of Hospital Manual Defibrillators.

    PubMed

    Fidler, Richard; Johnson, Meshell

    2016-04-01

    Equipment-related issues have recently been cited as a significant contributor to the suboptimal outcomes of resuscitation management. A systematic evaluation of the human-device interface was undertaken to evaluate the intuitive nature of three different defibrillators. Devices tested were the Physio-Control LifePak 15, the Zoll R Series Plus, and the Philips MRx. A convenience sample of 73 multidisciplinary health care providers from 5 different hospitals participated in this study. All subjects' performances were evaluated without any training on the devices being studied to assess the intuitiveness of the user interface to perform the functions of delivering an Automated External Defibrillator (AED) shock, a manual defibrillation, pacing to achieve 100% capture, and synchronized cardioversion on a rhythm simulator. Times to deliver an AED shock were fastest with the Zoll, whereas the Philips had the fastest times to deliver a manual defibrillation. Subjects took the least time to attain 100% capture for pacing with the Physio-Control device. No differences in performance times were seen with synchronized cardioversion among the devices. Human factors issues uncovered during this study included a preference for knobs over soft keys and a desire for clarity in control panel design. This study demonstrated no clearly superior defibrillator, as each of the models exhibited strengths in different areas. When asked their defibrillator preference, 67% of subjects chose the Philips. This comparison of user interfaces of defibrillators in simulated situations allows the assessment of usability that can provide manufacturers and educators with feedback about defibrillator implementation for these critical care devices. Published by Elsevier Ireland Ltd.

  15. Radiological findings for hip dysplasia at skeletal maturity. Validation of digital and manual measurement techniques.

    PubMed

    Engesæter, Ingvild Øvstebø; Laborie, Lene Bjerke; Lehmann, Trude Gundersen; Sera, Francesco; Fevang, Jonas; Pedersen, Douglas; Morcuende, José; Lie, Stein Atle; Engesæter, Lars Birger; Rosendahl, Karen

    2012-07-01

    To report on intra-observer, inter-observer, and inter-method reliability and agreement for radiological measurements used in the diagnosis of hip dysplasia at skeletal maturity, as obtained by a manual and a digital measurement technique. Pelvic radiographs from 95 participants (56 females) in a follow-up hip study of 18- to 19-year-old patients were included. Eleven radiological measurements relevant for hip dysplasia (Sharp's, Wiberg's, and Ogata's angles; acetabular roof angle of Tönnis; articulo-trochanteric distance; acetabular depth-width ratio; femoral head extrusion index; maximum teardrop width; and the joint space width in three different locations) were validated. Three observers measured the radiographs using both a digital measurement program and manually in AgfaWeb1000. Inter-method and inter- and intra-observer agreement were analyzed using the mean differences between the readings/readers, establishing the 95% limits of agreement. We also calculated the minimum detectable change and the intra-class correlation coefficient. Large variations among different radiological measurements were demonstrated. However, the variation was not related to the use of either the manual or digital measurement technique. For measurements with greater absolute values (Sharp's angle, femoral head extrusion index, and acetabular depth-width ratio) the inter- and intra-observer and inter-method agreements were better as compared to measurements with lower absolute values (acetabular roof angle, teardrop and joint space width). The inter- and intra-observer variation differs notably across different radiological measurements relevant for hip dysplasia at skeletal maturity, a fact that should be taken into account in clinical practice. The agreement between the manual and digital methods is good.

  16. Comparison of human septal nuclei MRI measurements using automated segmentation and a new manual protocol based on histology.

    PubMed

    Butler, Tracy; Zaborszky, Laszlo; Pirraglia, Elizabeth; Li, Jinyu; Wang, Xiuyuan Hugh; Li, Yi; Tsui, Wai; Talos, Delia; Devinsky, Orrin; Kuchna, Izabela; Nowicki, Krzysztof; French, Jacqueline; Kuzniecky, Rubin; Wegiel, Jerzy; Glodzik, Lidia; Rusinek, Henry; deLeon, Mony J; Thesen, Thomas

    2014-08-15

    Septal nuclei, located in basal forebrain, are strongly connected with hippocampi and important in learning and memory, but have received limited research attention in human MRI studies. While probabilistic maps for estimating septal volume on MRI are now available, they have not been independently validated against manual tracing of MRI, typically considered the gold standard for delineating brain structures. We developed a protocol for manual tracing of the human septal region on MRI based on examination of neuroanatomical specimens. We applied this tracing protocol to T1 MRI scans (n=86) from subjects with temporal epilepsy and healthy controls to measure septal volume. To assess the inter-rater reliability of the protocol, a second tracer used the same protocol on 20 scans that were randomly selected from the 72 healthy controls. In addition to measuring septal volume, maximum septal thickness between the ventricles was measured and recorded. The same scans (n=86) were also analyzed using septal probabilistic maps and DARTEL toolbox in SPM. Results show that our manual tracing algorithm is reliable, and that septal volume measurements obtained via manual and automated methods correlate significantly with each other (p<.001). Both manual and automated methods detected significantly enlarged septal nuclei in patients with temporal lobe epilepsy in accord with a proposed compensatory neuroplastic process related to the strong connections between septal nuclei and hippocampi. Septal thickness, which was simple to measure with excellent inter-rater reliability, correlated well with both manual and automated septal volume, suggesting it could serve as an easy-to-measure surrogate for septal volume in future studies. Our results call attention to the important though understudied human septal region, confirm its enlargement in temporal lobe epilepsy, and provide a reliable new manual delineation protocol that will facilitate continued study of this critical region

  17. Manually Interpreted Land-Use Change for Validation and Regional Assessments - 2001 TO 2011

    NASA Astrophysics Data System (ADS)

    Soulard, C. E.; Acevedo, W.; Sayler, K. L.; Taylor, J. L.

    2014-12-01

    Land-use/land-cover (LULC) change information for the entire conterminous United States is becoming more common, yet existing national-scale LULC datasets may provide an incomplete story of change or may contain questionable land change statistics. In order to evaluate these datasets appropriately, the overall quality, accuracy, or precision of LULC products needs be determined independently. To this end, the USGS Land Change Research Project manually collected LULC change for 676 sample blocks for the 2001-2006 and 2006-2011 time periods. The team identified 29 of 84 Level III EPA Ecoregions that underwent specific types and amounts of land change between 1973 and 2000, and updated LULC change information to 2011 in these regions using the same sample block classification procedure as the USGS Land Cover Trends project. Ecoregion specific alterations in the sampling density were made to expedite the completion of manual block interpretations. Results from this study include ecoregion-based statistical estimates of the amount of LULC change per time period, the most common types of conversions, rates of change, and percent composition. Overall estimated amount of change per ecoregion from 2001 to 2011 ranged from a low of 370 km2 in the Northern Basin and Range Ecoregion to a high of 78,782 km2 in the Southeastern Plains Ecoregion. The Southeastern Plains Ecoregion continues to undergo one of the most intense forest harvesting and regrowth cycles in the country, with 16.6% of the ecoregion changing between 2001 and 2011. These manually collected LULC change statistics provide a new, valuable resource that may be used along with other ground truth data and field verified LULC data to independently validate other land change products or used alone to conduct regional land change assessments.

  18. Validation of a protocol for manual segmentation of the thalamus on magnetic resonance imaging scans.

    PubMed

    Power, Brian D; Wilkes, Fiona A; Hunter-Dickson, Mitchell; van Westen, Danielle; Santillo, Alexander F; Walterfang, Mark; Nilsson, Christer; Velakoulis, Dennis; Looi, Jeffrey C L

    2015-04-30

    We present a validated protocol for manual segmentation of the thalamus on T1-weighted magnetic resonance imaging (MRI) scans using brain image analysis software. The MRI scans of five normal control subjects were randomly selected from a larger cohort recruited from Lund University Hospital and Landskrona Hospital, Sweden. MRIs were performed using a 3.0T Philips MR scanner, with an eight-channel head coil, and high resolution images were acquired using a T1-weighted turbo field echo (T1 TFE) pulse sequence, with resulting voxel size 1×1×1 mm3. Manual segmentation of the left and right thalami and volume measurement was performed on 28-30 contiguous coronal slices, using ANALYZE 11.0 software. Reliability of image analysis was performed by measuring intra-class correlations between initial segmentation and random repeated segmentation of the left and right thalami (in total 10 thalami for segmentation); inter-rater reliability was measured using volumes obtained by two other experienced tracers. Intra-class correlations for two independent raters were 0.95 and 0.98; inter-class correlations between the expert rater and two independent raters were 0.92 and 0.98. We anticipate that mapping thalamic morphology in various neuropsychiatric disorders may yield clinically useful disease-specific biomarkers. Crown Copyright © 2015. Published by Elsevier Ireland Ltd. All rights reserved.

  19. Affective Education: A Teacher's Manual to Promote Student Self-Actualization and Human Relations Skills.

    ERIC Educational Resources Information Center

    Snyder, Thomas R.

    This teacher's manual presents affective education as a program to promote student self-actualization and human relations skills. Abraham Maslow's hierarchy of needs and Erik Erikson's life stages of psychosocial development form the conceptual base for this program. The goals and objectives of this manual are concerned with problem-solving…

  20. Affective Education: A Teacher's Manual to Promote Student Self-Actualization and Human Relations Skills.

    ERIC Educational Resources Information Center

    Snyder, Thomas R.

    This teacher's manual presents affective education as a program to promote student self-actualization and human relations skills. Abraham Maslow's hierarchy of needs and Erik Erikson's life stages of psychosocial development form the conceptual base for this program. The goals and objectives of this manual are concerned with problem-solving…

  1. Validation of an educative manual for patients with head and neck cancer submitted to radiation therapy 1

    PubMed Central

    da Cruz, Flávia Oliveira de Almeida Marques; Ferreira, Elaine Barros; Vasques, Christiane Inocêncio; da Mata, Luciana Regina Ferreira; dos Reis, Paula Elaine Diniz

    2016-01-01

    Abstract Objective: develop the content and face validation of an educative manual for patients with head and neck cancer submitted to radiation therapy. Method: descriptive methodological research. The Theory of Psychometrics was used for the validation process, developed by 15 experts in the theme area of the educative manual and by two language and publicity professionals. A minimum agreement level of 80% was considered to guarantee the validity of the material. Results: the items addressed in the assessment tool of the educative manual were divided in three blocks: objectives, structure and format, and relevance. Only one item, related to the sociocultural level of the target public, obtained an agreement rate <80%, and was reformulated based on the participants' suggestions. All other items were considered appropriate and/or complete appropriate in the three blocks proposed: objectives - 92.38%, structure and form - 89.74%, and relevance - 94.44%. Conclusion: the face and content validation of the educative manual proposed were attended to. This can contribute to the understanding of the therapeutic process the head and neck cancer patient is submitted to during the radiation therapy, besides supporting clinical practice through the nursing consultation. PMID:27305178

  2. Comparing manual and automatic segmentation of hippocampal volumes: reliability and validity issues in younger and older brains.

    PubMed

    Wenger, Elisabeth; Mårtensson, Johan; Noack, Hannes; Bodammer, Nils Christian; Kühn, Simone; Schaefer, Sabine; Heinze, Hans-Jochen; Düzel, Emrah; Bäckman, Lars; Lindenberger, Ulman; Lövdén, Martin

    2014-08-01

    We compared hippocampal volume measures obtained by manual tracing to automatic segmentation with FreeSurfer in 44 younger (20-30 years) and 47 older (60-70 years) adults, each measured with magnetic resonance imaging (MRI) over three successive time points, separated by four months. Retest correlations over time were very high for both manual and FreeSurfer segmentations. With FreeSurfer, correlations over time were significantly lower in the older than in the younger age group, which was not the case with manual segmentation. Pearson correlations between manual and FreeSurfer estimates were sufficiently high, numerically even higher in the younger group, whereas intra-class correlation coefficient (ICC) estimates were lower in the younger than in the older group. FreeSurfer yielded higher volume estimates than manual segmentation, particularly in the younger age group. Importantly, FreeSurfer consistently overestimated hippocampal volumes independently of manually assessed volume in the younger age group, but overestimated larger volumes in the older age group to a less extent, introducing a systematic age bias in the data. Age differences in hippocampal volumes were significant with FreeSurfer, but not with manual tracing. Manual tracing resulted in a significant difference between left and right hippocampus (right > left), whereas this asymmetry effect was considerably smaller with FreeSurfer estimates. We conclude that FreeSurfer constitutes a feasible method to assess differences in hippocampal volume in young adults. FreeSurfer estimates in older age groups should, however, be interpreted with care until the automatic segmentation pipeline has been further optimized to increase validity and reliability in this age group. Copyright © 2014 Wiley Periodicals, Inc.

  3. JacketSE: An Offshore Wind Turbine Jacket Sizing Tool; Theory Manual and Sample Usage with Preliminary Validation

    SciTech Connect

    Damiani, Rick

    2016-02-08

    This manual summarizes the theory and preliminary verifications of the JacketSE module, which is an offshore jacket sizing tool that is part of the Wind-Plant Integrated System Design & Engineering Model toolbox. JacketSE is based on a finite-element formulation and on user-prescribed inputs and design standards' criteria (constraints). The physics are highly simplified, with a primary focus on satisfying ultimate limit states and modal performance requirements. Preliminary validation work included comparing industry data and verification against ANSYS, a commercial finite-element analysis package. The results are encouraging, and future improvements to the code are recommended in this manual.

  4. Variable Lifting Index for Manual-Lifting Risk Assessment: A Preliminary Validation Study.

    PubMed

    Battevi, Natale; Pandolfi, Monica; Cortinovis, Ivan

    2016-08-01

    The aim of this study was to evaluate the efficacy of the new Variable Lifting Index (VLI) method, theoretically based on the Revised National Institute for Occupational Safety and Health [NIOSH] Lifting Equation (RNLE), in predicting the risk of acute low-back pain (LBP) in the past 12 months. A new risk variable termed the VLI for assessing variable manual lifting has been developed, but there has been no epidemiological study that evaluates the relationship between the VLI and LBP. A sample of 3,402 study participants from 16 companies in different industrial sectors was analyzed. Of the participants, 2,374 were in the risk exposure group involving manual materials handling (MMH), and 1,028 were in the control group without MMH. The VLI was calculated for each participant in the exposure group using a systematic approach. LBP information was collected by occupational physicians at the study sites. The risk of acute LBP was estimated by calculating the odds ratio (OR) between levels of the risk exposure and the control group using a logistic regression analysis. Both crude and adjusted ORs for body mass index, gender, and age were analyzed. Both crude and adjusted ORs showed a dose-response relationship. As the levels of VLI increased, the risk of LBP increased. This risk relationship existed when VLI was greater than 1. The VLI method can be used to assess the risk of acute LBP, although further studies are needed to confirm the outcome and to define better VLI categories. © 2016, Human Factors and Ergonomics Society.

  5. Peptizer, a tool for assessing false positive peptide identifications and manually validating selected results.

    PubMed

    Helsens, Kenny; Timmerman, Evy; Vandekerckhove, Joël; Gevaert, Kris; Martens, Lennart

    2008-12-01

    False positive peptide identifications are a major concern in the field of peptidecentric, mass spectrometry-driven gel-free proteomics. They occur in regions where the score distributions of true positives and true negatives overlap. Removal of these false positive identifications necessarily involves a trade-off between sensitivity and specificity. Existing postprocessing tools typically rely on a fixed or semifixed set of assumptions in their attempts to optimize both the sensitivity and the specificity of peptide and protein identification using MS/MS spectra. Because of the expanding diversity in available proteomics technologies, however, these postprocessing tools often struggle to adapt to emerging technology-specific peculiarity. Here we present a novel tool named Peptizer that solves this adaptability issue by making use of pluggable assumptions. This research-oriented postprocessing tool also includes a graphical user interface to perform efficient manual validation of suspect identifications for optimal sensitivity recovery. Peptizer is open source software under the Apache2 license and is written in Java.

  6. Validating therapeutic targets through human genetics.

    PubMed

    Plenge, Robert M; Scolnick, Edward M; Altshuler, David

    2013-08-01

    More than 90% of the compounds that enter clinical trials fail to demonstrate sufficient safety and efficacy to gain regulatory approval. Most of this failure is due to the limited predictive value of preclinical models of disease, and our continued ignorance regarding the consequences of perturbing specific targets over long periods of time in humans. 'Experiments of nature' - naturally occurring mutations in humans that affect the activity of a particular protein target or targets - can be used to estimate the probable efficacy and toxicity of a drug targeting such proteins, as well as to establish causal rather than reactive relationships between targets and outcomes. Here, we describe the concept of dose-response curves derived from experiments of nature, with an emphasis on human genetics as a valuable tool to prioritize molecular targets in drug development. We discuss empirical examples of drug-gene pairs that support the role of human genetics in testing therapeutic hypotheses at the stage of target validation, provide objective criteria to prioritize genetic findings for future drug discovery efforts and highlight the limitations of a target validation approach that is anchored in human genetics.

  7. An evaluation of manual and mechanical methods to identify Candida spp. from human and animal sources.

    PubMed

    Oliveira, Geraldo dos Santos; Ribeiro, Elizabeth Teixeira; Baroni, Francisco de Assis

    2006-01-01

    To compare two yeast identification methods, i. e, the manual and the VITEK mechanical methods, 62 clinical samples from hemocultures and animal sources were analyzed. After identification as Candida yeasts by the VITEK method, the strains were recharacterized using manual assimilation methods and sugar fermentation tests. Our findings reveal 58% concurrent identification between the two methods for animal strains, and 51% for human hemoculture strains.

  8. Volumetrics of the caudate nucleus: reliability and validity of a new manual tracing protocol.

    PubMed

    Looi, Jeffrey Chee Leong; Lindberg, Olof; Liberg, Benny; Tatham, Vanessa; Kumar, Rajeev; Maller, Jerome; Millard, Ellen; Sachdev, Perminder; Högberg, Göran; Pagani, Marco; Botes, Lisa; Engman, Eva-Lena; Zhang, Yi; Svensson, Leif; Wahlund, Lars-Olof

    2008-08-30

    Our aim was to develop a reliable and valid manual segmentation protocol for tracing the caudate nucleus in MRI for volumetric and, potentially, shape analysis of the caudate. Using the protocol, two inter- and intra-rater reliability studies were conducted using five different raters on two different image analysis platforms (ANALYZE, Mayo Biomedical Imaging Resource, Rochester MN, USA, and HERMES, Nuclear Diagnostics AB, Stockholm, Sweden). Reference images for the detailed protocol are described. Two studies were performed. In study 1, the intra-rater class correlation ICC(1,1) for an experienced rater (JCLL) using this protocol for caudate nucleus volumes was evaluated by repeating right and left caudate measurements on 10 scans (20 comparisons) and was 0.972. The inter-rater class correlation ICC(1,k) with OL was 0.922 on 5 scans (10 comparisons) and with BL was 0.960 on 5 scans (10 comparisons). In study 2, VT obtained an intra-rater class correlation of 0.9 on 5 scans (involving 10 comparisons, e.g. right and left caudate). The inter-rater class correlation ICC(1,k) was 0.988 on 5 scans (again involving 10 comparisons) with EM. We therefore developed a novel, reliable and reference image-based, method of outlining the caudate nucleus on axial MRI scans, usable in two different image analysis laboratories, across two different sets number of tracers reliably, and across software platforms. This method is therefore potentially usable for any image analysis package capable of displaying and measuring outlined voxels from MRI brain scans.

  9. Human Growth: Guide to a Healthier You. A Middle School Science Curriculum. Instructor's Manual.

    ERIC Educational Resources Information Center

    Huba, Jeanne C.; Crow, Tracy L.

    This instructor's manual contains information and activities related to human growth processes. The curriculum focuses on choices students can make for a healthy lifestyle and is based on the most up-to-date research about human growth and development. Students generate and test their hypotheses throughout each of five modules which include…

  10. Prediction of Outcome in Women With Carpal Tunnel Syndrome Who Receive Manual Physical Therapy Interventions: A Validation Study.

    PubMed

    Fernández-de-Las-Peñas, César; Cleland, Joshua A; Salom-Moreno, Jaime; Palacios-Ceña, María; Martínez-Perez, Almudena; Pareja, Juan A; Ortega-Santiago, Ricardo

    2016-06-01

    Study Design Secondary analysis of a randomized trial. Background A clinical prediction rule to identify patients with carpal tunnel syndrome (CTS) most likely to respond to manual physical therapy has been published but requires further testing to determine its validity. Objective To assess the validity of a clinical prediction rule proposed for the management of patients with CTS in a different group of patients with a variety of treating clinicians. Methods A preplanned secondary analysis of a randomized controlled trial investigating the efficacy of manual physical therapies, including desensitization maneuvers of the central nervous system, in 120 women suffering from CTS was performed. Patients were randomized to receive 3 sessions of manual physical therapy (n = 60) or surgical release/decompression of the carpal tunnel (n = 60). Self-perceived improvement with a global rating of change was recorded at 6- and 12-month follow-ups. Pain intensity (mean pain and worst pain on a 0-to-10 numeric pain-rating scale) and scores on the Boston Carpal Tunnel Questionnaire (functional status and symptom severity subscales) were assessed at baseline and at 1, 3, 6, and 12 months. A baseline assessment of status on the clinical prediction rule was performed (positive status on the clinical prediction rule was defined as meeting at least 2 of the following criteria: pressure pain threshold of less than 137 kPa over the affected C5-6 joint; heat pain threshold of less than 39.6°C over the affected carpal tunnel; and general health score [Medical Outcomes Study 36-Item Short-Form Health Survey] of greater than 66 points). Linear mixed models with repeated measures were used to examine the validity of the rule. Results Participants with a positive status on the rule who received manual physical therapy did not experience greater improvements compared to those with a negative status on the rule for mean pain (P = .65), worst pain (P = .86), function (P = .99), or symptom

  11. International Validation of Two Human Recombinant Estrogen ...

    EPA Pesticide Factsheets

    An international validation study has been successfully completed for 2 competitive binding assays using human recombinant ERa. Assays evaluated included the Freyberger-Wilson (FW) assay using a full length human ER, and the Chemical Evaluation and Research Institute (CERI) assay using a ligand-binding domain of the human ER. Twenty three compounds were tested in 6 laboratories for the FW assay and 5 for the CERJ assay, which included three controls (used with every run), 9 uncoded, and 14 coded chemicals across 3 subtasks. The overall goal of this validation study was to demonstrate the ability of each of the two assays to reliably classify the test chemicals as binders or non-binders. Laboratories had little trouble with the ER binders that produced a full binding curve when using either the CERI or FW assays. As is typical with all ER competitive binding assays, the weak binders proved to be more challenging. However, overall results from both the FW and CERI assays were consistent and in agreement with expected classifications regardless of the form of the hrER (i.e., full length ER versus an ER ligand binding domain) or the subtle differences in the protocols for conducting each assay. The reproducibility and accuracy for classification of chemicals as potential ER binders and non- binders using the FW and CERI hrER binding assays were comparable to that of the U.S.EPA’s existing ER binding test guideline OPPTS 890.1250, while providing an improved, highe

  12. Validating New Software for Semiautomated Liver Volumetry--Better than Manual Measurement?

    PubMed

    Noschinski, L E; Maiwald, B; Voigt, P; Wiltberger, G; Kahn, T; Stumpp, P

    2015-09-01

    This prospective study compared a manual program for liver volumetry with semiautomated software. The hypothesis was that the semiautomated software would be faster, more accurate and less dependent on the evaluator's experience. Ten patients undergoing hemihepatectomy were included in this IRB approved study after written informed consent. All patients underwent a preoperative abdominal 3-phase CT scan, which was used for whole liver volumetry and volume prediction for the liver part to be resected. Two different types of software were used: 1) manual method: borders of the liver had to be defined per slice by the user; 2) semiautomated software: automatic identification of liver volume with manual assistance for definition of Couinaud segments. Measurements were done by six observers with different experience levels. Water displacement volumetry immediately after partial liver resection served as the gold standard. The resected part was examined with a CT scan after displacement volumetry. Volumetry of the resected liver scan showed excellent correlation to water displacement volumetry (manual: ρ = 0.997; semiautomated software: ρ = 0.995). The difference between the predicted volume and the real volume was significantly smaller with the semiautomated software than with the manual method (33% vs. 57%, p = 0.002). The semiautomated software was almost four times faster for volumetry of the whole liver (manual: 6:59 ± 3:04 min; semiautomated: 1:47 ± 1:11 min). Both methods for liver volumetry give an estimated liver volume close to the real one. The tested semiautomated software is faster, more accurate in predicting the volume of the resected liver part, gives more reproducible results and is less dependent on the user's experience. Both tested types of software allow exact volumetry of resected liver parts. Preoperative prediction can be performed more accurately with the semiautomated software. The semiautomated software is nearly four times faster than the

  13. Lnc2Cancer: a manually curated database of experimentally supported lncRNAs associated with various human cancers

    PubMed Central

    Ning, Shangwei; Zhang, Jizhou; Wang, Peng; Zhi, Hui; Wang, Jianjian; Liu, Yue; Gao, Yue; Guo, Maoni; Yue, Ming; Wang, Lihua; Li, Xia

    2016-01-01

    Lnc2Cancer (http://www.bio-bigdata.net/lnc2cancer) is a manually curated database of cancer-associated long non-coding RNAs (lncRNAs) with experimental support that aims to provide a high-quality and integrated resource for exploring lncRNA deregulation in various human cancers. LncRNAs represent a large category of functional RNA molecules that play a significant role in human cancers. A curated collection and summary of deregulated lncRNAs in cancer is essential to thoroughly understand the mechanisms and functions of lncRNAs. Here, we developed the Lnc2Cancer database, which contains 1057 manually curated associations between 531 lncRNAs and 86 human cancers. Each association includes lncRNA and cancer name, the lncRNA expression pattern, experimental techniques, a brief functional description, the original reference and additional annotation information. Lnc2Cancer provides a user-friendly interface to conveniently browse, retrieve and download data. Lnc2Cancer also offers a submission page for researchers to submit newly validated lncRNA-cancer associations. With the rapidly increasing interest in lncRNAs, Lnc2Cancer will significantly improve our understanding of lncRNA deregulation in cancer and has the potential to be a timely and valuable resource. PMID:26481356

  14. Lnc2Cancer: a manually curated database of experimentally supported lncRNAs associated with various human cancers.

    PubMed

    Ning, Shangwei; Zhang, Jizhou; Wang, Peng; Zhi, Hui; Wang, Jianjian; Liu, Yue; Gao, Yue; Guo, Maoni; Yue, Ming; Wang, Lihua; Li, Xia

    2016-01-04

    Lnc2Cancer (http://www.bio-bigdata.net/lnc2cancer) is a manually curated database of cancer-associated long non-coding RNAs (lncRNAs) with experimental support that aims to provide a high-quality and integrated resource for exploring lncRNA deregulation in various human cancers. LncRNAs represent a large category of functional RNA molecules that play a significant role in human cancers. A curated collection and summary of deregulated lncRNAs in cancer is essential to thoroughly understand the mechanisms and functions of lncRNAs. Here, we developed the Lnc2Cancer database, which contains 1057 manually curated associations between 531 lncRNAs and 86 human cancers. Each association includes lncRNA and cancer name, the lncRNA expression pattern, experimental techniques, a brief functional description, the original reference and additional annotation information. Lnc2Cancer provides a user-friendly interface to conveniently browse, retrieve and download data. Lnc2Cancer also offers a submission page for researchers to submit newly validated lncRNA-cancer associations. With the rapidly increasing interest in lncRNAs, Lnc2Cancer will significantly improve our understanding of lncRNA deregulation in cancer and has the potential to be a timely and valuable resource.

  15. Field Manual for Mental Health and Human Service Workers in Major Disasters.

    ERIC Educational Resources Information Center

    DeWolfe, Deborah J.

    This field manual is intended for mental health workers and other human service providers who assist survivors following a disaster. It provides the basics of disaster mental health, with both specific and practical suggestions for workers. Essential information is included about disaster survivors' reactions and needs such as dealing with grief;…

  16. Introduction to Therapeutic and Counseling Principles: A Manual for Human Service Workers.

    ERIC Educational Resources Information Center

    Alaska State Dept. of Health and Social Services, Juneau. Div. of Mental Health and Developmental Disabilities.

    This manual introduces some of the essential principles of counseling. It is geared toward the training and education of those who have not had significant prior counseling experiences and is not comprehensive. These topics are discussed, focusing on basic, introductory material: (1) general principles of human behavior and motivation including…

  17. Interactive production planning and ergonomic assessment with Digital Human Models--introducing the Editor for Manual Work Activities (ema).

    PubMed

    Fritzsche, Lars; Leidholdt, Wolfgang; Bauer, Sebastian; Jäckel, Thomas; Moreno, Adrian

    2012-01-01

    The aging workforce is a risk factor for manufacturing industries that contain many jobs with high physical workloads. Thus, ergonomic risk factors have to be avoided in early phases of production planning. This paper introduces a new tool for simulating manual work activities with 3D human models, the so-called emaΦ. For the most part, the emaΦ software is based on a unique modular approach including a number of complex operations that were theoretically developed and empirically validated by means of motion capturing technologies. Using these modules for defining the digital work process enables the production planner to compile human simulations more accurately and much quicker compared to any of the existing modeling tools. Features of the emaΦ software implementation, such as ergonomic evaluation and MTM-time analyses, and the workflow for practical application are presented.

  18. Motion cue effects on human pilot dynamics in manual control

    NASA Technical Reports Server (NTRS)

    Washizu, K.; Tanaka, K.; Endo, S.; Itoko, T.

    1977-01-01

    Two experiments were conducted to study the motion cue effects on human pilots during tracking tasks. The moving-base simulator of National Aerospace Laboratory was employed as the motion cue device, and the attitude director indicator or the projected visual field was employed as the visual cue device. The chosen controlled elements were second-order unstable systems. It was confirmed that with the aid of motion cues the pilot workload was lessened and consequently the human controllability limits were enlarged. In order to clarify the mechanism of these effects, the describing functions of the human pilots were identified by making use of the spectral and the time domain analyses. The results of these analyses suggest that the sensory system of the motion cues can yield the differential informations of the signal effectively, which coincides with the existing knowledges in the physiological area.

  19. Rational Manual and Automated Scoring Thresholds for the Immunohistochemical Detection of TP53 Missense Mutations in Human Breast Carcinomas.

    PubMed

    Taylor, Nicholas J; Nikolaishvili-Feinberg, Nana; Midkiff, Bentley R; Conway, Kathleen; Millikan, Robert C; Geradts, Joseph

    2016-07-01

    Missense mutations in TP53 are common in human breast cancer, have been associated with worse prognosis, and may predict therapy effect. TP53 missense mutations are associated with aberrant accumulation of p53 protein in tumor cell nuclei. Previous studies have used relatively arbitrary cutoffs to characterize breast tumors as positive for p53 staining by immunohistochemical assays. This study aimed to objectively determine optimal thresholds for p53 positivity by manual and automated scoring methods using whole tissue sections from the Carolina Breast Cancer Study. p53-immunostained slides were available for 564 breast tumors previously assayed for TP53 mutations. Average nuclear p53 staining intensity was manually scored as negative, borderline, weak, moderate, or strong and percentage of positive tumor cells was estimated. Automated p53 signal intensity was measured using the Aperio nuclear v9 algorithm combined with the Genie histology pattern recognition tool and tuned to achieve optimal nuclear segmentation. Receiver operating characteristic curve analysis was performed to determine optimal cutoffs for average staining intensity and percent cells positive to distinguish between tumors with and without a missense mutation. Receiver operating characteristic curve analysis demonstrated a threshold of moderate average nuclear staining intensity as a good surrogate for TP53 missense mutations in both manual (area under the curve=0.87) and automated (area under the curve=0.84) scoring systems. Both manual and automated immunohistochemical scoring methods predicted missense mutations in breast carcinomas with high accuracy. Validation of the automated intensity scoring threshold suggests a role for such algorithms in detecting TP53 missense mutations in high throughput studies.

  20. New techniques for the analysis of manual control systems. [mathematical models of human operator behavior

    NASA Technical Reports Server (NTRS)

    Bekey, G. A.

    1971-01-01

    Studies are summarized on the application of advanced analytical and computational methods to the development of mathematical models of human controllers in multiaxis manual control systems. Specific accomplishments include the following: (1) The development of analytical and computer methods for the measurement of random parameters in linear models of human operators. (2) Discrete models of human operator behavior in a multiple display situation were developed. (3) Sensitivity techniques were developed which make possible the identification of unknown sampling intervals in linear systems. (4) The adaptive behavior of human operators following particular classes of vehicle failures was studied and a model structure proposed.

  1. Human Reliability Prediction System User’s Manual

    DTIC Science & Technology

    1977-12-01

    expresed by joining all atements by "conjunction" (A).s a rIA2. This is called a series task. 24 4 Prs] Prrla r2a] i Prir2aI (2-3) Pr’r1, ral is a...H.5., & Costello, D.L System effectiveness-concepts and analytic techniques. 267-01.7-419. Annapolis: ARINC Research Corporation , 1964. 3. Bard, P...7RQC. 38. Leuba, H.R. The human factors ingredient in system effectiveness. Annapolis: ARINC Research Corporation , 1968. 39. Lewin, K. Time

  2. Development and validation of the V/STOL aerodynamics and stability and control manual

    NASA Technical Reports Server (NTRS)

    Henderson, C.; Walters, M. M.

    1981-01-01

    A V/STOL Aerodynamics and Stability and Control Manual was developed to provide prediction methods which are applicable to a wide range of V/STOL configurations in hover and transition flight, in and out of ground effect. Propulsion-induced effects have been combined with unpowered aerodynamics in a buildup of total forces and moments for the jet-lift concept, so that total aerodynamics can be used to predict aircraft stability, control, and flying qualities characteristics. Results of longitudinal aerodynamic predictions have been compared with test data, and indicate that the methods are fast, inexpensive, and within the desired accuracy for the objective preliminary design stage.

  3. Tracking evidence based practice with youth: validity of the MATCH and standard manual consultation records.

    PubMed

    Ward, Alyssa M; Regan, Jennifer; Chorpita, Bruce F; Starace, Nicole; Rodriguez, Adriana; Okamura, Kelsie; Daleiden, Eric L; Bearman, Sarah Kate; Weisz, John R

    2013-01-01

    This study sought to evaluate the agreement between therapist report and coder observation of therapy practices. The study sampled session data from a community-based, randomized trial of treatment for youth ages 7 to 13. We used therapist report of session content and coverage gathered using formal Consultation Records and developed complimentary records for coders to use when watching or listening to therapy tape. We established initial reliability between coders and then conducted a random, stratified, and comprehensive sample of sessions across youth (N = 121), therapists (N = 57), conditions (MATCH and Standard Manuals), and study sites (Honolulu and Boston) to code and compare with therapist record reports. Intraclass correlation coefficients (ICCs) representing coder versus therapist agreement on manual content delivered ranged from .42 to 1.0 across conditions and problem areas. Analyses revealed marked variability in agreement regarding whether behavioral rehearsals took place (ICCs from -.01 to 1.0) but strong agreement on client comprehension of therapy content and homework assignments. Overall, the findings indicate that therapists can be accurate reporters of the therapeutic practices they deliver, although they may need more support in reporting subtle but valuable aspects of implementation such as types of behavioral rehearsals. Developing means to support accurate reporting is important to developing future clinical feedback methodology applicable to the implementation of evidence-based treatments in the real world.

  4. Manual vs. computer-assisted sperm analysis: can CASA replace manual assessment of human semen in clinical practice?

    PubMed

    Talarczyk-Desole, Joanna; Berger, Anna; Taszarek-Hauke, Grażyna; Hauke, Jan; Pawelczyk, Leszek; Jedrzejczak, Piotr

    2017-01-01

    The aim of the study was to check the quality of computer-assisted sperm analysis (CASA) system in comparison to the reference manual method as well as standardization of the computer-assisted semen assessment. The study was conducted between January and June 2015 at the Andrology Laboratory of the Division of Infertility and Reproductive Endocrinology, Poznań University of Medical Sciences, Poland. The study group consisted of 230 men who gave sperm samples for the first time in our center as part of an infertility investigation. The samples underwent manual and computer-assisted assessment of concentration, motility and morphology. A total of 184 samples were examined twice: manually, according to the 2010 WHO recommendations, and with CASA, using the program set-tings provided by the manufacturer. Additionally, 46 samples underwent two manual analyses and two computer-assisted analyses. The p-value of p < 0.05 was considered as statistically significant. Statistically significant differences were found between all of the investigated sperm parameters, except for non-progressive motility, measured with CASA and manually. In the group of patients where all analyses with each method were performed twice on the same sample we found no significant differences between both assessments of the same probe, neither in the samples analyzed manually nor with CASA, although standard deviation was higher in the CASA group. Our results suggest that computer-assisted sperm analysis requires further improvement for a wider application in clinical practice.

  5. The 14th Annual Conference on Manual Control. [digital simulation of human operator dynamics

    NASA Technical Reports Server (NTRS)

    1978-01-01

    Human operator dynamics during actual manual control or while monitoring the automatic control systems involved in air-to-air tracking, automobile driving, the operator of undersea vehicles, and remote handling are examined. Optimal control models and the use of mathematical theory in representing man behavior in complex man machine system tasks are discussed with emphasis on eye/head tracking and scanning; perception and attention allocation; decision making; and motion simulation and effects.

  6. Guidelines for the verification and validation of expert system software and conventional software: User`s manual. Volume 7

    SciTech Connect

    Mirsky, S.M.; Hayes, J.E.; Miller, L.A.

    1995-03-01

    This report provides a step-by-step guide, or user manual, for personnel responsible for the planning and execution of the verification and validation (V&V), and developmental testing, of expert systems, conventional software systems, and various other types of artificial intelligence systems. While the guide was developed primarily for applications in the utility industry, it applies well to all industries. The user manual has three sections. In Section 1 the user assesses the stringency of V&V needed for the system under consideration, identifies the development stage the system is in, and identifies the component(s) of the system to be tested next. These three pieces of information determine which Guideline Package of V&V methods is most appropriate for those conditions. The V&V Guideline Packages are provided in Section 2. Each package consists of an ordered set of V&V techniques to be applied to the system, guides on choosing the review/evaluation team, measurement criteria, and references to a book or report which describes the application of the method. Section 3 presents details of 11 of the most important (or least well-explained in the literature) methods to assist the user in applying these techniques accurately.

  7. Is the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, histrionic personality disorder category a valid construct?

    PubMed

    Bakkevig, Jonas F; Karterud, Sigmund

    2010-01-01

    The study investigated crucial aspects of the construct validity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) histrionic personality disorder (HPD) category. The study included 2289 patients from the Norwegian Network of Psychotherapeutic Day Hospitals. Construct validity was assessed by means of prevalence, comorbidity with other personality disorders, internal consistency among HPD criteria, severity indices, as well as factor analyses. The prevalence of HPD was very low (0.4 %). The comorbidity was high, especially with borderline, narcissistic, and dependent personality disorders. The internal consistency was low. The criteria seemed to form 2 separate clusters: the first contained exhibitionistic and attention-seeking traits and the other contained impressionistic traits. The results indicated poor construct validity of the HPD category. Different options for the future of the category are discussed. The authors suggest the HPD category to be deleted from the DSM system. However, the clinical phenomena of exhibitionism and attention-seeking, which are the dominant personality features of HPD, should be preserved in an exhibitionistic subtype of narcissism. Copyright 2010 Elsevier Inc. All rights reserved.

  8. Validation of human clinical genetic tests.

    PubMed

    Peris-Vicente, Juan; Ochoa-Arand, Enrique; Carda-Broch, Samuel; Esteve-Romero, Josep

    2014-01-01

    In the last ten years, a high amount of genetic assays has been developed for molecular biopathology and genetic laboratories of the hospitals, mainly developed and provided by external companies. In some cases, the specialized staff members of the hospitals (doctors, biopathologists, geneticists or pharmacists) develop their own methods. The validation of these methods is required before their use in clinical testing, in order to assess its reliability. Analytical methods are validated under the requirements of International Guidelines, but validation procedures for clinical genetic tests are under study and need clarifications. In this manuscript, the main information related to the field of genetic validation is revised, including statistics, explaining the difficulty of validation for some of the developed genetic tests. The provided information is in agreement with all the International Guides. The information could be useful by the workers daily performing this kind of analysis.

  9. Validation and optimization of criteria for manual smear review following automated blood cell analysis in a large university hospital.

    PubMed

    Pratumvinit, Busadee; Wongkrajang, Preechaya; Reesukumal, Kanit; Klinbua, Cherdsak; Niamjoy, Patama

    2013-03-01

    Each laboratory should have criteria for manual smear review that limit workload without affecting patient care. The International Consensus Group for Hematology Review established guidelines for action after automated blood cell analysis in 2005. To compare the consensus group criteria with our laboratory criteria and optimize them for better efficiency. A total of 2114 first-time samples were collected consecutively from daily workload and were used to compare 2 criteria as well as establish the optimized criteria. Another set of 891 samples was used to validate the optimized criteria. All samples were run on either Sysmex XE-5000 or Coulter LH750 hematology analyzers and were investigated by manual smear review. The efficiency of each set of criteria was compared and optimized to obtain better efficiency, an acceptable review rate, and a low false-negative rate. From 2114 samples, 368 (17.40%) had positive smear results. Compared with that of our laboratory criteria, the efficiency of the consensus group criteria was higher (83.63% versus 78.86%, P < .001), the review rate was higher (29.33% versus 22.37%, P < .001), and the false-negative rate was lower (2.22% versus 8.09%, P < .001). After optimizing the rules, we obtained an efficiency of 87.13%, a review rate of 24.22%, and a false-negative rate of 2.98%. We validated the optimized criteria with another set of samples, and the efficiency, review rate, and false-negative rate were 87.32%, 25.25%, and 1.12%, respectively. Each laboratory should verify the criteria for smear review, based on the International Consensus Group for Hematology Review, and optimize them to maximize efficiency.

  10. Dual Extended Kalman Filter for the Identification of Time-Varying Human Manual Control Behavior

    NASA Technical Reports Server (NTRS)

    Popovici, Alexandru; Zaal, Peter M. T.; Pool, Daan M.

    2017-01-01

    A Dual Extended Kalman Filter was implemented for the identification of time-varying human manual control behavior. Two filters that run concurrently were used, a state filter that estimates the equalization dynamics, and a parameter filter that estimates the neuromuscular parameters and time delay. Time-varying parameters were modeled as a random walk. The filter successfully estimated time-varying human control behavior in both simulated and experimental data. Simple guidelines are proposed for the tuning of the process and measurement covariance matrices and the initial parameter estimates. The tuning was performed on simulation data, and when applied on experimental data, only an increase in measurement process noise power was required in order for the filter to converge and estimate all parameters. A sensitivity analysis to initial parameter estimates showed that the filter is more sensitive to poor initial choices of neuromuscular parameters than equalization parameters, and bad choices for initial parameters can result in divergence, slow convergence, or parameter estimates that do not have a real physical interpretation. The promising results when applied to experimental data, together with its simple tuning and low dimension of the state-space, make the use of the Dual Extended Kalman Filter a viable option for identifying time-varying human control parameters in manual tracking tasks, which could be used in real-time human state monitoring and adaptive human-vehicle haptic interfaces.

  11. Development and validation of a computer crash simulation model of an occupied adult manual wheelchair subjected to a frontal impact.

    PubMed

    Dsouza, R; Bertocci, G

    2010-04-01

    Wheelchairs are primarily designed for mobility and are not necessarily intended for use as motor vehicle seats. However, many wheelchairs serve as vehicle seats for individuals unable to transfer to a vehicle seat. Subjecting wheelchairs to sled testing, in part establishes the crashworthiness of wheelchairs used as motor vehicle seats. Computer simulations provide a supplemental approach for sled testing, to assess wheelchair response and loading under crash conditions. In this study a nonlinear, dynamic, computer model was developed and validated to simulate a wheelchair and occupant subjected to a frontal impact test (ANSI/RESNA WC19). This simulation model was developed utilizing data from two frontal impact 20 g/48 km/h sled tests, which consisted of identical, adult manual wheelchairs secured with 4-point tiedowns, occupied with a 50th percentile adult male anthropomorphic test device (ATD), restrained with a 3-point occupant restraint system. Additionally, the model was validated against sled data using visual comparisons of wheelchair and occupant kinematics, along with statistical assessments of outcome measures. All statistical evaluations were found to be within the acceptance criteria, indicating the model's high predictability of the sled tests. This model provides a useful tool for the development of crashworthy wheelchair design guidelines, as well as the development of transit-safe wheelchair technologies.

  12. Combined chamber-tower approach: Using eddy covariance measurements to cross-validate carbon fluxes modeled from manual chamber campaigns

    NASA Astrophysics Data System (ADS)

    Brümmer, C.; Moffat, A. M.; Huth, V.; Augustin, J.; Herbst, M.; Kutsch, W. L.

    2016-12-01

    Manual carbon dioxide flux measurements with closed chambers at scheduled campaigns are a versatile method to study management effects at small scales in multiple-plot experiments. The eddy covariance technique has the advantage of quasi-continuous measurements but requires large homogeneous areas of a few hectares. To evaluate the uncertainties associated with interpolating from individual campaigns to the whole vegetation period, we installed both techniques at an agricultural site in Northern Germany. The presented comparison covers two cropping seasons, winter oilseed rape in 2012/13 and winter wheat in 2013/14. Modeling half-hourly carbon fluxes from campaigns is commonly performed based on non-linear regressions for the light response and respiration. The daily averages of net CO2 modeled from chamber data deviated from eddy covariance measurements in the range of ± 5 g C m-2 day-1. To understand the observed differences and to disentangle the effects, we performed four additional setups (expert versus default settings of the non-linear regressions based algorithm, purely empirical modeling with artificial neural networks versus non-linear regressions, cross-validating using eddy covariance measurements as campaign fluxes, weekly versus monthly scheduling of campaigns) to model the half-hourly carbon fluxes for the whole vegetation period. The good agreement of the seasonal course of net CO2 at plot and field scale for our agricultural site demonstrates that both techniques are robust and yield consistent results at seasonal time scale even for a managed ecosystem with high temporal dynamics in the fluxes. This allows combining the respective advantages of factorial experiments at plot scale with dense time series data at field scale. Furthermore, the information from the quasi-continuous eddy covariance measurements can be used to derive vegetation proxies to support the interpolation of carbon fluxes in-between the manual chamber campaigns.

  13. Comparison on Human Resource Requirement between Manual and Automated Dispensing Systems.

    PubMed

    Noparatayaporn, Prapaporn; Sakulbumrungsil, Rungpetch; Thaweethamcharoen, Tanita; Sangseenil, Wunwisa

    2017-05-01

    This study was conducted to compare human resource requirement among manual, automated, and modified automated dispensing systems. Data were collected from the pharmacy department at the 2100-bed university hospital (Siriraj Hospital, Bangkok, Thailand). Data regarding the duration of the medication distribution process were collected by using self-reported forms for 1 month. The data on the automated dispensing machine (ADM) system were obtained from 1 piloted inpatient ward, whereas those on the manual system were the average of other wards. Data on dispensing, returned unused medication, and stock management processes under the traditional manual system and the ADM system were from actual activities, whereas the modified ADM system was modeled. The full-time equivalent (FTE) of each model was estimated for comparison. The result showed that the manual system required 46.84 FTEs of pharmacists and 132.66 FTEs of pharmacy technicians. By adding pharmacist roles on screening and verification under the ADM system, the ADM system required 117.61 FTEs of pharmacists. Replacing counting and filling medication functions by ADM has decreased the number of pharmacy technicians to 55.38 FTEs. After the modified ADM system canceled the return unused medication process, FTEs requirement for pharmacists and pharmacy technicians decreased to 69.78 and 51.90 FTEs, respectively. The ADM system decreased the workload of pharmacy technicians, whereas it required more time from pharmacists. However, the increased workload of pharmacists was associated with more comprehensive patient care functions, which resulted from the redesigned work process. Copyright © 2017. Published by Elsevier Inc.

  14. THE VALIDITY OF HUMAN AND COMPUTERIZED WRITING ASSESSMENT

    SciTech Connect

    Ronald L. Boring

    2005-09-01

    This paper summarizes an experiment designed to assess the validity of essay grading between holistic and analytic human graders and a computerized grader based on latent semantic analysis. The validity of the grade was gauged by the extent to which the student’s knowledge of the topic correlated with the grader’s expert knowledge. To assess knowledge, Pathfinder networks were generated by the student essay writers, the holistic and analytic graders, and the computerized grader. It was found that the computer generated grades more closely matched the definition of valid grading than did human generated grades.

  15. Validation of hippocampal volumes measured using a manual method and two automated methods (FreeSurfer and IBASPM) in chronic major depressive disorder.

    PubMed

    Tae, Woo Suk; Kim, Sam Soo; Lee, Kang Uk; Nam, Eui-Cheol; Kim, Keun Woo

    2008-07-01

    To validate the usefulness of the packages available for automated hippocampal volumetry, we measured hippocampal volumes using one manual and two recently developed automated volumetric methods. The study included T1-weighted magnetic resonance imaging (MRI) of 21 patients with chronic major depressive disorder (MDD) and 20 normal controls. Using coronal turbo field echo (TFE) MRI with a slice thickness of 1.3 mm, the hippocampal volumes were measured using three methods: manual volumetry, surface-based parcellation using FreeSurfer, and individual atlas-based volumetry using IBASPM. In addition, the intracranial cavity volume (ICV) was measured manually. The absolute left hippocampal volume of the patients with MDD measured using all three methods was significantly smaller than the left hippocampal volume of the normal controls (manual P = 0.029, FreeSurfer P = 0.035, IBASPM P = 0.018). After controlling for the ICV, except for the right hippocampal volume measured using FreeSurfer, both measured hippocampal volumes of the patients with MDD were significantly smaller than the measured hippocampal volumes of the normal controls (right manual P = 0.019, IBASPM P = 0.012; left manual P = 0.003, FreeSurfer P = 0.010, IBASPM P = 0.002),. In the intrarater reliability test, the intraclass correlation coefficients (ICCs) were all excellent (manual right 0.947, left 0.934; FreeSurfer right 1.000, left 1.000; IBASPM right 1.000, left 1.000). In the test of agreement between the volumetric methods, the ICCs were right 0.846 and left 0.848 (manual and FreeSurfer), and right 0.654 and left 0.717 (manual and IBASPM). The automated hippocampal volumetric methods showed good agreement with manual hippocampal volumetry, but the volume measured using FreeSurfer was 35% larger and the agreement was questionable with IBASPM. Although the automated methods could detect hippocampal atrophy in the patients with MDD, the results indicate that manual hippocampal volumetry is still the

  16. An Investigation of Human Performance Model Validation

    DTIC Science & Technology

    2005-03-01

    from both models and empirical activities, and the construction of scenarios that will sufficiently exercise model and human participants. 1 Development...Soar to represent peripheral players/platforms in simulation-based exercises that are used to evaluate system design concepts and tactics.) We expect...and operational concepts can best be employed to assist them." As noted above, models used in the JSB exercise must be highly accurate and accredited

  17. Flight Simulator and Training Human Factors Validation

    NASA Technical Reports Server (NTRS)

    Glaser, Scott T.; Leland, Richard

    2009-01-01

    Loss of control has been identified as the leading cause of aircraft accidents in recent years. Efforts have been made to better equip pilots to deal with these types of events, commonly referred to as upsets. A major challenge in these endeavors has been recreating the motion environments found in flight as the majority of upsets take place well beyond the normal operating envelope of large aircraft. The Environmental Tectonics Corporation has developed a simulator motion base, called GYROLAB, that is capable of recreating the sustained accelerations, or G-forces, and motions of flight. A two part research study was accomplished that coupled NASA's Generic Transport Model with a GYROLAB device. The goal of the study was to characterize physiological effects of the upset environment and to demonstrate that a sustained motion based simulator can be an effective means for upset recovery training. Two groups of 25 Air Transport Pilots participated in the study. The results showed reliable signs of pilot arousal at specific stages of similar upsets. Further validation also demonstrated that sustained motion technology was successful in improving pilot performance during recovery following an extensive training program using GYROLAB technology.

  18. Analysis of operational comfort in manual tasks using human force manipulability measure.

    PubMed

    Tanaka, Yoshiyuki; Nishikawa, Kazuo; Yamada, Naoki; Tsuji, Toshio

    2015-01-01

    This paper proposes a scheme for human force manipulability (HFM) based on the use of isometric joint torque properties to simulate the spatial characteristics of human operation forces at an end-point of a limb with feasible magnitudes for a specified limb posture. This is also applied to the evaluation/prediction of operational comfort (OC) when manually operating a human-machine interface. The effectiveness of HFM is investigated through two experiments and computer simulations of humans generating forces by using their upper extremities. Operation force generation with maximum isometric effort can be roughly estimated with an HFM measure computed from information on the arm posture during a maintained posture. The layout of a human-machine interface is then discussed based on the results of operational experiments using an electric gear-shifting system originally developed for robotic devices. The results indicate a strong relationship between the spatial characteristics of the HFM and OC levels when shifting, and the OC is predicted by using a multiple regression model with HFM measures.

  19. Goal saliency boosts infants' action prediction for human manual actions, but not for mechanical claws.

    PubMed

    Adam, Maurits; Reitenbach, Ivanina; Papenmeier, Frank; Gredebäck, Gustaf; Elsner, Claudia; Elsner, Birgit

    2016-08-01

    Previous research indicates that infants' prediction of the goals of observed actions is influenced by own experience with the type of agent performing the action (i.e., human hand vs. non-human agent) as well as by action-relevant features of goal objects (e.g., object size). The present study investigated the combined effects of these factors on 12-month-olds' action prediction. Infants' (N=49) goal-directed gaze shifts were recorded as they observed 14 trials in which either a human hand or a mechanical claw reached for a small goal area (low-saliency goal) or a large goal area (high-saliency goal). Only infants who had observed the human hand reaching for a high-saliency goal fixated the goal object ahead of time, and they rapidly learned to predict the action goal across trials. By contrast, infants in all other conditions did not track the observed action in a predictive manner, and their gaze shifts to the action goal did not change systematically across trials. Thus, high-saliency goals seem to boost infants' predictive gaze shifts during the observation of human manual actions, but not of actions performed by a mechanical device. This supports the assumption that infants' action predictions are based on interactive effects of action-relevant object features (e.g., size) and own action experience. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Manual versus automated coding of free-text self-reported medication data in the 45 and Up Study: a validation study.

    PubMed

    Gnjidic, Danijela; Pearson, Sallie-Anne; Hilmer, Sarah N; Basilakis, Jim; Schaffer, Andrea L; Blyth, Fiona M; Banks, Emily

    2015-03-30

    Increasingly, automated methods are being used to code free-text medication data, but evidence on the validity of these methods is limited. To examine the accuracy of automated coding of previously keyed in free-text medication data compared with manual coding of original handwritten free-text responses (the 'gold standard'). A random sample of 500 participants (475 with and 25 without medication data in the free-text box) enrolled in the 45 and Up Study was selected. Manual coding involved medication experts keying in free-text responses and coding using Anatomical Therapeutic Chemical (ATC) codes (i.e. chemical substance 7-digit level; chemical subgroup 5-digit; pharmacological subgroup 4-digit; therapeutic subgroup 3-digit). Using keyed-in free-text responses entered by non-experts, the automated approach coded entries using the Australian Medicines Terminology database and assigned corresponding ATC codes. Based on manual coding, 1377 free-text entries were recorded and, of these, 1282 medications were coded to ATCs manually. The sensitivity of automated coding compared with manual coding was 79% (n = 1014) for entries coded at the exact ATC level, and 81.6% (n = 1046), 83.0% (n = 1064) and 83.8% (n = 1074) at the 5, 4 and 3-digit ATC levels, respectively. The sensitivity of automated coding for blank responses was 100% compared with manual coding. Sensitivity of automated coding was highest for prescription medications and lowest for vitamins and supplements, compared with the manual approach. Positive predictive values for automated coding were above 95% for 34 of the 38 individual prescription medications examined. Automated coding for free-text prescription medication data shows very high to excellent sensitivity and positive predictive values, indicating that automated methods can potentially be useful for large-scale, medication-related research.

  1. Human machine interface to manually drive rhombic like vehicles in remote handling operations

    SciTech Connect

    Lopes, Pedro; Vale, Alberto; Ventura, Rodrigo

    2015-07-01

    In the thermonuclear experimental reactor ITER, a vehicle named CTS is designed to transport a container with activated components inside the buildings. In nominal operations, the CTS is autonomously guided under supervision. However, in some unexpected situations, such as in rescue and recovery operations, the autonomous mode must be overridden and the CTS must be remotely guided by an operator. The CTS is a rhombic-like vehicle, with two drivable and steerable wheels along its longitudinal axis, providing omni-directional capabilities. The rhombic kinematics correspond to four control variables, which are difficult to manage in manual mode operation. This paper proposes a Human Machine Interface (HMI) to remotely guide the vehicle in manual mode. The proposed solution is implemented using a HMI with an encoder connected to a micro-controller and an analog 2-axis joystick. Experimental results were obtained comparing the proposed solution with other controller devices in different scenarios and using a software platform that simulates the kinematics and dynamics of the vehicle. (authors)

  2. Evaluation of objectivity, reliability and criterion validity of the key indicator method for manual handling operations (KIM-MHO), draft 2007.

    PubMed

    Klußmann, André; Gebhardt, Hansjürgen; Rieger, Monika; Liebers, Falk; Steinberg, Ulf

    2012-01-01

    Upper extremity musculoskeletal symptoms and disorders are common in the working population. The economic and social impact of such disorders is considerable. Long-time, dynamic repetitive exposure of the hand-arm system during manual handling operations (MHO) alone or in combination with static and postural effort are recognised as causes of musculoskeletal symptoms and disorders. The assessment of these manual work tasks is crucial to estimate health risks of exposed employees. For these work tasks, a new method for the assessment of the working conditions was developed and a validation study was performed. The results suggest satisfying criterion validity and moderate objectivity of the KIM-MHO draft 2007. The method was modified and evaluated again. It is planned to release a new version of KIM-MHO in spring 2012.

  3. Validating the proposed diagnostic and statistical manual of mental disorders, 5th edition, severity indicator for personality disorder.

    PubMed

    Morey, Leslie C; Bender, Donna S; Skodol, Andrew E

    2013-09-01

    The authors sought to determine whether a 5-point global rating of personality dysfunction on the Level of Personality Functioning Scale proposed as a severity index for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), would be related to DSM-IV personality disorder diagnosis as well as to other key clinical judgments. Data were collected from a national sample of 337 mental health clinicians who provided complete diagnostic information relevant to DSM-IV and proposed DSM-5 personality disorder diagnoses, as well as demographic information and other clinical judgments, on one of their patients. Of the 337 patients described, 248 met criteria for 1 of the 10 specific DSM-IV personality disorders. A "moderate" or greater rating of impairment in personality functioning on the Level Scale demonstrated 84.6% sensitivity and 72.7% specificity for identifying patients meeting criteria for a specific DSM-IV personality disorder. The Level of Personality Functioning Scale had significant and substantial validity correlations with other measures of personality pathology and with clinical judgments regarding functioning, risk, prognosis, and optimal treatment intensity. Furthermore, the single-item Level of Personality Functioning rating was viewed as being as clinically useful as the 10 DSM-IV categories for treatment planning and patient description and was a better predictor of clinician ratings of broad psychosocial functioning than were the 10 DSM-IV categories combined. These results confirm hypotheses that the single-item Level of Personality Functioning Scale rating provides an indication of severity of personality pathology that predicts both assignment of personality disorder diagnosis and clinician appraisals of functioning, risk, prognosis, and needed treatment intensity.

  4. Validity and limitation of manual rotational test to detect impaired visual-vestibular interaction due to cerebellar disorders.

    PubMed

    Murai, Norihiko; Funabiki, Kazuo; Naito, Yasushi; Ito, Juichi; Fukuyama, Hidenao

    2005-03-01

    The aim of this study was to investigate validity and limitation of the novel infrared system to record and analyze horizontal visual-vestibular interaction using whole-body rotation rapidly and conveniently in the routine vestibular clinic. We examined 11 patients with cerebellar dysequilibrium and 25 patients with peripheral dysequilibrium for vestibulo-ocular reflex in darkness (DVOR), visually-enhanced vestibulo-ocular reflex (VEVOR), and fixation suppression of vestibulo-ocular reflex (FSVOR), and compared the results with those of examination for head-fixed smooth pursuit and fixation suppression during caloric stimulation. The manual rotation stimuli were 0.5-0.75 Hz in frequency and 60-90 degrees /s in maximal angular velocity. Gain of vestibulo-ocular reflex in darkness was not significantly correlated with maximal slow phase velocity (MSPV) of caloric-induced nystagmus at that stimulus condition either in patients with peripheral dysequilibrium or in those with cerebellar dysequilibrium. An index for fixation suppression of vestibulo-ocular reflex during rotation stimulus was significantly lower in patients with cerebellar dysequilibrium than in normal control subjects and those with peripheral dysequilibrium. On the other hand, there was no significant difference among the two disease groups and the normal control group in gain of visually-enhanced vestibulo-ocular reflex. In about a half of patients with cerebellar dysequilibrium, measured smooth pursuit gain was lower than estimated smooth pursuit gain calculated based on a simple superposition theory of vestibulo-ocular reflex and smooth pursuit. Testing fixation suppression using the present system is an unusually convenient tool for detection of cerebellar dysequilibrium.

  5. Human surrogate models of neuropathic pain: validity and limitations.

    PubMed

    Binder, Andreas

    2016-02-01

    Human surrogate models of neuropathic pain in healthy subjects are used to study symptoms, signs, and the hypothesized underlying mechanisms. Although different models are available, different spontaneous and evoked symptoms and signs are inducible; 2 key questions need to be answered: are human surrogate models conceptually valid, ie, do they share the sensory phenotype of neuropathic pain states, and are they sufficiently reliable to allow consistent translational research?

  6. Development and validation of a food photography manual, as a tool for estimation of food portion size in epidemiological dietary surveys in Tunisia.

