34 CFR 650.20 - What are the selection procedures?

Code of Federal Regulations, 2012 CFR

2012-07-01

... selection of fellows. (b) Each year the Fellowship Board selects specific fields of study, and the number of fellows in each field (within the humanities, arts and social sciences), for which fellowships will be...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

Proceedings of the Conference on Behavior Representation in Modeling and Simulation (19th), held in Charleston, South Carolina, 21 - 24 March 2010

DTIC Science & Technology

2010-03-01

user performance .” “Wonderful. I can clearly see how, as a practitioner in industry , I can apply this to the numerous projects I work on.” Proceedings...CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ...effects on performance ), libraries of basic human operator procedures (how-to knowledge) and geometries for building scenarios graphically (that

Evaluation of Suited and Unsuited Human Functional Strength Using Multipurpose, Multiaxial Isokinetic Dynamometer

NASA Technical Reports Server (NTRS)

Aghazadeh, Fred

2005-01-01

The objective of the planned summer research was to develop a procedure to determine the isokinetic functional strength of suited and unsuited participants in order to estimate the coefficient of micro-gravity suit on human strength. To accomplish this objective, the Anthropometry and Biomechanics Facility's Multipurpose, Multiaxial Isokinetic dynamometer (MMID) was used. Development of procedure involved selection and testing of seven routines to be tested on MMID. We conducted the related experiments and collected the data for 12 participants. In addition to the above objective, we developed a procedure to assess the fatiguing characteristics of suited and unsuited participants using EMG technique. We collected EMG data on 10 participants while performing a programmed routing on MMID. EMG data along with information on the exerted forces, effector speed, number of repetitions, and duration of each routine were recorded for further analysis. Finally, gathering and tabulation Of data for various human strengths for updating of MSIS (HSIS) strength requirement, which started in summer 2003, also continued.

[Prolapse of the uterus and cataract: a comparison of veterinary and human medicine in Greco-Roman antiquity].

PubMed

Fischer, K D

2005-01-01

A number of surgical interventions in ancient veterinary medicine were modelled on the same procedures in human medicine. This is discussed in some detail for the prolapse of the uterus and the couching of the cataract in horses. In the introductory section, the importance of Switzerland and neighbouring areas for the transmission of ancient veterinary medicine is highlighted.

ANIMAL COGNITION. Comment on "Number-space mapping in the newborn chick resembles humans' mental number line".

PubMed

Mangalam, Madhur; Karve, Shraddha Madhav

2015-06-26

Rugani et al. (Reports, 30 January 3015, p. 534) tested 3-day-old domestic chicks using an innovative experimental setup and demonstrate the presence of the mental number line. We raise concerns regarding this conclusion by highlighting the possible loopholes in the experimental design and the data analysis procedures. We further suggest auxiliary experiments that can substantiate the authors' claim. Copyright © 2015, American Association for the Advancement of Science.

Spatial representation of magnitude in humans (Homo sapiens), Western lowland gorillas (Gorilla gorilla gorilla), and American black bears (Ursus americanus).

PubMed

Johnson-Ulrich, Zoe; Vonk, Jennifer

2018-05-04

The spatial-numerical association of response codes (SNARC) effect is the tendency for humans to respond faster to relatively larger numbers on the left or right (or with the left or right hand) and faster to relatively smaller numbers on the other side. This effect seems to occur due to a spatial representation of magnitude either in occurrence with a number line (wherein participants respond to relatively larger numbers faster on the right), other representations such as clock faces (responses are reversed from number lines), or culturally specific reading directions, begging the question as to whether the effect may be limited to humans. Given that a SNARC effect has emerged via a quantity judgement task in Western lowland gorillas and orangutans (Gazes et al., Cog 168:312-319, 2017), we examined patterns of response on a quantity discrimination task in American black bears, Western lowland gorillas, and humans for evidence of a SNARC effect. We found limited evidence for SNARC effect in American black bears and Western lowland gorillas. Furthermore, humans were inconsistent in direction and strength of effects, emphasizing the importance of standardizing methodology and analyses when comparing SNARC effects between species. These data reveal the importance of collecting data with humans in analogous procedures when testing nonhumans for effects assumed to bepresent in humans.

The importance of the convex hull for human performance on the traveling salesman problem: a comment on MacGregor and Ormerod (1996)

PubMed

Lee, M D; Vickers, D

2000-01-01

MacGregor and Ormerod (1996) have presented results purporting to show that human performance on visually presented traveling salesman problems, as indexed by a measure of response uncertainty, is strongly determined by the number of points in the stimulus array falling inside the convex hull, as distinct from the total number of points. It is argued that this conclusion is artifactually determined by their constrained procedure for stimulus construction, and, even if true, would be limited to arrays with fewer than around 50 points.

A comparative study of working memory: immediate serial spatial recall in baboons (Papio papio) and humans.

PubMed

Fagot, Joël; De Lillo, Carlo

2011-12-01

Two experiments assessed if non-human primates can be meaningfully compared to humans in a non-verbal test of serial recall. A procedure was used that was derived from variations of the Corsi test, designed to test the effects of sequence structure and movement path length in humans. Two baboons were tested in Experiment 1. The monkeys showed several attributes of human serial recall. These included an easier recall of sequences with a shorter number of items and of sequences characterized by a shorter path length when the number of items was kept constant. However, the accuracy and speed of processing did not indicate that the monkeys were able to benefit from the spatiotemporal structure of sequences. Humans tested in Experiment 2 showed a quantitatively longer memory span, and, in contrast with monkeys, benefitted from sequence structure. The results are discussed in relation to differences in how human and non-human primates segment complex visual patterns. Copyright © 2011 Elsevier Ltd. All rights reserved.

Disaster Victim Identification using Orthopedic Implants in the 2011 East-Japan Earthquake and Tsunami.

PubMed

Numata, Norio; Makinae, Haruka; Yoshida, Wataru; Daimon, Masao; Murakami, Hideki

2017-03-01

On March 11, 2011, an earthquake (magnitude 9.0) devastated Japan's east coast, and the associated tsunami resulted in social and mechanical destruction. Search for the missing people is still ongoing. Surgical implants are common in the general population. Medical implants usually have lot numbers, and their forensic use is common for victim identification. This investigation was conducted mainly in the cities of Kamaishi and Otsuchi, both of which were affected by the tsunami disaster in 2011. We visited 6 mortuaries with the police between March 20 (9 days after the tsunami) and April 20 (40 days after the tsunami) to examine the presence of surgical scars and related information. Unidentified human remains were investigated by visual and tactile examination. We also visited temples where the ashes were preserved. If implants were found, their lot numbers and estimated surgical procedures were recorded to determine positive identification. Ten of 233 sets of unidentified human remains before cremation displayed characteristics of a potential past surgical history. However, only 2 of these 233 sets had orthopedic implants. Instead, non-combustible orthopedic implants were found and recognized in 8 of the 331 sets of unidentified human ashes in the temples after cremation; the lot numbers were fully legible in 2 of the 8 sets. We estimated the surgical procedures, which led to positive identification. In conclusion, lot numbers and the surgical knowledge of orthopedic surgeons could assist with the positive identification of disaster victims. However, the relevant information can be erased after cremation.

The Effect of Multispectral Image Fusion Enhancement on Human Efficiency

DTIC Science & Technology

2017-03-20

human visual system by applying a technique commonly used in visual percep- tion research : ideal observer analysis. Using this approach, we establish...applications, analytic tech- niques, and procedural methods used across studies. This paper uses ideal observer analysis to establish a frame- work that allows...augmented similarly to incorpo- rate research involving more complex stimulus content. Additionally, the ideal observer can be adapted for a number of

The Use of Behavior Models for Predicting Complex Operations

NASA Technical Reports Server (NTRS)

Gore, Brian F.

2010-01-01

Modeling and simulation (M&S) plays an important role when complex human-system notions are being proposed, developed and tested within the system design process. National Aeronautics and Space Administration (NASA) as an agency uses many different types of M&S approaches for predicting human-system interactions, especially when it is early in the development phase of a conceptual design. NASA Ames Research Center possesses a number of M&S capabilities ranging from airflow, flight path models, aircraft models, scheduling models, human performance models (HPMs), and bioinformatics models among a host of other kinds of M&S capabilities that are used for predicting whether the proposed designs will benefit the specific mission criteria. The Man-Machine Integration Design and Analysis System (MIDAS) is a NASA ARC HPM software tool that integrates many models of human behavior with environment models, equipment models, and procedural / task models. The challenge to model comprehensibility is heightened as the number of models that are integrated and the requisite fidelity of the procedural sets are increased. Model transparency is needed for some of the more complex HPMs to maintain comprehensibility of the integrated model performance. This will be exemplified in a recent MIDAS v5 application model and plans for future model refinements will be presented.

Human Monoclonal Antibodies Against a Plethora of Viral Pathogens From Single Combinatorial Libraries

NASA Astrophysics Data System (ADS)

Williamson, R. Anthony; Burioni, Roberto; Sanna, Pietro P.; Partridge, Lynda J.; Barbas, Carlos F., III; Burton, Dennis R.

1993-05-01

Conventional antibody generation usually requires active immunization with antigen immediately prior to the preparation procedure. Combinatorial antibody library technology offers the possibility of cloning a range of antibody specificities at a single point in time and then accessing these specificities at will. Here we show that human monoclonal antibody Fab fragments against a plethora of infectious agents can be readily derived from a single library. Further examination of a number of libraries shows that whenever antibody against a pathogen can be detected in the serum of the donor, then specific antibodies can be derived from the corresponding library. We describe the generation of human Fab fragments against herpes simplex virus types 1 and 2, human cytomegalovirus, varicella zoster virus, rubella, human immunodeficiency virus type 1, and respiratory syncytial virus. The antibodies are shown to be highly specific and a number are effective in neutralizing virus in vitro.

Blackout detection as a multiobjective optimization problem.

PubMed

Chaudhary, A M; Trachtenberg, E A

1991-01-01

We study new fast computational procedures for a pilot blackout (total loss of vision) detection in real time. Their validity is demonstrated by data acquired during experiments with volunteer pilots on a human centrifuge. A new systematic class of very fast suboptimal group filters is employed. The utilization of various inherent group invariancies of signals involved allows us to solve the detection problem via estimation with respect to many performance criteria. The complexity of the procedures in terms of the number of computer operations required for their implementation is investigated. Various classes of such prediction procedures are investigated, analyzed and trade offs are established. Also we investigated the validity of suboptimal filtering using different group filters for different performance criteria, namely: the number of false detections, the number of missed detections, the accuracy of detection and the closeness of all procedures to a certain bench mark technique in terms of dispersion squared (mean square error). The results are compared to recent studies of detection of evoked potentials using estimation. The group filters compare favorably with conventional techniques in many cases with respect to the above mentioned criteria. Their main advantage is the fast computational processing.

Diagnosis of basal cell carcinoma by two photon excited fluorescence combined with lifetime imaging

NASA Astrophysics Data System (ADS)

Fan, Shunping; Peng, Xiao; Liu, Lixin; Liu, Shaoxiong; Lu, Yuan; Qu, Junle

2014-02-01

Basal cell carcinoma (BCC) is the most common type of human skin cancer. The traditional diagnostic procedure of BCC is histological examination with haematoxylin and eosin staining of the tissue biopsy. In order to reduce complexity of the diagnosis procedure, a number of noninvasive optical methods have been applied in skin examination, for example, multiphoton tomography (MPT) and fluorescence lifetime imaging microscopy (FLIM). In this study, we explored two-photon optical tomography of human skin specimens using two-photon excited autofluorescence imaging and FLIM. There are a number of naturally endogenous fluorophores in skin sample, such as keratin, melanin, collagen, elastin, flavin and porphyrin. Confocal microscopy was used to obtain structures of the sample. Properties of epidermic and cancer cells were characterized by fluorescence emission spectra, as well as fluorescence lifetime imaging. Our results show that two-photon autofluorescence lifetime imaging can provide accurate optical biopsies with subcellular resolution and is potentially a quantitative optical diagnostic method in skin cancer diagnosis.

Comparison of Procedures for Dual and Triple Closely Spaced Parallel Runways

NASA Technical Reports Server (NTRS)

Verma, Savita; Ballinger, Deborah; Subramanian Shobana; Kozon, Thomas

2012-01-01

A human-in-the-loop high fidelity flight simulation experiment was conducted, which investigated and compared breakout procedures for Very Closely Spaced Parallel Approaches (VCSPA) with two and three runways. To understand the feasibility, usability and human factors of two and three runway VCSPA, data were collected and analyzed on the dependent variables of breakout cross track error and pilot workload. Independent variables included number of runways, cause of breakout and location of breakout. Results indicated larger cross track error and higher workload using three runways as compared to 2-runway operations. Significant interaction effects involving breakout cause and breakout location were also observed. Across all conditions, cross track error values showed high levels of breakout trajectory accuracy and pilot workload remained manageable. Results suggest possible avenues of future adaptation for adopting these procedures (e.g., pilot training), while also showing potential promise of the concept.

A Novel Technique to Follow Consequences of Exogenous Factors, Including Therapeutic Drugs, on Living Human Breast Epithelial Cells

DTIC Science & Technology

1999-07-01

and lipid vectors, are being tested. Concurrent with the development of procedures for live - cell imaging , we are examining the distribution of proteins...dimensional matrix. These studies have not yet begun. There are a number of procedures that must be developed and perfected in the live - cell imaging , as...components of the Wnt signaling pathway are too preliminary and require additional research prior to publication. (9) CONCLUSIONS Live cell imaging of

Design Guidelines and Criteria for User/Operator Transactions with Battlefield Automated Systems. Volume 2. Technical Discussion

DTIC Science & Technology

1981-02-01

Continue on tevetee «Id* If necemtery mid Identify br black number) Battlefield automated systems Human- computer interaction. Design criteria System...Report (this report) In-Depth Analyses of Individual Systems A. Tactical Fire Direction System (TACFIRE) (RP 81-26) B. Tactical Computer Terminal...select the design features and operating procedures of the human- computer Interface which best match the require- ments and capabilities of anticipated

Supporting the future nuclear workforce with computer-based procedures

DOE PAGES

Oxstrand, Johanna; Le Blanc, Katya

2016-05-01

Here we see that computer-based tools have dramatically increased ease and efficiency of everyday tasks. Gone are the days of paging through a paper catalog, transcribing product numbers, and calculating totals. Today, a consumer can find a product online with a simple search engine, and then purchase it in a matter of a few clicks. Paper catalogs have their place, but it is hard to imagine life without on-line shopping sites. All tasks conducted in a nuclear power plant are guided by procedures, which helps ensure safe and reliable operation of the plants. One prominent goal of the nuclear industrymore » is to minimize the risk of human errors. To achieve this goal one has to ensure tasks are correctly and consistently executed. This is partly achieved by training and by a structured approach to task execution, which is provided by procedures and work instructions. Procedures are used in the nuclear industry to direct workers' actions in a proper sequence. The governing idea is to minimize the reliance on memory and choices made in the field. However, the procedure document may not contain sufficient information to successfully complete the task. Therefore, the worker might have to carry additional documents such as turnover sheets, operation experience, drawings, and other procedures to the work site. The nuclear industry is operated with paper procedures like paper catalogs of the past. A field worker may carry a large stack of documents needed to complete a task to the field. Even though the paper process has helped keep the industry safe for decades, there are limitations to using paper. Paper procedures are static (i.e., the content does not change after the document is printed), difficult to search, and rely heavily on the field worker’s situational awareness and ability to consistently meet the high expectation of human performance excellence. With computer-based procedures (CBPs) that stack of papers may be reduced to the size of a small tablet or even a smart phone. Instead of manually matching equipment identification numbers listed in the procedure with the number on the physical equipment the field worker can simply scan a barcode to ensure the correct valve is opened while simultaneously creating a record. Instead of navigating through a maze of cross-references, CBPs enable intelligent work path navigation which accounts for past decisions and observation, thereby enabling more efficient and safe task completion.« less

Supporting the future nuclear workforce with computer-based procedures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oxstrand, Johanna; Le Blanc, Katya

Here we see that computer-based tools have dramatically increased ease and efficiency of everyday tasks. Gone are the days of paging through a paper catalog, transcribing product numbers, and calculating totals. Today, a consumer can find a product online with a simple search engine, and then purchase it in a matter of a few clicks. Paper catalogs have their place, but it is hard to imagine life without on-line shopping sites. All tasks conducted in a nuclear power plant are guided by procedures, which helps ensure safe and reliable operation of the plants. One prominent goal of the nuclear industrymore » is to minimize the risk of human errors. To achieve this goal one has to ensure tasks are correctly and consistently executed. This is partly achieved by training and by a structured approach to task execution, which is provided by procedures and work instructions. Procedures are used in the nuclear industry to direct workers' actions in a proper sequence. The governing idea is to minimize the reliance on memory and choices made in the field. However, the procedure document may not contain sufficient information to successfully complete the task. Therefore, the worker might have to carry additional documents such as turnover sheets, operation experience, drawings, and other procedures to the work site. The nuclear industry is operated with paper procedures like paper catalogs of the past. A field worker may carry a large stack of documents needed to complete a task to the field. Even though the paper process has helped keep the industry safe for decades, there are limitations to using paper. Paper procedures are static (i.e., the content does not change after the document is printed), difficult to search, and rely heavily on the field worker’s situational awareness and ability to consistently meet the high expectation of human performance excellence. With computer-based procedures (CBPs) that stack of papers may be reduced to the size of a small tablet or even a smart phone. Instead of manually matching equipment identification numbers listed in the procedure with the number on the physical equipment the field worker can simply scan a barcode to ensure the correct valve is opened while simultaneously creating a record. Instead of navigating through a maze of cross-references, CBPs enable intelligent work path navigation which accounts for past decisions and observation, thereby enabling more efficient and safe task completion.« less

Computerized Grading of Anatomy Laboratory Practical Examinations

ERIC Educational Resources Information Center

Krippendorf, Beth B.; Bolender, David L.; Kolesari, Gary L.

2008-01-01

At the Medical College of Wisconsin, a procedure was developed to allow computerized grading and grade reporting of laboratory practical examinations in the Clinical Human Anatomy course. At the start of the course, first year medical students were given four Lists of Structures. On these lists, numbered items were arranged alphabetically; the…

The MAM rodent model of schizophrenia

PubMed Central

Lodge, Daniel J.

2013-01-01

Rodent models of human disease are essential to obtain a better understanding of disease pathology, the mechanism of action underlying conventional treatments, as well as for the generation of novel therapeutic approaches. There are a number of rodent models of schizophrenia based on either genetic manipulations, acute or sub-chronic drug administration, or developmental disturbances. The prenatal methylazoxymethanol acetate (MAM) rodent model is a developmental disruption model gaining increased attention because it displays a number of histological, neurophysiological and behavioral deficits analogous to those observed in schizophrenia patients. This unit describes the procedures required to safely induce the MAM phenotype in rats. In addition, we describe a simple behavioral procedure, amphetamine-induced hyper-locomotion, which can be utilized to verify the MAM phenotype. PMID:23559309

Surgical Care Required for Populations Affected by Climate-related Natural Disasters: A Global Estimation.

PubMed

Lee, Eugenia E; Stewart, Barclay; Zha, Yuanting A; Groen, Thomas A; Burkle, Frederick M; Kushner, Adam L

2016-08-10

Climate extremes will increase the frequency and severity of natural disasters worldwide.  Climate-related natural disasters were anticipated to affect 375 million people in 2015, more than 50% greater than the yearly average in the previous decade. To inform surgical assistance preparedness, we estimated the number of surgical procedures needed.   The numbers of people affected by climate-related disasters from 2004 to 2014 were obtained from the Centre for Research of the Epidemiology of Disasters database. Using 5,000 procedures per 100,000 persons as the minimum, baseline estimates were calculated. A linear regression of the number of surgical procedures performed annually and the estimated number of surgical procedures required for climate-related natural disasters was performed. Approximately 140 million people were affected by climate-related natural disasters annually requiring 7.0 million surgical procedures. The greatest need for surgical care was in the People's Republic of China, India, and the Philippines. Linear regression demonstrated a poor relationship between national surgical capacity and estimated need for surgical care resulting from natural disaster, but countries with the least surgical capacity will have the greatest need for surgical care for persons affected by climate-related natural disasters. As climate extremes increase the frequency and severity of natural disasters, millions will need surgical care beyond baseline needs. Countries with insufficient surgical capacity will have the most need for surgical care for persons affected by climate-related natural disasters. Estimates of surgical are particularly important for countries least equipped to meet surgical care demands given critical human and physical resource deficiencies.

Molecular Characteristics of Multicorn, a New Large Proteolytic Assembly and Potential Anti-Cancer Drug Target, in Human Breast Cancer Cells

DTIC Science & Technology

2005-05-01

modifications: peptide N-terminal glutamine to pyroglutamic transformation, oxidation of methionine, acetylation of protein N-terminus, and...or identical with human tripeptidyl peptidase II (TPPII) with a sequence of 1249 amino acids , accession number CAH72179, GI:55661755, derived from the...34In- Gel" Digestion Procedure for the Micropreparation of Internal Protein Fragments for Amino Acid Sequencing. Anal. Biochem., 224, 451-455. Osmulski

Genesis & the Human Ribcage: An Opportunity to Correct a Misconception & Introduce an Evolution Lesson into the Anatomy Class

ERIC Educational Resources Information Center

Senter, Phil

2013-01-01

Many anatomy students begin the course with a misconception that human males and females do not have the same number of ribs. At the root of that misconception is Genesis 2:21-22, in which God removes a rib from Adam to make Eve. Removal of a body part is a surgical procedure, and one does not pass on the results of surgery to one's offspring. The…

Dog population management for the control of human echinococcosis.

PubMed

Kachani, Malika; Heath, David

2014-11-01

Cystic and alveolar hydatid disease of humans caused by infection with Echinococcus granulosus or Echinococcus multilocularis are significant zoonoses in developing countries. For human infections, the main definitive host is the dog, and reduction in the population of unwanted dogs, together with anthelmintic treatment of wanted dogs, are recommended control procedures for these zoonoses. Both owned and unowned dogs have been shown to be a major source of Echinococcus spp. infection in developing countries. Unowned dogs are the most challenging category in dog population management for the control of major zoonotic diseases. Unowned dogs are those dogs that do not have an owner, and those dogs whose owner cannot readily be identified. Control of numbers of unowned dogs can be done in various ways if funds are available. Fertility control and humane euthanasia are likely to be the most effective procedures in developing countries. Fertility control requires significant funding, and where resources are scarce humane euthanasia may be the most effective option. Both procedures are ongoing events, with no predictable end point. This paper examines the sociology and technology for the population management of owned and unowned dogs, specifically for the reduction of human hydatid disease. Examples are given for developing and developed countries. Although a "One Health" approach is desirable, the technology for hydatid control is different from that for rabies, and FAO Animal Welfare recommendations for dog population management should be adjusted accordingly. Copyright © 2014 Elsevier B.V. All rights reserved.

[Criterion of dental treatment for the disabled].

PubMed

Huchun, Wan; Zheng, Yang; Hongkun, Wu; Jianguo, Liu; Jin, Zhao; Xiaoping, Ji; Lin, Zhu; Deqin, Yang; Xuedong, Zhou

2017-08-01

The number of disabled persons increases in the course of human life and in the aging population. The high prevalence, low treatment rate, long therapy period, and sophisticated procedures prevent most of disabled individuals from availing dental services. Moreover, special dental institutions for the disabled are insufficient, and a certain treatment standard is commonly not complied. This study performed analysis and evaluation, including treatment features, pretreatment procedures, patient communication, treatment factors, and treatment standards to provide a targeted solution for the special requirements of the oral therapy for disabled patients.

Immediate Implants: Clinical Guidelines for Esthetic Outcomes

PubMed Central

Javaid, Mohammad A.; Khurshid, Zohaib; Zafar, Muhammad S.; Najeeb, Shariq

2016-01-01

Research has shown that tooth loss results in morphological changes in alveolar ridge that may influence the subsequent implant placement. Immediate implant placement was introduced as a possible means to limit bone resorption and reduce the number of surgical procedures following tooth extraction. Histological and clinical evidence from human clinical studies showing efficacy of immediate implants has come to light over the last decade or so. However, immediate implant placement is a challenging surgical procedure and requires proper case selection and surgical technique. Furthermore, there appears to be a lack of clinical guidelines for immediate implant placement case selection. Therefore, the aim of this mini-review is to analyze critical evidence from human studies in order to establish clinical guidelines which may help clinicians in case selection when considering immediate implant placement protocol. PMID:29563463

NASA Summer Faculty Fellowship Program 2004, Volumes 1 and 2

NASA Technical Reports Server (NTRS)

Hyman, William A. (Editor); Sickorez, Donn G. (Editor); Leveritt, Dawn M. (Editor)

2005-01-01

The objective of the planned summer research was to develop a procedure to determine the isokinetic functional strength of suited and unsuited participants in order to estimate the coefficient of micro-gravity suit on human strength. To accomplish this objective, the Anthropometry and Biomechanics Facility Multipurpose, Multiaxial Isokinetic dynamometer (MMID) was used. Development of procedure involved selection and testing of seven routines to be tested on MMID. We conducted the related experiments and collected the data for 12 participants. In addition to the above objective, we developed a procedure to assess the fatiguing characteristics of suited and unsuited participants using EMG technique. We collected EMG data on 10 participants while performing a programmed routing on MMID. EMG data along with information on the exerted forces, effector speed, number of repetitions, and duration of each routine were recorded for further analysis. Finally, gathering and tabulation Of data for various human strengths for updating of MSIS (HSIS) strength requirement, which started in summer 2003, also continued.

Improving the human readability of Arden Syntax medical logic modules using a concept-oriented terminology and object-oriented programming expressions.

PubMed

Choi, Jeeyae; Bakken, Suzanne; Lussier, Yves A; Mendonça, Eneida A

2006-01-01

Medical logic modules are a procedural representation for sharing task-specific knowledge for decision support systems. Based on the premise that clinicians may perceive object-oriented expressions as easier to read than procedural rules in Arden Syntax-based medical logic modules, we developed a method for improving the readability of medical logic modules. Two approaches were applied: exploiting the concept-oriented features of the Medical Entities Dictionary and building an executable Java program to replace Arden Syntax procedural expressions. The usability evaluation showed that 66% of participants successfully mapped all Arden Syntax rules to Java methods. These findings suggest that these approaches can play an essential role in the creation of human readable medical logic modules and can potentially increase the number of clinical experts who are able to participate in the creation of medical logic modules. Although our approaches are broadly applicable, we specifically discuss the relevance to concept-oriented nursing terminologies and automated processing of task-specific nursing knowledge.

Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care.

PubMed

Alikani, Mina; Go, Kathryn J; McCaffrey, Caroline; McCulloh, David H

2014-11-01

To consider how staffing requirements have changed with evolving and increasingly more complex assisted reproduction technology (ART) laboratory practice. Analysis by four laboratory directors from three different ART programs of the level of complexity and time requirements for contemporary ART laboratory activities to determine adequate staffing levels. University-based and private ART programs. None. None. Human resource requirements for ART procedures. Both complexity and time required for completion of a contemporary ART cycle have increased significantly compared with the same requirements for the "traditional cycle" of the past. The latter required roughly 9 personnel hours, but a contemporary cycle can require up to 20 hours for completion. Consistent with this increase, a quantitative analysis shows that the number of embryologists required for safe and efficient operation of the ART laboratory has also increased. This number depends on not only the volume but also the types of procedures performed: the higher the number of complex procedures, the more personnel required. An interactive Personnel Calculator is introduced that can help determine staffing needs. The increased complexity of the contemporary ART laboratory requires a new look at the allocation of human resources. Our work provides laboratory directors with a practical, individualized tool to determine their staffing requirements with a view to increasing the safety and efficiency of operations. The work could serve as the basis for revision of the 2008 American Society for Reproductive Medicine (ASRM) staffing guidelines. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Different strategies in solving series completion inductive reasoning problems: an fMRI and computational study.

PubMed

Liang, Peipeng; Jia, Xiuqin; Taatgen, Niels A; Zhong, Ning; Li, Kuncheng

2014-08-01

Neural correlate of human inductive reasoning process is still unclear. Number series and letter series completion are two typical inductive reasoning tasks, and with a common core component of rule induction. Previous studies have demonstrated that different strategies are adopted in number series and letter series completion tasks; even the underlying rules are identical. In the present study, we examined cortical activation as a function of two different reasoning strategies for solving series completion tasks. The retrieval strategy, used in number series completion tasks, involves direct retrieving of arithmetic knowledge to get the relations between items. The procedural strategy, used in letter series completion tasks, requires counting a certain number of times to detect the relations linking two items. The two strategies require essentially the equivalent cognitive processes, but have different working memory demands (the procedural strategy incurs greater demands). The procedural strategy produced significant greater activity in areas involved in memory retrieval (dorsolateral prefrontal cortex, DLPFC) and mental representation/maintenance (posterior parietal cortex, PPC). An ACT-R model of the tasks successfully predicted behavioral performance and BOLD responses. The present findings support a general-purpose dual-process theory of inductive reasoning regarding the cognitive architecture. Copyright © 2014 Elsevier B.V. All rights reserved.

Human memory reconsolidation: A guiding framework and critical review of the evidence.

PubMed

Elsey, James W B; Van Ast, Vanessa A; Kindt, Merel

2018-05-24

Research in nonhuman animals suggests that reactivation can induce a transient, unstable state in a previously consolidated memory, during which the memory can be disrupted or modified, necessitating a process of restabilization in order to persist. Such findings have sparked a wave of interest into whether this phenomenon, known as reconsolidation, occurs in humans. Translating research from animal models to human experiments and even to clinical interventions is an exciting prospect, but amid this excitement, relatively little work has critically evaluated and synthesized existing research regarding human memory reconsolidation. In this review, we formalize a framework for evaluating and designing studies aiming to demonstrate human memory reconsolidation. We use this framework to shed light on reconsolidation-based research in human procedural memory, aversive and appetitive memory, and declarative memory, covering a diverse selection of the most prominent examples of this research, including studies of memory updating, retrieval-extinction procedures, and pharmacological interventions such as propranolol. Across different types of memory and procedure, there is a wealth of observations consistent with reconsolidation. Moreover, some experimental findings are already being translated into clinically relevant interventions. However, there are a number of inconsistent findings, and the presence of alternative explanations means that we cannot conclusively infer the presence of reconsolidation at the neurobiological level from current evidence. Reconsolidation remains a viable but hotly contested explanation for some observed changes in memory expression in both humans and animals. Developing effective and efficient new reconsolidation-based treatments can be a goal that unites researchers and guides future experiments. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Natural orifice translumenal endoscopic surgery: Progress in humans since white paper

PubMed Central

Santos, Byron F; Hungness, Eric S

2011-01-01

Since the first description of the concept of natural orifice translumenal endoscopic surgery (NOTES), a substantial number of clinical NOTES reports have appeared in the literature. This editorial reviews the available human data addressing research questions originally proposed by the white paper, including determining the optimal method of access for NOTES, developing safe methods of lumenal closure, suturing and anastomotic devices, advanced multitasking platforms, addressing the risk of infection, managing complications, addressing challenges with visualization, and training for NOTES procedures. An analysis of the literature reveals that so far transvaginal access and closure appear to be the most feasible techniques for NOTES, with a limited, but growing transgastric, transrectal, and transesophageal NOTES experience in humans. The theoretically increased risk of infection as a result of NOTES procedures has not been substantiated in transvaginal and transgastric procedures so far. Development of suturing and anastomotic devices and advanced platforms for NOTES has progressed slowly, with limited clinical data on their use so far. Data on the optimal management and incidence of intraoperative complications remain sparse, although possible factors contributing to complications are discussed. Finally, this editorial discusses the likely direction of future NOTES development and its possible role in clinical practice. PMID:21483624

A Novel Approach in Facilitating Aviation Emergency Procedure Learning and Recall through an Intuitive Pictorial System

DTIC Science & Technology

2007-01-01

AUTHOR(S) Arthur Estrada; Jennifer Keeley; Patricia LeDuc; Julie Bass; Tiffany Rouse 5d. PROJECT NUMBER 878 5e. TASK NUMBER O 5f. WORK UNIT...renowned researcher of human memory, F. I. M. Craik , and co-author, R. S. Lockhart, published a review of the prevailing “multistore” theories of...limiting factor: storage capacity or the rate at which the processor could perform certain operations. Craik and Lockhart favored the latter: that the

An intravenous self-administration procedure for assessing the reinforcing effects of hallucinogens in nonhuman primates.

PubMed

Goodwin, Amy K

Self-administration procedures are the gold standard for investigating the reinforcing effects of drugs. The notable exception to good correspondence between laboratory self-administration studies and human drug taking behavior has historically been the classic hallucinogens. The present study used a well-established daily access procedure, followed by a novel intermittent access procedure, to investigate the reinforcing effects of LSD in baboons. Rates of self-injection in the daily access procedure were minimal. One baboon self-administered 0.001mg/kg and a second baboon self-administered 0.0032mg/kg above vehicle levels, though rates of self-injection were clearly low and neither of the two remaining baboons self-administered any LSD dose tested in the daily access procedure. Rates of self-injection using an intermittent access procedure with discriminative stimuli resulted in two doses of LSD being self-administered above vehicle levels in two of three baboons tested (0.01 and 0.032mg/kg in one baboon; 0.0032 and 0.01mg/kg in a second). In addition, the number of self-injections at these doses was higher (range=3-6 injections) in the intermittent access procedure than in the daily access procedure (range=1-2 injections). The present study is the first to demonstrate LSD self-administration in a laboratory animal, and though the results are limited, they indicate intermittent access procedures with discriminative stimuli may provide a reliable and valid method for investigating the reinforcing effects of IV self-administered hallucinogens in laboratory animals. The usefulness of such procedures should be further evaluated in a larger number of subjects. Copyright © 2016. Published by Elsevier Inc.

Comparing Efficacy and Costs of Four Facial Fillers in Human Immunodeficiency Virus-Associated Lipodystrophy: A Clinical Trial.

PubMed

Vallejo, Alfonso; Garcia-Ruano, Angela A; Pinilla, Carmen; Castellano, Michele; Deleyto, Esther; Perez-Cano, Rosa

2018-03-01

The objective of this study was to evaluate and compare the safety and effectiveness of four different dermal fillers in the treatment of facial lipoatrophy secondary to human immunodeficiency virus. The authors conducted a clinical trial including 147 patients suffering from human immunodeficiency virus-induced lipoatrophy treated with Sculptra (poly-L-lactic acid), Radiesse (calcium hydroxylapatite), Aquamid (polyacrylamide), or autologous fat. Objective and subjective changes were evaluated during a 24-month follow-up. Number of sessions, total volume injected, and overall costs of treatment were also analyzed. A comparative cost-effectiveness analysis of the treatment options was performed. Objective improvement in facial lipoatrophy, assessed by the surgeon in terms of changes from baseline using the published classification of Fontdevila, was reported in 53 percent of the cases. Patient self-evaluation showed a general improvement after the use of facial fillers. Patients reported being satisfied with the treatment and with the reduced impact of lipodystrophy on their quality of life. Despite the nonsignificant differences observed in the number of sessions and volume, autologous fat showed significantly lower costs than all synthetic fillers (p < 0.05). Surgical treatment of human immunodeficiency virus-associated facial lipoatrophy using dermal fillers is a safe and effective procedure that improves the aesthetic appearance and the quality of life of patients. Permanent fillers and autologous fat achieve the most consistent results over time, with lipofilling being the most cost-effective procedure.

Differences between Presentation Methods in Working Memory Procedures: A Matter of Working Memory Consolidation

ERIC Educational Resources Information Center

Ricker, Timothy J.; Cowan, Nelson

2014-01-01

Understanding forgetting from working memory, the memory used in ongoing cognitive processing, is critical to understanding human cognition. In the past decade, a number of conflicting findings have been reported regarding the role of time in forgetting from working memory. This has led to a debate concerning whether longer retention intervals…

Neuropsychology and the neurochemical lesion: evolution, applications and extensions.

PubMed

Hartman, D E

1988-01-01

The evolution of neuropsychology into a method for neurotoxic damage detection is reviewed. When neuropsychology is transformed into "neuropsychological toxicology", fundamental philosophical assumptions of the field are altered; the search for brain-behavior relationships must extend from structural damage into the analysis of neurochemical systems. The complementary relationship of human neuropsychology to basic toxicological and animal research is discussed. The great numbers of human "natural experiments" whose employment, medical history or substance abuse subjects them to contact with neurotoxic substances, suggest that there is a great need for expanded human investigations involving neuropsychological testing procedures in the service of research and clinical identification of neurotoxic syndromes. Further, it is argued that neurobehavioral procedures originally developed to detect industrial neurotoxic exposure will prove additionally useful assessing other brain-behavior disruptions mediated by neurochemistry or neurotoxicity rather than structural lesion. These frontiers include physical or emotional illness, substance abuse, effects of abused or prescription drugs as well as little-researched areas deserving of closer study, e.g., allergens or biotoxic exposure.

Chapter 17 Sterile Plate-Based Vitrification of Adherent Human Pluripotent Stem Cells and Their Derivatives Using the TWIST Method.

PubMed

Neubauer, Julia C; Stracke, Frank; Zimmermann, Heiko

2017-01-01

Due to their high biological complexity, e.g., their close cell-to-cell contacts, cryopreservation of human pluripotent stem cells with standard slow-rate protocols often is inefficient and can hardly be standardized. Vitrification that means ultrafast freezing already showed very good viability and recovery rates for this sensitive cell system, but is only applicable for low cell numbers, bears a high risk of contamination, and can hardly be implemented under GxP regulations. In this chapter, a sterile plate-based vitrification method for adherent pluripotent stem cells and their derivatives is presented based on a procedure and device for human embryonic stem cells developed by Beier et al. (Cryobiology 66:8-16, 2013). This protocol overcomes the limitations of conventional vitrification procedures resulting in the highly efficient preservation of ready-to-use adherent pluripotent stem cells with the possibility of vitrifying cells in multi-well formats for direct application in high-throughput screenings.

Toward granting linguistic competence to apes: A review of Savage-Rumbaugh et al.'s Language Comprehension in Ape and Child1

PubMed Central

Sundberg, Mark L.

1996-01-01

Savage-Rumbaugh et al.'s (1993) monograph describes a study that compared the language comprehension of an 8-year-old ape (a bonobo named Kanzi) with that of a normal 2-year-old human (Alia). The primary purpose of the research was to see if Kanzi could comprehend novel and compound spoken English commands without imitative prompts, contrived reinforcement contingencies, or explicit training procedures. As it turned out, Kanzi acquired a complex comprehension repertoire in a pattern similar to the human child's and even performed better than the human child in many cases. Although this review describes these empirical results favorably, it questions the authors' claim that the subjects learned the repertoire on their own, without reinforcement or training. A close examination of the subjects' histories and of the procedures, transcripts, and videos suggested that the training and testing procedures involved a number of independent variables and processes that were not discussed by the authors, including conditioned reinforcement and punishment, verbal prompts, stimulus control, establishing operations, and extinction. Nonetheless, the methodological and empirical contributions to ape and human language research are substantial and deserve behavior analysts' attention and support. Behavior analysts could contribute to this kind of research by applying the analytic and conceptual tools of behavior analysis in general and the concepts from Verbal Behavior (Skinner, 1957) in particular.

Trends and Cost of Posterior Cervical Fusions With and Without Recombinant Human Bone Morphogenetic Protein-2 in the US Medicare Population.

PubMed

Myhre, Sue Lynn; Buser, Zorica; Meisel, Hans-Joerg; Brodke, Darrel S; Yoon, S Tim; Wang, Jeffrey C; Park, Jong-Beom; Youssef, Jim A

2017-06-01

Retrospective database review. To analyze and report the trends and cost of posterior cervical fusions (PCFs) with and without off-label recombinant human bone morphogenetic protein-2 (rhBMP-2) in the Medicare population. Patient records from the PearlDiver database were retrospectively reviewed from January 1, 2005, to December 31, 2012, to distinguish individuals who underwent a PCF with or without rhBMP-2. Total numbers, incidence, age, gender, geographic region, reimbursement, and length of stay were analyzed and summarized. The combined total of non-rhBMP-2 (n = 39 479; 85.51%) and rhBMP-2 PCF (n = 6692; 14.49%) procedures performed between 2005 and 2012 was 46 171. In general, the number of PCFs without rhBMP-2 consistently increased over time, while the number of PCFs with rhBMP-2 had only a slight increase from 2005 to 2012. On average, PCFs without rhBMP-2 were associated with $1197 higher cost than those with rhBMP-2, but the average length of stay was similar (6 days). From 2005 to 2012, the average cost for procedures with and without rhBMP-2 increased by $12 605 and $7291, respectively. The percentage of rhBMP-2 use peaked in 2007 and dwindled until 2010, and declined an additional 2.84% from 2011 to 2012. Multiple age, region, and gender tendencies were observed. To our knowledge, this was the first study to use the PearlDiver database to report incidence and cost trends of PCF procedures. This article provides meaningful trend data on PCFs to surgeons and clinicians, researchers, and patients, as well as functions as a beacon for future research questions.

Portable medical status system. [potential hazards in the use of the telecare system

NASA Technical Reports Server (NTRS)

Lindsey, O. C.

1976-01-01

The hazards inherent in the Portable Medical Status System are identified, and the measures taken to reduce them to an acceptable level are described. Identification of these hazards is a prerequisite to use of the system on humans in the earth environment. One hazard which is insufficiently controlled and which is considered a constraint to use on humans is the level of current possible in the electrodes for the EEG (electroencephalograph) circuitry. It exceeds the maximum specified. A number of procedural and design recommendations for enhancement of safety are made.

Cryopreservation of Human Mucosal Leukocytes.

PubMed

Hughes, Sean M; Shu, Zhiquan; Levy, Claire N; Ferre, April L; Hartig, Heather; Fang, Cifeng; Lentz, Gretchen; Fialkow, Michael; Kirby, Anna C; Adams Waldorf, Kristina M; Veazey, Ronald S; Germann, Anja; von Briesen, Hagen; McElrath, M Juliana; Dezzutti, Charlene S; Sinclair, Elizabeth; Baker, Chris A R; Shacklett, Barbara L; Gao, Dayong; Hladik, Florian

2016-01-01

Understanding how leukocytes in the cervicovaginal and colorectal mucosae respond to pathogens, and how medical interventions affect these responses, is important for developing better tools to prevent HIV and other sexually transmitted infections. An effective cryopreservation protocol for these cells following their isolation will make studying them more feasible. To find an optimal cryopreservation protocol for mucosal mononuclear leukocytes, we compared cryopreservation media and procedures using human vaginal leukocytes and confirmed our results with endocervical and colorectal leukocytes. Specifically, we measured the recovery of viable vaginal T cells and macrophages after cryopreservation with different cryopreservation media and handling procedures. We found several cryopreservation media that led to recoveries above 75%. Limiting the number and volume of washes increased the fraction of cells recovered by 10-15%, possibly due to the small cell numbers in mucosal samples. We confirmed that our cryopreservation protocol also works well for both endocervical and colorectal leukocytes. Cryopreserved leukocytes had slightly increased cytokine responses to antigenic stimulation relative to the same cells tested fresh. Additionally, we tested whether it is better to cryopreserve endocervical cells on the cytobrush or in suspension. Leukocytes from cervicovaginal and colorectal tissues can be cryopreserved with good recovery of functional, viable cells using several different cryopreservation media. The number and volume of washes has an experimentally meaningful effect on the percentage of cells recovered. We provide a detailed, step-by-step protocol with best practices for cryopreservation of mucosal leukocytes.

Naturalistic Decision Making: Implications for Design

DTIC Science & Technology

1993-04-01

Cognitive Task Analysis Decision Making Design Engineer Design System Human-Computer Interface System Development 15. NUMBER OF PAGES 182 16...people use to select a course of action. The SOAR explains how stress affects the decision making of both individuals and teams. COGNITIVE TASK ANALYSIS : This...procedures for Cognitive Task Analysis , contrasting the strengths and weaknesses of each, and showing how a Cognitive Task Analysis

The Anatomy of the Aging Face: A Review.

PubMed

Cotofana, Sebastian; Fratila, Alina A M; Schenck, Thilo L; Redka-Swoboda, Wolfgang; Zilinsky, Isaac; Pavicic, Tatjana

2016-06-01

Rejuvenative procedures of the face are increasing in numbers, and a plethora of different therapeutic options are available today. Every procedure should aim for the patient's safety first and then for natural and long-lasting results. The face is one of the most complex regions in the human body and research continuously reveals new insights into the complex interplay of the different participating structures. Bone, ligaments, muscles, fat, and skin are the key players in the layered arrangement of the face.Aging occurs in all involved facial structures but the onset and the speed of age-related changes differ between each specific structure, between each individual, and between different ethnic groups. Therefore, knowledge of age-related anatomy is crucial for a physician's work when trying to restore a youthful face.This review focuses on the current understanding of the anatomy of the human face and tries to elucidate the morphological changes during aging of bone, ligaments, muscles, and fat, and their role in rejuvenative procedures. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Production and characterization of alginate microcapsules produced by a vibrational encapsulation device.

PubMed

Mazzitelli, S; Tosi, A; Balestra, C; Nastruzzi, C; Luca, G; Mancuso, F; Calafiore, R; Calvitti, M

2008-09-01

The optimization, through a Design of Experiments (DoE) approach, of a microencapsulation procedure for isolated neonatal porcine islets (NPI) is described. The applied method is based on the generation of monodisperse droplets by a vibrational nozzle. An alginate/polyornithine encapsulation procedure, developed and validated in our laboratory for almost a decade, was used to embody pancreatic islets. We analyzed different experimental parameters including frequency of vibration, amplitude of vibration, polymer pumping rate, and distance between the nozzle and the gelling bath. We produced calcium-alginate gel microbeads with excellent morphological characteristics as well as a very narrow size distribution. The automatically produced microcapsules did not alter morphology, viability and functional properties of the enveloped NPI. The optimization of this automatic procedure may provide a novel approach to obtain a large number of batches possibly suitable for large scale production of immunoisolated NPI for in vivo cell transplantation procedures in humans.

Comparison between Procedures using Sodium Dodecyl Sulfate for Shotgun Proteomic Analyses of Complex Samples

PubMed Central

Bereman, Michael S.; Egertson, Jarrett D.; MacCoss, Michael J.

2012-01-01

Filter aided sample preparation (FASP) and a new sample preparation method using a modified commercial SDS removal spin column are quantitatively compared in terms of their performance for shotgun proteomic experiments in three complex proteomic samples: a Saccharomyces cerevisiae lysate (insoluble fraction), a Caenorhabditis elegans lysate (soluble fraction), and a human embryonic kidney cell line (HEK293T). The characteristics and total number of peptides and proteins identified are compared between the two procedures. The SDS spin column procedure affords a conservative 4-fold improvement in throughput, is more reproducible, less expensive (i.e., requires less materials), and identifies between 30–107% more peptides at a q≤0.01, than the FASP procedure. The peptides identified by SDS spin column are more hydrophobic than species identified by the FASP procedure as indicated by the distribution of GRAVY scores. Ultimately, these improvements correlate to as great as a 50% increase in protein identifications with 2 or more peptides. PMID:21656683

The bovine kidney as an experimental model in urology: external gross anatomy.

PubMed

Carvalho, Francismar S; Bagetti Filho, Hélio J S; Henry, Robert W; Pereira-Sampaio, Marco A

2009-01-01

The objective of this work was to obtain and record detailed and accurate measurements of the bovine kidney and to compare these new data with findings in humans. Thirty-eight bovine kidneys were used. The total number of lobes, along with the number of lobes located in the cranial polar, caudal polar and hilar regions, were recorded. Several measurements of the kidneys were made and evaluated. The hilar region presents the greatest length (mean of 76.87 mm) of the 3 renal regions of the kidney. The large area of the bovine renal hilus could make access to hilar structures easier than in the human kidney. The coefficient of variation for renal length was small (8.14%), while the coefficient of variation for the lobar number was high (26.82%). The number of renal lobes ranged from 13 to 35, with a mean of 20.62. The hilar region presents the highest number of lobes, while the cranial pole presents the lowest. The number of lobes in the cranial and caudal poles increases with the width of these regions. This is different from the hilar region, in which the lobar number increases with the length of the hilus. These data indicate that the adult bovine kidney can be used as a model for certain urologic procedures, but researchers must be aware that there are some major differences between the adult bovine kidney and the human kidney, as indicated by the data reported in this paper. (c) 2008 S. Karger AG, Basel.

Encapsulating Non-Human Primate Multipotent Stromal Cells in Alginate via High Voltage for Cell-Based Therapies and Cryopreservation

PubMed Central

Gryshkov, Oleksandr; Pogozhykh, Denys; Hofmann, Nicola; Pogozhykh, Olena; Mueller, Thomas; Glasmacher, Birgit

2014-01-01

Alginate cell-based therapy requires further development focused on clinical application. To assess engraftment, risk of mutations and therapeutic benefit studies should be performed in an appropriate non-human primate model, such as the common marmoset (Callithrix jacchus). In this work we encapsulated amnion derived multipotent stromal cells (MSCs) from Callithrix jacchus in defined size alginate beads using a high voltage technique. Our results indicate that i) alginate-cell mixing procedure and cell concentration do not affect the diameter of alginate beads, ii) encapsulation of high cell numbers (up to 10×106 cells/ml) can be performed in alginate beads utilizing high voltage and iii) high voltage (15–30 kV) does not alter the viability, proliferation and differentiation capacity of MSCs post-encapsulation compared with alginate encapsulated cells produced by the traditional air-flow method. The consistent results were obtained over the period of 7 days of encapsulated MSCs culture and after cryopreservation utilizing a slow cooling procedure (1 K/min). The results of this work show that high voltage encapsulation can further be maximized to develop cell-based therapies with alginate beads in a non-human primate model towards human application. PMID:25259731

Individual Differences in Human Reliability Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jeffrey C. Joe; Ronald L. Boring

2014-06-01

While human reliability analysis (HRA) methods include uncertainty in quantification, the nominal model of human error in HRA typically assumes that operator performance does not vary significantly when they are given the same initiating event, indicators, procedures, and training, and that any differences in operator performance are simply aleatory (i.e., random). While this assumption generally holds true when performing routine actions, variability in operator response has been observed in multiple studies, especially in complex situations that go beyond training and procedures. As such, complexity can lead to differences in operator performance (e.g., operator understanding and decision-making). Furthermore, psychological research hasmore » shown that there are a number of known antecedents (i.e., attributable causes) that consistently contribute to observable and systematically measurable (i.e., not random) differences in behavior. This paper reviews examples of individual differences taken from operational experience and the psychological literature. The impact of these differences in human behavior and their implications for HRA are then discussed. We propose that individual differences should not be treated as aleatory, but rather as epistemic. Ultimately, by understanding the sources of individual differences, it is possible to remove some epistemic uncertainty from analyses.« less

Collection and reconstruction after harvesting donor tissues from the musculoskeletal system: Technique specific to the lower limbs.

PubMed

Erivan, R; Villatte, G; Lecointe, T; Descamps, S; Boisgard, S

2018-03-19

The lack of available musculoskeletal grafts in France forces us to import a very large quantity of these tissues to use in complex reconstruction procedures. The goal of this article is to describe methods for collecting donor tissues from the musculoskeletal system and for reconstructing the harvested areas. We also provide a summary of the collection procedures performed, harvested grafts and available tissues. While tissue collection requires a significant time investment, the emergence of dedicated teams may be a solution for increasing the number and quality of human musculoskeletal allograft tissues. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Human Histologic Repair and Regeneration After Biologic Preparation of Diseased Root Surfaces,

DTIC Science & Technology

1983-12-01

Continue on reverse side if neceesar and Identify by block number) Periodontal disease Tooth roots Connective tissue regeneration 20 ABSTRACT (Continue on... regeneration of periodontal attachment loss, due to inflammatory periodontal disease (1). Most procedures for new attachment achieve a new dentogingival...good appearance for a lifetime. Oral hygiene is the most important factor in the prevention and treatment of inflammatory periodontal diseases

Expansion of Human Induced Pluripotent Stem Cells in Stirred Suspension Bioreactors.

PubMed

Almutawaa, Walaa; Rohani, Leili; Rancourt, Derrick E

2016-01-01

Human induced pluripotent stem cells (hiPSCs) hold great promise as a cell source for therapeutic applications and regenerative medicine. Traditionally, hiPSCs are expanded in two-dimensional static culture as colonies in the presence or absence of feeder cells. However, this expansion procedure is associated with lack of reproducibility and low cell yields. To fulfill the large cell number demand for clinical use, robust large-scale production of these cells under defined conditions is needed. Herein, we describe a scalable, low-cost protocol for expanding hiPSCs as aggregates in a lab-scale bioreactor.

Procedure for the Isolation of Endothelial Cells from Human Cerebral Arteriovenous Malformation (cAVM) Tissues.

PubMed

Hao, Qiang; Chen, Xiao-Lin; Ma, Li; Wang, Tong-Tong; Hu, Yue; Zhao, Yuan-Li

2018-01-01

In this study, we successfully established a stable method for the isolation of endothelial cells (ECs) from human cerebral arteriovenous malformation (cAVM) tissues. Despite human cAVM tissues having a minor population of ECs, they play an important role in the manifestation and development of cAVM as well as in hemorrhagic stroke and thrombogenesis. To characterize and understand the biology of ECs in human cAVM (cAVM-ECs), methods for the isolation and purification of these cells are necessary. We have developed this method to reliably obtain pure populations of ECs from cAVMs. To obtain pure cell populations, cAVM tissues were mechanically and enzymatically digested and the resulting single cAVM-ECs suspensions were then labeled with antibodies of specific cell antigens and selected by flow cytometry. Purified ECs were detected using specific makers of ECs by immunostaining and used to study different cellular mechanisms. Compared to the different methods of isolating ECs from tissues, we could isolate ECs from cAVMs confidently, and the numbers of cAVM-ECs harvested were almost similar to the amounts present in vessel components. In addition to optimizing the protocol for isolation of ECs from human cAVM tissues, the protocol could also be applied to isolate ECs from other human neurovascular-diseased tissues. Depending on the tissues, the whole procedure could be completed in about 20 days.

Human Papillomavirus (HPV) Genotyping: Automation and Application in Routine Laboratory Testing

PubMed Central

Torres, M; Fraile, L; Echevarria, JM; Hernandez Novoa, B; Ortiz, M

2012-01-01

A large number of assays designed for genotyping human papillomaviruses (HPV) have been developed in the last years. They perform within a wide range of analytical sensitivity and specificity values for the different viral types, and are used either for diagnosis, epidemiological studies, evaluation of vaccines and implementing and monitoring of vaccination programs. Methods for specific genotyping of HPV-16 and HPV-18 are also useful for the prevention of cervical cancer in screening programs. Some commercial tests are, in addition, fully or partially automated. Automation of HPV genotyping presents advantages such as the simplicity of the testing procedure for the operator, the ability to process a large number of samples in a short time, and the reduction of human errors from manual operations, allowing a better quality assurance and a reduction of cost. The present review collects information about the current HPV genotyping tests, with special attention to practical aspects influencing their use in clinical laboratories. PMID:23248734

Derivation of Human Skin Fibroblast Lines for Feeder Cells of Human Embryonic Stem Cells.

