Sample records for clinical samples submitted
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Forrester, Janet E
2015-12-01
Errors in the statistical presentation and analyses of data in the medical literature remain common despite efforts to improve the review process, including the creation of guidelines for authors and the use of statistical reviewers. This article discusses common elementary statistical errors seen in manuscripts recently submitted to Clinical Therapeutics and describes some ways in which authors and reviewers can identify errors and thus correct them before publication. A nonsystematic sample of manuscripts submitted to Clinical Therapeutics over the past year was examined for elementary statistical errors. Clinical Therapeutics has many of the same errors that reportedly exist in other journals. Authors require additional guidance to avoid elementary statistical errors and incentives to use the guidance. Implementation of reporting guidelines for authors and reviewers by journals such as Clinical Therapeutics may be a good approach to reduce the rate of statistical errors. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.
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Picchio, Gaston; Vingerhoets, Johan; Tambuyzer, Lotke; Coakley, Eoin; Haddad, Mojgan; Witek, James
2011-12-01
Abstract The prevalence of susceptibility to etravirine was investigated among clinical samples submitted for routine clinical testing in the United States using two separate weighted genotypic scoring systems. The presence of etravirine mutations and susceptibility to etravirine by phenotype of clinical samples from HIV-1-infected patients, submitted to Monogram Biosciences for routine resistance testing between June 2008 and June 2009, were analyzed. Susceptibility by genotype was determined using the Monogram and Tibotec etravirine-weighted genotypic scoring systems, with scores of ≤3 and ≤2, respectively, indicating full susceptibility. Susceptibility by phenotype was determined using the PhenoSense HIV assay, with lower and higher clinical cut-offs of 2.9 and 10, respectively. The frequency of individual etravirine mutations and the impact of the K103N mutation on susceptibility to etravirine by genotype were also determined. Among the 5482 samples with ≥1 defined nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations associated with resistance, 67% were classed as susceptible to etravirine by genotype by both scoring systems. Susceptibility to etravirine by phenotype was higher (76%). The proportion of first-generation NNRTI-resistant samples with (n=3598) and without (n=1884) K103N with susceptibility to etravirine by genotype was 77% and 49%, respectively. Among samples susceptible to first-generation NNRTIs (n=9458), >99% of samples were susceptible to etravirine by phenotype (FC <2.9); the remaining samples had FC ≥2.9-10. In summary, among samples submitted for routine clinical testing in the United States, a high proportion of samples with first-generation NNRTI resistance was susceptible to etravirine by genotype and phenotype. A higher proportion of NNRTI-resistant samples with K103N than without was susceptible to etravirine.
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Nam, Anna S; Giorgadze, Tamara; Tam, Wayne; Chadburn, Amy
2018-01-01
We sought to assess the utility and limitations of both flow cytometry (FC) and cytology for the analysis of cerebrospinal fluid (CSF) in a practical clinical setting. A total of 393 consecutive CSF samples from 171 patients submitted for both cytomorphologic and FC assessments were analyzed. Both FC and cytology findings were negative for malignancy in 315/393 samples (80%), and either positive (POS) or suspicious/atypical (SUSP/AT) in 7% of samples. This resulted in high agreement between FC and cytology (87%). Minor discrepancies were present in 4% of the cases. In 28 samples, an abnormal population was detected by FC but not by cytology. FC and cytology are important complementary methods for analyzing CSF samples. In cases where cytology is SUSP/AT and FC is inconclusive or negative, additional specimens should be submitted for immunostaining, cytogenetics, and/or molecular studies. © 2018 S. Karger AG, Basel.
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Gounder, Shakti; Tayler-Smith, Katherine; Khogali, Mohammed; Raikabula, Maopa; Harries, Anthony D
2013-07-01
In Fiji, patients with suspected pulmonary tuberculosis (PTB) currently submit three sputum specimens for smear microscopy for acid-fast bacilli, but there is little information about how well this practice is carried out. A cross-sectional retrospective review was carried out in all four TB diagnostic laboratories in Fiji to determine among new patients presenting with suspected PTB in 2011: the quality of submitted sputum; the number of sputum samples submitted; the relationship between quality and number of submitted samples to smear-positivity; and positive yield from first, second and third samples. Of 1940 patients with suspected PTB, 3522 sputum samples were submitted: 997 (51.4%) patients submitted one sample, 304 (15.7%) patients submitted two samples and 639 (32.9%) submitted three samples. Sputum quality was recorded in 2528 (71.8%) of samples, of which 1046 (41.4%) were of poor quality. Poor quality sputum was more frequent in females, inpatients and children (0-14 years). Good quality sputum and a higher number of submitted samples positively correlated with smear-positivity for acid-fast bacilli. There were 122 (6.3%) patients with suspected PTB who were sputum smear positive. Of those, 89 had submitted three sputum samples: 79 (89%) were diagnosed based on the first sputum sample, 6 (7%) on the second sample and 4 (4%) on the third sample. This study shows that there are deficiencies in the practice of sputum smear examination in Fiji with respect to sputum quality and recommended number of submitted samples, although the results support the continued use of three sputum samples for TB diagnosis. Ways to improve sputum quality and adherence to recommended guidelines are needed.
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Angelin, Martin; Forsell, Joakim; Granlund, Margareta; Evengård, Birgitta; Palmgren, Helena; Johansson, Anders
2015-01-01
The increase of antibiotic resistance in clinically important bacteria is a worldwide threat, especially in healthcare environments. International travel is a risk factor for gut colonization with extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE). The risk for healthcare students of being colonized with ESBL-PE when participating in patient-related work abroad has not been previously investigated. Swedish healthcare students travelling for pre-clinical and clinical courses outside Scandinavia submitted faecal samples and survey data before and after travel. The faecal samples were screened for ESBL-PE and carbapenemase-producing Enterobacteriaceae (CPE). Screening results and survey data were analysed to identify risk factors for colonization. In the 99 subjects who submitted a full set of samples, 35% were colonized with a new ESBL-PE strain during travel. No CPE was found. The most important risk factor for ESBL-PE colonization was travel destination, and the highest colonization rate was found in the South-East Asia region. Antibiotic treatment during travel was an independent risk factor for ESBL-PE colonization but patient-related work was not significantly associated with an increased risk. Patient-related work abroad was not a risk factor for ESBL-PE suggesting that transmission from patients is uncommon. Pre-travel advice on avoiding unnecessary antibiotic treatment during travel is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.
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First report of Catharanthus mosaic virus in Mandevilla in the United States
USDA-ARS?s Scientific Manuscript database
Mandevilla (Apocynaceae) is an ornamental tropical vine popular for its bright and attractive flowers. During 2012-2013 twelve Mandevilla sp. samples from Minnesota and Florida nurseries were submitted for analysis at the University of Minnesota Plant Disease Clinic. Plants showed mosaic symptoms, ...
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Elbers, A R W; Gorgievski-Duijvesteijn, M J; van der Velden, P G; Loeffen, W L A
2007-05-01
Outbreaks of Classical Swine Fever (CSF) occurred in spring 2006 in Germany close to the Dutch border. On 6th April Dutch pig farmers were given the possibility to submit blood samples directly via their veterinary practitioner to the National Reference Laboratory for CSF if their pigs had non-specific clinical symptoms or if pigs were being treated with antibiotics. The pig farm was not quarantined and was not visited by the veterinary authorities. Over a period of 9 weeks 156 pig farmers submitted whole blood samples via 50 different veterinary practices. All samples tested negative in the PCR test. These pig farmers and veterinary practitioners were asked to respond to a postal questionnaire with questions regarding their experience with this new diagnostic possibility, the distribution of the costs involved, a comparison with other instruments, such as official notification or use of a leukocyte count test, and their knowledge of clinical signs of CSF. 65 pig farmers (42%) and 33 veterinary practices (66%) returned the questionnaire. The main results indicated that pig farmers (72%) would use this type of exclusion diagnostics sooner than that they would approach the veterinary authorities (practitioners: 86%). Moreover the respondents considered the fact that the farm was not quarantined immediately to be an advantage (pig farmers, 79%; practitioners, 88%). 32 percent of the pig farmers were not aware that they were required to submit blood samples if pigs were being treated with antibiotics (practitioners: 11%). The majority of pig farmers and practitioners were not satisfied with the current distribution of the costs involved: in their opinion the costs of the PCR test, the costs of the veterinary practitioner and the costs for shipping the samples to the reference laboratory should be paid out of the Animal Health Fund (50% government and 50% industry) or by the government. If the current distribution of the costs is not changed, a large proportion of the pig farmers indicated that they would not use this form of exclusion diagnostics for CSF in the future. Pig farmers appeared to have a rather limited knowledge of the clinical signs of CSF: 33% of the pig farmers could mention maximally three clinical signs of CSF, and 7% could not mention a single clinical sign of CSF and said they were entirely dependent on the practitioners' ability to judge a CSF-suspect situation.
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Retrospective testing and case series study of porcine delta coronavirus in U.S. swine herds.
McCluskey, Brian J; Haley, Charles; Rovira, Albert; Main, Rodger; Zhang, Yan; Barder, Sunny
2016-01-01
Porcine deltacoronavirus (PDCoV) was first reported in the United States (US) in February 2014. This was the second novel swine enteric coronavirus detected in the US since May 2013. In this study, we conducted retrospective testing of samples submitted to three veterinary diagnostic laboratories where qualifying biological samples were derived from previously submitted diagnostic case submissions from US commercial swine farms with a clinical history of enteric disease or from cases that had been previously tested for transmissible gastroenteritis virus, PEDV, or rotavirus. Overall, 2286 banked samples were tested from 27 States. Samples were collected in 3 separate years and in 17 different months. Test results revealed 4 positive samples, 3 collected in August 2013 and 1 collected in October 2013. In addition, a case series including 42 operations in 10 States was conducted through administration of a survey. Survey data collected included information on characteristics of swine operations that had experienced PDCoV clinical signs. Special emphasis was placed on obtaining descriptive estimates of biosecurity practices and disease status over time of each operation. Clinical signs of PDCoV were reported to be similar to those of PEDV. The average number of animals on each operation exhibiting clinical signs (morbidity) and the average number of case fatalities was greatest for suckling and weaned pigs. Average operation-level weaned pig morbidity was greatest in the first week of the outbreak while average operation-level suckling pig case fatality was greatest in the second week of the outbreak. The survey included questions regarding biosecurity practices for visitors and operation employees; trucks, equipment and drivers; and feed sources. These questions attempted to identify a likely pathway of introduction of PDCoV onto the operations surveyed. Published by Elsevier B.V.
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Rattacaso, Raphael Mendes Bezerra; da Fonseca Roberti Garcia, Lucas; Aguilar, Fabiano Gamero; Consani, Simonides; de Carvalho Panzeri Pires-de-Souza, Fernanda
2011-04-01
The purpose of this study was to evaluate the bleaching agent action on color stability, surface roughness and microhardness of composites (Charisma, Filtek Supreme and Heliomolar - A2) submitted to accelerated artificial aging (AAA). A Teflon matrix (12 x 2 mm) was used to fabricate 18 specimens (n=6) which, after polishing (Sof-Lex), were submitted to initial color reading (ΔE), Knoop microhardness (KHN) (50 g/15 s load) and roughness (R(a)) (cut-off 0.25 mm) tests. Afterwards, the samples were submitted to AAA for 384 hours and new color, microhardness and roughness readings were performed. After this, the samples were submitted to daily application (4 weeks) of 16% Carbamide Peroxide (NiteWhite ACP) for 8 hours and kept in artificial saliva for 16 hours. New color, microhardness and roughness readings were made at the end of the cycle, and 15 days after bleaching. Comparison of the ΔE means (2-way ANOVA, Bonferroni, P<.05) indicated clinically unacceptable color alteration for all composites after AAA, but without significant difference. Statistically significant increase in the KHN values after AAA was observed, but without significant alterations 15 days after bleaching. For R(a) there was no statistically significant difference after AAA and 15 days after bleaching. The alterations promoted by the bleaching agent and AAA are material dependent.
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First report of xanthomonas vasicola causing bacterial leaf streak on corn in the United States
USDA-ARS?s Scientific Manuscript database
In 2014 and 2015, Zea mays samples (field, seed, and popcorn) were submitted to the Plant and Pest Diagnostic Clinic at the University of Nebraska – Lincoln displaying long, dark, yellow to brown, water-soaked, linear lesions confined to the interveinal spaces of the leaves. Initial symptoms appeare...
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Goodwin, Andrew E; Merry, Gwenn E
2009-06-01
Infection by atypical Aeromonas salmonicida is regarded as the cause of ulcer disease (KUD) in koi carp Cyprinus carpio and goldfish Carassius auratus. However, other causes--including parasites, viral infection, and fungi--have been proposed. In our diagnostic work, we often fail to isolate A. salmonicida even when clear clinical signs of KUD are present. This failure may be because these fastidious and slow-growing bacteria are difficult to isolate in culture or because the bacteria are not actually present in the lesions. In this study, we used polymerase chain reaction (PCR) to detect A. salmonicida in DNA samples swabbed from koi carp ulcers. These alcohol-preserved samples were collected and submitted by hobbyists and included 40 separate cases from 12 different states. We identified atypical A. salmonicida by PCR in 52 of 62 samples submitted and in 33 of 40 unique cases. The negative findings for A. salmonicida by PCR could all be attributed to high water temperatures, prior antibiotic use, poor sample quality, or misdiagnosis of columnaris disease as KUD. Tests for Aphanomyces invadans by PCR were negative in every case. This work confirms that A. salmonicda is still the predominant cause of KUD and that our negative culture results were most likely due to technical failures rather than an absence of A. salmonicda in the ulcer lesions.
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Urinalysis requests on the elderly residing in the Auckland community: tick box requesting?
Upton, Arlo; McEwan, M; Williamson, Deborah
2016-01-29
Urinalysis for microscopy and culture is one of the most frequently requested tests for microbiology laboratories, particularly from elderly patients. This study sought to describe the clinical appropriateness of urinalysis from community-dwelling elderly patients and subsequent antibiotic prescription. Demographic, laboratory, and antibiotic prescription data were collected on all samples submitted from patients ≥ 70 years during August 2014 to Labtests Auckland. In addition, clinical data were collected by questionnaire from a subgroup of 200 patients. During August 2014, approximately 7% of the Auckland population aged ≥ 70 years had urinalysis submitted. Urine dipstick was not routinely performed before specimen submission, particularly from patients living at home rather than a long-term care facility, and nearly 50% of samples were not cultured due to absence of pyuria. Escherichia coli was isolated from 23% of female and 7% of male specimens. E. coli isolates from our cohort were less susceptible to all antibiotics tested against compared with all E. coli isolated from all urines in 2014. Clinical indications were absent in 40% of the subgroup of patients. Antibiotic prescription within 7 days of urinalysis was common (36%). This study highlights the frequency of urinalysis testing among the elderly residing in the community. Clinical indications are often absent, and treatment of asymptomatic bacteriuria is likely to be contributing to excessive antibiotic prescription in this group of patients.
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[The maximum heart rate in the exercise test: the 220-age formula or Sheffield's table?].
Mesquita, A; Trabulo, M; Mendes, M; Viana, J F; Seabra-Gomes, R
1996-02-01
To determine in the maximum cardiac rate in exercise test of apparently healthy individuals may be more properly estimated through 220-age formula (Astrand) or the Sheffield table. Retrospective analysis of clinical history and exercises test of apparently healthy individuals submitted to cardiac check-up. Sequential sampling of 170 healthy individuals submitted to cardiac check-up between April 1988 and September 1992. Comparison of maximum cardiac rate of individuals studied by the protocols of Bruce and modified Bruce, in interrupted exercise test by fatigue, and with the estimated values by the formulae: 220-age versus Sheffield table. The maximum cardiac heart rate is similar with both protocols. This parameter in normal individuals is better predicted by the 220-age formula. The theoretic maximum cardiac heart rate determined by 220-age formula should be recommended for a healthy, and for this reason the Sheffield table has been excluded from our clinical practice.
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Internal quality assurance in a clinical virology laboratory. II. Internal quality control.
Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R
1995-01-01
AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475
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Roveri, Flávia Lopes; Paranhos, Beatriz Aparecida Passos Bismara; Yonamine, Mauricio
2016-08-01
A method for identification and quantification of phenobarbital in hair samples by liquid phase microextraction (LPME) and gas chromatography-mass spectrometry (GC-MS) has been presented. Drug-free hair specimens were collected and separated in 50mg aliquots. Each aliquot was washed with 2.0mL of dichloromethane for 15min at 37°C. Standards and deuterated internal standards for calibration and quality control samples were added to the washed hair aliquot and the sample was submitted to complete digestion with sodium hydroxide (NaOH) 1.0mol/L for 15min at 70°C. The dissolved sample was submitted to LPME. After extraction, the residue was derivatized with tetramethylammonium hydroxide (TMAH) and analyzed by GC-MS. The limit of detection (LOD) was 0.1ng/mg and the limit of quantification (LOQ) was 0.25ng/mg. The calibration curve was linear over a concentration range of 0.25ng/mg to 10ng/mg (r(2)>0.99). The intra- and inter-assay precisions, given by RSD, were less than 6% for phenobarbital. Fortified samples of secobarbital and pentobarbital were also submitted to the validated method. The method was successfully applied to hair samples collected from three volunteers who reported regular use of phenobarbital (clinical treatment). The concentrations found were 9.5, 15.1 and 16.3ng/mg of phenobarbital. To contemplate the concentrations found, dilution integrity tests were also validated. The LPME and GC-MS method showed to be suitable for the detection of phenobarbital in hair samples and can be promptly used for different purposes whenever required. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
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Bio-repository of post-clinical test samples at the national cancer center hospital (NCCH) in Tokyo.
Furuta, Koh; Yokozawa, Karin; Takada, Takako; Kato, Hoichi
2009-08-01
We established the Bio-repository at the National Cancer Center Hospital in October 2002. The main purpose of this article is to show the importance and usefulness of a bio-repository of post-clinical test samples not only for translational cancer research but also for routine clinical oncology by introducing the experience of setting up such a facility. Our basic concept of a post-clinical test sample is not as left-over waste, but rather as frozen evidence of a patient's pathological condition at a particular point. We can decode, if not all, most of the laboratory data from a post-clinical test sample. As a result, the bio-repository is able to provide not only the samples, but potentially all related laboratory data upon request. The areas of sample coverage are the following: sera after routine blood tests; sera after cross-match tests for transfusion; serum or plasma submitted at a patient's clinically important time period by the physician; and samples collected by the individual investigator. The formats of stored samples are plasma or serum, dried blood spot (DBS) and buffy coat. So far, 150 218 plasmas or sera, 35 253 DBS and 536 buffy coats have been registered for our bio-repository system. We arranged to provide samples to various concerned parties under strict legal and ethical agreements. Although the number of the utilized samples was initially limited, the inquiries for sample utilization are now increasing steadily from both research and clinical sources. Further efforts to increase the benefits of the repository are intended.
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Middleton, Joanna; Lee, Bonita E; Fox, Julie D; Tilley, Peter A G; Robinson, Joan L
2008-07-01
The seasonality and clinical features of enterovirus (EV) infections overlap with those of West Nile virus (WNV). The purpose of this study was to determine the frequency of EV detection in patients being tested for WNV and to look for features that could be used to distinguish between infections with these two viruses. Nucleic acid amplification testing (NAT) for EV was performed on all plasma samples submitted for WNV testing in 2003 and 2004. Demographics, clinical features, and laboratory results for patients with documented EV viremia were compared with those for patients with confirmed WNV infection (as diagnosed by NAT and/or serology). NAT for EV was positive on 50 of 1,784 serum or plasma samples submitted for WNV testing (2.8%). Clinical information was compared for 45 patients with EV viremia and 214 patients with WNV infection. Patients with EV viremia were younger and less likely to have heart disease or a travel history (P<0.05). The EV viremia cases were distributed throughout the whole province while the WNV cases were predominantly in the southern part of the province. Symptoms were remarkably similar, although patients with WNV infection were more likely to have anorexia, dizziness, rash, and cranial nerve palsy (P<0.05). There are no consistent differences in the features of WNV infection and enteroviral viremia so diagnostic tests for both viruses should be performed when WNV is present in local mosquitoes.
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Heninger, Michael; Hanzlick, Randy
2011-03-01
Medical examiners and coroners occasionally encounter unidentified human bodies, which remain unidentified for extended periods. In such cases, when traditional methods of identification have failed or cannot be used, DNA profiling may be used. The Federal Bureau of Investigation has a National Missing Person DNA database (NMPDD) laboratory to which samples may be submitted on such cases and from possible relatives or environments of unidentified decedents. This article describes the experience of the Fulton County Medical Examiner (FCME) in submitting samples to the NMPDD laboratory. A database was established at the FCME to track the submission of samples from unidentified decedents to the NMPDD laboratory for DNA testing along with the results and turnaround times. In December 2004, the FCME inventoried all cases for which samples were available and began to submit them to the NMPDD laboratory for testing. DNA testing and isolation rates, sample type, and turnaround times were tabulated in October 2006 for samples submitted between December 16, 2004 and December 16, 2005. An overall summary of data was also prepared concerning the status of all samples submitted as of April 17, 2007. During the 1-year study period, samples from 77 unidentified decedents were submitted to the laboratory. As of October 2006 (22 months after submission of the first samples and 10 months after submission of the last samples), testing had been completed on 53% of the samples submitted, and 68% of those tested resulted in a mitochondrial DNA profile. Turnaround times ranged from 66 to 557 days, improved with time, and had a mean of 107 days for specimens submitted during the latter part of the study period. As of April 17, 2007, we had submitted samples involving 84 unidentified decedents. Seventy-five percent of the samples have now been tested. Data from the NMPDD laboratory have resulted in 4 identifications by comparison with putative relatives, 4 exclusions, and no cold hits through comparison NMPDD DNA profiles from missing persons. More extensive data are presented in the body of this article. The NMPDD laboratory provides useful and free services to medical examiners, coroners, and law enforcement agencies that require DNA services regarding missing and unidentified persons. Turnaround times have improved. The success of the system in getting cold hits will be heavily dependent on law enforcement filing missing persons reports and submission of reference samples from putative relatives of the decedent. We recommend collecting specimens for DNA analysis early on in the postmortem investigation, submitting samples to the NMPDD laboratory or one of its participating laboratories when traditional methods for identification cannot be used or have failed, not burying bodies until a DNA profile has been obtained, and not cremating unidentified remains.
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de Freitas Raso, Tânia; Seixas, Gláucia Helena Fernandes; Guedes, Neiva Maria Robaldo; Pinto, Aramis Augusto
2006-10-31
Chlamydophila psittaci (C. psittaci) infection was evaluated in 77 free-living nestlings of Blue-fronted Amazon parrots (Amazona aestiva) and Hyacinth macaws (Anodorhynchus hyacinthinus) in the Pantanal of Mato Grosso do Sul, Brazil. Tracheal and cloacal swab samples from 32 wild parrot and 45 macaw nestlings were submitted to semi-nested PCR, while serum samples were submitted to complement fixation test (CFT). Although all 32 Amazon parrot serum samples were negative by CFT, cloacal swabs from two birds were positive for Chlamydophila DNA by semi-nested PCR (6.3%); these positive birds were 32 and 45 days old. In macaws, tracheal and cloacal swabs were positive in 8.9% and 26.7% of the samples, respectively. Complement-fixing antibodies were detected in 4.8% of the macaw nestlings; macaw nestlings with positive findings were between 33 and 88 days old. These results indicate widespread dissemination of this pathogen in the two evaluated psittacine populations. No birds had clinical signs suggestive of chlamydiosis. To the best of our knowledge, this is the first report on C. psittaci in free-living Blue-fronted Amazon parrots and Hyacinth macaws in Brazil.
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Abdominal pythiosis in a Bengal tiger (Panthera tigris tigris).
Buergelt, Claus; Powe, Joshua; White, Tamara
2006-06-01
An adult Bengal tiger (Panthera tigris tigris) housed in an outdoor sanctuary in Florida exhibited vomiting, diarrhea, and weight loss. A clinical workup did not reveal the source of the clinical signs and antibiotic therapy was unrewarding. Radiographs revealed the presence of an abdominal mass. The tiger died during an immobilization for a follow-up clinical examination. A necropsy was performed and tissue samples of intestine and mesenteric lymph nodes were submitted for histopathologic diagnosis. A pyogranulomatous panenteritis and lymphadenitis with intralesional hyphae led to a presumptive etiologic diagnosis of intestinal/abdominal pythiosis. The diagnosis of pythiosis was confirmed by serology and immunoblotting.
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Skeletal and Clinical Effects of Exoskeletal Assisted - Gait
2016-10-01
assisted gait and derive estimates of loads applied to the bones. The research team continues to recruit study volunteers . 15. SUBJECT TERMS biomechanical...subjects. As we submit this annual report, we continue to actively schedule study volunteers for screening in order to reach the target sample size for... volunteers and apply the biomechanical models developed so far to the datasets that will be collected from study volunteers . We anticipate continuing to
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Pinto, Gustavo Da Col dos Santos; Dias, Kleber Campioni; Cruvinel, Diogo Rodrigues; Garcia, Lucas da Fonseca Roberti; Consani, Simonides; Pires-De-Souza, Fernanda de Carvalho Panzeri
2013-01-01
To assess the influence of finishing/polishing procedure on color stability (ΔE ) and surface roughness (R(a)) of composites (Heliomolar and Tetric - color A2) submitted to accelerated artificial aging (AAA). Sixty test specimens were made of each composite (12 mm × 2 mm) and separated into six groups (n = 10), according to the type of finishing/polishing to which they were submitted: C, control; F, tip 3195 F; FF, tip 3195 FF; FP, tip 3195 F + diamond paste; FFP, tip 3195 FF + diamond paste; SF, Sof-Lex discs. After polishing, controlled by an electromechanical system, initial color (spectrophotometer PCB 6807 BYK GARDNER) and R(a) (roughness meter Surfcorder SE 1700, cut-off 0.25 mm) readings were taken. Next, the test specimens were submitted to the AAA procedure (C-UV Comexim) for 384 hours, and at the end of this period, new color readings and R(a) were taken. Statistical analysis [2-way analysis of variance (ANOVA), Bonferroni, P < 0.05] showed that all composites demonstrated ΔE alteration above the clinically acceptable limits, with the exception of Heliomolar composite in FP. The greatest ΔE alteration occurred for Tetric composite in SF (13.38 ± 2.10) statistically different from F and FF (P < 0.05). For R(a), Group F showed rougher samples than FF with statistically significant difference (P < 0.05). In spite of the surface differences, the different finishing/polishing procedures were not capable of providing color stability within the clinically acceptable limits.
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49 CFR 1244.5 - Date of filing.
Code of Federal Regulations, 2010 CFR
2010-10-01
... waybill sample information shall be the audit (accounting) month except as specified below: (1) Subject railroads using the computerized system may submit waybill sample information quarterly as specified in Statement 81-1. (2) Subject railroad using the manual system may submit waybill sample information quarterly...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-25
...--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus... sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting...
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Protain, Holly J; Kutzler, Michelle A; Valentine, Beth A
2009-05-01
To determine whether results of cytologic evaluation of preputial epithelial cells correspond to results of a serum endocrine hormone assay and clinical signs associated with adrenocortical disease in castrated ferrets. 13 clinically normal ferrets and 8 ferrets with signs of adrenocortical disease. Blood and preputial lavage samples were collected from each ferret. Serum samples were submitted to the University of Tennessee Veterinary Diagnostic Laboratory for performance of an endocrine hormone assay. Differential epithelial cell counts were performed on preputial lavage samples to determine the percentage of cornified cells. Results of cytologic evaluation were compared with results of the endocrine hormone assay and clinical status of ferrets. The percentage of cornified preputial epithelial cells was not significantly correlated with serum 17B-estradiol or androstenedione concentration but was significantly correlated with serum 17-hydroxyprogesterone concentration (r = 0.60). The percentage of cornified preputial epithelial cells was higher in ferrets with clinical signs of adrenocortical disease (mean +/- SD, 71.3 +/- 16.9%) than in clinically normal ferrets (55.5 +/- 19.0%). Cornification of preputial epithelial cells was correlated with an increase in serum 17-hydroxyprogesterone concentration as well as clinical signs of adrenocortical disease in castrated ferrets. Additional investigation is needed to elucidate the mechanism of preputial epithelial cell cornification in castrated ferrets.
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The distribution of outcomes research papers across clinical journals.
Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S
2011-06-01
This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.
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Schmedt Auf Der Günne, H; Tenhagen, B A; Kutzer, P; Forderung, D; Heuwieser, W
2002-07-01
Lactoferrin, lysozyme and the lactoperoxidase-thiocyanate-peroxide-system are naturally occurring antimicrobial components of milk. The objective of this study was to examine, whether these components were responsible for negative results, when mastitis milk is cultured microbiologically. Quarter milk samples from 75 cows with clinical mastitis on a dairy farm in Brandenburg were submitted for microbiological culture and analysed for the content and the activities of the three components. Animals from all stages of lactation with clinical mastitis were included in the study. Animals were examined clinically and milk samples were collected prior to first treatment. Secretions from quarters with clinical mastitis were compared to those of neighbouring quarters without clinical mastitis. Secretions with positive cultural results were compared to those with negative results. The concentrations or activities of the three factors were significantly higher in the diseased quarters than in the quarters without clinical signs of mastitis. The concentration of lysozyme increased with severity of the clinical signs (local swelling and changes in secretion). The concentration of lactoferrin was significantly higher in quarters with slight alterations of glandular tissue than in quarters with medium or severe alterations (P < 0.05). LPS-activities did not correlate with the severity of clinical signs. No differences in the concentration of lactoferrin or LPS-activities were seen between mastitis with positive and negative culture results. The concentration of lysozyme was even higher in culturally positive samples than in negative samples (P < 0.05). Results from this study indicate that the three factors examined did not impair the results of microbiological culture of milk samples from quarters with clinical mastitis.
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For users submitting electronic notices through CDX, this page contains guidance documents and sample forms to help you, submit Premanufacture Notices (PMN), Bona Fide and biotechnology notices, among others.
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Human papillomavirus detection and typing using a nested-PCR-RFLP assay.
Coser, Janaina; Boeira, Thaís da Rocha; Fonseca, André Salvador Kazantzi; Ikuta, Nilo; Lunge, Vagner Ricardo
2011-01-01
It is clinically important to detect and type human papillomavirus (HPV) in a sensitive and specific manner. Development of a nested-polymerase chain reaction-restriction fragment length polymorphism (nested-PCR-RFLP) assay to detect and type HPV based on the analysis of L1 gene. Analysis of published DNA sequence of mucosal HPV types to select sequences of new primers. Design of an original nested-PCR assay using the new primers pair selected and classical MY09/11 primers. HPV detection and typing in cervical samples using the nested-PCR-RFLP assay. The nested-PCR-RFLP assay detected and typed HPV in cervical samples. Of the total of 128 clinical samples submitted to simple PCR and nested-PCR for detection of HPV, 37 (28.9%) were positive for the virus by both methods and 25 samples were positive only by nested-PCR (67.5% increase in detection rate compared with single PCR). All HPV positive samples were effectively typed by RFLP assay. The method of nested-PCR proved to be an effective diagnostic tool for HPV detection and typing.
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Frequent Questions about the Manifest Registry
FAQs Including Can I submit multiple form samples to the EPA Registry for approval? Must I submit a continuation sheet sample to the Manifest Registry under section 262.21(d)? Can I typeset the form after I am approved to print the manifest?
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7 CFR 28.954 - Costs of submitting samples.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 2 2010-01-01 2010-01-01 false Costs of submitting samples. 28.954 Section 28.954 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY STANDARDS AND STANDARD CONTAINER...
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49 CFR 1244.5 - Date of filing.
Code of Federal Regulations, 2011 CFR
2011-10-01
... railroads using the computerized system may submit waybill sample information quarterly as specified in Statement 81-1. (2) Subject railroad using the manual system may submit waybill sample information quarterly... OF TRANSPORTATION (CONTINUED) ACCOUNTS, RECORDS AND REPORTS WAYBILL ANALYSIS OF TRANSPORTATION OF...
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Antunes, Heliton S; Wajnberg, Gabriel; Pinho, Marcos B; Jorge, Natasha Andressa Nogueira; de Moraes, Joyce Luana Melo; Stefanoff, Claudio Gustavo; Herchenhorn, Daniel; Araújo, Carlos M M; Viégas, Celia Maria Pais; Rampini, Mariana P; Dias, Fernando L; de Araujo-Souza, Patricia Savio; Passetti, Fabio; Ferreira, Carlos G
2018-01-01
Oral mucositis is an acute toxicity that occurs in patients submitted to chemoradiotherapy to treat head and neck squamous cell carcinoma. In this study, we evaluated differences in gene expression in the keratinocytes of the oral mucosa of patients treated with photobiomodulation therapy and tried to associate the molecular mechanisms with clinical findings. From June 2009 to December 2010, 27 patients were included in a randomized double-blind pilot study. Buccal smears from 13 patients were obtained at days 1 and 10 of chemoradiotherapy, and overall gene expression of samples from both dates were analyzed by complementary DNA (cDNA) microarray. In addition, samples from other 14 patients were also collected at D1 and D10 of chemoradiotherapy for subsequent validation of cDNA microarray findings by qPCR. The expression array analysis identified 105 upregulated and 60 downregulated genes in our post-treatment samples when compared with controls. Among the upregulated genes with the highest fold change, it was interesting to observe the presence of genes related to keratinocyte differentiation. Among downregulated genes were observed genes related to cytotoxicity and immune response. The results indicate that genes known to be induced during differentiation of human epidermal keratinocytes were upregulated while genes associated with cytotoxicity and immune response were downregulated in the laser group. These results support previous clinical findings indicating that the lower incidence of oral mucositis associated with photobiomodulation therapy might be correlated to the activation of genes involved in keratinocyte differentiation.
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Initial abstinence status and contingency management treatment outcomes: does race matter?
Montgomery, LaTrice; Carroll, Kathleen M; Petry, Nancy M
2015-06-01
Limited research has evaluated African American substance users' response to evidence-based treatments. This study examined the efficacy of contingency management (CM) in African American and White cocaine users. A secondary analysis evaluated effects of race, treatment condition, and baseline cocaine urine sample results on treatment outcomes of African American (n = 444) and White (n = 403) cocaine abusers participating in one of six randomized clinical trials comparing CM to standard care. African American and White patients who initiated treatment with a cocaine-negative urine sample remained in treatment for similar durations and submitted a comparable proportion of negative samples during treatment regardless of treatment type; CM was efficacious in both races in terms of engendering longer durations of abstinence in patients who began treatment abstinent. Whites who began treatment with a cocaine positive sample remained in treatment longer and submitted a higher proportion of negative samples when assigned to CM than standard care. African Americans who initiated treatment with a cocaine positive sample, however, did not remain in treatment longer with CM compared with standard care, and gains in terms of drug use outcomes were muted in nature relative to Whites. This interaction effect persisted through the 9-month follow-up period. CM is not equally effective in reducing drug use among all subgroups, specifically African American patients who are using cocaine upon treatment entry. Future research on improving treatment outcomes in this population is needed. (c) 2015 APA, all rights reserved).
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-31
... sign or symptom recurrence. The section on trial endpoints was modified to note that a drug can be...] Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment; Availability...: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written...
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Accuracy of dentists in the clinical diagnosis of oral lesions.
Kondori, Ida; Mottin, Roberta W; Laskin, Daniel M
2011-01-01
Dentists play an important role in the early diagnosis and treatment of oral lesions. However, treatment based solely on a clinical impression of the diagnosis, without histologic confirmation, can result in serious consequences, particularly when the lesion is precancerous or cancerous. The purpose of this study was to determine the overall accuracy of clinical diagnoses made by dentists as well as to compare the diagnostic ability of general practitioners with members of various dental specialties. The biopsy reports of 976 specimens submitted to the Department of Oral and Maxillofacial Pathology, Virginia Commonwealth University School of Dentistry, between January 2009 and January 2010 were reviewed. The presumptive clinical diagnosis made by the practitioner and the final histologic diagnosis on each specimen were recorded in addition to whether the submitting dentist was a general practitioner or a specialist. Of the clinical diagnoses made by the submitting dentists, 43% were incorrect. General dentists misdiagnosed 45.9%, oral and maxillofacial surgeons 42.8%, endodontists 42.2%, and periodontists 41.2% of the time. The most commonly missed clinical diagnoses were hyperkeratosis (16%), focal inflammatory fibrous hyperplasia (10%), fibroma (8%), periapical granuloma (7%), and radicular cyst (6%). Cancerous lesions were misdiagnosed 5.6% of the time. The high rates of clinical misdiagnosis by dental practitioners indicate that all excised lesions should to be submitted for histologic diagnosis.
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Murray, Gerard M; O'Neill, Rónan G; Lee, Alison M; McElroy, Máire C; More, Simon J; Monagle, Aisling; Earley, Bernadette; Cassidy, Joseph P
2017-01-01
The bovine paranasal sinuses are a group of complex cavernous air-filled spaces, lined by respiratory epithelium, the exact function of which is unclear. While lesions affecting these sinuses are occasionally reported in cattle, their microbial flora has not been defined. Furthermore, given that the various bacterial and viral pathogens causing bovine respiratory disease (BRD) persist within herds, we speculated that the paranasal sinuses may serve as a refuge for such infectious agents. The paranasal sinuses of clinically normal cattle (n = 99) and of cattle submitted for post-mortem examination (PME: n = 34) were examined by microbial culture, PCR and serology to include bacterial and viral pathogens typically associated with BRD: Mycoplasma bovis, Histophilus somni, Mannheimia haemolytica and Pasteurella multocida, bovine respiratory syncytial virus (BRSV) and bovine parainfluenza-3 virus (BPIV-3). Overall, the paranasal sinuses were either predominantly sterile or did not contain detectable microbes (83.5%: 94.9% of clinically normal and 50.0% of cattle submitted for PME). Bacteria, including BRD causing pathogens, were identified in relatively small numbers of cattle (<10%). While serology indicated widespread exposure of both clinically normal and cattle submitted for PME to BPIV-3 and BRSV (seroprevalences of 91.6% and 84.7%, respectively), PCR identified BPIV-3 in only one animal. To further explore these findings we investigated the potential role of the antimicrobial molecule nitric oxide (NO) within paranasal sinus epithelium using immunohistochemistry. Expression of the enzyme responsible for NO synthesis, inducible nitric oxide synthase (iNOS), was detected to varying degrees in 76.5% of a sub-sample of animals suggesting production of this compound plays a similar protective role in the bovine sinus as it does in humans.
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Gautier, Isabelle; Janiaud, Perrine; Rollet, Nelly; André, Nicolas; Tsimaratos, Michel; Cornu, Catherine; Malik, Salma; Gentile, Stéphanie; Kassaï, Behrouz
2017-08-23
There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation. All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and ranked using the Jadad score. Out of 622 protocols submitted to the Institutional Review Board (IRB), 21% (133/622) included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5), 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-28
... persons to submit comments on this document. Comments may be submitted by one of the following methods... very low (less than one percent), and this carcass sampling was expensive for the Agency. As stated in.... Following the implementation of PR/HACCP, FSIS analyzed only one pathogen per sample. Then, in 2008, FSIS...
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Results of the Excreta Bioassay Quality Control Program for April 1, 2009 through March 31, 2010
DOE Office of Scientific and Technical Information (OSTI.GOV)
Antonio, Cheryl L.
2012-07-19
A total of 58 urine samples and 10 fecal samples were submitted during the report period (April 1, 2009 through March 31, 2010) to General Engineering Laboratories, South Carolina by the Hanford Internal Dosimetry Program (IDP) to check the accuracy, precision, and detection levels of their analyses. Urine analyses for Sr, 238Pu, 239Pu, 241Am, 243Am 235U, 238U, elemental uranium and fecal analyses for 241Am, 238Pu and 239Pu were tested this year as well as four tissue samples for 238Pu, 239Pu, 241Am and 241Pu. The number of QC urine samples submitted during the report period represented 1.3% of the total samplesmore » submitted. In addition to the samples provided by IDP, GEL was also required to conduct their own QC program, and submit the results of analyses to IDP. About 33% of the analyses processed by GEL during the third year of this contract were quality control samples. GEL tested the performance of 21 radioisotopes, all of which met or exceeded the specifications in the Statement of Work within statistical uncertainty (Table 4).« less
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Results of The Excreta Bioassay Quality Control Program For April 1, 2010 Through March 31, 2011
DOE Office of Scientific and Technical Information (OSTI.GOV)
Antonio, Cheryl L.
2012-07-19
A total of 76 urine samples and 10 spiked fecal samples were submitted during the report period (April 1, 2010 through March 31, 2011) to GEL Laboratories, LLC in South Carolina by the Hanford Internal Dosimetry Program (IDP) to check the accuracy, precision, and detection levels of their analyses. Urine analyses for 14C, Sr, for 238Pu, 239Pu, 241Am, 243Am, 235U, 238U, 238U-mass and fecal analyses for 241Am, 238Pu and 239Pu were tested this year. The number of QC urine samples submitted during the report period represented 1.1% of the total samples submitted. In addition to the samples provided by IDP,more » GEL was also required to conduct their own QC program, and submit the results of analyses to IDP. About 31% of the analyses processed by GEL during the first year of contract 112512 were quality control samples. GEL tested the performance of 23 radioisotopes, all of which met or exceeded the specifications in the Statement of Work within statistical uncertainty except the slightly elevated relative bias for 243,244Cm (Table 4).« less
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7 CFR 75.20 - Submitted sample inspection.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 3 2013-01-01 2013-01-01 false Submitted sample inspection. 75.20 Section 75.20 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 194...
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7 CFR 75.20 - Submitted sample inspection.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 3 2010-01-01 2010-01-01 false Submitted sample inspection. 75.20 Section 75.20 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 194...
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7 CFR 75.20 - Submitted sample inspection.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 3 2014-01-01 2014-01-01 false Submitted sample inspection. 75.20 Section 75.20 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 194...
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7 CFR 75.20 - Submitted sample inspection.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 3 2012-01-01 2012-01-01 false Submitted sample inspection. 75.20 Section 75.20 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 194...
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7 CFR 75.37 - Submitted samples.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 3 2014-01-01 2014-01-01 false Submitted samples. 75.37 Section 75.37 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE...
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7 CFR 75.37 - Submitted samples.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 3 2013-01-01 2013-01-01 false Submitted samples. 75.37 Section 75.37 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE...
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7 CFR 75.20 - Submitted sample inspection.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 7 Agriculture 3 2011-01-01 2011-01-01 false Submitted sample inspection. 75.20 Section 75.20 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 194...
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7 CFR 75.37 - Submitted samples.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 3 2012-01-01 2012-01-01 false Submitted samples. 75.37 Section 75.37 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE...
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Quality of clinical and economic evidence in dossier formulary submissions.
Colmenero, Fernando; Sullivan, Sean D; Palmer, Jennifer A; Brauer, Carmen A; Bungay, Kathleen; Watkins, John; Neumann, Peter J
2007-07-01
To investigate the quality and completeness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions. We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington; enrollment 1.6 million) between January 2002 and September 2005. For dossiers submitted in 2003, we examined the clinical studies included. Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs. Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. Of 115 dossiers submitted between 2002 and 2005, 53 (46%) included economic analyses. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis; 38% stated the study perspective; 37% discussed relevant treatment alternatives; 20% stated assumptions clearly; and 18% mentioned caveats to conclusions. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices. Drug companies are submitting dossiers of evidence to formulary committees. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.
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The ClinicalTrials.gov results database--update and key issues.
Zarin, Deborah A; Tse, Tony; Williams, Rebecca J; Califf, Robert M; Ide, Nicholas C
2011-03-03
The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.
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Clinical outcome of subchromosomal events detected by whole‐genome noninvasive prenatal testing
Helgeson, J.; Wardrop, J.; Boomer, T.; Almasri, E.; Paxton, W. B.; Saldivar, J. S.; Dharajiya, N.; Monroe, T. J.; Farkas, D. H.; Grosu, D. S.
2015-01-01
Abstract Objective A novel algorithm to identify fetal microdeletion events in maternal plasma has been developed and used in clinical laboratory‐based noninvasive prenatal testing. We used this approach to identify the subchromosomal events 5pdel, 22q11del, 15qdel, 1p36del, 4pdel, 11qdel, and 8qdel in routine testing. We describe the clinical outcomes of those samples identified with these subchromosomal events. Methods Blood samples from high‐risk pregnant women submitted for noninvasive prenatal testing were analyzed using low coverage whole genome massively parallel sequencing. Sequencing data were analyzed using a novel algorithm to detect trisomies and microdeletions. Results In testing 175 393 samples, 55 subchromosomal deletions were reported. The overall positive predictive value for each subchromosomal aberration ranged from 60% to 100% for cases with diagnostic and clinical follow‐up information. The total false positive rate was 0.0017% for confirmed false positives results; false negative rate and sensitivity were not conclusively determined. Conclusion Noninvasive testing can be expanded into the detection of subchromosomal copy number variations, while maintaining overall high test specificity. In the current setting, our results demonstrate high positive predictive values for testing of rare subchromosomal deletions. © 2015 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd. PMID:26088833
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Clarke, Loren E; Flake, Darl D; Busam, Klaus; Cockerell, Clay; Helm, Klaus; McNiff, Jennifer; Reed, Jon; Tschen, Jaime; Kim, Jinah; Barnhill, Raymond; Elenitsas, Rosalie; Prieto, Victor G; Nelson, Jonathan; Kimbrell, Hillary; Kolquist, Kathryn A; Brown, Krystal L; Warf, M Bryan; Roa, Benjamin B; Wenstrup, Richard J
2017-02-15
Recently, a 23-gene signature was developed to produce a melanoma diagnostic score capable of differentiating malignant and benign melanocytic lesions. The primary objective of this study was to independently assess the ability of the gene signature to differentiate melanoma from benign nevi in clinically relevant lesions. A set of 1400 melanocytic lesions was selected from samples prospectively submitted for gene expression testing at a clinical laboratory. Each sample was tested and subjected to an independent histopathologic evaluation by 3 experienced dermatopathologists. A primary diagnosis (benign or malignant) was assigned to each sample, and diagnostic concordance among the 3 dermatopathologists was required for inclusion in analyses. The sensitivity and specificity of the score in differentiating benign and malignant melanocytic lesions were calculated to assess the association between the score and the pathologic diagnosis. The gene expression signature differentiated benign nevi from malignant melanoma with a sensitivity of 91.5% and a specificity of 92.5%. These results reflect the performance of the gene signature in a diverse array of samples encountered in routine clinical practice. Cancer 2017;123:617-628. © 2016 American Cancer Society. © 2016 Myriad Genetics, Inc. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
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A multi-site feasibility study for personalized medicine in canines with Osteosarcoma
2013-01-01
Background A successful therapeutic strategy, specifically tailored to the molecular constitution of an individual and their disease, is an ambitious objective of modern medicine. In this report, we highlight a feasibility study in canine osteosarcoma focused on refining the infrastructure and processes required for prospective clinical trials using a series of gene expression-based Personalized Medicine (PMed) algorithms to predict suitable therapies within 5 days of sample receipt. Methods Tumor tissue samples were collected immediately following limb amputation and shipped overnight from veterinary practices. Upon receipt (day 1), RNA was extracted from snap-frozen tissue, with an adjacent H&E section for pathological diagnosis. Samples passing RNA and pathology QC were shipped to a CLIA-certified laboratory for genomic profiling. After mapping of canine probe sets to human genes and normalization against a (normal) reference set, gene level Z-scores were submitted to the PMed algorithms. The resulting PMed report was immediately forwarded to the veterinarians. Upon receipt and review of the PMed report, feedback from the practicing veterinarians was captured. Results 20 subjects were enrolled over a 5 month period. Tissue from 13 subjects passed both histological and RNA QC and were submitted for genomic analysis and subsequent PMed analysis and report generation. 11 of the 13 samples for which PMed reports were produced were communicated to the veterinarian within the target 5 business days. Of the 7 samples that failed QC, 4 were due to poor RNA quality, whereas 2 were failed following pathological review. Comments from the practicing veterinarians were generally positive and constructive, highlighting a number of areas for improvement, including enhanced education regarding PMed report interpretation, drug availability, affordable pricing and suitable canine dosing. Conclusions This feasibility trial demonstrated that with the appropriate infrastructure and processes it is possible to perform an in-depth molecular analysis of a patient’s tumor in support of real time therapeutic decision making within 5 days of sample receipt. A number of areas for improvement have been identified that should reduce the level of sample attrition and support clinical decision making. PMID:23815880
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Sex differences in opioid use and medical issues during buprenorphine/naloxone treatment.
Barbosa-Leiker, Celestina; McPherson, Sterling; Layton, Matthew E; Burduli, Ekaterina; Roll, John M; Ling, Walter
2018-01-01
There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive samples was found during treatment for men, but not women. In order to inform sex-based approaches to improve treatment outcomes, research is needed to determine if opioid use, and predictors of opioid use, differs between men and women during treatment. To test for sex differences in opioid use during a buprenorphine/naloxone clinical trial and determine if sex differences exist in the associations between addiction-related problem areas and opioid use over the course of the trial. This secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network (CTN) 0003 examined sex differences (men = 347, women = 169) in opioid-positive samples in a randomized clinical trial comparing 7-day vs. 28-day buprenorphine/naloxone tapering strategies. Addiction-related problem areas were defined by Addiction Severity-Lite (ASI-L) domain composite scores. Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial (B = .33, p = .01) and medical issues were positively related to submitting an opioid-positive sample during treatment for women (B = 1.67, p = .01). No ASI-L domain composite score was associated with opioid-positive samples during treatment for men. Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial, and medical issues predicted opioid use during treatment for women but not men. Complementary treatment for medical problems during opioid replacement therapy may benefit women.
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46 CFR 164.006-4 - Inspection and testing.
Code of Federal Regulations, 2010 CFR
2010-10-01
... the Coast Guard. (b) Smoke tests. (1) A sample of each thickness submitted shall be tested for smoke... observations shall be made at intervals not greater than five minutes during the one-hour period of test. (2... integrity tests. (1) A sample of each thickness submitted shall be tested for fire resistance and integrity...
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Canine ocular protothecosis: A review of 14 cases.
Shank, Alba Maria M; Dubielzig, Richard D; Teixeira, Leandro B C
2015-09-01
To examine a series of 14 cases of canine ocular protothecosis from archived cases from the Comparative Ocular Pathology Laboratory of Wisconsin (COPLOW), and compare gross and histologic findings. Archival records from COPLOW were searched for canine cases of ocular protothecosis. Fourteen cases that contained matching criteria were identified, and gross and histologic findings, and clinical records for each case were tabulated, examined, and compared (2001-2013). Of the 14 cases identified, six had evidence of systemic disease, as per clinical history. Two of the 14 cases had Prototheca identified via cytology of ocular fluid or retinal exudate; in the remainder of cases, Prototheca identified via cytology of ocular fluid or retinal exudate in the remaining 12 cases, Prototheca was identified upon histologic examination of the submitted globe(s). Presenting ocular clinical signs were variable and nonspecific. Duration of ocular clinical signs varied from days to months. Fundoscopically, white membranes or plaques were identified on or around the retina in five cases. Retinal detachment was identified in 13 of the 14 submitted globes on gross examination following fixation and sectioning. The predominant histologic finding was granulomatous chorioretinitis with retinal detachment, with variable numbers of Prototheca within the inflammatory infiltrate. Due to the nonspecific nature of the ocular signs, a diagnosis of protothecosis generally is not made until enucleation and histopathologic examination of the globe(s). Retinal detachment and blindness were common. Cytologic sampling of retinal plaques and exudate may provide a rapid way to identify Prototheca. © 2014 American College of Veterinary Ophthalmologists.
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Gazdik, Gertrude C.; Behum, Paul T.
1983-01-01
During the recent U.S. Bureau of Mines field investigation, 21 samples were collected (fig. 2) and were submitted to the Bureau's Reno Metallurgy Research Center, Reno, Nev., for analysis. All samples were tested for 40 elements by semiquantitative spectrographic analyses. Additional testing by atomic absorption, neutron activation, and wet chemical techniques was performed for selected elements on some samples. Two shale samples were submitted to the Bureau of Mines, Tuscaloosa Metallurgy Research Center, Tuscaloosa, Ala., for the evaluation of ceramic properties.
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Content Analysis of Papers Submitted to "Communications in Information Literacy," 2007-2013
ERIC Educational Resources Information Center
Hollister, Christopher V.
2014-01-01
The author conducted a content analysis of papers submitted to the journal, "Communications in Information Literacy," from the years 2007-2013. The purpose was to investigate and report on the overall quality characteristics of a statistically significant sample of papers submitted to a single-topic, open access, library and information…
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Margolin, Adam A.; Bilal, Erhan; Huang, Erich; Norman, Thea C.; Ottestad, Lars; Mecham, Brigham H.; Sauerwine, Ben; Kellen, Michael R.; Mangravite, Lara M.; Furia, Matthew D.; Vollan, Hans Kristian Moen; Rueda, Oscar M.; Guinney, Justin; Deflaux, Nicole A.; Hoff, Bruce; Schildwachter, Xavier; Russnes, Hege G.; Park, Daehoon; Vang, Veronica O.; Pirtle, Tyler; Youseff, Lamia; Citro, Craig; Curtis, Christina; Kristensen, Vessela N.; Hellerstein, Joseph; Friend, Stephen H.; Stolovitzky, Gustavo; Aparicio, Samuel; Caldas, Carlos; Børresen-Dale, Anne-Lise
2013-01-01
Although molecular prognostics in breast cancer are among the most successful examples of translating genomic analysis to clinical applications, optimal approaches to breast cancer clinical risk prediction remain controversial. The Sage Bionetworks–DREAM Breast Cancer Prognosis Challenge (BCC) is a crowdsourced research study for breast cancer prognostic modeling using genome-scale data. The BCC provided a community of data analysts with a common platform for data access and blinded evaluation of model accuracy in predicting breast cancer survival on the basis of gene expression data, copy number data, and clinical covariates. This approach offered the opportunity to assess whether a crowdsourced community Challenge would generate models of breast cancer prognosis commensurate with or exceeding current best-in-class approaches. The BCC comprised multiple rounds of blinded evaluations on held-out portions of data on 1981 patients, resulting in more than 1400 models submitted as open source code. Participants then retrained their models on the full data set of 1981 samples and submitted up to five models for validation in a newly generated data set of 184 breast cancer patients. Analysis of the BCC results suggests that the best-performing modeling strategy outperformed previously reported methods in blinded evaluations; model performance was consistent across several independent evaluations; and aggregating community-developed models achieved performance on par with the best-performing individual models. PMID:23596205
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Shovman, Ora; Gilburd, Boris; Chayat, Chen; Amital, Howard; Langevitz, Pnina; Watad, Abdulla; Guy, Adi; Perez, Dolores; Azoulay, Danielle; Blank, Miri; Segal, Yael; Bentow, Chelsea; Mahler, Michael; Shoenfeld, Yehuda
2018-01-01
Autoantibodies to the dense fine speckled 70 (DFS70) antigen are common among antinuclear antibodies (ANA) positive healthy individuals (HI). We assessed the prevalence of anti-DFS70 antibodies in patients with and without ANA-associated rheumatic diseases (AARDs) by two methods: chemiluminescent immunoassay (CIA) and an indirect immunofluorescence (IIF) assay based on immunoadsorption for DFS70. Fifty-one ANA-positive sera samples from patients with confirmed clinical diagnosis of AARD, 92 samples from HI and 85 samples submitted to a reference laboratory for routine ANA testing were evaluated for the presence of anti-DFS70 antibodies. The samples were evaluated by QUANTA Flash DFS70 CIA using BIO-FLASH instrument and by NOVA Lite selected HEp-2 kit on NOVA View - an automated IIF system. Sera with DFS positive pattern were pre-absorbed with highly purified human DFS70 antigen, and then tested again. Twenty-four samples (10.5%) tested by QUANTA Flash DFS70 CIA were positive for anti-DFS70 antibodies. The prevalence of monospecific anti-DFS70 antibodies was significantly higher in healthy subjects than in patients with AARDs (10.9% vs. 1.9%, p=0.02). The frequency of anti-DFS70 antibodies in samples submitted for routine ANA testing was 15.2%. A very good agreement was found between CIA and the DFS pattern identified by the automated HEp-2 IIF (kappa=0.97). In 80% of the samples obtained from patients without AARDs, immunoadsorption effectively inhibited the anti-DFS70 antibodies. The data confirm that mono-specific anti-DFS70 antibodies are a strong discriminator between ANA positive HI and AARD patients, and their evaluation should be included in ANA testing algorithms.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Plemons, R.E.; Hopwood, W.H. Jr.; Hamilton, J.H.
For a number of years the Oak Ridge Y-12 Plant Laboratory has been analyzing coal predominately for the utilities department of the Y-12 Plant. All laboratory procedures, except a Leco sulfur method which used the Leco Instruction Manual as a reference, were written based on the ASTM coal analyses. Sulfur is analyzed at the present time by two methods, gravimetric and Leco. The laboratory has two major endeavors for monitoring the quality of its coal analyses. (1) A control program by the Plant Statistical Quality Control Department. Quality Control submits one sample for every nine samples submitted by the utilitiesmore » departments and the laboratory analyzes a control sample along with the utilities samples. (2) An exchange program with the DOE Coal Analysis Laboratory in Bruceton, Pennsylvania. The Y-12 Laboratory submits to the DOE Coal Laboratory, on even numbered months, a sample that Y-12 has analyzed. The DOE Coal Laboratory submits, on odd numbered months, one of their analyzed samples to the Y-12 Plant Laboratory to be analyzed. The results of these control and exchange programs are monitored not only by laboratory personnel, but also by Statistical Quality Control personnel who provide statistical evaluations. After analysis and reporting of results, all utilities samples are retained by the laboratory until the coal contracts have been settled. The utilities departments have responsibility for the initiation and preparation of the coal samples. The samples normally received by the laboratory have been ground to 4-mesh, reduced to 0.5-gallon quantities, and sealed in air-tight containers. Sample identification numbers and a Request for Analysis are generated by the utilities departments.« less
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7 CFR 28.56 - Form A and Form D memorandum.
Code of Federal Regulations, 2011 CFR
2011-01-01
... classification and/or comparison has been made of any samples submitted by the owner of the cotton or the owner's... Certificates and Memoranda § 28.56 Form A and Form D memorandum. (a) When a classification and/or comparison has been made of any samples submitted to a Classing Office direct from a public warehouse, the...
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7 CFR 28.56 - Form A and Form D memorandum.
Code of Federal Regulations, 2010 CFR
2010-01-01
... classification and/or comparison has been made of any samples submitted by the owner of the cotton or the owner's... Certificates and Memoranda § 28.56 Form A and Form D memorandum. (a) When a classification and/or comparison has been made of any samples submitted to a Classing Office direct from a public warehouse, the...
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Post STS-135 Evaluation of Main Flame Deflector Witness Materials
NASA Technical Reports Server (NTRS)
Long, Victoria
2011-01-01
NASA and USA design engineers submitted witness materials from the solid rocket booster (SRB) main flame deflector for evaluation after the launch of STS-135. The following items were submitted for analysis: HY-80 steel witnes rods, 304 sta inles steel caps, and tungsten pistons. All of the items were photographed in order to document their condition after the launch of STS-135. The submitted samples were dimensionally measured in order to determine the amount of material lost during launch. Microstructural changes were observed in the HY-80 witness rod metallographic samples due to the heat of the launch.