    PubMed

    Bouchoucha, Mongia; Akrout, Mouna; Bellali, Hédia; Bouchoucha, Rim; Tarhouni, Fadwa; Mansour, Abderraouf Ben; Zouari, Béchir

    2016-01-01

    Estimation of food portion sizes has always been a challenge in dietary studies on free-living individuals. The aim of this work was to develop and validate a food photography manual to improve the accuracy of the estimated size of consumed food portions. A manual was compiled from digital photos of foods commonly consumed by the Tunisian population. The food was cooked and weighed before taking digital photographs of three portion sizes. The manual was validated by comparing the method of 24-hour recall (using photos) to the reference method [food weighing (FW)]. In both the methods, the comparison focused on food intake amounts as well as nutritional issues. Validity was assessed by Bland-Altman limits of agreement. In total, 31 male and female volunteers aged 9-89 participated in the study. We focused on eight food categories and compared their estimated amounts (using the 24-hour recall method) to those actually consumed (using FW). Animal products and sweets were underestimated, whereas pasta, bread, vegetables, fruits, and dairy products were overestimated. However, the difference between the two methods is not statistically significant except for pasta (p<0.05) and dairy products (p<0.05). The coefficient of correlation between the two methods is highly significant, ranging from 0.876 for pasta to 0.989 for dairy products. Nutrient intake calculated for both methods showed insignificant differences except for fat (p<0.001) and dietary fiber (p<0.05). A highly significant correlation was observed between the two methods for all micronutrients. The test agreement highlights the lack of difference between the two methods. The difference between the 24-hour recall method using digital photos and the weighing method is acceptable. Our findings indicate that the food photography manual can be a useful tool for quantifying food portion sizes in epidemiological dietary surveys.

  7. Development and validation of a food photography manual, as a tool for estimation of food portion size in epidemiological dietary surveys in Tunisia.

    PubMed

    Bouchoucha, Mongia; Akrout, Mouna; Bellali, Hédia; Bouchoucha, Rim; Tarhouni, Fadwa; Mansour, Abderraouf Ben; Zouari, Béchir

    2016-01-01

    Background Estimation of food portion sizes has always been a challenge in dietary studies on free-living individuals. The aim of this work was to develop and validate a food photography manual to improve the accuracy of the estimated size of consumed food portions. Methods A manual was compiled from digital photos of foods commonly consumed by the Tunisian population. The food was cooked and weighed before taking digital photographs of three portion sizes. The manual was validated by comparing the method of 24-hour recall (using photos) to the reference method [food weighing (FW)]. In both the methods, the comparison focused on food intake amounts as well as nutritional issues. Validity was assessed by Bland-Altman limits of agreement. In total, 31 male and female volunteers aged 9-89 participated in the study. Results We focused on eight food categories and compared their estimated amounts (using the 24-hour recall method) to those actually consumed (using FW). Animal products and sweets were underestimated, whereas pasta, bread, vegetables, fruits, and dairy products were overestimated. However, the difference between the two methods is not statistically significant except for pasta (p<0.05) and dairy products (p<0.05). The coefficient of correlation between the two methods is highly significant, ranging from 0.876 for pasta to 0.989 for dairy products. Nutrient intake calculated for both methods showed insignificant differences except for fat (p<0.001) and dietary fiber (p<0.05). A highly significant correlation was observed between the two methods for all micronutrients. The test agreement highlights the lack of difference between the two methods. Conclusion The difference between the 24-hour recall method using digital photos and the weighing method is acceptable. Our findings indicate that the food photography manual can be a useful tool for quantifying food portion sizes in epidemiological dietary surveys.

  8. Development and validation of a food photography manual, as a tool for estimation of food portion size in epidemiological dietary surveys in Tunisia

    PubMed Central

    Bouchoucha, Mongia; Akrout, Mouna; Bellali, Hédia; Bouchoucha, Rim; Tarhouni, Fadwa; Mansour, Abderraouf Ben; Zouari, Béchir

    2016-01-01

    Background Estimation of food portion sizes has always been a challenge in dietary studies on free-living individuals. The aim of this work was to develop and validate a food photography manual to improve the accuracy of the estimated size of consumed food portions. Methods A manual was compiled from digital photos of foods commonly consumed by the Tunisian population. The food was cooked and weighed before taking digital photographs of three portion sizes. The manual was validated by comparing the method of 24-hour recall (using photos) to the reference method [food weighing (FW)]. In both the methods, the comparison focused on food intake amounts as well as nutritional issues. Validity was assessed by Bland–Altman limits of agreement. In total, 31 male and female volunteers aged 9–89 participated in the study. Results We focused on eight food categories and compared their estimated amounts (using the 24-hour recall method) to those actually consumed (using FW). Animal products and sweets were underestimated, whereas pasta, bread, vegetables, fruits, and dairy products were overestimated. However, the difference between the two methods is not statistically significant except for pasta (p<0.05) and dairy products (p<0.05). The coefficient of correlation between the two methods is highly significant, ranging from 0.876 for pasta to 0.989 for dairy products. Nutrient intake calculated for both methods showed insignificant differences except for fat (p<0.001) and dietary fiber (p<0.05). A highly significant correlation was observed between the two methods for all micronutrients. The test agreement highlights the lack of difference between the two methods. Conclusion The difference between the 24-hour recall method using digital photos and the weighing method is acceptable. Our findings indicate that the food photography manual can be a useful tool for quantifying food portion sizes in epidemiological dietary surveys. PMID:27585631

  9. Human Rights Attitude Scale: A Validity and Reliability Study

    ERIC Educational Resources Information Center

    Ercan, Recep; Yaman, Tugba; Demir, Selcuk Besir

    2015-01-01

    The objective of this study is to develop a valid and reliable attitude scale having quality psychometric features that can measure secondary school students' attitudes towards human rights. The study group of the research is comprised by 710 6th, 7th and 8th grade students who study at 4 secondary schools in the centre of Sivas. The study group…

  10. Validation of Methodologies for Quantifying Isolated Human Islets: an Islet Cell Resources Study

    PubMed Central

    Kissler, H.J.; Niland, J.C.; Olack, B.; Ricordi, C.; Hering, B.J.; Naji, A.; Faoud, K.; Oberholzer, J.; Fernandez, L.; Contreras, J.; Stiller, T.; Sowinski, J.; Kaufman, D.B.

    2011-01-01

    Background Quantification of islet mass is a crucial criterion for defining the quality of the islet product ensuring a potent islet transplant when used as a therapeutic intervention for select patients with type I diabetes. Methods This multi-center study involved all 8 member institutions of the National Institutes of Health-supported Islet Cell Resources (ICR) consortium. The study was designed to validate the standard counting procedure for quantifying isolated, dithizone-stained human islets as a reliable methodology by ascertaining the accuracy, repeatability (intra-observer variability), and intermediate precision (inter-observer variability). The secondary aim of the study was to evaluate a new software-assisted digital image analysis method as a supplement for islet quantification. Results The study demonstrated the accuracy, repeatability and intermediate precision of the standard counting procedure for isolated human islets. This study also demonstrated that software-assisted digital image analysis as a supplemental method for islet quantification was more accurate and consistent than the standard manual counting method. Conclusions Standard counting procedures for enumerating isolated stained human islets is a valid methodology, but computer-assisted digital image analysis assessment of islet mass has the added benefit of providing a permanent record of the isolated islet product being evaluated that improves quality assurance operations of current good manufacturing practice (cGMP). PMID:19719726

  11. Biosafety Manual

    SciTech Connect

    King, Bruce W.

    2010-05-18

    Work with or potential exposure to biological materials in the course of performing research or other work activities at Lawrence Berkeley National Laboratory (LBNL) must be conducted in a safe, ethical, environmentally sound, and compliant manner. Work must be conducted in accordance with established biosafety standards, the principles and functions of Integrated Safety Management (ISM), this Biosafety Manual, Chapter 26 (Biosafety) of the Health and Safety Manual (PUB-3000), and applicable standards and LBNL policies. The purpose of the Biosafety Program is to protect workers, the public, agriculture, and the environment from exposure to biological agents or materials that may cause disease or other detrimental effects in humans, animals, or plants. This manual provides workers; line management; Environment, Health, and Safety (EH&S) Division staff; Institutional Biosafety Committee (IBC) members; and others with a comprehensive overview of biosafety principles, requirements from biosafety standards, and measures needed to control biological risks in work activities and facilities at LBNL.

  12. Validity aspects of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, narcissistic personality disorder construct.

    PubMed

    Karterud, Sigmund; Øien, Maria; Pedersen, Geir

    2011-01-01

    The Diagnostic and Statistical Manual of Mental Disorders (DSM), Fourth Edition, narcissistic personality disorder (NPD) construct has been criticized for being too narrowly defined, for example, by focusing on overt grandiosity at the expense of exhibitionism and narcissistic vulnerability and thus covering only parts of the domain of narcissism. The purpose of this study was to elucidate several validity aspects of the NPD construct. The material consisted of data from 2277 patients (80% of whom had a personality disorder [PD]) who were admitted to units connected to The Norwegian Network of Psychotherapeutic Day Hospitals. The Axis II diagnoses were assessed by Structured Clinical Interview for DSM, Fourth Edition, Axis II Personality Disorders. The frequency of NPD was very low (0.8%). Male patients were overrepresented both on a diagnostic level and on criteria levels. The NPD category was positively associated with other cluster B disorders and negatively associated with avoidant PD. The criteria "demands excessive admiration" and "fantasies of unlimited success" correlated almost as highly with the histrionic PD category and loaded primarily on a histrionic factor. The dominant NPD factor also included the antisocial criterion of "showing no regret having injured others." The major part of the patients' personality pathology could be attributed to other PD criteria. The results challenge the notion of NPD as a distinct diagnostic category. Rather, narcissism should be conceived as personality dimensions pertinent to the whole range of PDs. The results support the views put forward by Russ et al (Refining the construct of narcissistic personality disorder: diagnostic criteria and subtypes. Am J Psychiatry 2008;11:1473-1481) that what clinicians conceive as narcissism consists of several subtypes (dimensions). Our data support the existence of a grandiose/malignant type and an exhibitionistic type. Unfortunately, there was no measure of hypersensitivity. The

  13. The human operator in manual preview tracking /an experiment and its modeling via optimal control/

    NASA Technical Reports Server (NTRS)

    Tomizuka, M.; Whitney, D. E.

    1976-01-01

    A manual preview tracking experiment and its results are presented. The preview drastically improves the tracking performance compared to zero-preview tracking. Optimal discrete finite preview control is applied to determine the structure of a mathematical model of the manual preview tracking experiment. Variable parameters in the model are adjusted to values which are consistent to the published data in manual control. The model with the adjusted parameters is found to be well correlated to the experimental results.

  14. Semi-manual mastoidectomy assisted by human-robot collaborative control - A temporal bone replica study.

    PubMed

    Lim, Hoon; Matsumoto, Nozomu; Cho, Byunghyun; Hong, Jaesung; Yamashita, Makoto; Hashizume, Makoto; Yi, Byung-Ju

    2016-04-01

    To develop an otological robot that can protect important organs from being injured. We developed a five degree-of-freedom robot for otological surgery. Unlike the other robots that were reported previously, our robot does not replace surgeon's procedures, but instead utilizes human-robot collaborative control. The robot basically releases all of the actuators so that the surgeon can manipulate the drill within the robot's working area with minimal restriction. When the drill reaches a forbidden area, the surgeon feels as if the drill hits a wall. When an engineer performed mastoidectomy using the robot for assistance, the facial nerve in the segmented region was always protected with a more than 2.5mm margin, which was almost the same as the pre-set safety margin of 3mm. Semi-manual drilling using human-robot collaborative control was feasible, and may hold a realistic prospect of clinical use in the near future. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Comparing Manual Counting to Automated Image Analysis for the Assessment of Fungiform Papillae Density on Human Tongue.

    PubMed

    Piochi, Maria; Monteleone, Erminio; Torri, Luisa; Masi, Camilla; Almli, Valérie Lengard; Wold, Jens Petter; Dinnella, Caterina

    2017-09-01

    The density of fungiform papillae (FPD) on the human tongue is currently taken as index for responsiveness to oral chemosensory stimuli. Visual analysis of digital tongue picture and manual counting by trained operators represents the most popular technique for FPD assessment. Methodological issues mainly due to operator bias are considered among factors accounting for the uncertainty about the relationships between FPD and responsiveness to chemosensory stimuli. The present study describes a novel automated method to count fungiform papillae (FP) from image analysis of tongue pictures. The method was applied to tongue pictures from 133 subjects. Taking the manual count as reference method, a partial least squares regression model was developed to predict FPD from tongue automated analysis output. FPD from manual and automated count showed the same normal distribution and comparable descriptive statistic values. Consistent subject classifications as low and high FPD were obtained according to the median values from manual and automated count. The same results on the effect of FPD variation on taste perception were obtained both using predicted and counted values. The proposed method overcomes count uncertainties due to researcher bias in manual counting and is suited for large population studies. Additional information is provided such as FP size class distribution which would help for a better understanding of the relationships between FPD variation and taste functions. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. Human-Persons and the Use of Psychoactive Agents, Teachers' Manual and Student Rap Sheets.

    ERIC Educational Resources Information Center

    Myers, Eddie E.

    A drug education curriculum for senior high school students utilizing a behavioral approach is offered in this two volume set composed of a Teachers' Manual and Student Rap Sheets. The teachers' manual provides introductory material about the assumptions and rationale upon which the program is based, an understanding of student behavior involved…

  17. Career Education. Human Ecology/Home Economics Objectives, Grades 6-12. DS Manual 2850.1 [and] Approved List of Essential Textbooks/Instructional Materials for Human Ecology/Home Economics, Grades 6-12. DS Manual 2850.2; Revised.

    ERIC Educational Resources Information Center

    Dependents Schools (DOD), Washington, DC.

    This manual provides program and instructional objectives as guidelines for a human ecology/home economics program in Department of Defense Dependents Schools (DoDDS). Four sections are inlcuded in the manual: (1) Human Ecology/Home Economics Program Objectives; (2) Human Ecology/Home Economics, Grades 6-8, Exploratory; (3) Fundamentals Level…

  18. Automated and manual patch clamp data of human induced pluripotent stem cell-derived dopaminergic neurons

    PubMed Central

    Franz, Denise; Olsen, Hervør Lykke; Klink, Oliver; Gimsa, Jan

    2017-01-01

    Human induced pluripotent stem cells can be differentiated into dopaminergic neurons (Dopa.4U). Dopa.4U neurons expressed voltage-gated NaV and KV channels and showed neuron-like spontaneous electrical activity. In automated patch clamp measurements with suspended Dopa.4U neurons, delayed rectifier K+ current (delayed KV) and rapidly inactivating A-type K+ current (fast KV) were identified. Examination of the fast KV current with inhibitors yielded IC50 values of 0.4 mM (4-aminopyridine) and 0.1 mM (tetraethylammonium). In manual patch clamp measurements with adherent Dopa.4U neurons, fast KV current could not be detected, while the delayed KV current showed an IC50 of 2 mM for 4-aminopyridine. The NaV channels in adherent and suspended Dopa.4U neurons showed IC50 values for tetrodotoxin of 27 and 2.9 nM, respectively. GABA-induced currents that could be observed in adherent Dopa.4U neurons could not be detected in suspended cells. Application of current pulses induced action potentials in approx. 70 % of the cells. Our results proved the feasibility of automated electrophysiological characterization of neuronal cells. PMID:28440808

  19. Validation of Student and Parent Reported Data on the Basic Grant Application Form, 1978-79 Comprehensive Validation Guide. Procedural Manual for: Validation of Cases Referred by Institutions; Validation of Cases Referred by the Office of Education; Recovery of Overpayments.

    ERIC Educational Resources Information Center

    Smith, Karen; And Others

    Procedures for validating data reported by students and parents on an application for Basic Educational Opportunity Grants were developed in 1978 for the U.S. Office of Education (OE). Validation activities include: validation of flagged Student Eligibility Reports (SERs) for students whose schools are part of the Alternate Disbursement System;…

  20. Validation of a Manually Oscillating Chair for In-The-Field Assessment of Dynamic Visual Acuity on Crewmembers Within Hours of Returning from Long-Duration Spaceflight

    NASA Technical Reports Server (NTRS)

    Kreutzberg, G. A.; Rosenberg, M. J. F.; Peters, B. T.; Reschke, M. F.

    2017-01-01

    Due to the deconditioned state of crewmembers in the initial hours after landing, it is safer and more practical to perform a vision test while seated in a chair versus walking on a treadmill. The purpose of this study was to validate the ability of a manually operated oscillating chair to produce the oscillatory frequency and displacement equivalent of walking on a treadmill at a 4 mph pace. A fast Fourier transform (FFT)was performed on the vertical trunk acceleration to compare the peak and spread of the distribution of oscillation frequencies for each oscillating condition. Peak oscillation frequencies achieved with the manual chair were lower and more variable than those of treadmill walking and the automatic chair. This can mostly be attributed to operator fatigue. However, DVA scores across conditions were not significantly different, indicating that the manual chair can provide adequate vertical oscillation frequency and displacement with the added advantage of being portable enough for testing outside a laboratory. Furthermore the automatic chair very closely matches the oscillation frequency of treadmill walking, making it an ideal method for testing DVA in a laboratory setting.

  1. Whole slide imaging for human epidermal growth factor receptor 2 immunohistochemistry interpretation: Accuracy, Precision, and reproducibility studies for digital manual and paired glass slide manual interpretation

    PubMed Central

    Wilbur, David C.; Brachtel, Elena F.; Gilbertson, John R.; Jones, Nicholas C.; Vallone, John G.; Krishnamurthy, Savitra

    2015-01-01

    Background: The use of digital whole slide imaging for human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) could create improvements in workflow and performance, allowing for central archiving of specimens, distributed and remote interpretation, and the potential for additional computerized automation. Procedures: The accuracy, precision, and reproducibility of manual digital interpretation for HER2 IHC were determined by comparison to manual glass slide interpretation. Inter- and intra-pathologist reproducibility and precision between the glass slide and digital interpretations of HER2 IHC were determined in 5 studies using DAKO HercepTest-stained breast cancer slides with the Philips Digital Pathology System. In 2 inter-method studies, 3 pathologists interpreted glass and digital slides in sequence or in random order with a minimum of 7 days as a washout period. These studies also measured inter-observer reproducibility and precision. Another two studies measured intra-pathologist reproducibility on cases read 10 times by glass and digital methods. One additional study evaluated the effects of adding IHC control slides with each run, using 1 pathologist interpreting glass and digital slides randomized from the sets above along with appropriate controls for each slide in the set. Results: The overall results show that there is no statistical difference between the variance of performance when comparing glass and digital HER2 interpretations; and there were no effects noted when control tissues were evaluated in conjunction with the test slides. Conclusions: The results show that there is an equivalence of result when interpreting HER2 IHC slides in breast cancer by either glass slides or digital images. Digital interpretation can therefore be safely and effectively used for this purpose. PMID:26110090

  2. Resource Manual for Handling Body Fluids in the School Setting To Prevent Transmission of Human Immunodeficiency Virus and Hepatitis B Virus. Revised Edition.

    ERIC Educational Resources Information Center

    Maryland State Dept. of Health and Mental Hygiene, Baltimore.

    This Maryland resource manual provides local education agencies with guidelines on how to handle body fluids to prevent the transmission of diseases, especially Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV), in the school setting. The first section summarizes the reasons for development of the manual. The second section summarizes…

  3. Resource Manual for Handling Body Fluids in the School Setting To Prevent the Transmission of Human Immunodeficiency Virus and Hepatitis B Virus.

    ERIC Educational Resources Information Center

    Maryland State Dept. of Health and Mental Hygiene, Baltimore.

    Guidelines to prevent the transmission of blood-borne diseases, especially those caused by the Human Immunodeficiency Virus (HIV) and the Hepatitis B Virus (HBV), in the school setting are provided in this resource manual for school staff. Sections include information on the reasons for the development of this manual; a summary of the means of HIV…

  4. Resource Manual for Handling Body Fluids in the School Setting To Prevent the Transmission of Human Immunodeficiency Virus and Hepatitis B Virus.

    ERIC Educational Resources Information Center

    Maryland State Dept. of Health and Mental Hygiene, Baltimore.

    Guidelines to prevent the transmission of blood-borne diseases, especially those caused by the Human Immunodeficiency Virus (HIV) and the Hepatitis B Virus (HBV), in the school setting are provided in this resource manual for school staff. Sections include information on the reasons for the development of this manual; a summary of the means of HIV…

  5. Comparison of 3D laser-based photonic scans and manual anthropometric measurements of body size and shape in a validation study of 123 young Swiss men.

    PubMed

    Koepke, Nikola; Zwahlen, Marcel; Wells, Jonathan C; Bender, Nicole; Henneberg, Maciej; Rühli, Frank J; Staub, Kaspar

    2017-01-01

    Manual anthropometric measurements are time-consuming and challenging to perform within acceptable intra- and inter-individual error margins in large studies. Three-dimensional (3D) laser body scanners provide a fast and precise alternative: within a few seconds the system produces a 3D image of the body topography and calculates some 150 standardised body size measurements. The aim was to enhance the small number of existing validation studies and compare scan and manual techniques based on five selected measurements. We assessed the agreement between two repeated measurements within the two methods, analysed the direct agreement between the two methods, and explored the differences between the techniques when used in regressions assessing the effect of health related determinants on body shape indices. We performed two repeated body scans on 123 volunteering young men using a Vitus Smart XXL body scanner. We manually measured height, waist, hip, buttock, and chest circumferences twice for each participant according to the WHO guidelines. The participants also filled in a basic questionnaire. Mean differences between the two scan measurements were smaller than between the two manual measurements, and precision as well as intra-class correlation coefficients were higher. Both techniques were strongly correlated. When comparing means between both techniques we found significant differences: Height was systematically shorter by 2.1 cm, whereas waist, hip and bust circumference measurements were larger in the scans by 1.17-4.37 cm. In consequence, body shape indices also became larger and the prevalence of overweight was greater when calculated from the scans. Between 4.1% and 7.3% of the probands changed risk category from normal to overweight when classified based on the scans. However, when employing regression analyses the two measurement techniques resulted in very similar coefficients, confidence intervals, and p-values. For performing a large number of

  6. Comparison of 3D laser-based photonic scans and manual anthropometric measurements of body size and shape in a validation study of 123 young Swiss men

    PubMed Central

    Zwahlen, Marcel; Wells, Jonathan C.; Bender, Nicole; Henneberg, Maciej

    2017-01-01

    Background Manual anthropometric measurements are time-consuming and challenging to perform within acceptable intra- and inter-individual error margins in large studies. Three-dimensional (3D) laser body scanners provide a fast and precise alternative: within a few seconds the system produces a 3D image of the body topography and calculates some 150 standardised body size measurements. Objective The aim was to enhance the small number of existing validation studies and compare scan and manual techniques based on five selected measurements. We assessed the agreement between two repeated measurements within the two methods, analysed the direct agreement between the two methods, and explored the differences between the techniques when used in regressions assessing the effect of health related determinants on body shape indices. Methods We performed two repeated body scans on 123 volunteering young men using a Vitus Smart XXL body scanner. We manually measured height, waist, hip, buttock, and chest circumferences twice for each participant according to the WHO guidelines. The participants also filled in a basic questionnaire. Results Mean differences between the two scan measurements were smaller than between the two manual measurements, and precision as well as intra-class correlation coefficients were higher. Both techniques were strongly correlated. When comparing means between both techniques we found significant differences: Height was systematically shorter by 2.1 cm, whereas waist, hip and bust circumference measurements were larger in the scans by 1.17–4.37 cm. In consequence, body shape indices also became larger and the prevalence of overweight was greater when calculated from the scans. Between 4.1% and 7.3% of the probands changed risk category from normal to overweight when classified based on the scans. However, when employing regression analyses the two measurement techniques resulted in very similar coefficients, confidence intervals, and p

  7. Comparison of Manual, Femtosecond Laser, and Precision Pulse Capsulotomy Edge Tear Strength in Paired Human Cadaver Eyes.

    PubMed

    Thompson, Vance M; Berdahl, John P; Solano, Joel M; Chang, David F

    2016-02-01

    To compare the anterior lens capsulotomy edge tear strength created by manual continuous curvilinear capsulorhexis (CCC), femtosecond laser capsulotomy (FSLC), and a new automated precision pulse capsulotomy (PPC) device. A 3-arm study in paired human cadaver eyes. A total of 44 eye specimens from 22 donors in the United States. Capsulotomy was performed in all eye specimens using manual CCC, a femtosecond laser (LenSx, Alcon, Fort Worth, TX), or an automated PPC device (Zepto, Mynosys Inc., Fremont, CA). The first study arm consisted of 8 pairs of eyes in which 1 eye received PPC and the fellow eye received FSLC. The second study arm consisted of 8 pairs of eyes, with 1 eye receiving PPC and the fellow eye receiving manual CCC. The third study arm consisted of 6 pairs of eyes, with 1 eye receiving a manual CCC and the fellow eye receiving FSLC. After phacoemulsification, 2 capsulotomy edge retractors attached to force transducers were used to stretch the capsulotomy edge of each eye and to measure the resisting force until the capsulotomy edge was torn. Capsulotomy edge tear strength in millinewtons. The PPC edge tear strength was greater than that of FSLC for all 8 pairs of eyes by an average factor of 3.1-fold (PPC mean 73.3±24.9 mN vs. femtosecond laser mean 26.1±6.8 mN; P = 0.012, Wilcoxon matched-pairs, signed-ranks test). The PPC tear strength was greater than that of manual CCC for all 8 pairs of eyes by an average factor of 4.1-fold (PPC mean 95±35.2 mN vs. manual CCC mean 29.1±23.1 mN; P = 0.012, Wilcoxon matched-pairs signed-ranks test). There was no significant difference in the tear strength of capsulotomies produced by manual CCC (mean 21.3±4.9 mN) and FSLC (mean 24.5±11.4 mN) (P = 0.75, Wilcoxon matched-pairs signed-ranks test). The strength of the PPC capsulotomy edge was significantly stronger than that produced by femtosecond laser or manual CCC. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights

  8. A self-instructional manual for installing low-cost/no-cost weatherization materials: Experimental validation with scouts

    PubMed Central

    Pavlovich, Mark; Greene, Brandon F.

    1984-01-01

    In this study, we describe the development and evaluation of a self-instructional program for installing 10 low-cost/no-cost weatherization materials (e.g., weatherstripping, caulking). This program was a weatherization and retrofit manual (WARM) providing step-by-step instructions and illustrations. Boy and Girl Scouts participated and used either the WARM or existing product instructions (EPI) to apply the materials. Scouts installed the materials properly only when they used the WARM. PMID:16795671

  9. A self-instructional manual for installing low-cost/no-cost weatherization materials: Experimental validation with scouts.

    PubMed

    Pavlovich, M; Greene, B F

    1984-01-01

    In this study, we describe the development and evaluation of a self-instructional program for installing 10 low-cost/no-cost weatherization materials (e.g., weatherstripping, caulking). This program was a weatherization and retrofit manual (WARM) providing step-by-step instructions and illustrations. Boy and Girl Scouts participated and used either the WARM or existing product instructions (EPI) to apply the materials. Scouts installed the materials properly only when they used the WARM.

  10. Manual unloading of the lumbar spine: can it identify immediate responders to mechanical traction in a low back pain population? A study of reliability and criterion referenced predictive validity

    PubMed Central

    Swanson, Brian T.; Riley, Sean P.; Cote, Mark P.; Leger, Robin R.; Moss, Isaac L.; Carlos,, John

    2016-01-01

    Background To date, no research has examined the reliability or predictive validity of manual unloading tests of the lumbar spine to identify potential responders to lumbar mechanical traction. Purpose To determine: (1) the intra and inter-rater reliability of a manual unloading test of the lumbar spine and (2) the criterion referenced predictive validity for the manual unloading test. Methods Ten volunteers with low back pain (LBP) underwent a manual unloading test to establish reliability. In a separate procedure, 30 consecutive patients with LBP (age 50·86±11·51) were assessed for pain in their most provocative standing position (visual analog scale (VAS) 49·53±25·52 mm). Patients were assessed with a manual unloading test in their most provocative position followed by a single application of intermittent mechanical traction. Post traction, pain in the provocative position was reassessed and utilized as the outcome criterion. Results The test of unloading demonstrated substantial intra and inter-rater reliability K = 1·00, P = 0·002, K = 0·737, P = 0·001, respectively. There were statistically significant within group differences for pain response following traction for patients with a positive manual unloading test (P<0·001), while patients with a negative manual unloading test did not demonstrate a statistically significant change (P>0·05). There were significant between group differences for proportion of responders to traction based on manual unloading response (P = 0·031), and manual unloading response demonstrated a moderate to strong relationship with traction response Phi = 0·443, P = 0·015. Discussion and conclusion The manual unloading test appears to be a reliable test and has a moderate to strong correlation with pain relief that exceeds minimal clinically important difference (MCID) following traction supporting the validity of this test. PMID:27559274

  11. The frequency of human, manual adjustments in balancing an inverted pendulum is constrained by intrinsic physiological factors

    PubMed Central

    Loram, Ian D; Gawthrop, Peter J; Lakie, Martin

    2006-01-01

    While standing naturally and when manually or pedally balancing an equivalent inverted pendulum, the load sways slowly (characteristic unidirectional duration ∼1 s) and the controller, calf muscles or hand, makes more frequent adjustments (characteristic unidirectional duration 400 ms). Here we test the hypothesis that these durations reflect load properties rather than some intrinsic property of the human neuromuscular system. Using a specialized set-up mechanically analogous to real standing, subjects manually balanced inverted pendulums with different moments of inertia through a compliant spring representing the Achilles tendon. The spring bias was controlled by a sensitive joystick via a servo motor and accurate visual feedback was provided on an oscilloscope. As moment of inertia decreased, inverted pendulum sway size increased and it became difficult to sustain successful balance. The mean duration of unidirectional balance adjustments did not change. Moreover, the mean duration of unidirectional inverted pendulum sway reduced only slightly, remaining around 1 s. The simplest explanation is that balance was maintained by a process of manual adjustments intrinsically limited to a mean frequency of two to three unidirectional adjustments per second corresponding to intermittent control observed in manual tracking experiments. Consequently the inverted pendulum sway duration, mechanically related to the bias duration, reflects an intrinsic constraint of the neuromuscular control system. Given the similar durations of sway and muscle adjustments observed in real standing, we postulate that the characteristic duration of unidirectional standing sway reflects intrinsic intermittent control rather than the inertial properties of the body. PMID:16973712

  12. [WHO Laboratory Manual for the Examination and Processing of Human Semen: its applicability to andrology laboratories in China].

    PubMed

    Lu, Jin-Chun; Huang, Yu-Feng; Lü, Nian-Qing

    2010-10-01

    The 5th edition of WHO Laboratory Manual for the Examination and Processing of Human Semen (2010) represents a comprehensive revision. This article aims to explore the applicability of this manual to andrology laboratories in China mainland in view of sperm count analysis, sperm motility analysis, sperm morphology analysis, sperm function analysis, anti-sperm antibody and seminal plasma biochemical marker analysis, and quality assurance and quality control of semen analysis. The authors deem that its recommendation to the analysis method and lower reference limit of sperm concentration may be a little arbitrary and lack of evidence-based support, that the revised grading sperm motility, the strict criteria and the very low cut-off value of 4% morphologically normal spermatozoa for the evaluation of sperm morphology are not applicable to andrology laboratories in China mainland, that the sperm function markers need to be supplemented, and that the determination methods of anti-sperm antibody and seminal plasma biochemical markers are incompatible with the status of Chinese andrology laboratories. However, its recommended methods for quality assurance and quality control of semen analysis have a significant directive role in China mainland. It is worth to point out that the WHO manual ignored the data obtained from Chinese which accounts for approximate 20% of the world population. Thus, given the importance of the WHO manual, its general applicability should be evaluated in China.

  13. Development of the NRC`s Human Performance Investigation Process (HPIP). Volume 2, Investigators`s Manual

    SciTech Connect

    Paradies, M.; Unger, L.; Haas, P.; Terranova, M.

    1993-10-01

    The three volumes of this report detail a standard investigation process for use by US Nuclear Regulatory Commission (NRC) personnel when investigating human performance related events at nuclear power plants. The process, called the Human Performance Investigation Process (HPIP), was developed to meet the special needs of NRC personnel, especially NRC resident and regional inspectors. HPIP is a systematic investigation process combining current procedures and field practices, expert experience, NRC human performance research, and applicable investigation techniques. The process is easy to learn and helps NRC personnel perform better field investigations of the root causes of human performance problems. The human performance data gathered through such investigations provides a better understanding of the human performance issues that cause event at nuclear power plants. This document, Volume II, is a field manual for use by investigators when performing event investigations. Volume II includes the HPIP Procedure, the HPIP Modules, and Appendices that provide extensive documentation of each investigation technique.

  14. Validation of a finite element model of the human metacarpal.

    PubMed

    Barker, D S; Netherway, D J; Krishnan, J; Hearn, T C

    2005-03-01

    Implant loosening and mechanical failure of components are frequently reported following metacarpophalangeal (MCP) joint replacement. Studies of the mechanical environment of the MCP implant-bone construct are rare. The objective of this study was to evaluate the predictive ability of a finite element model of the intact second human metacarpal to provide a validated baseline for further mechanical studies. A right index human metacarpal was subjected to torsion and combined axial/bending loading using strain gauge (SG) and 3D finite element (FE) analysis. Four different representations of bone material properties were considered. Regression analyses were performed comparing maximum and minimum principal surface strains taken from the SG and FE models. Regression slopes close to unity and high correlation coefficients were found when the diaphyseal cortical shell was modelled as anisotropic and cancellous bone properties were derived from quantitative computed tomography. The inclusion of anisotropy for cortical bone was strongly influential in producing high model validity whereas variation in methods of assigning stiffness to cancellous bone had only a minor influence. The validated FE model provides a tool for future investigations of current and novel MCP joint prostheses.

  15. The ABILHAND questionnaire as a measure of manual ability in chronic stroke patients: Rasch-based validation and relationship to upper limb impairment.

    PubMed

    Penta, M; Tesio, L; Arnould, C; Zancan, A; Thonnard, J L

    2001-07-01

    Chronic hemiparetic patients often retain the ability to manage activities requiring both hands, either through the use of the affected arm or compensation with the unaffected limb. A measure of this overall ability was developed by adapting and validating the ABILHAND questionnaire through the Rasch measurement model. ABILHAND measures the patient's perceived difficulty in performing everyday manual activities. One hundred three chronic (>6 months) stroke outpatients (62% men; mean age, 63 years) were assessed (74 in Belgium, 29 in Italy). They lived at home and walked independently and were screened for the absence of major cognitive deficits (dementia, aphasia, hemineglect). The patients were administered the ABILHAND questionnaire, the Brunnström upper limb motricity test, the box-and-block manual dexterity test, the Semmes-Weinstein tactile sensation test, and the Geriatric Depression Scale. The brain lesion type and site were recorded. ABILHAND results were analyzed with the use of Winsteps Rasch software. The Rasch refinement of ABILHAND led to a change from the original unimanual and bimanual 56-item, 4-level scale to a bimanual 23-item, 3-level scale. The resulting ability scale had sufficient sensitivity to be clinically useful. Rasch reliability was 0.90, and the item-difficulty hierarchy was stable across demographic and clinical subgroups. Grip strength, motricity, dexterity, and depression were significantly correlated with the ABILHAND measures. The ABILHAND questionnaire results in a valid person-centered measure of manual ability in everyday activities. The stability of the item-difficulty hierarchy across different patient classes further supports the clinical application of the scale.

  16. Human machine interface to manually drive rhombic like vehicles such as transport casks in ITER

    SciTech Connect

    Lopes, Pedro; Vale, Alberto; Ventura, Rodrigo

    2015-07-01

    The Cask and Plug Remote Handling System (CPRHS) and the respective Cask Transfer System (CTS) are designed to transport activated components between the reactor and the hot cell buildings of ITER during maintenance operations. In nominal operation, the CPRHS/CTS shall operate autonomously under human supervision. However, in some unexpected situations, the automatic mode must be overridden and the vehicle must be remotely guided by a human operator due to the harsh conditions of the environment. The CPRHS/CTS is a rhombic-like vehicle with two independent steerable and drivable wheels along its longitudinal axis, giving it omni-directional capabilities. During manual guidance, the human operator has to deal with four degrees of freedom, namely the orientations and speeds of two wheels. This work proposes a Human Machine Interface (HMI) to manage the degrees of freedom and to remotely guide the CPRHS/CTS in ITER taking the most advantages of rhombic like capabilities. Previous work was done to drive each wheel independently, i.e., control the orientation and speed of each wheel independently. The results have shown that the proposed solution is inefficient. The attention of the human operator becomes focused in a single wheel. In addition, the proposed solution cannot assure that the commands accomplish the physical constrains of the vehicle, resulting in slippage or even in clashes. This work proposes a solution that consists in the control of the vehicle looking at the position of its center of mass and its heading in the world frame. The solution is implemented using a rotational disk to control the vehicle heading and a common analogue joystick to control the vector speed of the center of the mass of the vehicle. The number of degrees of freedom reduces to three, i.e., two angles (vehicle heading and the orientation of the vector speed) and a scalar (the magnitude of the speed vector). This is possible using a kinematic model based on the vehicle Instantaneous

  17. A smart micro-drill for cochleostomy formation: a comparison of cochlear disturbances with manual drilling and a human trial.

    PubMed

    Coulson, C J; Assadi, M Zoka; Taylor, R P; Du, X; Brett, P N; Reid, A P; Proops, D W

    2013-03-01

    Cochleostomy formation is a key stage of the cochlear implantation procedure. Minimizing the trauma sustained by the cochlea during this step is thought to be a critical feature in hearing preservation cochlear implantation. The aim of this paper is firstly, to assess the cochlea disturbances during manual and robotic cochleostomy formation. Secondly, to determine whether the use of a smart micro-drill is feasible during human cochlear implantation. The disturbances within the cochlea during cochleostomy formation were analysed in a porcine specimen by creating a third window cochleostomy, preserving the underlying endosteal membrane, on the anterior aspect of the basal turn of the cochlea. A laser vibrometer was aimed at this third window, to assess its movement while a traditional cochleostomy was performed. Six cochleostomies were performed in total, three manually and three with a smart micro-drill. The mean and peak membrane movement was calculated for both manual and smart micro-drill arms, to represent the disturbances sustained within cochlea during cochleostomy formation. The smart micro-drill was further used to perform live human robotic cochleostomies on three adult patients who met the National Institute of Health and Clinical Excellence criteria for undergoing cochlear implantation. In the porcine trial, the smart micro-drill preserved the endosteal membrane in all three cases. The velocity of movement of the endosteal membrane during manual cochleostomy is approximately 20 times higher on average and 100 times greater in peak velocity, than for robotic cochleostomy. The robot was safely utilized in theatre in all three cases and successfully created a bony cochleostomy while preserving the underlying endosteal membrane. Our experiments have revealed that controlling the force of drilling during cochleostomy formation and opening the endosteal membrane with a pick will minimize the trauma sustained by the cochlea by a factor of 20. Additionally, the

  18. A validation study of a stochastic model of human interaction

    NASA Astrophysics Data System (ADS)

    Burchfield, Mitchel Talmadge

    The purpose of this dissertation is to validate a stochastic model of human interactions which is part of a developmentalism paradigm. Incorporating elements of ancient and contemporary philosophy and science, developmentalism defines human development as a progression of increasing competence and utilizes compatible theories of developmental psychology, cognitive psychology, educational psychology, social psychology, curriculum development, neurology, psychophysics, and physics. To validate a stochastic model of human interactions, the study addressed four research questions: (a) Does attitude vary over time? (b) What are the distributional assumptions underlying attitudes? (c) Does the stochastic model, {-}N{intlimitssbsp{-infty}{infty}}varphi(chi,tau)\\ Psi(tau)dtau, have utility for the study of attitudinal distributions and dynamics? (d) Are the Maxwell-Boltzmann, Fermi-Dirac, and Bose-Einstein theories applicable to human groups? Approximately 25,000 attitude observations were made using the Semantic Differential Scale. Positions of individuals varied over time and the logistic model predicted observed distributions with correlations between 0.98 and 1.0, with estimated standard errors significantly less than the magnitudes of the parameters. The results bring into question the applicability of Fisherian research designs (Fisher, 1922, 1928, 1938) for behavioral research based on the apparent failure of two fundamental assumptions-the noninteractive nature of the objects being studied and normal distribution of attributes. The findings indicate that individual belief structures are representable in terms of a psychological space which has the same or similar properties as physical space. The psychological space not only has dimension, but individuals interact by force equations similar to those described in theoretical physics models. Nonlinear regression techniques were used to estimate Fermi-Dirac parameters from the data. The model explained a high degree

  19. Comparison of manual and semiautomated techniques for analyzing gastric volumes with MRI in humans.

    PubMed

    Bharucha, Adil E; Karwoski, Ronald A; Fidler, Jeff; Holmes, David R; Robb, Richard A; Riederer, Stephen J; Zinsmeister, Alan R

    2014-09-01

    Gastric emptying, accommodation, and motility can be quantified with magnetic resonance imaging (MRI). The first step in image analysis entails segmenting the stomach from surrounding structures, usually by a time-consuming manual process. We have developed a semiautomated process to segment and measure gastric volumes with MRI. Gastric images were acquired with a three-dimensional gradient echo MRI sequence at 5, 10, 20, and 30 min after ingestion of a liquid nutrient (Ensure, 296 ml) labeled with gadolinium in 20 healthy volunteers and 29 patients with dyspeptic symptoms. The agreement between gastric volumes measured by manual segmentation and our new semiautomated algorithm was assessed with Lin's concordance correlation coefficient (CCC) and the Bland Altman test. At 5 min after a meal, food volumes measured by manual (352 ± 4 ml) and semiautomated (346 ± 4 ml) techniques were correlated {CCC[95% confidence interval (CI)] 0.70 (0.52, 0.81)}; air volumes measured by manual (88 ± 6 ml) and semiautomated (84 ± 6 ml) techniques were also correlated [CCC (95% CI) 0.89 (0.82, 0.94)]. Findings were similar at subsequent time points. The Bland Altman test was not significant. The time required for semiautomated segmentation ranged from an average of 204 s for the 5-min images to 233 s for the 20-min images. These times were appreciably smaller than the typical times of many tens of minutes, even hours, required for manual segmentation. To conclude, a semiautomated process can measure gastric food and air volume using MRI with comparable accuracy and far better efficiency than a manual process. Copyright © 2014 the American Physiological Society.

  20. The Human Side of Child Care Administration: A How-To Manual.

    ERIC Educational Resources Information Center

    Storm, Sherry

    Produced as the result of a leadership training course for early childhood program directors and designed to be used by directors as an independent guide, this manual is a practical resource for program directors who do not have the time or funds to obtain the specialized training needed for effective administration. Contents focus on basic…

  1. Validation of simplified dosimetry approaches in ⁸⁹Zr-PET/CT: the use of manual versus semi-automatic delineation methods to estimate organ absorbed doses.

    PubMed

    Makris, N E; van Velden, F H P; Huisman, M C; Menke, C W; Lammertsma, A A; Boellaard, R

    2014-10-01

    Increasing interest in immuno-positron emission tomography (PET) studies requires development of dosimetry methods which will provide accurate estimations of organ absorbed doses. The purpose of this study is to develop and validate simplified dosimetry approaches for (89)Zirconium-PET (Zr-PET)/computed tomography (CT) studies. Five patients with advanced colorectal cancer received 37.1 ± 0.9 MBq (89)Zr-cetuximab within 2 h after administration of a therapeutic dose of 500 mg m(-2) cetuximab. PET/CT scans were obtained 1, 24, 48, 94, and 144 h post injection. Volumes of interest (VOIs) were manually delineated in lungs, liver, spleen, and kidneys for all scans, providing a reference VOI set. Simplified manual VOIs were drawn independently on CT scans using larger voxel sizes. The transformation of VOIs based on rigid and/or nonrigid registrations of the first CT scan (CT1) onto all successive CT scans was also investigated. The transformation matrix obtained from each registration was applied to the manual VOIs of CT₁ to obtain VOIs for the successive scans. Dice similarity coefficient (DSC) and Hausdorff distance were used to assess the performance of the registrations. Organ total activity, organ absorbed dose, and effective dose were calculated for all methods. Semi-automatic delineation based on nonrigid registration showed excellent agreement for lungs and liver (DSC: 0.90 ± 0.04; 0.81 ± 0.06) and good agreement for spleen and kidneys (DSC: 0.71 ± 0.07; 0.66 ± 0.08). Hausdorff distance ranged from 13 to 16 mm depending on the organ. Simplified manual delineation methods, in liver and lungs, performed similarly to semi-automatic delineation methods. For kidneys and spleen, however, poorer accuracy in total activity and absorbed dose was observed, as the voxel size increased. Organ absorbed dose and total activity based on nonrigid registration were within 10%. The effective dose was within ±3% for all VOI delineation methods. A fast, semi-automatic, and

  2. Enhancing the examiner's resisting force improves the validity of manual muscle strength measurements: application to knee extensors and flexors.

    PubMed

    Lu, Tung-Wu; Chien, Hui-Lien; Chang, Ling-Ying; Hsu, Horng-Chaung

    2012-09-01

    The purposes of this study were to test whether an examiner's strength may affect the validity of the knee muscle strength measurements using a hand-held dynamometer (HHD) and whether enhancing the forces applied by an examiner using a resistance-enhanced dynamometer (RED) would improve measurement validity. Twenty-five young male volunteers (mean [±SD] age: 22.5 ± 1.7 years) without a history of injury to the test limb and 6 male and 6 female experienced examiners participated in this study. Maximum resisting forces of the knee flexors and extensors were measured using RED, HHD, and a dynamometer (Kin-Com). For all testing conditions, poor to moderate associations were found between the HHD and Kin-Com, whereas there was a good to excellent relationship between RED and Kin-Com. The systematic variations between RED and Kin-Com were also smaller than those between HHD and Kin-Com. The force values measured by RED were very close to those measured by Kin-Com. An examiner's strength affects the validity of the measurements using HHD. Enhancing the forces applied by the examiner to the tested segment using RED appeared to improve the validity of muscle strength measurements.

  3. Multivariable manual control with simultaneous visual and auditory presentation of information. [for improved compensatory tracking performance of human operator

    NASA Technical Reports Server (NTRS)

    Uhlemann, H.; Geiser, G.

    1975-01-01

    Multivariable manual compensatory tracking experiments were carried out in order to determine typical strategies of the human operator and conditions for improvement of his performance if one of the visual displays of the tracking errors is supplemented by an auditory feedback. Because the tracking error of the system which is only visually displayed is found to decrease, but not in general that of the auditorally supported system, it was concluded that the auditory feedback unloads the visual system of the operator who can then concentrate on the remaining exclusively visual displays.

  4. Multivariable manual control with simultaneous visual and auditory presentation of information. [for improved compensatory tracking performance of human operator

    NASA Technical Reports Server (NTRS)

    Uhlemann, H.; Geiser, G.

    1975-01-01

    Multivariable manual compensatory tracking experiments were carried out in order to determine typical strategies of the human operator and conditions for improvement of his performance if one of the visual displays of the tracking errors is supplemented by an auditory feedback. Because the tracking error of the system which is only visually displayed is found to decrease, but not in general that of the auditorally supported system, it was concluded that the auditory feedback unloads the visual system of the operator who can then concentrate on the remaining exclusively visual displays.

  5. Validation of qualitative test for phosphine gas in human tissues.

    PubMed

    Raina, Anupuma; Shrivastava, H C; Mathur, Nitin; Dogra, T D

    2003-08-01

    Phosphine has been known to science since the birth of modern chemistry. WHO reports that the technical product usually has a foul odour, like "fishy" or "garlicky" because of the presence of substituted phosphines and diphosphine (P2H4). Many medico-legal autopsy cases have been reported positive for aluminium phosphide even though there was neither any suspicion of consuming aluminium phosphide nor any clinical findings, postmortem findings or circumstantial evidences. The present study was carried out to validate the qualitative test, presently applied in many laboratories for testing phosphine. It was observed that 65% of human tissues in saturated solution of common salt show positivity for phosphine gas on the first day of autopsy.

  6. A thermal manikin with human thermoregulatory control: Implementation and validation

    NASA Astrophysics Data System (ADS)

    Foda, Ehab; Sirén, Kai

    2012-09-01

    Tens of different sorts of thermal manikins are employed worldwide, mainly in the evaluation of clothing thermal insulation and thermal environments. They are regulated thermally using simplified control modes. This paper reports on the implementation and validation of a new thermoregulatory control mode for thermal manikins. The new control mode is based on a multi-segmental Pierce (MSP) model. In this study, the MSP control mode was implemented, using the LabVIEW platform, onto the control system of the thermal manikin `Therminator'. The MSP mode was then used to estimate the segmental equivalent temperature ( t eq) along with constant surface temperature (CST) mode under two asymmetric thermal conditions. Furthermore, subjective tests under the same two conditions were carried out using 17 human subjects. The estimated segmental t eq from the experiments with the two modes and from the subjective assessment were compared in order to validate the use of the MSP mode for the estimation of t eq. The results showed that the t eq values estimated by the MSP mode were closer to the subjective mean votes under the two test conditions for most body segments and compared favourably with values estimated by the CST mode.

  7. A thermal manikin with human thermoregulatory control: implementation and validation.

    PubMed

    Foda, Ehab; Sirén, Kai

    2012-09-01

    Tens of different sorts of thermal manikins are employed worldwide, mainly in the evaluation of clothing thermal insulation and thermal environments. They are regulated thermally using simplified control modes. This paper reports on the implementation and validation of a new thermoregulatory control mode for thermal manikins. The new control mode is based on a multi-segmental Pierce (MSP) model. In this study, the MSP control mode was implemented, using the LabVIEW platform, onto the control system of the thermal manikin 'Therminator'. The MSP mode was then used to estimate the segmental equivalent temperature (t(eq)) along with constant surface temperature (CST) mode under two asymmetric thermal conditions. Furthermore, subjective tests under the same two conditions were carried out using 17 human subjects. The estimated segmental t(eq) from the experiments with the two modes and from the subjective assessment were compared in order to validate the use of the MSP mode for the estimation of t(eq). The results showed that the t(eq) values estimated by the MSP mode were closer to the subjective mean votes under the two test conditions for most body segments and compared favourably with values estimated by the CST mode.

  8. Development and validation of rear impact computer simulation model of an adult manual transit wheelchair with a seated occupant.

    PubMed

    Salipur, Zdravko; Bertocci, Gina

    2010-01-01

    It has been shown that ANSI WC19 transit wheelchairs that are crashworthy in frontal impact exhibit catastrophic failures in rear impact and may not be able to provide stable seating support and thus occupant protection for the wheelchair occupant. Thus far only limited sled test and computer simulation data have been available to study rear impact wheelchair safety. Computer modeling can be used as an economic and comprehensive tool to gain critical knowledge regarding wheelchair integrity and occupant safety. This study describes the development and validation of a computer model simulating an adult wheelchair-seated occupant subjected to a rear impact event. The model was developed in MADYMO and validated rigorously using the results of three similar sled tests conducted to specifications provided in the draft ISO/TC 173 standard. Outcomes from the model can provide critical wheelchair loading information to wheelchair and tiedown manufacturers, resulting in safer wheelchair designs for rear impact conditions.

  9. The Investigation of Construct Validity of Diagnostic and Statistical Manual of Mental Disorder-5 Personality Traits on Iranian sample with Antisocial and Borderline Personality Disorders.

    PubMed

    Amini, Mehdi; Pourshahbaz, Abbas; Mohammadkhani, Parvaneh; Ardakani, Mohammad-Reza Khodaie; Lotfi, Mozhgan

    2014-12-01

    The goal of this study was to examine the construct validity of the diagnostic and statistical manual of mental disorder-5 (DSM-5) conceptual model of antisocial and borderline personality disorders (PDs). More specifically, the aim was to determine whether the DSM-5 five-factor structure of pathological personality trait domains replicated in an independently collected sample that differs culturally from the derivation sample. This study was on a sample of 346 individuals with antisocial (n = 122) and borderline PD (n = 130), and nonclinical subjects (n = 94). Participants randomly selected from prisoners, out-patient, and in-patient clients. Participants were recruited from Tehran prisoners, and clinical psychology and psychiatry clinics of Razi and Taleghani Hospital, Tehran, Iran. The SCID-II-PQ, SCID-II, DSM-5 Personality Trait Rating Form (Clinician's PTRF) were used to diagnosis of PD and to assessment of pathological traits. The data were analyzed by exploratory factor analysis. Factor analysis revealed a 5-factor solution for DSM-5 personality traits. Results showed that DSM-5 has adequate construct validity in Iranian sample with antisocial and borderline PDs. Factors similar in number with the other studies, but different in the content. Exploratory factor analysis revealed five homogeneous components of antisocial and borderline PDs. That may represent personality, behavioral, and affective features central to the disorder. Furthermore, the present study helps understand the adequacy of DSM-5 dimensional approach to evaluation of personality pathology, specifically on Iranian sample.

  10. The Investigation of Construct Validity of Diagnostic and Statistical Manual of Mental Disorder-5 Personality Traits on Iranian sample with Antisocial and Borderline Personality Disorders

    PubMed Central

    Amini, Mehdi; Pourshahbaz, Abbas; Mohammadkhani, Parvaneh; Ardakani, Mohammad-Reza Khodaie; Lotfi, Mozhgan

    2014-01-01

    Background: The goal of this study was to examine the construct validity of the diagnostic and statistical manual of mental disorder-5 (DSM-5) conceptual model of antisocial and borderline personality disorders (PDs). More specifically, the aim was to determine whether the DSM-5 five-factor structure of pathological personality trait domains replicated in an independently collected sample that differs culturally from the derivation sample. Methods: This study was on a sample of 346 individuals with antisocial (n = 122) and borderline PD (n = 130), and nonclinical subjects (n = 94). Participants randomly selected from prisoners, out-patient, and in-patient clients. Participants were recruited from Tehran prisoners, and clinical psychology and psychiatry clinics of Razi and Taleghani Hospital, Tehran, Iran. The SCID-II-PQ, SCID-II, DSM-5 Personality Trait Rating Form (Clinician's PTRF) were used to diagnosis of PD and to assessment of pathological traits. The data were analyzed by exploratory factor analysis. Results: Factor analysis revealed a 5-factor solution for DSM-5 personality traits. Results showed that DSM-5 has adequate construct validity in Iranian sample with antisocial and borderline PDs. Factors similar in number with the other studies, but different in the content. Conclusions: Exploratory factor analysis revealed five homogeneous components of antisocial and borderline PDs. That may represent personality, behavioral, and affective features central to the disorder. Furthermore, the present study helps understand the adequacy of DSM-5 dimensional approach to evaluation of personality pathology, specifically on Iranian sample. PMID:25709797

  11. Simple and rapid determination of zaltoprofen in human plasma by manual-shaking-assisted dispersive liquid-liquid microextraction followed by liquid chromatography with ultraviolet detection.

    PubMed

    Han, Se Young; Jeong, Kyung Min; Yoo, Da Eun; Jin, Yan; Kim, Eun Mi; Kim, Su Hyun; Lee, Seok-Yong; Kim, Se-Hyung; Zhao, Jing; Lee, Jeongmi

    2017-08-12

    A readily applicable method was developed to determine the concentration level of zaltoprofen, a non-steroidal antiinflammatory drug from the propionic acid family, in human plasma. This method is based on manual-shaking-assisted dispersive liquid-liquid microextraction coupled with liquid chromatography with ultraviolet detection. Factors affecting the extraction efficiency were screened and optimized by experimental design using fractional factorial and central composite designs, respectively. Optimal conditions were: 220 μL of C2 H4 Cl2 (extraction solvent), 5 mL of 3.75% w/v NaCl aqueous solution at pH 2.0, and manual shaking for 13 s (65 times). The resulting extraction method yielded a reasonable enrichment factor of 18.0 (±0.6, n = 3) and extraction recovery of 86.0% (±3.3%, n = 3). The established method was validated for selectivity, linearity, precision, accuracy, matrix effect, recovery, dilution integrity, and stability, and it met the acceptable criteria for all of the tested parameters. Specifically, the method was linear in the range of 0.16-50.0 mg/L, precise (< 8.8% RSD), accurate (-7.5-5.6% deviation), and showed negligible matrix effects (96.1-106.4%) with high absolute recovery (94.5-97.7%). Compared with previous methods involving labor-intensive liquid-liquid extraction or non-specific protein precipitation, our method allows the simple, rapid, and efficient determination of zaltoprofen using the most affordable analytical instrument, liquid chromatography with ultraviolet detection. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  12. Evaluating the iterative development of VR/AR human factors tools for manual work.

    PubMed

    Liston, Paul M; Kay, Alison; Cromie, Sam; Leva, Chiara; D'Cruz, Mirabelle; Patel, Harshada; Langley, Alyson; Sharples, Sarah; Aromaa, Susanna

    2012-01-01

    This paper outlines the approach taken to iteratively evaluate a set of VR/AR (virtual reality / augmented reality) applications for five different manual-work applications - terrestrial spacecraft assembly, assembly-line design, remote maintenance of trains, maintenance of nuclear reactors, and large-machine assembly process design - and examines the evaluation data for evidence of the effectiveness of the evaluation framework as well as the benefits to the development process of feedback from iterative evaluation. ManuVAR is an EU-funded research project that is working to develop an innovative technology platform and a framework to support high-value, high-knowledge manual work throughout the product lifecycle. The results of this study demonstrate the iterative improvements reached throughout the design cycles, observable through the trending of the quantitative results from three successive trials of the applications and the investigation of the qualitative interview findings. The paper discusses the limitations of evaluation in complex, multi-disciplinary development projects and finds evidence of the effectiveness of the use of the particular set of complementary evaluation methods incorporating a common inquiry structure used for the evaluation - particularly in facilitating triangulation of the data.

  13. Validation of a Manually Oscillating Chair for In-The-Field Assessment of Dynamic Visual Acuity on Crewmembers Within Hours of Returning From Long-Duration Spaceflight

    NASA Technical Reports Server (NTRS)

    Kreutzberg, G. A.; Rosenberg, M. J. F.; Peters, B. T.; Reschke,M. F.

    2017-01-01

    Long-duration spaceflight results in sensorimotor adaptations, which cause functional deficits during gravitational transitions, such as landing on a planetary surface after long-duration microgravity exposure. Both the vestibular system and the central nervous system are affected by gravitational transitions. These systems are responsible for coordinating head and eye movements via the vestibulo-ocular reflex (VOR) and go through an adaptation period upon exposure to microgravity. Consequently, they must also re-adapt to Earth's gravitational environment upon landing. This re-adaptation causes decrements in gaze control and dynamic visual acuity, with crewmembers reporting oscillopsia and blurred vision caused by retinal slip, or the inability to keep an image focused on their retina. This is thought to drive motion sickness symptoms experienced by most crewmembers following landing. Retinal slip can be estimated by dynamic visual acuity (DVA); visual acuity while in motion. Previously, DVA has been assessed in the laboratory where subjects walked at 6.4 km/hr on a motorized treadmill. Using this method, Peters et al. (2011) found that DVA is worsened in astronauts by an average of 0.75 eye-chart lines one day after landing. However, it is believed that re-adaptation occurs quickly and that DVA might be worse immediately upon re-exposure to a gravitational environment. Since many crewmembers are unable to walk safely upon landing, it was necessary to develop a method for replicating the vertical head movements associated with walking. In addition, the use of a chair to imitate the head displacement caused by walking isolates eye-head interactions without allowing for trunk and lower-body compensation, as seen with treadmill walking (Mulavara & Bloomberg 2003). Therefore, a modality for assessing DVA in the field within a few hours of landing was developed. In this study, we validated the ability of a manually operated oscillating chair to reproduce the oscillatory

  14. New validated method for piracetam HPLC determination in human plasma.

    PubMed

    Curticapean, Augustin; Imre, Silvia

    2007-01-10

    The new method for HPLC determination of piracetam in human plasma was developed and validated by a new approach. The simple determination by UV detection was performed on supernatant, obtained from plasma, after proteins precipitation with perchloric acid. The chromatographic separation of piracetam under a gradient elution was achieved at room temperature with a RP-18 LiChroSpher 100 column and aqueous mobile phase containing acetonitrile and methanol. The quantitative determination of piracetam was performed at 200 nm with a lower limit of quantification LLQ=2 microg/ml. For this limit, the calculated values of the coefficient of variation and difference between mean and the nominal concentration are CV%=9.7 and bias%=0.9 for the intra-day assay, and CV%=19.1 and bias%=-7.45 for the between-days assay. For precision, the range was CV%=1.8/11.6 in the intra-day and between-days assay, and for accuracy, the range was bias%=2.3/14.9 in the intra-day and between-days assay. In addition, the stability of piracetam in different conditions was verified. Piracetam proved to be stable in plasma during 4 weeks at -20 degrees C and for 36 h at 20 degrees C in the supernatant after protein precipitation. The new proposed method was used for a bioequivalence study of two medicines containing 800 mg piracetam.