PubMed

Unger, Christian; Felldin, Ulrika; Rodin, Sergey; Nordenskjöld, Agneta; Dilber, Sirac; Hovatta, Outi

2016-02-03

After the first derivations of human embryonic stem cell (hESC) lines on fetal mouse feeder cell layers, the idea of using human cells instead of mouse cells as feeder cells soon arose. Mouse cells bear a risk of microbial contamination, and nonhuman immunogenic proteins are absorbed from the feeders to hESCs. Human skin fibroblasts can be effectively used as feeder cells for hESCs. The same primary cell line, which can be safely used for up to 15 passages after stock preparations, can be expanded and used for large numbers of hESC derivations and cultures. These cells are relatively easy to handle and maintain. No animal facilities or animal work is needed. Here, we describe the derivation, culture, and cryopreservation procedures for research-grade human skin fibroblast lines. We also describe how to make feeder layers for hESCs using these fibroblasts. Copyright © 2016 John Wiley & Sons, Inc.

Math, monkeys, and the developing brain.

PubMed

Cantlon, Jessica F

2012-06-26

Thirty thousand years ago, humans kept track of numerical quantities by carving slashes on fragments of bone. It took approximately 25,000 y for the first iconic written numerals to emerge among human cultures (e.g., Sumerian cuneiform). Now, children acquire the meanings of verbal counting words, Arabic numerals, written number words, and the procedures of basic arithmetic operations, such as addition and subtraction, in just 6 y (between ages 2 and 8). What cognitive abilities enabled our ancestors to record tallies in the first place? Additionally, what cognitive abilities allow children to rapidly acquire the formal mathematics knowledge that took our ancestors many millennia to invent? Current research aims to discover the origins and organization of numerical information in humans using clues from child development, the organization of the human brain, and animal cognition.

Cryopreservation of Human Mucosal Leukocytes

PubMed Central

Shu, Zhiquan; Levy, Claire N.; Ferre, April L.; Hartig, Heather; Fang, Cifeng; Lentz, Gretchen; Fialkow, Michael; Kirby, Anna C.; Adams Waldorf, Kristina M.; Veazey, Ronald S.; Germann, Anja; von Briesen, Hagen; McElrath, M. Juliana; Dezzutti, Charlene S.; Sinclair, Elizabeth; Baker, Chris A. R.; Shacklett, Barbara L.; Gao, Dayong; Hladik, Florian

2016-01-01

Background Understanding how leukocytes in the cervicovaginal and colorectal mucosae respond to pathogens, and how medical interventions affect these responses, is important for developing better tools to prevent HIV and other sexually transmitted infections. An effective cryopreservation protocol for these cells following their isolation will make studying them more feasible. Methods and Findings To find an optimal cryopreservation protocol for mucosal mononuclear leukocytes, we compared cryopreservation media and procedures using human vaginal leukocytes and confirmed our results with endocervical and colorectal leukocytes. Specifically, we measured the recovery of viable vaginal T cells and macrophages after cryopreservation with different cryopreservation media and handling procedures. We found several cryopreservation media that led to recoveries above 75%. Limiting the number and volume of washes increased the fraction of cells recovered by 10–15%, possibly due to the small cell numbers in mucosal samples. We confirmed that our cryopreservation protocol also works well for both endocervical and colorectal leukocytes. Cryopreserved leukocytes had slightly increased cytokine responses to antigenic stimulation relative to the same cells tested fresh. Additionally, we tested whether it is better to cryopreserve endocervical cells on the cytobrush or in suspension. Conclusions Leukocytes from cervicovaginal and colorectal tissues can be cryopreserved with good recovery of functional, viable cells using several different cryopreservation media. The number and volume of washes has an experimentally meaningful effect on the percentage of cells recovered. We provide a detailed, step-by-step protocol with best practices for cryopreservation of mucosal leukocytes. PMID:27232996

Automation of Command and Data Entry in a Glovebox Work Volume: An Evaluation of Data Entry Devices

NASA Technical Reports Server (NTRS)

Steele, Marianne K.; Nakamura, Gail; Havens, Cindy; LeMay, Moira

1996-01-01

The present study was designed to examine the human-computer interface for data entry while performing experimental procedures within a glovebox work volume in order to make a recommendation to the Space Station Biological Research Project for a data entry system to be used within the Life Sciences Glovebox. Test subjects entered data using either a manual keypad, similar to a standard computer numerical keypad located within the glovebox work volume, or a voice input system using a speech recognition program with a microphone headset. Numerical input and commands were programmed in an identical manner between the two systems. With both electronic systems, a small trackball was available within the work volume for cursor control. Data, such as sample vial identification numbers, sample tissue weights, and health check parameters of the specimen, were entered directly into procedures that were electronically displayed on a video monitor within the glovebox. A pen and paper system with a 'flip-chart' format for procedure display, similar to that currently in use on the Space Shuttle, was used as a baseline data entry condition. Procedures were performed by a single operator; eight test subjects were used in the study. The electronic systems were tested under both a 'nominal' or 'anomalous' condition. The anomalous condition was introduced into the experimental procedure to increase the probability of finding limitations or problems with human interactions with the electronic systems. Each subject performed five test runs during a test day: two procedures each with voice and keypad, one with and one without anomalies, and one pen and paper procedure. The data collected were both quantitative (times, errors) and qualitative (subjective ratings of the subjects).

Trends of Posterior Long Segment Fusion with and without Recombinant Human Bone Morphogenetic Protein 2 in Patients with Scoliosis.

PubMed

Ruofeng, Yin; Cohen, Jeremiah R; Buser, Zorica; Yoon, S Tim; Meisel, Hans-Joerg; Youssef, Jim A; Park, Jong-Beom; Wang, Jeffrey C; Brodke, Darrel S

2016-08-01

Retrospective study. Symptomatic scoliosis can be a source of severe pain and disability. When nonoperative treatments fail, spine fusion is considered as an effective procedure in scoliosis management. The purpose of this study was to evaluate the trends of patients with scoliosis undergoing posterior long segment fusion (PLSF) with and without recombinant human bone morphogenetic protein 2 (rhBMP-2). Patients within the orthopedic subset of Medicare database undergoing PLSF from 2005 to 2011 were identified using the PearlDiver Patient Records Database. Both diagnosis and procedural International Classification of Diseases, ninth edition and Current Procedural Terminology codes were used. The year of procedure, age, sex, region, and rhBMP-2 use were recorded. In total, 1,265,591 patients with scoliosis were identified with 29,787 PLSF surgeries between 2005 and 2011. The incidence of PLSF procedures increased gradually from 2005 to 2009, decreased in 2010 (p < 0 0.01), and grew again in 2011. Patients over age 84 years had the highest incidence of PLSF. The lowest incidence of the procedures was in the Northeast, 5.96 per 100,000 patients. Sex differences were observed with a male-to-female ratio of 0.40 (p < 0.01). The use of rhBMP-2 for PLSF increased steadily from 2005 to 2009; the numbers dropped dramatically in 2010 and returned by 2011. According to our study, patients with scoliosis demonstrated a 0.6575 average incidence increase of PLSF treatments annually. There were significant differences in incidence of PLSF procedure and patient demographics. Additionally, rhBMP-2 consumption significantly changed when we stratified it by sex, age, and region respectively.

Platelet-rich plasma differs according to preparation method and human variability.

PubMed

Mazzocca, Augustus D; McCarthy, Mary Beth R; Chowaniec, David M; Cote, Mark P; Romeo, Anthony A; Bradley, James P; Arciero, Robert A; Beitzel, Knut

2012-02-15

Varying concentrations of blood components in platelet-rich plasma preparations may contribute to the variable results seen in recently published clinical studies. The purposes of this investigation were (1) to quantify the level of platelets, growth factors, red blood cells, and white blood cells in so-called one-step (clinically used commercial devices) and two-step separation systems and (2) to determine the influence of three separate blood draws on the resulting components of platelet-rich plasma. Three different platelet-rich plasma (PRP) separation methods (on blood samples from eight subjects with a mean age [and standard deviation] of 31.6 ± 10.9 years) were used: two single-spin processes (PRPLP and PRPHP) and a double-spin process (PRPDS) were evaluated for concentrations of platelets, red and white blood cells, and growth factors. Additionally, the effect of three repetitive blood draws on platelet-rich plasma components was evaluated. The content and concentrations of platelets, white blood cells, and growth factors for each method of separation differed significantly. All separation techniques resulted in a significant increase in platelet concentration compared with native blood. Platelet and white blood-cell concentrations of the PRPHP procedure were significantly higher than platelet and white blood-cell concentrations produced by the so-called single-step PRPLP and the so-called two-step PRPDS procedures, although significant differences between PRPLP and PRPDS were not observed. Comparing the results of the three blood draws with regard to the reliability of platelet number and cell counts, wide variations of intra-individual numbers were observed. Single-step procedures are capable of producing sufficient amounts of platelets for clinical usage. Within the evaluated procedures, platelet numbers and numbers of white blood cells differ significantly. The intra-individual results of platelet-rich plasma separations showed wide variations in platelet and cell numbers as well as levels of growth factors regardless of separation method.

SU-E-T-635: Process Mapping of Eye Plaque Brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huynh, J; Kim, Y

Purpose: To apply a risk-based assessment and analysis technique (AAPM TG 100) to eye plaque brachytherapy treatment of ocular melanoma. Methods: The role and responsibility of personnel involved in the eye plaque brachytherapy is defined for retinal specialist, radiation oncologist, nurse and medical physicist. The entire procedure was examined carefully. First, major processes were identified and then details for each major process were followed. Results: Seventy-one total potential modes were identified. Eight major processes (corresponding detailed number of modes) are patient consultation (2 modes), pretreatment tumor localization (11), treatment planning (13), seed ordering and calibration (10), eye plaque assembly (10),more » implantation (11), removal (11), and deconstruction (3), respectively. Half of the total modes (36 modes) are related to physicist while physicist is not involved in processes such as during the actual procedure of suturing and removing the plaque. Conclusion: Not only can failure modes arise from physicist-related procedures such as treatment planning and source activity calibration, but it can also exist in more clinical procedures by other medical staff. The improvement of the accurate communication for non-physicist-related clinical procedures could potentially be an approach to prevent human errors. More rigorous physics double check would reduce the error for physicist-related procedures. Eventually, based on this detailed process map, failure mode and effect analysis (FMEA) will identify top tiers of modes by ranking all possible modes with risk priority number (RPN). For those high risk modes, fault tree analysis (FTA) will provide possible preventive action plans.« less

Application of Ultrasound-Assisted Surfactant-Enhanced Emulsification Microextraction Based on Solidification of Floating Organic Droplets and High Performance Liquid Chromatography for Preconcentration and Determination of Alprazolam and Chlordiazepoxide in Human Serum Samples.

PubMed

Goudarzi, Nasser; Amirnavaee, Monavar; Arab Chamjangali, Mansour; Farsimadan, Sahar

2017-07-01

An improved microextraction method is proposed on the basis of ultrasound-assisted surfactant-enhanced emulsification and solidification of a floating organic droplet procedure combined with high performance liquid chromatography for the preconcentration and quantification of alprazolam (ALP) and chlordiazepoxide (CHL) present in a number of human serum samples. Several parameters affecting the extraction efficiency were investigated by the Plackett -Burman factorial design as the screening design. Then the response surface methodology based on the Box-Behnken design was used to optimize the effective parameters in the proposed procedure. The limits of detection for the proposed method were found to be 3.0 and 3.1 ng mL-1 for CHL and ALP, respectively. The calibration curves obtained for the method were linear in the ranges of 10.0-3,500.0 and 10.0-3,000.0 ng mL-1 for CHL and ALP, respectively, with a good determination coefficient. The recoveries of the drugs in the spiked human serum samples were above 93.0%. The developed method was successfully applied to the analysis of these studied drugs in human serum samples. The pre-treatment of the serum samples was performed using acetonitrile to remove the proteins. The proposed procedure was an accurate and reliable one for the determination and preconcentration of these drugs in blood samples. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Transplantation of spinal cord-derived neural stem cells for ALS: Analysis of phase 1 and 2 trials.

PubMed

Glass, Jonathan D; Hertzberg, Vicki S; Boulis, Nicholas M; Riley, Jonathan; Federici, Thais; Polak, Meraida; Bordeau, Jane; Fournier, Christina; Johe, Karl; Hazel, Tom; Cudkowicz, Merit; Atassi, Nazem; Borges, Lawrence F; Rutkove, Seward B; Duell, Jayna; Patil, Parag G; Goutman, Stephen A; Feldman, Eva L

2016-07-26

To test the safety of spinal cord transplantation of human stem cells in patients with amyotrophic lateral sclerosis (ALS) with escalating doses and expansion of the trial to multiple clinical centers. This open-label trial included 15 participants at 3 academic centers divided into 5 treatment groups receiving increasing doses of stem cells by increasing numbers of cells/injection and increasing numbers of injections. All participants received bilateral injections into the cervical spinal cord (C3-C5). The final group received injections into both the lumbar (L2-L4) and cervical cord through 2 separate surgical procedures. Participants were assessed for adverse events and progression of disease, as measured by the ALS Functional Rating Scale-Revised, forced vital capacity, and quantitative measures of strength. Statistical analysis focused on the slopes of decline of these phase 2 trial participants alone or in combination with the phase 1 participants (previously reported), comparing these groups to 3 separate historical control groups. Adverse events were mostly related to transient pain associated with surgery and to side effects of immunosuppressant medications. There was one incident of acute postoperative deterioration in neurologic function and another incident of a central pain syndrome. We could not discern differences in surgical outcomes between surgeons. Comparisons of the slopes of decline with the 3 separate historical control groups showed no differences in mean rates of progression. Intraspinal transplantation of human spinal cord-derived neural stem cells can be safely accomplished at high doses, including successive lumbar and cervical procedures. The procedure can be expanded safely to multiple surgical centers. This study provides Class IV evidence that for patients with ALS, spinal cord transplantation of human stem cells can be safely accomplished and does not accelerate the progression of the disease. This study lacks the precision to exclude important benefit or safety issues. © 2016 American Academy of Neurology.

Passive haemagglutination test for antibodies against rabies virus*

PubMed Central

Gough, P. M.; Dierks, R. E.

1971-01-01

All the procedures now available for the measurement of rabies virus antibodies in serum have certain disadvantages. The serum neutralization test (SN), whether carried out by assay in mice or by the plaque-reduction technique, requires several days before the titrations are completed, necessitates special facilities for keeping large numbers of animals and tissue-culture plates, and is relatively expensive. A complement-fixation test is very insensitive, giving low titres in comparison with SN tests, and a haemagglutination-inhibition procedure is complicated by the presence of nonspecific reactions. A rabies passive haemagglutination technique (RPHA), developed to overcome many of these problems, is described. Titres obtained with human sera by the RPHA procedure correlated well with those obtained by SN tests. Both IgG and IgM classes of antibodies were measured by the RPHA procedure; however, it appeared to be more sensitive for detecting IgM than was the SN test and, therefore, gave higher titres for this class of immunoglobulins. PMID:5317009

Relationship of procedural numbers with meaningful procedural autonomy in general surgery residents.

PubMed

Stride, Herbert P; George, Brian C; Williams, Reed G; Bohnen, Jordan D; Eaton, Megan J; Schuller, Mary C; Zhao, Lihui; Yang, Amy; Meyerson, Shari L; Scully, Rebecca; Dunnington, Gary L; Torbeck, Laura; Mullen, John T; Mandell, Samuel P; Choti, Michael; Foley, Eugene; Are, Chandrakanth; Auyang, Edward; Chipman, Jeffrey; Choi, Jennifer; Meier, Andreas; Smink, Douglas; Terhune, Kyla P; Wise, Paul; DaRosa, Debra; Soper, Nathaniel; Zwischenberger, Jay B; Lillemoe, Keith; Fryer, Jonathan P

2018-03-01

Concerns exist regarding the competency of general surgery graduates with performing core general surgery procedures. Current competence assessment incorporates minimal procedural numbers requirements. Based on the Zwisch scale we evaluated the level of autonomy achieved by categorical PGY1-5 general surgery residents at 14 U.S. general surgery resident training programs between September 1, 2015 and December 31, 2016. With 5 of the most commonly performed core general surgery procedures, we correlated the level of autonomy achieved by each resident with the number of procedures they had performed before the evaluation period, with the intent of identifying specific target numbers that would correlate with the achievement of meaningful autonomy for each procedure with most residents. Whereas a definitive target number was identified for laparoscopic appendectomy (i.e. 25), for the other 4 procedures studied (i.e. laparoscopic cholecystectomy, 52; open inguinal hernia repair, 42; ventral hernia repair, 35; and partial colectomy, 60), target numbers identified were less definitive and/or were higher than many residents will experience during their surgical residency training. We conclude that procedural target numbers are generally not effective in predicting procedural competence and should not be used as the basis for determining residents' readiness for independent practice. Copyright © 2017. Published by Elsevier Inc.

Unreliable numbers: error and harm induced by bad design can be reduced by better design

PubMed Central

Thimbleby, Harold; Oladimeji, Patrick; Cairns, Paul

2015-01-01

Number entry is a ubiquitous activity and is often performed in safety- and mission-critical procedures, such as healthcare, science, finance, aviation and in many other areas. We show that Monte Carlo methods can quickly and easily compare the reliability of different number entry systems. A surprising finding is that many common, widely used systems are defective, and induce unnecessary human error. We show that Monte Carlo methods enable designers to explore the implications of normal and unexpected operator behaviour, and to design systems to be more resilient to use error. We demonstrate novel designs with improved resilience, implying that the common problems identified and the errors they induce are avoidable. PMID:26354830

Serial interactome capture of the human cell nucleus.

PubMed

Conrad, Thomas; Albrecht, Anne-Susann; de Melo Costa, Veronica Rodrigues; Sauer, Sascha; Meierhofer, David; Ørom, Ulf Andersson

2016-04-04

Novel RNA-guided cellular functions are paralleled by an increasing number of RNA-binding proteins (RBPs). Here we present 'serial RNA interactome capture' (serIC), a multiple purification procedure of ultraviolet-crosslinked poly(A)-RNA-protein complexes that enables global RBP detection with high specificity. We apply serIC to the nuclei of proliferating K562 cells to obtain the first human nuclear RNA interactome. The domain composition of the 382 identified nuclear RBPs markedly differs from previous IC experiments, including few factors without known RNA-binding domains that are in good agreement with computationally predicted RNA binding. serIC extends the number of DNA-RNA-binding proteins (DRBPs), and reveals a network of RBPs involved in p53 signalling and double-strand break repair. serIC is an effective tool to couple global RBP capture with additional selection or labelling steps for specific detection of highly purified RBPs.

Modifications to the NIST reference measurement procedure (RMP) for the determination of serum glucose by isotope dilution gas chromatography/mass spectrometry.

PubMed

Prendergast, Jocelyn L; Sniegoski, Lorna T; Welch, Michael J; Phinney, Karen W

2010-07-01

The definitive method (DM), now known as the reference measurement procedure (RMP), for the analysis of glucose in serum was originally published in 1982 by the National Institute of Standards and Technology (NIST). Over the years the method has been subject to a number of modifications to adapt to newer technologies and simplify sample preparation. We discuss here an adaptation of the method associated with serum glucose measurements using a modified isotope dilution gas chromatography/mass spectrometry (ID-GC/MS) method. NIST has used this modified method to certify the concentrations of glucose in SRM 965b, Glucose in Frozen Human Serum, and SRM 1950, Metabolites in Human Plasma. Comparison of results from the revised method with certified values for existing Standard Reference Materials (SRMs) demonstrated that these modifications have not affected the quality of the measurements, giving both good precision and accuracy, while reducing the sample preparation time by a day and a half.

Lemurs and macaques show similar numerical sensitivity.

PubMed

Jones, Sarah M; Pearson, John; DeWind, Nicholas K; Paulsen, David; Tenekedjieva, Ana-Maria; Brannon, Elizabeth M

2014-05-01

We investigated the precision of the approximate number system (ANS) in three lemur species (Lemur catta, Eulemur mongoz, and Eulemur macaco flavifrons), one Old World monkey species (Macaca mulatta) and humans (Homo sapiens). In Experiment 1, four individuals of each nonhuman primate species were trained to select the numerically larger of two visual arrays on a touchscreen. We estimated numerical acuity by modeling Weber fractions (w) and found quantitatively equivalent performance among all four nonhuman primate species. In Experiment 2, we tested adult humans in a similar procedure, and they outperformed the four nonhuman species but showed qualitatively similar performance. These results indicate that the ANS is conserved over the primate order.

CBP for Field Workers – Results and Insights from Three Usability and Interface Design Evaluations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oxstrand, Johanna Helene; Le Blanc, Katya Lee; Bly, Aaron Douglas

2015-09-01

Nearly all activities that involve human interaction with the systems in a nuclear power plant are guided by procedures. Even though the paper-based procedures (PBPs) currently used by industry have a demonstrated history of ensuring safety, improving procedure use could yield significant savings in increased efficiency as well as improved nuclear safety through human performance gains. The nuclear industry is constantly trying to find ways to decrease the human error rate, especially the human errors associated with procedure use. As a step toward the goal of improving procedure use and adherence, researchers in the Light-Water Reactor Sustainability (LWRS) Program, togethermore » with the nuclear industry, have been investigating the possibility and feasibility of replacing the current paper-based procedure process with a computer-based procedure (CBP) system. This report describes a field evaluation of new design concepts of a prototype computer-based procedure system.« less

How often are x-rays used as diagnostic tool by healthcare providers in the Mazovian province of Poland.

PubMed

Bekas, Marcin; Gajewski, Antoni K; Pachocki, Krzysztof

2013-01-01

Within the medical facilities provided by state healthcare services, a universally applied technique for patient diagnosis and treatment relies on ionising radiation; for example in radiotherapy and X-ray (ie. examination). Human exposure to such radiation is not however entirely free of associated health risks. To determine and estimate the numbers and types of X-ray based medical procedures that are performed in general and dental radiography, mammography and computer tomography on patients from the Mazovian province in Poland, which included children, women and men subjects. The numbers of patient subjects undergoing X-rays was estimated by surveying the patient intake in X-ray testing rooms within the healthcare facilities of the Mazovian province. Questionnaires were either dispatched by mail to such healthcare centres or were completed by the X-ray operating staff during the testing of quality control. Results so obtained from the latter, were compared to entries from the X-ray rooms' register During 2009, the number of X-rays performed were 7612046 equivalent to 1460 examinations per 1000 inhabitants. The majority were done on women ie. 3847961 (50.55%), followed by 3193781 (41.96%) on men and 570 304 (7.49%) for children. Results indicated that the predominating medical procedure used of this type, was for making general diagnoses; especially through using chest radiography. Others included, in descending order; dental X-ray (mainly intra-oral examination), computer tomography (mainly CT head examinations) and mammography procedures. It was also found that the annual numbers of having X-rays has increased compared to previous years.

An analysis of US fertility centre educational materials suggests that informed consent for preimplantation genetic diagnosis may be inadequate.

PubMed

LaBonte, Michelle Lynne

2012-08-01

The use of preimplantation genetic diagnosis (PGD) has expanded both in number and scope over the past 2 decades. Initially carried out to avoid the birth of children with severe genetic disease, PGD is now used for a variety of medical and non-medical purposes. While some human studies have concluded that PGD is safe, animal studies and a recent human study suggest that the embryo biopsy procedure may result in neurological problems for the offspring. Given that the long-term safety of PGD has not been clearly established in humans, this study sought to determine how PGD safety is presented to prospective patients by means of a detailed website analysis. The websites of 262 US fertility centres performing PGD were analysed and comments about safety and risk were catalogued. Results of the analysis demonstrated that 78.2% of centre websites did not mention safety or risk of PGD at all. Of the 21.8% of centres that did contain safety or risk information about PGD, 28.1% included statements highlighting the potential risks, 38.6% presented information touting the procedure as safe and 33.3% included statements highlighting potential risks and the overall safety of the procedure. Thus, 86.6% of PGD-performing centres state that PGD is safe and/or fail to disclose any risks on their websites despite the fact that the impact of the procedure on the long-term health of offspring is unproven. This lack of disclosure suggests that informed consent is inadequate; this study examines numerous factors that are likely to inhibit comprehensive discussions of safety.

Intelligent Multisensor Prodder for Training Operators in Humanitarian Demining

PubMed Central

Fernández, Roemi; Montes, Héctor; Armada, Manuel

2016-01-01

Manual prodding is still one of the most utilized procedures for identifying buried landmines during humanitarian demining activities. However, due to the high number of accidents reported during its practice, it is considered an outmoded and risky procedure and there is a general consensus about the need of introducing upgrades for enhancing the safety of human operators. With the aim of contributing to reduce the number of demining accidents, this paper presents an intelligent multisensory system for training operators in the use of prodders. The proposed tool is able to provide to deminers useful information in two critical issues: (a) the amount of force exerted on the target and if it is greater than the safe limit and, (b) to alert them when the angle of insertion of the prodder is approaching or exceeding a certain dangerous limit. Results of preliminary tests show the feasibility and reliability of the proposed design and highlight the potential benefits of the tool. PMID:27347963

Nazi Medical Research in Neuroscience: Medical Procedures, Victims, and Perpetrators.

PubMed

Loewenau, Aleksandra; Weindling, Paul J

Issues relating to the euthanasia killings of the mentally ill, the medical research conducted on collected body parts, and the clinical investigations on living victims under National Socialism are among the best-known abuses in medical history. But to date, there have been no statistics compiled regarding the extent and number of the victims and perpetrators, or regarding their identities in terms of age, nationality, and gender. "Victims of Unethical Human Experiments and Coerced Research under National Socialism," a research project based at Oxford Brookes University, has established an evidence-based documentation of the overall numbers of victims and perpetrators through specific record linkages of the evidence from the period of National Socialism, as well as from post-WWII trials and other records. This article examines the level and extent of these unethical medical procedures as they relate to the field of neuroscience. It presents statistical information regarding the victims, as well as detailing the involvement of the perpetrators and Nazi physicians with respect to their post-war activities and subsequent court trials.

Intelligent Multisensor Prodder for Training Operators in Humanitarian Demining.

PubMed

Fernández, Roemi; Montes, Héctor; Armada, Manuel

2016-06-24

Manual prodding is still one of the most utilized procedures for identifying buried landmines during humanitarian demining activities. However, due to the high number of accidents reported during its practice, it is considered an outmoded and risky procedure and there is a general consensus about the need of introducing upgrades for enhancing the safety of human operators. With the aim of contributing to reduce the number of demining accidents, this paper presents an intelligent multisensory system for training operators in the use of prodders. The proposed tool is able to provide to deminers useful information in two critical issues: (a) the amount of force exerted on the target and if it is greater than the safe limit and, (b) to alert them when the angle of insertion of the prodder is approaching or exceeding a certain dangerous limit. Results of preliminary tests show the feasibility and reliability of the proposed design and highlight the potential benefits of the tool.

Development and application of a DNA microarray-based yeast two-hybrid system

PubMed Central

Suter, Bernhard; Fontaine, Jean-Fred; Yildirimman, Reha; Raskó, Tamás; Schaefer, Martin H.; Rasche, Axel; Porras, Pablo; Vázquez-Álvarez, Blanca M.; Russ, Jenny; Rau, Kirstin; Foulle, Raphaele; Zenkner, Martina; Saar, Kathrin; Herwig, Ralf; Andrade-Navarro, Miguel A.; Wanker, Erich E.

2013-01-01

The yeast two-hybrid (Y2H) system is the most widely applied methodology for systematic protein–protein interaction (PPI) screening and the generation of comprehensive interaction networks. We developed a novel Y2H interaction screening procedure using DNA microarrays for high-throughput quantitative PPI detection. Applying a global pooling and selection scheme to a large collection of human open reading frames, proof-of-principle Y2H interaction screens were performed for the human neurodegenerative disease proteins huntingtin and ataxin-1. Using systematic controls for unspecific Y2H results and quantitative benchmarking, we identified and scored a large number of known and novel partner proteins for both huntingtin and ataxin-1. Moreover, we show that this parallelized screening procedure and the global inspection of Y2H interaction data are uniquely suited to define specific PPI patterns and their alteration by disease-causing mutations in huntingtin and ataxin-1. This approach takes advantage of the specificity and flexibility of DNA microarrays and of the existence of solid-related statistical methods for the analysis of DNA microarray data, and allows a quantitative approach toward interaction screens in human and in model organisms. PMID:23275563

Detection and sequencing of West Nile virus RNA from human urine and serum samples during the 2014 seasonal period.

PubMed

Nagy, Anna; Bán, Enikő; Nagy, Orsolya; Ferenczi, Emőke; Farkas, Ágnes; Bányai, Krisztián; Farkas, Szilvia; Takács, Mária

2016-07-01

West Nile virus, a widely distributed mosquito-borne flavivirus, is responsible for numerous animal and human infections in Europe, Africa and the Americas. In Hungary, the average number of human infections falls between 10 and 20 cases each year. The severity of clinically manifesting infections varies widely from the milder form of West Nile fever to West Nile neuroinvasive disease (WNND). In routine laboratory diagnosis of human West Nile virus infections, serological methods are mainly applied due to the limited duration of viremia. However, recent studies suggest that detection of West Nile virus RNA in urine samples may be useful as a molecular diagnostic test for these infections. The Hungarian National Reference Laboratory for Viral Zoonoses serologically confirmed eleven acute human infections during the 2014 seasonal period. In three patients with neurological symptoms, viral RNA was detected from both urine and serum specimens, albeit for a longer period and in higher copy numbers with urine. Phylogenetic analysis of the NS3 genomic region of three strains and the complete genome of one selected strain demonstrated that all three patients had lineage-2 West Nile virus infections. Our findings reaffirm the utility of viral RNA detection in urine as a molecular diagnostic procedure for diagnosis of West Nile virus infections.

The effect of riboflavin-UV-A treatment on corneal limbal epithelial cells--a study on human cadaver eyes.

PubMed

Vimalin, Jeyalatha; Gupta, Nidhi; Jambulingam, Malathi; Padmanabhan, Prema; Madhavan, Hajib N

2012-09-01

To determine the effect of riboflavin-UV-A treatment on the corneal limbal epithelial cells during a corneal collagen cross-linking (CXL) procedure. Thirty freshly enucleated human cadaveric eyeballs were subjected to a CXL procedure, mimicking the clinical protocol. During the UV-A exposure, one half of the limbus (sector A) was left unprotected, whereas the other half (sector B) was covered by a metal shield. Limbal biopsies from both sectors before and after the procedure were analyzed. Each strip of tissue was divided into 3 segments, for cell count of viable cells, for cultivation on human amniotic membrane (HAM), and for stem cell and differentiated corneal epithelial cell marker studies using reverse transcriptase-polymerase chain reaction. Compared with the cell count before CXL, there was a statistically significant drop in the mean number of viable cells after CXL in sector A but not in sector B. Biopsies from both sectors before CXL and from sector B after CXL showed good growth on HAM. Biopsies from sector A after CXL showed no growth on HAM. The putative stem cell marker ABCG2 was absent in all samples and p63 was absent in 3 of 10 samples taken from sector A after CXL. All markers were present in all samples from sector B after CXL. Riboflavin-UV-A treatment can result in damage to limbal epithelial cells, particularly the stem cells. Covering the limbal region with a metal shield effectively prevents this damage.

[Heavy metals: soil characteristics and methods of evaluating parameters for defining "contaminated soils"].

PubMed

Gagliano-Candela, R; Cammarota, R

2000-01-01

The excessive content of toxic elements in the human environment is associated with the etiology of a number of diseases. Soils' pollutants decontamination regards the main industrialised countries. Heavy metals represent the main problem for soil pollution characterisation. The first approach for pollution evaluation is the determination of total metal concentration; the evaluation of their bioavailability is required for a correct knowledge of the environmental risk. In the present work is shown the procedure to evaluate the sites, which require decontamination and which need the following data: knowledge of the threshold for each metal in the soil and its range, chemical analysis of the components, determination of bioavailability and soil destination. The bioavailability is easily calculated by the procedure of aimed extractions.

Image enhancement of optical images for binary system of melanocytes and keratinocytes

NASA Astrophysics Data System (ADS)

Takanezawa, S.; Baba, A.; Sako, Y.; Ozaki, Y.; Date, A.; Toyama, K.; Morita, S.

2013-05-01

Automatic determination of the cell shapes of large numbers of melanocytes based on optical images of human skin models have been largely unsuccessful (the complexities introduced by dendrites and the melanin pigmentation over the keratinocytes to give unclear outlines). Here, we present an image enhancement procedure for enhancing the contrast of images with removing the non-uniformity of background. The brightness is normalized also for the non-uniform population density of melanocytes.

A marker-free system for the analysis of movement disabilities.

PubMed

Legrand, L; Marzani, F; Dusserre, L

1998-01-01

A major step toward improving the treatments of disabled persons may be achieved by using motion analysis equipment. We are developing such a system. It allows the analysis of plane human motion (e.g. gait) without using the tracking of markers. The system is composed of one fixed camera which acquires an image sequence of a human in motion. Then the treatment is divided into two steps: first, a large number of pixels belonging to the boundaries of the human body are extracted at each acquisition time. Secondly, a two-dimensional model of the human body, based on tapered superquadrics, is successively matched with the sets of pixels previously extracted; a specific fuzzy clustering process is used for this purpose. Moreover, an optical flow procedure gives a prediction of the model location at each acquisition time from its location at the previous time. Finally we present some results of this process applied to a leg in motion.

Periprocedural safety of aneurysm embolization with the Medina Coil System: the early human experience.

PubMed

Turk, Aquilla S; Maia, Orlando; Ferreira, Christian Candido; Freitas, Diogo; Mocco, J; Hanel, Ricardo

2016-02-01

Intracranial saccular aneurysms, if untreated, carry a high risk of morbidity and mortality from intracranial bleeding. Embolization coils are the most common treatment. We describe the periprocedural safety and performance of the initial human experience with the next generation Medina Coil System. The Medina Coil System is a layered three-dimensional coil made from a radiopaque, shape set core wire, and shape memory alloy outer coil filaments. Nine aneurysms in five patients were selected for treatment with the Medina Coil System. Nine aneurysms in five patients, ranging from 5 to 17 mm in size in various locations, were treated with the Medina Coil System. No procedural or periprocedural complications were encountered. Procedure times, number of coils used to treat the aneurysm, and use of adjunctive devices were much less than anticipated if conventional coil technology had been used. The Medina Coil System is a next generation coil that combines all of the familiar and expected procedural safety and technique concepts associated with conventional coils. We found improved circumferential aneurysm filling, which may lead to improved long term outcomes, with fewer devices and faster operating times. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

78 FR 46415 - Proposed Collection; Comment Request for Revenue Procedure 2001-37

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... Revenue Procedure 2001- 37 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request... comments concerning Revenue Procedure 2001-37, Extraterritorial Income Exclusion Elections. DATES: Written... Elections. OMB Number: 1545-1731. Revenue Procedure Number: Revenue Procedure 2001-37. Abstract: Revenue...

75 FR 47060 - Proposed Collection; Comment Request for Revenue Procedure 2001-37

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

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75 FR 21151 - Proposed Collection; Comment Request for Revenue Procedure 2004-18

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

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21 CFR 320.32 - Procedures for establishing or amending a bioequivalence requirement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.32 Procedures for...

76 FR 31013 - Proposed Collection; Comment Request for Revenue Procedure 99-17

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-27

... Revenue Procedure 99-17 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for... information collection requirements related to Revenue Procedure 99-17, Mark to Market Election for.... OMB Number: 1545-1641. Revenue Procedure Number: Revenue Procedure 99-17. Abstract: This revenue...

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 nonglycosylated tryptic peptides adjacent to N-linked glycosylation sites in N-linked glycoprotein biomarkers, which could be detected in human plasma samples without depleting highly abundant proteins. Second, human plasma proteins were digested with trypsin without reduction and alkylation procedures to minimize sample preparation. Third, trypsin digestion times were shortened so as to obtain reproducible results with maximization of the steric hindrance effect of the glycans during enzyme digestion. Finally, this rapid and simple sample preparation method was applied to validate targeted nonglycosylated tryptic peptides as liver cancer biomarker candidates for diagnosis in 40 normal and 41 hepatocellular carcinoma (HCC) human plasma samples. This strategy provided the necessary throughput required to monitor protein biomarkers, as well as quantitative accuracy in human plasma analysis. From biomarker discovery to clinical implementation, our method will provide a biomarker study platform that is suitable for clinical deployment, and can be applied to high-throughput approaches. Copyright © 2014 Elsevier B.V. All rights reserved.

A hierarchical Bayesian approach to adaptive vision testing: A case study with the contrast sensitivity function.

PubMed

Gu, Hairong; Kim, Woojae; Hou, Fang; Lesmes, Luis Andres; Pitt, Mark A; Lu, Zhong-Lin; Myung, Jay I

2016-01-01

Measurement efficiency is of concern when a large number of observations are required to obtain reliable estimates for parametric models of vision. The standard entropy-based Bayesian adaptive testing procedures addressed the issue by selecting the most informative stimulus in sequential experimental trials. Noninformative, diffuse priors were commonly used in those tests. Hierarchical adaptive design optimization (HADO; Kim, Pitt, Lu, Steyvers, & Myung, 2014) further improves the efficiency of the standard Bayesian adaptive testing procedures by constructing an informative prior using data from observers who have already participated in the experiment. The present study represents an empirical validation of HADO in estimating the human contrast sensitivity function. The results show that HADO significantly improves the accuracy and precision of parameter estimates, and therefore requires many fewer observations to obtain reliable inference about contrast sensitivity, compared to the method of quick contrast sensitivity function (Lesmes, Lu, Baek, & Albright, 2010), which uses the standard Bayesian procedure. The improvement with HADO was maintained even when the prior was constructed from heterogeneous populations or a relatively small number of observers. These results of this case study support the conclusion that HADO can be used in Bayesian adaptive testing by replacing noninformative, diffuse priors with statistically justified informative priors without introducing unwanted bias.

A hierarchical Bayesian approach to adaptive vision testing: A case study with the contrast sensitivity function

PubMed Central

Gu, Hairong; Kim, Woojae; Hou, Fang; Lesmes, Luis Andres; Pitt, Mark A.; Lu, Zhong-Lin; Myung, Jay I.

2016-01-01

Measurement efficiency is of concern when a large number of observations are required to obtain reliable estimates for parametric models of vision. The standard entropy-based Bayesian adaptive testing procedures addressed the issue by selecting the most informative stimulus in sequential experimental trials. Noninformative, diffuse priors were commonly used in those tests. Hierarchical adaptive design optimization (HADO; Kim, Pitt, Lu, Steyvers, & Myung, 2014) further improves the efficiency of the standard Bayesian adaptive testing procedures by constructing an informative prior using data from observers who have already participated in the experiment. The present study represents an empirical validation of HADO in estimating the human contrast sensitivity function. The results show that HADO significantly improves the accuracy and precision of parameter estimates, and therefore requires many fewer observations to obtain reliable inference about contrast sensitivity, compared to the method of quick contrast sensitivity function (Lesmes, Lu, Baek, & Albright, 2010), which uses the standard Bayesian procedure. The improvement with HADO was maintained even when the prior was constructed from heterogeneous populations or a relatively small number of observers. These results of this case study support the conclusion that HADO can be used in Bayesian adaptive testing by replacing noninformative, diffuse priors with statistically justified informative priors without introducing unwanted bias. PMID:27105061

Two complementary fluorimetric assays for the determination of aminoquinoline binding and uptake by human erythrocytes in vitro.

PubMed

Basilico, Nicoletta; Cortelezzi, Lucia; Serpellini, Chiara; Taramelli, Donatella; Omodeo-Salè, Fausta; Salè, Fausta

2009-02-15

We provide two simple low-cost and low-tech procedures to measure with good precision and accuracy the binding and internalization into human erythrocytes of chloroquine and other aminoquinolines. The methods are based on the high fluorescence of the quinoline ring and are complementary. Method A evaluates residual drugs in the supernatants of treated erythrocytes, whereas method B quantifies the total uptake by whole cells and the fraction bound to the membranes. Drug uptake is dose dependent and related to the number of erythrocytes. These assays could be useful when studying the cell interaction of quinoline-type compounds not available in the radioactive form.

Graphene Oxide Annealing Procedures for Graphene-Based Supercapacitors

DTIC Science & Technology

2015-09-01

Annealing Procedures for Graphene-Based Supercapacitors by Louis B Levine and Matthew H Ervin Sensors and Electron Devices Directorate, ARL...SUBTITLE Graphene Oxide Annealing Procedures for Graphene-Based Supercapacitors 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

Anatomy and bronchoscopy of the porcine lung. A model for translational respiratory medicine.

PubMed

Judge, Eoin P; Hughes, J M Lynne; Egan, Jim J; Maguire, Michael; Molloy, Emer L; O'Dea, Shirley

2014-09-01

The porcine model has contributed significantly to biomedical research over many decades. The similar size and anatomy of pig and human organs make this model particularly beneficial for translational research in areas such as medical device development, therapeutics and xenotransplantation. In recent years, a major limitation with the porcine model was overcome with the successful generation of gene-targeted pigs and the publication of the pig genome. As a result, the role of this model is likely to become even more important. For the respiratory medicine field, the similarities between pig and human lungs give the porcine model particular potential for advancing translational medicine. An increasing number of lung conditions are being studied and modeled in the pig. Genetically modified porcine models of cystic fibrosis have been generated that, unlike mouse models, develop lung disease similar to human cystic fibrosis. However, the scientific literature relating specifically to porcine lung anatomy and airway histology is limited and is largely restricted to veterinary literature and textbooks. Furthermore, methods for in vivo lung procedures in the pig are rarely described. The aims of this review are to collate the disparate literature on porcine lung anatomy, histology, and microbiology; to provide a comparison with the human lung; and to describe appropriate bronchoscopy procedures for the pig lungs to aid clinical researchers working in the area of translational respiratory medicine using the porcine model.

On the design of flight-deck procedures

DOT National Transportation Integrated Search

1994-06-01

In complex human-machine systems, operations, training, and standardization depend on an elaborate set of procedures which are specified and mandated by the operational management of the organization. These procedures indicate to the human operator (...

76 FR 30428 - Proposed Collection; Comment Request for Revenue Procedure 99-21

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... Revenue Procedure 99-21 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for...: Disability Suspension. OMB Number: 1545-1649. Revenue Procedure Number: Revenue Procedure 99-21. Abstract: Revenue Procedure 99-21 describes the information that is needed to establish a claim that a taxpayer was...

78 FR 16048 - Proposed Collection; Comment Request for Revenue Procedure 2010-9

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... Revenue Procedure 2010-9 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for... comments concerning Revenue Procedure 2010-9. DATES: Written comments should be received on or before May... INFORMATION: Title: Revenue Procedure 2010-9. OMB Number: 1545-2080. Revenue Procedure Number: 2010-9...

The interaction of C.I. acid red 27 with human hemoglobin in solution.

PubMed

Wang, Yan-Qing; Zhang, Hong-Mei; Tang, Bo-Ping

2010-08-02

The nature of the interaction between human hemoglobin and C.I. acid red 27 was investigated systematically by ultraviolet-vis absorbance, circular dichroism, fluorescence, synchronous fluorescence, and three-dimensional fluorescence spectra techniques at pH 7.40. The quenching mechanism, binding constants, and the number of binding sites were determined by the quenching of human hemoglobin fluorescence in presence of C.I. acid red 27. The results showed that the nature of the quenching was of static type and the process of binding acid red 27 on human hemoglobin was a spontaneous molecular interaction procedure. The electrostatic and hydrophobic interactions played a major role in stabilizing the complex; The distance r between donor and acceptor was obtained to be 4.40 nm according to Förster's theory; The effect of acid red 27 on the conformation of human hemoglobin was analyzed using synchronous fluorescence, circular dichroism and three-dimensional fluorescence spectra. 2010 Elsevier B.V. All rights reserved.

Calculation of Inertial Parameters to Find Dynamic Human Response

NASA Astrophysics Data System (ADS)

Shaibani, Saami J.

2004-03-01

A number of authenticated models of the human body have been produced during decades of research, and yet deficient substitutes continue to be concocted. Recent examples of the latter sadly include: (a) if human = water and potato = water, then human = potato; (b) pancreas = hot dog; and, (c) spine = plastic pipe. Omission of any suitable use of biology in these cases makes the inadequacies involved all the more unacceptable. The unduly simplistic nature seen there is contrasted with the correct procedures documented in this paper. Particular attention is paid here to the fields of anatomy and anthropometry, and the unique challenges[1] associated with pediatric cases are also discussed. The results of this study show that the naivety in the flawed examples above and elsewhere is completely unjustified, even for first-order speculations. The importance of first-hand clinical experience is explained as an essential component in the determination of accurate biomechanical data for human kinematics. 1. Bull. Am. Phys. Soc., 44, 273 (1999).

21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice drug...

21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice drug...

21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice drug...

Abstracts of Research Project Reports by National Naval Dental Center First-, Second-, and Third-Year Residents, June 1982.

DTIC Science & Technology

1982-12-01

date the evaluation procedure. All three disinfectants effectively reduced the number of spores: Sodium hypochlorite sterilized after 1 minute... endodontic locking forceps and the tip of the cone was lowered about 15 mm into the test solution. Soften- ing time-was determined as the time from...with phenol, citric acid, sodium deoxycholate at pH 12, sodium deoxycholate with human plasma fraction Cohn IV1 , and sodium deoxycholate with fresh

A Human-Centered Command and Control (C2) Assessment of an Experimental Campaign Planning Tool

DTIC Science & Technology

2014-04-01

and control (team without the CPT) groups . The two groups were designed to have an equal number of members; however, one member of the experimental...the researchers to analyze the planning process and outcomes. 3.3 Design and Procedure An experimental versus control group design was implemented...the post -PFnet (figure 16b). Within the PFnets, a concept can be focused on in order to identify how the individual or group is defining or

Using Civilian Supply Chain Management Best Practices to Improve Army Supply Chain Management Procedures

DTIC Science & Technology

2017-06-09

USING CIVILIAN SUPPLY CHAIN MANAGEMENT BEST PRACTICES TO IMPROVE ARMY SUPPLY CHAIN MANAGEMENT PROCEDURES A thesis presented to......Army Supply Chain Management Procedures 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Chief Warrant

Design Guidance for Computer-Based Procedures for Field Workers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oxstrand, Johanna; Le Blanc, Katya; Bly, Aaron

Nearly all activities that involve human interaction with nuclear power plant systems are guided by procedures, instructions, or checklists. Paper-based procedures (PBPs) currently used by most utilities have a demonstrated history of ensuring safety; however, improving procedure use could yield significant savings in increased efficiency, as well as improved safety through human performance gains. The nuclear industry is constantly trying to find ways to decrease human error rates, especially human error rates associated with procedure use. As a step toward the goal of improving field workers’ procedure use and adherence and hence improve human performance and overall system reliability, themore » U.S. Department of Energy Light Water Reactor Sustainability (LWRS) Program researchers, together with the nuclear industry, have been investigating the possibility and feasibility of replacing current paper-based procedures with computer-based procedures (CBPs). PBPs have ensured safe operation of plants for decades, but limitations in paper-based systems do not allow them to reach the full potential for procedures to prevent human errors. The environment in a nuclear power plant is constantly changing, depending on current plant status and operating mode. PBPs, which are static by nature, are being applied to a constantly changing context. This constraint often results in PBPs that are written in a manner that is intended to cover many potential operating scenarios. Hence, the procedure layout forces the operator to search through a large amount of irrelevant information to locate the pieces of information relevant for the task and situation at hand, which has potential consequences of taking up valuable time when operators must be responding to the situation, and potentially leading operators down an incorrect response path. Other challenges related to use of PBPs are management of multiple procedures, place-keeping, finding the correct procedure for a task, and relying on other sources of additional information to ensure a functional and accurate understanding of the current plant status (Converse, 1995; Fink, Killian, Hanes, and Naser, 2009; Le Blanc, Oxstrand, and Waicosky, 2012). This report provides design guidance to be used when designing the human-system interaction and the design of the graphical user interface for a CBP system. The guidance is based on human factors research related to the design and usability of CBPs conducted by Idaho National Laboratory, 2012 - 2016.« less

Impact of vaginal-rectal ultrasound examinations with covered and low-level disinfected transducers on infectious transmissions in france.

PubMed

Leroy, Sandrine; M'Zali, Fatima; Kann, Michael; Weber, David J; Smith, David D

2014-12-01

The risk of cross-infection from shared ultrasound probes in endorectal and vaginal ultrasonography due to low-level disinfection (LLD) is difficult to estimate because potential infections are also sexually transmitted diseases, and route of contamination is often difficult to establish. In France, the widely used standard for prevention of infections is through the use of probe covers and LLD of the ultrasound transducer by disinfectant wipes. We performed an in silico simulation based on a systematic review to estimate the number of patients infected after endorectal or vaginal ultrasonography examination using LLD for probes. We performed a stochastic Monte Carlo computer simulation to produce hypothetical cohorts for a population of 4 million annual ultrasound examinations performed in France, and we estimated the number of infected patients for human immunodeficiency virus (HIV), herpes simplex virus, hepatitis B virus, hepatitis C virus, human papilloma virus, cytomegalovirus, and Chlamydia trachomatis. Modeling parameters were estimated by meta-analysis when possible. The probability of infection from a contaminated probe ranged from 1% to 6%, depending on the pathogen. For cases of HIV infection, this would result in approximately 60 infected patients per year. For other common viral infections, the number of new cases ranged from 1,600 to 15,000 per year that could be attributable directly to ultrasound and LLD procedures. Our simulation results showed that, despite cumulative use of probe cover and LLD, there were still some cases of de novo infection that may be attributable to ultrasound procedures. These cases are preventable by reviewing the currently used LLD and/or upgrading LLD to high-level disinfection, as recommended by the US Centers for Disease Control and Prevention.

Simplification of the kinematic model of human movement

NASA Astrophysics Data System (ADS)

Dusza, Jacek J.; Wawrzyniak, Zbigniew M.; del Prado Martinez, David

2013-10-01

The paper presents a methods of simplification of the human gait model. The experimental data were obtained in the laboratory of the group SATI in the Electronics Engineering Department of the University of Valencia. As a result of the Mean Double Step (MDS) procedure, the human motion were described by a matrix containing the Cartesian coordinates of 26 markers placed on the human body recorded in the 100 time points. With these data it has been possible to develop an software application which performs a wide diversity of tasks like array simplification, mask calculation for the simplification, error calculation as well as tools for signals comparison and movement animation of the markers. Simplifications were made by the spectral analysis of signals and calculating the standard deviation of the differences between the signal and its approximation. Using this method the signals of displacement could be written as the time series limited to a small number of harmonic signals. This approach allows us for a high degree of data compression. The model presented in this work can be applied into the context of medical diagnostics or rehabilitation because for a given approximation error and a large number of harmonics may demonstrate some abnormalities (of orthopaedic symptoms) in the gait cycle analysis.

[Expression of the emotions in the drawing of a man by the child from 5 to 11 years of age].

PubMed

Brechet, Claire; Picard, Delphine; Baldy, René

2007-06-01

This study examines the development of children's ability to express emotions in their human figure drawing. Sixty children of 5, 8, and 11 years were asked to draw "a man," and then a "sad", "happy," "angry" and "surprised" man. Expressivity of the drawings was assessed by means of two procedures: a limited choice and a free labelling procedure. Emotionally expressive drawings were then evaluated in terms of the number and the type of graphic cues that were used to express emotion. It was found that children are able to depict happiness and sadness at 8, anger and surprise at 11. With age, children use increasingly numerous and complex graphic cues for each emotion (i.e., facial expression, body position, and contextual cues). Graphic cues for facial expression (e.g., concave mouth, curved eyebrows, wide opened eyes) share strong similarities with specific "action units" described by Ekman and Friesen (1978) in their Facial Action Coding System. Children's ability to depict emotion in their human figure drawing is discussed in relation to perceptual, conceptual, and graphic abilities.

Cytotoxic Effects of the Radiocontrast Agent Iotrolan and Anesthetic Agents Bupivacaine and Lidocaine in Three-Dimensional Cultures of Human Intervertebral Disc Nucleus Pulposus Cells: Identification of the Apoptotic Pathways

PubMed Central

Iwasaki, Koji; Sudo, Hideki; Yamada, Katsuhisa; Ito, Manabu; Iwasaki, Norimasa

2014-01-01

Background Discography and discoblock are imaging procedures used to diagnose discogenic low back pain. Although needle puncture of the intervertebral disc (IVD) itself induces disc degeneration, the agents used in these procedures may also have harmful effects on IVD cells. The purpose of this study was to analyze whether radiocontrast agents and local anesthetic agents have detrimental effects on human nucleus pulposus (NP) cells. Methods Healthy human NP cells were cultured for 7 days in three-dimensional (3D) cell–alginate bead composites, and were then exposed to clinically relevant doses of a radiocontrast agent (iotrolan) or local anesthetic (lidocaine or bupivacaine). Cell viability and apoptosis were measured by confocal microscopy and flow cytometry. On the basis of caspase expression profiles, the apoptotic pathways activated by the agents were identified by Western blot analysis. Results The radiocontrast agent iotrolan did not affect NP cell viability or induce apoptosis. In contrast, both the anesthetic agents significantly decreased cell viability and increased the apoptotic cell number in a time- and dose-dependent manner. After 120 min, 2% lidocaine and 0.5% bupivacaine decreased percent live cells to 13% and 10%, respectively (p<0.05). The number of apoptotic cells was doubled by increasing lidocaine dosage from 1% to 2% (23% and 42%) and bupivacaine from 0.25% to 0.50% (25% and 48%) (p<0.05). Western blot analysis revealed that both anesthetic agents upregulated cleaved caspase-3 and caspase-8, whereas only bupivacaine upregulated cleaved caspase-9. Conclusions/Significance The present study demonstrates that iotrolan does not affect the viability of healthy human NP cells. In contrast, the two anesthetic agents commonly used in discography or discoblock may cause extensive damage to IVDs by inducing apoptotic cell death. PMID:24642945

Spice drugs are more than harmless herbal blends: a review of the pharmacology and toxicology of synthetic cannabinoids

PubMed Central

Seely, Kathryn A.; Lapoint, Jeff; Moran, Jeffery H.; Fattore, Liana

2014-01-01

“K2” and “Spice” drugs (collectively hereafter referred to as Spice) represent a relatively new class of designer drugs that have recently emerged as popular alternatives to marijuana, otherwise characterized as “legal highs”. These drugs are readily available on the Internet and sold in many head shops and convenience stores under the disguise of innocuous products like herbal blends, incense, or air fresheners. Although package labels indicate “not for human consumption”, the number of intoxicated people presenting to emergency departments is dramatically increasing. The lack of validated and standardized human testing procedures and an endless supply of potential drugs of abuse are primary reasons why researchers find it difficult to fully characterize clinical consequences associated with Spice. While the exact chemical composition and toxicology of Spice remains to be determined, there is mounting evidence identifying several synthetic cannabinoids as causative agents responsible for psychoactive and adverse physical effects. This review provides updates of the legal status of common synthetic cannabinoids detected in Spice and analytical procedures used to test Spice products and human specimens collected under a variety of clinical circumstances. The pharmacological and toxicological consequences of synthetic cannabinoid abuse are also reviewed to provide a future perspective on potential short- and long-term implications. PMID:22561602

Comparative proteomics of human endothelial cell caveolae and rafts using two-dimensional gel electrophoresis and mass spectrometry.