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Prevalence of cognitive and functional impairment in a community sample in Ribeirão Preto, Brazil.
Lopes, Marcos A; Hototian, Sergio R; Bustamante, Sonia E Z; Azevedo, Dionísio; Tatsch, Mariana; Bazzarella, Mário C; Litvoc, Júlio; Bottino, Cássio M C
2007-08-01
This study aimed at estimating the prevalence of cognitive and functional impairment (CFI) in a community sample in Ribeirão Preto, Brazil, evaluating its distribution in relation to various socio-demographic and clinical factors. The population was a representative sample aged 60 and older, from three different socio-economic classes. Cluster sampling was applied. Instruments used to select CFI (a syndromic category that does not exclude dementia): 'Mini Mental State Examination' (MMSE), 'Fuld Object Memory Evaluation' (FOME), 'Informant Questionnaire on Cognitive Decline in the Elderly' (IQCODE), 'Bayer Activities of Daily Living Scale' (B-ADL) and clinical interviews. The data obtained were submitted to bivariate and logistic regression analysis. A sample of 1.145 elderly persons was evaluated, with a mean age of 70.9 years (60-100; DP: 7.7); 63.4% were female, and 52.8% had up to 4 years of schooling. CFI prevalence was 18.9% (n = 217). Following logistic regression analysis, higher age, low education, stroke, epilepsy and depression were associated with CFI. Female sex, widowhood, low social class and head trauma were associated with CFI only on bivariate analysis. CFI prevalence results were similar to those found by studies in Brazil, Puerto Rico and Malaysia. Cognitive and functional impairment is a rather heterogeneous condition which may be associated with various clinical conditions found in the elderly population. Due to its high prevalence and association with higher mortality and disability rates, this clinical syndrome should receive more attention on public health intervention planning.
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Schukken, Y H; Bennett, G J; Zurakowski, M J; Sharkey, H L; Rauch, B J; Thomas, M J; Ceglowski, B; Saltman, R L; Belomestnykh, N; Zadoks, R N
2011-12-01
The objective of this study was to evaluate the efficacy of intramammary treatment with ceftiofur hydrochloride of nonsevere, clinical coliform mastitis. One hundred four cases on 5 farms met the enrollment criteria for the study. Escherichia coli was the most common coliform species identified in milk samples from cows with mild to moderate clinical mastitis, followed by Klebsiella spp. and Enterobacter spp. At enrollment, a milk sample from the affected quarter was taken and used for on-farm culture or submitted to the laboratory. For cows in the treatment group, treatment was initiated with ceftiofur hydrochloride via intramammary infusion at 24-h intervals for 5 d according to label standards. Cows in the control group did not receive treatment. Culture results were available on the day after enrollment and only cows with coliform mastitis continued in the treatment and untreated control groups. Bacteriological cure was defined based on 2 posttreatment milk samples. Molecular typing was used for final definition of bacteriological cure. Treatment of nonsevere clinical gram-negative mastitis with ceftiofur hydrochloride resulted in a significant increase in bacteriological cure compared with nontreated controls in animals infected with E. coli or Klebsiella spp. Treated animals clinically improved significantly more compared with control cows. No significant differences were observed between treated and control animals in milk production or linear score before or after clinical mastitis. Treated animals left the study less frequently compared with control animals. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.
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The ClinicalTrials.gov Results Database — Update and Key Issues
Zarin, Deborah A.; Tse, Tony; Williams, Rebecca J.; Califf, Robert M.; Ide, Nicholas C.
2011-01-01
BACKGROUND The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data. PMID:21366476
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Abrahamson, Melanie; Hooker, Elizabeth; Ajami, Nadim J; Petrosino, Joseph F; Orwoll, Eric S
2017-09-01
The relationship of the gastrointestinal microbiome to health and disease is of major research interest, including the effects of the gut microbiota on age related conditions. Here we report on the outcome of a project to collect stool samples on a large number of community dwelling elderly men using the OMNIgene-GUT stool/feces collection kit (OMR-200, DNA Genotek, Ottawa, Canada). Among 1,328 men who were eligible for stool collection, 982 (74%) agreed to participate and 951 submitted samples. The collection process was reported to be acceptable, almost all samples obtained were adequate, the process of sample handling by mail was uniformly successful. The DNA obtained provided excellent results in microbiome analyses, yielding an abundance of species and a diversity of taxa as would be predicted. Our results suggest that population studies of older participants involving remote stool sample collection are feasible. These approaches would allow large scale research projects of the association of the gut microbiota with important clinical outcomes.
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Protein electrophoresis in cranes with presumed insect bite.
Hartup, Barry K; Schroeder, Carrie A
2006-06-01
Serum protein electrophoresis (SPE) has emerged as a potentially valuable diagnostic tool in avian medicine; yet, there is limited information regarding SPE in cranes. Since 2000, 20 cases of unilateral periocular or facial soft tissue swelling, blepharitis, feather loss, and ocular or nasal discharge attributed to insect bite hypersensitivity were observed in cranes from a captive breeding center. SPE may be useful for evaluating these lesions. The aim of this study was to characterize the inflammatory response in cranes with hypersensitivity reactions using SPE. Serum samples from 7 cranes diagnosed with hypersensitivity reactions were submitted to a diagnostic laboratory for agarose gel electrophoresis. Results were compared to those in control serum samples obtained from the same cranes during routine physical examination, when they were clinically healthy. Total protein and a- and g-globulin concentrations were significantly increased and albumin/globulin ratios were significantly decreased in serum samples from cranes with hypersensitivity lesions compared with control samples. Using SPE, we documented changes in protein fraction concentrations in cranes with clinical signs of hypersensitivity. The increase in alpha- and gamma-globulin concentrations suggested inflammation and antigenic stimulation, consistent with a Type I hypersensitivity reaction.
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Shirotani, Mari; Kurokawa, Tatsuo; Chiba, Koji
2014-07-01
The number of worldwide and Asian multiregional clinical trials (MRCTs) submitted for Japanese New Drug Applications increased markedly between 2009 and 2013, with an increasing number performed for simultaneously submission in the USA, EU, and Japan. Asian studies accounted for 32% of MRCTs (14/44 studies) and had comparatively small sample sizes (<500 subjects). Moreover, the number of Japanese subjects in Asian studies was 2.1- to 13.4-fold larger than the sample size estimated using the method described in Japanese MRCT guidelines, whereas the ratio for worldwide studies was 0.05- to 4.9-fold. Before the introduction of this guidelines, bridging or domestic clinical development strategies were used as the regional development strategy in accordance with ICH E5 guidelines. The results presented herein suggest that Asian studies were conducted when the drug had already been approved in the US/EU, when phase 3 clinical trials were not be planned in the USA/EU, when there was insufficient knowledge of ethnic differences in drug efficacy and safety, or when Caucasian data could not be extrapolated to the Japanese population. New strategies with Asian studies including the Japanese population could be conducted instead of Japanese domestic development strategy. © 2014, The American College of Clinical Pharmacology.
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Epidemiological Survey of Human Metapneumovirus Infection in a Large Pediatric Tertiary Care Center
Chano, Frédéric; Rousseau, Céline; Laferrière, Céline; Couillard, Michel; Charest, Hugues
2005-01-01
The human metapneumovirus (hMPV) was recently identified and linked to acute respiratory tract infections (ARTI). To assess the clinical importance of this virus in infants and children, we developed a rapid and efficient reverse transcription-PCR-based screening method for a large volume of samples and tested retrospectively a collection of 1,132 respiratory specimens submitted over a full year period to the virology laboratory of a large tertiary care pediatric center in Montreal, Canada. A total of 41 samples from 37 patients were positive by this method. During the winter months of 2001, up to 8% of specimens submitted for respiratory virus testing were hMPV positive. Sequencing data of the hMPV M gene revealed that two genogroups of the virus, each of which can be divided into two subgroups, cocirculated during this time period. A case-controlled study was conducted to compare the symptoms associated with hMPV infection with those involving other etiologic agents causing ARTI. Symptoms most frequently observed in hMPV-positive patients were cough, wheezing, and dyspnea, although the symptomatology could differ substantially from patient to patient. No distinct symptom profile could be associated with hMPV. Three nosocomial cases of hMPV infection were identified. Together, our data suggest that hMPV is a significant cause of symptomatic respiratory tract infections in infants and children. The incidence of the disease and the morbidity associated with the infection justify adding hMPV to the list of common respiratory viruses routinely screened for by clinical laboratories. PMID:16272480
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von Elm, Erik; Röllin, Alexandra; Blümle, Anette; Huwiler, Karin; Witschi, Mark; Egger, Matthias
2008-04-05
Not all clinical trials are published, which may distort the evidence that is available in the literature. We studied the publication rate of a cohort of clinical trials and identified factors associated with publication and nonpublication of results. We analysed the protocols of randomized clinical trials of drug interventions submitted to the research ethics committee of University Hospital (Inselspital) Bern, Switzerland from 1988 to 1998. We identified full articles published up to 2006 by searching the Cochrane CENTRAL database (issue 02/2006) and by contacting investigators. We analyzed factors associated with the publication of trials using descriptive statistics and logistic regression models. 451 study protocols and 375 corresponding articles were analyzed. 233 protocols resulted in at least one publication, a publication rate of 52%. A total of 366 (81%) trials were commercially funded, 47 (10%) had non-commercial funding. 346 trials (77%) were multi-centre studies and 272 of these (79%) were international collaborations. In the adjusted logistic regression model non-commercial funding (Odds Ratio [OR] 2.42, 95% CI 1.14-5.17), multi-centre status (OR 2.09, 95% CI 1.03-4.24), international collaboration (OR 1.87, 95% CI 0.99-3.55) and a sample size above the median of 236 participants (OR 2.04, 95% CI 1.23-3.39) were associated with full publication. In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.
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Martínez-Girón, Rafael; van Woerden, Hugo Cornelis
2013-01-01
The objective of this study is to assess the relationship between protozoa in spontaneously expectorated sputum samples and a range of clinical and immunological variables. Clinical details including age, gender, smoking status, and use of oral or inhaled steroids were recorded for a cohort of 199 patients whose spontaneously expectorated sputum samples were submitted to a Cytology Laboratory in Spain between January 2005 and December 2006. Slides were scanned for protozoa under light microscopy and scanned for monocytes/small macrophages highlighted by immunocytochemistry (CD68 monoclonal antibody). One hundred ninety-one patients provided adequate sputum samples, of whom 70 had protozoa in their sputum. There was a strong relationship between the presence of protozoa and monocytes/small macrophages identified under light microscopy (P < 0.001). A binary logistic regression model also indicated a relationship between protozoa and both smoking status and steroid use. The diagnoses in those with protozoa included infection (including tuberculosis), chronic obstructive pulmonary disease (COPD), lung fibrosis, asthma, chronic liver disease, immunosuppression, cancer, pancreatic or renal disease, heart failure, and AIDS. The identified association between protozoa and monocytes/small macrophages in sputum suggests an immune response and warrants further investigation to clarify whether or not these organisms have any pathological significance in this wide range of conditions. Copyright © 2011 Wiley Periodicals, Inc.
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Adverse drug event monitoring at the Food and Drug Administration.
Ahmad, Syed Rizwanuddin
2003-01-01
The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk.
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Adverse Drug Event Monitoring at the Food and Drug Administration
Ahmad, Syed Rizwanuddin
2003-01-01
The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk. PMID:12534765
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Pearson marrow pancreas syndrome in patients suspected to have Diamond-Blackfan anemia.
Gagne, Katelyn E; Ghazvinian, Roxanne; Yuan, Daniel; Zon, Rebecca L; Storm, Kelsie; Mazur-Popinska, Magdalena; Andolina, Laura; Bubala, Halina; Golebiowska, Sydonia; Higman, Meghan A; Kalwak, Krzysztof; Kurre, Peter; Matysiak, Michal; Niewiadomska, Edyta; Pels, Salley; Petruzzi, Mary Jane; Pobudejska-Pieniazek, Aneta; Szczepanski, Tomasz; Fleming, Mark D; Gazda, Hanna T; Agarwal, Suneet
2014-07-17
Pearson marrow pancreas syndrome (PS) is a multisystem disorder caused by mitochondrial DNA (mtDNA) deletions. Diamond-Blackfan anemia (DBA) is a congenital hypoproliferative anemia in which mutations in ribosomal protein genes and GATA1 have been implicated. Both syndromes share several features including early onset of severe anemia, variable nonhematologic manifestations, sporadic genetic occurrence, and occasional spontaneous hematologic improvement. Because of the overlapping features and relative rarity of PS, we hypothesized that some patients in whom the leading clinical diagnosis is DBA actually have PS. Here, we evaluated patient DNA samples submitted for DBA genetic studies and found that 8 (4.6%) of 173 genetically uncharacterized patients contained large mtDNA deletions. Only 2 (25%) of the patients had been diagnosed with PS on clinical grounds subsequent to sample submission. We conclude that PS can be overlooked, and that mtDNA deletion testing should be performed in the diagnostic evaluation of patients with congenital anemia. © 2014 by The American Society of Hematology.
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45 CFR 286.260 - May Tribes use sampling and electronic filing?
Code of Federal Regulations, 2010 CFR
2010-10-01
... quarterly reports electronically, based on format specifications that we will provide. Tribes who do not have the capacity to submit reports electronically may submit quarterly reports on a disk or in hard...
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Bielan, B
2001-08-01
The "Clinical Snapshot" series provides a concise examination of a clinical presentation including history, treatment, patient education, and nursing measures. Using the format here, you are invited to submit your "Clinical Snapshot" to Dermatology Nursing.
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21 CFR 1003.31 - Granting the exemption.
Code of Federal Regulations, 2010 CFR
2010-04-01
... applicable Federal standard is such as to create a significant risk of injury, including genetic injury, to... is desirable. Where such evidence includes nonclinical laboratory studies, the data submitted shall... includes clinical investigations involving human subjects, the data submitted shall include, with respect...
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Multicenter transversal two-phase study to determine a national prevalence of epilepsy in Algeria.
Moualek, Dalila; Pacha, Lamia Ali; Abrouk, Samira; Kediha, Mohamed Islam; Nouioua, Sonia; Aissa, Leila Ait; Bellatache, Mounia; Belarbi, Soreya; Slimani, Saddek; Khennouf, Houria; Fellahi, Lynda; El Amine Hamimed, Mohamed; Benali, Nadia; Chekkour, Mohamed Chahine; Maamoun, Ramdane; Dameche, Rachida; Assami, Salima; Tazir, Meriem
2012-01-01
The prevalence of epilepsy in Algeria is unknown. The aims of this multicenter transversal study were to determine the national prevalence and clinical characteristics of epilepsy in the Algerian population. This two-phase study was conducted in 5 circumscriptions and included 8,046 subjects aged over 2 months who attended the randomly selected public and private primary care clinics. In the phase 1 study, a questionnaire was submitted to the sample of patients. In the phase 2 study, all potentially epileptic people were examined by neurologists and a second questionnaire was submitted, eventually assessed by appropriate investigations. Sixty-seven patients were identified as having active epilepsy, giving a crude prevalence ratio of 8.32 per 1,000 (95% CI, 6.34-10.3) and an age-adjusted prevalence ratio of 8.9 per 1,000. The highest age-specific ratio was found in patients aged 10-19 years (16.92 per 1,000). Generalized seizures (68.7%) were more common than partial seizures (29.8%). Perinatal injuries were the major leading putative causes (11.9%). The prevalence of epilepsy of 8.32 determined in this study is relatively high. These results provide new epidemiological data and suggest that epilepsy remains an important public health issue to consider in Algeria. Copyright © 2012 S. Karger AG, Basel.
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40 CFR 63.1574 - What notifications must I submit and when?
Code of Federal Regulations, 2010 CFR
2010-07-01
... catalytic reforming unit when you use a colormetric tube sampling system, including procedures for..., you must submit all of the notifications in §§ 63.6(h), 63.7(b) and (c), 63.8(e), 63.8(f)(4), 63.8(f)(6), and 63.9(b) through (h) that apply to you by the dates specified. (1) You must submit the...
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Rapp-Santos, Kamala; Havas, Karyn; Vest, Kelly
2015-01-01
The Destination Monitoring Program, operated by the US Army Public Health Command (APHC), is one component that supports the APHC Veterinary Service's mission to ensure safety and quality of food procured for the Department of Defense (DoD). This program relies on retail product testing to ensure compliance of production facilities and distributors that supply food to the DoD. This program was assessed to determine the validity and timeliness by specifically evaluating whether sample size of items collected was adequate, if food samples collected were representative of risk, and whether the program returns results in a timely manner. Data was collected from the US Army Veterinary Services Lotus Notes database, including all food samples collected and submitted from APHC Region-North for the purposes of destination monitoring from January 1, 2013 to December 31, 2013. For most food items, only one sample was submitted for testing. The ability to correctly identify a contaminated food lot may be limited by reliance on test results from only one sample, as the level of confidence in a negative test result is low. The food groups most frequently sampled by APHC correlated with the commodities that were implicated in foodborne illness in the United States. Food items to be submitted were equally distributed among districts and branches, but sections within large branches submitted relatively few food samples compared to sections within smaller branches and districts. Finally, laboratory results were not available for about half the food items prior to their respective expiration dates.
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Goiato, Marcelo Coelho; Zuccolotti, Bruna Carolina Rossatti; Haddad, Marcela Filié; Moreno, Amália; Pesqueira, Aldiéris Alves; Gennari, Humberto Filho; Dos Santos, Daniela Micheline
2015-12-01
The aim of this study was to assess the flexural strength of two brands of thermopolymerisable acrylic resins (Onda Cryl, Artigos Odontológicos Clássico Ltda, São Paulo, SP, Brazil; and Lucitone 550, Dentsply, York, PA, USA) with varying concentrations of pigment (Poli-Côr, Artigos Odontológicos Clássico Ltda, São Paulo, SP, Brazil) under the influence of thermocycling, storage and disinfection. A total of 210 samples were manufactured (105 for each acrylic resin brand), with dimensions of 64 x 10 x 3.3 mm. The samples were divided into 30 subgroups (n = 7) according to the proportion of pigment used (without pigment, 3% and 7%), the assessment period (initial or thermocycling for 2000 cycles) and disinfection method (immersion in 1% sodium hypochlorite, (Apothicário, Araçatuba, SP, Brazil), microwave energy or immersion in alkaline peroxide (Efferdent, Pfizer, Morris Plains, NJ, USA). The samples were submitted to the flexural strength test before and after thermocycling, and after storage with disinfection. The disinfection process was performed every 3 days, for 60 days. Data were submitted to analysis of variance (ANOVA) and Tukey test (p < 0.05). The factors that provided statistical alteration in flexural strength values were resin type and assessment period. The Onda Cryl resin and the period after disinfection (126 ± 25 MPa) exhibited the higher values of flexural strength. Following disinfection, Onda-Cryl resin exhibited the highest values of flexural strength. All the samples obtained are considered clinically acceptable.
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Rodgers, C S; Creasy, M R; Fitchett, M; Maliszewska, C T; Pratt, N R; Waters, J J
1996-01-01
AIMS: To survey the diagnostic service provided by UK laboratories for the culture of solid tissue samples (excluding tumours) and in particular to examine the variation in culture success rates and the problems of maternal cell overgrowth. METHODS: Twenty seven laboratories took part in a collaborative survey during 1992. Each laboratory submitted data on up to a maximum of 60 consecutive specimens (n = 1361) over a six month period. RESULTS: Skin specimens, the largest category received (n = 520), were the most problematic (51% success rate). Culture success rates were significantly lower (43%) when skin specimens (n = 140) were transported dry to the laboratory. Success rates for skin specimens also varied, depending on the origin of the specimen, from 18% for intra-uterine deaths (IUD) (n = 94) to 85% for neonatal deaths (n = 33) and 83% for live patients (n = 54). Culture of selected extra-fetal tissues from IUD, stillbirths and following elective termination of pregnancy (TOP) gave comparable success rates to those achieved for skin samples from neonatal deaths and live births. Skewed sex ratios, female > male, were identified for products of conception (POC) (n = 298) and placental biopsy specimens (n = 97). CONCLUSIONS: By appropriate selection, transport and processing of tissues, and in particular by avoiding relying solely on skin samples from IUD, stillbirths and TOP, an increase in culture success rates for solid tissue samples submitted for cytogenetic analysis could be achieved. The high risk of maternal cell contamination from POC and placental biopsy specimens was also identified in this survey. PMID:8881913
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Melo, Radamés Bezerra; de Barros Silva, Paulo Goberlânio; Oriá, Reinaldo Barreto; Melo, José Ulisses de Souza; da Silva Martins, Conceição; Cunha, Aline Matos; Vasconcelos, Paulo Roberto Leitão
2017-02-01
To evaluate the anti-inflammatory effect of pretreatment for three days with a fatty acid mixture with high ω-9:ω-6 ratio and low ω-6:ω-3 ratio on rats submitted to dental extraction. Thirty-two male Wistar rats (270-310g) were randomly distributed in four groups (n=8/group): the sham control group and the negative control group received saline; the high omega-6/low omega-9 group received isolipid fatty acid with high ω-6:ω-3 ratio and low ω-9:ω-6 ratio; the high omega-3/low omega-6 group received fatty acid with low ω-6:ω-3 ratio and high ω-9:ω-6 ratio. Saline and oils were administered by gavage for 4days before exodontia and 3days after surgery, followed by euthanasia. Masseter edema was evaluated clinically and tissue samples were submitted to osteoclast count (H&E), myeloperoxidase assay, and western blotting (tumor necrosis factor-alpha and interleukin-1beta). In the high omega-3/low omega-6 group, a significant decrease was observed in masseter edema (p<0.0001), myeloperoxidase (p<0.0001), osteoclasts (p=0.0001) and TNF-α expression (p<0.0001), but not in IL-1β expression. The ingestion of fatty acid with high ω-9:ω-6 ratio and low ω-6:ω-3 ratio significantly reduced inflammatory response in rats submitted to dental extraction. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Pedrero-Pérez, Eduardo J; Ruiz-Sánchez de León, José M; Morales-Alonso, Sara; Pedrero-Aguilar, Jara; Fernández-Méndez, Laura M
2015-05-01
Estimation of daily symptoms of frontal dysfunction is considered to be essential in order to endow neuro-psychological assessments with ecological validity. The questionnaires available today were constructed to estimate executive problems in daily life in populations with neurological damage. There is a need for instruments focused on measuring these behaviours in the general population or in clinical populations with mild or moderate impairment. To examine the factorial validity and to find evidence of concurrent validity of the short version of the Prefrontal Symptoms Inventory. Three samples were obtained: the first, from the Internet (n = 504); the second, in a non-clinical population by means of paper and pencil (n = 1,257); and the third, from patients being treated for substance addiction (n = 602). A factorial analysis without restraints was used on the first sample and the results were submitted to confirmatory factorial analysis on the other two samples. The three-factor structure that was found was confirmed with excellent indicators of fit in the other two samples. Evidence of concurrent validity was found with quality of life and mental health tests. We propose a short questionnaire for detecting failures of a prefrontal origin in daily living, which improves on the psychometric qualities of similar tests, but is oriented towards severe neurological pathologies. The structural stability of the test ensures it can be used in the general population, for the early detection of cognitive impairment, and in clinical populations with mild or moderate deterioration. A set of criteria are proposed for use in interpreting the results.
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Chemical migration during soil water retention curve evaluation.
Pires, Luiz F; Villanueva, Felipe C A; Dias, Nivea M P; Bacchi, Osny O Santos; Reichardt, Klaus
2011-09-01
Wetting and drying (W-D) cycles can induce important elemental migrations in soils. The main purpose of this work was to study the possible existence of soil chemical elemental migrations in samples submitted to repeated W-D cycles during evaluations of soil water retention curve (SWRC). The experimental measurements were carried out by Atomic Absorption Spectrometry (AAS) for Ca(2+), Mg(2+) and K(+) on samples of three different Brazilian tropical soils (Geric Ferralsol, Eutric Nitosol and Rhodic Ferralsol). Results demonstrate an increase in the electrical conductivity of the water extracted from the samples and significant losses of Ca(2+), Mg(2+) and K(+) during the applications of up to nine W-D cycles. It was also observed differences in SWRC for all soils when samples submitted to the application of several W-D cycles were compared with samples not submitted to it. These differences occurred at the region of both structural and textural pores. A possible explanation for these results could be the soil chemical migration during the sequences of W-D cycles, which can affect the soil structure development.
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Sandusky, George E; Teheny, Katie Heinz; Esterman, Mike; Hanson, Jeff; Williams, Stephen D
2007-01-01
The success of molecular research and its applications in both the clinical and basic research arenas is strongly dependent on the collection, handling, storage, and quality control of fresh human tissue samples. This tissue bank was set up to bank fresh surgically obtained human tissue using a Clinical Annotated Tissue Database (CATD) in order to capture the associated patient clinical data and demographics using a one way patient encryption scheme to protect patient identification. In this study, we determined that high quality of tissue samples is imperative for both genomic and proteomic molecular research. This paper also contains a brief compilation of the literature involved in the patient ethics, patient informed consent, patient de-identification, tissue collection, processing, and storage as well as basic molecular research generated from the tissue bank using good clinical practices. The current applicable rules, regulations, and guidelines for handling human tissues are briefly discussed. More than 6,610 cancer patients have been consented (97% of those that were contacted by the consenter) and 16,800 tissue specimens have been banked from these patients in 9 years. All samples collected in the bank were QC'd by a pathologist. Approximately 1,550 tissue samples have been requested for use in basic, clinical, and/or biomarker cancer research studies. Each tissue aliquot removed from the bank for a research study were evaluated by a second H&E, if the samples passed the QC, they were submitted for genomic and proteomic molecular analysis/study. Approximately 75% of samples evaluated were of high histologic quality and used for research studies. Since 2003, we changed the patient informed consent to allow the tissue bank to gather more patient clinical follow-up information. Ninety two percent of the patients (1,865 patients) signed the new informed consent form and agreed to be re-contacted for follow-up information on their disease state. In addition, eighty five percent of patients (1,584) agreed to be re-contacted to provide a biological fluid sample to be used for biomarker research.
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Fetal Tissue Procurement for Karyotype Analysis: Clinician or Pathologist - Which is Better?
Conant, Joanna L; Tang, Mary E; Waters, Brenda L
2016-01-01
Chromosomal abnormalities are detected in up to 13% of stillbirths and over 20% of those with developmental anomalies. These estimates may be low since up to 50% of samples fail to achieve a result due to microbial overgrowth or nonviability. Tissue for cytogenetics can be procured at bedside by the clinician or by the pathologist in the laboratory. With clinical collection, tissue is placed into culture media immediately, increasing chances of growth. However, collection competes for attention with other activities, which may result in microbial overgrowth or selection of maternal rather than fetal tissue. Laboratory procurement occurs in a controlled environment using sterile technique, but delay in collection may decrease viability. Our goal was to determine which collection method yields better results. We reviewed cases from 2007-2013 that had two samples submitted for cytogenetics, one from the clinician and one from the pathologist. Specimen source, delivery, collection, and culture setup times, harvest date, cell growth, microbial overgrowth, maternal contamination and final result were obtained from medical records and cytogenetic culture sheets. There was no difference in growth rate, maternal cell contamination, or reporting time between clinician- and pathologist-procured samples despite delay in collection time for laboratory samples. Clinical samples had more microbial overgrowth. Compared to samples collected at bedside, samples collected in the laboratory had a lower rate of microbial contamination with similar growth and maternal cell contamination rates, despite prolonged time to collection. Collecting samples both at bedside and in the laboratory is unnecessary.
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Comazzi, S; Cozzi, M; Bernardi, S; Zanella, D R; Aresu, L; Stefanello, D; Marconato, L; Martini, V
2018-02-01
Flow cytometry (FC) is increasingly being used for immunophenotyping and staging of canine lymphoma. The aim of this retrospective study was to assess pre-analytical variables that might influence the diagnostic utility of FC of lymph node (LN) fine needle aspirate (FNA) specimens from dogs with lymphoproliferative diseases. The study included 987 cases with LN FNA specimens sent for immunophenotyping that were submitted to a diagnostic laboratory in Italy from 2009 to 2015. Cases were grouped into 'diagnostic' and 'non-diagnostic'. Pre-analytical factors analysed by univariate and multivariate analyses were animal-related factors (breed, age, sex, size), operator-related factors (year, season, shipping method, submitting veterinarian) and sample-related factors (type of sample material, cellular concentration, cytological smears, artefacts). The submitting veterinarian, sample material, sample cellularity and artefacts affected the likelihood of having a diagnostic sample. The availability of specimens from different sites and of cytological smears increased the odds of obtaining a diagnostic result. Major artefacts affecting diagnostic utility included poor cellularity and the presence of dead cells. Flow cytometry on LN FNA samples yielded conclusive results in more than 90% of cases with adequate sample quality and sampling conditions. Copyright © 2018 Elsevier Ltd. All rights reserved.
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Automated Microflow NMR: Routine Analysis of Five-Microliter Samples
Jansma, Ariane; Chuan, Tiffany; Geierstanger, Bernhard H.; Albrecht, Robert W.; Olson, Dean L.; Peck, Timothy L.
2006-01-01
A microflow CapNMR probe double-tuned for 1H and 13C was installed on a 400-MHz NMR spectrometer and interfaced to an automated liquid handler. Individual samples dissolved in DMSO-d6 are submitted for NMR analysis in vials containing as little as 10 μL of sample. Sets of samples are submitted in a low-volume 384-well plate. Of the 10 μL of sample per well, as with vials, 5 μL is injected into the microflow NMR probe for analysis. For quality control of chemical libraries, 1D NMR spectra are acquired under full automation from 384-well plates on as many as 130 compounds within 24 h using 128 scans per spectrum and a sample-to-sample cycle time of ∼11 min. Because of the low volume requirements and high mass sensitivity of the microflow NMR system, 30 nmol of a typical small molecule is sufficient to obtain high-quality, well-resolved, 1D proton or 2D COSY NMR spectra in ∼6 or 20 min of data acquisition time per experiment, respectively. Implementation of pulse programs with automated solvent peak identification and suppression allow for reliable data collection, even for samples submitted in fully protonated DMSO. The automated microflow NMR system is controlled and monitored using web-based software. PMID:16194121
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Butler, Christopher C; O'Brien, Kathryn; Wootton, Mandy; Pickles, Timothy; Hood, Kerenza; Howe, Robin; Waldron, Cherry-Ann; Thomas-Jones, Emma; Dudley, Jan; Van Der Voort, Judith; Rumsby, Kate; Little, Paul; Downing, Harriet; Harman, Kim; Hay, Alastair D
2016-04-01
Antibiotic treatment recommendations based on susceptibility data from routinely submitted urine samples may be biased because of variation in sampling, laboratory procedures and inclusion of repeat samples, leading to uncertainty about empirical treatment. To describe and compare susceptibilities of Escherichia coli cultured from routinely submitted samples, with E. coli causing urinary tract infection (UTI) from a cohort of systematically sampled, acutely unwell children. Susceptibilities of 1458 E. coli isolates submitted during the course of routine primary care for children <5 years (routine care samples), compared to susceptibilities of 79 E. coli isolates causing UTI from 5107 children <5 years presenting to primary care with an acute illness [systematic sampling: the Diagnosis of Urinary Tract infection in Young children (DUTY) cohort]. The percentage of E. coli sensitive to antibiotics cultured from routinely submitted samples were as follows: amoxicillin 45.1% (95% confidence interval: 42.5-47.7%); co-amoxiclav using the lower systemic break point (BP) 86.6% (84.7-88.3%); cephalexin 95.1% (93.9-96.1%); trimethoprim 74.0% (71.7-76.2%) and nitrofurantoin 98.2% (97.4-98.8%). The percentage of E. coli sensitive to antibiotics cultured from systematically sampled DUTY urines considered to be positive for UTI were as follows: amoxicillin 50.6% (39.8-61.4%); co-amoxiclav using the systemic BP 83.5% (73.9-90.1%); co-amoxiclav using the urinary BP 94.9% (87.7-98.4%); cephalexin 98.7% (93.2-99.8%); trimethoprim 70.9% (60.1-80.0%); nitrofurantoin 100% (95.3-100.0%) and ciprofloxacin 96.2% (89.4-98.7%). Escherichia coli susceptibilities from routine and systematically obtained samples were similar. Most UTIs in preschool children remain susceptible to nitrofurantoin, co-amoxiclav and cephalexin. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Hantavirus pulmonary syndrome clinical findings: evaluating a surveillance case definition.
Knust, Barbara; Macneil, Adam; Rollin, Pierre E
2012-05-01
Clinical cases of hantavirus pulmonary syndrome (HPS) can be challenging to differentiate from other acute respiratory diseases, which can lead to delays in diagnosis, treatment, and disease reporting. Rapid onset of severe disease occurs, at times before diagnostic test results are available. This study's objective was to examine the clinical characteristics of patients that would indicate HPS to aid in detection and reporting. Test results of blood samples from U.S. patients suspected of having HPS submitted to the Centers for Disease Control and Prevention from 1998-2010 were reviewed. Patient information collected by case report forms was compared between HPS-confirmed and test-negative patients. Diagnostic sensitivity, specificity, predictive values, and likelihood ratios were calculated for individual clinical findings and combinations of variables. Of 567 patients included, 36% were HPS-confirmed. Thrombocytopenia, chest x-rays with suggestive signs, and receiving supplemental oxygenation were highly sensitive (>95%), while elevated hematocrit was highly specific (83%) in detecting HPS. Combinations that maximized sensitivity required the presence of thrombocytopenia. Using a national sample of suspect patients, we found that thrombocytopenia was a highly sensitive indicator of HPS and should be included in surveillance definitions for suspected HPS. Using a sensitive suspect case definition to identify potential HPS patients that are confirmed by highly specific diagnostic testing will ensure accurate reporting of this disease.
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Sample Premanufacture Notification (PMN) Form
For users who need to submit a Premanufacture notice for new chemical substances, this document provides and example form. This form is not for submission, but it will help you figure out how to model your own form to submit to the agency.
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Wald, Regina; Baumgartner, Martina; Urbantke, Verena; Wittek, Thomas; Stessl, Beatrix
2016-10-12
This case report describes the isolation and differentiation of Weissella (W.) spp. from the milk of two cows (A and B) with clinical mastitis (milk changes, asymmetry of the udder and increased somatic cell counts). Quarter milk samples obtained from two dairy cows of different farms had been submitted to the diagnostic laboratory of the Clinic for Ruminants in Vienna for bacteriological examination. Alpha-hemolytic catalase-negative gram-positive cocci in pure culture on Columbia blood agar were isolated and could not be assigned to a Lancefield group. The isolates were biochemically characterized as Leuconostoc spp. (API ® 20 Strep, bioMérieux). A control examination of cow B within 7 weeks confirmed these findings. 16S rDNA sequencing indicated W. paramesenteroides (cow A) and W. cibaria (cow B). The analysis by pulsed-field gel electrophoresis (PFGE) showed identical SmaI/ApaI profiles for both W. cibaria isolates (cow B), which differed from the W. paramesenteroides fingerprint of cow A (67% similarity). This study indicates a possible relationship between the detection of Weissella spp. and the occurrence of bovine intramammary infections.
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Code of Federal Regulations, 2014 CFR
2014-04-01
... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-09
... public comment on proposed data collection projects, the National Institute Heart, Lung, and Blood... projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written... other technological collection techniques or other forms of information technology. To Submit Comments...
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DogMATIC--A Remote Biospecimen Collection Kit for Biobanking.
Milley, Kristi M; Nimmo, Judith S; Bacci, Barbara; Ryan, Stewart D; Richardson, Samantha J; Danks, Janine A
2015-08-01
Canine tumors are valuable comparative oncology models. This research was designed to create a sustainable biobank of canine mammary tumors for breast cancer research. The aim was to provide a well-characterized sample cohort for specimen sharing, data mining, and long-term research aims. Canine mammary tumors are most frequently managed at a local veterinary clinic or hospital. We adopted a biobank framework based on a large number of participating veterinary hospitals and clinics acting as collection centers that were serviced by a centralized storage facility. Recruitment was targeted at rural veterinary clinics. A tailored, stable collection kit (DogMATIC) was designed that was used by veterinarians in remote or rural locations to collect both fresh and fixed tissue for submission to the biobank. To validate this methodology the kit design, collection rate, and sample quality were analyzed. The Australian Veterinary Cancer Biobank was established as a network of 47 veterinary clinics and three veterinary pathology laboratories spanning over 200,000 km(2). In the first 12 months, 30 canine mammary tumor cases were submitted via the DogMATIC kit. Pure intact RNA was isolated in over 80% of samples with an average yield of 14.49 μg. A large network biobank, utilizing off-site collection with the DogMATIC kit, was successfully coordinated. The creation of the Australian Veterinary Cancer Biobank has established a long-term, sustainable, comparative oncology research resource in Australia. There are broader implications for biobanking with this very different form of collection and banking.
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Olmstead, Todd A; Sindelar, Jody L; Petry, Nancy M
2007-03-16
To evaluate the cost-effectiveness of a prize-based intervention as an addition to usual care for stimulant abusers. This cost-effectiveness analysis is based on a randomized clinical trial implemented within the National Drug Abuse Treatment Clinical Trials Network. The trial was conducted at eight community-based outpatient psychosocial drug abuse treatment clinics. Four hundred and fifteen stimulant abusers were assigned to usual care (N=206) or usual care plus abstinence-based incentives (N=209) for 12 weeks. Participants randomized to the incentive condition earned the chance to draw for prizes for submitting substance negative samples; the number of draws earned increased with continuous abstinence time. Incremental cost-effectiveness ratios were estimated to compare prize-based incentives relative to usual care. The primary patient outcome was longest duration of confirmed stimulant abstinence (LDA). Unit costs were obtained via surveys administered at the eight participating clinics. Resource utilizations and patient outcomes were obtained from the clinical trial. Acceptability curves are presented to illustrate the uncertainty due to the sample and to provide policy relevant information. The incremental cost to lengthen the LDA by 1 week was 258 US dollars (95% confidence interval, 191-401 US dollars). Sensitivity analyses on several key parameters show that this value ranges from 163 to 269 US dollars. Compared with the usual care group, the incentive group had significantly longer LDAs and significantly higher costs.
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Sigurdson, C.J.; Franson, J.C.; Fudge, A.M.
2000-01-01
This chapter describes the sources and pathophysiology of some potential poisons that affect birds and summarizes useful laboratory tests. The diagnosis of poisoning in birds, as in mammals, requires a complete and accurate history, careful observation of clinical signs, and a thorough necropsy evaluation. Appropriate sample handling and analysis, based on consultation with the diagnostic toxicologist, are critical (Table 19--1). Veterinary toxicology laboratories are becoming increasingly specialized, with only certain laboratories capable of analyzing for drug residues or anticoagulants, for example. Although a local laboratory may not be able to fulfill a specific test request, they may recommend an alternative laboratory or may be willing to forward the sample. As a general rule in suspect poisoning cases, large tissue samples of liver, kidney, brain, and subcutaneous fat and of crop, proventriculus, and ventriculus contents should be collected at necropsy and frozen. Appropriate samples should be submitted frozen, with the remainder held in the freezer for possible later testing. A second set of tissues should be placed in 10% formalin for histopathologic examination.
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The preanalytic phase in veterinary clinical pathology.
Braun, Jean-Pierre; Bourgès-Abella, Nathalie; Geffré, Anne; Concordet, Didier; Trumel, Cathy
2015-03-01
This article presents the general causes of preanalytic variability with a few examples showing specialists and practitioners that special and improved care should be given to this too often neglected phase. The preanalytic phase of clinical pathology includes all the steps from specimen collection to analysis. It is the phase where most laboratory errors occur in human, and probably also in veterinary clinical pathology. Numerous causes may affect the validity of the results, including technical factors, such as the choice of anticoagulant, the blood vessel sampled, and the duration and conditions of specimen handling. While the latter factors can be defined, influence of biologic and physiologic factors such as feeding and fasting, stress, and biologic and endocrine rhythms can often not be controlled. Nevertheless, as many factors as possible should at least be documented. The importance of the preanalytic phase is often not given the necessary attention, although the validity of the results and consequent clinical decision making and medical management of animal patients would likely be improved if the quality of specimens submitted to the laboratory was optimized. © 2014 American Society for Veterinary Clinical Pathology.
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Human papillomavirus detection using PCR and ATR-FTIR for cervical cancer screening
NASA Astrophysics Data System (ADS)
Rymsza, Taciana; Ribeiro, Eliane Aline; de Carvalho, Luis Felipe das Chagas e. Silva; Bhattacharjee, Tanmoy; de Azevedo Canevari, Renata
2018-05-01
The human papillomavirus (HPV) genital infection is considered one of the most common sexually transmitted diseases worldwide, and has been associated with cervical cancer. The objective of this study was to investigate the efficacy of the diagnostic methods: polymerase chain reaction (PCR) and Fourier transform infrared (FTIR) equipped with an ATR (Attenuated Total Reflectance) unit (Pike Tech) spectroscopy, to diagnose HPV infection in women undergoing gynecological examination. Seventeen patients (41.46%) of the 41 patients analyzed were diagnosed with exophytic/condyloma acuminate lesions by clinical analysis, 29 patients (70.7%) (G1 group) of the 41 patients, showed positive result for HPV cell injury by oncotic colpocitology and 12 patients (29.3%) (G2 group), presented negative result for cellular lesion and absence of clinical HPV lesion. Four samples were obtained per patient, which were submitted oncotic colpocitology analysis (Papanicolau staining, two samples), PCR (one sample) and ATR-FTIR analysis (one sample). L1 gene was amplified by PCR technique with specific GP5+/GP6+ and MY09/MY11 primers. PCR results were uniformly positive for presence of HPV in all analyzed samples. Multivariate analysis of ATR-FTIR spectra suggests no significant biochemical changes between groups and no clustering formed, concurring with results of PCR. This study suggests that PCR and ATR-FTIR are highly sensitive technique for HPV detection.
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Human papillomavirus detection using PCR and ATR-FTIR for cervical cancer screening.
Rymsza, Taciana; Ribeiro, Eliane Aline; de Carvalho, Luis Felipe das Chagas E Silva; Bhattacharjee, Tanmoy; de Azevedo Canevari, Renata
2018-05-05
The human papillomavirus (HPV) genital infection is considered one of the most common sexually transmitted diseases worldwide, and has been associated with cervical cancer. The objective of this study was to investigate the efficacy of the diagnostic methods: polymerase chain reaction (PCR) and Fourier transform infrared (FTIR) equipped with an ATR (Attenuated Total Reflectance) unit (Pike Tech) spectroscopy, to diagnose HPV infection in women undergoing gynecological examination. Seventeen patients (41.46%) of the 41 patients analyzed were diagnosed with exophytic/condyloma acuminate lesions by clinical analysis, 29 patients (70.7%) (G1 group) of the 41 patients, showed positive result for HPV cell injury by oncotic colpocitology and 12 patients (29.3%) (G2 group), presented negative result for cellular lesion and absence of clinical HPV lesion. Four samples were obtained per patient, which were submitted oncotic colpocitology analysis (Papanicolau staining, two samples), PCR (one sample) and ATR-FTIR analysis (one sample). L1 gene was amplified by PCR technique with specific GP5+/GP6+ and MY09/MY11 primers. PCR results were uniformly positive for presence of HPV in all analyzed samples. Multivariate analysis of ATR-FTIR spectra suggests no significant biochemical changes between groups and no clustering formed, concurring with results of PCR. This study suggests that PCR and ATR-FTIR are highly sensitive technique for HPV detection. Copyright © 2018 Elsevier B.V. All rights reserved.
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Prevalence of serum thyroid hormone autoantibodies in dogs with clinical signs of hypothyroidism.
Nachreiner, Raymond F; Refsal, Kent R; Graham, Peter A; Bowman, Mark M
2002-02-15
To determine prevalence of thyroid hormone autoantibodies (THAA) in serum of dogs with clinical signs of hypothyroidism. Cohort study. 287,948 serum samples from dogs with clinical signs consistent with hypothyroidism. Serum THAA were detected by use of a radiometric assay. Correlation and chi2 analyses were used to determine whether prevalence varied with breed, age, sex, or body weight. Only breeds for which > or = 50 samples had been submitted were used for analysis of breed prevalence. Thyroid hormone autoantibodies were detected in 18,135 (6.3%) samples. The 10 breeds with the highest prevalence of THAA were the Pointer, English Setter, English Pointer, Skye Terrier, German Wirehaired Pointer, Old English Sheepdog, Boxer, Maltese, Kuvasz, and Petit Basset Griffon Vendeen. Prevalence was significantly correlated with body weight and was highest in dogs between 2 and 4 years old. Females were significantly more likely to have THAA than were males. Thyroid hormone autoantibodies may falsely increase measured triiodothyronine (T3) and thyroxine (T4) concentrations in dogs; results suggest that T3 concentration may be falsely increased in approximately 57 of 1,000 dogs with hypothyroidism and that T4 concentration may be falsely increased in approximately 17 of 1,000 dogs with hypothyroidism. Results also suggested that dogs of certain breeds were significantly more or less likely to have THAA than were dogs in general.
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Noninvasive Prenatal Testing and Incidental Detection of Occult Maternal Malignancies.
Bianchi, Diana W; Chudova, Darya; Sehnert, Amy J; Bhatt, Sucheta; Murray, Kathryn; Prosen, Tracy L; Garber, Judy E; Wilkins-Haug, Louise; Vora, Neeta L; Warsof, Stephen; Goldberg, James; Ziainia, Tina; Halks-Miller, Meredith
2015-07-14
Understanding the relationship between aneuploidy detection on noninvasive prenatal testing (NIPT) and occult maternal malignancies may explain results that are discordant with the fetal karyotype and improve maternal clinical care. To evaluate massively parallel sequencing data for patterns of copy-number variations that might prospectively identify occult maternal malignancies. Case series identified from 125,426 samples submitted between February 15, 2012, and September 30, 2014, from asymptomatic pregnant women who underwent plasma cell-free DNA sequencing for clinical prenatal aneuploidy screening. Analyses were conducted in a clinical laboratory that performs DNA sequencing. Among the clinical samples, abnormal results were detected in 3757 (3%); these were reported to the ordering physician with recommendations for further evaluation. NIPT for fetal aneuploidy screening (chromosomes 13, 18, 21, X, and Y). Detailed genome-wide bioinformatics analysis was performed on available sequencing data from 8 of 10 women with known cancers. Genome-wide copy-number changes in the original NIPT samples and in subsequent serial samples from individual patients when available are reported. Copy-number changes detected in NIPT sequencing data in the known cancer cases were compared with the types of aneuploidies detected in the overall cohort. From a cohort of 125,426 NIPT results, 3757 (3%) were positive for 1 or more aneuploidies involving chromosomes 13, 18, 21, X, or Y. From this set of 3757 samples, 10 cases of maternal cancer were identified. Detailed clinical and sequencing data were obtained in 8. Maternal cancers most frequently occurred with the rare NIPT finding of more than 1 aneuploidy detected (7 known cancers among 39 cases of multiple aneuploidies by NIPT, 18% [95% CI, 7.5%-33.5%]). All 8 cases that underwent further bioinformatics analysis showed unique patterns of nonspecific copy-number gains and losses across multiple chromosomes. In 1 case, blood was sampled after completion of treatment for colorectal cancer and the abnormal pattern was no longer evident. In this preliminary study, a small number of cases of occult malignancy were subsequently diagnosed among pregnant women whose noninvasive prenatal testing results showed discordance with the fetal karyotype. The clinical importance of these findings will require further research.
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40 CFR 63.2382 - What notifications must I submit and when and what information should be submitted?
Code of Federal Regulations, 2010 CFR
2010-07-01
... sampling and analysis procedures and quality assurance procedures. (iii) Descriptions of monitoring devices... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS... compliance assessments, inspections and repairs, and calculations used to demonstrate initial compliance...
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de Almeida Ferreira, Sidney; Leite, Rodrigo Souza; Ituassu, Leonardo Trindade; Almeida, Gregório Guilherme; Souza, Daniel Menezes; Fujiwara, Ricardo Toshio; de Andrade, Antero Silva Ribeiro; Melo, Maria Norma
2012-01-01
Background We evaluated kDNA PCR/hybridization and quantitative real-time PCR (qPCR) targeting the gene of DNA polymerase of Leishmania infantum for CVL diagnosis and assessment of parasite load in clinical samples obtained invasively and non-invasively. Methodology/Principal Findings Eighty naturally infected dogs from an endemic urban area in Brazil were used. Animals were divided into two groups based on the presence or absence of CVL clinical sings. Skin biopsies, bone marrow, blood and conjunctival swabs samples were collected and submitted to L. infantum DNA detection. In addition, anti-Leishmania antibody titers were measured by Immunofluorescence antibody test. The symptomatic dogs had increased titers compared to asymptomatic dogs (P = 0.025). The frequencies of positive results obtained by kDNA PCR/hybridization for asymptomatic and symptomatic dogs, respectively, were as follows: right conjunctiva, 77.5% and 95.0%; left conjunctiva, 75.0% and 87.5%; skin, 45.0% and 75.0%; bone marrow, 50.0% and 77.5%; and blood, 27.5% and 22.5%. In both groups, the parasite load in the skin samples was the highest (P<0.0001). The parasite loads in the conjunctival swab and bone marrow samples were statistically equivalent within each group. The parasite burden in conjunctival swabs was higher in the dogs with clinical signs than in asymptomatic dogs (P = 0.028). This same relationship was also observed in the bone marrow samples (P = 0.002). No differences in amastigotes load in the skin were detected between the groups. Conclusions The conjunctival swab is a suitable clinical sample for qualitative molecular diagnosis of CVL. The highest parasite burdens were detected in skin regardless of the presence of VL-associated clinical signs. The qPCR results emphasized the role of dogs, particularly asymptomatic dogs, as reservoirs for CVL because of the high cutaneous parasite loads. These results may help to explain the maintenance of high transmission rates and numbers of CVL cases in endemic urban regions. PMID:22506084
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Karkaba, A; Benschop, J; Hill, K E; Grinberg, A
2017-03-01
To characterise methicillin-resistant Staphylococcus aureus (MRSA) isolates from infection sites in animals in New Zealand and assess the prevalence of subclinical MRSA colonisation in dogs and cats attending veterinary clinics in Auckland. MRSA isolates from clinical specimens obtained by the main New Zealand veterinary diagnostic laboratories between June 2012 and June 2013, were genotypically characterised by DNA microarray hybridisation analysis and spa typing. In addition, nasal or perineal skin swabs collected from a cross-sectional sample of dogs (n=361) and cats (n=225) attending 29 veterinary clinics in Auckland during the same period were analysed for MRSA by culture. Eight MRSA clinical isolates were submitted for characterisation by the participating laboratories. The isolates originated from five dogs, including two isolates from the same dog, one foal, and one isolate had no identification of the source. The strain-types identified were AK3 (ST-5 SCCmecIV t045; n=1), USA500 (ST8 SCCmecIV t064; n=1), WSPP (ST30 SCCmecIV t019; n=1), Rhine Hesse (ST5 SCCmecII t002; n=2), and EMRSA-15 (ST22 SCCmecIV t032; n=3). No MRSA were isolated from 586 cultured swabs. Methicillin-susceptible S. aureus were detected in 9/257 (3.5%) swabs and non-aureus staphylococci in 22/257 (8.5%) swabs. The estimated true MRSA subclinical colonisation prevalence was 0%, with an upper 95% CI boundary of 1.9% for cats and 1.4% for dogs. The modest number of MRSA isolates submitted for this study by the participating laboratories suggests clinical MRSA infection in animals in New Zealand continues to be sporadic. The wide variety of strain-types found mirrored the evolving strain-type diversity observed in humans. We cannot rule out bias due to the non-random sampling of dogs and cats, but the apparent colonisation prevalence of 0% was consistent with the low prevalence of subclinical colonisation in humans in New Zealand. These similarities indicate the epidemiology of animal and human MRSA infections are linked. In the last decade, the prevalence of human MRSA infections in New Zealand has steadily increased. This is the second published study of MRSA in animals in New Zealand. The results indicate clinical MRSA infection in animals remains sporadic, but the diversification of the strain-types may pose new therapeutic challenges to veterinarians, due to their diverse resistome.
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Resolution of aviation forensic toxicology findings with the aid of DNA profiling.
Chaturvedi, Arvind K; Craft, Kristi J; Kupfer, Doris M; Burian, Dennis; Canfield, Dennis V
2011-03-20
Body components of aviation accident fatalities are often scattered, disintegrated, commingled, contaminated, and/or putrefied at accident scenes. These situations may impose difficulties in victim identification/tissue matching. The prevalence of misidentification in relation to aviation accident forensic toxicology has not been well established. Therefore, the Civil Aerospace Medical Institute (CAMI) toxicology database was searched for the 1998-2008 period for those cases wherein DNA profiling was performed to resolve identity issue of the samples submitted to CAMI for toxicological evaluation. During this period, biological samples from the casualties of a total of 3523 accidents were submitted to CAMI. The submitted samples were primarily from pilots. Out of the 3523 accidents, at least, one fatality had occurred in 3366 (≈ 96%) accidents; thus, these accidents were considered fatal accidents. Accordingly, biological samples from 3319 pilots (3319 of the 3366 accidents) were received at CAMI for toxicological testing. Of these 3319 pilots, 3275 (≈ 99%) were fatally injured. DNA profiling was performed in 15 (≈ 0.5%) of the 3319 accidents. The profiling was conducted upon the requests of families in two accidents, accident investigators in three, and pathologists in four. In six accidents, contradictory toxicological findings led CAMI to initiate DNA profiling. The requests made by families and investigators were primarily triggered by inconsistency between the toxicological results and the history of drug use of the victims, while by pathologists because of commingling of samples. In three (20%) of the 15 accidents, at least one submitted sample was misidentified or mislabeled. The present study demonstrated that the number of aviation accident cases requiring DNA profiling was small and this DNA approach was effectively applied in resolving aviation toxicology findings associated with those accidents. Published by Elsevier Ireland Ltd.
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Rabies surveillance in the United States during 2015.
Birhane, Meseret G; Cleaton, Julie M; Monroe, Ben P; Wadhwa, Ashutosh; Orciari, Lillian A; Yager, Pamela; Blanton, Jesse; Velasco-Villa, Andres; Petersen, Brett W; Wallace, Ryan M
2017-05-15
OBJECTIVE To describe rabies and rabies-related events occurring during 2015 in the United States. DESIGN Observational study based on passive surveillance data. ANIMALS All animals submitted for rabies testing in the United States during 2015. PROCEDURES State and territorial public health programs provided data on animals submitted for rabies testing in 2015. Data were analyzed temporally and geographically to assess trends in domestic and sylvatic animal rabies cases. RESULTS During 2015, 50 states and Puerto Rico reported 5,508 rabid animals to the CDC, representing an 8.7% decrease from the 6,033 rabid animals reported in 2014. Of the 5,508 cases of animal rabies, 5,088 (92.4%) involved wildlife. Relative contributions by the major animal groups were as follows: 1,704 (30.9%) bats, 1,619 (29.4%) raccoons, 1,365 (24.8%) skunks, 325 (5.9%) foxes, 244 (4.4%) cats, 85 (1.5%) cattle, and 67 (1.2%) dogs. There was a 4.1% decrease in the number of samples submitted for testing in 2015, compared with the number submitted in 2014. Three human rabies deaths were reported in 2015, compared with only 1 in 2014. A 65-year-old man in Massachusetts was bitten by a rabid dog while abroad. A 77-year-old woman in Wyoming had contact with a bat. A 54-year-old man in Puerto Rico was bitten by a mongoose. The only connection among these 3 cases was that none received postexposure prophylaxis. CONCLUSIONS AND CLINICAL RELEVANCE Laboratory testing of animals suspected to be rabid remains a critical public health function and continues to be a cost-effective method to directly influence human rabies postexposure prophylaxis recommendations. (J Am Vet Med Assoc 2017;250:1117-1130).
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Leide da Silva Nunes, Francisca; Calado Ferreira Pinheiro Gadelha, Patricia; Damasceno de Souza Costa, Milena; Carolina Ribeiro de Amorim, Ana Carolina; Bezerra da Silva, Maria da Guia
2014-09-01
The nutritional state is the independent factor that most influences the post-operational results in elective surgeries. to evaluate the influence of the nutritional state on the hospitalization period and on the post-operative complications of patients submitted to abdominal surgery. prospective study with 99 surgical patients over 18 years of age, submitted to abdominal surgeries in the period from April to October of 2013, in the Instituto de Medicina Integral Professor Fernando Figueira (IMIP). All patients were submitted to anthropometric nutritional evaluations through the body mass Index (BMI), arm circumference (AC) and triceps skinfold thickness (TEST). The biochemical evaluation was carried out from the leukogram and serum albumin results. The identification of candidate patients to nutritional therapy (NT) was carried out through the nutritional risk (NR) evaluation by using the BMI, loss of weight and hypoalbuminemia. The information about post-operational complications, hospitalization period and clinical diagnosis was collected from the medical records. Program SPSS version 13.0 and significance level of 5% were used for the statistical analysis. The malnutrition diagnosed by the AC showed significant positive association with the presence of post-operative complications (p=0.02) and with hospitalization period (p=0.02). The presence of NR was greater when evaluated by hypoalbuminemia (28.9%), however, only 4% of the sample carried out the NT in the pre-operational period. The hospitalization period was greater for patients with malignant neoplasia (p<0.01). The malnutrition diagnosis of patients submitted to abdominal surgeries is associated to greater risk of post-operational complications and longer hospitalization permanence. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
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Szekely, Adrien; Palmer, Michael D.; Johnson, Elizabeth M.
2012-01-01
Rapid, accurate identification of yeast isolates from clinical samples has always been important given their innately variable antifungal susceptibility profiles. Recently, this has become paramount with the proposed introduction of species-specific interpretive breakpoints for MICs obtained in yeast antifungal susceptibility tests (M. A. Pfaller, D. Andes, D. J. Diekema, A. Espinel–Ingroff, D. Sheehan, and CLSI Subcommittee for Antifungal Susceptibility Testing, Drug Resist. Updat. 13:180–195, 2010). Here, we present the results of a 12-month evaluation of the accuracy of identifications that accompany yeast isolates submitted to the Mycology Reference Laboratory (United Kingdom) for either confirmation of identity or susceptibility testing. In total, 1,781 yeast isolates were analyzed, and the robustness of prior identifications obtained in microbiology laboratories throughout the United Kingdom was assessed using a combination of culture on chromogenic agar, morphology on cornmeal agar, and molecular identification by pyrosequencing. Over 40% of isolates (755) were submitted without any suggested identification. Of those isolates with a prior identification, 100 (9.7%) were incorrectly identified. Error rates ranged from 5.2% (for organisms submitted for antifungal susceptibility testing) to 18.2% (for organisms requiring confirmation of identity) and varied in a strictly species-specific manner. At least 50% of identification errors would be likely to affect interpretation of MIC data, with a possible impact on patient management. In addition, 2.3% of submitted cultures were found to contain mixtures of at least two yeast species. The vast majority of mixtures had gone undetected in the referring laboratory and would have impacted the interpretation of antifungal susceptibility profiles and patient management. Some of the more common misidentifications are discussed according to the identification method employed, with suggestions for avoiding such misinterpretations. PMID:22649009
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Borman, Andrew M; Szekely, Adrien; Palmer, Michael D; Johnson, Elizabeth M
2012-08-01
Rapid, accurate identification of yeast isolates from clinical samples has always been important given their innately variable antifungal susceptibility profiles. Recently, this has become paramount with the proposed introduction of species-specific interpretive breakpoints for MICs obtained in yeast antifungal susceptibility tests (M. A. Pfaller, D. Andes, D. J. Diekema, A. Espinel-Ingroff, D. Sheehan, and CLSI Subcommittee for Antifungal Susceptibility Testing, Drug Resist. Updat. 13:180-195, 2010). Here, we present the results of a 12-month evaluation of the accuracy of identifications that accompany yeast isolates submitted to the Mycology Reference Laboratory (United Kingdom) for either confirmation of identity or susceptibility testing. In total, 1,781 yeast isolates were analyzed, and the robustness of prior identifications obtained in microbiology laboratories throughout the United Kingdom was assessed using a combination of culture on chromogenic agar, morphology on cornmeal agar, and molecular identification by pyrosequencing. Over 40% of isolates (755) were submitted without any suggested identification. Of those isolates with a prior identification, 100 (9.7%) were incorrectly identified. Error rates ranged from 5.2% (for organisms submitted for antifungal susceptibility testing) to 18.2% (for organisms requiring confirmation of identity) and varied in a strictly species-specific manner. At least 50% of identification errors would be likely to affect interpretation of MIC data, with a possible impact on patient management. In addition, 2.3% of submitted cultures were found to contain mixtures of at least two yeast species. The vast majority of mixtures had gone undetected in the referring laboratory and would have impacted the interpretation of antifungal susceptibility profiles and patient management. Some of the more common misidentifications are discussed according to the identification method employed, with suggestions for avoiding such misinterpretations.