  15. Comparison of intra-arterial and manual auscultation of blood pressure during submaximal exercise in humans.

    PubMed

    Wheatley, Courtney M; Snyder, Eric M; Joyner, Michael J; Johnson, Bruce D; Olson, Thomas P

    2013-05-01

    Blood pressure (BP) is a key measure of cardiovascular function, and accurate measurement is important to ensure proper clinical evaluation, diagnosis, and treatment. We compared intra-arterial (direct) and cuff auscultation (manual) measurement techniques at rest and during 2 levels of submaximal constant-load exercise (9 min at 40% and 75% maximum watts). Sixty-four adults (aged 29.0 ± 0.7 years; 48% male; height, 173.7 ± 1.2 cm; mass, 73.0 ± 1.7 kg; body mass index, 24.1 ± 0.4 kg·m(-2); body surface area, 1.87 ± 0.03 m(2)) participated in the study. At rest, low, and moderate intensity, direct measurement demonstrated higher systolic BP (SBP) and diastolic BP (DBP) (bias for SBP: 22, 31, and 27 mm Hg and for DBP: 5, 7, and 17 mm Hg; rest, low-, and moderate-intensity, respectively; p < 0.01). At rest, the correlation and agreement between the 2 methods was modest (SBP: r = 0.56, bias = +22.1 mm Hg; DBP: r = 0.53, bias = +4.9 mm Hg; p < 0.001). There was good correlation and agreement with SBP at low and moderate intensity; however, DBP demonstrated a weaker relationship (SBP: r = 0.74 and 0.74, bias = +30.2 and +26.8 mm Hg; DBP: r = 0.39 and 0.28, bias = +7.1 and +13.4 mm Hg; for low and moderate intensity, respectively; p < 0.001). Further, manual measurement demonstrated a greater slope from rest to moderate exercise for the relationship between pulse pressure (PP) and cardiac output (13.6 ± 0.4 vs 12.3 ± 0.4, p = 0.03). As exercise intensity increases, manual DBP tends to bias low compared with direct DBP, which, when combined with parallel increases in SBP, leads to no differences in PP between methods at moderate exercise. Because PP is used to calculate other cardiovascular parameters (mean arterial pressure, systemic vascular resistance), measurement technique and exercise intensity should be considered when using cardiovascular variables as outcome measures.

  16. Safety manual

    SciTech Connect

    Not Available

    1983-05-01

    This manual, dedicated to that effort, has been prepared to help TVA employees perform their work safely. The information in this manual is the result of the experience and observations of many people in the Division of Power System Operations (PSO). As such, the manual offers a PSO employee the benefit of that accumulated knowledge of safe working in the Division.

  17. Development and application of a portable manual non-contact-type goniometric instrument for measuring human anatomical angular parameters.

    PubMed

    Susato, Shin-ichi

    2013-02-01

    Several manual contact-type goniometric instruments have previously been developed to measure joint range of motion (ROM) during physical-therapy evaluation. These include the universal goniometer and the gravity-dependent goniometer, or inclinometer, which are used to measure the ROM angle of a subject in a fully erect posture. Here, we developed a manual non-contact-type portable goniometric instrument for the measurement of anatomical angular parameters based on the principle of spot irradiation by using laser markers. The accuracy of the developed instrument was tested and its performance was compared with that of a contact-type instrument by using a skeletal model (14 static angle assessments), a free posture manikin (18 static angle assessments), and healthy human bodies (5 males and 5 females; 11 dynamic angle assessments). Measurement errors were examined also. When taking the measurements, a visual landmark-detection method was used in place of the conventional palpation method, which is inappropriate for a non-contact measuring system. The instrument developed here is applicable for practical non-contact goniometry and ROM measurements.

  18. Evidence in hand: recent discoveries and the early evolution of human manual manipulation.

    PubMed

    Kivell, Tracy L

    2015-11-19

    For several decades, it was largely assumed that stone tool use and production were abilities limited to the genus Homo. However, growing palaeontological and archaeological evidence, comparative extant primate studies, as well as results from methodological advancements in biomechanics and morphological analyses, have been gradually accumulating and now provide strong support for more advanced manual manipulative abilities and tool-related behaviours in pre-Homo hominins than has been traditionally recognized. Here, I review the fossil evidence related to early hominin dexterity, including the recent discoveries of relatively complete early hominin hand skeletons, and new methodologies that are providing a more holistic interpretation of hand function, and insight into how our early ancestors may have balanced the functional requirements of both arboreal locomotion and tool-related behaviours.

  19. Evidence in hand: recent discoveries and the early evolution of human manual manipulation

    PubMed Central

    Kivell, Tracy L.

    2015-01-01

    For several decades, it was largely assumed that stone tool use and production were abilities limited to the genus Homo. However, growing palaeontological and archaeological evidence, comparative extant primate studies, as well as results from methodological advancements in biomechanics and morphological analyses, have been gradually accumulating and now provide strong support for more advanced manual manipulative abilities and tool-related behaviours in pre-Homo hominins than has been traditionally recognized. Here, I review the fossil evidence related to early hominin dexterity, including the recent discoveries of relatively complete early hominin hand skeletons, and new methodologies that are providing a more holistic interpretation of hand function, and insight into how our early ancestors may have balanced the functional requirements of both arboreal locomotion and tool-related behaviours. PMID:26483538

  20. Validation of human physiologically based pharmacokinetic model for vinyl acetate against human nasal dosimetry data.

    PubMed

    Hinderliter, P M; Thrall, K D; Corley, R A; Bloemen, L J; Bogdanffy, M S

    2005-05-01

    Vinyl acetate has been shown to induce nasal lesions in rodents in inhalation bioassays. A physiologically based pharmacokinetic (PBPK) model for vinyl acetate has been used in human risk assessment, but previous in vivo validation was conducted only in rats. Controlled human exposures to vinyl acetate were conducted to provide validation data for the application of the model in humans. Five volunteers were exposed to 1, 5, and 10 ppm 13C1,13C2 vinyl acetate via inhalation. A probe inserted into the nasopharyngeal region sampled both 13C1,13C2 vinyl acetate and the major metabolite 13C1,13C2 acetaldehyde during rest and light exercise. Nasopharyngeal air concentrations were analyzed in real time by ion trap mass spectrometry (MS/MS). Experimental concentrations of both vinyl acetate and acetaldehyde were then compared to predicted concentrations calculated from the previously published human model. Model predictions of vinyl acetate nasal extraction compared favorably with measured values of vinyl acetate, as did predictions of nasopharyngeal acetaldehyde when compared to measured acetaldehyde. The results showed that the current PBPK model structure and parameterization are appropriate for vinyl acetate. These analyses were conducted from 1 to 10 ppm vinyl acetate, a range relevant to workplace exposure standards but which would not be expected to saturate vinyl acetate metabolism. Risk assessment based on this model further concluded that 24 h per day exposures up to 1 ppm do not present concern regarding cancer or non-cancer toxicity. Validation of the vinyl acetate human PBPK model provides support for these conclusions.

  1. Validation of Human Physiologically Based Pharmacokinetic Model for Vinyl Acetate Against Human Nasal Dosimetry Data

    SciTech Connect

    Hinderliter, Paul M.; Thrall, Karla D.; Corley, Rick A.; Bloemen, Louis J.; Bogdanffy, M S.

    2005-05-01

    Vinyl acetate has been shown to induce nasal lesions in rodents in inhalation bioassays. A physiologically based pharmacokinetic (PBPK) model for vinyl acetate has been used in human risk assessment, but previous in vivo validation was conducted only in rats. Controlled human exposures to vinyl acetate were conducted to provide validation data for the application of the model in humans. Five volunteers were exposed to 1, 5, and 10 ppm 13 C1 , 13 C2 vinyl acetate via inhalation. A probe inserted into thenasopharyngeal region sampled both 13 C1 , 13 C2 vinyl acetate and the major metabolite 13 C1 , 13 C2 acetaldehyde during rest and light exercise. Nasopharyngeal air concentrations were analyzed in real time by ion trap mass spectrometry (MS/MS). Experimental concentrations of both vinyl acetate and acetaldehyde were then compared to predicted concentrations calculated from the previously published human model. Model predictions of vinyl acetate nasal extraction compared favorably with measured values of vinyl acetate, as did predictions of nasopharyngeal acetaldehyde when compared to measured acetaldehyde. The results showed that the current PBPK model structure and parameterization are appropriate for vinyl acetate. These analyses were conducted from 1 to 10 ppm vinyl acetate, a range relevant to workplace exposure standards but which would not be expected to saturate vinyl acetate metabolism. Risk assessment based on this model further concluded that 24 h per day exposures up to 1 ppm do not present concern regarding cancer or non-cancer toxicity. Validation of the vinyl acetate human PBPK model provides support for these conclusions.

  2. Development and Initial Validation of an Instrument for Human Capital Planning

    ERIC Educational Resources Information Center

    Zula, Kenneth J.; Chermack, Thomas J.

    2008-01-01

    This article reports on development and validation of an instrument for use in human capital approaches for organizational planning. The article describes use of a team of subject matter experts in developing a measure of human capital planning, and use of exploratory factor analysis techniques to validate the resulting instrument. These data were…

  3. Development and Initial Validation of an Instrument for Human Capital Planning

    ERIC Educational Resources Information Center

    Zula, Kenneth J.; Chermack, Thomas J.

    2008-01-01

    This article reports on development and validation of an instrument for use in human capital approaches for organizational planning. The article describes use of a team of subject matter experts in developing a measure of human capital planning, and use of exploratory factor analysis techniques to validate the resulting instrument. These data were…

  4. The Human Touch: Skin Temperature during the Rubber Hand Illusion in Manual and Automated Stroking Procedures

    PubMed Central

    Rohde, Marieke; Wold, Andrew; Karnath, Hans-Otto; Ernst, Marc O.

    2013-01-01

    A difference in skin temperature between the hands has been identified as a physiological correlate of the rubber hand illusion (RHI). The RHI is an illusion of body ownership, where participants perceive body ownership over a rubber hand if they see it being stroked in synchrony with their own occluded hand. The current study set out to replicate this result, i.e., psychologically induced cooling of the stimulated hand using an automated stroking paradigm, where stimulation was delivered by a robot arm (PHANToMTM force-feedback device). After we found no evidence for hand cooling in two experiments using this automated procedure, we reverted to a manual stroking paradigm, which is closer to the one employed in the study that first produced this effect. With this procedure, we observed a relative cooling of the stimulated hand in both the experimental and the control condition. The subjective experience of ownership, as rated by the participants, by contrast, was strictly linked to synchronous stroking in all three experiments. This implies that hand-cooling is not a strict correlate of the subjective feeling of hand ownership in the RHI. Factors associated with the differences between the two designs (differences in pressure of tactile stimulation, presence of another person) that were thus far considered irrelevant to the RHI appear to play a role in bringing about this temperature effect. PMID:24260454

  5. Human events reference for ATHEANA (HERA) database description and preliminary user`s manual

    SciTech Connect

    Auflick, J.L.; Hahn, H.A.; Pond, D.J.

    1998-05-27

    The Technique for Human Error Analysis (ATHEANA) is a newly developed human reliability analysis (HRA) methodology that aims to facilitate better representation and integration of human performance into probabilistic risk assessment (PRA) modeling and quantification by analyzing risk-significant operating experience in the context of existing behavioral science models. The fundamental premise of ATHEANA is that error-forcing contexts (EFCs), which refer to combinations of equipment/material conditions and performance shaping factors (PSFs), set up or create the conditions under which unsafe actions (UAs) can occur. Because ATHEANA relies heavily on the analysis of operational events that have already occurred as a mechanism for generating creative thinking about possible EFCs, a database, called the Human Events Reference for ATHEANA (HERA), has been developed to support the methodology. This report documents the initial development efforts for HERA.

  6. Human Events Reference for ATHEANA (HERA) Database Description and Preliminary User's Manual

    SciTech Connect

    Auflick, J.L.

    1999-08-12

    The Technique for Human Error Analysis (ATHEANA) is a newly developed human reliability analysis (HRA) methodology that aims to facilitate better representation and integration of human performance into probabilistic risk assessment (PRA) modeling and quantification by analyzing risk-significant operating experience in the context of existing behavioral science models. The fundamental premise of ATHEANA is that error forcing contexts (EFCs), which refer to combinations of equipment/material conditions and performance shaping factors (PSFs), set up or create the conditions under which unsafe actions (UAs) can occur. Because ATHEANA relies heavily on the analysis of operational events that have already occurred as a mechanism for generating creative thinking about possible EFCs, a database (db) of analytical operational events, called the Human Events Reference for ATHEANA (HERA), has been developed to support the methodology. This report documents the initial development efforts for HERA.

  7. Modeling of human operator dynamics in simple manual control utilizing time series analysis. [tracking (position)

    NASA Technical Reports Server (NTRS)

    Agarwal, G. C.; Osafo-Charles, F.; Oneill, W. D.; Gottlieb, G. L.

    1982-01-01

    Time series analysis is applied to model human operator dynamics in pursuit and compensatory tracking modes. The normalized residual criterion is used as a one-step analytical tool to encompass the processes of identification, estimation, and diagnostic checking. A parameter constraining technique is introduced to develop more reliable models of human operator dynamics. The human operator is adequately modeled by a second order dynamic system both in pursuit and compensatory tracking modes. In comparing the data sampling rates, 100 msec between samples is adequate and is shown to provide better results than 200 msec sampling. The residual power spectrum and eigenvalue analysis show that the human operator is not a generator of periodic characteristics.

  8. The Bender Gestalt Test with the Human Figure Drawing Test for Young School Children. A Manual for Use with the Koppitz Scoring System.

    ERIC Educational Resources Information Center

    Koppitz, Elizabeth Munsterberg

    Presented is a manual for scoring the Bender Gestalt Test and the Human Figure Drawing Test for screening and diagnostic uses with emotionally disturbed, brain damaged, or perceptually handicapped 5- to 11-year-old children. Given are suggestions for administering and scoring the Bender test which examines distortion of shape, rotation,…

  9. Bigfoot Field Manual

    NASA Astrophysics Data System (ADS)

    Campbell, J. L.; Burrows, S.; Gower, S. T.; Cohen, W. B.

    1999-09-01

    The BigFoot Project is funded by the Earth Science Enterprise to collect and organize data to be used in the EOS Validation Program. The data collected by the BigFoot Project are unique in being ground-based observations coincident with satellite overpasses. In addition to collecting data, the BigFoot project will develop and test new algorithms for scaling point measurements to the same spatial scales as the EOS satellite products. This BigFoot Field Manual Mill be used to achieve completeness and consistency of data collected at four initial BigFoot sites and at future sites that may collect similar validation data. Therefore, validation datasets submitted to the ORNL DAAC that have been compiled in a manner consistent with the field manual will be especially valuable in the validation program.

  10. Reliability and validity of MRI-based automated volumetry software relative to auto-assisted manual measurement of subcortical structures in HIV-infected patients from a multisite study.

    PubMed

    Dewey, Jeffrey; Hana, George; Russell, Troy; Price, Jared; McCaffrey, Daniel; Harezlak, Jaroslaw; Sem, Ekta; Anyanwu, Joy C; Guttmann, Charles R; Navia, Bradford; Cohen, Ronald; Tate, David F

    2010-07-15

    The automated volumetric output of FreeSurfer and Individual Brain Atlases using Statistical Parametric Mapping (IBASPM), two widely used and well published software packages, was examined for accuracy and consistency relative to auto-assisted manual (AAM) tracings (i.e., manual correction of automated output) when measuring the caudate, putamen, amygdala, and hippocampus in the baseline scans of 120 HIV-infected patients (86.7% male, 47.3+/-6.3y.o., mean HIV duration 12.0+/-6.3years) from the NIH-funded HIV Neuroimaging Consortium (HIVNC) cohort. The data was examined for accuracy and consistency relative to auto-assisted manual tracing, and construct validity was assessed by correlating automated and AAM volumetric measures with relevant clinical measures of HIV progression. When results were averaged across all patients in the eight structures examined, FreeSurfer achieved lower absolute volume difference in five, higher sensitivity in seven, and higher spatial overlap in all eight structures. Additionally, FreeSurfer results exhibited less variability in all measures. Output from both methods identified discrepant correlations with clinical measures of HIV progression relative to AAM segmented data. Overall, FreeSurfer proved more effective in the context of subcortical volumetry in HIV-patients, particularly in a multisite cohort study such as this. These findings emphasize that regardless of the automated method used, visual inspection of segmentation output, along with manual correction if necessary, remains critical to ensuring the validity of reported results. Copyright 2010 Elsevier Inc. All rights reserved.

  11. Technical Manual: Handwriting Research Corporation.

    ERIC Educational Resources Information Center

    Robinson, Sharon E.; Hopper, Mark A.

    This technical manual discusses some of the recent developments in the science of graphology and their implications for the science. The manual contains the following sections: (1) Graphology: An Introduction; (2) "CHAPS": Computerized Handwriting Analysis Profiling Systems; (3) HRC Profiles; (4) Reliability; (5) Validity; (6) Historical…

  12. VALGENT: A protocol for clinical validation of human papillomavirus assays.

    PubMed

    Arbyn, Marc; Depuydt, Christophe; Benoy, Ina; Bogers, Johannes; Cuschieri, Kate; Schmitt, Markus; Pawlita, Michael; Geraets, Daan; Heard, Isabelle; Gheit, Tarik; Tommasino, Massimo; Poljak, Mario; Bonde, Jesper; Quint, Wim

    2016-03-01

    Testing for high-risk HPV is more effective in primary cervical cancer screening than the cytological examination of a Pap smear. Separate genotyping may be useful for triage in both HPV-based and cytology-based screening. Only clinically validated tests should be used in clinical practice. VALGENT is a study framework for test comparison and validation of HPV assays in general and HPV genotyping tests in particular according to clinically relevant outcomes and for clinical applications endorsed by scientific evidence. VALGENT involves the collation of fresh or archived cervical cell specimen from women attending routine screening supplemented with cytologically abnormal samples. Multiple aliquots of residual material are sent from a central laboratory to participating laboratories for testing with novel HPV assays with limited, extended or full genotyping capacity. Outcomes are derived from screening and pathology registries. Each VALGENT panel includes an assay already validated for screening. A series of accuracy and concordance statistics were generated. Currently, two VALGENT study rounds, originated from laboratories in Antwerp (Belgium) and Edinburgh (Scotland), were completed. Two new assays (G5+/6+ PCR-LMNX and Xpert HPV) were validated for screening by showing similar accuracy for cervical precancer as the standard comparator test. For two other tests (BD Onclarity, PapilloCheck) validation was confirmed. Inter-test agreement was high although certain type-specific discordances were observed which warrant further analysis. VALGENT extends current guidelines for high-risk HPV test validation in cervical cancer screening and has produced a large study resource for test comparison. More robust procedures of sample selection and handling and integration with the global WHO reference laboratory network focusing on analytical accuracy, may result in the generation of an international standard and a formalized system for clinical validation of HPV assays and

  13. Junior Science and Humanities Symposium, January 1994-July 1995. Pacific Region Program Operations Manual.

    ERIC Educational Resources Information Center

    Schlenker, Richard M.

    This informational packet contains the materials necessary to administer the annual Department of Defense Dependent Schools Pacific Region Junior Science and Humanities Symposium (JSHS) at the high school and middle school levels. The symposium program is a calendar year research program which includes one week symposium of students (grade 8-12)…

  14. Automated Airdrop Information Retrieval System-Human Fact ors Database (AAIRS-HFD) (Users Manual)

    DTIC Science & Technology

    1994-09-01

    Release Point Missed Drop Zone Low Velocity Platform Airdrop ( LVAD ) Incidents extraction phase extraction Parachute failed to deploy properly...Biomechanical Measurements Biomechanical Modeling 7. Aerospace Physiological/Medical Factors Medical History cardiovascular condition medication...System Used Breakaway Rigging Delivery System high velocity low velocity HAARS 12. Other Airdrop Human Factors Issues History of Parachuting

  15. Empowering Women at the Grassroots: A Manual for Women's Human Rights Education.

    ERIC Educational Resources Information Center

    Guhathakurta, Meghna; Lina, Khadija

    Nagorik Uddyog (Citizen's Initiative) is a non-profit, non-governmental Bangladeshi organization focused on empowering women at the grassroots level through human rights education. Although women constitute half of the total population of Bangladesh, their participation in social, cultural, and political activities is limited. Recently,…

  16. Intermittent Feedback-Control Strategy for Stabilizing Inverted Pendulum on Manually Controlled Cart as Analogy to Human Stick Balancing.

    PubMed

    Yoshikawa, Naoya; Suzuki, Yasuyuki; Kiyono, Ken; Nomura, Taishin

    2016-01-01

    The stabilization of an inverted pendulum on a manually controlled cart (cart-inverted-pendulum; CIP) in an upright position, which is analogous to balancing a stick on a fingertip, is considered in order to investigate how the human central nervous system (CNS) stabilizes unstable dynamics due to mechanical instability and time delays in neural feedback control. We explore the possibility that a type of intermittent time-delayed feedback control, which has been proposed for human postural control during quiet standing, is also a promising strategy for the CIP task and stick balancing on a fingertip. Such a strategy hypothesizes that the CNS exploits transient contracting dynamics along a stable manifold of a saddle-type unstable upright equilibrium of the inverted pendulum in the absence of control by inactivating neural feedback control intermittently for compensating delay-induced instability. To this end, the motions of a CIP stabilized by human subjects were experimentally acquired, and computational models of the system were employed to characterize the experimental behaviors. We first confirmed fat-tailed non-Gaussian temporal fluctuation in the acceleration distribution of the pendulum, as well as the power-law distributions of corrective cart movements for skilled subjects, which was previously reported for stick balancing. We then showed that the experimental behaviors could be better described by the models with an intermittent delayed feedback controller than by those with the conventional continuous delayed feedback controller, suggesting that the human CNS stabilizes the upright posture of the pendulum by utilizing the intermittent delayed feedback-control strategy.

  17. Intermittent Feedback-Control Strategy for Stabilizing Inverted Pendulum on Manually Controlled Cart as Analogy to Human Stick Balancing

    PubMed Central

    Yoshikawa, Naoya; Suzuki, Yasuyuki; Kiyono, Ken; Nomura, Taishin

    2016-01-01

    The stabilization of an inverted pendulum on a manually controlled cart (cart-inverted-pendulum; CIP) in an upright position, which is analogous to balancing a stick on a fingertip, is considered in order to investigate how the human central nervous system (CNS) stabilizes unstable dynamics due to mechanical instability and time delays in neural feedback control. We explore the possibility that a type of intermittent time-delayed feedback control, which has been proposed for human postural control during quiet standing, is also a promising strategy for the CIP task and stick balancing on a fingertip. Such a strategy hypothesizes that the CNS exploits transient contracting dynamics along a stable manifold of a saddle-type unstable upright equilibrium of the inverted pendulum in the absence of control by inactivating neural feedback control intermittently for compensating delay-induced instability. To this end, the motions of a CIP stabilized by human subjects were experimentally acquired, and computational models of the system were employed to characterize the experimental behaviors. We first confirmed fat-tailed non-Gaussian temporal fluctuation in the acceleration distribution of the pendulum, as well as the power-law distributions of corrective cart movements for skilled subjects, which was previously reported for stick balancing. We then showed that the experimental behaviors could be better described by the models with an intermittent delayed feedback controller than by those with the conventional continuous delayed feedback controller, suggesting that the human CNS stabilizes the upright posture of the pendulum by utilizing the intermittent delayed feedback-control strategy. PMID:27148031

  18. Retrospective Validation of a Computer-Assisted Quantification Model of Intracerebral Hemorrhage Volume on Accuracy, Precision, and Acquisition Time, Compared with Standard ABC/2 Manual Volume Calculation.

    PubMed

    Xue, W; Vegunta, S; Zwart, C M; Aguilar, M I; Patel, A C; Hoxworth, J M; Demaerschalk, B M; Mitchell, J R

    2017-08-01

    Intracerebral hemorrhage accounts for 6.5%-19.6% of all acute strokes. Initial intracerebral hemorrhage volume and expansion are both independent predictors of clinical outcomes and mortality. Therefore, a rapid, unbiased, and precise measurement of intracerebral hemorrhage volume is a key component of clinical management. The most commonly used method, ABC/2, results in overestimation. We developed an interactive segmentation program, SegTool, using a novel graphic processing unit, level set algorithm. Until now, the speed, bias, and precision of SegTool had not been validated. In a single stroke academic center, 2 vascular neurologists and 2 neuroradiologists independently performed a test-retest experiment that involved repeat measurements of static, unchanging intracerebral hemorrhage volumes on CT from 76 intracerebral hemorrhage cases. Measurements were made with SegTool and ABC/2. True intracerebral hemorrhage volumes were estimated from a consensus of repeat manual tracings by 2 operators. These data allowed us to estimate measurement bias, precision, and speed. The measurements with SegTool were not significantly different from the true intracerebral hemorrhage volumes, while ABC/2 overestimated volume by 45%. The interrater measurement variability with SegTool was 50% less than that with ABC/2. The average measurement times for ABC/2 and SegTool were 35.7 and 44.6 seconds, respectively. SegTool appears to have attributes superior to ABC/2 in terms of accuracy and interrater reliability with a 9-second delay in measurement time (on average); hence, it could be useful in clinical trials and practice. © 2017 by American Journal of Neuroradiology.

  19. Nuclear Computerized Library for Assessing Reactor Reliability (NUCLARR): Data manual. Part 2: Human error probability (HEP) data; Volume 5, Revision 4

    SciTech Connect

    Reece, W.J.; Gilbert, B.G.; Richards, R.E.

    1994-09-01

    This data manual contains a hard copy of the information in the Nuclear Computerized Library for Assessing Reactor Reliability (NUCLARR) Version 3.5 database, which is sponsored by the US Nuclear Regulatory Commission. NUCLARR was designed as a tool for risk analysis. Many of the nuclear reactors in the US and several outside the US are represented in the NUCLARR database. NUCLARR includes both human error probability estimates for workers at the plants and hardware failure data for nuclear reactor equipment. Aggregations of these data yield valuable reliability estimates for probabilistic risk assessments and human reliability analyses. The data manual is organized to permit manual searches of the information if the computerized version is not available. Originally, the manual was published in three parts. In this revision the introductory material located in the original Part 1 has been incorporated into the text of Parts 2 and 3. The user can now find introductory material either in the original Part 1, or in Parts 2 and 3 as revised. Part 2 contains the human error probability data, and Part 3, the hardware component reliability data.

  20. Terminology Manual.

    ERIC Educational Resources Information Center

    Felber, Helmut

    A product of the International Information Center for Terminology (Infoterm), this manual is designed to serve as a reference tool for practitioners active in terminology work and documentation. The manual explores the basic ideas of the Vienna School of Terminology and explains developments in the area of applied computer aided terminography…

  1. Quality Manual

    NASA Astrophysics Data System (ADS)

    Koch, Michael

    The quality manual is the “heart” of every management system related to quality. Quality assurance in analytical laboratories is most frequently linked with ISO/IEC 17025, which lists the standard requirements for a quality manual. In this chapter examples are used to demonstrate, how these requirements can be met. But, certainly, there are many other ways to do this.

  2. Management Manual.

    ERIC Educational Resources Information Center

    San Joaquin Delta Community Coll. District, CA.

    This manual articulates the rights, responsibilities, entitlements, and conditions of employment of management personnel at San Joaquin Delta College (SJDC). The manual first presents SJDC's mission statement and then discusses the college's management goals and priorities. An examination of SJDC's administrative organization and a list of…

  3. Resource Manual

    ERIC Educational Resources Information Center

    Human Development Institute, 2008

    2008-01-01

    This manual was designed primarily for use by individuals with developmental disabilities and related conditions. The main focus of this manual is to provide easy-to-read information concerning available resources, and to provide immediate contact information for the purpose of applying for resources and/or locating additional information. The…

  4. Validation of a semi-automated human hepatocyte assay for the determination and prediction of intrinsic clearance in discovery.

    PubMed

    Reddy, Anita; Heimbach, Tycho; Freiwald, Sascha; Smith, Danielle; Winters, Roger; Michael, Steven; Surendran, Narayanan; Cai, Hongliang

    2005-02-23

    An automated high throughput human hepatocyte assay has been established with a 96-well format using a Tecan Genesistrade mark Workstation. Validation of this assay was performed with nine commercially available compounds and an additional 10 Pfizer compounds with varying hepatic extraction ratios (E(H)) ranging from 0.02 to approximately 1. The incubation conditions in the automated assay are readily and precisely controlled and cell viability of over 80% was achieved in the automated assay further confirming its utility for absorption, distribution, metabolism, and excretion (toxicity) (ADME (T)) screening. The results of the nine commercial compounds correlate with both manually executed (R(2)=0.97) and literature reported experimental results (R(2)=0.93). Overall, measured E(H)s were within two-fold of the literature values for approximately 90% of the 19 compounds tested. Additionally, good inter- and intra-day reproducibility was observed for all the 19 compounds. In conclusion, an automated and robust assay suitable for simultaneously testing up to 48 compounds with multiple time points has been validated. Throughput of 192 compounds per run can be achieved using 384-well plates to meet increasing needs in drug discovery. Currently, this automated assay is used to support early discovery profiling towards lead optimization of various discovery targets/programs.

  5. Visualization and Rule Validation in Human-Behavior Representation

    ERIC Educational Resources Information Center

    Moya, Lisa Jean; McKenzie, Frederic D.; Nguyen, Quynh-Anh H.

    2008-01-01

    Human behavior representation (HBR) models simulate human behaviors and responses. The Joint Crowd Federate [TM] cognitive model developed by the Virginia Modeling, Analysis, and Simulation Center (VMASC) and licensed by WernerAnderson, Inc., models the cognitive behavior of crowds to provide credible crowd behavior in support of military…

  6. Visualization and Rule Validation in Human-Behavior Representation

    ERIC Educational Resources Information Center

    Moya, Lisa Jean; McKenzie, Frederic D.; Nguyen, Quynh-Anh H.

    2008-01-01

    Human behavior representation (HBR) models simulate human behaviors and responses. The Joint Crowd Federate [TM] cognitive model developed by the Virginia Modeling, Analysis, and Simulation Center (VMASC) and licensed by WernerAnderson, Inc., models the cognitive behavior of crowds to provide credible crowd behavior in support of military…

  7. Manual de Carpinteria (Carpentry Manual).

    ERIC Educational Resources Information Center

    TomSing, Luisa B.

    This manual is part of a Mexican series of instructional materials designed for Spanish speaking adults who are in the process of becoming literate or have recently become literate in their native language. The manual describes a carpentry course that is structured to appeal to the student as a self-directing adult. The following units are…

  8. Technical Manual: 2002 Series GED Tests

    ERIC Educational Resources Information Center

    Ezzelle, Carol; Setzer, J. Carl

    2009-01-01

    This manual was written to provide technical information regarding the 2002 Series GED (General Educational Development) Tests. Throughout this manual, documentation is provided regarding the development of the GED Tests, data collection activities, as well as reliability and validity evidence. The purpose of this manual is to provide evidence…

  9. The effects of acceleration stress on human workload and manual control

    NASA Technical Reports Server (NTRS)

    Gill, R. T.; Albery, W. B.; Ward, S. L.

    1986-01-01

    The effects of +Gz stress on operator task performance and workload were assessed. Subjects were presented a two dimensional maze and were required to solve it as rapidly as possible (by moving a light dot through it via a trim switch on a control stick) while under G-stress at levels from +1 Gz to +6 Gz. The G-stress was provided by a human centrifuge. The effects of this stress were assessed by two techniques; (1) objective performance measures on the primary maze-solving task, and (2) subjective workload measures obtained using the subjective workload assessment technique (SWAT). It was found that while neither moderate (+3 Gz) nor high (+5 Gz and +6 Gz) levels of G-stress affected maze solving performance, the high G levels did increase significantly the subjective workload of the maze task.

  10. Plasticity of human handedness: decreased one-hand bias and inter-manual performance asymmetry in expert basketball players.

    PubMed

    Stöckel, Tino; Weigelt, Matthias

    2012-01-01

    Athletes frequently have to adapt their skills to fast changes of play, often requiring the flexible execution of a particular movement skill with either hand. To assess the influence of sport-specific expertise and extensive sport training on human laterality, a video analysis of regular basketball games was performed for professional, semi-professional, and amateur players to investigate how non-dominant hand use and proficiency change with increasing expertise. Our results showed that the right-hand (i.e. dominant hand) bias in basketball players is reduced with increasing expertise (i.e., competitive level). Accordingly, we found that professional players use their non-dominant hand more often and with greater success than semi-professional and amateur players. This was true for most of the basketball-specific skills. Based on these results, we assume that increasing amounts of bilateral practice can lead to a shift in task-specific manual preference towards a higher use of both hands in competition, as well as to a higher proficiency for non-dominant hand actions in particular. From an applied perspective, the more frequent use and higher proficiency of the non-dominant hand in professional basketball players, compared with amateurs, suggests that the context-specific and skilled use of the non-dominant hand is crucial for successful play at higher competitive levels in the sport of basketball.

  11. Primary Blast Injury Criteria for Animal/Human TBI Models using Field Validated Shock Tubes

    DTIC Science & Technology

    2016-09-01

    AWARD NUMBER: W81XWH-15-1-0303 TITLE: Primary Blast Injury Criteria for Animal/ Human TBI Models using Field Validated Shock Tubes PRINCIPAL...2015 - 14 Aug 2016 4. TITLE AND SUBTITLE Primary Blast Injury Criteria for Animal/ Human TBI Models using Field Validated Shock Tubes 5a. CONTRACT...Mail: namas.chandra@njit.edu 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT

  12. Crazy like a fox. Validity and ethics of animal models of human psychiatric disease.

    PubMed

    Rollin, Michael D H; Rollin, Bernard E

    2014-04-01

    Animal models of human disease play a central role in modern biomedical science. Developing animal models for human mental illness presents unique practical and philosophical challenges. In this article we argue that (1) existing animal models of psychiatric disease are not valid, (2) attempts to model syndromes are undermined by current nosology, (3) models of symptoms are rife with circular logic and anthropomorphism, (4) any model must make unjustified assumptions about subjective experience, and (5) any model deemed valid would be inherently unethical, for if an animal adequately models human subjective experience, then there is no morally relevant difference between that animal and a human.

  13. Human Identification via Lateral Patella Radiographs: A Validation Study.

    PubMed

    Niespodziewanski, Emily; Stephan, Carl N; Guyomarc'h, Pierre; Fenton, Todd W

    2016-01-01

    This research examines the utility of patella outline shape for matching 3D scans of patellae to knee radiographs using elliptical Fourier analysis and subjective methods of human visual comparison of patellae across radiographs for identification purposes. Repeat radiographs were captured of cadaver's knees for visual comparison before patellae were extracted and skeletonized for quantitative comparisons. Quantitative methods provided significant narrowing down of the candidate pool to just a few potential matches (<5% of original sample), while the human analysts showed high capacity for correctly matching radiographs, irrespective of educational level (positive predictive value = 99.8%). The successful computerized matching based on a single quantified patella trait (outline shape) helps explain the potency achieved by subjective visual examination. This work adds to a growing body of studies demonstrating the value of single isolated infracranial bones for human identification via radiographic comparison.

  14. Salinas : theory manual.

    SciTech Connect

    Walsh, Timothy Francis; Reese, Garth M.; Bhardwaj, Manoj Kumar

    2011-11-01

    Salinas provides a massively parallel implementation of structural dynamics finite element analysis, required for high fidelity, validated models used in modal, vibration, static and shock analysis of structural systems. This manual describes the theory behind many of the constructs in Salinas. For a more detailed description of how to use Salinas, we refer the reader to Salinas, User's Notes. Many of the constructs in Salinas are pulled directly from published material. Where possible, these materials are referenced herein. However, certain functions in Salinas are specific to our implementation. We try to be far more complete in those areas. The theory manual was developed from several sources including general notes, a programmer notes manual, the user's notes and of course the material in the open literature.

  15. Ciencias 2. Manual do Professor (Science Teacher's Manual).

    ERIC Educational Resources Information Center

    Raposo, Lucilia

    This is the teacher's manual for Ciencias 2, the second in a series of elementary science textbooks for Portuguese-speaking students. The student textbook contains 10 chapters and 57 activities. The teacher's manual presents an explanation of the educational goals and the organization of the content, Topics included are environment, the human,…

  16. International Validation of Two Human Recombinant Estrogen Receptor (ERa) Binding Assays

    EPA Science Inventory

    An international validation study has been successfully completed for 2 competitive binding assays using human recombinant ERa. Assays evaluated included the Freyberger-Wilson (FW) assay using a full length human ER, and the Chemical Evaluation and Research Institute (CERI) assay...

  17. International Validation of Two Human Recombinant Estrogen Receptor (ERa) Binding Assays

    EPA Science Inventory

    An international validation study has been successfully completed for 2 competitive binding assays using human recombinant ERa. Assays evaluated included the Freyberger-Wilson (FW) assay using a full length human ER, and the Chemical Evaluation and Research Institute (CERI) assay...

  18. Validating an artificial intelligence human proximity operations system with test cases

    NASA Astrophysics Data System (ADS)

    Huber, Justin; Straub, Jeremy

    2013-05-01

    An artificial intelligence-controlled robot (AICR) operating in close proximity to humans poses risk to these humans. Validating the performance of an AICR is an ill posed problem, due to the complexity introduced by the erratic (noncomputer) actors. In order to prove the AICR's usefulness, test cases must be generated to simulate the actions of these actors. This paper discusses AICR's performance validation in the context of a common human activity, moving through a crowded corridor, using test cases created by an AI use case producer. This test is a two-dimensional simplification relevant to autonomous UAV navigation in the national airspace.

  19. A reliable protocol for the manual segmentation of the human amygdala and its subregions using ultra-high resolution MRI

    PubMed Central

    Entis, Jonathan J.; Doerga, Priya; Barrett, Lisa Feldman; Dickerson, Bradford C.

    2013-01-01

    The measurement of the volume of the human amygdala in vivo has received increasing attention over the past decade, but existing methods face several challenges. First, due to the amorphous appearance of the amygdala and the difficulties in interpreting its boundaries, it is common for protocols to omit sizable sections of the rostral and dorsal regions of the amygdala comprising parts of the basolateral complex (BL) and central nucleus (Ce), respectively. Second, segmentation of the amgydaloid complex into separate subdivisions is challenging due to the resolution of routinely acquired images and the lack of standard protocols. Recent advances in technology have made ultra-high resolution MR images available, and in this study we provide a detailed segmentation protocol for manually tracing the whole amygdala that incorporates a greater portion of the rostral and dorsal sections with techniques illustrated in detail to maximize reproducibility. In addition, we propose a geometrically-based protocol for segmenting the amygdala into four component subregions of interest (sROI), which correspond largely to amygdala subnuclear divisions: the BL sROI, centromedial (CM) sROI, basomedial (BM) sROI, and the amygdaloid cortical (ACo) sROI. We performed an intra- and inter-rater reliability study of our methods in 10 adults (5 young adults and 5 older adults). The results indicate that both protocols can be implemented with a high degree of reliability (the majority of intra-rater and inter-rater correlations were >0.81). This protocol should aid further research into the alterations in amygdala anatomy, connectivity, and function that accompany normal aging and pathology associated with neuropsychiatric disorders. PMID:22245260

  20. A reliable protocol for the manual segmentation of the human amygdala and its subregions using ultra-high resolution MRI.

    PubMed

    Entis, Jonathan J; Doerga, Priya; Barrett, Lisa Feldman; Dickerson, Bradford C

    2012-04-02

    The measurement of the volume of the human amygdala in vivo has received increasing attention over the past decade, but existing methods face several challenges. First, due to the amorphous appearance of the amygdala and the difficulties in interpreting its boundaries, it is common for protocols to omit sizable sections of the rostral and dorsal regions of the amygdala comprising parts of the basolateral complex (BL) and central nucleus (Ce), respectively. Second, segmentation of the amgydaloid complex into separate subdivisions is challenging due to the resolution of routinely acquired images and the lack of standard protocols. Recent advances in technology have made ultra-high resolution MR images available, and in this study we provide a detailed segmentation protocol for manually tracing the whole amygdala that incorporates a greater portion of the rostral and dorsal sections with techniques illustrated in detail to maximize reproducibility. In addition, we propose a geometrically-based protocol for segmenting the amygdala into four component subregions of interest (sROI), which correspond largely to amygdala subnuclear divisions: the BL sROI, centromedial (CM) sROI, basomedial (BM) sROI, and the amygdaloid cortical (ACo) sROI. We performed an intra- and inter-rater reliability study of our methods in 10 adults (5 young adults and 5 older adults). The results indicate that both protocols can be implemented with a high degree of reliability (the majority of intra-rater and inter-rater correlations were > 0.81). This protocol should aid further research into the alterations in amygdala anatomy, connectivity, and function that accompany normal aging and pathology associated with neuropsychiatric disorders. Copyright © 2011 Elsevier Inc. All rights reserved.

  1. Influence of Bristle Stiffness of Manual Toothbrushes on Eroded and Sound Human Dentin – An In Vitro Study

    PubMed Central

    Arnold, Wolfgang H.; Domin, Julia

    2016-01-01

    Aim The aim of this study was to determine the influence of manual toothbrushes with different bristle stiffness on the abrasivity on eroded and sound human dentin. Materials and Methods Dentin specimens were made from impacted third molars and attributed to three groups: erosion-abrasion (EA), abrasion (A) and erosion (E). The specimens from EA and E were treated with 1% citric acid (pH 2.3) for 1 min rinsed, and neutralized with artificial saliva for 15 min. This cycle was repeated five times. Thereafter, specimens from EA and A were treated with three toothbrushes types with different bristle stiffness (soft, medium, and hard) in a custom-made toothbrushing machine. The brushing was performed at a load of 3 N with a toothpaste slurry for 630 s. This procedure was repeated five times, in group EA after each erosion cycle. EA and A groups passed through five cycles with a total of 6300 strokes. The abrasivity was analyzed by contact-free profilometry. Kruskal-Wallis and Mann-Whitney U tests were performed for statistical analysis. Results With respect to bristle stiffness there was no statistically significant difference in dentin loss within the EA group. In group A, a statistically significantly higher dentin loss was found for the soft in comparison to the hard bristles. No statistically significant differences were measured between soft/medium and medium/hard toothbrushes. The amount of dentin loss from specimens in the EA group was significantly higher than in the A group. Conclusions Within the limitations of this study, the dentin loss in the Abrasion group was higher with soft bristles than with hard ones. This result might have an influence on the toothbrush recommendations for patients with non-carious cervical lesions. PMID:27070901

  2. Construct Validity of Fresh Frozen Human Cadaver as a Training Model in Minimal Access Surgery

    PubMed Central

    Macafee, David; Pranesh, Nagarajan; Horgan, Alan F.

    2012-01-01

    Background: The construct validity of fresh human cadaver as a training tool has not been established previously. The aims of this study were to investigate the construct validity of fresh frozen human cadaver as a method of training in minimal access surgery and determine if novices can be rapidly trained using this model to a safe level of performance. Methods: Junior surgical trainees, novices (<3 laparoscopic procedure performed) in laparoscopic surgery, performed 10 repetitions of a set of structured laparoscopic tasks on fresh frozen cadavers. Expert laparoscopists (>100 laparoscopic procedures) performed 3 repetitions of identical tasks. Performances were scored using a validated, objective Global Operative Assessment of Laparoscopic Skills scale. Scores for 3 consecutive repetitions were compared between experts and novices to determine construct validity. Furthermore, to determine if the novices reached a safe level, a trimmed mean of the experts score was used to define a benchmark. Mann-Whitney U test was used for construct validity analysis and 1-sample t test to compare performances of the novice group with the benchmark safe score. Results: Ten novices and 2 experts were recruited. Four out of 5 tasks (nondominant to dominant hand transfer; simulated appendicectomy; intracorporeal and extracorporeal knot tying) showed construct validity. Novices’ scores became comparable to benchmark scores between the eighth and tenth repetition. Conclusion: Minimal access surgical training using fresh frozen human cadavers appears to have construct validity. The laparoscopic skills of novices can be accelerated through to a safe level within 8 to 10 repetitions. PMID:23318058

  3. Validating and Verifying Biomathematical Models of Human Fatigue

    NASA Technical Reports Server (NTRS)

    Martinez, Siera Brooke; Quintero, Luis Ortiz; Flynn-Evans, Erin

    2015-01-01

    Airline pilots experience acute and chronic sleep deprivation, sleep inertia, and circadian desynchrony due to the need to schedule flight operations around the clock. This sleep loss and circadian desynchrony gives rise to cognitive impairments, reduced vigilance and inconsistent performance. Several biomathematical models, based principally on patterns observed in circadian rhythms and homeostatic drive, have been developed to predict a pilots levels of fatigue or alertness. These models allow for the Federal Aviation Administration (FAA) and commercial airlines to make decisions about pilot capabilities and flight schedules. Although these models have been validated in a laboratory setting, they have not been thoroughly tested in operational environments where uncontrolled factors, such as environmental sleep disrupters, caffeine use and napping, may impact actual pilot alertness and performance. We will compare the predictions of three prominent biomathematical fatigue models (McCauley Model, Harvard Model, and the privately-sold SAFTE-FAST Model) to actual measures of alertness and performance. We collected sleep logs, movement and light recordings, psychomotor vigilance task (PVT), and urinary melatonin (a marker of circadian phase) from 44 pilots in a short-haul commercial airline over one month. We will statistically compare with the model predictions to lapses on the PVT and circadian phase. We will calculate the sensitivity and specificity of each model prediction under different scheduling conditions. Our findings will aid operational decision-makers in determining the reliability of each model under real-world scheduling situations.

  4. Discretionary Grants Administration Manual.

    ERIC Educational Resources Information Center

    Office of Human Development Services (DHHS), Washington, DC.

    This manual sets forth applicable administrative policies and procedures to recipients of discretionary project grants or cooperative agreements awarded by program offices in the Office of Human Development Services (HDS). It is intended to serve as a basic reference for project directors and business officers of recipient organizations who are…

  5. Program Evaluation Using the Project Dakota Parent Satisfaction Survey. A Manual for Administration and Interpretation of Findings Using a Validated Instrument.

    ERIC Educational Resources Information Center

    Kovach, JoAnne; Jacks, Robert

    This manual presents an instrument (the Dakota Parent Satisfaction Survey) and procedures for evaluating parent satisfaction with early intervention programs. The survey procedures have been used to evaluate seven early intervention programs each year since 1985. Development of the Survey is discussed, including the identification of program…

  6. Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment.

    PubMed

    Rebelo, Sofia P; Dehne, Eva-Maria; Brito, Catarina; Horland, Reyk; Alves, Paula M; Marx, Uwe

    2016-01-01

    Equipment and device qualification and test assay validation in the field of tissue engineered human organs for substance assessment remain formidable tasks with only a few successful examples so far. The hurdles seem to increase with the growing complexity of the biological systems, emulated by the respective models. Controlled single tissue or organ culture in bioreactors improves the organ-specific functions and maintains their phenotypic stability for longer periods of time. The reproducibility attained with bioreactor operations is, per se, an advantage for the validation of safety assessment. Regulatory agencies have gradually altered the validation concept from exhaustive "product" to rigorous and detailed process characterization, valuing reproducibility as a standard for validation. "Human-on-a-chip" technologies applying micro-physiological systems to the in vitro combination of miniaturized human organ equivalents into functional human micro-organisms are nowadays thought to be the most elaborate solution created to date. They target the replacement of the current most complex models-laboratory animals. Therefore, we provide here a road map towards the validation of such "human-on-a-chip" models and qualification of their respective bioreactor and microchip equipment along a path currently used for the respective animal models.

  7. Foundry Manual

    DTIC Science & Technology

    1958-01-01

    AD-A956 386 · ~ 111111!1 illl 111111111 11!11 1/ l lllllf II!! llli DTIC SELECllED · APR091992 D t • Best Available Copy NAVSHIPS 250-0334 I...FOUNDRY MANUAL JAN BUREAU OF SHIPS NAVY DEPARTMENT WASHINGTON 25, D. C l’iiiTKlü ’h* Superintendent o( l )o*nmpnR^M^I?viTnmfnt P/lntlng ()fflo...Shipbuilding and Fleet Maintenance * »..•,. »^ ■ - • • i ♦■»■•< I . ,«,: >i > l I « ■. ■ ii » ■ _. — • I PREFACE This Manual is

  8. ECOTONE Manual

    DTIC Science & Technology

    2005-11-01

    ER D C /C ER L C R -0 5- 2 ECOTONE Manual Tamara Hochstrasser and Debra Peters November 2005 C on st ru ct io n E ng in ee ri ng R es ea rc...h La bo ra to ry Approved for public release; distribution is unlimited. ERDC/CERL CR-05-2 November 2005 ECOTONE Manual Tamara...tools, and procedures to periodically assess and evaluate land condition. One tool, the ECOTONE model, was set up to simulate vegetation recovery from

  9. Human oocyte cryopreservation: a valid alternative to embryo cryopreservation?

    PubMed

    Tucker, Michael; Morton, Paula; Liebermann, Juergen

    2004-04-05

    Embryo cryopreservation has become an ethical necessity due to the way human in vitro fertilization (IVF) infertility therapy has developed. Limited embryonic implantation has by necessity driven IVF therapy to adopt ways to maximize the harvest of oocytes following ovarian hyperstimulation with its attendant risks. Collection of more oocytes has allowed more embryos to be generated to compensate for poor embryonic viability, often leading to transfer of multiple embryos to increase per transfer pregnancy rates. In an era of improving embryonic viability and prevailing trend toward single embryo transfers, production of excessive numbers of surplus embryos appears increasingly inappropriate. At which stage embryo cryopreservation can be undertaken most effectively remains controversial. Embryo cryopreservation nevertheless represents the current solution to the problem of excessive embryo production, but inherently raises ethical concerns for certain couples uncomfortable with what they might perceive to be "experimental" cryostorage, who in extreme circumstances may even choose to limit the number of oocytes inseminated to obviate the production of spare embryos. On a more practical level, cryostored embryos are co-owned by two people who may separate, and as such the embryos then face an uncertain fate, commonly decided in courts of law. Oocyte cryopreservation, if consistent and successful, offers a way to avoid the above complications of routine IVF therapy. Oocytes may need to be cryostored in the event of unforeseen non-production of sperm during IVF therapy, allowing a more measured consideration of donor sperm use or other means of sperm retrieval. Beyond IVF for infertility therapy using a couple's own gametes, oocyte cryopreservation provides a wonderful opportunity to optimize donor oocyte cryo-banking, reducing costs and improving convenience. Meanwhile, frozen embryo donation is an approach that many couples are uncomfortable with, and allows only for

  10. Cloud cover retrieved from skyviewer: A validation with human observations

    NASA Astrophysics Data System (ADS)

    Kim, Bu-Yo; Jee, Joon-Bum; Zo, Il-Sung; Lee, Kyu-Tae

    2016-02-01

    Cloud cover information is used alongside weather forecasts in various fields of research; however, ground observation of cloud cover is conducted by human observers, a method that is subjective and has low temporal and spatial resolutions. To address these problems, we have developed an improved algorithm to calculate cloud cover using sky image data obtained with Skyviewer equipment. The algorithm uses a variable threshold for the Red Blue Ratio (RBR), determined from the frequency distribution of the Green Blue Ratio (GBR), to calculate cloud cover more accurately than existing algorithms. To verify the accuracy of the algorithm, we conducted daily, monthly, seasonal, and yearly statistical analyses of human observations of cloud cover, obtained every hour from 0800 to 1700 Local Standard Time (LST) for the entirety of 2012 at the Gangwon Regional Meteorological Administration (GRMA), Korea. A case study compared daily images taken at 1200 LST in each season with pixel images of cloud cover calculated by our improved algorithm. The selected cases yielded a high correlation coefficient of 0.93 with the GRMA data. A monthly case study showed low root mean square errors (RMSEs) and high correlation coefficients (Rs) for December (RMSE = 1.64 tenths and R = 0.92) and August (RMSE = 1.43 tenths and R = 0.91). In addition, seasonal cases yielded a high correlation of 0.9 and 87% consistency within ± 2 tenths for winter and a correlation of 0.83 and 82% consistency for summer, when cases of cloud-free or overcast conditions are frequent. Annual analyses showed that the bias of GRMA and Skyviewer cloud cover data for 2012 was -0.36 tenth, and the RMSE was 2.12 tenths, with the GRMA data showing more cloud cover. Considering that the GRMA and Skyviewer data were gathered at different spatial locations, GRMA and Skyviewer data were well correlated (R = 0.87) and showed a consistency of 80% in their cloud cover data (consistent within ± 2 tenths).

  11. Atlas-based Segmentation of Developing Tissues in the Human Brain with Quantitative Validation in Young Fetuses

    PubMed Central

    Habas, Piotr A.; Kim, Kio; Rousseau, Francois; Glenn, Orit A.; Barkovich, A. James; Studholme, Colin

    2011-01-01

    Imaging of the human fetus using magnetic resonance (MR) is an essential tool for quantitative studies of normal as well as abnormal brain development in utero. However, because of fundamental differences in tissue types, tissue properties and tissue distribution between the fetal and adult brain, automated tissue segmentation techniques developed for adult brain anatomy are unsuitable for this data. In this paper, we describe methodology for automatic atlas-based segmentation of individual tissue types in motion-corrected 3D volumes reconstructed from clinical MR scans of the fetal brain. To generate anatomically correct automatic segmentations, we create a set of accurate manual delineations and build an in utero 3D statistical atlas of tissue distribution incorporating developing grey and white matter as well as transient tissue types such as the germinal matrix. The probabilistic atlas is associated with an unbiased average shape and intensity template for registration of new subject images to the space of the atlas. Quantitative whole brain 3D validation of tissue labeling performed on a set of 14 fetal MR scans (20.57–22.86 weeks gestational age) demonstrates that this atlas-based EM segmentation approach achieves consistently high DSC performance for the main tissue types in the fetal brain. This work indicates that reliable measures of brain development can be automatically derived from clinical MR imaging and opens up possibility of further 3D volumetric and morphometric studies with multiple fetal subjects. PMID:20108226

  12. Molecular approaches to validate disinfectants against human hepatitis B virus.

    PubMed

    Jursch, C A; Gerlich, W H; Glebe, D; Schaefer, S; Marie, O; Thraenhart, O

    2002-03-01

    Disinfection is an important measure to prevent hepatitis B virus (HBV) transmission by instruments. However, virucidal testing of disinfectants against HBV is difficult, because no simple quantitative infectivity assay exists. Since molecular changes of viral epitopes and the genome may indicate virus inactivation, we measured the alteration of these constituents with 0.065% peracetic acid (PAA) for exposure times up to 1 h. Plasma of a chronic HBV carrier with 10(9) HBV genomes/ml served as viral source in the form of a 10% dilution or of a purified HB-antigen preparation. Alterations of HBV epitopes were analyzed with four monoclonal antibodies in an enzyme-linked immunosorbent assay. Changes of the HBV genomes were determined by the inability to amplify the target sequence with a quantitative real-time polymerase chain reaction, either of a short fragment (189 bp) or of the full-length (3,200 bp). The determination of the epitope and genome alteration was quantified as log10 reduction factor (RF) with the parallel line bioassay. Under a high protein load of 10% human plasma, PAA induced a HBV genome alteration of RF = 1.5 after an exposure time of 60 min. Similar RFs were seen with the four HB epitopes. Without protein load, the alteration of these epitopes amounted to a RF of more than 3.5 within 30 min. Such inhibition of PAA activity by protein load was also seen in the virucidal tests with parvovirus. Although the RF were higher in the virucidal tests, the time-dependent dose-response curves for the epitope and genome alteration and for the infectivity inactivation followed the same inactivation kinetics. The molecular alteration and disintegration epitope and genome test may therefore be suitable to measure antiviral activity of disinfectants against HBV.

  13. Recreation Manual.

    ERIC Educational Resources Information Center

    North Dakota Farmers Union, Jamestown. Dept. of Youth Activities.

    Suggestions for recreational activities are outlined in this manual. Instructions are given for games to play in small places, home or party games, paper and pencil games, children's singing games, and dances. Ideas for crafts and special parties are also included. (SW)

  14. Boilermaking Manual.

    ERIC Educational Resources Information Center

    British Columbia Dept. of Education, Victoria.

    This manual is intended (1) to provide an information resource to supplement the formal training program for boilermaker apprentices; (2) to assist the journeyworker to build on present knowledge to increase expertise and qualify for formal accreditation in the boilermaking trade; and (3) to serve as an on-the-job reference with sound, up-to-date…

  15. Recruiter's Manual.

    ERIC Educational Resources Information Center

    Reed, Michael; Recio, Manuel

    The manual assists both experienced and inexperienced personnel in defining and completing the entire range of tasks associated with the position of Pennsylvania Migrant Education Recruiter. The recruiter's primary responsibilities are to identify migrant children in the area and enroll those children eligible under Title I ESEA (Elementary and…

  16. Validation and substantiation of 25 kGy as sterilization dose for lyophilized human amnion membrane.

    PubMed

    Djefal, A; Tahtat, D; Khodja, A Nacer; Bouzid, S Saad; Remane, N

    2007-01-01

    The validation and substantiation of sterilization dose for lyophilized human amnion membrane by gamma irradiation delivered by Co60 source were investigated. The validation experiments were conducted according to ISO 13409 method B. A total of 120 human amnion membranes were collected. Of these, 10 membranes were used for estimation of bioburden and 20 membranes were used for the individual sterility test at verification dose. The average bioburden per product unit with sample item portion (SIP = 1) for lyophilized human amnion membrane was 572 cfu. The verification dose experiments were done at dose of 8.1 kGy and the results of sterility tests showed that human amnion membrane got one positive. Consequently, the sterilization dose of 25 kGy was confirmed and substantiated.

  17. Human DNA quantification and sample quality assessment: Developmental validation of the PowerQuant(®) system.

    PubMed

    Ewing, Margaret M; Thompson, Jonelle M; McLaren, Robert S; Purpero, Vincent M; Thomas, Kelli J; Dobrowski, Patricia A; DeGroot, Gretchen A; Romsos, Erica L; Storts, Douglas R

    2016-07-01

    Quantification of the total amount of human DNA isolated from a forensic evidence item is crucial for DNA normalization prior to short tandem repeat (STR) DNA analysis and a federal quality assurance standard requirement. Previous commercial quantification methods determine the total human DNA and total human male DNA concentrations, but provide limited information about the condition of the DNA sample. The PowerQuant(®) System includes targets for quantification of total human and total human male DNA as well as targets for evaluating whether the human DNA is degraded and/or PCR inhibitors are present in the sample. A developmental validation of the PowerQuant(®) System was completed, following SWGDAM Validation Guidelines, to evaluate the assay's specificity, sensitivity, precision and accuracy, as well as the ability to detect degraded DNA or PCR inhibitors. In addition to the total human DNA and total human male DNA concentrations in a sample, data from the degradation target and internal PCR control (IPC) provide a forensic DNA analyst meaningful information about the quality of the isolated human DNA and the presence of PCR inhibitors in the sample that can be used to determine the most effective workflow and assist downstream interpretation. Copyright © 2016 The Author(s). Published by Elsevier Ireland Ltd.. All rights reserved.

  18. SUBTLE Manual.

    DTIC Science & Technology

    1981-01-01

    behavior). The syntax of SUBTLE is a prefix version of the language of predicate calculus and is identical to that used by MRS [Genesereth, Greiner, Smith...detect incompleteness or inconsistency. For further information on SHAM, the reader should see [ Grinberg and Lark]. Chapter 2 of this manual describes...execution continues at the next sequential statement. (CONDITION <pred> <then>) which is identical to the first form except that there is no <else> function

  19. The predictive validity of the Örebro Musculoskeletal Pain Questionnaire and the clinicians' prognostic assessment following manual therapy treatment of patients with LBP and neck pain.

    PubMed

    Dagfinrud, H; Storheim, K; Magnussen, L H; Ødegaard, T; Hoftaniska, I; Larsen, L G; Ringstad, P O; Hatlebrekke, F; Grotle, M

    2013-04-01

    The purpose of this study was to compare the predictive ability of the standardised screening tool Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) and the clinicians' prognostic assessment in identifying patients with low back pain (LBP) and neck pain at risk for persistent pain and disability at eight weeks follow-up. Patients seeking care for LBP or neck pain were recruited by 19 manual therapists in Norway. Patients completed the ÖMPQ and the low back- or neck specific Oswestry Disability Index/Neck Disability Index at baseline and 8 weeks after first consultation. The manual therapists filled in their assessment of patient's prognosis immediately after the first consultation, blinded for patient's answers to the questionnaire. A total of 157 patients (81with neck pain and 76 with LBP) were included. The best odds for predicting the outcome for LBP patients was found for the clinicians' assessment of prognosis (LR+ = 2.1 and LR- = 0.55), whereas the likelihood ratios were similar for the two tools in the neck group. For LBP patients, both the clinicians' assessment and the ÖMPQ contributed significantly in the separate regression models (p = 0.02 and p = 0.002, resp), whereas none of the tools where significant contributors for neck patients (p = 0.67 and 0.07). Neither of the two methods showed high precision in their predictions of follow-up at eight weeks. However, for LBP patients, the ÖMPQ and the clinicians' prognostic assessment contributed significantly in the prediction of functional outcome 8 weeks after the initial assessment of manual therapist, whereas the prediction for neck patients was unsure.

  20. Validation of Human Body Model VIRTHUMAN and its Implementation in Crash Scenarios

    NASA Astrophysics Data System (ADS)

    Jaroslav Maňas, Ing.; Luděk Kovář, Ing.; Jan Petřík, Ing.; Hana Čechová, Ing.; Stanislav Špirk, Ing.

    Standard virtual prototyping approach of passive safety field is based on virtual models of dummies, but human body models become to be more and more important for specific crash scenarios. VIRTHUMAN is human body model based on MBS (Multi-Body Structure) approach. The model consists of movable rigid segments, which represent proper mass of each human part and enables to evaluate injury criteria describing safety risks during crash scenarios. There is evident advantage of the MBS approach in simple preparation of crash configuration—human body positioning, reasonable calculation times and mainly its applicability for robust designs development respecting variety of human population. The project VIRTHUMAN is directed on development of scaling technique enabling to generate human model based on the standard anthropometric inputs. The contribution describes status of the VIRTHUMAN model, procedures of its validation and results in standard crash scenarios.

  1. Development of a manual self-assembled colloidal gold nanoparticle-immunochromatographic strip for rapid determination of human interferon-γ.

