Sample records for included clinic site
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Quantifying and visualizing site performance in clinical trials.
Yang, Eric; O'Donovan, Christopher; Phillips, JodiLyn; Atkinson, Leone; Ghosh, Krishnendu; Agrafiotis, Dimitris K
2018-03-01
One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. The
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2010-01-06
... engaged in activities related to the production of integrated circuits. The company reports that on-site... Corporation Arlington Manufacturing Site Including On-Site Leased Workers From GCA, CMPA (Silverleaf), Custom..., applicable to workers of National Semiconductor Corporation, Arlington Manufacturing Site, including on-site...
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Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice
DEFF Research Database (Denmark)
Smed, Marie; Getz, Kenneth A.
2014-01-01
Investigative sites participating in clinical trials play an instrumental role in aiding market adoption. Site experiences in clinical research help physician investigators and research professionals gain familiarity with and exposure to investigational treatments. This knowledge may be passed...
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Financial Management of a Large Multi-site Randomized Clinical Trial
Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.
2014-01-01
Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748
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2011-10-05
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,540] Bmc Software, Inc... November 23, 2010, applicable to workers of BMC Software, Inc., including on-site leased workers from... BMC Software, inc., including on-site leased workers from Comsys ITS, and including remote workers...
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Quantifying and visualizing site performance in clinical trials
Eric Yang; Christopher O'Donovan; JodiLyn Phillips; Leone Atkinson; Krishnendu Ghosh; Dimitris K. Agrafiotis
2018-01-01
Background: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can co...
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Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.
Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed
2017-08-01
There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.
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Quantifying and visualizing site performance in clinical trials
Directory of Open Access Journals (Sweden)
Eric Yang
2018-03-01
Conclusions: The use of operational data from Covance Central Laboratories provides a unique perspective into the performance of clinical sites with respect to many important metrics such as patient enrollment and retention. These metrics can, in turn, be used to guide operational planning and site selection for new clinical trials, thereby accelerating recruitment, improving quality, and reducing cost.
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2010-10-29
... follows: ``All workers TTM Technologies, including on-site leased workers from Kelly Services and Aerotek... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-64,993] TTM Technologies, Including On-Site Leased Workers From Kelly Services, Aerotek, and an On-Site Leased Worker From Orbotech...
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Clinical Reasoning Terms Included in Clinical Problem Solving Exercises?
Musgrove, John L; Morris, Jason; Estrada, Carlos A; Kraemer, Ryan R
2016-05-01
Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms.
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40 CFR 60.1125 - What must I include in my siting analysis?
2010-07-01
... 40 Protection of Environment 6 2010-07-01 2010-07-01 false What must I include in my siting... § 60.1125 What must I include in my siting analysis? (a) Include an analysis of how your municipal...) Vegetation. (b) Include an analysis of alternatives for controlling air pollution that minimize potential...
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2010-07-19
..., Evansville Division, Including On-Site Leased Workers From Andrews International, Inc., M.H. Equipment, and... 10321). The notice was amended on May 25, 2010 to include on-site leased workers from Andrews... workers of Whirlpool Corporation, Evansville Division, including on-site leased workers from Andrews...
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2010-04-01
... Engineering Division, Including B&C Distribution Center, Including On-Site Leased Workers From B&C Services... occurred during the relevant time period at the B&C Distribution Center, Inc. of the B&C Corporation, JR Engineering Division, Barberton, Ohio. The B&C Distribution Center provides distribution and logistical...
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Méthot, Julie; Brisson, Diane; Gaudet, Daniel
2012-04-01
Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.
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Sellafield Site (including Drigg) emergency scheme manual
International Nuclear Information System (INIS)
1987-02-01
This Scheme defines the organisation and procedures available should there be an accident at the Sellafield Site which results in, or may result in, the release of radioactive material, or the generation of a high radiation field, which might present a hazard to employees and/or the general public. Several categories of emergencies on the Sellafield Site are mentioned; a building emergency which is confined to one building, a Site emergency standby when the effects of a building emergency go outside that building, a Site emergency alert (District Emergency Standby) when a release of activity affects Site operations and could have serious Site effects and a District Emergency Alert when a radioactivity release may interfere with the normal activity of the General Public. A Drigg Emergency Standby situation would operate similarly at the Drigg Site. The detailed arrangements and responsibilities of appointed personnel are set out in this manual. (UK)
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Environmental site assessments should include radon gas testing
International Nuclear Information System (INIS)
Nardi, M.A.
1991-01-01
There are two emerging influences that will require radon gas testing as part of many property transfers and most site assessments. These requirements come from lending regulators and state legislatures. Fannie Mae and others have developed environmental investigation guidelines for the purchase of environmentally contaminated real estate. These guidelines include radon gas testing for many properties. Several states have enacted laws that require environmental disclosure forms be prepared to ensure that the parties involved in certain real estate transactions are aware of the environmental liabilities that may come with the transfer of property. Indiana has recently enacted legislation that would require the disclosure of the presence of radon gas on many commercial real estate transactions. With more lenders and state governments likely to follow this trend, radon gas testing should be performed during all property transfers and site assessment to protect the parties involved from any legal liabilities
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The Use of Non-Variant Sites to Improve the Clinical Assessment of Whole-Genome Sequence Data.
Directory of Open Access Journals (Sweden)
Alberto Ferrarini
Full Text Available Genetic testing, which is now a routine part of clinical practice and disease management protocols, is often based on the assessment of small panels of variants or genes. On the other hand, continuous improvements in the speed and per-base costs of sequencing have now made whole exome sequencing (WES and whole genome sequencing (WGS viable strategies for targeted or complete genetic analysis, respectively. Standard WGS/WES data analytical workflows generally rely on calling of sequence variants respect to the reference genome sequence. However, the reference genome sequence contains a large number of sites represented by rare alleles, by known pathogenic alleles and by alleles strongly associated to disease by GWAS. It's thus critical, for clinical applications of WGS and WES, to interpret whether non-variant sites are homozygous for the reference allele or if the corresponding genotype cannot be reliably called. Here we show that an alternative analytical approach based on the analysis of both variant and non-variant sites from WGS data allows to genotype more than 92% of sites corresponding to known SNPs compared to 6% genotyped by standard variant analysis. These include homozygous reference sites of clinical interest, thus leading to a broad and comprehensive characterization of variation necessary to an accurate evaluation of disease risk. Altogether, our findings indicate that characterization of both variant and non-variant clinically informative sites in the genome is necessary to allow an accurate clinical assessment of a personal genome. Finally, we propose a highly efficient extended VCF (eVCF file format which allows to store genotype calls for sites of clinical interest while remaining compatible with current variant interpretation software.
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Clinical evaluation of post-extraction site wound healing.
Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Ogunlewe, Mobolanle Olugbemiga
2006-07-01
The aim of this prospective study was to evaluate the clinical pattern of post-extraction wound healing with a view to identify the types, incidence, and pattern of healing complications following non-surgical tooth extraction. A total of 311 patients, who were referred for non-surgical (intra-alveolar) extractions, were included in the study. The relevant pre-operative information recorded for each patient included age and gender of the patient, indications for extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessment. Data recorded were: biodata, day of presentation for alveolus healing assessment, day of onset of any symptoms, body temperature (degrees C) in cases of alveolus infection, and presence or absence of pain. Two hundred eighty-two patients (282) with 318 extraction sites were evaluated for alveolus healing. Healing was uneventful in 283 alveoli (89%), while 35 alveoli (11%) developed healing complications. These complications were: localized osteitis 26 (8.2%); acutely infected alveolus 5 (1.6%); and an acutely inflamed alveolus 4 (1.2%). Females developed more complications than males (p=0.003). Most complications were found in molars (60%) and premolars (37.1%). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain. Thirty patients (12%) among those without healing complications experienced mild pain. Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.
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Koçarslan, Sezen; Turan, Enver; Ekinci, Turan; Yesilova, Yavuz; Apari, Rabia
2013-01-01
The aim of our study was to investigate the clinical and histopathological characteristics of cutaneous leishmaniasis (CL) in the city of Sanliurfa in Turkey, where Syrian refugees also reside. At the Harran University Hospital outpatient clinics between 2012 and 2013, 54 CL cases, including 24 Syrian patients, underwent punch biopsy of the skin and/or a touch imprint. Patients in whom leishmania parasites were detected were included in the study. The clinical and histopathological data of the patients were obtained by a review of the patients' medical records. All the slides of each patient were re-evaluated histopathologically. Fifty-four cases (mean age; 17 ± 12 years), consisting of 32 males (59.3%) and 22 females (40.7%), were examined. The most common site of involvement was the face (63%). The most common presentation was noduloulcerative lesions (57.4%). Histopathologically, the majority of the cases exhibited hyperkeratosis, follicular plugging of the epidermis, chronic inflammatory infiltration, leishmania amastigotes and non-caseating granulomatous inflammation in the dermis. CL presents with a wide spectrum of expression, both clinically and histologically, and may mimic other inflammatory and neoplastic diseases. The diagnosis of CL relies on the identification of leishmania amastigotes in either a direct smear of the lesion or in a tissue section.
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2010-06-07
..., Evansville Division, Including On-Site Leased Workers from Andrews International, Inc., Evansville, IN... that workers leased from Andrews International, Inc. were employed on-site at the Evansville, Indiana... findings, the Department is amending this certification to include leased workers from Andrews...
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2011-12-29
..., Inc., Automation and Control Solutions Division, Including On-Site Leased Workers From Manpower...., Automation and Control Solutions Division. The Department has determined that these workers were sufficiently...., Automation and Control Solutions Division, including on-site leased workers from Manpower, Spherion...
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2011-04-07
... Builder Cabinet Group Including On-Site Leased Workers From Reserves Network, Reliable Staffing, and Third Dimension Waverly, OH; Masco Builder Cabinet Group Including On-Site Leased Workers From Reserves Network... Group including on-site leased workers from Reserves Network, Jackson, Ohio. The workers produce...
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Directory of Open Access Journals (Sweden)
Sezen Koçarslan
2013-01-01
Full Text Available Background: The aim of our study was to investigate the clinical and histopathological characteristics of cutaneous leishmaniasis (CL in the city of Sanliurfa in Turkey, where Syrian refugees also reside. Materials and Methods: At the Harran University Hospital outpatient clinics between 2012 and 2013, 54 CL cases, including 24 Syrian patients, underwent punch biopsy of the skin and/or a touch imprint. Patients in whom leishmania parasites were detected were included in the study. The clinical and histopathological data of the patients were obtained by a review of the patients′ medical records. All the slides of each patient were re-evaluated histopathologically. Results: Fifty-four cases (mean age; 17 ± 12 years, consisting of 32 males (59.3% and 22 females (40.7%, were examined. The most common site of involvement was the face (63%. The most common presentation was noduloulcerative lesions (57.4%. Histopathologically, the majority of the cases exhibited hyperkeratosis, follicular plugging of the epidermis, chronic inflammatory infiltration, leishmania amastigotes and non-caseating granulomatous inflammation in the dermis. Conclusion: CL presents with a wide spectrum of expression, both clinically and histologically, and may mimic other inflammatory and neoplastic diseases. The diagnosis of CL relies on the identification of leishmania amastigotes in either a direct smear of the lesion or in a tissue section.
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2013-04-01
... Kodak Company (GCG), Electrographic Print Solutions, Including On-Site Leased Workers From Adecco and Datrose, Spencerport, New York; Eastman Kodak Company, IPS, Including On-Site Leased Workers From Adecco..., 2011, applicable to workers of Eastman Kodak Company (GCG), Electrographic Print Solutions, including...
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Rosenkrantz, Andrew B; Doshi, Ankur M
2016-01-01
To assess information regarding radiology practices on public transparency Web sites. Eight Web sites comparing radiology centers' price and quality were identified. Web site content was assessed. Six of eight Web sites reported examination prices. Other reported information included hours of operation (4/8), patient satisfaction (2/8), American College of Radiology (ACR) accreditation (3/8), on-site radiologists (2/8), as well as parking, accessibility, waiting area amenities, same/next-day reports, mammography follow-up rates, examination appropriateness, radiation dose, fellowship-trained radiologists, and advanced technologies (1/8 each). Transparency Web sites had a preponderance of price (and to a lesser extent service quality) information, risking fostering price-based competition at the expense of clinical quality. Copyright © 2016 Elsevier Inc. All rights reserved.
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2012-07-10
..., Inc., Including On-Site Leased Workers From Insight Global Stone Staffing, and Randstad Formerly Known..., Massachusetts, including on-site leased workers from Insight Global, Stone Staffing, Randstad formerly known as... Insight Global, Stone Staffing, Randstad, formerly known as Sapphire Technologies, were employed on-site...
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2013-02-22
..., Inc., Wealth Management Americas Operations, Including On-Site Leased Workers From Leafstone... Services, Inc., Wealth Management Americas Operations (UBS), Weehawken, New Jersey. The workers are engaged... to include all leased workers on-site at UBS Financial Services, Inc., Wealth Management Americas...
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2013-05-15
... Kodak Company, Electrographic Print Solutions, Including On-Site Leased Workers From Adecco and Datrose, Spencerport, New York; Eastman Kodak Company, IPS, Including On-Site Leased Workers From Adecco, Dayton, Ohio... Trade Adjustment Assistance (TAA) filed on behalf of Eastman Kodak Company, Electrographic Print...
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2011-01-03
... Technologies Including On-Site Leased Workers From Adecco Employment Servcies and Emcon Technologies, Troy, MI..., applicable to workers of Faurecia Emissions Control Technologies, Troy, Michigan, including on-site leased workers from Adecco Employment Services, Troy, Michigan. The Department's notice of determination was...
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2010-05-20
.... The Department has determined that workers from Spherion Staffing were sufficiently under the control..., Including On-Site Leased Workers From Manpower and Spherion Staffing, Including On-Site Workers From Hagemeyer North America, Lake Mills, IA; Amended Certification Regarding Eligibility To Apply for Worker...
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On-site screening for maternal syphilis in an antenatal clinic ...