PubMed

Sprenger, Richard R; Speijer, Dave; Back, Jaap Willem; De Koster, Chris G; Pannekoek, Hans; Horrevoets, Anton J G

2004-01-01

The human endothelial cell plasma membrane harbors two subdomains of similar lipid composition, caveolae and rafts, both crucially involved in various essential cellular processes like transcytosis, signal transduction and cholesterol homeostasis. Caveolin-enriched membranes, isolated by either cationic silica or buoyant density methods, were explored by comparing large series of two-dimensional (2-D) maps and subsequent identification of over 100 protein spots by matrix-assisted laser desorption/ionization (MALDI) peptide mass fingerprinting. Improved representation and identification of membrane proteins and valuable information on various post-translational modifications was achieved by the presented optimized procedures for solubilization, destaining and database searching/computing. Whereas the cationic silica purification yielded predominantly known endoplasmic reticulum residents, the cold-detergent method yielded a large number of known caveolae residents, including caveolin-1. Thus, a large part of this subproteome was established, including known (trans-)membrane, signal transduction and glycosyl phosphatidylinositol (GPI)-anchored proteins. Several predicted proteins from the human genome were isolated for the first time from biological samples, including SGRP58, SLP-2, C8ORF2, and XRP-2. These findings and various optimized procedures can serve as a reference to study the differential composition of endothelial cell caveolae and rafts, known to be involved in pathologies like cancer and cardiovascular disease.

Development of a human cadaver model for training in laparoscopic donor nephrectomy.

PubMed

Sutton, Erica R H; Billeter, Adrian; Druen, Devin; Roberts, Henry; Rice, Jonathan

2017-06-01

The organ procurement network recommends a surgeon record 15 cases as surgeon or assistant for laparoscopic donor nephrectomies (LDN) prior to independent practice. The literature suggests that the learning curve for improved perioperative and patient outcomes is closer to 35 cases. In this article, we describe our development of a model utilizing fresh tissue and objective, quantifiable endpoints to document surgical progress, and efficiency in each of the major steps involved in LDN. Phase I of model development focused on the modifications necessary to maintain visualization for laparoscopic surgery in a human cadaver. Phase II tested proposed learner-based metrics of procedural competency for multiport LDN by timing procedural steps of LDN in a novice learner. Phases I and II required 12 and nine cadavers, with a total of 35 kidneys utilized. The following metrics improved with trial number for multiport LDN: time taken for dissection of the gonadal vein, ureter, renal hilum, adrenal and lumbrical veins, simulated warm ischemic time (WIT), and operative time. Human cadavers can be used for training in LDN as evidenced by improvements in timed learner-based metrics. This simulation-based model fills a gap in available training options for surgeons. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells

PubMed Central

Bieback, Karen; Kinzebach, Sven; Karagianni, Marianna

2010-01-01

It sounds simple to obtain sufficient numbers of cells derived from fetal or adult human tissues, isolate and/or expand the stem cells, and then transplant an appropriate number of these cells into the patient at the correct location. However, translating basic research into routine therapies is a complex multistep process which necessitates product regulation. The challenge relates to managing the expected therapeutic benefits with the potential risks and to balance the fast move to clinical trials with time-consuming cautious risk assessment. This paper will focus on the definition of mesenchymal stromal cells (MSCs), and challenges and achievements in the manufacturing process enabling their use in clinical studies. It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements. As cellular integrity and purity, formulation and lot release testing of the final product, validation of all procedures, and quality assurance are of utmost necessity, these topics will be addressed. PMID:21318154

Surgery via natural orifices in human beings: yesterday, today, tomorrow.

PubMed

Moris, Demetrios N; Bramis, Konstantinos J; Mantonakis, Eleftherios I; Papalampros, Efstathios L; Petrou, Athanasios S; Papalampros, Alexandros E

2012-07-01

We performed an evaluation of models, techniques, and applicability to the clinical setting of natural orifice surgery (mainly natural orifice transluminal endoscopic surgery [NOTES]) primarily in general surgery procedures. NOTES has attracted much attention recently for its potential to establish a completely alternative approach to the traditional surgical procedures performed entirely through a natural orifice. Beyond the potentially scar-free surgery and abolishment of dermal incision-related complications, the safety and efficacy of this new surgical technology must be evaluated. Studies were identified by searching MEDLINE, EMBASE, Cochrane Library, and Entrez PubMed from 2007 to February 2011. Most of the references were identified from 2009 to 2010. There were limitations as far as the population that was evaluated (only human beings, no cadavers or animals) was concerned, but there were no limitations concerning the level of evidence of the studies that were evaluated. The studies that were deemed applicable for our review were published mainly from 2007 to 2010 (see Methods section). All the evaluated studies were conducted only in human beings. We studied the most common referred in the literature orifices such as vaginal, oral, gastric, esophageal, anal, or urethral. The optimal access route and method could not be established because of the different nature of each procedure. We mainly studied procedures in the field of general surgery such as cholecystectomy, intestinal cancers, renal cancers, appendectomy, mediastinoscopy, and peritoneoscopy. All procedures were feasible and most of them had an uneventful postoperative course. A number of technical problems were encountered, especially as far as pure NOTES procedures are concerned, which makes the need of developing new endoscopic instruments, to facilitate each approach, undeniable. NOTES is still in the early stages of development and more robust technologies will be needed to achieve reliable closure and overcome technical challenges. Well-designed studies in human beings need to be conducted to determine the safety and efficacy of NOTES in a clinical setting. Among these NOTES approaches, the transvaginal route seems less complicated because it virtually eliminates concerns for leakage and fistulas. The transvaginal approach further favors upper-abdominal surgeries because it provides better maneuverability to upper-abdominal organs (eg, liver, gallbladder, spleen, abdominal esophagus, and stomach). The stomach is considered one of the most promising targets because this large organ, once adequately mobilized, can be transected easily with a stapler. The majority of the approaches seem to be feasible even with the equipment used nowadays, but to achieve better results and wider applications to human beings, the need to develop new endoscopic instruments to facilitate each approach is necessary. Copyright © 2012 Elsevier Inc. All rights reserved.

Modeling the behavior of human body tissues on penetration

NASA Astrophysics Data System (ADS)

Conci, A.; Brazil, A. L.; Popovici, D.; Jiga, G.; Lebon, F.

2018-02-01

Several procedures in medicine (such as anesthesia, injections, biopsies and percutaneous treatments) involve a needle insertion. Such procedures operate without vision of the internal involved areas. Physicians and anesthetists rely on manual (force and tactile) feedback to guide their movements, so a number of medical practice is strongly based on manual skill. In order to be expert in the execution of such procedures the medical students must practice a number of times, but before practice in a real patient they must be trained in some place and a virtual environment, using Virtual Reality (VR) or Augmented Reality (AR) is the best possible solution for such training. In a virtual environment the success of user practices is improved by the addition of force output using haptic device to improve the manual sensations in the interactions between user and computer. Haptic devices enable simulate the physical restriction of the diverse tissues and force reactions to movements of operator hands. The trainees can effectively "feel" the reactions to theirs movements and receive immediate feedback from the actions executed by them in the implemented environment. However, in order to implement such systems, the tissue reaction to penetration and cutting must be modeled. A proper model must emulate the physical sensations of the needle action in the skin, fat, muscle, and so one, as if it really done in a patient that is as they are holding a real needle and feeling each tissue resistance when inserting it through the body. For example an average force value for human skin puncture is 6.0 N, it is 2.0 N for subcutaneous fat tissue and 4.4 N for muscles: this difference of sensations to penetration of each layers trespassed by the needle makes possible to suppose the correct position inside the body. This work presents a model for tissues before and after the cutting that with proper assumptions of proprieties can model any part of human body. It was based on experiments and used in embryonic system for epidural anesthesia having good evaluation as presented in the last section "Preliminary Results".

CNV-seq, a new method to detect copy number variation using high-throughput sequencing.

PubMed

Xie, Chao; Tammi, Martti T

2009-03-06

DNA copy number variation (CNV) has been recognized as an important source of genetic variation. Array comparative genomic hybridization (aCGH) is commonly used for CNV detection, but the microarray platform has a number of inherent limitations. Here, we describe a method to detect copy number variation using shotgun sequencing, CNV-seq. The method is based on a robust statistical model that describes the complete analysis procedure and allows the computation of essential confidence values for detection of CNV. Our results show that the number of reads, not the length of the reads is the key factor determining the resolution of detection. This favors the next-generation sequencing methods that rapidly produce large amount of short reads. Simulation of various sequencing methods with coverage between 0.1x to 8x show overall specificity between 91.7 - 99.9%, and sensitivity between 72.2 - 96.5%. We also show the results for assessment of CNV between two individual human genomes.

Survey of Italian human milk banks.

PubMed

De Nisi, Giuseppe; Moro, Guido E; Arslanoglu, Sertac; Ambruzzi, Amalia M; Biasini, Augusto; Profeti, Claudio; Tonetto, Paola; Bertino, Enrico

2015-05-01

At present, the Italian Association of Donor Human Milk Banks (Associazione Italiana Banche del Latte Umano Donato, AIBLUD) consists of 31 milk banks, whose management is based on Italian Guidelines. In 2013, AIBLUD performed a systematic survey to collect data on the activities of banks operating in Italy in the years previous to this date. The purpose of this survey was to evaluate the operational procedures of Italian Human Milk Banks in order to identify both areas of strength and room for improvement. A questionnaire was utilized to obtain national data from the 28 banks active in the year 2012 in order to evaluate the number of donors, volume of human milk collected, and other information relating to the period 2007 to 2012. In all, 89% of the banks (25/28) responded to the survey. Data received primarily concerned the number of donors, volume of milk collected, and average amount of milk from each donor in the period 2007 to 2012. It was evident that in 2012 human milk banks collected a higher volume of milk than in 2007. Further, the average amount of milk from each donor was higher. Most of the milk banks were following the Italian Guidelines for traceability, control of donors, bacteriological checks, method of pasteurization, storage, thawing, type of containers, and utilization of the Hazard Analysis and Critical Control Points system. This survey identified both areas of strength and room for improvement in the Italian human milk banks. © The Author(s) 2015.

Impact of the 2006 Massachusetts health care insurance reform on neurosurgical procedures and patient insurance status.

PubMed

Villelli, Nicolas W; Das, Rohit; Yan, Hong; Huff, Wei; Zou, Jian; Barbaro, Nicholas M

2017-01-01

OBJECTIVE The Massachusetts health care insurance reform law passed in 2006 has many similarities to the federal Affordable Care Act (ACA). To address concerns that the ACA might negatively impact case volume and reimbursement for physicians, the authors analyzed trends in the number of neurosurgical procedures by type and patient insurance status in Massachusetts before and after the implementation of the state's health care insurance reform. The results can provide insight into the future of neurosurgery in the American health care system. METHODS The authors analyzed data from the Massachusetts State Inpatient Database on patients who underwent neurosurgical procedures in Massachusetts from 2001 through 2012. These data included patients' insurance status (insured or uninsured) and the numbers of procedures performed classified by neurosurgical procedural codes of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Each neurosurgical procedure was grouped into 1 of 4 categories based on ICD-9-CM codes: 1) tumor, 2) other cranial/vascular, 3) shunts, and 4) spine. Comparisons were performed of the numbers of procedures performed and uninsured patients, before and after the implementation of the reform law. Data from the state of New York were used as a control. All data were controlled for population differences. RESULTS After 2008, there were declines in the numbers of uninsured patients who underwent neurosurgical procedures in Massachusetts in all 4 categories. The number of procedures performed for tumor and spine were unchanged, whereas other cranial/vascular procedures increased. Shunt procedures decreased after implementation of the reform law but exhibited a similar trend to the control group. In New York, the number of spine surgeries increased, as did the percentage of procedures performed on uninsured patients. Other cranial/vascular procedures decreased. CONCLUSIONS After the Massachusetts health care insurance reform, the number of uninsured individuals undergoing neurosurgical procedures significantly decreased for all categories, but more importantly, the total number of surgeries performed did not change dramatically. To the extent that trends in Massachusetts can predict the overall US experience, we can expect that some aspects of reimbursement may be positively impacted by the ACA. Neurosurgeons, who often treat patients with urgent conditions, may be affected differently than other specialists.

Real-time implementation of second generation of audio multilevel information coding

NASA Astrophysics Data System (ADS)

Ali, Murtaza; Tewfik, Ahmed H.; Viswanathan, V.

1994-03-01

This paper describes real-time implementation of a novel wavelet- based audio compression method. This method is based on the discrete wavelet (DWT) representation of signals. A bit allocation procedure is used to allocate bits to the transform coefficients in an adaptive fashion. The bit allocation procedure has been designed to take advantage of the masking effect in human hearing. The procedure minimizes the number of bits required to represent each frame of audio signals at a fixed distortion level. The real-time implementation provides almost transparent compression of monophonic CD quality audio signals (samples at 44.1 KHz and quantized using 16 bits/sample) at bit rates of 64-78 Kbits/sec. Our implementation uses two ASPI Elf boards, each of which is built around a TI TMS230C31 DSP chip. The time required for encoding of a mono CD signal is about 92 percent of real time and that for decoding about 61 percent.

Evaluation of the behavioral characteristics of the mdx mouse model of duchenne muscular dystrophy through operant conditioning procedures.

PubMed

Lewon, Matthew; Peters, Christina M; Van Ry, Pam M; Burkin, Dean J; Hunter, Kenneth W; Hayes, Linda J

2017-09-01

The mdx mouse is an important nonhuman model for Duchenne muscular dystrophy (DMD) research. Characterizing the behavioral traits of the strain relative to congenic wild-type (WT) mice may enhance our understanding of the cognitive deficits observed in some humans with DMD and contribute to treatment development and evaluation. In this paper we report the results of a number of experiments comparing the behavior of mdx to WT mice in operant conditioning procedures designed to assess learning and memory. We found that mdx outperformed WT in all learning and memory tasks involving food reinforcement, and this appeared to be related to the differential effects of the food deprivation motivating operation on mdx mice. Conversely, WT outperformed mdx in an escape/avoidance learning task. These results suggest motivational differences between the strains and demonstrate the potential utility of operant conditioning procedures in the assessment of the behavioral characteristics of the mdx mouse. Copyright © 2017 Elsevier B.V. All rights reserved.

JSC Design and Procedural Standards, JSC-STD-8080

NASA Technical Reports Server (NTRS)

Punch, Danny T.

2011-01-01

This document provides design and procedural requirements appropriate for inclusion in specifications for any human spaceflight program, project, spacecraft, system, or end item. The term "spacecraft" as used in the standards includes launch vehicles, orbital vehicles, non-terrestrial surface vehicles, and modules. The standards are developed and maintained as directed by Johnson Space Center (JSC) Policy Directive JPD 8080.2, JSC Design and Procedural Standards for Human Space Flight Equipment. The Design and Procedural Standards contained in this manual represent human spacecraft design and operational knowledge applicable to a wide range of spaceflight activities. These standards are imposed on JSC human spaceflight equipment through JPD 8080.2. Designers shall comply with all design standards applicable to their design effort.

78 FR 43002 - Proposed Collection; Comment Request for Revenue Procedure 2004-29

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

... comments concerning statistical sampling in Sec. 274 Context. DATES: Written comments should be received on... INFORMATION: Title: Statistical Sampling in Sec. 274 Contest. OMB Number: 1545-1847. Revenue Procedure Number: Revenue Procedure 2004-29. Abstract: Revenue Procedure 2004-29 prescribes the statistical sampling...

A highly relevant and efficient single step method for simultaneous depletion and isolation of human regulatory T cells in a clinical setting.

PubMed

Brezar, Vedran; Ruffin, Nicolas; Lévy, Yves; Seddiki, Nabila

2014-09-01

Regulatory T cells (Tregs) are pivotal in preventing autoimmunity. They play a major but still ambiguous role in cancer and viral infections. Functional studies of human Tregs are often hampered by numerous technical difficulties arising from imperfections in isolating and depleting protocols, together with the usual low cell number available from clinical samples. We standardized a simple procedure (Single Step Method, SSM), based on magnetic beads technology, in which both depletion and isolation of human Tregs with high purities are simultaneously achieved. SSM is suitable when using low cell numbers either fresh or frozen from both patients and healthy individuals. It allows simultaneous Tregs isolation and depletion that can be used for further functional work to monitor suppressive function of isolated Tregs (in vitro suppression assay) and also effector IFN-γ responses of Tregs-depleted cell fraction (OX40 assay). To our knowledge, there is no accurate standardized method for Tregs isolation and depletion in a clinical context. SSM could thus be used and easily standardized across different laboratories. Copyright © 2014 Elsevier B.V. All rights reserved.

Human Factors Considerations for Area Navigation Departure and Arrival Procedures

NASA Technical Reports Server (NTRS)

Barhydt, Richard; Adams, Catherine A.

2006-01-01

Area navigation (RNAV) procedures are being implemented in the United States and around the world as part of a transition to a performance-based navigation system. These procedures are providing significant benefits and have also caused some human factors issues to emerge. Under sponsorship from the Federal Aviation Administration (FAA), the National Aeronautics and Space Administration (NASA) has undertaken a project to document RNAV-related human factors issues and propose areas for further consideration. The component focusing on RNAV Departure and Arrival Procedures involved discussions with expert users, a literature review, and a focused review of the NASA Aviation Safety Reporting System (ASRS) database. Issues were found to include aspects of air traffic control and airline procedures, aircraft systems, and procedure design. Major findings suggest the need for specific instrument procedure design guidelines that consider the effects of human performance. Ongoing industry and government activities to address air-ground communication terminology, design improvements, and chart-database commonality are strongly encouraged. A review of factors contributing to RNAV in-service errors would likely lead to improved system design and operational performance.

Missing value imputation for gene expression data by tailored nearest neighbors.

PubMed

Faisal, Shahla; Tutz, Gerhard

2017-04-25

High dimensional data like gene expression and RNA-sequences often contain missing values. The subsequent analysis and results based on these incomplete data can suffer strongly from the presence of these missing values. Several approaches to imputation of missing values in gene expression data have been developed but the task is difficult due to the high dimensionality (number of genes) of the data. Here an imputation procedure is proposed that uses weighted nearest neighbors. Instead of using nearest neighbors defined by a distance that includes all genes the distance is computed for genes that are apt to contribute to the accuracy of imputed values. The method aims at avoiding the curse of dimensionality, which typically occurs if local methods as nearest neighbors are applied in high dimensional settings. The proposed weighted nearest neighbors algorithm is compared to existing missing value imputation techniques like mean imputation, KNNimpute and the recently proposed imputation by random forests. We use RNA-sequence and microarray data from studies on human cancer to compare the performance of the methods. The results from simulations as well as real studies show that the weighted distance procedure can successfully handle missing values for high dimensional data structures where the number of predictors is larger than the number of samples. The method typically outperforms the considered competitors.

Deep Venous Procedures Performed in the National Health Service in England between 2005 and 2015.

PubMed

Lim, C S; Shalhoub, J; Davies, A H

2017-10-01

Recent advances in imaging technology and endovenous interventions have revolutionised the management of specific groups of patients with deep venous pathology. This study aimed to examine data published by Hospital Episode Statistics (HES) to assess trends in the number of endovascular and open surgical deep venous procedures performed in National Health Service (NHS) hospitals in England between 2005 and 2015. The main diagnosis of deep venous thrombosis (DVT), and total number of primary open and percutaneous procedures for deep venous pathology for patients admitted to the NHS hospitals in England from 2005 to 2015 were retrieved from the HES database and analysed. An overall declining trend in the annual number of admissions for a primary diagnosis of DVT was observed (linear regression r 2  = 0.9, p < .0001). The number of open surgical procedures for removal of thrombus remained largely unchanged (range 26-70); the frequency of percutaneous procedures increased steadily over the study period (range 0-311). The number of open surgical procedures relating to the vena cava fell between 2005 and 2009, and remained around 50 per year thereafter. Annual numbers of cases of deep venous bypass (range 17-33) and venous valve surgery (range 8-47) remained similar in trend over this period. The number of vena cava stent (range 0-405), other venous stent (range 0-316), and percutaneous venoplasty (range 0-972) procedures increased over the first 5 years of the study period. There is an increasing trend in relation to endovenous procedures but not open surgery, being carried out for deep venous pathology in the last decade in NHS hospitals in England. Despite a number of limitations with HES, the increase in the number of endovenous procedures shown is likely to have significant implications for the provision of care and healthcare resources for patients with deep venous pathology. Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Projected financial impact of noncoverage of elective circumcision by Louisiana medicaid in boys 0 to 5 years old.

PubMed

Ortenberg, Joseph; Roth, Christopher C

2013-10-01

Several states, including Louisiana since 2005, no longer cover elective circumcision under Medicaid programs. The recent AAP (American Academy of Pediatrics) policy statement recognizes the medical benefits of circumcision and recommends the removal of financial barriers to this procedure. Cost savings are a factor in the limitation of circumcision coverage, although to our knowledge the actual cost savings to Medicaid programs have not been reported. We analyzed the number of circumcisions performed before and after the policy change to determine an accurate cost of such procedures and whether the increased procedure expense mitigates the initial savings. We analyzed the number of neonatal and nonneonatal circumcisions in boys 0 to 5 years old to determine trends during the selected period. A cost model for each procedure was created. Neonatal procedure cost was based on professional fees. Nonneonatal procedure cost was based on professional (surgeon and anesthesia) plus facility fees. The number and cost of procedures were compared before (2002 to 2004) and after (2006 to 2010) the policy change. Linear regression was used to predict future costs. The average annual number and expense of neonatal circumcisions were significantly decreased after the policy change. There was no significant decrease in nonneonatal procedures and expense. Cost per procedure ranged from $88.34 for neonatal to $486.76 for nonneonatal circumcision. Secondary to the increasing number of more costly nonneonatal procedures, the annual expense was predicted to exceed pre-policy levels by 2015. The number of nonneonatal circumcisions is increasing and such procedures place a higher financial burden on the health care system. As a result, the financial benefits of noncoverage of elective circumcision are decreasing. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

76 FR 16855 - Proposed Collection; Comment Request for Revenue Procedure 2001-21

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... treat certain exchanges of debt instruments as realization events for Federal income tax purposes even... concerning Revenue Procedure 2001-21, Debt Roll-Ups. DATES: Written comments should be received on or before...: Title: Debt Roll-Ups. OMB Number: 1545-1647. Revenue Procedure Number: Revenue Procedure 2001-21...

21 CFR 640.120 - Alternative procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Alternative procedures. 640.120 Section 640.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Alternative Procedures § 640.120...

21 CFR 640.120 - Alternative procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Alternative procedures. 640.120 Section 640.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Alternative Procedures § 640.120...

Estimating multilevel logistic regression models when the number of clusters is low: a comparison of different statistical software procedures.

PubMed

Austin, Peter C

2010-04-22

Multilevel logistic regression models are increasingly being used to analyze clustered data in medical, public health, epidemiological, and educational research. Procedures for estimating the parameters of such models are available in many statistical software packages. There is currently little evidence on the minimum number of clusters necessary to reliably fit multilevel regression models. We conducted a Monte Carlo study to compare the performance of different statistical software procedures for estimating multilevel logistic regression models when the number of clusters was low. We examined procedures available in BUGS, HLM, R, SAS, and Stata. We found that there were qualitative differences in the performance of different software procedures for estimating multilevel logistic models when the number of clusters was low. Among the likelihood-based procedures, estimation methods based on adaptive Gauss-Hermite approximations to the likelihood (glmer in R and xtlogit in Stata) or adaptive Gaussian quadrature (Proc NLMIXED in SAS) tended to have superior performance for estimating variance components when the number of clusters was small, compared to software procedures based on penalized quasi-likelihood. However, only Bayesian estimation with BUGS allowed for accurate estimation of variance components when there were fewer than 10 clusters. For all statistical software procedures, estimation of variance components tended to be poor when there were only five subjects per cluster, regardless of the number of clusters.

Ethics and law in research with human biological samples: a new approach.

PubMed

Petrini, Carlo

2014-01-01

During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.

Microimaging FT-IR of oral cavity tumours. Part III: Cells, inoculated tissues and human tissues

NASA Astrophysics Data System (ADS)

Conti, C.; Ferraris, P.; Giorgini, E.; Pieramici, T.; Possati, L.; Rocchetti, R.; Rubini, C.; Sabbatini, S.; Tosi, G.; Mariggiò, M. A.; Lo Muzio, L.

2007-05-01

The biochemistry of healthy and tumour cell cultures, inoculated tissues and oral cavity tissues have been studied by FT-IR Microscopy with the aim to relate spectral patterns with microbiological and histopathological findings. 'Supervised' and 'unsupervised' procedures of data handling afforded a satisfactory degree of accordance between spectroscopic and the other two techniques. In particular, changes in frequency and intensity of proteins, connective and nucleic acids vibrational modes as well as the visualization of biochemical single wave number or band ratio images, allowed an evaluation of the pathological changes. The spectroscopic patterns of inoculated tissues resulted quite similar to human tissues; differences of both types of sections with cellular lines could be explained by the influence of the environment.

Gene expression analysis upon lncRNA DDSR1 knockdown in human fibroblasts

PubMed Central

Jia, Li; Sun, Zhonghe; Wu, Xiaolin; Misteli, Tom; Sharma, Vivek

2015-01-01

Long non-coding RNAs (lncRNAs) play important roles in regulating diverse biological processes including DNA damage and repair. We have recently reported that the DNA damage inducible lncRNA DNA damage-sensitive RNA1 (DDSR1) regulates DNA repair by homologous recombination (HR). Since lncRNAs also modulate gene expression, we identified gene expression changes upon DDSR1 knockdown in human fibroblast cells. Gene expression analysis after RNAi treatment targeted against DDSR1 revealed 119 genes that show differential expression. Here we provide a detailed description of the microarray data (NCBI GEO accession number GSE67048) and the data analysis procedure associated with the publication by Sharma et al., 2015 in EMBO Reports [1]. PMID:26697398

More Learners, Finite Resources, and the Changing Landscape of Procedural Training at the Bedside.

PubMed

Gisondi, Michael A; Regan, Linda; Branzetti, Jeremy; Hopson, Laura R

2018-05-01

There is growing competition for nonoperative, procedural training in teaching hospitals, due to an increased number of individuals seeking to learn procedures from a finite number of appropriate teaching cases. Procedural training is required by students, postgraduate learners, and practicing providers who must maintain their skills. These learner groups are growing in size as the number of medical schools increases and advance practice providers expand their skills to include complex procedures. These various learner needs occur against a background of advancing therapeutic techniques that improve patient care but also act to reduce the overall numbers of procedures available to learners. This article is a brief review of these and other challenges that are arising for program directors, medical school leaders, and hospital administrators who must act to ensure that all of their providers acquire and maintain competency in a wide array of procedural skills. The authors conclude their review with several recommendations to better address procedural training in this new era of learner competition. These include a call for innovative clinical rotations deliberately designed to improve procedural training, access to training opportunities at new clinical sites acquired in health system expansions, targeted faculty development for those who teach procedures, reporting of competition for bedside procedures by trainees, more frequent review of resident procedure and case logs, and the creation of an institutional oversight committee for procedural training.

76 FR 18381 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

... part 51, and Sec. 97.20 of Title 14 of the Code of Federal Regulations. The large number of SIAPs... the airport and its location, the procedure and the amendment number. The Rule This amendment to 14... this amendment will not have a significant economic impact on a substantial number of small entities...

Medicinal Product Regulation: Portugal׳s Framework.

PubMed

Herdeiro, Maria Teresa; Bastos, Paulo D; Teixeira-Rodrigues, António; Roque, Fátima

2016-09-01

The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Validation of a Full-Immersion Simulation Platform for Percutaneous Nephrolithotomy Using Three-Dimensional Printing Technology.

PubMed

Ghazi, Ahmed; Campbell, Timothy; Melnyk, Rachel; Feng, Changyong; Andrusco, Alex; Stone, Jonathan; Erturk, Erdal

2017-12-01

The restriction of resident hours with an increasing focus on patient safety and a reduced caseload has impacted surgical training. A complex and complication prone procedure such as percutaneous nephrolithotomy (PCNL) with a steep learning curve may create an unsafe environment for hands-on resident training. In this study, we validate a high fidelity, inanimate PCNL model within a full-immersion simulation environment. Anatomically correct models of the human pelvicaliceal system, kidney, and relevant adjacent structures were created using polyvinyl alcohol hydrogels and three-dimensional-printed injection molds. All steps of a PCNL were simulated including percutaneous renal access, nephroscopy, and lithotripsy. Five experts (>100 caseload) and 10 novices (<20 caseload) from both urology (full procedure) and interventional radiology (access only) departments completed the simulation. Face and content validity were calculated using model ratings for similarity to the real procedure and usefulness as a training tool. Differences in performance among groups with various levels of experience using clinically relevant procedural metrics were used to calculate construct validity. The model was determined to have an excellent face and content validity with an average score of 4.5/5.0 and 4.6/5.0, respectively. There were significant differences between novice and expert operative metrics including mean fluoroscopy time, the number of percutaneous access attempts, and number of times the needle was repositioned. Experts achieved better stone clearance with fewer procedural complications. We demonstrated the face, content, and construct validity of an inanimate, full task trainer for PCNL. Construct validity between experts and novices was demonstrated using incorporated procedural metrics, which permitted the accurate assessment of performance. While hands-on training under supervision remains an integral part of any residency, this full-immersion simulation provides a comprehensive tool for surgical skills development and evaluation before hands-on exposure.

Unaccompanied Children at the United States Border, a Human Rights Crisis that can be Addressed with Policy Change.

PubMed

Ataiants, Janna; Cohen, Chari; Riley, Amy Henderson; Tellez Lieberman, Jamile; Reidy, Mary Clare; Chilton, Mariana

2017-04-08

In recent years, unaccompanied minors have been journeying to the United States (U.S.)-Mexico border in great numbers in order to escape violence, poverty and exploitation in their home countries. Yet, unaccompanied children attempting to cross the United States border face treatment at the hands of government representatives which violates their inherent rights as children. The result is a human rights crisis that has severe health consequences for the children. Their rights as children are clearly delineated in various, international human rights documents which merit increased understanding of and recognition by the U.S. government. This paper calls for the improvement of policies and procedures for addressing the rights of unaccompanied immigrant children; it provides specific, rights-based recommendations which work together to safeguard the rights of the child at the U.S. southwestern border.

Cryopreservation of embryos and oocytes in human assisted reproduction.

PubMed

Konc, János; Kanyó, Katalin; Kriston, Rita; Somoskői, Bence; Cseh, Sándor

2014-01-01

Both sperm and embryo cryopreservation have become routine procedures in human assisted reproduction and oocyte cryopreservation is being introduced into clinical practice and is getting more and more widely used. Embryo cryopreservation has decreased the number of fresh embryo transfers and maximized the effectiveness of the IVF cycle. The data shows that women who had transfers of fresh and frozen embryos obtained 8% additional births by using their cryopreserved embryos. Oocyte cryopreservation offers more advantages compared to embryo freezing, such as fertility preservation in women at risk of losing fertility due to oncological treatment or chronic disease, egg donation, and postponing childbirth, and eliminates religious and/or other ethical, legal, and moral concerns of embryo freezing. In this review, the basic principles, methodology, and practical experiences as well as safety and other aspects concerning slow cooling and ultrarapid cooling (vitrification) of human embryos and oocytes are summarized.

Human error mitigation initiative (HEMI) : summary report.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stevens, Susan M.; Ramos, M. Victoria; Wenner, Caren A.

2004-11-01

Despite continuing efforts to apply existing hazard analysis methods and comply with requirements, human errors persist across the nuclear weapons complex. Due to a number of factors, current retroactive and proactive methods to understand and minimize human error are highly subjective, inconsistent in numerous dimensions, and are cumbersome to characterize as thorough. An alternative and proposed method begins with leveraging historical data to understand what the systemic issues are and where resources need to be brought to bear proactively to minimize the risk of future occurrences. An illustrative analysis was performed using existing incident databases specific to Pantex weapons operationsmore » indicating systemic issues associated with operating procedures that undergo notably less development rigor relative to other task elements such as tooling and process flow. Future recommended steps to improve the objectivity, consistency, and thoroughness of hazard analysis and mitigation were delineated.« less

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.

PubMed

Ekmekci, Perihan Elif; Arda, Berna

2017-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family - usually men - over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.

Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy.

PubMed

Giardina, M; Castiglia, F; Tomarchio, E

2014-12-01

Failure mode, effects and criticality analysis (FMECA) is a safety technique extensively used in many different industrial fields to identify and prevent potential failures. In the application of traditional FMECA, the risk priority number (RPN) is determined to rank the failure modes; however, the method has been criticised for having several weaknesses. Moreover, it is unable to adequately deal with human errors or negligence. In this paper, a new versatile fuzzy rule-based assessment model is proposed to evaluate the RPN index to rank both component failure and human error. The proposed methodology is applied to potential radiological over-exposure of patients during high-dose-rate brachytherapy treatments. The critical analysis of the results can provide recommendations and suggestions regarding safety provisions for the equipment and procedures required to reduce the occurrence of accidental events.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights

PubMed Central

Ekmekci, Perihan Elif; Arda, Berna

2018-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family – usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects. PMID:29645014

An analytical SMASH procedure (ASP) for sensitivity-encoded MRI.

PubMed

Lee, R F; Westgate, C R; Weiss, R G; Bottomley, P A

2000-05-01

The simultaneous acquisition of spatial harmonics (SMASH) method of imaging with detector arrays can reduce the number of phase-encoding steps, and MRI scan time several-fold. The original approach utilized numerical gradient-descent fitting with the coil sensitivity profiles to create a set of composite spatial harmonics to replace the phase-encoding steps. Here, an analytical approach for generating the harmonics is presented. A transform is derived to project the harmonics onto a set of sensitivity profiles. A sequence of Fourier, Hilbert, and inverse Fourier transform is then applied to analytically eliminate spatially dependent phase errors from the different coils while fully preserving the spatial-encoding. By combining the transform and phase correction, the original numerical image reconstruction method can be replaced by an analytical SMASH procedure (ASP). The approach also allows simulation of SMASH imaging, revealing a criterion for the ratio of the detector sensitivity profile width to the detector spacing that produces optimal harmonic generation. When detector geometry is suboptimal, a group of quasi-harmonics arises, which can be corrected and restored to pure harmonics. The simulation also reveals high-order harmonic modulation effects, and a demodulation procedure is presented that enables application of ASP to a large numbers of detectors. The method is demonstrated on a phantom and humans using a standard 4-channel phased-array MRI system. Copyright 2000 Wiley-Liss, Inc.

10 CFR 712.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the Human Reliability Program General Provisions § 712.1 Purpose. This part establishes the policies and procedures for a Human Reliability Program... judgment and reliability may be impaired by physical or mental/personality disorders, alcohol abuse, use of...

Fuzzy logic application for modeling man-in-the-loop space shuttle proximity operations. M.S. Thesis - MIT

NASA Technical Reports Server (NTRS)

Brown, Robert B.

1994-01-01

A software pilot model for Space Shuttle proximity operations is developed, utilizing fuzzy logic. The model is designed to emulate a human pilot during the terminal phase of a Space Shuttle approach to the Space Station. The model uses the same sensory information available to a human pilot and is based upon existing piloting rules and techniques determined from analysis of human pilot performance. Such a model is needed to generate numerous rendezvous simulations to various Space Station assembly stages for analysis of current NASA procedures and plume impingement loads on the Space Station. The advantages of a fuzzy logic pilot model are demonstrated by comparing its performance with NASA's man-in-the-loop simulations and with a similar model based upon traditional Boolean logic. The fuzzy model is shown to respond well from a number of initial conditions, with results typical of an average human. In addition, the ability to model different individual piloting techniques and new piloting rules is demonstrated.

45 CFR 1179.8 - Procedures for salary offset.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Procedures for salary offset. 1179.8 Section 1179.8 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE HUMANITIES SALARY OFFSET § 1179.8 Procedures for salary...

45 CFR 1179.8 - Procedures for salary offset.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 3 2011-10-01 2011-10-01 false Procedures for salary offset. 1179.8 Section 1179.8 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE HUMANITIES SALARY OFFSET § 1179.8 Procedures for salary...

21 CFR 314.201 - Procedure for hearings.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Procedure for hearings. 314.201 Section 314.201 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Hearing Procedures for New Drugs...

Effect of a Synbiotic Yogurt on Levels of Fecal Bifidobacteria, Clostridia, and Enterobacteria

PubMed Central

Palaria, Amrita; Johnson-Kanda, Ivy

2012-01-01

While ingestion of synbiotic yogurts containing Bifidobacterium animalis subsp. lactis and inulin is increasing, their effect on certain microbial groups in the human intestine is unclear. To further investigate this, a large-scale, crossover-design, placebo-controlled study was utilized to evaluate the effect of a synbiotic yogurt containing B. animalis subsp. lactis Bb-12 and inulin on the human intestinal bifidobacteria, clostridia, and enterobacteria. Fecal samples were collected at 14 time points from 46 volunteers who completed the study, and changes in the intestinal bacterial levels were monitored using real-time PCR. Strain Bb-12 could not be detected in feces after 2 weeks of washout. A live/dead PCR procedure indicated that the Bb-12 strain detected in the fecal samples was alive. A significant increase (P < 0.001) in the total bifidobacterial numbers was seen in both groups of subjects during the final washout period compared to the prefeeding period. This increase in total bifidobacteria corresponded with a significant decrease (P < 0.05) in numbers of clostridia but not enterobacteria. No significant differences in numbers of bifidobacteria, clostridia, or enterobacteria were observed between the probiotic and placebo groups during any of the feeding periods. However, subgrouping subjects based on lower initial bifidobacterial numbers or higher initial clostridial numbers did show corresponding significant differences between the synbiotic yogurt and placebo groups. This was not observed for a subgroup with higher initial enterobacterial numbers. While this synbiotic yogurt can increase bifidobacterial numbers and decrease clostridial numbers (but not enterobacterial numbers) in some individuals, it cannot modulate these microbial groups in the majority of individuals. PMID:22101054

The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

PubMed

Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark

2005-12-01

Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

Diversity and Similarity of Anesthesia Procedures in the United States During and Among Regular Work Hours, Evenings, and Weekends.

PubMed

Dexter, Franklin; Epstein, Richard H; Dutton, Richard P; Kordylewski, Hubert; Ledolter, Johannes; Rosenberg, Henry; Hindman, Bradley J

2016-12-01

Anesthesiologists providing care during off hours (ie, weekends or holidays, or cases started during the evening or late afternoon) are more likely to care for patients at greater risk of sustaining major adverse events than when they work during regular hours (eg, Monday through Friday, from 7:00 AM to 2:59 PM). We consider the logical inconsistency of using subspecialty teams during regular hours but not during weekends or evenings. We analyzed data from the Anesthesia Quality Institute's National Anesthesia Clinical Outcomes Registry (NACOR). Among the hospitals in the United States, we estimated the average number of common types of anesthesia procedures (ie, diversity measured as inverse of Herfindahl index), and the average difference in the number of common procedures between 2 off-hours periods (regular hours versus weekends, and regular hours versus evenings). We also used NACOR data to estimate the average similarity in the distributions of procedures between regular hours and weekends and between regular hours and evenings in US facilities. Results are reported as mean ± standard error of the mean among 399 facilities nationwide with weekend cases. The distributions of common procedures were moderately similar (ie, not large, <.8) between regular hours and evenings (similarity index .59 ± .01) and between regular hours and weekends (similarity index, .55 ± .02). For most facilities, the number of common procedures differed by <5 procedures between regular hours and evenings (74.4% of facilities, P < .0001) and between regular hours and weekends (64.7% of facilities, P < .0001). The average number of common procedures was 13.59 ± .12 for regular hours, 13.12 ± .13 for evenings, and 9.43 ± .13 for weekends. The pairwise differences by facility were .13 ± .07 procedures (P = .090) between regular hours and evenings and 3.37 ± .12 procedures (P < .0001) between regular hours and weekends. In contrast, the differences were -5.18 ± .12 and 7.59 ± .13, respectively, when calculated using nationally pooled data. This was because the numbers of common procedures were 32.23 ± .05, 37.41 ± .11, and 24.64 ± .12 for regular hours, evenings, and weekends, respectively (ie, >2x the number of common procedures calculated by facility). The numbers of procedures commonly performed at most facilities are fewer in number than those that are commonly performed nationally. Thus, decisions on anesthesia specialization should be based on quantitative analysis of local data rather than national recommendations using pooled data. By facility, the number of different procedures that take place during regular hours and off hours (diversity) is essentially the same, but there is only moderate similarity in the procedures performed. Thus, at many facilities, anesthesiologists who work principally within a single specialty during regular work hours will likely not have substantial contemporary experience with many procedures performed during off hours.

An outcomes analysis of five prenatal screening strategies for trisomy 21 in women younger than 35 years.

PubMed

Biggio, Joseph R; Morris, T Christopher; Owen, John; Stringer, Jeffery S A

2004-03-01

This study was undertaken to examine the cost-effectiveness and procedural-related losses associated with 5 prenatal screening strategies for fetal aneuploidy in women under 35 years old. Five prenatal screening strategies were compared in a decision analysis model: triple screen: maternal age and midtrimester serum alpha-fetoprotein, human chorionic gonadotropin (hCG), and unconjugated estriol; quad screen: triple screen plus serum dimeric inhibin A; first-trimester screen: maternal age, serum pregnancy-associated plasma protein A and free beta-hCG and fetal nuchal translucency at 10 to 14 weeks' gestation; integrated screen: first-trimester screen plus quad screen, but first-trimester results are withheld until the quad screen is completed when a composite result is provided; sequential screen: first-trimester screen plus quad screen, but the first-trimester screen results are provided immediately and prenatal diagnosis offered if positive; later prenatal diagnosis is available if the quad screen is positive. Model estimates were literature derived, and cost estimates also included local sources. The 5 strategies were compared for cost, the numbers of Down syndrome fetuses detected and live births averted, and the number of procedure-related euploid losses. Sensitivity analyses were performed for parameters with imprecise point estimates. In the baseline analysis, sequential screening was the least expensive strategy ($455 million). It detected the most Down syndrome fetuses (n=1213), averted the most Down syndrome live births (n=678), but led to the highest number of procedure-related euploid losses (n=859). The integrated screen had the fewest euploid losses (n=62) and averted the second most Down syndrome live births (n=520). If fewer than 70% of women diagnosed with fetal Down syndrome elect to abort, the quad screen became the least expensive strategy. Although sequential screening was the most cost-effective prenatal screening strategy for fetal trisomy 21, it had the highest procedure-related euploid loss rate. The patient's perspective on detection versus fetal safety may help define the optimal screening strategy.

Quantifying the Diversity and Similarity of Surgical Procedures Among Hospitals and Anesthesia Providers.

PubMed

Dexter, Franklin; Ledolter, Johannes; Hindman, Bradley J

2016-01-01

In this Statistical Grand Rounds, we review methods for the analysis of the diversity of procedures among hospitals, the activities among anesthesia providers, etc. We apply multiple methods and consider their relative reliability and usefulness for perioperative applications, including calculations of SEs. We also review methods for comparing the similarity of procedures among hospitals, activities among anesthesia providers, etc. We again apply multiple methods and consider their relative reliability and usefulness for perioperative applications. The applications include strategic analyses (e.g., hospital marketing) and human resource analytics (e.g., comparisons among providers). Measures of diversity of procedures and activities (e.g., Herfindahl and Gini-Simpson index) are used for quantification of each facility (hospital) or anesthesia provider, one at a time. Diversity can be thought of as a summary measure. Thus, if the diversity of procedures for 48 hospitals is studied, the diversity (and its SE) is being calculated for each hospital. Likewise, the effective numbers of common procedures at each hospital can be calculated (e.g., by using the exponential of the Shannon index). Measures of similarity are pairwise assessments. Thus, if quantifying the similarity of procedures among cases with a break or handoff versus cases without a break or handoff, a similarity index represents a correlation coefficient. There are several different measures of similarity, and we compare their features and applicability for perioperative data. We rely extensively on sensitivity analyses to interpret observed values of the similarity index.

Designing Flight-Deck Procedures

NASA Technical Reports Server (NTRS)

Degani, Asaf; Wiener, L.; Shafto, Mike (Technical Monitor)

1995-01-01

A complex human-machine system consists of more than merely one or more human operators and a collection of hardware components. In order to operate a complex system successfully, the human-machine system must be supported by an organizational infrastructure of operating concepts, rules, guidelines, and documents. The coherency of such operating concepts, in terms of consistency and logic, is vitally important for the efficiency and safety of any complex system. In high-risk endeavors such as aircraft operations, space flight, nuclear power production, manufacturing process control, and military operations, it is essential that such support be flawless, as the price of operational error can be high. When operating rules are not adhered to, or the rules are inadequate for the task at hand, not only will the system's goals be thwarted, but there may also be tragic human and material consequences. To ensure safe and predictable operations, support to the operators, in this case flight crews, often comes in the form of standard operating procedures. These provide the crew with step-by-step guidance for carrying out their operations. Standard procedures do indeed promote uniformity, but they do so at the risk of reducing the role of human operators to a lower level. Management, however, must recognize the danger of over-procedurization, which fails to exploit one of the most valuable assets in the system, the intelligent operator who is "on the scene." The alert system designer and operations manager recognize that there cannot be a procedure for everything, and the time will come in which the operators of a complex system will face a situation for which there is no written procedure. Procedures, whether executed by humans or machines, have their place, but so does human cognition.

Laboratory animal science: a resource to improve the quality of science.

PubMed

Forni, M

2007-08-01

The contribution of animal experimentation to biomedical research is of undoubted value, nevertheless the real usefulness of animal models is still being hotly debated. Laboratory Animal Science is a multidisciplinary approach to humane animal experimentation that allows the choice of the correct animal model and the collection of unbiased data. Refinement, Reduction and Replacement, the "3Rs rule", are now widely accepted and have a major influence on animal experimentation procedures. Refinement, namely any decrease in the incidence or severity of inhumane procedures applied to animals, has been today extended to the entire lives of the experimental animals. Reduction of the number of animals used to obtain statistically significant data may be achieved by improving experimental design and statistical analysis of data. Replacement refers to the development of validated alternative methods. A Laboratory Animal Science training program in biomedical degrees can promote the 3Rs and improve the welfare of laboratory animals as well as the quality of science with ethical, scientific and economic advantages complying with the European requirement that "persons who carry out, take part in, or supervise procedures on animals, or take care of animals used in procedures, shall have had appropriate education and training".

An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe.

PubMed

Ebbers, Hans C; Langedijk, Joris; Bouvy, Jacoline C; Hoekman, Jarno; Boon, Wouter P C; de Jong, Jean Philippe; De Bruin, Marie L

2015-10-01

The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures. All MRP/DCP procedures to the Co-ordination group for Mutual recognition and Decentralised procedures-human (CMDh) during the period from January 2006 to December 2013 were analysed. Reasons for starting referral procedures were scored. In addition, a survey under pharmaceutical companies was performed to estimate the frequency of licensing failure prior to CMDh referrals. During the study period, 10392 MRP/DCP procedures were finalized. Three hundred seventy-seven (3.6%) resulted in a referral procedure, of which 70 (19%) resulted in licensing failure, defined as refusal or withdrawal of the application. The frequency of CMDh referrals decreased from 14.5% in 2006 to 1.6% in 2013. Of all referrals, 272 (72%) were resolved through consensus within the CMDh, the remaining 105 (28%) were resolved at the level of the CHMP. Most referrals were started because of objections raised about the clinical development program. Study design issues and objections about the demonstration of equivalence were most likely to result in licensing failure. An estimated 11% of all MRP/DCP procedures resulted in licensing failure prior to CMDh referral. Whereas the absolute number of MRP/DCP procedures resulting in a referral has reduced substantially over the past years, no specific time trend could be observed regarding the frequency of referrals resulting in licensing failure. Increased knowledge at the level of companies and regulators has reduced the frequency of late-stage failure of marketing applications via the MRP/DCP.

[The ethical aspects of physiological experiment].

PubMed

Al'bertin, S V

2014-01-01

A modern classification of invasive procedures developed according to International Bioethical Principles has been presented. The experimental data convincingly demonstrate that using of noninvasive approaches and techniques give a good opportunity to reduce a number of animals recruited in experiment as well as to keep the normal (not distressful) physiological functions of animals. The data presented stress that development of noninvasive techniques is closely related both to scientific and social aspects of our life, allowing the scientists to provide high validity of experimental data obtained as well as to keep themselves as a human beings.

Self, other, and astrology: esoteric therapy in Sri Lanka.

PubMed

Perinbanayagam, R S

1981-02-01

HARRY STACK SULLIVAN'S argument that anxiety as a fundamental human experience is alleviated by the use of various procedures that he called "security operations" is used in this paper to examine the meaning of astrology in Sri Lanka. Astrology and the doctrine of karma provide the relevant framework in which various forms of misfortune are understood and handled. An examination of cases in Sri Lanka reveals that astrology and the doctrine of karma enable a person of that culture to create a number of structures which have a therapeutic effect.

Editorial: Challenges for the usability of AR and VR for clinical neurosurgical procedures.

PubMed

de Ribaupierre, Sandrine; Eagleson, Roy

2017-10-01

There are a number of challenges that must be faced when trying to develop AR and VR-based Neurosurgical simulators, Surgical Navigation Platforms, and "Smart OR" systems. Trying to simulate an operating room environment and surgical tasks in Augmented and Virtual Reality is a challenge many are attempting to solve, in order to train surgeons or help them operate. What are some of the needs of the surgeon, and what are the challenges encountered (human computer interface, perception, workflow, etc). We discuss these tradeoffs and conclude with critical remarks.

An effective method for the quantitative detection of porcine endogenous retrovirus in pig tissues.

PubMed

Zhang, Peng; Yu, Ping; Wang, Wei; Zhang, Li; Li, Shengfu; Bu, Hong

2010-05-01

Xenotransplantation shows great promise for providing a virtually limitless supply of cells, tissues, and organs for a variety of therapeutical procedures. However, the potential of porcine endogenous retrovirus (PERV) as a human-tropic pathogen, particularly as a public health risk, is a major concern for xenotransplantation. This study focus on the detection of copy number in various tissues and organs in Banna Minipig Inbreed (BMI) from 2006 to 2007 in West China Hospital, Sichuan University. Real-time quantitative polymerase chain reaction (SYBR Green I) was performed in this study. The results showed that the pol gene had the most copy number in tissues compared with gag, envA, and envB. Our experiment will offer a rapid and accurate method for the detection of the copy number in various tissues and was especially suitable for the selection of tissues or organs in future clinical xenotransplantation.

A standardized procedure for using human corpus cavernosum strips to evaluate drug activity.

PubMed

Mirone, V; Sorrentino, R; di Villa Bianca, R; Imbimbo, C; Palmieri, A; Fusco, F; Tajana, G; Cirino, G

2000-01-01

The main problem of using human corpus cavernosum (HCC) tissue to perform bioassay is linked to its limited availability further complicated by the heterogeneous source of the tissues used. Here, we show that gender reassignment is a reliable source of human tissue without major ethical problems. Indeed, the entire corpus cavernosum is obtained from the surgery procedure, which allows creating a standardized procedure to prepare HCC strip. In addition, human tissue, if kept in the fridge in the condition described, does not loose its ability to contract to phenylephrine (PE; alpha agonist), angiotensin II (AG II) and KCl up to 4 days. Furthermore, once contracted with PE, HCC relaxes to acetylcholine (endothelium-dependent mechanism); sodium nitroprusside (endothelium-independent mechanism); cromakalim (CRK), a K(ATP) channel opener; or alprostadil, a synthetic PGE2 (ALPR). In conclusion, we have standardized a procedure that allows the use of HCC strips to evaluate drug activity and/or to study pathophysiological mechanisms with an intact functional human tissue up to 4 days from the surgery procedure.

In-office vs. operating room procedures for recurrent respiratory papillomatosis.

PubMed

Miller, Anya J; Gardner, Glendon M

2017-01-01

We conducted a study to analyze hospital and patient costs, outcomes, and patient satisfaction among adults undergoing in-office and operating room procedures for the treatment of recurrent respiratory papillomatosis. Our final study population was made up of 17 patients-1 man and 16 women, aged 30 to 86 years (mean: 62). The mean number of in-office laser procedures per patient was 4.2, and the mean interval between procedures was 5.4 months (although 10 patients underwent only 1 office procedure); the mean number of operating room procedures was 13.5, and the mean interval between procedures was 14.3 months. An equal number of patients reported complications or adverse events with the two types of procedures-5 each. The difference in cost between the office procedure (mean: $3,413.00) and the operating room procedure (mean: $12,382.59) was almost $9,000, but these savings were offset by the fact that the office procedures needed to be performed three times as often. Patients reported slightly more anxiety and discomfort during the office procedures and, overall, they appeared to prefer the operating room procedure. We conclude that office procedures are significantly more cost-effective than operating room procedures, but their use may be limited by patient tolerance and the increased frequency of the procedure.

Reducing variation in a rabbit vaccine safety study with particular emphasis on housing conditions and handling.

PubMed

Verwer, Cynthia M; van der Ark, Arno; van Amerongen, Geert; van den Bos, Ruud; Hendriksen, Coenraad F M

2009-04-01

This paper describes the results of a study of the effects of modified housing conditions, conditioning and habituation on humans using a rabbit model for monitoring whole-cell pertussis vaccine (pWCV)-induced adverse effects. The study has been performed with reference to previous vaccine safety studies of pWCV in rabbits in which results were difficult to interpret due to the large variation in experimental outcome, especially in the key parameter deep-body temperature (T(b)). Certain stressful laboratory conditions, as well as procedures involving humans, e.g. blood sampling, inoculation and cage-cleaning, were hypothesized to cause this large variation. The results of this study show that under modified housing conditions rabbits have normal circadian body temperatures. This allowed discrimination of pWCV-induced adverse effects in which handled rabbits tended to show a dose-related increase in temperature after inoculation with little variance, whereas non-handled rabbits did not. Effects of experimental and routine procedures on body temperature were significantly reduced under modified conditions and were within the normal T(b) range. Handled animals reacted less strongly and with less variance to experimental procedures, such as blood sampling, injection and cage-cleaning, than non-handled rabbits. Overall, handling had a positive effect on the behaviour of the animals. Data show that the housing modifications have provided a more robust model for monitoring pWCV adverse effects. Furthermore, conditioning and habituation of rabbits to humans reduce the variation in experimental outcome, which might allow for a reduction in the number of animals used. In addition, this also reduces distress and thus contributes to refining this animal model.

HLA-typing analysis following allogeneic bone grafting for sinus lifting.

PubMed

Piaia, Marcelo; Bub, Carolina Bonet; Succi, Guilherme de Menezes; Torres, Margareth; Costa, Thiago Henrique; Pinheiro, Fabricio Costa; Napimoga, Marcelo Henrique

2017-03-01

According to the Brazilian Association of Organ Transplants, in 2015, 19,408 bone transplants were performed in Brazil, over 90% by Dental Surgeons. The surgical technique itself has a respectable number of reports regarding its clinical efficacy, as measured by long-term survival of dental implants in grafted areas. Uncertainty remains, however, as to whether fresh frozen grafts from human bone donors remain immunologically innocuous in the body of the host. Six male with no previous medical history of note, including systemic diseases, surgery or blood transfusion were selected. These patients underwent reconstructive procedures (sinus lifting) using fresh frozen human bone from a tissue bank. All patients had venous blood samples collected prior to surgery and 6 months after the procedure. Anti-HLA analysis for the detection of HLA (human leukocyte antigen) antibodies was performed using methods such as the LABScreen PRA Class I and Class II, LABScreen Single Antigen Class I and Class II, Luminex Platform. Reactive individuals to the screening tests (LABScreen PRA) were further investigated to determine the specificity of the antibodies detected (LABScreen Single Antigen) with a cutoff value of median fluorescence intensity ≥500. As a result, it was observed that two patients (33%) were positive in screening tests, one presenting with anti-HLA Class I and II sensitization and the other with anti-HLA class II. The specificity analysis showed that the patients sensitized to HLA class II presented 4 specificities, 3 of which immunologically relevant. In the second individual, 23 specificities were identified, 6 of which immunologically important for HLA class I and 4 specificities for HLA class II, 3 of these were immunologically important. All specificities detected had average fluorescence. These findings are suggestive that sinus-lifting procedures with allogeneic bone can induce immunological sensitization.