    PubMed

    Chou, Shu-Fen

    2013-05-07

    Interferons (IFNs) play a role in inhibition of tumor growth and participate in immunoreactions. Among IFNs, interferon-γ (IFNγ) is one of the most important therapeutic proteins and its immunodulation ability is better than that of other types. The objective of this study is to develop a manual self-assembled colloidal gold nanoparticle-immunochromatographic strip for human IFNγ using anti-human IFNγ polyclonal and monoclonal antibodies. Colloidal gold with a 25 nm diameter was made from chloroauric acid (HAuCl4), and labeled on anti-IFNγ mAbs as a chrominance reagent. A good linear relationship existed between the pixel intensity and the human IFNγ concentrations from 10-1000 ng mL(-1) in mouse serum and buffer, respectively, the regression equation was Y = 0.159logX + 0.0648, R(2) = 0.992 in mouse serum; Y = 0.294logX + 0.091, R(2) = 0.9969 in phosphate buffer by this proposed strip. Moreover, in the determination for mouse serum samples no cross-reaction occurred and the detection time was approximately 10 minutes. The shelf life of the strip was above 28 days at room temperature. The major advantages of the manual operation model were no expensive instruments and less reagents required. This proposed strip was highly specific, economic, convenient, and no machine was needed in clinical diagnosis.

  2. Assessment of the Biological Effects of Welding Fumes Emitted From Metal Active Gas and Manual Metal Arc Welding in Humans.

    PubMed

    Dewald, Eva; Gube, Monika; Baumann, Ralf; Bertram, Jens; Kossack, Veronika; Lenz, Klaus; Reisgen, Uwe; Kraus, Thomas; Brand, Peter

    2015-08-01

    Emissions from a particular welding process, metal inert gas brazing of zinc-coated steel, induce an increase in C-reactive protein. In this study, it was investigated whether inflammatory effects could also be observed for other welding procedures. Twelve male subjects were separately exposed to (1) manual metal arc welding fumes, (2) filtered air, and (3) metal active gas welding fumes for 6 hours. Inflammatory markers were measured in serum before, and directly, 1 and 7 days after exposure. Although C-reactive protein concentrations remained unchanged, neutrophil concentrations increased directly after exposure to manual metal arc welding fumes, and endothelin-1 concentrations increased directly and 24 hours after exposure. After exposure to metal active gas and filtered air, endothelin-1 concentrations decreased. The increase in the concentrations of neutrophils and endothelin-1 may characterize a subclinical inflammatory reaction, whereas the decrease of endothelin-1 may indicate stress reduction.

  3. Human performance measurement: Validation procedures applicable to advanced manned telescience systems

    NASA Technical Reports Server (NTRS)

    Haines, Richard F.

    1990-01-01

    As telescience systems become more and more complex, autonomous, and opaque to their operators it becomes increasingly difficult to determine whether the total system is performing as it should. Some of the complex and interrelated human performance measurement issues are addressed as they relate to total system validation. The assumption is made that human interaction with the automated system will be required well into the Space Station Freedom era. Candidate human performance measurement-validation techniques are discussed for selected ground-to-space-to-ground and space-to-space situations. Most of these measures may be used in conjunction with an information throughput model presented elsewhere (Haines, 1990). Teleoperations, teleanalysis, teleplanning, teledesign, and teledocumentation are considered, as are selected illustrative examples of space related telescience activities.

  4. Manual testing for ankle instability.

    PubMed

    Wilkin, Emily Jane; Hunt, Adrienne; Nightingale, Elizabeth Jean; Munn, Joanne; Kilbreath, Sharon Lynne; Refshauge, Kathryn Margaret

    2012-12-01

    To assess inter-rater reliability of ankle manual tests. We also correlated the manual tests with the Cumberland Ankle Instability Tool (CAIT). One ankle from each of 60 participants was assessed using four different manual tests (anterior drawer in supine and crook lying, talar tilt, inversion tilt). Three different raters, varying in experience, tested each participant. The CAIT questionnaire was also administered. The study received ethics approval from the University of Sydney Human Research Ethics Committee. Intraclass correlation coefficients (ICC), standard error of the mean (SEM) and percent close agreement (PCA) were used to determine reliability of the four tests. Pearson's correlation coefficients were used to determine relationships between the manual tests and CAIT scores. Inter-rater reliability for the four manual tests was poor regardless of therapist's experience (ICC([1,1]) -0.12 to 0.33; SEM 0.93-1.69). Correlations between the CAIT and manual tests were also low varying between r = -0.12 and -0.42. Inter-rater reliability was poor for manual tests of ankle stability. Reliability may be improved by using a grading scale with fewer intervals. The CAIT scores and manual tests correlated poorly, potentially reflecting the variety of conditions leading to ankle instability. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  5. Learning brain aneurysm microsurgical skills in a human placenta model: predictive validity.

    PubMed

    de Oliveira, Marcelo Magaldi Ribeiro; Ferrarez, Carlos Eduardo; Ramos, Taise Mosso; Malheiros, Jose Augusto; Nicolato, Arthur; Machado, Carla Jorge; Ferreira, Mauro Tostes; de Oliveira, Fellype Borges; de Sousa, Cecília Félix Penido Mendes; Costa, Pollyana Helena Vieira; Gusmao, Sebastiao; Lanzino, Giuseppe; Maestro, Rolando Del

    2017-03-24

    OBJECTIVE Surgery for brain aneurysms is technically demanding. In recent years, the process to learn the technical skills necessary for these challenging procedures has been affected by a decrease in the number of surgical cases available and progressive restrictions on resident training hours. To overcome these limitations, surgical simulators such as cadaver heads and human placenta models have been developed. However, the effectiveness of these models in improving technical skills is unknown. This study assessed concurrent and predictive validity of brain aneurysm surgery simulation in a human placenta model compared with a "live" human brain cadaveric model. METHODS Two human cadaver heads and 30 human placentas were used. Twelve neurosurgeons participated in the concurrent validity part of this study, each operating on 1 human cadaver head aneurysm model and 1 human placenta model. Simulators were evaluated regarding their ability to simulate different surgical steps encountered during real surgery. The time to complete the entire aneurysm task in each simulator was analyzed. The predictive validity component of the study involved 9 neurosurgical residents divided into 3 groups to perform simulation exercises, each lasting 6 weeks. The training for the 3 groups consisted of educational video only (3 residents), human cadaver only (3 residents), and human placenta only (3 residents). All residents had equivalent microsurgical experience with superficial brain tumor surgery. After completing their practice training, residents in each of the 3 simulation groups performed surgery for an unruptured middle cerebral artery (MCA) aneurysm, and their performance was assessed by an experienced vascular neurosurgeon who watched the operative videos. RESULTS All human cadaver heads and human placentas were suitable to simulate brain aneurysm surgery. In the concurrent validity portion of the experiment, the placenta model required a longer time (p < 0.001) than cadavers

  6. Astronaut training manual

    NASA Technical Reports Server (NTRS)

    Coleman, E. A.

    1980-01-01

    Scientific information from previous space flights, space medicine, exercise physiology, and sports medicine was used to prepare a physical fitness manual suitable for use by members of the NASA astronaut population. A variety of scientifically valid exercise programs and activities suitable for the development of physical fitness are provided. Programs, activities, and supportive scientific data are presented in a concise, easy to read format so as to permit the user to select his or her mode of training with confidence and devote time previously spent experimenting with training routines to preparation for space flight. The programs and activities included were tested and shown to be effective and enjoyable.

  7. An investigation of the validity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition avoidant personality disorder construct as a prototype category and the psychometric properties of the diagnostic criteria.

    PubMed

    Hummelen, Benjamin; Wilberg, Theresa; Pedersen, Geir; Karterud, Sigmund

    2006-01-01

    This study investigated several aspects of the validity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition avoidant personality disorder (APD) construct, with emphasis on the psychometric properties of the diagnostic criteria and the prototype nature of the construct. A sample of 1,058 patients from the Norwegian Network of Psychotherapeutic Day Hospitals was examined by means of exploratory factor analysis, correlation, and diagnostic efficiency statistics, chi(2) analysis, and frequency distribution. The results indicated that APD is a 1-dimensional construct with good internal consistency. The criteria had acceptable diagnostic efficiency; criterion 3 performed poorest. Number of APD criteria showed no distinct threshold between No-APD and patients with APD. Sixty-two different combinations of any 4 APD criteria occurred. It can be concluded that the prototype model fitted the data well and that the APD diagnostic criteria perform well in the current classification system. The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition hierarchy of criteria was not supported.

  8. Methodological issues in the validation of complex human-machine systems

    SciTech Connect

    O`Hara, J.; Stubler, W.; Wachtel, J.

    1995-05-01

    Integrated system validation is one aspect of the US Nuclear Regulatory Commission`s design review process for human-system interfaces. This paper will consider three methodological issues that must be addressed in validation and their implications for drawing conclusions about the acceptability of the integrated system. They are: representing the integrated system, representing the operational events it must handle, and representing system performance. A logical basis for generalizability from validation tests to predicted performance of the integrated system emerges from the comparability of the psychological and physical processes of the test and actual situations. Generalizability of results is supported when the integrated system, operating conditions and performance are representative of their real-world counterparts. The methodological considerations for establishing representativeness are discussed.

  9. Test Technical Manual 2014 GED® Test

    ERIC Educational Resources Information Center

    GED Testing Service, 2014

    2014-01-01

    This manual was written to provide technical information regarding the General Educational Development (GED®) test as evidence that the GED® test is technically sound. Throughout this manual, documentation is provided regarding the development of the GED® test and data collection activities, as well as evidence of reliability and validity. This…

  10. Real time contact-free and non-invasive tracking of the human skull: first light and initial validation

    NASA Astrophysics Data System (ADS)

    Ernst, Floris; Bruder, Ralf; Wissel, Tobias; Stüber, Patrick; Wagner, Benjamin; Schweikard, Achim

    2013-09-01

    In an increasing number of fields in medicine, precise and fast localisation of bony targets inside the body is essential. Up to now, exact localisation in the operation room can either be done with invasive methods like X-ray imaging and electromagnetic tracking systems, with volumetric ultrasound or by fixing the target in place. In this work, we present a new technology to directly track the position of the human skull through tissue in real time using infrared lasers. To achieve this, an experimental setup has been developed to precisely target a position on a subject's skin with an 850nm laser. The primary reflection on the skin is triangulated using a high-speed camera. Additionally, the reflections as well as in-tissue scattering are recorded with an in-beam setup of a NIR sensitive high-speed and high-resolution camera. Consequently, it is possible to record the scattering patterns specific to the composition of the tissue at the target. We have recorded MRI data of two test subjects (voxel size 0.15 x 0.15 x 1mm3) and extracted the soft tissue thickness with a semi-automatic segmentation approach. The MRI data was validated using force-controlled 2D ultrasound (tracked by an optical tracking system), from which soft tissue thickness was segmented manually. Optical measurements and MRI data were registered to determine soft tissue thickness for each measured laser target and finally used to train a support vector regression machine. Using the optical setup, we succeeded in computing the soft tissue thickness on the subjects' foreheads with sub-millimetre accuracy.

  11. Novel validated spectrofluorimetric methods for the determination of taurine in energy drinks and human urine.

    PubMed

    Sharaf El Din, M K; Wahba, M E K

    2015-03-01

    Two sensitive, selective, economic and validated spectrofluorimetric methods were developed for the determination of taurine in energy drinks and spiked human urine. Method Ι is based on fluorimetric determination of the amino acid through its reaction with Hantzsch reagent to form a highly fluorescent product measured at 490 nm after excitation at 419 nm. Method ΙΙ is based on the reaction of taurine with tetracyanoethylene yielding a fluorescent charge transfer complex, which was measured at λex /em of (360 nm/450 nm). The proposed methods were subjected to detailed validation procedures, and were statistically compared with the reference method, where the results obtained were in good agreement. Method Ι was further applied to determine taurine in energy drinks and spiked human urine giving promising results. Moreover, the stoichiometry of the reactions was studied, and reaction mechanisms were postulated. Copyright © 2014 John Wiley & Sons, Ltd.

  12. Information flow between interacting human brains: Identification, validation, and relationship to social expertise.

    PubMed

    Bilek, Edda; Ruf, Matthias; Schäfer, Axel; Akdeniz, Ceren; Calhoun, Vince D; Schmahl, Christian; Demanuele, Charmaine; Tost, Heike; Kirsch, Peter; Meyer-Lindenberg, Andreas

    2015-04-21

    Social interactions are fundamental for human behavior, but the quantification of their neural underpinnings remains challenging. Here, we used hyperscanning functional MRI (fMRI) to study information flow between brains of human dyads during real-time social interaction in a joint attention paradigm. In a hardware setup enabling immersive audiovisual interaction of subjects in linked fMRI scanners, we characterize cross-brain connectivity components that are unique to interacting individuals, identifying information flow between the sender's and receiver's temporoparietal junction. We replicate these findings in an independent sample and validate our methods by demonstrating that cross-brain connectivity relates to a key real-world measure of social behavior. Together, our findings support a central role of human-specific cortical areas in the brain dynamics of dyadic interactions and provide an approach for the noninvasive examination of the neural basis of healthy and disturbed human social behavior with minimal a priori assumptions.

  13. Face, content, and construct validity of human placenta as a haptic training tool in neurointerventional surgery.

    PubMed

    Ribeiro de Oliveira, Marcelo Magaldi; Nicolato, Arthur; Santos, Marcilea; Godinho, Joao Victor; Brito, Rafael; Alvarenga, Alexandre; Martins, Ana Luiza Valle; Prosdocimi, André; Trivelato, Felipe Padovani; Sabbagh, Abdulrahman J; Reis, Augusto Barbosa; Maestro, Rolando Del

    2016-05-01

    OBJECT The development of neurointerventional treatments of central nervous system disorders has resulted in the need for adequate training environments for novice interventionalists. Virtual simulators offer anatomical definition but lack adequate tactile feedback. Animal models, which provide more lifelike training, require an appropriate infrastructure base. The authors describe a training model for neurointerventional procedures using the human placenta (HP), which affords haptic training with significantly fewer resource requirements, and discuss its validation. METHODS Twelve HPs were prepared for simulated endovascular procedures. Training exercises performed by interventional neuroradiologists and novice fellows were placental angiography, stent placement, aneurysm coiling, and intravascular liquid embolic agent injection. RESULTS The endovascular training exercises proposed can be easily reproduced in the HP. Face, content, and construct validity were assessed by 6 neurointerventional radiologists and 6 novice fellows in interventional radiology. CONCLUSIONS The use of HP provides an inexpensive training model for the training of neurointerventionalists. Preliminary validation results show that this simulation model has face and content validity and has demonstrated construct validity for the interventions assessed in this study.

  14. Validated liquid chromatographic-fluorescence method for the quantitation of gemifloxacin in human plasma.

    PubMed

    Al-Hadiya, Badraddin M H; Khady, Adnan A; Mostafa, Gamal A E

    2010-11-15

    A highly selective, sensitive and rapid high performance liquid chromatographic method has been developed and validated to quantify gemifloxacin in human plasma. The gemifloxacin and internal standard (ciprofloxacin) were extracted by ultrafiltration technique followed by injection into chromatographic system. Chromatographic separation was achieved on a reversed phase C(18) column with a mobile phase of acetonitrile:0.1% trifluoroacetic acid (20:80, v/v) using isocratic elution (at flow rate 1 mL min(-1)). The analytes were detected at 269 and 393 nm for excitation and emission, respectively. The assay exhibited a linear range of 25-5000 ng mL(-1) for gemifloxacin in human plasma. The lower limit of detection was 10 ng mL(-1). The method was statistically validated for linearity, accuracy, precision and selectivity following FDA guidelines. The intra- and inter-assay coefficients of variation did not exceed 7.6% deviation of the nominal concentration. The recovery of gemifloxacin from plasma was greater than 97.0%. Stability of gemifloxacin in plasma was excellent with no evidence of degradation during sample processing (auto-sampler) and at least 3 months storage in a freezer at -70 °C. This validation method is applied for clinical study of the gemifloxacin in human volunteers. Copyright © 2010 Elsevier B.V. All rights reserved.

  15. Is the corticomedullary index valid to distinguish human from nonhuman bones: a multislice computed tomography study.

    PubMed

    Rérolle, Camille; Saint-Martin, Pauline; Dedouit, Fabrice; Rousseau, Hervé; Telmon, Norbert

    2013-09-10

    The first step in the identification process of bone remains is to determine whether they are of human or nonhuman origin. This issue may arise when only a fragment of bone is available, as the species of origin is usually easily determined on a complete bone. The present study aims to assess the validity of a morphometric method used by French forensic anthropologists to determine the species of origin: the corticomedullary index (CMI), defined by the ratio of the diameter of the medullary cavity to the total diameter of the bone. We studied the constancy of the CMI from measurements made on computed tomography images (CT scans) of different human bones, and compared our measurements with reference values selected in the literature. The measurements obtained on CT scans at three different sites of 30 human femurs, 24 tibias, and 24 fibulas were compared between themselves and with the CMI reference values for humans, pigs, dogs and sheep. Our results differed significantly from these reference values, with three exceptions: the proximal quarter of the femur and mid-fibular measurements for the human CMI, and the proximal quarter of the tibia for the sheep CMI. Mid-tibial, mid-femoral, and mid-fibular measurements also differed significantly between themselves. Only 22.6% of CT scans of human bones were correctly identified as human. We concluded that the CMI is not an effective method for determining the human origin of bone remains. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  16. PBPK modeling for PFOS and PFOA: validation with human experimental data.

    PubMed

    Fàbrega, Francesc; Kumar, Vikas; Schuhmacher, Marta; Domingo, José L; Nadal, Martí

    2014-10-15

    In recent years, because of the potential human toxicity, concern on perfluoroalkyl substances (PFASs) has increased notably with special attention to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Unfortunately, there is currently an important knowledge gap on the burdens of these chemicals in most human tissues, as the reported studies have been mainly focused on plasma. In order to overcome these limitations, the use of physiologically-based pharmacokinetic (PBPK) models has been extended. The present study was aimed at testing an existing PBPK model for their predictability of PFOS and PFOA in a new case-study, and also to adapt it to estimate the PFAS content in human tissue compartments. Model validation was conducted by means of PFOA and PFOS concentrations in food and human drinking water from Tarragona County (Catalonia, Spain), and being the predicted results compared with those experimentally found in human tissues (blood, liver, kidney, liver and brain) of subjects from the same area of study. The use of human-derived partition coefficient (Pk) data was proven as more suitable for application to this PBPK model than rat-based Pk values. However, the uncertainty and variability of the data are still too high to get conclusive results. Consequently, further efforts should be carried out to reduce parametric uncertainty of PBPK models. More specifically, a deeper knowledge on the distribution of PFOA and PFOS within the human body should be obtained by enlarging the number of biological monitoring studies on PFASs.

  17. Validation of a multiplex electrochemiluminescent immunoassay platform in human and mouse samples

    PubMed Central

    Bastarache, J.A.; Koyama, T.; Wickersham, N.E; Ware, L.B.

    2014-01-01

    Despite the widespread use of multiplex immunoassays, there are very few scientific reports that test the accuracy and reliability of a platform prior to publication of experimental data. Our laboratory has previously demonstrated the need for new assay platform validation prior to use of biologic samples from large studies in order to optimize sample handling and assay performance. In this study, our goal was to test the accuracy and reproducibility of an electrochemiluminescent multiplex immunoassay platform (Meso Scale Discovery, MSD®) and compare this platform to validated, singleplex immunoassays (R&D Systems®) using actual study subject (human plasma and mouse bronchoalveolar lavage fluid (BALF) and plasma) samples. We found that the MSD platform performed well on intra- and inter-assay comparisons, spike and recovery and cross-platform comparisons. The mean intra-assay CV% and range for MSD was 3.49 (0.0-10.4) for IL-6 and 2.04 (0.1-7.9) for IL-8. The correlation between values for identical samples measured on both MSD and R&D was R=0.97 for both analytes. The mouse MSD assay had a broader range of CV% with means ranging from 9.5-28.5 depending on the analyte. The range of mean CV% was similar for single plex ELISAs at 4.3-23.7 depending on the analyte. Regardless of species or sample type, CV% was more variable at lower protein concentrations. In conclusion, we validated a multiplex electrochemiluminscent assay system and found that it has superior test characteristics in human plasma compared to mouse BALF and plasma. Both human and MSD assays compared favorably to well-validated singleplex ELISA's PMID:24768796

  18. Validation of an in vitro digestive system for studying macronutrient decomposition in humans.

    PubMed

    Kopf-Bolanz, Katrin A; Schwander, Flurina; Gijs, Martin; Vergères, Guy; Portmann, Reto; Egger, Lotti

    2012-02-01

    The digestive process transforms nutrients and bioactive compounds contained in food to physiologically active compounds. In vitro digestion systems have proven to be powerful tools for understanding and monitoring the complex transformation processes that take place during digestion. Moreover, the investigation of the physiological effects of certain nutrients demands an in vitro digestive process that is close to human physiology. In this study, human digestion was simulated with a 3-step in vitro process that was validated in depth by choosing pasteurized milk as an example of a complex food matrix. The evolution and decomposition of the macronutrients was followed over the entire digestive process to the level of intestinal enterocyte action, using protein and peptide analysis by SDS-PAGE, reversed-phase HPLC, size exclusion HPLC, and liquid chromatography-MS. The mean peptide size after in vitro digestion of pasteurized milk was 5-6 amino acids (AA). Interestingly, mostly essential AA (93.6%) were released during in vitro milk digestion, a significantly different relative distribution compared to the total essential AA concentration of bovine milk (44.5%). All TG were degraded to FFA and monoacylglycerols. Herein, we present a human in vitro digestion model validated for its ability to degrade the macronutrients of dairy products comparable to physiological ranges. It is suited to be used in combination with a human intestinal cell culture system, allowing ex vivo bioavailability measurements and assessment of the bioactive properties of food components.

  19. Studying the neurobiology of human social interaction: Making the case for ecological validity.

    PubMed

    Hogenelst, Koen; Schoevers, Robert A; aan het Rot, Marije

    2015-01-01

    With this commentary we make the case for an increased focus on the ecological validity of the measures used to assess aspects of human social functioning. Impairments in social functioning are seen in many types of psychopathology, negatively affecting the lives of psychiatric patients and those around them. Yet the neurobiology underlying abnormal social interaction remains unclear. As an example of human social neuroscience research with relevance to biological psychiatry and clinical psychopharmacology, this commentary discusses published experimental studies involving manipulation of the human brain serotonin system that included assessments of social behavior. To date, these studies have mostly been laboratory-based and included computer tasks, observations by others, or single-administration self-report measures. Most laboratory measures used so far inform about the role of serotonin in aspects of social interaction, but the relevance for real-life interaction is often unclear. Few studies have used naturalistic assessments in real life. We suggest several laboratory methods with high ecological validity as well as ecological momentary assessment, which involves intensive repeated measures in naturalistic settings. In sum, this commentary intends to stimulate experimental research on the neurobiology of human social interaction as it occurs in real life.

  20. Independent Verification and Validation of Complex User Interfaces: A Human Factors Approach

    NASA Technical Reports Server (NTRS)

    Whitmore, Mihriban; Berman, Andrea; Chmielewski, Cynthia

    1996-01-01

    The Usability Testing and Analysis Facility (UTAF) at the NASA Johnson Space Center has identified and evaluated a potential automated software interface inspection tool capable of assessing the degree to which space-related critical and high-risk software system user interfaces meet objective human factors standards across each NASA program and project. Testing consisted of two distinct phases. Phase 1 compared analysis times and similarity of results for the automated tool and for human-computer interface (HCI) experts. In Phase 2, HCI experts critiqued the prototype tool's user interface. Based on this evaluation, it appears that a more fully developed version of the tool will be a promising complement to a human factors-oriented independent verification and validation (IV&V) process.

  1. Reverse engineering validation using a benchmark synthetic gene circuit in human cells.

    PubMed

    Kang, Taek; White, Jacob T; Xie, Zhen; Benenson, Yaakov; Sontag, Eduardo; Bleris, Leonidas

    2013-05-17

    Multicomponent biological networks are often understood incompletely, in large part due to the lack of reliable and robust methodologies for network reverse engineering and characterization. As a consequence, developing automated and rigorously validated methodologies for unraveling the complexity of biomolecular networks in human cells remains a central challenge to life scientists and engineers. Today, when it comes to experimental and analytical requirements, there exists a great deal of diversity in reverse engineering methods, which renders the independent validation and comparison of their predictive capabilities difficult. In this work we introduce an experimental platform customized for the development and verification of reverse engineering and pathway characterization algorithms in mammalian cells. Specifically, we stably integrate a synthetic gene network in human kidney cells and use it as a benchmark for validating reverse engineering methodologies. The network, which is orthogonal to endogenous cellular signaling, contains a small set of regulatory interactions that can be used to quantify the reconstruction performance. By performing successive perturbations to each modular component of the network and comparing protein and RNA measurements, we study the conditions under which we can reliably reconstruct the causal relationships of the integrated synthetic network.

  2. Reverse Engineering Validation using a Benchmark Synthetic Gene Circuit in Human Cells

    PubMed Central

    Kang, Taek; White, Jacob T.; Xie, Zhen; Benenson, Yaakov; Sontag, Eduardo; Bleris, Leonidas

    2013-01-01

    Multi-component biological networks are often understood incompletely, in large part due to the lack of reliable and robust methodologies for network reverse engineering and characterization. As a consequence, developing automated and rigorously validated methodologies for unraveling the complexity of biomolecular networks in human cells remains a central challenge to life scientists and engineers. Today, when it comes to experimental and analytical requirements, there exists a great deal of diversity in reverse engineering methods, which renders the independent validation and comparison of their predictive capabilities difficult. In this work we introduce an experimental platform customized for the development and verification of reverse engineering and pathway characterization algorithms in mammalian cells. Specifically, we stably integrate a synthetic gene network in human kidney cells and use it as a benchmark for validating reverse engineering methodologies. The network, which is orthogonal to endogenous cellular signaling, contains a small set of regulatory interactions that can be used to quantify the reconstruction performance. By performing successive perturbations to each modular component of the network and comparing protein and RNA measurements, we study the conditions under which we can reliably reconstruct the causal relationships of the integrated synthetic network. PMID:23654266

  3. Asphalt Raking. Instructor Manual. Trainee Manual.

    ERIC Educational Resources Information Center

    Laborers-AGC Education and Training Fund, Pomfret Center, CT.

    This packet consists of the instructor and trainee manuals for an asphalt raking course. The instructor manual contains a course schedule for 4 days of instruction, content outline, and instructor outline. The trainee manual is divided into five sections: safety, asphalt basics, placing methods, repair and patching, and clean-up and maintenance.…

  4. Asphalt Raking. Instructor Manual. Trainee Manual.

    ERIC Educational Resources Information Center

    Laborers-AGC Education and Training Fund, Pomfret Center, CT.

    This packet consists of the instructor and trainee manuals for an asphalt raking course. The instructor manual contains a course schedule for 4 days of instruction, content outline, and instructor outline. The trainee manual is divided into five sections: safety, asphalt basics, placing methods, repair and patching, and clean-up and maintenance.…

  5. Development and validation of the Hospitality Axiological Scale for Humanization of Nursing Care

    PubMed Central

    Galán González-Serna, José María; Ferreras-Mencia, Soledad; Arribas-Marín, Juan Manuel

    2017-01-01

    ABSTRACT Objective: to develop and validate a scale to evaluate nursing attitudes in relation to hospitality for the humanization of nursing care. Participants: the sample consisted of 499 nursing professionals and undergraduate students of the final two years of the Bachelor of Science in Nursing program. Method: the instrument has been developed and validated to evaluate the ethical values related to hospitality using a methodological approach. Subsequently, a model was developed to measure the dimensions forming the construct hospitality. Results: the Axiological Hospitality Scale showed a high internal consistency, with Cronbach’s Alpha=0.901. The validation of the measuring instrument was performed using factorial, exploratory and confirmatory analysis techniques with high goodness of fit measures. Conclusions: the developed instrument showed an adequate validity and a high internal consistency. Based on the consistency of its psychometric properties, it is possible to affirm that the scale provides a reliable measurement of the hospitality. It was also possible to determine the dimensions or sources that embrace it: respect, responsibility, quality and transpersonal care. PMID:28793127

  6. Challenges in validating the sterilisation dose for processed human amniotic membranes

    NASA Astrophysics Data System (ADS)

    Yusof, Norimah; Hassan, Asnah; Firdaus Abd Rahman, M. N.; Hamid, Suzina A.

    2007-11-01

    Most of the tissue banks in the Asia Pacific region have been using ionising radiation at 25 kGy to sterilise human tissues for save clinical usage. Under tissue banking quality system, any dose employed for sterilisation has to be validated and the validation exercise has to be a part of quality document. Tissue grafts, unlike medical items, are not produced in large number per each processing batch and tissues relatively have a different microbial population. A Code of Practice established by the International Atomic Energy Agency (IAEA) in 2004 offers several validation methods using smaller number of samples compared to ISO 11137 (1995), which is meant for medical products. The methods emphasise on bioburden determination, followed by sterility test on samples after they were exposed to verification dose for attaining of sterility assurance level (SAL) of 10 -1. This paper describes our experience in using the IAEA Code of Practice in conducting the validation exercise for substantiating 25 kGy as sterilisation dose for both air-dried amnion and those preserved in 99% glycerol.

  7. Human factors engineering and design validation for the redesigned follitropin alfa pen injection device

    PubMed Central

    Mahony, Mary C; Patterson, Patricia; Hayward, Brooke; North, Robert; Green, Dawne

    2015-01-01

    Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately. Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included ‘Instructions for Use’ (IFU) and pre-validation studies. Validation studies used simulated injections in a representative use environment; participants received prior training on pen use. Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies; previously reported use errors were not repeated. Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely. PMID:25895897

  8. Human factors engineering and design validation for the redesigned follitropin alfa pen injection device.

    PubMed

    Mahony, Mary C; Patterson, Patricia; Hayward, Brooke; North, Robert; Green, Dawne

    2015-05-01

    To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately. A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included 'Instructions for Use' (IFU) and pre-validation studies. Validation studies used simulated injections in a representative use environment; participants received prior training on pen use. User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies; previously reported use errors were not repeated. Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

  9. An investigation into the transference and survivability of human DNA following simulated manual strangulation with consideration of the problem of third party contamination.

    PubMed

    Rutty, G N

    2002-06-01

    Amplification was performed on human DNA material transferred during a model of manual strangulation. A total of 29 separate experiments were performed using a single male offender-female victim combination to observe whether DNA was transferred both from the offender's fingers to the victim's neck and vice versa and to consider the period of time after the event during which the material could potentially be recovered and amplified. DNA was amplified from either the victim's neck or the offender's fingers for at least 10 days after the contact although it is discussed whether this is potentially due to primary contact or a secondary/tertiary transfer event. The study highlights the problem of contamination of the offender's hands and victim's neck with third party DNA, the presence of which could have a significant outcome for both the investigating authority and the third party.

  10. An international system for the education of students of medicine and other health professionals in human reproduction. The FIGO teaching manual: a status report.

    PubMed

    Taylor, H C; Magarick, R H

    1981-03-01

    An analysis of the effectiveness of FIGO's Teaching Manual on Human Reproduction is reported on the basis of answers to a questionnaire received from 100 heads of teaching departments, chiefly of obstetrics and gynecology. These represented 32 countries widely distributed throughout the developing countries of the world. The most significant finding was the evidence of the very large number of medical and other students that could be reached through the principle of placing superlatively good teaching material in the hands of key educators in their native country. Additional answers to the questionnaire provided information on the way courses were organized about the material and suggestions as the useful changes, possible expansion of subject matter, and the felt need for an updated edition.

  11. Human biomonitoring of chromium and nickel from an experimental exposure to manual metal arc welding fumes of low and high alloyed steel.

    PubMed

    Bertram, Jens; Brand, Peter; Schettgen, Thomas; Lenz, Klaus; Purrio, Ellwyn; Reisgen, Uwe; Kraus, Thomas

    2015-05-01

    The uptake and elimination of metals from welding fumes is currently not fully understood. In the Aachen Workplace Simulation Laboratory (AWSL) it is possible to investigate the impact of welding fumes on human subjects under controlled exposure conditions. In this study, the uptake and elimination of chromium or chromium (VI) respectively as well as nickel was studied in subjects after exposure to the emissions of a manual metal arc welding process using low or high alloyed steel. In this present study 12 healthy male non-smokers, who never worked as welders before, were exposed for 6h to welding fumes of a manual metal arc welding process. In a three-fold crossover study design, subjects were exposed in randomized order to either clean air, emissions from welding low alloyed steel, and emissions from welding high alloyed steel. Particle mass concentration of the exposure aerosol was 2.5mg m(-3). The content of chromium and nickel in the air was determined by analysing air filter samples on a high emission scenario. Urine analysis for chromium and nickel was performed before and after exposure using methods of human biomonitoring. There were significantly elevated chromium levels after exposure to welding fumes from high alloyed steel compared to urinary chromium levels before exposure to high alloyed welding fumes, as well as compared to the other exposure scenarios. The mean values increased from 0.27 µg l(-1) to 18.62 µg l(-1). The results were in good agreement with already existing correlations between external and internal exposure (German exposure equivalent for carcinogenic working materials EKA). The variability of urinary chromium levels was high. For urinary nickel no significant changes could be detected at all. Six-hour exposure to 2.5mg m(-3) high alloyed manual metal arc welding fumes lead to elevated urinary chromium levels far higher (7.11-34.16 µg l(-1)) than the German biological exposure reference value (BAR) of 0.6 µg l(-1) directly after

  12. Risk assessment of manual handling operations at work with the key indicator method (KIM-MHO) - determination of criterion validity regarding the prevalence of musculoskeletal symptoms and clinical conditions within a cross-sectional study.

    PubMed

    Klussmann, Andre; Liebers, Falk; Gebhardt, Hansjürgen; Rieger, Monika A; Latza, Ute; Steinberg, Ulf

    2017-05-10

    Manual handling operations (MHO) are known to be risk factors for work-related upper limb disorders (WRULDs), e.g. symptoms and conditions such as carpal tunnel syndrome. To estimate the risk of WRULDs, a Key Indicator Method (KIM) for the risk assessment of MHO was developed. The method was validated in regard to different criteria, including face validity, criterion validity, reliability and further aspects concerning utility. This paper describes the KIM-MHO and criterion validity of this method with reference to prevalence of musculoskeletal disorders (MSDs). A cross-sectional sample of 643 employees exposed to MHO was compared to a reference group of 804 unexposed subjects predominantly working at visual display terminals. The Nordic Questionnaire and a standardized clinical examination were used to obtain the 7-day and 12-months prevalence of symptoms and clinical conditions of the musculoskeletal system. Job specific exposure levels to MHO were assessed by ergonomists using the KIM-MHO. The resulting risk scores were categorized into risk categories 1 - low risk (reference group), 2 - increased risk, 3 - highly increased risk, and 4 - high risk. Log-linear Poisson regression models were applied to obtain adjusted prevalence ratios (PR) with 95%-confidence intervals. The 7-day prevalence of symptoms for subjects in risk category 3 compared to risk category 1 was significant for the regions shoulder [women (w): PR 1.8 (1.2-2.7), men (m): PR 2.3 (1.2-4.4)], elbow [w: PR 3.3 (1.5-7.2), m: PR 2.4 (0.8-7.3)], and hand/wrist [w: PR 3.0 (1.7-5.3), m: PR 5.5 (2.7-11.3)]. The 7-day prevalence of symptoms for risk category 4 was also significant for the regions shoulder [w: PR 1.9 (1.3-2.8), m: PR 1.9 (1.3-2.7)], elbow [w: PR 4.5 (2.3-8.7), m: PR 3.3 (2.1-5.4)], and hand/wrist [w: PR 4.2 (2.6-6.9), m: PR 5.5 (3.5-8.5)]. The 12-months prevalence in these joint regions show comparable increases in the risk categories 3 and 4. The KIM-MHO is valid in regard to criterion

  13. Instrumentation for low frequency EIT studies of the human head and its validation in phantom experiments

    NASA Astrophysics Data System (ADS)

    Esler, Brian; Lyons, Thomas; Turovets, Sergei; Tucker, Don

    2010-04-01

    We describe instrumentation for low frequency (< 500 Hz) EIT studies of the human head and its calibration, testing and validation in the phantom experiments. Our EIT system prototype is based on a 256 channel commercial EEG system complimented by the current injection module and lock-in detection software. We have designed and built two types of head phantoms: i) a resistor network and ii) a cylinder tank filled with saline and gel insertions with chemically targeted conductivity values. We have developed a technology for fabricating, handling and storage of agar TX151 gel insertions. Independent and direct conductivity measurements of gel samples have been performed using a HP LCR meter in a four electrode conductivity cell specifically designed and built for this purpose. Measurements of saline conductivity were done with commercially available salinity / conductivity meters. Our inverse conductivity estimates in the phantom experiments with EIDORS and in-house software cross-validate the viability of the EIT-EEG system.

  14. Inference of human affective states from psychophysiological measurements extracted under ecologically valid conditions

    PubMed Central

    Betella, Alberto; Zucca, Riccardo; Cetnarski, Ryszard; Greco, Alberto; Lanatà, Antonio; Mazzei, Daniele; Tognetti, Alessandro; Arsiwalla, Xerxes D.; Omedas, Pedro; De Rossi, Danilo; Verschure, Paul F. M. J.

    2014-01-01

    Compared to standard laboratory protocols, the measurement of psychophysiological signals in real world experiments poses technical and methodological challenges due to external factors that cannot be directly controlled. To address this problem, we propose a hybrid approach based on an immersive and human accessible space called the eXperience Induction Machine (XIM), that incorporates the advantages of a laboratory within a life-like setting. The XIM integrates unobtrusive wearable sensors for the acquisition of psychophysiological signals suitable for ambulatory emotion research. In this paper, we present results from two different studies conducted to validate the XIM as a general-purpose sensing infrastructure for the study of human affective states under ecologically valid conditions. In the first investigation, we recorded and classified signals from subjects exposed to pictorial stimuli corresponding to a range of arousal levels, while they were free to walk and gesticulate. In the second study, we designed an experiment that follows the classical conditioning paradigm, a well-known procedure in the behavioral sciences, with the additional feature that participants were free to move in the physical space, as opposed to similar studies measuring physiological signals in constrained laboratory settings. Our results indicate that, by using our sensing infrastructure, it is indeed possible to infer human event-elicited affective states through measurements of psychophysiological signals under ecological conditions. PMID:25309310

  15. An agent-based model of exposure to human toxocariasis: a multi-country validation.

    PubMed

    Kanobana, K; Devleesschauwer, B; Polman, K; Speybroeck, N

    2013-07-01

    Seroprevalence data illustrate that human exposure to Toxocara is frequent. Environmental contamination with Toxocara spp. eggs is assumed to be the best indicator of human exposure, but increased risk of exposure has also been associated with many other factors. Reported associations are inconsistent, however, and there is still ambiguity regarding the factors driving the onset of Toxocara antibody positivity. The objective of this work was to assess the validity of our current conceptual understanding of the key processes driving human exposure to Toxocara. We constructed an agent-based model predicting Toxocara antibody positivity (as a measure of exposure) in children. Exposure was assumed to depend on the joint probability of 3 parameters: (1) environmental contamination with Toxocara spp. eggs, (2) larvation of these eggs and (3) the age-related contact with these eggs. This joint probability was linked to processes of acquired humoral immunity, influencing the rate of antibody seroreversion. The results of the simulation were validated against published data from 5 different geographical settings. Using simple rules and a stochastic approach with parameter estimates derived from the respective contexts, plausible serological patterns emerged from the model in nearly all settings. Our approach leads to novel insights in the transmission dynamics of Toxocara.

  16. Manually controlled human balancing using visual, vestibular and proprioceptive senses involves a common, low frequency neural process

    PubMed Central

    Lakie, Martin; Loram, Ian D

    2006-01-01

    Ten subjects balanced their own body or a mechanically equivalent unstable inverted pendulum by hand, through a compliant spring linkage. Their balancing process was always characterized by repeated small reciprocating hand movements. These bias adjustments were an observable sign of intermittent alterations in neural output. On average, the adjustments occurred at intervals of ∼400 ms. To generate appropriate stabilizing bias adjustments, sensory information about body or load movement is needed. Subjects used visual, vestibular or proprioceptive sensation alone and in combination to perform the tasks. We first ask, is the time between adjustments (bias duration) sensory specific? Vision is associated with slow responses. Other senses involved with balance are known to be faster. Our second question is; does bias duration depend on sensory abundance? An appropriate bias adjustment cannot occur until unplanned motion is unambiguously perceived (a sensory threshold). The addition of more sensory data should therefore expedite action, decreasing the mean bias adjustment duration. Statistical analysis showed that (1) the mean bias adjustment duration was remarkably independent of the sensory modality and (2) the addition of one or two sensory modalities made a small, but significant, decrease in the mean bias adjustment duration. Thus, a threshold effect can alter only a very minor part of the bias duration. The bias adjustment duration in manual balancing must reflect something more than visual sensation and perceptual thresholds; our suggestion is that it is a common central motor planning process. We predict that similar processes may be identified in the control of standing. PMID:16959857

  17. Sierra Structural Dynamics Theory Manual

    SciTech Connect

    Reese, Garth M.

    2015-10-19

    Sierra/SD provides a massively parallel implementation of structural dynamics finite element analysis, required for high fidelity, validated models used in modal, vibration, static and shock analysis of structural systems. This manual describes the theory behind many of the constructs in Sierra/SD. For a more detailed description of how to use Sierra/SD , we refer the reader to Sierra/SD, User's Notes . Many of the constructs in Sierra/SD are pulled directly from published material. Where possible, these materials are referenced herein. However, certain functions in Sierra/SD are specific to our implementation. We try to be far more complete in those areas. The theory manual was developed from several sources including general notes, a programmer notes manual, the user's notes and of course the material in the open literature. This page intentionally left blank.

  18. Evaluating Nextgen Closely Spaced Parallel Operations Concepts with Validated Human Performance Models: Flight Deck Guidelines

    NASA Technical Reports Server (NTRS)

    Hooey, Becky Lee; Gore, Brian Francis; Mahlstedt, Eric; Foyle, David C.

    2013-01-01

    The objectives of the current research were to develop valid human performance models (HPMs) of approach and land operations; use these models to evaluate the impact of NextGen Closely Spaced Parallel Operations (CSPO) on pilot performance; and draw conclusions regarding flight deck display design and pilot-ATC roles and responsibilities for NextGen CSPO concepts. This document presents guidelines and implications for flight deck display designs and candidate roles and responsibilities. A companion document (Gore, Hooey, Mahlstedt, & Foyle, 2013) provides complete scenario descriptions and results including predictions of pilot workload, visual attention and time to detect off-nominal events.

  19. A system to reproduce human breathing patterns: its development and validation.

    PubMed

    Häussermann, S; Bailey, A G; Maul, C

    2000-01-01

    Studies of aerosol deposition in models of the human respiratory tract play a significant role in developing our understanding of drug delivery by inhalation and particle retention in the lungs during exposure to polluted environments. To use replica casts of human airways and compare the results with in vivo data, a device is required to simulate human breathing. The objective of this study was to simulate human breathing for nasal casts. Breathing through the nose is normally limited to about 50 L/min. Therefore, a system was built to simulate human breathing patterns as well as artificial ones up to this flow rate. The system consists of a reciprocating piston in a cylinder, which is displaced by a synchronous motor via a linear actuator. The desired signal to drive the motor is given in real time by purpose-written software. The rotation and position of the motor are controlled by an electronic position control unit. The validation of the system shows that it simulates breathing up to 50 L/min closely even for complex waveforms. At breathing rates above 50 L/min, a slight difference is apparent between the desired breathing pattern and the simulated one. The breathing simulator has been shown to be a reliable tool for reproducing a wide variety of breathing patterns.

  20. The use of MR B+1 imaging for validation of FDTD electromagnetic simulations of human anatomies.

    PubMed

    Van den Berg, Cornelis A T; Bartels, Lambertus W; van den Bergen, Bob; Kroeze, Hugo; de Leeuw, Astrid A C; Van de Kamer, Jeroen B; Lagendijk, Jan J W

    2006-10-07

    In this study, MR B(+)(1) imaging is employed to experimentally verify the validity of FDTD simulations of electromagnetic field patterns in human anatomies. Measurements and FDTD simulations of the B(+)(1) field induced by a 3 T MR body coil in a human corpse were performed. It was found that MR B(+)(1) imaging is a sensitive method to measure the radiofrequency (RF) magnetic field inside a human anatomy with a precision of approximately 3.5%. A good correlation was found between the B(+)(1) measurements and FDTD simulations. The measured B(+)(1) pattern for a human pelvis consisted of a global, diagonal modulation pattern plus local B(+)(1) heterogeneties. It is believed that these local B(+)(1) field variations are the result of peaks in the induced electric currents, which could not be resolved by the FDTD simulations on a 5 mm(3) simulation grid. The findings from this study demonstrate that B(+)(1) imaging is a valuable experimental technique to gain more knowledge about the dielectric interaction of RF fields with the human anatomy.

  1. Systems analysis programs for Hands-on integrated reliability evaluations (SAPHIRE) Version 5.0: Verification and validation (V&V) manual. Volume 9

    SciTech Connect

    Jones, J.L.; Calley, M.B.; Capps, E.L.; Zeigler, S.L.; Galyean, W.J.; Novack, S.D.; Smith, C.L.; Wolfram, L.M.

    1995-03-01

    A verification and validation (V&V) process has been performed for the System Analysis Programs for Hands-on Integrated Reliability Evaluation (SAPHIRE) Version 5.0. SAPHIRE is a set of four computer programs that NRC developed for performing probabilistic risk assessments. They allow an analyst to perform many of the functions necessary to create, quantify, and evaluate the risk associated with a facility or process being analyzed. The programs are Integrated Reliability and Risk Analysis System (IRRAS) System Analysis and Risk Assessment (SARA), Models And Results Database (MAR-D), and Fault tree, Event tree, and Piping and instrumentation diagram (FEP) graphical editor. Intent of this program is to perform a V&V of successive versions of SAPHIRE. Previous efforts have been the V&V of SAPHIRE Version 4.0. The SAPHIRE 5.0 V&V plan is based on the SAPHIRE 4.0 V&V plan with revisions to incorporate lessons learned from the previous effort. Also, the SAPHIRE 5.0 vital and nonvital test procedures are based on the test procedures from SAPHIRE 4.0 with revisions to include the new SAPHIRE 5.0 features as well as to incorporate lessons learned from the previous effort. Most results from the testing were acceptable; however, some discrepancies between expected code operation and actual code operation were identified. Modifications made to SAPHIRE are identified.

  2. Carcinogen biomonitoring in human exposures and laboratory research: validation and application to human occupational exposures.

    PubMed

    Talaska, Glenn; Maier, Andrew; Henn, Scott; Booth-Jones, Angela; Tsuneoka, Yutaka; Vermeulen, Roel; Schumann, Brenda L

    2002-08-05

    A multiple biomarker approach is required to integrate for metabolism, temporal response and exposure-response kinetics, biological relevance, and positive predictive value. Carcinogen DNA adduct analysis can be used in animal and in vitro studies to detect absorption permutations caused by mixture interactions, and to control metabolic variation when specific CYP450 genes (1A1 or 1A2) are knocked out. These enzymes are not critical to the metabolic activation of model Polycyclic Aromatic Compounds (PAC) and aromatic amines, respectively, as suggested by in vitro analysis. Several human studies have been carried out where multiple biomarkers have been measured. In a study of benzidine workers, the similarities in elimination kinetics between urinary metabolites and mutagenicity is likely responsible for a better correlation between these markers than to BZ-DNA adducts in exfoliated cells. In a study of rubber workers, the relationship between specific departments, urinary 1 HP and DNA adducts in exfoliated cells coincided with the historical urinary bladder cancer risk in these departments; the same relationship did not hold for urinary mutagenicity. In a study of automotive mechanics, biomarkers were used to monitor the effectiveness of exposure interventions. These data reinforce the notion that carcinogen biomarkers are useful to monitor exposure, but that a complementary approaches involving effect and perhaps susceptibility biomarkers is necessary to obtain the necessary information.

  3. A Pulsatile Fresh Frozen Human Cadaver Circulation Model for Endovascular Training: A Trial of Face Validity.

    PubMed

    Nesbitt, Craig; Tingle, Samuel James; Williams, Robin; McCaslin, James; Searle, Roger; Mafeld, Sebastian; Stansby, Gerard

    2017-09-06

    The authors have published their design of a pulsatile fresh frozen human cadaver circulation model (PHCM) for endovascular training the face validity of the PHCM for training endovascular practitioners was subsequently assessed. Twelve endovascular clinicians performed the same 2 procedures (catheterization of the left renal artery and left subclavian artery) on PHCM and Simbionix angiomentor virtual reality simulator (SVR). They were randomized to begin on either the PHCM or SVR. A pretrial questionnaire determined participants' endovascular experience. After training, participants rated statements relating to their experience on a numerical scale from 1 to 5, with 1 representing the strongest agreement with the statement. When participants were asked to compare the realism of training modalities with live patients, PHCM scored significantly higher than SVR on statements regarding "realism of vascular access" (P = 0.002), "guide-wire manipulation" (P = 0.001), and "vessel catheterization" (P = 0.004). Candidates again favored PHCM as "a valuable learning exercise" (P = 0.016) and strongly favored PHCM as a "useful training model" compared to SVR (P = 0.004). This is the first published trial in world literature to assess the validity of a PHCM for training endovascular practitioners. The PHCM demonstrates good face validity when compared to both real patients and the SVR model and holds exciting potential. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Sensitivity analysis of a validated subject-specific finite element model of the human craniofacial skeleton.

    PubMed

    Szwedowski, T D; Fialkov, J; Whyne, C M

    2011-01-01

    Developing a more complete understanding of the mechanical response of the craniofacial skeleton (CFS) to physiological loads is fundamental to improving treatment for traumatic injuries, reconstruction due to neoplasia, and deformities. Characterization of the biomechanics of the CFS is challenging due to its highly complex structure and heterogeneity, motivating the utilization of experimentally validated computational models. As such, the objective of this study was to develop, experimentally validate, and parametrically analyse a patient-specific finite element (FE) model of the CFS to elucidate a better understanding of the factors that are of intrinsic importance to the skeletal structural behaviour of the human CFS. An FE model of a cadaveric craniofacial skeleton was created from subject-specific computed tomography data. The model was validated based on bone strain measurements taken under simulated physiological-like loading through the masseter and temporalis muscles (which are responsible for the majority of craniofacial physiologic loading due to mastication). The baseline subject-specific model using locally defined cortical bone thicknesses produced the strongest correlation to the experimental data (r2 = 0.73). Large effects on strain patterns arising from small parametric changes in cortical thickness suggest that the very thin bony structures present in the CFS are crucial to characterizing the local load distribution in the CFS accurately.

  5. Quantitative Validation of a Human Body Finite Element Model Using Rigid Body Impacts.

    PubMed

    Vavalle, Nicholas A; Davis, Matthew L; Stitzel, Joel D; Gayzik, F Scott

    2015-09-01

    Validation is a critical step in finite element model (FEM) development. This study focuses on the validation of the Global Human Body Models Consortium full body average male occupant FEM in five localized loading regimes-a chest impact, a shoulder impact, a thoracoabdominal impact, an abdominal impact, and a pelvic impact. Force and deflection outputs from the model were compared to experimental traces and corridors scaled to the 50th percentile male. Predicted fractures and injury severity measures were compared to evaluate the model's injury prediction capabilities. The methods of ISO/TS 18571 were used to quantitatively assess the fit of model outputs to experimental force and deflection traces. The model produced peak chest, shoulder, thoracoabdominal, abdominal, and pelvis forces of 4.8, 3.3, 4.5, 5.1, and 13.0 kN compared to 4.3, 3.2, 4.0, 4.0, and 10.3 kN in the experiments, respectively. The model predicted rib and pelvic fractures related to Abbreviated Injury Scale scores within the ranges found experimentally all cases except the abdominal impact. ISO/TS 18571 scores for the impacts studied had a mean score of 0.73 with a range of 0.57-0.83. Well-validated FEMs are important tools used by engineers in advancing occupant safety.

  6. Chemical validation of trypanothione synthetase: a potential drug target for human trypanosomiasis.

    PubMed

    Torrie, Leah S; Wyllie, Susan; Spinks, Daniel; Oza, Sandra L; Thompson, Stephen; Harrison, Justin R; Gilbert, Ian H; Wyatt, Paul G; Fairlamb, Alan H; Frearson, Julie A

    2009-12-25

    In the search for new therapeutics for the treatment of human African trypanosomiasis, many potential drug targets in Trypanosoma brucei have been validated by genetic means, but very few have been chemically validated. Trypanothione synthetase (TryS; EC 6.3.1.9; spermidine/glutathionylspermidine:glutathione ligase (ADP-forming)) is one such target. To identify novel inhibitors of T. brucei TryS, we developed an in vitro enzyme assay, which was amenable to high throughput screening. The subsequent screen of a diverse compound library resulted in the identification of three novel series of TryS inhibitors. Further chemical exploration resulted in leads with nanomolar potency, which displayed mixed, uncompetitive, and allosteric-type inhibition with respect to spermidine, ATP, and glutathione, respectively. Representatives of all three series inhibited growth of bloodstream T. brucei in vitro. Exposure to one of our lead compounds (DDD86243; 2 x EC(50) for 72 h) decreased intracellular trypanothione levels to <10% of wild type. In addition, there was a corresponding 5-fold increase in the precursor metabolite, glutathione, providing strong evidence that DDD86243 was acting on target to inhibit TryS. This was confirmed with wild-type, TryS single knock-out, and TryS-overexpressing cell lines showing expected changes in potency to DDD86243. Taken together, these data provide initial chemical validation of TryS as a drug target in T. brucei.

  7. Enhanced Oceanic Operations Human-In-The-Loop In-Trail Procedure Validation Simulation Study

    NASA Technical Reports Server (NTRS)

    Murdoch, Jennifer L.; Bussink, Frank J. L.; Chamberlain, James P.; Chartrand, Ryan C.; Palmer, Michael T.; Palmer, Susan O.

    2008-01-01

    The Enhanced Oceanic Operations Human-In-The-Loop In-Trail Procedure (ITP) Validation Simulation Study investigated the viability of an ITP designed to enable oceanic flight level changes that would not otherwise be possible. Twelve commercial airline pilots with current oceanic experience flew a series of simulated scenarios involving either standard or ITP flight level change maneuvers and provided subjective workload ratings, assessments of ITP validity and acceptability, and objective performance measures associated with the appropriate selection, request, and execution of ITP flight level change maneuvers. In the majority of scenarios, subject pilots correctly assessed the traffic situation, selected an appropriate response (i.e., either a standard flight level change request, an ITP request, or no request), and executed their selected flight level change procedure, if any, without error. Workload ratings for ITP maneuvers were acceptable and not substantially higher than for standard flight level change maneuvers, and, for the majority of scenarios and subject pilots, subjective acceptability ratings and comments for ITP were generally high and positive. Qualitatively, the ITP was found to be valid and acceptable. However, the error rates for ITP maneuvers were higher than for standard flight level changes, and these errors may have design implications for both the ITP and the study's prototype traffic display. These errors and their implications are discussed.

  8. Granulosa cells and retinoic acid co-treatment enrich potential germ cells from manually selected Oct4-EGFP expressing human embryonic stem cells.

    PubMed

    Chen, Hsin-Fu; Jan, Pey-Shynan; Kuo, Hung-Chih; Wu, Fang-Chun; Lan, Chen-Wei; Huang, Mei-Chi; Chien, Chung-Liang; Ho, Hong-Nerng

    2014-09-01

    Differentiation of human embryonic stem (HES) cells to germ cells may become clinically useful in overcoming diseases related to germ-cell development. Niches were used to differentiate HES cell lines, NTU1 and H9 Oct4-enhanced green fluorescence protein (EGFP), including laminin, granulosa cell co-culture or conditioned medium, ovarian stromal cell co-culture or conditioned medium, retinoic acid, stem cell factor (SCF) and BMP4-BMP7-BMP8b treatment. Flow cytometry showed that granulosa cell co-culture (P < 0.001) or conditioned medium (P = 0.007) treatment for 14 days significantly increased the percentages of differentiated H9 Oct4-EGFP cells expressing early germ cell marker stage-specific embryonic antigen 1(SSEA1); sorted SSEA1[+] cells did not express higher levels of germ cell gene VASA and GDF9. Manually collected H9 Oct4-EGFP[+] cells expressed significantly higher levels of VASA (P = 0.005) and GDF9 (P = 0.001). H9 Oct4-EGFP[+] cells developed to ovarian follicle-like structures after culture for 28 days but with low efficiency. Unlike SCF and BMP4, retinoic acid co-treatment enhanced VASA, GDF9 and SCP3 expression. A protocol is recommended to enrich differentiated HES cells with germ-cell potential by culture with granulosa cells, conditioned medium or retinoic acid, manual selection of Oct4-EGFP[+] cells, and analysis of VASA, GDF9 expression, or both. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  9. Validating Human Performance Models of the Future Orion Crew Exploration Vehicle

    NASA Technical Reports Server (NTRS)

    Wong, Douglas T.; Walters, Brett; Fairey, Lisa

    2010-01-01

    NASA's Orion Crew Exploration Vehicle (CEV) will provide transportation for crew and cargo to and from destinations in support of the Constellation Architecture Design Reference Missions. Discrete Event Simulation (DES) is one of the design methods NASA employs for crew performance of the CEV. During the early development of the CEV, NASA and its prime Orion contractor Lockheed Martin (LM) strived to seek an effective low-cost method for developing and validating human performance DES models. This paper focuses on the method developed while creating a DES model for the CEV Rendezvous, Proximity Operations, and Docking (RPOD) task to the International Space Station. Our approach to validation was to attack the problem from several fronts. First, we began the development of the model early in the CEV design stage. Second, we adhered strictly to M&S development standards. Third, we involved the stakeholders, NASA astronauts, subject matter experts, and NASA's modeling and simulation development community throughout. Fourth, we applied standard and easy-to-conduct methods to ensure the model's accuracy. Lastly, we reviewed the data from an earlier human-in-the-loop RPOD simulation that had different objectives, which provided us an additional means to estimate the model's confidence level. The results revealed that a majority of the DES model was a reasonable representation of the current CEV design.

  10. Validation of an HPLC method for sildenafil citrate analysis in human plasma samples.

    PubMed

    Quintero, A; Caldera, A; Milano, B; Odreman, I; Hurtado, A; Manzanares, L; Villamizar, J

    2009-12-01

    A simple, precise, rapid and accurate HPLC method for the determination of sildenafil citrate (SLD) in human plasma has been developed based on previous reports, to offer an alternative way to detect and quantify SLD and also to improve some characteristics of the validation process. Chromatography was carried out on a C18 reversed-phase column, using a mixture of acetonitrile: ammonium acetate (0.3 M pH 6.8) (1:1 v/v) as the mobile phase at a flow of 0.750 mL/min. Diazepam was used as an internal standard (IS) and detection was by UV at 240 nm. Samples were extracted with 200 microl of 0.1 M Na2CO3 and 5 mL of diethyl ether: dichloromethane (60:40). Retention times of SLD and IS were 4.8 and 7.1 min, respectively; total run time was 10 min. The linear range of SLD was found to be 20 - 1000 ng/mL. Limit of quantitation (LOQ) and limit of detection (LOD) were calculated to be 10 and 20 ng/mL, respectively. An improved percentage recovery of analyte is reported, showing a fast and reproducible approach to detect SLD in plasma human sample. The method was validated for its linearity, precision, accuracy, recovery, stability and specificity.

  11. Method Development and Validation for UHPLC-MS-MS Determination of Hop Prenylflavonoids in Human Serum

    PubMed Central

    Yuan, Yang; Qiu, Xi; Nikolic, Dejan; Dahl, Jeffrey H.; van Breemen, Richard B.

    2013-01-01

    Hops (Humulus lupulus L.) are used in the brewing of beer, and hop extracts containing prenylated compounds such as xanthohumol and 8-prenylnaringenin are under investigation as dietary supplements for cancer chemoprevention and for the management of hot flashes in menopausal women. To facilitate clinical studies of hop safety and efficacy, a selective, sensitive, and fast ultra-high pressure liquid chromatography tandem mass spectrometry (UHPLC-MS-MS) method was developed and validated for the simultaneous determination of the hop prenylflavonoids xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin in human serum. The analytical method requires 300 μL of human serum which is processed using liquid-liquid extraction. UHPLC separation was carried out in 2.5 min with gradient elution using a reversed phase column containing 1.6 μm packing material. Prenylflavonoids were measured using negative ion electrospray mass spectrometry with collision-induced dissociation and selected reaction monitoring. The method was validated and showed good accuracy and precision with a lower limit of quantitation (LLOQ) of 0.50 ng/mL for XN (1.4 nM) and 1.0 ng/mL for 6-PN (2.8 nM), XN and IX (2.9 nM) in serum for each analyte. PMID:23451393

  12. High-definition fiber tractography of the human brain: neuroanatomical validation and neurosurgical applications.

    PubMed

    Fernandez-Miranda, Juan C; Pathak, Sudhir; Engh, Johnathan; Jarbo, Kevin; Verstynen, Timothy; Yeh, Fang-Cheng; Wang, Yibao; Mintz, Arlan; Boada, Fernando; Schneider, Walter; Friedlander, Robert

    2012-08-01

    High-definition fiber tracking (HDFT) is a novel combination of processing, reconstruction, and tractography methods that can track white matter fibers from cortex, through complex fiber crossings, to cortical and subcortical targets with subvoxel resolution. To perform neuroanatomical validation of HDFT and to investigate its neurosurgical applications. Six neurologically healthy adults and 36 patients with brain lesions were studied. Diffusion spectrum imaging data were reconstructed with a Generalized Q-Ball Imaging approach. Fiber dissection studies were performed in 20 human brains, and selected dissection results were compared with tractography. HDFT provides accurate replication of known neuroanatomical features such as the gyral and sulcal folding patterns, the characteristic shape of the claustrum, the segmentation of the thalamic nuclei, the decussation of the superior cerebellar peduncle, the multiple fiber crossing at the centrum semiovale, the complex angulation of the optic radiations, the terminal arborization of the arcuate tract, and the cortical segmentation of the dorsal Broca area. From a clinical perspective, we show that HDFT provides accurate structural connectivity studies in patients with intracerebral lesions, allowing qualitative and quantitative white matter damage assessment, aiding in understanding lesional patterns of white matter structural injury, and facilitating innovative neurosurgical applications. High-grade gliomas produce significant disruption of fibers, and low-grade gliomas cause fiber displacement. Cavernomas cause both displacement and disruption of fibers. Our HDFT approach provides an accurate reconstruction of white matter fiber tracts with unprecedented detail in both the normal and pathological human brain. Further studies to validate the clinical findings are needed.