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Lawrence, K E; Forsyth, S F; Vaatstra, B L; McFadden, Amj; Pulford, D J; Govindaraju, K; Pomroy, W E
2017-11-01
AIM To determine the most commonly used words in the clinical histories of animals naturally infected with Theileria orientalis Ikeda type; whether these words differed between cases categorised by age, farm type or haematocrit (HCT), and if there was any clustering of the common words in relation to these categories. METHODS Clinical histories were transcribed for 605 cases of bovine anaemia associated with T. orientalis (TABA), that were submitted to laboratories with blood samples which tested positive for T. orientalis Ikeda type infection by PCR analysis, between October 2012 and November 2014. χ 2 tests were used to determine whether the proportion of submissions for each word was similar across the categories of HCT (normal, moderate anaemia or severe anaemia), farm type (dairy or beef) and age (young or old). Correspondence analysis (CA) was carried out on a contingency table of the frequency of the 28 most commonly used history words, cross-tabulated by age categories (young, old or unknown). Agglomerative hierarchical clustering, using Ward's method, was then performed on the coordinates from the correspondence analysis. RESULTS The six most commonly used history words were jaundice (204/605), lethargic (162/605), pale mucous membranes (161/605), cow (151/605), anaemia (147/605), and off milk (115/605). The proportion of cases with some history words differed between categories of age, farm type and HCT. The cluster analysis indicated that the recorded history words were grouped in two main clusters. The first included the words weight loss, tachycardia, pale mucous membranes, anaemia, lethargic and thin, and was associated with adult (p<0.001), severe anaemia (p<0.001) and dairy (p<0.001). The second cluster included the words deaths, ill-thrift, calves, calf and diarrhoea, and was associated with young (p<0.001), normal HCT (p<0.001), beef (p<0.001) and moderate anaemia (p<0.001). CONCLUSIONS AND CLINICAL RELEVANCE Cluster analysis of words recorded in clinical histories submitted with blood samples from cases of TABA indicates that two potentially different disease syndromes were associated with T. orientalis Ikeda type infection. One was consistent with the affected cattle suffering from a severe regenerative extravascular haemolytic anaemia, the second displaying as ill thrift and diarrhoea, particularly in young beef cattle.
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Izquierdo, Paula P; de Biasi, Ronaldo S; Elias, Carlos N; Nojima, Lincoln I
2010-12-01
Our purpose was to study the mechanical properties and phase transformations of orthodontic wires submitted to in-vivo exposure in the mouth for different periods of time. Stainless steel wires were tied to fixed orthodontic appliances of 30 patients from the orthodontics clinic of Universidade Federal do Rio de Janeiro School of Dentistry in Brazil. According to the duration of the clinical treatment, the patients were divided into 3 groups. After in-vivo exposure, the samples were studied by mechanical testing (torsion) and ferromagnetic resonance. Statistical analyses were carried out to evaluate the correlation between time of exposure, mechanical properties, and austenite-to-martensite transformation among the groups. The results were compared with as-received control samples. The torque values increased as time in the mouth increased. The increase in torque resistance showed high correlations with time of exposure (P = 0.005) and austenite-martensite phase transformation. The resistance of stainless steel orthodontic wires increases as the time in the mouth increases; this effect is attributed to the austenite-to-martensite transformation. Copyright © 2010 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.
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Web-based unfolding cases: a strategy to enhance and evaluate clinical reasoning skills.
Johnson, Gail; Flagler, Susan
2013-10-01
Clinical reasoning involves the use of both analytical and nonanalytical intuitive cognitive processes. Fostering student development of clinical reasoning skills and evaluating student performance in this cognitive arena can challenge educators. The use of Web-based unfolding cases is proposed as a strategy to address these challenges. Unfolding cases mimic real-life clinical situations by presenting only partial clinical information in sequential segments. Students receive immediate feedback after submitting a response to a given segment. The student's comparison of the desired and submitted responses provides information to enhance the development of clinical reasoning skills. Each student's set of case responses are saved for the instructor in an individual-student electronic file, providing a record of the student's knowledge and thinking processes for faculty evaluation. For the example case given, the approaches used to evaluate individual components of clinical reasoning are provided. Possible future uses of Web-based unfolding cases are described. Copyright 2013, SLACK Incorporated.
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Forrester, Leslie; Collet, Jun Chen; Mitchell, Robyn; Pelude, Linda; Henderson, Elizabeth; Vayalumkal, Joseph; Leduc, Stephanie; Ghahreman, Saeed; Weir, Christine; Gravel, Denise
2012-03-01
The Canadian Nosocomial Infection Surveillance Program (CNISP) has conducted surveillance for incident cases of methicillin-resistant Staphylococcus aureus (MRSA) in sentinel hospitals since 1995. In 2007, a reliability audit of the 2005 data was conducted. In 2005, 5,652 cases were submitted to the CNISP from 43 hospitals. A proportional sample of submitted forms (up to 25) from each site were randomly selected. Stratified random sampling was used to obtain the comparison data. The original data were compared with the reabstracted data for congruence on 7 preselected variables. Reabstracted data were received from 30 out of 43 hospitals (70%), providing 443 of the 598 case forms requested (74%). Of these, 397 (90%) had matching case identification numbers. Overall, the percentage of discordant responses was 7.0%, ranging from 3.5% for sex and up to 23.7% for less well-defined variables (eg, where MRSA was acquired). Our findings suggest that, in general, the 2005 MRSA data are reliable. However to improve reliability a data quality framework with quality assurance practices, including ongoing auditing should be integrated into the CNISP's surveillance programs. Providing training to data collectors and standard definitions with practical examples may help to improve data quality, especially for those variables that require clinical judgment. Crown Copyright © 2012. Published by Mosby, Inc. All rights reserved.
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Liu, Jiayou; O'Connor, Thomas; Beall, Melissa; Chandrashekar, Ramaswamy; Lappin, Michael
2016-01-01
Feline leukemia virus (FeLV) is a potentially life-threatening oncogenic retrovirus. The p27 viral core protein is produced by the virus in infected feline cells, is found in the cytoplasm in several blood cells and can be free in the serum and plasma. ELISA or particle-based immunoassay are commonly used to detect the presence of the p27 core protein in samples obtained from blood. The objective of this study was to compare the performance of several in-clinic tests: the SNAP Feline Triple Test (IDEXX Laboratories), the WITNESS FeLV-FIV Test (Zoetis) and the VetScan Feline FeLV/FIV Rapid Test (Abaxis). The sample population (100 positive, 105 negative samples) consisted of serum and plasma samples submitted to IDEXX's worldwide reference laboratory for feline retrovirus testing. Virus isolation and reverse transcriptase PCR results were not available and so samples were judged to be positive or negative based on the results of the ViraCHEK FeLV (Zoetis) microtiter plate assay. The percentage of samples positive and negative for FeLV p27 antigen using the three in-clinic tests compared with the ViraCHEK method were as follows: IDEXX Feline Triple (positive 98.0%, negative 100%); Zoetis WITNESS (positive 79.0%, negative 97.1%); Abaxis VetScan (positive 73.0%, negative 97.1%). The SNAP Feline Triple Test demonstrated a high level of agreement for FeLV-positive and FeLV-negative samples when assessed in this model. Results of FeLV assays can vary among tests.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-02
... either electronic or written comments on the collection of information by October 1, 2013. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov . Submit... detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
... determination that an Exempted Fishing Permit (EFP) application submitted by the Northeast Fisheries Science... dependent catch data and biological samples. Regulations under the Magnuson-Stevens Fishery Conservation and...: NEFSC submitted a complete application for an EFP on February 28, 2012, to enable data collection...
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Information Model for Reusability in Clinical Trial Documentation
ERIC Educational Resources Information Center
Bahl, Bhanu
2013-01-01
In clinical research, New Drug Application (NDA) to health agencies requires generation of a large number of documents throughout the clinical development life cycle, many of which are also submitted to public databases and external partners. Current processes to assemble the information, author, review and approve the clinical research documents,…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-08
... embolism, muscle/nerve stimulation, stenosis, and erosion/extrusion may occur as a result of the clinical... advises that to ensure timely filing of any such petition, any request should be submitted to the Division... timely request for a change in the classification of this device is submitted, the Agency will, within 60...
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KCBX Petroleum Coke Storage Pile Sampling Logbook and Photos
This documentation of KCBX's petcoke sampling locations and methods demonstrates adherence to the pet coke sampling plan previously submitted and approved by EPA, at both North Terminal and South Terminal stockpiles.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-22
...] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY: Food... establishment and operation of clinical trial data monitoring committees. DATES: Submit either electronic or...
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21 CFR 54.4 - Certification and disclosure requirements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS § 54.4 Certification and disclosure requirements. For purposes of this part, an applicant must submit a list of all clinical investigators who conducted covered clinical studies to determine whether the applicant's product meets FDA's marketing requirements...
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78 FR 20112 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-03
...-related information. The respondents would be clinical laboratory supervisors, nurses, and other.../60 300 Supervisors. Influenza Diagnostic Test Practices in Clinical Laboratories. Nurses Survey of... this notice. Proposed Project Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Clinical...
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Investigating Group Contingencies to Promote Brief Abstinence from Cigarette Smoking
Meredith, Steven E.; Dallery, Jesse
2013-01-01
In contingency management (CM), monetary incentives are contingent on evidence of drug abstinence. Typically, incentives (e.g., “vouchers” exchangeable for goods or services) are contingent on individual performance. We programmed vouchers contingent on group performance to investigate whether these contingencies would promote brief abstinence from cigarette smoking. Thirty-two participants were divided into small teams (n = 3 per team). During three 5-day within-subject experimental conditions, participants submitted video recordings of breath carbon monoxide (CO) measures twice daily via Mōtiv8 Systems™, an Internet-based remote monitoring application. During the interdependent contingency condition, participants earned vouchers each time they and their teammates submitted breath CO samples indicative of abstinence (i.e., negative samples). During the independent contingency condition, participants earned vouchers each time they submitted negative samples, regardless of their teammates' performance. During the no vouchers condition, no monetary incentives were contingent on abstinence. In addition, half of the participants (n = 16) could communicate with their teammates through an online peer support forum. Although forum access did not appear to promote smoking abstinence, monetary incentives did promote brief abstinence. Significantly more negative samples were submitted when vouchers were contingent on individual performance (56%) or team performance (53%) relative to when no vouchers were available (35%; F = 6.9, p = 0.002). The results show that interdependent contingencies can promote brief abstinence from cigarette smoking. Moreover, the results suggest that these contingencies may help lower treatment costs and promote social support. PMID:23421358
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Acharya, A; Khanal, A; Kanungo, R; Mohapatra, T
2007-12-01
Life threatening infections caused by enterococcus species with multidrug resistance has emerged as a threat to medical care in the present era. This study was conducted to characterize enterococcus species isolated from different clinical samples and to detect the pattern of susceptibility to some of the commonly used antibiotics in B.P Koirala Institute of Health Sciences (BPKIHS), a tertiary care hospital in eastern Nepal. Clinical samples submitted to the microbiology unit of Central Laboratory Service (CLS) for culture and sensitivity during March 2002 - February 2003 was analyzed. Enterococcus species were identified by colony characteristics, gram staining and relevant biochemical tests. Antibiotic susceptibility test was done by the Kirby Bauer disc diffusion technique. Of 50 Enterococcus species isolated, E. faecalis was the predominant isolate (48.0%) followed by E. faecium (32.0%) and E. avium (20.0%). Eighty-eight percent of E. faecalis showed sensitivity to cephotaxime and 87.0% to vancomycin. Multiple drug resistance was observed most commonly in E. faecium. Seventeen percent of E. faecium were resistant to vancomycin and 63.0% to ciprofloxacin and 44.0% to ampicillin. On the contrary E. avium rarely showed resistance to the antimicrobials tested including vancomycin. Enterococcal infections are common nowadays specially in hospitalized patients. Inappropriate use of antibiotics in clinical practice and poultry should be discouraged to prevent the emergence of multidrug resistant species.
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Potentially malignant oral lesions: clinicopathological correlations
Maia, Haline Cunha de Medeiros; Pinto, Najara Alcântara Sampaio; Pereira, Joabe dos Santos; de Medeiros, Ana Miryam Costa; da Silveira, Éricka Janine Dantas; Miguel, Márcia Cristina da Costa
2016-01-01
ABSTRACT Objective To determine the incidence of potentially malignant oral lesions, and evaluate and correlate their clinical and pathological aspects. Methods The sample consisted of cases clinically diagnosed as oral leukoplakia, oral erythroplakia, erythroleukoplakia, actinic cheilitis, and oral lichen planus treated at a diagnostic center, between May 2012 and July 2013. Statistical tests were conducted adopting a significance level of 5% (p≤0.05). Results Out of 340 patients, 106 (31.2%) had potentially malignant oral lesions; and 61 of these (17.9%) were submitted to biopsy. Actinic cheilitis was the most frequent lesion (37.5%) and the lower lip was the most affected site (49.6%). Among 106 patients in the sample, 48 (45.3%) reported nicotine consumption, 35 (33%) reported alcohol intake and 34 (32.1%) sun exposure while working. When clinical and histopathological diagnoses were compared, oral erythroplakia and atypical ulcer were the lesions that exhibited greater compatibility (100% each). Conclusion In most cases, clinical and histopathological diagnoses were compatible. An association between the occurrence of erythroplakia, leukoplakia and erythroleukoplakia with smoking was observed. Similarly, an association between actinic cheilitis and sun exposure was noted. Erythroleukoplakia presented the highest malignancy grade in this study. Finally, dental surgeons should draw special attention to diagnosis of potentially malignant oral lesions, choose the best management, and control the lesions to avoid their malignant transformation. PMID:27074232
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Screening protocol for dysphagia in adults: comparison with videofluoroscopic findings.
Sassi, Fernanda C; Medeiros, Gisele C; Zilberstein, Bruno; Jayanthi, Shri Krishna; de Andrade, Claudia R F
2017-12-01
To compare the videofluoroscopic findings of patients with suspected oropharyngeal dysphagia with the results of a clinical screening protocol. A retrospective observational cohort study was conducted on all consecutive patients with suspected oropharyngeal dysphagia between March 2015 and February 2016 who were assigned to receive a videofluoroscopic assessment of swallowing. All patients were first submitted to videofluoroscopy and then to the clinical assessment of swallowing. The clinical assessment was performed within the first 24 hours after videofluoroscopy. The videofluoroscopy results were analyzed regarding penetration/aspiration using an 8-point multidimensional perceptual scale. The accuracy of the clinical protocol was analyzed using the sensitivity, specificity, likelihood ratios and predictive values. The selected sample consisted of 50 patients. The clinical protocol presented a sensitivity of 50% and specificity of 95%, with an accuracy of 88%. "Cough" and "wet-hoarse" vocal quality after/during swallowing were clinical indicators that appeared to correctly identify the presence of penetration/aspiration risk. The clinical protocol used in the present study is a simple, rapid and reliable clinical assessment. Despite the absence of a completely satisfactory result, especially in terms of the sensitivity and positive predictive values, we suggest that lower rates of pneumonia can be achieved using a formal dysphagia screening method.
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Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia
2018-06-01
There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.
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77 FR 64521 - Announcement of Requirements and Registration for “Health Design Challenge”
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-22
... it with visuals and a better layout. Innovators will be invited to submit their best designs for a... a sample CCD. Challenge entrants will submit a design that: [ssquf] Improves the visual layout and... Design Challenge'' AGENCY: Office of the National Coordinator for Health Information Technology, HHS...
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Age-specific seroprevalence of dengue infection in Hong Kong.
Lee, Polly; Yeung, Apple C M; Chen, Zigui; Chan, Martin C W; Sze, Kin Ho; Chan, Paul K S
2018-05-02
A newly developed dengue virus vaccine (chimeric yellow fever virus-tetravalent dengue vaccine [CYD-TDV]) has recently been licensed for clinical use. The World Health Organization recommends vaccination for populations with seroprevalence of at least 70% to maximize public health impact. This study aimed to delineate the seroprevalence of dengue infection in Hong Kong. A total of 105 972 serum samples submitted for clinical testing during the period 2013-2015 were age-stratified and sex-stratified. For each year of collection, 25 samples were randomly selected from each age-sex group. Altogether, 2100 samples were tested for the dengue immunoglobulin G (IgG) antibody using a non-type-specific ELISA kit. The overall dengue IgG-positive rate was 4.6% and showed no significant change over the 3 years. The positive rate was not associated with sex, but a steep rise in seroprevalence for persons above 65 years (32.7%) was observed. The low dengue seroprevalence in Hong Kong does not support implementation of a national immunization program. Majority of the population in Hong Kong are susceptible to dengue infection, and a substantial proportion of persons older than 65 years could acquire secondary infection and are prone to develop severe dengue. © 2018 Wiley Periodicals, Inc.
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EPA required KCBX to submit samples of the petroleum coke stored at their North and South Chicago terminals to EPA's Chicago Regional Laboratory for analysis of pollutant levels. Results will be compared to coal and pet coke sampled in Detroit.
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Propylene glycol intoxication in a dog.
Claus, Melissa A; Jandrey, Karl E; Poppenga, Robert H
2011-12-01
To describe the clinical course, treatment, and outcome of a dog with propylene glycol intoxication. An adult castrated male Australian cattle dog presented to an emergency clinic for an acute onset of ataxia and disorientation after roaming a construction site unsupervised. He tested positive for ethylene glycol using a point-of-care test kit. Treatment for ethylene glycol intoxication included intermittent intravenous boluses of 20% ethanol and hemodialysis. Predialysis and postdialysis blood samples were submitted to the toxicology lab to assess for both ethylene and propylene glycol. The patient tested negative for ethylene glycol and positive for propylene glycol at 1100 mg/dL predialysis and 23 mg/dL postdialysis. The dog made a full recovery. To the authors' knowledge, this is the first report of documented propylene glycol intoxication in a dog, as well as the first report to describe hemodialysis as treatment for propylene glycol intoxication in a dog. © Veterinary Emergency and Critical Care Society 2011.
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Suresh, Lakshmanan; Neiders, Mirdza E
2012-10-01
Desquamative gingivitis (DG) is a common clinical manifestation of oral autoimmune vesiculobullous diseases (VBDs). Their polymorphous clinical presentations coupled with similar histologic features make diagnosis indistinguishable among the different VBDs. Direct immunofluorescence (IF) studies are valuable gold-standard diagnostic tests that allow for discrimination among the various VBDs that present with DG. There have been no recent detailed analyses done that have used conventional light microscopy and direct IF in diagnosis to document the clinical associations of DG with various autoimmune oral diseases. The aim of this study is to examine retrospectively a large cohort of patients with DG for associated diseases and to determine the utility of direct IF and conventional light microscopy in establishing a definitive diagnosis. During a 14-month period, our laboratory in Buffalo, New York, received 239 consecutive archival cases of gingival biopsy with a clinical diagnosis of DG. These specimens were submitted to establish or rule out a diagnosis of a direct IF-positive VBD. The demographic, clinical, and microscopic findings were tabulated using established inclusion and diagnostic criteria. Approximately half the number (48.1%) of biopsies received for direct IF studies were submitted by periodontists. Slightly more than half of the patients (53%) previously had biopsies submitted for both hematoxylin and eosin (H & E) and direct IF testing. There was a female predilection for all the diseases studied except for pemphigus and linear immunoglobulin A disease. Oral lichen planus was the most common disease presenting as DG, followed by pemphigoid. The clinical diagnosis of lichen planus correlated with the biopsy findings in 80% of the cases and with pemphigoid in 60%. Definitive diagnosis was rendered to ≈80% of the gingival biopsies submitted. Negative cases of direct IF presenting as DG had significant pathology, such as dysplasia and carcinoma, which would have been otherwise missed if H & E studies had not been performed. This study has the largest cohort of patients with DG suspected of VBD reported in the literature. The patients were predominantly females who had most often been seen by a periodontist. The definitive diagnosis of DG was most accurately achieved when H & E along with two biopsies for direct IF studies were submitted for testing. H & E studies were particularly important for definitive diagnosis of negative cases. Oral lichen planus was the most common disease presenting as DG, which is consistent with recent studies. Systemic connective tissue disorders that present as DG at initial clinical examination require direct IF and serum studies for a conclusive diagnosis. Clinical pathologic correlation, including history, presentation, H & E, and direct IF studies, are essential in establishing a definitive and differential diagnosis for cases presenting with DG.
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Code of Federal Regulations, 2012 CFR
2012-01-01
..., TESTING, AND STANDARDS Cotton Classification and Market News Service for Producers Sampling § 28.908... submitted for classification under this subpart. This does not prohibit the submission of an additional sample from a bale for review classification if the producer so desires. (b) Drawing of samples manual...
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Code of Federal Regulations, 2014 CFR
2014-01-01
..., TESTING, AND STANDARDS Cotton Classification and Market News Service for Producers Sampling § 28.908... submitted for classification under this subpart. This does not prohibit the submission of an additional sample from a bale for review classification if the producer so desires. (b) Drawing of samples manual...
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Code of Federal Regulations, 2013 CFR
2013-01-01
..., TESTING, AND STANDARDS Cotton Classification and Market News Service for Producers Sampling § 28.908... submitted for classification under this subpart. This does not prohibit the submission of an additional sample from a bale for review classification if the producer so desires. (b) Drawing of samples manual...
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Code of Federal Regulations, 2010 CFR
2010-01-01
..., TESTING, AND STANDARDS Cotton Classification and Market News Service for Producers Sampling § 28.908... submitted for classification under this subpart. This does not prohibit the submission of an additional sample from a bale for review classification if the producer so desires. (b) Drawing of samples manual...
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Detection of Theileria luwenshuni in sheep from Great Britain.
Phipps, L Paul; Hernández-Triana, Luis M; Goharriz, Hooman; Welchman, David; Johnson, Nicholas
2016-04-13
Theileria spp. are tick-borne protozoan parasites of the Phylum Apicomplexa, Order Piroplasmida that infect a wide range of wild and domestic animals. In Great Britain, Theileria spp. have been reported from livestock associated with transmission by the tick Haemaphysalis punctata. However, these reports have not been associated with disease. This study has investigated the cause of a disease outbreak accompanied by mortality in a flock of sheep grazing reclaimed marshland in north Kent. A polymerase chain reaction-reverse line blot assay indicated the presence of Theileria spp. in blood samples from five animals. Subsequent testing with a pan-piroplasm PCR of a larger panel of blood samples detected a piroplasm amplicon in 19 of 21 sheep submitted from the affected flock. Automated sequencing confirmed that these amplicons shared 99-100% identity with T. luwenshuni. The clinical and PCR data suggest infection with T. luwenshuni was associated with disease and mortality in this flock.
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Blair, Daniel A.; Woolley, Thomas W.
2014-01-01
The purpose of this research was to determine the proportion of abstracts in pharmacy journals that are prepared according to the CONsolidated Standards Of Reporting Trials (CONSORT) criteria for abstracts. Certain abstracts for randomized controlled clinical trials (RCTs) indexed in PubMed were eligible for inclusion, with the primary endpoint being median overall compliance to CONSORT recommendations for abstracts. A total of 63 RCT abstracts were included in the analysis, with only 56% of the recommended CONSORT items represented in the sample. It is recommended that pharmacy journals encourage authors to follow CONSORT recommendations for abstracts when submitting RCTs for publication. PMID:24860268
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Jennings, Cheryl; Wager, Carrie G; Scianna, Salvatore R; Zaccaro, Daniel J; Couzens, Amy; Mellors, John W; Coombs, Robert W; Bremer, James W
2018-06-01
The National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group (ACTG) stores specimens from its clinical trials in a biorepository and permits the use of these specimens for nonprotocol exploratory studies, once the studies for the original protocol are concluded. We sought to assess the comparability of the data generated from real-time HIV-1 RNA testing during two clinical trials with the data generated from the retesting of different aliquots of the same samples after years of storage at -80°C. Overall, there was 92% agreement in the data generated for 1,570 paired samples (kappa statistic = 0.757; 95% confidence interval [CI], 0.716 to 0.797), where samples were tested in one laboratory using the microwell plate (MWP) version of the Roche HIV-1 Monitor test within 1 to 37 days of collection and retested in another laboratory using the Cobas version of the assay after a median of 6.7 years of storage (range, 5.7 to 8.6 years). Historical external quality control data submitted to the NIAID Virology Quality Assurance program (VQA) by client laboratories using the same two versions of the Monitor assay were used to differentiate between systematic differences in the assays to evaluate the stability of HIV-1 RNA in the stored samples. No significant loss of RNA was noted in samples containing either a low concentration (<50 copies/ml) or a high concentration (≥50 copies/ml) of HIV-1 RNA ( P = 0.10 and P = 0.90, respectively) regardless of the time in storage. These data confirm the quality of the plasma samples in the ACTG biorepository following long-term storage. Copyright © 2018 American Society for Microbiology.
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Savage, E J; Mohammed, H; Leong, G; Duffell, S; Hughes, G
2014-12-04
A new electronic surveillance system for sexually transmitted infections (STIs) was introduced in England in 2009. The genitourinary medicine clinic activity dataset (GUMCAD) is a mandatory, disaggregated, pseudo-anonymised data return submitted by all STI clinics across England. The dataset includes information on all STI diagnoses made and services provided alongside demographic characteristics for every patient attendance at a clinic. The new system enables the timely analysis and publication of routine STI data, detailed analyses of risk groups and longitudinal analyses of clinic attendees. The system offers flexibility so new codes can be introduced to help monitor outbreaks or unusual STI activity. From January 2009 to December 2013 inclusive, over twenty-five million records from a total of 6,668,648 patients of STI clinics have been submitted. This article describes the successful implementation of this new surveillance system and the types of epidemiological outputs and analyses that GUMCAD enables. The challenges faced are discussed and forthcoming developments in STI surveillance in England are described.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-21
... Collection: (PACT Clinical Innovation Study: Engaging Caregivers in the Care of Veterans With Dementia... announces that the Department of Veterans Affairs (VA), will submit to the Office of Management and Budget... Form 10-0537). SUPPLEMENTARY INFORMATION: Title: PACT Clinical Innovation Study: Engaging Caregivers in...
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46 CFR 164.009-15 - Test procedure.
Code of Federal Regulations, 2012 CFR
2012-10-01
... submitted for approval, except fiberglass and other materials that melt at 750° ±10 °C. Paragraph (l) of this section contains test procedures for fiberglass and other materials that melt at 750° ±10 °C. (b... properties of the sample submitted for testing. The dimensions of each specimen are as follows: diameter: 45...
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46 CFR 164.009-15 - Test procedure.
Code of Federal Regulations, 2013 CFR
2013-10-01
... submitted for approval, except fiberglass and other materials that melt at 750° ±10 °C. Paragraph (l) of this section contains test procedures for fiberglass and other materials that melt at 750° ±10 °C. (b... properties of the sample submitted for testing. The dimensions of each specimen are as follows: diameter: 45...
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Nødtvedt, Ane; Bergvall, Kerstin; Emanuelson, Ulf; Egenvall, Agneta
2006-01-01
A cross-sectional study of insured Swedish dogs with a recorded diagnosis of canine atopic dermatitis (CAD) was performed. In order to validate the correctness of this specific diagnosis in the insurance database, medical records were requested by mail from the attending veterinarians. All dogs with a reimbursed claim for the disease during 2002 were included in the original study sample (n = 373). Medical records were available for 335 individuals (response rate: 89.8%). By scrutinizing the submitted records it was determined that all dogs had been treated for dermatologic disease, and that 327 (97.6%) could be considered to have some allergic skin disease. However, as information regarding dietary trial testing was missing in many dogs the number that were truly atopic could not be determined. The clinical presentation and nature of test diet for dogs with or without response to dietary trial testing was compared for a subset of 109 individuals that had undergone such testing. The only significant difference between these two groups was that the proportion of dogs with reported gastrointestinal signs was higher in the group that subsequently responded to a diet trial. In conclusion, the agreement between the recorded diagnosis in the insurance database and the clinical manifestations recorded in the submitted medical records was considered acceptable. The concern was raised that many attending veterinarians did not exclude cutaneous adverse food reactions before making the diagnosis of CAD. PMID:16987404
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Aagaard, Kjersti; Petrosino, Joseph; Keitel, Wendy; Watson, Mark; Katancik, James; Garcia, Nathalia; Patel, Shital; Cutting, Mary; Madden, Tessa; Hamilton, Holli; Harris, Emily; Gevers, Dirk; Simone, Gina; McInnes, Pamela; Versalovic, James
2013-01-01
The Human Microbiome Project used rigorous good clinical practice standards to complete comprehensive body site sampling in healthy 18- to 40-yr-old adults, creating an unparalleled reference set of microbiome specimens. To ensure that specimens represented minimally perturbed microbiomes, we first screened potential participants using exclusion criteria based on health history, including the presence of systemic diseases (e.g., hypertension, cancer, or immunodeficiency or autoimmune disorders), use of potential immunomodulators, and recent use of antibiotics or probiotics. Subsequent physical examinations excluded individuals based on body mass index (BMI), cutaneous lesions, and oral health. We screened 554 individuals to enroll 300 (149 men and 151 women, mean age 26 yr, mean BMI 24 kg/m2, 20.0% racial minority, and 10.7% Hispanic). We obtained specimens from the oral cavity, nares, skin, gastrointestinal tract, and vagina (15 specimens from men and 18 from women). The study evaluated longitudinal changes in an individual's microbiome by sampling 279 participants twice (mean 212 d after the first sampling; range 30-359 d) and 100 individuals 3 times (mean 72 d after the second sampling; range 30-224 d). This sampling strategy yielded 11,174 primary specimens, from which 12,479 DNA samples were submitted to 4 centers for metagenomic sequencing. Our clinical design and well-defined reference cohort has laid a foundation for microbiome research.—Aagaard, K., Petrosino, J., Keitel, W., Watson, M., Katancik, J., Garcia, N., Patel, S., Cutting, M., Madden, T., Hamilton, H., Harris, E., Gevers, D., Simone, G., McInnes, P., Versalovic, J. The Human Microbiome Project strategy for comprehensive sampling of the human microbiome and why it matters. PMID:23165986
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Code of Federal Regulations, 2013 CFR
2013-07-01
... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Test samples. 15.5 Section 15.5 Mineral... § 15.5 Test samples. (a) Submission of test samples. (1) The applicant shall not submit explosives or... magazine for at least 30 days before gallery tests are conducted. ...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Test samples. 15.5 Section 15.5 Mineral... § 15.5 Test samples. (a) Submission of test samples. (1) The applicant shall not submit explosives or... magazine for at least 30 days before gallery tests are conducted. ...
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Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Test samples. 15.5 Section 15.5 Mineral... § 15.5 Test samples. (a) Submission of test samples. (1) The applicant shall not submit explosives or... magazine for at least 30 days before gallery tests are conducted. ...
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* Minimum # Experimental Samples DNA Volume (ul) Genomic DNA Concentration (ng/ul) Low Input DNA Volume (ul . **Please inquire about additional cost for low input option. Genotyping Minimum # Experimental Samples DNA sample quality. If you do submit WGA samples, you should anticipate a higher non-random missing data rate
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Hierarchical data security in a Query-By-Example interface for a shared database.
Taylor, Merwyn
2002-06-01
Whenever a shared database resource, containing critical patient data, is created, protecting the contents of the database is a high priority goal. This goal can be achieved by developing a Query-By-Example (QBE) interface, designed to access a shared database, and embedding within the QBE a hierarchical security module that limits access to the data. The security module ensures that researchers working in one clinic do not get access to data from another clinic. The security can be based on a flexible taxonomy structure that allows ordinary users to access data from individual clinics and super users to access data from all clinics. All researchers submit queries through the same interface and the security module processes the taxonomy and user identifiers to limit access. Using this system, two different users with different access rights can submit the same query and get different results thus reducing the need to create different interfaces for different clinics and access rights.
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Evaluating the bonding of two adhesive systems to enamel submitted to whitening dentifrices.
Briso, André Luiz Fraga; Toseto, Roberta Mariano; de Arruda, Alex Mendes; Tolentino, Patricia Ramos; de Alexandre, Rodrigo Sversut; dos Santos, Paulo Henrique
2010-01-01
The aim of this study was to evaluate by micro-shear bond strength test, the bond strength of composite resin restoration to enamel submitted to whitening dentifrices. Forty bovine teeth were embedded in polystyrene resin and polished. The specimens were randomly divided into eight groups (n=5), according to the dentifrice (carbamide peroxide, hydrogen peroxide and conventional dentifrice) and the adhesive system (Prime & Bond 2.1 and Adper Single Bond 2). Dentifrice was applied for 15 minutes a day, for 21 days. Thirty minutes after the last exposure to dentifrice, the samples were submitted to a bonding procedure with the respective adhesive system. After that, four buttons of resin were bonded in each sample using transparent cylindrical molds. After 24 hours, the teeth were submitted to the micro-shear bond strength test and subsequent analysis of the fracture mode. Data were submitted to analysis of variance and Fisher's PLSD test (alpha = 0.05). The micro-shear bond strength showed no difference between adhesives systems but a significant reduction was found between the control and carbamide groups (p = 0.0145) and the control and hydrogen groups (p = 0.0370). The evaluation of the failures modes showed that adhesive failures were predominant. Cohesive failures were predominant in group IV The use of dentifrice with peroxides can decrease bonding strength in enamel.
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MONITORING ENVIRONMENTAL RADIATION IN THE UNITED STATES(RADNET)
Operate a national network of sampling stations that regularly submit environmental samples of air, precipitation and drinking water; analyze all samples for radiation at the laboratory; and report data to the public and the radiation protection community. During national radiat...
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21 CFR 660.6 - Samples; protocols; official release.
Code of Federal Regulations, 2013 CFR
2013-04-01
... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...
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21 CFR 660.6 - Samples; protocols; official release.
Code of Federal Regulations, 2014 CFR
2014-04-01
... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...
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21 CFR 660.6 - Samples; protocols; official release.
Code of Federal Regulations, 2012 CFR
2012-04-01
... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...
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Gotlib, Dorothy; Bostwick, Jolene R; Calip, Seema; Perelstein, Elizabeth; Kurlander, Jacob E; Fluent, Thomas
2017-09-15
To determine the volume and nature (or topic) of consultations submitted to a psychiatric pharmacist embedded in an ambulatory psychiatry clinic, within a tertiary care academic medical center and to increase our understanding about the ways in which providers consult with an available psychiatric pharmacist. Authors analyze and describe the ambulatory psychiatric pharmacist consultation log at an academic ambulatory clinic. All consultation questions were submitted between July 2012 and October 2014. Psychiatry residents, attending physicians, and advanced practice nurse practitioners submitted 280 primary questions. The most common consultation questions from providers consulted were related to drug-drug interactions (n =70), drug formulations/dosing (n =48), adverse effects (n =43), and pharmacokinetics/lab monitoring/cross-tapering (n =36). This is a preliminary analysis that provides information about how psychiatry residents, attending physicians, and advanced practice nurse practitioners at our health system utilize a psychiatric pharmacist. This collaborative relationship may have implications for the future of psychiatric care delivery.
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Cummings, Kevin J; Aprea, Victor A; Altier, Craig
2014-01-01
Monitoring antimicrobial resistance trends among bacteria isolated from food animals and people is necessary to inform risk analyses and guide public policy regarding antimicrobial use. Our objectives were to describe the antimicrobial resistance status of Escherichia coli isolates from dairy cattle in the northeastern United States and to identify trends in resistance to selected antimicrobial agents over time. We collected data retrospectively for all bovine E. coli isolates that were obtained from samples submitted to Cornell University's Animal Health Diagnostic Center between January 1, 2004 and December 31, 2011. We investigated temporal trends in the prevalence of resistant E. coli for each antimicrobial agent using the Cochran-Armitage trend test. Antimicrobial susceptibility testing was performed on 3373 bovine E. coli isolates from clinical samples submitted during the study period. Overall resistance to each antimicrobial agent ranged from 2.7% (enrofloxacin) to 91.3% (oxytetracycline). There was evidence of a significantly decreasing trend in prevalence of resistance to several agents: chlortetracycline, florfenicol, neomycin, oxytetracycline, spectinomycin, and trimethoprim/sulfamethoxazole. However, a significantly increasing trend in prevalence of resistance to enrofloxacin was also evident. These results do not support the idea that current antimicrobial use practices on dairy operations are driving a general increase in the emergence and dissemination of drug-resistant E. coli in the region served by the laboratory. However, resistance to some drugs remained consistently high during the study period, and increasing resistance to enrofloxacin is a key area of concern.
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40 CFR 141.702 - Sampling schedules.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 23 2011-07-01 2011-07-01 false Sampling schedules. 141.702 Section... Monitoring Requirements § 141.702 Sampling schedules. (a) Systems required to conduct source water monitoring under § 141.701 must submit a sampling schedule that specifies the calendar dates when the system will...
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40 CFR 141.702 - Sampling schedules.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Sampling schedules. 141.702 Section... Monitoring Requirements § 141.702 Sampling schedules. (a) Systems required to conduct source water monitoring under § 141.701 must submit a sampling schedule that specifies the calendar dates when the system will...
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7 CFR 800.82 - Sampling provisions by level of service.
Code of Federal Regulations, 2010 CFR
2010-01-01
... be performed on the basis of the sample as submitted. (b) Reinspection, and appeal inspection... requested. In performing these services, a sample obtained with an approved diverter-type mechanical sampler... criteria, and a sample obtained with a probe at the time of the reinspection or appeal, generally, shall be...
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7 CFR 28.178 - Submission of cotton samples.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 2 2010-01-01 2010-01-01 false Submission of cotton samples. 28.178 Section 28.178... REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Classification for Foreign Growth Cotton § 28.178 Submission of cotton samples. Samples of cotton submitted to a Classing Office for classification and/or...
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7 CFR 28.178 - Submission of cotton samples.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 2 2013-01-01 2013-01-01 false Submission of cotton samples. 28.178 Section 28.178... REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Classification for Foreign Growth Cotton § 28.178 Submission of cotton samples. Samples of cotton submitted to a Classing Office for classification and/or...
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7 CFR 28.178 - Submission of cotton samples.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 2 2012-01-01 2012-01-01 false Submission of cotton samples. 28.178 Section 28.178... REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Classification for Foreign Growth Cotton § 28.178 Submission of cotton samples. Samples of cotton submitted to a Classing Office for classification and/or...
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7 CFR 28.178 - Submission of cotton samples.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 2 2014-01-01 2014-01-01 false Submission of cotton samples. 28.178 Section 28.178... REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Classification for Foreign Growth Cotton § 28.178 Submission of cotton samples. Samples of cotton submitted to a Classing Office for classification and/or...
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7 CFR 28.178 - Submission of cotton samples.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 7 Agriculture 2 2011-01-01 2011-01-01 false Submission of cotton samples. 28.178 Section 28.178... REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Classification for Foreign Growth Cotton § 28.178 Submission of cotton samples. Samples of cotton submitted to a Classing Office for classification and/or...
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Brüns, Angela C; Tanner, Manfred; Williams, Mark C; Botha, Louise; O'Brien, Amanda; Fosgate, Geoffrey T; van Helden, Paul D; Clarke, John; Michel, Anita L
2017-01-01
Bovine tuberculosis (bTB) was first diagnosed in the Kruger National Park (KNP) in 1990. Research has since focused on the maintenance host, the African buffalo ( Syncerus caffer ) and clinically affected lion ( Panthera leo ). However, little is known about the role of small predators in tuberculosis epidemiology. During 2011-12, we screened banded mongooses ( Mungos mungo ) in the bTB high-prevalence zone of the KNP for Mycobacterium tuberculosis complex members. Fecal swabs, tracheal swabs, and tracheal lavages of 76 banded mongooses caught in cage traps within a 2-km radius of Skukuza Rest Camp were submitted for Mycobacterium culture, isolation, and species identification. Lesions and lymph node samples collected from 12 animals at postmortem examination were submitted for culture and histopathology. In lung and lymph nodes of two banded mongooses, well demarcated, irregularly margined, gray-yellow nodules of up to 5 mm diameter were identified with either central necrosis or calcification, characterized on histopathology as caseating necrosis with epithelioid macrophages or necrogranuloma with calcified centre. No acid fast bacteria were identified with Ziehl-Neelsen stain. We isolated Mycobacterium bovis from lung, lymph node, and liver samples, as well as from tracheal lavages and tracheal swab from the same two banded mongooses. Blood samples were positive by ElephantTB STAT-PAK® Assay for 12 and Enferplex™ TB Assay for five animals. Only the two banded mongooses positive on pathology and M. bovis culture were positive on both serologic assays. We provide evidence of bTB infection in banded mongooses in the KNP, demonstrate their ability to shed M. bovis , and propose a possible antemortem diagnostic algorithm. Our findings open the discussion around possible sources of infection and their significance at the human/wildlife interface in and around Skukuza.
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Eisinger, Stephen W; Schwartz, Matthew; Dam, Lisa; Riedel, Stefan
2013-09-01
The stability of urine specimens submitted for culture remains a challenge for many laboratories because of delays in specimen transport. We evaluated the usefulness of BD Vacutainer Plus Urine C&S Preservative Tube in ensuring specimen stability. Clinical urine specimens collected in sterile collection cups (n = 110) were plated onto sheep blood and MacConkey agar following standard laboratory procedures guidelines. Thereafter, specimens were divided into 3 storage conditions: nonpreservative, refrigerated; nonpreservative, room temperature (RT); BD Vacutainer Plus Urine C&S Preservative Tube, RT. For each sample type, additional cultures were set up at 2, 4, 24, and 48 hours. Initially, 18 specimens had no growth, 32 showed mixed skin flora, and 60 yielded at least 1 uropathogen. Increased colony counts of uropathogens were observed for nonpreserved urine samples stored at RT; these changes were statistically significant. Minor differences between refrigerated urine samples and BD Vacutainer Plus Urine C&S Preservative Tube samples were seen but were not statistically significant. The use of preservative-containing collection tubes is desirable to ensure specimen stability when prompt processing or refrigeration is not feasible.
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Sputum color: potential implications for clinical practice.
Johnson, Allen L; Hampson, David F; Hampson, Neil B
2008-04-01
Respiratory infections with sputum production are a major reason for physician visits, diagnostic testing, and antibiotic prescription in the United States. We sought to determine whether the simple characteristic of sputum color provides information that impacts resource utilization such as laboratory testing and prescription of antibiotics. Out-patient sputum samples submitted to the microbiology laboratory for routine analysis were assigned to one of 8 color categories (green, yellow-green, rust, yellow, red, cream, white, and clear), based on a key made from paint chip color samples. Subsequent Gram stain and culture results were compared to sputum color. Of 289 consecutive samples, 144 (50%) met standard Gram-stain criteria for being acceptable lower-respiratory-tract specimens. In the acceptable Gram-stain group, 60 samples had a predominant organism on Gram stain, and the culture yielded a consistent result in 42 samples (15% of the 289 total specimens). Yield at each level of analysis differed greatly by color. The yield from sputum colors green, yellow-green, yellow, and rust was much higher than the yield from cream, white, or clear. If out-patient sputum is cream, white, or clear, the yield from bacteriologic analysis is extremely low. This information can reduce laboratory processing costs and help minimize unnecessary antibiotic prescription.
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Byrne, Brenda G.; McColm, Sarah; McElmurry, Shawn P.; Sobeck, Joanne; Sadler, Rick; Love, Nancy G.
2018-01-01
ABSTRACT Coinciding with major changes to its municipal water system, Flint, MI, endured Legionnaires’ disease outbreaks in 2014 and 2015. By sampling premise plumbing in Flint in the fall of 2016, we found that 12% of homes harbored legionellae, a frequency similar to that in residences in neighboring areas. To evaluate the genetic diversity of Legionella pneumophila in Southeast Michigan, we determined the sequence type (ST) and serogroup (SG) of the 18 residential isolates from Flint and Detroit, MI, and the 33 clinical isolates submitted by hospitals in three area counties in 2013 to 2016. Common to one environmental and four clinical samples were strains of L. pneumophila SG1 and ST1, the most prevalent ST worldwide. Among the Flint premise plumbing isolates, 14 of 16 strains were of ST367 and ST461, two closely related SG6 strain types isolated previously from patients and corresponding environmental samples. Each of the representative SG1 clinical strains and SG6 environmental isolates from Southeast Michigan infected and survived within macrophage cultures at least as well as a virulent laboratory strain, as judged by microscopy and by enumerating CFU. Likewise, 72 h after infection, the yield of viable-cell counts increased >100-fold for each of the representative SG1 clinical isolates, Flint premise plumbing SG6 ST367 and -461 isolates, and two Detroit residential isolates. We verified by immunostaining that SG1-specific antibody does not cross-react with the SG6 L. pneumophila environmental strains. Because the widely used urinary antigen diagnostic test does not readily detect non-SG1 L. pneumophila, Legionnaires’ disease caused by SG6 L. pneumophila is likely underreported worldwide. PMID:29437918
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Ihekwaba, Ugo K; Kudesia, Goura; McKendrick, Michael W
2008-09-15
In this retrospective study, our objective was to review the epidemiology of viral meningitis and to compare clinical features associated with enterovirus, herpes simplex virus (HSV), and varicella zoster virus (VZV) infections in immunocompetent adults. Data on cerebrospinal fluid (CSF) samples submitted to the Trust Virology Laboratory (Sheffield, UK) from April 2004 through April 2007 were reviewed. Notes on immunocompetent adults who were polymerase chain reaction (PCR) positive for enterovirus, HSV type 2, or VZV and who had presented to local clinical departments were scrutinized (4 patients were positive for HSV type 1 and did not meet the inclusion criteria). A total of 2045 samples were analyzed for viral pathogens during the 3-year period. Of the 109 PCR-positive samples, 38 (35%) were from immunocompetent adults, of whom 22 were infected with enterovirus, 8 were infected with HSV type 2, and 8 were infected with VZV. The median ages were 32 years (range, 16-39 years), 39 years (range, 22-53 years), and 47.5 years (range, 26-80 years), respectively. Rash occurred after the meningitis symptoms in 5 patients infected with VZV (median time from meningitis symptoms to rash, 6 days). Protein levels were significantly higher in CSF samples from patients infected with HSV type 2 (median, 1205 mg/L) and in samples from those infected with VZV (median, 974 mg/L) than in samples from those infected with enterovirus (median, 640 mg/L; P = .001 and P = .01, respectively). White blood cell counts were significantly higher in CSF samples from patients infected with HSV type 2 (median, 240 x 10(6) cells/L) than in samples from those infected with enterovirus (median, 51 x 10(6) cells/L; P = .01). Enterovirus infection was the most common cause of viral meningitis in immunocompetent adults in this study. White blood cell counts and protein levels were significantly higher in CSF samples from patients infected with HSV type 2 than in samples from patients with enterovirus infection. Zoster rash often occurs after meningitis. PCR testing provides a rapid and specific etiological diagnosis.
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Santana, Fernanda Ribeiro; Soares, Carlos José; Silva, Júlio Almeida; Alencar, Ana Helena Gonçalves; Renovato, Sara Rodrigues; Lopes, Lawrence Gonzaga; Estrela, Carlos
2015-07-01
To evaluate the effect of instrumentation techniques, irrigant solutions and specimen aging on fiberglass posts bond strength to intraradicular dentine. A total of 120 bovine teeth were prepared and randomized into control and experimental groups resulting from three study factors (instrumentation techniques, irrigant solutions, specimen aging). Posts were cemented with RelyX U100. Samples were submitted to push-out test and failure mode was evaluated under a confocal microscope. In specimens submitted to water artificial aging, nickel-titanium rotary instruments group presented higher bond strength values in apical third irrigated with NaOCl or chlorhexi-dine. Irrigation with NaOCl resulted in higher bond strength than ozonated water. Artificial aging resulted in significant bond strength increase. Adhesive cement-dentin failure was prevalent in all the groups. Root canal preparation with NiTi instruments associated with NaOCl irrigation and ethylenediaminetetra acetic acid (EDTA) increased bond strength of fiberglass posts cemented with self-adhesive resin cement to intraradicular dentine. Water artificial aging significantly increased post-Clinical significance: The understanding of factors that may influence the optimal bond between post-cement and cement-dentin are essential to the success of endodontically treated tooth restoration.
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Alfonso Farnós, Iciar; Hernández Gil, Arantza; Rodríguez Velasco, María
2013-01-01
Research on human genome and its applications open great perspectives to improve human beings' health. However, these advances must never endanger the respect of dignity, freedom and rights of the participants in medical research, assuring prohibition of any way of discrimination because of genetic features. The Independent Research Boards (IRB), responsible for safeguarding rights, safety and well-being of the subjects taking part in the biomedical research, assess independently submitted genetic studies, clinical trials whose primary objective is obtaining genetic information and genetic sub-studies of clinical trials with drugs. Biobanks, as safeguarding means to preserve biological samples in suitable quality conditions, must be assigned to two external committees, a scientific one and an ethics one. External ethics committees of biobanks have to make the ethical assessment of the submissions of samples transfers and associated data, in order to carry out research projects. On the other hand, they have to advise biobanks on the compliance of ethical and legal principles, which, in many committees, has turned into the performance of informed consent forms which are in accordance with current laws.
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Abutarbush, S M
2013-07-27
The objective of this observational study is to describe clinical, haematological and serum biochemical findings of horses affected with alfalfa dodder (Cuscuta campestris) toxicity. Twenty horses naturally exposed to alfalfa dodder toxicity were examined and information was collected on history and clinical signs. Physical examination was done on horses in the premises (n=20), and venous blood samples of 12 horses were submitted for haematology and serum biochemical examination for each horse. Abnormal clinical signs started around 36 hours after horses were fed the contaminated alfalfa. Abnormal signs were seen in 11 horses and those included diarrhoea (n=8), decreased appetite (n=7), neurological signs (n=4) and abdominal pain (n=1). Some horses had multiple clinical signs of the above. The results of complete blood cell count revealed leukocytopenia, neutropenia and thrombocytopenia. Serum biochemical analysis revealed decreased ALP, AST and CPK levels and increased direct bilirubin level. The used alfalfa was stopped immediately and a different alfalfa from a new container that did not contain any weeds was fed. Horses on the premises were observed closely, and the abnormal clinical signs resolved within three days. No treatment was implemented. Knowledge about toxicity of horses by Cuscuta species is scarce in the English veterinary literature and very limited.
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Comparing Two Examination Results Using Means of Sample Means and Control Charts
ERIC Educational Resources Information Center
Alabi-Labaika, A. Bisi; Ahani, E.
2015-01-01
Some examination candidates submit their scripts first, sometimes, for recognition as being brilliant, and some do for not knowing what to write. However, some equally submit last because they want to dot i's and cross t's. The objective of this research is to compare the results of both the earliest and latest submissions with the aim of finding…
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ERIC Educational Resources Information Center
hatamleh, habes Moh'd; al Khaza'leh, Mohammed Salman
2016-01-01
The study aimed to identify the (appropriate educational means of dealing with the phenomenon of smoking among Zarqa University students), and to achieve this goal, the descriptive approach has been used, also used a questionnaire submitted to (800) students of the sample, and a couple of open questions has been submitted to 70 members of the…
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Peirce, Jessica M; Petry, Nancy M; Stitzer, Maxine L; Blaine, Jack; Kellogg, Scott; Satterfield, Frank; Schwartz, Marion; Krasnansky, Joe; Pencer, Eileen; Silva-Vazquez, Lolita; Kirby, Kimberly C; Royer-Malvestuto, Charlotte; Roll, John M; Cohen, Allan; Copersino, Marc L; Kolodner, Ken; Li, Rui
2006-02-01
Contingency management interventions that provide tangible incentives based on objective indicators of drug abstinence have improved treatment outcomes of substance abusers, but have not been widely implemented in community drug abuse treatment settings. To compare outcomes achieved when a lower-cost prize-based contingency management treatment is added to usual care in community methadone hydrochloride maintenance treatment settings. Random assignment to usual care with (n = 198) or without (n = 190) abstinence incentives during a 12-week trial. Six community-based methadone maintenance drug abuse treatment clinics in locations across the United States. Three hundred eighty-eight stimulant-abusing patients enrolled in methadone maintenance programs for at least 1 month and no more than 3 years. Participants submitting stimulant- and alcohol-negative samples earned draws for a chance to win prizes; the number of draws earned increased with continuous abstinence time. Total number of stimulant- and alcohol-negative samples provided, percentage of stimulant- and alcohol-negative samples provided, longest duration of abstinence, retention, and counseling attendance. Submission of stimulant- and alcohol-negative samples was twice as likely for incentive as for usual care group participants (odds ratio, 1.98; 95% confidence interval, 1.42-2.77). Achieving 4 or more, 8 or more, and 12 weeks of continuous abstinence was approximately 3, 9, and 11 times more likely, respectively, for incentive vs usual care participants. Groups did not differ on study retention or counseling attendance. The average cost of prizes was 120 dollars per participant. An abstinence incentive approach that paid 120 dollars in prizes per participant effectively increased stimulant abstinence in community-based methadone maintenance treatment clinics.
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Colón, Cristóbal; Alvarez, J Victor; Castaño, Cristina; Gutierrez-Solana, Luís G; Marquez, Ana M; O'Callaghan, María; Sánchez-Valverde, Félix; Yeste, Carmen; Couce, María-Luz
2017-05-01
The mucopolysaccharidoses (MPSs) are underdiagnosed but they are evaluated in few newborn screening programs, probably due to the many challenges remaining, such as the identification of late-onset phenotypes. Systematic screening at the onset of clinical symptoms could help to early identify patients who may benefit from specific treatments. The aim of this prospective study was to assess a novel selective screening program, the FIND project, targeting patients aged 0 to 16 years with clinical manifestations of MPS. The project was designed to increase awareness of these diseases among pediatricians and allow early diagnosis.From July 2014 to June 2016, glycosaminoglycan (GAG) levels normalized to creatinine levels were determined in urine-impregnated analytical paper submitted by pediatricians who had patients with clinical signs and/or symptoms compatible with MPS. When high GAG concentrations were detected, a new liquid urine sample was requested to confirm and identify the GAG present. When a specific form of MPS was suspected, enzyme activity was analyzed using blood-impregnated paper to determine MPS type (I, IIIB, IIIC, IVA, IVB, VI, or VII). Age-specific reference values for GAG were previously established using 145 urine samples from healthy children.GAG levels were normal in 147 (81.7%) of the 180 initial samples received. A liquid sample was requested for the other 33 cases (18.3%); GAG levels were normal in 13 of these and slightly elevated in 12, although the electrophoresis study showed no evidence of MPS. Elevated levels with corresponding low enzymatic activity were confirmed in 8 cases. The mean time from onset of clinical symptoms to detection of MPS was 22 months, and just 2 cases were detected at the beginning of the project were detected with 35 and 71 months of evolution of clinical symptoms. Our screening strategy for MPS had a sensitivity of 100%, a specificity of 85%, and a positive predictive value of 24%.The FIND project is a useful and cost-effective screening method for increasing awareness of MPS among pediatricians and enabling the detection of MPS at onset of clinical symptoms.
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The molecular identification of Streptococcus equi subsp. equi strains isolated within New Zealand.
Patty, O A; Cursons, R T M
2014-03-01
To identify Streptococcus equi subsp. equi (S. equi) by PCR analysis and obtain isolates by culture, in order to investigate the strains of S. equi infecting horses within New Zealand. A diagnostic PCR, based on the amplification of the seeI gene for S. equi, was used on 168 samples submitted from horses with and without clinical signs of strangles. Samples were also processed and cultured on selective media for the isolation of β-haemolytic colonies. In addition, the hypervariable region of the seM gene of S. equi was amplified and then sequenced for strain typing purposes. Of the 168 samples, 35 tested positive for S. equi using PCR. Thirty-two confirmed samples were from horses with a clinical diagnosis of strangles and three were from horses where clinical information was unavailable. Only 22/35 (63%) confirmed S. equi samples were successfully isolated following culture. Strain typing demonstrated that two novel seM alleles of S. equi were found in New Zealand with SeM-99 strains being restricted to the North Island while SeM-100 strains were found in both North and South Islands. The application of PCR for the laboratory confirmation of strangles allowed for a rapid and sensitive identification of S. equi. Moreover, seM typing revealed that within the samples examined two strains of S. equi co-circulated within the North Island of New Zealand but only one strain in the South Island. PCR reduces the time required to obtain laboratory confirmation of strangles compared with culture methods. It also has greater sensitivity in detecting S. equi infections, which is of particular importance in the detection of carrier animals which normally shed low numbers of bacteria. Additionally, seM molecular typing can differentiate between bacterial strains, assisting in the monitoring of local strains of S. equi subsp. equi causing disease.
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McDonell, Michael G.; Skalisky, Jordan; Leickly, Emily; Orr, Michael F.; Roll, John; McPherson, Sterling; Hill-Kapturczak, Nathalie; Javors, Martin
2018-01-01
Phosphatidylethanol (PEth) can be detected in blood from 14 to as many as 28 days after alcohol consumption, depending on the amount and frequency of alcohol consumed. PEth may have utility for verifying abstinence in a contingency management (CM) intervention for alcohol use, particularly in settings where frequent verification of abstinence is impossible or impractical. Five nontreatment-seeking heavy drinkers (40% men) participated in an 11-week, ABA-phased within-subject experiment for which they submitted blood spots for PEth measurement, urine samples for ethyl glucuronide (EtG) testing, and self-report drinking data weekly. Participants received reinforcers for submitting samples throughout the A phases. During the B phase (CM phase), they received additional reinforcers when their PEth level was reduced from the previous week and was verified by a negative EtG (<150 ng/ml) urine test and self-report. PEth, EtG, and self-report outcomes were compared between A phases (Weeks 1–3, 8–11) and B phases (Weeks 4–7). During the A phases, 23% of PEth results indicated alcohol abstinence, whereas 53% of PEth samples submitted during the CM (B phase) indicated alcohol abstinence. Participants were more likely to submit EtG-negative urine samples and report lower levels of drinking and heavy drinking during the B phase, relative to the A phases. We also explored the ability of PEth to detect self-reported drinking. The combined PEth homologs (16:0/18:1 and 16:0/18:2) predicted self-reported drinking with area under the curve from 0.81 (1 week) to 0.80 (3 weeks). Results support the initial feasibility of a Peth-based CM intervention. PMID:28714726
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Dharne, M.S.; Gupta, A.K.; Rangrez, A.Y.; Ghate, H.V.; Patole, M.S.; Shouche, Y.S.