African Journals Online (AJOL)
Study objective. To determine the sensitivity, specificity, negative predictive value and positive predictive value of the rapid plasma reagin (RPR) test as performed on site in an antenatal clinic to facilitate immediate diagnosis and treatment of maternal syphilis. Design. Open, descriptive study. Setting. Antenatal clinic ...
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2010-10-08
... related to the production of scientific laboratory equipment. New information shows that workers leased... Corporation, a Subsidiary of Thermo Fisher Scientific, Including On-Site Leased Workers From Sedona Staffing... Scientific, including on- site leased workers from Sedona Staffing, Dubuque, Iowa. The notice was published...
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2012-10-15
... Aluminum North America, Inc., Midwest Region, Including On- Site Leased Workers From Employment Group, Aerotek, and Manpower, Kalamazoo, Michigan; Hydro Aluminum North America, Inc., Midwest Region, Including... Aluminum North America, Inc., Kalamazoo, Michigan. The subject worker group includes on-site leased workers...
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2011-05-11
... Logistics Division, Including On-Site Leased Workers From Prologistix, Including Workers Whose Unemployment..., applicable to workers of CEVA Freight, LLC, Dell Logistics Division, including on-site leased workers from... workers employed at CEVA Freight, LLC, Dell Logistics Division, Winston-Salem, North Carolina who were...
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2012-01-27
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-75,201] Abbott Laboratories..., applicable to workers of Abbott Laboratories, Diagnostics Division, including on-site leased workers from... (clerical) were employed on-site at the Irving, Texas location of Abbott Laboratories, Diagnostics Division...
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2010-05-12
... & Wine, Including On-Site Leased Workers from Adecco, St. Elizabeth Business Health, Guardsmark, and Lab... 26, 2010, applicable to workers of Beam Global Spirits & Wine, including on-site leased workers from... on-site at the Cincinnati, Ohio location of Beam Global Spirits & Wine. The Department has determined...
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2010-03-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-72,924] Heritage Aviation, Ltd., Including On-Site Leased Workers From Global Technical Services and Global, Inc. (Global Employment... from Heritage Aviation, Ltd, including on-site leased workers from Global Technical Services, Grand...
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2011-01-12
... Company, Franklin Pulp & Paper Mill, Including On-Site Leased Workers From Railserve, Franklin, VA..., applicable to workers and former workers of International Paper Company, Franklin Pulp & Paper Mill, Franklin... follows: All workers International Paper Company, Franklin Pulp & Paper Mill, including on-site leased...
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2011-10-07
...., Including On-Site Leased Workers From Spherion/Source Right, Springdale, Ohio; Amended Certification... workers of the subject firm. The company reports that workers leased from Spherion/Source Right were...., including on-site leased workers from Spherion/Source Right, Springdale, Ohio, who became totally or...
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2013-02-22
... office financial services from India and the Philippines. Based on these findings, the Department is..., Financial Shared Services West, Including On- Site Leased Workers From Aerotek, eXcel Staffing, Experis..., applicable to workers of Cardinal Health, Financial Shared Services West, including on-site leased workers...
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2011-08-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-75,099] West, A Thomson Reuters Business, Thomson Reuters Legal Division, Including On-Site Leased Workers From Adecco, Albuquerque, New... former workers of West, A Thomson Reuters Business, Thomson Reuters Legal Division, including On-Site...
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DEFF Research Database (Denmark)
Antonsen, Sofie L; Meyhoff, Christian Sylvest; Lundvall, Lene
2011-01-01
between November 2006 and October 2008 and data from the DGCD. METHODS: Outcomes within 30 days from the trial and the database were compared and levels of agreements were calculated with kappa-statistics. MAIN OUTCOME MEASURES: Primary outcome was surgical-site infection. Other outcomes included re-operation...... registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia). CONCLUSIONS: The randomized trial reported significantly more surgical-site infections......OBJECTIVE: Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits. DESIGN...
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2012-01-24
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-71,501M] Sony Electronics, Inc... Electronics, Inc., SEL Headquarters, including on-site leased workers of SelectRemedy, StaffMark, and Payrolling.com , San Diego, California (TA-W-71,501); Sony Electronics, Inc., including on-site leased...
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2013-10-03
..., LLC, Wafer Slicing and Quality Control Operations, Including On-Site Leased Workers From Brown and... Quality Control Operations, Salem, Oregon, including on-site leased workers from Brown and Dunton, Inc... and included workers who supplied quality control and support functions. The company reports that...
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Harrell, Angela; Matthews, Eric
2016-07-01
To determine whether a relationship exists between the number of clinical sites available in radiography programs accredited by the Joint Review Committee on Education in Radiologic Technology and the job placement rates of graduates. We performed a secondary analysis of data on job placement rates and the number of clinical sites available in 438 degree-granting radiography programs from January 2015 to March 2015. A weak, negative, nonsignificant correlation existed between the number of clinical sites and the job placement rate (Spearman's rho = -.113, n = 438, P = .018). The coefficient of determination was 1.28%.Discussion Research evaluating factors contributing to graduate employability is limited but indicates no need for radiography program administrators to adjust clinical site numbers solely on the basis of improving graduate employability. The number of clinical sites available in a radiography program is not related to the job placement rate of its graduates. ©2016 American Society of Radiologic Technologists.
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Surgical site infections in women and their association with clinical conditions
Directory of Open Access Journals (Sweden)
Maria Zélia de Araújo Madeira
2014-07-01
Full Text Available Introduction Surgical site infections (SSIs can affect body tissues, cavities, or organs manipulated in surgery and constitute 14% to 16% of all infections. This study aimed to determine the incidence of SSIs in women following their discharge from a gynecology outpatient clinic, to survey different types of SSIs among women, and to verify the association of SSIs with comorbidities and clinical conditions. Methods Data were collected via analytical observation with a cross-sectional design, and the study was conducted in 1,026 women who underwent gynecological surgery in a teaching hospital in the municipality of Teresina, in the northeast Brazilian State of Piauí, from June 2011 to March 2013. Results The incidence of SSIs after discharge was 5.8% among the women in the outpatient clinic. The most prevalent surgery among the patients was hysterectomy, while the most prevalent type of SSI was superficial incisional. Comorbidities in women with SSIs included cancer, diabetes mellitus, and hypertension. Conclusions Surveillance of SSIs during the post-discharge period is critical for infection prevention and control. It is worth reflecting on the planning of surgical procedures for patients who have risk factors for the development of SSIs.
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Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina
2016-03-22
To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.
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2013-08-08
..., Electronics and Safety Division, Including On-Site Leased Workers From Securitas, Bartech, Flint Janitorial... Adjustment Assistance on May 20, 2013, applicable to workers of Delphi Corporation, Electronics and Safety... on- site at the Flint, Michigan location of Delphi Corporation, Electronics and Safety Division. The...
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2010-09-13
... Including On-Site Leased Workers From Schenkers Logistics, Inc., Florence, SC; Amended Certification... Teijin Films, including on-site leased workers from Schenkers Logistics, Inc., Florence, South Carolina... leased workers of Schenkers Logistics, Inc., Florence, South Carolina, who became totally or partially...
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Documet, Jorge; Liu, Brent J; Documet, Luis; Huang, H K
2006-07-01
This paper describes a picture archiving and communication system (PACS) tool based on Web technology that remotely manages medical images between a PACS archive and remote destinations. Successfully implemented in a clinical environment and also demonstrated for the past 3 years at the conferences of various organizations, including the Radiological Society of North America, this tool provides a very practical and simple way to manage a PACS, including off-site image distribution and disaster recovery. The application is robust and flexible and can be used on a standard PC workstation or a Tablet PC, but more important, it can be used with a personal digital assistant (PDA). With a PDA, the Web application becomes a powerful wireless and mobile image management tool. The application's quick and easy-to-use features allow users to perform Digital Imaging and Communications in Medicine (DICOM) queries and retrievals with a single interface, without having to worry about the underlying configuration of DICOM nodes. In addition, this frees up dedicated PACS workstations to perform their specialized roles within the PACS workflow. This tool has been used at Saint John's Health Center in Santa Monica, California, for 2 years. The average number of queries per month is 2,021, with 816 C-MOVE retrieve requests. Clinical staff members can use PDAs to manage image workflow and PACS examination distribution conveniently for off-site consultations by referring physicians and radiologists and for disaster recovery. This solution also improves radiologists' effectiveness and efficiency in health care delivery both within radiology departments and for off-site clinical coverage.
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2013-04-09
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-81,387] Eastman Kodak Company, IPS--Dayton Location, Including On-site Leased Workers From Adecco, Dayton, Ohio; Notice of... and former workers of Eastman Kodak Company, IPS--Dayton Location, including on-site leased workers...
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2010-07-01
... Logistics Division, Including On-Site Leased Workers From Prologistix and Employment Staffing Solutions... 19, 2010, applicable to workers of CEVA Freight, LLC, Dell Logistics Division, including on-site..., North Carolina location of CEVA Freight, LLC, Dell Logistics Division. The Department has determined...
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International Nuclear Information System (INIS)
Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina
2016-01-01
To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users
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DEFF Research Database (Denmark)
Henriksen, N A; Meyhoff, C S; Wetterslev, J
2010-01-01
Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant (C...... a suitable standard definition for monitoring and identifying SSI, even if some cases of less clinically significant superficial SSI are included.......Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant...... hospital stay or referral to an intensive care unit for SSI. The rate of CRSSI was 38 of 54 (70%) in patients with CDC-diagnosed SSI and none in patients without a CDC-diagnosed SSI. Sixty-one percent of the CDC-diagnosed SSIs were superficial, of which 48% were considered clinically relevant...
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2011-10-07
.... Including On-Site Leased Workers From Spherion/Source Right, Springdale, OH; Amended Certification Regarding... workers of the subject firm. The company reports that workers leased from Spherion/Source Right were...., including on-site leased workers from Spherion/Source Right, Springdale, Ohio, who became totally or...
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2010-08-02
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-71,014] Jeld-Wen, Inc., Hawkins Window Division, Including On-Site Leased Workers of Nicolet Staffing, Hawkins, WI; Notice of Negative...., Hawkins Window Division, including on-site leased workers of Nicolet Staffing, Hawkins, Wisconsin. Signed...
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2011-03-23
... workers of ETHICON, A Johnson and Johnson Company, San Angelo, Texas, separated from employment on or... Johnson & Johnson Including On-Site Leased Workers From Kelly Temporary Services, San Angelo, TX; Amended... of ETHICON, a subsidiary of Johnson & Johnson, including on-site leased workers from Kelly Temporary...
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2010-02-01
...,763B] Acushnet Company a Subsidiary of Fortune Brands Including On-Site Leased Workers From Olsten Staffing Services Fairhaven, MA; Acushnet Company a Subsidiary of Fortune Brands Including On-Site Leased Workers From Olsten Staffing Services New Bedford, MA; Acushnet Company a Subsidiary of Fortune Brands...
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TU-A-201-02: Treatment Site-Specific Considerations for Clinical IGRT
Energy Technology Data Exchange (ETDEWEB)
Wijesooriya, K. [University of Virginia Health Systems (United States)
2016-06-15
Recent years have seen a widespread proliferation of available in-room image guidance systems for radiation therapy target localization with many centers having multiple in-room options. In this session, available imaging systems for in-room IGRT will be reviewed highlighting the main differences in workflow efficiency, targeting accuracy and image quality as it relates to target visualization. Decision-making strategies for integrating these tools into clinical image guidance protocols that are tailored to specific disease sites like H&N, lung, pelvis, and spine SBRT will be discussed. Learning Objectives: Major system characteristics of a wide range of available in-room imaging systems for IGRT. Advantages / disadvantages of different systems for site-specific IGRT considerations. Concepts of targeting accuracy and time efficiency in designing clinical imaging protocols.
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Gheorghiade, Mihai; Vaduganathan, Muthiah; Greene, Stephen J; Mentz, Robert J; Adams, Kirkwood F; Anker, Stefan D; Arnold, Malcolm; Baschiera, Fabio; Cleland, John G F; Cotter, Gadi; Fonarow, Gregg C; Giordano, Christopher; Metra, Marco; Misselwitz, Frank; Mühlhofer, Eva; Nodari, Savina; Frank Peacock, W; Pieske, Burkert M; Sabbah, Hani N; Sato, Naoki; Shah, Monica R; Stockbridge, Norman L; Teerlink, John R; van Veldhuisen, Dirk J; Zalewski, Andrew; Zannad, Faiez; Butler, Javed
2014-03-01
There are over 1 million hospitalizations for heart failure (HF) annually in the United States alone, and a similar number has been reported in Europe. Recent clinical trials investigating novel therapies in patients with hospitalized HF (HHF) have been negative, and the post-discharge event rate remains unacceptably high. The lack of success with HHF trials stem from problems with understanding the study drug, matching the drug to the appropriate HF subgroup, and study execution. Related to the concept of study execution is the importance of including appropriate study sites in HHF trials. Often overlooked issues include consideration of the geographic region and the number of patients enrolled at each study center. Marked differences in baseline patient co-morbidities, serum biomarkers, treatment utilization and outcomes have been demonstrated across geographic regions. Furthermore, patients from sites with low recruitment may have worse outcomes compared to sites with higher enrollment patterns. Consequently, sites with poor trial enrollment may influence key patient end points and likely do not justify the costs of site training and maintenance. Accordingly, there is an unmet need to develop strategies to identify the right study sites that have acceptable patient quantity and quality. Potential approaches include, but are not limited to, establishing a pre-trial registry, developing site performance metrics, identifying a local regionally involved leader and bolstering recruitment incentives. This manuscript summarizes the roundtable discussion hosted by the Food and Drug Administration between members of academia, the National Institutes of Health, industry partners, contract research organizations and academic research organizations on the importance of selecting optimal sites for successful trials in HHF.
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2012-04-10
... Subsidiary of Tomkins, PLC Including On- Site Leased Workers from Reliable, Masiello Employment Services..., applicable to workers of Hart and Cooley, Inc., a subsidiary of Tomkins, PLC, including on-site leased... workers. Based on these findings, the Department is amending this certification to include workers leased...