  13. Validation of the Turkish Cervical Cancer and Human Papilloma Virus Awareness Questionnaire.

    PubMed

    Özdemir, E; Kısa, S

    2016-09-01

    The aim of this study was to determine the validity and reliability of the 'Cervical Cancer and Human Papilloma Virus Awareness Questionnaire' among fertility age women by adapting the scale into Turkish. Cervical cancer is the fourth most commonly form seen among women. Death from cervical cancer ranks third among causes and is one of the most preventable forms of cancer. This cross-sectional study included 360 women from three family health centres between January 5 and June 25, 2014. Internal consistency showed that the Kuder-Richardson 21 reliability coefficient in the first part was 0.60, Cronbach's alpha reliability coefficient was 0.61 in the second part. The Kaiser-Meyer-Olkin value of the items on the scale was 0.712. The Barlett test was significant. The confirmatory factor analysis indicated that the model matched the data adequately. This study shows that the Turkish version of the instrument is a valid and reliable tool to evaluate knowledge, perceptions and preventive behaviours of women regarding human papilloma virus and cervical cancer. Nurses who work in the clinical and primary care settings need to screen, detect and refer women who may be at risk from cervical cancer. © 2016 International Council of Nurses.

  14. Validation study of human figure drawing test in a Colombian school children population.

    PubMed

    Vélez van Meerbeke, Alberto; Sandoval-Garcia, Carolina; Ibáñez, Milciades; Talero-Gutiérrez, Claudia; Fiallo, Dolly; Halliday, Karen

    2011-05-01

    The aim of this article was to assess the validity of the emotional and developmental components of the Koppitz human figure drawing test. 2420 children's drawings available in a database resulting from a previous cross sectional study designed to determine the prevalence of neurological diseases in children between 0 and 12 years old in Bogota schools were evaluated. They were scored using the criteria proposed by Koppitz, and classified into 16 groups according to age, gender, and presence/absence of learning or attention problems. The overall results were then compared with the normative study to assess whether descriptive parameters of the two populations were significantly different. There were no significant differences associated with presence/absence of learning and attention disorders or school attended within the overall sample. An Interrater reliability test has been made to assure the homogeneity of scoring by the evaluator team. There were significant differences between this population and that of the original study. New scoring tables contextualized for our population based on the frequency of appearance in this sample are presented. We can conclude that various ethnic, social, and cultural factors can influence the way children draw the human figure. It is thus important to establish local reference values to adequately distinguish between normality and abnormality. The new scoring tables proposed here should be followed up with a clinical study to corroborate their validity.

  15. Validation of connectivity-based thalamic segmentation with direct electrophysiologic recordings from human sensory thalamus.

    PubMed

    Elias, W Jeffrey; Zheng, Zhong A; Domer, Paul; Quigg, Mark; Pouratian, Nader

    2012-02-01

    Connectivity-based segmentation has been used to identify functional gray matter subregions that are not discernable on conventional magnetic resonance imaging. However, the accuracy and reliability of this technique has only been validated using indirect means. In order to provide direct electrophysiologic validation of connectivity-based thalamic segmentations within human subjects, we assess the correlation of atlas-based thalamic anatomy, connectivity-based thalamic maps, and somatosensory evoked thalamic potentials in two adults with medication-refractory epilepsy who were undergoing intracranial EEG monitoring with intrathalamic depth and subdural cortical strip electrodes. MRI with atlas-derived localization was used to delineate the anatomic boundaries of the ventral posterolateral (VPL) nucleus of the thalamus. Somatosensory evoked potentials with intrathalamic electrodes physiologically identified a discrete region of phase reversal in the ventrolateral thalamus. Finally, DTI was obtained so that probabilistic tractography and connectivity-based segmentation could be performed to correlate the region of thalamus linked to sensory areas of the cortex, namely the postcentral gyrus. We independently utilized these three different methods in a blinded fashion to localize the "sensory" thalamus, demonstrating a high-degree of reproducible correlation between electrophysiologic and connectivity-based maps of the thalamus. This study provides direct electrophysiologic validation of probabilistic tractography-based thalamic segmentation. Importantly, this study provides an electrophysiological basis for using connectivity-based segmentation to further study subcortical anatomy and physiology while also providing the clinical basis for targeting deep brain nuclei with therapeutic stimulation. Finally, these direct recordings from human thalamus confirm early inferences of a sensory thalamic component of the N18 waveform in somatosensory evoked potentials.

  16. Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay.

    PubMed

    Ni, Yan G; Yuan, Xiling; Newitt, John A; Peterson, Jon E; Gleason, Carol R; Haulenbeek, Jonathan; Santockyte, Rasa; Lafont, Virginie; Marsilio, Frank; Neely, Robert J; DeSilva, Binodh; Piccoli, Steven P

    2015-07-01

    Programmed death-1 (PD-1) protein is a co-inhibitory receptor which negatively regulates immune cell activation and permits tumors to evade normal immune defense. Anti-PD-1 antibodies have been shown to restore immune cell activation and effector function-an exciting breakthrough in cancer immunotherapy. Recent reports have documented a soluble form of PD-1 (sPD-1) in the circulation of normal and disease state individuals. A clinical assay to quantify sPD-1 would contribute to the understanding of sPD-1-function and facilitate the development of anti-PD-1 drugs. Here, we report the development and validation of a sPD-1 protein assay. The assay validation followed the framework for full validation of a biotherapeutic pharmacokinetic assay. A purified recombinant human PD-1 protein was characterized extensively and was identified as the assay reference material which mimics the endogenous analyte in structure and function. The lower limit of quantitation (LLOQ) was determined to be 100 pg/mL, with a dynamic range spanning three logs to 10,000 pg/mL. The intra- and inter-assay imprecision were ≤15%, and the assay bias (percent deviation) was ≤10%. Potential matrix effects were investigated in sera from both normal healthy volunteers and selected cancer patients. Bulk-prepared frozen standards and pre-coated Streptavidin plates were used in the assay to ensure consistency in assay performance over time. This assay appears to specifically measure total sPD-1 protein since the human anti-PD-1 antibody, nivolumab, and the endogenous ligands of PD-1 protein, PDL-1 and PDL-2, do not interfere with the assay.

  17. The development, assessment and validation of virtual reality for human anatomy instruction

    NASA Technical Reports Server (NTRS)

    Marshall, Karen Benn

    1996-01-01

    This research project seeks to meet the objective of science training by developing, assessing, validating and utilizing VR as a human anatomy training medium. Current anatomy instruction is primarily in the form of lectures and usage of textbooks. In ideal situations, anatomic models, computer-based instruction, and cadaver dissection are utilized to augment traditional methods of instruction. At many institutions, lack of financial resources limits anatomy instruction to textbooks and lectures. However, human anatomy is three-dimensional, unlike the one-dimensional depiction found in textbooks and the two-dimensional depiction found on the computer. Virtual reality allows one to step through the computer screen into a 3-D artificial world. The primary objective of this project is to produce a virtual reality application of the abdominopelvic region of a human cadaver that can be taken back to the classroom. The hypothesis is that an immersive learning environment affords quicker anatomic recognition and orientation and a greater level of retention in human anatomy instruction. The goal is to augment not replace traditional modes of instruction.

  18. Development and validation of an extraction method for the analysis of perfluoroalkyl substances in human hair.

    PubMed

    Kim, Da-Hye; Oh, Jeong-Eun

    2017-05-01

    Human hair has many advantages as a non-invasive sample; however, analytical methods for detecting perfluoroalkyl substances (PFASs) in human hair are still in the development stage. Therefore, the aim of this study was to develop and validate a method for monitoring 11 PFASs in human hair. Solid-phase extraction (SPE), ion-pairing extraction (IPE), a combined method (SPE+IPE) and solvent extraction with ENVI-carb clean-up were compared to develop an optimal extraction method using two types of hair sample (powder and piece forms). Analysis of PFASs was performed using liquid chromatography and tandem mass spectrometry. Among the four different extraction procedures, the SPE method using powdered hair showed the best extraction efficiency and recoveries ranged from 85.8 to 102%. The method detection limits for the SPE method were 0.114-0.796 ng/g and good precision (below 10%) and accuracy (66.4-110%) were obtained. In light of these results, SPE is considered the optimal method for PFAS extraction from hair. It was also successfully used to detect PFASs in human hair samples. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Using experimental human influenza infections to validate a viral dynamic model and the implications for prediction.

    PubMed

    Chen, S C; You, S H; Liu, C Y; Chio, C P; Liao, C M

    2012-09-01

    The aim of this work was to use experimental infection data of human influenza to assess a simple viral dynamics model in epithelial cells and better understand the underlying complex factors governing the infection process. The developed study model expands on previous reports of a target cell-limited model with delayed virus production. Data from 10 published experimental infection studies of human influenza was used to validate the model. Our results elucidate, mechanistically, the associations between epithelial cells, human immune responses, and viral titres and were supported by the experimental infection data. We report that the maximum total number of free virions following infection is 10(3)-fold higher than the initial introduced titre. Our results indicated that the infection rates of unprotected epithelial cells probably play an important role in affecting viral dynamics. By simulating an advanced model of viral dynamics and applying it to experimental infection data of human influenza, we obtained important estimates of the infection rate. This work provides epidemiologically meaningful results, meriting further efforts to understand the causes and consequences of influenza A infection.

  20. Uptake of dietary milk miRNAs by adult humans: a validation study

    PubMed Central

    Auerbach, Amanda; Vyas, Gopi; Li, Anne; Halushka, Marc; Witwer, Kenneth

    2016-01-01

    Breast milk is replete with nutritional content as well as nucleic acids including microRNAs (miRNAs). In a recent report, adult humans who drank bovine milk appeared to have increased circulating levels of miRNAs miR-29b-3p and miR-200c-3p. Since these miRNAs are homologous between human and cow, these results could be explained by xeno-miRNA influx, endogenous miRNA regulation, or both. More data were needed to validate the results and explore for additional milk-related alterations in circulating miRNAs. Samples from the published study were obtained, and 223 small RNA features were profiled with a custom OpenArray, followed by individual quantitative PCR assays for selected miRNAs. Additionally, small RNA sequencing (RNA-seq) data obtained from plasma samples of the same project were analyzed to find human and uniquely bovine miRNAs. OpenArray revealed no significantly altered miRNA signals after milk ingestion, and this was confirmed by qPCR. Plasma sequencing data contained no miR-29b or miR-200c reads and no intake-consistent mapping of uniquely bovine miRNAs. In conclusion, the results do not support transfer of dietary xenomiRs into the circulation of adult humans. PMID:27158459

  1. A realistic phantom for validating MRI-based synthetic CT images of the human skull.

    PubMed

    Soliman, Abraam S; Burns, Levi; Owrangi, Amir; Lee, Young; Song, William Y; Stanisz, Greg; Chugh, Brige P

    2017-06-23

    To introduce a new realistic human skull phantom for the validation of synthetic CT images of cortical bone from ultra-short echo-time (UTE) sequences. A human skull of an adult female was utilized as a realistic representation of skull cortical bone. The skull was stabilized in a special acrylic container and was filled with contrast agents that have T1 and T2 relaxation times similar to human brain. The phantom was MR scanned at 3T with UTE and T2 -weighted sequences, followed by CT. A clustering approach was developed to extract the cortical bone signal from MR images. T2∗ maps of the skull were calculated. Synthetic CT images of the bone were compared to cortical bone signal extracted from CT images and confounding factors, such as registration errors, were analyzed. Dice similarity coefficient (DSC) of UTE-detected cortical bone was 0.84 and gradually decreased with decreasing number of spokes. DSC did not significantly depend on echo-time. Registration errors were found to be significant confounding factors, with 25% decrease in DSC for consistent 2 mm error at each axis. This work introduced a new realistic human skull phantom, specifically for the evaluation and analysis of synthetic CT images of cortical bone. © 2017 American Association of Physicists in Medicine.

  2. 21 CFR 868.1030 - Manual algesimeter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual algesimeter. 868.1030 Section 868.1030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1030 Manual algesimeter. (a) Identification. A...

  3. 21 CFR 882.4840 - Manual rongeur.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual rongeur. 882.4840 Section 882.4840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4840 Manual rongeur. (a) Identification. A...

  4. 21 CFR 886.1770 - Manual refractor.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual refractor. 886.1770 Section 886.1770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A...

  5. GRSAC Users Manual

    SciTech Connect

    Ball, S.J.; Nypaver, D.J.

    1999-02-01

    An interactive workstation-based simulation code (GRSAC) for studying postulated severe accidents in gas-cooled reactors has been developed to accommodate user-generated input with ''smart front-end'' checking. Code features includes on- and off-line plotting, on-line help and documentation, and an automated sensitivity study option. The code and its predecessors have been validated using comparisons with a variety of experimental data and similar codes. GRSAC model features include a three-dimensional representation of the core thermal hydraulics, and optional ATWS (anticipated transients without scram) capabilities. The user manual includes a detailed description of the code features, and includes four case studies which guide the user through four different examples of the major uses of GRSAC: an accident case; an initial conditions setup and run; a sensitivity study; and the setup of a new reactor model.

  6. Large-scale identification and characterization of alternative splicing variants of human gene transcripts using 56 419 completely sequenced and manually annotated full-length cDNAs

    PubMed Central

    Takeda, Jun-ichi; Suzuki, Yutaka; Nakao, Mitsuteru; Barrero, Roberto A.; Koyanagi, Kanako O.; Jin, Lihua; Motono, Chie; Hata, Hiroko; Isogai, Takao; Nagai, Keiichi; Otsuki, Tetsuji; Kuryshev, Vladimir; Shionyu, Masafumi; Yura, Kei; Go, Mitiko; Thierry-Mieg, Jean; Thierry-Mieg, Danielle; Wiemann, Stefan; Nomura, Nobuo; Sugano, Sumio; Gojobori, Takashi; Imanishi, Tadashi

    2006-01-01

    We report the first genome-wide identification and characterization of alternative splicing in human gene transcripts based on analysis of the full-length cDNAs. Applying both manual and computational analyses for 56 419 completely sequenced and precisely annotated full-length cDNAs selected for the H-Invitational human transcriptome annotation meetings, we identified 6877 alternative splicing genes with 18 297 different alternative splicing variants. A total of 37 670 exons were involved in these alternative splicing events. The encoded protein sequences were affected in 6005 of the 6877 genes. Notably, alternative splicing affected protein motifs in 3015 genes, subcellular localizations in 2982 genes and transmembrane domains in 1348 genes. We also identified interesting patterns of alternative splicing, in which two distinct genes seemed to be bridged, nested or having overlapping protein coding sequences (CDSs) of different reading frames (multiple CDS). In these cases, completely unrelated proteins are encoded by a single locus. Genome-wide annotations of alternative splicing, relying on full-length cDNAs, should lay firm groundwork for exploring in detail the diversification of protein function, which is mediated by the fast expanding universe of alternative splicing variants. PMID:16914452

  7. Manual evaluation of tissue microarrays in a high-throughput research project: The contribution of Indian surgical pathology to the Human Protein Atlas (HPA) project.

    PubMed

    Navani, Sanjay

    2016-04-01

    The Human Protein Atlas (HPA) program (www.proteinatlas.org) is an international program that has been set up to allow for a systematic exploration of the human proteome using antibody-based proteomics. This is accomplished by combining high-throughput generation of affinity-purified (mono-specific) antibodies with protein profiling in a multitude of tissues/cell types assembled in tissue microarrays. Twenty-six surgical pathologists over a seven-and-half year period have annotated and curated approximately sixteen million tissue images derived from immunostaining of normal and cancer tissues by approximately 23 000 antibodies. Web-based annotation software that allows for a basic and rapid evaluation of immunoreactivity in tissues has been utilized. Intensity, fraction of immunoreactive cells and subcellular localization were recorded for each given cell population. A text comment summarizing the characteristics for each antibody was added. The methods used and the challenges encountered for this exercise, the largest effort ever by a single group of surgical pathologists, are discussed. Manual annotation of digital images is an important tool that may be successfully utilized in high-throughput research projects. This is the first time an Indian private pathology laboratory has been associated with cutting-edge research internationally providing a classic example of developed and emerging nation collaboration. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  8. Drugs, Alcohol, Tobacco, and Human Behavior: Teacher Manual, Junior High School, and Student Book, Junior High School.

    ERIC Educational Resources Information Center

    Ohio State Dept. of Education, Columbus.

    A causal approach to human behavior (in this case, substance usage) has been adopted. This framework views each individual as having personality tasks, such as achieving self-respect or emotional security or dealing with sex feelings, which must be worked out. If a person meets barriers while trying to work them out, he may attempt to remove them…

  9. Comparison of automated and manual segmentation of hippocampus MR images

    NASA Astrophysics Data System (ADS)

    Haller, John W.; Christensen, Gary E.; Miller, Michael I.; Joshi, Sarang C.; Gado, Mokhtar; Csernansky, John G.; Vannier, Michael W.

    1995-05-01

    The precision and accuracy of area estimates from magnetic resonance (MR) brain images and using manual and automated segmentation methods are determined. Areas of the human hippocampus were measured to compare a new automatic method of segmentation with regions of interest drawn by an expert. MR images of nine normal subjects and nine schizophrenic patients were acquired with a 1.5-T unit (Siemens Medical Systems, Inc., Iselin, New Jersey). From each individual MPRAGE 3D volume image a single comparable 2-D slice (matrix equals 256 X 256) was chosen which corresponds to the same coronal slice of the hippocampus. The hippocampus was first manually segmented, then segmented using high dimensional transformations of a digital brain atlas to individual brain MR images. The repeatability of a trained rater was assessed by comparing two measurements from each individual subject. Variability was also compared within and between subject groups of schizophrenics and normal subjects. Finally, the precision and accuracy of automated segmentation of hippocampal areas were determined by comparing automated measurements to manual segmentation measurements made by the trained rater on MR and brain slice images. The results demonstrate the high repeatability of area measurement from MR images of the human hippocampus. Automated segmentation using high dimensional transformations from a digital brain atlas provides repeatability superior to that of manual segmentation. Furthermore, the validity of automated measurements was demonstrated by a high correlation with manual segmentation measurements made by a trained rater. Quantitative morphometry of brain substructures (e.g. hippocampus) is feasible by use of a high dimensional transformation of a digital brain atlas to an individual MR image. This method automates the search for neuromorphological correlates of schizophrenia by a new mathematically robust method with unprecedented sensitivity to small local and regional differences.

  10. Development of a finite element human head model partially validated with thirty five experimental cases.

    PubMed

    Mao, Haojie; Zhang, Liying; Jiang, Binhui; Genthikatti, Vinay V; Jin, Xin; Zhu, Feng; Makwana, Rahul; Gill, Amandeep; Jandir, Gurdeep; Singh, Amrinder; Yang, King H

    2013-11-01

    This study is aimed to develop a high quality, extensively validated finite element (FE) human head model for enhanced head injury prediction and prevention. The geometry of the model was based on computed tomography (CT) and magnetic resonance imaging scans of an adult male who has the average height and weight of an American. A feature-based multiblock technique was adopted to develop hexahedral brain meshes including the cerebrum, cerebellum, brainstem, corpus callosum, ventricles, and thalamus. Conventional meshing methods were used to create the bridging veins, cerebrospinal fluid, skull, facial bones, flesh, skin, and membranes-including falx, tentorium, pia, arachnoid, and dura. The head model has 270,552 elements in total. Thirty five loading cases were selected from a range of experimental head impacts to check the robustness of the model predictions based on responses including the brain pressure, relative skull-brain motion, skull response, and facial response. The brain pressure was validated against intracranial pressure data reported by Nahum et al. (1977, "Intracranial Pressure Dynamics During Head Impact," Proc. 21st Stapp Car Crash Conference, SAE Technical Paper No. 770922) and Trosseille et al. (1992, "Development of a F.E.M. of the Human Head According to a Specific Test Protocol," Proc. 36th Stapp Car Crash Conference, SAE Technical Paper No. 922527). The brain motion was validated against brain displacements under sagittal, coronal, and horizontal blunt impacts performed by Hardy et al. (2001, "Investigation of Head Injury Mechanisms Using Neutral Density Technology and High-Speed Biplanar X-Ray," Stapp Car Crash Journal, 45, pp. 337-368; and 2007, "A Study of the Response of the Human Cadaver Head to Impact," Stapp Car Crash Journal, 51, pp. 17-80). The facial bone responses were validated under nasal impact (Nyquist et al. 1986, "Facial Impact Tolerance and Response," Proc. 30th Stapp Car Crash Conference, SAE Technical Paper No. 861896

  11. Quantifying Human Movement Using the Movn Smartphone App: Validation and Field Study.

    PubMed

    Maddison, Ralph; Gemming, Luke; Monedero, Javier; Bolger, Linda; Belton, Sarahjane; Issartel, Johann; Marsh, Samantha; Direito, Artur; Solenhill, Madeleine; Zhao, Jinfeng; Exeter, Daniel John; Vathsangam, Harshvardhan; Rawstorn, Jonathan Charles

    2017-08-17

    The use of embedded smartphone sensors offers opportunities to measure physical activity (PA) and human movement. Big data-which includes billions of digital traces-offers scientists a new lens to examine PA in fine-grained detail and allows us to track people's geocoded movement patterns to determine their interaction with the environment. The objective of this study was to examine the validity of the Movn smartphone app (Moving Analytics) for collecting PA and human movement data. The criterion and convergent validity of the Movn smartphone app for estimating energy expenditure (EE) were assessed in both laboratory and free-living settings, compared with indirect calorimetry (criterion reference) and a stand-alone accelerometer that is commonly used in PA research (GT1m, ActiGraph Corp, convergent reference). A supporting cross-validation study assessed the consistency of activity data when collected across different smartphone devices. Global positioning system (GPS) and accelerometer data were integrated with geographical information software to demonstrate the feasibility of geospatial analysis of human movement. A total of 21 participants contributed to linear regression analysis to estimate EE from Movn activity counts (standard error of estimation [SEE]=1.94 kcal/min). The equation was cross-validated in an independent sample (N=42, SEE=1.10 kcal/min). During laboratory-based treadmill exercise, EE from Movn was comparable to calorimetry (bias=0.36 [-0.07 to 0.78] kcal/min, t82=1.66, P=.10) but overestimated as compared with the ActiGraph accelerometer (bias=0.93 [0.58-1.29] kcal/min, t89=5.27, P<.001). The absolute magnitude of criterion biases increased as a function of locomotive speed (F1,4=7.54, P<.001) but was relatively consistent for the convergent comparison (F1,4=1.26, P<.29). Furthermore, 95% limits of agreement were consistent for criterion and convergent biases, and EE from Movn was strongly correlated with both reference measures (criterion r

  12. Rivet user manual

    NASA Astrophysics Data System (ADS)

    Buckley, Andy; Butterworth, Jonathan; Grellscheid, David; Hoeth, Hendrik; Lönnblad, Leif; Monk, James; Schulz, Holger; Siegert, Frank

    2013-12-01

    This is the manual and user guide for the Rivet system for the validation and tuning of Monte Carlo event generators. As well as the core Rivet library, this manual describes the usage of the rivet program and the AGILe generator interface library. The depth and level of description is chosen for users of the system, starting with the basics of using validation code written by others, and then covering sufficient details to write new Rivet analyses and calculational components. Catalogue identifier: AEPS_v1_0 Program summary URL:http://cpc.cs.qub.ac.uk/summaries/AEPS_v1_0.html Program obtainable from: CPC Program Library, Queen’s University, Belfast, N. Ireland Licensing provisions: Standard CPC licence, http://cpc.cs.qub.ac.uk/licence/licence.html No. of lines in distributed program, including test data, etc.: 571126 No. of bytes in distributed program, including test data, etc.: 4717522 Distribution format: tar.gz Programming language: C++, Python. Computer: PC running Linux, Mac. Operating system: Linux, Mac OS. RAM: 20 MB Classification: 11.9, 11.2. External routines: HepMC (https://savannah.cern.ch/projects/hepmc/), GSL (http://www.gnu.org/software/gsl/manual/gsl-ref.html), FastJet (http://fastjet.fr/), Python (http://www.python.org/), Swig (http://www.swig.org/), Boost (http://www.boostsoftware.com/), YAML (http://www.yaml.org/spec/1.2/spec.html) Nature of problem: Experimental measurements from high-energy particle colliders should be defined and stored in a general framework such that it is simple to compare theory predictions to them. Rivet is such a framework, and contains at the same time a large collection of existing measurements. Solution method: Rivet is based on HepMC events, a standardised output format provided by many theory simulation tools. Events are processed by Rivet to generate histograms for the requested list of analyses, incorporating all experimental phase space cuts and histogram definitions. Restrictions: Cannot calculate

  13. The use of reconstructed human epidermis for skin absorption testing: Results of the validation study.

    PubMed

    Schäfer-Korting, Monika; Bock, Udo; Diembeck, Walter; Düsing, Hans-Jürgen; Gamer, Armin; Haltner-Ukomadu, Eleonore; Hoffmann, Christine; Kaca, Monika; Kamp, Hennicke; Kersen, Silke; Kietzmann, Manfred; Korting, Hans Christian; Krächter, Hans-Udo; Lehr, Claus-Michael; Liebsch, Manfred; Mehling, Annette; Müller-Goymann, Christel; Netzlaff, Frank; Niedorf, Frank; Rübbelke, Maria K; Schäfer, Ulrich; Schmidt, Elisabeth; Schreiber, Sylvia; Spielmann, Horst; Vuia, Alexander; Weimer, Michaela

    2008-05-01

    A formal validation study was performed, in order to investigate whether the commercially-available reconstructed human epidermis (RHE) models, EPISKIN, EpiDerm and SkinEthic, are suitable for in vitro skin absorption testing. The skin types currently recommended in the OECD Test Guideline 428, namely, ex vivo human epidermis and pig skin, were used as references. Based on the promising outcome of the prevalidation study, the panel of test substances was enlarged to nine substances, covering a wider spectrum of physicochemical properties. The substances were tested under both infinite-dose and finite-dose conditions, in ten laboratories, under strictly controlled conditions. The data were subjected to independent statistical analyses. Intra-laboratory and inter-laboratory variability contributed almost equally to the total variability, which was in the same range as that in preceding studies. In general, permeation of the RHE models exceeded that of human epidermis and pig skin (the SkinEthic RHE was found to be the most permeable), yet the ranking of substance permeation through the three tested RHE models and the pig skin reflected the permeation through human epidermis. In addition, both infinite-dose and finite-dose experiments are feasible with RHE models. The RHE models did not show the expected significantly better reproducibility, as compared to excised skin, despite a tendency toward lower variability of the data. Importantly, however, the permeation data showed a sufficient correlation between all the preparations examined. Thus, the RHE models, EPISKIN, EpiDerm and SkinEthic, are appropriate alternatives to human and pig skin, for the in vitro assessment of the permeation and penetration of substances when applied as aqueous solutions.

  14. Development and validation of primary human myometrial cell culture models to study pregnancy and labour.

    PubMed

    Mosher, Andrea A; Rainey, Kelly J; Bolstad, Seunghwa S; Lye, Stephen J; Mitchell, Bryan F; Olson, David M; Wood, Stephen L; Slater, Donna M

    2013-01-01

    The development of the in vitro cell culture model has greatly facilitated the ability to study gene expression and regulation within human tissues. Within the human uterus, the upper (fundal) segment and the lower segment may provide distinct functions throughout pregnancy and during labour. We have established primary cultured human myometrial cells, isolated from both upper and lower segment regions of the pregnant human uterus, and validated them for the purpose of studying human pregnancy and labour. The specific objectives of this study were to monitor the viability and characterize the expression profile using selected cellular, contractile and pregnancy associated markers in the primary cultured human myometrial cells. Labour has been described as an inflammatory process; therefore, the ability of these cells to respond to an inflammatory stimulus was also investigated. Myometrial cells isolated from paired upper segment (US) and lower segment (LS) biopsies, obtained from women undergoing Caesarean section deliveries at term prior to the onset of labour, were used to identify expression of; α smooth muscle actin, calponin, caldesmon, connexin 43, cyclo-oxygenase-2 (COX-2), oxytocin receptor, tropomyosin and vimentin, by RT-PCR and/or immunocytochemistry. Interleukin (IL)-1β was used to treat cells, subsequently expression of COX-2 mRNA and release of interleukin-8 (CXCL8), were measured. ANOVA followed by Bonferroni's multiple comparisons test was performed. We demonstrate that US and LS human myometrial cells stably express all markers examined to at least passage ten (p10). Connexin 43, COX-2 and vimentin mRNA expression were significantly higher in LS cells compared to US cells. Both cell populations respond to IL-1β, demonstrated by a robust release of CXCL8 and increased expression of COX-2 mRNA from passage one (p1) through to p10. Isolated primary myometrial cells maintain expression of smooth muscle and pregnancy-associated markers and retain

  15. Human Mendelian pain disorders: a key to discovery and validation of novel analgesics.

    PubMed

    Goldberg, Y P; Pimstone, S N; Namdari, R; Price, N; Cohen, C; Sherrington, R P; Hayden, M R

    2012-10-01

    We have utilized a novel application of human genetics, illuminating the important role that rare genetic disorders can play in the development of novel drugs that may be of relevance for the treatment of both rare and common diseases. By studying a very rare Mendelian disorder of absent pain perception, congenital indifference to pain, we have defined Nav1.7 (endocded by SCN9A) as a critical and novel target for analgesic development. Strong human validation has emerged with SCN9A gain-of-function mutations causing inherited erythromelalgia (IEM) and paroxysmal extreme pain disorder, both Mendelian disorder of spontaneous or easily evoked pain. Furthermore, variations in the Nav1.7 channel also modulate pain perception in healthy subjects as well as in painful conditions such as osteoarthritis and Parkinson disease. On the basis of this, we have developed a novel compound (XEN402) that exhibits potent, voltage-dependent block of Nav1.7. In a small pilot study, we showed that XEN402 blocks Nav1.7 mediated pain associated with IEM thereby demonstrating the use of rare genetic disorders with mutant target channels as a novel approach to rapid proof-of-concept. Our approach underscores the critical role that human genetics can play by illuminating novel and critical pathways pertinent for drug discovery.

  16. The validation and application of a finite element human head model for frontal skull fracture analysis.

    PubMed

    Asgharpour, Z; Baumgartner, D; Willinger, R; Graw, M; Peldschus, S

    2014-05-01

    Traumatic head injuries can result from vehicular accidents, sports, falls or assaults. The current advances in computational methods and the detailed finite element models of the human head provide a significant opportunity for biomechanical study of human head injuries. The biomechanical characteristics of the human head through head impact scenarios can be studied in detail by using the finite element models. Skull fracture is one of the most frequent occurring types of head injuries. The purpose of this study is to analyse the experimental head impacts on cadavers by means of the Strasbourg University Finite Element Head Model (SUFEHM). The results of the numerical model and experimental data are compared for validation purpose. The finite element model has also been applied to predict the skull bone fracture in frontal impacts. The head model includes the scalp, the facial bone, the skull, the cerebral spinal fluid, the meninges, the cerebrum and the cerebellum. The model is used to simulate the experimental frontal head impact tests using a cylindrical padded impactor. Results of the computational simulation shows that the model correlated well with a number of experimental data and a global fracture pattern has been predicted well by the model. Therefore the presented numerical model could be used for reconstruction of head impacts in different impact conditions also the forensic application of the head model would provide a tool for investigation of the causes and mechanism of head injuries.

  17. Identification and Validation of Novel Contraction-Regulated Myokines Released from Primary Human Skeletal Muscle Cells

    PubMed Central

    Raschke, Silja; Eckardt, Kristin; Bjørklund Holven, Kirsten; Jensen, Jørgen; Eckel, Jürgen

    2013-01-01

    Proteins secreted by skeletal muscle, so called myokines, have been shown to affect muscle physiology and additionally exert systemic effects on other tissues and organs. Although recent profiling studies have identified numerous myokines, the amount of overlap from these studies indicates that the secretome of skeletal muscle is still incompletely characterized. One limitation of the models used is the lack of contraction, a central characteristic of muscle cells. Here we aimed to characterize the secretome of primary human myotubes by cytokine antibody arrays and to identify myokines regulated by contraction, which was induced by electrical pulse stimulation (EPS). In this study, we validated the regulation and release of two selected myokines, namely pigment epithelium derived factor (PEDF) and dipeptidyl peptidase 4 (DPP4), which were recently described as adipokines. This study reveals that both factors, DPP4 and PEDF, are secreted by primary human myotubes. PEDF is a contraction-regulated myokine, although PEDF serum levels from healthy young men decrease after 60 min cycling at VO2max of 70%. Most interestingly, we identified 52 novel myokines which have not been described before to be secreted by skeletal muscle cells. For 48 myokines we show that their release is regulated by contractile activity. This profiling study of the human skeletal muscle secretome expands the number of myokines, identifies novel contraction-regulated myokines and underlines the overlap between proteins which are adipokines as well as myokines. PMID:23637948

  18. College Text Test Validity.

    ERIC Educational Resources Information Center

    McAfee, Donald C.

    1979-01-01

    A team of faculty members and graduate students identified major concepts and developed validated test questions for two widely used textbooks in personal hygiene classes in order to standardize norms for classes and supplement inadequate instructor's manuals. (JMF)

  19. Computational modeling and validation of human nasal airflow under various breathing conditions.

    PubMed

    Li, Chengyu; Jiang, Jianbo; Dong, Haibo; Zhao, Kai

    2017-09-05

    The human nose serves vital physiological functions, including warming, filtration, humidification, and olfaction. These functions are based on transport phenomena that depend on nasal airflow patterns and turbulence. Accurate prediction of these airflow properties requires careful selection of computational fluid dynamics models and rigorous validation. The validation studies in the past have been limited by poor representations of the complex nasal geometry, lack of detailed airflow comparisons, and restricted ranges of flow rate. The objective of this study is to validate various numerical methods based on an anatomically accurate nasal model against published experimentally measured data under breathing flow rates from 180 to 1100ml/s. The numerical results of velocity profiles and turbulence intensities were obtained using the laminar model, four widely used Reynolds-averaged Navier-Stokes (RANS) turbulence models (i.e., k-ε, standard k-ω, Shear Stress Transport k-ω, and Reynolds Stress Model), large eddy simulation (LES) model, and direct numerical simulation (DNS). It was found that, despite certain irregularity in the flow field, the laminar model achieved good agreement with experimental results under restful breathing condition (180ml/s) and performed better than the RANS models. As the breathing flow rate increased, the RANS models achieved more accurate predictions but still performed worse than LES and DNS. As expected, LES and DNS can provide accurate predictions of the nasal airflow under all flow conditions but have an approximately 100-fold higher computational cost. Among all the RANS models tested, the standard k-ω model agrees most closely with the experimental values in terms of velocity profile and turbulence intensity. Copyright © 2017. Published by Elsevier Ltd.

  20. Derivation and Validation of the Denver Human Immunodeficiency Virus (HIV) Risk Score for Targeted HIV Screening

    PubMed Central

    Haukoos, Jason S.; Lyons, Michael S.; Lindsell, Christopher J.; Hopkins, Emily; Bender, Brooke; Rothman, Richard E.; Hsieh, Yu-Hsiang; MacLaren, Lynsay A.; Thrun, Mark W.; Sasson, Comilla; Byyny, Richard L.

    2012-01-01

    Targeted screening remains an important approach to human immunodeficiency virus (HIV) testing. The authors aimed to derive and validate an instrument to accurately identify patients at risk for HIV infection, using patient data from a metropolitan sexually transmitted disease clinic in Denver, Colorado (1996–2008). With multivariable logistic regression, they developed a risk score from 48 candidate variables using newly identified HIV infection as the outcome. Validation was performed using an independent population from an urban emergency department in Cincinnati, Ohio. The derivation sample included 92,635 patients; 504 (0.54%) were diagnosed with HIV infection. The validation sample included 22,983 patients; 168 (0.73%) were diagnosed with HIV infection. The final score included age, gender, race/ethnicity, sex with a male, vaginal intercourse, receptive anal intercourse, injection drug use, and past HIV testing, and values ranged from −14 to +81. For persons with scores of <20, 20–29, 30–39, 40–49, and ≥50, HIV prevalences were 0.31% (95% confidence interval (CI): 0.20, 0.45) (n = 27/8,782), 0.41% (95% CI: 0.29, 0.57) (n = 36/8,677), 0.99% (95% CI: 0.63, 1.47) (n = 24/2,431), 1.59% (95% CI: 1.02, 2.36) (n = 24/1,505), and 3.59% (95% CI: 2.73, 4.63) (n = 57/1,588), respectively. The risk score accurately categorizes patients into groups with increasing probabilities of HIV infection. PMID:22431561

  1. Validation of the Maslach Burnout Inventory-Human Services Survey for Estimating Burnout in Dental Students.

    PubMed

    Montiel-Company, José María; Subirats-Roig, Cristian; Flores-Martí, Pau; Bellot-Arcís, Carlos; Almerich-Silla, José Manuel

    2016-11-01

    The aim of this study was to examine the validity and reliability of the Maslach Burnout Inventory-Human Services Survey (MBI-HSS) as a tool for assessing the prevalence and level of burnout in dental students in Spanish universities. The survey was adapted from English to Spanish. A sample of 533 dental students from 15 Spanish universities and a control group of 188 medical students self-administered the survey online, using the Google Drive service. The test-retest reliability or reproducibility showed an Intraclass Correlation Coefficient of 0.95. The internal consistency of the survey was 0.922. Testing the construct validity showed two components with an eigenvalue greater than 1.5, which explained 51.2% of the total variance. Factor I (36.6% of the variance) comprised the items that estimated emotional exhaustion and depersonalization. Factor II (14.6% of the variance) contained the items that estimated personal accomplishment. The cut-off point for the existence of burnout achieved a sensitivity of 92.2%, a specificity of 92.1%, and an area under the curve of 0.96. Comparison of the total dental students sample and the control group of medical students showed significantly higher burnout levels for the dental students (50.3% vs. 40.4%). In this study, the MBI-HSS was found to be viable, valid, and reliable for measuring burnout in dental students. Since the study also found that the dental students suffered from high levels of this syndrome, these results suggest the need for preventive burnout control programs.

  2. Concrete Practices & Procedures. Instructor Manual. Trainee Manual.

    ERIC Educational Resources Information Center

    Laborers-AGC Education and Training Fund, Pomfret Center, CT.

    This packet consists of the instructor and trainee manuals for a concrete practices and procedures course. The instructor manual contains a schedule for an 80-hour, 10-day course and instructor outline. The outline provides a step-by-step description of the instructor's activities and includes answer sheets to accompany questions on information…

  3. Workplace Literacy Program. Administrative Manual. Teacher Manual.

    ERIC Educational Resources Information Center

    Western Suffolk BOCES, Northport, NY.

    These two manuals are designed to aid prospective providers of workplace literacy programs in program organization and implementation. The administrator's manual addresses the following topics: program philosophy, history, potential clients, advertising, guidelines for client meetings, instructor recruitment and training, client goals, learning…

  4. Validation of a standardised method for determining beryllium in human urine at nanogram level.

    PubMed

    Devoy, Jérôme; Melczer, Mathieu; Antoine, Guillaume; Remy, Aurélie; Heilier, Jean-François

    2013-10-01

    The potential toxicity of beryllium at low levels of exposure means that a biological and/or air monitoring strategy may be required to monitor the exposure of subjects. The main objective of the work presented in this manuscript was to develop and validate a sensitive and reproducible method for determining levels of beryllium in human urine and to establish reference values in workers and in non-occupationally exposed people. A chelate of beryllium acetylacetonate formed from beryllium(II) in human urine was pre-concentrated on a SPE C18 cartridge and eluted with methanol. After drying the eluate, the residue was solubilised in nitric acid and analysed by atomic absorption spectrometry and/or inductively coupled plasma mass spectrometry. The proposed method is 4 to 100 times more sensitive than other methods currently in routine use. The new method was validated with the concordance correlation coefficient test for beryllium concentrations ranging from 10 to 100 ng/L. Creatinine concentration, urine pH, interfering compounds and freeze-thaw cycles were found to have only slight effects on the performance of the method (less than 6%). The effectiveness of the two analytical techniques was compared statistically with each other and to direct analysis techniques. Even with a detection limit of 0.6 ng/L (obtained with inductively coupled plasma mass spectrometry), the method is not sensitive enough to detect levels in non-occupationally exposed persons. The method performance does however appear to be suitable for monitoring worker exposure in some industrial settings and it could therefore be of use in biological monitoring strategies.

  5. Validated High Resolution Mass Spectrometry-Based Approach for Metabolomic Fingerprinting of the Human Gut Phenotype.

    PubMed

    Vanden Bussche, Julie; Marzorati, Massimo; Laukens, Debby; Vanhaecke, Lynn

    2015-11-03

    Fecal samples are an obvious choice for metabolomic approaches, since they can be obtained noninvasively and allow one to study the interactions between the gut microbiota and the host. The use of ultrahigh performance liquid chromatography hyphenated to Orbitrap high-resolution mass spectrometry (UHPLC-Orbitrap HRMS) in this field is unique. Hence, this study relied on Orbitrap HRMS to develop and validate a metabolic fingerprinting workflow for human feces and in vitro digestive fluids. After chemometric sample extraction optimization, an aqueous dilution appeared necessary to comply to the dynamic range of the MS. The method was proven "fit-for-purpose" through a validation procedure that monitored endogenous metabolites in quality control samples, which displayed in both matrices an excellent linearity (R(2) > 0.990), recoveries ranging from 93% to 105%, and precision with coefficients of variation (CVs) < 15%. Finally, feces from 10 healthy individuals and 13 patients diagnosed with inflammatory bowel disease were subjected to metabolomic fingerprinting. 9553 ions were detected, as well as differentiating profiles between Crohn's disease and ulcerative colitis by means of (orthogonal) partial least-square analysis ((O)PLS)-DA (discriminate analysis) models. Additionally, samples from the dynamic gastrointestinal tract simulator (SHIME (Simulator of the Human Intestinal Microbial Ecosystem) platform) were analyzed resulting in 6446 and 5010 ions for the proximal and distal colonic samples, respectively. Supplementing SHIME feed with antibiotics resulted in a significant shift (P < 0.05) of 27.7% of the metabolites from the proximal data set and 34.3% for the distal one. As a result, the presented fingerprinting approach provided predictive modeling of the gastrointestinal metabolome in vivo and in vitro, offering a window to reveal disease related biomarkers and potential insight into the mechanisms behind pathologies.

  6. A cross-validated cytoarchitectonic atlas of the human ventral visual stream.

    PubMed

    Rosenke, Mona; Weiner, Kevin S; Barnett, Michael A; Zilles, Karl; Amunts, Katrin; Goebel, Rainer; Grill-Spector, Kalanit

    2017-02-16

    The human ventral visual stream consists of several areas that are considered processing stages essential for perception and recognition. A fundamental microanatomical feature differentiating areas is cytoarchitecture, which refers to the distribution, size, and density of cells across cortical layers. Because cytoarchitectonic structure is measured in 20-micron-thick histological slices of postmortem tissue, it is difficult to assess (a) how anatomically consistent these areas are across brains and (b) how they relate to brain parcellations obtained with prevalent neuroimaging methods, acquired at the millimeter and centimeter scale. Therefore, the goal of this study was to (a) generate a cross-validated cytoarchitectonic atlas of the human ventral visual stream on a whole brain template that is commonly used in neuroimaging studies and (b) to compare this atlas to a recently published retinotopic parcellation of visual cortex (Wang et al., 2014). To achieve this goal, we generated an atlas of eight cytoarchitectonic areas: four areas in the occipital lobe (hOc1-hOc4v) and four in the fusiform gyrus (FG1-FG4), then we tested how the different alignment techniques affect the accuracy of the resulting atlas. Results show that both cortex-based alignment (CBA) and nonlinear volumetric alignment (NVA) generate an atlas with better cross-validation performance than affine volumetric alignment (AVA). Additionally, CBA outperformed NVA in 6/8 of the cytoarchitectonic areas. Finally, the comparison of the cytoarchitectonic atlas to a retinotopic atlas shows a clear correspondence between cytoarchitectonic and retinotopic areas in the ventral visual stream. The successful performance of CBA suggests a coupling between cytoarchitectonic areas and macroanatomical landmarks in the human ventral visual stream, and furthermore, that this coupling can be utilized for generating an accurate group atlas. In addition, the coupling between cytoarchitecture and retinotopy highlights

  7. Treatment manuals: use in the treatment of bulimia nervosa.

    PubMed

    Wallace, Laurel M; von Ranson, Kristin M

    2011-11-01

    As psychology has moved toward emphasizing evidence-based practice, use of treatment manuals has extended from research trials into clinical practice. Minimal research has directly evaluated use of manuals in clinical practice. This survey of international eating disorder professionals examined use of manuals with 259 clinicians' most recent client with bulimia nervosa. Although evidence-based manuals for bulimia nervosa exist, only 35.9% of clinicians reported using a manual. Clinicians were more likely to use a manual if they were younger; were treating an adult client; were clinical psychologists; were involved in research related to eating disorders; and endorsed a cognitive-behavioral orientation. Clinicians were less likely to use a manual if they provided eclectic psychotherapy that incorporated multiple psychotherapeutic approaches. We conclude that psychotherapy provided in clinical practice often does not align with the specific form validated in research trials, and "eclecticism" is at odds with efforts to disseminate manuals into clinical practice.

  8. Sixteenth Annual Conference on Manual Control

    NASA Technical Reports Server (NTRS)

    1982-01-01

    Manual control is discussed in terms of operator modeling, measurement of human response, mental workload, pilot/operator opinion, effects of motion, aircraft displays, supervisory control, automobile driving, and remote manipulation.

  9. Intrasurgical Human Retinal Imaging With Manual Instrument Tracking Using a Microscope-Integrated Spectral-Domain Optical Coherence Tomography Device

    PubMed Central

    Hahn, Paul; Carrasco-Zevallos, Oscar; Cunefare, David; Migacz, Justin; Farsiu, Sina; Izatt, Joseph A.; Toth, Cynthia A.

    2015-01-01

    Purpose: To characterize the first in-human intraoperative imaging using a custom prototype spectral-domain microscope-integrated optical coherence tomography (MIOCT) device during vitreoretinal surgery with instruments in the eye. Methods: Under institutional review board approval for a prospective intraoperative study, MIOCT images were obtained at surgical pauses with instruments held static in the vitreous cavity and then concurrently with surgical maneuvers. Postoperatively, MIOCT images obtained at surgical pauses were compared with images obtained with a high-resolution handheld spectral-domain OCT (HHOCT) system with objective endpoints, including acquisition of images acceptable for analysis and identification of predefined macular morphologic or pathologic features. Results: Human MIOCT images were successfully obtained before incision and during pauses in surgical maneuvers. MIOCT imaging confirmed preoperative diagnoses, such as epiretinal membrane, full-thickness macular hole, and vitreomacular traction and demonstrated successful achievement of surgical goals. MIOCT and HHOCT images obtained at surgical pauses in two cohorts of five patients were comparable with greater than or equal to 80% correlation in 80% of patients. Real-time video-imaging concurrent with surgical manipulations enabled, for the first time using this device, visualization of dynamic instrument-retina interaction with targeted OCT tracking. Conclusion: MIOCT is successful for imaging at surgical pauses and for real-time image guidance with implementation of targeted OCT tracking. Even faster acquisition speeds are currently being developed with incorporation of a swept-source MIOCT engine. Further refinements and investigations will be directed toward continued integration for real-time volumetric imaging of surgical maneuvers. Translational Relevance: Ongoing development of seamless MIOCT systems will likely transform surgical visualization, approaches, and decision-making. PMID

  10. Validation of the murine aortic arch as a model to study human vascular diseases

    PubMed Central

    Casteleyn, Christophe; Trachet, Bram; Van Loo, Denis; Devos, Daniel G H; Van den Broeck, Wim; Simoens, Paul; Cornillie, Pieter

    2010-01-01

    Although the murine thoracic aorta and its main branches are widely studied to gain more insight into the pathogenesis of human vascular diseases, detailed anatomical data on the murine aorta are sparse. Moreover, comparative studies between mice and men focusing on the topography and geometry of the heart and aorta are lacking. As this hampers the validation of murine vascular models, the branching pattern of the murine thoracic aorta was examined in 30 vascular corrosion casts. On six casts the intrathoracic position of the heart was compared with that of six younger and six older men of whom contrast-enhanced computer tomography images of the thorax were three-dimensionally reconstructed. In addition, the geometry of the human thoracic aorta was compared with that of the mouse by reconstructing micro-computer tomography images of six murine casts. It was found that the right brachiocephalic trunk, left common carotid artery and left subclavian artery branched subsequently from the aortic arch in both mice and men. The geometry of the branches of the murine aortic arch was quite similar to that of men. In both species the initial segment of the aorta, comprising the ascending aorta, aortic arch and cranial/superior part of the descending aorta, was sigmoidally curved on a cranial/superior view. Although some analogy between the intrathoracic position of the murine and human heart was observed, the murine heart manifestly deviated more ventrally. The major conclusion of this study is that, in both mice and men, the ascending and descending aorta do not lie in a single vertical plane (non-planar aortic geometry). This contrasts clearly with most domestic mammals in which a planar aortic pattern is present. As the vascular branching pattern of the aortic arch is also similar in mice and men, the murine model seems valuable to study human vascular diseases. PMID:20345858

  11. Validation of the murine aortic arch as a model to study human vascular diseases.

    PubMed

    Casteleyn, Christophe; Trachet, Bram; Van Loo, Denis; Devos, Daniel G H; Van den Broeck, Wim; Simoens, Paul; Cornillie, Pieter

    2010-05-01

    Although the murine thoracic aorta and its main branches are widely studied to gain more insight into the pathogenesis of human vascular diseases, detailed anatomical data on the murine aorta are sparse. Moreover, comparative studies between mice and men focusing on the topography and geometry of the heart and aorta are lacking. As this hampers the validation of murine vascular models, the branching pattern of the murine thoracic aorta was examined in 30 vascular corrosion casts. On six casts the intrathoracic position of the heart was compared with that of six younger and six older men of whom contrast-enhanced computer tomography images of the thorax were three-dimensionally reconstructed. In addition, the geometry of the human thoracic aorta was compared with that of the mouse by reconstructing micro-computer tomography images of six murine casts. It was found that the right brachiocephalic trunk, left common carotid artery and left subclavian artery branched subsequently from the aortic arch in both mice and men. The geometry of the branches of the murine aortic arch was quite similar to that of men. In both species the initial segment of the aorta, comprising the ascending aorta, aortic arch and cranial/superior part of the descending aorta, was sigmoidally curved on a cranial/superior view. Although some analogy between the intrathoracic position of the murine and human heart was observed, the murine heart manifestly deviated more ventrally. The major conclusion of this study is that, in both mice and men, the ascending and descending aorta do not lie in a single vertical plane (non-planar aortic geometry). This contrasts clearly with most domestic mammals in which a planar aortic pattern is present. As the vascular branching pattern of the aortic arch is also similar in mice and men, the murine model seems valuable to study human vascular diseases.

  12. Nutrient Control Design Manual

    EPA Science Inventory

    The Nutrient Control Design Manual will present an extensive state-of-the-technology review of the engineering design and operation of nitrogen and phosphorous control technologies and techniques applied at municipal wastewater treatment plants (WWTPs). This manual will present ...

  13. Nutrient Control Design Manual

    EPA Science Inventory

    The Nutrient Control Design Manual will present an extensive state-of-the-technology review of the engineering design and operation of nitrogen and phosphorous control technologies and techniques applied at municipal wastewater treatment plants (WWTPs). This manual will present ...

  14. 76 FR 37118 - Manual Materials Handling (MMH) Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Centers for Disease Control and Prevention Manual Materials Handling (MMH) Workshop... Health, will be holding a two-day Manual Materials Handling (MMH) Workshop. The Workshop is a National... engineering solutions for manual materials handling jobs in Retail, Wholesale and Warehouse industries....

  15. 21 CFR 880.6785 - Manual patient transfer device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual patient transfer device. 880.6785 Section 880.6785 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Miscellaneous Devices § 880.6785 Manual patient transfer device. (a) Identification. A manual patient...

  16. 21 CFR 892.5650 - Manual radionuclide applicator system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual radionuclide applicator system. 892.5650 Section 892.5650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... system. (a) Identification. A manual radionuclide applicator system is a manually operated...

  17. 21 CFR 892.5650 - Manual radionuclide applicator system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual radionuclide applicator system. 892.5650 Section 892.5650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... system. (a) Identification. A manual radionuclide applicator system is a manually operated...

  18. 21 CFR 892.5650 - Manual radionuclide applicator system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual radionuclide applicator system. 892.5650 Section 892.5650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... system. (a) Identification. A manual radionuclide applicator system is a manually operated...

  19. Development and validation of a sensitive assay for the quantification of imatinib using LC/LC-MS/MS in human whole blood and cell culture

    PubMed Central

    Klawitter, Jelena; Zhang, Yan Ling; Klawitter, Jost; Anderson, Nora; Serkova, Natalie J.; Christians, Uwe

    2011-01-01

    We developed and validated a semi-automated LC/LC-MS/MS assay for the quantification of imatinib in human whole blood and leukemia cells. After protein precipitation, samples were injected into the HPLC system and trapped onto the enrichment column (flow 5 mL/min); extracts were back-flushed onto the analytical column. Ion transitions [M + H]+ of imatinib (m/z = 494.3 → 394.3) and its internal standard trazodone (372.5 → 176.3) were monitored. The range of reliable response was 0.03–75 ng/mL. The inter-day precisions were: 8.4% (0.03 ng/mL), 7.2% (0.1 ng/mL), 6.5% (1 ng/mL), 8.2% (10 ng/mL) and 4.3% (75 ng/mL) with no interference from ion suppression. Autosampler stability was 24 hs and samples were stable over three freeze–thaw cycles. This semi-automated method is simple with only one manual step, uses a commercially available internal standard, and has proven to be robust in larger studies. PMID:19517424

  20. Digital and manual cephalometric analysis.

    PubMed

    Thurzo, A; Javorka, V; Stanko, P; Lysy, J; Suchancova, B; Lehotska, V; Valkovic, L; Makovnik, M

    2010-01-01

    To compare the manual and digital cephalometric analyses and to research a new procedure of analog cephalogram digitalization. 40 repeated measurements were used to evaluate the reproducibility and reliability of both methods. The analog x-ray was CHIRALUX2, the digital camera used was Canon PowerShot G5 and the digital tracing was done by Dolphin imaging version 10. The sample dispersion has been evaluated for each of the monitored cephalometric variables (SNA, SNB, ANB, PP/ML, inter-incisal angle and Wits). The difference of sample dispersion was tested (Morgan-Pitman). Four doctors processed 100 random analog cephalograms in total and evaluated them in a way established by Bland and Altman. Validity and reproducibility of analyses carried out manually and digitally is in high mutual correlation and therefore the software analysis can fully substitute the manual method. The dispersion of values in repeated measurements was higher in manual method and therefore we consider the digital method more accurate (Fig. 4, Tab. 1, Ref. 15). Full Text (Free, PDF) www.bmj.sk.

  1. Nutrient Control Design Manual

    EPA Science Inventory

    The purpose of this EPA design manual is to provide updated, state‐of‐the‐technology design guidance on nitrogen and phosphorus control at municipal Wastewater Treatment Plants (WWTPs). Similar to previous EPA manuals, this manual contains extensive information on the principles ...

  2. A Manual of Style.

    ERIC Educational Resources Information Center

    Nebraska State Dept. of Education, Lincoln.

    This "Manual of Style" is offered as a guide to assist Nebraska State employees in producing quality written communications and in presenting a consistently professional image of government documents. The manual is not designed to be all-inclusive. Sections of the manual discuss formatting documents, memorandums, letters, mailing…

  3. KDYNA user's manual

    SciTech Connect

    Levatin, J.A.L.; Attia, A.V.; Hallquist, J.O.

    1990-09-28

    This report is a complete user's manual for KDYNA, the Earth Sciences version of DYNA2D. Because most features of DYNA2D have been retained in KDYNA much of this manual is identical to the DYNA2D user's manual.

  4. Nutrient Control Design Manual

    EPA Science Inventory

    The purpose of this EPA design manual is to provide updated, state‐of‐the‐technology design guidance on nitrogen and phosphorus control at municipal Wastewater Treatment Plants (WWTPs). Similar to previous EPA manuals, this manual contains extensive information on the principles ...

  5. Validation of microwave radiometry for measuring the internal temperature profile of human tissue

    NASA Astrophysics Data System (ADS)

    Levick, A.; Land, D.; Hand, J.

    2011-06-01

    A phantom target with a known linear temperature gradient has been developed for validating microwave radiometry for measuring internal temperature profiles within human tissue. The purpose of the phantom target is to simulate the temperature gradient found within the surface layers of a baby's brain during hypothermal neuroprotection therapy, in which the outer surface of the phantom represents the skin surface and the inner surface the brain core. The target comprises a volume of phantom tissue material with similar dielectric properties to high water-content human tissue, contained between two copper plates at known temperatures. The antenna of a microwave radiometer is in contact with one surface of the phantom material. We have measured the microwave temperature of the phantom with microwave radiometry in a frequency band of 3.0-3.5 GHz. Our microwave temperature measurements have small 0.05 °C (type A) uncertainties associated with random effects and provide temperatures consistent with values determined using theoretical models of the antenna-target system within uncertainties. The measurements are in good agreement with the major signal contribution being formed over a near plane-wave response within the material with a much smaller contribution from close to the antenna face.

  6. Implementation and validation of thoracic side impact injury prediction metrics in a human body model.

    PubMed

    Golman, Adam J; Danelson, Kerry A; Gaewsky, James P; Stitzel, Joel D

    2015-08-01

    This study's purpose was to implement injury metrics into the Total Human Model for Safety (THUMS) mirroring the spinal accelerometers, rib accelerometers and chest band instrumentation from two lateral post-mortem human subject sled test configurations. In both sled configurations, THUMS contacted a flat rigid surface (either a wall or beam) at 6.7 m/s. Sled A maximum simulated wall forces for the thorax, abdomen and pelvis were 7.1, 5.0 and 10.0 kN versus 5.7 ± 0.8, 3.4 ± 1.2 and 6.2 ± 2.7 kN experimentally. Sled B maximum simulated beam forces for the torso and pelvis were 8.0 and 7.6 kN versus 8.5 ± 0.2 and 7.9 ± 2.5 kN experimentally. Quantitatively, force magnitude contributed more to variation between simulated and experimental forces than phase shift. Acceleration-based injury metrics were within one standard deviation of experimental means except for the lower spine in the rigid wall sled test. These validated metrics will be useful for quantifying occupant loading conditions and calculating injury risks in various loading configurations.

  7. Validation of the auditory hazard assessment algorithm for the human with impulse noise data.

    PubMed

    Price, G Richard

    2007-11-01

    Predicting auditory hazard from intense acoustic impulses, such as weapons fire or airbags, has been an intractable problem. The U.S. Army developed a theoretically based mathematical model of the ear designed to predict such hazards [the Auditory Hazard Assessment Algorithm for the Human (AHAAH)]. To validate it as a predictor of hazard, data from the literature (wave forms and changes in hearing sensitivity) were processed with the model in order to predict the onset of unacceptable threshold shift (25 dB or more) in the 95th percentile human ear. For comparison, alternate standards MIL-STD-1747D and A-weighted energy were also used to compute hazards for the same data. The primary dataset was that of the US Army's "Albuquerque studies" (53 different cases) and other impulses from the literature (19 additional predictions). The AHAAH model predicted correctly in over 95% of the cases, the MIL-STD-1474D was correct in 42% of the cases, and A-weighted energy was correct in 25% of the cases. Errors for all methods tended to be in the direction of overprediction of hazard. In addition to greatly increased accuracy, the AHAAH model also has the advantage of being theoretically based and including novel diagnostic features.

  8. Validity of Measurement of Shear Modulus by Ultrasound Shear Wave Elastography in Human Pennate Muscle

    PubMed Central

    Miyamoto, Naokazu; Hirata, Kosuke; Kanehisa, Hiroaki; Yoshitake, Yasuhide

    2015-01-01

    Ultrasound shear wave elastography is becoming a valuable tool for measuring mechanical properties of individual muscles. Since ultrasound shear wave elastography measures shear modulus along the principal axis of the probe (i.e., along the transverse axis of the imaging plane), the measured shear modulus most accurately represents the mechanical property of the muscle along the fascicle direction when the probe’s principal axis is parallel to the fascicle direction in the plane of the ultrasound image. However, it is unclear how the measured shear modulus is affected by the probe angle relative to the fascicle direction in the same plane. The purpose of the present study was therefore to examine whether the angle between the principal axis of the probe and the fascicle direction in the same plane affects the measured shear modulus. Shear modulus in seven specially-designed tissue-mimicking phantoms, and in eleven human in-vivo biceps brachii and medial gastrocnemius were determined by using ultrasound shear wave elastography. The probe was positioned parallel or 20° obliquely to the fascicle across the B-mode images. The reproducibility of shear modulus measurements was high for both parallel and oblique conditions. Although there was a significant effect of the probe angle relative to the fascicle on the shear modulus in human experiment, the magnitude was negligibly small. These findings indicate that the ultrasound shear wave elastography is a valid tool for evaluating the mechanical property of pennate muscles along the fascicle direction. PMID:25853777

  9. Validity of 3-methylhistidine excretion as an indicator of skeletal muscle protein breakdown in humans.

    PubMed

    Long, C L; Dillard, D R; Bodzin, J H; Geiger, J W; Blakemore, W S

    1988-09-01

    The urinary excretion of 3-methylhistidine (3MEH) in humans and animals has been used as a biologic marker for skeletal muscle protein breakdown. In rats, it has been recently suggested that there is a significant contribution of 3MEH in urine from the gastrointestinal tract due to the rapid turnover of protein in that tissue. To evaluate this point in humans, six patients with short bowel were evaluated. They were placed on three-day meat-free diets while 24-hour urine collections were obtained. The mean +/- SEM 3MEH in the short-bowel group was 3.27 +/- 0.34 mumol/kg/d and the mean +/- SEM molar ratio of 3MEH to creatinine was 0.0212 +/- 0.0012. These data were not significantly different from the control group at 95% confidence level. The results suggest that the contribution of the small intestine appears to be negligible, therefore urinary 3MEH should continue to be a valid index of skeletal muscle breakdown in man.