2008-01-01
Flesh flies (Diptera: Sarcophagidae) are well known cause of myiasis and their gut bacteria have never been studied for antimicrobial activity against bacteria. Antimicrobial studies of Myroides spp. are restricted to nosocomial strains. A Gram-negative bacterium, Myroides sp., was isolated from the gut of adult flesh flies (Sarcophaga sp.) and submitted to evaluation of nutritional parameters using Biolog GN, 16S rRNA gene sequencing, susceptibility to various antimicrobials by disc diffusion method and detection of metallo β-lactamase genes (TUS/MUS). The antagonistic effects were tested on Gram-negative and Gram-positive bacteria isolated from human clinical specimens, environmental samples and insect mid gut. Bacterial species included were Aeromonas hydrophila, A. culicicola, Morganella morganii subsp. sibonii, Ochrobactrum anthropi, Weissella confusa, Escherichia coli, Ochrobactrum sp., Serratia sp., Kestersia sp., Ignatzschineria sp., Bacillus sp. The Myroides sp. strain was resistant to penicillin-G, erythromycin, streptomycin, amikacin, kanamycin, gentamycin, ampicillin, trimethoprim and tobramycin. These strain showed antibacterial action against all bacterial strains except W. confusa, Ignatzschineria sp., A. hydrophila and M. morganii subsp. sibonii. The multidrug resistance of the strain was similar to the resistance of clinical isolates, inhibiting growth of bacteria from clinical, environmental and insect gut samples. The metallo β-lactamase (TUS/MUS) genes were absent, and resistance due to these genes was ruled out, indicating involvement of other secretion machinery. PMID:24031236
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NASA Astrophysics Data System (ADS)
Sandford, S. A.; Chabot, N. L.; Dello Russo, N.; Leary, J. C.; Reynolds, E. L.; Weaver, H. A.; Wooden, D. H.
2017-07-01
CORSAIR (COmet Rendezvous, Sample Acquisition, Investigation, and Return) is a mission concept submitted in response to NASA's New Frontiers 4 call. CORSAIR's proposed mission is to return comet nucleus samples to Earth for detailed analysis.
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Oosterhuis, Ingrid; Taavola, Henric; Tregunno, Philip M; Mas, Petar; Gama, Sara; Newbould, Victoria; Caster, Ola; Härmark, Linda
2018-05-14
Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. The app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis. Higher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78-85%, reference: 78-98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled. The WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection.
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Tank 40 Final SB7b Chemical Characterization Results
DOE Office of Scientific and Technical Information (OSTI.GOV)
Bannochie, C. J.
2012-11-06
A sample of Sludge Batch 7b (SB7b) was taken from Tank 40 in order to obtain radionuclide inventory analyses necessary for compliance with the Waste Acceptance Product Specifications (WAPS). The SB7b WAPS sample was also analyzed for chemical composition including noble metals and fissile constituents. At the Savannah River National Laboratory (SRNL) the 3-L Tank 40 SB7b sample was transferred from the shipping container into a 4-L high density polyethylene bottle and solids were allowed to settle over the weekend. Supernate was then siphoned off and circulated through the shipping container to complete the transfer of the sample. Following thoroughmore » mixing of the 3-L sample, a 558 g sub-sample was removed. This sub-sample was then utilized for all subsequent analytical samples. Eight separate aliquots of the slurry were digested, four with HNO{sub 3}/HCl (aqua regia) in sealed Teflon vessels and four with NaOH/Na{sub 2}O{sub 2} (alkali or peroxide fusion) using Zr crucibles. Two Analytical Reference Glass ? 1 (ARG-1) standards were digested along with a blank for each preparation. Each aqua regia digestion and blank was diluted to 1:100 mL with deionized water and submitted to Analytical Development (AD) for inductively coupled plasma ? atomic emission spectroscopy (ICP-AES) analysis, inductively coupled plasma ? mass spectrometry (ICP-MS) analysis, atomic absorption spectroscopy (AA) for As and Se, and cold vapor atomic absorption spectroscopy (CV-AA) for Hg. Equivalent dilutions of the alkali fusion digestions and blank were submitted to AD for ICP-AES analysis. Tank 40 SB7b supernate was collected from a mixed slurry sample in the SRNL Shielded Cells and submitted to AD for ICP-AES, ion chromatography (IC), total base/free OH{sup -}/other base, total inorganic carbon/total organic carbon (TIC/TOC) analyses, and Cs-137 gamma scan. Weighted dilutions of slurry were submitted for IC, TIC/TOC, and total base/free OH-/other base analyses. Activities for U-233, U-235, and Pu-239 were determined from the ICP-MS data for the aqua regia digestions of the Tank 40 WAPS slurry using the specific activity of each isotope. The Pu-241 value was determined from a Pu-238/-241 method.« less
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Lee, Todd A; Hacek, Donna M; Stroupe, Kevin T; Collins, Susan M; Peterson, Lance R
2005-01-01
To evaluate the cost-effectiveness and detection sensitivity associated with three active surveillance strategies for the identification of patients harboring vancomycin-resistant enterococci (VRE) to determine which is the most medically and economically useful. Culture for VRE from 200 consecutive stool specimens submitted for Clostridium difficile culture. Following this, risk factors were assessed for patients whose culture yielded VRE, and a cost-effectiveness evaluation was performed using a decision analytic model with a probabilistic analysis. A 688-bed, tertiary-care facility in Chicago, Illinois, with approximately 39,000 annual admissions, 7,000 newborn deliveries, 56,000 emergency department visits, and 115,000 home care and 265,000 outpatient visits. All stool specimens submitted to the clinical microbiology laboratory for C. difficile culture from hospital inpatients. From 200 stool samples submitted for C. difficile testing, we identified 5 patients with VRE in non-high-risk areas not screened as part of our routine patient surveillance. Medical record review revealed that all 5 had been hospitalized within the prior 2 years. Three of 5 had a history of renal impairment. The strategy that would involve screening the greatest number of patients (all those with a history of hospital admission in the prior 2 years) resulted in highest screening cost per patient admitted (dollars 2.48), lower per patient admission costs (dollars 480), and the best survival rates. An expanded VRE surveillance program that encompassed all patients hospitalized within the prior 2 years was a cost-effective screening strategy compared with a more traditional one focused on high-risk units.
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Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Test samples. 14.5 Section 14.5 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Test samples. Upon request by MSHA, the applicant must submit 3 precut, unrolled, flat conveyor belt...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Test samples. 14.5 Section 14.5 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Test samples. Upon request by MSHA, the applicant must submit 3 precut, unrolled, flat conveyor belt...
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Code of Federal Regulations, 2013 CFR
2013-07-01
... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Test samples. 14.5 Section 14.5 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Test samples. Upon request by MSHA, the applicant must submit 3 precut, unrolled, flat conveyor belt...
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Skalisky, Jordan; Leickly, Emily; Oluwoye, Oladunni; McPherson, Sterling M; Srebnik, Debra; Roll, John M; Ries, Richard K; McDonell, Michael G
2017-01-01
Introduction: People with serious mental illness (SMI) use cannabis more than any other illicit drug. Cannabis use is associated with increased psychotic symptoms and is highly comorbid with alcohol use disorders (AUDs). Despite the national trend toward decriminalization, little is known about the prevalence, correlates, and impact of cannabis use on those with SMI receiving treatment for substance use disorders, a group at high risk for the negative effects of cannabis use. Methods: In this secondary data analysis, cannabis use prevalence, correlates, and impact on treatment outcomes were examined in 121 adults with cooccurring SMI and AUDs receiving outpatient addiction treatment in a randomized trial of contingency management (CM) for alcohol. Prevalence and frequency of cannabis use were calculated across the 7-month study period using self-report and urine tests. Cannabis users were compared with nonusers by SMI diagnosis, psychiatric symptoms, medical problems, legal problems, and HIV-risk behavior. The relationship between cannabis use and longest duration of alcohol abstinence in participants randomized to CM ( n =40) was assessed. Results: Fifty-seven (47%) of participants submitted at least one cannabis-positive urine sample during the study. Out of the 2834 total samples submitted, 751 (27%) were positive for cannabis. Cannabis users were 2.2 times more likely to submit an alcohol-positive sample, and 2.5 times more likely to submit a cocaine-positive sample at baseline, relative to noncannabis users ( p =0.01). Cannabis users were more likely to engage in risky sexual behavior ( p =0.01) and to report being homeless ( p =0.03) than nonusers. When controlling for pretreatment alcohol use, the relationship between comorbid cannabis use and alcohol abstinence during CM was not significant ( p =0.77). Conclusion: Rates of comorbid cannabis use were high in this sample of adults with SMI and AUDs. Cannabis use was correlated with recent alcohol and cocaine use, risky sexual behavior, and homelessness, but not with alcohol abstinence during CM.
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Code of Federal Regulations, 2010 CFR
2010-04-01
... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... made with S.D.A. Formula No. 39-C and containing an essential oil, the manufacturer shall submit a 0.5-ounce sample of the essential oil used in the article. The appropriate TTB officer may also require the...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... made with S.D.A. Formula No. 39-C and containing an essential oil, the manufacturer shall submit a 0.5-ounce sample of the essential oil used in the article. The appropriate TTB officer may also require the...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... made with S.D.A. Formula No. 39-C and containing an essential oil, the manufacturer shall submit a 0.5-ounce sample of the essential oil used in the article. The appropriate TTB officer may also require the...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... made with S.D.A. Formula No. 39-C and containing an essential oil, the manufacturer shall submit a 0.5-ounce sample of the essential oil used in the article. The appropriate TTB officer may also require the...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... made with S.D.A. Formula No. 39-C and containing an essential oil, the manufacturer shall submit a 0.5-ounce sample of the essential oil used in the article. The appropriate TTB officer may also require the...
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Effect of pulsed Nd:YAG on dentin morphological changes
NASA Astrophysics Data System (ADS)
Moriyama, Eduardo H.; Zangaro, Renato A.; Villaverde, Antonio G. J. B.; Watanabe-Sei, Ii; Munin, Egberto; Sasaki, Luis H.; Otsuka, Daniel K.; Lobo, Paulo D. d. C.; Pacheco, Marcos T. T.; Junior, Durval R.
2002-06-01
Infrared lasers have been used for several clinical applications in dentistry, including laser ablation, oral surgeries and dentin hypersensitivity treatment. Despite of dentin low absorption coefficient in the near infrared spectrum, Nd:YAG laser radiation ((lambda) = 1064 nm) is able to melt the human dentin surface resulting in dentin tubules closure that can suppress the symptoms of dentin hypersensitivity pathology. Objectives: This study aims to analyze, through SEM technique, the morphological changes in dentin surface after Nd:YAG laser irradiation using different parameters in energy distribution. Materials and Methods: In this study sixteen human dentin samples were submitted to Nd:YAG laser radiation using a total energy of 900mJ distributed in one, two, three or six laser pulses with energy for each pulse of 900, 450, 300 or 150 mJ respectively. All the samples were irradiated with laser pulse width of 90ms, pulse intervals of 300 ms and spot size area of 0,005 cm2. Results: SEM analysis suggests that differences in energy distribution results in morphological differences even though the same energy is used for all the samples.
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da Costa, Elizabeth Oliveira; Ribeiro, Márcio Garcia; Ribeiro, Andréa Rentz; Rocha, Noeme Sousa; de Nardi Júnior, Geraldo
2004-07-01
Biopsy by fine needle aspiration together with microbiological examination and scanning electron microscopy were evaluated in diagnosis of clinical bovine mastitis in a Prototheca zopfii outbreak. Fine needle aspiration was performed in 21 mammary quarters from ten Holstein cows presenting clinical mastitis caused by P. zopfii. The algae were previously identified in the microbiological examination of milk collected from these cows. Material aspirated from these 21 mammary glands was submitted to cytological staining (Gram, Giemsa and/or Shor staining). Fine needle aspiration enabled cytological identification of the algae in these 21 mammary glands, from which P. zopfii was isolated in the milk. Simultaneously, five mammary fragments collected by fine needle aspiration from these 21 mammary glands presenting clinical mastitis were also submitted to microbiological examination. P. zopfii was also isolated from these five fragments. Scanning electron microscopy technique also identified three of these five P zopfii strains isolated from mammary fragments collected by cytological aspiration. These results suggest that fine needle aspiration may be an alternative method for the diagnosis of clinical mastitis.
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Resende, Lucas; Carmo, Carolina do; Mocellin, Leão; Pasinato, Rogério; Mocellin, Marcos
2017-07-29
Septal deviations might cause nasal obstruction and negative impact on the quality of life of individuals. The efficacy of septoplasty for treatment of septal deviation and the predictors of satisfactory surgical outcomes remain controversial. Technical variability, heterogeneity of research samples and absence of a solid tool for clinical evaluation are the main hindrances to the establishment of reliable statistical data regarding the procedure. To evaluate the clinical improvements in the disease-specific quality-of-life between patients submitted to septoplasty with bilateral outfracture of the inferior turbinate under sedation and local anesthesia in a tertiary hospital and to assess possible clinical-epidemiological variables associated with functional outcome. Fifty-two patients consecutively submitted to septoplasty with bilateral outfracture of the inferior turbinate for treatment of nasal obstruction filled in forms regarding clinical and epidemiological information during enrollment and had their symptom objectively quantified using the Nose Obstruction Symptom Evaluation (NOSE) scale preoperatively and one and three months after the procedure. Statistical analysis aimed to determine overall and stratified surgical outcomes and to investigate correlations between the clinical-epidemiological variables with the scores obtained. Statistically significant improvement in the preoperative NOSE questionnaire compared to the scores obtained three months after surgery was demonstrated (p<0.001, T-Wilcoxon), with strong correlation between the preoperative score and the postoperative improvement during this period (r=-0.614, p<0.001, Spearman). After one month, patients reached in average 87.15% of the result obtained at the study termination. Smokers and patients with rhinitis and/or pulmonary comorbidity showed increased average preoperative NOSE scores, although without statistical significance (p>0.05). Gender, age, history of rhinitis and presence of pulmonary comorbidity did not influence significantly surgical outcomes (p>0.05). Smokers presented greater reduction in NOSE scores during the study (p=0.043, U-Mann-Whitney). Septoplasty with bilateral outfracture of the inferior turbinate has proven to significantly improve disease-specific quality-of-life and this favorable outcome seems to occur precociously. Copyright © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.
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46 CFR 164.006-4 - Inspection and testing.
Code of Federal Regulations, 2013 CFR
2013-10-01
... attachments shall be incorporated in the samples. Each sample shall be heated in a furnace whose temperature... minutes—60 percent light transmission. 60 minutes—50 percent light transmission. (c) Fire resistance and integrity tests. (1) A sample of each thickness submitted shall be tested for fire resistance and integrity...
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46 CFR 164.006-4 - Inspection and testing.
Code of Federal Regulations, 2012 CFR
2012-10-01
... attachments shall be incorporated in the samples. Each sample shall be heated in a furnace whose temperature... minutes—60 percent light transmission. 60 minutes—50 percent light transmission. (c) Fire resistance and integrity tests. (1) A sample of each thickness submitted shall be tested for fire resistance and integrity...
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46 CFR 164.006-4 - Inspection and testing.
Code of Federal Regulations, 2011 CFR
2011-10-01
... attachments shall be incorporated in the samples. Each sample shall be heated in a furnace whose temperature... minutes—60 percent light transmission. 60 minutes—50 percent light transmission. (c) Fire resistance and integrity tests. (1) A sample of each thickness submitted shall be tested for fire resistance and integrity...
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46 CFR 164.006-4 - Inspection and testing.
Code of Federal Regulations, 2014 CFR
2014-10-01
... attachments shall be incorporated in the samples. Each sample shall be heated in a furnace whose temperature... minutes—60 percent light transmission. 60 minutes—50 percent light transmission. (c) Fire resistance and integrity tests. (1) A sample of each thickness submitted shall be tested for fire resistance and integrity...
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NASA Astrophysics Data System (ADS)
Duarte, C. L.; Ribeiro, M. A.; Oikawa, H.; Mori, M. N.; Napolitano, C. M.; Galvão, C. A.
2012-08-01
The use of microbial cellulolytic enzymes is the most efficient process to liberate glucose from cellulose in biomass without the formation of fermentation inhibitors. A combination of pretreatment technologies is an alternative way to increase the access of enzymes to cellulose, and consequently, the conversion yield. In this way, the present study reports on the enzymatic hydrolysis of SCB submitted to three kinds of pretreatment: electron beam processing (EBP), and EBP followed by hydrothermal (TH) and diluted acid (AH) treatment. SCB samples were irradiated using a radiation dynamics electron beam accelerator, and then submitted to thermal and acid (0.1% sulfuric acid) hydrolysis for 40 and 60 min at 180 °C. These samples were submitted to enzymatic hydrolysis (EH) using commercial preparations, including Celluclast 1.5 L and beta-glycosidase. The addition of diluted acid improved TH treatment allowing for a shorter application time. EBP with 50 kGy increased the enzymatic hydrolysis yield of cellulose by 20% after TH and 30% after AH.
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Helicobacter pylori in dental plaque and stomach of patients from Northern Brazil.
Assumpção, Mônica Baraúna; Martins, Luisa Caricio; Melo Barbosa, Hivana Patricia; Barile, Katarine Antonia dos Santos; de Almeida, Sintia Silva; Assumpção, Paulo Pimentel; Corvelo, Tereza Cristina de Oliveira
2010-06-28
To establish whether virulence factor genes vacA and cagA are present in Helicobacter pylori (H. pylori) retrieved from gastric mucosa and dental plaque in patients with dyspepsia. Cumulative dental plaque specimens and gastric biopsies were submitted to histological examination, rapid urease test and polymerase chain reaction (PCR) assays to detect the presence of cagA and vacA polymorphisms. Detection of H. pylori from dental plaque and gastric biopsy samples was greater by PCR compared to histological examination and the rapid urease test. DNA from H. pylori was detected in 96% of gastric mucosa samples and in 72% of dental plaque samples. Sixty-three (89%) of 71 dental plaque samples that were H. pylori-positive also exhibited identical vacA and cagA genotypes in gastric mucosa. The most common genotype was vacAs1bm1 and cagA positive, either in dental plaque or gastric mucosa. These virulent H. pylori isolates were involved in the severity of clinical outcome. These pathogenic strains were found simultaneously in dental plaque and gastric mucosa, which suggests that gastric infection is correlated with the presence of H. pylori in the mouth.
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Helicobacter pylori in dental plaque and stomach of patients from Northern Brazil
Assumpção, Mônica Baraúna; Martins, Luisa Caricio; Melo Barbosa, Hivana Patricia; dos Santos Barile, Katarine Antonia; de Almeida, Sintia Silva; Assumpção, Paulo Pimentel; de Oliveira Corvelo, Tereza Cristina
2010-01-01
AIM: To establish whether virulence factor genes vacA and cagA are present in Helicobacter pylori (H. pylori) retrieved from gastric mucosa and dental plaque in patients with dyspepsia. METHODS: Cumulative dental plaque specimens and gastric biopsies were submitted to histological examination, rapid urease test and polymerase chain reaction (PCR) assays to detect the presence of cagA and vacA polymorphisms. RESULTS: Detection of H. pylori from dental plaque and gastric biopsy samples was greater by PCR compared to histological examination and the rapid urease test. DNA from H. pylori was detected in 96% of gastric mucosa samples and in 72% of dental plaque samples. Sixty-three (89%) of 71 dental plaque samples that were H. pylori-positive also exhibited identical vacA and cagA genotypes in gastric mucosa. The most common genotype was vacAs1bm1 and cagA positive, either in dental plaque or gastric mucosa. These virulent H. pylori isolates were involved in the severity of clinical outcome. CONCLUSION: These pathogenic strains were found simultaneously in dental plaque and gastric mucosa, which suggests that gastric infection is correlated with the presence of H. pylori in the mouth. PMID:20572307
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76 FR 33303 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-08
... comments should be received within 60 days of this notice. Proposed Project Survey of Rapid Influenza... Description The Survey of Rapid Influenza Diagnostic Testing Practices in Clinical Laboratories is a national systematic study investigating rapid influenza diagnostic testing practices in clinical [[Page 33304...
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Editorial: Conflict of interest policy for Editors of The American Journal of Clinical Nutrition
USDA-ARS?s Scientific Manuscript database
Integrity in the publication process requires impartiality at all levels of review. The American Journal of Clinical Nutrition (AJCN) adheres to the policy of the International Committee of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writin...
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[Sequential monitoring of renal transplant with aspiration cytology].
Manfro, R C; Gonçalves, L F; de Moura, L A
1998-01-01
To evaluate the utility of kidney aspiration cytology in the sequential monitorization of acute rejection in renal transplant patients. Thirty patients were submitted to 376 aspirations. The clinical diagnoses were independently established. The representativity of the samples reached 82.7%. The total corrected increment index and the number of immunoactivated cells were higher during acute rejection as compared to normal allograft function, acute tubular necrosis, and cyclosporine nephrotoxicity. The parameters to the diagnosis of acute rejection were sensitivity: 71.8%, specificity: 87.3%, positive predictive value: 50.9%, negative predictive value: 94.9% and accuracy 84.9%. The false positive results were mainly related to cytomegalovirus infection or to the administration of OKT3. In 10 out of 11 false negative results incipient immunoactivation was present alerting to the possibility of acute rejection. Kidney aspiration cytology is a useful tool for the sequential monitorization of acute rejection in renal transplant patients. The best results are reached when the results of aspiration cytology are analyzed with the clinical data.
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Candida in saliva of Brazilian hemophilic patients.
Pereira, Claudio Maranhão; Pires, Fábio Ramôa; Corrêa, Maria Elvira Pizzigatti; di Hipólito Júnior, Osvaldo; Almeida, Oslei Paes de
2004-12-01
Hemophilia is a common hereditary hemorrhagic disorder, however little is known about the oral microflora of hemophilic patients. The aim of this study was to quantify the Candida and identify its species in non-stimulated saliva of hemophilic patients, and consider its relationship with clinical factors influencing Candida carriage. This study comprised evaluation of 86 hemophilic patients of the Hematology Center/UNICAMP and 43 healthy subjects as controls. All patients were submitted to anamnesis, intraoral examination and unstimulated saliva collection. Candida counts and species identification were performed in salivary samples. Candida was present in 64% of the hemophilic patients and in 44% of the healthy controls. C. albicans represented 65% and 68% of the isolated species, in hemophiliacs and control group respectively, and C. tropicalis was the second most common species in both groups. These results indicate that hemophilic patients carry Candida more frequently and in higher counts than healthy controls, independently of oral clinical parameter considered, as viral infections, complete dentures, transfusions of hemoderivatives, and salivary flow.
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Spatial and temporal trends of bat-borne rabies in Chile.
Escobar, L E; Restif, O; Yung, V; Favi, M; Pons, D J; Medina-Vogel, G
2015-05-01
In Chile, while dog rabies has decreased markedly over the last 30 years, bat rabies is still reported frequently. In order to shed new light on the spatiotemporal trends of these reports, we analysed active and passive data from years 1985 and 2012, which included 61 076 samples from 289 counties of Chile. We found that from 1994 to 2012, more than 15 000 bat samples were submitted for diagnostics through passive surveillance, 9·5% of which tested positive for rabies. By contrast, the prevalence of infection was only ~0·4% among the nearly 12 000 bat samples submitted through active surveillance. We found that the prevalence of dog rabies dropped steadily over the same period, with just a single confirmed case since 1998. None of the 928 samples from wild animals, other than bats, were positive for rabies. Although there has been only one confirmed case of human rabies in Chile since 1985, and a single confirmed case in a dog since 1998, bats remain a reservoir for rabies viruses. While active surveillance indicates that rabies prevalence is low in bat colonies, the high proportion of positive bats submitted through passive surveillance is a concern. To prevent human rabies, local public health agencies should increase research on the basic ecology of bats and the role of stray dogs and cats as potential rabies amplifiers.
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Miller, David S; Weiser, Glen C; Ward, Alton C S; Drew, Mark L; Chapman, Phillip L
2011-06-02
A retrospective study of Pasteurellaceae isolated from domestic sheep (Ovis aries) was conducted. The aim was to identify Pasteurellaceae present in animals that were clinically healthy and others with evidence of respiratory disease. The bacteria had been isolated from samples submitted to the University of Idaho Caine Veterinary Teaching Center as part of disease diagnostic testing. The 844 isolates identified mainly three species of Pasteurellaceae: Mannheimia haemolytica, Pasteurella multocida, and Pasteurella (Bibersteinia) trehalosi. A total of 114 biovariants were identified among these three species. Individual biovariants were identified 1-180 times. Two of those (M. haemolytica 1 and P. (B.) trehalosi 2) constituted 36% of the isolates, and were the only biovariants sufficiently numerous to account for >7% of the total isolates. Samples were primarily submitted from sheep with signs of respiratory disease. Eighty percent of biovariants were identified most often in animals with signs of respiratory disease, but 26% of biovariants were isolated from both sheep with respiratory disease and apparently healthy sheep. P. multocida constituted 4.7% of isolates, and were exclusively associated with animals with respiratory disease. The ability of isolates to produce beta-hemolysis on culture media was not associated with animals with respiratory disease (odds ratio 0.77, 95% CI 0.50-1.19). The inference of this study is limited due to the retrospective study design. However, it is the first study that provides an extensive baseline list of biovariants associated with respiratory disease in domestic sheep. Copyright © 2011 Elsevier B.V. All rights reserved.
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42 CFR 405.2470 - Reports and maintenance of records.
Code of Federal Regulations, 2013 CFR
2013-10-01
... initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for..., including the allowable costs actually incurred for the period and the actual number of visits for rural... estimated costs and visits for rural health clinic services or Federally qualified health center services...
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42 CFR 405.2470 - Reports and maintenance of records.
Code of Federal Regulations, 2011 CFR
2011-10-01
... initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for..., including the allowable costs actually incurred for the period and the actual number of visits for rural... estimated costs and visits for rural health clinic services or Federally qualified health center services...
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42 CFR 405.2470 - Reports and maintenance of records.
Code of Federal Regulations, 2012 CFR
2012-10-01
... initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for..., including the allowable costs actually incurred for the period and the actual number of visits for rural... estimated costs and visits for rural health clinic services or Federally qualified health center services...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to... in this notice finalizes the draft guidance of the same title dated September 2009. DATES: Submit...), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-15
...] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for... devices intended for the treatment of atrial fibrillation. DATES: Submit either electronic or written... Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation'' to the Division of...
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Hydrogen Safety Project: Chemical analysis support task. Window ``E`` analyses
DOE Office of Scientific and Technical Information (OSTI.GOV)
Jones, T E; Campbell, J A; Hoppe, E W
1992-09-01
Core samples taken from tank 101-SY at Hanford during ``window E`` were analyzed for organic and radiochemical constituents by staff of the Analytical Chemistry Laboratory at Pacific Northwest Laboratory. Westinghouse Hanford company submitted these samples to the laboratory.
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The Sampling Issues in Quantitative Research
ERIC Educational Resources Information Center
Delice, Ali
2010-01-01
A concern for generalization dominates quantitative research. For generalizability and repeatability, identification of sample size is essential. The present study investigates 90 qualitative master's theses submitted for the Primary and Secondary School Science and Mathematics Education Departments, Mathematic Education Discipline in 10…
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de Abreu E Silva, Mariana À; Salum, Fernanda G; Figueiredo, Maria A; Lopes, Tiago G; da Silva, Vinicius D; Cherubini, Karen
2013-03-01
This study aimed to analyze the oral lesions of chronic paracoccidioidomycosis concerning their histomorphometric, immunohistochemical, and clinical features in a standardized sample. Fifty biopsy specimens of oral lesions of chronic paracoccidioidomycosis were submitted to hematoxylin and eosin (H&E), Grocott-Gomori and immunohistochemical staining. Data regarding disease duration and size and number of oral lesions, as well as erythrocytes, leukocytes, lymphocytes, hematocrit, hemoglobin, and erythrocyte sedimentation rate, were collected from medical charts. Granuloma density and number and diameter of buds and fungal cells, and IL-2, TNF-alpha and IFN-gamma expression, as well as clinical and hematological features, were quantified and correlated. Bud diameter was significantly greater in intermediate density granulomas compared to higher density granulomas. The other variables (number of buds, number and diameter of fungi, expression of IL-2, TNF-alpha and IFN-gamma, and clinical and hematological features) did not significantly change with the density of granulomas. There was a positive correlation between bud number and fungal cell number (r = 0.834), bud diameter and fungal cell diameter (r = 0.496), erythrocytes and number of fungi (r = 0.420), erythrocytes and bud number (r = 0.408), and leukocytes and bud number (r = 0.396). Negative correlation occurred between number and diameter of fungi (r = -0.419), bud diameter and granuloma density (r = -0.367), TNF-alpha expression and number of fungi (r = -0.372), and TNF-alpha expression and bud number (r = -0.300). The histological, immunological, and clinical features of oral lesions evaluated did not differ significantly between patients in our sample of chronic paracoccidioidomycosis. TNF-alpha levels were inversely correlated with intensity of infection. © 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.
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Incorrect diagnosis of Clostridium difficile infection in a university hospital in Japan.
Mori, Nobuaki; Yoshizawa, Sadako; Saga, Tomoo; Ishii, Yoshikazu; Murakami, Hinako; Iwata, Morihiro; Collins, Deirdre A; Riley, Thomas V; Tateda, Kazuhiro
2015-10-01
Physicians often fail to suspect Clostridium difficile infection (CDI) and many microbiology laboratories use suboptimal diagnostic techniques. To estimate the extent of and reasons for incorrect diagnosis of CDI in Japan, we investigated toxigenic C. difficile isolated from all stool culture samples and clinical course. Over a 12-month period in 2010, all stool culture samples (n = 975) submitted from inpatients in a university hospital in Japan were cultured for C. difficile and routine microbiological testing was conducted. In total, 177 C. difficile isolates were recovered, and 127 isolates were toxigenic. Among the toxin-A-positive/toxin-B-positive isolates, 12 were also positive for the binary toxin gene. However, clinically important ribotypes, such as 027 and 078, were not identified. A total of 58 (45.7%) cases with toxigenic C. difficile had unformed stool, and the incidence CDI was 1.6 cases per 10,000 patient-days. Of these 58 cases, 40 were not diagnosed in routine testing due to a lack of clinical suspicion (24.1%, 14/58) or a negative C. difficile toxin assay result (44.8%, 26/58). A stool toxin assay was performed in 54 patients (78.2%, 54/69) who did not have unformed stool. The present study demonstrated that a significant number of CDI cases in Japan might be overlooked or misdiagnosed in clinical practice due to a lack of clinical suspicion and limitations of microbiological testing for CDI in Japan. Providing education to promote awareness of CDI among physicians is important to improve the accuracy of diagnosis in Japan. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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Patterns of preventive practice in New Brunswick
Battista, Renaldo N.; Palmer, Cynthia S.; Marchand, Beatrice M.; Spitzer, Walter O.
1985-01-01
A survey of active general practitioners was conducted in New Brunswick to ascertain their patterns of preventive practice with respect to cancer of four anatomic sites: the breast, the cervix, the colon and rectum, and the lung. Ninety-two percent of the physicians reported that they taught breast self-examination to their female patients, 98% that they performed breast examinations, 98% that they did Papanicolaou smears routinely, and 97% that they provided counselling against smoking. Few of the physicians reported that they submitted women aged 50 to 59 years to annual mammography (3%) or examined stool samples from asymptomatic patients over 44 years of age for occult blood (20%). Many (77%) said they still routinely performed chest roentgenography for early detection of lung cancer; an estimated 49% of the physicians said they performed cytologic screening of sputum samples for the same purpose. Preventive practices, when used, were usually carried out during major encounters with patients, such as general check-ups. The potential for prevention through this clinically based approach is still largely unrealized. PMID:3986725
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-27
... for Dogs Treated With SLENTROL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... on the sample collection plan for dogs treated with the drug SLENTROL. DATES: Submit either... technology. Sample Collection Plan for Dogs Treated With SLENTROL--21 CFR 514.80 (OMB Control Number 0910-NEW...
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NASA Astrophysics Data System (ADS)
Abrunhosa, Viviane M.; Mermelstein, Claudia S.; Costa, Manoel L.; Costa-Felix, Rodrigo P. B.
2011-02-01
Therapeutic ultrasound has been used in physiotherapy to accelerate tissue healing. Although the ultrasonic wave is widely used in clinical practice, not much is known about the biological effects of ultrasound on cells and tissues. This study aims to evaluate the biological response of ultrasound in primary cultures of chick myogenic cells. To ensure the metrological reliability of whole measurement process, the ultrasound equipment was calibrated in accordance with IEC 61689:2007. The skeletal muscle cells were divided in four samples. One sample was used as a control group and the others were submitted to different time and intensity and operation mode of ultrasound: 1) 0.5 W/cm2 continuous for 5 minutes, 2) 0.5 W/cm2 pulsed for 5 minutes, 3) 1.0 W/cm2 pulsed for 10 minutes. The samples were analyzed with phase contrast optical microscopy before and after the treatment. The results showed alignment of myogenic cells in the sample treated with 0.5 W/cm2 continuous during 5 minutes when compared with the control group and the other samples. This study is a first step towards a metrological and scientific based protocol to cells and tissues treatment under different ultrasound field exposures.
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Automated diagnostic kiosk for diagnosing diseases
Regan, John Frederick; Birch, James Michael
2014-02-11
An automated and autonomous diagnostic apparatus that is capable of dispensing collection vials and collections kits to users interesting in collecting a biological sample and submitting their collected sample contained within a collection vial into the apparatus for automated diagnostic services. The user communicates with the apparatus through a touch-screen monitor. A user is able to enter personnel information into the apparatus including medical history, insurance information, co-payment, and answer a series of questions regarding their illness, which is used to determine the assay most likely to yield a positive result. Remotely-located physicians can communicate with users of the apparatus using video tele-medicine and request specific assays to be performed. The apparatus archives submitted samples for additional testing. Users may receive their assay results electronically. Users may allow the uploading of their diagnoses into a central databank for disease surveillance purposes.
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Integrative Lifecourse and Genetic Analysis of Military Working Dogs
2013-10-01
Working Dogs 5b. GRANT NUMBER W81XWH-11-2-0226 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Dr. Kun Huang 5d. PROJECT NUMBER 5e. TASK...we submitted final revisions on our IACUC protocol for the collection of biological samples and Lackland veterinary approval was granted ; and...final Lackland AFB oversight approval was granted and those documents were submitted to DoD CDMRP grant administration. Currently, there is one final
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Cox, Marsha E.; DiNello, Robert K.; Geisberg, Mark; Abbott, April; Roberts, Pacita L.; Hooton, Thomas M.
2015-01-01
Urinary tract infections (UTIs) are frequently encountered in clinical practice and most commonly caused by Escherichia coli and other Gram-negative uropathogens. We tested RapidBac, a rapid immunoassay for bacteriuria developed by Silver Lake Research Corporation (SLRC), compared with standard bacterial culture using 966 clean-catch urine specimens submitted to a clinical microbiology laboratory in an urban academic medical center. RapidBac was performed in accordance with instructions, providing a positive or negative result in 20 min. RapidBac identified as positive 245/285 (sensitivity 86%) samples with significant bacteriuria, defined as the presence of a Gram-negative uropathogen or Staphylococcus saprophyticus at ≥103 CFU/ml. The sensitivities for Gram-negative bacteriuria at ≥104 CFU/ml and ≥105 CFU/ml were 96% and 99%, respectively. The specificity of the test, detecting the absence of significant bacteriuria, was 94%. The sensitivity and specificity of RapidBac were similar on samples from inpatient and outpatient settings, from male and female patients, and across age groups from 18 to 89 years old, although specificity was higher in men (100%) compared with that in women (92%). The RapidBac test for bacteriuria may be effective as an aid in the point-of-care diagnosis of UTIs especially in emergency and primary care settings. PMID:26063858
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Stark, D; Al-Qassab, S E; Barratt, J L N; Stanley, K; Roberts, T; Marriott, D; Harkness, J; Ellis, J T
2011-01-01
The aim of this study was to describe the first development and evaluation of a multiplex tandem PCR (MT-PCR) assay for the detection and identification of 4 common pathogenic protozoan parasites, Cryptosporidium spp., Dientamoeba fragilis, Entamoeba histolytica, and Giardia intestinalis, from human clinical samples. A total of 472 fecal samples submitted to the Department of Microbiology at St. Vincent's Hospital were included in the study. The MT-PCR assay was compared to four real-time PCR (RT-PCR) assays and microscopy by a traditional modified iron hematoxylin stain. The MT-PCR detected 28 G. intestinalis, 26 D. fragilis, 11 E. histolytica, and 9 Cryptosporidium sp. isolates. Detection and identification of the fecal protozoa by MT-PCR demonstrated 100% correlation with the RT-PCR results, and compared to RT-PCR, MT-PCR exhibited 100% sensitivity and specificity, while traditional microscopy of stained fixed fecal smears exhibited sensitivities and specificities of 56% and 100% for Cryptosporidium spp., 38% and 99% for D. fragilis, 47% and 97% for E. histolytica, and 50% and 100% for G. intestinalis. No cross-reactivity was detected in 100 stool samples containing various other bacterial, viral, and protozoan species. The MT-PCR assay was able to provide rapid, sensitive, and specific simultaneous detection and identification of the four most important diarrhea-causing protozoan parasites that infect humans. This study also highlights the lack of sensitivity demonstrated by microscopy, and thus, molecular methods such as MT-PCR must be considered the diagnostic methods of choice for enteric protozoan parasites.
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Levy, J K; Crawford, P Cynda; Tucker, S J
2017-03-01
More than 3 million cats in the United States are infected with FeLV or FIV. The cornerstone of control is identification and segregation of infected cats. To compare test performance with well-characterized clinical samples of currently available FeLV antigen/FIV antibody combination test kits. Surplus serum and plasma from diagnostic samples submitted by animal shelters, diagnostic laboratories, veterinary clinics, and cat research colonies. None of the cats had been vaccinated against FIV. The final sample set included 146 FeLV+, 154 FeLV-, 94 FIV+, and 97 FIV- samples. Prospective, blind comparison to a gold standard: Samples were evaluated in 4 different point-of-care tests by ELISA antigen plate tests (FeLV) and virus isolation (FIV) as the reference standards. All test results were visually read by 2 blinded observers. Sensitivity and specificity, respectively, for FeLV were SNAP ® (100%/100%), WITNESS ® (89.0%/95.5%), Anigen ® (91.8%/95.5%), and VetScan ® (85.6%/85.7%). Sensitivity and specificity for FIV were SNAP ® (97.9%/99.0%), WITNESS ® (94.7%/100%), Anigen ® (96.8%/99.0%), and VetScan ® (91.5%/99.0%). The SNAP ® test had the best performance for FeLV, but there were no significant differences for FIV. In typical cat populations with seroprevalence of 1-5%, a majority of positive results reported by most point-of-care test devices would be false-positives. This could result in unnecessary segregation or even euthanasia. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
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Tank 40 Final Sludge Batch 8 Chemical Characterization Results
DOE Office of Scientific and Technical Information (OSTI.GOV)
Bannochie, Christopher J.
2013-09-19
A sample of Sludge Batch 8 (SB8) was pulled from Tank 40 in order to obtain radionuclide inventory analyses necessary for compliance with the Waste Acceptance Product Specifications (WAPS). The SB8 WAPS sample was also analyzed for chemical composition, including noble metals, and fissile constituents, and these results are reported here. These analyses along with the WAPS radionuclide analyses will help define the composition of the sludge in Tank 40 that is currently being fed to the Defense Waste Processing Facility (DWPF) as SB8. At SRNL, the 3-L Tank 40 SB8 sample was transferred from the shipping container into amore » 4-L high density polyethylene bottle and solids were allowed to settle. Supernate was then siphoned off and circulated through the shipping container to complete the transfer of the sample. Following thorough mixing of the 3-L sample, a 553 g sub-sample was removed. This sub-sample was then utilized for all subsequent slurry sample preparations. Eight separate aliquots of the slurry were digested, four with HNO{sub 3}/HCl (aqua regia) in sealed Teflon(r) vessels and four with NaOH/Na{sub 2}O{sub 2} (alkali or peroxide fusion) using Zr crucibles. Two Analytical Reference Glass - 1 (ARG-1) standards were digested along with a blank for each preparation. Each aqua regia digestion and blank was diluted to 1:100 mL with deionized water and submitted to Analytical Development (AD) for inductively coupled plasma - atomic emission spectroscopy (ICP-AES) analysis, inductively coupled plasma - mass spectrometry (ICP-MS) analysis, atomic absorption spectroscopy (AA) for As and Se, and cold vapor atomic absorption spectroscopy (CV-AA) for Hg. Equivalent dilutions of the alkali fusion digestions and blank were submitted to AD for ICP-AES analysis. Tank 40 SB8 supernate was collected from a mixed slurry sample in the SRNL Shielded Cells and submitted to AD for ICP-AES, ion chromatography (IC), total base/free OH-/other base, total inorganic carbon/total organic carbon (TIC/TOC) analyses. Weighted dilutions of slurry were submitted for IC, TIC/TOC, and total base/free OH-/other base analyses. Activities for U-233, U-235, and Pu-239 were determined from the ICP-MS data for the aqua regia digestions of the Tank 40 WAPS slurry using the specific activity of each isotope. The Pu-241 value was determined from a Pu-238/-241 method developed by SRNL AD and previously described.« less
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Tank 40 final sludge batch 9 chemical and fissile radionuclide characterization results
DOE Office of Scientific and Technical Information (OSTI.GOV)
Bannochie, C. J.; Kubilius, W. P.; Pareizs, J. M.
A sample of Sludge Batch (SB) 9 was pulled from Tank 40 in order to obtain radionuclide inventory analyses necessary for compliance with the Waste Acceptance Product Specifications (WAPS)i. The SB9 WAPS sample was also analyzed for chemical composition, including noble metals, and fissile constituents, and these results are reported here. These analyses along with the WAPS radionuclide analyses will help define the composition of the sludge in Tank 40 that is fed to the Defense Waste Processing Facility (DWPF) as SB9. At the Savannah River National Laboratory (SRNL), the 3-L Tank 40 SB9 sample was transferred from the shippingmore » container into a 4-L high density polyethylene bottle and solids were allowed to settle. Supernate was then siphoned off and circulated through the shipping container to complete the transfer of the sample. Following thorough mixing of the 3-L sample, a 547 g sub-sample was removed. This sub-sample was then utilized for all subsequent slurry sample preparations. Eight separate aliquots of the slurry were digested, four with HNO3/HCl (aqua regiaii) in sealed Teflon® vessels and four with NaOH/Na2O2 (alkali or peroxide fusioniii) using Zr crucibles. Three Analytical Reference Glass – 1iv (ARG-1) standards were digested along with a blank for each preparation. Each aqua regia digestion and blank was diluted to 1:100 with deionized water and submitted to Analytical Development (AD) for inductively coupled plasma – atomic emission spectroscopy (ICP-AES) analysis, inductively coupled plasma – mass spectrometry (ICP-MS) analysis, atomic absorption spectroscopy (AA) for As and Se, and cold vapor atomic absorption spectroscopy (CV-AA) for Hg. Equivalent dilutions of the alkali fusion digestions and blank were submitted to AD for ICP-AES analysis. Tank 40 SB9 supernate was collected from a mixed slurry sample in the SRNL Shielded Cells and submitted to AD for ICP-AES, ion chromatography (IC), total base/free OH-/other base, total inorganic carbon/total organic carbon (TIC/TOC) analyses. Weighted dilutions of slurry were submitted for IC, TIC/TOC, and total base/free OH-/other base analyses. Activities for U-233, U-235, and Pu-239 were determined from the ICP-MS data for the aqua regia digestions of the SB9 WAPS slurry using the specific activity of each isotope. The Pu-241 value was determined from a Pu-238/-241 method developed by SRNL AD and previously described.v« less
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Prevalence and risk factors for hyperthyroidism in Irish cats from the greater Dublin area.
Bree, Laura; Gallagher, Barbara A; Shiel, Robert E; Mooney, Carmel T
2018-01-01
Hyperthyroidism is common in older cats. Prevalence varies geographically, but is anecdotally considered low in Ireland. The aim of this study was to document prevalence of hyperthyroidism in older cats in the greater Dublin area of Ireland and to assess environmental and clinical associations for development and identification of the disease. Primary-care veterinary practices were requested to select cats aged 10 years or older where blood sampling was being performed for health screening or clinical investigations. Surplus serum/plasma samples were submitted to University College Dublin Diagnostic Endocrine Laboratory for total thyroxine (T 4 ) measurement. Cats were classified as hyperthyroid, equivocal or euthyroid based on a total T 4 concentration (reference interval, 15-60 nmol/L), of >60 nmol/L, 30-60 nmol/L or <30 nmol/L, respectively. Simultaneous free T 4 or repeat (after 4-6 weeks) total T 4 measurement was recommended in all equivocal cases. Animals receiving treatment for hyperthyroidism were excluded. A questionnaire completed by the client and veterinarian detailing historical and physical information was also required. Associations between categorical variables were analysed by Chi-square or Fisher's exact test and odds ratio (OR) calculated. A P value of <0.05 was considered statistically significant. Samples were submitted from 507 cats including 107 (21.1%) hyperthyroid, 54 (10.6%) equivocal and 346 (68.2%) euthyroid. The presence of goitre ( P < 0.0001), tachypnoea ( P = 0.0378), tachycardia ( P = 0.002), polyphagia ( P = 0.0003) and weight loss ( P < 0.0001) were significantly associated with hyperthyroidism. Cats with goitre were more likely to be diagnosed as hyperthyroid [OR 2.85, (95% CI 1.75-4.62] compared to those without. However, goitre was only palpated in 40 of 102 (39.2%) hyperthyroid cats. Increasing age was the only significant ( P < 0.002) risk factor for development of hyperthyroidism. A relationship between hyperthyroidism and sex, breed, lifestyle, parasite control, vaccination status or feeding habits was not identified. Hyperthyroidism is not uncommon in Irish cats. Age was the only significant risk factor for its development. The high proportion of hyperthyroid cats without palpable goitre (> 60%) may reflect failure to detect goitre and account for the perceived low prevalence of this condition in Ireland.
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Paasinen-Sohns, Aino; Koelzer, Viktor H; Frank, Angela; Schafroth, Julian; Gisler, Aline; Sachs, Melanie; Graber, Anne; Rothschild, Sacha I; Wicki, Andreas; Cathomas, Gieri; Mertz, Kirsten D
2017-03-01
Companion diagnostics rely on genomic testing of molecular alterations to enable effective cancer treatment. Here we report the clinical application and validation of the Oncomine Focus Assay (OFA), an integrated, commercially available next-generation sequencing (NGS) assay for the rapid and simultaneous detection of single nucleotide variants, short insertions and deletions, copy number variations, and gene rearrangements in 52 cancer genes with therapeutic relevance. Two independent patient cohorts were investigated to define the workflow, turnaround times, feasibility, and reliability of OFA targeted sequencing in clinical application and using archival material. Cohort I consisted of 59 diagnostic clinical samples from the daily routine submitted for molecular testing over a 4-month time period. Cohort II consisted of 39 archival melanoma samples that were up to 15years old. Libraries were prepared from isolated nucleic acids and sequenced on the Ion Torrent PGM sequencer. Sequencing datasets were analyzed using the Ion Reporter software. Genomic alterations were identified and validated by orthogonal conventional assays including pyrosequencing and immunohistochemistry. Sequencing results of both cohorts, including archival formalin-fixed, paraffin-embedded material stored up to 15years, were consistent with published variant frequencies. A concordance of 100% between established assays and OFA targeted NGS was observed. The OFA workflow enabled a turnaround of 3½ days. Taken together, OFA was found to be a convenient tool for fast, reliable, broadly applicable and cost-effective targeted NGS of tumor samples in routine diagnostics. Thus, OFA has strong potential to become an important asset for precision oncology. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
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Chemoreceptor Tumors Diagnosed at the Western College of Veterinary Medicine 1967-1979
Yates, W. D. G.; Lester, S. J.; Mills, J. H. L.
1980-01-01
Twenty-nine chemoreceptor tumors submitted to the Western College of Veterinary Medicine, Saskatoon, Saskatchewan between 1967 and 1979 were compared with those previously reported. The prevalence was low, with 28 cases occurring in dogs while only one was diagnosed in a cat. Old male dogs and the Boxer, Boston bull terrier and Collie breeds were affected most commonly. The prevalence in Collies (five of 28 dogs) was unexpected but may have been coincidental in this size of sample. The chemoreceptor tumor was often of clinical significance because in two-thirds of the cases it was either the presenting complaint or considered at necropsy to have caused illness or death. ImagesFigure 1.Figure 2.Figure 3.Figure 4.Figure 5.Figure 6.Figure 7. PMID:6249479
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Effect of Xerostomia on the Functional Capacity of Subjects with Rheumatoid Arthritis.
Lins E Silva, Marília; Carvalho, Camila Nunes; Carvalho, Alessandra de Albuquerque Tavares; Leão, Jair Carneiro; Duarte, Angela Luzia Pinto; Gueiros, Luiz Alcino
2016-10-01
To evaluate the intensity of xerostomia and hyposalivation in subjects with rheumatoid arthritis (RA) as well as the effects of these conditions on functional incapacity and disease activity. The study sample comprised 236 individuals of both sexes who had RA. All the individuals were submitted to clinical evaluation and unstimulated sialometry. Functional capacity was determined by using the Health Assessment Questionnaire (HAQ), xerostomia was assessed using the Xerostomia Inventory, and disease activity was evaluated with the 28-joint Disease Activity Score (DAS28). The effect of Sjögren syndrome (SS) was analyzed, and the sample was divided into 2 groups: RA (191 subjects) and RA/SS (45 subjects). The Xerostomia Inventory showed positive and significant correlation with fatigue (r = 0.243; p < 0.0001), number of painful joints (r = 0.218; p = 0.001), HAQ (r = 0.279; p < 0.0001), and DAS28 (r = 0.156; p < 0.0001). On regression analysis, both xerostomia (OR 3.89, 95% CI 1.84-8.23, p < 0.001) and DAS28 (for severe disease activity: OR 13.26, 95% CI 3.15-55.79, p < 0.001) showed influence on functional incapacity. Forty-five individuals (19.1%) presented with secondary SS, and having this diagnosis was not associated with disease activity or functional capacity. Xerostomia demonstrated an adverse effect on quality of life of subjects with RA, being associated with a reduction in functional capacity. In this clinical setting, xerostomia can be monitored as a marker of worse clinical evolution.
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Ethics review of health research on human participants in South Africa.
van Wyk, Christa
2010-06-01
In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-29
... risk-based approach to the oversight of clinical investigations. It does not create or confer any... a range of approaches to monitoring. FDA currently has OMB approval for the information collection... Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or...
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Raising suspicions with the Food and Drug Administration: detecting misconduct.
Hamrell, Michael R
2010-12-01
The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.
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7 CFR 28.910 - Classification of samples and issuance of classification data.
Code of Federal Regulations, 2010 CFR
2010-01-01
... classification data. 28.910 Section 28.910 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY... of classification data. (a)(1) The samples submitted as provided in the subpart shall be classified...
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D'Angelino, Rubens Henrique Ramos; Pituco, Edviges Maristela; Villalobos, Eliana Monteforte Cassaro; Harakava, Ricardo; Gregori, Fábio
2013-01-01
Bovine leukemia virus (BLV) was investigated in the central nervous system (CNS) of cattle with neurological syndrome. A total of 269 CNS samples were submitted to nested-PCR (BLV env gene gp51), and the viral genotypes were identified. The nested-PCR was positive in 4.8% (13/269) CNS samples, with 2.7% (2/74) presenting at histological examination lesions of nonpurulent meningoencephalitis (NPME), whereas 5.6% (11/195) not presenting NPME (P > 0.05). No samples presented lymphosarcoma. The PCR products (437 bp) were sequenced and submitted to phylogenetic analysis by neighbor-joining and maximum composite likelihood methods, and genotypes 1, 5, and 6 were detected, corroborating other South American studies. The genotype 6 barely described in Brazil and Argentina was more frequently detected in this study. The identity matrices showed maximum similarity (100%) among some samples of this study and one from Argentina (FJ808582), recovered from GenBank. There was no association among the genotypes and NPME lesions. PMID:23710448
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Salgado, Miguel; Otto, Barbara; Moroni, Manuel; Sandoval, Errol; Reinhardt, German; Boqvist, Sofia; Encina, Carolina; Muñoz-Zanzi, Claudia
2015-03-18
Although Leptospira isolation has been reported in Chilean cattle, only serological evidence of serovar Hardjo bovis infection has been routinely reported. The present report provides characterization of the pathological presentation and etiology of a clinical case of leptospirosis in a calf from the Los Rios Region in Chile. In a dairy herd in southern Chile, 11 of 130 calves died after presenting signs such as depression and red-tinged urine. One of these calves, a female of eight months, was necropsied, and all the pathological findings were consistent with Leptospira infection. A urine sample was submitted to conventional bacteriological analysis together with highly specific molecular biology typing tools, in order to unravel the specific Leptospira specie and serovar associated with this clinical case. A significant finding of this study was that the obtained isolate was confirmed by PCR as L. interrogans, its VNTR profile properly matching with L. interrogans Hardjoprajitno as well as its specific genomic identity revealed by secY gen. Leptospira interrogans serovar Hardjoprajitno was associated with the investigated calf clinical case. This information adds to the value of serologic results commonly reported, which encourage vaccination improvements to match circulating strains. In addition, this finding represents the first case report of this serovar in Chilean cattle.
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de Souza, Elaine Waite; Borba, Cintia de Moraes; Pereira, Sandro Antonio; Gremião, Isabella Dib Ferreira; Langohr, Ingeborg Maria; Oliveira, Manoel Marques Evangelista; de Oliveira, Raquel de Vasconcellos Carvalhaes; da Cunha, Camila Rocha; Zancopé-Oliveira, Rosely Maria; de Miranda, Luisa Helena Monteiro; Menezes, Rodrigo Caldas
2018-06-13
Zoonotic sporotrichosis caused by the fungus Sporothrix brasiliensis is usually severe in cats. This study investigated the associations between clinical features, fungal load, coinfections, histological skin changes, and response to itraconazole in cats with sporotrichosis caused by S. brasiliensis. Fifty-two cats with skin lesions and a definitive diagnosis of sporotrichosis were treated with itraconazole for a maximum period of 36 weeks. The animals were submitted to clinical examination and two subsequent collections of samples from the same skin lesion for fungal diagnosis and histopathology, as well as serology for feline immunodeficiency (FIV) and leukaemia (FeLV) viruses. Thirty-seven (71%) cats were clinically cured. Nasal mucosa lesions and respiratory signs were associated with treatment failure. Cats coinfected with FIV/FeLV (n = 12) had a lower neutrophil count in the lesion. A high fungal load in skin lesions was linked to young age and treatment failure, as well as to a longer time of wound healing, poorly formed granulomas and fewer neutrophils, macrophages and lymphocytes in these lesions. These results indicate that itraconazole is effective, but nasal mucosal involvement, respiratory signs and high fungal loads in skin lesions are predictors of treatment failure that will assist in the development of better treatment protocols for cats.
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Cunha, Joanna Farias; Gomes, Carolina Cavalieri; de Mesquita, Ricardo Alves; Andrade Goulart, Eugênio Marcos; de Castro, Wagner Henriques; Gomez, Ricardo Santiago
2016-06-01
The aim of this study was to evaluate the influence of clinical, radiographic, surgical and histopathologic parameters in the recurrence of disease in a series of odontogenic keratocysts (OKCs). The sample comprised 24 sporadic OKC lesions from 24 patients. All patients had no previous treatment history and were treated by the same surgeon using a uniform treatment protocol (enucleation with peripheral ostectomy preceded or not preceded by decompression). Fourteen lesions (58.4%) were first submitted to decompression procedure. Eight patients (33%) developed recurrent lesions, with a mean follow-up time of 60.5 months (standard deviation [SD] = 31.3) and a mean disease-free interval for recurrent lesions of 19 months (SD = 4.9). Recurrence was significantly associated with poor clinical response to decompression (P = .027), remaining tooth with radiographic evidence of insinuation of the lesion between the dental roots (P = .009), and the presence of budding of the basal cells layer together with epithelial islands in the fibrous capsule (P = .019). Clinical, radiographic and histopathologic parameters may affect the relapse rate of OKCs and should individually guide treatment choice. Copyright © 2016 Elsevier Inc. All rights reserved.
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Semantic dementia Brazilian study of nineteen cases
Senaha, Mirna Lie Hosogi; Caramelli, Paulo; Porto, Claudia Sellitto; Nitrini, Ricardo
2007-01-01
The term semantic dementia was devised by Snowden et al. in 1989 and nowadays, the semantic dementia syndrome is recognized as one of the clinical forms of frontotemporal lobar degeneration (FTLD) and is characterized by a language semantic disturbance associated to non-verbal semantic memory impairment. Objectives The aim of this study was to describe a Brazilian sample of 19 semantic dementia cases, emphasizing the clinical characteristics important for differential diagnosis of this syndrome. Methods Nineteen cases with semantic dementia were evaluated between 1999 and 2007. All patients were submitted to neurological evaluation, neuroimaging exams and cognitive, language and semantic memory evaluation. Results All patients presented fluent spontaneous speech, preservation of syntactic and phonological aspects of the language, word-finding difficulty, semantic paraphasias, word comprehension impairment, low performance in visual confrontation naming tasks, impairment on tests of non-verbal semantic memory and preservation of autobiographical memory and visuospatial skills. Regarding radiological investigations, temporal lobe atrophy and/or hypoperfusion were found in all patients. Conclusions The cognitive, linguistic and of neuroimaging data in our case series corroborate other studies showing that semantic dementia constitutes a syndrome with well defined clinical characteristics associated to temporal lobe atrophy. PMID:29213413
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2017-03-21
FINAL REPORT Project Title: Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial...Center ATTN: DTIC-OA 8725 John J. Kingman Rd Fort Belvoir, VA 22060-6218 Submitted by: Jill M. Clark, MBA/HCM, CCRP, CCRC Senior Research ...Associate/ Research Manager Clinical Investigation Program Mike O’Callaghan Federal Medical Center (MOFMC) 4700 Las Vegas Blvd North, Bldg 1300, Room
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Paediatric investigation plans for pain: painfully slow!
Davies, Elin H; Ollivier, Cecile M; Saint Raymond, Agnes
2010-11-01
To examine the early impact of the Paediatric Regulation, which entered into force in Europe on 27 January 2007, on the development of pharmaceutical drugs in the therapeutic field of pain submitted to the Paediatric Committee (PDCO) and to the European Medicines Agency (EMA). Paediatric Investigations Plans (PIPs) submitted with a Decision (outcome) reached between September 2007 and March 2010 were included in the analysis. Of the 17 Paediatric Investigation Plans submitted, 14 have resulted in an EMA Decision, 3 were withdrawn by the applicants, 8 were granted a full waiver from development, and 1 resulted in a negative opinion. Decisions as issued included 15 clinical trials, with at least 1,282 children to be recruited into studies across five different products. Neonates were included in four of the products. The small number of submissions indicates a lack of new drugs being developed for the management of pain. Ethical concerns that too many vulnerable children will be recruited into clinical trials must be balanced against limiting the number of off-label prescribing and obtaining age-appropriate information on paediatric use. Now is an opportune time for clinicians, academics, learned societies and industry to collaborate for the benefit of children in pain.