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Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko
2016-01-01
Objective Dysphagia develops with low frequency in patients with dermatomyositis. Our objective was to determine the clinical and laboratory features that can estimate the development of dysphagia in dermatomyositis. Methods This study included 92 Japanese patients with adult-onset dermatomyositis. The associations between dysphagia and clinical and laboratory features including disease-specific autoantibodies determined by immunoprecipitation assays were analyzed. Results Videofluoroscopy sw...
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2010-01-05
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-72,048] FLSMidth, Inc., Cement..., Inc., Cement Division, Product Engineering, including on-site leased workers of Aerotek Contract.... were also employed on-site at FLSmidth, Inc., Cement Division, Product Engineering, Bethlehem...
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On-site screening for maternal syphilis in an antenatal clinic
African Journals Online (AJOL)
Abstract Study objective. To determine the sensitivity, specificity, negative predictive value and positive predictive value of the rapid plasma reagin (RPR) test as performed on site in an antenatal clinic to facilitate immediate diagnosis and treatment of maternal syphilis. Design. Open, descriptive study. Setting. Antenatal ...
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2012-05-17
... Division, Including On-Site Leased Workers From Manpower Staffing and Dow Cleaning Services, Malvern, AR..., and components. The company reports that workers from Dow Cleaning Services were employed on-site at... leased from Dow Cleaning Services working on-site at the Malvern, Arkansas location of Kohler Company...
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2010-04-23
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,642] Intel Corporation, Fab 20... of Intel Corporation, Fab 20 Division, including on-site leased workers of Volt Technical Resources... Precision, Inc. were employed on-site at the Hillsboro, Oregon location of Intel Corporation, Fab 20...
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2013-01-10
... subsidiary of Daimler North America Corp., including on-site leased workers from Noramtec, First Choice... America, Inc., a Subsidiary of Daimler North America Corp, Including On-Site Leased Workers From Noramtec, First Choice Staffing, Staff Works, and Mr. Santo Lamarco From Wurth Revcar Fasteners, Inc., Oriskany...
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Directory of Open Access Journals (Sweden)
Renan Cardoso Soares
2016-11-01
Full Text Available Dandruff is a prevalent chronic inflammatory skin condition of the scalp that has been associated with Malassezia yeasts. However, the microbial role has not been elucidated yet, and the etiology of the disorder remains poorly understood. Using high-throughput 16S rDNA and ITS1 sequencing, we characterized cutaneous bacterial and fungal microbiotas from healthy and dandruff subjects, comparing scalp and forehead (lesional and non-lesional skin sites. Bacterial and fungal communities from dandruff analyzed at genus level differed in comparison with healthy ones, presenting higher diversity and greater intragroup variation. The microbial shift was observed also in non-lesional sites from dandruff subjects, suggesting that dandruff is related to a systemic process that is not restricted to the site exhibiting clinical symptoms. In contrast, Malassezia microbiota analyzed at species level did not differ according to health status. A 2-step OTU assignment using combined databases substantially increased fungal assigned sequences, and revealed the presence of highly prevalent uncharacterized Malassezia organisms (>37% of the reads. Although clinical symptoms of dandruff manifest locally, microbial dysbiosis beyond clinically affected skin sites suggests that subjects undergo systemic alterations, which could be considered for redefining therapeutic approaches.
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Kortüm, K; Reznicek, L; Leicht, S; Ulbig, M; Wolf, A
2013-07-01
The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner. Georg Thieme Verlag KG Stuttgart · New York.
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Pfeiffer, Carol A; Palley, Jane E; Harrington, Karen L
2010-07-01
The assessment of clinical competence and the impact of training in ambulatory settings are two issues of importance in the evaluation of medical student performance. This study compares the clinical skills performance of students placed in three types of community preceptors' offices (pediatrics, medicine, family medicine) on yearly clinical skills assessments with standardized patients. Our goal was to see if the site specialty impacted on clinical performance. The students in the study were completing a 3-year continuity preceptorship at a site representing one of the disciplines. Their performance on the four clinical skills assessments was compared. There was no significant difference in history taking, physical exam, communication, or clinical reasoning in any year (ANOVA p< or = .05) There was a small but significant difference in performance on a measure of interpersonal and interviewing skills during Years 1 and 2. The site specialty of an early clinical experience does not have a significant impact on performance of most of the skills measured by the assessments.
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2010-12-07
... Subdivision of Zambon Company, SPA Including On-Site Leased Workers of Turner Industries and Go Johnson, La..., including on-site leased workers from Turner Industries and Go Johnson, La Porte, Texas. The Department's... investigation revealed that Zach System Corporation is a subdivision of Zambon Company, SPA, not Zach System SPA...
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Da Vinci single site© surgical platform in clinical practice: a systematic review.
Morelli, Luca; Guadagni, Simone; Di Franco, Gregorio; Palmeri, Matteo; Di Candio, Giulio; Mosca, Franco
2016-12-01
The Da Vinci single-site© surgical platform (DVSSP) is a set of single-site instruments and accessories specifically dedicated to robot-assisted single-site surgery. The PubMed database from inception to June 2015 was searched for English literature on the clinical use of DVSSP in general surgery, urology and gynecology. Twenty-nine articles involving the clinical application of DVSSP were identified; 15 articles on general surgery (561 procedures), four articles on urology (48 procedures) and 10 articles on gynecology (212 procedures). All studies have proven the safety and feasibility of the use of DVSSP. The principal reported advantage is the restoration of intra-abdominal triangulation, while the main reported limitation is the lack of the endowrist. Da Vinci systems have proven to be valuable assets in single-site surgery, owing to the combination of robot use with the dedicated single-incision platform. However, case-control or prospective trials are warranted to draw more definitive conc lusions. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
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2012-08-14
... Services, Post Production Feature Mastering Division Including On-Site Leased Workers From Ajilon... Services, Post Production Feature Mastering Division, Hollywood, California (subject firm). The worker... the workers meet the eligibility requirements of the Trade Act of 1974. Conclusion After careful...
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2010-12-13
..., Inc., Automation and Control Solutions Division, Including On-Site Leased Workers From Manpower... Solutions Division. The Department has determined that these workers were sufficiently under the control of Honeywell International, Inc., Automation and Control Solutions Division to be considered leased workers...
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Sellafield site (including Drigg) emergency scheme manual
International Nuclear Information System (INIS)
1987-02-01
This Emergency Scheme defines the organisation and procedures available should there be an accident at the Sellafield Site which results in, or may result in, the release of radioactive material, or the generation of a high radiation field, which might present a hazard to employees and/or the general public. This manual covers the general principles of the total emergency scheme and those detailed procedures which are not specific to any single department. (U.K.)
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2010-04-19
...-site leased workers of Bosch Management Services North America, South Haven Community Hospital... leased workers of Bosch Management Services North America, South Haven Community Hospital, Huffmaster Inc..., Including On-Site Leased Workers From Bosch Management Services North America, South Haven Community...
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WE-D-204-01: Site-Specific Clinical Rotation: Into the Minds of the Radiation Oncologists
Energy Technology Data Exchange (ETDEWEB)
Hendrickson, K. [University of Washington (United States)
2016-06-15
Speakers in this session will present overview and details of a specific rotation or feature of their Medical Physics Residency Program that is particularly exceptional and noteworthy. The featured rotations include foundational topics executed with exceptional acumen and innovative educational rotations perhaps not commonly found in Medical Physics Residency Programs. A site-specific clinical rotation will be described, where the medical physics resident follows the physician and medical resident for two weeks into patient consultations, simulation sessions, target contouring sessions, planning meetings with dosimetry, patient follow up visits, and tumor boards, to gain insight into the thought processes of the radiation oncologist. An incident learning rotation will be described where the residents learns about and practices evaluating clinical errors and investigates process improvements for the clinic. The residency environment at a Canadian medical physics residency program will be described, where the training and interactions with radiation oncology residents is integrated. And the first month rotation will be described, where the medical physics resident rotates through the clinical areas including simulation, dosimetry, and treatment units, gaining an overview of the clinical flow and meeting all the clinical staff to begin the residency program. This session will be of particular interest to residency programs who are interested in adopting or adapting these curricular ideas into their programs and to residency candidates who want to learn about programs already employing innovative practices. Learning Objectives: To learn about exceptional and innovative clinical rotations or program features within existing Medical Physics Residency Programs. To understand how to adopt/adapt innovative curricular designs into your own Medical Physics Residency Program, if appropriate.
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WE-D-204-01: Site-Specific Clinical Rotation: Into the Minds of the Radiation Oncologists
International Nuclear Information System (INIS)
Hendrickson, K.
2016-01-01
Speakers in this session will present overview and details of a specific rotation or feature of their Medical Physics Residency Program that is particularly exceptional and noteworthy. The featured rotations include foundational topics executed with exceptional acumen and innovative educational rotations perhaps not commonly found in Medical Physics Residency Programs. A site-specific clinical rotation will be described, where the medical physics resident follows the physician and medical resident for two weeks into patient consultations, simulation sessions, target contouring sessions, planning meetings with dosimetry, patient follow up visits, and tumor boards, to gain insight into the thought processes of the radiation oncologist. An incident learning rotation will be described where the residents learns about and practices evaluating clinical errors and investigates process improvements for the clinic. The residency environment at a Canadian medical physics residency program will be described, where the training and interactions with radiation oncology residents is integrated. And the first month rotation will be described, where the medical physics resident rotates through the clinical areas including simulation, dosimetry, and treatment units, gaining an overview of the clinical flow and meeting all the clinical staff to begin the residency program. This session will be of particular interest to residency programs who are interested in adopting or adapting these curricular ideas into their programs and to residency candidates who want to learn about programs already employing innovative practices. Learning Objectives: To learn about exceptional and innovative clinical rotations or program features within existing Medical Physics Residency Programs. To understand how to adopt/adapt innovative curricular designs into your own Medical Physics Residency Program, if appropriate.
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Defining robustness protocols: a method to include and evaluate robustness in clinical plans
International Nuclear Information System (INIS)
McGowan, S E; Albertini, F; Lomax, A J; Thomas, S J
2015-01-01
We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties. (paper)
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Defining robustness protocols: a method to include and evaluate robustness in clinical plans
McGowan, S. E.; Albertini, F.; Thomas, S. J.; Lomax, A. J.
2015-04-01
We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties.
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On-site screening for syphilis at an antenatal clinic | Delport | South ...
African Journals Online (AJOL)
Objective. To determine the validity, predictive value and accuracy of the rapid plasma reagin card test performed on site to diagnose active syphilis in pregnant women so that immediate treatment can be offered to prevent congenital syphilis. Design. Open, descriptive study. Setting. Antenatal clinic, Mamelodi Hospital, ...
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A Study on Site Selecting for National Project including High Level Radioactive Waste Disposal
Energy Technology Data Exchange (ETDEWEB)
Kim, Kilyoo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)
2016-10-15
Many national projects are stopped since sites for the projects are not determined. The sites selections are hold by NIMBY for unpleasant facilities or by PYMFY for preferable facilities among local governments. The followings are the typical ones; NIMBY projects: high level radioactive waste disposal, THAAD, Nuclear power plant(NPP), etc. PIMFY projects: South-east new airport, KTX station, Research center for NPP decommission, etc. The site selection for high level radioactive waste disposal is more difficult problem, and thus government did not decide and postpone to a dead end street. Since it seems that there is no solution for site selection for high level radioactive waste disposal due to NIMBY among local governments, a solution method is proposed in this paper. To decide a high level radioactive waste disposal, the first step is to invite a bid by suggesting a package deal including PIMFY projects such as Research Center for NPP decommission. Maybe potential host local governments are asked to submit sealed bids indicating the minimum compensation sum that they would accept the high level radioactive waste disposal site. If there are more than one local government put in a bid, then decide an adequate site by considering both the accumulated PESS point and technical evaluation results. By considering how fairly preferable national projects and unpleasant national projects are distributed among local government, sites selection for NIMBY or PIMFY facilities is suggested. For NIMBY national projects, risk, cost benefit analysis is useful and required since it generates cost value to be used in the PESS. For many cases, the suggested method may be not adequate. However, similar one should be prepared, and be basis to decide sites for NIMBY or PIMFY national projects.
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International Nuclear Information System (INIS)
Talmage, S.S.; Chilton, B.D.
1987-09-01
This review summarizes available information on cleanup procedures at the Nevada Test Site and at other radioactively contaminated sites. Radionuclide distribution and inventory, size of the contaminated areas, equipment, and cleanup procedures and results are included. Information about the cost of cleanup and treatment for contaminated land is presented. Selected measures that could be useful in estimating the costs of cleaning up radioactively contaminated areas are described. 76 refs., 16 tabs
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2013-08-27
....; d/b/a Colorado Springs Marble and Granite Including On-Site Leased Workers From Express Employment... Colorado Springs Marble and Granite, Colorado Springs, Colorado (hereafter collectively referred to as..., Inc., d/b/a Colorado Springs Marble and Granite, including on-site leased workers from Express...
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2011-10-05
...) Including On-Site Leased Workers From Interplace, Inc., Apple One and Robert Half Legal Santa Monica, CA...-site leased workers from Interplace, Inc., and Apple One, Santa Monica, California. The workers are... from Interplace, Inc., Apple One and Robert Half Legal, Santa Monica, California, who became totally or...
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2010-12-07
... Logistics, North America a Subsidiary of HAVI Group, LP Including On-Site Leased Workers of Express Personnel Services and the La Salle Network, Bloomingdale, IL; Havi Logistics, North America, Lisle, IL..., applicable to workers of HAVI Logistics, North America, a subsidiary of HAVI Group, LP, including on-site...
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Randell, Rebecca; Backhouse, Michael R; Nelson, E Andrea
2016-12-01
A critical issue for multicentre clinical studies is conducting site initiations, ensuring sites are trained in study procedures and comply with relevant governance requirements before they begin recruiting patients. How technology can support site initiations has not previously been explored. This study sought to evaluate use of off-the-shelf web-based videoconferencing to deliver site initiations for a large national multicentre study. Participants in the initiations, including podiatrists, diabetologists, trial coordinators, and research nurses, completed an online questionnaire based on the System Usability Scale (SUS) (N = 15). This was followed by semi-structured interviews, with a consultant diabetologist, a trial coordinator, and three research nurses, exploring perceived benefits and limitations of videoconferencing. The mean SUS score for the videoconferencing platform was 87.2 (SD = 13.7), suggesting a good level of usability. Interview participants perceived initiations delivered by videoconferencing as being more interactive and easier to follow than those delivered by teleconference. In comparison to face-to-face initiations, videoconferencing takes less time, easily fitting in with the work of staff at the local sites. Perceptions of impact on communication varied according to the hardware used. Off-the-shelf videoconferencing is a viable alternative to face-to-face site initiations and confers advantages over teleconferencing.