  10. Effects of human running cadence and experimental validation of the bouncing ball model

    NASA Astrophysics Data System (ADS)

    Bencsik, László; Zelei, Ambrus

    2017-05-01

    The biomechanical analysis of human running is a complex problem, because of the large number of parameters and degrees of freedom. However, simplified models can be constructed, which are usually characterized by some fundamental parameters, like step length, foot strike pattern and cadence. The bouncing ball model of human running is analysed theoretically and experimentally in this work. It is a minimally complex dynamic model when the aim is to estimate the energy cost of running and the tendency of ground-foot impact intensity as a function of cadence. The model shows that cadence has a direct effect on energy efficiency of running and ground-foot impact intensity. Furthermore, it shows that higher cadence implies lower risk of injury and better energy efficiency. An experimental data collection of 121 amateur runners is presented. The experimental results validate the model and provides information about the walk-to-run transition speed and the typical development of cadence and grounded phase ratio in different running speed ranges.

  11. The validity of wireless iButtons and thermistors for human skin temperature measurement.

    PubMed

    Smith, A D Harper; Crabtree, D R; Bilzon, J L J; Walsh, N P

    2010-01-01

    Skin temperature is a fundamental variable in human thermo-physiology, and yet skin temperature measurement remains impractical in most free-living, exercise and clinical settings, using currently available hard-wired methods. The purpose of this study was to compare wireless iButtons and hard-wired thermistors for human skin temperature measurement. In the first of two investigations, iButtons and thermistors monitored temperature in a controlled water bath (range: 10-40 degrees C) and were referenced against a certified, mercury thermometer. In the second investigation, eight healthy males completed three randomized trials (ambient temperature = 10 degrees C, 20 degrees C and 30 degrees C) while both devices recorded skin temperature at rest (in low and high wind velocities) and during cycle-ergometry exercise. The results are as follows. Investigation 1: both devices displayed very high validity correlation with the reference thermometer (r > 0.999). Prior to correction, the mean bias was +0.121 degrees C for iButtons and +0.045 degrees C for thermistors. Upon calibration correction the mean bias for iButtons and thermistors was not significantly different from zero bias. Interestingly, a typical error of the estimate of iButtons (0.043 degrees C) was 1.5 times less than that of thermistors (0.062 degrees C), demonstrating iButtons' lower random error. Investigation 2: the offset between iButton and thermistor readings was generally consistent across conditions; however, thermistor responses gave readings that were always closer to ambient temperature than those given by iButtons, suggesting potential thermistor drift towards environmental conditions. Mean temperature differences between iButtons and thermistors during resting trials ranged from 0.261 degrees C to 1.356 degrees C. Mean temperature differences between iButtons and thermistors during exercise were 0.989 degrees C (ambient temperature = 10 degrees C), 0.415 degrees C (ambient temperature = 20

  12. High-resolution In Vivo Manual Segmentation Protocol for Human Hippocampal Subfields Using 3T Magnetic Resonance Imaging.

    PubMed

    Winterburn, Julie; Pruessner, Jens C; Sofia, Chavez; Schira, Mark M; Lobaugh, Nancy J; Voineskos, Aristotle N; Chakravarty, M Mallar

    2015-11-10

    The human hippocampus has been broadly studied in the context of memory and normal brain function and its role in different neuropsychiatric disorders has been heavily studied. While many imaging studies treat the hippocampus as a single unitary neuroanatomical structure, it is, in fact, composed of several subfields that have a complex three-dimensional geometry. As such, it is known that these subfields perform specialized functions and are differentially affected through the course of different disease states. Magnetic resonance (MR) imaging can be used as a powerful tool to interrogate the morphology of the hippocampus and its subfields. Many groups use advanced imaging software and hardware (>3T) to image the subfields; however this type of technology may not be readily available in most research and clinical imaging centers. To address this need, this manuscript provides a detailed step-by-step protocol for segmenting the full anterior-posterior length of the hippocampus and its subfields: cornu ammonis (CA) 1, CA2/CA3, CA4/dentate gyrus (DG), strata radiatum/lacunosum/moleculare (SR/SL/SM), and subiculum. This protocol has been applied to five subjects (3F, 2M; age 29-57, avg. 37). Protocol reliability is assessed by resegmenting either the right or left hippocampus of each subject and computing the overlap using the Dice's kappa metric. Mean Dice's kappa (range) across the five subjects are: whole hippocampus, 0.91 (0.90-0.92); CA1, 0.78 (0.77-0.79); CA2/CA3, 0.64 (0.56-0.73); CA4/dentate gyrus, 0.83 (0.81-0.85); strata radiatum/lacunosum/moleculare, 0.71 (0.68-0.73); and subiculum 0.75 (0.72-0.78). The segmentation protocol presented here provides other laboratories with a reliable method to study the hippocampus and hippocampal subfields in vivo using commonly available MR tools.

  13. Successful validation of genomic biomarkers for human immunotoxicity in Jurkat T cells in vitro.

    PubMed

    Schmeits, Peter C J; Shao, Jia; van der Krieken, Danique A; Volger, Oscar L; van Loveren, Henk; Peijnenburg, Ad A C M; Hendriksen, Peter J M

    2015-07-01

    Previously, we identified 25 classifier genes that were able to assess immunotoxicity using human Jurkat T cells. The present study aimed to validate these classifiers. For that purpose, Jurkat cells were exposed for 6 h to subcytotoxic doses of nine immunotoxicants, five non-immunotoxicants and four compounds for which human immunotoxicity has not yet been fully established. RNA was isolated and subjected to Fluidigm quantitative real time (qRT)-PCR analysis. The sensitivity, specificity and accuracy of the screening assay as based on the nine immunotoxicants and five non-immunotoxicants used in this study were 100%, 80% and 93%, respectively, which is better than the performance in our previous study. Only one compound was classified as false positive (benzo-e-pyrene). Of the four potential (non-)immunotoxicants, chlorantraniliprole and Hidrasec were classified immunotoxic and Sunset yellow and imidacloprid as non-immunotoxic. ToxPi analysis of the PCR data provided insight in the molecular pathways that were affected by the compounds. The immunotoxicants 2,3-dichloro-propanol and cypermethrin, although structurally different, affected protein metabolism and cholesterol biosynthesis and transport. In addition, four compounds, i.e. chlorpyrifos, aldicarb, benzo-e-pyrene and anti-CD3, affected genes in cholesterol metabolism and transport, protein metabolism and transcription regulation. qRT-PCR on eight additional genes coding for similar processes as defined in ToxPi analyzes, supported these results. In conclusion, the 25 immunotoxic classifiers performed very well in a screening with new non-immunotoxic and immunotoxic compounds. Therefore, the Jurkat screening assay has great promise to be applied within a tiered approach for animal free testing of human immunotoxicity.

  14. Functional Validation of ABCA3 as a Miltefosine Transporter in Human Macrophages

    PubMed Central

    Dohmen, Luuk C. T.; Navas, Adriana; Vargas, Deninson Alejandro; Gregory, David J.; Kip, Anke; Dorlo, Thomas P. C.; Gomez, Maria Adelaida

    2016-01-01

    Within its mammalian host, Leishmania resides and replicates as an intracellular parasite. The direct activity of antileishmanials must therefore depend on intracellular drug transport, metabolism, and accumulation within the host cell. In this study, we explored the role of human macrophage transporters in the intracellular accumulation and antileishmanial activity of miltefosine (MLF), the only oral drug available for the treatment of visceral and cutaneous leishmaniasis (CL). Membrane transporter gene expression in primary human macrophages infected in vitro with Leishmania Viannia panamensis and exposed to MLF showed modulation of ABC and solute liquid carrier transporters gene transcripts. Among these, ABCA3, a lipid transporter, was significantly induced after exposure to MLF, and this induction was confirmed in primary macrophages from CL patients. Functional validation of MLF as a substrate for ABCA3 was performed by shRNA gene knockdown (KD) in THP-1 monocytes. Intracellular accumulation of radiolabeled MLF was significantly higher in ABCA3KD macrophages. ABCA3KD resulted in increased cytotoxicity induced by MLF exposure. ABCA3 gene expression inversely correlated with intracellular MLF content in primary macrophages from CL patients. ABCA3KD reduced parasite survival during macrophage infection with an L. V. panamensis strain exhibiting low in vitro susceptibility to MLF. Confocal microscopy showed ABCA3 to be located in the cell membrane of resting macrophages and in intracellular compartments in L. V. panamensis-infected cells. These results provide evidence of ABCA3 as an MLF efflux transporter in human macrophages and support its role in the direct antileishmanial effect of this alkylphosphocholine drug. PMID:26903515

  15. Computerized polymorphic marker identification: Experimental validation and a predicted human polymorphism catalog

    PubMed Central

    Fondon, John W.; Mele, Gina M.; Brezinschek, Ruth I.; Cummings, Donna; Pande, Ashwini; Wren, Jonathan; O’Brien, Kevin M.; Kupfer, Kenneth C.; Wei, Ming-Hui; Lerman, Michael; Minna, John D.; Garner, Harold R.

    1998-01-01

    A computational system for the prediction of polymorphic loci directly and efficiently from human genomic sequence was developed and verified. A suite of programs, collectively called pompous (polymorphic marker prediction of ubiquitous simple sequences) detects tandem repeats ranging from dinucleotides up to 250 mers, scores them according to predicted level of polymorphism, and designs appropriate flanking primers for PCR amplification. This approach was validated on an approximately 750-kilobase region of human chromosome 3p21.3, involved in lung and breast carcinoma homozygous deletions. Target DNA from 36 paired B lymphoblastoid and lung cancer lines was amplified and allelotyped for 33 loci predicted by pompous to be variable in repeat size. We found that among those 36 predominately Caucasian individuals 22 of the 33 (67%) predicted loci were polymorphic with an average heterozygosity of 0.42. Allele loss in this region was found in 27/36 (75%) of the tumor lines using these markers. pompous provides the genetic researcher with an additional tool for the rapid and efficient identification of polymorphic markers, and through a World Wide Web site, investigators can use pompous to identify polymorphic markers for their research. A catalog of 13,261 potential polymorphic markers and associated primer sets has been created from the analysis of 141,779,504 base pairs of human genomic sequence in GenBank. This data is available on our Web site (pompous.swmed.edu) and will be updated periodically as GenBank is expanded and algorithm accuracy is improved. PMID:9636181

  16. The nondecussating pathway of the dentatorubrothalamic tract in humans: human connectome-based tractographic study and microdissection validation.

    PubMed

    Meola, Antonio; Comert, Ayhan; Yeh, Fang-Cheng; Sivakanthan, Sananthan; Fernandez-Miranda, Juan C

    2016-05-01

    OBJECT The dentatorubrothalamic tract (DRTT) is the major efferent cerebellar pathway arising from the dentate nucleus (DN) and decussating to the contralateral red nucleus (RN) and thalamus. Surprisingly, hemispheric cerebellar output influences bilateral limb movements. In animals, uncrossed projections from the DN to the ipsilateral RN and thalamus may explain this phenomenon. The aim of this study was to clarify the anatomy of the dentatorubrothalamic connections in humans. METHODS The authors applied advanced deterministic fiber tractography to a template of 488 subjects from the Human Connectome Project (Q1-Q3 release, WU-Minn HCP consortium) and validated the results with microsurgical dissection of cadaveric brains prepared according to Klingler's method. RESULTS The authors identified the "classic" decussating DRTT and a corresponding nondecussating path (the nondecussating DRTT, nd-DRTT). Within each of these 2 tracts some fibers stop at the level of the RN, forming the dentatorubro tract and the nondecussating dentatorubro tract. The left nd-DRTT encompasses 21.7% of the tracts and 24.9% of the volume of the left superior cerebellar peduncle, and the right nd-DRTT encompasses 20.2% of the tracts and 28.4% of the volume of the right superior cerebellar peduncle. CONCLUSIONS The connections of the DN with the RN and thalamus are bilateral, not ipsilateral only. This affords a potential anatomical substrate for bilateral limb motor effects originating in a single cerebellar hemisphere under physiological conditions, and for bilateral limb motor impairment in hemispheric cerebellar lesions such as ischemic stroke and hemorrhage, and after resection of hemispheric tumors and arteriovenous malformations. Furthermore, when a lesion is located on the course of the dentatorubrothalamic system, a careful preoperative tractographic analysis of the relationship of the DRTT, nd-DRTT, and the lesion should be performed in order to tailor the surgical approach properly

  17. Validation of a laboratory‐developed test of human sperm capacitation

    PubMed Central

    Moody, Melissa A.; Cardona, Cristina; Simpson, Alana J.; Smith, T. Timothy; Travis, Alexander J.

    2017-01-01

    Sperm must undergo capacitation to become fertilization competent. Here we validated that monosialotetrahexosylganglioside (GM1) localization patterns, which were assessed in the Cap‐Score™ Sperm Function Test, reflect a capacitated state in human sperm. First, we defined patterns representing sperm that do or do not respond to stimuli for capacitation. Sperm with “capacitated” patterns had exposed acrosomal carbohydrates and underwent acrosome exocytosis in response to calcium ionophore (A23187). Precision was evaluated by percent change of the Cap‐Score measured for 50, 100, 150, and 200 sperm. Changes of 11%, 6%, and 5% were observed (n ≥ 23); therefore, we counted ≥150 sperm per condition. Variance within and between readers was evaluated using 20 stitched image files generated from unique ejaculates. Two trained readers randomly resampled each image 20 times, reporting an average standard deviation of 3 Cap‐Score units and coefficient of variation of 13% when rescoring samples, with no difference between readers. Semen liquefaction times ≤2 hr and mechanical liquefaction with Pasteur or wide‐orifice transfer pipettes did not alter Cap‐Score values. However, liquefaction with chymotrypsin (p = 0.002) and bromelain (p = 0.049) reduced response to capacitating stimuli and induced membrane damage, while counterintuitively improving sperm motility. Together, these data validate the Cap‐Score assay for the intended purpose of providing information on sperm capacitation and male fertility. In addition to its clinical utility as a diagnostic tool, this test of sperm function can reveal the impact of common practices of semen handling on the ability of sperm to respond to capacitation stimuli. PMID:28418600

  18. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients.

    PubMed

    Brand-Schieber, Elimor; Munjal, Sagar; Kumar, Rajesh; Andre, Anthony D; Valladao, Will; Ramirez, Margarita

    2016-01-01

    Migraine pain relief is reported by more than 50% of patients who receive low dose (3 mg) of sumatriptan. Currently, there is no two-step autoinjector of low-dose sumatriptan available on the market for acute migraine treatment. To fulfill this need, a fully assembled, single-dose, subcutaneous autoinjector (sumatriptan 3 mg; product-code DFN-11) was developed. The device allows for injection with a simple two-step, push-to-inject process and provides feedback of the injection activation, progress, and completion. To determine if DFN-11 autoinjector can be used correctly and safely by migraine patients. A human factors validation study was conducted with 45 migraine patients (30 oral-only medications users; 15 injectable sumatriptan users) who performed one unaided simulated injection. Two days prior, half the oral participants were briefly trained. All others were only given the device to inspect and written instructions to review. No injections were performed during the initial session. All participants received written instructions at the injection session. All participants (45/45; 100%) performed the injection without any errors. Objective measures included device removal from packaging, cap removal, expiration date check, inspection of fluid in window, identification of allowable injection site, proper device positioning, dose confirmation, and device disposal. All participants (45/45; 100%) reported no difficulty administering the injection and no concerns about using the autoinjector during a severe migraine onset. The results showed that the DFN-11 autoinjector can be used with safe handling without patterns of confusion, failures, high-risk errors, wet injections, or patient safety risks. The DFN-11 autoinjector was validated to be used correctly and safely by migraine patients, whether they were injection experienced, unexperienced, trained, or self-trained.

  19. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients

    PubMed Central

    Brand-Schieber, Elimor; Munjal, Sagar; Kumar, Rajesh; Andre, Anthony D; Valladao, Will; Ramirez, Margarita

    2016-01-01

    Background Migraine pain relief is reported by more than 50% of patients who receive low dose (3 mg) of sumatriptan. Currently, there is no two-step autoinjector of low-dose sumatriptan available on the market for acute migraine treatment. To fulfill this need, a fully assembled, single-dose, subcutaneous autoinjector (sumatriptan 3 mg; product-code DFN-11) was developed. The device allows for injection with a simple two-step, push-to-inject process and provides feedback of the injection activation, progress, and completion. Objective To determine if DFN-11 autoinjector can be used correctly and safely by migraine patients. Methods and participants A human factors validation study was conducted with 45 migraine patients (30 oral-only medications users; 15 injectable sumatriptan users) who performed one unaided simulated injection. Two days prior, half the oral participants were briefly trained. All others were only given the device to inspect and written instructions to review. No injections were performed during the initial session. All participants received written instructions at the injection session. Results All participants (45/45; 100%) performed the injection without any errors. Objective measures included device removal from packaging, cap removal, expiration date check, inspection of fluid in window, identification of allowable injection site, proper device positioning, dose confirmation, and device disposal. All participants (45/45; 100%) reported no difficulty administering the injection and no concerns about using the autoinjector during a severe migraine onset. Conclusion The results showed that the DFN-11 autoinjector can be used with safe handling without patterns of confusion, failures, high-risk errors, wet injections, or patient safety risks. The DFN-11 autoinjector was validated to be used correctly and safely by migraine patients, whether they were injection experienced, unexperienced, trained, or self-trained. PMID:27313479

  20. Validation of an immunoassay to measure plasminogen-activator inhibitor-1 concentrations in human saliva

    PubMed Central

    Zhang, Xi; Dimeski, Goce; Punyadeera, Chamindie

    2014-01-01

    Introduction: We have previously shown that the concentrations of D-dimer are significantly elevated in saliva compared with plasma. Saliva offers several advantages compared with blood analysis. We hypothesised that human saliva contains plasminogen activator inhibitor-1 (PAI-1) and that the concentrations are not affected by the time of saliva collection. The aim was to adopt and validate an immunoassay to quantify PAI-1 concentrations in saliva and to determine whether saliva collection time has an influence in the measurement. Materials and methods: Two saliva samples (morning and afternoon) from the same day were collected from healthy subjects (N = 40) who have had no underlying heart conditions. A customized AlphaLISA® immunoassay (PerkinElmer®, MA, USA) was adopted and used to quantify PAI-1 concentrations. We validated the analytical performance of the customized immunoassay by calculating recovery of known amount of analyte spiked in saliva. Results: The recovery (95.03%), intra- (8.59%) and inter-assay (7.52%) variations were within the acceptable ranges. The median salivary PAI-1 concentrations were 394 pg/mL (interquartile ranges (IQR) 243.4–833.1 pg/mL) in the morning and 376 (129.1–615.4) pg/mL in the afternoon and the plasma concentration was 59,000 (24,000–110,000) pg/mL. Salivary PAI-1 did not correlate with plasma (P = 0.812). Conclusions: The adopted immunoassay produced acceptable assay sensitivity and specificity. The data demonstrated that saliva contains PAI-1 and that its concentration is not affected by the time of saliva collection. There is no correlation between salivary and plasma PAI-1 concentrations. Further studies are required to demonstrate the utility of salivary PAI-1 in CVD risk factor studies. PMID:24969919

  1. Bridging the gap between computation and clinical biology: validation of cable theory in humans

    PubMed Central

    Finlay, Malcolm C.; Xu, Lei; Taggart, Peter; Hanson, Ben; Lambiase, Pier D.

    2013-01-01

    Introduction: Computerized simulations of cardiac activity have significantly contributed to our understanding of cardiac electrophysiology, but techniques of simulations based on patient-acquired data remain in their infancy. We sought to integrate data acquired from human electrophysiological studies into patient-specific models, and validated this approach by testing whether electrophysiological responses to sequential premature stimuli could be predicted in a quantitatively accurate manner. Methods: Eleven patients with structurally normal hearts underwent electrophysiological studies. Semi-automated analysis was used to reconstruct activation and repolarization dynamics for each electrode. This S2 extrastimuli data was used to inform individualized models of cardiac conduction, including a novel derivation of conduction velocity restitution. Activation dynamics of multiple premature extrastimuli were then predicted from this model and compared against measured patient data as well as data derived from the ten-Tusscher cell-ionic model. Results: Activation dynamics following a premature S3 were significantly different from those after an S2. Patient specific models demonstrated accurate prediction of the S3 activation wave, (Pearson's R2 = 0.90, median error 4%). Examination of the modeled conduction dynamics allowed inferences into the spatial dispersion of activation delay. Further validation was performed against data from the ten-Tusscher cell-ionic model, with our model accurately recapitulating predictions of repolarization times (R2 = 0.99). Conclusions: Simulations based on clinically acquired data can be used to successfully predict complex activation patterns following sequential extrastimuli. Such modeling techniques may be useful as a method of incorporation of clinical data into predictive models. PMID:24027527

  2. Human-parathormone assay for use in dogs: validation, sample handling studies, and parathyroid function testing.

    PubMed

    Torrance, A G; Nachreiner, R

    1989-07-01

    Ten commercially available parathormone (PTH) assays were competitively validated, using dilutional parallelism, intra-assay and interassay coefficients of variation, and sensitivity and measured responses of 2 dogs to calcium and EDTA infusions. A 2-site immunoradiometric assay for intact human-PTH was superior to the others for estimating canine-PTH, met the criteria for validity, and was further investigated. A series of sample-handling studies was performed. Serum and plasma samples stored at 24 C lost 15% (n = 5; P less than 0.05) of PTH between 2 and 24 hours. This did not occur at 6 C. The mean PTH concentration of sera from blood samples clotted at 24 C was 6% (P less than 0.05) higher than equivalent EDTA samples. Serum samples stored at 6 and 37 C deteriorated 35% and 100% (n = 5; P less than 0.05), respectively, after 1 week, whereas samples stored at -20 and -70 C for 4 weeks did not deteriorate. There was no significant deterioration of PTH in samples frozen (-40 C) and thawed up to 7 times (n = 5). Parathyroid function testing was investigated by use of 2-hour infusions of disodium EDTA (25 mg/kg/h), 10-minute infusions of calcium gluconate (3 mg of elemental calcium/kg/10 min), and physiologic saline controls (n = 8). Renal function was monitored before and after EDTA infusion by exogenous creatinine clearance. Infusion of disodium EDTA increased mean PTH concentration from 67 (time 0) to 317 and 235 pg/ml at 90 and 180 minutes, respectively (P less than 0.001). Infusion of calcium gluconate decreased mean PTH concentration from 84 (time 0) to 14 and 12 pg/ml at 15 and 60 minutes, respectively (P less than 0.005). There were no observable side effects of the infusions in normal conscious dogs and no differences in exogenous creatinine clearance after EDTA infusion.

  3. Histological validation of high-resolution DTI in human post mortem tissue

    PubMed Central

    Seehaus, Arne; Roebroeck, Alard; Bastiani, Matteo; Fonseca, Lúcia; Bratzke, Hansjürgen; Lori, Nicolás; Vilanova, Anna; Goebel, Rainer; Galuske, Ralf

    2015-01-01

    Diffusion tensor imaging (DTI) is amongst the simplest mathematical models available for diffusion magnetic resonance imaging, yet still by far the most used one. Despite the success of DTI as an imaging tool for white matter fibers, its anatomical underpinnings on a microstructural basis remain unclear. In this study, we used 65 myelin-stained sections of human premotor cortex to validate modeled fiber orientations and oft used microstructure-sensitive scalar measures of DTI on the level of individual voxels. We performed this validation on high spatial resolution diffusion MRI acquisitions investigating both white and gray matter. We found a very good agreement between DTI and myelin orientations with the majority of voxels showing angular differences less than 10°. The agreement was strongest in white matter, particularly in unidirectional fiber pathways. In gray matter, the agreement was good in the deeper layers highlighting radial fiber directions even at lower fractional anisotropy (FA) compared to white matter. This result has potentially important implications for tractography algorithms applied to high resolution diffusion MRI data if the aim is to move across the gray/white matter boundary. We found strong relationships between myelin microstructure and DTI-based microstructure-sensitive measures. High FA values were linked to high myelin density and a sharply tuned histological orientation profile. Conversely, high values of mean diffusivity (MD) were linked to bimodal or diffuse orientation distributions and low myelin density. At high spatial resolution, DTI-based measures can be highly sensitive to white and gray matter microstructure despite being relatively unspecific to concrete microarchitectural aspects. PMID:26257612

  4. 21 CFR 878.4950 - Manual operating table and accessories and manual operating chair and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual operating table and accessories and manual operating chair and accessories. 878.4950 Section 878.4950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  5. 21 CFR 878.4950 - Manual operating table and accessories and manual operating chair and accessories.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual operating table and accessories and manual operating chair and accessories. 878.4950 Section 878.4950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  6. 21 CFR 878.4950 - Manual operating table and accessories and manual operating chair and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual operating table and accessories and manual operating chair and accessories. 878.4950 Section 878.4950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  7. 21 CFR 878.4950 - Manual operating table and accessories and manual operating chair and accessories.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual operating table and accessories and manual operating chair and accessories. 878.4950 Section 878.4950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  8. 21 CFR 878.4950 - Manual operating table and accessories and manual operating chair and accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual operating table and accessories and manual operating chair and accessories. 878.4950 Section 878.4950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  9. Validation of an LC-MS/MS method for the quantitative determination of mavoglurant (AFQ056) in human plasma.

    PubMed

    Jakab, Annamaria; Winter, Serge; Raccuglia, Marc; Picard, Frank; Dumitras, Swati; Woessner, Ralph; Mistry, Sanket; Chudasama, Jayraj; Guttikar, Swati; Kretz, Olivier

    2013-01-01

    A simple, sensitive, and selective liquid chromatography/tandem mass spectrometry method was validated for the identification and quantification of mavoglurant (AFQ056) in human plasma. The chromatographic separation was performed using a Cosmosil 5 C18 (150 × 4.6 mm, 5 μm) column at 40 ± 0.5 °C with a mobile phase consisting of acetic acid in water (0.1%, v/v)/methanol (10:90, v/v) with a flow rate of 1.0 mL/min followed by quantification with tandem mass spectrometry, operating with electrospray ionization in positive ion mode and applying multiple reaction monitoring. The validated method described in this paper presents high absolute recovery with precision and accuracy meeting the acceptance criteria. The method was precise and accurate for 2- and 10-fold dilution of samples. The method was validated using sodium heparin as specific anticoagulant, and the anticoagulant effect was tested by lithium heparin and K(3)EDTA. The method was successfully cross-validated between two bioanalytical sites. The method was specific for mavoglurant within the given criteria for acceptance (apparent peak area at the retention time of mavoglurant in zero samples was less than 20% compared with the mean peak area at LLOQ) in human plasma. The method was fully validated for the quantitative determination of mavoglurant in human plasma between the range of 2.00 and 2,500 ng/mL.

  10. Mechanical dissociation of human embryonic stem cell colonies by manual scraping after collagenase treatment is much more detrimental to cellular viability than is trypsinization with gentle pipetting.

    PubMed

    Heng, Boon Chin; Liu, Hua; Ge, Zigang; Cao, Tong

    2007-05-01

    Because hESC (human embryonic stem cells) are 'social cells' that require co-operative interactions and intimate physical contact with each other, it is absolutely essential to dissociate hESC colonies into cellular clumps rather than into a single-cell suspension during serial passage. The present study compared two commonly used protocols for dissociating hESC colonies. The first protocol involved mild enzymatic treatment with collagenase type IV (1 mg/ml) for approx. 5-10 min, prior to mechanical dissociation into cellular clumps through manual scraping with a plastic pipette tip. The second protocol involved a short duration of exposure (2-3 min) to low concentrations of trypsin (0.05%), followed by gentle pipetting. The MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-2H-tetrazolium bromide] assay was used to compare the recovery of viable cells after dissociating hESC colonies with these two protocols, before and after conventional freeze-thawing with 10% (v/v) DMSO. Besides undifferentiated hESC, the randomly differentiated fibroblastic progenies of hESC at various passages (P0-P4), together with an immortalized cell line (CRL-1486), were also utilized to compare the two protocols. The results demonstrated that the second protocol (trypsinization with gentle pipetting) is much less detrimental to cellular viability than is the first protocol (collagenase treatment with scratching). This in turn translated to higher freeze-thaw survival rates. It is hypothesized that scratching after collagenase treatment (first protocol) somehow induces physical damage to the cells, thereby leading to a lower recovery of viable cells, both before and after freeze-thawing.

  11. Validation of human periodontal ligament-derived cells as a reliable source for cytotherapeutic use.

    PubMed

    Iwata, Takanori; Yamato, Masayuki; Zhang, Zheng; Mukobata, Shigeki; Washio, Kaoru; Ando, Tomohiro; Feijen, Jan; Okano, Teruo; Ishikawa, Isao

    2010-12-01

    Periodontal ligament (PDL) is a reliable cell source for periodontal regeneration. In this study, an optimal protocol for the extraction, expansion, and characterization of human PDL (hPDL) cells was examined for clinical trials. hPDL tissues were obtained from 41 surgically extracted teeth and digested with enzymes. Human adipose-derived stem cells (hADSCs), bone marrow-derived mesenchymal stem cells (hBMMSCs), and gingival fibroblasts (hGFs) were used for comparison. For each sample, the proliferative capacity, colony-forming ability, alkaline phosphatase activity, differentiation ability, the cell surface antigens, gene expression, and regenerative potential were examined. hPDL cells were more successfully extracted with collagenase/dispase [29/30 (96.7%)] than with trypsin/EDTA [8/11 (72.7%)], and exhibited osteogenic potential both in vitro and in vivo. The proliferation of hPDL cells was rapid at a low cell density. hPDL cells frequently differentiated into cementoblastic/osteoblastic lineage (∼60%). In contrast, their adipogenic and chondrogenic potentials were lower than those of hADSCs and hBMMSCs. Some genes (NCAM1, S100A4, and periostin) were preferentially expressed in hPDL cells compared with those of hBMMSCs and hGFs. Immunohistochemical studies revealed the expressions of S100A4 and periostin in hPDL tissue. A protocol for the successful cultivation and validation of hPDL cells is proposed for clinical settings. © 2010 John Wiley & Sons A/S.

  12. Cross-validation of murine UV signal transduction pathways in human skin.

    PubMed

    Einspahr, Janine G; Bowden, G Timothy; Alberts, David S; McKenzie, Naja; Saboda, Kathylynn; Warneke, James; Salasche, Stuart; Ranger-Moore, James; Curiel-Lewandrowski, Clara; Nagle, Raymond B; Nickoloff, Brian J; Brooks, Christine; Dong, Zigang; Stratton, Steven P

    2008-01-01

    Acute UVB irradiation of mouse skin results in activation of phospatidyinositol-3 (PI-3) kinase and mitogen-activated protein kinase (MAPK) pathways leading to altered protein phosphorylation and downstream transcription of genes. We determined whether activation of these pathways also occurs in human skin exposed to 4x minimal erythemic dose of UVB in 23 volunteers. Biopsies were taken prior to, at 30 min, 1 and 24 h post-UVB. In agreement with mouse studies, the earliest UV-induced changes in epidermis were seen in phospho-CREB (two- and five-fold at 30 min and 1 h) and in phospho-MAPKAPK-2 (three-fold at both 30 min and 1 h). At 1 h, phospho-c-JUN and phospho-p38 were increased five- and two-fold, respectively. Moreover, phospho-c-JUN and phospho-p38 were further increased at 24 h (12- and six-fold, respectively). Phospho-GSK-3beta was similarly increased at all time points. Increases in phospho-p53 (12-fold), COX-2 (four-fold), c-FOS (14-fold) and apoptosis were not seen until 24 h. Our data suggest that UVB acts through MAPK p38 and PI-3 kinase with phosphorylation of MAPKAPK-2, CREB, c-JUN, p38, GSK-3beta and p53 leading to marked increases in c-FOS, COX-2 and apoptosis. Validation of murine models in human skin will aid in development of effective skin cancer chemoprevention and prevention strategies.

  13. Integrated Summary Report: Validation of Two Binding Assays Using Human Recombinant Estrogen Receptor Alpha (hrERa)

    EPA Science Inventory

    This Integrated Summary Report (ISR) summarizes, in a single document, the results from an international multi-laboratory validation study conducted for two in vitro estrogen receptor (ER) binding assays. These assays both use human recombinant estrogen receptor, alpha subtype (h...

  14. Integrated Summary Report: Validation of Two Binding Assays Using Human Recombinant Estrogen Receptor Alpha (hrERa)

    EPA Science Inventory

    This Integrated Summary Report (ISR) summarizes, in a single document, the results from an international multi-laboratory validation study conducted for two in vitro estrogen receptor (ER) binding assays. These assays both use human recombinant estrogen receptor, alpha subtype (h...

  15. Developing a Valid and Reliable Instrument to Predict the Protective Sexual Behaviors in Women at Risk of Human Immunodeficiency Virus

    PubMed Central

    Lotfi, Razieh; Ramezani Tehrani, Fahimeh; Yaghmaei, Farideh; Hajizadeh, Ebrahim

    2014-01-01

    Background: One much needed tool to assist with the monitoring and evaluation of Human Immunodeficiency Virus (HIV) prevention programs is to provide a valid instrument to measure protective sexual behavior and related factors. Objectives: The current study aimed to design a valid and reliable instrument to predict the protective sexual behaviors of women at risk of HIV in Iran. Patients and Methods: The current study was a sequential mixed cross-sectional and methodological research. Initially, via a qualitative research, constructs and factors associated with sexual protective behavior of women at risk were identified through 25 in-depth interviews. The questionnaire on predictors of protective sexual behaviors in women at risk of HIV (PSPB) was designed based on a qualitative study, and then its qualitative validity, content, and construct validity were evaluated. Exploratory factor analysis was performed and 200 women at risk participated. Results: Seven concepts emerged after exploratory factor analysis of the 48 items. The content validity ratio (CVR) of the questionnaire constructs were 0.55 to 0.76, and content validity index (CVI) structure was 0.86 to 0.95. Cronbach's alpha coefficient for the entire questionnaire was 0.78, and correlation coefficient of the test-retest reliability for the constructs was from 0.73 to 0.89. Conclusions: The current study proved the capability of the predictors of sexual protective behavior in women at risk for HIV questionnaire as a valid and reliable instrument for the Iranian community. PMID:25593717

  16. Development and validation of the Hospitality Axiological Scale for Humanization of Nursing Care.

    PubMed

    Galán González-Serna, José María; Ferreras-Mencia, Soledad; Arribas-Marín, Juan Manuel

    2017-08-03

    to develop and validate a scale to evaluate nursing attitudes in relation to hospitality for the humanization of nursing care. Participants: the sample consisted of 499 nursing professionals and undergraduate students of the final two years of the Bachelor of Science in Nursing program. the instrument has been developed and validated to evaluate the ethical values related to hospitality using a methodological approach. Subsequently, a model was developed to measure the dimensions forming the construct hospitality. the Axiological Hospitality Scale showed a high internal consistency, with Cronbach's Alpha=0.901. The validation of the measuring instrument was performed using factorial, exploratory and confirmatory analysis techniques with high goodness of fit measures. the developed instrument showed an adequate validity and a high internal consistency. Based on the consistency of its psychometric properties, it is possible to affirm that the scale provides a reliable measurement of the hospitality. It was also possible to determine the dimensions or sources that embrace it: respect, responsibility, quality and transpersonal care. desenvolver e validar uma escala que permita avaliar a atitude dos enfermeiros em termos de hospitalidade, visando a humanização da enfermagem.Participantes: a amostra foi constituída por 499 profissionais e estudantes de enfermagem dos dois últimos anos do curso de graduação em Enfermagem. utilizando-seuma abordagem metodológica, foi desenvolvido e validado um instrumento para avaliar os valores éticos relacionados com a hospitalidade. Subsequentemente, foi formulado um modelo para mediras dimensões que constituem o construto hospitalidade. a Escala Axiológica de Hospitalidade mostrou uma consistência interna elevada, com Alfa de Cronbach=0,901. A validação do instrumento de medição foi realizada usando-se métodos de análise fatorial, exploratória e confirmatória, que apresentaram bons índices de qualidade de ajuste. o

  17. Validated spectrofluorimetric method for the determination of tamsulosin in spiked human urine, pure and pharmaceutical preparations.

    PubMed

    Karasakal, A; Ulu, S T

    2014-05-01

    A novel, sensitive and selective spectrofluorimetric method was developed for the determination of tamsulosin in spiked human urine and pharmaceutical preparations. The proposed method is based on the reaction of tamsulosin with 1-dimethylaminonaphthalene-5-sulfonyl chloride in carbonate buffer pH 10.5 to yield a highly fluorescent derivative. The described method was validated and the analytical parameters of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, recovery and robustness were evaluated. The proposed method showed a linear dependence of the fluorescence intensity on drug concentration over the range 1.22 × 10(-7) to 7.35 × 10(-6)  M. LOD and LOQ were calculated as 1.07 × 10(-7) and 3.23 × 10(-7)  M, respectively. The proposed method was successfully applied for the determination of tamsulosin in pharmaceutical preparations and the obtained results were in good agreement with those obtained using the reference method.

  18. Validation of the simplified UVB model to assess the pharmacodynamics of analgesics in healthy human volunteers.

    PubMed

    Ing Lorenzini, Kuntheavy; Besson, Marie; Daali, Youssef; Salomon, Denis; Dayer, Pierre; Desmeules, Jules

    2012-01-01

    A pharmacokinetic/pharmacodynamic, randomized, crossover, placebo-controlled study was conducted in healthy human volunteers with the primary objective of exploring the existence of a positive interaction between paracetamol 1 g and ketorolac 20 mg intravenously on experimental pain models. Further, the simplified UVB model was validated as a screening tool for analgesics or a combination of analgesics in clinical drug development. It was observed that the UVB irradiation induced primary hyperalgesia, evidenced by significant decreases of the heat pain threshold from (mean ± SD) 46.9 ± 1.1 °C to 40.1 ± 1.7 °C (p <0.001) and of the mechanical pain threshold (62% decrease). A small intra- and inter-individual variability was observed as well as consistent intra-day stability for the heat pain threshold. The UVB irradiation also resulted in the development of an area of secondary hyperalgesia of 21.3 ± 11.3 cm(2). The mechanical pain threshold and area of secondary hyperalgesia showed small intra-individual variability and consistent intra-day stability. However, a greater variability was observed between subjects, which suggests that a crossover design would allow limiting the number of subjects.

  19. Iodonium Ylide Mediated Radiofluorination of 18F-FPEB and Validation for Human Use

    PubMed Central

    Stephenson, Nickeisha A.; Holland, Jason P.; Kassenbrock, Alina; Yokell, Daniel L.; Livni, Eli; Liang, Steven H.; Vasdev, Neil

    2016-01-01

    Translation of new methodologies for labeling non-activated aromatic molecules with fluorine-18 remains a challenge. Here, we report a one-step, regioselective, metal-free 18F-labeling method that employs a hypervalent iodonium(III) ylide precursor, to prepare the radiopharmaceutical 18F-FPEB. Methods Automated radiosynthesis of 18F-FPEB was achieved by reaction of the ylide precursor (4 mg) with 18F-NEt4F in DMF at 80 °C for 5 minutes, and formulated for injection within 1 hour. Results 18F-FPEB was synthesized in 15 – 25% (n = 3) uncorrected radiochemical yields relative to 18F-fluoride, with specific activities of 666 ± 51.8 GBq/μmol (18 ± 1.4 Ci/μmol) at the end-of-synthesis (EOS). The radiopharmaceutical was validated for human use. Conclusions Radiofluorination of iodonium (III) ylides proved to be an efficient radiosynthetic strategy for synthesis of 18F-labeled radiopharmaceuticals. PMID:25655630

  20. validated microbiological and HPLC methods for the determination of moxifloxacin in pharmaceutical preparations and human plasma

    PubMed Central

    Abdelaziz, Ahmed A.; Elbanna, Tarek E.; Gamaleldeen, Noha M.

    2012-01-01

    The article presents a comparison between microbiological and high performance liquid chromatographic (HPLC) assays for quantification of moxifloxacin in tablets, ophthalmic solutions and human plasma. The microbiological method employed a cylinder-plate agar diffusion assay using a strain of Esherichia coli ATCC 25922 as the test organism and phosphate buffer (pH8) as the diluent. The calibration curves were linear (R2 > 0.98) over a concentration range of 0.125 to 16 µgml-1. The within day and between days precisions were ≤ 4.47% and ≤ 6.39% respectively. Recovery values were between 89.4 and 110.2%. The HPLC assay used Hypersil® BDS C18 reversed phase column (250×4.6 mm, 5µm) with a mobile phase comprising 20 mM ammonium dihydrogen orthophosphate (pH3) and acetonitrile (75:25) and flowing at 1.5 ml/min. The detection was at 295nm. The calibration curves were linear (R2 > 0.999) over the range of 0.125 to 16 µg ml-1. The within day and between days precisions were ≤ 4.07% and ≤ 5.09% respectively. Recovery values were between 97.7 and 107.6%. Similar potencies were obtained after the analysis of moxifloxacin tablets and ophthalmic solutions by both methods. Also pharmacokinetic parameters were calculated after the analysis of plasma samples of six male healthhy volunteers by both validated methods. PMID:24031955

  1. Surface Environmental Surveillance Procedures Manual

    SciTech Connect

    RW Hanf; TM Poston

    2000-09-20

    Environmental surveillance data are used in assessing the impact of current and past site operations on human health and the environment, demonstrating compliance with applicable local, state, and federal environmental regulations, and verifying the adequacy of containment and effluent controls. SESP sampling schedules are reviewed, revised, and published each calendar year in the Hanford Site Environmental Surveillance Master Sampling Schedule. Environmental samples are collected by SESP staff in accordance with the approved sample collection procedures documented in this manual.

  2. The AASM scoring manual: a critical appraisal.

    PubMed

    Grigg-Damberger, Madeleine M

    2009-11-01

    Summarize recently published studies and critiques evaluating the effects of the American Academy of Sleep Medicine (AASM) Sleep Scoring Manual. Only a few retrospective studies have been published evaluating the new AASM Scoring Manual. These have shown that when scoring polysomnograms (PSGs) using the AASM rules compared to previous standards and guidelines: increased amount and percentage of sleep time in Non-Rapid Eye Movement Sleep (NREM) 1 (N1) and N3 sleep, and decreased NREM 2 (N2) sleep; improved interscorer reliability when scoring sleep stages in adults; large differences in apnea-hypopnea indexes (AHIs) using different hypopnea scoring definitions; and PSGs scored using the 'recommended' hypopnea definition in the new manual identified no significant sleep disordered breathing in 40% of lean individuals with symptomatic OSA (AHI ≥5/h by 1999 'Chicago' criteria) and a favorable response to treatment. Two years have passed since the AASM Scoring Manual was published, garnering less criticism than was feared by those who developed it. The improvement in interscorer reliability using the Manual is heartening since this goal shaped many of the choices made. The alternative hypopnea rule should be endorsed as a recommended option. The AASM Scoring Manual provides a foundation upon which we all can build rules and methods that quantify the complexity of sleep and its disorders. Multicenter validation and refinement of the Manual is encouraged.

  3. Microbial ecology laboratory procedures manual NASA/MSFC

    NASA Technical Reports Server (NTRS)

    Huff, Timothy L.

    1990-01-01

    An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

  4. Modular use of human body models of varying levels of complexity: Validation of head kinematics.

    PubMed

    Decker, William; Koya, Bharath; Davis, Matthew L; Gayzik, F Scott

    2017-05-29

    The significant computational resources required to execute detailed human body finite-element models has motivated the development of faster running, simplified models (e.g., GHBMC M50-OS). Previous studies have demonstrated the ability to modularly incorporate the validated GHBMC M50-O brain model into the simplified model (GHBMC M50-OS+B), which allows for localized analysis of the brain in a fraction of the computation time required for the detailed model. The objective of this study is to validate the head and neck kinematics of the GHBMC M50-O and M50-OS (detailed and simplified versions of the same model) against human volunteer test data in frontal and lateral loading. Furthermore, the effect of modular insertion of the detailed brain model into the M50-OS is quantified. Data from the Navy Biodynamics Laboratory (NBDL) human volunteer studies, including a 15g frontal, 8g frontal, and 7g lateral impact, were reconstructed and simulated using LS-DYNA. A five-point restraint system was used for all simulations, and initial positions of the models were matched with volunteer data using settling and positioning techniques. Both the frontal and lateral simulations were run with the M50-O, M50-OS, and M50-OS+B with active musculature for a total of nine runs. Normalized run times for the various models used in this study were 8.4 min/ms for the M50-O, 0.26 min/ms for the M50-OS, and 0.97 min/ms for the M50-OS+B, a 32- and 9-fold reduction in run time, respectively. Corridors were reanalyzed for head and T1 kinematics from the NBDL studies. Qualitative evaluation of head rotational accelerations and linear resultant acceleration, as well as linear resultant T1 acceleration, showed reasonable results between all models and the experimental data. Objective evaluation of the results for head center of gravity (CG) accelerations was completed via ISO TS 18571, and indicated scores of 0.673 (M50-O), 0.638 (M50-OS), and 0.656 (M50-OS+B) for the 15g frontal impact

  5. CSTEM User Manual

    NASA Technical Reports Server (NTRS)

    Hartle, M.; McKnight, R. L.

    2000-01-01

    This manual is a combination of a user manual, theory manual, and programmer manual. The reader is assumed to have some previous exposure to the finite element method. This manual is written with the idea that the CSTEM (Coupled Structural Thermal Electromagnetic-Computer Code) user needs to have a basic understanding of what the code is actually doing in order to properly use the code. For that reason, the underlying theory and methods used in the code are described to a basic level of detail. The manual gives an overview of the CSTEM code: how the code came into existence, a basic description of what the code does, and the order in which it happens (a flowchart). Appendices provide a listing and very brief description of every file used by the CSTEM code, including the type of file it is, what routine regularly accesses the file, and what routine opens the file, as well as special features included in CSTEM.

  6. Industrial labor relations manual

    NASA Technical Reports Server (NTRS)

    1992-01-01

    The NASA Industrial Labor Relations Manual provides internal guidelines and procedures to assist NASA Field Installations in dealing with contractor labor management disputes, Service Contract Act variance hearings, and to provide access of Labor Union Representatives to NASA for the purpose of maintaining schedules and goals in connection with vital NASA programs. This manual will be revised by page changes as revisions become necessary. Initial distribution of this manual has been made to NASA Headquarters and Field Installations.

  7. Bigfoot Field Manual, Version 2.1

    SciTech Connect

    Campbell, J.L.; Burrows, S.; Gower, S.T.; Cohen, W.B.

    1999-09-01

    The BigFoot Project is funded by the Earth Science Enterprise to collect and organize data to be used in the National Aeronautics and Space Administration's Earth Observing System (EOS) Validation Program. The data collected by the BigFoot Project are unique in being ground-based observations coincident with satellite overpasses. In addition to collecting data, the BigFoot project will develop and test new algorithms for scaling point measurements to the same spatial scales as the EOS satellite products. This BigFoot Field Manual will be used to achieve completeness and consistency of data collected at four initial BigFoot sites and at future sites that may collect similar validation data. Therefore, validation datasets submitted to the Oak Ridge National Laboratory Distributed Active Archive Center that have been compiled in a manner consistent with the field manual will be especially valuable in the validation program.

  8. EMSL Operations Manual

    SciTech Connect

    Foster, Nancy S.

    2009-03-25

    This manual is a general resource tool to assist EMSL users and Laboratory staff within EMSL locate official policy, practice and subject matter experts. It is not intended to replace or amend any formal Battelle policy or practice. Users of this manual should rely only on Battelle’s Standard Based Management System (SBMS) for official policy. No contractual commitment or right of any kind is created by this manual. Battelle management reserves the right to alter, change, or delete any information contained within this manual without prior notice.

  9. EMSL Operations Manual

    SciTech Connect

    Foster, Nancy S.

    2009-06-18

    This manual is a general resource tool to assist EMSL users and Laboratory staff within EMSL locate official policy, practice and subject matter experts. It is not intended to replace or amend any formal Battelle policy or practice. Users of this manual should rely only on Battelle’s Standard Based Management System (SBMS) for official policy. No contractual commitment or right of any kind is created by this manual. Battelle management reserves the right to alter, change, or delete any information contained within this manual without prior notice.

  10. Instruct coders' manual

    NASA Technical Reports Server (NTRS)

    Friend, J.

    1971-01-01

    A manual designed both as an instructional manual for beginning coders and as a reference manual for the coding language INSTRUCT, is presented. The manual includes the major programs necessary to implement the teaching system and lists the limitation of current implementation. A detailed description is given of how to code a lesson, what buttons to push, and what utility programs to use. Suggestions for debugging coded lessons and the error messages that may be received during assembly or while running the lesson are given.

  11. Radiological Control Manual

    SciTech Connect

    Not Available

    1993-04-01

    This manual has been prepared by Lawrence Berkeley Laboratory to provide guidance for site-specific additions, supplements, and clarifications to the DOE Radiological Control Manual. The guidance provided in this manual is based on the requirements given in Title 10 Code of Federal Regulations Part 835, Radiation Protection for Occupational Workers, DOE Order 5480.11, Radiation Protection for Occupational Workers, and the DOE Radiological Control Manual. The topics covered are (1) excellence in radiological control, (2) radiological standards, (3) conduct of radiological work, (4) radioactive materials, (5) radiological health support operations, (6) training and qualification, and (7) radiological records.

  12. Reflective oxygen saturation monitoring at hypothenar and its validation by human hypoxia experiment.

    PubMed

    Guo, Tao; Cao, Zhengtao; Zhang, Zhengbo; Li, Deyu; Yu, Mengsun

    2015-08-05

    Pulse oxygen saturation (SpO2) is an important parameter for healthcare, and wearable sensors and systems for SpO2 monitoring have become increasingly popular. The aim of this paper is to develop a novel SpO2 monitoring system, which detects photoplethysmographic (PPG) signals at hypothenar with a reflection-mode sensor embedded into a glove. A special photo-detector section was designed with two photodiodes arranged symmetrically to the red and infrared light-emitting diodes (LED) to enhance the signal quality. The reflective sensor was placed in a soft silicon substrate sewn in a glove to fit the surface of the hypothenar. To lower the power consumption, the LED driving current was reduced and energy-efficient electronic components were applied. The performance for PPG signal detection and SpO2 monitoring was evaluated by human hypoxia experiments. Accelerometer-based adaptive noise cancellation (ANC) methods applying the least mean squares (LMS) and recursive least squares (RLS) algorithms were studied to suppress motion artifact. A total of 20 subjects participated in the hypoxia experiment. The degree of comfort for wearing this system was accepted by them. The PPG signals were detected effectively at SpO2 levels from about 100-70%. The experiment validated the accuracy of the system was 2.34%, compared to the invasive measurements. Both the LMS and RLS algorithms improved the performance during motion. The total current consumed by the system was only 8 mA. It is feasible to detect PPG signal and monitor SpO2 at the location of hypothenar. This novel system can achieve reliable SpO2 measurements at different SpO2 levels and on different individuals. The system is light-weighted, easy to wear and power-saving. It has the potential to be a solution for wearable monitoring, although more work should be conducted to improve the motion-resistant performance significantly.

  13. Validation of a rapid, automated method for the measurement of ethylene glycol in human plasma.

    PubMed

    Robson, Anna F; Lawson, Alexander J; Lewis, Laura; Jones, Alan; George, Stephen

    2017-07-01

    Background Ethylene glycol is a highly toxic compound found in various household products. Cases of poisoning are rare but may be fatal unless diagnosed and treated promptly. Early recognition of poisoning is critical for the management and recovery of patients. Indirect testing is not specific for the presence of ethylene glycol. Therefore, urgent and accurate measurement should be sought if ingestion is suspected in order to determine the need for treatment with an antidote. Here, we present the validation of an automated assay for measurement of ethylene glycol on an Abbott Architect using a commercially available kit (Catachem). Methods Analytical parameters of imprecision, linearity, stability and bias were determined using spiked human plasma samples processed on both the Catachem assay and on an in-house gas chromatography-mass spectrometry method. Interference was assessed using samples collected into a variety of sample collection tubes and spiked with a number of alcohols. Results Excellent agreement was observed between the two methodologies with the enzymatic assay demonstrating linearity and precision across the relevant clinical range (50-3000 mg/L). In addition, the Catachem assay displayed no interference from a number of different sample tubes and alcohols. However, propylene glycol interference was observed at concentrations associated with excessive use (>1 g/L) and 2,3-butanediol interference observed at concentrations associated with butanone ingestion. Inspection of the enzymatic reaction profile was found to differentiate between alcohols. Conclusions This automated assay is suitable for the diagnosis of ethylene glycol poisoning and is now in routine use, enabling the laboratory to provide a rapid 24 h service with support by gas chromatography-mass spectrometry as necessary.

  14. Quantitative MR Imaging of Hepatic Steatosis: Validation in Ex Vivo Human Livers

    PubMed Central

    Bannas, Peter; Kramer, Harald; Hernando, Diego; Agni, Rashmi; Cunningham, Ashley M.; Mandal, Rakesh; Motosugi, Utaroh; Sharma, Samir D.; del Rio, Alejandro Munoz; Fernandez, Luis; Reeder, Scott B.

    2015-01-01

    Emerging magnetic resonance imaging (MRI) biomarkers of hepatic steatosis have demonstrated tremendous promise for accurate quantification of hepatic triglyceride concentration. These methods quantify the “proton density fat-fraction” (PDFF), which reflects the concentration of triglycerides in tissue. Previous in vivo studies have compared MRI-PDFF with histologic steatosis grading for assessment of hepatic steatosis. However, the correlation of MRI-PDFF with the underlying hepatic triglyceride content remained unknown. The aim of this ex vivo study was to validate the accuracy of MRI-PDFF as an imaging biomarker of hepatic steatosis. Using ex vivo human livers, we compared MRI-PDFF with magnetic resonance spectroscopy-PDFF (MRS-PDFF), biochemical triglyceride extraction and histology as three independent reference standards. A secondary aim was to compare the precision of MRI-PDFF relative to biopsy for the quantification of hepatic steatosis. MRI-PDFF was prospectively performed at 1.5T in 13 explanted human livers. We performed co-localized paired evaluation of liver fat content in all nine Couinaud segments using single-voxel MRS-PDFF (n=117), tissue wedges for biochemical triglyceride extraction (n=117), and five core biopsies performed in each segment for histologic grading (n=585). Accuracy of MRI-PDFF was assessed through linear regression with MRS-PDFF, triglyceride extraction and histology. Intra-observer agreement, inter-observer agreement and repeatability of MRI-PDFF and histologic grading were assessed through Bland-Altman analyses. MRI-PDFF showed an excellent correlation with MRS-PDFF (r=0.984; CI: 0.978–0.989) and strong correlation with histology (r=0.850; CI: 0.791–0.894) and triglyceride extraction (r=0.871; CI: 0.818–0.909). Intra-observer agreement, inter-observer agreement and repeatability showed a significantly smaller variance for MRI-PDFF than for histologic steatosis grading (all p<0.001). Conclusion MRI-PDFF is an accurate

  15. Quantitative detection of caffeine in human skin by confocal Raman spectroscopy--A systematic in vitro validation study.

    PubMed

    Franzen, Lutz; Anderski, Juliane; Windbergs, Maike

    2015-09-01

    For rational development and evaluation of dermal drug delivery, the knowledge of rate and extent of substance penetration into the human skin is essential. However, current analytical procedures are destructive, labor intense and lack a defined spatial resolution. In this context, confocal Raman microscopy bares the potential to overcome current limitations in drug depth profiling. Confocal Raman microscopy already proved its suitability for the acquisition of qualitative penetration profiles, but a comprehensive investigation regarding its suitability for quantitative measurements inside the human skin is still missing. In this work, we present a systematic validation study to deploy confocal Raman microscopy for quantitative drug depth profiling in human skin. After we validated our Raman microscopic setup, we successfully established an experimental procedure that allows correlating the Raman signal of a model drug with its controlled concentration in human skin. To overcome current drawbacks in drug depth profiling, we evaluated different modes of peak correlation for quantitative Raman measurements and offer a suitable operating procedure for quantitative drug depth profiling in human skin. In conclusion, we successfully demonstrate the potential of confocal Raman microscopy for quantitative drug depth profiling in human skin as valuable alternative to destructive state-of-the-art techniques.

  16. Development of dioxin toxicity evaluation method in human milk by enzyme-linked immunosorbent assay--assay validation for human milk.

    PubMed

    Sugawara, Yukio; Saito, Koichi; Ogawa, Masahiko; Kobayashi, Susumu; Shan, Guomin; Sanborn, James R; Hammock, Bruce D; Nakazawa, Hiroyuki; Matsuki, Yasuhiko

    2002-03-01

    In this study, the development of a toxicity evaluation method for dioxins in human milk by enzyme-linked immunosorbent assay (ELISA) was reported. A total of 17 human milk samples were tested by ELISA and by gas chromatography/mass spectrometry (GC/MS) to assess whether the ELISA performed on samples obtained from primiparas could be considered as reliable enough for identifying a dioxins contamination in human milk. The concept of toxicity equivalent quantity (TEQ) screening was validated by comparing TEQ values for a set of human milk samples to the ELISA responses predicted for those samples. A fairly good correlation (r = 0.920) between immunoassay and GC/MS was achieved for human milk. This ELISA should be useful for biological samples monitoring.

  17. Boating Safety Training Manual.

    ERIC Educational Resources Information Center

    Coast Guard, Washington, DC.

    The training manual serves as the text for the Coast Guard's boating safety 32-hour course and for the D-8 Qualification Code Recertification Course. The manual is designed for self-study or for use with an instructor-led course. Each chapter concludes with a quiz to be used as a review of chaper content. Opening chapters review the use of the…

  18. Dental Charting. Student's Manual.

    ERIC Educational Resources Information Center

    Weaver, Trudy Karlene; Apfel, Maura

    This manual is part of a series dealing with skills and information needed by students in dental assisting. The individualized student materials are suitable for classroom, laboratory, or cooperative training programs. This student manual contains four units covering the following topics: dental anatomical terminology; tooth numbering systems;…

  19. Indoor Air Quality Manual.

    ERIC Educational Resources Information Center

    Baldwin Union Free School District, NY.

    This manual identifies ways to improve a school's indoor air quality (IAQ) and discusses practical actions that can be carried out by school staff in managing air quality. The manual includes discussions of the many sources contributing to school indoor air pollution and the preventive planning for each including renovation and repair work,…

  20. Biology Laboratory Safety Manual.

    ERIC Educational Resources Information Center

    Case, Christine L.

    The Centers for Disease Control (CDC) recommends that schools prepare or adapt a biosafety manual, and that instructors develop a list of safety procedures applicable to their own lab and distribute it to each student. In this way, safety issues will be brought to each student's attention. This document is an example of such a manual. It contains…

  1. Idaho Special Education Manual.

    ERIC Educational Resources Information Center

    Idaho State Dept. of Education. Special Education Section.

    This manual is a set of guidelines to assist Idaho school districts in carrying out the provisions of the Individuals with Disabilities Education Act (IDEA) Amendments of 1997, and its implementing regulations which became final on March 12, 1999. The manual also incorporates changes in Administrative Rules of the Idaho State Board of Education,…

  2. Bicycle Skills Test Manual.

    ERIC Educational Resources Information Center

    North Carolina Univ., Chapel Hill. Highway Safety Research Center.

    This manual provides the guidelines and components necessary for the planning and implementation of a basic bicycle skills test program. It is intended for use by enforcement personnel, city and town government officials, education and school groups, civic groups, or other interested persons. An introduction covers use of the manual and the…

  3. Technical Manual. The ACT®

    ERIC Educational Resources Information Center

    ACT, Inc., 2014

    2014-01-01

    This manual contains technical information about the ACT® college readiness assessment. The principal purpose of this manual is to document the technical characteristics of the ACT in light of its intended purposes. ACT regularly conducts research as part of the ongoing formative evaluation of its programs. The research is intended to ensure that…

  4. Kobuk Inupiaq Literacy Manual.

    ERIC Educational Resources Information Center

    Kaplan, Larry

    The manual is designed to teach writing to native speakers of Kobuk Inupiaq, a regional dialect of Alaskan Inupiaq Eskimo. Spelling is emphasized. An introductory section for teachers details the use of the manual, chapter by chapter, and suggests classroom activities. The first chapter provides an introduction to the writing system of Kobuk…

  5. Qawiaraq Inupiaq Literacy Manual.

    ERIC Educational Resources Information Center

    Kaplan, Lawrence D.

    This manual is designed to teach writing to native speakers of Qawiaraq Inupiaq, a regional dialect of Alaskan Inupiaq Eskimo. Spelling is emphasized. An introductory section for teachers details the use of the manual, chapter by chapter, and suggests classroom activities. The first chapter provides an introduction to the writing system of…

  6. Police Robbery Control Manual.

    ERIC Educational Resources Information Center

    Ward, Richard H.; And Others

    The manual was designed as a practical guide for police department personnel in developing robbery control programs. An introductory chapter defines types of robberies and suggests administrative and operational uses of the manual. Research and control strategies are reported according to five robbery types: street (visible and non-visible),…

  7. School District Energy Manual.

    ERIC Educational Resources Information Center

    Association of School Business Officials International, Reston, VA.

    This manual serves as an energy conservation reference and management guide for school districts. The School District Energy Program (SDEP) is designed to provide information and/or assistance to school administrators planning to implement a comprehensive energy management program. The manual consists of 15 parts. Part 1 describes the SDEP; Parts…

  8. Manual for Refugee Sponsorship.

    ERIC Educational Resources Information Center

    Brewer, Kathleen; Taran, Patrick A.