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Gill, Ritu R; Naidich, David P; Mitchell, Alan; Ginsberg, Michelle; Erasmus, Jeremy; Armato, Samuel G; Straus, Christopher; Katz, Sharyn; Patios, Demetrois; Richards, William G; Rusch, Valerie W
2016-08-01
Clinical tumor (T), node, and metastasis staging is based on a qualitative assessment of features defining T descriptors and has been found to be suboptimal for predicting the prognosis of patients with malignant pleural mesothelioma (MPM). Previous work suggests that volumetric computed tomography (VolCT) is prognostic and, if found practical and reproducible, could improve clinical MPM classification. Six North American institutions electronically submitted clinical, pathologic, and imaging data on patients with stages I to IV MPM to an established multicenter database and biostatistical center. Two reference radiologists blinded to clinical data independently reviewed the scans; calculated clinical T, node, and metastasis stage by standard criteria; performed semiautomated tumor volume calculations using commercially available software; and submitted the findings to the biostatistical center. Study end points included the feasibility of a multi-institutional VolCT network, concordance of independent VolCT assessments, and association of VolCT with pathological T classification. Of 164 submitted cases, 129 were evaluated by both reference radiologists. Discordant clinical staging of most cases confirmed the inadequacy of current criteria. The overall correlation between VolCT estimates was good (Spearman correlation 0.822), but some were significantly discordant. Root cause analysis of the most discordant estimates identified four common sources of variability. Despite these limitations, median tumor volume estimates were similar within subgroups of cases representing each pathological T descriptor and increased monotonically for each reference radiologist with increasing pathological T status. The good correlation between VolCT estimates obtained for most cases reviewed by two independent radiologists and qualitative association of VolCT with pathological T status combine to encourage further study. The identified sources of user error will inform design of a follow-up prospective trial to more formally assess interobserver variability of VolCT and its potential contribution to clinical MPM staging. Copyright © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
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Alexander, C L; Shankland, G S; Carman, W; Williams, C
2011-05-01
Dermatophytes are the major cause of superficial mycoses in samples submitted to Clinical Mycology, Glasgow. The most prevalent species is Trichophyton rubrum as identified classically by microscopy and culture. Recent advances in polymerase chain reaction (PCR) technology were examined for the feasibility of introducing a T. rubrum real-time PCR assay into a routine diagnostic service. To improve the diagnostic mycology service by the introduction of a real-time PCR test for T. rubrum. The DNA from 4972 nail and skin samples was obtained using the Qiagen QIAsymphony automated extractor. This DNA was subjected to real-time PCR using T. rubrum-specific primers and a probe. During phase 1 of the study, 862 samples were analysed; 446 of 470 specimens that grew T. rubrum were detected by PCR. Out of 4110 samples analysed during phase 2, 753 T. rubrum infections were diagnosed and reported within 72 h. A total of 3357 samples were negative for a fungal infection by PCR and microscopy; these were also reported within 72 h. A vast reduction in the turnaround times can be achieved using this technique as opposed to classical methods. Samples which are PCR negative but microscopy positive are still subjected to culture. Screening samples for their suitability for PCR prior to processing eliminates the application of PCR for T. rubrum on inappropriate samples such those from the scalp or pityriasis versicolor. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-06
..., alpha plus beta measurements, smear sampling, and soil sampling activities. As a result of the...-Agency Radiation Survey and Site Investigation Manual.'' The U of AZ submitted a revised FSS Plan on... and that the [[Page 13377
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Riley, Matthew C; Wilkes, Rebecca P
2015-12-18
Recent outbreaks of canine distemper have prompted examination of strains from clinical samples submitted to the University of Tennessee College of Veterinary Medicine (UTCVM) Clinical Virology Lab. We previously described a new strain of CDV that significantly diverged from all genotypes reported to date including America 2, the genotype proposed to be the main lineage currently circulating in the US. The aim of this study was to determine when this new strain appeared and how widespread it is in animal populations, given that it has also been detected in fully vaccinated adult dogs. Additionally, we sequenced complete viral genomes to characterize the strain and determine if variation is confined to known variable regions of the genome or if the changes are also present in more conserved regions. Archived clinical samples were genotyped using real-time RT-PCR amplification and sequencing. The genomes of two unrelated viruses from a dog and fox each from a different state were sequenced and aligned with previously published genomes. Phylogenetic analysis was performed using coding, non-coding and genome-length sequences. Virus neutralization assays were used to evaluate potential antigenic differences between this strain and a vaccine strain and mixed ANOVA test was used to compare the titers. Genotyping revealed this strain first appeared in 2011 and was detected in dogs from multiple states in the Southeast region of the United States. It was the main strain detected among the clinical samples that were typed from 2011-2013, including wildlife submissions. Genome sequencing demonstrated that it is highly conserved within a new lineage and preliminary serologic testing showed significant differences in neutralizing antibody titers between this strain and the strain commonly used in vaccines. This new strain represents an emerging CDV in domestic dogs in the US, may be associated with a stable reservoir in the wildlife population, and could facilitate vaccine escape.
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Jeffers, Adam B; Saghir, Amina; Camacho, Marc
2012-06-01
The purpose of this study is to describe a system for formally reporting second-opinion interpretations of CT imaging exams accompanying patients transferred emergently to a tertiary care center. Second-opinion interpretations of cross-sectional imaging exams rendered in the emergency department setting over 6 months spanning 22 September 2009 to 22 March 2010 were reviewed and tallied by two radiologists and a research assistant, with a focus on professional fee reimbursement rates. A more in depth review was performed of those exams for which a clinical referral request form was available, detailing such information as the clinical history, content and source of available initial interpretation, and congruity of the initial interpretation with clinical data. Discrepancies between outside and second-opinion interpretations were also assessed. This quality assurance exercise was reviewed by our institutional review board, which waived formal informed consent. Formal second-opinion interpretation was rendered for 370 exams on 198 patients (mean age, 53.5 years; 45.1% female), received from 50 referring facilities. Head CT was the most common imaging exam referred for second opinion. Forty-one of 370 exams (11%) were submitted for self-pay, and 43 (12%) were written off as free care. The remaining 286 exams (77%) were submitted for reimbursement of the professional fee only. Ultimately, of the 286 exams submitted, 260 (91%) were reimbursed for professional fees, 199 (70%) on the initial submission. Of 29 health plans contracted with our facility, 22 ultimately approved all claims made. Three plans denied all claims submitted. The largest payer was Medicare, which reimbursed 88 of 90 submitted claims. Clinical intake forms were available for 184 exams on 107 patients (mean age, 52.7 years, 43.0% female). Trauma was the most common indication, or history, provided (55% of 184 exams, 40% of 107 patients). An outside report of some form was available for 112 of the 184 exams (61%), although only 18 were formal, signed radiology reports from the referring facility. Discrepancies between available outside reports and second-opinion interpretations were noted for 17 out of 112 exams. Need for reimaging was substantially curtailed, with only ten exams repeated within 24 h. A formal process for issuing second-opinion interpretations of cross-sectional exams performed at outside institutions is feasible in the emergency department setting. In the majority of cases, reimbursement for full professional fees can be obtained.
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The phylogeography of rabies in Grenada, West Indies, and implications for control.
Zieger, Ulrike; Marston, Denise A; Sharma, Ravindra; Chikweto, Alfred; Tiwari, Keshaw; Sayyid, Muzzamil; Louison, Bowen; Goharriz, Hooman; Voller, Katja; Breed, Andrew C; Werling, Dirk; Fooks, Anthony R; Horton, Daniel L
2014-10-01
In Grenada, West Indies, rabies is endemic, and is thought to be maintained in a wildlife host, the small Indian mongoose (Herpestes auropunctatus) with occasional spillover into other hosts. Therefore, the present study was undertaken to improve understanding of rabies epidemiology in Grenada and to inform rabies control policy. Mongooses were trapped island-wide between April 2011 and March 2013 and examined for the presence of Rabies virus (RABV) antigen using the direct fluorescent antibody test (dFAT) and PCR, and for serum neutralizing antibodies (SNA) using the fluorescent antibody virus neutralization test (FAVN). An additional cohort of brain samples from clinical rabies suspects submitted between April 2011 and March 2014 were also investigated for the presence of virus. Two of the 171 (1.7%) live-trapped mongooses were RABV positive by FAT and PCR, and 20 (11.7%) had SNAs. Rabies was diagnosed in 31 of the submitted animals with suspicious clinical signs: 16 mongooses, 12 dogs, 2 cats and 1 goat. Our investigation has revealed that rabies infection spread from the northeast to the southwest of Grenada within the study period. Phylogenetic analysis revealed that the viruses from Grenada formed a monophyletic clade within the cosmopolitan lineage with a common ancestor predicted to have occurred recently (6-23 years ago), and are distinct from those found in Cuba and Puerto Rico, where mongoose rabies is also endemic. These data suggest that it is likely that this specific strain of RABV was imported from European regions rather than the Americas. These data contribute essential information for any potential rabies control program in Grenada and demonstrate the importance of a sound evidence base for planning interventions.
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The Phylogeography of Rabies in Grenada, West Indies, and Implications for Control
Zieger, Ulrike; Marston, Denise A.; Sharma, Ravindra; Chikweto, Alfred; Tiwari, Keshaw; Sayyid, Muzzamil; Louison, Bowen; Goharriz, Hooman; Voller, Katja; Breed, Andrew C.; Werling, Dirk; Fooks, Anthony R.; Horton, Daniel L.
2014-01-01
In Grenada, West Indies, rabies is endemic, and is thought to be maintained in a wildlife host, the small Indian mongoose (Herpestes auropunctatus) with occasional spillover into other hosts. Therefore, the present study was undertaken to improve understanding of rabies epidemiology in Grenada and to inform rabies control policy. Mongooses were trapped island-wide between April 2011 and March 2013 and examined for the presence of Rabies virus (RABV) antigen using the direct fluorescent antibody test (dFAT) and PCR, and for serum neutralizing antibodies (SNA) using the fluorescent antibody virus neutralization test (FAVN). An additional cohort of brain samples from clinical rabies suspects submitted between April 2011 and March 2014 were also investigated for the presence of virus. Two of the 171 (1.7%) live-trapped mongooses were RABV positive by FAT and PCR, and 20 (11.7%) had SNAs. Rabies was diagnosed in 31 of the submitted animals with suspicious clinical signs: 16 mongooses, 12 dogs, 2 cats and 1 goat. Our investigation has revealed that rabies infection spread from the northeast to the southwest of Grenada within the study period. Phylogenetic analysis revealed that the viruses from Grenada formed a monophyletic clade within the cosmopolitan lineage with a common ancestor predicted to have occurred recently (6–23 years ago), and are distinct from those found in Cuba and Puerto Rico, where mongoose rabies is also endemic. These data suggest that it is likely that this specific strain of RABV was imported from European regions rather than the Americas. These data contribute essential information for any potential rabies control program in Grenada and demonstrate the importance of a sound evidence base for planning interventions. PMID:25330178
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Anderson, Chelsea E; Haulena, Martin; Zabek, Erin; Habing, Gregory; Raverty, Stephen
2015-06-01
Between 1998 and 2008, 15 cases of segmental to diffuse hemorrhagic to necrohemorrhagic enterocolitis were diagnosed in neonatal and weaned juvenile harbor seals (Phoca vitulina) presented from the Vancouver Aquarium Marine Mammal Rescue Centre for rehabilitation. Based on a combination of gross pathology, histopathology, bacterial isolation, and toxin testing, Clostridium difficile enterocolitis was diagnosed. Most pups were anorexic or inappetant and died acutely with few other premonitory signs. Due to ongoing clinical concerns and possible emergence of this pathogen at the facility, efforts to better characterize the disease and understand the epidemiology of C. difficile was initiated in 95 harbor seal pups presented for rehabilitation in a single stranding season. Fecal samples were collected on admission, following completion of antibiotic treatment, and also prerelease or postmortem. All samples were collected fresh and submitted either directly or stored frozen. Fecal samples were inoculated into selective media for culture and screened by enzyme-linked immunosorbant assay (ELISA) for C. difficile toxins A, B, or both. Results of the 95 seals in the study were as follows: on hospital admit 72 seals were sampled, 10 were culture positive, 12 were ELISA positive; following antibiotic therapy 46 seals were sampled noting three culture positive and nine ELISA positive; prior to release 58 seals were sampled noting zero culture positive and one ELISA positive; and on postmortem exam seven seals were sampled noting zero culture positive and two ELISA positive. Clostridium difficile was not deemed to be the cause of death in any of the animals. Although the exact mechanism of disease is unknown, this study suggests that C. difficile infection is not a significant cause of mortality and may be part of the normal flora in harbor seals undergoing rehabilitation. Morbidity and mortality from this bacterium can likely be minimized by judicious use of antibiotics, effective biosecurity-biocontainment protocols, and clean husbandry practices.
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Tiwari, Sapana; Kumar, Ashu; Mangalgi, Smita; Rathod, Vedika; Prakash, Archana; Barua, Anita; Arora, Sonia; Sathyaseelan, Kannusamy
2013-01-01
Brucellosis is an important zoonotic infectious disease of humans and livestock with worldwide distribution and is caused by bacteria of the genus Brucella. The diagnosis of brucellosis always requires laboratory confirmation by either isolation of pathogens or detection of specific antibodies. The conventional serological tests available for the diagnosis of brucellosis are less specific and show cross-reactivity with other closely related organisms. These tests also necessitate the handling of Brucella species for antigen preparation. Therefore, there is a need to develop reliable, rapid, and user-friendly systems for disease diagnosis and alternatives to vaccine approaches. Keeping in mind the importance of brucellosis as an emerging infection and the prevalence in India, we carried out the present study to compare the recombinant antigens with the native antigens (cell envelope and sonicated antigen) of Brucella for diagnosis of human brucellosis by an indirect plate enzyme-linked immunosorbent assay (ELISA). Recombinant outer membrane protein 28 (rOmp28) and rOmp31 antigens were cloned, expressed, and purified in the bacterial expression system, and the purified proteins were used as antigens. Indirect plate ELISAs were then performed and standardized for comparison of the reactivities of recombinant and native antigens against the 433 clinical samples submitted for brucellosis testing, 15 culture-positive samples, and 20 healthy donor samples. The samples were separated into four groups based on their positivity to rose bengal plate agglutination tests (RBPTs), standard tube agglutination tests (STATs), and 2-mercaptoethanol (2ME) tests. The sensitivities and specificities of all the antigens were calculated, and the rOmp28 antigen was found to be more suitable for the clinical diagnosis of brucellosis than the rOmp31 antigen and native antigens. The rOmp28-based ELISA showed a very high degree of agreement with the conventional agglutination tests and promising results for further use in clinical screening and serodiagnosis of human brucellosis. PMID:23761658
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Monif, G R; Carson, H J
1998-01-01
OBJECTIVE: In vitro, Candida albicans has demonstrated the ability to inhibit replication of selected bacteria. Little information exists on the impact of C. albicans on the vaginal bacterial flora in vivo. The purpose of this study is to identify the coexisting bacterial flora when C. albicans is isolated from vaginal cultures submitted to a hospital-based testing facility for reasons other than vulvovaginitis. METHODOLOGY: All specimens (240) received from ambulatory care clinics over a six-month period were cultured for aerobic and anaerobic bacteria and Candida species. Those specimens submitted for cervicitis, vaginitis, or vaginal discharge and those from which yeasts other than C. albicans were isolated were eliminated. To control for sample biases, a subgroup composed of all pregnant women for whom cultures were done as screening procedures was similarly studied. Chi-square analyses, comparing the prevalence of individual bacteria isolated with and without the presence of C. albicans, were done for all study populations using SPSS for Windows software (1994). RESULTS: Two hundred and forty consecutive specimens were bacteriologically analyzed. Of the 220 vaginal samples used in the study, C. albicans was isolated in 44 instances (20%). Neither the presence of the lactobacilli nor the presence of Gardnerella vaginalis markedly influenced the isolation rate of C. albicans. The group B streptococci had a greater probability of coisolation when C. albicans was present (27.3% verses 16%), but this was not statistically significant (P < 0.8). Dissociation between the presence of C. albicans and the coisolation of Peptostreptococcus species and anaerobic gram-positive cocci and/or bacilli was noted (P < 0.0819), while the incidence of gram-positive aerobic bacilli was reduced in the presence of C. albicans (30/176 [17.1%] versus 6/44 [13.6%]), this reduced incidence was not statistically significant. Isolation data of the subgroup of pregnant women supported these observations. CONCLUSION: Within the limitations of the study, statistically, the data suggests that an inverse relationship exists between the presence of C. albicans and recovery of Peptostreptococcus and anaerobic gram-positive cocci and bacilli. PMID:9702585
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Monif, G R; Carson, H J
1998-01-01
In vitro, Candida albicans has demonstrated the ability to inhibit replication of selected bacteria. Little information exists on the impact of C. albicans on the vaginal bacterial flora in vivo. The purpose of this study is to identify the coexisting bacterial flora when C. albicans is isolated from vaginal cultures submitted to a hospital-based testing facility for reasons other than vulvovaginitis. All specimens (240) received from ambulatory care clinics over a six-month period were cultured for aerobic and anaerobic bacteria and Candida species. Those specimens submitted for cervicitis, vaginitis, or vaginal discharge and those from which yeasts other than C. albicans were isolated were eliminated. To control for sample biases, a subgroup composed of all pregnant women for whom cultures were done as screening procedures was similarly studied. Chi-square analyses, comparing the prevalence of individual bacteria isolated with and without the presence of C. albicans, were done for all study populations using SPSS for Windows software (1994). Two hundred and forty consecutive specimens were bacteriologically analyzed. Of the 220 vaginal samples used in the study, C. albicans was isolated in 44 instances (20%). Neither the presence of the lactobacilli nor the presence of Gardnerella vaginalis markedly influenced the isolation rate of C. albicans. The group B streptococci had a greater probability of coisolation when C. albicans was present (27.3% verses 16%), but this was not statistically significant (P < 0.8). Dissociation between the presence of C. albicans and the coisolation of Peptostreptococcus species and anaerobic gram-positive cocci and/or bacilli was noted (P < 0.0819), while the incidence of gram-positive aerobic bacilli was reduced in the presence of C. albicans (30/176 [17.1%] versus 6/44 [13.6%]), this reduced incidence was not statistically significant. Isolation data of the subgroup of pregnant women supported these observations. Within the limitations of the study, statistically, the data suggests that an inverse relationship exists between the presence of C. albicans and recovery of Peptostreptococcus and anaerobic gram-positive cocci and bacilli.
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2015-10-13
attack, status epilepticus , and other clinical scenarios. Interservice/Industry Training, Simulation, and Education Conference (I/ITSEC) 2015 2015...volume: year; page numbers; status of publication (published; accepted, awaiting publication; submitted, under review; other); acknowledgement of...collection, if applicable; bibliographic information; year; type of publication (e.g., book, thesis or dissertation); status of publication (published
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Garrett, David J; Saunders, Alexia L; McGowan, Ceara; Specks, Joscha; Ganesan, Kumaravelu; Meffin, Hamish; Williams, Richard A; Nayagam, David A X
2016-01-01
Recently, there has been interest in investigating diamond as a material for use in biomedical implants. Diamond can be rendered electrically conducting by doping with boron or nitrogen. This has led to inclusion of boron doped and nitrogen included diamond elements as electrodes and/or feedthroughs for medical implants. As these conductive device elements are not encapsulated, there is a need to establish their clinical safety for use in implants. This article compares the biocompatibility of electrically conducting boron doped diamond (BDD) and nitrogen included diamond films and electrically insulating poly crystalline diamond films against a silicone negative control and a BDD sample treated with stannous octoate as a positive control. Samples were surgically implanted into the back muscle of a guinea pig for a period of 4-15 weeks, excised and the implant site sectioned and submitted for histological analysis. All forms of diamond exhibited a similar or lower thickness of fibrotic tissue encapsulating compared to the silicone negative control samples. All forms of diamond exhibited similar or lower levels of acute, chronic inflammatory, and foreign body responses compared to the silicone negative control indicating that the materials are well tolerated in vivo. © 2015 Wiley Periodicals, Inc.
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de Almeida, Marília Viana Albuquerque; Cangussú, Ítalo Mendes; de Carvalho, Antonia Leonadia Siqueira; Brito, Izabelly Linhares Ponte; Costa, Renata Albuquerque
2017-01-01
ABSTRACT The present study aims to detect the production of extended-spectrum beta-lactamases (ESBL) by enterobacteria isolated from samples of fresh shrimp and fish obtained from the retail trade of the city of Sobral, Ceará State, Brazil. All bacterial isolates were submitted to identification and antimicrobial susceptibility testing using aminopenicillin, beta-lactamase inhibitors, carbapenem, 1st, 2nd, 3rd and 4th generation cephalosporins, and monobactam. Three types of beta-lactamases - ESBL, AmpC and KPC - were investigated. 103 strains were identified, and the most frequent species in shrimp and fish samples was Enterobacter cloacae (n = 54). All the strains were resistant to penicillin and more than 50% of the isolates were resistant to ampicillin and cephalothin. Resistance to three 3rd generation cephalosporins (cefotaxime, ceftriaxone and ceftazidime) and one fourth generation cephalosporin (cefepime) was detected in two isolates of E. cloacae from shrimp samples. Phenotypic detection of AmpC was confirmed in seven strains. The ESBL was detected in two strains of E. cloacae from shrimp samples. No strain showed KPC production. These data can be considered alarming, since food (shrimp and fish) may be carriers of enterobacteria resistant to drugs of clinical interest. PMID:29116290
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Diarrheagenic pathogens in adults attending a hospital in Singapore.
Chau, Man Ling; Hartantyo, Sri Harminda Pahm; Yap, Min; Kang, Joanne Su Lin; Aung, Kyaw Thu; Gutiérrez, Ramona Alikiiteaga; Ng, Lee Ching; Tam, Clarence C; Barkham, Timothy
2016-01-28
Singapore's diarrhoeal notification system is based on specific pathogens. Official data may thus be skewed towards notifiable diseases. Limited information is available on the profiles of aetiological agents responsible for acute gastroenteritis (AGE) cases, especially among the adult population. To understand the frequency and distribution of potential causative agents of diarrheal disease in Singapore, we screened adults' stool samples collected from a large public hospital. The stool samples were screened for 18 diarrheagenic pathogens using a combination of commercial multiplex polymerase chain reaction (PCR), in-house singleplex PCR and immunochromatographic assays. One hundred adult faecal samples that were collected from October 2013 to January 2014 for routine diagnostic purposes and submitted for culture at Tan Tock Seng Hospital, Singapore were used. Pathogens were detected in 32% of the samples. The predominant organisms encountered were norovirus genogroup II (11%), Aeromonas spp. (9%) and Campylobacter spp. (5%). One sample was positive for both verocytotoxigenic E. coli (VTEC) and E. coli O157:H7. Two other samples were positive for VTEC only, and one other sample was positive for E. coli O157:H7 only. Astrovirus, C. perfringens, Shigella spp. and toxigenic C. difficile were each detected in 2% of the samples. Cryptosporidium parvum, Giardia lamblia, group A rotavirus, Salmonella spp. and Vibrio spp. were each detected in 1% of the samples. No L. monocytogenes, Y. enterocolitica, enteric adenovirus, or norovirus genogroup I were detected. Our preliminary findings suggest that pathogens causing non-notifiable diseases might have contributed considerably to the adult hospitalised AGE cases. However, as the samples were from an adult hospital, the data obtained may not be representative of the whole community. Thus, a larger study to collect clinical samples and risk exposure data from primary healthcare clinics and children hospital is planned for, to gain a more holistic perspective on the epidemiology of AGE in Singapore. A larger study may also offer valuable insights for improving the approach of microbiological surveillance of food, as well as strategizing inspection efforts along the food supply chain by public health authorities.
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76 FR 28786 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-18
.... The sample size is based on recommendations related to qualitative interview methods and the research... than 10 employees (CPWR, 2007), and this establishment size experiences the highest fatality rate... out occupational safety and health training. This interview will be administered to a sample of...
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76 FR 62044 - Alternative Testing Requirements for Small Batch Manufacturers
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-06
... every manufacturer of a children's product that is subject to a children's product safety rule shall submit sufficient samples of the children's product, or samples that are identical in all material... compliance with such children's product safety rule. Further, section 14(i)(2) requires continued testing of...
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77 FR 27135 - HACCP Systems Validation
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-09
.... Comments may be submitted by either of the following methods: Federal eRulemaking Portal: This Web site... those CCPs and the method of monitoring of them and provides certificates of analysis that specify the sampling method that the supplier uses and the results of that sampling. The receiving establishment should...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Samples. 24.82 Section 24.82 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE... vinegar and salted wine as defined in § 24.215, the proprietor shall submit under separate cover at the...
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75 FR 26185 - Notice of Funds Availability; Inviting Applications for the Quality Samples Program
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-11
... the U.S. commodity (e.g., because of improper specification, blending, formulation, sanitary, or... of QSP reimbursement as these projects require smaller samples. Financial assistance will be made... Strategy (UES) application Internet Web site. The UES allows applicants to submit a single consolidated and...
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21 CFR 600.13 - Retention samples.
Code of Federal Regulations, 2011 CFR
2011-04-01
... specific products required to be submitted to the Center for Biologics Evaluation and Research or the... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Retention samples. 600.13 Section 600.13 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS...
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21 CFR 600.13 - Retention samples.
Code of Federal Regulations, 2010 CFR
2010-04-01
... specific products required to be submitted to the Center for Biologics Evaluation and Research or the... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Retention samples. 600.13 Section 600.13 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS...
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OCCURRENCE AND SIGNIFICANCE OF TETRAVALENT LEAD IN NEW ENGLAND
USEPA analyses of lead service line specimens throughout the United States have found evidence of substantial tetravalent lead (Pb+4 in the form of PbO2 solids) in one or more samples from over 25% of systems who have submitted pipe samples. The most “newsworthy” instance of the ...
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42 CFR 426.417 - Contractor's statement regarding new evidence.
Code of Federal Regulations, 2010 CFR
2010-10-01
... evidence submitted with an amended complaint; (3) New evidence produced during discovery; (4) New evidence produced when the ALJ consults with scientific and clinical experts; and (5) New evidence presented during...
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42 CFR 426.417 - Contractor's statement regarding new evidence.
Code of Federal Regulations, 2012 CFR
2012-10-01
... complaint; (2) New evidence submitted with an amended complaint; (3) New evidence produced during discovery; (4) New evidence produced when the ALJ consults with scientific and clinical experts; and (5) New...
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42 CFR 426.417 - Contractor's statement regarding new evidence.
Code of Federal Regulations, 2013 CFR
2013-10-01
... complaint; (2) New evidence submitted with an amended complaint; (3) New evidence produced during discovery; (4) New evidence produced when the ALJ consults with scientific and clinical experts; and (5) New...
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42 CFR 426.417 - Contractor's statement regarding new evidence.
Code of Federal Regulations, 2014 CFR
2014-10-01
... complaint; (2) New evidence submitted with an amended complaint; (3) New evidence produced during discovery; (4) New evidence produced when the ALJ consults with scientific and clinical experts; and (5) New...
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42 CFR 426.417 - Contractor's statement regarding new evidence.
Code of Federal Regulations, 2011 CFR
2011-10-01
... evidence submitted with an amended complaint; (3) New evidence produced during discovery; (4) New evidence produced when the ALJ consults with scientific and clinical experts; and (5) New evidence presented during...
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[Natural infection by hemoparasites in calves submitted to chemoprophylaxis at 30 days of age].
da Silva, Rosângela A; Corrêa, Fabíola do N; Botteon, Rita de Cássia C M; Botteon, Paulo de Tarso L
2007-01-01
The tick-borne disease (TBD) brings great damages to cattle breeding. The most important etiologic agents are Babesia bigemina, B. bovis and Anaplasma marginale, being the tick Boophilus microplus the main vector. This work reports the occurrence of natural infection by hemoparasites of TBD in 36 calves with high ticks natural infestation submitted to chemoprophylaxis with 30 days year-old. The blood smears from animals of different ages were analized and were found B. bigemina (33.3%), B. bovis (11.1%) and A. marginale (13.9%). Six animals had clinical symptoms (16.7%) and one dead (2.8%). The number of clinical cases ocurred in consequence of an association of factors as high infestation of ticks and low passive immunity in period that calves had not developed enough active immunity.
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Vieira, Paula Ferreiro; Garcia, Paula Dalsoglio; Bregagnollo, Edson Antonio; Carvalho, Fábio Cardoso; Kochi, Ana Cláudia; Martins, Antonio Sérgio; Caramori, Jaqueline Costa Teixeira; Franco, Roberto Jorge da Silva; Barretti, Pasqual; Martin, Luis Cuadrado
2007-05-01
Interventional treatment of coronary insufficiency is underemployed among dialysis patients. Studies confirming its efficacy in this set of patients are scarce. To assess the results of interventional treatment of coronary artery disease in patients undergoing dialysis. A total of 34 dialysis patients submitted to coronary angiography between September 1995 and October 2004 were divided according to presence or absence of coronary lesion, type of treatment and presence or absence of diabetes mellitus. The groups were compared according to their clinical and survival characteristics. Survival of patients undergoing interventional treatment was compared to overall survival of 146 dialysis patients at the institution in the same period. Interventional treatment was indicated to the same clinical conditions in the general population. Thirteen patients with no angiography coronary lesions presented a survival rate of 100% in 48 months as compared to 35% of 21 patients with coronary artery disease. Diabetic patients had a lower survival rate compared with non-diabetics. Angioplasty had a worse prognosis compared to surgery; however, 80% of patients undergoing angioplasty were diabetic. Seventeen patients submitted to interventional procedures presented a survival rate similar to that of the others 146 hemodialysis patients without clinical evidence of coronary disease. This small series shows that myocardial revascularization, whenever indicated, can be performed in dialysis patients. This conclusion is corroborated by similar mortality rates in two groups of patients: coronary patients submitted to revascularization and overall dialysis patients.
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Waggoner, Jesse J; Gresh, Lionel; Vargas, Maria Jose; Ballesteros, Gabriela; Tellez, Yolanda; Soda, K James; Sahoo, Malaya K; Nuñez, Andrea; Balmaseda, Angel; Harris, Eva; Pinsky, Benjamin A
2016-12-15
Zika virus (ZIKV), chikungunya virus (CHIKV), and dengue virus (DENV) cocirculate in Nicaragua. In this study, we sought to compare the quantified viremia and clinical presentation of patients infected with 1 or more of these viruses. Acute-phase serum samples from 346 patients with a suspected arboviral illness were tested using a multiplex real-time reverse-transcription polymerase chain reaction for ZIKV, CHIKV, and DENV. Viremia was quantitated for each detected virus, and clinical information from request forms submitted with each sample was recorded. A total of 263 patients tested positive for 1 or more viruses: 192 patients tested positive for a single virus (monoinfections) and 71 patients tested positive for 2 or all 3 viruses (coinfections). Quantifiable viremia was lower in ZIKV infections compared with CHIKV or DENV (mean 4.70 vs 6.42 and 5.84 log 10 copies/mL serum, respectively; P < .001 for both comparisons), and for each virus, mean viremia was significantly lower in coinfections than in monoinfections. Compared with patients with CHIKV or DENV, ZIKV patients were more likely to have a rash (P < .001) and less likely to be febrile (P < .05) or require hospitalization (P < .001). Among all patients, hospitalized cases had higher viremia than those who did not require hospitalization (7.1 vs 4.1 log10 copies/mL serum, respectively; P < .001). ZIKV, CHIKV, and DENV result in similar clinical presentations, and coinfections may be relatively common. Our findings illustrate the need for accurate, multiplex diagnostics for patient care and epidemiologic surveillance. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.
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Waggoner, Jesse J.; Gresh, Lionel; Vargas, Maria Jose; Ballesteros, Gabriela; Tellez, Yolanda; Soda, K. James; Sahoo, Malaya K.; Nuñez, Andrea; Balmaseda, Angel; Harris, Eva; Pinsky, Benjamin A.
2016-01-01
Background. Zika virus (ZIKV), chikungunya virus (CHIKV), and dengue virus (DENV) cocirculate in Nicaragua. In this study, we sought to compare the quantified viremia and clinical presentation of patients infected with 1 or more of these viruses. Methods. Acute-phase serum samples from 346 patients with a suspected arboviral illness were tested using a multiplex real-time reverse-transcription polymerase chain reaction for ZIKV, CHIKV, and DENV. Viremia was quantitated for each detected virus, and clinical information from request forms submitted with each sample was recorded. Results. A total of 263 patients tested positive for 1 or more viruses: 192 patients tested positive for a single virus (monoinfections) and 71 patients tested positive for 2 or all 3 viruses (coinfections). Quantifiable viremia was lower in ZIKV infections compared with CHIKV or DENV (mean 4.70 vs 6.42 and 5.84 log10 copies/mL serum, respectively; P < .001 for both comparisons), and for each virus, mean viremia was significantly lower in coinfections than in monoinfections. Compared with patients with CHIKV or DENV, ZIKV patients were more likely to have a rash (P < .001) and less likely to be febrile (P < .05) or require hospitalization (P < .001). Among all patients, hospitalized cases had higher viremia than those who did not require hospitalization (7.1 vs 4.1 log10 copies/mL serum, respectively; P < .001). Conclusions. ZIKV, CHIKV, and DENV result in similar clinical presentations, and coinfections may be relatively common. Our findings illustrate the need for accurate, multiplex diagnostics for patient care and epidemiologic surveillance. PMID:27578819
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Wissing, Michel D; Kluetz, Paul G; Ning, Yang-Min; Bull, Jonca; Merenda, Christine; Murgo, Anthony J; Pazdur, Richard
2014-10-01
US Food and Drug Administration (FDA) approval of new drugs depends on results from clinical trials that must be generalized to the US population. However, racial minorities are frequently under-represented in clinical studies. The enrollment of racial minorities was compared in key clinical studies submitted to the FDA in the last 10 years in support of potential marketing approval for prostate cancer (PCa) prevention or treatment. Patient demographic data were obtained from archival data sets of large registration trials submitted to the FDA to support proposed PCa indications. Six countries/regions were analyzed: the United States, Canada, Australia, Europe, the United Kingdom, and Eastern Europe. Background racial demographics were collected from national census data. Seventeen key PCa clinical trials were analyzed. These trials were conducted in the past 20 years, comprising 39,574 patients with known racial information. Most patients were enrolled in the United States, but there appeared to be a trend toward increased non-US enrollment over time. In all countries, racial minorities were generally under-represented. There was no significant improvement in racial minority enrollment over time. The United States enrolled the largest nonwhite population (7.1%). Over the past 20 years, racial minorities were consistently under-represented in key PCa trials. There is a need for effective measures that will improve enrollment of racial minorities. With increased global enrollment, drug developers should aim to recruit a patient population that resembles the racial demographics of the patient population to which drug use will be generalized upon approval. © 2014 American Cancer Society.
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2013-01-01
Background A number of problems involving the temporomandibular joint (TMJ) and associated structures can lead to temporomandibular disorder (TMD). The aim of the proposed study is to assess the effect of low-level laser therapy on occlusal contacts, mandibular movements, electromyography activity in the muscles of mastication and pain in adolescents with TMD. Methods/Design A randomized, controlled, double-blind, clinical trial will be carried out involving 85 male and female adolescents between 15 and 18 years of age. The research diagnostic criteria for TMD will be used to assess all individuals who agree to participate. All participants will be submitted to a clinical examination and electromyographic analysis of the masseter muscles and anterior bundle of the temporal muscles bilaterally, to determine TMD. Based on the clinical findings, the participants will be classified as having or not having TMD. Those with TMD will be divided into four groups, three of which will receive low-level laser therapy and one of which will receive a placebo treatment. The treatments will involve the TMJ region alone, the masseter and temporal muscles alone, or both these regions together. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher’s exact test will be used to determine associations among the categorical variables. The Student’s t test and analysis of variance will be used for the comparison of mean electromyographic signals. Pearson’s correlation coefficients will be calculated for the analysis of correlations among the continuous variables. Trial registration The protocol for this study has been submitted to Clinical Trials – registration number (NCT01846000). PMID:23876095
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Sedgwick, Monique; Kellett, Peter; Kalischuck, Ruth Grant
2014-03-01
Nursing programs across Canada have begun to implement at an unprecedented rate second-degree nursing programs in response to consumer demands and a nursing shortage. While these types of programs are enjoying considerable popularity among prospective students and employers, it is imperative that nursing programs assess their graduates' ability to meet Registered Nursing entry-to-practice competencies (ETCs). This study sought to determine if second-degree undergraduate nursing students achieved the entry-to-practice competencies established by the provincial regulatory body for registered nurses of Alberta, Canada. The study took place in southern Alberta, Canada as the first cohort of second-degree undergraduate nursing students were completing the final practice course for the program. In this exploratory study, quantitative and qualitative data generation approaches were used. Quantitative data were collected using the nursing program's standardized Clinical Evaluation Tool which is mapped to the 119 ETCs established by the regulatory body. Qualitative data were generated by conducting focus group interviews with students, faculty advisors, and preceptors. A convenience sample consisting of both male and female students (n=14) submitted their mid-term and final clinical evaluations for inclusion in the dataset. Thirteen preceptors submitted mid-term and final clinical evaluations. Three students, three faculty advisors, and two preceptors participated in focus group interviews. At mid-term, statistically significant differences were noted on 31% of the indicators within the clinical evaluation tool between students and preceptors with preceptors consistently ranking students higher than the students' ratings of their performance. Student and preceptor ratings of students' clinical performance were more consistent on the final evaluation. However, where there were differences, preceptors rated students higher than student ratings. Qualitative data analysis suggests that the concept of competence is complex and multifaceted and understood differently by students, preceptors, and advisors. The findings of this study suggest that there is ambiguity among second-degree students, preceptors and faculty advisors surrounding the concept of competence. In order to develop an understanding of competence, nursing program administrators must encourage faculty advisors, preceptors and students to engage in a discussion at the outset of the preceptored practice experience in regard to what is meant by competence within various practice setting. Further, we suggest nursing programs in collaboration with their clinical partners and re-examine their practice evaluation tools to determine the degree to which they are sensitive to the clinical practice context. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Passive tick surveillance, dog seropositivity, and incidence of human Lyme disease
Johnson, Jaree L.; Ginsberg, Howard S.; Zhioua, Elyes; Whitworth, Ulysses G.; Markowski, Daniel; Hyland, Kerwin E.; Hu, Renjie
2004-01-01
Data on nymphal Ixodes scapularis ticks submitted by the public to the University of Rhode Island Tick Research Laboratory for testing from 1991 to 2000 were compared with human case data from the Rhode Island Department of Health to determine the efficacy of passive tick surveillance at assessing human risk of Lyme disease. Numbers of ticks submitted were highly correlated with human cases by county (r = 0.998, n = 5 counties) and by town (r = 0.916, n = 37 towns), as were the numbers of positive ticks submitted (r = 0.989 by county, r = 0.787 by town). Human cases were correlated with ticks submitted by town each year, and with positive ticks in all but 2 years. Thus, passive tick surveillance effectively assessed geographical risk of human Lyme disease. In contrast, tick submissions through time were not correlated with human cases from year to year. Dog seropositivity was significantly correlated with human cases by county in both years tested, but by town in only one of two years. Numbers of ticks submitted were correlated with dog seropositivity by county but not by town, apparently because of high variability among towns with small sample sizes. Our results suggest that passive tick surveillance, using ticks submitted by the public for Lyme spirochete testing, can be used to assess the geographical distribution of Lyme disease risk, but cannot reliably predict Lyme incidence from year to year.
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Collection of biological samples in forensic toxicology.
Dinis-Oliveira, R J; Carvalho, F; Duarte, J A; Remião, F; Marques, A; Santos, A; Magalhães, T
2010-09-01
Forensic toxicology is the study and practice of the application of toxicology to the purposes of the law. The relevance of any finding is determined, in the first instance, by the nature and integrity of the specimen(s) submitted for analysis. This means that there are several specific challenges to select and collect specimens for ante-mortem and post-mortem toxicology investigation. Post-mortem specimens may be numerous and can endow some special difficulties compared to clinical specimens, namely those resulting from autolytic and putrefactive changes. Storage stability is also an important issue to be considered during the pre-analytic phase, since its consideration should facilitate the assessment of sample quality and the analytical result obtained from that sample. The knowledge on degradation mechanisms and methods to increase storage stability may enable the forensic toxicologist to circumvent possible difficulties. Therefore, advantages and limitations of specimen preservation procedures are thoroughfully discussed in this review. Presently, harmonized protocols for sampling in suspected intoxications would have obvious utility. In the present article an overview is given on sampling procedures for routinely collected specimens as well as on alternative specimens that may provide additional information on the route and timing of exposure to a specific xenobiotic. Last, but not least, a discussion on possible bias that can influence the interpretation of toxicological results is provided. This comprehensive review article is intented as a significant help for forensic toxicologists to accomplish their frequently overwhelming mission.
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Chen, Qixia; An, Jingna; Rao, Chenli; Wang, Tingting; Li, Dongdong; Feng, Shu; Tao, Chuanmin
2016-01-01
Syphilis is a major concern to global public health with increasing incidence. So its screening test should have sufficient sensitivity and specificity. We evaluated the performance of the Lumipulse G TP-N assay detection for syphilis screening and compared it with the InTec ELISA test kit for TP, which is widely used. Samples of several patient groups including 133 clinical and serologically characterized syphilitic sera, 175 samples containing potentially interfering agents, and 2290 unselected samples submitted for routine screening were detected by both the Lumipulse G TP-N assay and the InTec ELISA test kit for TP. Inconsistent samples were confirmed by RecomLine Treponema IgG, IgM immunoblot. Coefficient of variations of the Lumipulseo G TP-N assay at both levels were below 5% and of the InTec ELISA test kit for TP both over 5%. The sensitivity of the Lumipulse G TP-N assay and the InTec ELISA test kit for TP were 100% for all stages of syphilis. The two methods had consistent analytical specificity of 100% (95% CI: 97.21 - 100.00), while the clinical specificity was 100% (95% CI: 99.79 - 100.00) and 99.82% (95% CI: 99.51 - 99.94), respectively. Between them, Spearman's correlation coefficient was 0.455 and kappa value was 0.986. The overall sensitivity and specificity of the Lumipulse G TP-N assay was higher than the InTec ELISA test kit for TP (sensitivity: 100.0 versus 99.5, specificity: 100.0 versus 99.8). The automated Lumipulse G TP-N assay demonstrated excellent diagnostic sensitivity and specificity when evaluated as a screening test for syphilis. Thus, it can be an alternative to the treponemal screening test.
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Voltarelli, Daniele Cristina; de Alcântara, Brígida Kussumoto; Lunardi, Michele; Alfieri, Alice Fernandes; de Arruda Leme, Raquel; Alfieri, Amauri Alcindo
2018-01-01
Bacteria classified in Mycoplasma (M. bovis and M. bovigenitalium) and Ureaplasma (U. diversum) genera are associated with granular vulvovaginitis that affect heifers and cows at reproductive age. The traditional means for detection and speciation of mollicutes from clinical samples have been culture and serology. However, challenges experienced with these laboratory methods have hampered assessment of their impact in pathogenesis and epidemiology in cattle worldwide. The aim of this study was to develop a PCR strategy to detect and primarily discriminate between the main species of mollicutes associated with reproductive disorders of cattle in uncultured clinical samples. In order to amplify the 16S-23S rRNA internal transcribed spacer region of the genome, a consensual and species-specific nested-PCR assay was developed to identify and discriminate between main species of mollicutes. In addition, 31 vaginal swab samples from dairy and beef affected cows were investigated. This nested-PCR strategy was successfully employed in the diagnosis of single and mixed mollicute infections of diseased cows from cattle herds from Brazil. The developed system enabled the rapid and unambiguous identification of the main mollicute species known to be associated with this cattle reproductive disorder through differential amplification of partial fragments of the ITS region of mollicute genomes. The development of rapid and sensitive tools for mollicute detection and discrimination without the need for previous cultures or sequencing of PCR products is a high priority for accurate diagnosis in animal health. Therefore, the PCR strategy described herein may be helpful for diagnosis of this class of bacteria in genital swabs submitted to veterinary diagnostic laboratories, not demanding expertise in mycoplasma culture and identification. Copyright © 2017 Elsevier B.V. All rights reserved.
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Kohal, Ralf-Joachim; Finke, Hans Christian; Klaus, Gerold
2009-12-01
Zirconia oral implants are a new topic in implant dentistry. So far, no data are available on the biomechanical behavior of two-piece zirconia implants. Therefore, the purpose of this pilot investigation was to test in vitro the fracture strength of two-piece cylindrical zirconia implants after aging in a chewing simulator. This laboratory in vitro investigation comprised three different treatment groups. Each group consisted of 16 specimens. In group 1, two-piece zirconia implants were restored with zirconia crowns (zirconia copings veneered with Triceram; Esprident, Ispringen, Germany), and in group 2 zirconia implants received Empress 2 single crowns (Ivoclar Vivadent AG, Schaan, Liechtenstein). The implants, including the abutments, in the two zirconia groups were identical. In group 3, similar titanium implants were reconstructed with porcelain-fused-to-metal crowns. Eight samples of each group were submitted to artificial aging with a long-term load test in the artificial mouth (chewing simulator). Subsequently, all not artificially aged samples and all artificially aged samples that survived the long-term loading of each group were submitted to a fracture strength test in a universal testing machine. For the pairwise comparisons in the different test groups with or without artificial loading and between the different groups at a given artificial loading condition, the Wilcoxon rank-sum test for independent samples was used. The significance level was set at 5%. One sample of group 1 (veneer fracture), none of group 2, and six samples of group 3 (implant abutment screw fractures) failed while exposed to the artificial mouth. The values for the fracture strength after artificial loading with 1.2 million cycles for group 1 were between 45 and 377 N (mean: 275.7 N), in group 2 between 240 and 314 N (mean: 280.7 N), and in the titanium group between 45 and 582 N (mean: 165.7 N). The fracture strength results without artificial load for group 1 amounted to between 270 and 393 N (mean: 325.1 N), for group 2 between 235 and 321 N (mean: 281.8 N), and between 474 and 765 N (mean: 595.2 N) for the titanium group. The failure mode during the fracture testing in the zirconia implant groups was a fracture of the implant head and a bending/fracture of the abutment screw in the titanium group. Within the limits of this pilot investigation, the biomechanical stability of all tested prototype implant groups seems to be - compared with the possibly exerted occlusal forces - borderline for clinical use. A high number of failures occurred already during the artificial loading in the titanium group at the abutment screw level. The zirconia implant groups showed irreparable implant head fractures at relatively low fracture loads. Therefore, the clinical use of the presented prototype implants has to be questioned.
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Zhen-Yu, Wang; Li, Jiang; Yao-Guang, Zhang; Min, Zhu; Xiao-Ping, Zhang; Xiao-Jiang, Ma; Qian, Zhu; Yan-Yan, He; Shou-Fu, Jiang; Li, Cai
2017-02-27
To compare the application effects of three methods, namely microscopic examination, antigen detection (RDT) and nucleic acid test (PCR) in malaria detection between municipal and districts/counties centers for disease control and prevention in Shanghai, and analyze the malaria detection ability of the laboratories in Shanghai. The blood smears, whole blood samples, case review confirmation records and case data of malaria cases and suspected cases in Shanghai from 2012 to 2015 were collected by Shanghai Municipal Center for Disease Control and Prevention, and the detection results were analyzed and compared. A total of 212 samples with complete data were submitted by all districts (counties) in Shanghai from 2012 to 2015, the samples submitted by Jinshan Districts were the most (41.98%), and among the first diagnosis hospitals, those submitted by the tertiary hospitals were the most (82.07%). The submitted samples in the whole year were increased gradually from January to October. All the 212 samples were detected by three methods (the microscopic examination, RDT and PCR) in the laboratory of Shanghai Municipal Center for Disease Control and Prevention, and 167 were tested and confirmed comprehensively as positives, accounting for 78.77%, and 45 were confirmed as negatives, accounting for 21.23%. The samples were detected by the method of microscopy and domestic RDT in the laboratories of the centers for disease control and prevention at district/county level, totally 153 were tested as positives, accounting for 72.17%, 41 were unclassified, accounting for 19.34%, 53 were negative, accounting for 25.00%, and 6 were undetected, accounting for 2.83%. The coincidence of microscopic examination between the report hospitals and the centers for disease control and prevention at district/county level was 78.16%, and the coincidence between centers for disease control and prevention at district/county level and municipal level was 93.20%. The utilization rate of RDT in the laboratory of district/county level was 73.58%. The coincidence of RDT tests between those domestic and imported was 93.59%. Compared with the detection results by municipal center for disease control and prevention, 37 samples were misjudged by the laboratories of district/county level. Almost all (99.37%) of the confirmed malaria cases were imported overseas, including Africa (85.44%), Asia (13.92%) and America (0.63%). The surveillance after malaria elimination in Shanghai should be carried out by combining with different detection methods and resource integration.
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Andrade, Vera Lúcia Fonseca; Fernandes, Filipa Alexandra Veludo
2016-01-01
to describe strategies used by health professionals on the implementation of the Centers for Disease Control and Prevention guidelines for the prevention of urinary infection related to catheterism. systematic review on literature based on data from CINAHL(r), Nursing & Allied Health Collection, Cochrane Plus Collection, MedicLatina, MEDLINE(r), Academic Search Complete, ACS - American Chemical Society, Health Reference Center Academic, Nursing Reference Center, ScienceDirect Journals and Wiley Online Library. A sample of 13 articles was selected. studies have highlighted the decrease of urinary tract infection related to catheterism through reminder systems to decrease of people submitted to urinary catheterism, audits about nursing professionals practice and bundles expansion. the present review systemizes the knowledge of used strategies by health professionals on introduction to international recommendations, describing a rate decrease of such infection in clinical practice.
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Aghaeepour, Nima; Chattopadhyay, Pratip; Chikina, Maria; Dhaene, Tom; Van Gassen, Sofie; Kursa, Miron; Lambrecht, Bart N; Malek, Mehrnoush; McLachlan, G J; Qian, Yu; Qiu, Peng; Saeys, Yvan; Stanton, Rick; Tong, Dong; Vens, Celine; Walkowiak, Sławomir; Wang, Kui; Finak, Greg; Gottardo, Raphael; Mosmann, Tim; Nolan, Garry P; Scheuermann, Richard H; Brinkman, Ryan R
2016-01-01
The Flow Cytometry: Critical Assessment of Population Identification Methods (FlowCAP) challenges were established to compare the performance of computational methods for identifying cell populations in multidimensional flow cytometry data. Here we report the results of FlowCAP-IV where algorithms from seven different research groups predicted the time to progression to AIDS among a cohort of 384 HIV+ subjects, using antigen-stimulated peripheral blood mononuclear cell (PBMC) samples analyzed with a 14-color staining panel. Two approaches (FlowReMi.1 and flowDensity-flowType-RchyOptimyx) provided statistically significant predictive value in the blinded test set. Manual validation of submitted results indicated that unbiased analysis of single cell phenotypes could reveal unexpected cell types that correlated with outcomes of interest in high dimensional flow cytometry datasets. © 2015 International Society for Advancement of Cytometry.
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Bellino, Claudio; Arnaudo, Fabrizio; Biolatti, Cristina; Borrelli, Antonio; Gianella, Paola; Maurella, Cristiana; Zabaldano, Giuseppe; Cagnasso, Aurelio; D'Angelo, Antonio
2012-02-01
To develop a diagnostic diagram for rapid field assessment of acidosis severity in diarrheic calves. Prospective cross-sectional study. 148 Piedmontese calves (38 calves in preliminary experiments; 83 diarrheic calves and 27 healthy control calves in the primary experiment). Physical examination was performed and a standard data collection form was completed for each calf. Blood samples were obtained and submitted for evaluation of acid-base balance, performance of a CBC, and measurement of electrolyte and total protein concentrations. Severe metabolic acidosis (extracellular base excess more negative than -10 mmol/L) was associated with abnormal mental status, delayed or absent suckle reflex, abnormal posture or gait, enophthalmos, and cold oral mucosal membranes. Clinical signs associated with severe metabolic acidosis were arranged into a grid to create a diagnostic diagram. Sensitivity and specificity of the diagnostic diagram for the prediction of severe metabolic acidosis were 88% and 79%, respectively. Use of the diagnostic diagram may aid differentiation between severe and nonsevere acidosis patterns as determined on the basis of clinical signs.
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29 CFR 1952.246 - Changes to approved plans.
Code of Federal Regulations, 2010 CFR
2010-07-01
..., 1985. (2) The State submitted an industrial hygiene technical manual patterned after and responsive to... personal sampling, ex parte warrants, petition to modify abatement dates, withdrawal of contest...
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Lewy Body Dementia Association
... Services Local LBD Support Groups Caregiver Link Caregiving Materials Virtual Groups Caregiver Resources Related Organizations LBD stories submit a caregiver story forums Research Research News LBD: State of the Science Learn About Clinical Trials Participate in Research Funding ...
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Özbilgin, Ahmet; Harman, Mehmet; Karakuş, Mehmet; Bart, Aldert; Töz, Seray; Kurt, Özgür; Çavuş, İbrahim; Polat, Erdal; Gündüz, Cumhur; Van Gool, Tom; Özbel, Yusuf
2017-09-01
In Turkey, the main causative agents are Leishmania tropica (L. tropica) and Leishmania infantum (L. infantum) for cutaneous leishmaniasis (CL) and L. infantum for visceral leishmaniasis (VL). In this study, we investigated leishmaniasis cases caused by L. donovani and established animal models for understanding its tropism in in vivo conditions. Clinical samples (lesion aspirations and bone marrow) obtained from CL/VL patients were investigated using parasitological (smear/NNN) and DNA-based techniques. For species identification, a real time ITS1-PCR was performed using isolates and results were confirmed by hsp70 PCR-N/sequencing and cpb gene PCR/sequencing in order to reveal Leishmania donovani and Leishmania infantum discrimination. Clinical materials from CL and VL patients were also inoculated into two experimental groups (Group CL and Group VL) of Balb/C mice intraperitoneally for creating clinical picture of Turkish L. donovani strains. After 45days, the samples from visible sores of the skin were taken, and spleens and livers were removed. Measurements of the internal organs were done and touch preparations were prepared for checking the presence of amastigotes. The strains were isolated from all patients and amastigotes were seen in all smears of the patients, and then isolates were immediately stored in liquid nitrogen. In real time ITS1-PCR, the melting temperatures of all samples were out of range of L. infantum, L. tropica and L. major. Sequencing of hsp70 PCR-N showed that all isolates highly identical to previously submitted L. donovani sequences in GenBank, and cpb gene sequencing showed five isolates had longer cpbF allele, whereas one isolate contained a mixed sequence of both cpbF and cpbE. All mice in both experimental groups became infected. Compared to controls, the length and width of both liver and spleen were significantly elevated (p<0.001) in both groups of mice. However, the weight of the liver increased significantly in all mice whereas the weight of spleen increased only in VL group. Amastigotes were also seen in all touch preparations prepared from skin sores, spleen and liver. L. donovani strain was isolated from autocutaneous a VL patient first time in Turkey. Animal models using clinical samples were successfully established and important clinical differences of the isolated strains were observed. Copyright © 2017 Elsevier B.V. All rights reserved.
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Federating heterogeneous datasets to enhance data sharing and experiment reproducibility
NASA Astrophysics Data System (ADS)
Prieto, Juan C.; Paniagua, Beatriz; Yatabe, Marilia S.; Ruellas, Antonio C. O.; Fattori, Liana; Muniz, Luciana; Styner, Martin; Cevidanes, Lucia
2017-03-01
Recent studies have demonstrated the difficulties to replicate scientific findings and/or experiments published in past.1 The effects seen in the replicated experiments were smaller than previously reported. Some of the explanations for these findings include the complexity of the experimental design and the pressure on researches to report positive findings. The International Committee of Medical Journal Editors (ICMJE) suggests that every study considered for publication must submit a plan to share the de-identified patient data no later than 6 months after publication. There is a growing demand to enhance the management of clinical data, facilitate data sharing across institutions and also to keep track of the data from previous experiments. The ultimate goal is to assure the reproducibility of experiments in the future. This paper describes Shiny-tooth, a web based application created to improve clinical data acquisition during the clinical trial; data federation of such data as well as morphological data derived from medical images; Currently, this application is being used to store clinical data from an osteoarthritis (OA) study. This work is submitted to the SPIE Biomedical Applications in Molecular, Structural, and Functional Imaging conference.
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Probst-Schendzielorz, Kristina; Scholl, Catharina; Efimkina, Olga; Ersfeld, Eva; Viviani, Roberto; Serretti, Alessandro; Fabbri, Chiara; Gurwitz, David; Lucae, Susanne; Ising, Marcus; Paul, Anna Maria; Lehmann, Marie-Louise; Steffens, Michael; Crisafulli, Concetta; Calabrò, Marco; Holsboer, Florian; Stingl, Julia
2015-01-01
The identification of antidepressant drugs (ADs) response biomarkers in depression is of high clinical importance. We explored CHL1 and ITGB3 expression as tentative response biomarkers. In vitro sensitivity to ADs, as well as gene expression and genetic variants of the candidate genes CHL1, ITGB3 and SLC6A4 were measured in lymphoblastoid cell lines (LCLs) of 58 depressed patients. An association between the clinical remission of depression and the basal expression of CHL1 and ITGB3 was discovered. Individuals whose LCLs expressed higher levels of CHL1 or ITGB3 showed a significantly better remission upon AD treatment. In addition individuals with the CHL1 rs1516338 TT genotype showed a significantly better remission after 5 weeks AD treatment than those carrying a CC genotype. No association between the in vitro sensitivity of LCLs toward AD and the clinical remission could be detected. CHL1 expression in patient-derived LCLs correlated with the clinical outcome. Thus, it could be a valid biomarker to predict the success of an antidepressant therapy. Original submitted 8 December 2014; Revision submitted 2 March 2015.