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2013-02-06
....; Blanchester Plant, Including On-Site Leased Workers From Adecco and Sims Bros., Inc.; Blanchester, OH; Amended... workers from Sims Bros., Inc. were working on-site at the subject firm during the relevant period and that the services supplied by Sims Bros., Inc. were related to the production of gear boxes (and parts...
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2010-11-12
... Corporation, Containerboard Mill, Including On-Site Leased Workers From KMW Enterprises, Ontonagon, MI... to workers of Smurfit-Stone Container Corporation, Containerboard Mill, Ontonagon, Michigan. The... Ontonagon, Michigan location of Smurfit-Stone Container Corporation, Containerboard Mill. The Department has...
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2011-01-12
.... Information Technology Help Desk Services Including On-Site Leased Workers From Modis, West Norriton, PA..., applicable to workers of Quest Diagnostics, Inc., Information Technology Help Desk Services, West Norriton... Quest Diagnostics, Inc., Information Technology Help Desk [[Page 2145
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2010-08-13
... Company, Duncan Mfg., Including On-Site Leased Workers from Express Personnel, Clayton Personnel Service, and Manpower Planning, Duncan, OK; Halliburton Company, Technology and Engineering Division, Finance... Halliburton Company, Technology and Engineering Division, and Finance and Administration Division, Duncan...
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2011-03-14
...., Mailing Solutions Management, Global Engineering Group, Including On-Site Leased Workers From Guidant... workers and former workers of Pitney Bowes, Inc., Mailing Solutions Management Division, Engineering... reviewed the certification to clarify the subject worker group's identity. Additional information revealed...
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Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming
2017-09-18
Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive
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2012-07-10
... Corporation, Containerboard Mill, Including On-Site Leased Workers From KMW Enterprises and General Security... Assistance on May 6, 2010, applicable to workers of Smurfit-Stone Container Corporation, Containerboard Mill... Ontonagon, Michigan location of Smurfit-Stone Container Corporation, Containerboard Mill, Ontonagon...
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Review of MammoSite brachytherapy: Advantages, disadvantages and clinical outcomes
Energy Technology Data Exchange (ETDEWEB)
Bensaleh, Saleh; Bezak, Eva; Borg, Martin (Dept. of Radiation Oncology, Royal Adelaide Hospital, Adelaide (Australia))
2009-05-15
Background. The MammoSite radiotherapy system is an alternative treatment option for patients with early-stage breast cancer to overcome the longer schedules associated with external beam radiation therapy. The device is placed inside the breast surgical cavity and inflated with a combination of saline and radiographic contrast to completely fill the cavity. The treatment schedule for the MammoSite monotherapy is 34 Gy delivered in 10 fractions at 1.0 cm from the balloon surface with a minimum of 6 hours between fractions on the same day. Material and methods. This review article presents the advantages, disadvantages, uncertainties and clinical outcomes associated with the MammoSite brachytherapy (MSB). Results. Potential advantages of MSB are: high localised dose with rapid falloff for normal tissue sparing, minimum delay between surgery and RT, catheter moves with breast, improved local control, no exposure to staff, likely side-effects reduction and potential cost/time saving (e.g. for country patients). The optimal cosmetic results depend on the balloon-to-skin distance. Good-to-excellent cosmetic results are achieved for patients with balloon-skin spacing of =7 mm. There have been very few published data regarding the long term tumour control and cosmesis associated with the MSB. The available data on the local control achieved with the MSB were comparable with other accelerated partial breast irradiation techniques. The contrast medium inside the balloon causes dose reduction at the prescription point. Current brachytherapy treatment planning systems (BTPS) do not take into account the increased photon attenuation due to high Z of contrast. Some BTPS predicted up to 10% higher dose near the balloon surface compared with Monte Carlo calculations using various contrast concentrations (5-25%). Conclusion. Initial clinical results have shown that the MammoSite device could be used as a sole radiation treatment for selected patients with early stage breast cancer
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Review of MammoSite brachytherapy: Advantages, disadvantages and clinical outcomes
International Nuclear Information System (INIS)
Bensaleh, Saleh; Bezak, Eva; Borg, Martin
2009-01-01
Background. The MammoSite radiotherapy system is an alternative treatment option for patients with early-stage breast cancer to overcome the longer schedules associated with external beam radiation therapy. The device is placed inside the breast surgical cavity and inflated with a combination of saline and radiographic contrast to completely fill the cavity. The treatment schedule for the MammoSite monotherapy is 34 Gy delivered in 10 fractions at 1.0 cm from the balloon surface with a minimum of 6 hours between fractions on the same day. Material and methods. This review article presents the advantages, disadvantages, uncertainties and clinical outcomes associated with the MammoSite brachytherapy (MSB). Results. Potential advantages of MSB are: high localised dose with rapid falloff for normal tissue sparing, minimum delay between surgery and RT, catheter moves with breast, improved local control, no exposure to staff, likely side-effects reduction and potential cost/time saving (e.g. for country patients). The optimal cosmetic results depend on the balloon-to-skin distance. Good-to-excellent cosmetic results are achieved for patients with balloon-skin spacing of =7 mm. There have been very few published data regarding the long term tumour control and cosmesis associated with the MSB. The available data on the local control achieved with the MSB were comparable with other accelerated partial breast irradiation techniques. The contrast medium inside the balloon causes dose reduction at the prescription point. Current brachytherapy treatment planning systems (BTPS) do not take into account the increased photon attenuation due to high Z of contrast. Some BTPS predicted up to 10% higher dose near the balloon surface compared with Monte Carlo calculations using various contrast concentrations (5-25%). Conclusion. Initial clinical results have shown that the MammoSite device could be used as a sole radiation treatment for selected patients with early stage breast cancer
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2010-03-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-71,054C] Apria Healthcare..., 2009, applicable to workers of Apria Healthcare, including on-site leased workers from Corestaff... subject firm. The workers are engaged in activities related to the information technology and patient...
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2013-08-27
... these workers were sufficiently under the control of the subject firm to be considered leased workers...; Springfield, Missouri Division Including On-site Leased Workers From Penmac Personnel Services and GCA Services Group Springfield, Missouri; Amended Certification Regarding Eligibility to Apply for Worker...
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2011-11-28
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,593] Whirlpool Corporation Including On-Site Leased Workers From Career Solutions TEC Staffing, Andrews International, IBM Corporation... workers are engaged in the production of refrigerators and trash compactors. The notice was published in...
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2011-03-15
... undated planning and organizing products. The review shows that on August 21, 2008, a certification of..., Consumer and Office Products Division, Including On-Site Leased Workers From Pro-Tel People, Sidney, NY; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordance with...
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2013-07-17
... Distribution Operations Including On- Site Leased Workers From Action Personnel, CGA Staffing Services, Dynamic... from Action Personnel, CGA Staffing Services, Dynamic Staffing, Kelly Services, and Manpower, Scranton... (Volume 78 FR Pages 28628-28630). At the request of the State Workforce Office, the Department reviewed...
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2013-07-17
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-82,346] Whirlpool Corporation, Including On-Site Leased Workers From Aerotek/Tek Systems (Subcontractor of IBM Corporation) and Jones Lang... firm. The workers were engaged in production of refrigerators and trash compactors as well as...
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2011-11-29
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,593] Whirlpool Corporation, Including On-Site Leased Workers From Career Solutions TEC Staffing, Andrews International, IBM Corporation... refrigerators and trash compactors. The notice was published in the Federal Register on October 25, 2010 (75 FR...
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Hughes, Elizabeth; Terry, David; Huynh, Chi; Petridis, Konstantinos; Aiello, Matthew; Mazard, Louis; Ubhi, Hirminder; Terry, Alex; Wilson, Keith; Sinclair, Anthony
2017-01-01
Background There are concerns about maintaining appropriate clinical staffing levels in Emergency Departments. Pharmacists may be one possible solution. Objective To determine if Emergency Department attendees could be clinically managed by pharmacists with or without advanced clinical practice training. Setting Prospective 49 site cross-sectional observational study of patients attending Emergency Departments in England. Method Pharmacist data collectors identified patient attendance at thei...
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2010-12-08
..., Commercial Vehicle Systems, Including On-Site Leased Workers of Johnston Integration Technologies, a... Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974, as amended (``Act''), 19 U.S.C... system components. The company reports that workers leased from Johnston Integration Technologies, a...
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Participants as community-based peer educators: Impact on a clinical trial site in KwaZulu-Natal
Directory of Open Access Journals (Sweden)
Sarita Naidoo
2013-07-01
Full Text Available Participant recruitment, retention and product adherence are necessary to measure the efficacy or effectiveness of an intervention in a clinical trial. As part of a Phase III HIV prevention trial in a rural area in Kwazulu-Natal, South Africa, a peer educator programme was initiated to aid in recruitment and retention of trial participants from the community. Enrolled trial participants who had completed at least 6 months of trial participation and who had honoured all of their scheduled trial visits within that period were approached to be peer educators. Following additional selection criteria, 24 participants were eligible to be trained as peer educators. Training topics included HIV/AIDS, sexually transmitted infections, nutrition, antiretrovirals, clinical trials, and methods of disseminating this information to the community. The role of peer educators was to bring interested women from their community to the trial site for comprehensive education and information about the trial and possibly trial participation. A total of 1879 women were educated by peer educators between July 2004 and December 2006. Of these, 553 women visited the trial site for further education and screening for participation in the trial. Peer educators provided continuous education and support to women enrolled in the trial which also promoted retention, ultimately contributing to the site's 94% retention rate. Recruitment and retention efforts of trial participants are likely to be enhanced by involving trial participants as peer educators. Such trial participants are in a better position to understand cultural dynamics and hence capable of engaging the community with appropriate HIV prevention and trial-related messaging.
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2013-02-06
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-81,755] Thomson Reuters, Finance Operations & Technology Division, Including On-Site Leased Workers From Adecco; Eagan, MN; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974, as amended (`...
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2011-08-01
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,198] West, a Thomson Reuters Business, Thomson Reuters Legal, Including On-Site Leased Workers From Adecco, Including a Teleworker...-W-73,198 is hereby issued as follows: All workers of West, A Thomson Reuters Business, Thomson...
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2012-03-13
...., Including On-Site Leased Workers From Balance Staffing, Insight Global Staffing, and Technisource..., Insight Global Staffing, and Technisource, Scarborough, Maine. The workers are engaged in activities... leased workers from Balance Staffing, Insight Global Staffing, and Technisource, Scarborough, Maine, who...
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Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.
Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a
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Good clinical practice regulatory inspections: Lessons for Indian investigator sites
Directory of Open Access Journals (Sweden)
R Marwah
2010-01-01
Full Text Available Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs, protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15-30 days with effective Corrective and Preventive Action Plan (CAPA. Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective.
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Aponte-Rivera, Vivianne; Dunlop, Boadie W; Ramirez, Cynthia; Kelley, Mary E; Schneider, Rebecca; Blastos, Beatriz; Larson, Jacqueline; Mercado, Flavia; Mayberg, Helen; Craighead, W Edward
2014-03-01
Hispanics, particularly those with limited English proficiency, are underrepresented in psychiatric clinical research studies. We developed a bilingual and bicultural research clinic dedicated to the recruitment and treatment of Spanish-speaking subjects in the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) study, a large clinical trial of treatment-naïve subjects with major depressive disorder (MDD). Demographic and clinical data derived from screening evaluations of the first 1,174 subjects presenting for participation were compared between the Spanish-speaking site (N = 275) and the primary English-speaking site (N = 899). Reasons for ineligibility (N = 888) for the PReDICT study were tallied for each site. Compared to English speakers, Spanish speakers had a lower level of education and were more likely to be female, uninsured, and have uncontrolled medical conditions. Clinically, Spanish speakers demonstrated greater depression severity, with higher mean symptom severity scores, and a greater number of previous suicide attempts. Among the subjects who were not randomized into the PReDICT study, Spanish-speaking subjects were more likely to have an uncontrolled medical condition or refuse participation, whereas English-speaking subjects were more likely to have bipolar disorder or a non-MDD depressive disorder. Recruitment of Hispanic subjects with MDD is feasible and may enhance efforts at signal detection, given the higher severity of depression among Spanish-speaking participants presenting for clinical trials. Specific approaches for the recruitment and retention of Spanish-speaking participants are required. © 2013 Wiley Periodicals, Inc.
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2010-03-12
... workers of the subject firm. The workers are engaged in the production of electronic design automation software and related services including quality assurance and learning products, marketing, product development, marketing and administration. The company reports that on-site leased workers from Managed...
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2011-06-03
..., Inc., Including On-Site Leased Workers From Comsys Information Technology Services, Megaforce, and Kelly Services Kansas City, MO; DST Technologies, a Wholly Owned Subsidiary of DST Systems, Inc., Boston... Information Technology Services, Megaforce, and Kelly Services, Kansas City, Missouri (subject firm). The...
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2011-01-14
...., Mailing Solutions Management Division Including On-Site Leased Workers of Guidant Group, and Teleworkers... Bowes, Inc., Mailing Solutions Management Division, Engineering Quality Assurance, Shelton, Connecticut... identity of the subject worker group. The worker group consists of workers of Pitney Bowes, Inc., the...
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2011-12-21
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,072] Android Industries..., 2010, applicable to workers of Android Industries Belvidere, LLC, including on-site leased workers from... Belvidere, Illinois location of Android Industries Belvidere, LLC. The Department has determined that these...
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2010-07-26
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,666] Badger Meter, Inc... of Badger Meter, Inc., including on-site leased workers from Sourcepoint Staffing, Milwaukee... workers are engaged in the production of flow measurement devices and automatic meter reading equipment...