Complete automation of solid-phase extraction with subsequent liquid chromatography-tandem mass spectrometry for the quantification of benzoylecgonine, m-hydroxybenzoylecgonine, p-hydroxybenzoylecgonine, and norbenzoylecgonine in urine--application to a high-throughput urine analysis laboratory.

PubMed

Robandt, Paul P; Reda, Louis J; Klette, Kevin L

2008-10-01

A fully automated system utilizing a liquid handler and an online solid-phase extraction (SPE) device coupled with liquid chromatography-tandem mass spectrometry (LC-MS-MS) was designed to process, detect, and quantify benzoylecgonine (BZE), meta-hydroxybenzoylecgonine (m-OH BZE), para-hydroxybenzoylecgonine (p-OH BZE), and norbenzoylecgonine (nor-BZE) metabolites in human urine. The method was linear for BZE, m-OH BZE, and p-OH BZE from 1.2 to 10,000 ng/mL with limits of detection (LOD) and quantification (LOQ) of 1.2 ng/mL. Nor-BZE was linear from 5 to 10,000 ng/mL with an LOD and LOQ of 1.2 and 5 ng/mL, respectively. The intrarun precision measured as the coefficient of variation of 10 replicates of a 100 ng/mL control was less than 2.6%, and the interrun precision for 5 replicates of the same control across 8 batches was less than 4.8% for all analytes. No assay interference was noted from controls containing cocaine, cocaethylene, and ecgonine methyl ester. Excellent data concordance (R2 > 0.994) was found for direct comparison of the automated SPE-LC-MS-MS procedure and an existing gas chromatography-MS procedure using 94 human urine samples previously determined to be positive for BZE. The automated specimen handling and SPE procedure, when compared to the traditional extraction schema, eliminates the human factors of specimen handling, processing, extraction, and derivatization, thereby reducing labor costs and rework resulting from batch handling issues, and may reduce the number of fume hoods required in the laboratory.

Self-administration of cocaine, cannabis and heroin in the human laboratory: benefits and pitfalls.

PubMed

Haney, Margaret

2009-01-01

The objective of this review is to describe self-administration procedures for modeling addiction to cocaine, cannabis and heroin in the human laboratory, the benefits and pitfalls of the approach, and the methodological issues unique to each drug. In addition, the predictive validity of the model for testing treatment medications will be addressed. The results show that all three drugs of abuse are reliably and robustly self-administered by non-treatment-seeking research volunteers. In terms of pharmacotherapies, cocaine use is extraordinarily difficult to disrupt either in the laboratory or in the clinic. A range of medications has been shown to significantly decrease cocaine's subjective effects and craving without decreasing either cocaine self-administration or cocaine abuse by patients. These negative data combined with recent positive findings with modafinil suggest that self-administration procedures are an important intermediary step between pre-clinical and clinical studies. In terms of cannabis, a recent study suggests that medications that improve sleep and mood during cannabis withdrawal decrease the resumption of marijuana self-administration in abstinent volunteers. Clinical data on patients seeking treatment for their marijuana use are needed to validate these laboratory findings. Finally, in contrast to cannabis or cocaine dependence, there are three efficacious Food and Drug Administration-approved medications to treat opioid dependence, all of which decrease both heroin self-administration and subjective effects in the human laboratory. In summary, self-administration procedures provide meaningful behavioral data in a small number of individuals. These studies contribute to our understanding of the variables maintaining cocaine, marijuana and heroin intake, and are important in guiding the development of more effective drug treatment programs.

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

EPA Order 1000.17 on Policy and Procedures of Protection of Human Research Subjects in EPA Conducted or Supported Research

EPA Pesticide Factsheets

This Order supersedes EPA Order 1000.17 Policy and Procedures on Protection of Human Subjects, July 30, 1999 including changes thereto, and establishes EPA responsibilities and policies for the use of human subjects in research.

Autonomous spacecraft landing through human pre-attentive vision.

PubMed

Schiavone, Giuseppina; Izzo, Dario; Simões, Luís F; de Croon, Guido C H E

2012-06-01

In this work, we exploit a computational model of human pre-attentive vision to guide the descent of a spacecraft on extraterrestrial bodies. Providing the spacecraft with high degrees of autonomy is a challenge for future space missions. Up to present, major effort in this research field has been concentrated in hazard avoidance algorithms and landmark detection, often by reference to a priori maps, ranked by scientists according to specific scientific criteria. Here, we present a bio-inspired approach based on the human ability to quickly select intrinsically salient targets in the visual scene; this ability is fundamental for fast decision-making processes in unpredictable and unknown circumstances. The proposed system integrates a simple model of the spacecraft and optimality principles which guarantee minimum fuel consumption during the landing procedure; detected salient sites are used for retargeting the spacecraft trajectory, under safety and reachability conditions. We compare the decisions taken by the proposed algorithm with that of a number of human subjects tested under the same conditions. Our results show how the developed algorithm is indistinguishable from the human subjects with respect to areas, occurrence and timing of the retargeting.

Human interface design using Button-type PEDOT electrode array in EIT

NASA Astrophysics Data System (ADS)

Wi, Hun; In Oh, Tong; Yoon, Sun; Kim, Kap Jin; Woo, Eung Je

2010-04-01

Animal and human experiments using a multi-channel EIT system requires a cumbersome procedure to attach multiple electrodes. We have to ensure good contact of all electrodes and manage many lead wires during experiments. The problem becomes more severe as we increase the number of electrodes. These may limit the applicability of the imaging method in practice. Noting this technical difficulty, there have been a few trials to design human interface means such as electrode belts, helmets or rings. In this study, we developed an electrode belt for long-term monitoring of human lung ventilation. The belt includes 16 embossed electrodes which make good contact with the skin. The electrode is made by conductive polymer and metallic thread. Soft cushion and wide contact area minimize uncomfortable sensation and reduce contact impedances. The electrodes are attached to an elastic fabric belt at equal spacing. We describe details of its design and fabrication. Using the electrode belt and recently developed multi-frequency EIT system KHU Mark2, we show time-difference chest images of three human subjects during normal breathing cycles.

Cognition and procedure representational requirements for predictive human performance models

NASA Technical Reports Server (NTRS)

Corker, K.

1992-01-01

Models and modeling environments for human performance are becoming significant contributors to early system design and analysis procedures. Issues of levels of automation, physical environment, informational environment, and manning requirements are being addressed by such man/machine analysis systems. The research reported here investigates the close interaction between models of human cognition and models that described procedural performance. We describe a methodology for the decomposition of aircrew procedures that supports interaction with models of cognition on the basis of procedures observed; that serves to identify cockpit/avionics information sources and crew information requirements; and that provides the structure to support methods for function allocation among crew and aiding systems. Our approach is to develop an object-oriented, modular, executable software representation of the aircrew, the aircraft, and the procedures necessary to satisfy flight-phase goals. We then encode in a time-based language, taxonomies of the conceptual, relational, and procedural constraints among the cockpit avionics and control system and the aircrew. We have designed and implemented a goals/procedures hierarchic representation sufficient to describe procedural flow in the cockpit. We then execute the procedural representation in simulation software and calculate the values of the flight instruments, aircraft state variables and crew resources using the constraints available from the relationship taxonomies. The system provides a flexible, extensible, manipulative and executable representation of aircrew and procedures that is generally applicable to crew/procedure task-analysis. The representation supports developed methods of intent inference, and is extensible to include issues of information requirements and functional allocation. We are attempting to link the procedural representation to models of cognitive functions to establish several intent inference methods including procedural backtracking with concurrent search, temporal reasoning, and constraint checking for partial ordering of procedures. Finally, the representation is being linked to models of human decision making processes that include heuristic, propositional and prescriptive judgement models that are sensitive to the procedural content in which the valuative functions are being performed.

The Human EST Ontology Explorer: a tissue-oriented visualization system for ontologies distribution in human EST collections.

PubMed

Merelli, Ivan; Caprera, Andrea; Stella, Alessandra; Del Corvo, Marcello; Milanesi, Luciano; Lazzari, Barbara

2009-10-15

The NCBI dbEST currently contains more than eight million human Expressed Sequenced Tags (ESTs). This wide collection represents an important source of information for gene expression studies, provided it can be inspected according to biologically relevant criteria. EST data can be browsed using different dedicated web resources, which allow to investigate library specific gene expression levels and to make comparisons among libraries, highlighting significant differences in gene expression. Nonetheless, no tool is available to examine distributions of quantitative EST collections in Gene Ontology (GO) categories, nor to retrieve information concerning library-dependent EST involvement in metabolic pathways. In this work we present the Human EST Ontology Explorer (HEOE) http://www.itb.cnr.it/ptp/human_est_explorer, a web facility for comparison of expression levels among libraries from several healthy and diseased tissues. The HEOE provides library-dependent statistics on the distribution of sequences in the GO Direct Acyclic Graph (DAG) that can be browsed at each GO hierarchical level. The tool is based on large-scale BLAST annotation of EST sequences. Due to the huge number of input sequences, this BLAST analysis was performed with the aid of grid computing technology, which is particularly suitable to address data parallel task. Relying on the achieved annotation, library-specific distributions of ESTs in the GO Graph were inferred. A pathway-based search interface was also implemented, for a quick evaluation of the representation of libraries in metabolic pathways. EST processing steps were integrated in a semi-automatic procedure that relies on Perl scripts and stores results in a MySQL database. A PHP-based web interface offers the possibility to simultaneously visualize, retrieve and compare data from the different libraries. Statistically significant differences in GO categories among user selected libraries can also be computed. The HEOE provides an alternative and complementary way to inspect EST expression levels with respect to approaches currently offered by other resources. Furthermore, BLAST computation on the whole human EST dataset was a suitable test of grid scalability in the context of large-scale bioinformatics analysis. The HEOE currently comprises sequence analysis from 70 non-normalized libraries, representing a comprehensive overview on healthy and unhealthy tissues. As the analysis procedure can be easily applied to other libraries, the number of represented tissues is intended to increase.

Adaptive Spontaneous Transitions between Two Mechanisms of Numerical Averaging.

PubMed

Brezis, Noam; Bronfman, Zohar Z; Usher, Marius

2015-06-04

We investigated the mechanism with which humans estimate numerical averages. Participants were presented with 4, 8 or 16 (two-digit) numbers, serially and rapidly (2 numerals/second) and were instructed to convey the sequence average. As predicted by a dual, but not a single-component account, we found a non-monotonic influence of set-size on accuracy. Moreover, we observed a marked decrease in RT as set-size increases and RT-accuracy tradeoff in the 4-, but not in the 16-number condition. These results indicate that in accordance with the normative directive, participants spontaneously employ analytic/sequential thinking in the 4-number condition and intuitive/holistic thinking in the 16-number condition. When the presentation rate is extreme (10 items/sec) we find that, while performance still remains high, the estimations are now based on intuitive processing. The results are accounted for by a computational model postulating population-coding underlying intuitive-averaging and working-memory-mediated symbolic procedures underlying analytical-averaging, with flexible allocation between the two.

76 FR 30243 - Minimum Security Devices and Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Minimum Security Devices and Procedures.... Title of Proposal: Minimum Security Devices and Procedures. OMB Number: 1550-0062. Form Number: N/A. Description: The requirement that savings associations establish a written security program is necessitated by...

Capturing the Value: Earth Applications of Space Human Factors Research

NASA Technical Reports Server (NTRS)

Connors, Mary M.; Shafto, Michael G. (Technical Monitor)

1995-01-01

This paper details how the Space Human Factors/Life Sciences program at Ames Research Center (ARC) has provided, and continues to provide, a variety of Earth-based benefits. These benefits will be considered under five categories: aeronautics, space-like environments, general applications, human/automation interaction, and methodology. The human factors work at ARC includes a range of activities whose products serve the aerospace community. Some areas of research focus specifically on aeronautical requirements; others are driven by space needs. However, the symbiosis between these two domains allows a sharing of resources, and the insights and experimental results gathered in one domain can often be applied in the other. Aeronautics is an industry whose survival is generally viewed as critical to American competitiveness, and where benefits can result in a very high payoff. The ability to apply space-initiated research to aeronautical requirements represents one example of bringing space benefits down to Earth. The second-order value of space human factors research goes well beyond the aerospace community. Spaceflight shares with a number of other activities certain environmental characteristics that drive human factors engineering design and procedural specification. Spaceflight is an isolated activity, conducted under severely confined conditions, with a high level of risk, and where provisions are restricted and opportunities for outside help are limited. A number of Earth-based activities including submarines and other naval vessels, oil rigs, remote weather stations, and scientific and polar expeditions, share many of these characteristics. These activities serve as testbeds for space-related research and, in turn, space-related research provides beneficial insight to the conduct of these activities.

Human Factors Considerations for Performance-Based Navigation

NASA Technical Reports Server (NTRS)

Barhydt, Richard; Adams, Catherine A.

2006-01-01

A transition toward a performance-based navigation system is currently underway in both the United States and around the world. Performance-based navigation incorporates Area Navigation (RNAV) and Required Navigation Performance (RNP) procedures that do not rely on the location of ground-based navigation aids. These procedures offer significant benefits to both operators and air traffic managers. Under sponsorship from the Federal Aviation Administration (FAA), the National Aeronautics and Space Administration (NASA) has undertaken a project to document human factors issues that have emerged during RNAV and RNP operations and propose areas for further consideration. Issues were found to include aspects of air traffic control and airline procedures, aircraft systems, and procedure design. Major findings suggest the need for human factors-specific instrument procedure design guidelines. Ongoing industry and government activities to address air-ground communication terminology, procedure design improvements, and chart-database commonality are strongly encouraged.

Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study.

PubMed

El-Chami, Mikhael; Kowal, Robert C; Soejima, Kyoko; Ritter, Philippe; Duray, Gabor Z; Neuzil, Petr; Mont, Lluis; Kypta, Alexander; Sagi, Venkata; Hudnall, John Harrison; Stromberg, Kurt; Reynolds, Dwight

2017-07-01

Leadless pacemaker systems have been designed to avoid the need for a pocket and transvenous lead. However, delivery of this therapy requires a new catheter-based procedure. This study evaluates the role of operator experience and different training strategies on procedural outcomes. A total of 726 patients underwent implant attempt with the Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA) by 94 operators trained in a teaching laboratory using a simulator, cadaver, and large animal models (lab training) or locally at the hospital with simulator/demo model and proctorship (hospital training). Procedure success, procedure duration, fluoroscopy time, and safety outcomes were compared between training methods and experience (implant case number). The Micra TPS procedure was successful in 99.2% of attempts and did not differ between the 55 operators trained in the lab setting and the 39 operators trained locally at the hospital (P = 0.189). Implant case number was also not a determinant of procedural success (P = 0.456). Each operator performed between one and 55 procedures. Procedure time and fluoroscopy duration decreased by 2.0% (P = 0.002) and 3.2% (P < 0.001) compared to the previous case. Major complication rate and pericardial effusion rate were not associated with case number (P = 0.755 and P = 0.620, respectively). There were no differences in the safety outcomes by training method. Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies. © 2017 Wiley Periodicals, Inc.

Surveillance of laboratory exposures to human pathogens and toxins: Canada 2016.

PubMed

Bienek, A; Heisz, M; Su, M

2017-11-02

Canada recently enacted legislation to authorize the collection of data on laboratory incidents involving a biological agent. This is done by the Public Health Agency of Canada (PHAC) as part of a comprehensive national program that protects Canadians from the health and safety risks posed by human and terrestrial animal pathogens and toxins. To describe the first year of data on laboratory exposure incidents and/or laboratory-acquired infections in Canada since the Human Pathogens and Toxins Regulations came into effect. Incidents that occurred between January 1 and December 31, 2016 were self-reported by federally-regulated parties across Canada using a standardized form from the Laboratory Incident Notification Canada (LINC) surveillance system. Exposure incidents were described by sector, frequency of occurrence, timeliness of reporting, number of affected persons, human pathogens and toxins involved, causes and corrective actions taken. Microsoft Excel 2010 was used for basic descriptive analyses. In 2016, 46 exposure incidents were reported by holders of 835 active licences in Canada representing 1,352 physical areas approved for work involving a biological agent, for an overall incidence of 3.4%. The number of incidents was highest in the academic (n=16; 34.8%) and hospital (n=12; 26.1%) sectors, while the number of reported incidents was relatively low in the private industry sector. An average of four to five incidents occurred each month; the month of September presented as an outlier with 10 incidents. ​: A total of 100 people were exposed, with no reports of secondary exposure. Four incidents led to suspected (n=3) or confirmed (n=1) cases of laboratory-acquired infection. Most incidents involved pathogens classified at a risk group 2 level that were manipulated in a containment level 2 laboratory (91.3%). Over 22 different species of human pathogens and toxins were implicated, with bacteria the most frequent (34.8%), followed by viruses (26.1%). Eleven (23.9%) incidents involved a security sensitive biologic agent. Procedure breaches (n=15) and sharps-related incidents (n=14) were the most common antecedents to an exposure. In 10 (21.7%) cases, inadvertent possession (i.e., isolation of an unexpected biological agent during routine work) played a role. Possible improvements to standard operating procedures were cited in 71.7% of incidents. Improvements were also indicated for communication (26.1%) and management (23.9%). The Laboratory Incident Notification Canada is one of the first surveillance systems in the world to gather comprehensive data on laboratory incidents involving human pathogens and toxins. Exposure incidents reported in the first year were relatively rare, occurring in less than 4% of containment zones within laboratory settings.

Surveillance of laboratory exposures to human pathogens and toxins: Canada 2016

PubMed Central

Bienek, A; Heisz, M; Su, M

2017-01-01

Background Canada recently enacted legislation to authorize the collection of data on laboratory incidents involving a biological agent. This is done by the Public Health Agency of Canada (PHAC) as part of a comprehensive national program that protects Canadians from the health and safety risks posed by human and terrestrial animal pathogens and toxins. Objective To describe the first year of data on laboratory exposure incidents and/or laboratory-acquired infections in Canada since the Human Pathogens and Toxins Regulations came into effect. Methods Incidents that occurred between January 1 and December 31, 2016 were self-reported by federally-regulated parties across Canada using a standardized form from the Laboratory Incident Notification Canada (LINC) surveillance system. Exposure incidents were described by sector, frequency of occurrence, timeliness of reporting, number of affected persons, human pathogens and toxins involved, causes and corrective actions taken. Microsoft Excel 2010 was used for basic descriptive analyses. Results In 2016, 46 exposure incidents were reported by holders of 835 active licences in Canada representing 1,352 physical areas approved for work involving a biological agent, for an overall incidence of 3.4%. The number of incidents was highest in the academic (n=16; 34.8%) and hospital (n=12; 26.1%) sectors, while the number of reported incidents was relatively low in the private industry sector. An average of four to five incidents occurred each month; the month of September presented as an outlier with 10 incidents. ​ A total of 100 people were exposed, with no reports of secondary exposure. Four incidents led to suspected (n=3) or confirmed (n=1) cases of laboratory-acquired infection. Most incidents involved pathogens classified at a risk group 2 level that were manipulated in a containment level 2 laboratory (91.3%). Over 22 different species of human pathogens and toxins were implicated, with bacteria the most frequent (34.8%), followed by viruses (26.1%). Eleven (23.9%) incidents involved a security sensitive biologic agent. Procedure breaches (n=15) and sharps-related incidents (n=14) were the most common antecedents to an exposure. In 10 (21.7%) cases, inadvertent possession (i.e., isolation of an unexpected biological agent during routine work) played a role. Possible improvements to standard operating procedures were cited in 71.7% of incidents. Improvements were also indicated for communication (26.1%) and management (23.9%). Conclusions The Laboratory Incident Notification Canada is one of the first surveillance systems in the world to gather comprehensive data on laboratory incidents involving human pathogens and toxins. Exposure incidents reported in the first year were relatively rare, occurring in less than 4% of containment zones within laboratory settings. PMID:29770052

A karyometric note on nucleoli in human early granulocytic precursors.

PubMed

Smetana, K; Mikulenková, D; Jirásková, I; Klamová, H

2006-01-01

The diameter of nucleoli was measured in human bone marrow early granulocytic precursors after visualization by a simple cytochemical method for demonstration of RNA. Such method facilitated to clearly see nucleolar bodies without perinucleolar chromatin, including those of micronucleoli. The bone marrow of patients suffering from chronic myeloid leukaemia (untreated with cytostatics) provided a satisfactory number of both myeloblasts and promyelocytes for nucleolar measurements because of prevailing granulopoiesis. The direct nucleolar measurement was carried out on digitized and processed images on the screen at magnification 4,300x. It seems to be likely that the nucleolar size is directly related to the number of nucleoli per cell. The largest nucleoli were present in both myeloblasts and promyelocytes that possessed a single nucleolus. In contrast, the nucleolar diameter was significantly smaller in cells with multiple nucleoli. However, in cells with small multiple nucleoli, one of them was always larger and dominant with a large number of AgNORs. Such large nucleoli are possibly visible in specimens stained with panoptic procedures or methods staining nuclear chromatin or DNA. It should also be mentioned that both myeloblasts and promyelocytes mostly possessed two nucleoli with the mean diameter close to 1.5 microm. The incidence of early granulocytic precursors classified according to the nucleolar number and size strongly suggested that the various nucleolar number and nucleolar size in these cells might be related to the different stage of the cell cycle and might also explain their heterogeneity.

A Likelihood-Based Framework for Association Analysis of Allele-Specific Copy Numbers.

PubMed

Hu, Y J; Lin, D Y; Sun, W; Zeng, D

2014-10-01

Copy number variants (CNVs) and single nucleotide polymorphisms (SNPs) co-exist throughout the human genome and jointly contribute to phenotypic variations. Thus, it is desirable to consider both types of variants, as characterized by allele-specific copy numbers (ASCNs), in association studies of complex human diseases. Current SNP genotyping technologies capture the CNV and SNP information simultaneously via fluorescent intensity measurements. The common practice of calling ASCNs from the intensity measurements and then using the ASCN calls in downstream association analysis has important limitations. First, the association tests are prone to false-positive findings when differential measurement errors between cases and controls arise from differences in DNA quality or handling. Second, the uncertainties in the ASCN calls are ignored. We present a general framework for the integrated analysis of CNVs and SNPs, including the analysis of total copy numbers as a special case. Our approach combines the ASCN calling and the association analysis into a single step while allowing for differential measurement errors. We construct likelihood functions that properly account for case-control sampling and measurement errors. We establish the asymptotic properties of the maximum likelihood estimators and develop EM algorithms to implement the corresponding inference procedures. The advantages of the proposed methods over the existing ones are demonstrated through realistic simulation studies and an application to a genome-wide association study of schizophrenia. Extensions to next-generation sequencing data are discussed.

Modeling of body tissues for Monte Carlo simulation of radiotherapy treatments planned with conventional x-ray CT systems

NASA Astrophysics Data System (ADS)

Kanematsu, Nobuyuki; Inaniwa, Taku; Nakao, Minoru

2016-07-01

In the conventional procedure for accurate Monte Carlo simulation of radiotherapy, a CT number given to each pixel of a patient image is directly converted to mass density and elemental composition using their respective functions that have been calibrated specifically for the relevant x-ray CT system. We propose an alternative approach that is a conversion in two steps: the first from CT number to density and the second from density to composition. Based on the latest compilation of standard tissues for reference adult male and female phantoms, we sorted the standard tissues into groups by mass density and defined the representative tissues by averaging the material properties per group. With these representative tissues, we formulated polyline relations between mass density and each of the following; electron density, stopping-power ratio and elemental densities. We also revised a procedure of stoichiometric calibration for CT-number conversion and demonstrated the two-step conversion method for a theoretically emulated CT system with hypothetical 80 keV photons. For the standard tissues, high correlation was generally observed between mass density and the other densities excluding those of C and O for the light spongiosa tissues between 1.0 g cm-3 and 1.1 g cm-3 occupying 1% of the human body mass. The polylines fitted to the dominant tissues were generally consistent with similar formulations in the literature. The two-step conversion procedure was demonstrated to be practical and will potentially facilitate Monte Carlo simulation for treatment planning and for retrospective analysis of treatment plans with little impact on the management of planning CT systems.

Compression-RSA technique: A more efficient encryption-decryption procedure

NASA Astrophysics Data System (ADS)

Mandangan, Arif; Mei, Loh Chai; Hung, Chang Ee; Che Hussin, Che Haziqah

2014-06-01

The efficiency of encryption-decryption procedures has become a major problem in asymmetric cryptography. Compression-RSA technique is developed to overcome the efficiency problem by compressing the numbers of kplaintext, where k∈Z+ and k > 2, becoming only 2 plaintext. That means, no matter how large the numbers of plaintext, they will be compressed to only 2 plaintext. The encryption-decryption procedures are expected to be more efficient since these procedures only receive 2 inputs to be processed instead of kinputs. However, it is observed that as the numbers of original plaintext are increasing, the size of the new plaintext becomes bigger. As a consequence, it will probably affect the efficiency of encryption-decryption procedures, especially for RSA cryptosystem since both of its encryption-decryption procedures involve exponential operations. In this paper, we evaluated the relationship between the numbers of original plaintext and the size of the new plaintext. In addition, we conducted several experiments to show that the RSA cryptosystem with embedded Compression-RSA technique is more efficient than the ordinary RSA cryptosystem.

Morphological variations of papillary muscles in the mitral valve complex in human cadaveric hearts.

PubMed

Gunnal, Sandhya Arvind; Wabale, Rajendra Namdeo; Farooqui, Mujeebuddin Samsamuddin

2013-01-01

Papillary muscle rupture and dysfunction can lead to complications of prolapsed mitral valve and mitral regurgitation. Multiple operative procedures of the papillary muscles, such as resection, repositioning and realignment, are carried out to restore normal physiological function. Therefore, it is important to know both the variations and the normal anatomy of papillary muscles. This study was carried out on 116 human cadaveric hearts. The left ventricles were opened along the left border in order to view the papillary muscles. The number, shape, position and pattern of the papillary muscles were observed. In this series, the papillary muscles were mostly found in groups instead of in twos, as is described in standard textbooks. Four different shapes of papillary muscles were identified - conical, broad-apexed, pyramidal and fan-shaped. We also discovered various patterns of papillary muscles. No two mitral valve complexes have the same architectural arrangement. Each case seems to be unique. Therefore, it is important for scientists worldwide to study the variations in the mitral valve complex in order to ascertain the reason behind each specific architectural arrangement. This will enable cardiothoracic surgeons to tailor the surgical procedures according to the individual papillary muscle pattern.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR COLLECTION, STORAGE, AND SHIPMENT OF HUMAN HAIR (UA-F-26.0)

EPA Science Inventory

The purpose of this SOP is to describe how to collect, store, and ship human hair for analysis of mercury. This SOP provides a brief description of the sample containers, collection, storage, shipping and custody procedures. This procedure was followed to ensure consistent data ...

Avian influenza outbreak management: action at time of confirmation, depopulation and disposal methods; the 'Belgian experience' during the H7N7 highly pathogenic avian influenza epidemic in 2003.

PubMed

van den Berg, T; Houdart, P

2008-01-01

Eradication of H5 and H7 influenza in a positive flock will include mass depopulation of birds, containment and inactivation of the virus in the carcasses and litter, and decontamination of the facility. A quick response is desired in the event of a disease outbreak. Ideally, birds should be depopulated within 24 h after detecting the virus. Mass depopulation of birds must be performed in a humane manner while minimizing human health and biosecurity risks. In the framework of the European legislation, a number of methods are authorized for the killing of poultry for processing prior to marketing. However, during emergencies such as a disease outbreak, there are fewer options. The current most commonly used procedures for large-scale emergency depopulation of birds consist of exposing poultry to CO or CO(2) gas. Both gasses have been used in Belgium during the H7N7 crisis in 2003. The gassing procedures include whole house gassing, portable panel enclosures, cage cabinets, containers and polyethylene tent method. Whole house gassing requires sealing the house to prevent gas leakage and, using specialized equipment, introducing large volumes of gas evenly over the birds. All procedures are very labour intensive, create a biosecurity risk and require a large number of personnel. There are considerable region-to-region differences in emergency depopulation techniques and disposal of carcasses and infected material. Because of the differences in bird type and species, management, housing and stocking density, it is difficult to propose a depopulation technique that will be suitable for all circumstances. Safety of the human operators is an increasing concern with all H5 and H7 strains and in particular with the highly pathogenic H5N1 strain. Researchers and commercial poultry companies in the United States recently established that non-toxic water-based foam with a certain bubble size presents a practicable, effective and humane method for mass depopulation. Foam of the right bubble size creates an occlusion in the trachea of birds, causing a rapid onset of hypoxia. The foam that blankets the broiler house induces physical hypoxia - the same cause of death as the approved method using carbon dioxide gas (CO(2)). The article illustrates the different culling and disposal methods with a focus on the methods used during the 2003 H7N7 crisis in Belgium.

Fetal liver-derived mesenchymal stromal cells augment engraftment of transplanted hepatocytes

PubMed Central

Joshi, Meghnad; Patil, Pradeep B.; He, Zhong; Holgersson, Jan; Olausson, Michael; Sumitran-Holgersson, Suchitra

2012-01-01

Background aims One important problem commonly encountered after hepatocyte transplantation is the low numbers of transplanted cells found in the graft. If hepatocyte transplantation is to be a viable therapeutic approach, significant liver parenchyma repopulation is required. Mesenchymal stromal cells (MSC) produce high levels of various growth factors, cytokines and metalloproteinases, and have immunomodulatory effects. We therefore hypothesized that co-transplantation of MSC with human fetal hepatocytes (hFH) could augment in vivo expansion after transplantation. We investigated the ability of human fetal liver MSC (hFLMSC) to augment expansion of phenotypically and functionally well-characterized hFH. Methods Two million hFH (passage 6) were either transplanted alone or together (1:1 ratio) with green fluorescence protein-expressing hFLMSC into the spleen of C57BL/6 nude mice with retrorsine-induced liver injury. Results After 4 weeks, engraftment of cells was detected by fluorescence in situ hybridization using a human-specific DNA probe. Significantly higher numbers of cells expressing human cytokeratin (CK)8, CK18, CK19, Cysteine-rich MNNG HOS Transforming gene (c-Met), alpha-fetoprotein (AFP), human nuclear antigen, mitochondrial antigen, hepatocyte-specific antigen and albumin (ALB) were present in the livers of recipient animals co-transplanted with hFLMSC compared with those without. Furthermore, expression of human hepatocyte nuclear factor (HNF)-4α and HNF-1β, and cytochrome P450 (CYP) 3A7 mRNA was demonstrated by reverse transcriptase-polymerase chain reaction (RT-PCR) in these animals. In addition, significantly increased amounts of human ALB were detected. Importantly, hFLMSC did not transdifferentiate into hepatocytes. Conclusions Our study reports the use of a novel strategy for enhanced liver repopulation and thereby advances this experimental procedure closer to clinical liver cell therapy. PMID:22424216

78 FR 15406 - Proposed Collection; Comment Request for Revenue Procedure 2013-XX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-11

... Revenue Procedure 2013- XX AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request... comments concerning Revenue Procedure 2013-XX, Disaster Relief. DATES: Written comments should be received... . SUPPLEMENTARY INFORMATION: Title: Disaster Relief. OMB Number: 1545-2237. Form Number: Rev. Proc. 2013-XX...

The Barcelona Hospital Clínic therapeutic apheresis database.

PubMed

Cid, Joan; Carbassé, Gloria; Cid-Caballero, Marc; López-Púa, Yolanda; Alba, Cristina; Perea, Dolores; Lozano, Miguel

2017-09-22

A therapeutic apheresis (TA) database helps to increase knowledge about indications and type of apheresis procedures that are performed in clinical practice. The objective of the present report was to describe the type and number of TA procedures that were performed at our institution in a 10-year period, from 2007 to 2016. The TA electronic database was created by transferring patient data from electronic medical records and consultation forms into a Microsoft Access database developed exclusively for this purpose. Since 2007, prospective data from every TA procedure were entered in the database. A total of 5940 TA procedures were performed: 3762 (63.3%) plasma exchange (PE) procedures, 1096 (18.5%) hematopoietic progenitor cell (HPC) collections, and 1082 (18.2%) TA procedures other than PEs and HPC collections. The overall trend for the time-period was progressive increase in total number of TA procedures performed each year (from 483 TA procedures in 2007 to 822 in 2016). The tracking trend of each procedure during the 10-year period was different: the number of PE and other type of TA procedures increased 22% and 2818%, respectively, and the number of HPC collections decreased 28%. The TA database helped us to increase our knowledge about various indications and type of TA procedures that were performed in our current practice. We also believe that this database could serve as a model that other institutions can use to track service metrics. © 2017 Wiley Periodicals, Inc.

Time-Domain Receiver Function Deconvolution using Genetic Algorithm

NASA Astrophysics Data System (ADS)

Moreira, L. P.

2017-12-01

Receiver Functions (RF) are well know method for crust modelling using passive seismological signals. Many different techniques were developed to calculate the RF traces, applying the deconvolution calculation to radial and vertical seismogram components. A popular method used a spectral division of both components, which requires human intervention to apply the Water Level procedure to avoid instabilities from division by small numbers. One of most used method is an iterative procedure to estimate the RF peaks and applying the convolution with vertical component seismogram, comparing the result with the radial component. This method is suitable for automatic processing, however several RF traces are invalid due to peak estimation failure.In this work it is proposed a deconvolution algorithm using Genetic Algorithm (GA) to estimate the RF peaks. This method is entirely processed in the time domain, avoiding the time-to-frequency calculations (and vice-versa), and totally suitable for automatic processing. Estimated peaks can be used to generate RF traces in a seismogram format for visualization. The RF trace quality is similar for high magnitude events, although there are less failures for RF calculation of smaller events, increasing the overall performance for high number of events per station.

NHEXAS PHASE I MARYLAND STUDY--STANDARD OPERATING PROCEDURE FOR IDENTIFICATION NUMBERS FOR SAMPLES AND FORMS (G03)

EPA Science Inventory

The purpose of this SOP is to indicate the proper method for assigning unique Identification Numbers for all samples taken and forms used in the collection of NHEXAS Pilot Studies. All data tracking procedures were built upon these ID numbers. Inspection of these ID numbers pro...

Improving Performance During Image-Guided Procedures

PubMed Central

Duncan, James R.; Tabriz, David

2015-01-01

Objective Image-guided procedures have become a mainstay of modern health care. This article reviews how human operators process imaging data and use it to plan procedures and make intraprocedural decisions. Methods A series of models from human factors research, communication theory, and organizational learning were applied to the human-machine interface that occupies the center stage during image-guided procedures. Results Together, these models suggest several opportunities for improving performance as follows: 1. Performance will depend not only on the operator’s skill but also on the knowledge embedded in the imaging technology, available tools, and existing protocols. 2. Voluntary movements consist of planning and execution phases. Performance subscores should be developed that assess quality and efficiency during each phase. For procedures involving ionizing radiation (fluoroscopy and computed tomography), radiation metrics can be used to assess performance. 3. At a basic level, these procedures consist of advancing a tool to a specific location within a patient and using the tool. Paradigms from mapping and navigation should be applied to image-guided procedures. 4. Recording the content of the imaging system allows one to reconstruct the stimulus/response cycles that occur during image-guided procedures. Conclusions When compared with traditional “open” procedures, the technology used during image-guided procedures places an imaging system and long thin tools between the operator and the patient. Taking a step back and reexamining how information flows through an imaging system and how actions are conveyed through human-machine interfaces suggest that much can be learned from studying system failures. In the same way that flight data recorders revolutionized accident investigations in aviation, much could be learned from recording video data during image-guided procedures. PMID:24921628

Vector ecology and integrated control procedures

PubMed Central

Laird, Marshall

1963-01-01

The elucidation of population regulatory mechanisms calls for exhaustive biological and ecological studies of whole ecosystems. Until lately, little effort was made to relate insect control activities to such a background, and the use of non-selective pesticides has often resulted in biotic equilibria being disrupted to the ultimate advantage of the organism under attack or of some other undesirable species. However, there is a growing realization in the field of economic entomology at large that biotic control agents usually constitute the major portion of the environmental resistance to increases in pest numbers and that insecticides should be fitted into the ecosystem, and not imposed upon it—in fact, that integrated control procedures are called for. The author considers such integrated procedures from the standpoint of vector control. His paper points out their potentialities in helping to solve resistance problems and in increasing the selectivity of control operations. It further suggests that they offer the means of achieving economical and lasting reductions of vector populations to levels at which human disease transmission is interrupted and pest problems lose much of their importance. PMID:20604165

24 CFR 5.238 - Criminal and civil penalties.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Development GENERAL HUD PROGRAM REQUIREMENTS; WAIVERS Disclosure and Verification of Social Security Numbers and Employer Identification Numbers; Procedures for Obtaining Income Information Procedures for...

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield.

PubMed

Politi, Luigi; Biondi-Zoccai, Giuseppe; Nocetti, Luca; Costi, Tiziana; Monopoli, Daniel; Rossi, Rosario; Sgura, Fabio; Modena, Maria Grazia; Sangiorgi, Giuseppe M

2012-01-01

Occupational radiation exposure is a growing problem due to the increasing number and complexity of interventional procedures performed. Radial artery access has reduced the number of complications at the price of longer procedure duration. Radpad® scatter protection is a sterile, disposable bismuth-barium radiation shield drape that should be able to decrease the dose of operator radiation during diagnostic and interventional procedures. Such radiation shield has never been tested in a randomized study in humans. Sixty consecutive patients undergoing coronary angiography by radial approach were randomized 1:1 to Radpad use versus no radiation shield protection. The sterile shield was placed around the area of right radial artery sheath insertion and extended medially to the patient trunk. All diagnostic procedures were performed by the same operator to reduce variability in radiation absorption. Radiation exposure was measured blindly using thermoluminescence dosimeters positioned at the operator's chest, left eye, left wrist, and thyroid. Despite similar fluoroscopy time (3.52 ± 2.71 min vs. 3.46 ± 2.77 min, P = 0.898) and total examination dose (50.5 ± 30.7 vs. 45.8 ± 18.0 Gycm(2), P = 0.231), the mean total radiation exposure to the operator was significantly lower when Radpad was utilized (282.8 ± 32.55 μSv vs. 367.8 ± 105.4 μSv, P < 0.0001) corresponding to a 23% total reduction. Moreover, mean radiation exposure was lower with Radpad utilization at all body locations ranging from 13 to 34% reduction. This first-in-men randomized trial demonstrates that Radpad significantly reduces occupational radiation exposure during coronary angiography performed through right radial artery access. Copyright © 2011 Wiley Periodicals, Inc.

The anatomy of the caudal zona incerta in rodents and primates

PubMed Central

Watson, Charles; Lind, Christopher R P; Thomas, Meghan G

2014-01-01

The caudal zona incerta is the target of a recent modification of established procedures for deep brain stimulation (DBS) for Parkinson's disease and tremor. The caudal zona incerta contains a number of neuronal populations that are distinct in terms of their cytoarchitecture, connections, and pattern of immunomarkers and is located at a position where a number of major tracts converge before turning toward their final destination in the forebrain. However, it is not clear which of the anatomical features of the region are related to its value as a target for DBS. This paper has tried to identify features that distinguish the caudal zona incerta of rodents (mouse and rat) and primates (marmoset, rhesus monkey, and human) from the remainder of the zona incerta. We studied cytoarchitecture, anatomical relationships, the pattern of immunomarkers, and gene expression in both of these areas. We found that the caudal zona incerta has a number of histological and gene expression characteristics that distinguish it from the other subdivisions of the zona incerta. Of particular note are the sparse population of GABA neurons and the small but distinctive population of calbindin neurons. We hope that a clearer appreciation of the anatomy of the region will in the end assist the interpretation of cases in which DBS is used in human patients. PMID:24138151

Vectors for co-expression of an unrestricted number of proteins

PubMed Central

Scheich, Christoph; Kümmel, Daniel; Soumailakakis, Dimitri; Heinemann, Udo; Büssow, Konrad

2007-01-01

A vector system is presented that allows generation of E. coli co-expression clones by a standardized, robust cloning procedure. The number of co-expressed proteins is not limited. Five ‘pQLink’ vectors for expression of His-tag and GST-tag fusion proteins as well as untagged proteins and for cloning by restriction enzymes or Gateway cloning were generated. The vectors allow proteins to be expressed individually; to achieve co-expression, two pQLink plasmids are combined by ligation-independent cloning. pQLink co-expression plasmids can accept an unrestricted number of genes. As an example, the co-expression of a heterotetrameric human transport protein particle (TRAPP) complex from a single plasmid, its isolation and analysis of its stoichiometry are shown. pQLink clones can be used directly for pull-down experiments if the proteins are expressed with different tags. We demonstrate pull-down experiments of human valosin-containing protein (VCP) with fragments of the autocrine motility factor receptor (AMFR). The cloning method avoids PCR or gel isolation of restriction fragments, and a single resistance marker and origin of replication are used, allowing over-expression of rare tRNAs from a second plasmid. It is expected that applications are not restricted to bacteria, but could include co-expression in other hosts such as Bacluovirus/insect cells. PMID:17311810

Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol

PubMed Central

Audrey, Suzanne; Ferrie, Joanne; Evans, Karen; Bell, Michael; Yates, Julie; Roderick, Marion; MacLeod, John; Hickman, Matthew

2018-01-01

Introduction The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures. Methods and analysis Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures. Ethics and dissemination The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and parents as requested. Trial registration number ISRCTN49086105; Pre-results. PMID:29502095

20 CFR 422.103 - Social security numbers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Social security numbers. 422.103 Section 422.103 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.103 Social security numbers. (a) General. The Social Security Administration (SSA) maintains a...

20 CFR 422.103 - Social security numbers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Social security numbers. 422.103 Section 422.103 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.103 Social security numbers. (a) General. The Social Security Administration (SSA) maintains a...

20 CFR 422.103 - Social security numbers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Social security numbers. 422.103 Section 422.103 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.103 Social security numbers. (a) General. The Social Security Administration (SSA) maintains a...

20 CFR 422.103 - Social security numbers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Social security numbers. 422.103 Section 422.103 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.103 Social security numbers. (a) General. The Social Security Administration (SSA) maintains a...

20 CFR 422.103 - Social security numbers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Social security numbers. 422.103 Section 422.103 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.103 Social security numbers. (a) General. The Social Security Administration (SSA) maintains a...

Consequences of common data analysis inaccuracies in CNS trauma injury basic research.

PubMed

Burke, Darlene A; Whittemore, Scott R; Magnuson, David S K

2013-05-15

The development of successful treatments for humans after traumatic brain or spinal cord injuries (TBI and SCI, respectively) requires animal research. This effort can be hampered when promising experimental results cannot be replicated because of incorrect data analysis procedures. To identify and hopefully avoid these errors in future studies, the articles in seven journals with the highest number of basic science central nervous system TBI and SCI animal research studies published in 2010 (N=125 articles) were reviewed for their data analysis procedures. After identifying the most common statistical errors, the implications of those findings were demonstrated by reanalyzing previously published data from our laboratories using the identified inappropriate statistical procedures, then comparing the two sets of results. Overall, 70% of the articles contained at least one type of inappropriate statistical procedure. The highest percentage involved incorrect post hoc t-tests (56.4%), followed by inappropriate parametric statistics (analysis of variance and t-test; 37.6%). Repeated Measures analysis was inappropriately missing in 52.0% of all articles and, among those with behavioral assessments, 58% were analyzed incorrectly. Reanalysis of our published data using the most common inappropriate statistical procedures resulted in a 14.1% average increase in significant effects compared to the original results. Specifically, an increase of 15.5% occurred with Independent t-tests and 11.1% after incorrect post hoc t-tests. Utilizing proper statistical procedures can allow more-definitive conclusions, facilitate replicability of research results, and enable more accurate translation of those results to the clinic.

IARC monographs: 40 years of evaluating carcinogenic hazards to humans.

PubMed

Pearce, Neil; Blair, Aaron; Vineis, Paolo; Ahrens, Wolfgang; Andersen, Aage; Anto, Josep M; Armstrong, Bruce K; Baccarelli, Andrea A; Beland, Frederick A; Berrington, Amy; Bertazzi, Pier Alberto; Birnbaum, Linda S; Brownson, Ross C; Bucher, John R; Cantor, Kenneth P; Cardis, Elisabeth; Cherrie, John W; Christiani, David C; Cocco, Pierluigi; Coggon, David; Comba, Pietro; Demers, Paul A; Dement, John M; Douwes, Jeroen; Eisen, Ellen A; Engel, Lawrence S; Fenske, Richard A; Fleming, Lora E; Fletcher, Tony; Fontham, Elizabeth; Forastiere, Francesco; Frentzel-Beyme, Rainer; Fritschi, Lin; Gerin, Michel; Goldberg, Marcel; Grandjean, Philippe; Grimsrud, Tom K; Gustavsson, Per; Haines, Andy; Hartge, Patricia; Hansen, Johnni; Hauptmann, Michael; Heederik, Dick; Hemminki, Kari; Hemon, Denis; Hertz-Picciotto, Irva; Hoppin, Jane A; Huff, James; Jarvholm, Bengt; Kang, Daehee; Karagas, Margaret R; Kjaerheim, Kristina; Kjuus, Helge; Kogevinas, Manolis; Kriebel, David; Kristensen, Petter; Kromhout, Hans; Laden, Francine; Lebailly, Pierre; LeMasters, Grace; Lubin, Jay H; Lynch, Charles F; Lynge, Elsebeth; 't Mannetje, Andrea; McMichael, Anthony J; McLaughlin, John R; Marrett, Loraine; Martuzzi, Marco; Merchant, James A; Merler, Enzo; Merletti, Franco; Miller, Anthony; Mirer, Franklin E; Monson, Richard; Nordby, Karl-Cristian; Olshan, Andrew F; Parent, Marie-Elise; Perera, Frederica P; Perry, Melissa J; Pesatori, Angela Cecilia; Pirastu, Roberta; Porta, Miquel; Pukkala, Eero; Rice, Carol; Richardson, David B; Ritter, Leonard; Ritz, Beate; Ronckers, Cecile M; Rushton, Lesley; Rusiecki, Jennifer A; Rusyn, Ivan; Samet, Jonathan M; Sandler, Dale P; de Sanjose, Silvia; Schernhammer, Eva; Costantini, Adele Seniori; Seixas, Noah; Shy, Carl; Siemiatycki, Jack; Silverman, Debra T; Simonato, Lorenzo; Smith, Allan H; Smith, Martyn T; Spinelli, John J; Spitz, Margaret R; Stallones, Lorann; Stayner, Leslie T; Steenland, Kyle; Stenzel, Mark; Stewart, Bernard W; Stewart, Patricia A; Symanski, Elaine; Terracini, Benedetto; Tolbert, Paige E; Vainio, Harri; Vena, John; Vermeulen, Roel; Victora, Cesar G; Ward, Elizabeth M; Weinberg, Clarice R; Weisenburger, Dennis; Wesseling, Catharina; Weiderpass, Elisabete; Zahm, Shelia Hoar

2015-06-01

Recently, the International Agency for Research on Cancer (IARC) Programme for the Evaluation of Carcinogenic Risks to Humans has been criticized for several of its evaluations, and also for the approach used to perform these evaluations. Some critics have claimed that failures of IARC Working Groups to recognize study weaknesses and biases of Working Group members have led to inappropriate classification of a number of agents as carcinogenic to humans. The authors of this Commentary are scientists from various disciplines relevant to the identification and hazard evaluation of human carcinogens. We examined criticisms of the IARC classification process to determine the validity of these concerns. Here, we present the results of that examination, review the history of IARC evaluations, and describe how the IARC evaluations are performed. We concluded that these recent criticisms are unconvincing. The procedures employed by IARC to assemble Working Groups of scientists from the various disciplines and the techniques followed to review the literature and perform hazard assessment of various agents provide a balanced evaluation and an appropriate indication of the weight of the evidence. Some disagreement by individual scientists to some evaluations is not evidence of process failure. The review process has been modified over time and will undoubtedly be altered in the future to improve the process. Any process can in theory be improved, and we would support continued review and improvement of the IARC processes. This does not mean, however, that the current procedures are flawed. The IARC Monographs have made, and continue to make, major contributions to the scientific underpinning for societal actions to improve the public's health.

Standardized Procedure Content And Data Structure Based On Human Factors Requirements For Computer-Based Procedures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bly, Aaron; Oxstrand, Johanna; Le Blanc, Katya L

2015-02-01

Most activities that involve human interaction with systems in a nuclear power plant are guided by procedures. Traditionally, the use of procedures has been a paper-based process that supports safe operation of the nuclear power industry. However, the nuclear industry is constantly trying to find ways to decrease the human error rate, especially the human errors associated with procedure use. Advances in digital technology make computer-based procedures (CBPs) a valid option that provides further enhancement of safety by improving human performance related to procedure use. The transition from paper-based procedures (PBPs) to CBPs creates a need for a computer-based proceduremore » system (CBPS). A CBPS needs to have the ability to perform logical operations in order to adjust to the inputs received from either users or real time data from plant status databases. Without the ability for logical operations the procedure is just an electronic copy of the paper-based procedure. In order to provide the CBPS with the information it needs to display the procedure steps to the user, special care is needed in the format used to deliver all data and instructions to create the steps. The procedure should be broken down into basic elements and formatted in a standard method for the CBPS. One way to build the underlying data architecture is to use an Extensible Markup Language (XML) schema, which utilizes basic elements to build each step in the smart procedure. The attributes of each step will determine the type of functionality that the system will generate for that step. The CBPS will provide the context for the step to deliver referential information, request a decision, or accept input from the user. The XML schema needs to provide all data necessary for the system to accurately perform each step without the need for the procedure writer to reprogram the CBPS. The research team at the Idaho National Laboratory has developed a prototype CBPS for field workers as well as the underlying data structure for such CBPS. The objective of the research effort is to develop guidance on how to design both the user interface and the underlying schema. This paper will describe the result and insights gained from the research activities conducted to date.« less

Fumed silica nanoparticle mediated biomimicry for optimal cell-material interactions for artificial organ development.

PubMed

de Mel, Achala; Ramesh, Bala; Scurr, David J; Alexander, Morgan R; Hamilton, George; Birchall, Martin; Seifalian, Alexander M

2014-03-01

Replacement of irreversibly damaged organs due to chronic disease, with suitable tissue engineered implants is now a familiar area of interest to clinicians and multidisciplinary scientists. Ideal tissue engineering approaches require scaffolds to be tailor made to mimic physiological environments of interest with specific surface topographical and biological properties for optimal cell-material interactions. This study demonstrates a single-step procedure for inducing biomimicry in a novel nanocomposite base material scaffold, to re-create the extracellular matrix, which is required for stem cell integration and differentiation to mature cells. Fumed silica nanoparticle mediated procedure of scaffold functionalization, can be potentially adapted with multiple bioactive molecules to induce cellular biomimicry, in the development human organs. The proposed nanocomposite materials already in patients for number of implants, including world first synthetic trachea, tear ducts and vascular bypass graft. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Informative-frame filtering in endoscopy videos

NASA Astrophysics Data System (ADS)

An, Yong Hwan; Hwang, Sae; Oh, JungHwan; Lee, JeongKyu; Tavanapong, Wallapak; de Groen, Piet C.; Wong, Johnny

2005-04-01

Advances in video technology are being incorporated into today"s healthcare practice. For example, colonoscopy is an important screening tool for colorectal cancer. Colonoscopy allows for the inspection of the entire colon and provides the ability to perform a number of therapeutic operations during a single procedure. During a colonoscopic procedure, a tiny video camera at the tip of the endoscope generates a video signal of the internal mucosa of the colon. The video data are displayed on a monitor for real-time analysis by the endoscopist. Other endoscopic procedures include upper gastrointestinal endoscopy, enteroscopy, bronchoscopy, cystoscopy, and laparoscopy. However, a significant number of out-of-focus frames are included in this type of videos since current endoscopes are equipped with a single, wide-angle lens that cannot be focused. The out-of-focus frames do not hold any useful information. To reduce the burdens of the further processes such as computer-aided image processing or human expert"s examinations, these frames need to be removed. We call an out-of-focus frame as non-informative frame and an in-focus frame as informative frame. We propose a new technique to classify the video frames into two classes, informative and non-informative frames using a combination of Discrete Fourier Transform (DFT), Texture Analysis, and K-Means Clustering. The proposed technique can evaluate the frames without any reference image, and does not need any predefined threshold value. Our experimental studies indicate that it achieves over 96% of four different performance metrics (i.e. precision, sensitivity, specificity, and accuracy).

Image-guided automatic triggering of a fractional CO2 laser in aesthetic procedures.

PubMed

Wilczyński, Sławomir; Koprowski, Robert; Wiernek, Barbara K; Błońska-Fajfrowska, Barbara

2016-09-01

Laser procedures in dermatology and aesthetic medicine are associated with the need for manual laser triggering. This leads to pulse overlapping and side effects. Automatic laser triggering based on image analysis can provide a secure fit to each successive doses of radiation. A fractional CO2 laser was used in the study. 500 images of the human skin of healthy subjects were acquired. Automatic triggering was initiated by an application together with a camera which tracks and analyses the skin in visible light. The tracking algorithm uses the methods of image analysis to overlap images. After locating the characteristic points in analysed adjacent areas, the correspondence of graphs is found. The point coordinates derived from the images are the vertices of graphs with respect to which isomorphism is sought. When the correspondence of graphs is found, it is possible to overlap the neighbouring parts of the image. The proposed method of laser triggering owing to the automatic image fitting method allows for 100% repeatability. To meet this requirement, there must be at least 13 graph vertices obtained from the image. For this number of vertices, the time of analysis of a single image is less than 0.5s. The proposed method, applied in practice, may help reduce the number of side effects during dermatological laser procedures resulting from laser pulse overlapping. In addition, it reduces treatment time and enables to propose new techniques of treatment through controlled, precise laser pulse overlapping. Copyright © 2016 Elsevier Ltd. All rights reserved.

Procedures to increase some aspects of creativity.

PubMed Central

Glover, J; Gary, A L

1976-01-01

Instructions reinforcement (team points), and practice were applied to four behaviorally defined creative behaviors of eight fourth- and fifth-grade students. All four aspects (number of different responses, fluency; number of verb forms, flexibility; number of words per response, elaboration; and statistical infrequency of response forms, originality) were demonstrated to be under experimental control. The procedures also raised students' scores on Torrance's tests of creativity. Application of the experimental procedures may well be practical for classroom teachers. PMID:943391

Procedures to increase some aspects of creativity.

PubMed

Glover, J; Gary, A L

1976-01-01

Instructions reinforcement (team points), and practice were applied to four behaviorally defined creative behaviors of eight fourth- and fifth-grade students. All four aspects (number of different responses, fluency; number of verb forms, flexibility; number of words per response, elaboration; and statistical infrequency of response forms, originality) were demonstrated to be under experimental control. The procedures also raised students' scores on Torrance's tests of creativity. Application of the experimental procedures may well be practical for classroom teachers.

Training potential in minimally invasive surgery in a tertiary care, paediatric urology centre.