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Picchio, Gaston R; Rimsky, Laurence T; Van Eygen, Veerle; Haddad, Mojgan; Napolitano, Laura A; Vingerhoets, Johan
2014-01-01
The prevalence of rilpivirine resistance-associated mutations (RAMs) in the USA, and their effect on phenotypic susceptibility to rilpivirine and etravirine, was evaluated in clinical samples from HIV-1-infected patients. In total, 15,991 samples submitted to Monogram Biosciences (South San Francisco, CA, USA) for routine resistance testing between January 2010 and June 2011 were assessed for the presence of known rilpivirine RAMs K101E/P, E138A/G/K/Q/R, V179L, Y181C/I/V, Y188L, H221Y, F227C and M230I/L; non-nucleoside reverse transcriptase inhibitor (NNRTI) RAMs K103N, L100I and L100I+K103N; and the nucleoside reverse transcriptase inhibitor (NRTI) RAMs M184I/V and their combinations with rilpivirine RAMs. Phenotypic susceptibility (PhenoSenseGT(®) assay; Monogram Biosciences) was evaluated, with reduced susceptibility defined as fold change (FC) in 50% inhibitory concentration (IC50)>2.0 for rilpivirine and FC>2.9 for etravirine. Of the 15,991 samples, 17% harboured ≥1 rilpivirine RAMs. The prevalence of most rilpivirine RAMs and combinations of NNRTI RAMs of interest was low (≤3%), except for Y181C (7%). Rilpivirine RAMs were often associated with reduced rilpivirine phenotypic susceptibility. Median FC values >2.0 were observed for clinical isolates with rilpivirine RAMs K101P, E138Q/R, Y181C/I/V, Y188L or M230L, and for the combination of E138K with M184I/V, and K101E with M184I. Most rilpivirine FC values >2.0 were associated with etravirine FC values >2.9 for individual rilpivirine RAMs and those combined with M184I/V. There was no relationship between the presence of K103N and rilpivirine FC. However, the L100I+K103N combination (without rilpivirine RAMs), at <2% prevalence, was associated with a rilpivirine FC>2.0. Based on 15,991 US clinical samples from HIV-1-infected patients, the frequency of most known rilpivirine RAMs apart from Y181C was low.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-20
... restricted by statute. FOR FURTHER INFORMATION CONTACT: Charles M. Petko, Office of Radiation and Indoor Air... national network of stations collecting sampling media that include air, precipitation, drinking water, and milk. Samples are sent to EPA's National Air and Radiation Environmental Laboratory (NAREL) in...
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Seixas, Fábio Heredia; Estrela, Carlos; Bueno, Mike Reis; Sousa-Neto, Manoel Damião; Pécora, Jesus Djalma
2015-06-01
The aim of this study was to determine the root canal area before and after the instrumentation 1 mm short of the apical foramen by clinical and cone beam computed tomography (CBCT) methods, and to evaluate the cleanliness of the apical region in mesiodistal flattened teeth by using optical microscopy. Forty-two human single-canal mandibular incisors were instrumented using the Free Tip Preparation technique up to three, four or five instruments from the initial. Cone beam computed tomography scans were acquired of the samples before and after root canal preparation (RCP). Irrigation was performed by conventional or hydrodynamic means, using 2.5% sodium hypochlorite. The samples were prepared for observation under an optical microscope. Images were digitally obtained, analyzed and the results were submitted to statistical analysis (two-way ANOVA complemented by Bonferroni's post-test). There was no significant difference between the studied anatomical areas with both CBCT and clinical methods. There were no differences between irrigation methods. It was verified differences between instrumentation techniques. Instrumentation with four instruments from the initial instrument determined a significant increase in the contact area when compared to preparation with three instruments, but RCP with 5 instruments did not result in a better cleanliness. The analysis with CBCT was not capable to determine the precise shape of surgical apical area comparing to the clinical method. Both the conventional and hydrodynamic irrigation techniques were not able to promote root canals debris-free. The instruments action in root canal walls was proportional to the number of instruments used from the initial apical instrument.
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Using Facebook ads with traditional paper mailings to recruit adolescent girls for a clinical trial.
Schwinn, Traci; Hopkins, Jessica; Schinke, Steven P; Liu, Xiang
2017-02-01
Clinical trials require sufficient samples recruited within limited time and budget constraints. Trials with minors are additionally burdened by the requirement for youth assent and parental permission. This paper details the use of Facebook ads and traditional paper mailings to enroll 797 adolescent girls for a longitudinal, web-based, drug abuse prevention trial. Data on sample representativeness and retention are also provided. Facebook ads appeared on the pages of females aged 13 or 14years who reside in the U.S. Ads linked girls to a recruitment website. Girls who wanted more information submitted contact information and were mailed information packets to their homes containing, among other things, youth assent and parent permission forms. Returned forms were verified for accuracy and validity. The Facebook ad campaign reached 2,267,848 girls and had a unique click-through rate of 3.0%. The campaign cost $41,202.37 with an average cost of $51.70 per enrolled girl. Information packets were mailed to 1,873 girls. Approximately one-half of girls returned the forms, and 797 girls were enrolled. The Facebook campaign's success varied by ad type, month, and day of the week. Baseline data revealed comparability to national data on demographic and substance use variables. Results suggest that Facebook ads provide a useful initial point of access to unparalleled numbers of adolescents. Clinical trials may benefit from a two-fold recruitment strategy that uses online ads to attract interested adolescents followed by traditional recruitment methods to communicate detailed information to adolescents and parents. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Using Facebook ads with traditional paper mailings to recruit adolescent girls for a clinical trial
Schwinn, Traci; Hopkins, Jessica; Schinke, Steven P; Liu, Xiang
2016-01-01
Introduction Clinical trials require sufficient samples recruited within limited time and budget constraints. Trials with minors are additionally burdened by the requirement for youth assent and parental permission. This paper details the use of Facebook ads and traditional paper mailings to enroll 797 adolescent girls for a longitudinal, web-based, drug abuse prevention trial. Data on sample representativeness and retention are also provided. Methods Facebook ads appeared on the pages of females aged 13 or 14 years who reside in the U.S. Ads linked girls to a recruitment website. Girls who wanted more information submitted contact information and were mailed information packets to their homes containing, among other things, youth assent and parent permission forms. Returned forms were verified for accuracy and validity. Results The Facebook ad campaign reached 2,267,848 girls and had a unique click-through rate of 3.0%. The campaign cost $41,202.37 with an average cost of $51.70 per enrolled girl. Information packets were mailed to 1,873 girls. Approximately one-half of girls returned the forms, and 797 girls were enrolled. The Facebook campaign's success varied by ad type, month, and day of the week. Baseline data revealed comparability to national data on demographic and substance use variables. Conclusions Results suggest that Facebook ads provide a useful initial point of access to unparalleled numbers of adolescents. Clinical trials may benefit from a two-fold recruitment strategy that uses online ads to attract interested adolescents followed by traditional recruitment methods to communicate detailed information to adolescents and parents. PMID:27835860
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Current Cytology Practices in Korea: A Nationwide Survey by the Korean Society for Cytopathology
Oh, Eun Ji; Jung, Chan Kwon; Kim, Dong-Hoon; Kim, Han Kyeom; Kim, Wan Seop; Jin, So-Young; Yoon, Hye Kyoung
2017-01-01
Background Limited data are available on the current status of cytology practices in Korea. This nationwide study presents Korean cytology statistics from 2015. Methods A nationwide survey was conducted in 2016 as a part of the mandatory quality-control program by the Korean Society for Cytopathology. The questionnaire was sent to 208 medical institutions performing cytopathologic examinations in Korea. Individual institutions were asked to submit their annual cytology statistical reports and gynecologic cytology-histology correlation data for 2015. Results Responses were obtained from 206 medical institutions including 83 university hospitals, 87 general hospitals, and 36 commercial laboratories. A total of 8,284,952 cytologic examinations were performed in 2015, primarily in commercial laboratories (74.9%). The most common cytology specimens were gynecologic samples (81.3%). Conventional smears and liquid-based cytology were performed in 6,190,526 (74.7%) and 2,094,426 (25.3%) cases, respectively. The overall diagnostic concordance rate between cytologic and histologic diagnoses of uterine cervical samples was 70.5%. Discordant cases were classified into three categories: category A (minimal clinical impact, 17.4%), category B (moderate clinical impact, 10.2%), and category C (major clinical impact, 1.9%). The ratio of atypical squamous cells of undetermined significance to squamous intraepithelial lesion was 1.6 in university hospitals, 2.9 in general hospitals, and 4.9 in commercial laboratories. Conclusions This survey reveals the current status and trend of cytology practices in Korea. The results of this study can serve as basic data for the establishment of nationwide cytopathology policies and quality improvement guidelines in Korean medical institutions. PMID:28950443
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Oliveira, Julyana de Araújo; da Silva, Ingrid Carla Guedes; Trindade, Leonardo Antunes; Lima, Edeltrudes Oliveira; Carlo, Hugo Lemes; Cavalcanti, Alessandro Leite; de Castro, Ricardo Dias
2014-01-01
The anti-Candida activity of essential oil from Cinnamomum zeylanicum Blume, as well as its effect on the roughness and hardness of the acrylic resin used in dental prostheses, was assessed. The safety and tolerability of the test product were assessed through a phase I clinical trial involving users of removable dentures. Minimum inhibitory concentration (MIC) and minimum fungicidal concentrations (MFC) were determined against twelve Candida strains. Acrylic resin specimens were exposed to artificial saliva (GI), C. zeylanicum (GII), and nystatin (GIII) for 15 days. Data were submitted to ANOVA and Tukey posttest (α = 5%). For the phase I clinical trial, 15 healthy patients used solution of C. zeylanicum at MIC (15 days, 3 times a day) and were submitted to clinical and mycological examinations. C. zeylanicum showed anti-Candida activity, with MIC = 625.0 µg/mL being equivalent to MFC. Nystatin caused greater increase in roughness and decreased the hardness of the material (P < 0.0001), with no significant differences between GI and GII. As regards the clinical trial, no adverse clinical signs were observed after intervention. The substance tested had a satisfactory level of safety and tolerability, supporting new advances involving the clinical use of essential oil from C. zeylanicum. PMID:25574178
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Magneto immunofluorescence assay for diagnosis of celiac disease.
Kergaravat, Silvina V; Beltramino, Luis; Garnero, Nidia; Trotta, Liliana; Wagener, Marta; Fabiano, Silvia N; Pividori, Maria Isabel; Hernandez, Silvia R
2013-10-10
A magneto immunofluorescence assay for the detection of anti-transglutaminase antibodies (ATG2) in celiac disease was developed. The ATG2 were recognized by transglutaminase enzyme immobilized on the magnetic beads and then the immunological reaction was revealed by antibodies labeled with peroxidase. The fluorescent response of the enzymatic reaction with o-phenylenediamine and H2O2 as substrates was correlated with anti-transglutaminase titer, showing EC50 and LOD values of 1:11,600 and 1:74,500 of antibody titers, respectively. A total number of 29 sera samples from clinically confirmed cases of celiac disease and 19 negative control samples were tested by the novel magneto immunofluorescence assay. The data were submitted to the receiver-operating characteristic plot (ROC) analysis which indicated that 8.1 U was the most effective cut-off value to discriminate correctly between celiac and non-celiac patients. The immunofluorescence assay exhibited a sensitivity of 96.6%, a specificity of 89.5% and an efficiency 93.8% compared with the commercial optical ELISA kit. Copyright © 2013 Elsevier B.V. All rights reserved.
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Rickettsia parkeri rickettsiosis and its clinical distinction from Rocky Mountain spotted fever.
Paddock, Christopher D; Finley, Richard W; Wright, Cynthia S; Robinson, Howard N; Schrodt, Barbara J; Lane, Carole C; Ekenna, Okechukwu; Blass, Mitchell A; Tamminga, Cynthia L; Ohl, Christopher A; McLellan, Susan L F; Goddard, Jerome; Holman, Robert C; Openshaw, John J; Sumner, John W; Zaki, Sherif R; Eremeeva, Marina E
2008-11-01
Rickettsia parkeri rickettsiosis, a recently identified spotted fever transmitted by the Gulf Coast tick (Amblyomma maculatum), was first described in 2004. We summarize the clinical and epidemiological features of 12 patients in the United States with confirmed or probable disease attributable to R. parkeri and comment on distinctions between R. parkeri rickettsiosis and other United States rickettsioses. Clinical specimens from patients in the United States who reside within the range of A. maculatum for whom an eschar or vesicular rash was described were evaluated by > or =1 laboratory assays at the Centers for Disease Control and Prevention (Atlanta, GA) to identify probable or confirmed infection with R. parkeri. During 1998-2007, clinical samples from 12 patients with illnesses epidemiologically and clinically compatible with R. parkeri rickettsiosis were submitted for diagnostic evaluation. Using indirect immunofluorescence antibody assays, immunohistochemistry, polymerase chain reaction assays, and cell culture isolation, we identified 6 confirmed and 6 probable cases of infection with R. parkeri. The aggregate clinical characteristics of these patients revealed a disease similar to but less severe than classically described Rocky Mountain spotted fever. Closer attention to the distinct clinical features of the various spotted fever syndromes that exist in the United States and other countries of the Western hemisphere, coupled with more frequent use of specific confirmatory assays, may unveil several unique diseases that have been identified collectively as Rocky Mountain spotted fever during the past century. Accurate assessments of these distinct infections will ultimately provide a more valid description of the currently recognized distribution, incidence, and case-fatality rate of Rocky Mountain spotted fever.
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Vail, Paris J; Morris, Brian; van Kan, Aric; Burdett, Brianna C; Moyes, Kelsey; Theisen, Aaron; Kerr, Iain D; Wenstrup, Richard J; Eggington, Julie M
2015-10-01
Genetic variants of uncertain clinical significance (VUSs) are a common outcome of clinical genetic testing. Locus-specific variant databases (LSDBs) have been established for numerous disease-associated genes as a research tool for the interpretation of genetic sequence variants to facilitate variant interpretation via aggregated data. If LSDBs are to be used for clinical practice, consistent and transparent criteria regarding the deposition and interpretation of variants are vital, as variant classifications are often used to make important and irreversible clinical decisions. In this study, we performed a retrospective analysis of 2017 consecutive BRCA1 and BRCA2 genetic variants identified from 24,650 consecutive patient samples referred to our laboratory to establish an unbiased dataset representative of the types of variants seen in the US patient population, submitted by clinicians and researchers for BRCA1 and BRCA2 testing. We compared the clinical classifications of these variants among five publicly accessible BRCA1 and BRCA2 variant databases: BIC, ClinVar, HGMD (paid version), LOVD, and the UMD databases. Our results show substantial disparity of variant classifications among publicly accessible databases. Furthermore, it appears that discrepant classifications are not the result of a single outlier but widespread disagreement among databases. This study also shows that databases sometimes favor a clinical classification when current best practice guidelines (ACMG/AMP/CAP) would suggest an uncertain classification. Although LSDBs have been well established for research applications, our results suggest several challenges preclude their wider use in clinical practice.
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Bagust, Adrian; Greenhalgh, Janette; Boland, Angela; Fleeman, Nigel; McLeod, Claire; Dickson, Rumona; Dundar, Yenal; Proudlove, Christine; Shaw, Richard
2010-01-01
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cetuximab (Merck Serono) to submit evidence for the clinical and cost effectiveness of cetuximab in combination with platinum-based chemotherapy (CTX) for the treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) according to the Institute's Single Technology Appraisal (STA) process. The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article summarizes the ERG's review of the evidence submitted by the manufacturer. A summary of the Appraisal Committee (AC) decision is provided. The ERG reviewed the clinical evidence in accordance with the decision problem defined by NICE. The analysis of the submitted model assessed the appropriateness of the manufacturer's approach to modelling the decision problem, the reliability of model implementation and the extent of conformity to published standards and prevailing norms of practice within the health economics modelling community. Particular attention was paid to issues likely to impact substantially on the base-case cost-effectiveness results. Clinical-effectiveness evidence was derived from a single randomized controlled trial (RCT). Results presented for clinical outcomes were strongly supportive of benefits resulting from the use of cetuximab. Cetuximab + platinum-based CTX with 5 fluorouracil (5-FU) extended median overall survival (OS) from 7.4 months in the CTX group to 10.1 months in the cetuximab + CTX group. Median progression-free survival rose from 3.3 months to 5.6 months, best overall response to therapy increased from 19.5% to 35.6%, disease control rate rose from 60% to 81.1% and median time to treatment failure was 4.8 months compared with 3.0 months. Exploratory subgroup analyses indicated significant OS benefits in 11 of 16 pre-planned analyses. The ERG identified a number of issues relating to the clinical-effectiveness results: consideration was limited to first-line use of cetuximab; patients in the trial were younger and fitter than those presenting in UK clinical practice; there was no evidence of survival advantage for patients with metastatic disease; there was no evidence of effectiveness in patients not cetuximab-naive; and the quality-of-life data were poor. The submitted incremental cost-effectiveness ratio was considerably above the NICE threshold. The ERG questioned the submitted economic model on a number of grounds: the rationale for creating an economic model rather than direct analysis of trial data; the use of Weibull functions for survival models; inaccurate CTX costs; selection of health state utilities; inaccurate unit costs; and lack of mid-cycle correction. After amending the model, the ERG considered the use of cetuximab to be not cost effective for NICE at any price. The AC concluded that cetuximab in combination with platinum-based CTX should not be recommended for the treatment of patients with recurrent and/or metastatic SCCHN. Patients already receiving this treatment for this indication should have the option to continue treatment until they and their clinician consider it appropriate to stop. This was the first appraisal to consider the end-of-life medicines criteria introduced by NICE in January 2009.
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Brooks, M.H.; Schroder, L.J.; Willoughby, T.C.
1987-01-01
The U.S. Geological Survey operated a blind audit sample program during 1974 to test the effects of the sample handling and shipping procedures used by the National Atmospheric Deposition Program and National Trends Network on the quality of wet deposition data produced by the combined networks. Blind audit samples, which were dilutions of standard reference water samples, were submitted by network site operators to the central analytical laboratory disguised as actual wet deposition samples. Results from the analyses of blind audit samples were used to calculate estimates of analyte bias associated with all network wet deposition samples analyzed in 1984 and to estimate analyte precision. Concentration differences between double blind samples that were submitted to the central analytical laboratory and separate analyses of aliquots of those blind audit samples that had not undergone network sample handling and shipping were used to calculate analyte masses that apparently were added to each blind audit sample by routine network handling and shipping procedures. These calculated masses indicated statistically significant biases for magnesium, sodium , potassium, chloride, and sulfate. Median calculated masses were 41.4 micrograms (ug) for calcium, 14.9 ug for magnesium, 23.3 ug for sodium, 0.7 ug for potassium, 16.5 ug for chloride and 55.3 ug for sulfate. Analyte precision was estimated using two different sets of replicate measures performed by the central analytical laboratory. Estimated standard deviations were similar to those previously reported. (Author 's abstract)
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NASA Technical Reports Server (NTRS)
Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.
2007-01-01
Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.
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de Melo, Gileno Edu Lameira; Kleiner, Ana Francisca Rozin; Lopes, Jamile Benite Palma; Dumont, Arislander Jonathan Lopes; Lazzari, Roberta Delasta; Galli, Manuela; Oliveira, Claudia Santos
2018-04-07
To evaluate the effects of gait training with virtual reality (VR) on walking distance and physical fitness in individuals with Parkinson's Disease (PD). Thirty-seven individuals with PD participated in this prospective, randomized, controlled clinical trial. They were randomly allocated to a control group submitted to conventional training (n = 12), a treadmill group submitted to gait training on a treadmill (n = 13) and a VR group submitted to gait training using the XboxTM (n = 12). Clinical measures, gait variables and the Six-Minute Walk Test (6MWT) were evaluated: pre-intervention, after one intervention session, post-intervention and follow up (30 days after intervention). The VR and treadmill groups travelled longer distances on the 6MWT and had faster gait speed in comparison to the control group. The VR and treadmill groups demonstrated an increase in pre-6MWT HR. The VR group had more intense HR after the first session and throughout training, but these gains were not maintained at the follow-up. The present findings demonstrate that gait training with a VR program is as effective as treadmill training with regard to gains in walking distance and improvements in temporal gait variables in individuals with PD.
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77 FR 47075 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-07
... days of this notice. Proposed Project Proficiency Testing in U.S. Clinical Laboratories: Perception... would impact their costs, PT practices, and perceived risk of failing PT. The goal of this project is to...
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McMeekin, C H; Hill, K E; Gibson, I R; Bridges, J P; Benschop, J
2017-03-01
To identify and describe culture and antimicrobial resistance (AMR) patterns in bacteria isolated from canine urinary samples submitted to a New Zealand veterinary diagnostic laboratory. Records from a veterinary diagnostic laboratory were examined for bacterial isolates cultured from canine urine samples between January 2005 and December 2012. Culture and susceptibility results were compiled with information on the age, sex and breed of dog. Repeat submissions were removed. Susceptibility was assessed using results of the Kirby-Bauer disk diffusion method, for a standard panel including amoxicillin-clavulanic acid (AMC), cefovecin (from 2010-2012), cephalothin, clindamycin, enrofloxacin and trimethoprim-sulphonamide (TMS). A total of 5,786 urine samples were submitted for analysis, and 3,135 bacterial isolates were cultured from 2,184 samples. Of these 3,135 isolates, 1,104 (35.2%) were Escherichia coli, 442 (14.1%) were Staphylococcus spp., 357 (11.4%) Proteus mirabilis and 276 (8.8%) were Enterococcus spp. The frequency of culture-positive samples increased with increasing age in both female and male dogs (p<0.001). The percentage of E. coli isolates resistant to AMC and cephalothin increased between 2005 and 2012 (p<0.001), as did resistance to enrofloxacin (p=0.022), but there was no change in resistance to TMS (p=0.696). Enrofloxacin was the antimicrobial with the least resistance shown by the four most common bacteria isolated during the course of the study. The results of this study provide important regional information regarding the prevalence of bacterial uropathogens and their susceptibility patterns. There was an increase in resistance to some commonly used antimicrobials in the treatment of urinary tract infections. Having access to regional antimicrobial susceptibility results is crucial when forming guidelines for the use of antimicrobials for the treatment of urinary tract infections. Given changes in practising habits and antimicrobial usage over time, ongoing monitoring and surveillance of resistance in pathogens is needed.
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Sánchez-Lázaro, Ignacio; Herrero, María José; Jordán-De Luna, Consuelo; Bosó, Virginia; Almenar, Luis; Rojas, Luis; Martínez-Dolz, Luis; Megías-Vericat, Juan E; Sendra, Luis; Miguel, Antonio; Poveda, José L; Aliño, Salvador F
2015-01-01
Studying the possible influence of SNPs on efficacy and safety of calcineurin inhibitors upon heart transplantation. In 60 heart transplant patients treated with tacrolimus or cyclosporine, we studied a panel of 36 SNPs correlated with a series of clinical parameters during the first post-transplantation year. The presence of serious infections was correlated to ABCB1 rs1128503 (p = 0.012), CC genotype reduced the probability of infections being also associated with lower blood cyclosporine concentrations. Lower renal function levels were found in patients with rs9282564 AG (p = 0.003), related to higher blood cyclosporine blood levels. A tendency toward increased graft rejection (p = 0.05) was correlated to rs2066844 CC in NOD2/CARD15, a gene related to lymphocyte activation. Pharmacogenetics can help identify patients at increased risk of clinical complications. Original submitted 30 January 2015; revision submitted 27 March 2015.
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Variability of the institutional review board process within a national research network.
Khan, Muhammad A; Barratt, Michelle S; Krugman, Scott D; Serwint, Janet R; Dumont-Driscoll, Marilyn
2014-06-01
To determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study. Participants included 24 Continuity Research Network (CORNET) sites of the Academic Pediatric Association that participated in a cross-sectional study. Each site obtained individual institutional IRB approval. An anonymous questionnaire went to site investigators about the IRB process at their institution. Twenty-two of 24 sites (92%) responded. Preparation time ranged from 1 to 20 hours, mean of 7.1 hours. Individuals submitting ≤3 IRB applications/year required more time for completion than those submitting >3/year (P < .05). Thirteen of 22 (59%) study sites received approval with "exempt" status, and 6 (27%) approved as "expedited" studies. IRB experiences were highly variable across study sites. These findings indicate that multicenter research projects should anticipate barriers to timely study implementation. Improved IRB standardization or centralization for multicenter clinical studies would facilitate this type of practice-based clinical research.
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[Chronic inflammatory demyelinating polyneuropathy. Findings in 30 patients].
Villa, A M; Molina, H; Sanz, O P; Sica, R E
1999-01-01
Chronic demyelinating inflammatory polineuropathy (CIDP) is a disease which was recognized several years ago. However, the mechanism underlying its pathogenesis remains poorly understood. Nevertheless, there are some clues which strongly suggest that it constitutes an autoimmune disease. Since 1992 we have studied 30 cases. All them were clinically assessed and submitted to laboratory investigations encompassing nerve conduction studies, sera proteins immunoelectrophoresis, spinal fluid analysis and sural nerve biopsies. Upon clinical examination the usual findings were weakness, muscle atrophy, absence or diminished tendon jerks, paresthesias and hyposthesias. Electrophysiological studies disclosed marked slowing of the nerve conduction velocities, suggesting demyelination. Sera immunoelectrophoresis detected monoclonal gammopathy in 17% of the studied patients, which was not associated with lymphoproliferative illnesses. Of the patients 79% had increased levels of spinal fluid proteins. Seventeen patients gave their consent for performing a sural nerve biopsy; all the samples showed demyelination. In conclusion, we think that CDIP is a disease which can be recognized when the clinical assessment, the nerve conduction studies and the spinal fluid findings suggest the diagnosis. Although nerve biopsy may be strongly supporting, we believe that it has to be performed only if doubts arise from the clinical, electrophysiological or spinal fluid observations. It is worth noting that its early detection may benefit the patient through the administration of the right therapy precluding the eventual sequelae of the disease.
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Evaluation of the efficacy of photodynamic therapy for the treatment of actinic cheilitis.
Chaves, Yuri N; Torezan, Luis Antonio; Lourenço, Silvia Vanessa; Neto, Cyro Festa
2017-01-01
Actinic cheilitis (AC) is a lip intraepithelial neoplasia, whose cells present alterations similar to those presented by invasive squamous cell carcinomas (SCCs). To conduct clinical and laboratory evaluation by histopathology and immunohistochemistry of the efficacy of actinic cheilitis treatment using photodynamic therapy (PDT) with methyl aminolevulinate (MAL) and noncoherent red light. Patients with actinic cheilitis detected by histopathological examination were submitted to two sessions of photodynamic therapy with a two-week interval between them. They were examined immediately after the sessions, four, six, and twelve weeks after beginning treatment when a new biopsy was carried out. Clinical histopathological and immunohistochemical parameters were evaluated before and after treatment. Of the 23 patients who underwent biopsy, 16 completed two photodynamic therapy sessions and the material of one patient was insufficient for immunohistochemistry. Complete clinical response was achieved in 62.5% (10 of 16 patients) and 37.5% still remained with clinical evidence of AC. In spite of this, no case of cure by histopathological analysis was found. There was no significant statistical change among the values of Ki-67, survivin, and p53 observed before and after treatment. Photodynamic therapy, as carried out in this trial, was not an efficacious therapeutic option for treating patients with actinic cheilitis included in this sample. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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... cosmetics, and medical devices. These color additives (except coal-tar hair dyes) are subject by law to ... are man-made, derived primarily from petroleum and coal sources. The manufacturer submits a sample from the ...
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Chen, Wei; Liu, Yongxia; Barkema, Herman W; Gao, Jian; De Buck, Jeroen; Kastelic, John P; Liu, Gang; Ali, Tariq; Shahid, Muhammad; Han, Bo
2017-10-01
The occurrence of nocardial mastitis, mostly in the context of outbreaks, has been reported in many countries. However, there is a paucity of reports regarding detailed characterization of Nocardia cyriacigeorgica from bovine mastitis. Thus, herein we report characteristics, antimicrobial susceptibility patterns, molecular identification, and pathogenicity of N. cyriacigeorgica isolated from an outbreak of clinical mastitis in a dairy herd in northern China. A total of 182 (80.2%) lactating cows had clinical mastitis with severe inflammation and firmness of the udder, reduced milk production, and anorexia, with no apparent clinical response to common antibiotics. Out of 22 mastitic milk samples submitted to our laboratory, 12 N. cyriacigeorgica were isolated and characterized using standard microbiological analysis, 16S rRNA gene sequencing, random amplified polymorphic DNA PCR analysis, biochemical assays, and antibiotic susceptibility testing. Additionally, in vivo experiments were done to determine pathogenicity of these clinical mastitis isolates. All isolates were resistant to ampicillin, amoxicillin-clavulanic acid, ciprofloxacin, minocycline, rifampicin, and aminoglycosides (type VI pattern). Additionally, intramammary inoculation of mice with N. cyriacigeorgica caused chronic inflammatory changes, including hyperemia, edema, and infiltration of lymphocytes and neutrophils, as well as hyperplasia of lymph nodules in mammary glands. Therefore, we concluded that N. cyriacigeorgica was involved in the current outbreak of mastitis. To our best knowledge, this is the first report to characterize N. cyriacigeorgica isolated from cases of bovine mastitis in China. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.
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Asymptomatic bacteriuria in puppies with canine parvovirus infection: a cohort study.
Koutinas, A F; Heliadis, N; Saridomichelakis, M N; Leontides, L; Terpsidis, K; Christodoulou, C
1998-10-01
This study aimed to investigate the possible association between canine parvoviral enteritis and asymptomatic bacteriuria. Forty-three puppies that were admitted to the outpatient service of the Animal Medical Clinic with clinical signs compatible with parvoviral enteritis formed the exposed group. The clinical diagnosis was subsequently confirmed by a positive fecal ELISA test (CITE test: IDDEX Lab., Westbrook, ME). Twenty-three (53.5%) of these puppies were males and 20 (46.5%) were females. Their age ranged from 1.5 to 5.5 months. Forty-eight clinically normal and age-matched puppies, that had been admitted to the clinic for vaccinations and had a negative result in the aforementioned ELISA test, were randomly selected to form the unexposed group. Urine samples were collected by antebupic cystocentesis from all puppies and submitted for bacterial culture. In the parvovirus exposed group, 11 of 43 puppies had detectable bacteriuria. The isolates were Escherichia coli alone (8/11-72.7%) Staphylococcus aureus alone (1/11-9.1%) and mixed cultures of E. coli and S. epidermitis (2/11-18.2%). In the unexposed group there were three puppies with detectable bacteriuria, one isolate each of E. coli, Enterococcus durans and Corynebacterium spp. Puppies with parvoviral enteritis had five (95% CI: 1.3-19.8) times higher odds of developing asymptomatic bacteriuria than puppies without the disease. The observed increased risk of asymptomatic bacteriuria among puppies with parvoviral enteritis was probably due to the fecal contamination of the external genitalia and the neutropenia these puppies exhibited.
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Cortisol Responses to Perceived Stress in Depressed Individuals and Healthy Controls
2007-01-01
permission of the copyright owner. hannon Branlund Department of Medical and Clinical Psychology Uniformed Services University of the Health...submitted to the faculty of the Department of Medical and Clinical Psychology Graduate Program at the Uniformed Services University of the Health... medical conditions (Ormel et al., 1994; Spitzer et al., 1994.) The comorbidity of medical illness and MDD has been associated with increased
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A Clinical Evaluation of Cone Beam Computed Tomography
2015-06-01
the extent of dental caries . The radiographic image is essential to successfully diagnose pathosis of odontogenic and non-odontogenic origin. The...A CLINICAL EVALUATION OF CONE BEAM COMPUTED TOMOGRAPHY by Thomas Patrick Cairnll, D.D.S. Commander, Dental Corps United States Navy A thesis...submitted to the Faculty of the Endodontics Graduate Program Naval Postgraduate Dental School Uniformed Services University of the Health Sciences in
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Effects of Stress and Nicotine on Cognitive Function in Male and Female Rats
2016-05-20
abnormal psychology 109:188-97 84. Shih RA, Glass TA, Bandeen-Roche K, Carlson MC, Bolla KI, et al. 2006. Environmental lead exposure and cognitive...submitted to the Faculty of the Medical and Clinical Psychology Graduate Program Uniformed Services University of the Health Sciences In partial...Molecular & Cell Biology -Neuroscience Departmental -Cli.nical Psychology -Environmental Health Sciences -Medical Psychology -Medical Zoology
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Prevention of Posttraumatic Contractures with Ketotifen (PERK)
2016-10-01
the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed
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Mooney, LaVerne A; Fay, Lorna
2016-07-18
To estimate the proportion of Pfizer-sponsored clinical trials that completed in 2010 and are published as manuscripts in the peer-reviewed literature, and to assess the manuscript development history. Retrospective, cross-sectional analysis. Clinical trials registered in ClinicalTrials.gov that completed in 2010 for approved, Pfizer prescription products in patients or vaccines in healthy participants. The proportion of studies for which the primary outcome(s) was published and the median time from study completion to publication. The manuscript development history included the number of times a manuscript was submitted before it was accepted for publication. Among registered clinical trials for which Pfizer was the sponsor that completed in 2010, 76 met all inclusion criteria. The primary outcome(s) for 65 (85%) studies was published in 71 manuscripts; the median time to publication was 31 months (range 3-63 months). Of the remaining 11 studies, 2 had been submitted to at least one journal, 2 had not yet been submitted and 7 had no plans to publish because the study had terminated early due to recruitment challenges. Manuscripts accepted at the first choice journal were published at median time of 28 months (range 8-63, n=31), those accepted at second choice journal were published at 32 months (3-45, n=19), and for those accepted at third choice journal, it was 40 months (range 24-53, n=13). The publication rate and median time to publication from study completion for Pfizer-sponsored studies were comparable to those previously reported for combined analyses of industry and non-industry sectors. Opportunities exist for sponsors, authors and journals to explore ideas that would facilitate more timely publication for clinical trial results. However, to be effective, such changes may need to revisit the entire publication process. 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/
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Granholm, Anders; Perner, Anders; Krag, Mette; Hjortrup, Peter Buhl; Haase, Nicolai; Holst, Lars Broksø; Marker, Søren; Collet, Marie Oxenbøll; Jensen, Aksel Karl Georg; Møller, Morten Hylander
2017-03-09
Mortality prediction scores are widely used in intensive care units (ICUs) and in research, but their predictive value deteriorates as scores age. Existing mortality prediction scores are imprecise and complex, which increases the risk of missing data and decreases the applicability bedside in daily clinical practice. We propose the development and validation of a new, simple and updated clinical prediction rule: the Simplified Mortality Score for use in the Intensive Care Unit (SMS-ICU). During the first phase of the study, we will develop and internally validate a clinical prediction rule that predicts 90-day mortality on ICU admission. The development sample will comprise 4247 adult critically ill patients acutely admitted to the ICU, enrolled in 5 contemporary high-quality ICU studies/trials. The score will be developed using binary logistic regression analysis with backward stepwise elimination of candidate variables, and subsequently be converted into a point-based clinical prediction rule. The general performance, discrimination and calibration of the score will be evaluated, and the score will be internally validated using bootstrapping. During the second phase of the study, the score will be externally validated in a fully independent sample consisting of 3350 patients included in the ongoing Stress Ulcer Prophylaxis in the Intensive Care Unit trial. We will compare the performance of the SMS-ICU to that of existing scores. We will use data from patients enrolled in studies/trials already approved by the relevant ethical committees and this study requires no further permissions. The results will be reported in accordance with the Transparent Reporting of multivariate prediction models for Individual Prognosis Or Diagnosis (TRIPOD) statement, and submitted to a peer-reviewed journal. 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/.
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Fatal Canid Herpesvirus 1 Respiratory Infections in 4 Clinically Healthy Adult Dogs.
Kumar, S; Driskell, E A; Cooley, A J; Jia, K; Blackmon, S; Wan, X-F; Uhl, E W; Saliki, J T; Sanchez, S; Krimer, P M; Hogan, R J
2015-07-01
Four healthy adult dogs (Golden Retrievers aged 6 years and 9 years, Dalmatian aged 13 years, and Mastiff aged 5 years) developed clinical signs of acute respiratory disease and died within 2 to 7 days of onset of clinical signs. The lungs of the 3 dogs submitted for necropsy were diffusely and severely reddened due to hyperemia and hemorrhage. Microscopic lesions in all dogs were suggestive of acute viral or toxic respiratory damage and varied from acute severe fibrinonecrotic or hemorrhagic bronchopneumonia to fibrinous or necrotizing bronchointerstitial pneumonia. Necropsied dogs also had hemorrhagic rhinitis and tracheitis with necrosis. Virus isolation, transmission electron microscopy, and polymerase chain reaction were used to confirm the presence of canid herpesvirus 1 (CaHV-1) in the lung samples of these dogs. Lung tissues were negative for influenza A virus, canine distemper virus, canine parainfluenza virus, canine respiratory coronavirus, and canine adenovirus 2. Canid herpesvirus 1 has been isolated from cases of acute infectious respiratory disease in dogs but has only rarely been associated with fatal primary viral pneumonia in adult dogs. The cases in the current report document lesions observed in association with CaHV-1 in 4 cases of fatal canine herpesvirus pneumonia in adult dogs. © The Author(s) 2014.
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DAISY Nurses-Recognizing Clinical Expertise Through Certification.
Sweeney, Cynthia Divens
2018-04-01
The DAISY Foundation is dedicated to recognizing nurses who provide compassionate, skilled, and extraordinary nursing care. Nominations for The DAISY Award are typically submitted in the form of a story. Stories are an opportunity to share with others what compassionate and extraordinary nursing care looks like and to recognize the individual nurses who provide that care. Clinical competence delivered with compassion is a hallmark of DAISY Award recipients. Professional certification provides an additional form of recognition of a nurse's clinical competence.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-27
... a Patient Centered Medical Home for OEF/OIF Veterans With PTSD: Bridging Primary and Behavioral... with PTSD. DATES: Comments must be submitted on or before September 6, 2012. ADDRESSES: Send comments...
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46 CFR 164.013-5 - Acceptance tests.
Code of Federal Regulations, 2013 CFR
2013-10-01
... described in UL 1191, as appropriate, are performed on a minimum of five samples in each of the lightest and darkest colors submitted for acceptance by a recognized laboratory accepted under § 164.019. ...
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46 CFR 164.013-5 - Acceptance tests.
Code of Federal Regulations, 2012 CFR
2012-10-01
... described in UL 1191, as appropriate, are performed on a minimum of five samples in each of the lightest and darkest colors submitted for acceptance by a recognized laboratory accepted under § 164.019. ...
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46 CFR 164.013-5 - Acceptance tests.
Code of Federal Regulations, 2014 CFR
2014-10-01
... described in UL 1191, as appropriate, are performed on a minimum of five samples in each of the lightest and darkest colors submitted for acceptance by a recognized laboratory accepted under § 164.019. ...
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Cameron, Colin; Bell-Rogers, Patricia; McDowall, Rebeccah; Rebelo, Ana R.; Cai, Hugh Y.
2014-01-01
This study analyzed sheep prion protein (PrP) genotypes of samples submitted from Ontario and other provinces of Canada to the Animal Health Laboratory at the University of Guelph, Guelph, Ontario, between 2005 and 2012. In Ontario, the proportion of scrapie-resistant sheep increased from 2005 to 2012 as evidenced by an increase in the ARR haplotype. When Canadian provinces (Alberta, Ontario, Quebec, and Nova Scotia) were compared from 2008 to 2012, a high proportion of scrapie-resistant sheep was found in all the provinces. The proportions of resistant sheep were lower in Alberta and Quebec than in Ontario and Nova Scotia. Alberta had higher proportions of susceptible sheep and a higher frequency of VRQ alleles, and Quebec had a higher frequency of the ARQ allele. PMID:25355994
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-02
... of the true value of the audit sample to the compliance authority (state, local or EPA Regional... AASP. The AASP would report the true value of the audit sample to the compliance authority (state..., validating, disturbing and reporting the audit results. Changes in the Estimates: There are no changes in the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-01
... sample data on transactions and positions between U.S.-owned foreign business enterprises and their U.S... commentator may be publicly accessible. Do not submit confidential business information or otherwise sensitive... positions between U.S.-owned foreign business enterprises and their U.S. parents. The sample data are used...
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Code of Federal Regulations, 2013 CFR
2013-07-01
..., hydrogeology, climate); (iii) Results of any monitoring or sampling conducted in connection with the release (if available). If sampling or monitoring data relating to the release are not available within 30 days, these data must be submitted to the Regional Administrator as soon as they become available. (iv...
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Code of Federal Regulations, 2012 CFR
2012-07-01
..., hydrogeology, climate); (iii) Results of any monitoring or sampling conducted in connection with the release (if available). If sampling or monitoring data relating to the release are not available within 30 days, these data must be submitted to the Regional Administrator as soon as they become available. (iv...
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Code of Federal Regulations, 2014 CFR
2014-07-01
..., hydrogeology, climate); (iii) Results of any monitoring or sampling conducted in connection with the release (if available). If sampling or monitoring data relating to the release are not available within 30 days, these data must be submitted to the Regional Administrator as soon as they become available. (iv...
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Code of Federal Regulations, 2011 CFR
2011-07-01
..., hydrogeology, climate); (iii) Results of any monitoring or sampling conducted in connection with the release (if available). If sampling or monitoring data relating to the release are not available within 30 days, these data must be submitted to the Regional Administrator as soon as they become available. (iv...
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Massey, Paul R; Wang, Ruibin; Prasad, Vinay; Bates, Susan E; Fojo, Tito
2016-03-01
Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4-6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11-1.36], p < .001; and 1.64 [1.15-2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38-1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61-1.29]; p = .532). This is the largest reported study examining why oncology trials are not published. The data show that 4-6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. ©AlphaMed Press.
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Sample features associated with success rates in population-based EGFR mutation testing.
Shiau, Carolyn J; Babwah, Jesse P; da Cunha Santos, Gilda; Sykes, Jenna R; Boerner, Scott L; Geddie, William R; Leighl, Natasha B; Wei, Cuihong; Kamel-Reid, Suzanne; Hwang, David M; Tsao, Ming-Sound
2014-07-01
Epidermal growth factor receptor (EGFR) mutation testing has become critical in the treatment of patients with advanced non-small-cell lung cancer. This study involves a large cohort and epidemiologically unselected series of EGFR mutation testing for patients with nonsquamous non-small-cell lung cancer in a North American population to determine sample-related factors that influence success in clinical EGFR testing. Data from consecutive cases of Canadian province-wide testing at a centralized diagnostic laboratory for a 24-month period were reviewed. Samples were tested for exon-19 deletion and exon-21 L858R mutations using a validated polymerase chain reaction method with 1% to 5% detection sensitivity. From 2651 samples submitted, 2404 samples were tested with 2293 samples eligible for analysis (1780 histology and 513 cytology specimens). The overall test-failure rate was 5.4% with overall mutation rate of 20.6%. No significant differences in the failure rate, mutation rate, or mutation type were found between histology and cytology samples. Although tumor cellularity was significantly associated with test-success or mutation rates in histology and cytology specimens, respectively, mutations could be detected in all specimen types. Significant rates of EGFR mutation were detected in cases with thyroid transcription factor (TTF)-1-negative immunohistochemistry (6.7%) and mucinous component (9.0%). EGFR mutation testing should be attempted in any specimen, whether histologic or cytologic. Samples should not be excluded from testing based on TTF-1 status or histologic features. Pathologists should report the amount of available tumor for testing. However, suboptimal samples with a negative EGFR mutation result should be considered for repeat testing with an alternate sample.
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Pires-de-Souza, Fernanda de Carvalho Panzeri; Garcia, Lucas da Fonseca Roberti; Roselino, Lourenço de Moraes Rego; Naves, Lucas Zago
2011-07-01
To assess the in situ color stability, surface and the tooth/restoration interface degradation of a silorane-based composite (P90, 3M ESPE) after accelerated artificial ageing (AAA), in comparison with other dimethacrylate monomer-based composites (Z250/Z350, 3M ESPE and Esthet-X, Dentsply). Class V cavities (25 mm(2) × 2 mm deep) were prepared in 48 bovine incisors, which were randomly allocated into 4 groups of 12 specimens each, according to the type of restorative material used. After polishing, 10 specimens were submitted to initial color readings (Easyshade, Vita) and 2 to analysis by scanning electronic microscopy (SEM). Afterwards, the teeth were submitted to AAA for 384 h, which corresponds to 1 year of clinical use, after which new color readings and microscopic images were obtained. The values obtained for the color analysis were submitted to statistical analysis (1-way ANOVA, Tukey, p<0.05). With regard to color stability, it was verified that all the composites showed color alteration above the clinically acceptable levels (ΔE ≥ 3.3), and that the silorane-based composite showed higher ΔE (18.6), with a statistically significant difference in comparison with the other composites (p<0.05). The SEM images showed small alterations for the dimethacrylate-based composites after AAA and extensive degradation for the silorane-based composite with a rupture at the interface between the matrix/particle. It may be concluded that the silorane-based composite underwent greater alteration with regard to color stability and greater surface and tooth/restoration interface degradation after AAA. Copyright © 2011 Elsevier Ltd. All rights reserved.
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Sakundarno, Mateus; Nurjazuli, Nurjazuli; Jati, Sutopo Patria; Sariningdyah, Retna; Purwadi, Sumarsono; Alisjahbana, Bachti; van der Werf, Marieke J
2009-01-01
Background Sputum smear microscopy is the standard diagnostic method for detection of smear positive pulmonary tuberculosis (TB). Insufficient quality of sputum might result in missing cases. In this study we aimed at assessing the quality of sputum in a district in Central Java and determining patient and health worker factors associated with submission of three good quality sputum samples. Methods In 16 health centers information was collected on the quality of sputum submitted by TB suspects, i.e. volume, color, and viscosity. TB suspects were interviewed to assess their knowledge of TB, motivation to provide sputum and whether they were informed why and how to produce a sputum sample. Health workers were interviewed to assess what information they provided to TB suspects about the reason for sputum examination, methods to produce sputum and characteristics of a good quality sputum sample. All health worker and patient factors were evaluated for association with sputum quality. Results Of 387 TB suspects, 294 (76.0%) could be traced and interviewed, and of 272 (70.3%) information about sputum quality was available. Of those 203 (74.6%) submitted three samples, 90 (33.1%) provided at least one good sample, and 37 (13.6%) provided three good quality sputum samples. Of the 272 TB suspects, 168 (61.8%) mentioned that information on the reason for sputum examination was provided, 66 (24.3%) remembered that they were informed about how to produce sputum and 40 (14.7%) recalled being informed about the characteristics of good quality sputum. Paramedics reported to provide often/always information on the importance of sputum examination, and when to produce sputum. Information on how to produce sputum and characteristics of a good sputum sample was less often provided. None of the studied patient characteristics or health worker factors was associated with providing good quality sputum. Conclusion A considerable number of TB suspects did not provide three sputum samples and a large number of sputum samples were of insufficient quality. Training of health workers in providing health education to the TB suspect about the reason for sputum examination and how to produce a good quality sputum sample should be a priority of the TB program. PMID:19426477
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Palma-Conesa, Álvaro José; Ventura, Mireia; Galindo, Liliana; Fonseca, Francina; Grifell, Marc; Quintana, Pol; Fornís, Iván; Gil, Cristina; Farré, Magí; Torrens, Marta
2017-01-01
New psychoactive tryptamines may be a public health risk since they intend to mimic the hallucinogenic effects of regulated psychoactive drugs. Few studies describe uses and clinical effects of unregulated new psychoactive tryptamines. This study aims (1) to explore the presence of tryptamines classified as NPS among the substances delivered for analysis to a harm-reduction organization; (2) to describe the substances found in the samples after analysis; and (3) to compare analytical results of regulated vs. non-regulated tryptamines. Samples delivered and analyzed by gas chromatography-mass spectrometry from 2006 to 2015 were included. A descriptive study of results was conducted. From 25,296 samples that were delivered, 436 were tryptamines; from these 232 (53.21%) were non-regulated. The most delivered non-regulated tryptamine was 4-AcO-DMT. A search of the PubMed database in July 2016 revealed that no studies in humans have ever been carried out with 4-AcO-DMT. Unregulated tryptamines likely contained one unadulterated substance (p ≤ 0.001). The number of samples submitted which contained tryptamines increased during the course of the study, with significant differences in client expectations vs. analysis results between the controlled and uncontrolled groups. There is a need for further research in order to prevent the potential health risks associated with their use.
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Frickmann, Hagen; Hinz, Rebecca; Rojak, Sandra; Bonow, Insa; Ruben, Stefanie; Wegner, Christine; Zielke, Iris; Hagen, Ralf Matthias; Tannich, Egbert
2018-05-12
We assessed a commercial loop-mediated amplification (LAMP) platform for its reliability as a screening tool for malaria parasite detection. A total of 1000 blood samples from patients with suspected or confirmed malaria submitted to the German National Reference Center for Tropical Pathogens were subjected to LAMP using the Meridian illumigene Malaria platform. Results were compared with microscopy from thick and thin blood films in all cases. In case of discordant results between LAMP and microscopy (n = 60), confirmation testing was performed with real-time PCR. Persistence of circulating parasite DNA was analyzed by serial assessments of blood samples following malaria treatment. Out of 1000 blood samples analyzed, 238 were positive for malaria parasites according to microscopy (n = 181/1000) or PCR (additional n = 57/60). LAMP demonstrated sensitivity of 98.7% (235/238), specificity of 99.6% (759/762), positive predictive value (PPV) of 98.7% (235/238) and negative predictive value (NPV) of 99.6% (759/762), respectively. For first slides of patients with malaria and for follow-up slides, sensitivity values were 99.1% (106/107) and 98.5% (129/131), respectively. The performance of the Meridian illumigene Malaria platform is suitable for initial screening of patients suspected of clinical malaria. Copyright © 2018 Elsevier Ltd. All rights reserved.
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Zirconia-implant-supported all-ceramic crowns withstand long-term load: a pilot investigation.
Kohal, Ralf-J; Klaus, Gerold; Strub, Jörg R
2006-10-01
The purpose of this pilot investigation was to test whether zirconia implants restored with different all-ceramic crowns would fulfill the biomechanical requirements for clinical use. Therefore, all-ceramic Empress-1 and Procera crowns were cemented on zirconia implants and exposed to the artificial mouth. Afterwards, the fracture strength of the all-ceramic implant-crown systems was evaluated. Conventional titanium implants restored with porcelain-fused-to-metal (PFM) crowns served as controls. Sixteen titanium implants with 16 PFM crowns and 32 zirconia implants with 16 Empress-1 crowns and 16 Procera crowns each--i.e., three implant-crown groups--were used in this investigation. The titanium implants were fabricated using the ReImplant system and the zirconia implants using the Celay system. The upper left central incisor served as a model for the fabrication of the implants and the crowns. Eight samples of each group were submitted to a long-term load test in the artificial mouth (1.2 million chewing cycles). Subsequently, a fracture strength test was performed with seven of the eight crowns. The remaining eight samples of each group were not submitted to the long-term load in the artificial mouth but were fracture-tested immediately. One loaded and one unloaded sample of each group were evaluated regarding the marginal fit of the crowns. All test samples survived the exposure to the artificial mouth. Three Empress-1 crowns showed cracks in the area of the loading steatite ball. The values for the fracture load in the titanium implant-PFM crown group without artificial loading ranged between 420 and 610 N (mean: 531.4 N), between 460 and 570 N (mean: 512.9 N) in the Empress-1 crown group, and in the Procera crown group the values were between 475 and 700 N (mean: 575.7 N) when not loaded artificially. The results when the specimens were loaded artificially with 1.2 million cycles were as follows: the titanium implant-PFM crowns fractured between 440 and 950 N (mean: 668.6 N), the Empress-1 crowns between 290 and 550 N (mean: 410.7 N), and the Procera crowns between 450 and 725 N (mean: 555.5 N). No statistically significant differences could be found among the groups without artificial load. The fracture values for the PFM and the Procera crowns after artificial loading were statistically significantly higher than that for the loaded Empress-1 crowns. There was no significant difference between the PFM crown group and the Procera group. Within the limits of this pilot investigation, it seems that zirconia implants restored with the Procera crowns possibly fulfill the biomechanical requirements for anterior teeth. However, further investigations with larger sample sizes have to confirm these preliminary results. As three Empress-1 crowns showed crack development in the loading area of the steatite balls in the artificial mouth, their clinical use on zirconia implants has to be questioned.
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Filler Wire Development for 2195 Aluminum-Lithium. Pt. 2
NASA Technical Reports Server (NTRS)
Bjorkman, Gerald W.; Cho, Alex
1998-01-01
The objective of the research was to determine the susceptibility of submitted welded 2195 plate in an AI (Alternate Immersion) environment. Forty-day AI exposure was completed on 8 welded 2195 stress corrosion samples. No stress corrosion cracking (SCC) was found on any of the samples tested. All 8 samples experienced exfoliation corrosion attack in the heat-affected zone (HAZ) adjacent to the weld. All samples were examined metallographically and showed varying degrees of intergranular corrosion (IG). The filler metal on all samples showed moderate to heavy pitting.
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Using soil test results to determine fertilizer applications
C. B. Davey
2002-01-01
Using soil test results is a very useful practice IF the sample(s) of soil are good representations of the nursery soil. The lab results can be no more accurate than the samples submitted, and IF you know the texture of the nursery soil, and IF you know which soil extractant was used by the lab, and IF you know what crop is to be grown, and IF, for trees, which species...
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Diode step stress program for JANTX1N5615
NASA Technical Reports Server (NTRS)
1979-01-01
The effect of power/temperature step stress when applied to the switching diode JANTX1N5615 manufactured by Semtech and Micro semiconductor was examined. A total of 48 samples from each manufacturer were submitted to the process. In addition, two control sample units were maintained for verification of the electrical parametric testing. All test samples were subjected to the electrical tests after completing the prior power/temperature step stress point. Results are presented.
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Stomach gas analyses in canine acute gastric dilatation with volvulus.
Van Kruiningen, H J; Gargamelli, C; Havier, J; Frueh, S; Jin, L; Suib, S
2013-01-01
The origin of the gas in the stomachs of dogs with acute gastric dilatation or gastric dilatation with volvulus (GDV) often is disputed. We tested the hypothesis that gaseous distention resulted from aerophagia. Ten cases of GDV that were submitted to an emergency clinic were sampled intraoperatively. With the abdomen open, the needle of a vacutainer blood collection set was inserted into the distended stomach, and gas was collected into 10 mL glass vacutainer vials with rubber stoppers. These were stored at room temperature for 1-7 days and then analyzed by gas chromatography and mass spectroscopy. CO2 composition ranged from 13 to 20%. One dog had an H2 concentration of 29%. Because the CO2 content of atmospheric air is less than 1%, these findings suggest that the gaseous gastric distention in GDV is not the result of aerophagia. Copyright © 2013 by the American College of Veterinary Internal Medicine.
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Wuersch, K; Bischoff, M; Thoma, R; Matter, M S
2009-01-01
An 8-year-old Brown Swiss dairy cow was presented with unilateral epistaxis and mild inspiratory stridor. At that time endoscopic examination revealed a smooth-surfaced mass within the left nasal cavity. Biopsy samples were collected and a diagnosis of fibrosarcoma was made. Eighteen months later the animal developed severe respiratory distress that led to difficulties in feeding and consequently to emaciation and a dramatic drop in milk production. The cow was humanely destroyed and submitted for post-mortem examination. The head was subject to further investigation by radiography, computed tomography and magnetic resonance imaging. These techniques revealed a non-infiltrative, well-circumscribed mass of both radiodense and heterogeneously intense structures. Histopathological examination revealed a mass consisting of well-differentiated and interlacing bone trabeculae lined by osteoblasts and multinucleated osteoclasts. In contrast to the initial diagnosis, the later diagnostic approaches supported the diagnosis of osteoma.
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Do Men Produce Higher Quality Ejaculates When Primed With Thoughts of Partner Infidelity?
Pham, Michael N; Barbaro, Nicole; Holub, Andrew M; Holden, Christopher J; Mogilski, Justin K; Lopes, Guilherme S; Nicolas, Sylis C A; Sela, Yael; Shackelford, Todd K; Zeigler-Hill, Virgil; Welling, Lisa L M
2018-01-01
Sperm competition theory can be used to generate the hypothesis that men alter the quality of their ejaculates as a function of sperm competition risk. Using a repeated measures experimental design, we investigated whether men produce a higher quality ejaculate when primed with cues to sperm competition (i.e., imagined partner infidelity) relative to a control prime. Men ( n = 45) submitted two masturbatory ejaculates-one ejaculate sample for each condition (i.e., sperm competition and control conditions). Ejaculates were assessed on 17 clinical parameters. The results did not support the hypothesis: Men did not produce higher quality ejaculates in the sperm competition condition relative to the control condition. Despite the null results of the current research, there is evidence for psychological and physiological adaptations to sperm competition in humans. We discuss methodological limitations that may have produced the null results and present methodological suggestions for research on human sperm competition.
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SAFOD Brittle Microstructure and Mechanics Knowledge Base (SAFOD BM2KB)
NASA Astrophysics Data System (ADS)
Babaie, H. A.; Hadizadeh, J.; di Toro, G.; Mair, K.; Kumar, A.
2008-12-01
We have developed a knowledge base to store and present the data collected by a group of investigators studying the microstructures and mechanics of brittle faulting using core samples from the SAFOD (San Andreas Fault Observatory at Depth) project. The investigations are carried out with a variety of analytical and experimental methods primarily to better understand the physics of strain localization in fault gouge. The knowledge base instantiates an specially-designed brittle rock deformation ontology developed at Georgia State University. The inference rules embedded in the semantic web languages, such as OWL, RDF, and RDFS, which are used in our ontology, allow the Pellet reasoner used in this application to derive additional truths about the ontology and knowledge of this domain. Access to the knowledge base is via a public website, which is designed to provide the knowledge acquired by all the investigators involved in the project. The stored data will be products of studies such as: experiments (e.g., high-velocity friction experiment), analyses (e.g., microstructural, chemical, mass transfer, mineralogical, surface, image, texture), microscopy (optical, HRSEM, FESEM, HRTEM]), tomography, porosity measurement, microprobe, and cathodoluminesence. Data about laboratories, experimental conditions, methods, assumptions, equipments, and mechanical properties and lithology of the studied samples will also be presented on the website per investigation. The ontology was modeled applying the UML (Unified Modeling Language) in Rational Rose, and implemented in OWL-DL (Ontology Web Language) using the Protégé ontology editor. The UML model was converted to OWL-DL by first mapping it to Ecore (.ecore) and Generator model (.genmodel) with the help of the EMF (Eclipse Modeling Framework) plugin in Eclipse. The Ecore model was then mapped to a .uml file, which later was converted into an .owl file and subsequently imported into the Protégé ontology editing environment. The web-interface was developed in java using eclipse as the IDE. The web interfaces to query and submit data were implemented applying JSP, servlets, javascript, and AJAX. The Jena API, a Java framework for building Semantic Web applications, was used to develop the web-interface. Jena provided a programmatic environment for RDF, RDFS, OWL, and SPARQL query engine. Building web applications with AJAX helps retrieving data from the server asynchronously in the background without interfering with the display and behavior of the existing page. The application was deployed on an apache tomcat server at GSU. The SAFOD BM2KB website provides user-friendly search, submit, feedback, and other services. The General Search option allows users to search the knowledge base by selecting the classes (e.g., Experiment, Surface Analysis), their respective attributes (e.g., apparatus, date performed), and the relationships to other classes (e.g., Sample, Laboratory). The Search by Sample option allows users to search the knowledge base based on sample number. The Search by Investigator lets users to search the knowledge base by choosing an investigator who is involved in this project. The website also allows users to submit new data. The Submit Data option opens a page where users can submit the SAFOD data to our knowledge base by selecting specific classes and attributes. The submitted data then become available for query as part of the knowledge base. The SAFOD BM2KB can be accessed from the main SAFOD website.