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Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko
2016-01-01
Dysphagia develops with low frequency in patients with dermatomyositis. Our objective was to determine the clinical and laboratory features that can estimate the development of dysphagia in dermatomyositis. This study included 92 Japanese patients with adult-onset dermatomyositis. The associations between dysphagia and clinical and laboratory features including disease-specific autoantibodies determined by immunoprecipitation assays were analyzed. Videofluoroscopy swallow study (VFSS) was performed for all patients with clinical dysphagia (n = 13, 14.1%) but not for patients without clinical dysphagia. Typical findings of dysphagia (pharyngeal pooling, n = 11 and/or nasal regurgitation, n = 4) was detected by VFSS in all patients with clinical dysphagia. Eleven patients with dysphagia (84.6%) had anti-transcription intermediary factor 1γ (TIF-1γ) antibody. By univariate analysis, the average age and the male to female ratio, internal malignancy, and anti-TIF-1γ antibody were significantly higher and the frequency of interstitial lung diseases and manual muscle testing (MMT) scores of sternomastoid and dertoid muscles were significantly lower in patients with dysphagia than in patients without dysphagia. Among patients with anti-TIF-1γ antibody, the mean age, the ratios of male to female and internal malignancy were significantly higher and mean MMT scores of sternomastoid muscle were significantly lower in patients with dysphagia compared with patients without dysphagia. By multivariable analysis, the risk of dysphagia was strongly associated with the existence of internal malignancy and ant-TIF-1γ antibody and was also associated with reduced scores of manual muscle test of sternomastoid muscle. Dysphagia was markedly improved after the treatment against myositis in all 13 patients. These findings indicate that dysphagia can develop frequently in patients with internal malignancy, anti-TIF-1γ antibody, or severe muscle weakness of sternomastoid muscle.
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2012-03-26
... International Income Fund had their wages reported through a separate unemployment insurance (UI) tax account..., a Subsidiary of Cinram International Income Fund, Including On-Site Leased Workers From Good People..., 2012, applicable to workers of Cinram Distribution, LLC, a subsidiary of Cinram International Income...
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2010-08-02
... account under the name Harrow Products, Inc. Accordingly, the Department is amending this certification to... Products, Inc., Formerly Known as Locknetics Including On-Site Leased Workers From Monroe Staffing Services, Adecco USA, Inc., and Infinistaff, LLC, Bristol, CT; Amended Certification Regarding Eligibility To Apply...
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2010-03-12
... to the production of high intensity discharge lamps. The review shows that on August 24, 2007, a...-Ravenna Lamp Plant, Lighting Division, Including On-Site Leased Workers from Devore Technologies, Ravenna..., 2009, applicable to workers of General Electric Lighting-Ravenna Lamp Plant, Lighting Division...
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2011-05-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,897] Penske Logistics LLC, a Subsidiary of General Electric/Penske Corporation Including On-Site Leased Workers From Kelly Temporary... workers and former workers of Penske Logistics LLC, a subsidiary of General Electric/Penske Corporation...
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2010-05-12
... Company Franklin Pulp & Paper Mill Including On-Site Leased Workers From Railserve, Franklin, VA; Amended... workers of International Paper Company, Franklin Pulp & Paper Mill, Franklin, Virginia. The notice was... Pulp & Paper Mill. The Department has determined that these workers were sufficiently under the control...
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2012-07-30
..., Trainer Refinery, Including On-Site Leased Workers From Shrack, Young, and Associates, Inc., and Project Control Associates, Trainer, PA; Notice of Revised Determination on Reconsideration On April 30, 2012, the... applicable to workers and former workers of ConocoPhillips Company, Trainer Refinery, Trainer, Pennsylvania...
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2010-12-13
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,593] Whirlpool Corporation, Including On-Site Leased Workers From Career Solutions TEC Staffing and Andrews International, Fort Smith... subject firm. The workers are engaged in the production of refrigerators and trash compactors. The company...
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2011-05-11
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-75,099] West, A Thomson Reuters Business, Thomson Reuters Legal Division, Including On-Site Leased Workers From ADECCO, Albuquerque, NM... Adjustment Assistance (TAA) applicable to workers and former workers of West, A Thomson Reuters Business...
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2013-06-21
... supply of administrative support services (in support of production). The worker group includes on-site... components produced by the subject workers. Further, aggregate imports of articles like or directly... reconsideration, the worker supplied new information regarding a possible shift in the production of like or...
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2012-11-26
..., Sartell Mill Division, Including On-Site Leased Workers From Securitas Security Services, Manpower, Inc..., applicable to workers and former workers of Verso Paper Corporation, Sartell Mill Division, Sartell... to TA-W-81,210 is hereby issued as follows: All workers of Verso Paper Corporation, Sartell Mill...
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Hughes, Elizabeth; Terry, David; Huynh, Chi; Petridis, Konstantinos; Aiello, Matthew; Mazard, Louis; Ubhi, Hirminder; Terry, Alex; Wilson, Keith; Sinclair, Anthony
2017-08-01
Background There are concerns about maintaining appropriate clinical staffing levels in Emergency Departments. Pharmacists may be one possible solution. Objective To determine if Emergency Department attendees could be clinically managed by pharmacists with or without advanced clinical practice training. Setting Prospective 49 site cross-sectional observational study of patients attending Emergency Departments in England. Method Pharmacist data collectors identified patient attendance at their Emergency Department, recorded anonymized details of 400 cases and categorized each into one of four possible options: cases which could be managed by a community pharmacist; could be managed by a hospital pharmacist independent prescriber; could be managed by a hospital pharmacist independent prescriber with additional clinical training; or medical team only (unsuitable for pharmacists to manage). Impact indices sensitive to both workload and proportion of pharmacist manageable cases were calculated for each clinical group. Main outcome measure Proportion of cases which could be managed by a pharmacist. Results 18,613 cases were observed from 49 sites. 726 (3.9%) of cases were judged suitable for clinical management by community pharmacists, 719 (3.9%) by pharmacist prescribers, 5202 (27.9%) by pharmacist prescribers with further training, and 11,966 (64.3%) for medical team only. Impact Indices of the most frequent clinical groupings were general medicine (13.18) and orthopaedics (9.69). Conclusion The proportion of Emergency Department cases that could potentially be managed by a pharmacist was 36%. Greatest potential for pharmacist management was in general medicine and orthopaedics (usually minor trauma). Findings support the case for extending the clinical role of pharmacists.
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Integration of Medical Imaging Including Ultrasound into a New Clinical Anatomy Curriculum
Moscova, Michelle; Bryce, Deborah A.; Sindhusake, Doungkamol; Young, Noel
2015-01-01
In 2008 a new clinical anatomy curriculum with integrated medical imaging component was introduced into the University of Sydney Medical Program. Medical imaging used for teaching the new curriculum included normal radiography, MRI, CT scans, and ultrasound imaging. These techniques were incorporated into teaching over the first two years of the…
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2012-11-26
... Unlimited and Green Energy Initiatives LLC, Including Workers Whose Wages Were Reported Through Severstal..., Wheeling Office, a division of RG Steel, LLC, including on-site leased workers from Pro Unlimited and Green Energy Initiatives, LLC, Wheeling, West Virginia (TA-W-81,880) and Mountain State Carbon, LLC, including...
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Dolor, Rowena; Victorson, David; Amoils, Steve
2013-01-01
Focus Areas: Integrative Approaches to Care The purpose of this panel discussion is to share successful efforts from a practice-based research network (PBRN) including ten integrative medicine clinics. The BraveNet PBRN includes integrative medicine clinics with academic health centers, large health systems, and a stand-alone private practice clinic. While clinical care is prioritized across all of these centers, introducing research into clinical sites oriented to providing care poses challenges that vary by clinic environment. We will highlight some of the unique issues encountered when trying to standardize data collection in sites practicing a patient-centered, whole-systems approach to healing as well as the solutions used to overcome these issues. We will present some operational solutions and data collected from the PBRN's ongoing data registry, entitled PRIMIER. The panel will engage attendees in a dialogue centering on potential for future analyses of existing results, ideas for possible upcoming studies, and creative ways to expand the PBRN data registry to include additional sites that may have expertise and interest in participating.
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Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...
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2010-07-01
..., North Penn Plant, Electronics Products Group to be covered by this certification. The intent of the... North Penn Plant Electronics Products Group Including On-Site Leased Workers From Ryder Integrated... Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment...
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2013-11-06
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-81,387] Eastman Kodak Company... workers of Eastman Kodak Company, IPS-Dayton Location, including on-site leased workers from Adecco, Dayton, Ohio (hereafter referred to as ``Eastman Kodak-IPS- Dayton''). On May 18, 2012, the Department...
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2011-03-29
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,897] Penske Logistics LLC a Subsidiary of General Electric/Penske Corporation Including On-Site Leased Workers From Kelly Temporary... (TAA) applicable to workers and former workers of Penske Logistics LLC, a subsidiary of General...
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2010-10-29
..., Including On-Site Leased Workers From Employment Control, D/B/A Employment Staffing, Inc., Spindale, NC; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordance with... a Certification of Eligibility to Apply for Worker Adjustment Assistance on May 27, 2010, applicable...
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Energy Technology Data Exchange (ETDEWEB)
Vargas, Hebert Alberto; Micco, Maura; Lakhman, Yulia; Meier, Andreas A.; Sosa, Ramon; Hricak, Hedvig; Sala, Evis [Memorial Sloan Kettering Cancer Center, Department of Radiology, New York, NY (United States); Veeraraghavan, Harini; Deasy, Joseph [Memorial Sloan Kettering Cancer Center, Department of Medical Physics, New York, NY (United States); Nougaret, Stephanie [Memorial Sloan Kettering Cancer Center, Department of Radiology, New York, NY (United States); Service de Radiologie, Institut Regional du Cancer de Montpellier, Montpellier (France); INSERM, U1194, Institut de Recherche en Cancerologie de Montpellier (IRCM), Montpellier (France); Soslow, Robert A.; Weigelt, Britta [Memorial Sloan Kettering Cancer Center, Department of Pathology, New York, NY (United States); Levine, Douglas A. [Memorial Sloan Kettering Cancer Center, Department of Surgery, New York, NY (United States); Aghajanian, Carol; Snyder, Alexandra [Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, NY (United States)
2017-09-15
To evaluate the associations between clinical outcomes and radiomics-derived inter-site spatial heterogeneity metrics across multiple metastatic lesions on CT in patients with high-grade serous ovarian cancer (HGSOC). IRB-approved retrospective study of 38 HGSOC patients. All sites of suspected HGSOC involvement on preoperative CT were manually segmented. Gray-level correlation matrix-based textures were computed from each tumour site, and grouped into five clusters using a Gaussian Mixture Model. Pairwise inter-site similarities were computed, generating an inter-site similarity matrix (ISM). Inter-site texture heterogeneity metrics were computed from the ISM and compared to clinical outcomes. Of the 12 inter-site texture heterogeneity metrics evaluated, those capturing the differences in texture similarities across sites were associated with shorter overall survival (inter-site similarity entropy, similarity level cluster shade, and inter-site similarity level cluster prominence; p ≤ 0.05) and incomplete surgical resection (similarity level cluster shade, inter-site similarity level cluster prominence and inter-site cluster variance; p ≤ 0.05). Neither the total number of disease sites per patient nor the overall tumour volume per patient was associated with overall survival. Amplification of 19q12 involving cyclin E1 gene (CCNE1) predominantly occurred in patients with more heterogeneous inter-site textures. Quantitative metrics non-invasively capturing spatial inter-site heterogeneity may predict outcomes in patients with HGSOC. (orig.)
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2012-10-05
... relevant period and that the subject firm had sufficient control over the leased workers for the Department to determine that there was operational control of the leased workers by the subject firm. The... Managerial Services, Inc., Including On-Site Leased Workers of Entegee East Longmeadow, MA Amended...
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2012-05-29
... Subsidiary of Android Industries Including On-Site Leased Workers From Career Adventures, Inc. Shreveport..., 2011, applicable to workers of AI-Shreveport, LLC, a subsidiary of Android Industries, Shreveport...- Shreveport, LLC, a subsidiary of Android Industries. The amended notice applicable to TA-W-80,515 is hereby...
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2010-03-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-72,011] General Electric Kentucky Glass Plant, Lighting, LLC, Including On-Site Leased Workers From the Patty Tipton Company, Aetna Building Maintenance, and Concentra, Lexington, KY; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordanc...
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2011-03-23
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,880] Lafarge North America, Inc., a Subsidiary of Lafarge, Including On-Site Leased Workers From Industrial Services, Incorporated and Summit Building Maintenance, Seattle, WA; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordance...
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2011-01-12
...,287B; TA-W-71,287C] Masco Builder Cabinet Group Including On-Site Leased Workers From Reserves Network, Jackson, OH; Masco Builder Cabinet Group, Waverly, OH; Masco Builder Cabinet Group, Seal Township, OH; Masco Builder Cabinet Group, Seaman, OH; Amended Certification Regarding Eligibility To Apply for Worker...
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2011-10-26
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-80,110] Callaway Golf Ball... Golf Ball Operations, Inc., including on-site leased workers from Reliable Temp Services, Inc., and... production of golf balls. The notice was published in the Federal Register on July 8, 2011 (76 FR 40401). At...
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Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John
2014-07-01
The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in
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2010-03-12
... Elliott Tool and Die, Including On-Site Leased Workers From Modern Professional Services, TAC Automotive... Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the...
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Directory of Open Access Journals (Sweden)
Peter I. K. Mochungong
2011-03-01
Full Text Available Clinical waste is ineffectively treated and disposed in Cameroon. Disposal sites have unrestricted access and are located within communities. We hypothesize that vector proliferation and exposure to chronic low-level emissions will increase morbidity in children living around such sites. Self-reported disease frequency questionnaires were used to estimate the frequency of new episodes of intestinal, respiratory and skin infections among exposed children less than 10 years. Data was simultaneously collected for unexposed children of the same age, using the same questionnaire. Data reporting by the parents was done in the first week in each of the 6 months study period. The risk ratios were 3.54 (95% CI, 2.19-5.73, 3.20 (95% CI, 1.34-7.60 and 1.35 (95% CI, 0.75-2.44 for respiratory, intestinal and skin infections respectively. Their respective risk differences were 0.47 (47%, 0.18 (18% and 0.08 (8%. The study revealed that poor treatment and disposal of clinical waste sites enhance morbidity in children living close to such areas. Simple health promotion and intervention programs such as relocating such sites can significantly reduce morbidity.