PubMed

Schroeder, R P J; Chrzan, R J; Klijn, A J; Kuijper, C F; Dik, P; de Jong, T P V M

2015-10-01

Minimally invasive surgery (MIS) is being utilized more frequently as a surgical technique in general surgery and in paediatric urology. It is associated with a steep learning curve. Currently, the centre does not offer a MIS training programme. It is hypothesized that the number of MIS procedures performed in the low-volume specialty of paediatric urology will offer insufficient training potential for surgeons. To assess the MIS training potential of a highly specialized, tertiary care, paediatric urology training centre that has been accredited by the Joint Committee of Paediatric Urology (JCPU). The clinical activity of the department was retrospectively reviewed by extracting the annual number of admissions, outpatient consultations and operative procedures. The operations were divided into open procedures and MIS. Major ablative procedures (nephrectomy) and reconstructive procedures (pyeloplasty) were analysed with reference to the patients' ages. The centre policy is not to perform major MIS in children who are under 2 years old or who weigh less than 12 kg. Every year, this institution provides approximately 4300 out-patient consultations, 600 admissions, and 1300 procedures under general anaesthesia for children with urological problems. In 2012, 35 patients underwent major intricate MIS: 16 pyeloplasties, eight nephrectomies and 11 operations for incontinence (seven Burch, and four bladder neck procedures). In children ≥2 years of age, 16/21 of the pyeloplasties and 8/12 of the nephrectomies were performed laparoscopically. The remaining MIS procedures included 25 orchidopexies and one intravesical ureteral reimplantation. There is no consensus on how to assess laparoscopic training. It would be valuable to reach a consensus on a standardized laparoscopic training programme in paediatric urology. Often training potential is based on operation numbers only. In paediatric urology no minimum requirement has been specified. The number of procedures quoted for proficiency in MIS remains controversial. The MIS numbers for this centre correspond to, or exceed, numbers mentioned in other literature. To provide high-quality MIS training, exposure to laparoscopic procedures should be expanded. This may be achieved by centralizing patients into a common centre, collaborating with other specialities, modular training and training outside the operating theatre. Even in a high-volume, paediatric urology educational centre, the number of major MIS procedures performed remains relatively low, leading to limited training potential. Copyright © 2015. Published by Elsevier Ltd.

Method for Studying a Human Ecology: An Adaptation of the Grounded Theory Tradition.

ERIC Educational Resources Information Center

McCaslin, Mark L.; Scott, Karen Wilson

Constructivist grounded theory is focused on discovery through understanding data in a human ecology. The procedures outlined in this paper are designed to guide the beginning theorist through the process of creating a theory grounded in data that is a product of the human ecology under study. These new procedures extend grounded theory, providing…

Ethical review of human experimentation in the consumer products industry.

PubMed

Steadman, J H

1998-04-01

Ethical review of human experimentation in the consumer products industry is important and provides instructive parallels and contrasts with clinical medical research. The procedures used in Unilever NV/plc are described. A central body sets standards for and monitors compliance with ethical review of human studies throughout Unilever. Guidance has been produced on many topics including issues applying generally to human experimentation and more specifically to the consumer products sector. Deficiencies and inconsistencies in the procedures for ethical review and the care of subjects during the conduct of studies have been identified and corrected. Appropriate uniform standards have been achieved across all Unilever operations. All human experimentation in the industry needs adequate ethical review. Although the methods used by individual companies may differ, procedures must ensure uniform high standards across a global industry.

Mortuary operations in the aftermath of the 2009 Victorian bushfires.

PubMed

Leditschke, Jodie; Collett, Sarsha; Ellen, Rebecca

2011-02-25

On the day of the 2009 Victorian bushfires the Victorian Institute of Forensic Medicine activated its emergency plan. Within 48 h a temporary body storage facility was constructed adjacent to the existing mortuary. This temporary facility had the capacity to store up to 300 deceased persons. Pathologists, anthropologists, odontologists, police and mortuary assistants responded from all around Australia, New Zealand and Indonesia. The existing forensic mortuary and staff were divided into two areas: DVI (disaster victim identification) and "routine operations". A high priority for the mortuary was to ensure the casework of the "routine" deceased persons (those cases which were not related to the bushfires) was handled concurrently and in a timely manner. On admission each set of victim remains was given both a Coroner's case number in addition to the DVI number allocated at the scene. The case was CT scanned, examined by a pathologist, an anthropologist, and odontologist and in some instances a fingerprint expert. Where possible a DNA sample was taken. All processes, samples, labels and paperwork underwent a quality assurance check prior to the case completion. Regular audits were conducted. All of post mortem examinations were completed within 20 days of admission. Occupational health and safety issues of the staff were a high priority; this included correct manual handling, infection control and psychological debriefings. During the operation it was found that some remains were contaminated with asbestos. Procedures were set in place to manage these cases individually and each was isolated to reduce the risk of exposure by staff to asbestos. This overall mortuary operation identified a number of significant challenges, in particular the management of multiple parts of human remains for one individual. A new procedure was developed to ensure that all human remains, where possible, were reconciled with identified deceased persons prior to the release to the funeral director. It also highlighted the need to have well documented plans in place including plans for temporary mortuary facilities. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

77 FR 6862 - Proposed Collection; Comment Request for Revenue Procedure 2004-53

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

...: Direct all written comments to Yvette Lawrence, Internal Revenue Service, room 6129, 1111 Constitution... Forms W-2 in certain acquisitions. OMB Number: 1545-1510. Revenue Procedure Number: Revenue Procedure... sections 6051 and 6011 for Forms W-2 and 941. Current Actions: There are no changes being made to the...

Extremes in Otolaryngology Resident Surgical Case Numbers: An Update.

PubMed

Baugh, Tiffany P; Franzese, Christine B

2017-06-01

Objectives The purpose of this study is to examine the effect of minimum case numbers on otolaryngology resident case log data and understand differences in minimum, mean, and maximum among certain procedures as a follow-up to a prior study. Study Design Cross-sectional survey using a national database. Setting Academic otolaryngology residency programs. Subjects and Methods Review of otolaryngology resident national data reports from the Accreditation Council for Graduate Medical Education (ACGME) resident case log system performed from 2004 to 2015. Minimum, mean, standard deviation, and maximum values for total number of supervisor and resident surgeon cases and for specific surgical procedures were compared. Results The mean total number of resident surgeon cases for residents graduating from 2011 to 2015 ranged from 1833.3 ± 484 in 2011 to 2072.3 ± 548 in 2014. The minimum total number of cases ranged from 826 in 2014 to 1004 in 2015. The maximum total number of cases increased from 3545 in 2011 to 4580 in 2015. Multiple key indicator procedures had less than the required minimum reported in 2015. Conclusion Despite the ACGME instituting required minimum numbers for key indicator procedures, residents have graduated without meeting these minimums. Furthermore, there continues to be large variations in the minimum, mean, and maximum numbers for many procedures. Variation among resident case numbers is likely multifactorial. Ensuring proper instruction on coding and case role as well as emphasizing frequent logging by residents will ensure programs have the most accurate data to evaluate their case volume.

A Connectionist Model of Stimulus Class Formation with a Yes/No Procedure and Compound Stimuli

ERIC Educational Resources Information Center

Tovar, Angel E.; Chavez, Alvaro Torres

2012-01-01

We analyzed stimulus class formation in a human study and in a connectionist model (CM) with a yes/no procedure, using compound stimuli. In the human study, the participants were six female undergraduate students; the CM was a feed-forward back-propagation network. Two 3-member stimulus classes were trained with a similar procedure in both the…

The history behind successful uterine transplantation in humans

PubMed Central

Castellón, Luis Arturo Ruvalcaba; Amador, Martha Isolina García; González, Roberto Enrique Díaz; Eduardo, Montoya Sarmiento Jorge; Díaz-García, César; Kvarnström, Niclas; Bränström, Mats

2017-01-01

This paper aimed to describe the basic aspects of uterine transplant (UTx) research in humans, including preliminary experiences in rodents and domestic species. Studies in rats, domestic species, and non-human primates validated and optimized the UTx procedure in terms of its surgical aspects, immunosuppression, rejection diagnosis, peculiarities of pregnancy in immunosuppressed patients, and patients with special uterine conditions. In animal species, the first live birth from UTx was achieved in a syngeneic mouse model in 2003. Twenty-five UTx procedures have been performed in humans. The first two cases were unsuccessful, but established the need for rigorous research to improve success rates. As a result of a controlled clinical study under a strictly designed research protocol, nine subsequent UTx procedures have resulted in six healthy live births, the first of them in 2014. Further failed UTx procedures have been performed in China, Czech Republic, Brazil, Germany, and the United States, most of which using living donors. Albeit still an experimental procedure in, UTx is the first potential alternative for the treatment of absolute uterine factor infertility (AUFI). PMID:28609280

Handbook of Human Tissue Sources. A National Resource of Human Tissue Samples

DTIC Science & Technology

1999-01-01

be frozen and thawed and still be viable for artificial insemination procedures or implan- tation. The newest type of human tissue storage for future...use is the storage of umbilical cord blood. SPERM, OVUM, AND EMBRYO BANKS Artificial insemination or donor insemination (DI) is a procedure to...anonymous human sperm for use in artificial insemination ; long-term semen storage for men facing the possibility of steril- ization, reduction in fertility

Metabolic activity, experiment M171. [space flight effects on human metabolism

NASA Technical Reports Server (NTRS)

Michel, E. L.; Rummel, J. A.

1973-01-01

The Skylab metabolic activity experiment determines if man's metabolic effectiveness in doing mechanical work is progressively altered by a simulated Skylab environment, including environmental factors such as slightly increased pCO2. This test identified several hardware/procedural anomalies. The most important of these were: (1) the metabolic analyzer measured carbon dioxide production and expired water too high; (2) the ergometer load module failed under continuous high workload conditions; (3) a higher than desirable number of erroneous blood pressure measurements were recorded; (4) vital capacity measurements were unreliable; and (5) anticipated crew personal exercise needs to be more structured.

Life and Microgravity Sciences Spacelab Mission: Human Research Pilot Study

NASA Technical Reports Server (NTRS)

Arnaud, Sara B. (Editor); Walker, Karen R. (Editor); Hargens, Alan (Editor)

1996-01-01

The Life Sciences, Microgravity Science and Spacelab Mission contains a number of human experiments directed toward identifying the functional, metabolic and neurological characteristics of muscle weakness and atrophy during space flight. To ensure the successful completion of the flight experiments, a ground-based pilot study, designed to mimic the flight protocols as closely as possible, was carried out in the head-down tilt bed rest model. This report records the rationales, procedures, preliminary results and estimated value of the pilot study, the first of its kind, for 12 of the 13 planned experiments in human research. The bed rest study was conducted in the Human Research Facility at Ames Research Center from July 11 - August 28, 1995. Eight healthy male volunteers performed the experiments before, during and after 17 days bed rest. The immediate purposes of this simulation were to integrate the experiments, provide data in a large enough sample for publication of results, enable investigators to review individual experiments in the framework of a multi-disciplinary study and relay the experience of the pilot study to the mission specialists prior to launch.

Laser-assisted treatment of patients with hemorrhagic diathesis

NASA Astrophysics Data System (ADS)

Neckel, Claus P.

2000-03-01

Today more and more patients with bleeding disorder come to our office for treatment. The number of patients with therapeutic anticoagulation is growing steadily. Discontinuation of this therapy can often be crucial. On the other hand are oralsurgical procedures extremely sensitive to bleeding due to the constant presents of saliva with its high fibrinolytic activity. The aim of this study was to evaluate the use of a surgical diode (wavelength 810 nm) laser as accessory tool in the treatment of patients with hemorrhagic diathesis. Enclosed in the study were 123 patients with: (1) Coumarintherapy, a Quick test ratio of 15 - 25%; (2) More than 300 mg of ASS/die; (3) Hemophilia, a factor activity under 35%; (4) Morbus Werlhof with less than 30000 thrombocytes. 179 Surgical procedures: (1) Tooth extraction 86%; (2) Apexectomy 3%; (3) Tumorexcision 9%; (4) Curettage and flapsurgery 1%; (5) Gingivectomy 1%. All procedures were laser-assisted with a diode laser emitting 810 nm. The glass fibers used were depending on the procedures either 200, 400, or 600 micron. No coagulating agents or tissue adhesives were used in addition. The postoperative outcome and complication rates were compared to substitution therapy and tissue adhesives. Laser-assisted treatment of these patients shows a high predictability and success rate leaving out side effects of drugs and human cryoprecipitates. Postoperative impairment is diminished.

Improved-resolution real-time skin-dose mapping for interventional fluoroscopic procedures

NASA Astrophysics Data System (ADS)

Rana, Vijay K.; Rudin, Stephen; Bednarek, Daniel R.

2014-03-01

We have developed a dose-tracking system (DTS) that provides a real-time display of the skin-dose distribution on a 3D patient graphic during fluoroscopic procedures. Radiation dose to individual points on the skin is calculated using exposure and geometry parameters from the digital bus on a Toshiba C-arm unit. To accurately define the distribution of dose, it is necessary to use a high-resolution patient graphic consisting of a large number of elements. In the original DTS version, the patient graphics were obtained from a library of population body scans which consisted of larger-sized triangular elements resulting in poor congruence between the graphic points and the x-ray beam boundary. To improve the resolution without impacting real-time performance, the number of calculations must be reduced and so we created software-designed human models and modified the DTS to read the graphic as a list of vertices of the triangular elements such that common vertices of adjacent triangles are listed once. Dose is calculated for each vertex point once instead of the number of times that a given vertex appears in multiple triangles. By reformatting the graphic file, we were able to subdivide the triangular elements by a factor of 64 times with an increase in the file size of only 1.3 times. This allows a much greater number of smaller triangular elements and improves resolution of the patient graphic without compromising the real-time performance of the DTS and also gives a smoother graphic display for better visualization of the dose distribution.

[Examination of diagnosis procedure combination survey data that influence function evaluation coefficient II].

PubMed

Nakajima, Hisato; Yano, Kouya; Nagasawa, Kaoko; Kobayashi, Eiji; Yokota, Kuninobu

2015-01-01

On the basis of Diagnosis Procedure Combination (DPC) survey data, the factors that increase the value of function evaluation coefficient II were considered. A total of 1,505 hospitals were divided into groups I, II, and III, and the following items were considered. 1. Significant differences in function evaluation coefficient II and DPC survey data. 2. Examination of using the Mahalanobis-Taguchi (MT) method. 3. Correlation between function evaluation coefficient II and each DPC survey data item. 1. Function evaluation coefficient II was highest in group II. Group I hospitals showed the highest bed capacity, and numbers of hospitalization days, operations, chemotherapies, radiotherapies and general anesthesia procedures. 2. Using the MT method, we found that the number of ambulance conveyances was effective factor in group I hospitals, the number of general anesthesia procedures was effective factor in group II hospitals, and the bed capacity was effective factor in group III hospitals. 3. In group I hospitals, function evaluation coefficient II significantly correlated to the numbers of ambulance conveyances and chemotherapies. In group II hospitals, function evaluation coefficient II significantly correlated to bed capacity, the numbers of ambulance conveyances, hospitalization days, operations, general anesthesia procedures, and mean hospitalization days. In group III hospitals, function evaluation coefficient II significantly correlated to all items. The factors that improve the value of function evaluation coefficient II were the increases in the numbers of ambulance conveyances, chemotherapies and radiotherapies in group I hospitals, increases in the numbers of hospitalization days, operations, ambulance conveyances and general anesthesia procedures in group II hospitals, and increases in the numbers of hospitalization days, operations and ambulance conveyances. These results indicate that the profit of a hospital will increase, which will lead to medical services of good quality.

Tick-Borne Pathogen – Reversed and Conventional Discovery of Disease

PubMed Central

Tijsse-Klasen, Ellen; Koopmans, Marion P. G.; Sprong, Hein

2014-01-01

Molecular methods have increased the number of known microorganisms associated with ticks significantly. Some of these newly identified microorganisms are readily linked to human disease while others are yet unknown to cause human disease. The face of tick-borne disease discovery has changed with more diseases now being discovered in a “reversed way,” detecting disease cases only years after the tick-borne microorganism was first discovered. Compared to the conventional discovery of infectious diseases, reverse order discovery presents researchers with new challenges. Estimating public health risks of such agents is especially challenging, as case definitions and diagnostic procedures may initially be missing. We discuss the advantages and shortcomings of molecular methods, serology, and epidemiological studies that might be used to study some fundamental questions regarding newly identified tick-borne diseases. With increased tick-exposure and improved detection methods, more tick-borne microorganisms will be added to the list of pathogens causing disease in humans in the future. PMID:25072045

Adaptive sampling of information in perceptual decision-making.

PubMed

Cassey, Thomas C; Evens, David R; Bogacz, Rafal; Marshall, James A R; Ludwig, Casimir J H

2013-01-01

In many perceptual and cognitive decision-making problems, humans sample multiple noisy information sources serially, and integrate the sampled information to make an overall decision. We derive the optimal decision procedure for two-alternative choice tasks in which the different options are sampled one at a time, sources vary in the quality of the information they provide, and the available time is fixed. To maximize accuracy, the optimal observer allocates time to sampling different information sources in proportion to their noise levels. We tested human observers in a corresponding perceptual decision-making task. Observers compared the direction of two random dot motion patterns that were triggered only when fixated. Observers allocated more time to the noisier pattern, in a manner that correlated with their sensory uncertainty about the direction of the patterns. There were several differences between the optimal observer predictions and human behaviour. These differences point to a number of other factors, beyond the quality of the currently available sources of information, that influences the sampling strategy.

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum leasing notifications or...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum leasing notifications or...

A High-Throughput Screening Method for Identification of Inhibitors of the Deubiquitinating Enzyme USP14

PubMed Central

Lee, Byung-Hoon; Finley, Daniel; King, Randall W.

2013-01-01

Deubiquitinating enzymes (DUBs) reverse the process of ubiquitination, and number nearly 100 in humans. In principle, DUBs represent promising drug targets, as several of the enzymes have been implicated in human diseases. The isopeptidase activity of DUBs can be selectively inhibited by targeting the catalytic site with drug-like compounds. Notably, the mammalian 26S proteasome is associated with three major DUBs: RPN11, UCH37 and USP14. Because the ubiquitin ‘chain-trimming’ activity of USP14 can inhibit proteasome function, inhibitors of USP14 can stimulate proteasomal degradation. We recently established a high-throughput screening (HTS) method to discover small-molecule inhibitors specific for USP14. The protocols in this article cover the necessary procedures for preparing assay reagents, performing HTS for USP14 inhibitors, and carrying out post-HTS analysis. PMID:23788557

Current perspectives on the epidemiology and pathogenesis of clinically significant Vibrio spp.

PubMed Central

Janda, J M; Powers, C; Bryant, R G; Abbott, S L

1988-01-01

Recent taxonomic advances have now implicated several different Vibrio species as human pathogens. While the most common clinical presentation of Vibrio infection continues to be gastroenteritis, an increasing number of extraintestinal infections are being reported, particularly in immunocompromised individuals. Detection of Vibrio infections requires a good clinical history and the use of appropriate isolation and identification procedures by the laboratory to confirm illnesses attributed to Vibrio species. Except for Vibrio cholerae O1 and Vibrio parahaemolyticus, there is little direct evidence linking the production of a myriad of cell-associated or extracellular factors produced by each species with human disease and pathogenesis. Many questions regarding pathogenic Vibrio species remain unanswered, including their frequency and distribution in environmental specimens (water, shellfish), infective doses, virulence potential of individual isolates, and markers associated with such strains. Images PMID:3058295

Constant temperature hot wire anemometry data reduction procedure

NASA Technical Reports Server (NTRS)

Klopfer, G. H.

1974-01-01

The theory and data reduction procedure for constant temperature hot wire anemometry are presented. The procedure is valid for all Mach and Prandtl numbers, but limited to Reynolds numbers based on wire diameter between 0.1 and 300. The fluids are limited to gases which approximate ideal gas behavior. Losses due to radiation, free convection and conduction are included.

76 FR 13449 - Proposed Collection; Comment Request for Revenue Procedure 2009-41 (Rev. Proc. 2002-59 Is...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-11

... Classification Elections. DATES: Written comments should be received on or before May 10, 2011 to be assured of... Classification Elections. OMB Number: 1545-1771. Revenue Procedure Number: Revenue Procedure 2009-41. (Rev. Proc... Internal Revenue Code for an eligible entity that requests relief for a late classification election filed...

21 CFR 1305.11 - Procedure for obtaining DEA Forms 222.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the name, address, and registration number of the registrant and the number of books of DEA Forms 222... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Procedure for obtaining DEA Forms 222. 1305.11... I AND II CONTROLLED SUBSTANCES DEA Form 222 § 1305.11 Procedure for obtaining DEA Forms 222. (a) DEA...

76 FR 19022 - Rules of Practice and Procedure

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... depositions, written interrogatories, and discovery procedures under regulations prescribed by the Commission... number (FRCP 30(a)(2)) and conduct of depositions (FRCP 30(d)); and a limitation on the number of...

Validation of biological activity testing procedure of recombinant human interleukin-7.

PubMed

Lutsenko, T N; Kovalenko, M V; Galkin, O Yu

2017-01-01

Validation procedure for method of monitoring the biological activity of reсombinant human interleukin-7 has been developed and conducted according to the requirements of national and international recommendations. This method is based on the ability of recombinant human interleukin-7 to induce proliferation of T lymphocytes. It has been shown that to control the biological activity of recombinant human interleukin-7 peripheral blood mononuclear cells (PBMCs) derived from blood or cell lines can be used. Validation charac­teristics that should be determined depend on the method, type of product or object test/measurement and biological test systems used in research. The validation procedure for the method of control of biological activity of recombinant human interleukin-7 in peripheral blood mononuclear cells showed satisfactory results on all parameters tested such as specificity, accuracy, precision and linearity.

Iraq’s Debt Relief: Procedure and Potential Implications for International Debt Relief

DTIC Science & Technology

2008-10-02

Order Code RL33376 Iraq’s Debt Relief: Procedure and Potential Implications for International Debt Relief Updated October 2, 2008 Martin A. Weiss...4. TITLE AND SUBTITLE Iraq?s Debt Relief: Procedure and Potential Implications for International Debt Relief 5a. CONTRACT NUMBER 5b. GRANT NUMBER...b. ABSTRACT unclassified c. THIS PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 Iraq’s Debt Relief: Procedure

The Five Key Questions of Human Performance Modeling.

PubMed

Wu, Changxu

2018-01-01

Via building computational (typically mathematical and computer simulation) models, human performance modeling (HPM) quantifies, predicts, and maximizes human performance, human-machine system productivity and safety. This paper describes and summarizes the five key questions of human performance modeling: 1) Why we build models of human performance; 2) What the expectations of a good human performance model are; 3) What the procedures and requirements in building and verifying a human performance model are; 4) How we integrate a human performance model with system design; and 5) What the possible future directions of human performance modeling research are. Recent and classic HPM findings are addressed in the five questions to provide new thinking in HPM's motivations, expectations, procedures, system integration and future directions.

Operative Landscape at Canadian Neurosurgery Residency Programs.

PubMed

Tso, Michael K; Dakson, Ayoub; Ahmed, Syed Uzair; Bigder, Mark; Elliott, Cameron; Guha, Daipayan; Iorio-Morin, Christian; Kameda-Smith, Michelle; Lavergne, Pascal; Makarenko, Serge; Taccone, Michael S; Wang, Bill; Winkler-Schwartz, Alexander; Sankar, Tejas; Christie, Sean D

2017-07-01

Background Currently, the literature lacks reliable data regarding operative case volumes at Canadian neurosurgery residency programs. Our objective was to provide a snapshot of the operative landscape in Canadian neurosurgical training using the trainee-led Canadian Neurosurgery Research Collaborative. Anonymized administrative operative data were gathered from each neurosurgery residency program from January 1, 2014, to December 31, 2014. Procedures were broadly classified into cranial, spine, peripheral nerve, and miscellaneous procedures. A number of prespecified subspecialty procedures were recorded. We defined the resident case index as the ratio of the total number of operations to the total number of neurosurgery residents in that program. Resident number included both Canadian medical and international medical graduates, and included residents on the neurosurgery service, off-service, or on leave for research or other personal reasons. Overall, there was an average of 1845 operative cases per neurosurgery residency program. The mean numbers of cranial, spine, peripheral nerve, and miscellaneous procedures were 725, 466, 48, and 193, respectively. The nationwide mean resident case indices for cranial, spine, peripheral nerve, and total procedures were 90, 58, 5, and 196, respectively. There was some variation in the resident case indices for specific subspecialty procedures, with some training programs not performing carotid endarterectomy or endoscopic transsphenoidal procedures. This study presents the breadth of neurosurgical training within Canadian neurosurgery residency programs. These results may help inform the implementation of neurosurgery training as the Royal College of Physicians and Surgeons residency training transitions to a competence-by-design curriculum.

Rapid determination of myosin heavy chain expression in rat, mouse, and human skeletal muscle using multicolor immunofluorescence analysis.

PubMed

Bloemberg, Darin; Quadrilatero, Joe

2012-01-01

Skeletal muscle is a heterogeneous tissue comprised of fibers with different morphological, functional, and metabolic properties. Different muscles contain varying proportions of fiber types; therefore, accurate identification is important. A number of histochemical methods are used to determine muscle fiber type; however, these techniques have several disadvantages. Immunofluorescence analysis is a sensitive method that allows for simultaneous evaluation of multiple MHC isoforms on a large number of fibers on a single cross-section, and offers a more precise means of identifying fiber types. In this investigation we characterized pure and hybrid fiber type distribution in 10 rat and 10 mouse skeletal muscles, as well as human vastus lateralis (VL) using multicolor immunofluorescence analysis. In addition, we determined fiber type-specific cross-sectional area (CSA), succinate dehydrogenase (SDH) activity, and α-glycerophosphate dehydrogenase (GPD) activity. Using this procedure we were able to easily identify pure and hybrid fiber populations in rat, mouse, and human muscle. Hybrid fibers were identified in all species and made up a significant portion of the total population in some rat and mouse muscles. For example, rat mixed gastrocnemius (MG) contained 12.2% hybrid fibers whereas mouse white tibialis anterior (WTA) contained 12.1% hybrid fibers. Collectively, we outline a simple and time-efficient method for determining MHC expression in skeletal muscle of multiple species. In addition, we provide a useful resource of the pure and hybrid fiber type distribution, fiber CSA, and relative fiber type-specific SDH and GPD activity in a number of rat and mouse muscles.

[The role of the Committee for Medicinal Products for Human Use (CHMP) in the European centralised procedure].

PubMed

Enzmann, Harald; Schneider, C

2008-07-01

The centralised procedure for marketing authorisation at the European Medicines Agency (EMEA) started more than 10 years ago, offering marketing authorisation for all member states of the European Union in a single procedure. Originally it was a purely optional alternative to the established national procedures; however, its importance has been growing ever since. The introduction of the mandatory scope for several important indications was a crucial step. The increasing importance of the centralised procedure was paralleled by the increasing weight of the EMEA and of the Committee for Human Medicinal Products (CHMP) who is responsible for scientific evaluation in the centralised procedure. This paper describes the basic principles of the centralised procedure including the definitions of the mandatory and optional scope, and how the CHMP works including its responsibility in European referrals that provide a link to national procedures.

Occupational health and safety aspects of animal handling in dairy production.

PubMed

Lindahl, Cecilia; Lundqvist, Peter; Hagevoort, G Robert; Lunner Kolstrup, Christina; Douphrate, David I; Pinzke, Stefan; Grandin, Temple

2013-01-01

Livestock handling in dairy production is associated with a number of health and safety issues. A large number of fatal and nonfatal injuries still occur when handling livestock. The many animal handling tasks on a dairy farm include moving cattle between different locations, vaccination, administration of medication, hoof care, artificial insemination, ear tagging, milking, and loading onto trucks. There are particular problems with bulls, which continue to cause considerable numbers of injuries and fatalities in dairy production. In order to reduce the number of injuries during animal handling on dairy farms, it is important to understand the key factors in human-animal interactions. These include handler attitudes and behavior, animal behavior, and fear in cows. Care when in close proximity to the animal is the key for safe handling, including knowledge of the flight zone, and use of the right types of tools and suitable restraint equipment. Thus, in order to create safe working conditions during livestock handling, it is important to provide handlers with adequate training and to establish sound safety management procedures on the farm.

Effects of reinforcement value on instruction following under schedules of negative reinforcement.

PubMed

Alessandri, Jérôme; Cançado, Carlos R X; Abreu-Rodrigues, Josele

2017-12-01

The effects of reinforcement value and social control on instruction following under a negative-reinforcement (escape) schedule were studied. Initially, responding produced timeouts from pressing a force cell under a low and a high force requirement on a fixed-ratio 1 schedule of reinforcement. Next, participants were reexposed to the low and high force requirements, but were instructed that the experimenter expected them to decrease the number of timeouts relative to the previous exposures to the procedure. Even though following the instruction led to a decrease in number of timeouts and to an increase in effort (i.e., was non-efficient), instruction following occurred consistently for each participant and was modulated by reinforcement value. That is, the decrease in the number of timeouts (i.e., instruction following) was lower under the high force requirement than under the low force requirement. These results replicate and extend previous findings that instructions interact with social and nonsocial contingencies in controlling human behavior. Copyright © 2017 Elsevier B.V. All rights reserved.

20 CFR 422.104 - Who can be assigned a social security number.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Who can be assigned a social security number. 422.104 Section 422.104 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.104 Who can be assigned a social security number. (a) Persons eligible for SSN...

20 CFR 422.104 - Who can be assigned a social security number.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Who can be assigned a social security number. 422.104 Section 422.104 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.104 Who can be assigned a social security number. (a) Persons eligible for SSN...

20 CFR 422.104 - Who can be assigned a social security number.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Who can be assigned a social security number. 422.104 Section 422.104 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.104 Who can be assigned a social security number. (a) Persons eligible for SSN...

20 CFR 422.104 - Who can be assigned a social security number.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Who can be assigned a social security number. 422.104 Section 422.104 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.104 Who can be assigned a social security number. (a) Persons eligible for SSN...

20 CFR 422.104 - Who can be assigned a social security number.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Who can be assigned a social security number. 422.104 Section 422.104 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.104 Who can be assigned a social security number. (a) Persons eligible for SSN...

Autonomous Real Time Requirements Tracing

NASA Technical Reports Server (NTRS)

Plattsmier, George I.; Stetson, Howard K.

2014-01-01

One of the more challenging aspects of software development is the ability to verify and validate the functional software requirements dictated by the Software Requirements Specification (SRS) and the Software Detail Design (SDD). Insuring the software has achieved the intended requirements is the responsibility of the Software Quality team and the Software Test team. The utilization of Timeliner-TLX(sup TM) Auto-Procedures for relocating ground operations positions to ISS automated on-board operations has begun the transition that would be required for manned deep space missions with minimal crew requirements. This transition also moves the auto-procedures from the procedure realm into the flight software arena and as such the operational requirements and testing will be more structured and rigorous. The autoprocedures would be required to meet NASA software standards as specified in the Software Safety Standard (NASASTD- 8719), the Software Engineering Requirements (NPR 7150), the Software Assurance Standard (NASA-STD-8739) and also the Human Rating Requirements (NPR-8705). The Autonomous Fluid Transfer System (AFTS) test-bed utilizes the Timeliner-TLX(sup TM) Language for development of autonomous command and control software. The Timeliner- TLX(sup TM) system has the unique feature of providing the current line of the statement in execution during real-time execution of the software. The feature of execution line number internal reporting unlocks the capability of monitoring the execution autonomously by use of a companion Timeliner-TLX(sup TM) sequence as the line number reporting is embedded inside the Timeliner-TLX(sup TM) execution engine. This negates I/O processing of this type data as the line number status of executing sequences is built-in as a function reference. This paper will outline the design and capabilities of the AFTS Autonomous Requirements Tracker, which traces and logs SRS requirements as they are being met during real-time execution of the targeted system. It is envisioned that real time requirements tracing will greatly assist the movement of autoprocedures to flight software enhancing the software assurance of auto-procedures and also their acceptance as reliable commanders

Autonomous Real Time Requirements Tracing

NASA Technical Reports Server (NTRS)

Plattsmier, George; Stetson, Howard

2014-01-01

One of the more challenging aspects of software development is the ability to verify and validate the functional software requirements dictated by the Software Requirements Specification (SRS) and the Software Detail Design (SDD). Insuring the software has achieved the intended requirements is the responsibility of the Software Quality team and the Software Test team. The utilization of Timeliner-TLX(sup TM) Auto- Procedures for relocating ground operations positions to ISS automated on-board operations has begun the transition that would be required for manned deep space missions with minimal crew requirements. This transition also moves the auto-procedures from the procedure realm into the flight software arena and as such the operational requirements and testing will be more structured and rigorous. The autoprocedures would be required to meet NASA software standards as specified in the Software Safety Standard (NASASTD- 8719), the Software Engineering Requirements (NPR 7150), the Software Assurance Standard (NASA-STD-8739) and also the Human Rating Requirements (NPR-8705). The Autonomous Fluid Transfer System (AFTS) test-bed utilizes the Timeliner-TLX(sup TM) Language for development of autonomous command and control software. The Timeliner-TLX(sup TM) system has the unique feature of providing the current line of the statement in execution during real-time execution of the software. The feature of execution line number internal reporting unlocks the capability of monitoring the execution autonomously by use of a companion Timeliner-TLX(sup TM) sequence as the line number reporting is embedded inside the Timeliner-TLX(sup TM) execution engine. This negates I/O processing of this type data as the line number status of executing sequences is built-in as a function reference. This paper will outline the design and capabilities of the AFTS Autonomous Requirements Tracker, which traces and logs SRS requirements as they are being met during real-time execution of the targeted system. It is envisioned that real time requirements tracing will greatly assist the movement of autoprocedures to flight software enhancing the software assurance of auto-procedures and also their acceptance as reliable commanders.

Soil Conservation Service Curve Number method: How to mend a wrong soil moisture accounting procedure?

NASA Astrophysics Data System (ADS)

Michel, Claude; Andréassian, Vazken; Perrin, Charles

2005-02-01

This paper unveils major inconsistencies in the age-old and yet efficient Soil Conservation Service Curve Number (SCS-CN) procedure. Our findings are based on an analysis of the continuous soil moisture accounting procedure implied by the SCS-CN equation. It is shown that several flaws plague the original SCS-CN procedure, the most important one being a confusion between intrinsic parameter and initial condition. A change of parameterization and a more complete assessment of the initial condition lead to a renewed SCS-CN procedure, while keeping the acknowledged efficiency of the original method.

Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures.

PubMed

Hill, Maureen V; McMahon, Michelle L; Stucke, Ryland S; Barth, Richard J

2017-04-01

To examine opioid prescribing patterns after general surgery procedures and to estimate an ideal number of pills to prescribe. Diversion of prescription opioids is a major contributor to the rising mortality from opioid overdoses. Data to inform surgeons on the optimal dose of opioids to prescribe after common general surgical procedures is lacking. We evaluated 642 patients undergoing 5 outpatient procedures: partial mastectomy (PM), partial mastectomy with sentinel lymph node biopsy (PM SLNB), laparoscopic cholecystectomy (LC), laparoscopic inguinal hernia repair (LIH), and open inguinal hernia repair (IH). Postoperative opioid prescriptions and refill data were tabulated. A phone survey was conducted to determine the number of opioid pills taken. There was a wide variation in the number of opioid pills prescribed to patients undergoing the same operation. The median number (and range) prescribed were: PM 20 (0-50), PM SLNB 20 (0-60), LC 30 (0-100), LIH 30 (15-70), and IH 30 (15-120). Only 28% of the prescribed pills were taken. This percentage varied by operation: PM 15%, PM SLNB 25%, LC 33%, LIH 15%, and IH 31%. Less than 2% of patients obtained refills.We identified the number of pills that would fully supply the opioid needs of 80% of patients undergoing each operation: PM 5, PM SLNB 10, LC 15, LIH 15, and IH 15. If this number were prescribed, the number of opioid initially prescribed would be 43% of the actual number prescribed. There is wide variability in opioid prescriptions for common general surgery procedures. In many cases excess pills are prescribed. Using our ideal number, surgeons can adequately treat postoperative pain and markedly decrease the number of opioids prescribed.

76 FR 34809 - Proposed Collection; Comment Request for Revenue Procedures 2003-79, 2007-64, and 2006-46

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-14

... required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently... Periods of Accounting. DATES: Written comments should be received on or before August 15, 2011 to be... Periods of Accounting. OMB Number: 1545-1786. Revenue Procedure Numbers: Revenue Procedures 2003-79, 2007...

Plating isolation of various catalase-negative microorganisms from soil

NASA Technical Reports Server (NTRS)

Labeda, D. P.; Hunt, C. M.; Casida, L. E., Jr.

1974-01-01

A unique plating procedure was developed that allows isolation, but not enumeration, of representatives of the catalase-negative soil microflora. The numbers recovered, however, are low as compared to the numbers recovered when the modified dilution-to-extinction isolation procedure is used. The latter procedure provides prolonged inoculation in sealed tubes containing a nutritionally rich broth medium over small submerged agar slants. In contrast, the plating procedure utilizes nutritionally minimal media and the shorter incubations mandated by the inherent problems associated with plating.

Analysis of Recombinant Human Bone Morphogenetic Protein-2 Use in the Treatment of Lumbar Degenerative Spondylolisthesis.

PubMed

Yao, Qingqiang; Cohen, Jeremiah R; Buser, Zorica; Park, Jong-Beom; Brodke, Darrel S; Meisel, Hans-Joerg; Youssef, Jim A; Wang, Jeffrey C; Yoon, S Tim

2016-12-01

Study Design  Retrospective database review. Objective  To identify trends of the recombinant human bone morphogenetic protein-2 (rhBMP-2) use in the treatment of lumbar degenerative spondylolisthesis (LDS). Methods  PearlDiver Patient Record Database was used to identify patients who underwent lumbar fusion for LDS between 2005 and 2011. The distribution of bone morphogenetic protein use rate (BR) in various surgical procedures was recorded. Patient numbers, reoperation numbers, BR, and per year BR (PYBR) were stratified by geographic region, gender, and age. Results  There were 11,335 fusion surgeries, with 3,461 cases using rhBMP-2. Even though PYRB increased between 2005 and 2008, there was a significant decrease in 2010 for each procedure: 404 (34.5%) for posterior interbody fusion, 1,282 (34.3%) for posterolateral plus posterior interbody fusion (PLPIF), 1,477 (29.2%) for posterolateral fusion, and 335 (22.4%) for anterior lumbar interbody fusion. In patients using rhBMP-2, the reoperation rate was significantly lower than in patients not using rhBMP-2 (0.69% versus 1.07%, p  < 0.0001). Male patients had higher PYBR compared with female patients in 2008 and 2009 ( p  < 0.05). The West region and PLPIF had the highest BR and PYBR. Conclusions Our data shows that the revision rates were significantly lower in patients treated with rhBMP-2 compared with patients not treated with rhBMP-2. Furthermore, rhBMP-2 use in LDS varied by year, region, gender, and type of fusion technique. In the West region, the posterior approach and patients 65 to 69 years of age had the highest rate of rhBMP-2 use.

Analysis of Recombinant Human Bone Morphogenetic Protein-2 Use in the Treatment of Lumbar Degenerative Spondylolisthesis

PubMed Central

Yao, Qingqiang; Cohen, Jeremiah R.; Buser, Zorica; Park, Jong-Beom; Brodke, Darrel S.; Meisel, Hans-Joerg; Youssef, Jim A.; Wang, Jeffrey C.; Yoon, S. Tim

2016-01-01

Study Design Retrospective database review. Objective To identify trends of the recombinant human bone morphogenetic protein-2 (rhBMP-2) use in the treatment of lumbar degenerative spondylolisthesis (LDS). Methods PearlDiver Patient Record Database was used to identify patients who underwent lumbar fusion for LDS between 2005 and 2011. The distribution of bone morphogenetic protein use rate (BR) in various surgical procedures was recorded. Patient numbers, reoperation numbers, BR, and per year BR (PYBR) were stratified by geographic region, gender, and age. Results There were 11,335 fusion surgeries, with 3,461 cases using rhBMP-2. Even though PYRB increased between 2005 and 2008, there was a significant decrease in 2010 for each procedure: 404 (34.5%) for posterior interbody fusion, 1,282 (34.3%) for posterolateral plus posterior interbody fusion (PLPIF), 1,477 (29.2%) for posterolateral fusion, and 335 (22.4%) for anterior lumbar interbody fusion. In patients using rhBMP-2, the reoperation rate was significantly lower than in patients not using rhBMP-2 (0.69% versus 1.07%, p < 0.0001). Male patients had higher PYBR compared with female patients in 2008 and 2009 (p < 0.05). The West region and PLPIF had the highest BR and PYBR. Conclusions Our data shows that the revision rates were significantly lower in patients treated with rhBMP-2 compared with patients not treated with rhBMP-2. Furthermore, rhBMP-2 use in LDS varied by year, region, gender, and type of fusion technique. In the West region, the posterior approach and patients 65 to 69 years of age had the highest rate of rhBMP-2 use. PMID:27853658

Clarissa Spoken Dialogue System for Procedure Reading and Navigation

NASA Technical Reports Server (NTRS)

Hieronymus, James; Dowding, John

2004-01-01

Speech is the most natural modality for humans use to communicate with other people, agents and complex systems. A spoken dialogue system must be robust to noise and able to mimic human conversational behavior, like correcting misunderstandings, answering simple questions about the task and understanding most well formed inquiries or commands. The system aims to understand the meaning of the human utterance, and if it does not, then it discards the utterance as being meant for someone else. The first operational system is Clarissa, a conversational procedure reader and navigator, which will be used in a System Development Test Objective (SDTO) on the International Space Station (ISS) during Expedition 10. In the present environment one astronaut reads the procedure on a Manual Procedure Viewer (MPV) or paper, and has to stop to read or turn pages, shifting focus from the task. Clarissa is designed to read and navigate ISS procedures entirely with speech, while the astronaut has his eyes and hands engaged in performing the task. The system also provides an MPV like graphical interface so the procedure can be read visually. A demo of the system will be given.

45 CFR 1168.405 - Penalty procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Penalty procedures. 1168.405 Section 1168.405 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE HUMANITIES NEW RESTRICTIONS ON LOBBYING Penalties and Enforcement...

45 CFR 1168.405 - Penalty procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 3 2011-10-01 2011-10-01 false Penalty procedures. 1168.405 Section 1168.405 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE HUMANITIES NEW RESTRICTIONS ON LOBBYING Penalties and Enforcement...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2014 CFR

2014-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

Variability in spine surgery procedures performed during orthopaedic and neurological surgery residency training: an analysis of ACGME case log data.

PubMed

Daniels, Alan H; Ames, Christopher P; Smith, Justin S; Hart, Robert A

2014-12-03

Current spine surgeon training in the United States consists of either an orthopaedic or neurological surgery residency, followed by an optional spine surgery fellowship. Resident spine surgery procedure volume may vary between and within specialties. The Accreditation Council for Graduate Medical Education surgical case logs for graduating orthopaedic surgery and neurosurgery residents from 2009 to 2012 were examined and were compared for spine surgery resident experience. The average number of reported spine surgery procedures performed during residency was 160.2 spine surgery procedures performed by orthopaedic surgery residents and 375.0 procedures performed by neurosurgery residents; the mean difference of 214.8 procedures (95% confidence interval, 196.3 to 231.7 procedures) was significant (p = 0.002). From 2009 to 2012, the average total spinal surgery procedures logged by orthopaedic surgery residents increased 24.3% from 141.1 to 175.4 procedures, and those logged by neurosurgery residents increased 6.5% from 367.9 to 391.8 procedures. There was a significant difference (p < 0.002) in the average number of spinal deformity procedures between graduating orthopaedic surgery residents (9.5 procedures) and graduating neurosurgery residents (2.0 procedures). There was substantial variability in spine surgery exposure within both specialties; when comparing the top 10% and bottom 10% of 2012 graduates for spinal instrumentation or arthrodesis procedures, there was a 13.1-fold difference for orthopaedic surgery residents and an 8.3-fold difference for neurosurgery residents. Spine surgery procedure volumes in orthopaedic and neurosurgery residency training programs vary greatly both within and between specialties. Although orthopaedic surgery residents had an increase in the number of spine procedures that they performed from 2009 to 2012, they averaged less than half of the number of spine procedures performed by neurological surgery residents. However, orthopaedic surgery residents appear to have greater exposure to spinal deformity than neurosurgery residents. Furthermore, orthopaedic spine fellowship training provides additional spine surgery case exposure of approximately 300 to 500 procedures; thus, before entering independent practice, when compared with neurosurgery residents, most orthopaedic spine surgeons complete as many spinal procedures or more. Although case volume is not the sole determinant of surgical skills or clinical decision making, variability in spine surgery procedure volume does exist among residency programs in the United States. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

Comparative evaluation of seven commercial products for human serum enrichment/depletion by shotgun proteomics.

PubMed

Pisanu, Salvatore; Biosa, Grazia; Carcangiu, Laura; Uzzau, Sergio; Pagnozzi, Daniela

2018-08-01

Seven commercial products for human serum depletion/enrichment were tested and compared by shotgun proteomics. Methods were based on four different capturing agents: antibodies (Qproteome Albumin/IgG Depletion kit, ProteoPrep Immunoaffinity Albumin and IgG Depletion Kit, Top 2 Abundant Protein Depletion Spin Columns, and Top 12 Abundant Protein Depletion Spin Columns), specific ligands (Albumin/IgG Removal), mixture of antibodies and ligands (Albumin and IgG Depletion SpinTrap), and combinatorial peptide ligand libraries (ProteoMiner beads), respectively. All procedures, to a greater or lesser extent, allowed an increase of identified proteins. ProteoMiner beads provided the highest number of proteins; Albumin and IgG Depletion SpinTrap and ProteoPrep Immunoaffinity Albumin and IgG Depletion Kit resulted the most efficient in albumin removal; Top 2 and Top 12 Abundant Protein Depletion Spin Columns decreased the overall immunoglobulin levels more than other procedures, whereas specifically gamma immunoglobulins were mostly removed by Albumin and IgG Depletion SpinTrap, ProteoPrep Immunoaffinity Albumin and IgG Depletion Kit, and Top 2 Abundant Protein Depletion Spin Columns. Albumin/IgG Removal, a resin bound to a mixture of protein A and Cibacron Blue, behaved less efficiently than the other products. Copyright © 2018 Elsevier B.V. All rights reserved.

DESIGNING PHASE 0 CANCER CLINICAL TRIALS

PubMed Central

Murgo, Anthony J.; Kummar, Shivaani; Rubinstein, Larry; Gutierrez, Martin; Collins, Jerry; Kinders, Robert; Parchment, Ralph E.; Ji, Jiuping; Steinberg, Seth M.; Yang, Sherry X.; Hollingshead, Melinda; Chen, Alice; Helman, Lee; Wiltrout, Robert; Tomaszewski, Joseph E.; Doroshow, James H.

2008-01-01

Phase 0 trials are designed primarily to evaluate the pharmacodynamic and/or pharmacokinetic properties of selected investigational agents prior to initiating more traditional phase 1 testing. One of the major objectives of phase 0 trials is to interrogate and refine a target or biomarker assay for drug effect in human samples implementing procedures developed and validated in preclinical models. Thus, close collaboration between laboratory scientists and clinical investigators is essential to the design and conduct of phase 0 trials. Given the relatively small number of patients and tissue samples, demonstrating a significant drug effect in phase 0 trials requires precise and reproducible assay procedures and innovative statistical methodology. Furthermore, phase 0 trials involving limited exposure of study agent administered at low doses and/or for a short period allows them to be initiated under the FDA Exploratory IND Guidance with less preclinical toxicity data than usually required for traditional first-in-human studies. Because of the very limited drug exposure, phase 0 trials offer no chance of therapeutic benefit, which can impede patient enrollment, particularly if invasive tumor biopsies are required. However, the challenges to accrual are not insurmountable, and well-designed and executed phase 0 trials are feasible and have great potential for improving the efficiency and success of subsequent trials, particularly those evaluating molecularly targeted agents. PMID:18559582

Quantum squeezed state analysis of spontaneous ultra weak light photon emission of practitioners of meditation and control subjects.

PubMed

Van Wijk, Eduard P A; Van Wijk, Roeland; Bajpai, Rajendra P

2008-05-01

Research on human ultra-weak photon emission (UPE) has suggested a typical human emission anatomic percentage distribution pattern. It was demonstrated that emission intensities are lower in long-term practitioners of meditation as compared to control subjects. The percent contribution of emission from different anatomic locations was not significantly different for meditation practitioners and control subjects. Recently, a procedure was developed to analyze the fluctuations in the signals by measuring probabilities of detecting different numbers of photons in a bin and correct these for background noise. The procedure was tested utilizing the signal from three different body locations of a single subject, demonstrating that probabilities have non-classical features and are well described by the signal in a coherent state from the three body sites. The values indicate that the quantum state of photon emitted by the subject could be a coherent state in the subject being investigated. The objective in the present study was to systematically quantify, in subjects with long-term meditation experience and subjects without this experience, the photon count distribution of 12 different locations. Data show a variation in quantum state parameters within each individual subject as well as variation in quantum state parameters between the groups.

Standardized Methods to Generate Mock (Spiked) Clinical Specimens by Spiking Blood or Plasma with Cultured Pathogens

PubMed Central

Dong, Ming; Fisher, Carolyn; Añez, Germán; Rios, Maria; Nakhasi, Hira L.; Hobson, J. Peyton; Beanan, Maureen; Hockman, Donna; Grigorenko, Elena; Duncan, Robert

2016-01-01

Aims To demonstrate standardized methods for spiking pathogens into human matrices for evaluation and comparison among diagnostic platforms. Methods and Results This study presents detailed methods for spiking bacteria or protozoan parasites into whole blood and virus into plasma. Proper methods must start with a documented, reproducible pathogen source followed by steps that include standardized culture, preparation of cryopreserved aliquots, quantification of the aliquots by molecular methods, production of sufficient numbers of individual specimens and testing of the platform with multiple mock specimens. Results are presented following the described procedures that showed acceptable reproducibility comparing in-house real-time PCR assays to a commercially available multiplex molecular assay. Conclusions A step by step procedure has been described that can be followed by assay developers who are targeting low prevalence pathogens. Significance and Impact of Study The development of diagnostic platforms for detection of low prevalence pathogens such as biothreat or emerging agents is challenged by the lack of clinical specimens for performance evaluation. This deficit can be overcome using mock clinical specimens made by spiking cultured pathogens into human matrices. To facilitate evaluation and comparison among platforms, standardized methods must be followed in the preparation and application of spiked specimens. PMID:26835651

Theoretical implications of the neurotic paradox as a problem in behavior theory: An experimental resolution

PubMed Central

Stampfl, Thomas G.

1987-01-01

Why do human phobias last for months or years when such behavior should undergo extinction? This failure of extinction or persistence of self-defeating behavior of human disorders was labeled by Mowrer as the neurotic paradox. The paradox is cited by an ever-increasing number of critics who challenge any laboratory-based learning model of human psychopathology. Laboratory research, of course, omits essential requirements in the analysis of behavior, and the principles derived from such analyses must be combined in order to explain complex human behavaior. Validation for a behavioral model can thus be achieved if (a) basic principles inferred from observation of humans treated with a laboratory-derived extinction procedure (e.g., implosive therapy) are combined with (b) principles examined in laboratory research that are combined to generate unique predictions that correspond to known features of human phobic behavior. The latter evidence is briefly reviewed in research demonstrating sustained responding over one thousand consecutive active avoidance responses with complete avoidance of the “phobic” CS for an initial single shock trial. Differential reinforcement for responses to early sequential stimuli depends on minimal work requirement, and reinforcement by timeout from avoidance. This combination of factors effectively precludes extinction to main conditioned aversive stimuli for nonhumans, as it does for human phobias. Support for a laboratory model of human phobia is thereby attained. PMID:22477974

The chorioallantoic membrane (CAM) assay for the study of human bone regeneration: a refinement animal model for tissue engineering

NASA Astrophysics Data System (ADS)

Moreno-Jiménez, Inés; Hulsart-Billstrom, Gry; Lanham, Stuart A.; Janeczek, Agnieszka A.; Kontouli, Nasia; Kanczler, Janos M.; Evans, Nicholas D.; Oreffo, Richard Oc

2016-08-01

Biomaterial development for tissue engineering applications is rapidly increasing but necessitates efficacy and safety testing prior to clinical application. Current in vitro and in vivo models hold a number of limitations, including expense, lack of correlation between animal models and human outcomes and the need to perform invasive procedures on animals; hence requiring new predictive screening methods. In the present study we tested the hypothesis that the chick embryo chorioallantoic membrane (CAM) can be used as a bioreactor to culture and study the regeneration of human living bone. We extracted bone cylinders from human femoral heads, simulated an injury using a drill-hole defect, and implanted the bone on CAM or in vitro control-culture. Micro-computed tomography (μCT) was used to quantify the magnitude and location of bone volume changes followed by histological analyses to assess bone repair. CAM blood vessels were observed to infiltrate the human bone cylinder and maintain human cell viability. Histological evaluation revealed extensive extracellular matrix deposition in proximity to endochondral condensations (Sox9+) on the CAM-implanted bone cylinders, correlating with a significant increase in bone volume by μCT analysis (p < 0.01). This human-avian system offers a simple refinement model for animal research and a step towards a humanized in vivo model for tissue engineering.

The Gap Procedure: for the identification of phylogenetic clusters in HIV-1 sequence data.

PubMed

Vrbik, Irene; Stephens, David A; Roger, Michel; Brenner, Bluma G

2015-11-04

In the context of infectious disease, sequence clustering can be used to provide important insights into the dynamics of transmission. Cluster analysis is usually performed using a phylogenetic approach whereby clusters are assigned on the basis of sufficiently small genetic distances and high bootstrap support (or posterior probabilities). The computational burden involved in this phylogenetic threshold approach is a major drawback, especially when a large number of sequences are being considered. In addition, this method requires a skilled user to specify the appropriate threshold values which may vary widely depending on the application. This paper presents the Gap Procedure, a distance-based clustering algorithm for the classification of DNA sequences sampled from individuals infected with the human immunodeficiency virus type 1 (HIV-1). Our heuristic algorithm bypasses the need for phylogenetic reconstruction, thereby supporting the quick analysis of large genetic data sets. Moreover, this fully automated procedure relies on data-driven gaps in sorted pairwise distances to infer clusters, thus no user-specified threshold values are required. The clustering results obtained by the Gap Procedure on both real and simulated data, closely agree with those found using the threshold approach, while only requiring a fraction of the time to complete the analysis. Apart from the dramatic gains in computational time, the Gap Procedure is highly effective in finding distinct groups of genetically similar sequences and obviates the need for subjective user-specified values. The clusters of genetically similar sequences returned by this procedure can be used to detect patterns in HIV-1 transmission and thereby aid in the prevention, treatment and containment of the disease.

Contemporary trends in urinary tract stone surgery, a regional perspective: Auckland, New Zealand.

PubMed

Acland, George; Zargar-Shoshtari, Kamran; Rice, Michael

2016-04-01

The aim of the study is to assess the contemporary patterns of utilization of various therapeutic options for the management of nephrolithiasis in our tertiary referral institution in Auckland, New Zealand. A retrospective audit was conducted for all urinary stone procedures between January 2007 and December 2013. Procedure-related information was collected for each year. All elective and emergency procedures were included. Data were collected on the elective waiting lists for each procedure. A total of 5512 stone-related cases were performed during the study period. Six hundred and fifty-three cases were performed in 2007 compared with 945 in 2013. Total number of percutaneous nephrolithotomy (PCNLs) performed, as well as the proportion of PCNL cases, demonstrated a significant decline from 84 (12.9%) in 2007 to 67 (7.1%) in 2013. While the annual numbers of extracorporeal shock wave lithotripsy (ESWLs) have increased, the percentage of ESWLs performed relative to total stone procedures has declined from 33% to 23% over the last 4 years of this audit. There has been a significant rise in the numbers of rigid and flexible ureteroscopies, with these now being the most utilized procedure. The number of patients awaiting elective procedures declined over the duration of this audit, with an associated improvement in meeting annual demand for treatment of nephrolithiasis from 78% in 2007 to 91% in 2013. A proportional decline in PCNL and ESWL utilization with a significant increase in flexible and rigid ureteroscopic procedures has been observed over this time and this pattern has been associated with improved adherence to surgical targets despite an increasing number of cases. © 2015 Royal Australasian College of Surgeons.