    This manual provides guidelines for religious congregations interested in setting up programs to sponsor refugees. The manual describes the psychological implications of the refugee experience and discusses initial steps in organizing for sponsorship. Detailed information is provided for sponsors regarding: finances and mobilization of resources;…

  9. School Reform Resource Manual.

    ERIC Educational Resources Information Center

    Mid-Continent Research for Education and Learning, Aurora, CO.

    This manual is designed to help schools make successful school reform a reality. It provides the background and perspectives necessary for a school constituency to understand the current climate of education reform in the United States and what is known about successful school reform. The manual also provides inquiry-based techniques for…

  10. Institutional Effectiveness Resource Manual.

    ERIC Educational Resources Information Center

    Cannon, Delinda T.; And Others

    This resource manual was produced to assist the South Carolina Technical College System's efforts to improve institutional effectiveness and accountability. The first two sections of the manual provide a brief foreword, a description of state initiatives for research and academic excellence in South Carolina, the text of state legislation…

  11. Dental Charting. Student's Manual.

    ERIC Educational Resources Information Center

    Weaver, Trudy Karlene; Apfel, Maura

    This manual is part of a series dealing with skills and information needed by students in dental assisting. The individualized student materials are suitable for classroom, laboratory, or cooperative training programs. This student manual contains four units covering the following topics: dental anatomical terminology; tooth numbering systems;…

  12. Manual for Refugee Sponsorship.

    ERIC Educational Resources Information Center

    Brewer, Kathleen; Taran, Patrick A.

    This manual provides guidelines for religious congregations interested in setting up programs to sponsor refugees. The manual describes the psychological implications of the refugee experience and discusses initial steps in organizing for sponsorship. Detailed information is provided for sponsors regarding: finances and mobilization of resources;…

  13. Home Maintenance Manual.

    ERIC Educational Resources Information Center

    Richmond, Jim; And Others

    This manual, written especially for the Navajo and Hopi Indian Relocation Commission, is a simply worded, step-by-step guide to home maintenance for new homeowners. It can be used for self-study or it can serve as instructional material for a training class on home ownership. The manual is organized in nine sections that cover the following…

  14. Induction brazing manual

    NASA Technical Reports Server (NTRS)

    1971-01-01

    Manual presents standards and techniques which are known or are particular to specific industry, and is useful as guide in closing tolerance brazing. Material and equipment specifications, tool setting tables, and quality control data and instructions are included. Since similar standards are available, manual is supplementary reference.

  15. School District Energy Manual.

    ERIC Educational Resources Information Center

    Association of School Business Officials International, Reston, VA.

    This manual serves as an energy conservation reference and management guide for school districts. The School District Energy Program (SDEP) is designed to provide information and/or assistance to school administrators planning to implement a comprehensive energy management program. The manual consists of 15 parts. Part 1 describes the SDEP; Parts…

  16. Automatic Versus Manual Indexing

    ERIC Educational Resources Information Center

    Vander Meulen, W. A.; Janssen, P. J. F. C.

    1977-01-01

    A comparative evaluation of results in terms of recall and precision from queries submitted to systems with automatic and manual subject indexing. Differences were attributed to query formulation. The effectiveness of automatic indexing was found equivalent to manual indexing. (Author/KP)

  17. Circulation Aide Training Manual.

    ERIC Educational Resources Information Center

    Bergeson, Alan O.

    This training manual provides instruction on shelving and other duties for student assistants in the learning resources center at the College of Dupage, located in Illinois. It is noted that prospective student circulation aides are required to read the manual and pass a written test on policies and procedures before they are allowed to shelve…

  18. Christmas Tree Pest Manual

    Treesearch

    Department of Entomology Michigan State University

    1998-01-01

    This manual can help you identify and control damaging Christmas tree pests in the North Central region of the United States. Most of the information also applies to the northeastern states and to the southern portions of the Canadian Provinces that border these states. You do not have to be a pest specialist to use this information; we wrote the manual in everyday...

  19. Materials inventory management manual

    NASA Technical Reports Server (NTRS)

    1992-01-01

    This NASA Materials Inventory Management Manual (NHB 4100.1) is issued pursuant to Section 203(c)(1) of the National Aeronautics and Space Act of 1958 (42 USC 2473). It sets forth policy, performance standards, and procedures governing the acquisition, management and use of materials. This Manual is effective upon receipt.

  20. Learning Resources Evaluations Manual.

    ERIC Educational Resources Information Center

    Nunes, Evelyn H., Ed.

    This manual contains evaluations of 196 instructional products listed in Virginia's Adult Basic Education Curricula Resource Catalog. It is intended as a convenient reference manual for making informed decisions concerning materials for adult learners in adult basic education, English-as-a-Second-Language instruction, and general educational…

  1. Miami University Information Manual.

    ERIC Educational Resources Information Center

    Miami Univ., Oxford, OH.

    The 1975 information manual is designed to provide current data on policies, procedures, services, facilities, organization and governance of Miami University and, through the extensive index, quick access to this information. The manual is complementary to the university catalog and directory. Information relating to students is in the Student…

  2. The Model Human Processor and the Older Adult: Parameter Estimation and Validation Within a Mobile Phone Task

    PubMed Central

    Jastrzembski, Tiffany S.; Charness, Neil

    2009-01-01

    The authors estimate weighted mean values for nine information processing parameters for older adults using the Card, Moran, and Newell (1983) Model Human Processor model. The authors validate a subset of these parameters by modeling two mobile phone tasks using two different phones and comparing model predictions to a sample of younger (N = 20; Mage = 20) and older (N = 20; Mage = 69) adults. Older adult models fit keystroke-level performance at the aggregate grain of analysis extremely well (R = 0.99) and produced equivalent fits to previously validated younger adult models. Critical path analyses highlighted points of poor design as a function of cognitive workload, hardware/software design, and user characteristics. The findings demonstrate that estimated older adult information processing parameters are valid for modeling purposes, can help designers understand age-related performance using existing interfaces, and may support the development of age-sensitive technologies. PMID:18194048

  3. [Physiotherapy as manual therapy].

    PubMed

    Torstensen, T A; Nielsen, L L; Jensen, R; Reginiussen, T; Wiesener, T; Kirkesola, G; Mengshoel, A M

    1999-05-30

    Manual therapy includes methods where the therapist's hands are used to stretch, mobilize or manipulate the spinal column, paravertebral structures or extremity joints. The aims of these methods are to relieve pain and improve function. In Norway only specially qualified physiotherapists and chiropractors are authorized to perform manipulation of joints (high velocity thrust techniques). To become a qualified manual therapist in Norway one must have a minimum of two years of clinical practice as physiotherapist followed by two year full time postgraduate training in manual therapy (a total of six years). Historically the Norwegian manual therapy system was developed in the 1950s by physiotherapists and medical doctors in England (James Cyriax and James Mennell) and Norway. As a result doctors allowed physiotherapists to use manipulation as a treatment method of both spinal and peripheral joints. In 1957 the Norwegian health authorities introduced reimbursement for manual therapy performed by physiotherapists.

  4. Psychiatry's new manual (DSM-5): ethical and conceptual dimensions.

    PubMed

    Blumenthal-Barby, J S

    2014-08-01

    The introduction of the Diagnostic and statistical manual of mental disorders (DSM-5) in May 2013 is being hailed as the biggest event in psychiatry in the last 10 years. In this paper I examine three important issues that arise from the new manual:(1) Expanding nosology: Psychiatry has again broadened its nosology to include human experiences not previously under its purview (eg, binge eating disorder, internet gaming disorder, caffeine use disorder, hoarding disorder, premenstrual dysphoric disorder). Consequence-based ethical concerns about this expansion are addressed, along with conceptual concerns about a confusion of "construct validity" and "conceptual validity" and a failure to distinguish between "disorder" and "non disordered conditions for which we help people."(2) The role of claims about societal impact in changes in nosology: Several changes in the DSM-5 involved claims about societal impact in their rationales. This is due in part to a new online open comment period during DSM development. Examples include advancement of science, greater access to treatment, greater public awareness of condition, loss of identify or harm to those with removed disorders, stigmatization, offensiveness, etc. I identify and evaluate four importantly distinct ways in which claims about societal impact might operate in DSM development. (3) Categorisation nosology to spectrum nosology: The move to "degrees of severity" of mental disorders, a major change for DSM-5, raises concerns about conceptual clarity and uniformity concerning what it means to have a severe form of a disorder, and ethical concerns about communication.

  5. Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: Method development, optimization, validation, and its application to a pharmacokinetic study.

    PubMed

    Khan, Abbas; Iqbal, Zafar; Khan, Muhammad Imran; Javed, Khalid; Khan, Abad; Ahmad, Lateef; Shah, Yasar; Nasir, Fazli

    2011-08-15

    A novel isocratic reversed-phase high performance liquid-chromatography/ultraviolet detection method for simultaneous determination of cefdinir and cefixime in human plasma was developed and validated after optimization of various chromatographic conditions and other experimental parameters. Sample preparation based on a simple extraction procedure consisting of deproteination and extraction with 3 parts of 6% trichloroacetic acid aqueous solution followed by volume make up with the aqueous component of the mobile phase obtained best recoveries of the two analytes. Samples were separated on a Supelco Discovery HS C(18) (150 mm × 4.6 mm, 5 μm) analytical column protected by a Perkin Elmer C(18) (30 mm × 4.6 mm, 10 μm) guard cartridge. The mobile phase, methanol/acetonitrile (50/50, v/v):0.05% trifluoroacetic acid (19:81, v/v), operated at 50°C column oven temperature was pumped at a flow rate of 2.0 mL min(-1) and the column eluents were monitored at a wavelength of 285 nm. When Sample was injected into the Perkin Elmer high performance liquid-chromatography system through Rheodyne manual (or auto-sampler) injector equipped with 20 μL loop, separation was achieved within 4 min. The present method demonstrated acceptable values for selectivity, linearity within the expected concentration range (0.004-5.0 μg mL(-1); r(2)>0.999 for both analytes), recovery (>95% for cefdinir and >96% for cefixime), precision (%RSD<2.0 for cefdinir and <2.2 for cefixime), sensitivity (limit of detection: 1 ng mL(-1) and lower limit of quantification: 4 ng mL(-1) for both analytes), stability of solutions, and robustness. The method was efficiently applied to a pharmacokinetic study in healthy volunteers. Copyright © 2011 Elsevier B.V. All rights reserved.

  6. Fast sampling, rapid filtration apparatus: principal characteristics and validation from studies of D-glucose transport in human jejunal brush-border membrane vesicles.

    PubMed

    Berteloot, A; Malo, C; Breton, S; Brunette, M

    1991-06-01

    Kinetic data in (brush-border) membrane vesicles which rely on the validity of the initial rate assumption for their interpretation and depend on tracer flux studies using the rapid filtration technique for their experimental measurement have been limited to some extent by the absence of techniques that would allow for real-time data analysis. In this paper, we report on our successful design of a fast sampling, rapid filtration apparatus (FSRFA) which seems to fill up this technical gap since showing the following characteristics: (i) rapid injection (5 msec) and mixing (less than 100 msec) of small amounts of vesicles (10-40 microliters) with an incubation medium (0.2-1.0 ml); (ii) fast (20 to 80 msec depending on the sample volume) and multiple (up to 18 samples at a maximal rate of 4 sec) sampling of the uptake mixture followed by rapid quenching in the stop solution (approximately 5 msec) according to a predetermined time schedule (any time combination from 0.25 to 9999 sec); and (iii) fast, automated, and sampling-synchronized filtration and washings of the quenched uptake medium (only 15-20 sec are necessary for the first filtration followed by two washings and extra filtrations). As demonstrated using adult human jejunal brush-border membrane vesicles and Na(+)-D-glucose cotransport as models, the FSRFA accurately reproduces the manual aspects of the rapid filtration technique while allowing for very precise initial rate determinations. Moreover, the FSRFA has also been designed to provide as much versatility as possible and, in its present version, allows for a very precise control of the incubation temperature and also permits a few efflux protocols to be performed. Finally, its modular design, which separates the fast sampling unit from the rapid filtration device, should help in extending its use to fields other than transport measurement.

  7. The canine model of human cognitive aging and dementia: pharmacological validity of the model for assessment of human cognitive-enhancing drugs.

    PubMed

    Studzinski, Christa M; Araujo, Joseph A; Milgram, Norton W

    2005-03-01

    For the past 15 years we have investigated the aged beagle dog as a model for human aging and dementia. We have shown that dogs develop cognitive deficits and neuropathology seen in human aging and dementia. These similarities increase the likelihood that the model will be able to accurately predict the efficacy of Alzheimer's disease (AD) treatments as well as detect therapeutics with limited or no efficacy. Better predictive validity of cognitive-enhancing therapeutics (CETs) could lead to enormous cost savings by reducing the number of failed human clinical trials and also may reduce the likelihood of negative outcomes such as those recently observed in the AN-1792 clinical trials. The current review assesses the pharmacological validity of the canine model of human aging and dementia. We tested the efficacy of (1) CP-118,954 and phenserine, two acetylcholinesterase inhibitors, (2) an ampakine, (3) selegiline hydrochloride, two drugs that have failed human AD trials, and (4) adrafinil, a putative CET. Our research demonstrates that dogs not only develop isomorphic changes in human cognition and brain pathology, but also accurately predict the efficacy of known AD treatments and the absence or limited efficacy of treatments that failed clinical trials. These findings collectively support the utilization of the dog model as a preclinical screen for identifying novel CETs for both age-associated memory disorder and dementia.

  8. Why test animals to treat humans? On the validity of animal models.

    PubMed

    Shelley, Cameron

    2010-09-01

    Critics of animal modeling have advanced a variety of arguments against the validity of the practice. The point of one such form of argument is to establish that animal modeling is pointless and therefore immoral. In this article, critical arguments of this form are divided into three types, the pseudoscience argument, the disanalogy argument, and the predictive validity argument. I contend that none of these criticisms currently succeed, nor are they likely to. However, the connection between validity and morality is important, suggesting that critical efforts would be instructive if they addressed it in a more nuanced way. Copyright © 2010 Elsevier Ltd. All rights reserved.

  9. Experimental validation of a reach-and grasp optimization algorithm inspired to human arm-hand control.

    PubMed

    Cordella, F; Zollo, L; Salerno, A; Guglielmelli, E; Siciliano, B

    2011-01-01

    Taking inspiration from neurophysiological studies on synergies in the human grasping action, this paper tries to demonstrate that it is possible to find a general rule for performing a stable, human-like cylindrical grasp with a robotic hand. To this purpose, the theoretical formulation and the experimental validation of a reach-and-grasp algorithm for determining the optimal hand position and the optimal finger configuration for grasping a cylindrical object with known features are presented. The proposed algorithm is based on the minimization of an objective function expressed by the sum of the distances of the hand joints from the object surface. Algorithm effectiveness has preliminarily been tested by means of simulation trials. Experimental trials on a real arm-hand robotic system have then been carried out in order to validate the approach and evaluate algorithm performance.

  10. Human factors design, verification, and validation for two types of control room upgrades at a nuclear power plant

    SciTech Connect

    Boring, Laurids Ronald

    2014-10-01

    This paper describes the NUREG-0711 based human factors engineering (HFE) phases and associated elements required to support design, verification and validation (V&V), and implementation of a new plant process computer (PPC) and turbine control system (TCS) at a representative nuclear power plant. This paper reviews ways to take a human-system interface (HSI) specification and use it when migrating legacy PPC displays or designing displays with new functionality. These displays undergo iterative usability testing during the design phase and then undergo an integrated system validation (ISV) in a full scope control room training simulator. Following the successful demonstration of operator performance with the systems during the ISV, the new system is implemented at the plant, first in the training simulator and then in the main control room.

  11. Product Manuals: A Consumer Perspective.

    ERIC Educational Resources Information Center

    Showers, Linda S.; And Others

    1993-01-01

    Qualitative analysis of insights from consumer focus groups on product manual usage reveals consumer perceptions and preferences regarding manual and safety message format. Results can be used to improve manual design and content. (JOW)

  12. MRM validation of targeted nonglycosylated peptides from N-glycoprotein biomarkers using direct trypsin digestion of undepleted human plasma.

    PubMed

    Lee, Ju Yeon; Kim, Jin Young; Cheon, Mi Hee; Park, Gun Wook; Ahn, Yeong Hee; Moon, Myeong Hee; Yoo, Jong Shin

    2014-02-26

    A rapid, simple, and reproducible MRM-based validation method for serological glycoprotein biomarkers in clinical use was developed by targeting the nonglycosylated tryptic peptides adjacent to N-glycosylation sites. Since changes in protein glycosylation are known to be associated with a variety of diseases, glycoproteins have been major targets in biomarker discovery. We previously found that nonglycosylated tryptic peptides adjacent to N-glycosylation sites differed in concentration between normal and hepatocellular carcinoma (HCC) plasma due to differences in steric hindrance of the glycan moiety in N-glycoproteins to tryptic digestion (Lee et al., 2011). To increase the feasibility and applicability of clinical validation of biomarker candidates (nonglycosylated tryptic peptides), we developed a method to effectively monitor nonglycosylated tryptic peptides from a large number of plasma samples and to reduce the total analysis time with maximizing the effect of steric hindrance by the glycans during digestion of glycoproteins. The AUC values of targeted nonglycosylated tryptic peptides were excellent (0.955 for GQYCYELDEK, 0.880 for FEDGVLDPDYPR and 0.907 for TEDTIFLR), indicating that these could be effective biomarkers for hepatocellular carcinoma. This method provides the necessary throughput required to validate glycoprotein biomarkers, as well as quantitative accuracy for human plasma analysis, and should be amenable to clinical use. Difficulties in verifying and validating putative protein biomarkers are often caused by complex sample preparation procedures required to determine their concentrations in a large number of plasma samples. To solve the difficulties, we developed MRM-based protein biomarker assays that greatly reduce complex, time-consuming, and less reproducible sample pretreatment steps in plasma for clinical implementation. First, we used undepleted human plasma samples without any enrichment procedures. Using nanoLC/MS/MS, we targeted

  13. Patient-specific finite element analysis of the human femur--a double-blinded biomechanical validation.

    PubMed

    Trabelsi, Nir; Yosibash, Zohar; Wutte, Christof; Augat, Peter; Eberle, Sebastian

    2011-06-03

    Patient-specific finite element (PSFE) models based on quantitative computer tomography (qCT) are generally used to "predict" the biomechanical response of human bones with the future goal to be applied in clinical decision-making. However, clinical applications require a well validated tool that is free of numerical errors and furthermore match closely experimental findings. In previous studies, not all measurable data (strains and displacements) were considered for validation. Furthermore, the same research group performed both the experiments and PSFE analyses; thus, the validation may have been biased. The aim of the present study was therefore to validate PSFE models with biomechanical experiments, and to address the above-mentioned issues of measurable data and validation bias. A PSFE model (p-method) of each cadaver femur (n = 12) was generated based on qCT scans of the specimens. The models were validated by biomechanical in-vitro experiments, which determined strains and local displacements on the bone surface and the axial stiffness of the specimens. The validation was performed in a double-blinded manner by two different research institutes to avoid any bias. Inspecting all measurements (155 values), the numerical results correlated well with the experimental results (R(2) = 0.93, slope 1.0093, mean of absolute deviations 22%). In conclusion, a method to generate PSFE models from qCT scans was used in this study on a sample size not yet considered in the past, and compared to experiments in a douple-blinded manner. The results demonstrate that the presented method is in an advanced stage, and can be used in clinical computer-aided decision-making.

  14. Parametric Comparisons of Intracranial Mechanical Responses from Three Validated Finite Element Models of the Human Head

    PubMed Central

    Ji, Songbai; Ghadyani, Hamidreza; Bolander, Richard P.; Beckwith, Jonathan G.; Ford, James C.; Mcallister, Thomas W.; Flashman, Laura A.; Paulsen, Keith D.; Ernstrom, Karin; Jain, Sonia; Raman, Rema; Zhang, Liying; Greenwald, Richard M.

    2015-01-01

    A number of human head finite element (FE) models have been developed from different research groups over the years to study the mechanisms of traumatic brain injury. These models can vary substantially in model features and parameters, making it important to evaluate whether simulation results from one model are readily comparable with another, and whether response-based injury thresholds established from a specific model can be generalized when a different model is employed. The purpose of this study is to parametrically compare regional brain mechanical responses from three validated head FE models to test the hypothesis that regional brain responses are dependent on the specific head model employed as well as the region of interest (ROI). The Dartmouth Scaled and Normalized Model (DSNM), the Simulated Injury Monitor (SIMon), and the Wayne State University Head Injury Model (WSUHIM) were selected for comparisons. For model input, 144 unique kinematic conditions were created to represent the range of head impacts sustained by male collegiate hockey players during play. These impacts encompass the 50th, 95th, and 99th percentile peak linear and rotational accelerations at 16 impact locations around the head. Five mechanical variables (strain, strain rate, strain × strain rate, stress, and pressure) in seven ROIs reported from the FE models were compared using Generalized Estimating Equation statistical models. Highly significant differences existed among FE models for nearly all output variables and ROIs. The WSUHIM produced substantially higher peak values for almost all output variables regardless of the ROI compared to the DSNM and SIMon models (p < 0.05). DSNM also produced significantly different stress and pressure compared with SIMon for all ROIs (p < 0.05), but such differences were not consistent across ROIs for other variables. Regardless of FE model, most output variables were highly correlated with linear and rotational peak accelerations. The

  15. Human liver finite element model validation using compressive and tensile experimental data - biomed 2013.

    PubMed

    Davis, Matthew L; Moreno, Daniel P; Vavalle, Nicholas A; Gayzik, F Scott

    2013-01-01

    Motor vehicle crashes commonly result in blunt abdominal trauma. Approximately 19,000 such injuries occur each year in the United States. While finite element models of the human body are becoming an important tool for injury assessment, their reliability depends on the accuracy of the material models used. Recently, Samur et al. proposed a hyperelastic and viscoelastic material model of the liver. The aim of this study was to compare the results of a computational model using this material law to uniaxial tension and compression data from biomechanical tests on liver samples by Kemper et al. In this study, the liver samples were modeled using the finite element method. Both the tension and compression test specimen geometries were created from descriptions in the literature. Each sample was meshed using four approaches: fine hexahedral, coarse hexahedral, fine tetrahedral, and coarse tetrahedral. The average element edge lengths of the coarse and fine meshes were 5 mm and 2.5 mm respectively. The samples were loaded in both tension and compression at four rates: 0.01 strain/sec, 0.1 strain/sec, 1 strain/sec, and 10 strain/sec. For each mesh type (n=4), strain rate (n=4), and loading condition (n=2), 32 simulations in total, the results were plotted against the published experimental data. The results were quantitatively evaluated for magnitude and phase agreement with the experimental data using an objective comparison software package, CORA. The model predicted the tensile response of the liver sample more accurately than the compressive response with an average CORA size error factor of 0.66 versus 0.19 for the compressive model (1 is a perfect match). The fine tetrahedral, fine hexahedral, and coarse hexahedral meshes predicted a similar response. The worst performing mesh was the coarse tetrahedral mesh, which had an average size error factor of 8.6% higher than the fine tetrahedral simulations. The peak stress in both tension and compression varied as a

  16. EOS imaging of the human pelvis: reliability, validity, and controlled comparison with radiography.

    PubMed

    Bittersohl, Bernd; Freitas, Joana; Zaps, Daniela; Schmitz, Matthew R; Bomar, James D; Muhamad, Abd R; Hosalkar, Harish S

    2013-05-01

    The EOS technique represents a unique imaging modality combining low radiation exposure with high image quality. As its applications for pelvic imaging may increase with time, we performed a pilot study to evaluate the validity and reliability of this technique for the assessment of gross pelvic and acetabular morphology. Consecutive conventional and EOS radiographs of a human cadaveric pelvis were made in 5° intervals of sagittal tilt and axial rotation (range, -15° to 15° for each). Six measurements were made on each image: (1) the vertical distance between the sacrococcygeal joint and the upper border of the pubic symphysis, (2) the horizontal distance between the midpoints of these structures, (3) the distance between the anterior superior iliac spines, (4) the distance between the facets of S1, (5) the Sharp angle, and (6) the Tönnis angle. Coxa profunda and crossover signs were also evaluated. The findings of the two imaging techniques were correlated with each other and with true linear measurements made on the cadaveric pelvis. All measurements were performed by two independent observers, and one observer repeated all measurements to assess reproducibility. Both observers were blinded to the true linear measurements made on the pelvis. There was a strong correlation between the results of the conventional and EOS radiography (Pearson correlation coefficient, 0.644 to 0.998), and both modalities had high intraobserver and interobserver reproducibility (intraclass correlation coefficient, 0.795 to 1.000). Intraobserver and interobserver agreement on the presence of coxa profunda were both 100%. Intraobserver agreement (96.2%) and interobserver agreement (92.3%) on the presence of the crossover sign were marginally lower. Linear measurements differed significantly between the two modalities because of distortion caused by magnification effects in the conventional radiographic imaging (p < 0.05). The EOS imaging technique proved reliable for the

  17. Intra-Laboratory Pre-Validation of a Human Cell Based in vitro Angiogenesis Assay for Testing Angiogenesis Modulators

    PubMed Central

    Sarkanen, Jertta-Riina; Mannerström, Marika; Vuorenpää, Hanna; Uotila, Jukka; Ylikomi, Timo; Heinonen, Tuula

    2010-01-01

    The developed standardized human cell based in vitro angiogenesis assay was intra-laboratory pre-validated to verify that the method is reliable and relevant for routine testing of modulators of angiogenesis, e.g., pharmaceuticals and industrial chemicals. This assay is based on the earlier published method but it was improved and shown to be more sensitive and rapid than the previous assay. The performance of the assay was assessed by using six reference chemicals, which are widely used pharmaceuticals that inhibit angiogenesis: acetyl salicylic acid, erlotinib, 2-methoxyestradiol, levamisole, thalidomide, and anti-vascular endothelial growth factor. In the intra-laboratory pre-validation, the sensitivity of the assay (upper and lower limits of detection and linearity of response in tubule formation), batch to batch variation in tubule formation between different Master cell bank batches, and precision as well as the reliability of the assay (reproducibility and repeatability) were tested. The pre-set acceptance criteria for the intra-laboratory pre-validation study were met. The relevance of the assay in man was investigated by comparing the effects of reference chemicals and their concentrations to the published human data. The comparison showed a good concordance, which indicates that this human cell based angiogenesis model predicts well the effects in man and has the potential to be used to supplement and/or replace of animal tests. PMID:21779245

  18. Salinas : theory manual.

    SciTech Connect

    Walsh, Timothy Francis; Reese, Garth M.; Bhardwaj, Manoj Kumar

    2004-08-01

    This manual describes the theory behind many of the constructs in Salinas. For a more detailed description of how to use Salinas , we refer the reader to Salinas, User's Notes. Many of the constructs in Salinas are pulled directly from published material. Where possible, these materials are referenced herein. However, certain functions in Salinas are specific to our implementation. We try to be far more complete in those areas. The theory manual was developed from several sources including general notes, a programer-notes manual, the user's notes and of course the material in the open literature.

  19. CMS RATFOR System Manual.

    DTIC Science & Technology

    1979-07-01

    CMS RATFOR SYSTEM MANUAL.(U) U 79 S M CHOQUETTE, R J ORGASS AFOSR-79-O021 NCLASSIFIED VPI/SU-TM-79- AFOSR -TR-80-0277 NI MEhLlllllElIIIIIIII...GRADUATE PROGRAM IN NORTHERN VIRGINIA FAtheqsow, AC 20041 (703) 471-4600 CMS RATFOR SYSTEM MANUAL*t Stephen M. Choquette and Richard J. Orgass DTIO...the System Manual for the RATFOR preprocessor on the IBM CMS timesharing system . Included in this paper is a language description of RATPOR, an

  20. Fire Protection Program Manual

    SciTech Connect

    Sharry, J A

    2012-05-18

    This manual documents the Lawrence Livermore National Laboratory (LLNL) Fire Protection Program. Department of Energy (DOE) Orders 420.1B, Facility Safety, requires LLNL to have a comprehensive and effective fire protection program that protects LLNL personnel and property, the public and the environment. The manual provides LLNL and its facilities with general information and guidance for meeting DOE 420.1B requirements. The recommended readers for this manual are: fire protection officers, fire protection engineers, fire fighters, facility managers, directorage assurance managers, facility coordinators, and ES and H team members.

  1. Simultaneous determination and validated quantification of human insulin and its synthetic analogues in human blood serum by immunoaffinity purification and liquid chromatography-mass spectrometry.

    PubMed

    Hess, Cornelius; Thomas, Andreas; Thevis, Mario; Stratmann, Bernd; Quester, Wulf; Tschoepe, Diethelm; Madea, Burkhard; Musshoff, Frank

    2012-10-01

    Possible fatal complications of human insulin and its synthetic analogues like hypoglycemia require precise classification and quantitative determination of these drugs both for clinical purposes as well as for forensic toxicologists. A procedure was developed for the identification and quantification of human insulin and different long-acting as well as short-acting synthetic insulins in human blood serum specimens. After an immunoaffinity purification step and separation by liquid chromatography, the insulins were characterized by their five- or sixfold protonated molecule ions and diagnostic product ions. Clinical samples of 207 diabetic and 50 non-diabetic patients after the administration of human insulin or oral antidiabetics and forensic samples were analyzed for human/synthetic insulin concentrations. The method was validated according to international guidelines. Limits of detection of the insulins ranged between 1.3 and 2.8 μU/ml. Recoveries ranged between 33.2 % and 51.7 %. Precision data was in accordance with international guidelines. Clinical samples showed concentrations of human insulin lower than 301 μU/ml. Our liquid chromatography tandem mass spectrometry procedure allows unambiguous identification and quantification of the intact human insulin and its intact synthetic analogues Humalog®, Novolog®, Apidra®, Lantus®, and Levemir® in human blood serum in clinical and overdose cases. The assay could be successfully tested in patients with diabetes mellitus on therapy with insulins or oral antidiabetics.

  2. Vegetation Change Analysis User's Manual

    SciTech Connect

    D. J. Hansen; W. K. Ostler

    2002-10-01

    Approximately 70 percent of all U.S. military training lands are located in arid and semi-arid areas. Training activities in such areas frequently adversely affect vegetation, damaging plants and reducing the resilience of vegetation to recover once disturbed. Fugitive dust resulting from a loss of vegetation creates additional problems for human health, increasing accidents due to decreased visibility, and increasing maintenance costs for roads, vehicles, and equipment. Diagnostic techniques are needed to identify thresholds of sustainable military use. A cooperative effort among U.S. Department of Energy, U.S. Department of Defense, and selected university scientists was undertaken to focus on developing new techniques for monitoring and mitigating military impacts in arid lands. This manual focuses on the development of new monitoring techniques that have been implemented at Fort Irwin, California. New mitigation techniques are described in a separate companion manual. This User's Manual is designed to address diagnostic capabilities needed to distinguish between various degrees of sustainable and nonsustainable impacts due to military training and testing and habitat-disturbing activities in desert ecosystems. Techniques described here focus on the use of high-resolution imagery and the application of image-processing techniques developed primarily for medical research. A discussion is provided about the measurement of plant biomass and shrub canopy cover in arid. lands using conventional methods. Both semiquantitative methods and quantitative methods are discussed and reference to current literature is provided. A background about the use of digital imagery to measure vegetation is presented.

  3. [Development of a Crisis Management Manual for Occupational Health Experts].

    PubMed

    Matsuoka, Juri; Tateishi, Seiichiro; Igarashi, Yu; Ide, Hiroshi; Miyamoto, Toshiaki; Hara, Tatsuhiko; Kobashi, Masaki; Inoue, Megumi; Kawashima, Megumi; Okada, Takeo; Mori, Koji

    2015-12-01

    When crises such as natural disasters or industrial accidents occur in workplaces, not only the workers who are injured, but also those who engage in emergency or recovery work may be exposed to various health hazards. We developed a manual to enable occupational health (OH) experts to prevent health hazards. The manual includes detailed explanations of the characteristics and necessary actions for each need in the list of "OH Needs During Crisis Management" developed after an analysis of eight cases in our previous research. We changed the endings of explanatory sentences so that users could learn how often each need occurred in these eight cases. We evaluated the validity of the manual using two processes: 1) Providing the manual to OH physicians during an industrial accident; 2) Asking crisis management experts to review the manual. We made improvements based on their feedback and completed the manual. The manual includes explanations about 99 OH needs, and users can learn how and what to do for each need during various crisis cases. Because additional OH needs may occur in other crises, it is necessary to collect information about new cases and to improve the comprehensiveness of the manual continuously. It is critical that this crisis management manual be available when a crisis occurs. We need to inform potential users of the manual through various media, as well as by posting it on our website.

  4. Immunohistochemical validation and expression profiling of NKG2D ligands in a wide spectrum of human epithelial neoplasms.

    PubMed

    Fujita, Hiromi; Hatanaka, Yutaka; Sutoh, Yoichi; Suzuki, Yuta; Oba, Koji; Hatanaka, Kanako C; Mitsuhashi, Tomoko; Otsuka, Noriyuki; Fugo, Kazunori; Kasahara, Masanori; Matsuno, Yoshihiro

    2015-03-01

    The MHC class I-chain-related proteins (MICs) and the UL16-binding proteins (ULBPs) are inducible stress response molecules that work as activators of a specific receptor, NKG2D, which is expressed on effector cells, such as NK cells and subsets of T cells. In this study, we sought to explore the biological significance of NKG2D ligands in human neoplasms by comprehensively examining the immunohistochemical expression profile of NKG2D ligands in a variety of human epithelial neoplasms. Following careful validation of the immunohistochemical specificity and availability of anti-human ULBP antibodies for formalin-fixed paraffin-embedded (FFPE) materials, the expression of NKG2D ligands was analyzed in FFPE tissue microarrays comprising 22 types of epithelial neoplastic tissue with their non-neoplastic counterpart from various organs. Hierarchical cluster analysis demonstrated a positive relationship among ULBP2/6, ULBP3, ULBP1, and ULBP5, whose expression patterns were similar across all of the neoplastic tissues examined. In contrast, MICA/B, as well as ULBP4, did not appear to be related to any other ligand. These expression profiles of NKG2D ligands in human neoplasms based on well-validated specific antibodies, followed by hierarchical cluster analysis, should help to clarify some functional aspects of these molecules in cancer biology, and also provide a path to the development of novel tumor-type-specific treatment strategies.

  5. A validation study for the extraction and analysis of DNA from human nail material and its application to forensic casework.

    PubMed

    Anderson, T D; Ross, J P; Roby, R K; Lee, D A; Holland, M M

    1999-09-01

    A validation study was conducted to demonstrate that deoxyribonucleic acid (DNA) could be successfully extracted from human nail material and analyzed using short tandem repeat (STR) profiling and/or mitochondrial DNA (mtDNA) sequencing. This study involved the development of a DNA extraction protocol that includes a cleaning procedure designed to remove external contaminants (e.g., biological, chemical). This protocol was used to test human nail material that had been soaked in whole blood from a second donor and coated with gold-palladium to simulate scanning electron microscopic analysis. The results showed no indication of a mixture and were consistent with that of the nail donor. Fresh human nail material usually yielded both STR profiles and mtDNA sequence information; however, aged human nail material (approximately eight years old) yielded only mtDNA sequence information. Upon completion of the validation study, the extraction protocol was used for the analysis of a torn fingernail fragment recovered from the scene of a violent homicide in 1983. A partial STR profile and mtDNA sequence information indicated that the fingernail fragment was excluded as originating from the suspect and was, in fact, consistent with originating from one of the victims.

  6. Immunohistochemical Validation and Expression Profiling of NKG2D Ligands in a Wide Spectrum of Human Epithelial Neoplasms

    PubMed Central

    Fujita, Hiromi; Hatanaka, Yutaka; Sutoh, Yoichi; Suzuki, Yuta; Oba, Koji; Hatanaka, Kanako C.; Mitsuhashi, Tomoko; Otsuka, Noriyuki; Fugo, Kazunori; Kasahara, Masanori

    2015-01-01

    The MHC class I-chain-related proteins (MICs) and the UL16-binding proteins (ULBPs) are inducible stress response molecules that work as activators of a specific receptor, NKG2D, which is expressed on effector cells, such as NK cells and subsets of T cells. In this study, we sought to explore the biological significance of NKG2D ligands in human neoplasms by comprehensively examining the immunohistochemical expression profile of NKG2D ligands in a variety of human epithelial neoplasms. Following careful validation of the immunohistochemical specificity and availability of anti-human ULBP antibodies for formalin-fixed paraffin-embedded (FFPE) materials, the expression of NKG2D ligands was analyzed in FFPE tissue microarrays comprising 22 types of epithelial neoplastic tissue with their non-neoplastic counterpart from various organs. Hierarchical cluster analysis demonstrated a positive relationship among ULBP2/6, ULBP3, ULBP1, and ULBP5, whose expression patterns were similar across all of the neoplastic tissues examined. In contrast, MICA/B, as well as ULBP4, did not appear to be related to any other ligand. These expression profiles of NKG2D ligands in human neoplasms based on well-validated specific antibodies, followed by hierarchical cluster analysis, should help to clarify some functional aspects of these molecules in cancer biology, and also provide a path to the development of novel tumor-type-specific treatment strategies. PMID:25473094

  7. Toward experimental validation of a model for human sensorimotor learning and control in teleoperation

    NASA Astrophysics Data System (ADS)

    Roth, Eatai; Howell, Darrin; Beckwith, Cydney; Burden, Samuel A.

    2017-05-01

    Humans, interacting with cyber-physical systems (CPS), formulate beliefs about the system's dynamics. It is natural to expect that human operators, tasked with teleoperation, use these beliefs to control the remote robot. For tracking tasks in the resulting human-cyber-physical system (HCPS), theory suggests that human operators can achieve exponential tracking (in stable systems) without state estimation provided they possess an accurate model of the system's dynamics. This internalized inverse model, however, renders a portion of the system state unobservable to the human operator—the zero dynamics. Prior work shows humans can track through observable linear dynamics, thus we focus on nonlinear dynamics rendered unobservable through tracking control. We propose experiments to assess the human operator's ability to learn and invert such models, and distinguish this behavior from that achieved by pure feedback control.

  8. Validating genetic markers of response to recombinant human growth hormone in children with growth hormone deficiency and Turner syndrome: the PREDICT validation study

    PubMed Central

    Stevens, Adam; Murray, Philip; Wojcik, Jerome; Raelson, John; Koledova, Ekaterina; Chatelain, Pierre

    2016-01-01

    Objective Single-nucleotide polymorphisms (SNPs) associated with the response to recombinant human growth hormone (r-hGH) have previously been identified in growth hormone deficiency (GHD) and Turner syndrome (TS) children in the PREDICT long-term follow-up (LTFU) study (Nbib699855). Here, we describe the PREDICT validation (VAL) study (Nbib1419249), which aimed to confirm these genetic associations. Design and methods Children with GHD (n = 293) or TS (n = 132) were recruited retrospectively from 29 sites in nine countries. All children had completed 1 year of r-hGH therapy. 48 SNPs previously identified as associated with first year growth response to r-hGH were genotyped. Regression analysis was used to assess the association between genotype and growth response using clinical/auxological variables as covariates. Further analysis was undertaken using random forest classification. Results The children were younger, and the growth response was higher in VAL study. Direct genotype analysis did not replicate what was found in the LTFU study. However, using exploratory regression models with covariates, a consistent relationship with growth response in both VAL and LTFU was shown for four genes – SOS1 and INPPL1 in GHD and ESR1 and PTPN1 in TS. The random forest analysis demonstrated that only clinical covariates were important in the prediction of growth response in mild GHD (>4 to <10 μg/L on GH stimulation test), however, in severe GHD (≤4 μg/L) several SNPs contributed (in IGF2, GRB10, FOS, IGFBP3 and GHRHR). Conclusions The PREDICT validation study supports, in an independent cohort, the association of four of 48 genetic markers with growth response to r-hGH treatment in both pre-pubertal GHD and TS children after controlling for clinical/auxological covariates. However, the contribution of these SNPs in a prediction model of first-year response is not sufficient for routine clinical use. PMID:27651465

  9. Peace Corps Aquaculture Training Manual. Training Manual T0057.

    ERIC Educational Resources Information Center

    Peace Corps, Washington, DC. Information Collection and Exchange Div.

    This Peace Corps training manual was developed from two existing manuals to provide a comprehensive training program in fish production for Peace Corps volunteers. The manual encompasses the essential elements of the University of Oklahoma program that has been training volunteers in aquaculture for 25 years. The 22 chapters of the manual are…

  10. Geochemical engineering reference manual

    SciTech Connect

    Owen, L.B.; Michels, D.E.

    1984-01-01

    The following topics are included in this manual: physical and chemical properties of geothermal brine and steam, scale and solids control, processing spent brine for reinjection, control of noncondensable gas emissions, and goethermal mineral recovery. (MHR)

  11. MARSAME Manual and Resources

    EPA Pesticide Factsheets

    MARSAME provides technical information on survey approaches to determine proper disposition of materials and equipment (M&E). MARSAME is a supplement to the Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM).

  12. FIFRA Project Officers Manual

    EPA Pesticide Factsheets

    The FIFRA Project Officers Manual provides guidance to new as well as experienced project officers in the management of grants and cooperative agreements under the Federal Insecticide, Fungicide and Rodenticide Act.

  13. Case Resolution Manual

    EPA Pesticide Factsheets

    This Case Resolution Manual (CRM) is intended to provide procedural guidance to ECRCO case managers to ensure EPA’s prompt, effective, and efficient resolution of civil rights cases consistent with science and the civil rights laws.

  14. Interactive Office user's manual

    NASA Technical Reports Server (NTRS)

    Montgomery, Edward E.; Lowers, Benjamin; Nabors, Terri L.

    1990-01-01

    Given here is a user's manual for Interactive Office (IO), an executive office tool for organization and planning, written specifically for Macintosh. IO is a paperless management tool to automate a related group of individuals into one productive system.

  15. Validation of In utero Tractography of Human Fetal Commissural and Internal Capsule Fibers with Histological Structure Tensor Analysis

    PubMed Central

    Mitter, Christian; Jakab, András; Brugger, Peter C.; Ricken, Gerda; Gruber, Gerlinde M.; Bettelheim, Dieter; Scharrer, Anke; Langs, Georg; Hainfellner, Johannes A.; Prayer, Daniela; Kasprian, Gregor

    2015-01-01

    Diffusion tensor imaging (DTI) and tractography offer the unique possibility to visualize the developing white matter macroanatomy of the human fetal brain in vivo and in utero and are currently under investigation for their potential use in the diagnosis of developmental pathologies of the human central nervous system. However, in order to establish in utero DTI as a clinical imaging tool, an independent comparison between macroscopic imaging and microscopic histology data in the same subject is needed. The present study aimed to cross-validate normal as well as abnormal in utero tractography results of commissural and internal capsule fibers in human fetal brains using postmortem histological structure tensor (ST) analysis. In utero tractography findings from two structurally unremarkable and five abnormal fetal brains were compared to the results of postmortem ST analysis applied to digitalized whole hemisphere sections of the same subjects. An approach to perform ST-based deterministic tractography in histological sections was implemented to overcome limitations in correlating in utero tractography to postmortem histology data. ST analysis and histology-based tractography of fetal brain sections enabled the direct assessment of the anisotropic organization and main fiber orientation of fetal telencephalic layers on a micro- and macroscopic scale, and validated in utero tractography results of corpus callosum and internal capsule fiber tracts. Cross-validation of abnormal in utero tractography results could be achieved in four subjects with agenesis of the corpus callosum (ACC) and in two cases with malformations of internal capsule fibers. In addition, potential limitations of current DTI-based in utero tractography could be demonstrated in several brain regions. Combining the three-dimensional nature of DTI-based in utero tractography with the microscopic resolution provided by histological ST analysis may ultimately facilitate a more complete morphologic

  16. Validation of In utero Tractography of Human Fetal Commissural and Internal Capsule Fibers with Histological Structure Tensor Analysis.

    PubMed

    Mitter, Christian; Jakab, András; Brugger, Peter C; Ricken, Gerda; Gruber, Gerlinde M; Bettelheim, Dieter; Scharrer, Anke; Langs, Georg; Hainfellner, Johannes A; Prayer, Daniela; Kasprian, Gregor

    2015-01-01

    Diffusion tensor imaging (DTI) and tractography offer the unique possibility to visualize the developing white matter macroanatomy of the human fetal brain in vivo and in utero and are currently under investigation for their potential use in the diagnosis of developmental pathologies of the human central nervous system. However, in order to establish in utero DTI as a clinical imaging tool, an independent comparison between macroscopic imaging and microscopic histology data in the same subject is needed. The present study aimed to cross-validate normal as well as abnormal in utero tractography results of commissural and internal capsule fibers in human fetal brains using postmortem histological structure tensor (ST) analysis. In utero tractography findings from two structurally unremarkable and five abnormal fetal brains were compared to the results of postmortem ST analysis applied to digitalized whole hemisphere sections of the same subjects. An approach to perform ST-based deterministic tractography in histological sections was implemented to overcome limitations in correlating in utero tractography to postmortem histology data. ST analysis and histology-based tractography of fetal brain sections enabled the direct assessment of the anisotropic organization and main fiber orientation of fetal telencephalic layers on a micro- and macroscopic scale, and validated in utero tractography results of corpus callosum and internal capsule fiber tracts. Cross-validation of abnormal in utero tractography results could be achieved in four subjects with agenesis of the corpus callosum (ACC) and in two cases with malformations of internal capsule fibers. In addition, potential limitations of current DTI-based in utero tractography could be demonstrated in several brain regions. Combining the three-dimensional nature of DTI-based in utero tractography with the microscopic resolution provided by histological ST analysis may ultimately facilitate a more complete morphologic

  17. ICP-MS/MS-Based Ionomics: A Validated Methodology to Investigate the Biological Variability of the Human Ionome.

    PubMed

    Konz, Tobias; Migliavacca, Eugenia; Dayon, Loïc; Bowman, Gene; Oikonomidi, Aikaterini; Popp, Julius; Rezzi, Serge

    2017-05-05

    We here describe the development, validation and application of a quantitative methodology for the simultaneous determination of 29 elements in human serum using state-of-the-art inductively coupled plasma triple quadrupole mass spectrometry (ICP-MS/MS). This new methodology offers high-throughput elemental profiling using simple dilution of minimal quantity of serum samples. We report the outcomes of the validation procedure including limits of detection/quantification, linearity of calibration curves, precision, recovery and measurement uncertainty. ICP-MS/MS-based ionomics was used to analyze human serum of 120 older adults. Following a metabolomic data mining approach, the generated ionome profiles were subjected to principal component analysis revealing gender and age-specific differences. The ionome of female individuals was marked by higher levels of calcium, phosphorus, copper and copper to zinc ratio, while iron concentration was lower with respect to male subjects. Age was associated with lower concentrations of zinc. These findings were complemented with additional readouts to interpret micronutrient status including ceruloplasmin, ferritin and inorganic phosphate. Our data supports a gender-specific compartmentalization of the ionome that may reflect different bone remodelling in female individuals. Our ICP-MS/MS methodology enriches the panel of validated "Omics" approaches to study molecular relationships between the exposome and the ionome in relation with nutrition and health.

  18. Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma.

    PubMed

    Abu El-Enin, Mohammed Abu Bakr; Al-Ghaffar Hammouda, Mohammed El-Sayed Abd; El-Sherbiny, Dina Tawfik; El-Wasseef, Dalia Rashad; El-Ashry, Saadia Mahmoud

    2016-02-01

    A valid, sensitive and rapid spectrofluorimetric method has been developed and validated for determination of both tadalafil (TAD) and vardenafil (VAR) either in their pure form, in their tablet dosage forms or spiked in human plasma. This method is based on measurement of the native fluorescence of both drugs in acetonitrile at λem 330 and 470 nm after excitation at 280 and 275 nm for tadalafil and vardenafil, respectively. Linear relationships were obtained over the concentration range 4-40 and 10-250 ng/mL with a minimum detection of 1 and 3 ng/mL for tadalafil and vardenafil, respectively. Various experimental parameters affecting the fluorescence intensity were carefully studied and optimized. The developed method was applied successfully for the determination of tadalafil and vardenafil in bulk drugs and tablet dosage forms. Moreover, the high sensitivity of the proposed method permitted their determination in spiked human plasma. The developed method was validated in terms of specificity, linearity, lower limit of quantification (LOQ), lower limit of detection (LOD), precision and accuracy. The mean recoveries of the analytes in pharmaceutical preparations were in agreement with those obtained from the comparison methods, as revealed by statistical analysis of the obtained results using Student's t-test and the variance ratio F-test.

  19. Advanced forensic validation for human spermatozoa identification using SPERM HY-LITER™ Express with quantitative image analysis.

    PubMed

    Takamura, Ayari; Watanabe, Ken; Akutsu, Tomoko

    2017-01-19

    Identification of human semen is indispensable for the investigation of sexual assaults. Fluorescence staining methods using commercial kits, such as the series of SPERM HY-LITER™ kits, have been useful to detect human sperm via strong fluorescence. These kits have been examined from various forensic aspects. However, because of a lack of evaluation methods, these studies did not provide objective, or quantitative, descriptions of the results nor clear criteria for the decisions reached. In addition, the variety of validations was considerably limited. In this study, we conducted more advanced validations of SPERM HY-LITER™ Express using our established image analysis method. Use of this method enabled objective and specific identification of fluorescent sperm's spots and quantitative comparisons of the sperm detection performance under complex experimental conditions. For body fluid mixtures, we examined interference with the fluorescence staining from other body fluid components. Effects of sample decomposition were simulated in high humidity and high temperature conditions. Semen with quite low sperm concentrations, such as azoospermia and oligospermia samples, represented the most challenging cases in application of the kit. Finally, the tolerance of the kit against various acidic and basic environments was analyzed. The validations herein provide useful information for the practical applications of the SPERM HY-LITER™ Express kit, which were previously unobtainable. Moreover, the versatility of our image analysis method toward various complex cases was demonstrated.

  20. Salinas. Theory Manual Version 2.8

    SciTech Connect

    Reese, Garth M.; Walsh, Timothy; Bhardwaj, Manoj K.

    2009-02-01

    Salinas provides a massively parallel implementation of structural dynamics finite element analysis, required for high fidelity, validated models used in modal, vibration, static and shock analysis of structural systems. This manual describes the theory behind many of the constructs in Salinas. For a more detailed description of how to use Salinas , we refer the reader to Salinas, Users Notes. Many of the constructs in Salinas are pulled directly from published material. Where possible, these materials are referenced herein. However, certain functions in Salinas are specific to our implementation. We try to be far more complete in those areas. The theory manual was developed from several sources including general notes, a programmer notes manual, the user's notes and of course the material in the open literature.

  1. Validation of bovine hoof slices as a model for infected human toenails: in vitro ciclopirox transungual permeation.

    PubMed

    Monti, D; Saccomani, L; Chetoni, P; Burgalassi, S; Tampucci, S; Mailland, F

    2011-07-01

    Topical therapy has recently been proposed for treating onychomycosis and other nail disturbances. However, the clinical outcome may be limited by the difficulty of active ingredients effectively penetrating the nail plate. Bovine hoof membranes have been widely used to predict in vitro efficacy of drug products in nail diseases. Many studies have compared bovine hooves with human healthy nails, considering the difference between healthy and unhealthy nails to be negligible. To validate bovine hoof slices as a model for human unhealthy nails by investigating the transungual permeation/retention of ciclopirox (CPX) through bovine hoof slices and excised infected human toenails after application of a new film-forming formulation (P-3051). To investigate the ability of CPX to achieve fungicidal concentrations in and through infected toenails. A new experimental technique based on a permeation unit allowed analysis by high-performance liquid chromatography of the amounts of CPX permeating through and retained in the membranes. The efficacy index was evaluated as follows: amount of permeated CPX/Trichophyton rubrum minimum inhibiting concentration. Extrapolated CPX flux through bovine hoof slices was about 14-fold higher than through infected human toenails, the difference being mainly due to the fourfold higher thickness of the toenails. In toenails, the CPX efficacy index for T. rubrum was positive (>1·0) soon after P-3051 application. This study confirms the validity of bovine hoof slices as a model for infected human nails, and suggests a substantial equivalence between the two models. Following P-3051 application, CPX reaches fungicidal concentrations in and through human infected toenails. © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011.

  2. Automated cortical bone segmentation for multirow-detector CT imaging with validation and application to human studies

    PubMed Central

    Li, Cheng; Jin, Dakai; Chen, Cheng; Letuchy, Elena M.; Janz, Kathleen F.; Burns, Trudy L.; Torner, James C; Levy, Steven M.; Saha, Punam K

    2015-01-01

    Purpose: Cortical bone supports and protects human skeletal functions and plays an important role in determining bone strength and fracture risk. Cortical bone segmentation at a peripheral site using multirow-detector CT (MD-CT) imaging is useful for in vivo assessment of bone strength and fracture risk. Major challenges for the task emerge from limited spatial resolution, low signal-to-noise ratio, presence of cortical pores, and structural complexity over the transition between trabecular and cortical bones. An automated algorithm for cortical bone segmentation at the distal tibia from in vivo MD-CT imaging is presented and its performance and application are examined. Methods: The algorithm is completed in two major steps—(1) bone filling, alignment, and region-of-interest computation and (2) segmentation of cortical bone. After the first step, the following sequence of tasks is performed to accomplish cortical bone segmentation—(1) detection of marrow space and possible pores, (2) computation of cortical bone thickness, detection of recession points, and confirmation and filling of true pores, and (3) detection of endosteal boundary and delineation of cortical bone. Effective generalizations of several digital topologic and geometric techniques are introduced and a fully automated algorithm is presented for cortical bone segmentation. Results: An accuracy of 95.1% in terms of volume of agreement with manual outlining of cortical bone was observed in human MD-CT scans, while an accuracy of 88.5% was achieved when compared with manual outlining on postregistered high resolution micro-CT imaging. An intraclass correlation coefficient of 0.98 was obtained in cadaveric repeat scans. A pilot study was conducted to describe gender differences in cortical bone properties. This study involved 51 female and 46 male participants (age: 19–20 yr) from the Iowa Bone Development Study. Results from this pilot study suggest that, on average after adjustment for height

  3. Manual control of unstable systems

    NASA Technical Reports Server (NTRS)

    Allen, R. W.; Hogue, J. R.; Parseghian, Z.

    1986-01-01

    Under certain operational regimes and failure modes, air and ground vehicles can present the human operator with a dynamically unstable or divergent control task. Research conducted over the last two decades has explored the ability of the human operator to control unstable systems under a variety of circumstances. Past research is reviewed and human operator control capabilities are summarized. A current example of automobile directional control under rear brake lockup conditions is also reviewed. A control system model analysis of the driver's steering control task is summarized, based on a generic driver/vehicle model presented at last year's Annual Manual. Results from closed course braking tests are presented that confirm the difficulty the average driver has in controlling the unstable directional dynamics arising from rear wheel lockup.

  4. Mathematical Capture of Human Data for Computer Model Building and Validation

    DTIC Science & Technology

    2014-04-03

    model building and validation Gladstone Reid, MSBME; Gordon Cooke, MEME ; Robert Demarco, MSBME; Caitlin Weaver, MSBME, MSME; John Riedener, MSSE...experimental automation design and implementation. GORDON COOKE, MEME , is a Principal Investigator at the TBRL. He was also a Chief Engineer, USMA

  5. Measuring the Monday Blues: Validation of a Job Satisfaction Scale for the Human Services.

    ERIC Educational Resources Information Center

    Koeske, Gary F.; And Others

    1994-01-01

    Developed and validated Job Satisfaction Scale (JSS) in series of studies from 1980 to 1991 involving over 600 helping professionals. Across administrations, alpha reliabilities ranged between 0.83 and 0.91, and reliabilities of intrinsic and organizational satisfaction subscales ranged from 0.85 to 0.90 and 0.78 to 0.90, respectively. (Author/NB)

  6. Examining the Validity of Different Assessment Modes in Measuring Competence in Performing Human Services

    ERIC Educational Resources Information Center

    Njora, Hungi; Darmawan, I Gusti Ngurah; Keeves, John P.

    2004-01-01

    This article addresses an important problem that faces educators in assessing students' competence levels in learned tasks. Data from 165 students from Massachusetts and Minnesota in the United States are used to examine the validity of five assessment modes (multiple choice test, scenario, portfolio, self-assessment and supervisor rating) in…

  7. Involvement of the left insula in the ecological validity of the human voice

    PubMed Central

    Tamura, Yuri; Kuriki, Shinji; Nakano, Tamami

    2015-01-01

    A subtle difference between a real human and an artificial object that resembles a human evokes an impression of a large qualitative difference between them. This suggests the existence of a neural mechanism that processes the sense of humanness. To examine the presence of such a mechanism, we compared the behavioral and brain responses of participants who listened to human and artificial singing voices created from vocal fragments of a real human voice. The behavioral experiment showed that the song sung by human voices more often elicited positive feelings and feelings of humanness than the same song sung by artificial voices, although the lyrics, melody, and rhythm were identical. Functional magnetic resonance imaging revealed significantly higher activation in the left posterior insula in response to human voices than in response to artificial voices. Insular activation was not merely evoked by differences in acoustic features between the voices. Therefore, these results suggest that the left insula participates in the neural processing of the ecological quality of the human voice. PMID:25739519

  8. The controversial existence of the human superior fronto-occipital fasciculus: Connectome-based tractographic study with microdissection validation.

    PubMed

    Meola, Antonio; Comert, Ayhan; Yeh, Fang-Cheng; Stefaneanu, Lucia; Fernandez-Miranda, Juan C

    2015-12-01

    The superior fronto-occipital fasciculus (SFOF), a long association bundle that connects frontal and occipital lobes, is well-documented in monkeys but is controversial in human brain. Its assumed role is in visual processing and spatial awareness. To date, anatomical and neuroimaging studies on human and animal brains are not in agreement about the existence, course, and terminations of SFOF. To clarify the existence of the SFOF in human brains, we applied deterministic fiber tractography to a template of 488 healthy subjects and to 80 individual subjects from the Human Connectome Project (HCP) and validated the results with white matter microdissection of post-mortem human brains. The imaging results showed that previous reconstructions of the SFOF were generated by two false continuations, namely between superior thalamic peduncle (STP) and stria terminalis (ST), and ST and posterior thalamic peduncle. The anatomical microdissection confirmed this finding. No other fiber tracts in the previously described location of the SFOF were identified. Hence, our data suggest that the SFOF does not exist in the human brain.

  9. Automation and validation of micronucleus detection in the 3D EpiDerm™ human reconstructed skin assay and correlation with 2D dose responses

    PubMed Central

    Chapman, K. E.; Thomas, A. D.; Jenkins, G. J. S.

    2014-01-01

    Recent restrictions on the testing of cosmetic ingredients in animals have resulted in the need to test the genotoxic potential of chemicals exclusively in vitro prior to licensing. However, as current in vitro tests produce some misleading positive results, sole reliance on such tests could prevent some chemicals with safe or beneficial exposure levels from being marketed. The 3D human reconstructed skin micronucleus (RSMN) assay is a promising new in vitro approach designed to assess genotoxicity of dermally applied compounds. The assay utilises a highly differentiated in vitro model of the human epidermis. For the first time, we have applied automated micronucleus detection to this assay using MetaSystems Metafer Slide Scanning Platform (Metafer), demonstrating concordance with manual scoring. The RSMN assay’s fixation protocol was found to be compatible with the Metafer, providing a considerably shorter alternative to the recommended Metafer protocol. Lowest observed genotoxic effect levels (LOGELs) were observed for mitomycin-C at 4.8 µg/ml and methyl methanesulfonate (MMS) at 1750 µg/ml when applied topically to the skin surface. In-medium dosing with MMS produced a LOGEL of 20 µg/ml, which was very similar to the topical LOGEL when considering the total mass of MMS added. Comparisons between 3D medium and 2D LOGELs resulted in a 7-fold difference in total mass of MMS applied to each system, suggesting a protective function of the 3D microarchitecture. Interestingly, hydrogen peroxide (H2O2), a positive clastogen in 2D systems, tested negative in this assay. A non-genotoxic carcinogen, methyl carbamate, produced negative results, as expected. We also demonstrated expression of the DNA repair protein N-methylpurine-DNA glycosylase in EpiDerm™. Our preliminary validation here demonstrates that the RSMN assay may be a valuable follow-up to the current in vitro test battery, and together with its automation, could contribute to minimising unnecessary in

  10. Design and Validation of a Morphing Myoelectric Hand Posture Controller Based on Principal Component Analysis of Human Grasping

    PubMed Central

    Segil, Jacob L.; Weir, Richard F. ff.

    2015-01-01

    An ideal myoelectric prosthetic hand should have the ability to continuously morph between any posture like an anatomical hand. This paper describes the design and validation of a morphing myoelectric hand controller based on principal component analysis of human grasping. The controller commands continuously morphing hand postures including functional grasps using between two and four surface electromyography (EMG) electrodes pairs. Four unique maps were developed to transform the EMG control signals in the principal component domain. A preliminary validation experiment was performed by 10 nonamputee subjects to determine the map with highest performance. The subjects used the myoelectric controller to morph a virtual hand between functional grasps in a series of randomized trials. The number of joints controlled accurately was evaluated to characterize the performance of each map. Additional metrics were studied including completion rate, time to completion, and path efficiency. The highest performing map controlled over 13 out of 15 joints accurately. PMID:23649286

  11. Design and validation of a morphing myoelectric hand posture controller based on principal component analysis of human grasping.