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On-site preparation of technetium-99m labeled human serum albumin for clinical application
International Nuclear Information System (INIS)
Wang Yuhfeng; Chuang Meihua; Cham Thauming; Chung Meiing; Chiu Jainnshiun
2007-01-01
Technetium-99m labeled human serum albumin (Tc-99m HSA) is an important radiopharmaceutical for clinical applications, such as cardiac function tests or protein-losing gastroenteropathy assessment. However, because of transfusion-induced infectious diseases, the safety of serum products is a serious concern. In this context, serum products acquired from patients themselves are the most ideal tracer. However, the development of rapid separation and easy clinical labeling methods is not yet well established. Under such situation, products from the same ethnic group or country are now recommended by the World Health Organization as an alternative preparation. This article describes the on-site preparation of Tc-99m HSA from locally supplied serum products. Different formulations were prepared and the labeling efficiency and stability were examined. Radio-labeling efficiencies were more than 90% in all preparation protocols, except for one that omitted the stannous solution. The most cost-effective protocol contained HSA 0.1 mg, treated with stannous fluoride 0.2 mg, and mixed with Tc-99m pertechnetate 30 mCi. A biodistribution study was performed in rats using a gamma camera immediately after intravenous administration of radiolabeled HSA. Tissue/organ uptake was obtained by measuring the radioactivity in organs after sacrificing the rats at timed intervals. The biologic half-life was about 32 min, determined from sequential venous blood collections. These data indicate that our preparation of Tc-99m HSA is useful and potentially applicable clinically. In addition, this on-site preparation provides the possibility of labeling a patient's own serum for subsequent clinical application. (author)
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Longitudinal Hypertension Outcomes at Four Student-Run Free Clinic Sites.
Smith, Sunny D; Rojas, Steven M; Huang, Junwen; Yang, Kuangyi; Vaida, Florin
2017-01-01
Student-Run Free Clinics (SRFCs) play a significant role in medical education yet there is minimal information about patient outcomes over time in this setting. The purpose of this study was to assess longitudinal outcomes of hypertension management during routine care at four SRFC sites, while comparing control rates with national standards, and examining for characteristics independently associated with uncontrolled hypertension. The authors conducted a retrospective medical record review of visits from January 2004 through April 2016 with an initial visit for hypertension and a follow-up visit 9 to 15 months later. Hypertension control was analyzed using descriptive statistics, paired t tests, logistic regression, and a longitudinal linear mixed-effects model. This study included 496 patients and 4,798 visits. The mean age was 50.9 (SD 10.8) years old, 71.2% (346) were Latinos, 63.3% (314) were Spanish speaking, and 15.5% (72) were homeless. Mean blood pressure was reduced from 141.6 (SD 21.8)/85.1 (SD 13.2) to 132.1 (SD 17.3)/79.4 (SD10.8), a decrease of 9.5 (CI 7.4, 11.5)/5.7 (CI 4.4, 7.0) mmHg. Blood pressure was significantly reduced within the first month of treatment, and this reduction was sustained throughout the follow-up period. Using the National Health and Nutrition Examination Survey (NHANES) definition (hypertension management and achieve rates of control that exceed national averages despite serving those least likely to be controlled.
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Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N
2012-07-01
Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.
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2010-04-19
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-71,321] Auburn Hosiery Mills, Inc... Auburn Hosiery Mills, Inc., including on-site leased workers from Quality Personnel, Auburn, Kentucky... related to apparel. Information shows that Auburn Hosiery Mills was merged into its parent company, Delta...
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2012-10-17
... workers of Johnson Controls, Inc., including on-site leased workers from Valley Staffing, Hudson..., Wisconsin location of Johnson Controls, Inc. The Department has determined that these workers were sufficiently under the control of the subject firm to be considered leased workers. Based on these findings...
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2010-11-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-70,143] JL French Automotive... workers of JL French Automotive Castings LLC, including on-site leased workers Labor Ready, Sheboygan... Sheboygan, Wisconsin location of JL French Automotive Castings LLC. The Department has determined that these...
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2010-08-13
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-72,781] World Color (USA), LLC Formerly Known as Quebecor World World Color Covington Including On-Site Leased Workers From Randstad... Adjustment Assistance on May 14, 2010, applicable to workers of World Color (USA), LLC, formerly known as...
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2010-04-19
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-70,115] Senco Brands, Inc., fka... workers of Senco Brands, Inc., fka Senco Products, Inc., including the on-site leased workers of Manpower... Brands, Inc., fka Senco Products, Inc. The Department has determined that these workers were sufficiently...
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2013-07-05
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,813A] Eastman Kodak Company... Eastman Kodak Company, IPS, including on-site leased workers from Adecco, Dayton, Ohio (TA-W-74, 813A). At the request of Eastman Kodak Company, the Department reviewed the certification applicable to workers...
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2012-02-21
... Johnson Controls, including on-site leased workers from Kelly Services, Sycamore, Illinois. The notice was... amended notice applicable to TA-W-73,074 is hereby issued as follows: ''All workers of Johnston Controls... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,074] Johnson Controls D/B/A...
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2013-04-09
... Paper, LLC, A Subsidiary of Boise Paper Holdings, LLC, Including On-Site Leased Workers From Guardsmark.... Helens, OR; Boise White Paper, LLC, A Subsidiary of Boise Paper Holdings, LLC, Vancouver, WA; Amended... workers and former workers of Boise White Paper, LLC, a subsidiary of Boise Paper Holdings, LLC, St...
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DEFF Research Database (Denmark)
Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik
2017-01-01
(1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting......Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were...... trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities...
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2010-05-21
... Spherion Corporation; Round Rock, TX; Dell Products LP--Parmer North One; Austin, TX; Amended Certification... Products LP--Parmer North Location, a Subsidiary of Dell, Inc., Including On-Site Leased Workers From... Act of 1974, as amended (``Act''), 19 U.S.C. 2273, the Department of Labor issued a Certification of...
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The student-run free clinic: an ideal site to teach interprofessional education?
Sick, Brian; Sheldon, Lisa; Ajer, Katy; Wang, Qi; Zhang, Lei
2014-09-01
Student-run free clinics (SRFCs) often include an interprofessional group of health professions students and preceptors working together toward the common goal of caring for underserved populations. Therefore, it would seem that these clinics would be an ideal place for students to participate in an interprofessional collaborative practice and for interprofessional education to occur. This article describes a prospective, observational cohort study of interprofessional attitudes and skills including communication and teamwork skills and attitudes about interprofessional learning, relationships and interactions of student volunteers in a SRFC compared to students who applied and were not accepted to the clinic and to students who never applied to the clinic. This study showed a decrease in attitudes and skills after the first year for all groups. Over the next two years, the total score on the survey for the accepted students was higher than the not accepted students. The students who were not accepted also became more similar to students who never applied. This suggests a protective effect against declining interprofessional attitudes and skills for the student volunteers in a SRFC. These findings are likely a function of the design of the clinical and educational experience in the clinic and of the length of contact the students have with other professions.
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2010-04-29
... North Assembly Plant Including On-Site Leased Workers From HAAS TCM, Inc., Logistics Services, Inc., Robinson Solutions, Logistics Management Services, Inc., Corrigan Company and Murphy Company, Fenton, MO... workers from HAAS TCM, Inc., Logistics Services, Inc., Robinson Solutions, Logistics Management Services...
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Kim, Seon-Jeong; Lee, Sang Hoon; Chung, Hye Won; Lee, Min Hee; Shin, Myung Jin; Park, Seoung Woo
2017-07-01
To investigate the magnetic resonance imaging (MRI) findings and the patterns of postoperative spinal infection according to the passage of time. Institutional review board approval was obtained, and informed consent was not obtained for the retrospective review of patients' medical records. A total of 43 patients (27 men and 16 women; mean age, 64) diagnosed with postoperative spinal infection were included in this study. We retrospectively reviewed the MRI findings and the medical records and categorized the infection sites based on MRI, i.e., anterior, posterior, and both parts. The duration of the clinical onset from surgery was divided, i.e., acute (≤2 weeks), subacute (2-4 weeks), and late (>4 weeks). Postoperative spinal infection was involved in the posterior part in 31 (72%), anterior part in two (4.7%), and both parts in 10 patients (23.3%). Abscess or phlegmon in the back muscles and laminectomy site were the most common MRI findings. The number of patients with acute, subacute, and late clinical onset were 35, two, and six, respectively (mean, 33.4 days; range, 1-730 days). The mean duration of the clinical onset was 12 days in the posterior part, 15.2 days in both parts, and 456.5 days in the anterior part. Postoperative spinal infection usually occurred within four weeks in the posterior part and over time the infection was considered to spread into the anterior part. For the evaluation of postoperative spinal infection, the posterior surgical field was more important than the vertebral body or the disc space on MRI.
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de Carvalho, Elias Cesar Araujo; Batilana, Adelia Portero; Claudino, Wederson; Reis, Luiz Fernando Lima; Schmerling, Rafael A; Shah, Jatin; Pietrobon, Ricardo
2012-01-01
With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial
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Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha
2018-01-01
Introduction: The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. Material and Methods: This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Results: Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler’s value model for the consumer. Conclusion: In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations. PMID:29719318
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Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha
2018-01-01
The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler's value model for the consumer. In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations.
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2010-04-19
...., Diversified Contract Service, Inc. 639, and Logistics Management Services, Inc., Fenton, MO; Amended... Logistics Management Services, Inc. worked on-site at the Chrysler LLC, Fenton, Missouri plant (Logistics... Department is amending this certification to include workers leased from Logistics Management Services, Inc...
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2010-04-19
.... Diversified Contract Service, Inc. 639, and Logistics Management Services, Inc. Fenton, MO; Amended... Logistics Management Services, Inc. worked on-site at the Chrysler LLC, Fenton, Missouri plant (Logistics... Department is amending this certification to include workers leased from Logistics Management Services, Inc...
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Directory of Open Access Journals (Sweden)
Mika Ohta
2011-01-01
Full Text Available We have been investigating the molecular efficacy of electroacupuncture (EA, which is one type of acupuncture therapy. In our previous molecular biological study of acupuncture, we found an EA-induced gene, named acupuncture-induced 1-L (Aig1l, in mouse skeletal muscle. The aims of this study consisted of identification of the full-length cDNA sequence of Aig1l including the transcriptional start site, determination of the tissue distribution of Aig1l and analysis of the effect of EA on Aig1l gene expression. We determined the complete cDNA sequence including the transcriptional start site via cDNA cloning with the cap site hunting method. We then analyzed the tissue distribution of Aig1l by means of northern blot analysis and real-time quantitative polymerase chain reaction. We used the semiquantitative reverse transcriptase-polymerase chain reaction to examine the effect of EA on Aig1l gene expression. Our results showed that the complete cDNA sequence of Aig1l was 6073 bp long, and the putative protein consisted of 962 amino acids. All seven tissues that we analyzed expressed the Aig1l gene. In skeletal muscle, EA induced expression of the Aig1l gene, with high expression observed after 3 hours of EA. Our findings thus suggest that the Aig1l gene may play a key role in the molecular mechanisms of EA efficacy.
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Sadi, Jackie; MacDermid, Joy C; Chesworth, Bert; Birmingham, Trevor
2007-12-01
The purpose of this study was to describe the rate and distribution of treatment visits provided in an on-site, automotive plant, physiotherapy clinic over a 13-year period. A retrospective cohort study was conducted using data collected at an on-site physiotherapy clinic (1990-2002, 65,977 visits; n = 2,636 workers). The average age of workers was 43 +/- 9 years; most remained at work (85%) when treated. Disorders most commonly affected the shoulder, lumbar, and cervical regions; the median number of visits for these was 7, 6, and 5, respectively. Elbow disorders occurred commonly only for work-related complaints and required a median of eight visits. Rate of utilization was higher for women, with 47% of the plant's female workers attending physiotherapy in 1 year. Women had higher rates of cervical spine (12 vs. 22%) and wrist (5 vs. 10%) disorders. The two most common causes of injury reported by workers with an industrial injury were "frank injury arising out of normal employment" (51%) and "gradual onset/no frank injury" (37%). The diagnosis most often reported by the physiotherapist after initial assessment was "strain" which was similar for both industrial (43%) and non-industrial (49%) injuries. The six main departments in this automotive plant account for 93% of all industrial injuries reported. Final Assembly accounted for the largest number and highest rate of injury, although shift variability was noted in utilization rates (13 vs. 26%), despite the same tasks, shift schedules, and demographics. Although there was no control group, the number of visits to discharge was lower than reported in the literature for off-site physical therapy; there was a large reduction in claims (441-275) following introduction of the clinic and reduced duration/costs of lost time were identified by the employer as a rationale to continue and enhance the service over time. On-site physiotherapy services can provide early, cost-effective management of WRMSD in the automotive
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2013-06-21
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-82,440] Stone Age Interiors, Inc., D/B/A Colorado Springs Marble and Granite, Including On-Site Leased Workers From Express Employment... Marble and Granite, Colorado Springs, Colorado (subject firm). The negative determination was issued on...
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2011-06-15
... of Nokia Group; Including On-Site Leased Workers From ATC Logistics and Electronics and Adecco Fort... workers from ATC Logistics and Electronics, Fort Worth, Texas. The workers supplied planning and materials... ATC Logistics and Electronics, and Adecco, Fort Worth, Texas, who became totally or partially...