PubMed Central

TATARELLI, P.; LORENZI, I.; CAVIGLIA, I.; SACCO, R.A.; LA MASA, D.

2016-01-01

Summary Introduction. Hand decontamination with alcohol-based antiseptic agents is considered the best practise to reduce healthcare associated infections. We present a new method to monitor hand hygiene, introduced in a tertiary care pediatric hospital in Northern Italy, which estimates the mean number of daily hand decontamination procedures performed per patient. Methods. The total amount of isopropyl alcohol and chlorhexidine solution supplied in a trimester to each hospital ward was put in relation with the number of hospitalization days, and expressed as litres/1000 hospitalization-days (World Health Organization standard method). Moreover, the ratio between the total volume of hand hygiene products supplied and the effective amount of hand disinfection product needed for a correct procedure was calculated. Then, this number was divided by 90 (days in a quarter) and then by the mean number of bed active in each day in a Unit, resulting in the mean estimated number of hand hygiene procedures per patient per day (new method). Results. The two methods had similar performance for estimating the adherence to correct hand disinfection procedures. The new method identified wards and/or periods with high or low adherence to the procedure and indicated where to perform interventions and their effectiveness. The new method could result easy-to understand also for non-infection control experts. Conclusions. This method can help non-infection control experts to understand adherence to correct hand-hygiene procedures and improve quality standards. PMID:28167854

Rapid screening procedure based on headspace solid-phase microextraction and gas chromatography-mass spectrometry for the detection of many recreational drugs in hair.

PubMed

Gentili, Stefano; Cornetta, Maria; Macchia, Teodora

2004-03-05

An increasing number of synthetic drugs are appearing on the illicit market and on the scene of drug use by youngsters. Official figures are underestimated. In addition, immunochemical tests are blind to many of these drugs and appropriate analytical procedures for routine clinical and epidemiological purposes are lacking. Therefore, the perceived increasing abuse of recreational drugs has not been proved yet. In a previous paper, we proposed a procedure for the preliminary screening of several recreational substances in hair and other biological matrices. Unfortunately, this procedure cannot apply to cocaine. Consequently, we performed a new headspace solid-phase microextraction and gas chromatography-mass spectrometry (HS-SPME-GC-MS) procedure for the simultaneous detection of cocaine, amphetamine (A), methamphetamine (MA), methylen-dioxyamphetamine (MDA), methylen-dioxymethamphetamine (MDMA), methylen-dioxyethamphetamine (MDE), N-methyl-1-(1,3-benzodioxol-5-yl)-2-butanamine (MBDB), ketamine, and methadone in human hair. Hair was washed with water and acetone in an ultrasonic bath. A short acid extraction with 1M hydrochloric acid was needed; the fiber was exposed to a 5 min absorption at 90 degrees C and thermal desorption was performed at 250 degrees C for 3 min. The procedure was simple, rapid, required small quantities of sample and no derivatization. Good linearity was obtained over the 0.1-20.0 ng/mg range for the target compounds. Sensitivity was good enough: limits of detection (LOD) were 0.7 ng/mg of hair for the majority of substances. The intra-day precision ranged between 7 and 20%. This paper deals with the analytical performance of this procedure and its preliminary application to hair samples obtained on a voluntary basis from 183 young people (138 males and 45 females) in the Rome area.

75 FR 38872 - Proposed Collection; Comment Request for Revenue Procedure 2000-12

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

... Revenue Procedure 2000- 12 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request... comments concerning Revenue Procedure 2000-12, Application Procedures for Qualified Intermediary Status...-1597. Revenue Procedure Number: 2000-12 (Revenue Procedure 2000-12 is modified by Announcement 2000-50...

78 FR 27297 - Proposed Collection; Comment Request for Revenue Procedure 2000-12

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Revenue Procedure 2000- 12 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request... comments concerning Revenue Procedure 2000-12, Application Procedures for Qualified Intermediary Status.... Revenue Procedure Number: 2000-12 (Revenue Procedure 2000-12 is modified by Announcement 2000-50, Revenue...

A human fecal contamination index for ranking impaired ...

EPA Pesticide Factsheets

Human fecal pollution of surface water remains a public health concern worldwide. As a result, there is a growing interest in the application of human-associated fecal source identification quantitative real-time PCR (qPCR) technologies for recreational water quality risk management. The transition from a research subject to a management tool requires the integration of standardized water sampling, laboratory, and data analysis procedures. In this study, a standardized HF183/BacR287 qPCR method was combined with a water sampling strategy and Bayesian data algorithm to establish a human fecal contamination index that can be used to rank impaired recreational water sites polluted with human waste. Stability and bias of index predictions were investigated under various parameters including siteswith different pollution levels, sampling period time range (1-15 weeks), and number of qPCR replicates per sample (2-14 replicates). Sensitivity analyses were conducted with simulated data sets (100 iterations) seeded with HF183/BacR287 qPCR laboratory measurements from water samples collected from three Southern California sites (588 qPCR measurements). Findings suggest that site ranking is feasible and that all parameters tested influence stability and bias in human fecal contamination indexscoring. Trends identified by sensitivity analyses will provide managers with the information needed to design and conduct field studies to rank impaired recreational water sites based

E6 and E7 oncogene expression by human papilloma virus (HPV) and the aggressive behavior of recurrent laryngeal papillomatosis (RLP).

PubMed

Shehata, Bahig M; Otto, Kristen J; Sobol, Steven E; Stockwell, Christina A; Foulks, Cora; Lancaster, Wayne; Gregoire, Lucie; Hill, Charles E

2008-01-01

Recurrent laryngeal papillomatosis (RLP), a chronic disease associated with human papilloma virus (HPV), requires serial surgical procedures for debulking, resulting in debilitating long-term dysphonia, laryngeal scarring, and rarely malignant degeneration. Human papilloma virus 11 tumors have been widely accepted as more aggressive than HPV 6 tumors; however, the clinical course has been difficult to predict at disease onset, and the biologic mediators of proliferation have not been well characterized. A retrospective case review of 43 patients (4 months to 10 years at diagnosis) was performed on children treated for recurrent laryngeal papillomatosis. Patient charts were reviewed for demographic information, age at RLP diagnosis, approximate frequency of surgical intervention, and absolute number of surgical procedures performed. Human papilloma virus subtyping was performed. Expression analysis of the HPV-encoded E6 and E7 oncogenes was performed by reverse-transcriptase polymerase chain reaction. Fourteen patients had subtype 11 (33%) and 29 patients had subtype 6 (67%). As expected, HPV 11 patients showed a more aggressive clinical course than HPV 6 patients. However, 38% of patients with subtype 6 (11 patients) followed a clinical course that mirrored the more severe subtype 11 patients. These patients expressed the disease at a younger age (P < 0.0002) and showed higher levels of E6 and E7 oncogenes compared to the patients with the more indolent course. Although HPV subtype and early onset of RLP are well characterized prognostic factors, our study documents the significance of E6 and E7 oncogene expression as potential biologic mediators of proliferation and thereby clinical behavior.

Advanced medical countermeasures for radiological accidents and nuclear disasters: prevention, prophylaxis, treatment and pre- and post-exposure management.

NASA Astrophysics Data System (ADS)

Popov, Dmitri; Maliev, Slava; Jones, Jeffrey

Countermeasures against nuclear terrorism to prevent or limit the number of irradiated human population or radiation intoxications include early identification of the nuclear terrorism event and all persons which exposed by radiation, decontamination program and procedures, radiation control, and medical countermeasures which include medical diagnosis,differential diagnosis of Acute Radiation Syndromes by Immune Enzyme Assay , pre-exposure vaccination with Human Antiradiation Vaccine, post-exposure specific treatment - de-intoxication with Radiation Antidote IgG (blocking Antiradiation Antibodies). Our Advanced Medical Technology elaborated as a part of effective countermeasure include Plan of Action.Countermeasures against nuclear terrorism to prevent or limit the number of high level of lethality and severe forms of radiation illness or intoxications include A.early identification of the nuclear terrorism event and persons exposed,b. appropriate decontamination, c. radiation control, and d.medical countermeasures and medical management of ARS. Medical countermeasures, which include medical interventions such as active immuneprophylaxis with Human Antiradiation Vaccine , passive immune-prophylaxis with Antiradiation Antitoxins immune-globulins IgG , and chemoprophylaxis - post-exposure antioxidants prophylaxis and antibioticprophylaxis. Medical countermeasures with Antiradiation Vaccine should be initiated before an exposure (if individuals are identified as being at high risk for exposure)but after a confirmed exposure event Antiradiation Vaccine not effective and Antiradiation Antidot IgG must be applyed for treatment of Acute Radiation Syndromes.

Cryo-image Analysis of Tumor Cell Migration, Invasion, and Dispersal in a Mouse Xenograft Model of Human Glioblastoma Multiforme

PubMed Central

Qutaish, Mohammed Q.; Sullivant, Kristin E.; Burden-Gulley, Susan M.; Lu, Hong; Roy, Debashish; Wang, Jing; Basilion, James P.; Brady-Kalnay, Susann M.; Wilson, David L.

2012-01-01

Purpose The goals of this study were to create cryo-imaging methods to quantify characteristics (size, dispersal, and blood vessel density) of mouse orthotopic models of glioblastoma multiforme (GBM) and to enable studies of tumor biology, targeted imaging agents, and theranostic nanoparticles. Procedures Green fluorescent protein-labeled, human glioma LN-229 cells were implanted into mouse brain. At 20–38 days, cryo-imaging gave whole brain, 4-GB, 3D microscopic images of bright field anatomy, including vasculature, and fluorescent tumor. Image analysis/visualization methods were developed. Results Vessel visualization and segmentation methods successfully enabled analyses. The main tumor mass volume, the number of dispersed clusters, the number of cells/cluster, and the percent dispersed volume all increase with age of the tumor. Histograms of dispersal distance give a mean and median of 63 and 56 μm, respectively, averaged over all brains. Dispersal distance tends to increase with age of the tumors. Dispersal tends to occur along blood vessels. Blood vessel density did not appear to increase in and around the tumor with this cell line. Conclusion Cryo-imaging and software allow, for the first time, 3D, whole brain, microscopic characterization of a tumor from a particular cell line. LN-229 exhibits considerable dispersal along blood vessels, a characteristic of human tumors that limits treatment success. PMID:22125093

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... follow written procedures for cleaning the physical plant and for pest control. ...

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... follow written procedures for cleaning the physical plant and for pest control. ...

10 CFR 712.18 - Transferring HRP certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Transferring HRP certification. 712.18 Section 712.18 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the Human Reliability Program Procedures § 712.18 Transferring HRP certification. (a) For HRP certification to be...

10 CFR 712.22 - Hearing officer's report and recommendation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Hearing officer's report and recommendation. 712.22 Section 712.22 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the Human Reliability Program Procedures § 712.22 Hearing officer's report and recommendation. Within...

45 CFR 1160.12 - Appraisal procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 3 2011-10-01 2011-10-01 false Appraisal procedures. 1160.12 Section 1160.12 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES FEDERAL COUNCIL ON THE ARTS AND THE HUMANITIES INDEMNITIES UNDER THE ARTS AND ARTIFACTS INDEMNITY...

45 CFR 1170.55 - Endowment enforcement and compliance procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Endowment enforcement and compliance procedures. 1170.55 Section 1170.55 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE HUMANITIES NONDISCRIMINATION ON THE...

45 CFR 1170.55 - Endowment enforcement and compliance procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 3 2011-10-01 2011-10-01 false Endowment enforcement and compliance procedures. 1170.55 Section 1170.55 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE HUMANITIES NONDISCRIMINATION ON THE...

21 CFR 1270.31 - Written procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Written procedures. 1270.31 Section 1270.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN TISSUE INTENDED...

45 CFR 1160.12 - Appraisal procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Appraisal procedures. 1160.12 Section 1160.12 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES FEDERAL COUNCIL ON THE ARTS AND THE HUMANITIES INDEMNITIES UNDER THE ARTS AND ARTIFACTS INDEMNITY...

Amniotic Constriction Bands: Secondary Deformities and Their Treatments.

PubMed

Drury, Benjamin T; Rayan, Ghazi M

2018-01-01

The purpose of this study was to report the surgical treatment experience of patients with amniotic constriction bands (ACB) over a 35-year interval and detail consequential limb deformities with emphasis on hands and upper extremities, along with the nature and frequency of their surgical treatment methods. Fifty-one patients were identified; 26 were males and 25 females. The total number of deformities was listed. The total number of operations, individual procedures, and operations plus procedures that were done for each patient and their frequency were recorded. The total number of operations was 117, and total number of procedures was 341. More procedures were performed on the upper extremity (85%) than the lower extremity (15%). Including the primary deformity ACB, 16 different hand deformities secondary to ACB were encountered. Sixteen different surgical methods for the upper extremity were utilized; a primary procedure for ACB and secondary reconstructions for all secondary deformities. Average age at the time of the first procedure was 9.3 months. The most common procedures performed, in order of frequency, were excision of ACB plus Z-plasty, release of partial syndactyly, release of fenestrated syndactyly, full-thickness skin grafts, resection of digital bony overgrowth from amputation stumps, and deepening of first and other digital web spaces. Many hand and upper extremity deformities secondary to ACB are encountered. Children with ACB may require more than one operation including multiple procedures. Numerous surgical methods of reconstruction for these children's secondary deformities are necessary in addition to the customary primary procedure of excision of ACB and Z-plasty.

Learning curves for urological procedures: a systematic review.

PubMed

Abboudi, Hamid; Khan, Mohammed Shamim; Guru, Khurshid A; Froghi, Saied; de Win, Gunter; Van Poppel, Hendrik; Dasgupta, Prokar; Ahmed, Kamran

2014-10-01

To determine the number of cases a urological surgeon must complete to achieve proficiency for various urological procedures. The MEDLINE, EMBASE and PsycINFO databases were systematically searched for studies published up to December 2011. Studies pertaining to learning curves of urological procedures were included. Two reviewers independently identified potentially relevant articles. Procedure name, statistical analysis, procedure setting, number of participants, outcomes and learning curves were analysed. Forty-four studies described the learning curve for different urological procedures. The learning curve for open radical prostatectomy ranged from 250 to 1000 cases and for laparoscopic radical prostatectomy from 200 to 750 cases. The learning curve for robot-assisted laparoscopic prostatectomy (RALP) has been reported to be 40 procedures as a minimum number. Robot-assisted radical cystectomy has a documented learning curve of 16-30 cases, depending on which outcome variable is measured. Irrespective of previous laparoscopic experience, there is a significant reduction in operating time (P = 0.008), estimated blood loss (P = 0.008) and complication rates (P = 0.042) after 100 RALPs. The available literature can act as a guide to the learning curves of trainee urologists. Although the learning curve may vary among individual surgeons, a consensus should exist for the minimum number of cases to achieve proficiency. The complexities associated with defining procedural competence are vast. The majority of learning curve trials have focused on the latest surgical techniques and there is a paucity of data pertaining to basic urological procedures. © 2013 The Authors. BJU International © 2013 BJU International.

Non-terminal blood sampling techniques in guinea pigs.

PubMed

Birck, Malene M; Tveden-Nyborg, Pernille; Lindblad, Maiken M; Lykkesfeldt, Jens

2014-10-11

Guinea pigs possess several biological similarities to humans and are validated experimental animal models(1-3). However, the use of guinea pigs currently represents a relatively narrow area of research and descriptive data on specific methodology is correspondingly scarce. The anatomical features of guinea pigs are slightly different from other rodent models, hence modulation of sampling techniques to accommodate for species-specific differences, e.g., compared to mice and rats, are necessary to obtain sufficient and high quality samples. As both long and short term in vivo studies often require repeated blood sampling the choice of technique should be well considered in order to reduce stress and discomfort in the animals but also to ensure survival as well as compliance with requirements of sample size and accessibility. Venous blood samples can be obtained at a number of sites in guinea pigs e.g., the saphenous and jugular veins, each technique containing both advantages and disadvantages(4,5). Here, we present four different blood sampling techniques for either conscious or anaesthetized guinea pigs. The procedures are all non-terminal procedures provided that sample volumes and number of samples do not exceed guidelines for blood collection in laboratory animals(6). All the described methods have been thoroughly tested and applied for repeated in vivo blood sampling in studies within our research facility.

Procedural abortion rights: Ireland and the European Court of Human Rights.

PubMed

Erdman, Joanna N

2014-11-01

The Irish Protection of Life During Pregnancy Act seeks to clarify the legal ground for abortion in cases of risk to life, and to create procedures to regulate women's access to services under it. This article explores the new law as the outcome of an international human rights litigation strategy premised on state duties to implement abortion laws through clear standards and procedural safeguards. It focuses specifically on the Irish law reform and the jurisprudence of the European Court of Human Rights, including A. B. and C. v. Ireland (2010). The article examines how procedural rights at the international level can engender domestic law reform that limits or expands women's access to lawful abortion services, serving conservative or progressive ends. Copyright © 2014 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

20 CFR 422.120 - Earnings reported without a social security number or with an incorrect employee name or social...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Earnings reported without a social security number or with an incorrect employee name or social security number. 422.120 Section 422.120 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.120 Earnings...

20 CFR 422.120 - Earnings reported without a social security number or with an incorrect employee name or social...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Earnings reported without a social security number or with an incorrect employee name or social security number. 422.120 Section 422.120 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.120 Earnings...

20 CFR 422.120 - Earnings reported without a social security number or with an incorrect employee name or social...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Earnings reported without a social security number or with an incorrect employee name or social security number. 422.120 Section 422.120 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.120 Earnings...

20 CFR 422.120 - Earnings reported without a social security number or with an incorrect employee name or social...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Earnings reported without a social security number or with an incorrect employee name or social security number. 422.120 Section 422.120 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.120 Earnings...

20 CFR 422.120 - Earnings reported without a social security number or with an incorrect employee name or social...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Earnings reported without a social security number or with an incorrect employee name or social security number. 422.120 Section 422.120 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ORGANIZATION AND PROCEDURES General Procedures § 422.120 Earnings...

Development of a novel ex vivo porcine laparoscopic Heller myotomy and Nissen fundoplication training model (Toronto lap-Nissen simulator).

PubMed

Ujiie, Hideki; Kato, Tatsuya; Hu, Hsin-Pei; Bauer, Patrycja; Patel, Priya; Wada, Hironobu; Lee, Daiyoon; Fujino, Kosuke; Schieman, Colin; Pierre, Andrew; Waddell, Thomas K; Keshavjee, Shaf; Darling, Gail E; Yasufuku, Kazuhiro

2017-06-01

Surgical trainees are required to develop competency in a variety of laparoscopic operations. Developing laparoscopic technical skills can be difficult as there has been a decrease in the number of procedures performed. This study aims to develop an inexpensive and anatomically relevant model for training in laparoscopic foregut procedures. An ex vivo , anatomic model of the human upper abdomen was developed using intact porcine esophagus, stomach, diaphragm and spleen. The Toronto lap-Nissen simulator was contained in a laparoscopic box-trainer and included an arch system to simulate the normal radial shape and tension of the diaphragm. We integrated the use of this training model as a part of our laparoscopic skills laboratory-training curriculum. Afterwards, we surveyed trainees to evaluate the observed benefit of the learning session. Twenty-five trainees and five faculty members completed a survey regarding the use of this model. Among the trainees, only 4 (16%) had experience with laparoscopic Heller myotomy and Nissen fundoplication. They reported that practicing with the model was a valuable use of their limited time, repeating the exercise would be of additional benefit, and that the exercise improved their ability to perform or assist in an actual case in the operating room. Significant improvements were found in the following subjective measures comparing pre- vs. post-training: (I) knowledge level (5.6 vs. 8.0, P<0.001); (II) comfort level in assisting (6.3 vs. 7.6, P<0.001); and (III) comfort level in performing as the primary surgeon (4.9 vs. 7.1, P<0.001). The trainees and faculty members agreed that this model was of adequate fidelity and was a representative simulation of actual human anatomy. We developed an easily reproducible training model for laparoscopic procedures. This simulator reproduces human anatomy and increases the trainees' comfort level in performing and assisting with myotomy and fundoplication.

Development of a novel ex vivo porcine laparoscopic Heller myotomy and Nissen fundoplication training model (Toronto lap-Nissen simulator)

PubMed Central

Ujiie, Hideki; Kato, Tatsuya; Hu, Hsin-Pei; Bauer, Patrycja; Patel, Priya; Wada, Hironobu; Lee, Daiyoon; Fujino, Kosuke; Schieman, Colin; Pierre, Andrew; Waddell, Thomas K.; Keshavjee, Shaf; Darling, Gail E.

2017-01-01

Background Surgical trainees are required to develop competency in a variety of laparoscopic operations. Developing laparoscopic technical skills can be difficult as there has been a decrease in the number of procedures performed. This study aims to develop an inexpensive and anatomically relevant model for training in laparoscopic foregut procedures. Methods An ex vivo, anatomic model of the human upper abdomen was developed using intact porcine esophagus, stomach, diaphragm and spleen. The Toronto lap-Nissen simulator was contained in a laparoscopic box-trainer and included an arch system to simulate the normal radial shape and tension of the diaphragm. We integrated the use of this training model as a part of our laparoscopic skills laboratory-training curriculum. Afterwards, we surveyed trainees to evaluate the observed benefit of the learning session. Results Twenty-five trainees and five faculty members completed a survey regarding the use of this model. Among the trainees, only 4 (16%) had experience with laparoscopic Heller myotomy and Nissen fundoplication. They reported that practicing with the model was a valuable use of their limited time, repeating the exercise would be of additional benefit, and that the exercise improved their ability to perform or assist in an actual case in the operating room. Significant improvements were found in the following subjective measures comparing pre- vs. post-training: (I) knowledge level (5.6 vs. 8.0, P<0.001); (II) comfort level in assisting (6.3 vs. 7.6, P<0.001); and (III) comfort level in performing as the primary surgeon (4.9 vs. 7.1, P<0.001). The trainees and faculty members agreed that this model was of adequate fidelity and was a representative simulation of actual human anatomy. Conclusions We developed an easily reproducible training model for laparoscopic procedures. This simulator reproduces human anatomy and increases the trainees’ comfort level in performing and assisting with myotomy and fundoplication. PMID:28740664

Optimization of analytical and pre-analytical conditions for MALDI-TOF-MS human urine protein profiles.

PubMed

Calvano, C D; Aresta, A; Iacovone, M; De Benedetto, G E; Zambonin, C G; Battaglia, M; Ditonno, P; Rutigliano, M; Bettocchi, C

2010-03-11

Protein analysis in biological fluids, such as urine, by means of mass spectrometry (MS) still suffers for insufficient standardization in protocols for sample collection, storage and preparation. In this work, the influence of these variables on healthy donors human urine protein profiling performed by matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF-MS) was studied. A screening of various urine sample pre-treatment procedures and different sample deposition approaches on the MALDI target was performed. The influence of urine samples storage time and temperature on spectral profiles was evaluated by means of principal component analysis (PCA). The whole optimized procedure was eventually applied to the MALDI-TOF-MS analysis of human urine samples taken from prostate cancer patients. The best results in terms of detected ions number and abundance in the MS spectra were obtained by using home-made microcolumns packed with hydrophilic-lipophilic balance (HLB) resin as sample pre-treatment method; this procedure was also less expensive and suitable for high throughput analyses. Afterwards, the spin coating approach for sample deposition on the MALDI target plate was optimized, obtaining homogenous and reproducible spots. Then, PCA indicated that low storage temperatures of acidified and centrifuged samples, together with short handling time, allowed to obtain reproducible profiles without artifacts contribution due to experimental conditions. Finally, interesting differences were found by comparing the MALDI-TOF-MS protein profiles of pooled urine samples of healthy donors and prostate cancer patients. The results showed that analytical and pre-analytical variables are crucial for the success of urine analysis, to obtain meaningful and reproducible data, even if the intra-patient variability is very difficult to avoid. It has been proven how pooled urine samples can be an interesting way to make easier the comparison between healthy and pathological samples and to individuate possible differences in the protein expression between the two sets of samples. Copyright 2009 Elsevier B.V. All rights reserved.

An investigation of the uniform random number generator

NASA Technical Reports Server (NTRS)

Temple, E. C.

1982-01-01

Most random number generators that are in use today are of the congruential form X(i+1) + AX(i) + C mod M where A, C, and M are nonnegative integers. If C=O, the generator is called the multiplicative type and those for which C/O are called mixed congruential generators. It is easy to see that congruential generators will repeat a sequence of numbers after a maximum of M values have been generated. The number of numbers that a procedure generates before restarting the sequence is called the length or the period of the generator. Generally, it is desirable to make the period as long as possible. A detailed discussion of congruential generators is given. Also, several promising procedures that differ from the multiplicative and mixed procedure are discussed.

Validation of current procedural terminology codes for rotavirus vaccination among infants in two commercially insured US populations.

PubMed

Hoffman, Veena; Everage, Nicholas J; Quinlan, Scott C; Skerry, Kathleen; Esposito, Daina; Praet, Nicolas; Rosillon, Dominique; Holick, Crystal N; Dore, David D

2016-12-01

We validated procedure codes used in health insurance claims for reimbursement of rotavirus vaccination by comparing claims for monovalent live-attenuated human rotavirus vaccine (RV1) and live, oral pentavalent rotavirus vaccine (RV5) to medical records. Using administrative data from two commercially insured United States populations, we randomly sampled vaccination claims for RV1 and RV5 from a cohort of infants aged less than 1 year from an ongoing post-licensure safety study of rotavirus vaccines. The codes for RV1 and RV5 found in claims were confirmed through medical record review. The positive predictive value (PPV) of the Current Procedural Terminology codes for RV1 and RV5 was calculated as the number of medical record-confirmed vaccinations divided by the number of medical records obtained. Medical record review confirmed 92 of 104 RV1 vaccination claims (PPV: 88.5%; 95% CI: 80.7-93.9%) and 98 of 113 RV5 vaccination claims (PPV: 86.7%; 95% CI: 79.1-92.4%). Among the 217 medical records abstracted, only three (1.4%) of vaccinations were misclassified in claims-all were RV5 misclassified as RV1. The medical records corresponding to 9 RV1 and 15 RV5 claims contained insufficient information to classify the type of rotavirus vaccine. Misclassification of rotavirus vaccines is infrequent within claims. The PPVs reported here are conservative estimates as those with insufficient information in the medical records were assumed to be incorrectly coded in the claims. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Effects of imprint training procedure at birth on the reactions of foals at age six months.

PubMed

Williams, J L; Friend, T H; Collins, M N; Toscano, M J; Sisto-Burt, A; Nevill, C H

2003-03-01

While imprint training procedures have been promoted in popular magazines, they have received limited scientific investigation. To determine the effects of a neonatal imprint training procedure on 6-month-old foals and to determine if any one session had a greater effect than others. Foals (n = 131) were divided into the following treatments: no imprint training, imprint training at birth, 12, 24 and 48 h after birth or imprint training only at birth, 12, 24, 48, or 72 h after birth. Foals then received minimal human handling until they were tested at 6 months. During training, time to complete exposure to the stimulus was significant for only 2 of 6 stimuli. Percentage change in baseline heart rate was significant for only 2 of 10 stimuli. These 4 effects were randomly spread across treatments. Neither the number of imprint training sessions (0, 1, or 4) nor the timing of imprint training sessions (none, birth, 12, 24, 48, or 72 h after birth) influenced the foal's behaviour at 6 months of age. In this study, imprint training did not result in better behaved, less reactive foals.

Assessment of capacity for surgery, obstetrics and anaesthesia in 17 Ghanaian hospitals using a WHO assessment tool.

PubMed

Choo, Shelly; Perry, Henry; Hesse, Afua A J; Abantanga, Francis; Sory, Elias; Osen, Hayley; Fleischer-Djoleto, Charles; Moresky, Rachel; McCord, Colin W; Cherian, Meena; Abdullah, Fizan

2010-09-01

To survey infrastructure characteristics, personnel, equipment and procedures of surgical, obstetric and anaesthesia care in 17 hospitals in Ghana. The assessment was completed by WHO country offices using the World Health Organization Tool for Situational Analysis to Assess Emergency and Essential Surgical Care, which surveyed infrastructure, human resources, types of surgical interventions and equipment in each facility. Overall, hospitals were well equipped with general patient care and surgical supplies. The majority of hospitals had a basic laboratory (100%), running water (94%) and electricity (82%). More than 75% had the basic supplies needed for general patient care and basic intra-operative care, including sterilization. Almost all hospitals were able to perform major surgical procedures such as caesarean sections (88%), herniorrhaphy (100%) and appendectomy (94%), but formal training of providers was limited: a few hospitals had a fully qualified surgeon (29%) or obstetrician (36%) available. The greatest barrier to improving surgical care at district hospitals in Ghana is the shortage of adequately trained medical personnel for emergency and essential surgical procedures. Important future steps include strengthening their number and qualifications. © 2010 Blackwell Publishing Ltd.

10 CFR 712.21 - Office of Hearings and Appeals.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Office of Hearings and Appeals. 712.21 Section 712.21 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the Human Reliability Program Procedures § 712.21 Office of Hearings and Appeals. (a) The certification review hearing...

21 CFR 123.11 - Sanitation control procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Sanitation control procedures. 123.11 Section 123.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.11 Sanitation control...

21 CFR 601.92 - Withdrawal procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Withdrawal procedures. 601.92 Section 601.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.92...

21 CFR 601.92 - Withdrawal procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Withdrawal procedures. 601.92 Section 601.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.92...

21 CFR 601.92 - Withdrawal procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Withdrawal procedures. 601.92 Section 601.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.92...

45 CFR 1355.33 - Procedures for the review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false Procedures for the review. 1355.33 Section 1355.33 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON CHILDREN, YOUTH AND FAMILIES, FOSTER CARE...

45 CFR 1355.33 - Procedures for the review.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Procedures for the review. 1355.33 Section 1355.33 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON CHILDREN, YOUTH AND FAMILIES, FOSTER CARE...

45 CFR 1355.33 - Procedures for the review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false Procedures for the review. 1355.33 Section 1355.33 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON CHILDREN, YOUTH AND FAMILIES, FOSTER CARE...

21 CFR 120.6 - Sanitation standard operating procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Sanitation standard operating procedures. 120.6 Section 120.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

21 CFR 120.6 - Sanitation standard operating procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Sanitation standard operating procedures. 120.6 Section 120.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

21 CFR 530.24 - Procedure for announcing analytical methods for drug residue quantification.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.24 Procedure for announcing analytical methods for drug residue quantification. (a...

Human Blood Typing: A Forensic Science Approach: Part II. Experiments.

ERIC Educational Resources Information Center

Kobilinsky, Lawrence; Sheehan, Francis X.

1988-01-01

Describes several experiments that explore the methodology available to the forensic serologist for typing a human bloodstain in the ABH grouping system. Presents ABO blood group of wet blood, Lattes Crust test procedure, and the absorption-elution procedure. Uses outdated blood; equipment requirements are minimal. (ML)

SPSS and SAS programs for determining the number of components using parallel analysis and velicer's MAP test.

PubMed

O'Connor, B P

2000-08-01

Popular statistical software packages do not have the proper procedures for determining the number of components in factor and principal components analyses. Parallel analysis and Velicer's minimum average partial (MAP) test are validated procedures, recommended widely by statisticians. However, many researchers continue to use alternative, simpler, but flawed procedures, such as the eigenvalues-greater-than-one rule. Use of the proper procedures might be increased if these procedures could be conducted within familiar software environments. This paper describes brief and efficient programs for using SPSS and SAS to conduct parallel analyses and the MAP test.

Efficient production by sperm-mediated gene transfer of human decay accelerating factor (hDAF) transgenic pigs for xenotransplantation

PubMed Central

Lavitrano, Marialuisa; Bacci, Maria Laura; Forni, Monica; Lazzereschi, Davide; Di Stefano, Carla; Fioretti, Daniela; Giancotti, Paola; Marfé, Gabriella; Pucci, Loredana; Renzi, Luigina; Wang, Hongjun; Stoppacciaro, Antonella; Stassi, Giorgio; Sargiacomo, Massimo; Sinibaldi, Paola; Turchi, Valeria; Giovannoni, Roberto; Della Casa, Giacinto; Seren, Eraldo; Rossi, Giancarlo

2002-01-01

A large number of hDAF transgenic pigs to be used for xenotransplantation research were generated by using sperm-mediated gene transfer (SMGT). The efficiency of transgenesis obtained with SMGT was much greater than with any other method. In the experiments reported, up to 80% of pigs had the transgene integrated into the genome. Most of the pigs carrying the hDAF gene transcribed it in a stable manner (64%). The great majority of pigs that transcribed the gene expressed the protein (83%). The hDAF gene was transmitted to progeny. Expression was stable and found in caveolae as it is in human cells. The expressed gene was functional based on in vitro experiments performed on peripheral blood mononuclear cells. These results show that our SMGT approach to transgenesis provides an efficient procedure for studies involving large animal models. PMID:12393815

Flexible Automatic Discretization for Finite Differences: Eliminating the Human Factor

NASA Astrophysics Data System (ADS)

Pranger, Casper

2017-04-01

In the geophysical numerical modelling community, finite differences are (in part due to their small footprint) a popular spatial discretization method for PDEs in the regular-shaped continuum that is the earth. However, they rapidly become prone to programming mistakes when physics increase in complexity. To eliminate opportunities for human error, we have designed an automatic discretization algorithm using Wolfram Mathematica, in which the user supplies symbolic PDEs, the number of spatial dimensions, and a choice of symbolic boundary conditions, and the script transforms this information into matrix- and right-hand-side rules ready for use in a C++ code that will accept them. The symbolic PDEs are further used to automatically develop and perform manufactured solution benchmarks, ensuring at all stages physical fidelity while providing pragmatic targets for numerical accuracy. We find that this procedure greatly accelerates code development and provides a great deal of flexibility in ones choice of physics.

The automatic human

NASA Technical Reports Server (NTRS)

Billings, Charles

1991-01-01

An overview is presented of the growth and role of automation in civil aircraft operations for both cockpit management and ground control. NASA has initiated a research program centered on furthering automation and developing a consistent and rational philosophy of human centered aircraft and air traffic control automation. Introduction of the NASA Aviation Safety Reporting System (ASRS) has proved successful in bringing together pilots and ground controllers to report incidents of operational anomalies that can then be analyzed, leading to corrective action to prevent similar reoccurrences. Attention is given to the growing trend of extensive automation in the cockpit that appears to be leading to a diminution of management control of the aircraft by the decreasing number of flight crew members. A majority of reports indicate that there is a serious mismatch between new aircraft capabilities and ATC procedures, which were designed for older aircraft. ASRS has also kept research oriented toward real problems and community needs.

Scientific procedures on living animals in Great Britain in 2003: the facts, figures and consequences.

PubMed

Hudson, Michelle; Bhogal, Nirmala

2004-11-01

The statistics for animal procedures performed in 2003 were recently released by the Home Office. They indicate that, for the second year running, there was a significant increase in the number of laboratory animal procedures undertaken in Great Britain. The species and genera used, the numbers of toxicology and non-toxicology procedures, and the overall trends, are described. The implications of these latest statistics are discussed with reference to key areas of interest and to the impact of existing regulations and pending legislative reforms.

Technical approaches for measurement of human errors

NASA Technical Reports Server (NTRS)

Clement, W. F.; Heffley, R. K.; Jewell, W. F.; Mcruer, D. T.

1980-01-01

Human error is a significant contributing factor in a very high proportion of civil transport, general aviation, and rotorcraft accidents. The technical details of a variety of proven approaches for the measurement of human errors in the context of the national airspace system are presented. Unobtrusive measurements suitable for cockpit operations and procedures in part of full mission simulation are emphasized. Procedure, system performance, and human operator centered measurements are discussed as they apply to the manual control, communication, supervisory, and monitoring tasks which are relevant to aviation operations.

The surgical experience of general surgery residents: an analysis of the applicability of the specialty program in General and Digestive Surgery.

PubMed

Targarona Soler, Eduardo Ma; Jover Navalon, Jose Ma; Gutierrez Saiz, Javier; Turrado Rodríguez, Víctor; Parrilla Paricio, Pascual

2015-03-01

Residents in our country have achieved a homogenous surgical training by following a structured residency program. This is due to the existence of specific training programs for each specialty. The current program, approved in 2007, has a detailed list of procedures that a surgeon should have performed in order to complete training. The aim of this study is to analyze the applicability of the program with regard to the number of procedures performed during the residency period. A data collection form was designed that included the list of procedures from the program of the specialty; it was sent in April 2014 to all hospitals with accredited residency programs. In September 2014 the forms were analysed, and a general descriptive study was performed; a subanalysis according to the resident's sex and Autonomous region was also performed. The number of procedures performed according to the number of residents in the different centers was also analyzed. The survey was sent to 117 hospitals with accredited programs, which included 190 resident places. A total of 91 hospitals responded (53%). The training offered adapts in general to the specialty program. The total number of procedures performed in the different sub-areas, in laparoscopic and emergency surgery is correct or above the number recommended by the program, with the exception of esophageal-gastric and hepatobiliary surgery. The sub-analysis according to Autonomous region did not show any significant differences in the total number of procedures, however, there were significant differences in endocrine surgery (P=.001) and breast surgery (P=.042). A total of 55% of residents are female, with no significant differences in distribution in Autonomous regions. However, female surgeons operate more than their male counterparts during the residency period (512±226 vs. 625±244; P<.01). The number of residents in the hospital correlates with the number of procedures performed; the residents with more procedures trained in hospitals where there were less residents (669±237 vs. 527±209; P=.004). The surgical activity performed by spanish surgeons is adequate to the specialty program, except in hepatobiliary and esophageal-gastric surgery. The distribution is homogeneous in the different autonomous regions, although there are differences that depend on the number and sex the of residents in each hospital. This information is essential to evaluate the quality of the specialty program and to design new training programs. Copyright © 2015 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Isolation of GMP Grade Human Hepatocytes from Remnant Liver Tissue of Living Donor Liver Transplantation.

PubMed

Enosawa, Shin

2017-01-01

For the purpose of clinical research of hepatocyte transplantation, procedures for isolation, cryopreservation, thawing, and functional assessment of hepatocytes are described. Although demands for human hepatocytes are increasing in not only cell therapy but also drug development, it is highly difficult to obtain good lots of hepatocytes from human liver tissue. This chapter describes essential issues such as alleviation of warm ischemia, prevention of shear stress, optimization of cryopreservation, and functional assessment, along with securement of quality. All procedures described here are compliant with good manufacturing procedure (GMP) in cell processing facility, approved by the act on measures to ensure safety of regenerative medicine and ethical regulations in Japan.

Enhanced procedural learning of speech sound categories in a genetic variant of FOXP2.

PubMed

Chandrasekaran, Bharath; Yi, Han-Gyol; Blanco, Nathaniel J; McGeary, John E; Maddox, W Todd

2015-05-20

A mutation of the forkhead box protein P2 (FOXP2) gene is associated with severe deficits in human speech and language acquisition. In rodents, the humanized form of FOXP2 promotes faster switching from declarative to procedural learning strategies when the two learning systems compete. Here, we examined a polymorphism of FOXP2 (rs6980093) in humans (214 adults; 111 females) for associations with non-native speech category learning success. Neurocomputational modeling results showed that individuals with the GG genotype shifted faster to procedural learning strategies, which are optimal for the task. These findings support an adaptive role for the FOXP2 gene in modulating the function of neural learning systems that have a direct bearing on human speech category learning. Copyright © 2015 the authors 0270-6474/15/357808-05$15.00/0.

Laboratory activities involving transmissible spongiform encephalopathy causing agents

PubMed Central

Leunda, Amaya; Van Vaerenbergh, Bernadette; Baldo, Aline; Roels, Stefan; Herman, Philippe

2013-01-01

Since the appearance in 1986 of epidemic of bovine spongiform encephalopathy (BSE), a new form of neurological disease in cattle which also affected human beings, many diagnostic and research activities have been performed to develop detection and therapeutic tools. A lot of progress was made in better identifying, understanding and controlling the spread of the disease by appropriate monitoring and control programs in European countries. This paper reviews the recent knowledge on pathogenesis, transmission and persistence outside the host of prion, the causative agent of transmissible spongiform encephalopathies (TSE) in mammals with a particular focus on risk (re)assessment and management of biosafety measures to be implemented in diagnostic and research laboratories in Belgium. Also, in response to the need of an increasing number of European diagnostic laboratories stopping TSE diagnosis due to a decreasing number of TSE cases reported in the last years, decontamination procedures and a protocol for decommissioning TSE diagnostic laboratories is proposed. PMID:24055928

Application of the Hardman methodology to the Army Remotely Piloted Vehicle (RPV)

NASA Technical Reports Server (NTRS)

1983-01-01

The application of the HARDMAN Methodology to the Remotely Piloted Vehicle (RPV) is described. The methodology was used to analyze the manpower, personnel, and training (MPT) requirements of the proposed RPV system design for a number of operating scenarios. The RPV system is defined as consisting of the equipment, personnel, and operational procedures needed to perform five basic artillery missions: reconnaissance, target acquisition, artillery adjustment, target designation and damage assessment. The RPV design evaluated includes an air vehicle (AV), a modular integrated communications and navigation system (MICNS), a ground control station (GCS), a launch subsystem (LS), a recovery subsystem (RS), and a number of ground support requirements. The HARDMAN Methodology is an integrated set of data base management techniques and analytic tools, designed to provide timely and fully documented assessments of the human resource requirements associated with an emerging system's design.

Survey of laboratory-acquired infections around the world in biosafety level 3 and 4 laboratories.

PubMed

Wurtz, N; Papa, A; Hukic, M; Di Caro, A; Leparc-Goffart, I; Leroy, E; Landini, M P; Sekeyova, Z; Dumler, J S; Bădescu, D; Busquets, N; Calistri, A; Parolin, C; Palù, G; Christova, I; Maurin, M; La Scola, B; Raoult, D

2016-08-01

Laboratory-acquired infections due to a variety of bacteria, viruses, parasites, and fungi have been described over the last century, and laboratory workers are at risk of exposure to these infectious agents. However, reporting laboratory-associated infections has been largely voluntary, and there is no way to determine the real number of people involved or to know the precise risks for workers. In this study, an international survey based on volunteering was conducted in biosafety level 3 and 4 laboratories to determine the number of laboratory-acquired infections and the possible underlying causes of these contaminations. The analysis of the survey reveals that laboratory-acquired infections have been infrequent and even rare in recent years, and human errors represent a very high percentage of the cases. Today, most risks from biological hazards can be reduced through the use of appropriate procedures and techniques, containment devices and facilities, and the training of personnel.

Stepwise detection of recombination breakpoints in sequence alignments.

PubMed

Graham, Jinko; McNeney, Brad; Seillier-Moiseiwitsch, Françoise

2005-03-01

We propose a stepwise approach to identify recombination breakpoints in a sequence alignment. The approach can be applied to any recombination detection method that uses a permutation test and provides estimates of breakpoints. We illustrate the approach by analyses of a simulated dataset and alignments of real data from HIV-1 and human chromosome 7. The presented simulation results compare the statistical properties of one-step and two-step procedures. More breakpoints are found with a two-step procedure than with a single application of a given method, particularly for higher recombination rates. At higher recombination rates, the additional breakpoints were located at the cost of only a slight increase in the number of falsely declared breakpoints. However, a large proportion of breakpoints still go undetected. A makefile and C source code for phylogenetic profiling and the maximum chi2 method, tested with the gcc compiler on Linux and WindowsXP, are available at http://stat-db.stat.sfu.ca/stepwise/ jgraham@stat.sfu.ca.

Risk analysis of analytical validations by probabilistic modification of FMEA.

PubMed

Barends, D M; Oldenhof, M T; Vredenbregt, M J; Nauta, M J

2012-05-01

Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure. Copyright © 2012 Elsevier B.V. All rights reserved.

Human Geophagia, Calabash Chalk and Undongo: Mineral Element Nutritional Implications

PubMed Central

Abrahams, Peter W.; Davies, Theo C.; Solomon, Abiye O.; Trow, Amanda J.; Wragg, Joanna

2013-01-01

The prime aim of our work is to report and comment on the bioaccessible concentrations – i.e., the soluble content of chemical elements in the gastrointestinal environment that is available for absorption – of a number of essential mineral nutrients and potentially harmful elements (PHEs) associated with the deliberate ingestion of African geophagical materials, namely Calabash chalk and Undongo. The pseudo-total concentrations of 13 mineral nutrients/PHEs were quantified following a nitric-perchloric acid digestion of nine different Calabash chalk samples, and bioaccessible contents of eight of these chemical elements were determined in simulated saliva/gastric and intestinal solutions obtained via use of the Fed ORganic Estimation human Simulation Test (FOREhST) in vitro procedure. The Calabash chalk pseudo-total content of the chemical elements is often below what may be regarded as average for soils/shales, and no concentration is excessively high. The in vitro leachate solutions had concentrations that were often lower than those of the blanks used in our experimental procedure, indicative of effective adsorption: lead, a PHE about which concern has been previously raised in connection with the consumption of Calabash chalk, was one such chemical element where this was evident. However, some concentrations in the leachate solutions are suggestive that Calabash chalk can be a source of chemical elements to humans in bioaccessible form, although generally the materials appear to be only a modest supplier: this applies even to iron, a mineral nutrient that has often been linked to the benefits of geophagia in previous academic literature. Our investigations indicate that at the reported rates of ingestion, Calabash chalk on the whole is not an important source of mineral nutrients or PHEs to humans. Similarly, although Undongo contains elevated pseudo-total concentrations of chromium and nickel, this soil is not a significant source to humans for any of the bioaccessible elements investigated. PMID:23308189

Human geophagia, calabash chalk and undongo: mineral element nutritional implications.

PubMed

Abrahams, Peter W; Davies, Theo C; Solomon, Abiye O; Trow, Amanda J; Wragg, Joanna

2013-01-01

The prime aim of our work is to report and comment on the bioaccessible concentrations - i.e., the soluble content of chemical elements in the gastrointestinal environment that is available for absorption - of a number of essential mineral nutrients and potentially harmful elements (PHEs) associated with the deliberate ingestion of African geophagical materials, namely Calabash chalk and Undongo. The pseudo-total concentrations of 13 mineral nutrients/PHEs were quantified following a nitric-perchloric acid digestion of nine different Calabash chalk samples, and bioaccessible contents of eight of these chemical elements were determined in simulated saliva/gastric and intestinal solutions obtained via use of the Fed ORganic Estimation human Simulation Test (FOREhST) in vitro procedure. The Calabash chalk pseudo-total content of the chemical elements is often below what may be regarded as average for soils/shales, and no concentration is excessively high. The in vitro leachate solutions had concentrations that were often lower than those of the blanks used in our experimental procedure, indicative of effective adsorption: lead, a PHE about which concern has been previously raised in connection with the consumption of Calabash chalk, was one such chemical element where this was evident. However, some concentrations in the leachate solutions are suggestive that Calabash chalk can be a source of chemical elements to humans in bioaccessible form, although generally the materials appear to be only a modest supplier: this applies even to iron, a mineral nutrient that has often been linked to the benefits of geophagia in previous academic literature. Our investigations indicate that at the reported rates of ingestion, Calabash chalk on the whole is not an important source of mineral nutrients or PHEs to humans. Similarly, although Undongo contains elevated pseudo-total concentrations of chromium and nickel, this soil is not a significant source to humans for any of the bioaccessible elements investigated.

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

Evaluating the Performance Diagnostic Checklist-Human Services to Assess Incorrect Error-Correction Procedures by Preschool Paraprofessionals

ERIC Educational Resources Information Center

Bowe, Melissa; Sellers, Tyra P.

2018-01-01

The Performance Diagnostic Checklist-Human Services (PDC-HS) has been used to assess variables contributing to undesirable staff performance. In this study, three preschool teachers completed the PDC-HS to identify the factors contributing to four paraprofessionals' inaccurate implementation of error-correction procedures during discrete trial…

Joint Operations. Change 1

DTIC Science & Technology

2008-02-13

procedures not ratified by the United States, commanders should evaluate and follow the multinational command’s doctrine and procedures, where applicable... human intelligence sources to be effective and implementation of appropriate force protection measures regardless of the operational...intelligence requirements needed to support the anticipated operation. Human intelligence often may provide the most useful source of information. Even

Robotic Camera Assistance and Its Benefit in 1033 Traditional Laparoscopic Procedures: Prospective Clinical Trial Using a Joystick-guided Camera Holder.

PubMed

Holländer, Sebastian W; Klingen, Hans Joachim; Fritz, Marliese; Djalali, Peter; Birk, Dieter

2014-11-01

Despite advances in instruments and techniques in laparoscopic surgery, one thing remains uncomfortable: the camera assistance. The aim of this study was to investigate the benefit of a joystick-guided camera holder (SoloAssist®, Aktormed, Barbing, Germany) for laparoscopic surgery and to compare the robotic assistance to human assistance. 1033 consecutive laparoscopic procedures were performed assisted by the SoloAssist®. Failures and aborts were documented and nine surgeons were interviewed by questionnaire regarding their experiences. In 71 of 1033 procedures, robotic assistance was aborted and the procedure was continued manually, mostly because of frequent changes of position, narrow spaces, and adverse angular degrees. One case of short circuit was reported. Emergency stop was necessary in three cases due to uncontrolled movement into the abdominal cavity. Eight of nine surgeons prefer robotic to human assistance, mostly because of a steady image and self-control. The SoloAssist® robot is a reliable system for laparoscopic procedures. Emergency shutdown was necessary in only three cases. Some minor weak spots could have been identified. Most surgeons prefer robotic assistance to human assistance. We feel that the SoloAssist® makes standard laparoscopic surgery more comfortable and further development is desirable, but it cannot fully replace a human assistant.

Effects of daytime food intake on memory consolidation during sleep or sleep deprivation.

PubMed

Herzog, Nina; Friedrich, Alexia; Fujita, Naoko; Gais, Steffen; Jauch-Chara, Kamila; Oltmanns, Kerstin M; Benedict, Christian

2012-01-01

Sleep enhances memory consolidation. Bearing in mind that food intake produces many metabolic signals that can influence memory processing in humans (e.g., insulin), the present study addressed the question as to whether the enhancing effect of sleep on memory consolidation is affected by the amount of energy consumed during the preceding daytime. Compared to sleep, nocturnal wakefulness has been shown to impair memory consolidation in humans. Thus, a second question was to examine whether the impaired memory consolidation associated with sleep deprivation (SD) could be compensated by increased daytime energy consumption. To these aims, 14 healthy normal-weight men learned a finger tapping sequence (procedural memory) and a list of semantically associated word pairs (declarative memory). After the learning period, standardized meals were administered, equaling either ∼50% or ∼150% of the estimated daily energy expenditure. In the morning, after sleep or wakefulness, memory consolidation was tested. Plasma glucose was measured both before learning and retrieval. Polysomnographic sleep recordings were performed by electroencephalography (EEG). Independent of energy intake, subjects recalled significantly more word pairs after sleep than they did after SD. When subjects stayed awake and received an energy oversupply, the number of correctly recalled finger sequences was equal to those seen after sleep. Plasma glucose did not differ among conditions, and sleep time in the sleep conditions was not influenced by the energy intake interventions. These data indicate that the daytime energy intake level affects neither sleep's capacity to boost the consolidation of declarative and procedural memories, nor sleep's quality. However, high energy intake was followed by an improved procedural but not declarative memory consolidation under conditions of SD. This suggests that the formation of procedural memory is not only triggered by sleep but is also sensitive to the fluctuations in the energy state of the body.

Effects of Daytime Food Intake on Memory Consolidation during Sleep or Sleep Deprivation

PubMed Central

Herzog, Nina; Friedrich, Alexia; Fujita, Naoko; Gais, Steffen; Jauch-Chara, Kamila; Oltmanns, Kerstin M.; Benedict, Christian

2012-01-01

Sleep enhances memory consolidation. Bearing in mind that food intake produces many metabolic signals that can influence memory processing in humans (e.g., insulin), the present study addressed the question as to whether the enhancing effect of sleep on memory consolidation is affected by the amount of energy consumed during the preceding daytime. Compared to sleep, nocturnal wakefulness has been shown to impair memory consolidation in humans. Thus, a second question was to examine whether the impaired memory consolidation associated with sleep deprivation (SD) could be compensated by increased daytime energy consumption. To these aims, 14 healthy normal-weight men learned a finger tapping sequence (procedural memory) and a list of semantically associated word pairs (declarative memory). After the learning period, standardized meals were administered, equaling either ∼50% or ∼150% of the estimated daily energy expenditure. In the morning, after sleep or wakefulness, memory consolidation was tested. Plasma glucose was measured both before learning and retrieval. Polysomnographic sleep recordings were performed by electroencephalography (EEG). Independent of energy intake, subjects recalled significantly more word pairs after sleep than they did after SD. When subjects stayed awake and received an energy oversupply, the number of correctly recalled finger sequences was equal to those seen after sleep. Plasma glucose did not differ among conditions, and sleep time in the sleep conditions was not influenced by the energy intake interventions. These data indicate that the daytime energy intake level affects neither sleep’s capacity to boost the consolidation of declarative and procedural memories, nor sleep’s quality. However, high energy intake was followed by an improved procedural but not declarative memory consolidation under conditions of SD. This suggests that the formation of procedural memory is not only triggered by sleep but is also sensitive to the fluctuations in the energy state of the body. PMID:22768272

21 CFR 1271.47 - What procedures must I establish and maintain?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Donor Eligibility § 1271.47 What procedures... technical manual prepared by another organization, provided that you have verified that the procedures are...

Global aesthetic surgery statistics: a closer look.

PubMed

Heidekrueger, Paul I; Juran, S; Ehrl, D; Aung, T; Tanna, N; Broer, P Niclas

2017-08-01

Obtaining quality global statistics about surgical procedures remains an important yet challenging task. The International Society of Aesthetic Plastic Surgery (ISAPS) reports the total number of surgical and non-surgical procedures performed worldwide on a yearly basis. While providing valuable insight, ISAPS' statistics leave two important factors unaccounted for: (1) the underlying base population, and (2) the number of surgeons performing the procedures. Statistics of the published ISAPS' 'International Survey on Aesthetic/Cosmetic Surgery' were analysed by country, taking into account the underlying national base population according to the official United Nations population estimates. Further, the number of surgeons per country was used to calculate the number of surgeries performed per surgeon. In 2014, based on ISAPS statistics, national surgical procedures ranked in the following order: 1st USA, 2nd Brazil, 3rd South Korea, 4th Mexico, 5th Japan, 6th Germany, 7th Colombia, and 8th France. When considering the size of the underlying national populations, the demand for surgical procedures per 100,000 people changes the overall ranking substantially. It was also found that the rate of surgical procedures per surgeon shows great variation between the responding countries. While the US and Brazil are often quoted as the countries with the highest demand for plastic surgery, according to the presented analysis, other countries surpass these countries in surgical procedures per capita. While data acquisition and quality should be improved in the future, valuable insight regarding the demand for surgical procedures can be gained by taking specific demographic and geographic factors into consideration.

Pediatric surgical capacity building - a pathway to improving access to pediatric surgical care in Haiti.