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Patterson, Carly A; Bishop, Micah A; Pack, Julie D; Cook, Audrey K; Lawhon, Sara D
2016-01-15
To determine the impact of processing delay, temperature, and transport tube type on results of quantitative bacterial culture (QBC) of canine urine. Diagnostic test evaluation. 60 mL of pooled urine from 4 dogs, divided into six 10-mL aliquots. Urine aliquots were spiked with bacteria from 1 of 6 independent Escherichia coli cultures to achieve a target bacterial concentration of 10(5) CFUs/mL. One milliliter from each aliquot was transferred into 5 silicone-coated clot tubes (SCTs) and 5 urine transport tubes (UTTs). Samples were stored at 4°C (39°F) and 25°C (77°F) for 0, 8, and 24 hours, and then standard QBCs were performed. Median bacterial concentration for urine samples stored in a UTT for 24 hours at 4°C was lower than that for samples stored in an SCT under the same conditions. Conversely, a substantial decrease in median bacterial concentration was identified for samples stored for 24 hours in an SCT at 25°C, compared with the median concentration for samples stored in a UTT under the same conditions. Median bacterial concentration in samples stored in an SCT at 25°C for 24 hours (275 CFUs/mL) was less than the cutoff typically used to define clinically important bacteriuria by use of urine samples obtained via cystocentesis (ie, > 1,000 CFUs/mL). Canine urine samples submitted for immediate QBC should be transported in plain sterile tubes such as SCTs. When prolonged (24-hour) storage at room temperature is anticipated, urine samples should be transported in UTTs.
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A Clinical Evaluation Of Cone Beam Computed Tomography
2016-06-01
A CLINICAL EVALUATION OF CONE BEAM COMPUTED TOMOGRAPHY by Bryan James Behm, D.D.S. Lieutenant, Dental Corps United States Navy A thesis...submitted to the Faculty of the Endodontic Graduate Program Naval Postgraduate Dental School Uniformed Services University of the Health Sciences in...partial fulfillment of the requirements for the degree of Master of Science in Oral Biology June 2016 Naval Postgraduate Dental School Unif01med
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Crawford, J. Kent; Loper, Connie A.; Beaman, Joseph R.; Soehl, Anna G.; Brown, Will S.
2007-01-01
States are required by the U.S. Environmental Protection Agency to establish nutrient criteria (concentrations of nutrients above which water quality is deteriorated) as part of their water-quality regulations. A study of wadable streams in the Mid-Atlantic Region was undertaken by the U.S. Geological Survey, the U.S. Environmental Protection Agency, and the Maryland Department of the Environment, with assistance from the Pennsylvania Department of Environmental Protection, to help define current concentrations of nutrients in streams with the goal of associating different nutrient-concentration levels with their effects on water quality. During the summers of 2004 and 2005, diel concentrations of dissolved oxygen, nutrient concentrations, concentrations of chlorophyll a in attached algae, and algal-community structure were measured at 46 stream sites in Maryland, Pennsylvania, Virginia, and West Virginia. Data from this work can be used by individual state agencies to define nutrient criteria. Quality-control measures for the study included submitting blank samples, duplicate samples, and reference samples for analysis of nutrients, total organic carbon, chlorophyll a, and algal biomass. Duplicate and split samples were submitted for periphyton identifications. Three periphyton split samples were sent to an independent lab for a check on periphyton identifications. Neither total organic carbon nor nutrients were detected in blank samples. Concentrations of nutrients and total organic carbon were similar for most duplicate sample pairs, with the exception of a duplicate pair from Western Run. Concentrations of ammonia plus organic nitrogen for this duplicate pair differed by as much as 34 percent. Total organic carbon for the duplicate pair from Western Run differed by 102 percent. The U.S. Geological Survey National Water Quality Laboratory performance on the only valid reference sample submitted was excellent; the relative percent difference values were no larger than 5 percent for any constituent analyzed. For periphyton identifications, duplicate samples had Jaccard Coefficient of Community values slightly greater than 0.5. This indicates the periphyton sampling protocol used provided a sample that was only moderately reproducible. Jaccard Coefficients for three periphyton samples split between two independent labs were 0.2, 0.11, and 0.08. These very low values suggest a poor concurrence on species identifications performed by the two labs. As a result of these quality-control samples, the slides prepared for diatom identifications were sent to the Academy of Natural Sciences for re-identification. Caution is urged when interpreting periphyton-community information from this study. This report and the raw data from the study are available online at http://pubs.usgs.gov/ds257
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[Responsibilities of ethics committees].
von Bergmann, K
1999-01-15
Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.
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[Responsibilities of ethics committees].
von Bergmann, K
2000-05-01
Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.
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Jeffrey, M
1992-10-10
Bovine spongiform encephalopathy was not confirmed histologically in 225 of 829 bovine brains submitted for diagnosis. Several previously described disorders of the central nervous system were observed in these brains as well as disorders not previously recognised in Britain, including bilateral vacuolation of the substantia nigra, hippocampal sclerosis with brainstem neuronal chromatolysis and necrosis, focal symmetrical encephalomalacia and meningio-angiomatosis. Severe cerebellar dysplasia consistent with pre-natal bovine viral diarrhoea--mucosal disease virus infection or mineralisation of the blood vessels of the basal ganglia were interpreted respectively as congenital changes or changes due to ageing and were considered to be of no clinical significance.
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Post STS-134 Evaluation of Main Flame Deflector Witness Materials
NASA Technical Reports Server (NTRS)
Long, Victoria
2011-01-01
NASA and USA design engineers submitted witness materials from the solid rocket booster (SRB) main flame deflector for evaluation after the launch of STS-134. The following items were submitted for analysis: 1018 steel witness rods 304 stainless steel caps, tungsten pistons, and A-286 piston sleeves. All of the items were photographed in order to document their condition after the launch of STS-134. All of the items were dimensionally measured in order to determine the amount of material lost during launch. Microstructural changes were observed in the 1018 witness rod metallographic samples due to the heat of the launch
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NASA Astrophysics Data System (ADS)
Leal-Junior, Arnaldo; Frizera, Anselmo; Marques, Carlos; Pontes, Maria José
2018-07-01
This paper presents the dynamic mechanical analysis (DMA) in polymer optical fibers (POFs) made of Polymethyl Methacrylate (PMMA) that were submitted to different thermal and chemical treatments, namely annealing and etching processes. The prepared samples were submitted to stress-strain cycles to evaluate the Young's modulus of each fiber. Also, test with constant stress and temperature variation were performed to estimate the thermal expansion coefficient of the fibers submitted to each thermal and chemical treatment. The samples were also tested under different temperature, humidity and strain cycle frequency conditions to analyze the variation of their mechanical properties with these parameters. Results show that the thermal and chemical treatments lead to a reduction of Young's modulus and an increase of the thermal expansion coefficient, which can produce sensors based on intensity variation or fiber Bragg grating with higher dynamic range, stress and temperature sensitivity. Furthermore, the etching and annealing resulted in fiber that presents lower Young's modulus variation with temperature, humidity and strain cycling frequency in most cases. However, the annealing made under water and the combinations of etching and annealing resulted in POFs with higher modulus variation with humidity, which enable their application as intensity variation or FBG-based sensors in humidity/moisture assessment.
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Gazola, Eloá Aguiar; Rego, Marcos Augusto; Brandt, William Cunha; D’Arce, Maria Beatriz Freitas; Liporoni, Priscila Christiane Suzy
2015-01-01
Abstract Objective: The aim of this study was to evaluate the Knoop hardness number (KHN) of methacrylate (MC) and silorane (SC) composites after being submitted to erosion and abrasion processes. Material and methods: Forty samples were made with each composite: MC and SC. The samples were divided into eight groups (n = 10) according to the type of composite (G1–G4, MC; G5–G8, SC) and the beverages involved in the erosion process (G1 and G5 – Control (C), without erosion, with abrasion; G2 and G6 – Orange Juice (OJ), abrasion; G3 and G7 – Smirnoff Ice® (SI), abrasion; G4 and G8 – Gatorade® (GA), abrasion). The KHN test was performed 24 h after the last cycle of erosion/abrasion. Results: The MC groups showed smaller KHN values for the SI group (p < 0.05) when compared to the Control and OJ groups; however, for the SC groups, no differences were found (p > 0.05). Conclusion: Methacrylate composite when submitted to acidic beverages erosive challenge combined with abrasive process might alter its surface microhardness. However, the beverages used in the present study were not able to interfere in silorane composite surface microhardness. PMID:28642903
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Targeting Sulfotransferase (SULT) 2B1b as a Regulator of Cholesterol Metabolism in Prostate Cancer
2015-10-01
Roswell Park shared resource to arrange for sample analysis. Determine requirements for analysis: Completed, several samples of LNCaP with siRNA-based...SULT2b1knocked down greater than 80% were submitted to The Roswell park shared resource for lipid analysis Cell lines used: wt LNCaP, VCaP
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AlGaAsSb Vapor Phase Epitaxy and Laser Program.
1983-06-01
graded or step-graded ternary film structures to fulfill the role of a sub- strate. One of the objectives of the program, however, was to determine the...0.02 ur/mmn. 27 MRDC81-14083 Fig. 11 RED pattern of the ( iaSb sample of Fig. 6. 28 7- 7 crystal. No samples from this group were submitted to SEM
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Transistor step stress testing program for JANTX2N2484
NASA Technical Reports Server (NTRS)
1979-01-01
The effect of power/temperature step stress when applied to the transistor JANTX2N2484, manufactured by Raytheon and Teledyne was evaluated. Forty-eight samples from each manufacturer were divided equally (16 per group) into three groups and submitted to the processes outlined. In addition, two control sample units were maintained for verification of the electrical parametric testing.
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ERIC Educational Resources Information Center
Spratley, Ernell; Johnson, Ayah; Sochalski, Julie; Fritz, Marshall; Spencer, William
The characteristics, education, employment patterns, salaries, job satisfaction, and other characteristics of registered nurses (RNs) across the United States were examined in a national survey. Of the initial sample of approximately 54,000 of the nation's more than 3,066,000 licensed RNs, 35,579 RNs (72%) submitted usable responses. From 1980 to…
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
... sufficient samples of the product, or samples that are identical in all material respects to the product. The... 1220, Safety Standards for Full-Size Baby Cribs and Non-Full- Size Baby Cribs. A true copy, in English... assessment bodies seeking accredited status must submit to the Commission copies, in English, of their...
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Crössmann, Alexander; Pauli, Paul
2006-01-01
Background The Illness Attitude Scales (IAS), designed by Kellner in 1986, assesses fears, beliefs, and attitudes associated with hypochondriasis and abnormal illness behaviour. However, its factor structure is, especially for translations of the IAS, not sufficiently explored. Thus, the present Study aimed to analyse the factor structure of the IAS in a German student and a patient population using exploratory factor analysis. Methods A mixed student (N = 296) and a mixed patient (N = 130) sample completed the IAS. The data was submitted to principal components analyses (PCA) with subsequent oblique rotations. From identified factor structures, scales were derived and submitted to reliability analyses as well as to a preliminary validity analysis. Results The PCA revealed a four-factor solution in the student sample: (1) fear of illness and death; (2) treatment experience; (3) hypochondriacal beliefs; and (4) effect of symptoms. In the patient sample, the data was best explained by a two-factor solution: (1) health related anxiety and (2) effect of symptoms and treatment experience. All scales reached good to acceptable reliability coefficients. The scales derived from the student sample and those derived from the patient sample were able to distinguish between pain patients and a matched group of normal controls. Conclusion Our data suggests that the IAS is in student samples best represented by a four factor-solution and in patient samples by a two-factor-solution. PMID:17067384
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Jacomelli, Márcia; Silva, Priscila Regina Alves Araújo; Rodrigues, Ascedio Jose; Demarzo, Sergio Eduardo; Seicento, Márcia; Figueiredo, Viviane Rossi
2012-01-01
To evaluate the diagnostic accuracy of bronchoscopy in patients with clinical or radiological suspicion of tuberculosis who were unable to produce sputum or with negative sputum smear microscopy results. A prospective cross-sectional study involving 286 patients under clinical or radiological suspicion of having pulmonary tuberculosis and submitted to bronchoscopy-BAL and transbronchial biopsy (TBB). The BAL specimens were submitted to direct testing and culture for AFB and fungi, whereas the TBB specimens were submitted to histopathological examination. Of the 286 patients studied, 225 (79%) were diagnosed on the basis of bronchoscopic findings, as follows: pulmonary tuberculosis, in 127 (44%); nonspecific chronic inflammation, in 51 (18%); pneumocystis, fungal infections, or nocardiosis, in 20 (7%); bronchiolitis obliterans organizing pneumonia, alveolites, or pneumoconiosis, in 14 (5%); lung or metastatic neoplasms, in 7 (2%); and nontuberculous mycobacterium infections, in 6 (2%). For the diagnosis of tuberculosis, BAL showed a sensitivity and a specificity of 60% and 100%, respectively. Adding the TBB findings significantly increased this sensitivity (to 84%), as did adding the post-bronchoscopy sputum smear microscopy results (total sensitivity, 94%). Minor post-procedure complications occurred in 5.6% of the cases. Bronchoscopy is a reliable method for the diagnosis of pulmonary tuberculosis, with low complication rates. The combination of TBB and BAL increases the sensitivity of the method and facilitates the differential diagnosis with other diseases.
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Carroll, Christopher; Tappenden, Paul; Rafia, Rachid; Hamilton, Jean; Chambers, Duncan; Clowes, Mark; Durrington, Paul; Qureshi, Nadeem; Wierzbicki, Anthony S
2016-11-16
As part of its Single Technology Appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of evolocumab (Amgen) to submit evidence on the clinical and cost effectiveness of evolocumab. The appraisal assessed evolocumab as monotherapy or in combination with a statin (HMG-CoA reductase inhibitor) with or without ezetimibe, or in combination with ezetimibe (without statin therapy), in adult patients with primary hypercholesterolaemia (which includes mixed dyslipidaemia), for whom statins do not provide optimal control of their low-density lipoprotein cholesterol (LDL-C) levels and/or for whom statins are contraindicated or not tolerated. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology, based on the company's submission to NICE. The evidence was derived mainly from four randomised controlled trials comparing evolocumab either with ezetimibe or placebo in adults with primary familial or non-familial hypercholesterolaemia, who were either able to take statins or who were statin-intolerant. The clinical effectiveness review found that evolocumab is efficacious at lowering LDL-C but that there was uncertainty regarding its impact on cardiovascular disease outcomes. In response to the ERG's critique of the submitted health economic model, the company submitted an amended model, which also included a Patient Access Scheme (PAS). Based on this, the deterministic incremental cost-effectiveness ratios (ICERs) for evolocumab against ezetimibe were above £74,000 and £45,000 per quality-adjusted life-year (QALY) gained within the non-familial primary and secondary prevention population, respectively, whilst the ICERs within the heterozygous familial hypercholesterolaemia population were approximately £23,000 per QALY gained. The final determination was that evolocumab would be a clinically and cost effective use of UK National Health Service resources in certain patient subgroups.
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76 FR 62068 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-06
... methodological objectives. The first objective is to test the feasibility of the proposed sampling frame and to... minutes. Results of the methodological component of the feasibility study will be used to assess the...
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Toxicological findings in fatally injured pilots of 979 amateur-built aircraft accidents.
DOT National Transportation Integrated Search
2011-12-01
"Biological samples collected from fatally injured pilots in aviation accidents involving all types of aircraft, including : amateur-built aircraft, are submitted to the Civil Aerospace Medical Institute (CAMI) for accident investigation. : These sam...
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7 CFR 28.25 - Samples for Form A determination.
Code of Federal Regulations, 2014 CFR
2014-01-01
... each side of the bale, and the portion of cotton removed from each cut should be broken in half across... provided the outside portion from each side is submitted for the official classification. (d) Dressing...
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7 CFR 28.25 - Samples for Form A determination.
Code of Federal Regulations, 2012 CFR
2012-01-01
... each side of the bale, and the portion of cotton removed from each cut should be broken in half across... provided the outside portion from each side is submitted for the official classification. (d) Dressing...
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7 CFR 28.25 - Samples for Form A determination.
Code of Federal Regulations, 2013 CFR
2013-01-01
... each side of the bale, and the portion of cotton removed from each cut should be broken in half across... provided the outside portion from each side is submitted for the official classification. (d) Dressing...
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Keuken, Debby G; Haafkens, Joke A; Klazinga, Niek S
2007-10-24
Several measures have been implemented at international level to ensure that there is a greater focus on sex differences in health research. This study evaluates the effect of various formal incentives that were introduced by a Dutch financer of health research to encourage applicants to include sex differences in research proposals. We sampled 213 health research proposals submitted in 2003 to the programmes Prevention (N = 104) and Innovation (N = 109) by the Netherlands Organization for Health Research and Development (ZonMw). These proposals were analysed and categorized with regard to the expressed intention to take sex differences into consideration. Furthermore, those proposals in which such intention was absent were appraised by researchers to determine whether an intention of this kind would have been relevant. We found that 23 % of proposals submitted to Prevention (incentive: programme specific instructions) and 10% of those submitted to Innovation (general set of guidelines) took account of sex differences (difference 13%; 95% CI: 3.1-22.9). Conversely, 66% of the research proposals in Prevention, and 20% in Innovation, failed to take sex differences into consideration, even though this might well have been relevant. There is still insufficient incentive for those submitting research proposals to ZonMw to systematically incorporate sex differences when drafting such documents. The provisions in ZonMw's policy need to be amended and better monitored. For this, we formulated some recommendations.
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Transistor step stress testing program for JANTX2N2905A
NASA Technical Reports Server (NTRS)
1979-01-01
The effect of power/temperature step stress when applied to the transistor JANTX2N2905A manufactured by Texas Instruments and Motorola is reported. A total of 48 samples from each manufacturer was submitted to the process outlined. In addition, two control sample units were maintained for verification of the electrical parametric testing. All test samples were subjected to the electrical tests outlined in Table 2 after completing the prior power/temperature step stress point.
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Greven, Marcus; Wismeijer, Daniel
2017-01-01
PURPOSE To integrate extra-oral facial scanning information with CAD/CAM complete dentures to immediately rehabilitate terminal dentition. MATERIALS AND METHODS Ten patients with terminal dentition scheduled for total extraction and immediate denture placement were recruited for this study. The patients were submitted to a facial scanning procedure using the in-office PritiMirror scanner with bite registration records in-situ. Definitive stone cast models and bite records were subsequently submitted to a lab scanning procedure using the lab scanner (iSeries DWOS; Dental Wings). The scanned models were used to create a virtual teeth setup of a complete denture. Using the intra-oral bite records as a reference, the virtual setup was incorporated in the facial scan thereby facilitating a virtual clinical evaluation (teeth try-in) phase. After applying necessary adjustments, the virtual setup was submitted to a CAM procedure where a 5-axis industrial milling machine (M7 CNC; Darton AG General) was used to fabricate a full-milled PMMA immediate provisional prosthesis. RESULTS Total extractions were performed, the dentures were immediately inserted, and subjective clinical fit was evaluated. The immediate provisional prostheses were inserted and clinical fit, occlusion/articulation, and esthetics were subjectively assessed; the results were deemed satisfactory. All provisional prostheses remained three months in function with no notable technical complications. CONCLUSION Ten patients with terminal dentition were treated using a complete digital approach to fabricate complete dentures using CAD/CAM technology. The proposed technique has the potential to accelerate the rehabilitation procedure starting from immediate denture to final implant-supported prosthesis leading to more predictable functional and aesthetics outcomes. PMID:29142646
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Rueda, Sylvia; Fathima, Sana; Knight, Caroline L; Yaqub, Mohammad; Papageorghiou, Aris T; Rahmatullah, Bahbibi; Foi, Alessandro; Maggioni, Matteo; Pepe, Antonietta; Tohka, Jussi; Stebbing, Richard V; McManigle, John E; Ciurte, Anca; Bresson, Xavier; Cuadra, Meritxell Bach; Sun, Changming; Ponomarev, Gennady V; Gelfand, Mikhail S; Kazanov, Marat D; Wang, Ching-Wei; Chen, Hsiang-Chou; Peng, Chun-Wei; Hung, Chu-Mei; Noble, J Alison
2014-04-01
This paper presents the evaluation results of the methods submitted to Challenge US: Biometric Measurements from Fetal Ultrasound Images, a segmentation challenge held at the IEEE International Symposium on Biomedical Imaging 2012. The challenge was set to compare and evaluate current fetal ultrasound image segmentation methods. It consisted of automatically segmenting fetal anatomical structures to measure standard obstetric biometric parameters, from 2D fetal ultrasound images taken on fetuses at different gestational ages (21 weeks, 28 weeks, and 33 weeks) and with varying image quality to reflect data encountered in real clinical environments. Four independent sub-challenges were proposed, according to the objects of interest measured in clinical practice: abdomen, head, femur, and whole fetus. Five teams participated in the head sub-challenge and two teams in the femur sub-challenge, including one team who tackled both. Nobody attempted the abdomen and whole fetus sub-challenges. The challenge goals were two-fold and the participants were asked to submit the segmentation results as well as the measurements derived from the segmented objects. Extensive quantitative (region-based, distance-based, and Bland-Altman measurements) and qualitative evaluation was performed to compare the results from a representative selection of current methods submitted to the challenge. Several experts (three for the head sub-challenge and two for the femur sub-challenge), with different degrees of expertise, manually delineated the objects of interest to define the ground truth used within the evaluation framework. For the head sub-challenge, several groups produced results that could be potentially used in clinical settings, with comparable performance to manual delineations. The femur sub-challenge had inferior performance to the head sub-challenge due to the fact that it is a harder segmentation problem and that the techniques presented relied more on the femur's appearance.
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Boyle, A G; Rankin, S C; Duffee, L A; Morris, D
2017-09-01
Methicillin-resistant Staphylococcus aureus (MRSA) is recognized as a cause of nosocomial infections in both human and veterinary medicine. Studies that examine the nasopharynx and guttural pouches of the horse as carriage sites for MRSA have not been reported. MRSA colonizes the nasopharynx and guttural pouch of horses. To determine the prevalence of MRSA in equine nasopharyngeal wash (NPW) and guttural pouch lavage (GPL) samples in a field population of horses. One hundred seventy-eight samples (123 NPW and 55 GPL) from 108 horses. Prospective study. Samples were collected from a convenience population of clinically ill horses with suspected Streptococcus equi subsp. equi (S. equi) infection, horses convalescing from a known S. equi infection, and asymptomatic horses undergoing S. equi screening. Samples were submitted for S. aureus aerobic bacterial culture with mannitol salt broth and two selective agars (cefoxitin CHROMagar as the PBP2a inducer and mannitol salt agar with oxacillin). Biochemical identification of Staphylococcus species and pulsed-field gel electrophoresis (PFGE), to determine clonal relationships between isolates, were performed. Methicillin-resistant Staphylococcus (MRS) was isolated from the nasopharynx of 7/108 (4%) horses. Three horses had MRSA (2.7%), and 4 had MR-Staphylococcus pseudintermedius (MRSP). MRSA was isolated from horses on the same farm. PFGE revealed the 3 MRSA as USA 500 strains. Sampling the nasopharynx and guttural pouch of community-based horses revealed a similarly low prevalence rate of MRSA as other studies sampling the nares of community-based horses. More study is required to determine the need for sampling multiple anatomic sites when screening horses for MRSA. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
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Griemberg, Gloria; Ferrarotti, Nidia F; Svibel, Graciela; Ravelli, Maria R; Taranto, Nestor J; Malchiodi, Emilio L; Pizzimenti, Maria C
2006-01-01
Anti-native DNA antibodies can be detected by indirect immunofluorescence assay with Crithidia luciliae, displaying an annular image due to a kinetoplast containing double stranded DNA. Other structures such as membrane, flagellum and basal corpuscle can be stained as well, showing what is called atypical fluorescent images. As C. luciliae belongs to the Trypanosomatidae family, which include the human pathogens Trypanosoma cruzi and Leishmania spp., it was considered that these atypical images could be caused by cross-reactions. Serological studies for Chagas' disease were performed in 105 serum samples displaying atypical images. Sixty four percent of the samples from non endemic and 78.3% from endemic areas for Chagas' disease showed fluorescence in both, membrane and flagellum (joint image). Fifty samples from normal blood donors and 57 samples from patients with conective tissue diseases were tested with C. luciliae. None of them presented the joint image except for two patients with lupus who were also chagasic. In addition, 54 samples from chagasic patients were studied and all of them presented the joint image. We also studied 46 samples from patients with leishmaniasis from whom 28 were coinfected with T. cruzi. The joint image was observed in 88.0% of the samples with leishmaniasis and in 89.3% of the co-infected samples. The results suggest that C. luciliae could be used as an economical, and of low risk, alternative substrate for the serological diagnosis of Chagas' disease, even though it does not discriminate for Leishmania spp. infection. This study also suggests that whenever atypical images are observed in C. luciliae during the search for anti-DNA antibodies, it would be convenient to submit the patient to clinical and serological tests for the diagnosis of leishmaniosis and Chagas' disease.
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Kirk, Shelley; Armstrong, Sarah; King, Eileen; Trapp, Christine; Grow, Mollie; Tucker, Jared; Joseph, Madeline; Liu, Lenna; Weedn, Ashley; Sweeney, Brooke; Fox, Claudia; Fathima, Samreen; Williams, Ronald; Kim, Roy; Stratbucker, William
2017-02-01
Prospective patient registries have been successfully utilized in several disease states with a goal of improving treatment approaches through multi-institutional collaboration. The prevalence of youth with severe obesity is at a historic high in the United States, yet evidence to guide effective weight management is limited. The Pediatric Obesity Weight Evaluation Registry (POWER) was established in 2013 to identify and promote effective intervention strategies for pediatric obesity. Sites in POWER provide multicomponent pediatric weight management (PWM) care for youth with obesity and collect a defined set of demographic and clinical parameters, which they regularly submit to the POWER Data Coordinating Center. A program profile survey was completed by sites to describe characteristics of the respective PWM programs. From January 2014 through December 2015, 26 US sites were enrolled in POWER and had submitted data on 3643 youth with obesity. Ninety-five percent were 6-18 years of age, 54% female, 32% nonwhite, 32% Hispanic, and 59% publicly insured. Over two-thirds had severe obesity. All sites included a medical provider and used weight status in their referral criteria. Other program characteristics varied widely between sites. POWER is an established national registry representing a diverse sample of youth with obesity participating in multicomponent PWM programs across the United States. Using high-quality data collection and a collaborative research infrastructure, POWER aims to contribute to the development of evidence-based guidelines for multicomponent PWM programs.
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Diversity of Hepatozoon species in naturally infected dogs in the southern United States.
Allen, Kelly E; Li, Yihang; Kaltenboeck, Bernhard; Johnson, Eileen M; Reichard, Mason V; Panciera, Roger J; Little, Susan E
2008-07-04
Hepatozoon americanum is a protozoan that causes American canine hepatozoonosis (ACH) in the southern United States; Hepatozoon canis, the causative agent of canine hepatozoonosis in Africa, Asia, Europe, and South America, has not previously been definitively identified in dogs in the United States. To characterize the diversity of Hepatozoon spp. in domestic dogs from Oklahoma, blood samples collected from dogs residing in an endemic area of the state, clinical cases presented to veterinarians with symptoms of ACH, and dogs housed at a local shelter were evaluated by a nested PCR designed to amplify a variable region of the 18S rRNA gene of blood ampicomplexa, including Hepatozoon spp. Hepatozoon sequences recovered from a dog from an area where ACH is endemic, from clinically ill dogs, and from one shelter dog most closely resembled H. americanum. However, two other shelter dogs had evidence of infection with H. canis or a closely related organism. A subsequent review of real-time PCR results from the Molecular Diagnostics Laboratory at Auburn University revealed that the majority of samples submitted from dogs from across the United States which tested positive for Hepatozoon spp. had H. americanum. However, some submissions were also found which contained DNA sequence of H. canis. Mixed H. americanum and H. canis-like infections also were detected. Our data suggest that H. americanum, H. canis, as well as H. canis-like organisms are present and may cause disease in dogs in the southern U.S.
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Peters, L M; Glanemann, B; Garden, O A; Szladovits, B
2016-01-01
Cholecystocentesis can be part of the diagnostic workup of hepatobiliary disease in small animals, but literature on cytological evaluation of bile is scant. To determine the diagnostic utility of cytological assessment of bile aspirates. Fifty-six and 78 client-owned dogs and cats, respectively, with bile collected by cholecystocentesis and submitted to our diagnostic laboratory between 1999 and 2014. Retrospective study describing cytological findings of bile, concurrent bacterial culture results, hematological and serum biochemical data, gallbladder biopsy results, as well as final diagnosis and complications after cholecystocentesis. Infectious agents were found in 30% of canine and 22% of feline bile aspirates, and inflammation in 5% and 19% respectively. Presence of microorganisms was more often detected on cytological examination (24%) than by culture (21%). The most common bacterial isolates were Escherichia coli and Enterococcus spp., isolated from 14.8% and 6.7% of cultured samples respectively. Only increased canine pancreatic lipase immunoreactivity concentration (cPLI) was significantly associated with the presence of microorganisms, inflammatory cells, or both in bile. Clinically relevant complications of cholecystocentesis occurred in 2 dogs. The majority of the animals undergoing cholecystocentesis suffered from hepatic, pancreatic, gastrointestinal disease, or a combination thereof. Cytological examination of bile is inexpensive and straightforward, and yields diagnostically relevant information that precedes and complements bacterial culture. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
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VINEGAR AS AN ANTIMICROBIAL AGENT FOR CONTROL OF Candida spp. IN COMPLETE DENTURE WEARERS
Pinto, Telma Maria Silva; Neves, Ana Christina Claro; Leão, Mariella Vieira Pereira; Jorge, Antonio Olavo Cardoso
2008-01-01
The use of denture is known to increase the carriage of Candida in healthy patients, and the proliferation of Candida albicans strains can be associated with denture-induced stomatitis. The aim of this study was to evaluate the use of vinegar as an antimicrobial agent for control of Candida spp. in complete upper denture wearers. Fifty-five patients were submitted to a detailed clinical interview and oral clinical examination, and were instructed to keep their dentures immersed in a 10% vinegar solution (pH less than 3) overnight for 45 days. Before and after the experimental period, saliva samples were collected for detection of Candida, counting of cfu/mL and identification of species by phenotypical tests (germ tube formation, chlamidoconidia production, and carbohydrate fermentation and assimilation). The results were analyzed using Spearman's correlation and Student's t-test (p≤0.05). Candida yeasts were present in 87.3% of saliva samples before the treatment. A significant reduction was verified in CFU/mL counts of Candida after treatment. A positive correlation between Candida and denture stomatitis was verified, since the decrease of cfu/mL counts was correlated with a reduction in cases of denture stomatitis. Although it was not able to eliminate C. albicans, the immersion of the complete denture in 10% vinegar solution, during the night, reduced the amounts (cfu/mL) of Candida spp. in the saliva and the presence of denture stomatitis in the studied patients. PMID:19082396
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Sato, Yuka; Seimiya, Masanori; Yoshida, Toshihiko; Sawabe, Yuji; Hokazono, Eisaku; Osawa, Susumu; Matsushita, Kazuyuki
2017-01-01
Background The indocyanine green retention rate is important for assessing the severity of liver disorders. In the conventional method, blood needs to be collected twice. In the present study, we developed an automated indocyanine green method that does not require blood sampling before intravenous indocyanine green injections and is applicable to an automated biochemical analyser. Methods The serum samples of 471 patients collected before and after intravenous indocyanine green injections and submitted to the clinical laboratory of our hospital were used as samples. The standard procedure established by the Japan Society of Hepatology was used as the standard method. In the automated indocyanine green method, serum collected after an intravenous indocyanine green injection was mixed with the saline reagent containing a surfactant, and the indocyanine green concentration was measured at a dominant wavelength of 805 nm and a complementary wavelength of 884 nm. Results The coefficient of variations of the within- and between-run reproducibilities of this method were 2% or lower, and dilution linearity passing the origin was noted up to 10 mg/L indocyanine green. The reagent was stable for four weeks or longer. Haemoglobin, bilirubin and chyle had no impact on the results obtained. The correlation coefficient between the standard method (x) and this method (y) was r=0.995; however, slight divergence was noted in turbid samples. Conclusion Divergence in turbid samples may have corresponded to false negativity with the standard procedure. Our method may be highly practical because blood sampling before indocyanine green loading is unnecessary and measurements are simple.
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Andreasen, C B; Pearson, E G; Smith, B B; Gerros, T C; Lassen, E D
1998-04-01
Fifty clinically healthy llamas, 0.5-13 years of age (22 intact males, 10 neutered males, 18 females), with no biochemical evidence of liver disease or hematologic abnormalities, were selected to establish serum bile acid reference intervals. Serum samples submitted to the clinical pathology laboratory were analyzed using a colorimetric enzymatic assay to establish bile acid reference intervals. A nonparametric distribution of llama bile acid concentrations was 1-23 micromol/liter for llamas >1 year of age and 10-44 micromol/liter for llamas < or = 1 year of age. A significant difference was found between these 2 age groups. No correlation was detected between gender and bile acid concentrations. The reference intervals were 1.1-22.9 micromol/liter for llamas >1 year of age and 1.8-49.8 micromol/liter for llamas < or = 1 year of age. Additionally, a separate group of 10 healthy adult llamas (5 males, 5 females, 5-11 years of age) without biochemical or hematologic abnormalities was selected to assess the effects of feeding and time intervals on serum bile acid concentrations. These 10 llamas were provided fresh water and hay ad libitum, and serum samples were obtained via an indwelling jugular catheter hourly for 11 hours. Llamas were then kept from food overnight (12 hours), and subsequent samples were taken prior to feeding (fasting baseline time, 23 hours after trial initiation) and postprandially at 0.5, 1, 2, 4, and 8 hours. In feeding trials, there was no consistent interaction between bile acid concentrations and time, feeding, or 12-hour fasting. Prior feeding or time of day did not result in serum bile acid concentrations outside the reference interval, but concentrations from individual llamas varied within this interval over time.
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Crestani, Anelise Henrich; Moraes, Anaelena Bragança de; Souza, Ana Paula Ramos de
2017-08-10
To analyze the results of the validation of building enunciative signs of language acquisition for children aged 3 to 12 months. The signs were built based on mechanisms of language acquisition in an enunciative perspective and on clinical experience with language disorders. The signs were submitted to judgment of clarity and relevance by a sample of six experts, doctors in linguistic in with knowledge of psycholinguistics and language clinic. In the validation of reliability, two judges/evaluators helped to implement the instruments in videos of 20% of the total sample of mother-infant dyads using the inter-evaluator method. The method known as internal consistency was applied to the total sample, which consisted of 94 mother-infant dyads to the contents of the Phase 1 (3-6 months) and 61 mother-infant dyads to the contents of Phase 2 (7 to 12 months). The data were collected through the analysis of mother-infant interaction based on filming of dyads and application of the parameters to be validated according to the child's age. Data were organized in a spreadsheet and then converted to computer applications for statistical analysis. The judgments of clarity/relevance indicated no modifications to be made in the instruments. The reliability test showed an almost perfect agreement between judges (0.8 ≤ Kappa ≥ 1.0); only the item 2 of Phase 1 showed substantial agreement (0.6 ≤ Kappa ≥ 0.79). The internal consistency for Phase 1 had alpha = 0.84, and Phase 2, alpha = 0.74. This demonstrates the reliability of the instruments. The results suggest adequacy as to content validity of the instruments created for both age groups, demonstrating the relevance of the content of enunciative signs of language acquisition.
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González, Carolina; Tabernero, David; Cortese, Maria Francesca; Gregori, Josep; Casillas, Rosario; Riveiro-Barciela, Mar; Godoy, Cristina; Sopena, Sara; Rando, Ariadna; Yll, Marçal; Lopez-Martinez, Rosa; Quer, Josep; Esteban, Rafael; Buti, Maria; Rodríguez-Frías, Francisco
2018-05-21
To detect hyper-conserved regions in the hepatitis B virus (HBV) X gene ( HBX ) 5' region that could be candidates for gene therapy. The study included 27 chronic hepatitis B treatment-naive patients in various clinical stages (from chronic infection to cirrhosis and hepatocellular carcinoma, both HBeAg-negative and HBeAg-positive), and infected with HBV genotypes A-F and H. In a serum sample from each patient with viremia > 3.5 log IU/mL, the HBX 5' end region [nucleotide (nt) 1255-1611] was PCR-amplified and submitted to next-generation sequencing (NGS). We assessed genotype variants by phylogenetic analysis, and evaluated conservation of this region by calculating the information content of each nucleotide position in a multiple alignment of all unique sequences (haplotypes) obtained by NGS. Conservation at the HBx protein amino acid (aa) level was also analyzed. NGS yielded 1333069 sequences from the 27 samples, with a median of 4578 sequences/sample (2487-9279, IQR 2817). In 14/27 patients (51.8%), phylogenetic analysis of viral nucleotide haplotypes showed a complex mixture of genotypic variants. Analysis of the information content in the haplotype multiple alignments detected 2 hyper-conserved nucleotide regions, one in the HBX upstream non-coding region (nt 1255-1286) and the other in the 5' end coding region (nt 1519-1603). This last region coded for a conserved amino acid region (aa 63-76) that partially overlaps a Kunitz-like domain. Two hyper-conserved regions detected in the HBX 5' end may be of value for targeted gene therapy, regardless of the patients' clinical stage or HBV genotype.
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Magnetic Resonance Biomarkers in Neonatal Encephalopathy (MARBLE): a prospective multicountry study.
Lally, Peter J; Pauliah, Shreela; Montaldo, Paolo; Chaban, Badr; Oliveira, Vania; Bainbridge, Alan; Soe, Aung; Pattnayak, Santosh; Clarke, Paul; Satodia, Prakash; Harigopal, Sundeep; Abernethy, Laurence J; Turner, Mark A; Huertas-Ceballos, Angela; Shankaran, Seetha; Thayyil, Sudhin
2015-09-30
Despite cooling, adverse outcomes are seen in up to half of the surviving infants after neonatal encephalopathy. A number of novel adjunct drug therapies with cooling have been shown to be highly neuroprotective in animal studies, and are currently awaiting clinical translation. Rigorous evaluation of these therapies in phase II trials using surrogate MR biomarkers may speed up their bench to bedside translation. A recent systematic review of single-centre studies has suggested that MR spectroscopy biomarkers offer the best promise; however, the prognostic accuracy of these biomarkers in cooled encephalopathic babies in a multicentre setting using different MR scan makers is not known. The MR scanners (3 T; Philips, Siemens, GE) in all the participating sites will be harmonised using phantom experiments and healthy adult volunteers before the start of the study. We will then recruit 180 encephalopathic infants treated with whole body cooling from the participating centres. MRI and spectroscopy will be performed within 2 weeks of birth. Neurodevelopmental outcomes will be assessed at 18-24 months of age. Agreement between MR cerebral biomarkers and neurodevelopmental outcome will be reported. The sample size is calculated using the 'rule of 10', generally used to calculate the sample size requirements for developing prognostic models. Considering 9 parameters, we require 9×10 adverse events, which suggest that a total sample size of 180 is required. Human Research Ethics Committee approvals have been received from Brent Research Ethics Committee (London), and from Imperial College London (Sponsor). We will submit the results of the study to relevant journals and offer national and international presentations. Clinical Trials.gov Number: NCT01309711. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Effect of a Novel Engagement Strategy Using Twitter on Test Performance.
Webb, Amanda L; Dugan, Adam; Burchett, Woodrow; Barnett, Kelly; Patel, Nishi; Morehead, Scott; Silverberg, Mark; Doty, Christopher; Adkins, Brian; Falvo, Lauren
2015-11-01
Medical educators in recent years have been using social media for more penetrance to technologically-savvy learners. The utility of using Twitter for curriculum content delivery has not been studied. We sought to determine if participation in a social media-based educational supplement would improve student performance on a test of clinical images at the end of the semester. 116 second-year medical students were enrolled in a lecture-based clinical medicine course, in which images of common clinical exam findings were presented. An additional, optional assessment was performed on Twitter. Each week, a clinical presentation and physical exam image (not covered in course lectures) were distributed via Twitter, and students were invited to guess the exam finding or diagnosis. After the completion of the course, students were asked to participate in a slideshow "quiz" with 24 clinical images, half from lecture and half from Twitter. We conducted a one-way analysis of variance to determine the effect Twitter participation had on total, Twitter-only, and lecture-only scores. Twitter participation data was collected from the end-of-course survey and was defined as submitting answers to the Twitter-only questions "all or most of the time", "about half of the time", and "little or none of the time." We found a significant difference in overall scores (p<0.001) and in Twitter-only scores (p<0.001). There was not enough evidence to conclude a significant difference in lecture-only scores (p=0.124). Students who submitted answers to Twitter "all or most of the time" or "about half the time" had significantly higher overall scores and Twitter-only scores (p<0.001 and p<0.001, respectively) than those students who only submitted answers "little or none of the time." While students retained less information from Twitter than from traditional classroom lecture, some retention was noted. Future research on social media in medical education would benefit from clear control and experimental groups in settings where quantitative use of social media could be measured. Ultimately, it is unlikely for social media to replace lecture in medical curriculum; however, there is a reasonable role for social media as an adjunct to traditional medical education.
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Clinical Features of Infectious Keratitis Caused by Propionibacterium Acnes.
Lim, Sung A; Na, Kyung-Sun; Joo, Choun-Ki
2017-09-01
Propionibacterium acnes is a commensal bacteria whose pathogenicity in infectious keratitis is unclear. In this study, we report infectious keratitis cultured with P. acnes and evaluate its clinical characteristics. All cases of infectious keratitis submitted to the microbiology laboratory of St. Mary's Hospital of Seoul between January 2013 and April 2014 were reviewed. Nonpretreated cases that were positive for P. acnes were identified, and clinical characteristics and treatment outcomes were studied. Of 132 cultures submitted to the microbiology laboratory, 89 (67.4%) were positive for growth, and a total of 16 (17.9%) of the 89 cases yielded P. acnes in culture medium. Infectious keratitis that was positive for P. acnes was generally small (62.5%) with deep stromal infiltration (81.25%) and a peripheral location (56.25%). The average incubation period was 11.06±5.76 days, and the average time to reepithelialization was 23.50+13.52 days. All the cases of P. acnes evaluated in this report responded well to medical treatment. Infectious keratitis with P. acnes is not uncommon and can be confused with other Gram-positive cocci. Thus, P. acnes should be suspected in small-sized keratitis with an unusually long incubation period.
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GELLO: an object-oriented query and expression language for clinical decision support.
Sordo, Margarita; Ogunyemi, Omolola; Boxwala, Aziz A; Greenes, Robert A
2003-01-01
GELLO is a purpose-specific, object-oriented (OO) query and expression language. GELLO is the result of a concerted effort of the Decision Systems Group (DSG) working with the HL7 Clinical Decision Support Technical Committee (CDSTC) to provide the HL7 community with a common format for data encoding and manipulation. GELLO will soon be submitted for ballot to the HL7 CDSTC for consideration as a standard.
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A Hybrid Approach to Clinical Question Answering
2014-11-01
participation in TREC, we submitted a single run using a hybrid Natural Language Processing ( NLP )-driven approach to accomplish the given task. Evaluation re...for the CDS track uses a variety of NLP - based techniques to address the clinical questions provided. We present a description of our approach, and...discuss our experimental setup, results and eval- uation in the subsequent sections. 2 Description of Our Approach Our hybrid NLP -driven method presents a
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Koenig, Vinciane; Wulfman, Claudine P; Derbanne, Mathieu A; Dupont, Nathalie M; Le Goff, Stéphane O; Tang, Mie-Leng; Seidel, Laurence; Dewael, Thibaut Y; Vanheusden, Alain J; Mainjot, Amélie K
2016-12-15
Recent introduction of computer-aided design/computer-aided manufacturing (CAD/CAM) monolithic zirconia dental prostheses raises the issue of material low thermal degradation (LTD), a well-known problem with zirconia hip prostheses. This phenomenon could be accentuated by masticatory mechanical stress. Until now zirconia LTD process has only been studied in vitro . This work introduces an original protocol to evaluate LTD process of monolithic zirconia prostheses in the oral environment and to study their general clinical behavior, notably in terms of wear. 101 posterior monolithic zirconia tooth elements (molars and premolars) are included in a 5-year prospective clinical trial. On each element, several areas between 1 and 2 mm 2 (6 on molars, 4 on premolars) are determined on restoration surface: areas submitted or non-submitted to mastication mechanical stress, glazed or non-glazed. Before prosthesis placement, ex vivo analyses regarding LTD and wear are performed using Raman spectroscopy, SEM imagery and 3D laser profilometry. After placement, restorations are clinically evaluated following criteria of the World Dental Federation (FDI), complemented by the analysis of fracture clinical risk factors. Two independent examiners perform the evaluations. Clinical evaluation and ex vivo analyses are carried out after 6 months and then each year for up to 5 years. For clinicians and patients, the results of this trial will justify the use of monolithic zirconia restorations in dental practice. For researchers, the originality of a clinical study including ex vivo analyses of material aging will provide important data regarding zirconia properties.Trial registration: ClinicalTrials.gov Identifier: NCT02150226.
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Stedtfeld, Robert D.; Williams, Maggie R.; Fakher, Umama; Johnson, Timothy A.; Stedtfeld, Tiffany M.; Wang, Fang; Khalife, Walid T.; Hughes, Mary; Etchebarne, Brett E.; Tiedje, James M.; Hashsham, Syed A.
2016-01-01
An antibiotic resistance (AR) Dashboard application is being developed regarding the occurrence of antibiotic resistance genes (ARG) and bacteria (ARB) in environmental and clinical settings. The application gathers and geospatially maps AR studies, reported occurrence and antibiograms, which can be downloaded for offline analysis. With the integration of multiple data sets, the database can be used on a regional or global scale to identify hot spots for ARGs and ARB; track and link spread and transmission, quantify environmental or human factors influencing presence and persistence of ARG harboring organisms; differentiate natural ARGs from those distributed via human or animal activity; cluster and compare ARGs connections in different environments and hosts; and identify genes that can be used as proxies to routinely monitor anthropogenic pollution. To initially populate and develop the AR Dashboard, a qPCR ARG array was tested with 30 surface waters, primary influent from three waste water treatment facilities, ten clinical isolates from a regional hospital and data from previously published studies including river, park soil and swine farm samples. Interested users are invited to download a beta version (available on iOS or Android), submit AR information using the application, and provide feedback on current and prospective functionalities. PMID:26850162
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Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam
2017-12-08
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis. © 2017 American Society for Clinical Pharmacology and Therapeutics.
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30 CFR 250.469 - What other well records could I be required to submit?
Code of Federal Regulations, 2010 CFR
2010-07-01
... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations... reports identifying microscopic fossils by depth and/or washed samples of drill cuttings that you normally...
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40 CFR 146.87 - Logging, sampling, and testing prior to injection well operation.
Code of Federal Regulations, 2014 CFR
2014-07-01
... owner or operator must submit to the Director a descriptive report prepared by a knowledgeable log... installed; and (ii) A cement bond and variable density log to evaluate cement quality radially, and a...
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40 CFR 146.87 - Logging, sampling, and testing prior to injection well operation.
Code of Federal Regulations, 2012 CFR
2012-07-01
... owner or operator must submit to the Director a descriptive report prepared by a knowledgeable log... installed; and (ii) A cement bond and variable density log to evaluate cement quality radially, and a...
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40 CFR 146.87 - Logging, sampling, and testing prior to injection well operation.
Code of Federal Regulations, 2011 CFR
2011-07-01
... owner or operator must submit to the Director a descriptive report prepared by a knowledgeable log... installed; and (ii) A cement bond and variable density log to evaluate cement quality radially, and a...
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40 CFR 146.87 - Logging, sampling, and testing prior to injection well operation.
Code of Federal Regulations, 2013 CFR
2013-07-01
... owner or operator must submit to the Director a descriptive report prepared by a knowledgeable log... installed; and (ii) A cement bond and variable density log to evaluate cement quality radially, and a...
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Code of Federal Regulations, 2012 CFR
2012-10-01
..., renderings, models, depictions or samples of exterior materials and components, and photographs of existing..., interested members of the public, or the submitting party may augment any submission by additional relevant...
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Code of Federal Regulations, 2013 CFR
2013-10-01
..., renderings, models, depictions or samples of exterior materials and components, and photographs of existing..., interested members of the public, or the submitting party may augment any submission by additional relevant...
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Code of Federal Regulations, 2011 CFR
2011-10-01
..., renderings, models, depictions or samples of exterior materials and components, and photographs of existing..., interested members of the public, or the submitting party may augment any submission by additional relevant...
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Code of Federal Regulations, 2014 CFR
2014-10-01
..., renderings, models, depictions or samples of exterior materials and components, and photographs of existing..., interested members of the public, or the submitting party may augment any submission by additional relevant...
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78 FR 18599 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-27
... performance of the functions of the agency, including whether the information shall have practical utility; (b... samples for two waves of the National Study of Long-Term Care Providers (NSLTCP). The frame- related data...
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Mankertz, Annette; Beutel, Ulrike; Schmidt, Franz-Josef; Borgmann, Stefan; Wenzel, Jürgen J; Ziegler, Peter; Weißbrich, Benedikt; Santibanez, Sabine
2015-10-01
From 2008 to 2013, sample sets from 534 patients displaying clinical symptoms of mumps were submitted to the German Reference Centre for Measles, Mumps and Rubella. Mumps virus infection was confirmed in 216 cases (40%) by PCR and/or serology. Confirmed cases were more frequently seen in male than in female patients (128 vs. 81); the age group predominantly affected was 15 to 29 years old (65%, median age: 26.4 years). The majority of the confirmed cases had a remote history of vaccination with one or two doses of a mumps-containing vaccine (69%). Our results indicate that mumps virus caused two outbreaks in Bavaria in 2008 and 2010/2011 and a third one in Lower Saxony in 2011. Mumps virus genotype G was preponderantly detected from 2008 to 2013. For 107 of the 216 patients with a confirmed mumps infection, we correlated the results from PCR and serology. PCR detected cases during the first week after onset of symptoms (74% positive results). PCR worked best with throat swabs and oral fluids (61% and 60% positive results, respectively). IgM was more reliable with a longer time after onset of symptoms (67%), but indirect IgM serology was of insufficient sensitivity for vaccinated mumps cases (30%); the IgM μ-capture assay detected more cases in this group. Mumps virus is able to initiate an infection in vaccinated patients (secondary vaccine failure, SVF) although it is unclear to what extent. Since SVF does occur in highly vaccinated populations and IgM will not increase to detectable levels in all SVF patients, we strongly recommend using PCR plus serology tests to avoid false-negative diagnoses in vaccinated individuals with clinical signs of mumps. Copyright © 2015 Elsevier GmbH. All rights reserved.
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Liddy, Clare; Arbab-Tafti, Sadaf; Moroz, Isabella; Keely, Erin
2017-08-22
In many countries, the referral-consultation process faces a number of challenges from inefficiencies and rising demand, resulting in excessive wait times for many specialties. We collected referral data from a sample of family doctors across the province of Ontario, Canada as part of a larger program of research. The purpose of this study is to describe referral patterns from primary care to specialist and allied health services from the primary care perspective. We conducted a prospective study of patient referral data submitted by primary care providers (PCP) from 20 clinics across Ontario between June 2014 and January 2016. Monthly referral volumes expressed as a total number of referrals to all medical and allied health professionals per month. For each referral, we also collected data on the specialty type, reason for referral, and whether the referral was for a procedure. PCPs submitted a median of 26 referrals per month (interquartile range 11.5 to 31.8). Of 9509 referrals eligible for analysis, 97.8% were directed to medical professionals and 2.2% to allied health professionals. 55% of medical referrals were directed to non-surgical specialties and 44.8% to surgical specialties. Medical referrals were for procedures in 30.8% of cases and non-procedural in 40.9%. Gastroenterology received the largest share (11.2%) of medical referrals, of which 62.3% were for colonoscopies. Psychology received the largest share (28.3%) of referrals to allied health professionals. We described patterns of patient referral from primary care to specialist and allied health services for 30 PCPs in 20 clinics across Ontario. Gastroenterology received the largest share of referrals, nearly two-thirds of which were for colonoscopies. Future studies should explore the use of virtual care to help manage non-procedural referrals and examine the impact that procedural referrals have on wait times for gastroenterology.
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Mengucci, P; Gatto, A; Bassoli, E; Denti, L; Fiori, F; Girardin, E; Bastianoni, P; Rutkowski, B; Czyrska-Filemonowicz, A; Barucca, G
2017-07-01
Direct Metal Laser Sintering (DMLS) technology was used to produce tensile and flexural samples based on the Ti-6Al-4V biomedical composition. Tensile samples were produced in three different orientations in order to investigate the effect of building direction on the mechanical behavior. On the other hand, flexural samples were submitted to thermal treatments to simulate the firing cycle commonly used to veneer metallic devices with ceramics in dental applications. Roughness and hardness measurements as well as tensile and flexural mechanical tests were performed to study the mechanical response of the alloy while X-ray diffraction (XRD), electron microscopy (SEM, TEM, STEM) techniques and microanalysis (EDX) were used to investigate sample microstructure. Results evidenced a difference in the mechanical response of tensile samples built in orthogonal directions. In terms of microstructure, samples not submitted to the firing cycle show a single phase acicular α' (hcp) structure typical of metal parts subject to high cooling rates. After the firing cycle, samples show a reduction of hardness and strength due to the formation of laths of the β (bcc) phase at the boundaries of the primary formed α' plates as well as to lattice parameters variation of the hcp phase. Element partitioning during the firing cycle gives rise to high concentration of V atoms (up to 20wt%) at the plate boundaries where the β phase preferentially forms. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Pritt, Bobbi S; Mead, Paul S; Johnson, Diep K Hoang; Neitzel, David F; Respicio-Kingry, Laurel B; Davis, Jeffrey P; Schiffman, Elizabeth; Sloan, Lynne M; Schriefer, Martin E; Replogle, Adam J; Paskewitz, Susan M; Ray, Julie A; Bjork, Jenna; Steward, Christopher R; Deedon, Alecia; Lee, Xia; Kingry, Luke C; Miller, Tracy K; Feist, Michelle A; Theel, Elitza S; Patel, Robin; Irish, Cole L; Petersen, Jeannine M
2016-05-01
Lyme borreliosis is the most common tick-borne disease in the northern hemisphere. It is a multisystem disease caused by Borrelia burgdorferi sensu lato genospecies and characterised by tissue localisation and low spirochaetaemia. In this study we aimed to describe a novel Borrelia species causing Lyme borreliosis in the USA. At the Mayo clinic, from 2003 to 2014, we tested routine clinical diagnostic specimens from patients in the USA with PCR targeting the oppA1 gene of B burgdorferi sensu lato. We identified positive specimens with an atypical PCR result (melting temperature outside of the expected range) by sequencing, microscopy, or culture. We collected Ixodes scapularis ticks from regions of suspected patient tick exposure and tested them by oppA1 PCR. 100 545 specimens were submitted by physicians for routine PCR from Jan 1, 2003 to Sept 30, 2014. From these samples, six clinical specimens (five blood, one synovial fluid) yielded an atypical oppA1 PCR product, but no atypical results were detected before 2012. Five of the six patients with atypical PCR results had presented with fever, four had diffuse or focal rash, three had symptoms suggestive of neurological inclusion, and two were admitted to hospital. The sixth patient presented with knee pain and swelling. Motile spirochaetes were seen in blood samples from one patient and cultured from blood samples from two patients. Among the five blood specimens, the median oppA1 copy number was 180 times higher than that in 13 specimens that tested positive for B burgdorferi sensu stricto during the same time period. Multigene sequencing identified the spirochaete as a novel B burgdorferi sensu lato genospecies. This same genospecies was detected in ticks collected at a probable patient exposure site. We describe a new pathogenic Borrelia burgdorferi sensu lato genospecies (candidatus Borrelia mayonii) in the upper midwestern USA, which causes Lyme borreliosis with unusually high spirochaetaemia. Clinicians should be aware of this new B burgdorferi sensu lato genospecies, its distinct clinical features, and the usefulness of oppA1 PCR for diagnosis. US Centers for Disease Control and Prevention Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement and Mayo Clinic Small Grant programme. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Reibnitz, M G; Tavares, L B; García, J A
1998-01-01
Twenty cheese samples were collected at Blumenau (SC) and were submitted to analysis in order to verify the presence of fecal coliforms, Escherichia coli and Staphylococcus aureus. Among the 20 samples of cheese, analysis revealed that 70% and 20% respectively, were not within present legal specifications (Norma 001/87-DNVSA) for fecal coliforms and Escherichia coli. For Staphylococcus, 95% of the samples were not within present legal specifications.
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McDonald, Daniel; Clemente, Jose C; Kuczynski, Justin; Rideout, Jai Ram; Stombaugh, Jesse; Wendel, Doug; Wilke, Andreas; Huse, Susan; Hufnagle, John; Meyer, Folker; Knight, Rob; Caporaso, J Gregory
2012-07-12
We present the Biological Observation Matrix (BIOM, pronounced "biome") format: a JSON-based file format for representing arbitrary observation by sample contingency tables with associated sample and observation metadata. As the number of categories of comparative omics data types (collectively, the "ome-ome") grows rapidly, a general format to represent and archive this data will facilitate the interoperability of existing bioinformatics tools and future meta-analyses. The BIOM file format is supported by an independent open-source software project (the biom-format project), which initially contains Python objects that support the use and manipulation of BIOM data in Python programs, and is intended to be an open development effort where developers can submit implementations of these objects in other programming languages. The BIOM file format and the biom-format project are steps toward reducing the "bioinformatics bottleneck" that is currently being experienced in diverse areas of biological sciences, and will help us move toward the next phase of comparative omics where basic science is translated into clinical and environmental applications. The BIOM file format is currently recognized as an Earth Microbiome Project Standard, and as a Candidate Standard by the Genomic Standards Consortium.
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Anaphylaxis to gelatin-containing rectal suppositories.
Sakaguchi, M; Inouye, S
2001-12-01
Some children--though the number is few-have been sensitized with gelatin. To investigate the relationship between the presence of antigelatin IgE and anaphylaxis to gelatin-containing rectal suppository, we measured antigelatin IgE in the sera of the children with anaphylaxis. Ten children showed systemic allergic reactions, including anaphylaxis, to a chloral hydrate rectal suppository containing gelatin (231 mg/dose) that had been used as a sedative. These children's clinical histories and serum samples were submitted from physicians to the National Institute of Infectious Diseases during a 2-year period from 1996 to 1997. Of the 10 children, 5 showed apparent anaphylaxis, including hypotension and/or cyanosis, along with urticaria or wheezing; 2 showed both urticaria and wheezing without hypotension or cyanosis; the other 3 showed only urticaria. All of the children had antigelatin IgE (mean value +/- SD, 7.9 +/- 8.4 Ua/mL). As a control, samples from 250 randomly selected children had no antigelatin IgE. These findings suggest that the 10 children's systemic allergic reactions to this suppository were caused by the gelatin component. Gelatin-containing suppositories must be used with the same caution as gelatin-containing vaccines and other medications.