    PubMed

    Segil, Jacob L; Weir, Richard F ff

    2014-03-01

    An ideal myoelectric prosthetic hand should have the ability to continuously morph between any posture like an anatomical hand. This paper describes the design and validation of a morphing myoelectric hand controller based on principal component analysis of human grasping. The controller commands continuously morphing hand postures including functional grasps using between two and four surface electromyography (EMG) electrodes pairs. Four unique maps were developed to transform the EMG control signals in the principal component domain. A preliminary validation experiment was performed by 10 nonamputee subjects to determine the map with highest performance. The subjects used the myoelectric controller to morph a virtual hand between functional grasps in a series of randomized trials. The number of joints controlled accurately was evaluated to characterize the performance of each map. Additional metrics were studied including completion rate, time to completion, and path efficiency. The highest performing map controlled over 13 out of 15 joints accurately.

  12. Human Caring in the Social Work Context: Continued Development and Validation of a Complex Measure

    ERIC Educational Resources Information Center

    Ellis, Jacquelyn I.; Ellett, Alberta J.; DeWeaver, Kevin

    2007-01-01

    Objectives: (a) to continue the development of a measure of human caring in the context of social work practice and (b) to expand a line of inquiry exploring the relationship between human caring characteristics and the retention of public child welfare workers. Methodology: Surveys were received from a sample (n = 786) child welfare workers in…

  13. Isoprenoid quantitation in human brain tissue: a validated HPLC-fluorescence detection method for endogenous farnesyl- (FPP) and geranylgeranylpyrophosphate (GGPP).

    PubMed

    Hooff, Gero P; Volmer, Dietrich A; Wood, W Gibson; Müller, Walter E; Eckert, Gunter P

    2008-10-01

    Farnesyl- and geranylgeranylpyrophosphate (FPP and GGPP) are isoprenoid intermediates in the mevalonate pathway. They play a crucial role in cell survival, growth and differentiation due to their attachment (isoprenylation) to small GTPases (Ras, Rho, etc.). Isoprenoid formation seems to be tightly regulated within the mevalonate pathway and its perturbation has been linked to certain diseases (e.g., cancer, Alzheimer's disease), but tissue levels are unknown. It is therefore of the utmost importance to quantify these isoprenoids in diseased tissue or in tissue after drug administration. The current work describes an isolation procedure utilizing a combination of Extrelut(R) liquid/liquid and reversed-phase solid-phase extraction (SPE) for homogenized human frontal cortex tissue. In addition, after a careful validation of an HPLC-fluorescence method, this assay allowed the determination of nanomolar concentrations of endogenous FPP and GGPP levels (4.5 and 10.6 ng/mg protein, respectively) in human brain tissue. The method is selective, precise (<15% RSD), accurate (<15% relative error) and sensitive over a linear range of 10-400 ng/mL for FPP and 50-1000 ng/mL for GGPP according to the current FDA criteria for bioanalytical method validation. Overall, this new method introduces the ability to simultaneously quantify FPP and GGPP in human brain tissue, and is potentially applicable to several other tissues and species.

  14. Isoprenoid quantitation in human brain tissue. A validated HPLC-fluorescence detection method for endogenous farnesyl- (FPP) and geranylgeranylpyrophosphate (GGPP)

    PubMed Central

    2010-01-01

    Farnesyl- and geranylgeranylpyrophosphate (FPP and GGPP) are isoprenoid intermediates in the mevalonate pathway. They play a crucial role in cell survival, growth and differentiation by their attachment (isoprenylation) to small GTPases (Ras, Rho etc.). Isoprenoid formation seems to be tightly regulated within the mevalonate pathway and its perturbation has been linked to certain diseases (e.g., cancer, Alzheimer's disease) but tissue levels are unknown. It is therefore of utmost importance to quantify these isoprenoids in diseased tissue or in tissue after drug administration. The current work describes an isolation procedure utilizing a combination of Extrelut® liquid/liquid and reversed-phase solid-phase extraction (SPE) for homogenized human frontal cortex tissue. In addition, after a careful validation of an HPLC-fluorescence method, this assay allowed determination of nanomolar concentrations of endogenous FPP and GGPP levels (4.5 and 10.6 ng/mg protein, respectively) in human brain tissue. The method is selective, precise (< 15% RSD), accurate (< 15% relative error) and sensitive over a linear range of 10 – 400 ng/mL for FPP and 50 – 1000 ng/mL for GGPP according to the current FDA criteria for bioanalytical method validation. Overall, this new method introduces the ability to simultaneously quantify FPP and GGPP in human brain tissue with the prospect for application to several other tissues and species. PMID:18690423

  15. Evaluation of validity and reliability of a methodology for measuring human postural attitude and its relation to temporomandibular joint disorders

    PubMed Central

    Fernández, Ramón Fuentes; Carter, Pablo; Muñoz, Sergio; Silva, Héctor; Venegas, Gonzalo Hernán Oporto; Cantin, Mario; Ottone, Nicolás Ernesto

    2016-01-01

    INTRODUCTION Temporomandibular joint disorders (TMJDs) are caused by several factors such as anatomical, neuromuscular and psychological alterations. A relationship has been established between TMJDs and postural alterations, a type of anatomical alteration. An anterior position of the head requires hyperactivity of the posterior neck region and shoulder muscles to prevent the head from falling forward. This compensatory muscular function may cause fatigue, discomfort and trigger point activation. To our knowledge, a method for assessing human postural attitude in more than one plane has not been reported. Thus, the aim of this study was to design a methodology to measure the external human postural attitude in frontal and sagittal planes, with proper validity and reliability analyses. METHODS The variable postures of 78 subjects (36 men, 42 women; age 18–24 years) were evaluated. The postural attitudes of the subjects were measured in the frontal and sagittal planes, using an acromiopelvimeter, grid panel and Fox plane. RESULTS The method we designed for measuring postural attitudes had adequate reliability and validity, both qualitatively and quantitatively, based on Cohen’s Kappa coefficient (> 0.87) and Pearson’s correlation coefficient (r = 0.824, > 80%). CONCLUSION This method exhibits adequate metrical properties and can therefore be used in further research on the association of human body posture with skeletal types and TMJDs. PMID:26768173

  16. SHARP User Manual

    SciTech Connect

    Yu, Y. Q.; Shemon, E. R.; Thomas, J. W.; Mahadevan, Vijay S.; Rahaman, Ronald O.; Solberg, Jerome

    2016-03-31

    SHARP is an advanced modeling and simulation toolkit for the analysis of nuclear reactors. It is comprised of several components including physical modeling tools, tools to integrate the physics codes for multi-physics analyses, and a set of tools to couple the codes within the MOAB framework. Physics modules currently include the neutronics code PROTEUS, the thermal-hydraulics code Nek5000, and the structural mechanics code Diablo. This manual focuses on performing multi-physics calculations with the SHARP ToolKit. Manuals for the three individual physics modules are available with the SHARP distribution to help the user to either carry out the primary multi-physics calculation with basic knowledge or perform further advanced development with in-depth knowledge of these codes. This manual provides step-by-step instructions on employing SHARP, including how to download and install the code, how to build the drivers for a test case, how to perform a calculation and how to visualize the results. Since SHARP has some specific library and environment dependencies, it is highly recommended that the user read this manual prior to installing SHARP. Verification tests cases are included to check proper installation of each module. It is suggested that the new user should first follow the step-by-step instructions provided for a test problem in this manual to understand the basic procedure of using SHARP before using SHARP for his/her own analysis. Both reference output and scripts are provided along with the test cases in order to verify correct installation and execution of the SHARP package. At the end of this manual, detailed instructions are provided on how to create a new test case so that user can perform novel multi-physics calculations with SHARP. Frequently asked questions are listed at the end of this manual to help the user to troubleshoot issues.

  17. Anisotropic composite human skull model and skull fracture validation against temporo-parietal skull fracture.

    PubMed

    Sahoo, Debasis; Deck, Caroline; Yoganandan, Narayan; Willinger, Rémy

    2013-12-01

    A composite material model for skull, taking into account damage is implemented in the Strasbourg University finite element head model (SUFEHM) in order to enhance the existing skull mechanical constitutive law. The skull behavior is validated in terms of fracture patterns and contact forces by reconstructing 15 experimental cases. The new SUFEHM skull model is capable of reproducing skull fracture precisely. The composite skull model is validated not only for maximum forces, but also for lateral impact against actual force time curves from PMHS for the first time. Skull strain energy is found to be a pertinent parameter to predict the skull fracture and based on statistical (binary logistical regression) analysis it is observed that 50% risk of skull fracture occurred at skull strain energy of 544.0mJ.

  18. Validity and reliability of biostereometric measurement of the human female breast.

    PubMed

    Sheffer, D B; Price, T E; Loughry, C W; Bolyard, B L; Morek, W M; Varga, R S

    1986-01-01

    A measurement technique has been developed for application in the area of noninvasive breast cancer detection. The measurement process involves the use of close-range stereophotogrammetry as a data acquisition device necessary for determination of breast volume and volume distribution. This report details the methodology used to acquire and analyze stereopair photographs necessary to document the validity and reliability of this application. The volume of a test object was determined by both water displacement and stereophotogrammetric analysis to estimate the precision of the proposed methodology. Additionally, the reliability component of the study was documented by analyzing variability of coordinates representing a series of locations marked on the surface of an irregularly shaped object. Both tests confirm that this stereometric analysis is a reliable and valid method of measurement and may be well suited for further development in the field of breast cancer detection.

  19. Validation of radioimmunoassay for human lactalbumin in the serum by testing the endogenous antibodies interference.

    PubMed

    Zangerle, P F; Franchimont, P

    1985-10-01

    For re-establishing the value of human lactalbumin as a functional marker of normal and pathological activity of the breast a sensitive and specific radioimmunoassay was established with the prior important control of the interference of endogenous antibodies. The specificity of the assay was assessed by the absence of interference from other proteins in milk or in breast cyst fluid, various hormones and tumor markers. Bovine lactalbumin showed incomplete and weak cross-reactivity. By an enzymoimmunoassay method it was shown that all the 222 human sera studied contain IgG immunoglobulins which bind bovine and human lactalbumin with greater reactivity of children's serum and without relationship to the blood groups. The maximum affinity constant of these endogenous immunoglobulins determined by the radioimmunoassay method is 4.5 times greater for bovine (Kd = 18 X 4(-11) M) than for human (Kd = 4 X 10(-11) M) lactalbumin. These endogenous anti-lactalbumin immunoglobulins caused no interference in the radioimmunoassay as shown by the complete correlation between the concentrations of human lactalbumin previously incubated and added to sera containing high-affinity antibodies and those measured directly in the radioimmunoassay. This lack of interference was explained by the higher (22-fold) affinity constant of the rabbit antiserum against human lactalbumin (Kd = 9 X 10(-12) M). The study of endogenous antibodies by the two enzymes and radioimmunoassay methods is needed before assessing and using a radioimmunoassay of human lactalbumin in serum.

  20. Development and validation of a high-performance liquid chromatography-tandem mass spectrometry assay quantifying olaparib in human plasma.

    PubMed

    Nijenhuis, C M; Lucas, L; Rosing, H; Schellens, J H M; Beijnen, J H

    2013-12-01

    Olaparib is an inhibitor of poly ADP ribose polymerase 1 (PARP-1). Phase I and II trials showed promising results of olaparib against tumours in BRCA mutation carriers. Currently an increasing number of clinical trials with olaparib in combination with other compounds or radiotherapy are conducted. To support these clinical trials an LC-MS/MS method was developed and validated for the quantification of olaparib in human plasma. Human plasma samples were collected in the clinic and stored at nominally -20°C. Olaparib was isolated from plasma by liquid-liquid extraction, separated on a C18 column with gradient elution and analyzed with triple quadrupole mass spectrometry in positive ion mode. A deuterated isotope was used as internal standard for the quantification. The assay, ranging from 10 to 5000ng/mL, was linear with correlation coefficients (r(2)) of 0.9994 or better. The assay was accurate and precise, with inter-assay and intra-assay accuracies within ±7.6% of nominal and inter-assay and intra-assay precision ≤9.3% at the lower limit of quantification and ≤5.7% at the other concentration levels tested. All results were within the acceptance criteria of the US FDA and the latest EMA guidelines for method validation. A quantitative method was developed and validated for the quantification of olaparib in human plasma. The method could successfully be applied for the pharmacokinetic quantification of olaparib in cancer patients treated with olaparib. Copyright © 2013 Elsevier B.V. All rights reserved.

  1. Mathematical Capture of Human Data for Computer Model Building and Validation (Briefing Charts)

    DTIC Science & Technology

    2014-04-03

    Mezzacappa April 3, 2014 Distribution A : Approved for Public Release Distribution A : Approved for Public Release Report Documentation Page Form ApprovedOMB...4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to a penalty for failing to comply with a ...collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 03 APR 2014 2. REPORT TYPE Conference

  2. Development and Validation of Protein Microarray Technology for Simultaneous Inflammatory Mediator Detection in Human Sera

    PubMed Central

    Negm, Ola H.; Hamed, Mohamed R.; Tubby, Carolyn; Todd, Ian; Tighe, Patrick J.; Harrison, Tim; Fairclough, Lucy C.

    2014-01-01

    Biomarkers, including cytokines, can help in the diagnosis, prognosis, and prediction of treatment response across a wide range of disease settings. Consequently, the recent emergence of protein microarray technology, which is able to quantify a range of inflammatory mediators in a large number of samples simultaneously, has become highly desirable. However, the cost of commercial systems remains somewhat prohibitive. Here we show the development, validation, and implementation of an in-house microarray platform which enables the simultaneous quantitative analysis of multiple protein biomarkers. The accuracy and precision of the in-house microarray system were investigated according to the Food and Drug Administration (FDA) guidelines for pharmacokinetic assay validation. The assay fell within these limits for all but the very low-abundant cytokines, such as interleukin- (IL-) 10. Additionally, there were no significant differences between cytokine detection using our microarray system and the “gold standard” ELISA format. Crucially, future biomarker detection need not be limited to the 16 cytokines shown here but could be expanded as required. In conclusion, we detail a bespoke protein microarray system, utilizing well-validated ELISA reagents, that allows accurate, precise, and reproducible multiplexed biomarker quantification, comparable with commercial ELISA, and allowing customization beyond that of similar commercial microarrays. PMID:25382942

  3. Development and validation of protein microarray technology for simultaneous inflammatory mediator detection in human sera.

    PubMed

    Selvarajah, Senthooran; Negm, Ola H; Hamed, Mohamed R; Tubby, Carolyn; Todd, Ian; Tighe, Patrick J; Harrison, Tim; Fairclough, Lucy C

    2014-01-01

    Biomarkers, including cytokines, can help in the diagnosis, prognosis, and prediction of treatment response across a wide range of disease settings. Consequently, the recent emergence of protein microarray technology, which is able to quantify a range of inflammatory mediators in a large number of samples simultaneously, has become highly desirable. However, the cost of commercial systems remains somewhat prohibitive. Here we show the development, validation, and implementation of an in-house microarray platform which enables the simultaneous quantitative analysis of multiple protein biomarkers. The accuracy and precision of the in-house microarray system were investigated according to the Food and Drug Administration (FDA) guidelines for pharmacokinetic assay validation. The assay fell within these limits for all but the very low-abundant cytokines, such as interleukin- (IL-) 10. Additionally, there were no significant differences between cytokine detection using our microarray system and the "gold standard" ELISA format. Crucially, future biomarker detection need not be limited to the 16 cytokines shown here but could be expanded as required. In conclusion, we detail a bespoke protein microarray system, utilizing well-validated ELISA reagents, that allows accurate, precise, and reproducible multiplexed biomarker quantification, comparable with commercial ELISA, and allowing customization beyond that of similar commercial microarrays.

  4. HPLC/UV or bioassay: two valid methods for posaconazole quantification in human serum samples.

    PubMed

    Cendejas-Bueno, E; Forastiero, A; Rodriguez-Tudela, J L; Cuenca-Estrella, M; Gomez-Lopez, A

    2012-12-01

    In this paper we report on the development and validation of two different methods for posaconazole quantification from serum samples, HPLC/UV and bioassay. Both methods have been validated according to international guidelines and were also applied to the analysis of 61 trough serum samples from treated patients. A good correlation between both methods was observed. The HPLC method, more laborious and expensive, was demonstrated to be more accurate, precise and faster (analytical range 0.125-16 μg/mL, accuracy between -2.48 and 3.70% and precision between 2.77 and 5.93%, with an analytical run time of 11 min), making it a valuable tool for reference laboratories that centralize high numbers of samples. The microbiological method, however, is simple and offers sufficient precision and accuracy (analytical range 0.125-16 μg/mL, accuracy between -8.10 and 3.77% and a precision between 4.52 and 10.07%), to be used to monitor posaconazole. It may be a valid alternative to chromatographic methods in clinical laboratories without specialized facilities. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.

  5. Apparatus for Histological Validation of In Vivo and Ex Vivo Magnetic Resonance Imaging of the Human Prostate

    PubMed Central

    Bourne, Roger M.; Bailey, Colleen; Johnston, Edward William; Pye, Hayley; Heavey, Susan; Whitaker, Hayley; Siow, Bernard; Freeman, Alex; Shaw, Greg L.; Sridhar, Ashwin; Mertzanidou, Thomy; Hawkes, David J.; Alexander, Daniel C.; Punwani, Shonit; Panagiotaki, Eleftheria

    2017-01-01

    This article describes apparatus to aid histological validation of magnetic resonance imaging studies of the human prostate. The apparatus includes a 3D-printed patient-specific mold that facilitates aligned in vivo and ex vivo imaging, in situ tissue fixation, and tissue sectioning with minimal organ deformation. The mold and a dedicated container include MRI-visible landmarks to enable consistent tissue positioning and minimize image registration complexity. The inclusion of high spatial resolution ex vivo imaging aids in registration of in vivo MRI and histopathology data. PMID:28393049

  6. Validation of murine and human placental explant cultures for use in sex steroid and phase II conjugation toxicology studies.

    PubMed

    Sato, Brittany L; Ward, Monika A; Astern, Joshua M; Kendal-Wright, Claire E; Collier, Abby C

    2015-02-01

    Human primary placental explant culture is well established for cytokine signaling and toxicity, but has not been validated for steroidogenic or metabolic toxicology. The technique has never been investigated in the mouse. We characterized human and mouse placental explants for up to 96 h in culture. Explant viability (Lactate dehydrogenase) and sex steroid levels were measured in media using spectrophotometry and ELISA, respectively. Expression and activities of the steroidogenic (3β-hydroxysteroid dehydrogenase, Cytochrome P45017A1, Cytochrome P45019), conjugation (UDP-glucuronosyltransferase, sulfotransferase (SULT)), and regeneration (β-glucuronidase, arylsulfatase C (ASC)) enzymes were determined biochemically in tissues with fluorimetric and spectrophotometric assays, and western blot. Explants were viable up to 96 h, but progesterone, estrone, and 17β-estradiol secretion decreased. Steroidogenic enzyme expression and activities were stable in mouse explants and similar to levels in freshly isolated tissues, but were lower in human explants than in fresh tissue (P<0.01). Human and mouse explants exhibited significantly less conjugation after 96 h, SULT was not detected in the mouse, and neither explants had active ASC, although proteins were expressed. Mouse explants may be useful for steroid biochemistry and endocrine disruption studies, but not metabolic conjugation. In contrast, human explants may be useful for studying conjugation for <48 h, but not for steroid/endocrine studies.

  7. 21 CFR 864.6160 - Manual blood cell counting device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual blood cell counting device. 864.6160 Section 864.6160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6160...

  8. 21 CFR 890.5180 - Manual patient rotation bed.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual patient rotation bed. 890.5180 Section 890.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5180 Manual...

  9. 21 CFR 890.5180 - Manual patient rotation bed.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual patient rotation bed. 890.5180 Section 890.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5180 Manual...

  10. 21 CFR 892.5650 - Manual radionuclide applicator system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual radionuclide applicator system. 892.5650 Section 892.5650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5650 Manual radionuclide...

  11. 21 CFR 892.5650 - Manual radionuclide applicator system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual radionuclide applicator system. 892.5650 Section 892.5650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5650 Manual radionuclide...

  12. 21 CFR 866.2180 - Manual colony counter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual colony counter. 866.2180 Section 866.2180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2180 Manual colony counter...

  13. 21 CFR 866.2180 - Manual colony counter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual colony counter. 866.2180 Section 866.2180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2180 Manual colony counter...

  14. 21 CFR 866.2180 - Manual colony counter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual colony counter. 866.2180 Section 866.2180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2180 Manual colony counter...

  15. 21 CFR 890.5180 - Manual patient rotation bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual patient rotation bed. 890.5180 Section 890.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5180 Manual...

  16. 21 CFR 890.5180 - Manual patient rotation bed.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual patient rotation bed. 890.5180 Section 890.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5180 Manual...

  17. 21 CFR 890.5180 - Manual patient rotation bed.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual patient rotation bed. 890.5180 Section 890.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5180 Manual...

  18. 21 CFR 866.2180 - Manual colony counter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual colony counter. 866.2180 Section 866.2180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2180 Manual colony counter...

  19. 21 CFR 866.2180 - Manual colony counter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual colony counter. 866.2180 Section 866.2180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2180 Manual colony counter...

  20. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... affect a member of the public are available for public disclosure. An index of all such manuals is... Information Public Reading Room, located in rm. 1050, at the same address. The index and all manuals...

  1. Validation of Normal Human Bronchial Epithelial Cells as a Model for Influenza A Infections in Human Distal Trachea

    PubMed Central

    Davis, A. Sally; Chertow, Daniel S.; Moyer, Jenna E.; Suzich, Jon; Sandouk, Aline; Dorward, David W.; Logun, Carolea; Shelhamer, James H.

    2015-01-01

    Primary normal human bronchial/tracheal epithelial (NHBE) cells, derived from the distal-most aspect of the trachea at the bifurcation, have been used for a number of studies in respiratory disease research. Differences between the source tissue and the differentiated primary cells may impact infection studies based on this model. Therefore, we examined how well-differentiated NHBE cells compared with their source tissue, the human distal trachea, as well as the ramifications of these differences on influenza A viral pathogenesis research using this model. We employed a histological analysis including morphological measurements, electron microscopy, multi-label immunofluorescence confocal microscopy, lectin histochemistry, and microarray expression analysis to compare differentiated NHBEs to human distal tracheal epithelium. Pseudostratified epithelial height, cell type variety and distribution varied significantly. Electron microscopy confirmed differences in cellular attachment and paracellular junctions. Influenza receptor lectin histochemistry revealed that α2,3 sialic acids were rarely present on the apical aspect of the differentiated NHBE cells, but were present in low numbers in the distal trachea. We bound fluorochrome bioconjugated virus to respiratory tissue and NHBE cells and infected NHBE cells with human influenza A viruses. Both indicated that the pattern of infection progression in these cells correlated with autopsy studies of fatal cases from the 2009 pandemic. PMID:25604814

  2. Radmodl Modeling Manual

    SciTech Connect

    Murphy, S.L.; Stevens, K.A.; Weister, T.E.

    1993-04-01

    RADMODL is a set of computer codes that model the transport of material through a network of interconnected compartments. This version of RADMODL is designed to model the transport of radioactive material from either a loss of coolant accident (LOCA) or a fuel handling accident into a set of interconnected compartments and determine the equivalent dose each compartment will see for the duration of the accident. The code is flexible enough to allow modeling of other types of materials and their dilution/dispersion during transport by designing a new set of input files corresponding to the facility layout and the dilution/dispersion factors. This report documents the issuance of the Modeling Manual, originally developed by EGS Corporation and ISSI as volume 1 of the Programmer`s Manual, with the incorporation of minor editorial comments. Though a Modeling Manual in itself is not required for the RADMODL code certification, this manual does contain information that is required for the one of the requirements for code User`s Manual and hence certification.

  3. 21 CFR 872.6855 - Manual toothbrush.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual toothbrush. 872.6855 Section 872.6855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class I...

  4. 21 CFR 872.6855 - Manual toothbrush.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual toothbrush. 872.6855 Section 872.6855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class I...

  5. 21 CFR 868.1030 - Manual algesimeter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after... manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with...

  6. The Intergenerational Caregiving Program: A Replication Manual.

    ERIC Educational Resources Information Center

    Cohen, Marlene Cresci; And Others

    The Intergenerational Caregiving Program (ICP), a year long educational experience in human development and child care for older adults, is described in this replication manual. In its first year of operation, the ICP recruited older, usually retired adults from agencies and organizations in San Francisco that serve older people. The 22 older…

  7. 21 CFR 872.6855 - Manual toothbrush.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual toothbrush. 872.6855 Section 872.6855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class...

  8. 21 CFR 872.6855 - Manual toothbrush.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual toothbrush. 872.6855 Section 872.6855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class...

  9. 21 CFR 872.6855 - Manual toothbrush.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual toothbrush. 872.6855 Section 872.6855 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class...

  10. A validated HPLC method with electrochemical detection for simultaneous assay of 5-aminosalicylic acid and its metabolite in human plasma.

    PubMed

    Palumbo, Giancarlo; Bacchi, Simona; Primavera, Luisa; Palumbo, Paola; Carlucci, Giuseppe

    2005-06-01

    A high-performance liquid chromatographic method was developed, validated and applied to the simultaneous determination of 5-aminosalicylic acid (5-ASA) and its acetylated metabolite (acetyl-5-ASA) in human plasma. The method involves liquid-liquid extraction with methanol followed by isocratic reversed-phase chromatography on a Kromasil KR100 C(18) column with electrochemical detection. The recovery, selectivity, linearity, precision and accuracy of the method were evaluated from spiked human plasma samples. The effects of mobile phase composition, buffer concentration, mobile phase pH and concentration of organic modifiers on retention of 5-ASA, acetyl 5-ASA and internal standard were investigated. Limits' of detection were 5 ng/mL for 5-ASA and 10 ng/mL for acetyl-5-ASA, respectively. The method can be used for supporting therapeutical drug monitoring and pharmacokinetic studies.

  11. Validated HPLC method for determination of caffeine level in human plasma using synthetic plasma: application to bioavailability studies.

    PubMed

    Alvi, Syed N; Hammami, Muhammad M

    2011-04-01

    Several high-performance liquid chromatography (HPLC) methods have been described for the determination of caffeine in human plasma. However, none have been cross validated using synthetic plasma. The present study describes a simple and reliable HPLC method for the determination of the caffeine level in human plasma. Synthetic plasma was used to construct calibration curves and quality control samples to avoid interference by caffeine commonly present in donor's human plasma. After deproteination of plasma samples with perchloric acid, caffeine and antipyrine (internal standard, IS) were separated on a Waters Atlantis C18 column using a mobile phase of 15 mM potassium phosphate (pH 3.5) and acetonitrile (83:17, v/v), and monitored by photodiode array detector, with the wavelength set at 274 nm. The relationship between caffeine concentrations and peak area ratio (caffeine-IS) was linear over the range of 0.05-20 μg/mL. Inter-run coefficient of variation was ≤ 5.4% and ≤ 6.0% and bias was ≤ 3% and ≤ 7% using human and synthetic plasma, respectively. Mean extraction recovery from human plasma of caffeine and the IS was 91% and 86%, respectively. Caffeine in human plasma was stable for at least 24 h at room temperature or 12 weeks at -20 °C, and after three freeze-thaw cycles. The method was successfully applied to monitor caffeine levels in healthy volunteers with correction of caffeine levels using the mean ratio of the slopes of the calibration's curves constructed using human and synthetic plasma.

  12. TRANSWRAP II: problem definition manual. [LMFBR

    SciTech Connect

    Knittle, D.E.

    1981-02-01

    The TRANSWRAP II computer code, written in Fortran IV and described in this Problem Definition Manual, was developed to analytically predict the magnitude of pressure pulses of large scale sodium-wate reactions in LMFBR secondary systems. It is currently being used for the Clinch River Breeder Reactor Program. The code provides the options, flexibility and features necessary to consider any system configuration. The code methodology has been validated with the aid of extensive sodium-water reaction test programs.

  13. Validation of an Immunodiagnostic Assay for Detection of 13 Streptococcus pneumoniae Serotype-Specific Polysaccharides in Human Urine

    PubMed Central

    Huijts, Susanne M.; Wu, Kangjian; Souza, Victor; Passador, Sherry; Tinder, Chunyan; Song, Esther; Elfassy, Arik; McNeil, Lisa; Menton, Ronald; French, Roger; Callahan, Janice; Webber, Chris; Gruber, William C.; Bonten, Marc J. M.; Jansen, Kathrin U.

    2012-01-01

    To improve the clinical diagnosis of pneumococcal infection in bacteremic and nonbacteremic community-acquired pneumonia (CAP), a Luminex technology-based multiplex urinary antigen detection (UAD) diagnostic assay was developed and validated. The UAD assay can simultaneously detect 13 different serotypes of Streptococcus pneumoniae by capturing serotype-specific S. pneumoniae polysaccharides (PnPSs) secreted in human urine. Assay specificity is achieved by capturing the polysaccharides with serotype-specific monoclonal antibodies (MAbs) on spectrally unique microspheres. Positivity for each serotype was based on positivity cutoff values calculated from a standard curve run on each assay plate together with positive- and negative-control urine samples. The assay is highly specific, since significant signals are detected only when each PnPS was paired with its homologous MAb-coated microspheres. Validation experiments demonstrated excellent accuracy and precision. The UAD assay and corresponding positivity cutoff values were clinically validated by assessing 776 urine specimens obtained from patients with X-ray-confirmed CAP. The UAD assay demonstrated 97% sensitivity and 100% specificity using samples obtained from patients with bacteremic, blood culture-positive CAP. Importantly, the UAD assay identified Streptococcus pneumoniae (13 serotypes) in a proportion of individuals with nonbacteremic CAP, a patient population for which the pneumococcal etiology of CAP was previously difficult to assess. Therefore, the UAD assay provides a specific, noninvasive, sensitive, and reproducible tool to support vaccine efficacy as well as epidemiological evaluation of pneumococcal disease, including CAP, in adults. PMID:22675155

  14. Validation of an immunodiagnostic assay for detection of 13 Streptococcus pneumoniae serotype-specific polysaccharides in human urine.

    PubMed

    Pride, Michael W; Huijts, Susanne M; Wu, Kangjian; Souza, Victor; Passador, Sherry; Tinder, Chunyan; Song, Esther; Elfassy, Arik; McNeil, Lisa; Menton, Ronald; French, Roger; Callahan, Janice; Webber, Chris; Gruber, William C; Bonten, Marc J M; Jansen, Kathrin U

    2012-08-01

    To improve the clinical diagnosis of pneumococcal infection in bacteremic and nonbacteremic community-acquired pneumonia (CAP), a Luminex technology-based multiplex urinary antigen detection (UAD) diagnostic assay was developed and validated. The UAD assay can simultaneously detect 13 different serotypes of Streptococcus pneumoniae by capturing serotype-specific S. pneumoniae polysaccharides (PnPSs) secreted in human urine. Assay specificity is achieved by capturing the polysaccharides with serotype-specific monoclonal antibodies (MAbs) on spectrally unique microspheres. Positivity for each serotype was based on positivity cutoff values calculated from a standard curve run on each assay plate together with positive- and negative-control urine samples. The assay is highly specific, since significant signals are detected only when each PnPS was paired with its homologous MAb-coated microspheres. Validation experiments demonstrated excellent accuracy and precision. The UAD assay and corresponding positivity cutoff values were clinically validated by assessing 776 urine specimens obtained from patients with X-ray-confirmed CAP. The UAD assay demonstrated 97% sensitivity and 100% specificity using samples obtained from patients with bacteremic, blood culture-positive CAP. Importantly, the UAD assay identified Streptococcus pneumoniae (13 serotypes) in a proportion of individuals with nonbacteremic CAP, a patient population for which the pneumococcal etiology of CAP was previously difficult to assess. Therefore, the UAD assay provides a specific, noninvasive, sensitive, and reproducible tool to support vaccine efficacy as well as epidemiological evaluation of pneumococcal disease, including CAP, in adults.

  15. Initial construct validity evidence of a virtual human application for competency assessment in breaking bad news to a cancer patient

    PubMed Central

    Guetterman, Timothy C; Kron, Frederick W; Campbell, Toby C; Scerbo, Mark W; Zelenski, Amy B; Cleary, James F; Fetters, Michael D

    2017-01-01

    Background Despite interest in using virtual humans (VHs) for assessing health care communication, evidence of validity is limited. We evaluated the validity of a VH application, MPathic-VR, for assessing performance-based competence in breaking bad news (BBN) to a VH patient. Methods We used a two-group quasi-experimental design, with residents participating in a 3-hour seminar on BBN. Group A (n=15) completed the VH simulation before and after the seminar, and Group B (n=12) completed the VH simulation only after the BBN seminar to avoid the possibility that testing alone affected performance. Pre- and postseminar differences for Group A were analyzed with a paired t-test, and comparisons between Groups A and B were analyzed with an independent t-test. Results Compared to the preseminar result, Group A’s postseminar scores improved significantly, indicating that the VH program was sensitive to differences in assessing performance-based competence in BBN. Postseminar scores of Group A and Group B were not significantly different, indicating that both groups performed similarly on the VH program. Conclusion Improved pre–post scores demonstrate acquisition of skills in BBN to a VH patient. Pretest sensitization did not appear to influence posttest assessment. These results provide initial construct validity evidence that the VH program is effective for assessing BBN performance-based communication competence. PMID:28794664

  16. Determination of alpha-methyldopa in human plasma by validated high-performance liquid chromatography with fluorescence detection.

    PubMed

    Róna, K; Ary, K; Gachályi, B; Klebovich, I

    1996-04-12

    A sensitive reversed-phase gradient elution high-performance liquid chromatographic method with fluorescence detection has been developed for the determination of alpha-methyldopa (AMD) in human plasma. Separation of the investigated compound and the 3,4-dihydroxyphenylalanine (DOPA) internal standard was achieved on a Nucleosil 7 C18 column with a 5 mM heptanesulphonic acid sodium salt containing 0.05 M potassium dihydrogenphosphate (pH 3.2)-acetonitrile mobile phase. The composition of the mobile phase was changed according to a linear gradient time program. Detection was performed at 270 nm fluorimetric excitation and 320 nm emission. The compounds were isolated from plasma by Bond-Elut C18 solid-phase extraction. The limit of quantitation was found to be 10 ng/ml plasma. The assay was validated with respect to accuracy, precision and system suitability. All validated parameters were found to be within the 20% required limits. On the basis of the sensitivity, linearity and validation parameters the developed analytical method was found to be suitable for application in a bioequivalency study.

  17. In-Depth Characterization and Validation of Human Urine Metabolomes Reveal Novel Metabolic Signatures of Lower Urinary Tract Symptoms

    NASA Astrophysics Data System (ADS)

    Hao, Ling; Greer, Tyler; Page, David; Shi, Yatao; Vezina, Chad M.; Macoska, Jill A.; Marker, Paul C.; Bjorling, Dale E.; Bushman, Wade; Ricke, William A.; Li, Lingjun

    2016-08-01

    Lower urinary tract symptoms (LUTS) are a range of irritative or obstructive symptoms that commonly afflict aging population. The diagnosis is mostly based on patient-reported symptoms, and current medication often fails to completely eliminate these symptoms. There is a pressing need for objective non-invasive approaches to measure symptoms and understand disease mechanisms. We developed an in-depth workflow combining urine metabolomics analysis and machine learning bioinformatics to characterize metabolic alterations and support objective diagnosis of LUTS. Machine learning feature selection and statistical tests were combined to identify candidate biomarkers, which were statistically validated with leave-one-patient-out cross-validation and absolutely quantified by selected reaction monitoring assay. Receiver operating characteristic analysis showed highly-accurate prediction power of candidate biomarkers to stratify patients into disease or non-diseased categories. The key metabolites and pathways may be possibly correlated with smooth muscle tone changes, increased collagen content, and inflammation, which have been identified as potential contributors to urinary dysfunction in humans and rodents. Periurethral tissue staining revealed a significant increase in collagen content and tissue stiffness in men with LUTS. Together, our study provides the first characterization and validation of LUTS urinary metabolites and pathways to support the future development of a urine-based diagnostic test for LUTS.

  18. Method validation and reference range values for a peripheral blood immunophenotyping assay in non-human primates.

    PubMed

    Caldwell, Robert G; Marshall, Peggy; Fishel, Jared

    2016-01-01

    A peripheral blood immunophenotyping assay was developed and validated for determination of total T-lymphocytes, helper T-lymphocytes, cytotoxic T-lymphocytes, B-lymphocytes, and natural killer cells in cynomolgus monkeys. Validation parameters included assessment of precision, linearity, antibody optimization, stability of peripheral blood samples, and stability of fixed immunophenotyping samples. Total lymphocyte populations were determined using a heterogeneous lymphocyte gating strategy consisting of CD45 fluorescent staining and side-scatter demarcation. Relative lymphocyte subset values were determined using antigen-specific gating strategies. Absolute subset concentrations for each lymphocyte subset were subsequently determined using a dual-platform methodology wherein relative lymphocyte subset values (via flow cytometry analyses) were multiplied by the absolute total lymphocyte (via hematology analyses) values. Reference ranges are presented for cynomolgus monkey, rhesus monkey, and baboon. Additional 1-year longitudinal immunophenotyping values are presented for the cynomolgus monkey. The method validation and reference ranges presented in this research provide a robust analytical methodology for determination of peripheral blood lymphocyte subsets in various non-human primate species.

  19. In-Depth Characterization and Validation of Human Urine Metabolomes Reveal Novel Metabolic Signatures of Lower Urinary Tract Symptoms

    PubMed Central

    Hao, Ling; Greer, Tyler; Page, David; Shi, Yatao; Vezina, Chad M.; Macoska, Jill A.; Marker, Paul C.; Bjorling, Dale E.; Bushman, Wade; Ricke, William A.; Li, Lingjun

    2016-01-01

    Lower urinary tract symptoms (LUTS) are a range of irritative or obstructive symptoms that commonly afflict aging population. The diagnosis is mostly based on patient-reported symptoms, and current medication often fails to completely eliminate these symptoms. There is a pressing need for objective non-invasive approaches to measure symptoms and understand disease mechanisms. We developed an in-depth workflow combining urine metabolomics analysis and machine learning bioinformatics to characterize metabolic alterations and support objective diagnosis of LUTS. Machine learning feature selection and statistical tests were combined to identify candidate biomarkers, which were statistically validated with leave-one-patient-out cross-validation and absolutely quantified by selected reaction monitoring assay. Receiver operating characteristic analysis showed highly-accurate prediction power of candidate biomarkers to stratify patients into disease or non-diseased categories. The key metabolites and pathways may be possibly correlated with smooth muscle tone changes, increased collagen content, and inflammation, which have been identified as potential contributors to urinary dysfunction in humans and rodents. Periurethral tissue staining revealed a significant increase in collagen content and tissue stiffness in men with LUTS. Together, our study provides the first characterization and validation of LUTS urinary metabolites and pathways to support the future development of a urine-based diagnostic test for LUTS. PMID:27502322

  20. In-Depth Characterization and Validation of Human Urine Metabolomes Reveal Novel Metabolic Signatures of Lower Urinary Tract Symptoms.

    PubMed

    Hao, Ling; Greer, Tyler; Page, David; Shi, Yatao; Vezina, Chad M; Macoska, Jill A; Marker, Paul C; Bjorling, Dale E; Bushman, Wade; Ricke, William A; Li, Lingjun

    2016-08-09

    Lower urinary tract symptoms (LUTS) are a range of irritative or obstructive symptoms that commonly afflict aging population. The diagnosis is mostly based on patient-reported symptoms, and current medication often fails to completely eliminate these symptoms. There is a pressing need for objective non-invasive approaches to measure symptoms and understand disease mechanisms. We developed an in-depth workflow combining urine metabolomics analysis and machine learning bioinformatics to characterize metabolic alterations and support objective diagnosis of LUTS. Machine learning feature selection and statistical tests were combined to identify candidate biomarkers, which were statistically validated with leave-one-patient-out cross-validation and absolutely quantified by selected reaction monitoring assay. Receiver operating characteristic analysis showed highly-accurate prediction power of candidate biomarkers to stratify patients into disease or non-diseased categories. The key metabolites and pathways may be possibly correlated with smooth muscle tone changes, increased collagen content, and inflammation, which have been identified as potential contributors to urinary dysfunction in humans and rodents. Periurethral tissue staining revealed a significant increase in collagen content and tissue stiffness in men with LUTS. Together, our study provides the first characterization and validation of LUTS urinary metabolites and pathways to support the future development of a urine-based diagnostic test for LUTS.

  1. Initial construct validity evidence of a virtual human application for competency assessment in breaking bad news to a cancer patient.

    PubMed

    Guetterman, Timothy C; Kron, Frederick W; Campbell, Toby C; Scerbo, Mark W; Zelenski, Amy B; Cleary, James F; Fetters, Michael D

    2017-01-01

    Despite interest in using virtual humans (VHs) for assessing health care communication, evidence of validity is limited. We evaluated the validity of a VH application, MPathic-VR, for assessing performance-based competence in breaking bad news (BBN) to a VH patient. We used a two-group quasi-experimental design, with residents participating in a 3-hour seminar on BBN. Group A (n=15) completed the VH simulation before and after the seminar, and Group B (n=12) completed the VH simulation only after the BBN seminar to avoid the possibility that testing alone affected performance. Pre- and postseminar differences for Group A were analyzed with a paired t-test, and comparisons between Groups A and B were analyzed with an independent t-test. Compared to the preseminar result, Group A's postseminar scores improved significantly, indicating that the VH program was sensitive to differences in assessing performance-based competence in BBN. Postseminar scores of Group A and Group B were not significantly different, indicating that both groups performed similarly on the VH program. Improved pre-post scores demonstrate acquisition of skills in BBN to a VH patient. Pretest sensitization did not appear to influence posttest assessment. These results provide initial construct validity evidence that the VH program is effective for assessing BBN performance-based communication competence.

  2. Development and retranslational validation of an in vitro model to characterize acute infections in large human joints.

    PubMed

    Pilz, Ingo H; Mehlhorn, Alexander; Dovi-Akue, David; Langenmair, Elia Raoul; Südkamp, Norbert P; Schmal, Hagen

    2014-01-01

    Bacterial infections can destroy cartilage integrity, resulting in osteoarthritis. Goal was to develop an in vitro model with in vivo validation of acute joint inflammation. Inflammation in cocultivated human synovial fibroblasts (SFB), chondrocytes (CHDR), and mononuclear cells (MNC) was successively relieved for 10 days. Articular effusions from patients with (n = 7) and without (n = 5) postoperative joint infection in healthy patients (ASA 1-2) were used as model validation. Inflammation in vitro resulted in an enormous increase in IL-1 and a successive reduction in SFB numbers. CHDR however, maintained metabolic activity and proteoglycan synthesis. While concentrations of bFGF in vivo and in vitro rose consistently, the mRNA increase was only moderate. Concurring with our in vivo data, cartilage-specific IGF-1 steadily increased, while IGF-1 mRNA in the CHDR and SFB did not correlate with protein levels. Similarly, aggrecan (ACAN) protein concentrations increased in vivo and failed to correlate in vitro with gene expression in either the CHDR or the SFB, indicating extracellular matrix breakdown. Anabolic cartilage-specific BMP-7 with highly significant intra-articular levels was significantly elevated in vitro on day 10 following maximum inflammation. Our in vitro model enables us to validate early inflammation of in vivo cell- and cytokine-specific regulatory patterns. This trial is registered with MISSinG, DRKS 00003536.

  3. Aircraft operations management manual

    NASA Technical Reports Server (NTRS)

    1992-01-01

    The NASA aircraft operations program is a multifaceted, highly diverse entity that directly supports the agency mission in aeronautical research and development, space science and applications, space flight, astronaut readiness training, and related activities through research and development, program support, and mission management aircraft operations flights. Users of the program are interagency, inter-government, international, and the business community. This manual provides guidelines to establish policy for the management of NASA aircraft resources, aircraft operations, and related matters. This policy is an integral part of and must be followed when establishing field installation policy and procedures covering the management of NASA aircraft operations. Each operating location will develop appropriate local procedures that conform with the requirements of this handbook. This manual should be used in conjunction with other governing instructions, handbooks, and manuals.

  4. Nuclear material operations manual

    SciTech Connect

    Tyler, R.P.

    1981-02-01

    This manual provides a concise and comprehensive documentation of the operating procedures currently practiced at Sandia National Laboratories with regard to the management, control, and accountability of nuclear materials. The manual is divided into chapters which are devoted to the separate functions performed in nuclear material operations-management, control, accountability, and safeguards, and the final two chapters comprise a document which is also issued separately to provide a summary of the information and operating procedures relevant to custodians and users of radioactive and nuclear materials. The manual also contains samples of the forms utilized in carrying out nuclear material activities. To enhance the clarity of presentation, operating procedures are presented in the form of playscripts in which the responsible organizations and necessary actions are clearly delineated in a chronological fashion from the initiation of a transaction to its completion.

  5. Developing a policy manual.

    PubMed

    Hotta, Tracey A

    2013-01-01

    Do you really need to have a policy and procedure in the office? Frequently they are seen sitting on the shelf, collecting dust. The answer is yes for a number of very important reasons. A policy and procedure manual is a tool to set guidelines and expectations on the basis of the mission and vision of the office. A well-written manual is a powerful training tool for new staff so they can get a feel for the office culture. Furthermore, it is a provincial or state legislative requirement that can reduce management's concern about potential legal issues or problems. If an office does not have a manual to set guidelines, the employees may be forced to make their own decisions to solve problems, which can often result in confusion, inconsistencies, and mistakes.

  6. Attempts to validate a possible predictive animal model for human erythrocyte G-6-PD deficiency

    SciTech Connect

    Horton, H.M.; Calabrese, E.J.

    1986-01-01

    The use of Dorset sheep erythrocytes as a model for human G-6-PD deficient erythrocytes was investigated. Seven pharmaceuticals were examined for oxidant stressor effects using a liver microsomal enzyme system to generate metabolites of the drugs. The pharmaceuticals examined were salicyclic acid, dapsone, naphthalene, B-naphtol, p-aminobenzoic acid, sulfanilamide and sulfapyridine. The test compounds were incubated with Dorset sheep erythrocytes and oxidant stressor effects were measured through reduced glutathione (GSH) levels and methemaglobin formation. The response of the Dorset sheep erythrocytes to the seven agents was compared to previous studies revealing the response of human G-6-PD deficient erythrocytes to these agents. The results indicated that metabolites of the pharmaceuticals, B-naphthol, dapsone, and sulfanilamide, are oxidant stressor agents towards sheep G-6-PD deficient erythrocytes. These results agreed with studies on the response of human G-6-PD deficient erythrocytes. The metabolized naphthalene and sulfapyridine did not cause oxidant stress in the sheep erythrocytes, despite the fact that these two agents caused oxidizing effects in human G-6-PD deficient erythrocytes in previous studies. None of the non-metabolized parent compounds caused oxidant stress in the sheep erythrocytes, which agreed with the responses of human G-6-PD deficient erythrocytes.

  7. The importance of valid disclosures in the human embryonic stem cell research debate.

    PubMed

    Sherley, J L

    2008-02-01

    Misinformation erodes the legitimacy of any public debate. Since the start of human embryonic stem cell research deliberations in the USA, misinformation concerning the nature of human embryos, their availability for research, and the potential for using them to develop new medical therapies have been widespread and persistent. Basic facts, well understood by physicians and biologists, have been so misstated and misrepresented in the news media and political speeches that the general public has been put in a state of constant uncertainty. The solution to the present troubling condition is better education in the form of diligent, honest, and complete scientific disclosure by responsible scientists and physicians; and more care given to accurate reporting by news media. Several key aspects of newly emerging embryonic and non-embryonic stem cell technologies are defined and discussed as they relate to the debate over the use of human embryos for medical research. An important topic for consideration is how to disclose with clarity the scientific basis for human embryonic life. Thereafter, failings in proposed technologies for developing new therapies with human embryonic stem cells, that have been grossly under-reported, are examined. Finally, properties of adult stem cells are presented in contradistinction to embryonic stem cells, both in terms of adult stem cells as a scientifically better alternative to embryonic stem cells and in terms of the technological challenges that must be overcome to realize the potential of adult stem cells for new medical therapies.

  8. Reassessing manual proportions in Australopithecus afarensis.

    PubMed

    Rolian, Campbell; Gordon, Adam D

    2013-11-01

    Previous analyses of hand morphology in Australopithecus afarensis have concluded that this taxon had modern human-like manual proportions, with relatively long thumbs and short fingers. These conclusions are based on the A.L.333 composite fossil assemblage from Hadar, Ethiopia, and are premised on the ability to assign phalanges to a single individual, and to the correct side and digit. Neither assignment is secure, however, given the taphonomy and sample composition at A.L.333. We use a resampling approach that includes the entire assemblage of complete hand elements at Hadar, and takes into account uncertainties in identifying phalanges by individual, side and digit number. This approach provides the most conservative estimates of manual proportions in Au. afarensis. We resampled hand long bone lengths in Au. afarensis and extant hominoids, and obtained confidence limits for distributions of manual proportions in the latter. Results confirm that intrinsic manual proportions in Au. afarensis are dissimilar to Pan and Pongo. However, manual proportions in Au. afarensis often fall at the upper end of the distribution in Gorilla, and very lower end in Homo, corresponding to disproportionately short thumbs and long medial digits in Homo. This suggests that manual proportions in Au. afarensis, particularly metacarpal proportions, were not as derived towards Homo as previously described, but rather are intermediate between gorillas and humans. Functionally, these results suggest Au. afarensis could not produce precision grips with the same efficiency as modern humans, which may in part account for the absence of lithic technology in this fossil taxon. Copyright © 2013 Wiley Periodicals, Inc.

  9. Use of Laboratory Studies for the Design, Explanation, and Validation of Human Micronutrient Intervention Studies123

    PubMed Central

    Ross, A. Catharine

    2012-01-01

    Many micronutrient supplementation trials have led to important new findings relevant to public health, but some outcomes have been unclear or concerning. Can and should laboratory studies and animal models be used more extensively to pretest the proposed designs of human studies? This paper illustrates, as examples, the contributions that animal models have made to several major advances in understanding the biology of the micronutrients vitamin A and carotenoids, and it proposes that animal studies can play a more integrated role in public health nutrition by serving as a first line of interrogation for study designs and thereby as a means of refining the designs of human studies so that large, expensive, and logistically difficult human trials will yield the best possible information. PMID:22090470

  10. Validation of a HPLC/FLD Method for Quantification of Tocotrienols in Human Plasma

    PubMed Central

    Che, Hui-Ling; Tan, Doryn Meam-Yee; Meganathan, Puvaneswari; Gan, Yee-Lin; Abdul Razak, Ghazali; Fu, Ju-Yen

    2015-01-01

    Quantification of tocotrienols in human plasma is critical when the attention towards tocotrienols on its distinctive properties is arising. We aim to develop a simple and practical normal-phase high performance liquid chromatography method to quantify the amount of four tocotrienol homologues in human plasma. Using both the external and internal standards, tocotrienol homologues were quantified via a normal-phase high performance liquid chromatography with fluorescence detector maintained at the excitation wavelength of 295 nm and the emission wavelength of 325 nm. The four tocotrienol homologues were well separated within 30 minutes. A large interindividual variation between subjects was observed as the absorption of tocotrienols is dependent on food matrix and gut lipolysis. The accuracies of lower and upper limit of quantification ranged between 92% and 109% for intraday assays and 90% and 112% for interday assays. This method was successfully applied to quantify the total amount of four tocotrienol homologues in human plasma. PMID:26604927

  11. RELAP-7 Theory Manual

    SciTech Connect

    Berry, Ray Alden; Zou, Ling; Zhao, Haihua; Zhang, Hongbin; Peterson, John William; Martineau, Richard Charles; Kadioglu, Samet Yucel; Andrs, David

    2016-03-01

    This document summarizes the physical models and mathematical formulations used in the RELAP-7 code. In summary, the MOOSE based RELAP-7 code development is an ongoing effort. The MOOSE framework enables rapid development of the RELAP-7 code. The developmental efforts and results demonstrate that the RELAP-7 project is on a path to success. This theory manual documents the main features implemented into the RELAP-7 code. Because the code is an ongoing development effort, this RELAP-7 Theory Manual will evolve with periodic updates to keep it current with the state of the development, implementation, and model additions/revisions.

  12. Manuals of Cultural Systems

    NASA Astrophysics Data System (ADS)

    Ballonoff, Paul

    2014-10-01

    Ethnography often studies social networks including empirical descriptions of marriages and families. We initially concentrate on a special subset of networks which we call configurations. We show that descriptions of the possible outcomes of viable histories form a manual, and an orthoalgebra. We then study cases where family sizes vary, and show that this also forms a manual. In fact, it demonstrates adiabatic invariance, a property often associated with physical system conservation laws, and which here expresses conservation of the viability of a cultural system.

  13. Equipment Management Manual

    NASA Technical Reports Server (NTRS)

    1992-01-01

    The NASA Equipment Management Manual (NHB 4200.1) is issued pursuant to Section 203(c)(1) of the National Aeronautics and Space Act of 1958, as amended (42 USC 2473), and sets forth policy, uniform performance standards, and procedural guidance to NASA personnel for the acquisition, management, and use of NASA-owned equipment. This revision is effective upon receipt. This is a controlled manual, issued in loose-leaf form, and revised through page changes. Additional copies for internal use may be obtained through normal distribution.

  14. Fastener Design Manual

    NASA Technical Reports Server (NTRS)

    Barrett, Richard T.

    1990-01-01

    This manual was written for design engineers to enable them to choose appropriate fasteners for their designs. Subject matter includes fastener material selection, platings, lubricants, corrosion, locking methods, washers, inserts, thread types and classes, fatigue loading, and fastener torque. A section on design criteria covers the derivation of torque formulas, loads on a fastener group, combining simultaneous shear and tension loads, pullout load for tapped holes, grip length, head styles, and fastener strengths. The second half of this manual presents general guidelines and selection criteria for rivets and lockbolts.

  15. Validation of an LC-MS bioanalytical method for quantification of phytate levels in rat, dog and human plasma.

    PubMed

    Tur, Fernando; Tur, Eva; Lentheric, Irene; Mendoza, Paula; Encabo, Maximo; Isern, Bernat; Grases, Felix; Maraschiello, Ciriaco; Perelló, Joan

    2013-06-01

    Myo-inositol hexakisphosphate (phytate, IP6) is a naturally occuring compound whose determination in biological matrices is chanllenging. Several benefitial properties have been attributed to IP6 in parallel with the development of suitable analytical methodologies for its analytical determination in urine and some tissues. However, there is a lack of appropriate tools for its determination in plasma samples. In this paper, a direct, sensitive and selective bioanalytical method for the determination of IP6 based on LC-MS is presented. It is the first method published to quantify IP6 in plasma matrices directly through its molecular weight, being consequently a highly specific methodology. The method has been validated in rat, dog and human plasma, according to the acceptance criteria laid down in the FDA guidance Bioanalytical Method Validation. Accuracy and precision were not greater than 15% at medium and high concentrations and not greater than 20% at the LLOQ concentration. The mean absolute recovery obtained ranged from 78.74 to 102.44%, 62.10 to 87.21% and 61.61 to 86.99% for rat, dog and human plasma respectively. The LLOQ was 500ngmL(-1) due to the presence of endogenous IP6 in blank plasma samples and the limit of detection was within the range 30-80ngmL(-1).

  16. Validated HPLC-UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol.

    PubMed

    Filist, Monika; Szlaska, Iwona; Kaza, Michał; Pawiński, Tomasz

    2016-06-01

    Estimating the influence of interfering compounds present in the biological matrix on the determination of an analyte is one of the most important tasks during bioanalytical method development and validation. Interferences from endogenous components and, if necessary, from major metabolites as well as possible co-administered medications should be evaluated during a selectivity test. This paper describes a simple, rapid and cost-effective HPLC-UV method for the determination of naproxen in human plasma in the presence of two other analgesics, ibuprofen and paracetamol. Sample preparation is based on a simple liquid-liquid extraction procedure with a short, 5 s mixing time. Fenoprofen, which is characterized by a similar structure and properties to naproxen, was first used as the internal standard. The calibration curve is linear in the concentration range of 0.5-80.0 µg/mL, which is suitable for pharmacokinetic studies following a single 220 mg oral dose of naproxen sodium. The method was fully validated according to international guidelines and was successfully applied in a bioequivalence study in humans. Copyright © 2015 John Wiley & Sons, Ltd.

  17. [Construction and validation of the "La Salle Instrument" to evaluate the ethical aspects in biomedical research on human beings].

    PubMed

    Valdivia-Gómez, Gilberto Guzmán; Velasco-Jiménez, María Teresa; Domínguez-González, Alejandro; Meneses-Ruíz, Dulce María; Padilla-García, Raúl Amauri

    2017-01-01

    Research projects must demonstrate not only a rigorous scientific methodology, but also the ethical aspects that require profound reflection of the reviewers. Current regulations establish criteria for research projects on human health, but many of these aspects are subjective. How can the evaluation of such projects be standardized? This is the main subject of the current project. This project comprises two phases. First, the design and construction of an instrument of evaluation based on the fundamental principles of bioethics, which are autonomy, beneficence, non-maleficence, and justice, and other aspects. The second phase consists of content validation through expert. During the phase of reviewing the instrument, it was necessary to make changes by adding, removing, or changing the concepts or criteria, which lead to the construction of the second version of the format. This new instrument was reviewed and analyzed by using the AGREE II instrument, and this version was validated by experts by greater than 95%. There are some recommendations to analyze the ethical aspects in research protocols involving human subjects, but they define the concepts and criteria to be evaluated. By presenting the criteria to be evaluated individually, the "La Salle instrument" allows the evaluation to be more objective and standardized.

  18. Tumorigenicity and Validity of Fluorescence Labelled Mesenchymal and Epithelial Human Oral Cancer Cell Lines in Nude Mice.

    PubMed

    Cai, Wei Xin; Zheng, Li Wu; Ma, Li; Huang, Hong Zhang; Yu, Ru Qing; Zwahlen, Roger A

    2016-01-01

    Tumorigenicity and metastatic activity can be visually monitored in cancer cells that were labelled with stable fluorescence. The aim was to establish and validate local and distant spread of subcutaneously previously injected fluorescence transduced human tongue cancer cell lines of epithelial and mesenchymal phenotype in nude mice. A total of 32 four-week-old male athymic Balb/c nude mice were randomly allocated into 4 groups (n = 8). A single dose of 0.3 mL PBS containing 1 × 107 of four different cancer cell-lines (UM1, UM1-GFP, UM2, and UM2-RFP) was injected subcutaneously into the right side of their posterolateral back. Validity assessment of the labelled cancer cells' tumorigenicity was assessed by physical examination, imaging, and histology four weeks after the injection. The tumor take rate of cancer cells was similar in animals injected with either parental or transduced cancer cells. Transduced cancer cells in mice were easily detectable in vivo and after cryosection using fluorescent imaging. UM1 cells showed increased tumor take rate and mean tumor volume, presenting with disorganized histopathological patterns. Fluorescence labelled epithelial and mesenchymal human tongue cancer cell lines do not change in tumorigenicity or cell phenotype after injection in vivo.

  19. Method development and validation for ultra-high-pressure LC/MS/MS determination of hop prenylflavonoids in human serum.

    PubMed

    Yuan, Yang; Qiu, Xi; Nikolic, Dejan; Dahl, Jeffrey H; van Breemen, Richard B

    2012-01-01

    Hops (Humulus lupulus L.) are used in the brewing of beer, and hop extracts containing prenylated compounds, such as xanthohumol (XN) and 8-prenylnaringenin (8-PN), are under investigation as dietary supplements for cancer chemoprevention and the management of hot flashes in menopausal women. To facilitate clinical studies of hop safety and efficacy, a selective, sensitive, and fast ultra-high-pressure LC (UHPLC) tandem MS method was developed and validated for the simultaneous determination of the hop prenylflavonoids XN, isoxanthohumol (IX), 6-prenylnaringenin (6-PN), and 8-PN in human serum. The analytical method requires 300 microL of human serum, which is processed using liquid-liquid extraction. UHPLC separation was carried out in 2.5 min with gradient elution using an RP C18 column containing 1.6 pm particle size packing material. Prenylflavonoids were measured using negative ion electrospray MS with collision-induced dissociation and selected reaction monitoring. The method was validated and showed good accuracy and precision with an LOQ of 0.50 ng/mL for XN (1.4 nM) and 1.0 ng/mL for 6-PN, 8-PN (2.94 nM), and IX (2.82 nM) in serum.

  20. Detection and validated quantification of 21 benzodiazepines and 3 "z-drugs" in human hair by LC-MS/MS.

    PubMed

    Rust, Kristina Y; Baumgartner, Markus R; Meggiolaro, Natascha; Kraemer, Thomas

    2012-02-10

    A method for detection and quantification of 21 benzodiazepines and the pharmacologically related "z-drugs" in human hair samples was developed and fully validated using liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). After methanolic and methanolic/aqueous extraction, the analytes were separated using two different LC-MS systems (AB Sciex 3200 QTRAP and AB Sciex 5500 QTRAP). Separation columns, mobile phases and MS modes for both systems were: Phenomenex Kinetex, 2.6 μm, 50/2.1; 5mM ammonium formate buffer pH 3.5/methanol, total flow 0.75 mL/min; electrospray ionization (ESI), multiple reaction monitoring (MRM), information dependent acquisition (IDA), enhanced product ion scan (EPI). The assays were found to be selective for the tested compounds (alprazolam, 7-aminoclonazepam, 7-aminoflunitrazepam, bromazepam, chlordiazepoxide, clonazepam, N-desalkylflurazepam, diazepam, flunitrazepam, flurazepam, alpha-hydroxymidazolam, lorazepam, lormetazepam, midazolam, nitrazepam, nordazepam, oxazepam, phenazepam, prazepam, temazepam, triazolam, zaleplon, zolpidem and zopiclone), all validation criteria were in the required ranges according to international guidelines, except for bromazepam. Matrix effects, and process efficiencies were in the acceptable ranges evaluated using the post-extraction addition approach. Lower limits of quantification were between 0.6 and 16 pg/mg of hair. The LC-MS/MS assay has proven to be applicable for determination of the studied analytes in human hair in numerous authentic cases (n=175). Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.