PubMed

Kaseje, Neema; Jenny, Hillary; Jeudy, Andre Patrick; MacLee, Jean Louis; Meara, John G; Ford, Henri R

2018-02-01

Lack of human resources is a major barrier to accessing pediatric surgical care globally. Our aim was to establish a model for pediatric surgical training of general surgery residents in a resource constrained region. A pediatric surgical program with a pediatric surgical rotation for general surgery residents in a tertiary hospital in Haiti in 2015 was established. We conducted twice daily patient rounds, ran an outpatient clinic, and provided emergent and elective pediatric surgical care, with tasks progressively given to residents until they could run clinic and perform the most common elective and emergent procedures. We conducted baseline and post-intervention knowledge exams and dedicated 1 day a week to teaching and research activities. We measured the following outcomes: number of residents that completed the rotation, mean pre and post intervention test scores, patient volume in clinic and operating room, postoperative outcomes, resident ability to perform most common elective and emergent procedures, and resident participation in research. Nine out of 9 residents completed the rotation; 987 patients were seen in outpatient clinic, and 564 procedures were performed in children <15years old. There was a 50% increase in volume of pediatric cases and a 100% increase in procedures performed in children <4years old. Postoperative outcomes were: 0% mortality for elective cases and 18% mortality for emergent cases, 3% complication rate for elective cases and 6% complication rate for emergent cases. Outcomes did not change with increased responsibility given to residents. All senior residents (n=4) could perform the most common elective and emergent procedures without changes in mortality and complication rates. Increases in mean pre and post intervention test scores were 12% (PGY1), 24% (PGY2), and 10% (PGY3). 75% of senior residents participated in research activities as first or second authors. Establishing a program in pediatric surgery with capacity building of general surgery residents for pediatric surgical care provision is feasible in a resource constrained setting without negative effects on patient outcomes. This model can be applied in other resource constrained settings to increase human resources for global pediatric surgical care provision. III. Copyright © 2017 Elsevier Inc. All rights reserved.

Human Factors and ISS Medical Systems: Highlights of Procedures and Equipment Findings

NASA Technical Reports Server (NTRS)

Byrne, V. E.; Hudy, C.; Smith, D.; Whitmore, M.

2005-01-01

As part of the Space Human Factors Engineering Critical Questions Roadmap, a three year Technology Development Project (TDP) was funded by NASA Headquarters to examine emergency medical procedures on ISS. The overall aim of the emergency medical procedures project was to determine the human factors issues in the procedures, training, communications and equipment, and to recommend solutions that will improve the survival rate of crewmembers in the event of a medical emergency. Currently, each ISS crew remains on orbit for six month intervals. As there is not standing requirement for a physician crewmember, during such time, the maintenance of crew health is dependant on individual crewmembers. Further, in the event of an emergency, crew will need to provide prolonged maintenance care, as well as emergency treatment, to an injured crewmember while awaiting transport to Earth. In addition to the isolation of the crew, medical procedures must be carried out within the further limitations imposed by the physical environment of the space station. For example, in order to administer care on ISS without the benefit of gravity, the Crew Medical Officers (CMOs) must restrain the equipment required to perform the task, restrain the injured crewmember, and finally, restrain themselves. Both the physical environment and the physical space available further limit the technology that can be used onboard. Equipment must be compact, yet able to withstand high levels of radiation and function without gravity. The focus here is to highlight the human factors impacts from our three year project involving the procedures and equipment areas that have been investigated and provided valuable to ISS and provide groundwork for human factors requirements for medical applications for exploration missions.

HGVS Recommendations for the Description of Sequence Variants: 2016 Update.

PubMed

den Dunnen, Johan T; Dalgleish, Raymond; Maglott, Donna R; Hart, Reece K; Greenblatt, Marc S; McGowan-Jordan, Jean; Roux, Anne-Francoise; Smith, Timothy; Antonarakis, Stylianos E; Taschner, Peter E M

2016-06-01

The consistent and unambiguous description of sequence variants is essential to report and exchange information on the analysis of a genome. In particular, DNA diagnostics critically depends on accurate and standardized description and sharing of the variants detected. The sequence variant nomenclature system proposed in 2000 by the Human Genome Variation Society has been widely adopted and has developed into an internationally accepted standard. The recommendations are currently commissioned through a Sequence Variant Description Working Group (SVD-WG) operating under the auspices of three international organizations: the Human Genome Variation Society (HGVS), the Human Variome Project (HVP), and the Human Genome Organization (HUGO). Requests for modifications and extensions go through the SVD-WG following a standard procedure including a community consultation step. Version numbers are assigned to the nomenclature system to allow users to specify the version used in their variant descriptions. Here, we present the current recommendations, HGVS version 15.11, and briefly summarize the changes that were made since the 2000 publication. Most focus has been on removing inconsistencies and tightening definitions allowing automatic data processing. An extensive version of the recommendations is available online, at http://www.HGVS.org/varnomen. © 2016 WILEY PERIODICALS, INC.

Decontamination Efficacy and Skin Toxicity of Two Decontaminants against Bacillus anthracis

PubMed Central

Stratilo, Chad W.; Crichton, Melissa K. F.; Sawyer, Thomas W.

2015-01-01

Decontamination of bacterial endospores such as Bacillus anthracis has traditionally required the use of harsh or caustic chemicals. The aim of this study was to evaluate the efficacy of a chlorine dioxide decontaminant in killing Bacillus anthracis spores in solution and on a human skin simulant (porcine cadaver skin), compared to that of commonly used sodium hypochlorite or soapy water decontamination procedures. In addition, the relative toxicities of these decontaminants were compared in human skin keratinocyte primary cultures. The chlorine dioxide decontaminant was similarly effective to sodium hypochlorite in reducing spore numbers of Bacillus anthracis Ames in liquid suspension after a 10 minute exposure. After five minutes, the chlorine dioxide product was significantly more efficacious. Decontamination of isolated swine skin contaminated with Bacillus anthracis Sterne with the chlorine dioxide product resulted in no viable spores sampled. The toxicity of the chlorine dioxide decontaminant was up to two orders of magnitude less than that of sodium hypochlorite in human skin keratinocyte cultures. In summary, the chlorine dioxide based decontaminant efficiently killed Bacillus anthracis spores in liquid suspension, as well as on isolated swine skin, and was less toxic than sodium hypochlorite in cultures of human skin keratinocytes. PMID:26394165

Humanized Foxp2 accelerates learning by enhancing transitions from declarative to procedural performance.

PubMed

Schreiweis, Christiane; Bornschein, Ulrich; Burguière, Eric; Kerimoglu, Cemil; Schreiter, Sven; Dannemann, Michael; Goyal, Shubhi; Rea, Ellis; French, Catherine A; Puliyadi, Rathi; Groszer, Matthias; Fisher, Simon E; Mundry, Roger; Winter, Christine; Hevers, Wulf; Pääbo, Svante; Enard, Wolfgang; Graybiel, Ann M

2014-09-30

The acquisition of language and speech is uniquely human, but how genetic changes might have adapted the nervous system to this capacity is not well understood. Two human-specific amino acid substitutions in the transcription factor forkhead box P2 (FOXP2) are outstanding mechanistic candidates, as they could have been positively selected during human evolution and as FOXP2 is the sole gene to date firmly linked to speech and language development. When these two substitutions are introduced into the endogenous Foxp2 gene of mice (Foxp2(hum)), cortico-basal ganglia circuits are specifically affected. Here we demonstrate marked effects of this humanization of Foxp2 on learning and striatal neuroplasticity. Foxp2(hum/hum) mice learn stimulus-response associations faster than their WT littermates in situations in which declarative (i.e., place-based) and procedural (i.e., response-based) forms of learning could compete during transitions toward proceduralization of action sequences. Striatal districts known to be differently related to these two modes of learning are affected differently in the Foxp2(hum/hum) mice, as judged by measures of dopamine levels, gene expression patterns, and synaptic plasticity, including an NMDA receptor-dependent form of long-term depression. These findings raise the possibility that the humanized Foxp2 phenotype reflects a different tuning of corticostriatal systems involved in declarative and procedural learning, a capacity potentially contributing to adapting the human brain for speech and language acquisition.

77 FR 6862 - Proposed Collection; Comment Request for Revenue Procedure 99-50

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

... Revenue Procedure 99-50 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for... Revenue Procedure 99-50, Combined Information Reporting. DATES: Written comments should be received on or... Number: Revenue Procedure 99-50. Abstract: Revenue Procedure 99-50 permits combined information reporting...

Social equality in the number of choice options is represented in the ventromedial prefrontal cortex.

PubMed

Aoki, Ryuta; Matsumoto, Madoka; Yomogida, Yukihito; Izuma, Keise; Murayama, Kou; Sugiura, Ayaka; Camerer, Colin F; Adolphs, Ralph; Matsumoto, Kenji

2014-04-30

A distinct aspect of the sense of fairness in humans is that we care not only about equality in material rewards but also about equality in nonmaterial values. One such value is the opportunity to choose freely among many options, often regarded as a fundamental right to economic freedom. In modern developed societies, equal opportunities in work, living, and lifestyle are enforced by antidiscrimination laws. Despite the widespread endorsement of equal opportunity, no studies have explored how people assign value to it. We used functional magnetic resonance imaging to identify the neural substrates for subjective valuation of equality in choice opportunity. Participants performed a two-person choice task in which the number of choices available was varied across trials independently of choice outcomes. By using this procedure, we manipulated the degree of equality in choice opportunity between players and dissociated it from the value of reward outcomes and their equality. We found that activation in the ventromedial prefrontal cortex (vmPFC) tracked the degree to which the number of options between the two players was equal. In contrast, activation in the ventral striatum tracked the number of options available to participants themselves but not the equality between players. Our results demonstrate that the vmPFC, a key brain region previously implicated in the processing of social values, is also involved in valuation of equality in choice opportunity between individuals. These findings may provide valuable insight into the human ability to value equal opportunity, a characteristic long emphasized in politics, economics, and philosophy.

The effect of clustering on perceived quantity in humans (Homo sapiens) and in chicks (Gallus gallus).

PubMed

Bertamini, Marco; Guest, Martin; Vallortigara, Giorgio; Rugani, Rosa; Regolin, Lucia

2018-04-30

Animals can perceive the numerosity of sets of visual elements. Qualitative and quantitative similarities in different species suggest the existence of a shared system (approximate number system). Biases associated with sensory properties are informative about the underlying mechanisms. In humans, regular spacing increases perceived numerosity (regular-random numerosity illusion). This has led to a model that predicts numerosity based on occupancy (a measure that decreases when elements are close together). We used a procedure in which observers selected one of two stimuli and were given feedback with respect to whether the choice was correct. One configuration had 20 elements and the other 40, randomly placed inside a circular region. Participants had to discover the rule based on feedback. Because density and clustering covaried with numerosity, different dimensions could be used. After reaching a criterion, test trials presented two types of configurations with 30 elements. One type had a larger interelement distance than the other (high or low clustering). If observers had adopted a numerosity strategy, they would choose low clustering (if reinforced with 40) and high clustering (if reinforced with 20). A clustering or density strategy predicts the opposite. Human adults used a numerosity strategy. Chicks were tested using a similar procedure. There were two behavioral measures: first approach response and final circumnavigation (walking behind the screen). The prediction based on numerosity was confirmed by the first approach data. For chicks, one clear pattern from both responses was a preference for the configurations with higher clustering. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Isolation of Exosomes from the Plasma of HIV-1 Positive Individuals

PubMed Central

Konadu, Kateena Addae; Huang, Ming Bo; Roth, William; Armstrong, Wendy; Powell, Michael; Villinger, Francois; Bond, Vincent

2016-01-01

Exosomes are small vesicles ranging in size from 30 nm to 100 nm that are released both constitutively and upon stimulation from a variety of cell types. They are found in a number of biological fluids and are known to carry a variety of proteins, lipids, and nucleic acid molecules. Originally thought to be little more than reservoirs for cellular debris, the roles of exosomes regulating biological processes and in diseases are increasingly appreciated. Several methods have been described for isolating exosomes from cellular culture media and biological fluids. Due to their small size and low density, differential ultracentrifugation and/or ultrafiltration are the most commonly used techniques for exosome isolation. However, plasma of HIV-1 infected individuals contains both exosomes and HIV viral particles, which are similar in size and density. Thus, efficient separation of exosomes from HIV viral particles in human plasma has been a challenge. To address this limitation, we developed a procedure modified from Cantin et. al., 2008 for purification of exosomes from HIV particles in human plasma. Iodixanol velocity gradients were used to separate exosomes from HIV-1 particles in the plasma of HIV-1 positive individuals. Virus particles were identified by p24 ELISA. Exosomes were identified on the basis of exosome markers acetylcholinesterase (AChE), and the CD9, CD63, and CD45 antigens. Our gradient procedure yielded exosome preparations free of virus particles. The efficient purification of exosomes from human plasma enabled us to examine the content of plasma-derived exosomes and to investigate their immune modulatory potential and other biological functions. PMID:26780239

Epidemiologic Analysis of Elective Operative Procedures in Infants Less Than 6 Months of Age in the United States.

PubMed

Einhorn, Lisa M; Young, Brian J; Routh, Jonathan C; Allori, Alexander C; Tracy, Elisabeth T; Greene, Nathaniel H

2017-11-01

This study uses publicly available data to analyze the total number of elective, potentially deferrable operative procedures involving infants <6 months of age in the United States. We investigated the factors associated with the performance of these procedures in this population. The State Ambulatory Surgery Database was used to identify patients in California, North Carolina, New York, and Utah during the years of 2007-2010 who were younger than 6 months of age at the time that they underwent outpatient (ambulatory) surgery. Operations that could reasonably be postponed until 6 months of age were classified as potentially deferrable procedures. Hernia repairs were analyzed separately from other deferrable procedures. Primary outcomes included the total number of elective procedures and the number and rates of potentially deferrable procedures per state per year in this population. Over the study period, a total of 27,540 procedures were identified as meeting inclusion criteria; of those, 7832 (28%) were classified as potentially deferrable, 4315 of which were hernia repairs. The average rates of potentially deferrable nonhernia procedures in California, North Carolina, New York, and Utah were 8.3, 43.8, 30.0, and 11.7 per 10,000 person-years, respectively. In multivariable analysis, private insurance (odds ratio [OR] = 1.36), self-pay status (OR = 1.50), and treatment in a different state (OR = 0.48-3.16) were independent predictors of a potentially deferrable procedure being performed on an infant younger than 6 months. Potentially deferrable procedures are still performed in infants <6 months of age. There appears to be significant variation in timing of these procedures among states. Insurance status and geography may be independent predictors of a procedure being potentially deferrable.

Profound and pervasive degradation of Madagascar's freshwater wetlands and links with biodiversity.

PubMed

Bamford, Andrew J; Razafindrajao, Felix; Young, Richard P; Hilton, Geoff M

2017-01-01

Reflecting a global trend, freshwater wetlands in Madagascar have received little conservation or research attention. Madagascar is a global conservation priority due to its high level of species endemism but most work has focused on protecting forests. For the first time, we investigated the state of wetlands across the country to determine the effects of human disturbance. We conducted a rapid survey of 37 wetlands, using waterbirds and benthic invertebrates as ecological indicators. We recorded nine variables relating to human disturbance, revealing widespread wetland destruction. Principal Components Analysis reduced the nine variables to a single Principal Component (PC) that explained 50% of the dataset variance, demonstrating that different forms of human disturbance are ubiquitous and inseparable. The disturbance PC provides an index of how pristine a lake is and in Generalized Linear Models (GLMs) was significantly inversely related to the number of waterbird species present and the density of Chironomidae. The disturbance PC was estimated for every wetland in a GIS-derived dataset of wetland locations in Madagascar, giving a country-wide frequency distribution of disturbance. To validate the estimated PC values, we used the GLMs to predict the number of endemic bird species at an independent sample of 22 lakes. The predicted values correlated with the observed number of species, demonstrating that our procedure can identify lakes with high biodiversity value. The disturbance PC provides a convenient method for ranking sites, and a country-wide ranking demonstrates that the only near-pristine lakes in Madagascar are small sites that have been preserved by remoteness from human activity and not conservation management. The strategy of conserving high biodiversity remnants is insufficient because existing remnants suffer some degree of degradation and only support small populations of threatened species. Large-scale restoration of degraded wetlands is required for the long-term conservation of Madagascar's freshwater biodiversity.

Profound and pervasive degradation of Madagascar’s freshwater wetlands and links with biodiversity

PubMed Central

Razafindrajao, Felix; Young, Richard P.; Hilton, Geoff M.

2017-01-01

Reflecting a global trend, freshwater wetlands in Madagascar have received little conservation or research attention. Madagascar is a global conservation priority due to its high level of species endemism but most work has focused on protecting forests. For the first time, we investigated the state of wetlands across the country to determine the effects of human disturbance. We conducted a rapid survey of 37 wetlands, using waterbirds and benthic invertebrates as ecological indicators. We recorded nine variables relating to human disturbance, revealing widespread wetland destruction. Principal Components Analysis reduced the nine variables to a single Principal Component (PC) that explained 50% of the dataset variance, demonstrating that different forms of human disturbance are ubiquitous and inseparable. The disturbance PC provides an index of how pristine a lake is and in Generalized Linear Models (GLMs) was significantly inversely related to the number of waterbird species present and the density of Chironomidae. The disturbance PC was estimated for every wetland in a GIS-derived dataset of wetland locations in Madagascar, giving a country-wide frequency distribution of disturbance. To validate the estimated PC values, we used the GLMs to predict the number of endemic bird species at an independent sample of 22 lakes. The predicted values correlated with the observed number of species, demonstrating that our procedure can identify lakes with high biodiversity value. The disturbance PC provides a convenient method for ranking sites, and a country-wide ranking demonstrates that the only near-pristine lakes in Madagascar are small sites that have been preserved by remoteness from human activity and not conservation management. The strategy of conserving high biodiversity remnants is insufficient because existing remnants suffer some degree of degradation and only support small populations of threatened species. Large-scale restoration of degraded wetlands is required for the long-term conservation of Madagascar’s freshwater biodiversity. PMID:28792516

Approach for Identifying Human Leukocyte Antigen (HLA)-DR Bound Peptides from Scarce Clinical Samples *

PubMed Central

Heyder, Tina; Kohler, Maxie; Tarasova, Nataliya K.; Haag, Sabrina; Rutishauser, Dorothea; Rivera, Natalia V.; Sandin, Charlotta; Mia, Sohel; Malmström, Vivianne; Wheelock, Åsa M.; Wahlström, Jan; Holmdahl, Rikard; Eklund, Anders; Zubarev, Roman A.; Grunewald, Johan; Ytterberg, A. Jimmy

2016-01-01

Immune-mediated diseases strongly associating with human leukocyte antigen (HLA) alleles are likely linked to specific antigens. These antigens are presented to T cells in the form of peptides bound to HLA molecules on antigen presenting cells, e.g. dendritic cells, macrophages or B cells. The identification of HLA-DR-bound peptides presents a valuable tool to investigate the human immunopeptidome. The lung is likely a key player in the activation of potentially auto-aggressive T cells prior to entering target tissues and inducing autoimmune disease. This makes the lung of exceptional interest and presents an ideal paradigm to study the human immunopeptidome and to identify antigenic peptides. Our previous investigation of HLA-DR peptide presentation in the lung required high numbers of cells (800 × 106 bronchoalveolar lavage (BAL) cells). Because BAL from healthy nonsmokers typically contains 10–15 × 106 cells, there is a need for a highly sensitive approach to study immunopeptides in the lungs of individual patients and controls. In this work, we analyzed the HLA-DR immunopeptidome in the lung by an optimized methodology to identify HLA-DR-bound peptides from low cell numbers. We used an Epstein-Barr Virus (EBV) immortalized B cell line and bronchoalveolar lavage (BAL) cells obtained from patients with sarcoidosis, an inflammatory T cell driven disease mainly occurring in the lung. Specifically, membrane complexes were isolated prior to immunoprecipitation, eluted peptides were identified by nanoLC-MS/MS and processed using the in-house developed ClusterMHCII software. With the optimized procedure we were able to identify peptides from 10 × 106 cells, which on average correspond to 10.9 peptides/million cells in EBV-B cells and 9.4 peptides/million cells in BAL cells. This work presents an optimized approach designed to identify HLA-DR-bound peptides from low numbers of cells, enabling the investigation of the BAL immunopeptidome from individual patients and healthy controls in order to identify disease-associated peptides. PMID:27452731

Human Thiel-Embalmed Cadaveric Aortic Model with Perfusion for Endovascular Intervention Training and Medical Device Evaluation.

PubMed

McLeod, Helen; Cox, Ben F; Robertson, James; Duncan, Robyn; Matthew, Shona; Bhat, Raj; Barclay, Avril; Anwar, J; Wilkinson, Tracey; Melzer, Andreas; Houston, J Graeme

2017-09-01

The purpose of this investigation was to evaluate human Thiel-embalmed cadavers with the addition of extracorporeal driven ante-grade pulsatile flow in the aorta as a model for simulation training in interventional techniques and endovascular device testing. Three human cadavers embalmed according to the method of Thiel were selected. Extracorporeal pulsatile ante-grade flow of 2.5 L per min was delivered directly into the aorta of the cadavers via a surgically placed connection. During perfusion, aortic pressure and temperature were recorded and optimized for physiologically similar parameters. Pre- and post-procedure CT imaging was conducted to plan and follow up thoracic and abdominal endovascular aortic repair as it would be in a clinical scenario. Thoracic endovascular aortic repair (TEVAR) and endovascular abdominal repair (EVAR) procedures were conducted in simulation of a clinical case, under fluoroscopic guidance with a multidisciplinary team present. The Thiel cadaveric aortic perfusion model provided pulsatile ante-grade flow, with pressure and temperature, sufficient to conduct a realistic simulation of TEVAR and EVAR procedures. Fluoroscopic imaging provided guidance during the intervention. Pre- and post-procedure CT imaging facilitated planning and follow-up evaluation of the procedure. The human Thiel-embalmed cadavers with the addition of extracorporeal flow within the aorta offer an anatomically appropriate, physiologically similar robust model to simulate aortic endovascular procedures, with potential applications in interventional radiology training and medical device testing as a pre-clinical model.

A novel tree-based procedure for deciphering the genomic spectrum of clinical disease entities.

PubMed

Mbogning, Cyprien; Perdry, Hervé; Toussile, Wilson; Broët, Philippe

2014-01-01

Dissecting the genomic spectrum of clinical disease entities is a challenging task. Recursive partitioning (or classification trees) methods provide powerful tools for exploring complex interplay among genomic factors, with respect to a main factor, that can reveal hidden genomic patterns. To take confounding variables into account, the partially linear tree-based regression (PLTR) model has been recently published. It combines regression models and tree-based methodology. It is however computationally burdensome and not well suited for situations for which a large number of exploratory variables is expected. We developed a novel procedure that represents an alternative to the original PLTR procedure, and considered different selection criteria. A simulation study with different scenarios has been performed to compare the performances of the proposed procedure to the original PLTR strategy. The proposed procedure with a Bayesian Information Criterion (BIC) achieved good performances to detect the hidden structure as compared to the original procedure. The novel procedure was used for analyzing patterns of copy-number alterations in lung adenocarcinomas, with respect to Kirsten Rat Sarcoma Viral Oncogene Homolog gene (KRAS) mutation status, while controlling for a cohort effect. Results highlight two subgroups of pure or nearly pure wild-type KRAS tumors with particular copy-number alteration patterns. The proposed procedure with a BIC criterion represents a powerful and practical alternative to the original procedure. Our procedure performs well in a general framework and is simple to implement.

26 CFR 301.7701-12 - Employer identification number.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Employer identification number. 301.7701-12 Section 301.7701-12 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) PROCEDURE AND ADMINISTRATION PROCEDURE AND ADMINISTRATION Definitions § 301.7701-12 Employer identification...

Human factors research plan for instrument procedures : FY12 version 1.1

DOT National Transportation Integrated Search

2012-06-19

This research will support the development of instrument procedures for performance-based navigation (PBN) operations. These procedures include, but are not limited to, area navigation (RNAV) and required navigation performance (RNP) operations. The ...

Spacecraft crew procedures from paper to computers

NASA Technical Reports Server (NTRS)

Oneal, Michael; Manahan, Meera

1991-01-01

Described here is a research project that uses human factors and computer systems knowledge to explore and help guide the design and creation of an effective Human-Computer Interface (HCI) for spacecraft crew procedures. By having a computer system behind the user interface, it is possible to have increased procedure automation, related system monitoring, and personalized annotation and help facilities. The research project includes the development of computer-based procedure system HCI prototypes and a testbed for experiments that measure the effectiveness of HCI alternatives in order to make design recommendations. The testbed will include a system for procedure authoring, editing, training, and execution. Progress on developing HCI prototypes for a middeck experiment performed on Space Shuttle Mission STS-34 and for upcoming medical experiments are discussed. The status of the experimental testbed is also discussed.

Iraq’s Debt Relief: Procedure and Potential Implications for International Debt Relief

DTIC Science & Technology

2009-01-26

countries use different interest rates and levy different penalties for Iraq’s payment arrears . Hence, the debt owed to each creditor can grow at...REPORT DATE 26 JAN 2009 2. REPORT TYPE 3. DATES COVERED 00-00-2009 to 00-00-2009 4. TITLE AND SUBTITLE Iraq’s Debt Relief: Procedure and...Potential Implications for International Debt Relief 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e

CaseMIDAS - A reactive planning architecture for the man-machine integration design and analysis system

NASA Technical Reports Server (NTRS)

Pease, R. Adam

1995-01-01

MIDAS is a set of tools which allow a designer to specify the physical and functional characteristics of a complex system such as an aircraft cockpit, and analyze the system with regard to human performance. MIDAS allows for a number of static analyses such as military standard reach and fit analysis, display legibility analysis, and vision polars. It also supports dynamic simulation of mission segments with 3d visualization. MIDAS development has incorporated several models of human planning behavior. The CaseMIDAS effort has been to provide a simplified and unified approach to modeling task selection behavior. Except for highly practiced, routine procedures, a human operator exhibits a cognitive effort while determining what step to take next in the accomplishment of mission tasks. Current versions of MIDAS do not model this effort in a consistent and inclusive manner. CaseMIDAS also attempts to address this issue. The CaseMIDAS project has yielded an easy to use software module for case creation and execution which is integrated with existing MIDAS simulation components.

[Quantitative measures for assessing the functional state of the human body during diagnostic procedure].

PubMed

Artemenko, M V

2008-01-01

Two approaches to calculation of the qualitative measures for assessing the functional state level of human body are considered. These approaches are based on image and fuzzy set recognition theories and are used to construct diagnostic decision rules. The first approach uses the data on deviation of detected parameters from those for healthy persons; the second approach analyzes the degree of deviation of detected parameters from the approximants characterizing the correlation differences between the parameters. A method for synthesis of decision rules and the results of blood count-based research for a number of diseases (hemophilia, thrombocytopathy, hypertension, arrhythmia, hepatic cirrhosis, trichophytia) are considered. An effect of a change in the functional link between the cholesterol content in blood and the relative rate of variation of AST and ALT enzymes in blood from direct proportional (healthy state) to inverse proportional (hepatic cirrhosis) is discussed. It is shown that analysis of correlation changes in detected parameters of the human body state during diagnostic process is more effective for application in decision support systems than the state space analysis.

Experimental methods to validate measures of emotional state and readiness for duty in critical operations.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Weston, Louise Marie

2007-09-01

A recent report on criticality accidents in nuclear facilities indicates that human error played a major role in a significant number of incidents with serious consequences and that some of these human errors may be related to the emotional state of the individual. A pre-shift test to detect a deleterious emotional state could reduce the occurrence of such errors in critical operations. The effectiveness of pre-shift testing is a challenge because of the need to gather predictive data in a relatively short test period and the potential occurrence of learning effects due to a requirement for frequent testing. This reportmore » reviews the different types of reliability and validity methods and testing and statistical analysis procedures to validate measures of emotional state. The ultimate value of a validation study depends upon the percentage of human errors in critical operations that are due to the emotional state of the individual. A review of the literature to identify the most promising predictors of emotional state for this application is highly recommended.« less

Computer-assisted design and synthesis of molecularly imprinted polymers for selective extraction of acetazolamide from human plasma prior to its voltammetric determination.

PubMed

Khodadadian, Mehdi; Ahmadi, Farhad

2010-06-15

Molecularly imprinted polymers (MIPs) were computationally designed and synthesized for the selective extraction of a carbonic anhydrase inhibitor, i.e. acetazolamide (ACZ), from human plasma. Density functional theory (DFT) calculations were performed to study the intermolecular interactions in the pre-polymerization mixture and to find a suitable functional monomer in MIP preparation. The interaction energies were corrected for the basis set superposition error (BSSE) using the counterpoise (CP) correction. The polymerization solvent was simulated by means of polarizable continuum model (PCM). It was found that acrylamide (AAM) is the best candidate to prepare MIPs. To confirm the results of theoretical calculations, three MIPs were synthesized with different functional monomers and evaluated using Langmuir-Freundlich (LF) isotherm. The results indicated that the most homogeneous MIP with the highest number of binding sites is the MIP prepared by AAM. This polymer was then used as a selective adsorbent to develop a molecularly imprinted solid-phase extraction procedure followed by differential pulse voltammetry (MISPE-DPV) for clean-up and determination of ACZ in human plasma.

The augmentation algorithm and molecular phylogenetic trees

NASA Technical Reports Server (NTRS)

Holmquist, R.

1978-01-01

Moore's (1977) augmentation procedure is discussed, and it is concluded that the procedure is valid for obtaining estimates of the total number of fixed nucleotide substitutions both theoretically and in practice, for both simulated and real data, and in agreement, for experimentally dense data sets, with stochastic estimates of the divergence, provided the restrictions on codon mutability resulting from natural selection are explicitly allowed for. Tateno and Nei's (1978) critique that the augmentation procedure has a systematic bias toward overestimation of the total number of nucleotide replacements is disputed, and a data analysis suggests that ancestral sequences inferred by the method of parsimony contain a large number of incorrectly assigned nucleotides.

Evaluating innovation. Part 2: Development in neurosurgery.

PubMed

Schnurman, Zane; Kondziolka, Douglas

2016-01-01

OBJECT Patients, practitioners, payers, and regulators are advocating for reform in how medical advances are evaluated. Because surgery does not adhere to a standardized developmental pathway, how the medical community accepts a procedure remains unclear. The authors developed a new model, using publication data and patterns, that quantifies this process. Using this technique, the authors identified common archetypes and influences on neurosurgical progress from idea inception to acceptance. METHODS Seven neurosurgical procedures developed in the past 15-25 years were used as developmental case studies (endovascular coil, deep brain stimulation, vagus nerve stimulation, 1,3-bis(2-chloroethyl)-l-nitrosourea wafer, and 3 radiosurgery procedures), and the literature on each topic was evaluated. A new metric the authors termed "progressive scholarly acceptance" (PSA) was used as an end point for community acceptance. PSA was reached when the number of investigations that refine or improve a procedure eclipsed the total number of reports assessing initial efficacy. Report characteristics, including the number of patients studied, study design, and number of authoring groups from the first report to the point of PSA, were assessed. RESULTS Publication data implicated factors that had an outsized influence on acceptance. First, procedural accessibility to investigators was found to influence the number of reports, number of patients studied, and number of authoring groups contributing. Barriers to accessibility included target disease rarity, regulatory restrictions, and cost. Second, the ease or difficulty in applying a randomized controlled trial had an impact on study design. Based on these 2 factors, 3 developmental archetypes were characterized to generally describe the development of surgery. CONCLUSIONS Common surgical development archetypes can be described based on factors that impact investigative methods, data accumulation, and ultimate acceptance by society. The approach and proposed terminologies in this report could inform future procedural development as well as any attempts to regulate surgical innovation.

Risk Factors for Postoperative Respiratory Mortality and Morbidity in Patients Undergoing Coronary Artery Bypass Grafting

PubMed Central

Rajaei, Samira; Dabbagh, Ali

2012-01-01

ABSTRACT Nowadays, coronary artery bypass grafting (CABG) is considered to be one of the most common surgical procedures. This procedure has been the main topic in many clinical research studies, which have assessed the effect of the procedure on patients’ outcomes. Like other surgical procedures, this procedure is also accompanied by a number of unwanted complications, including those of the respiratory system. Since the respiratory system plays an integral role in defining the clinical outcome of patients, improvements in studies that can assess and predict clinical outcomes of the respiratory system, assume greater importance. There are a number of predictive models which can assess patients in the preoperative period and introduce a number of risk factors, which could be considered as prognostic factors for patients undergoing CABG. The respiratory system is among the clinical systems that are assessed in many prediction scoring systems. This review assesses the main studies which have evaluated the possible risk factors for postoperative respiratory mortality and morbidity, in patients undergoing CABG. PMID:24223339

21 CFR 111.25 - What are the requirements under this subpart D for written procedures?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What are the requirements under this subpart D for written procedures? 111.25 Section 111.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

21 CFR 111.25 - What are the requirements under this subpart D for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements under this subpart D for written procedures? 111.25 Section 111.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

21 CFR 111.25 - What are the requirements under this subpart D for written procedures?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What are the requirements under this subpart D for written procedures? 111.25 Section 111.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

21 CFR 111.8 - What are the requirements under this subpart B for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements under this subpart B for written procedures? 111.8 Section 111.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

40 CFR 26.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-07-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... kinds of research involving no more than minimal risk, and for minor changes in approved research. 26... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2011 CFR

2011-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2012 CFR

2012-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2010 CFR

2010-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2013 CFR

2013-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure for...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2014 CFR

2014-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure for...

21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...

78 FR 16914 - Proposed Collection; Comment Request for Revenue Procedure 2010-13

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... soliciting comments concerning Revenue Procedure 2010-13, Section 469 Grouping activities. DATES: Written... . SUPPLEMENTARY INFORMATION: Title: Section 469 Grouping activities. OMB Number: 1545-2156. Notice Number: Revenue... Service their groupings and regroupings of activities and the addition of specific activities within their...

SELECTIVE ENUMERATION OF AROMATIC AND ALIPHATIC HYDROCARBON DEGRADING BACTERIA BY A MOST-PROBABLE-NUMBER PROCEDURE

EPA Science Inventory

A most-portable-number (MPN) procedure was developed to separately enumerate aliphatic and aromatic hydrocarbon degrading bacteria, because most of the currently available methods are unable to distinguish between these two groups. Separate 96-well microtiter plates are used to ...

Vitrification of zona-free rabbit expanded or hatching blastocysts: a possible model for human blastocysts.

PubMed

Cervera, R P; Garcia-Ximénez, F

2003-10-01

The purpose of this study was to test the effectiveness of one two-step (A) and two one-step (B1 and B2) vitrification procedures on denuded expanded or hatching rabbit blastocysts held in standard sealed plastic straws as a possible model for human blastocysts. The effect of blastocyst size was also studied on the basis of three size categories (I: diameter <200 micro m; II: diameter 200-299 micro m; III: diameter >/==" BORDER="0">300 micro m). Rabbit expanded or hatching blastocysts were vitrified at day 4 or 5. Before vitrification, the zona pellucida was removed using acidic phosphate buffered saline. For the two-step procedure, prior to vitrification, blastocysts were pre- equilibrated in a solution containing 10% dimethyl sulphoxide (DMSO) and 10% ethylene glycol (EG) for 1 min. Different final vitrification solutions were compared: 20% DMSO and 20% EG with (A and B1) or without (B2) 0.5 mol/l sucrose. Of 198 vitrified blastocysts, 181 (91%) survived, regardless of the vitrification procedure applied. Vitrification procedure A showed significantly higher re-expansion (88%), attachment (86%) and trophectoderm outgrowth (80%) rates than the two one-step vitrification procedures, B1 and B2 (46 and 21%, 20 and 33%, and 18 and 23%, respectively). After warming, blastocysts of greater size (II and III) showed significantly higher attachment (54 and 64%) and trophectoderm outgrowth (44 and 58%) rates than smaller blastocysts (I, attachment: 29%; trophectoderm outgrowth: 25%). These result demonstrate that denuded expanded or hatching rabbit blastocysts of greater size can be satisfactorily vitrified by use of a two-step procedure. The similarity of vitrification solutions used in humans could make it feasible to test such a procedure on human denuded blastocysts of different sizes.

Simulation center training as a means to improve resident performance in percutaneous noncontinuous CT-guided fluoroscopic procedures with dose reduction.

PubMed

Mendiratta-Lala, Mishal; Williams, Todd R; Mendiratta, Vivek; Ahmed, Hafeez; Bonnett, John W

2015-04-01

The purpose of this study was to evaluate the effectiveness of a multifaceted simulation-based resident training for CT-guided fluoroscopic procedures by measuring procedural and technical skills, radiation dose, and procedure times before and after simulation training. A prospective analysis included 40 radiology residents and eight staff radiologists. Residents took an online pretest to assess baseline procedural knowledge. Second-through fourth-year residents' baseline technical skills with a procedural phantom were evaluated. First-through third-year residents then underwent formal didactic and simulation-based procedural and technical training with one of two interventional radiologists and followed the training with 1 month of supervised phantom-based practice. Thereafter, residents underwent final written and practical examinations. The practical examination included essential items from a 20-point checklist, including site and side marking, consent, time-out, and sterile technique along with a technical skills portion assessing pedal steps, radiation dose, needle redirects, and procedure time. The results indicated statistically significant improvement in procedural and technical skills after simulation training. For residents, the median number of pedal steps decreased by three (p=0.001), median dose decreased by 15.4 mGy (p<0.001), median procedure time decreased by 4.0 minutes (p<0.001), median number of needle redirects decreased by 1.0 (p=0.005), and median number of 20-point checklist items successfully completed increased by three (p<0.001). The results suggest that procedural skills can be acquired and improved by simulation-based training of residents, regardless of experience. CT simulation training decreases procedural time, decreases radiation dose, and improves resident efficiency and confidence, which may transfer to clinical practice with improved patient care and safety.

Bariatric Surgery and Endoluminal Procedures: IFSO Worldwide Survey 2014.

PubMed

Angrisani, L; Santonicola, A; Iovino, P; Vitiello, A; Zundel, N; Buchwald, H; Scopinaro, N

2017-09-01

Several bariatric surgery worldwide surveys have been previously published to illustrate the evolution of bariatric surgery in the last decades. The aim of this survey is to report an updated overview of all bariatric procedures performed in 2014.For the first time, a special section on endoluminal techniques was added. The 2014 International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) survey form evaluating the number and the type of surgical and endoluminal bariatric procedures was emailed to all IFSO societies. Trend analyses from 2011 to 2014 were also performed. There were 56/60 (93.3%) responders. The total number of bariatric/metabolic procedures performed in 2014 consisted of 579,517 (97.6%) surgical operations and 14,725 (2.4%) endoluminal procedures. The most commonly performed procedure in the world was sleeve gastrectomy (SG) that reached 45.9%, followed by Roux-en-Y gastric bypass (RYGB) (39.6%), and adjustable gastric banding (AGB) (7.4%). The annual percentage changes from 2013 revealed the increase of SG and decrease of RYGB in all the IFSO regions (USA/Canada, Europe, and Asia/Pacific) with the exception of Latin/South America, where SG decreased and RYGB represented the most frequent procedure. There was a further increase in the total number of bariatric/metabolic procedures in 2014 and SG is currently the most frequent surgical procedure in the world. This is the first survey that describes the endoluminal procedures, but the accuracy of provided data should be hopefully improved in the next future. We encourage the creation of further national registries and their continuous updates taking into account all new bariatric procedures including the endoscopic procedures that will obtain increasing importance in the near future.

Large-scale Isolation of Highly Pure "Untouched" Regulatory T Cells in a GMP Environment for Adoptive Cell Therapy.

PubMed

Haase, Doreen; Puan, Kia Joo; Starke, Mireille; Lai, Tuck Siong; Soh, Melissa Yan Ling; Karunanithi, Iyswariya; San Luis, Boris; Poh, Tuang Yeow; Yusof, Nurhashikin; Yeap, Chun Hsien; Phang, Chew Yen; Chye, Willis Soon Yuan; Chan, Marieta; Koh, Mickey Boon Chai; Goh, Yeow Tee; Bertin-Maghit, Sebastien; Nardin, Alessandra; Ho, Liam Pock; Rotzschke, Olaf

2015-01-01

Adoptive cell therapy is an emerging treatment strategy for a number of serious diseases. Regulatory T (Treg) cells represent 1 cell type of particular interest for therapy of inflammatory conditions, as they are responsible for controlling unwanted immune responses. Initial clinical trials of adoptive transfer of Treg cells in patients with graft-versus-host disease were shown to be safe. However, obtaining sufficient numbers of highly pure and functional Treg cells with minimal contamination remains a challenge. We developed a novel approach to isolate "untouched" human Treg cells from healthy donors on the basis of negative selection using the surface markers CD49d and CD127. This procedure, which uses an antibody cocktail and magnetic beads for separation in an automated system (RoboSep), was scaled up and adapted to be compatible with good manufacturing practice conditions. With this setup we performed 9 Treg isolations from large-scale leukapheresis samples in a good manufacturing practice facility. These runs yielded sufficient numbers of "untouched" Treg cells for immediate use in clinical applications. The cell preparations consisted of viable highly pure FoxP3-positive Treg cells that were functional in suppressing the proliferation of effector T cells. Contamination with CD4 effector T cells was <10%. All other cell types did not exceed 2% in the final product. Remaining isolation reagents were reduced to levels that are considered safe. Treg cells isolated with this procedure will be used in a phase I clinical trial of adoptive transfer into leukemia patients developing graft-versus-host disease after stem cell transplantation.

Shortfalls in pediatric hydrocephalus clinical outcome analysis.

PubMed

Walid, Mohammad Sami; Robinson, Joe Sam

2012-06-01

In this paper, we used search engine technology to study outcome analysis and cost awareness of child hydrocephalus in the literature. The aggregate hospital charges of hydrocephalus treatment procedures for patients <18 years old was extracted from the Nationwide Inpatient Sample (NIS) data. Hydrocephalus literature was probed through the PubMed biomedical search engine. Aggregate hospital charges associated with ventriculo-peritoneal shunting as the principle procedure for patients <18 years old have increased 1.7-fold over a 13-year period to 235.6 million in 2009. Hospital discharges, however, decreased from 3,390 in 1997 to 2,525 in 2009 (25.5% decrease over 13 years). The number of papers in English language indexed by PubMed in relation to child hydrocephalus in humans increased from 81 papers in 1996 to 133 in 2010 (1.6-fold increase), totaling 1,694 over 15 years. Randomized controlled trials published in relation to child hydrocephalus totaled 16 over the same period (0.94% of child hydrocephalus papers). Papers related to child hydrocephalus with "costs and cost analysis" as medical subject heading totaled 13 papers (0.77%). Over the past 15 years, disappointingly the number of printed child hydrocephalus papers appeared to have only plateaued. Strikingly, only a very small number of these papers were directed toward randomized control studies, the sine qua non of high-grade clinical evidence. Moreover, very few papers make reference to cost analysis or economics in the treatment of hydrocephalus - an issue coming increasingly before the nation at this point.

Validating Diagnostic and Screening Procedures for Pre-Motor Parkinson’s Disease

DTIC Science & Technology

2013-04-01

Screening Procedures for Pre-motor Parkinson’s Disease 5b. GRANT NUMBER W81XWH-11-1-0310 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR( S ) Dr. J William...Procedures for Pre-Motor Parkinson’s Disease PRINCIPAL INVESTIGATOR: Dr. J William Langston CONTRACTING ORGANIZATION: Parkinson’s...those of the author( s ) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other

Validating Diagnostic and Screening Procedures for Pre-Motor Parkinson’s Disease

DTIC Science & Technology

2014-04-01

Screening Procedures for Pre-motor Parkinson’s Disease 5b. GRANT NUMBER W81XWH-11-1-0310 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR( S ) Dr. J William...Procedures for Pre-Motor Parkinson’s Disease PRINCIPAL INVESTIGATOR: Dr. J William Langston CONTRACTING ORGANIZATION: Parkinson’s...are those of the author( s ) and should not be construed as an official Department of the Army position, policy or decision unless so designated by

The procedure for isolation of neoplasms on the retina of the eye

NASA Astrophysics Data System (ADS)

Komkova, S. V.

2018-01-01

In operation, a computer diagnostic procedure on the human retina neoplasms. The use of this technique in medical institutions in the operation of the ophthalmic practitioner allows earlv detection of the disease, at periodic inspection of a pictorial pattern of disease progression. The test procedure is performed on a set of real human retinal photographs taken from international STARE database with known diagnoses. Given the numerous experiments which show the possibility of using this technique, developed on the basis of the diagnostic system in a doctor’s office-ophthalmic.

Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays.

PubMed

Rossum, Huub H van; Kemperman, Hans

2017-07-26

General application of a moving average (MA) as continuous analytical quality control (QC) for routine chemistry assays has failed due to lack of a simple method that allows optimization of MAs. A new method was applied to optimize the MA for routine chemistry and was evaluated in daily practice as continuous analytical QC instrument. MA procedures were optimized using an MA bias detection simulation procedure. Optimization was graphically supported by bias detection curves. Next, all optimal MA procedures that contributed to the quality assurance were run for 100 consecutive days and MA alarms generated during working hours were investigated. Optimized MA procedures were applied for 24 chemistry assays. During this evaluation, 303,871 MA values and 76 MA alarms were generated. Of all alarms, 54 (71%) were generated during office hours. Of these, 41 were further investigated and were caused by ion selective electrode (ISE) failure (1), calibration failure not detected by QC due to improper QC settings (1), possible bias (significant difference with the other analyzer) (10), non-human materials analyzed (2), extreme result(s) of a single patient (2), pre-analytical error (1), no cause identified (20), and no conclusion possible (4). MA was implemented in daily practice as a continuous QC instrument for 24 routine chemistry assays. In our setup when an MA alarm required follow-up, a manageable number of MA alarms was generated that resulted in valuable MA alarms. For the management of MA alarms, several applications/requirements in the MA management software will simplify the use of MA procedures.

Optimization of Unnicked β2-Glycoprotein I and High Avidity Anti-β2-Glycoprotein I Antibodies Isolation

PubMed Central

Artenjak, Andrej; Leonardi, Adrijana; Križaj, Igor; Ambrožič, Aleš; Sodin-Semrl, Snezna; Božič, Borut; Čučnik, Saša

2014-01-01

Patient biological material for isolation of β2-glycoprotein I (β2GPI) and high avidity IgG anti-β2-glycoprotein I antibodies (HAv anti-β2GPI) dictates its full utilization. The aim of our study was to evaluate/improve procedures for isolation of unnicked β2GPI and HAv aβ2GPI to gain unmodified proteins in higher yields/purity. Isolation of β2GPI from plasma was a stepwise procedure combining nonspecific and specific methods. For isolation of polyclonal HAv aβ2GPI affinity chromatographies with immobilized protein G and human β2GPI were used. The unknown protein found during isolation was identified by liquid chromatography electrospray ionization mass spectrometry and the nonredundant National Center for Biotechnology Information database. The average mass of the isolated unnicked purified β2GPI increased from 6.56 mg to 9.94 mg. In the optimized isolation procedure the high molecular weight protein (proteoglycan 4) was successfully separated from β2GPI in the 1st peaks with size exclusion chromatography. The average efficiency of the isolation procedure for polyclonal HAv anti-β2GPI from different matrixes was 13.8%, as determined by our in-house anti-β2GPI ELISA. We modified the in-house isolation and purification procedures of unnicked β2GPI and HAv anti-β2GPI, improving the purity of antigen and antibodies as well as increasing the number of tests routinely performed with the in-house ELISA by ~50%. PMID:24741579

Activity of the Human Rhinovirus 3C Protease Studied in Various Buffers, Additives and Detergents Solutions for Recombinant Protein Production

PubMed Central

Tufail, Soban; Ismat, Fouzia; Imran, Muhammad; Iqbal, Mazhar; Mirza, Osman; Rhaman, Moazur

2016-01-01

Proteases are widely used to remove affinity and solubility tags from recombinant proteins to avoid potential interference of these tags with the structure and function of the fusion partner. In recent years, great interest has been seen in use of the human rhinovirus 3C protease owing to its stringent sequence specificity and enhanced activity. Like other proteases, activity of the human rhinovirus 3C protease can be affected in part by the buffer components and additives that are generally employed for purification and stabilization of proteins, hence, necessitate their removal by tedious and time-consuming procedures before proteolysis can occur. To address this issue, we examined the effect of elution buffers used for common affinity based purifications, salt ions, stability/solubility and reducing agents, and detergents on the activity of the human rhinovirus 3C protease using three different fusion proteins at 4°C, a temperature of choice for purification of many proteins. The results show that the human rhinovirus 3C protease performs better at 4°C than the frequently used tobacco etch virus protease and its activity was insensitive to most of the experimental conditions tested. Though number of fusion proteins tested is limited, we expect that these finding will facilitate the use of the human rhinovirus 3C protease in recombinant protein production for pharmaceutical and biotechnological applications. PMID:27093053

Activity of the Human Rhinovirus 3C Protease Studied in Various Buffers, Additives and Detergents Solutions for Recombinant Protein Production.

PubMed

Ullah, Raheem; Shah, Majid Ali; Tufail, Soban; Ismat, Fouzia; Imran, Muhammad; Iqbal, Mazhar; Mirza, Osman; Rhaman, Moazur

2016-01-01

Proteases are widely used to remove affinity and solubility tags from recombinant proteins to avoid potential interference of these tags with the structure and function of the fusion partner. In recent years, great interest has been seen in use of the human rhinovirus 3C protease owing to its stringent sequence specificity and enhanced activity. Like other proteases, activity of the human rhinovirus 3C protease can be affected in part by the buffer components and additives that are generally employed for purification and stabilization of proteins, hence, necessitate their removal by tedious and time-consuming procedures before proteolysis can occur. To address this issue, we examined the effect of elution buffers used for common affinity based purifications, salt ions, stability/solubility and reducing agents, and detergents on the activity of the human rhinovirus 3C protease using three different fusion proteins at 4°C, a temperature of choice for purification of many proteins. The results show that the human rhinovirus 3C protease performs better at 4°C than the frequently used tobacco etch virus protease and its activity was insensitive to most of the experimental conditions tested. Though number of fusion proteins tested is limited, we expect that these finding will facilitate the use of the human rhinovirus 3C protease in recombinant protein production for pharmaceutical and biotechnological applications.

Advances in Significance Testing for Cluster Detection

NASA Astrophysics Data System (ADS)

Coleman, Deidra Andrea

Over the past two decades, much attention has been given to data driven project goals such as the Human Genome Project and the development of syndromic surveillance systems. A major component of these types of projects is analyzing the abundance of data. Detecting clusters within the data can be beneficial as it can lead to the identification of specified sequences of DNA nucleotides that are related to important biological functions or the locations of epidemics such as disease outbreaks or bioterrorism attacks. Cluster detection techniques require efficient and accurate hypothesis testing procedures. In this dissertation, we improve upon the hypothesis testing procedures for cluster detection by enhancing distributional theory and providing an alternative method for spatial cluster detection using syndromic surveillance data. In Chapter 2, we provide an efficient method to compute the exact distribution of the number and coverage of h-clumps of a collection of words. This method involves defining a Markov chain using a minimal deterministic automaton to reduce the number of states needed for computation. We allow words of the collection to contain other words of the collection making the method more general. We use our method to compute the distributions of the number and coverage of h-clumps in the Chi motif of H. influenza.. In Chapter 3, we provide an efficient algorithm to compute the exact distribution of multiple window discrete scan statistics for higher-order, multi-state Markovian sequences. This algorithm involves defining a Markov chain to efficiently keep track of probabilities needed to compute p-values of the statistic. We use our algorithm to identify cases where the available approximation does not perform well. We also use our algorithm to detect unusual clusters of made free throw shots by National Basketball Association players during the 2009-2010 regular season. In Chapter 4, we give a procedure to detect outbreaks using syndromic surveillance data while controlling the Bayesian False Discovery Rate (BFDR). The procedure entails choosing an appropriate Bayesian model that captures the spatial dependency inherent in epidemiological data and considers all days of interest, selecting a test statistic based on a chosen measure that provides the magnitude of the maximumal spatial cluster for each day, and identifying a cutoff value that controls the BFDR for rejecting the collective null hypothesis of no outbreak over a collection of days for a specified region.We use our procedure to analyze botulism-like syndrome data collected by the North Carolina Disease Event Tracking and Epidemiologic Collection Tool (NC DETECT).

Visual Contrast Sensitivity Functions Obtained from Untrained Observers Using Tracking and Staircase Procedures. Final Report.

ERIC Educational Resources Information Center

Geri, George A.; Hubbard, David C.

Two adaptive psychophysical procedures (tracking and "yes-no" staircase) for obtaining human visual contrast sensitivity functions (CSF) were evaluated. The procedures were chosen based on their proven validity and the desire to evaluate the practical effects of stimulus transients, since tracking procedures traditionally employ gradual…

45 CFR 16.4 - Summary of procedures below.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Summary of procedures below. 16.4 Section 16.4 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROCEDURES OF THE DEPARTMENTAL GRANT APPEALS BOARD § 16.4 Summary of procedures below. The Board's basic process is review of a...

The procedure execution manager and its application to Advanced Photon Source operation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Borland, M.

1997-06-01

The Procedure Execution Manager (PEM) combines a complete scripting environment for coding accelerator operation procedures with a manager application for executing and monitoring the procedures. PEM is based on Tcl/Tk, a supporting widget library, and the dp-tcl extension for distributed processing. The scripting environment provides support for distributed, parallel execution of procedures along with join and abort operations. Nesting of procedures is supported, permitting the same code to run as a top-level procedure under operator control or as a subroutine under control of another procedure. The manager application allows an operator to execute one or more procedures in automatic, semi-automatic,more » or manual modes. It also provides a standard way for operators to interact with procedures. A number of successful applications of PEM to accelerator operations have been made to date. These include start-up, shutdown, and other control of the positron accumulator ring (PAR), low-energy transport (LET) lines, and the booster rf systems. The PAR/LET procedures make nested use of PEM`s ability to run parallel procedures. There are also a number of procedures to guide and assist tune-up operations, to make accelerator physics measurements, and to diagnose equipment. Because of the success of the existing procedures, expanded use of PEM is planned.« less

Fluorescence- and magnetic-activated cell sorting strategies to separate spermatozoa involving plural contributors from biological mixtures for human identification

PubMed Central

Xu, Yan; Xie, Jianhui; Chen, Ronghua; Cao, Yu; Ping, Yuan; Xu, Qingwen; Hu, Wei; Wu, Dan; Gu, Lihua; Zhou, Huaigu; Chen, Xin; Zhao, Ziqin; Zhong, Jiang; Li, Rui

2016-01-01

No effective method has been developed to distinguish sperm cells originating from different men in multi-suspect sexual assault cases. Here we combined MACS and FACS to isolate single donor sperm cells from forensic mixture samples including female vaginal epithelial cells and sperm cells from multiple contributors. Sperms from vaginal swab were isolated by MACS using FITC-conjugated A kinase anchor protein 3 (AKAP3) antibody; target individual sperm cells involving two or three donors were separated by FACS using FITC-labeled blood group A/B antigen antibody. This procedure was further tested in two mock multi-suspect sexual assault samples and one practical casework sample. Our results showed that complete single donor STR profiles could be successfully obtained from sperm/epithelial cell and sperm mixtures from two contributors. For unbalanced sperm/epithelial cells and sperm cells mixtures, sensitivity results revealed that target cells could be detected at as low as 1:32 and 1:8 mixed ratios, respectively. Although highly relies on cell number and blood types or secretor status of the individuals, this procedure would still be useful tools for forensic DNA analysis of multi-suspect sexual assault cases by the combined use of FACS and MACS based on sperm-specific AKAP3 antigen and human blood type antigen. PMID:27857155

Vitrification and xenografting of human ovarian tissue.