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Keilwagen, Jens; Grau, Jan; Paponov, Ivan A; Posch, Stefan; Strickert, Marc; Grosse, Ivo
2011-02-10
Transcription factors are a main component of gene regulation as they activate or repress gene expression by binding to specific binding sites in promoters. The de-novo discovery of transcription factor binding sites in target regions obtained by wet-lab experiments is a challenging problem in computational biology, which has not been fully solved yet. Here, we present a de-novo motif discovery tool called Dispom for finding differentially abundant transcription factor binding sites that models existing positional preferences of binding sites and adjusts the length of the motif in the learning process. Evaluating Dispom, we find that its prediction performance is superior to existing tools for de-novo motif discovery for 18 benchmark data sets with planted binding sites, and for a metazoan compendium based on experimental data from micro-array, ChIP-chip, ChIP-DSL, and DamID as well as Gene Ontology data. Finally, we apply Dispom to find binding sites differentially abundant in promoters of auxin-responsive genes extracted from Arabidopsis thaliana microarray data, and we find a motif that can be interpreted as a refined auxin responsive element predominately positioned in the 250-bp region upstream of the transcription start site. Using an independent data set of auxin-responsive genes, we find in genome-wide predictions that the refined motif is more specific for auxin-responsive genes than the canonical auxin-responsive element. In general, Dispom can be used to find differentially abundant motifs in sequences of any origin. However, the positional distribution learned by Dispom is especially beneficial if all sequences are aligned to some anchor point like the transcription start site in case of promoter sequences. We demonstrate that the combination of searching for differentially abundant motifs and inferring a position distribution from the data is beneficial for de-novo motif discovery. Hence, we make the tool freely available as a component of the open
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2010-10-08
...-Branded as HP--Enterprise Services) Including On-Site Workers From: Abel Personnel Inc., Advantage Tech... February 4, 2010, applicable to workers of EDS, an HP Company (Re- branded as HP--Enterprise Services...-branded as HP-- Enterprise Services). These employees provided various activities related to the supply of...
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Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F
2017-06-01
Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.
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2012-02-08
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-64,292] PHB Die Casting a... 19, 2008, applicable to workers of PHB Die Casting, a subsidiary of PHB, Inc., including on-site... production of die castings. New information shows that a worker from Burns Industrial Group (BIG Inc) was...
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Hamilton, Murray G; Hill, Ira; Conley, John; Sawyer, Thomas W; Caneva, Duane C; Lundy, Paul M
2004-11-01
O-ethyl S-(2-diisopropylaminoethyl) methylphosphonothioate (VX) is an extremely toxic organophosphate nerve agent that has been weaponized and stockpiled in a number of different countries, and it has been used in recent terrorist events. It differs from other well-known organophosphate nerve agents in that its primary use is as a contact poison rather than as an inhalation hazard. For this reason, we examined the effects of application site and skin decontamination on VX toxicity in anesthetized domestic swine after topical application. VX applied to the surface of the ear rapidly resulted in signs of toxicity consistent with the development of cholinergic crisis, including apnea and death. VX on the epigastrium resulted in a marked delayed development of toxic signs, reduced toxicity, and reduction in the rate of cholinesterase depression compared with animals exposed on the ear. Skin decontamination (15 minutes post-VX on the ear) arrested the development of clinical signs and prevented further cholinesterase inhibition and death. These results confirm earlier work that demonstrates the importance of exposure site on the resultant toxicity of this agent and they also show that decontamination postexposure has the potential to be an integral and extremely important component of medical countermeasures against this agent.
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Unfulfilled translation opportunities in industry sponsored clinical trials
DEFF Research Database (Denmark)
Smed, Marie; Getz, Kenneth A.
2013-01-01
in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract...... Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited......' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable...
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[The informed consent in international clinical trials including developing countries].
Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine
2008-01-01
The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.
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Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...
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International Nuclear Information System (INIS)
House, W.B.; Ebenhack, D.G.
1989-01-01
This chapter is a discussion of the management and operations practices used at the Barnwell Waste Management Facility in Barnwell, SC. The following topics are discussed: (1) Waste receiving and inspection, including manifest and certificates of compliance, radiological surveys, disposition of nonconforming items, and decontamination and disposition of secondary waste streams; (2) Waste disposal, including Title 10 CFR 61 requirements, disposal area evaluations, shipment offloading, container emplacement, and radiation protection; (3) Trench closure, including trench backfilling, trench capping, and permanent markers; (4) Site maintenance and stabilization, including trench maintenance, surface water management, and site closure activities; (5) Site monitoring programs, including operational monitoring, and environmental monitoring program; (6) Personnel training and qualifications, including basic training program, safety training program, special skills training, and physical qualifications; (7) Records management, including waste records, personnel training records, personnel dosimetry records, site monitoring records, trench qualification and construction records, and site drawings and stabilization records; (8) Site security; (9) Emergency response plans; and (10) Quality assurance
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International Nuclear Information System (INIS)
2006-09-01
The Laxemar subarea is the focus for the complete site investigations in the Simpevarp area. The south and southwestern parts of the subarea (the so-called 'focused area') have been designated for focused studies during the remainder of the site investigations. This area, some 5.3 square kilometres in size, is characterised on the surface by an arc shaped body of quartz monzodiorite gently dipping to the north, flanked in the north and south by Aevroe granite. The current report documents work conducted during stage 2.1 of the site-descriptive modelling of the Laxemar subarea. The primary objective of the work performed is to provide feedback to the site investigations at Laxemar to ensure that adequate and timely data and information are obtained during the remaining investigation stage. The work has been conducted in cooperation with the site investigation team at Laxemar and representatives from safety assessment and repository engineering. The principal aim of this joint effort has been to safeguard that adequate data are collected that resolve the remaining issues/uncertainties which are of importance for repository layout and long-term safety. The proposed additional works presented in this report should be regarded as recommended additions and/or modifications in relation to the CSI programme published early 2006. The overall conclusion of the discipline-wise review of critical issues is that the CSI programme overall satisfies the demands to resolve the remaining uncertainties. This is interpreted to be partly a result of the close interaction between the site modelling team, site investigation team and the repository engineering teams, which has been in operation since early 2005. In summary, the performed interpretations and modelling have overall confirmed the version 1.2 results. The exception being Hydrogeology where the new Laxemar 2.1 borehole data suggest more favourable conditions in the south and west parts of the focused area compared with the
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STREAM II-V7: Revision for STREAM II-V6 to include outflow from all Savannah River Site tributaries
Energy Technology Data Exchange (ETDEWEB)
Maze, Grace M. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)
2017-01-01
STREAM II is the aqueous transport model of the Weather Information Display (WIND) emergency response system at Savannah River Site. It is used to calculate transport in the event of a chemical or radiological spill into the waterways on the Savannah River Site. Improvements were made to the code (STREAM II V7) to include flow from all site tributaries to the Savannah River total flow and utilize a 4 digit year input. The predicted downstream concentrations using V7 were generally on the same order of magnitude as V6 with slightly lower concentrations and quicker arrival times when all onsite stream flows are contributing to the Savannah River flow. The downstream arrival time at the Savannah River Water Plant ranges from no change to an increase of 8.77%, with minimum changes typically in March/April and maximum changes typically in October/November. The downstream concentrations are generally no more than 15% lower using V7 with the maximum percent change in January through April and minimum changes in June/July.
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International Nuclear Information System (INIS)
Defraene, Gilles; Van den Bergh, Laura; Al-Mamgani, Abrahim; Haustermans, Karin; Heemsbergen, Wilma; Van den Heuvel, Frank; Lebesque, Joos V.
2012-01-01
Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011–0.013) clinical factor was “previous abdominal surgery.” As second significant (p = 0.012–0.016) factor, “cardiac history” was included in all three rectal bleeding fits, whereas including “diabetes” was significant (p = 0.039–0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003–0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D 50 . Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions
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Energy Technology Data Exchange (ETDEWEB)
Defraene, Gilles, E-mail: gilles.defraene@uzleuven.be [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Van den Bergh, Laura [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Al-Mamgani, Abrahim [Department of Radiation Oncology, Erasmus Medical Center - Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Haustermans, Karin [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Heemsbergen, Wilma [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Van den Heuvel, Frank [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Lebesque, Joos V. [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands)
2012-03-01
Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints
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Rosenberger, Laura H; Politano, Amani D; Sawyer, Robert G
2011-06-01
In response to inconsistent compliance with infection prevention measures, the Centers for Medicare & Medicaid Services collaborated with the U.S. Centers for Disease Control and Prevention on the Surgical Infection Prevention (SIP) project, introduced in 2002. Quality improvement measures were developed to standardize processes to increase compliance. In 2006, the Surgical Care Improvement Project (SCIP) developed out of the SIP project and its process measures. These initiatives, published in the Specifications Manual for National Inpatient Quality Measures, outline process and outcome measures. This continually evolving manual is intended to provide standard quality measures to unify documentation and track standards of care. Seven of the SCIP initiatives apply to the peri-operative period: Prophylactic antibiotics should be received within 1 h prior to surgical incision (1), be selected for activity against the most probable antimicrobial contaminants (2), and be discontinued within 24 h after the surgery end-time (3); (4) euglycemia should be maintained, with well-controlled morning blood glucose concentrations on the first two post-operative days, especially in cardiac surgery patients; (6) hair at the surgical site should be removed with clippers or by depilatory methods, not with a blade; (9) urinary catheters are to be removed within the first two post-operative days; and (10) normothermia should be maintained peri-operatively. There is strong evidence that implementation of protocols that standardize practices reduce the risk of surgical infection. The SCIP initiative targets complications that account for a significant portion of preventable morbidity as well as cost. One of the goals of the SCIP guidelines was a 25% reduction in the incidence of surgical site infections from implementation through 2010. Process measures are becoming routine, and as we practice more evidence-based medicine, it falls to us, the surgeons and scientists, to be active
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Inter-Site Consistency at a Multi-Site Psychiatry Clerkship
Shultes von Schlageter, Margo; Park, EunMi; Tucker, Phebe
2006-01-01
Objective: This study examines the effects of clinical site assignment within a multiple-site psychiatry clerkship program on the convergent outcome of the National Board of Medical Examiners (NBME) subject examination. Method: NBME scores, controlled for baseline pre-clerkship knowledge base as measured by second year human behavior scores, were…
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Directory of Open Access Journals (Sweden)
Nagmoti J
2008-01-01
Full Text Available Anaerobic gram-negative bacteria (AGNB produce enzymes that play a significant role in the development of disease. We tested 50 AGNB isolates, 25 each from clinically diseased and healthy human sites for in vitro production of caseinase, collagenase, etc. Majority of the isolates were Bacteroides fragilis and Porphyromonas gingivalis, which more commonly produced collagenase and haemolysin. Comparatively larger number of clinical AGNB produced collagenase (P = 0.004. No such difference was observed with other enzymes. Hence, collagenase is probably one of the key virulence markers of pathogenic AGNB, and the inhibitors targeting collagenases might help in the therapy of anaerobic infections.
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Today, the U.S. Environmental Protection Agency released the list of Superfund sites that Administrator Pruitt has targeted for immediate and intense attention. The Centredale Manor Restoration Project superfund site is one of the 21 sites on the list.
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Energy Technology Data Exchange (ETDEWEB)
NONE
2006-09-15
The Laxemar subarea is the focus for the complete site investigations in the Simpevarp area. The south and southwestern parts of the subarea (the so-called 'focused area') have been designated for focused studies during the remainder of the site investigations. This area, some 5.3 square kilometres in size, is characterised on the surface by an arc shaped body of quartz monzodiorite gently dipping to the north, flanked in the north and south by Aevroe granite. The current report documents work conducted during stage 2.1 of the site-descriptive modelling of the Laxemar subarea. The primary objective of the work performed is to provide feedback to the site investigations at Laxemar to ensure that adequate and timely data and information are obtained during the remaining investigation stage. The work has been conducted in cooperation with the site investigation team at Laxemar and representatives from safety assessment and repository engineering. The principal aim of this joint effort has been to safeguard that adequate data are collected that resolve the remaining issues/uncertainties which are of importance for repository layout and long-term safety. The proposed additional works presented in this report should be regarded as recommended additions and/or modifications in relation to the CSI programme published early 2006. The overall conclusion of the discipline-wise review of critical issues is that the CSI programme overall satisfies the demands to resolve the remaining uncertainties. This is interpreted to be partly a result of the close interaction between the site modelling team, site investigation team and the repository engineering teams, which has been in operation since early 2005. In summary, the performed interpretations and modelling have overall confirmed the version 1.2 results. The exception being Hydrogeology where the new Laxemar 2.1 borehole data suggest more favourable conditions in the south and west parts of the focused area compared
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Real-time enrollment dashboard for multisite clinical trials
Directory of Open Access Journals (Sweden)
William A. Mattingly
2015-10-01
Conclusion: We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are useful for clinical trial management. They can be used in a standalone trial or can be included into a larger management system.
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2010-01-20
... subject firm. The workers are engaged in the production of penicillin-based antibiotics for humans and animals. The company reports that on-site leased workers from Dream Clean, Inc. were employed on-site at...
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Biopharmaceutical industry-sponsored global clinical trials in emerging countries.
Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira
2010-01-01
To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pattractiveness for biopharmaceutical industry-sponsored clinical trials.
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Alqumber, Mohammed A; Arafa, Khaled A
2014-11-01
To determine whether site-specific mouth rinsing with oral disinfectants can improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by targeting specifically oral malodor implicated anaerobic bacteria. Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive correlational crossover cross-section clinical trial conducted during the month of Ramadan between July and August 2013 in Albaha province in Saudi Arabia involving the application of Listerine Cool Mint mouth rinse by either the traditional panoral rinsing method, or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum, while avoiding the remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor, and the tongue-coating index were compared at baseline, one, 5, and 9 hours after the treatment. The site-specific disinfection method reduced the VSCs and anaerobic bacterial loads while keeping the aerobic bacterial numbers higher than the traditional panoral rinsing method. Site-specific disinfection can more effectively maintain a healthy oral cavity by predominantly disinfecting the niches of anaerobic bacteria within the oral cavity.