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Cummings, Kevin J; Perkins, Gillian A; Khatibzadeh, Sarah M; Warnick, Lorin D; Altier, Craig
2013-04-01
Monitoring antimicrobial resistance trends among bacteria isolated from food animals and people is necessary to inform public policy regarding appropriate antimicrobial use. Our objectives were to describe the antimicrobial resistance status of Salmonella isolates from dairy cattle in the northeastern United States and to identify trends in resistance to various antimicrobial agents over time. Data were collected retrospectively for all bovine Salmonella isolates that were obtained from samples submitted to Cornell University's Animal Health Diagnostic Center between January 1, 2004 and December 31, 2011. Temporal trends in the prevalence of resistant Salmonella were investigated for each antimicrobial agent using the Cochran-Armitage trend test. Antimicrobial susceptibility testing was performed on 2745 bovine Salmonella isolates from clinical samples submitted during the study period. Overall resistance to each antimicrobial agent ranged from 0% (amikacin, ciprofloxacin, and nalidixic acid) to 72.0% (sulfadimethoxine). There was evidence of a significantly decreasing trend in prevalence of resistance to most agents: amoxicillin/clavulanic acid (AUG), ampicillin (AMP), cefoxitin (FOX), ceftiofur (TIO), ceftriaxone (AXO), chloramphenicol (CHL), chlortetracycline (CTET), florfenicol (FFN), kanamycin (KAN), neomycin (NEO), oxytetracycline (OXY), spectinomycin (SPE), streptomycin (STR), sulfadimethoxine (SDM), sulfisoxazole (FIS), and tetracycline (TET). Among the 265 isolates that were tested using the National Antimicrobial Resistance Monitoring System (NARMS) panel, the most common resistance patterns were pansusceptible (54.0%), AUG-AMP-FOX-TIO-AXO-CHL-KAN-STR-FIS-TET (18.1%), and AUG-AMP-FOX-TIO-AXO-CHL-STR-FIS-TET (12.1%). Increasing prevalence of S. enterica serovar Cerro over the course of the study period presumably had an impact on the observed resistance trends. Nevertheless, these results do not support the notion that the current level of antimicrobial use in dairy cattle is driving an increase in the emergence and dissemination of drug-resistant Salmonella in the region served by the laboratory.
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High-end clinical domain information systems for effective healthcare delivery.
Mangalampalli, Ashish; Rama, Chakravarthy; Muthiyalian, Raja; Jain, Ajeet K
2007-01-01
The Electronic Health Record (EHR) provides doctors with a quick, reliable, secure, real-time and user-friendly source of all relevant patient data. The latest information system technologies, such as Clinical Data Warehouses (CDW), Clinical Decision-Support (CDS) systems and data-mining techniques (Online Analytical Processing (OLAP) and Online Transactional Processing (OLTP)), are used to maintain and utilise patient data intelligently, based on the users' requirements. Moreover, clinical trial reports for new drug approvals are now being submitted electronically for faster and easier processing. Also, information systems are used in educating patients about the latest developments in medical science through the internet and specially configured kiosks in hospitals and clinics.
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Precision versus Practicality.
ERIC Educational Resources Information Center
Brito, Cindy
2000-01-01
Studied reducing the number of slides submitted by candidates taking the histology technician examination of the American Society of Clinical Pathologists. Results from 145 candidates show that slides can be reduced from 15 (with coverslipping and block preparation scores) to 9 without affecting the mean ability level of candidates and only a…
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Code of Federal Regulations, 2014 CFR
2014-04-01
... laboratory studies and on clinical investigations involving human subjects. A PMA shall be submitted in six... physical and performance characteristics of the device. A brief description of the manufacturing process... and, if known, the history of the marketing of the device by any other person. (v) Summary of studies...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-21
...] Draft Guidance for Industry on Providing Submissions in Electronic Format--Standardized Study Data... Submissions in Electronic Format--Standardized Study Data.'' This draft guidance establishes FDA's recommendation that sponsors and applicants submit nonclinical and clinical study data in a standardized...
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2001-07-01
patients’ oral morning temperatures fall approximately ten days after starting cholesterol-lowering statin medication such as simvastatin, atorvastatin or...application for DREAMS renewal for fiscal years 2001-2002 (submitted June 2001). Appendix: Effect of Atorvastatin (Lipitor®) Therapy on Morning
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75 FR 152 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-04
... activities described in RFA DP0-901, Healthy Communities, Tobacco Control, Diabetes Prevention and Control... physical activity; improved nutrition (e.g., increased fruit/vegetable consumption, reduced consumption of... activities. The Recovery Act included $650 million for evidence-based clinical and community-based prevention...
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Silame, F D J; Tonani, R; Alandia-Roman, C C; Chinelatti, M; Panzeri, H; Pires-de-Souza, F C P
2013-12-01
This study evaluated the colour stability of temporary prosthetic restorations with different thicknesses submitted to artificial accelerated aging. The occlusal surfaces of 40 molars were grinded to obtain flat enamel surfaces. Twenty acrylic resin specimens [Polymethyl methacrylate (Duralay) and Bis-methyl acrylate (Luxatemp)] were made with two different thicknesses, 0.5 mm and 1.0 mm. Temporary restorations were fixed on enamel and CIE L*a*b* colour parameters of each specimen were assessed before and after artificial accelerated aging. All groups showed colour alterations above the clinically acceptable limit. Luxatemp showed the lowest colour alteration regardless its thickness and Duralay showed the greatest alteration with 0.5 mm.
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Code of Federal Regulations, 2014 CFR
2014-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.87 Analysis. (a) Local education agencies shall have bulk samples, collected under § 763.86 and submitted for analysis, analyzed for asbestos using laboratories...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.87 Analysis. (a) Local education agencies shall have bulk samples, collected under § 763.86 and submitted for analysis, analyzed for asbestos using laboratories...
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Code of Federal Regulations, 2013 CFR
2013-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.87 Analysis. (a) Local education agencies shall have bulk samples, collected under § 763.86 and submitted for analysis, analyzed for asbestos using laboratories...
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Code of Federal Regulations, 2012 CFR
2012-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.87 Analysis. (a) Local education agencies shall have bulk samples, collected under § 763.86 and submitted for analysis, analyzed for asbestos using laboratories...
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Code of Federal Regulations, 2011 CFR
2011-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.87 Analysis. (a) Local education agencies shall have bulk samples, collected under § 763.86 and submitted for analysis, analyzed for asbestos using laboratories...
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Code of Federal Regulations, 2011 CFR
2011-04-01
..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and... members voting for, against, and abstaining; the basis for requiring changes in or disapproving research...
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77 FR 61745 - Submission for OMB Review; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-11
... submitted by small entities. Out of a sample size of 3,100 for each wave of data collection, the USPTO... by fax to 202-395-5167, marked to the attention of Nicholas A. Fraser. Dated: October 5, 2012. Susan...
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Viral Infection in Adults with Severe Acute Respiratory Infection in Colombia
Remolina, Yuly Andrea; Ulloa, María Mercedes; Vargas, Hernán; Díaz, Liliana; Gómez, Sandra Liliana; Saavedra, Alfredo; Sánchez, Edgar; Cortés, Jorge Alberto
2015-01-01
Objectives To identify the viral aetiology in adult patients with severe acute respiratory infection (SARI) admitted to sentinel surveillance institutions in Bogotá in 2012. Design A cross-sectional study was conducted in which microarray molecular techniques for viral identification were used on nasopharyngeal samples of adult patients submitted to the surveillance system, and further descriptions of clinical features and relevant clinical outcomes, such as mortality, need for critical care, use of mechanical ventilation and hospital stay, were obtained. Setting Respiratory infections requiring hospital admission in surveillance centres in Bogotá, Colombia. Participants Ninety-one adult patients with acute respiratory infection (55% were female). Measurements Viral identification, intensive care unit admission, hospital stay, and mortality. Results Viral identification was achieved for 63 patients (69.2%). Comorbidity was frequently identified and mainly involved chronic pulmonary disease or pregnancy. Influenza, Bocavirus and Adenovirus were identified in 30.8%, 28.6% and 18.7% of the cases, respectively. Admission to the intensive care unit occurred in 42.9% of the cases, while mechanical ventilation was required for 36.3%. The average hospital stay was 9.9 days, and mortality was 15.4%. Antibiotics were empirically used in 90.1% of patients. Conclusions The prevalence of viral aetiology of SARI in this study was high, with adverse clinical outcomes, intensive care requirements and high mortality. PMID:26576054
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Factors associated with negative self-perception of oral health among institutionalized elderly.
Melo, Laércio Almeida de; Sousa, Meily de Mello; Medeiros, Annie Karoline Bezerra de; Carreiro, Adriana da Fonte Porto; Lima, Kenio Costa de
2016-11-01
The aim of this study was to determine self-perception of oral-health in institutionalized elderly, and look into the sociodemographic and clinical aspects associated with negative self-perception. One hundred and sixty-six elderly were assessed by answering a self-perception question that predicts the GOHAI (Geriatric Oral Health Assessment Index). Sociodemographic data was obtained from a previously validated questionnaire and clinical data taken from the WHO file and QST-TMD used to check the existence of TMD (temporomandibular disturbance). The data gathered was submitted to Mann-Whitney, Fisher's Exact and Chi-squared tests with a 5% significance level. The average age of the study population was 80.5, and 75.9% were women. The mean DMFT (decayed, missing, and filled teeth in permanent teeth) was 28.9, the majority of the sample subject (65%) reported good to excellent teeth, gums and prostheses (dentures and bridges). Three questions in the TMD questionnaire (QST-DTM) were associated with negative self-perception. Those claiming that their jaws "lock" when they open or close their mouth, who always have pain at the front or side of their jaw, or whose jaws get tired during the course of the day are less satisfied with their oral health. We conclude that clinical and sociodemographic conditions have little influence on self-perception of oral health, possibly because pain is the main factor associated with negative self-perception in these individuals.
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Clustering Suicide Attempters: Impulsive-Ambivalent, Well-Planned, or Frequent.
Lopez-Castroman, Jorge; Nogue, Erika; Guillaume, Sebastien; Picot, Marie Christine; Courtet, Philippe
2016-06-01
Attempts to predict suicidal behavior within high-risk populations have so far shown insufficient accuracy. Although several psychosocial and clinical features have been consistently associated with suicide attempts, investigations of latent structure in well-characterized populations of suicide attempters are lacking. We analyzed a sample of 1,009 hospitalized suicide attempters that were recruited between 1999 and 2012. Eleven clinically relevant items related to the characteristics of suicidal behavior were submitted to a Hierarchical Ascendant Classification. Phenotypic profiles were compared between the resulting clusters. A decisional tree was constructed to facilitate the differentiation of individuals classified within the first 2 clusters. Most individuals were included in a cluster characterized by less lethal means and planning ("impulse-ambivalent"). A second cluster featured more carefully planned attempts ("well-planned"), more alcohol or drug use before the attempt, and more precautions to avoid interruptions. Finally, a small, third cluster included individuals reporting more attempts ("frequent"), more often serious or violent attempts, and an earlier age at first attempt. Differences across clusters by demographic and clinical characteristics were also found, particularly with the third cluster whose participants had experienced high levels of childhood abuse. Cluster analysis consistently supported 3 distinct clusters of individuals with specific features in their suicidal behaviors and phenotypic profiles that could help clinicians to better focus prevention strategies. © Copyright 2016 Physicians Postgraduate Press, Inc.
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Salomão, Dlf; Santos, Dm; Nogueira, Rd; Palma-Dibb, Rg; Geraldo-Martins, Vr
2014-01-01
The aim of the current study was to assess the acid demineralization susceptibility of bleached dental enamel submitted to different fluoride regimens. One hundred bovine enamel blocks (6×6×3 mm) were randomly divided into 10 groups (n=10). Groups 1 and 2 received no bleaching. Groups 3 to 6 were submitted to an at-home bleaching technique using 6% hydrogen peroxide (HP; G3 and G4) or 10% carbamide peroxide (CP; G5 and G6). Groups 7 to 10 were submitted to an in-office bleaching technique using 35% HP (G7 and G8) or 35% CP (G9 and G10). During bleaching, a daily fluoridation regimen of 0.05% sodium fluoride (NaF) solution was performed on groups 3, 5, 7, and 9, while weekly fluoridation with a 2% NaF gel was performed on groups 4, 6, 8, and 10. The samples in groups 2 to 10 were pH cycled for 14 consecutive days. The samples from all groups were then assessed by cross-sectional Knoop microhardness at different depths from the outer enamel surface. The average Knoop hardness numbers (KHNs) were compared using one-way analysis of variance and Tukey tests (α=0.05). The comparison between groups 1 and 2 showed that the demineralization method was effective. The comparison among groups 2 to 6 showed the same susceptibility to acid demineralization, regardless of the fluoridation method used. However, the samples from groups 8 and 10 showed more susceptibility to acid demineralization when compared with group 2 (p<0.05). Groups 7 and 9 provided similar results to group 2, but the results of those groups were different when compared with groups 8 and 10. The use of 6% HP and 10% CP associated with daily or weekly fluoridation regimens did not increase the susceptibility of enamel to acid demineralization. However, the use of 35% HP and 35% CP must be associated with a daily fluoridation regimen, otherwise the in-office bleaching makes the bleached enamel more susceptible to acid demineralization.
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Valenzuela, J R; Sethi, A K; Aulik, N A; Poulsen, K P
2017-02-01
Salmonellosis on the dairy continues to have a significant effect on animal health and productivity and in the United States. Additionally, Salmonella enterica ssp. enterica causes an estimated 1.2 million cases of human illness annually. Contributing to the morbidity and mortality in both human and domestic animal species is emergence of antimicrobial resistance by Salmonella species and increased incidence of multidrug-resistant isolates. This study describes serotype distribution and the antimicrobial resistance patterns for various Salmonella serotypes isolated from bovine samples submitted to the Wisconsin Veterinary Diagnostic Laboratory (WVDL) over the past 10 yr. Salmonella serotyping and antimicrobial susceptibility testing data were obtained from the laboratory information management system at WVDL. Data from accessions were limited to bovine samples submitted to the WVDL between January 2006 and June 2015 and those that had both a definitive serotype and complete results for antimicrobial susceptibility testing. A total of 4,976 isolates were identified. Salmonella enterica ser. Dublin was the most prevalent serotype identified among bovine samples submitted to the WVDL, accounting for a total of 1,153 isolates (23% of total isolates) over the study period. Along with Dublin, Salmonella enterica ser. Cerro (795, 16%), Newport (720, 14%), Montevideo (421, 8%), Kentucky (419, 8%), and Typhimurium (202, 4%) comprised the top 6 most commonly isolated serotypes during that time. Overall, resistance of bovine Salmonella isolates in the study population remained stable, although decreases in resistance were noted for gentamicin, neomycin, and trimethoprim sulfamethoxazole during the study period. All isolates remained susceptible to enrofloxacin. These data show that antimicrobial susceptibility for bovine Salmonella has changed in the population served by WVDL in the past 10 yr. This information is important for understanding Salmonella disease ecology in Wisconsin. Our findings are also relevant for animal and public health by improving informed antimicrobial use, new drug development, and regulation of their use in food animals. The Authors. Published by the Federation of Animal Science Societies and Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
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Immunotherapeutic Strategies in Breast Cancer: Preclinical and Clinical Trials
2008-09-01
submitted. No further follow-up is required. 13.6 If patient is found on central review to be MUC1 negative, the patient will be considered a cancel...vaccine strategy into a phase I clinical trial in patients with undetectable disease following standard therapy . The model of spontaneous mammary...focused on the development of novel tumor vaccines directed at MUC1, a transmembrane mucin that is aberrantly expressed in cancer. MUC1 is expressed on
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Clinical indicators associated with HIV acquisition in the United States Air Force
2016-12-09
59 MDW/SGYU SUBJECT: Profess ional Presentation Approval 30 NOV 20 16 I. Your journal, entitled Clinica l indicators associated w ith HIV ...presentation. a new 5g MOW Form 303g must be submitted for review and approval.) Epidemiology and Risk Factors for HIV Infection in U.S. Air Force...Service Members, 1996-20 11 6. TITLE OF MATERIAL TO BE PUBLISHED OR PRESENTED: Clinical indicators associated with HIV acquisition in the United States
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Fagundes-Neto, Ulysses; Ganc, Arnaldo José
2013-01-01
Allergic colitis is a clinical manifestation of food allergy during the first months of life. It is estimated that genetic factors play a role in the expression of this allergic disease. This case report described the clinical progress of infants who were cousins from two distinct family groups with allergic colitis. Five infants under six months of age and of both sexes were studied, with a diagnosis of allergic colitis characterized clinically and histologically by (1) rectal bleeding; (2) exclusion of infectious causes of colitis; (3) disappearance of symptoms after elimination of cow's milk and dairy products from the child's and/or the mother's diet. Patients were submitted to the following diagnostic investigation: complete blood count; stool culture; parasitologic examination of stools; rectoscopy or colonoscopy; and rectal biopsy. Patient age varied from 40 days to six months; three were males. All patients presented with complaints of intense colic and rectal bleeding. The colonoscopy showed presence of hyperemia of the mucosa with microerosions and spontaneous bleeding upon the procedure. Microscopy revealed the existence of colitis with eosinophilia > 20 e/HPF. Patients were treated with a hypoallergenic formula and showed remission of symptoms. After one year of age, all were submitted to an oral challenge with a milk formula and presented food tolerance. Allergic colitis is a disease with evident genetic inheritance and a temporary character.
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Bayesian network interface for assisting radiology interpretation and education
NASA Astrophysics Data System (ADS)
Duda, Jeffrey; Botzolakis, Emmanuel; Chen, Po-Hao; Mohan, Suyash; Nasrallah, Ilya; Rauschecker, Andreas; Rudie, Jeffrey; Bryan, R. Nick; Gee, James; Cook, Tessa
2018-03-01
In this work, we present the use of Bayesian networks for radiologist decision support during clinical interpretation. This computational approach has the advantage of avoiding incorrect diagnoses that result from known human cognitive biases such as anchoring bias, framing effect, availability bias, and premature closure. To integrate Bayesian networks into clinical practice, we developed an open-source web application that provides diagnostic support for a variety of radiology disease entities (e.g., basal ganglia diseases, bone lesions). The Clinical tool presents the user with a set of buttons representing clinical and imaging features of interest. These buttons are used to set the value for each observed feature. As features are identified, the conditional probabilities for each possible diagnosis are updated in real time. Additionally, using sensitivity analysis, the interface may be set to inform the user which remaining imaging features provide maximum discriminatory information to choose the most likely diagnosis. The Case Submission tools allow the user to submit a validated case and the associated imaging features to a database, which can then be used for future tuning/testing of the Bayesian networks. These submitted cases are then reviewed by an assigned expert using the provided QC tool. The Research tool presents users with cases with previously labeled features and a chosen diagnosis, for the purpose of performance evaluation. Similarly, the Education page presents cases with known features, but provides real time feedback on feature selection.
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Binnicker, Matthew J; Espy, Mark J; Duresko, Brian; Irish, Cole; Mandrekar, Jay
2017-04-01
Recently, automated platforms have been developed that can perform processing, extraction and testing for herpes simplex virus (HSV) nucleic acid on a single instrument. In this study, we compared three commercially-available systems; Aptima ® /Panther (Hologic, San Diego, CA), ARIES ® (Luminex Corporation, Austin, TX), and cobas ® 4800 (Roche Molecular Systems Inc, Pleasanton, CA) for the qualitative detection of HSV-1/2 in clinical samples. Two-hundred seventy-seven specimens (genital [n=193], dermal [n=84]) were submitted for routine HSV-1/2 real-time PCR by a laboratory developed test. Following routine testing, samples were also tested by the Aptima, ARIES, and cobas HSV-1/2 assays per the manufacturer's recommendations. Results were compared to a "consensus standard" defined as the result obtained from ≥3 of the 4 assays. Following testing of 277 specimens, the cobas and ARIES assays demonstrated a sensitivity of 100% for HSV-1 (61/61) and HSV-2 (55/55). The Aptima assays showed a sensitivity of 91.8% (56/61) for HSV-1 and 90.9% (50/55) for HSV-2. Percent specificities for HSV-1 were 96.2% (202/210) by cobas, 99.5% (209/210) by ARIES and 100% (236/236) by Aptima. For HSV-2, the specificities were 98.1% (211/215) by cobas, 99.5% (215/216) by ARIES and 100% (216/216) by Aptima. The turnaround time for testing 24 samples was 2.5h by the cobas 4800, 3.1h by Aptima/Panther, and 3.9h by ARIES. The three commercial systems can perform all current functions on a single platform, thereby improving workflow and potentially reducing errors associated with manual processing of samples. Copyright © 2017 Elsevier B.V. All rights reserved.
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Klein, Eileen J.; Galanakis, Emmanouil; Thomas, Anita A.; Stapp, Jennifer R.; Rich, Shannon; Buccat, Anne Marie; Tarr, Phillip I.
2015-01-01
Timely accurate diagnosis of Shiga toxin-producing Escherichia coli (STEC) infections is important. We evaluated a laboratory-developed real-time PCR (LD-PCR) assay targeting stx1, stx2, and rfbEO157 with 2,386 qualifying stool samples submitted to the microbiology laboratory of a tertiary care pediatric center between July 2011 and December 2013. Broth cultures of PCR-positive samples were tested for Shiga toxins by enzyme immunoassay (EIA) (ImmunoCard STAT! enterohemorrhagic E. coli [EHEC]; Meridian Bioscience) and cultured in attempts to recover both O157 and non-O157 STEC. E. coli O157 and non-O157 STEC were detected in 35 and 18 cases, respectively. Hemolytic uremic syndrome (HUS) occurred in 12 patients (10 infected with STEC O157, one infected with STEC O125ac, and one with PCR evidence of STEC but no resulting isolate). Among the 59 PCR-positive STEC specimens from 53 patients, only 29 (54.7%) of the associated specimens were toxin positive by EIA. LD-PCR differentiated STEC O157 from non-O157 using rfbEO157, and LD-PCR results prompted successful recovery of E. coli O157 (n = 25) and non-O157 STEC (n = 8) isolates, although the primary cultures and toxin assays were frequently negative. A rapid “mega”-multiplex PCR (FilmArray gastrointestinal panel; BioFire Diagnostics) was used retrospectively, and results correlated with LD-PCR findings in 25 (89%) of the 28 sorbitol-MacConkey agar culture-negative STEC cases. These findings demonstrate that PCR is more sensitive than EIA and/or culture and distinguishes between O157 and non-O157 STEC in clinical samples and that E. coli O157:H7 remains the predominant cause of HUS in our institution. PCR is highly recommended for rapid diagnosis of pediatric STEC infections. PMID:25926491
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Lathouwers, Erkki; Gupta, Soumi; Haddad, Mojgan; Paquet, Agnes; de Meyer, Sandra; Baugh, Bryan
2015-06-01
HIV-1 samples submitted by clinicians from the United States for routine drug susceptibility testing (PhenoSense GT) were evaluated for genotypic and phenotypic resistance to darunavir and other protease inhibitors (PIs). Among these samples (Monogram Biosciences database January 2006-June 2012; N=78,843), isolates harboring zero IAS-USA darunavir resistance-associated mutations (RAMs) increased from 77.7% in 2006 to 92.8% through the first half of 2012 (H1 2012; upward trend, p=0.0008); a downward trend seen for samples with three or more darunavir RAMs (7.5% in 2006 and 2.6% in H1 2012; p=0.002). Among samples with any PI resistance (N=15,932), samples harboring zero darunavir RAMs gradually increased (39.9% in 2006 vs. 55.0% in H1 2012; upward trend, p=0.005), but three or more darunavir RAMs did not change over time (21.7% in 2006 and 19.2% in H1 2012; p=0.27). During this period, the frequency of the 11 individual darunavir RAMs (IAS-USA 2011 list) decreased among all samples. The frequency of each darunavir RAM in PI-resistant samples decreased or remained relatively stable. The prevalence of samples with phenotypic resistance to darunavir (partial-to-full) decreased over time in all samples (8.2% in 2006 vs. 2.3% in H1 2012), as did resistance to other PIs (p<0.006 for all PIs). Phenotypic resistance to darunavir and other PIs also decreased in PI-resistant samples (darunavir: 23.9% in 2006 vs. 17.1% in H1 2012; p<0.013 for all PIs). Since approval of darunavir in 2006, there was a significant decrease in prevalence of samples with genotypic and phenotypic resistance to darunavir in commercially tested HIV-1 isolates. Furthermore, the prevalence of phenotypic resistance to darunavir was lower than all other PIs.
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Chagas, Aline Garcia da Rosa; Spinelli, Eliani; Fiaux, Sorele Batista; Barreto, Adriana da Silva; Rodrigues, Silvana Vianna
2017-08-01
Different types of hair were submitted to different milling procedures and their resulting powders were analyzed by scanning electron microscopy (SEM) and laser diffraction (LD). SEM results were qualitative whereas LD results were quantitative and accurately characterized the hair powders through their particle size distribution (PSD). Different types of hair were submitted to an optimized milling conditions and their PSD was quite similar. A good correlation was obtained between PSD results and ketamine concentration in a hair sample analyzed by LC-MS/MS. Hair samples were frozen in liquid nitrogen for 5min and pulverized at 25Hz for 10min, resulting in 61% of particles <104μm and 39% from 104 to 1000μm. Doing so, a 359% increment on ketamine concentration was obtained for an authentic sample extracted after pulverization comparing with the same sample cut in 1mm fragments. When milling time was extended to 25min, >90% of particles were <60μm and an additional increment of 52.4% in ketamine content was obtained. PSD is a key feature on analysis of pulverized hair as it can affect the method recovery and reproducibility. In addition, PSD is an important issue on sample retesting and quality control procedures. Copyright © 2017 Elsevier B.V. All rights reserved.
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Valente, Eduardo S; Campos, Tarcísio P R
2010-12-01
Ceramic seeds were synthesized by the sol-gel technique with Si:Sm:Ca and Si:Ho:Ca. One set of seeds was irradiated in the TRIGA type nuclear reactor IPR-R1 and submitted to instrumental neutron activation analysis (INAA), K(0) method, to determine mass percentage concentration of natural samarium and holmium in the seed as well as to determine all existing radionuclides and their activities. Attention was paid to discrimination of Si-31, Ca-40, Ca-45, Ca-47, Ca-49, Sm-145, Sm-155, Sm-153 and Ho-166. A second sample was submitted to atomic emission spectrometry (ICP-AES) also to determine samarium and holmium concentrations in weight. A third sample was submitted to X-ray fluorescence spectrometry to qualitatively determine chemical composition. The measured activity was due to Sm-153 and Ho-166 with a well-characterized gamma spectrum. The X-ray fluorescence spectrum demonstrated that there is no discrepancy in seed composition. The maximum ranges in the water of beta particles from Sm-153 and Ho-166 decay were evaluated, as well as the dose rate and total dose delivered within the volume delimited by the range of the beta particles. The results are relevant for investigation of the viability of producing Sm-153 and Ho-166 radioactive seeds for use in brachytherapy. Copyright 2010 Elsevier Ltd. All rights reserved.
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Attitudes towards HIV testing via home-sampling kits ordered online (RUClear pilots 2011-12).
Ahmed-Little, Y; Bothra, V; Cordwell, D; Freeman Powell, D; Ellis, D; Klapper, P; Scanlon, S; Higgins, S; Vivancos, R
2016-09-01
The burden of disease relating to undiagnosed HIV infection is significant in the UK. BHIVA (British HIV Association) recommends population screening in high prevalence areas, expanding outside traditional antenatal/GUM settings. RUClear 2011-12 piloted expanding HIV testing outside traditional settings using home-sampling kits (dry-blood-spot testing) ordered online. Greater Manchester residents (≥age 16) could request testing via an established, online chlamydia testing service (www.ruclear.co.uk). Participant attitudes towards this new service were assessed. Qualitative methods (thematic analysis) were used to analyse free-text data submitted by participants via hard copy questionnaires issued in all testing kits. 79.9% (2447/3062) participants completed questionnaires, of which 30.9% (756/2447) provided free-text data. Participants overwhelmingly supported the service, valuing particularly accessibility and convenience, allowing individuals to order tests any time of day and self-sample comfortably at home; avoiding the invasive nature of venipuncture and avoiding the need for face-to-face interaction with health services. The pilot was also clinically and cost-effective. Testing via home-sampling kits ordered online (dry-blood-spot testing) was felt to be an acceptable and convenient method for accessing a HIV test. Many individuals undertook HIV testing where they would otherwise not have been tested at all. Expansion of similar services may increase the uptake of HIV testing. © The Author 2015. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David
2014-09-01
To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.
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Rodgers, Kirsten C; Akintobi, Tabia; Thompson, Winifred Wilkins; Evans, Donoria; Escoffery, Cam; Kegler, Michelle C
2014-06-01
Community-engaged research is effective in addressing health disparities but may present challenges for both academic institutions and community partners. Therefore, the need to build capacity for conducting collaborative research exists. The purpose of this study is to present a model for building research capacity in academic-community partnerships. The Building Collaborative Research Capacity Model was developed as part of the Community Engagement Research Program (CERP) of the Atlanta Clinical and Translational Science Institute (ACTSI). Six domains of collaborative research capacity were identified and used to develop a model. Inputs, activities, outputs, and outcomes of building collaborative research capacity are described. To test this model, a competitive request for applications was widely distributed and four community-based organizations were funded to participate in a 2-year program with the aim of conducting a pilot study and submitting a research proposal for funding to National Institutes of Health or another major funding agency. During the first year, the community-based organization partners were trained on conducting collaborative research and matched with an academic partner from an ACTSI institution. Three of the academic-community partnerships submitted pilot study results and two submitted a grant proposal to a national agency. The Building Collaborative Research Capacity Model is an innovative approach to strengthening academic-community partnerships. This model will help build needed research capacity, serve as a framework for academicians and community partners, and lead to sustainable partnerships that improve community health. © 2013 Society for Public Health Education.
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Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Scope. 54.3 Section 54.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS § 54.3 Scope. The requirements in this part apply to any applicant who submits a marketing...
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78 FR 70300 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-25
... and other preventive services; and (4) Community-clinical linkages to support cardiovascular disease... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-14-14CP... on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will...
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Sen. Inouye, Daniel K. [D-HI
2012-08-01
Senate - 08/01/2012 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:
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Task Specific Cognitive Challenges in Brain Cancer Survivors at Work
2013-03-25
Thesis submitted to the Faculty of the Medical and Clinical Psychology Graduate Program Uniformed Services University of the Health Sciences In...n = 99) completed an online survey that included socio-demographic information, job characteristics, health behaviors, and the Cognitive Symptom...5 Job-related and health -related information
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Code of Federal Regulations, 2014 CFR
2014-04-01
... agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events... criteria in § 1271.10(a) and that is also regulated as a device. (q) Unique device identifier (UDI) means...
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Defense.gov Special Report: Travels with Battaglia
Department of Defense Submit Search Travels with Battaglia, U.S. Marine Corps Sgt. Maj. Bryan B. Battaglia to say, 'Thank you for your service,'" Marine Corps Sgt. Maj. Bryan B. Battaglia, senior . Story Enlisted Leader Visits Mayor, Transitional Housing, Clinic Marine Corps Sgt. Maj. Bryan B
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78 FR 18983 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-28
... maximum limit of 100 slides in no less than an 8-hour day. On August 29, 2011 the American Society of...: American Society for Clinical Pathology, American Society for Cytotechnology, American Society of Cytopathology, and Papanicolaou Society of Cytopathology. The College of American Pathologists also acknowledged...
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Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration
2014-10-01
Evaluation Research (CDER), the Center for Biologics Evaluation Research (CBER), and the Center for Devices and Radiological Health ( CDRH ) to clarify...submitting a new application to the CDRH for a new product. This new product is the material that is produced in the validated manufacturing facility
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77 FR 25482 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-30
... (exp. 1/31/2013). The interview template has been revised to include four additional questions related... residing within participating jurisdictions are interviewed using locally designed interview templates... factors and clinical history of persons with gonorrhea. Each of the 12 sites will interview 60 persons...
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Sen. Inouye, Daniel K. [D-HI
2010-09-23
Senate - 09/23/2010 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:
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Code of Federal Regulations, 2010 CFR
2010-04-01
... necessary to assure that all batches of the same drug product meet an appropriate in vitro test, he shall include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... necessary to assure that all batches of the same drug product meet an appropriate in vitro test, he shall include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch...
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Status report on Virginia's program to combat drug-impaired driving.
DOT National Transportation Integrated Search
1989-01-01
Beginning on April 1, 1988, police officers in the Commonwealth of Virginia were given the statutory authority to require that drivers suspected of driving under the influence of drugs (DUID) submit a blood sample to be tested for drug content. Altho...
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Development of a real-time PCR for detection of Mycoplasma bovis in bovine milk and lung samples.
Cai, Hugh Y; Bell-Rogers, Patricia; Parker, Lois; Prescott, John F
2005-11-01
A real-time polymerase chain reaction (PCR) assay using hybridization probes on a LightCycler platform was developed for detection of Mycoplasma bovis from individual bovine mastitis milk and pneumonic lung tissues. The detection limit was 550 colony forming units (cfu)/ml of milk and 650 cfu/25 mg of lung tissue. A panel of bovine Mycoplasma and of other bovine-origin bacteria were tested; only M. bovis strains were positive, with a melting peak of 66.6 degrees C. Mycoplasma agalactiae PG2 was also positive and could be distinguished because it had a melting peak of 63.1 degrees C. In validation testing of clinical samples, the relative sensitivity and specificity were 100% and 99.3% for individual milks and 96.6% and 100% for the lung tissue. Using M. bovis real-time PCR, the M. bovis culture-positive milk samples were estimated to contain between 5 x 10(4) and 7.7 x 10(8) cfu/ml and the M. bovis culture-positive lungs between 1 x 10(3) and 1 x 10(9) cfu/25 mg. Isolation, confirmed with the real-time PCR and colony fluorescent antibody test, showed that at the herd level, the proportion of samples positive for M. bovis isolation in mastitis milk samples submitted to the Mastitis Laboratory, Animal Health Laboratory, University of Guelph, Ontario, Canada, was 2.4% (5/201). We conclude that this probe-based real-time PCR assay is a sensitive, specific, and rapid method to identify M. bovis infection in bovine milk and pneumonic lungs.
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Silva, Amanda Pagliotto da; Sassi, Fernanda Chiarion; Andrade, Claudia Regina Furquim de
To characterize the oral-motor system of adults with mandibular condyle facture comparing the performance of individuals submitted to open reduction with internal fixation (ORIF) and closed reduction with mandibulomaxillary fixation (CRMMF). Study participants were 26 adults divided into three groups: G1 - eight individuals submitted to ORIF for correction of condyle fracture; G2 - nine individuals submitted to CRMMF for correction of condyle fracture; CG - nine healthy volunteers with no alterations of the orofacial myofunctional system. All participants underwent the same clinical protocol: assessment of the orofacial myofunctional system; evaluation of the mandibular range of motion; and surface electromyography (sEMG) of the masticatory muscles. Results indicated that patients with condyle fractures from both groups presented significant differences compared with those from the control group in terms of mobility of the oral-motor organs, mastication, and deglutition. Regarding the measures obtained for mandibular movements, participants with facial fractures from both groups showed significant differences compared with those from the control group, indicating greater restrictions in mandibular motion. As for the analysis of sEMG results, G1 patients presented more symmetrical masseter activation during the task of maximal voluntary teeth clenching. Patients with mandibular condyle fractures present significant deficits in posture, mobility, and function of the oral-motor system. The type of medical treatment does not influence the results of muscle function during the first six months after fracture reduction. Individuals submitted to ORIF of the condyle fracture present more symmetrical activation of the masseter muscle.
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Surgical treatment analysis of idiopathic esophageal achalasia.
Aquino, José Luis Braga de; Said, Marcelo Manzano; Pereira, Douglas Rizzanti; Amaral, Paula Casals do; Lima, Juliana Carolina Alves; Leandro-Merhi, Vânia Aparecida
2015-01-01
Idiopathic esophageal achalasia is an inflammatory disease of unknown origin, characterized by aperistalsis of the esophageal body and failure of the lower esophageal sphincter in response to swallowing, with consequent dysphagia. To demonstrate the results of surgical therapy in these patients, evaluating the occurred local and systemic complications. Were studied retrospectively 32 patients, 22 of whom presented non-advanced stage of the disease (Stage I/II) and 10 with advanced disease (Stage III/IV). All of them had the clinical conditions to be submitted to surgery. The diagnoses were done by clinical, endoscopic, cardiological, radiological and esophageal manometry analysis. Pre-surgical evaluation was done with a questionnaire based on the most predisposing factors in the development of the disease and the surgical indication was based on the stage of the disease. The patients with non-advanced stages were submitted to cardiomyotomy with fundoplication, wherein in the post-surgical early assessment, only one (4,4%) presented pulmonary infection, but had a good outcome. In patients with advanced disease, seven were submitted to esophageal mucosectomy preserving the muscular layer, wherein one patient (14,2%) presented dehiscence of gastric cervical esophagus anastomosis as well as pulmonary infection; all of these complications were resolved with proper specific treatment; the other three patients with advanced stage were submitted to transmediastinal esophagectomy; two of them presented hydropneumothorax with good evolution, and one of them also presented fistula of the cervical esophagogastric anastomosis, but with spontaneous healing after conservative treatment and nutritional support. The two patients with fistula of the cervical anastomosis progressed to stenosis, with good results after endoscopic dilations. In the medium and long term assessment done in 23 patients, all of them reported improvement in life quality, with return to swallowing. The strategy proposed for the surgical treatment of idiopathic esophageal achalasia according to the stages of the disease was of great value, due to post-surgical low morbidity complications and proper recovery of swallowing.
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Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M
2017-07-05
Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M
2017-01-01
Introduction Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. Methods and analysis The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. Ethics and dissemination The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. PMID:28679677
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Antonelli, Giorgia; Padoan, Andrea; Artusi, Carlo; Marinova, Mariela; Zaninotto, Martina; Plebani, Mario
2016-04-01
The aim of this study was to implement in our routine practice an automated saliva preparation protocol for quantification of cortisol (F) and cortisone (E) by LC-MS/MS using a liquid handling platform, maintaining the previously defined reference intervals with the manual preparation. Addition of internal standard solution to saliva samples and calibrators and SPE on μ-elution 96-well plate were performed by liquid handling platform. After extraction, the eluates were submitted to LC-MS/MS analysis. The manual steps within the entire process were to transfer saliva samples in suitable tubes, to put the cap mat and transfer of the collection plate to the LC auto sampler. Transference of the reference intervals from the manual to the automated procedure was established by Passing Bablok regression on 120 saliva samples analyzed simultaneously with the two procedures. Calibration curves were linear throughout the selected ranges. The imprecision ranged from 2 to 10%, with recoveries from 95 to 116%. Passing Bablok regression demonstrated no significant bias. The liquid handling platform translates the manual steps into automated operations allowing for saving hands-on time, while maintaining assay reproducibility and ensuring reliability of results, making it implementable in our routine with the previous established reference intervals. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
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Suspected lead toxicosis in a bald eagle
Jacobson, E.; Carpenter, J.W.; Novilla, M.
1977-01-01
An immature bald eagle (Haliaeetus leucocephalus) was submitted to the University of Maryland, College Park, for clinical examination. The bird was thin, had green watery feces, and was unable to maintain itself in upright posture. Following radiography, the bird went into respiratory distress and died. Numerous lead shot were recovered from the gizzard, and chemical analysis of liver and kidney tissue revealed 22.9 and 11.3 ppm lead, respectively. The clinical signs, necropsy findings, and chemical analysis of the eagle were compatible with lead toxicosis.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-27
...The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.
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2013-03-26
Inventory (MGRSI) by Arlie Graham Sterling IV Master’s Thesis submitted to the faculty of the Department of Medical and Clinical...Gender Role Stress using the Male Gender Role Stressor Inventory (MGRSI) Name of Candidate: A. Graham Sterling IV Department of Medical and...MGRSI) Name ofCandicbte: LT.JG Arlie Grnham Sterling JV, Master of Science in Medical and Clinical Psychology, Date: 03/26/20 lJ Tl IESIS /\\ND
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Pullout bond strength of fiber posts luted to different depths and submitted to artificial aging.
Macedo, V C; Souza, N A Y; Faria e Silva, A L; Cotes, C; da Silva, C; Martinelli, M; Kimpara, E T
2013-01-01
The extension of fiber post cementation often does not seem to influence the fracture resistance of restorations. This study evaluated the effects of cementation depths on the retention of fiber posts submitted to artificial aging. One hundred and sixty bovine incisors were selected to assess post retention. Following endodontic treatment, the canals were flared with diamonds burs. Postholes were prepared in lengths of 5 or 10 mm, after which fiber posts were relined with composite resin and luted with RelyX ARC or RelyX Unicem. The samples were then submitted to thermal and/or mechanical cycling before testing their pullout bond strengths. Absence of cycling was used as a control. The results of each cement were submitted to two-way and post hoc Tukey tests (α=0.05). Independent of the aging protocol, a depth of 10 mm showed higher pullout bond strength than did 5 mm, except for RelyX Unicem without cycling. For RelyX ARC, thermomechanical cycling resulted in lower values than in the absence of cycling. Mechanical cycling alone promoted the highest bond strength when the posts were luted with RelyX Unicem. The effect of artificial aging on the pullout bond strength is dependent on the type of material and the depth.
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Paquette, Colleen E.; Buchner, Cari; Tanguay, Robert L.; Guillemin, Karen; Mason, Timothy J.; Peterson, Tracy S.
2013-01-01
Abstract For over a decade, spontaneous intestinal neoplasia has been observed in zebrafish (Danio rerio) submitted to the ZIRC (Zebrafish International Resource Center) diagnostic service. In addition, zebrafish displayed preneoplastic intestinal changes including hyperplasia, dysplasia, and enteritis. A total of 195 zebrafish, representing 2% of the total fish submitted to the service, were diagnosed with these lesions. Neoplastic changes were classified either as adenocarcinoma or small cell carcinoma, with a few exceptions (carcinoma not otherwise specified, tubular adenoma, and tubulovillous adenoma). Tumor prevalence appeared similarly distributed between sexes and generally occurred in zebrafish greater than 1 year of age, although neoplastic changes were observed in fish 6 months of age. Eleven lines displayed these preneoplastic and neoplastic changes, including wild-types and mutants. Affected zebrafish originated from 18 facilities, but the majority of fish were from a single zebrafish research facility (hereafter referred to as the primary facility) that has submitted numerous samples to the ZIRC diagnostic service. Zebrafish from the primary facility submitted as normal sentinel fish demonstrate that these lesions are most often subclinical. Fish fed the diet from the primary facility and held at another location did not develop intestinal lesions, indicating that diet is not the etiologic agent. PMID:23544991
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77 FR 18788 - Submission for OMB Review; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-28
... submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection... fundamental purposes: First and most important, it provides sampling populations and enumeration lists for the...) or email ( [email protected] ). Dated: March 23, 2012. Glenna Mickelson, Management Analyst...
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9 CFR 317.5 - Generically approved labeling.
Code of Federal Regulations, 2014 CFR
2014-01-01
... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington... particular. (2) The Food Safety and Inspection Service shall select samples of generically approved labeling...
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Impact properties of steels taken from four failed tank cars.
DOT National Transportation Integrated Search
1976-06-01
An overview of the results and metallurgical analyses o f the findings of impact tests conducted at the National Bureau of Standards on samples of tank-car matertals subhi'tted by the Federal Railroad Adminl'stration i s presented. The submitted samp...
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Virginia's program to combat drug-related DUI, 1988-1989.
DOT National Transportation Integrated Search
1992-01-01
Beginning on April 1, 1988, a revision to Virginia law gave police officers the authority to require an individual suspected of driving under the influence (DUI) of drugs to submit a blood sample to be tested for drug content. Concurrent with the imp...
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Legislative approaches to increasing Virginia's conviction rate for drug-related DUI.
DOT National Transportation Integrated Search
1992-01-01
Beginning on April 1, 1988, a revision of Virginia's law concerning drug-related driving under the influence (DUI) enabled police officers to require a person suspected of driving under the influence of drugs to submit a blood sample to be tested for...
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The high vaginal swab in general practice: clinical correlates of possible pathogens.
Dykhuizen, R S; Harvey, G; Gould, I M
1995-06-01
Clinical features, diagnosis and treatment of 286 women whose high vaginal swabs (HVS) submitted by their general practitioners showed pure, heavy growth of Staphylococcus aureus, beta haemolytic streptococci groups A, C or G, Streptococcus milleri, Streptococcus pneumoniae or Haemophilus influenzae were analysed. Women with group A, C and G streptococci frequently had clinical vulvovaginitis and although the numbers were too small for statistical confirmation, S. pneumoniae and H. influenzae appeared to cause clinical disease as well. The association of S. aureus or S. milleri with clinical vulvovaginitis was much less convincing. It seems relevant for laboratories to report sensitivities for group A, C and G streptococci. Further research is needed to determine the pathogenicity of S. pneumoniae and H. influenzae.
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Sensitivity and Specificity of Histoplasma Antigen Detection by Enzyme Immunoassay.
Cunningham, Lauren; Cook, Audrey; Hanzlicek, Andrew; Harkin, Kenneth; Wheat, Joseph; Goad, Carla; Kirsch, Emily
2015-01-01
The objective of this study was to evaluate the sensitivity and specificity of an antigen enzyme immunoassay (EIA) on urine samples for the diagnosis of histoplasmosis in dogs. This retrospective medical records review included canine cases with urine samples submitted for Histoplasma EIA antigen assay between 2007 and 2011 from three veterinary institutions. Cases for which urine samples were submitted for Histoplasma antigen testing were reviewed and compared to the gold standard of finding Histoplasma organisms or an alternative diagnosis on cytology or histopathology. Sensitivity, specificity, negative predictive value, positive predictive value, and the kappa coefficient and associated confidence interval were calculated for the EIA-based Histoplasma antigen assay. Sixty cases met the inclusion criteria. Seventeen cases were considered true positives based on identification of the organism, and 41 cases were considered true negatives with an alternative definitive diagnosis. Two cases were considered false negatives, and there were no false positives. Sensitivity was 89.47% and the negative predictive value was 95.35%. Specificity and the positive predictive value were both 100%. The kappa coefficient was 0.9207 (95% confidence interval, 0.8131-1). The Histoplasma antigen EIA test demonstrated high specificity and sensitivity for the diagnosis of histoplasmosis in dogs.
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Unreliability of modified inguinal lymphadenectomy for clinical staging of penile carcinoma.
Lopes, A; Rossi, B M; Fonseca, F P; Morini, S
1996-05-15
In 1988, Catalona proposed a modified bilateral inguinal lymphadenectomy for staging of lymph node metastasis from penile carcinoma. All three patients with penile carcinoma submitted to this procedure and without histologically confirmed metastases were free of disease within a mean follow-up time of 14.6 months. In a prospective study, the authors evaluated thirteen patients staged by the TNM system and submitted to modified bilateral inguinal lymphadenectomy. None of the patients had histologic metastases in the medial quadrant lymph nodes. Two of these patients developed regional lymph node metastases within 13.2 months (mean follow-up time). Catalona's procedure was not reliable. We therefore recommend standard inguinal lymphadenectomy as the minimal treatment for patients with infiltrating carcinoma of the penis.
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Chemistry Data for Geothermometry Mapping of Deep Hydrothermal Reservoirs in Southeastern Idaho
Earl Mattson
2016-01-18
This dataset includes chemistry of geothermal water samples of the Eastern Snake River Plain and surrounding area. The samples included in this dataset were collected during the springs and summers of 2014 and 2015. All chemical analysis of the samples were conducted in the Analytical Laboratory at the Center of Advanced Energy Studies in Idaho Falls, Idaho. This data set supersedes #425 submission and is the final submission for AOP 3.1.2.1 for INL. Isotopic data collected by Mark Conrad will be submitted in a separate file.
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Mentoring Clinical Nurses to Write for Publication: Strategies for Success.
Oman, Kathleen S; Mancuso, Mary P; Ceballos, Kirtley; Makic, MaryBeth Flynn; Fink, Regina M
2016-05-01
: Clinical nurses often find writing a challenge, but it's important to disseminate clinical practice initiatives that result in notable patient outcomes. Nurses have a responsibility to share what they do to improve patient care. The increased emphasis on the development and evaluation of evidence-based practice has made it necessary for nurses to share best practices that are associated with improved patient outcomes. We developed a six-month Writing for Publication workshop series designed to teach clinical nurses about the writing process and mentor them through the stages of preparing a manuscript to submit for publication. This successful program helped novice nurse authors become published professionals and had a great impact on our organization.
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F-aggregate centers formation in BaLiF3 crystals
NASA Astrophysics Data System (ADS)
Prado, L.; Gomes, L.; Baldochi, S. L.; Morato, S. P.; Vieira, N. D.
The kinetics of F-aggregate centers formation is investigated in the inverted fluoroperovskite of BaLiF3 submitted to electron-irradiation. By studies of the changes in the absorption spectra during storage of samples in the dark, at room temperature, it was possible to verify a surprising and interesting dependence on defect formation with the crystal growth direction. In spite of its cubic structure, crystals grown in the <100> and <111> directions and submitted to the same conditions of irradiation, showed in particular, to enhance the production of a defect absorbing at 630 nm in <100> crystals which we believe to correspond to F+2-centers in BaLiF3
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Thomsen, Martin Christen Frølund; Ahrenfeldt, Johanne; Cisneros, Jose Luis Bellod; Jurtz, Vanessa; Larsen, Mette Voldby; Hasman, Henrik; Aarestrup, Frank Møller; Lund, Ole
2016-01-01
Recent advances in whole genome sequencing have made the technology available for routine use in microbiological laboratories. However, a major obstacle for using this technology is the availability of simple and automatic bioinformatics tools. Based on previously published and already available web-based tools we developed a single pipeline for batch uploading of whole genome sequencing data from multiple bacterial isolates. The pipeline will automatically identify the bacterial species and, if applicable, assemble the genome, identify the multilocus sequence type, plasmids, virulence genes and antimicrobial resistance genes. A short printable report for each sample will be provided and an Excel spreadsheet containing all the metadata and a summary of the results for all submitted samples can be downloaded. The pipeline was benchmarked using datasets previously used to test the individual services. The reported results enable a rapid overview of the major results, and comparing that to the previously found results showed that the platform is reliable and able to correctly predict the species and find most of the expected genes automatically. In conclusion, a combined bioinformatics platform was developed and made publicly available, providing easy-to-use automated analysis of bacterial whole genome sequencing data. The platform may be of immediate relevance as a guide for investigators using whole genome sequencing for clinical diagnostics and surveillance. The platform is freely available at: https://cge.cbs.dtu.dk/services/CGEpipeline-1.1 and it is the intention that it will continue to be expanded with new features as these become available.
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Baldassano, Steven N; Brinkmann, Benjamin H; Ung, Hoameng; Blevins, Tyler; Conrad, Erin C; Leyde, Kent; Cook, Mark J; Khambhati, Ankit N; Wagenaar, Joost B; Worrell, Gregory A; Litt, Brian
2017-06-01
There exist significant clinical and basic research needs for accurate, automated seizure detection algorithms. These algorithms have translational potential in responsive neurostimulation devices and in automatic parsing of continuous intracranial electroencephalography data. An important barrier to developing accurate, validated algorithms for seizure detection is limited access to high-quality, expertly annotated seizure data from prolonged recordings. To overcome this, we hosted a kaggle.com competition to crowdsource the development of seizure detection algorithms using intracranial electroencephalography from canines and humans with epilepsy. The top three performing algorithms from the contest were then validated on out-of-sample patient data including standard clinical data and continuous ambulatory human data obtained over several years using the implantable NeuroVista seizure advisory system. Two hundred teams of data scientists from all over the world participated in the kaggle.com competition. The top performing teams submitted highly accurate algorithms with consistent performance in the out-of-sample validation study. The performance of these seizure detection algorithms, achieved using freely available code and data, sets a new reproducible benchmark for personalized seizure detection. We have also shared a 'plug and play' pipeline to allow other researchers to easily use these algorithms on their own datasets. The success of this competition demonstrates how sharing code and high quality data results in the creation of powerful translational tools with significant potential to impact patient care. © The Author (2017). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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Anie, Kofi A; Paintsil, Vivian; Owusu-Dabo, Ellis; Ansong, Daniel; Osei-Akoto, Alex; Ohene-Frempong, Kwaku; Amissah, Kofi Aikins; Addofoh, Nicholas; Ackah, Ezekiel Bonwin; Owusu-Ansah, Amma Twumwa; Ofori-Acquah, Solomon Fiifi
2017-08-28
Sickle cell disease is highly prevalent in Africa with a significant public health burden. Nonetheless, morbidity and mortality in sickle cell disease that result from the progression of organ damage is not well understood. The Organ Damage in Sickle Cell Disease Study (ORDISS) is designed as a longitudinal cohort study to provide critical insight into cellular and molecular pathogenesis of chronic organ damage for the development of future innovative treatment. ORDISS aims to recruit children aged 0-15 years who attend the Kumasi Centre for Sickle Cell Disease based at the Komfo Anokye Teaching Hospital in Kumasi, Ghana. Consent is obtained to collect blood and urine samples from the children during specified clinic visits and hospitalisations for acute events, to identify candidate and genetic markers of specific organ dysfunction and end-organ damage, over a 3 year period. In addition, data concerning clinical history and complications associated with sickle cell disease are collected. Samples are stored in biorepositories and analysed at the Kumasi Centre for Collaborative Research in Tropical Medicine, Ghana and the Centre for Translational and International Haematology, University of Pittsburgh, USA. Appropriate statistical analyses will be performed on the data acquired. Research ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals, and the key findings presented at national and international conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Lima, Estela de Oliveira; de Macedo, Cristiana Santos; Esteves, Cibele Zanardi; de Oliveira, Diogo Noin; Pessolani, Maria Cristina Vidal; Nery, José Augusto da Costa; Sarno, Euzenir Nunes; Catharino, Rodrigo Ramos
2015-04-07
Leprosy is a chronic infectious disease caused by Mycobacterium leprae, which primarily infects macrophages and Schwann cells, affecting skin and peripheral nerves. Clinically, the most common form of identification is through the observation of anesthetic lesions on skin; however, up to 30% of infected patients may not present this clinical manifestation. Currently, the gold standard diagnostic test for leprosy is based on skin lesion biopsy, which is invasive and presents low sensibility for suspect cases. Therefore, the development of a fast, sensible and noninvasive method that identifies infected patients would be helpful for assertive diagnosis. The aim of this work was to identify lipid markers in leprosy patients directly from skin imprints, using a mass spectrometric analytical strategy. For skin imprint samples, a 1 cm(2) silica plate was gently pressed against the skin of patients or healthy volunteers. Imprinted silica lipids were extracted and submitted to direct-infusion electrospray ionization high-resolution mass spectrometry (ESI-HRMS). All samples were differentiated using a lipidomics-based data workup employing multivariate data analysis, which helped electing different lipid markers, for example, mycobacterial mycolic acids, inflammatory and apoptotic molecules were identified as leprosy patients' markers. Otherwise, phospholipids and gangliosides were pointed as healthy volunteers' skin lipid markers, according to normal skin composition. Results indicate that silica plate skin imprinting associated with ESI-HRMS is a promising fast and sensible leprosy diagnostic method. With a prompt leprosy diagnosis, an early and effective treatment could be feasible and thus the chain of leprosy transmission could be abbreviated.
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Richter, S. S.; Beekmann, S. E.; Croco, J. L.; Diekema, D. J.; Koontz, F. P.; Pfaller, M. A.; Doern, G. V.
2002-01-01
An algorithm was implemented in the clinical microbiology laboratory to assess the clinical significance of organisms that are often considered contaminants (coagulase-negative staphylococci, aerobic and anaerobic diphtheroids, Micrococcus spp., Bacillus spp., and viridans group streptococci) when isolated from blood cultures. From 25 August 1999 through 30 April 2000, 12,374 blood cultures were submitted to the University of Iowa Clinical Microbiology Laboratory. Potential contaminants were recovered from 495 of 1,040 positive blood cultures. If one or more additional blood cultures were obtained within ±48 h and all were negative, the isolate was considered a contaminant. Antimicrobial susceptibility testing (AST) of these probable contaminants was not performed unless requested. If no additional blood cultures were submitted or there were additional positive blood cultures (within ±48 h), a pathology resident gathered patient clinical information and made a judgment regarding the isolate's significance. To evaluate the accuracy of these algorithm-based assignments, a nurse epidemiologist in approximately 60% of the cases performed a retrospective chart review. Agreement between the findings of the retrospective chart review and the automatic classification of the isolates with additional negative blood cultures as probable contaminants occurred among 85.8% of 225 isolates. In response to physician requests, AST had been performed on 15 of the 32 isolates with additional negative cultures considered significant by retrospective chart review. Agreement of pathology resident assignment with the retrospective chart review occurred among 74.6% of 71 isolates. The laboratory-based algorithm provided an acceptably accurate means for assessing the clinical significance of potential contaminants recovered from blood cultures. PMID:12089259
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Jenkins, Mary M; Reefhuis, Jennita; Herring, Amy H; Honein, Margaret A
2017-12-01
To better understand the impact that nonresponse for specimen collection has on the validity of estimates of association, we examined associations between self-reported maternal periconceptional smoking, folic acid use, or pregestational diabetes mellitus and six birth defects among families who did and did not submit buccal cell samples for DNA following a telephone interview as part of the National Birth Defects Prevention Study (NBDPS). Analyses included control families with live born infants who had no birth defects (N = 9,465), families of infants with anorectal atresia or stenosis (N = 873), limb reduction defects (N = 1,037), gastroschisis (N = 1,090), neural tube defects (N = 1,764), orofacial clefts (N = 3,836), or septal heart defects (N = 4,157). Estimated dates of delivery were between 1997 and 2009. For each exposure and birth defect, odds ratios and 95% confidence intervals were calculated using logistic regression stratified by race-ethnicity and sample collection status. Tests for interaction were applied to identify potential differences between estimated measures of association based on sample collection status. Significant differences in estimated measures of association were observed in only four of 48 analyses with sufficient sample sizes. Despite lower than desired participation rates in buccal cell sample collection, this validation provides some reassurance that the estimates obtained for sample collectors and noncollectors are comparable. These findings support the validity of observed associations in gene-environment interaction studies for the selected exposures and birth defects among NBDPS participants who submitted DNA samples. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
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Sen. Merkley, Jeff [D-OR
2014-07-23
Senate - 07/23/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:
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Sen. Inouye, Daniel K. [D-HI
2012-11-29
Senate - 11/29/2012 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:
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[Evaluation of medication risk in pregnant women: methodology of evaluation and risk management].
Eléfant, E; Sainte-Croix, A
1997-01-01
This round table discussion was devoted to the description of the tools currently available for the evaluation of drug risks and management during pregnancy. Five topics were submitted for discussion: pre-clinical data, methodological tools, benefit/risk ratio before prescription, teratogenic or fetal risk evaluation, legal comments.
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78 FR 9923 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-12
... antiretroviral therapy (ART), (3) attend clinic regularly for primary care, and (4) practice safer sex. These are... screener completed by patients; (2) a computer-based intervention (CBI) in which patients see short videos... attendance, adherence to ART, and safer sex; and (3) one-on-one counseling from a prevention specialist if...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-12
... grants to law school legal clinics, legal aid or legal services programs, domestic violence victims..., Office on Violence Against Women (OVW) will be submitting the following information collection request to... collection, please Cathy Poston, Office on Violence Against Women, at 202-514-5430 or the DOJ Desk Officer at...
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75 FR 71708 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-24
... level data, from recruited hospitals for the year 2011 onward. A pretest of a survey supplement on acute... demographic information, clinical capabilities, and financial information. The pretest of the supplement on... and re-filing Patient Records 151 133 1/60 335 (ED, OPD, and ASC). ACUTE CORONARY SYNDROME PRETEST...
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Medical School Salary Study, 1971-72.
ERIC Educational Resources Information Center
Association of American Medical Colleges, Washington, DC.
The Association of American Medical Colleges presents the results of their Annual Salary Questionnaire for medical school faculties for the fiscal year 1971-72. Ninety-five schools submitted returns and salaries of 4,930 basic scientists and 11,941 clinical scientists are reported in the survey. The areas covered include strict full-time faculty…