PubMed

Amorim, Christiani Andrade; Dolmans, Marie-Madeleine; David, Anu; Jaeger, Jonathan; Vanacker, Julie; Camboni, Alessandra; Donnez, Jacques; Van Langendonckt, Anne

2012-11-01

To assess the efficiency of two vitrification protocols to cryopreserve human preantral follicles with the use of a xenografting model. Pilot study. Gynecology research unit in a university hospital. Ovarian biopsies were obtained from seven women aged 30-41 years. Ovarian tissue fragments were subjected to one of three cryopreservation protocols (slow freezing, vitrification protocol 1, and vitrification protocol 2) and xenografted for 1 week to nude mice. The number of morphologically normal follicles after cryopreservation and grafting and fibrotic surface area were determined by histologic analysis. Apoptosis was assessed by the TUNEL method. Morphometric analysis of TUNEL-positive surface area also was performed. Follicle proliferation was evaluated by immunohistochemistry. After xenografting, a difference was observed between the cryopreservation procedures applied. According to TUNEL analysis, both vitrification protocols showed better preservation of preantral follicles than the conventional freezing method. Moreover, histologic evaluation showed a significantly higher proportion of primordial follicles in vitrified (protocol 2)-warmed ovarian tissue than in frozen-thawed tissue. The proportion of growing follicles and fibrotic surface area was similar in all groups. Vitrification procedures appeared to preserve not only the morphology and survival of preantral follicles after 1 week of xenografting, but also their ability to resume folliculogenesis. In addition, vitrification protocol 2 had a positive impact on the quiescent state of primordial follicles after xenografting. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Direct Conversion of Human Fibroblasts into Schwann Cells that Facilitate Regeneration of Injured Peripheral Nerve In Vivo

PubMed Central

Sowa, Yoshihiro; Kishida, Tsunao; Tomita, Koichi; Yamamoto, Kenta; Numajiri, Toshiaki

2017-01-01

Abstract Schwann cells (SCs) play pivotal roles in the maintenance and regeneration of the peripheral nervous system. Although transplantation of SCs enhances repair of experimentally damaged peripheral and central nerve tissues, it is difficult to prepare a sufficient number of functional SCs for transplantation therapy without causing adverse events for the donor. Here, we generated functional SCs by somatic cell reprogramming procedures and demonstrated their capability to promote peripheral nerve regeneration. Normal human fibroblasts were phenotypically converted into SCs by transducing SOX10 and Krox20 genes followed by culturing for 10 days resulting in approximately 43% directly converted Schwann cells (dSCs). The dSCs expressed SC‐specific proteins, secreted neurotrophic factors, and induced neuronal cells to extend neurites. The dSCs also displayed myelin‐forming capability both in vitro and in vivo. Moreover, transplantation of the dSCs into the transected sciatic nerve in mice resulted in significantly accelerated regeneration of the nerve and in improved motor function at a level comparable to that with transplantation of the SCs obtained from a peripheral nerve. The dSCs induced by our procedure may be applicable for novel regeneration therapy for not only peripheral nerve injury but also for central nerve damage and for neurodegenerative disorders related to SC dysfunction. Stem Cells Translational Medicine 2017;6:1207–1216 PMID:28186702

78 FR 18285 - Direct Final Rulemaking Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... issue a direct final rule adopting amendments that become effective a number of days (specified in the... rules. NHTSA would not use direct final rule procedures for complex or controversial issues. [[Page... to http://www.regulations.gov and search by Docket ID number NHTSA-2013-0042 at any time. Follow the...

75 FR 59320 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... Number: 2120-0018. Title: Certification Procedures for Products and Parts. Form Numbers: FAA Forms 8110... Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection(s): Certification Procedures for Products and Parts AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice and...

Very Large Data Volumes Analysis of Collaborative Systems with Finite Number of States

ERIC Educational Resources Information Center

Ivan, Ion; Ciurea, Cristian; Pavel, Sorin

2010-01-01

The collaborative system with finite number of states is defined. A very large database is structured. Operations on large databases are identified. Repetitive procedures for collaborative systems operations are derived. The efficiency of such procedures is analyzed. (Contains 6 tables, 5 footnotes and 3 figures.)

Association between participation and compliance with Continuing Medical Education and care production by physicians: a cross-sectional study

PubMed Central

Carrera, Renato Melli; Cendoroglo, Miguel; Gonçales, Paulo David Scatena; Marques, Flavio Rocha Brito; Sardenberg, Camila; Glezer, Milton; dos Santos, Oscar Fernando Pavão; Rizzo, Luiz Vicente; Lottenberg, Claudio Luiz; Schvartsman, Cláudio

2015-01-01

Objective Physician participation in Continuing Medical Education programs may be influenced by a number of factors. To evaluate the factors associated with compliance with the Continuing Medical Education requirements at a private hospital, we investigated whether physicians’ activity, measured by volumes of admissions and procedures, was associated with obtaining 40 Continuing Medical Education credits (40 hours of activities) in a 12-month cycle. Methods In an exclusive and non-mandatory Continuing Medical Education program, we collected physicians’ numbers of hospital admissions and numbers of surgical procedures performed. We also analyzed data on physicians’ time since graduation, age, and gender. Results A total of 3,809 credentialed, free-standing, private practice physicians were evaluated. Univariate analysis showed that the Continuing Medical Education requirements were more likely to be achieved by male physicians (odds ratio 1.251; p=0.009) and who had a higher number of hospital admissions (odds ratio 1.022; p<0.001). Multivariate analysis showed that age and number of hospital admissions were associated with achievement of the Continuing Medical Education requirements. Each hospital admission increased the chance of achieving the requirements by 0.4%. Among physicians who performed surgical procedures, multivariate analysis showed that male physicians were 1.3 time more likely to achieve the Continuing Medical Education requirements than female physicians. Each surgical procedure performed increased the chance of achieving the requirements by 1.4%. Conclusion The numbers of admissions and number of surgical procedures performed by physicians at our hospital were associated with the likelihood of meeting the Continuing Medical Education requirements. These findings help to shed new light on our Continuing Medical Education program. PMID:25807247

Risk-sensitive choice in humans as a function of an earnings budget.

PubMed Central

Pietras, C J; Hackenberc, T D

2001-01-01

Risky choice in 3 adult humans was investigated across procedural manipulations designed to model energy-budget manipulations conducted with nonhumans. Subjects were presented with repeated choices between a fixed and a variable number of points. An energy budget was simulated by use of an earnings budget, defined as the number of points needed within a block of trials for points to be exchanged for money. During positive earnings-budget conditions, exclusive preference for the fixed option met the earnings requirement. During negative earnings-budget conditions, exclusive preference for the certain option did not meet the earnings requirement, but choice for the variable option met the requirement probabilistically. Choice was generally risk averse (the fixed option was preferred) when the earnings budget was positive and risk prone (the variable option was preferred) when the earnings budget was negative. Furthermore, choice was most risk prone during negative earnings-budget conditions in which the earnings requirement was most stringent. Local choice patterns were also frequently consistent with the predictions of a dynamic optimization model, indicating that choice was simultaneously sensitive to short-term choice contingencies, current point earnings, and the earnings requirement. Overall, these results show that the patterns of risky choice generated by energy-budget variables can also be produced by choice contingencies that do not involve immediate survival, and that risky choice in humans may be similar to that shown in nonhumans when choice is studied under analogous experimental conditions. PMID:11516113

No evidence of purported lunar effect on hospital admission rates or birth rates.

PubMed

Margot, Jean-Luc

2015-01-01

Studies indicate that a fraction of nursing professionals believe in a "lunar effect"-a purported correlation between the phases of the Earth's moon and human affairs, such as birth rates, blood loss, or fertility. This article addresses some of the methodological errors and cognitive biases that can explain the human tendency of perceiving a lunar effect where there is none. This article reviews basic standards of evidence and, using an example from the published literature, illustrates how disregarding these standards can lead to erroneous conclusions. Román, Soriano, Fuentes, Gálvez, and Fernández (2004) suggested that the number of hospital admissions related to gastrointestinal bleeding was somehow influenced by the phases of the Earth's moon. Specifically, the authors claimed that the rate of hospital admissions to their bleeding unit is higher during the full moon than at other times. Their report contains a number of methodological and statistical flaws that invalidate their conclusions. Reanalysis of their data with proper procedures shows no evidence that the full moon influences the rate of hospital admissions, a result that is consistent with numerous peer-reviewed studies and meta-analyses. A review of the literature shows that birth rates are also uncorrelated to lunar phases. Data collection and analysis shortcomings, as well as powerful cognitive biases, can lead to erroneous conclusions about the purported lunar effect on human affairs. Adherence to basic standards of evidence can help assess the validity of questionable beliefs.

Garrison Clinical Setting Inadequate for Maintenance of Procedural Skills for Emergency Medicine Physicians: A Cross-Sectional Study.

PubMed

Schauer, Steven G; Varney, Shawn M; Cox, Kristin L

2015-01-01

Emergency medicine physicians (EPs) are often placed in far-forward, isolated areas in theater. Maintenance of their emergency intervention skills is vital to keep the medical forces deployment ready. The US Army suggests that working at a Military Treatment Facility (MTF) is sufficient to keep emergency procedural skills at a deployment-ready level. We sought to compare the volume of emergency procedures that providers reported necessary to maintain their skills with the number available in the MTF setting. EPs were surveyed to quantify the number of procedures they reported they would need to perform yearly to stay deployment-ready. We obtained procedure data for their duty stations and compared the procedure volume with the survey responses to determine if working at an MTF is sufficient to keep providers' skills deployment ready. The reported necessary average numbers per year were as follows: tube thoracostomy (5.9), intubation (11.4), cricothyrotomy (4.2), lumbar puncture (5.2), central line (10.0), focused assessment with sonography for trauma (FAST) (21.3), reductions (10.6), splints (10.5), and sedations (11.7). None of the procedure volumes at MTFs met provider requirements with the exception of FAST examinations at the only trauma center. This suggests the garrison clinical environment is inadequate for maintaining procedure skills. Further research is needed to determine modalities that will provide adequate training volume. 2015.

The application of rules in morphology, syntax and number processing: a case of selective deficit of procedural or executive mechanisms?

PubMed

Macoir, Joël; Fossard, Marion; Nespoulous, Jean-Luc; Demonet, Jean-François; Bachoud-Lévi, Anne-Catherine

2010-08-01

Declarative memory is a long-term store for facts, concepts and words. Procedural memory subserves the learning and control of sensorimotor and cognitive skills, including the mental grammar. In this study, we report a single-case study of a mild aphasic patient who showed procedural deficits in the presence of preserved declarative memory abilities. We administered several experiments to explore rule application in morphology, syntax and number processing. Results partly support the differentiation between declarative and procedural memory. Moreover, the patient's performance varied according to the domain in which rules were to be applied, which underlines the need for more fine-grained distinctions in cognition between procedural rules.

Acceptance procedures for dense-graded mixes

DOT National Transportation Integrated Search

2001-03-01

Recent literature related to acceptance procedures for dense-graded mixtures is summarized. Current state of practice and development of acceptance procedures are reviewed. Many agencies are reducing the number of process control-related parameters i...

Prognostic factors for patients undergoing vitrified-warmed human embryo transfer cycles: a retrospective cohort study.

PubMed

Takahashi, Toshifumi; Hasegawa, Ayumi; Igarashi, Hideki; Amita, Mitsuyoshi; Matsukawa, Jun; Takehara, Isao; Suzuki, Satoko; Nagase, Satoru

2017-06-01

We examined the prognostic factors for pregnancy in 210 vitrified-warmed embryo transfer (ET) cycles in 121 patients. The univariate analysis showed that age, gravida, the number of cycles associated with infertility caused by endometriosis, the number of previous assisted reproductive technology (ART) treatment cycles, and the number of ICSI procedures were significantly lower in pregnant cycles compared with non-pregnant cycles. The percentages of ET using at least one intact embryo and of ET using at least one embryo that had developed further after warming were significantly higher in pregnant cycles compared with non-pregnant cycles. Multivariate logistic regression analysis showed that previous ART treatment cycles, ET with at least one intact embryo, and ET using at least one embryo that had developed further were independent prognostic factors for pregnancy in vitrified-warmed ET cycles. We conclude that fewer previous ART treatment cycles, ET using at least one intact embryo, and ET with embryos that have developed further after warming might be favourable prognostic factors for pregnancy in vitrified-warmed ET cycles.

42 CFR 83.2 - How will DOL use the designations established under the procedures in this part?

Code of Federal Regulations, 2012 CFR

2012-10-01

... HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES PROCEDURES FOR... for a qualified member of the Cohort with a specified cancer, pursuant to the procedures set forth in...

42 CFR 83.2 - How will DOL use the designations established under the procedures in this part?

Code of Federal Regulations, 2013 CFR

2013-10-01

... HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES PROCEDURES FOR... for a qualified member of the Cohort with a specified cancer, pursuant to the procedures set forth in...

42 CFR 83.2 - How will DOL use the designations established under the procedures in this part?

Code of Federal Regulations, 2014 CFR

2014-10-01

... HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES PROCEDURES FOR... for a qualified member of the Cohort with a specified cancer, pursuant to the procedures set forth in...

42 CFR 83.2 - How will DOL use the designations established under the procedures in this part?

Code of Federal Regulations, 2011 CFR

2011-10-01

... HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES PROCEDURES FOR... for a qualified member of the Cohort with a specified cancer, pursuant to the procedures set forth in...

42 CFR 83.2 - How will DOL use the designations established under the procedures in this part?

Code of Federal Regulations, 2010 CFR

2010-10-01

... HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES PROCEDURES FOR... for a qualified member of the Cohort with a specified cancer, pursuant to the procedures set forth in...

An "on-matrix" digestion procedure for AP-MS experiments dissects the interplay between complex-conserved and serotype-specific reactivities in Dengue virus-human plasma interactome.

PubMed

Ramos, Yassel; Huerta, Vivian; Martín, Dayron; Palomares, Sucel; Yero, Alexis; Pupo, Dianne; Gallien, Sebastien; Martín, Alejandro M; Pérez-Riverol, Yasset; Sarría, Mónica; Guirola, Osmany; Chinea, Glay; Domon, Bruno; González, Luis Javier

2017-07-13

The interactions between the four Dengue virus (DENV) serotypes and plasma proteins are crucial in the initial steps of viral infection to humans. Affinity purification combined with quantitative mass spectrometry analysis, has become one of the most powerful tools for the investigation on novel protein-protein interactions. Using this approach, we report here that a significant number of bait-interacting proteins do not dissociate under standard elution conditions, i.e. acid pH and chaotropic agents, and that this problem can be circumvented by using the "on-matrix" digestion procedure described here. This procedure enabled the identification of 16 human plasma proteins interacting with domain III from the envelope protein of DENV serotypes 1, 3 and 4 that would have not been detected otherwise and increased the known DIIIE interactors in human plasma to 59 proteins. Selected Reaction Monitoring analysis evidenced DENV interactome in human plasma is rather conserved although significant differences on the reactivity of viral serotypes with specific proteins do exist. A comparison between the serotype-dependent profile of reactivity and the conservation pattern of amino acid residues suggests an evolutionary selection of highly conserved interactions with the host and other interactions mediated for surface regions of higher variability. False negative results on the identification of interacting proteins in pull-down experiments compromise the subsequent interpretation of results and the formulation of a working hypothesis for the derived future work. In this study we demonstrate the presence of bait-interacting proteins reluctant to dissociate under elution conditions of acid pH and presence of chaotropics. We propose the direct proteolytic digestion of proteins while still bound to the affinity matrix ("on-matrix" digestion) and evaluate the impact of this methodology in the comparative study of the interactome of the four serotypes of Dengue virus mediated by the domain III of the viral envelope glycoprotein. Fifty nine proteins were identified as putative interaction partners of Dengue virus (IPs) either due to direct binding or by co-isolation with interacting proteins. Collectively the IPs identified from the pull-down with the recombinant domain III proteins representing the four viral serotypes, 29% were identified only after "on-matrix" digestion which demonstrate the usefulness of this method of recovering bait-bound proteins. Results highlight a particular importance of "on-matrix" digestion procedure for comparative studies where a stronger interaction with one of the interest baits could prevent a bound protein to elute under standard conditions thus leading to misinterpretation as absent in the interactome of this particular bait. The analysis of the Interaction Network indicates that Dengue virus interactome mediated by the domain III of the envelope protein is rather conserved in the viral complex suggesting a key role of these interactions for viral infection thus making candidates to explore for potential biomarkers of clinical outcome in DENV-caused disease. Interestingly, some particular IPs exhibit significant differences in the strength of the interaction with the viral serotypes representing interactions that involve more variable regions in the surface of the domain III. Since such variable regions are the consequence of the interaction with antibodies generated by human immune response; this result relates the interaction with proteins from human plasma with the interplay of the virus and the human immune system. Copyright © 2017 Elsevier B.V. All rights reserved.

[Focus on planning the supply of physicians in Belgium].

PubMed

Benahmed, N; Alexander, S; De Wever, A; Deliège, D

2013-01-01

The planning of human medical resources has been in progress since 1996. The aim of this paper is to describe the process which occurred in Belgium and to point out its assets and limits. Literature review, analysis of the Belgian legislation at national and community (Flemish and French-speaking) level and analysis of the projection model. In Belgium, planniing is performed at two different levels of power. Firstly, the federal State determines the number of physicians who will access to the professional titles enabling them to obtain reimbursement of care by Health Funds. It is sustained by a supply projection type " stock and flows", an assessment of the number of required physicians (including healthcare expenditures by age and sex) and the purpose of equalizing Dutch-speaking and French-speaking medical densities. Secondly, Communities, are responsible for training and, as such, are organizing the selection at this level : entrance examination in the North and various selection procedures (now repealed) in the South. Worldwide, the managers of medical planning are faced with decisions related to appropriate numbers for human resources, given population needs, use of services and professional productivity. They have to address concerns from medical surplus to shortage. The case study of Belgium provides insight of various parameters which should be taken into account for national planning of physicians. It also shows the difficulty to assess a complex future and the factors which often hinder the implementation of evidence-based decisions.

Operational Interventions to Maintenance Error

NASA Technical Reports Server (NTRS)

Kanki, Barbara G.; Walter, Diane; Dulchinos, VIcki

1997-01-01

A significant proportion of aviation accidents and incidents are known to be tied to human error. However, research of flight operational errors has shown that so-called pilot error often involves a variety of human factors issues and not a simple lack of individual technical skills. In aircraft maintenance operations, there is similar concern that maintenance errors which may lead to incidents and accidents are related to a large variety of human factors issues. Although maintenance error data and research are limited, industry initiatives involving human factors training in maintenance have become increasingly accepted as one type of maintenance error intervention. Conscientious efforts have been made in re-inventing the team7 concept for maintenance operations and in tailoring programs to fit the needs of technical opeRAtions. Nevertheless, there remains a dual challenge: 1) to develop human factors interventions which are directly supported by reliable human error data, and 2) to integrate human factors concepts into the procedures and practices of everyday technical tasks. In this paper, we describe several varieties of human factors interventions and focus on two specific alternatives which target problems related to procedures and practices; namely, 1) structured on-the-job training and 2) procedure re-design. We hope to demonstrate that the key to leveraging the impact of these solutions comes from focused interventions; that is, interventions which are derived from a clear understanding of specific maintenance errors, their operational context and human factors components.

Reduction of Maintenance Error Through Focused Interventions

NASA Technical Reports Server (NTRS)

Kanki, Barbara G.; Walter, Diane; Rosekind, Mark R. (Technical Monitor)

1997-01-01

It is well known that a significant proportion of aviation accidents and incidents are tied to human error. In flight operations, research of operational errors has shown that so-called "pilot error" often involves a variety of human factors issues and not a simple lack of individual technical skills. In aircraft maintenance operations, there is similar concern that maintenance errors which may lead to incidents and accidents are related to a large variety of human factors issues. Although maintenance error data and research are limited, industry initiatives involving human factors training in maintenance have become increasingly accepted as one type of maintenance error intervention. Conscientious efforts have been made in re-inventing the "team" concept for maintenance operations and in tailoring programs to fit the needs of technical operations. Nevertheless, there remains a dual challenge: to develop human factors interventions which are directly supported by reliable human error data, and to integrate human factors concepts into the procedures and practices of everyday technical tasks. In this paper, we describe several varieties of human factors interventions and focus on two specific alternatives which target problems related to procedures and practices; namely, 1) structured on-the-job training and 2) procedure re-design. We hope to demonstrate that the key to leveraging the impact of these solutions comes from focused interventions; that is, interventions which are derived from a clear understanding of specific maintenance errors, their operational context and human factors components.

45 CFR 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.110 Section 46.110 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN...

45 CFR 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.110 Section 46.110 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN...

45 CFR 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.110 Section 46.110 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN...

45 CFR 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.110 Section 46.110 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN...

34 CFR 97.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-07-01

... research involving no more than minimal risk, and for minor changes in approved research. 97.110 Section 97... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk...

Installation of Computerized Procedure System and Advanced Alarm System in the Human Systems Simulation Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Le Blanc, Katya Lee; Spielman, Zachary Alexander; Rice, Brandon Charles

2016-04-01

This report describes the installation of two advanced control room technologies, an advanced alarm system and a computerized procedure system, into the Human Systems Simulation Laboratory (HSSL). Installation of these technologies enables future phases of this research by providing a platform to systematically evaluate the effect of these technologies on operator and plant performance.

34 CFR 97.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-07-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... research involving no more than minimal risk, and for minor changes in approved research. 97.110 Section 97... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects...

A Modular Set of Mixed Reality Simulators for Blind and Guided Procedures

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-14-1-0113 TITLE: A Modular Set of Mixed Reality Simulators for “blind” and Guided Procedures PRINCIPAL INVESTIGATOR...2015 – 07/31/2016 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Modular Set of Mixed Reality Simulators for “Blind” and Guided Procedures 5b...editor developed to facilitate creation by non-technical educators of ITs for the set of modular simulators, (c) a curriculum for self-study and self

Imitation and Emulation by Dogs Using a Bidirectional Control Procedure

PubMed Central

Miller, Holly C.; Rayburn-Reeves, Rebecca; Zentall, Thomas R.

2009-01-01

A successful procedure for studying imitative behavior in non-humans is the bidirectional control procedure in which observers are exposed to a demonstrator that responds by moving a manipulandum in one of two different directions (e.g., left vs. right). Imitative learning is demonstrated when observers make the response in the direction that they observed it being made. This procedure controls for socially mediated effects (the mere presence of a demonstrator), stimulus enhancement (attention drawn to a manipulandum by its movement), and if an appropriate control is included, emulation (learning how the environment works). Recent research with dogs has found that dogs may not demonstrate imitative learning when the demonstrator is human. In the present research, we found that when odors were controlled for, dogs imitated the direction of a screen push demonstrated by another dog more than in a control condition in which they observed the screen move independently while another dog was present. Furthermore, we found that dogs would match the direction of screen push demonstrated by a human and they were equally likely to match the direction in which the screen moved independently while a human was present. PMID:18977419

An investigation into the effect of surface roughness of stainless steel on human umbilical vein endothelial cell gene expression.

PubMed

McLucas, E; Moran, M T; Rochev, Y; Carroll, W M; Smith, T J

2006-01-01

The surface properties of vascular devices dictate the initial postimplantation reactions that occur and thus the efficacy of the implantation procedure. Over the last number of years, a number of different stent designs have emerged and stents are generally polished to a mirror finish during the manufacturing procedure. This study sought to investigate the effect of stainless steel surface roughness on endothelial cell gene expression using an appropriate cell culture in vitro assay system. Stainless steel discs were roughened by shot blasting or polished by mechanical polishing. The surface roughness of the treated and untreated discs was determined by atomic force microscopy (AFM). Cells were seeded on collagen type 1 gels and left to attach for 24 h. Stainless steel discs of varying roughness were then placed in contact with the cells and incubated for 24 h. RNA extractions and quantitative real-time reverse transcriptase-polymerase chain reaction (RT-PCR) was then performed to determine the expression levels of candidate genes in the treated cells compared to suitable control cells. E-selectin and vascular cellular adhesion molecule (VCAM-1) were found to be significantly up-regulated in cells incubated with polished and roughened samples, indicating endothelial cell activation and inflammation. This study indicates that the surface roughness of stainless steel is an important surface property in the development of vascular stents.

High-resolution anoscopy: Unchartered territory for gastroenterologists?

PubMed

Albuquerque, Andreia

2015-09-25

High-resolution anoscopy (HRA) is a procedure where patients with an increased risk of anal cancer, like men who have sex with men, human immunodeficiency virus infected individuals, transplant patients and women with a history of lower genital tract neoplasia, with abnormal anal cytology results, are submitted to anal and perianal visualization under magnification. This will allow for a better detection of anal high-grade lesions that can be treated, in an effort to prevent anal cancer. Anal cancer screening follows the same principles that cervical cancer screening. During this procedure, an anoscope is inserted and a colposcope is used to examine systematically the squamocolumnar junction, the transformation zone and the perianal skin. Initially the observation is done with no staining and then with the application of acetic acid and Lugol's iodine solution, allowing for better lesion identification and characterization. Any suspicious lesion seen should be carefully evaluated and biopsied. Without HRA only a small percentage of suspicious lesions are identified. High-grade lesions that are detected can be ablated under HRA. This is a challenging exam to perform, with a long learning curve and the number of clinicians performing it is limited, although the growing number of patients that need to been screened. Specific equipment is required, with these patients ideally been followed by a multidisciplinary team, in a reference centre. HRA remains unfamiliar for many gastroenterologists.

Validating Diagnostic and Screening Procedures for Pre-Motor Parkinson’s Disease

DTIC Science & Technology

2012-04-01

motor Parkinson’s Disease 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR( S ) Dr. J William Langston 5d. PROJECT NUMBER 5e. TASK...Procedures for Pre-Motor Parkinson’s Disease PRINCIPAL INVESTIGATOR: Dr. J William Langston CONTRACTING ORGANIZATION: Parkinson’s...the author( s ) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other

Numerical procedure to determine geometric view factors for surfaces occluded by cylinders

NASA Technical Reports Server (NTRS)

Sawyer, P. L.

1978-01-01

A numerical procedure was developed to determine geometric view factors between connected infinite strips occluded by any number of infinite circular cylinders. The procedure requires a two-dimensional cross-sectional model of the configuration of interest. The two-dimensional model consists of a convex polygon enclosing any number of circles. Each side of the polygon represents one strip, and each circle represents a circular cylinder. A description and listing of a computer program based on this procedure are included in this report. The program calculates geometric view factors between individual strips and between individual strips and the collection of occluding cylinders.

A new transformation-regeneration procedure in the model legume Lotus japonicus: root explants as a source of large numbers of cells susceptible to Agrobacterium-mediated transformation.

PubMed

Lombari, P; Ercolano, E; El Alaoui, H; Chiurazzi, M

2003-04-01

We describe herein a simple and efficient transformation procedure for the production of transgenic Lotus japonicus plants. In this new procedure, dedifferentiated root explants, used as starting material, are the source of a large number of cells that are competent for the regeneration procedure, with a high susceptibility to Agrobacterium infection. The application of this protocol resulted in a tenfold increase in the number of transformants produced by a single plant in comparison to the widely used hypocotyl transformation procedure. Furthermore, our procedure allowed the use of intact plants stored for a long time at 4 degrees C, thus providing a potential continuous supply of explants for transformation experiments. The overall time of incubation under tissue culture conditions required to obtain a plant transferable into soil is 4 months. The transgenic nature of the transformants was demonstrated by the detection of beta-glucuronidase (GUS) activity in the primary transformants and by molecular analysis. Stable transformation was indicated by Mendelian segregation of the hygromycin selectable marker and of the gusA activity after selfing of the transgenic plants.

Adaptive segmentation of cerebrovascular tree in time-of-flight magnetic resonance angiography.

PubMed

Hao, J T; Li, M L; Tang, F L

2008-01-01

Accurate segmentation of the human vasculature is an important prerequisite for a number of clinical procedures, such as diagnosis, image-guided neurosurgery and pre-surgical planning. In this paper, an improved statistical approach to extracting whole cerebrovascular tree in time-of-flight magnetic resonance angiography is proposed. Firstly, in order to get a more accurate segmentation result, a localized observation model is proposed instead of defining the observation model over the entire dataset. Secondly, for the binary segmentation, an improved Iterative Conditional Model (ICM) algorithm is presented to accelerate the segmentation process. The experimental results showed that the proposed algorithm can obtain more satisfactory segmentation results and save more processing time than conventional approaches, simultaneously.

Acceptance procedures for dense-graded mixes : literature review.

DOT National Transportation Integrated Search

2001-03-01

Recent literature related to acceptance procedures for dense-graded mixtures is summarized. Current state of practice and development of acceptance procedures are reviewed. Many agencies are reducing the number of process control-related parameters i...

48 CFR 342.7101-2 - Procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Procedures. 342.7101-2 Section 342.7101-2 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES CONTRACT MANAGEMENT CONTRACT ADMINISTRATION Administrative Actions for Cost Overruns 342.7101-2 Procedures. (a) Upon...

75 FR 47817 - Notice of Availability: Test Tools and Test Procedures Approved for the Office of the National...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of Availability: Test Tools and Test Procedures.... SUMMARY: This notice announces the availability of test tools and test procedures approved by the National... certification program. The approved test tools and test procedures are identified on the ONC Web site at: http...

77 FR 64343 - Notice of Availability: Test Tools and Test Procedures Approved for the Office of the National...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of Availability: Test Tools and Test Procedures.... SUMMARY: This notice announces the availability of test tools and test procedures approved by the National... test tools and test procedures are identified on the ONC Web site at: http://www.healthit.gov/policy...

Induction of peritoneal endometriosis in nude mice with use of human immortalized endometriosis epithelial and stromal cells: a potential experimental tool to study molecular pathogenesis of endometriosis in humans.

PubMed

Banu, Sakhila K; Starzinski-Powitz, Anna; Speights, V O; Burghardt, Robert C; Arosh, Joe A

2009-05-01

To determine whether a mixed population of immortalized human endometriosis epithelial and stromal cells is able to induce peritoneal endometriosis in nude mice. Prospective experimental study. Human immortalized endometriosis epithelial and stromal cells were xenografted into ovariectomized nude mice. Macroscopically, the number of induced endometriosis-like lesions and their color were determined. Microscopically, histomorphology of endometriosis glands and their structure were analyzed, and comparisons were made with tissue from spontaneous endometriosis in women. College of Veterinary Medicine and Biomedical Sciences, Texas A&M University. Seven ovariectomized nude mice. Minimal invasive procedures were performed to administer estrogen pellets and transplant immortalized human endometriosis epithelial and stromal cells into nude mice. Peritoneal endometriosis-like lesions induced in nude mice were characterized and compared with spontaneous peritoneal endometriosis in women. Xenografts of human immortalized endometriosis epithelial and stromal cells into the peritoneal cavity of the recipient nude mice are able to proliferate, attach, invade, reorganize, and establish peritoneal endometriosis. Endometriosis glands at different stages of growth were present in induced endometriosis-like lesions. Proliferating cell nuclear antigen, metalloproteinase 2, estrogen receptor-alpha, cyclooxygenase-2, and prostaglandin E(2) receptors EP2 and EP4 proteins were expressed in both endometriosis glandular epithelial and stromal cells of the induced endometriosis-like lesions. This xenograft model could be used as a potential experimental tool to understand the molecular and cellular aspects of the pathogenesis of endometriosis in humans.

Measuring the Effect of Chemicals on the Growth and Reproduction of Caenorhabditis elegans.

PubMed

Lee, So Young; Kang, Kyungsu

2017-10-05

Toxicological evaluation is crucial for understanding the effects of chemicals on living organisms in basic and applied biological science fields. A non-mammalian soil round worm, Caenorhabditis elegans, is a valuable model organism for toxicology studies due to its convenience and lack of animal ethics issues compared with mammalian animal systems. In this protocol, a detailed procedure of toxicological evaluation of chemicals in C. elegans is described. A clinical anticancer drug, etoposide, which targets human topoisomerase II and inhibits DNA replication of human cancer cells, was selected as a model testing chemical. Age-synchronized C. elegans eggs were exposed to either dimethyl sulfoxide (DMSO) or etoposide, and then the growth of C. elegans was monitored every day for 4 days by the stereo microscope observation. The total number of eggs laid from C. elegans treated with DMSO or etoposide was also counted by using the stereo microscope. Etoposide treatment significantly affected the growth and reproduction of C. elegans. By comparison of the total number of eggs laid from worms with different treatment periods of chemicals, it can be decided that the reproductive toxicity of chemicals on C. elegans reproduction is reversible or irreversible. These protocols may be helpful for both the development of various drugs and risk assessment of environmental toxicants.

IPD-MHC 2.0: an improved inter-species database for the study of the major histocompatibility complex

PubMed Central

Maccari, Giuseppe; Robinson, James; Ballingall, Keith; Guethlein, Lisbeth A.; Grimholt, Unni; Kaufman, Jim; Ho, Chak-Sum; de Groot, Natasja G.; Flicek, Paul; Bontrop, Ronald E.; Hammond, John A.; Marsh, Steven G. E.

2017-01-01

The IPD-MHC Database project (http://www.ebi.ac.uk/ipd/mhc/) collects and expertly curates sequences of the major histocompatibility complex from non-human species and provides the infrastructure and tools to enable accurate analysis. Since the first release of the database in 2003, IPD-MHC has grown and currently hosts a number of specific sections, with more than 7000 alleles from 70 species, including non-human primates, canines, felines, equids, ovids, suids, bovins, salmonids and murids. These sequences are expertly curated and made publicly available through an open access website. The IPD-MHC Database is a key resource in its field, and this has led to an average of 1500 unique visitors and more than 5000 viewed pages per month. As the database has grown in size and complexity, it has created a number of challenges in maintaining and organizing information, particularly the need to standardize nomenclature and taxonomic classification, while incorporating new allele submissions. Here, we describe the latest database release, the IPD-MHC 2.0 and discuss planned developments. This release incorporates sequence updates and new tools that enhance database queries and improve the submission procedure by utilizing common tools that are able to handle the varied requirements of each MHC-group. PMID:27899604

CD133 antibody conjugation to decellularized human heart valves intended for circulating cell capture.

PubMed

Vossler, John D; Min Ju, Young; Williams, J Koudy; Goldstein, Steven; Hamlin, James; Lee, Sang Jin; Yoo, James J; Atala, Anthony

2015-09-03

The long term efficacy of tissue based heart valve grafts may be limited by progressive degeneration characterized by immune mediated inflammation and calcification. To avoid this degeneration, decellularized heart valves with functionalized surfaces capable of rapid in vivo endothelialization have been developed. The aim of this study is to examine the capacity of CD133 antibody-conjugated valve tissue to capture circulating endothelial progenitor cells (EPCs). Decellularized human pulmonary valve tissue was conjugated with CD133 antibody at varying concentrations and exposed to CD133 expressing NTERA-2 cl.D1 (NT2) cells in a microflow chamber. The amount of CD133 antibody conjugated on the valve tissue surface and the number of NT2 cells captured in the presence of shear stress was measured. Both the amount of CD133 antibody conjugated to the valve leaflet surface and the number of adherent NT2 cells increased as the concentration of CD133 antibody present in the surface immobilization procedure increased. The data presented in this study support the hypothesis that the rate of CD133(+) cell adhesion in the presence of shear stress to decellularized heart valve tissue functionalized by CD133 antibody conjugation increases as the quantity of CD133 antibody conjugated to the tissue surface increases.

Jersey number detection in sports video for athlete identification

NASA Astrophysics Data System (ADS)

Ye, Qixiang; Huang, Qingming; Jiang, Shuqiang; Liu, Yang; Gao, Wen

2005-07-01

Athlete identification is important for sport video content analysis since users often care about the video clips with their preferred athletes. In this paper, we propose a method for athlete identification by combing the segmentation, tracking and recognition procedures into a coarse-to-fine scheme for jersey number (digital characters on sport shirt) detection. Firstly, image segmentation is employed to separate the jersey number regions with its background. And size/pipe-like attributes of digital characters are used to filter out candidates. Then, a K-NN (K nearest neighbor) classifier is employed to classify a candidate into a digit in "0-9" or negative. In the recognition procedure, we use the Zernike moment features, which are invariant to rotation and scale for digital shape recognition. Synthetic training samples with different fonts are used to represent the pattern of digital characters with non-rigid deformation. Once a character candidate is detected, a SSD (smallest square distance)-based tracking procedure is started. The recognition procedure is performed every several frames in the tracking process. After tracking tens of frames, the overall recognition results are combined to determine if a candidate is a true jersey number or not by a voting procedure. Experiments on several types of sports video shows encouraging result.

Repeatability precision of the falling number procedure under standard and modified methodologies

USDA-ARS?s Scientific Manuscript database

The falling number (FN) procedure is used worldwide to assess the integrity of the starch stored within wheat seed. As an indirect measurement of the activity level of alpha-amylase, FN relies on a dedicated viscometer that measures the amount of time needed for a metal stirring rod of precise geome...

[Absolute numbers of peripheral blood CD34+ hematopoietic stem cells prior to a leukapheresis procedure as a parameter predicting the efficiency of stem cell collection].

PubMed

Galtseva, I V; Davydova, Yu O; Gaponova, T V; Kapranov, N M; Kuzmina, L A; Troitskaya, V V; Gribanova, E O; Kravchenko, S K; Mangasarova, Ya K; Zvonkov, E E; Parovichnikova, E N; Mendeleeva, L P; Savchenko, V G

To identify a parameter predicting a collection of at least 2·106 CD34+ hematopoietic stem cells (HSC)/kg body weight per leukapheresis (LA) procedure. The investigation included 189 patients with hematological malignancies and 3 HSC donors, who underwent mobilization of stem cells with their subsequent collection by LA. Absolute numbers of peripheral blood leukocytes and CD34+ cells before a LA procedure, as well as a number of CD34+ cells/kg body weight (BW) in the LA product stored on the same day were determined in each patient (donor). There was no correlation between the number of leukocytes and that of stored CD34+ cells/kg BW. There was a close correlation between the count of peripheral blood CD34+ cells prior to LA and that of collected CD34+ cells calculated with reference to kg BW. The optimal absolute blood CD34+ cell count was estimated to 20 per µl, at which a LA procedure makes it possible to collect 2·106 or more CD34+ cells/kg BW.

Radiofrequency ablation of retained placenta accreta after conservative management: preliminary evaluation in the pregnant ewe and in normal human placenta in vitro.

PubMed

Morel, O; Monceau, E; Tran, N; Malartic, C; Morel, F; Barranger, E; Côté, J F; Gayat, E; Chavatte-Palmer, P; Cabrol, D; Tsatsaris, V

2009-06-01

To evaluate radiofrequency (RF) efficiency and safety for the ablation of retained placenta in humans, using a pregnant sheep model. Experimental study. Laboratory of Surgery School, Nancy, France. Three pregnant ewes/ten human placentas. Various RF procedures were tested in pregnant ewes on 50 placentomes (individual placental units). Reproducibility of the best procedure was then evaluated in a further 20 placentomes and on ten human term placentas in vitro after delivery. Placental tissues destruction, lesions' size, myometrial lesions. Low power (100 W) and low target temperatures (60 degrees C) lead to homogenous tissue destruction, without myometrial lesion. No significant difference was observed in terms of lesion size and procedure duration for in the placentomes of pregnant ewe in vivo and in human placentas in vitro. The diameter of the ablation could be correlated with the tines deployment. The placental tissue structure is very permissive to RF energy, which suggests that RF could be used for the ablation of retained placenta, providing optimal control of tissue destruction. These results call for further experimental evaluations.

Optimization of wearable microwave antenna with simplified electromagnetic model of the human body

NASA Astrophysics Data System (ADS)

Januszkiewicz, Łukasz; Barba, Paolo Di; Hausman, Sławomir

2017-12-01

In this paper the problem of optimization design of a microwave wearable antenna is investigated. Reference is made to a specific antenna design that is a wideband Vee antenna the geometry of which is characterized by 6 parameters. These parameters were automatically adjusted with an evolution strategy based algorithm EStra to obtain the impedance matching of the antenna located in the proximity of the human body. The antenna was designed to operate in the ISM (industrial, scientific, medical) band which covers the frequency range of 2.4 GHz up to 2.5 GHz. The optimization procedure used the finite-difference time-domain method based full-wave simulator with a simplified human body model. In the optimization procedure small movements of antenna towards or away of the human body that are likely to happen during real use were considered. The stability of the antenna parameters irrespective of the movements of the user's body is an important factor in wearable antenna design. The optimization procedure allowed obtaining good impedance matching for a given range of antenna distances with respect to the human body.

Wearable Sensor Data Classification for Human Activity Recognition Based on an Iterative Learning Framework.

PubMed

Davila, Juan Carlos; Cretu, Ana-Maria; Zaremba, Marek

2017-06-07

The design of multiple human activity recognition applications in areas such as healthcare, sports and safety relies on wearable sensor technologies. However, when making decisions based on the data acquired by such sensors in practical situations, several factors related to sensor data alignment, data losses, and noise, among other experimental constraints, deteriorate data quality and model accuracy. To tackle these issues, this paper presents a data-driven iterative learning framework to classify human locomotion activities such as walk, stand, lie, and sit, extracted from the Opportunity dataset. Data acquired by twelve 3-axial acceleration sensors and seven inertial measurement units are initially de-noised using a two-stage consecutive filtering approach combining a band-pass Finite Impulse Response (FIR) and a wavelet filter. A series of statistical parameters are extracted from the kinematical features, including the principal components and singular value decomposition of roll, pitch, yaw and the norm of the axial components. The novel interactive learning procedure is then applied in order to minimize the number of samples required to classify human locomotion activities. Only those samples that are most distant from the centroids of data clusters, according to a measure presented in the paper, are selected as candidates for the training dataset. The newly built dataset is then used to train an SVM multi-class classifier. The latter will produce the lowest prediction error. The proposed learning framework ensures a high level of robustness to variations in the quality of input data, while only using a much lower number of training samples and therefore a much shorter training time, which is an important consideration given the large size of the dataset.

Human spermatozoa selected by Percoll gradient or swim-up are equally capable of binding to the human zona pellucida and undergoing the acrosome reaction.

PubMed

Morales, P; Vantman, D; Barros, C; Vigil, P

1991-03-01

Several techniques have been used for selecting motile spermatozoa including Percoll and albumin gradients, swim-up, and glass wool filtration. A high yield of motile spermatozoa as well as an enhancement of motility are the most desirable features of a practical method. An equally important consideration is whether or not these techniques select functionally normal spermatozoa. In this study we have compared two methods for separation of motile cells, swim-up and Percoll gradient. Normal semen samples from 12 different men were used in this study. Each sample was simultaneously processed by swim-up and Percoll gradient using modified Tyrode's medium. After the sperm concentration was adjusted to 1 x 10(7) spermatozoa/ml, the suspensions were incubated at 37 degrees C, 5% CO2 in air. In each suspension the percentage of sperm recovery, percentage of motile spermatozoa, percentage of acrosome reacted spermatozoa (either spontaneously or stimulated with human follicular fluid), percentage of zona-free hamster oocytes penetrated, and number of spermatozoa bound to the human zona pellucida were determined. The results obtained indicated that the percentage of sperm recovery was higher with the Percoll gradient than with the swim-up procedure (P less than 0.001). However, no significant differences were found between these two sperm populations in the percentage of motile cells, in the percentage of acrosome reacted spermatozoa, and in the percentage of zona-free hamster oocytes penetrated. In addition, the number of spermatozoa bound per zona pellucida was similar for spermatozoa selected by Percoll or swim-up. We conclude that there were no functional differences between the spermatozoa selected by either method.

Sunspot Dynamics Are Reflected in Human Physiology and Pathophysiology

NASA Astrophysics Data System (ADS)

Hrushesky, William J. M.; Sothern, Robert B.; Du-Quiton, Jovelyn; Quiton, Dinah Faith T.; Rietveld, Wop; Boon, Mathilde E.

2011-03-01

Periodic episodes of increased sunspot activity (solar electromagnetic storms) occur with 10-11 and 5-6 year periodicities and may be associated with measurable biological events. We investigated whether this sunspot periodicity characterized the incidence of Pap smear-determined cervical epithelial histopathologies and human physiologic functions. From January 1983 through December 2003, monthly averages were obtained for solar flux and sunspot numbers; six infectious, premalignant and malignant changes in the cervical epithelium from 1,182,421 consecutive, serially independent, screening Pap smears (59°9"N, 4°29"E); and six human physiologic functions of a healthy man (oral temperature, pulse, systolic and diastolic blood pressure, respiration, and peak expiratory flow), which were measured ∼5 times daily during ∼34,500 self-measurement sessions (44°56"N, 93°8"W). After determining that sunspot numbers and solar flux, which were not annually rhythmic, occurred with a prominent 10-year and a less-prominent 5.75-year periodicity during this 21-year study span, each biological data set was analyzed with the same curve-fitting procedures. All six annually rhythmic Pap smear-detected infectious, premalignant and malignant cervical epithelial pathologies showed strong 10-year and weaker 5.75-year cycles, as did all six self-measured, annually rhythmic, physiologic functions. The phases (maxima) for the six histopathologic findings and five of six physiologic measurements were very near, or within, the first two quarters following the 10-year solar maxima. These findings add to the growing evidence that solar magnetic storm periodicities are mirrored by cyclic phase-locked rhythms of similar period length or lengths in human physiology and pathophysiology.

Biobanking human endometrial tissue and blood specimens: standard operating procedure and importance to reproductive biology research and diagnostic development.

PubMed

Sheldon, Elizabeth; Vo, Kim Chi; McIntire, Ramsey A; Aghajanova, Lusine; Zelenko, Zara; Irwin, Juan C; Giudice, Linda C

2011-05-01

To develop a standard operating procedure (SOP) for collection, transport, storage of human endometrial tissue and blood samples, subject and specimen annotation, and establishing sample priorities. The SOP synthesizes sound scientific procedures, the literature on ischemia research, sample collection and gene expression profiling, good laboratory practices, and the authors' experience of workflow and sample quality. The National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. Women undergoing endometrial biopsy or hysterectomy for nonmalignant indications. Collecting, processing, storing, distributing endometrial tissue and blood samples under approved institutional review board protocols and written informed consent from participating subjects. Standard operating procedure. The SOP addresses rigorous and consistent subject annotation, specimen processing and characterization, strict regulatory compliance, and a reference for researchers to track collection and storage times that may influence their research. The comprehensive and systematic approach to the procurement of human blood and endometrial tissue in this SOP ensures the high quality, reliability, and scientific usefulness of biospecimens made available to investigators by the National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. The detail and perspective in this SOP also provides a blueprint for implementation of similar collection programs at other institutions. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Development and Execution of Autonomous Procedures Onboard the International Space Station to Support the Next Phase of Human Space Exploration

NASA Technical Reports Server (NTRS)

Beisert, Susan; Rodriggs, Michael; Moreno, Francisco; Korth, David; Gibson, Stephen; Lee, Young H.; Eagles, Donald E.

2013-01-01

Now that major assembly of the International Space Station (ISS) is complete, NASA's focus has turned to using this high fidelity in-space research testbed to not only advance fundamental science research, but also demonstrate and mature technologies and develop operational concepts that will enable future human exploration missions beyond low Earth orbit. The ISS as a Testbed for Analog Research (ISTAR) project was established to reduce risks for manned missions to exploration destinations by utilizing ISS as a high fidelity micro-g laboratory to demonstrate technologies, operations concepts, and techniques associated with crew autonomous operations. One of these focus areas is the development and execution of ISS Testbed for Analog Research (ISTAR) autonomous flight crew procedures intended to increase crew autonomy that will be required for long duration human exploration missions. Due to increasing communications delays and reduced logistics resupply, autonomous procedures are expected to help reduce crew reliance on the ground flight control team, increase crew performance, and enable the crew to become more subject-matter experts on both the exploration space vehicle systems and the scientific investigation operations that will be conducted on a long duration human space exploration mission. These tests make use of previous or ongoing projects tested in ground analogs such as Research and Technology Studies (RATS) and NASA Extreme Environment Mission Operations (NEEMO). Since the latter half of 2012, selected non-critical ISS systems crew procedures have been used to develop techniques for building ISTAR autonomous procedures, and ISS flight crews have successfully executed them without flight controller involvement. Although the main focus has been preparing for exploration, the ISS has been a beneficiary of this synergistic effort and is considering modifying additional standard ISS procedures that may increase crew efficiency, reduce operational costs, and raise the amount of crew time available for scientific research. The next phase of autonomous procedure development is expected to include payload science and human research investigations. Additionally, ISS International Partners have expressed interest in participating in this effort. The recently approved one-year crew expedition starting in 2015, consisting of one Russian and one U.S. Operating Segment (USOS) crewmember, will be used not only for long duration human research investigations but also for the testing of exploration operations concepts, including crew autonomy.

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. Copyright © 2015 Elsevier B.V. All rights reserved.

Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial.

PubMed

Rouchy, R C; Moreau-Gaudry, A; Chipon, E; Aubry, S; Pazart, L; Lapuyade, B; Durand, M; Hajjam, M; Pottier, S; Renard, B; Logier, R; Orry, X; Cherifi, A; Quehen, E; Kervio, G; Favelle, O; Patat, F; De Kerviler, E; Hughes, C; Medici, M; Ghelfi, J; Mounier, A; Bricault, I

2017-07-06

Interventional radiology includes a range of minimally invasive image-guided diagnostic and therapeutic procedures that have become routine clinical practice. Each procedure involves a percutaneous needle insertion, often guided using computed tomography (CT) because of its availability and usability. However, procedures remain complicated, in particular when an obstacle must be avoided, meaning that an oblique trajectory is required. Navigation systems track the operator's instruments, meaning the position and progression of the instruments are visualised in real time on the patient's images. A novel electromagnetic navigation system for CT-guided interventional procedures (IMACTIS-CT®) has been developed, and a previous clinical trial demonstrated improved needle placement accuracy in navigation-assisted procedures. In the present trial, we are evaluating the clinical benefit of the navigation system during the needle insertion step of CT-guided procedures in the thoraco-abdominal region. This study is designed as an open, multicentre, prospective, randomised, controlled interventional clinical trial and is structured as a standard two-arm, parallel-design, individually randomised trial. A maximum of 500 patients will be enrolled. In the experimental arm (navigation system), the procedures are carried out using navigation assistance, and in the active comparator arm (CT), the procedures are carried out with conventional CT guidance. The randomisation is stratified by centre and by the expected difficulty of the procedure. The primary outcome of the trial is a combined criterion to assess the safety (number of serious adverse events), efficacy (number of targets reached) and performance (number of control scans acquired) of navigation-assisted, CT-guided procedures as evaluated by a blinded radiologist and confirmed by an expert committee in case of discordance. The secondary outcomes are (1) the duration of the procedure, (2) the satisfaction of the operator and (3) the irradiation dose delivered, with (4) subgroup analysis according to the expected difficulty of the procedure, as well as an evaluation of (5) the usability of the device. This trial addresses the lack of published high-level evidence studies in which navigation-assisted CT-guided interventional procedures are evaluated. This trial is important because it addresses the problems associated with conventional CT guidance and is particularly relevant because the number of interventional radiology procedures carried out in routine clinical practice is increasing. ClinicalTrials.gov identifier: NCT01896219 . Registered on 5 July 2013.

Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series.

PubMed

Cuadrado-Garcia, Angel; Noguera, Jose F; Olea-Martinez, Jose M; Morales, Rafael; Dolz, Carlos; Lozano, Luis; Vicens, Jose-Carlos; Pujol, Juan José

2011-01-01

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. Currently, it is not possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids fusing minilaparoscopy and transluminal endoscopic surgery. This report presents a prospective clinical series of 25 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. The study comprised a clinical series of 25 consecutive nonrandomized women who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two trocars for cholelithiasis: one 5-mm umbilical trocar and one 3-mm trocar in the upper left quadrant. The study had no control group. The scheduled surgical intervention was performed for all 25 women. No intraoperative complications occurred. One patient had mild hematuria that resolved in less than 12 h, but no other complications occurred during an average follow-up period of 140 days. Of the 25 women, 20 were discharged in 24 h, and 5 were discharged less than 12 h after the procedure. Hybrid transvaginal cholecystectomy, combining NOTES and minilaparoscopy, is a good surgical model for minimally invasive surgery. It can be performed in surgical settings where laparoscopy is practiced regularly using the instruments normally used for endoscopy and laparoscopic surgery. Due to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.

Therapeutic apheresis in the Republic of Macedonia - our five years experience (2000-2004).

PubMed

Milovanceva-Popovska, M; Stojkovski, Lj; Grcevska, L; Dzikova, S; Ristovska, V; Gogovska, L; Polenakovic, M

2006-07-01

Membrane plasma exchange (PE) is a mode of extracorporeal blood purification. Since 1985 membrane PE has been in regular use at the Department of Nephrology, Medical Faculty of Skopje, R.Macedonia. In this paper we report on five years (2000-2004) of single centre plasma exchange activity. We performed 540 PE treatments (108 PE/per year) on 99 patients. The M/F ratio was 40/48. The patients underwent a median of 5.45 procedures (range, 1-16). The treated patients were from different Departments. Protocols for PE depend on the disease and its severity. PE were performed 2-4 times weekly using Gambro PF 2000 N filters with an adaptation of the Gambro AK10 dialysis machine or with the Gambro Prizma machine (2 cases). Blood access was achieved through femoral vein. Substitution was made with fresh frozen plasma and/or with 20% human albumin combined with Ringer's solution. An average amount of 2150 ml plasmafiltrate per treatment (respectively 30 to 40 ml plasmafiltrate/kg body weight) was eliminated. Most therapeutic procedures were performed on patients from the Department of Neurology. 63.6% of all patients were referred for Myasthenia gravis and the Guillian Barre syndrome. The total number of procedures per year has remained fairly stable, corresponding to a median of 5.4 treatments/100 000 inhabitants. We observed hypocalcaemia in 8% of the patients, urticarial reactions in 7.3%, pruritic reactions in 12%, and hypotension/headache in 6.8%. No major procedural complications were seen.

42 CFR 7.5 - Payment procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Payment procedures. 7.5 Section 7.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS § 7.5 Payment procedures. The requester may...

45 CFR 98.66 - Disallowance procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Disallowance procedures. 98.66 Section 98.66 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Financial Management § 98.66 Disallowance procedures. (a) Any expenditures not made in accordance...

45 CFR 98.66 - Disallowance procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Disallowance procedures. 98.66 Section 98.66 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Financial Management § 98.66 Disallowance procedures. (a) Any expenditures not made in accordance...

45 CFR 98.66 - Disallowance procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Disallowance procedures. 98.66 Section 98.66 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Financial Management § 98.66 Disallowance procedures. (a) Any expenditures not made in accordance...

45 CFR 98.66 - Disallowance procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Disallowance procedures. 98.66 Section 98.66 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Financial Management § 98.66 Disallowance procedures. (a) Any expenditures not made in accordance...

45 CFR 98.66 - Disallowance procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Disallowance procedures. 98.66 Section 98.66 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Financial Management § 98.66 Disallowance procedures. (a) Any expenditures not made in accordance...

Cultivation and grafting of human keratinocytes on a poly(hydroxyethyl methacrylate) support to the wound bed: a clinical study.

PubMed

Dvoránková, B; Smetana, K; Königová, R; Singerová, H; Vacík, J; Jelínková, M; Kapounková, Z; Zahradník, M

1998-01-01

Cultured epithelial sheets on a textile support are used for the treatment of seriously burned patients. In this study we demonstrate a new procedure for the grafting of keratinocytes directly on a polymer cultivation support. This procedure is much easier in comparison with classical techniques, and encouraging results of clinical trials demonstrate the improved healing of the wound bed after the use of this procedure. There is no difference in the cytokeratine pattern (LP-34, cytokeratin-10) of the reconstructed epidermis and normal human skin.