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Imaging and Clinical Data of Placental Site Trophoblastic Tumor: A Case Report
International Nuclear Information System (INIS)
Niknejadi, Maryam; Ahmadi, Firoozeh; Akhbari, Farnaz
2016-01-01
Placental site trophoblastic tumor (PSTT) is a very rare variant of gestational trophoblastic tumor. It can occur after normal termination of pregnancy or spontaneous abortion and ectopic or molar pregnancy. There is a wide range of clinical manifestations from a benign condition to an aggressive disease with fatal outcome. One of the most important characteristics of PSTT, unlike other forms of gestational trophoblastic diseases (GTD) is the presence of low beta-subunit of human chorionic gonadotropin (β-hCG) levels because it is a neoplastic proliferation of intermediate trophoblastic cells. However, human placental lactogen (hPL) is increased on histologic section and in the serum of patients too. We present a case of PSTT and discuss the differential diagnosis in order to further familiarize physicians with the diagnosis and treatment of this disease. It has a varied clinical spectrum and usually presents with irregular vaginal bleeding or amenorrhea. Diagnosis is confirmed by dilatation and curettage (D and C) and hysterectomy. Because chemotherapy is not effective, surgery is the cornerstone of treatment. This case is presented because it is a rare neoplasm with different treatments and it should be differentiated from molar pregnancy
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Developing and promoting an intranet site for a drug information service.
Costerison, Emily C; Graham, Angie S
2008-04-01
The development and promotion of a drug information service (DIS) intranet site are described. Stanford Hospital and Clinics (SHC) is an acute and tertiary care facility with 613 licensed inpatient beds and 48 outpatient clinics. A DIS intranet site was developed to allow better accessibility to pharmacy forms and products (e.g., drug shortage list, reference guides) and to reduce repetitive requests to the DIS. The goal was to continue to provide information to SHC health care providers but allow the drug information specialist to focus on answering clinical questions. The intranet site was completed over a four-month period. The intranet site was divided into seven webpages: DIS overview, pharmacy and therapeutics, frequently asked questions, quick drug reference guide, ask the pharmacist, drug information resources, and referral center. The preparation for and implementation of the promotional phase took approximately two months. Promotional strategies included the creation and dissemination of brochures and stickers. The intranet site went live on January 1, 2007, and the advertising campaign began one month later. The utility of the site was measured for five months by tracking the number of visits to the site, the number of visits to each webpage, and the number of downloaded files. Request volume, caller affiliation, and question types received by the DIS call center were also recorded. Establishing a DIS intranet site required a considerable time investment and a willingness to work with existing infrastructures, such as the marketing and communications department and Web marketing staff.
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Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT.
Inaba, Shinji; Mintz, Gary S; Farhat, Naim Z; Fajadet, Jean; Dudek, Dariusz; Marzocchi, Antonio; Templin, Barry; Weisz, Giora; Xu, Ke; de Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko
2014-01-01
This study investigated coronary artery remodeling patterns associated with clinical outcomes. In the prospective, multicenter PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree: An Imaging Study in Patients With Unstable Atherosclerotic Lesions) study, reported predictors of nonculprit lesion (NCL) major adverse cardiac events (MACE) were an intravascular ultrasound (IVUS) minimal lumen area (MLA) ≤4 mm(2), a plaque burden ≥70%, and a IVUS-virtual histology (VH) thin-cap fibroatheroma (TCFA), but not lesion site remodeling. Overall, 697 consecutive patients with an acute coronary syndrome were enrolled and underwent 3-vessel gray-scale and IVUS-VH; 3,223 NCLs were identified by IVUS. The remodeling index (RI) was calculated as the external elastic membrane area at the MLA site divided by the average of the proximal and distal reference external elastic membrane areas. First, one third of the patients were randomly selected to determine RI cutoffs related to NCL MACE (development cohort). Receiver-operating characteristic analysis showed that there were 2 separate cut points that predicted NCL MACE: RI = 0.8789 and RI = 1.0046 (area under the curve = 0.663). These cut points were used to define negative remodeling as an RI 1.00. Second, we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes (validation cohort). Kaplan-Meier curve analysis in the validation cohort showed that NCL MACE occurred more frequent (and equally) in negative and positive remodeling lesions compared with intermediate remodeling lesions. In this cohort, negative remodeling lesions had the smallest MLA, positive remodeling lesions had the largest plaque burden, and VH TCFA, especially VH TCFA with multiple necrotic cores, was most common in negatively remodeling lesions. The present study showed the novel concept that positive and negative lesion site remodeling was
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Directory of Open Access Journals (Sweden)
Frank A Giordano
Full Text Available Gene transfer to hematopoietic stem cells with integrating vectors not only allows sustained correction of monogenic diseases but also tracking of individual clones in vivo. Quantitative real-time PCR (qPCR has been shown to be an accurate method to quantify individual stem cell clones, yet due to frequently limited amounts of target material (especially in clinical studies, it is not useful for large-scale analyses. To explore whether vector integration site (IS recovery techniques may be suitable to describe clonal contributions if combined with next-generation sequencing techniques, we designed artificial ISs of different sizes which were mixed to simulate defined clonal situations in clinical settings. We subjected all mixes to either linear amplificationâmediated PCR (LAM-PCR or nonrestrictive LAM-PCR (nrLAM-PCR, both combined with 454 sequencing. We showed that nrLAM-PCR/454-detected clonality allows estimating qPCR-detected clonality in vitro. We then followed the kinetics of two clones detected in a patient enrolled in a clinical gene therapy trial using both, nrLAM-PCR/454 and qPCR and also saw nrLAM-PCR/454 to correlate to qPCR-measured clonal contributions. The method presented here displays a feasible high-throughput strategy to monitor clonality in clinical gene therapy trials is at hand.
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Nakayama, A.; Nakaoka, H.; Yamamoto, K.; Sakiyama, M.; Shaukat, A.; Toyoda, Y.; Okada, Y.; Kamatani, Y.; Nakamura, T.; Takada, T.; Inoue, K.; Yasujima, T.; Yuasa, H.; Shirahama, Y.; Nakashima, H.; Shimizu, S.; Higashino, T.; Kawamura, Y.; Ogata, H.; Kawaguchi, M.; Ohkawa, Y.; Danjoh, I.; Tokumasu, A.; Ooyama, K.; Ito, T.; Kondo, T.; Wakai, K.; Stiburkova, B.; Pavelka, K.; Stamp, L.K.; Dalbeth, N.; Sakurai, Y.; Suzuki, H; Hosoyamada, M.; Fujimori, S.; Yokoo, T.; Hosoya, T.; Inoue, I.; Takahashi, A.; Kubo, M.; Ooyama, H.; Shimizu, T.; Ichida, K.; Shinomiya, N.; Merriman, T.R.; Matsuo, H.; Andres, M; Joosten, L.A.; Janssen, M.C.H.; Jansen, T.L.; Liote, F.; Radstake, T.R.; Riches, P.L.; So, A.; Tauches, A.K.
2017-01-01
OBJECTIVE: A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. METHODS: Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were
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CliniProteus: A flexible clinical trials information management system
Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael
2007-01-01
Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796
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Directory of Open Access Journals (Sweden)
Horsburgh D
2013-12-01
Full Text Available David Horsburgh,1 Yi-Chen Josey Lee,2 Elvira Zenaida Lansang,1 Ken J Lee,3 Malcolm Ogg,4 Karen Wai1 1Feasibility and Site Identification Asia, Quintiles East Asia Pte Ltd, Singapore; 2Feasibility and Site Identification Asia, Quintiles East Asia Pte Ltd, Taipei, Taiwan; 3Site Services Asia, Quintiles East Asia Pte Ltd, Singapore; 4Global Integrated Site Services, Quintiles, Green Park, Reading, Berkshire, United Kingdom Background: Asia-Pacific represents the fastest-growing region for clinical trials, with growth in oncology studies being a strong contributor. Such demand has seen a rapid change in Asia's total site pool and the number of experienced and inexperienced, or naïve, sites being activated. Given the perceived risks involved with naïve sites, this study aims to investigate changes in the rate of naïve site selection and how this risk management may influence future growth within the region. Methods: Rates of total naïve and experienced sites initiated per year, per protocol, and the relative contribution of each to the yearly site total were analyzed. Data was collected from Quintiles internal metrics as well as from the publicly available ClinicalTrials.gov database and was filtered to include oncology studies involving at least one Asian country, between the years 2000 and 2012. Results and discussion: Despite a general increase in the number of sites activated overall, the contribution of naïve sites to the yearly total fell to 20% in 2012. Experienced sites were heavily favored, with reliance on the existing site network preferred to expansion through naïve sites. This is likely a result of the perceived challenges with using inexperienced sites and the industry desire to avoid this risk. However, fluctuations in naïve sites activation suggest that the limited level of growth in the site pool may not be enough to sustain demand, with sudden outreaches to naïve sites necessary as current site pool capacity is occasionally
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Site matters: winning the hearts and minds of patients in a cardiology clinic.
Annunziato, Rachel A; Rubinstein, David; Sheikh, Saqib; Maurer, Martin; Cotter, Gad; McKay, Mary M; Milo-Cotter, Olga; Gorman, Jack M; Shemesh, Eyal
2008-01-01
In medical care settings, mental health symptoms of depression and distress are associated with poor medical outcomes, yet they are often underrecognized. Authors sought to examine the effect of having immediate mental-health screening in the cardiology clinic. The Patient Health Questionnaire and the Impact of Event Scale were used to screen for depression and distress in 316 patients at an urban cardiology clinic. Because of poor follow-up rates, a psychiatrist was placed on the premises of the cardiology clinic to facilitate referrals. Placing a psychiatrist within the cardiology clinic significantly improved the rate of successful referrals. Because 45 patients (14%) endorsed suicidal thoughts, authors conclude that mental health screening programs should include an immediate evaluation by a clinician.
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Laparoendoscopic Single-Site Surgery (LESS for a Large Ovarian Tumour: First Clinical Case Report
Directory of Open Access Journals (Sweden)
Yao Dong Chua
2011-01-01
Main Outcome Measure(s. Conversion to standard laparoscopic technique or laparotomy, estimated blood loss, operative time , extent of scarring, occurrence of intra- and perioperative surgical complications, technical adequacy, and clinical outcome. Result(s. No conversion to standard laparoscopic technique or laparotomy, and no intraoperative or postoperative complications were observed. Total operative time was 99 minutes. The patient was discharged home on postoperative day one. Conclusion(s. Laparoendoscopic single-site bilateral salpingo-oophorectomy of a large ovarian tumour is feasible with standard laparoscopic instruments. It is safe and effective, with good results in terms of excellent cosmesis and minimal postoperative pain.
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Clinical trials integrity: a CRO perspective.
Beach, J E
2001-01-01
When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.
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G Pitman, Alexander
2017-06-01
Referral to a clinical radiologist is the prime means of communication between the referrer and the radiologist. Current Australian and New Zealand government regulations do not prescribe what clinical information should be included in a referral. This work presents a qualitative compilation of clinical radiologist opinion, relevant professional recommendations, governmental regulatory positions and prior work on diagnostic error to synthesise recommendations on what clinical information should be included in a referral. Recommended requirements on what clinical information should be included in a referral to a clinical radiologist are as follows: an unambiguous referral; identity of the patient; identity of the referrer; and sufficient clinical detail to justify performance of the diagnostic imaging examination and to confirm appropriate choice of the examination and modality. Recommended guideline on the content of clinical detail clarifies when the information provided in a referral meets these requirements. High-quality information provided in a referral allows the clinical radiologist to ensure that exposure of patients to medical radiation is justified. It also minimises the incidence of perceptual and interpretational diagnostic error. Recommended requirements and guideline on the clinical detail to be provided in a referral to a clinical radiologist have been formulated for professional debate and adoption. © 2017 The Royal Australian and New Zealand College of Radiologists.
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Clinical presentation of late haemorrhagic disease of newborn
International Nuclear Information System (INIS)
Majeed, R.; Memon, Y.; Majeed, F.
2008-01-01
To observe the clinical presentation of late haemorrhagic disease of the newborn (LHDNB), and clinical improvement after the administration of vitamin K/sub 1/. This is a prospective descriptive study. All the children older than seven days who presented with bleeding were admitted in pediatrics ward of Isra University Hyderabad from April 2006 to April 2007 were included. Data collection was done by means of detailed proforma. Analysis was done on SPSS version 11. Thirty five cases were included. Commonest site of bleeding was subcutaneous followed by oral and injection site. Mean age of late haemorrhagic disease of newborn was 109 days and minimum age of presentation was 28 days. Common clinical presentations were irritability, convulsions, poor reflexes and poor feeding. Mostly recovery was within 24 hours after vit K. Late HDN results in severe hemorrhage especially hemorrhage in the central nervous system. Administration of Vitamin K (1mg, 1M) at birth can present these severe complications. (author)
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Koutroumanidis, Michalis; Tsirka, Vasiliki; Panayiotopoulos, Chrysostomos
2015-09-01
To evaluate the clinical associations of adult-onset photosensitivity, we studied the clinical and EEG data of patients who were referred due to a possible first seizure and who had a photoparoxysmal response on their EEG. Patients with clinical evidence of photosensitivity before the age of 20 were excluded. Of a total of 30 patients, four had acute symptomatic seizures, two had vasovagal syncope, and 24 were diagnosed with epilepsy. Nine of the 24 patients had idiopathic (genetic) generalized epilepsies and predominantly generalized photoparoxysmal response, but also rare photically-induced seizures, while 15 had exclusively, or almost exclusively, reflex photically-induced occipital seizures with frequent secondary generalization and posterior photoparoxysmal response. Other important differences included a significantly older age at seizure onset and paucity of spontaneous interictal epileptic discharges in patients with photically-induced occipital seizures; only a quarter of these had occasional occipital spikes, in contrast to the idiopathic (genetic) generalized epilepsy patients with typically generalized epileptic discharges. On the other hand, both groups shared a positive family history of epilepsy, common seizure threshold modulators (such as tiredness and sleep deprivation), normal neurological examination and MRI, a generally benign course, and good response to valproic acid. We demonstrated that photosensitivity can first occur in adult life and manifest, either as idiopathic (possibly genetic) photosensitive occipital epilepsy with secondary generalization or as an EEG, and less often, a clinical/EEG feature of idiopathic (genetic) generalized epilepsies. Identification of idiopathic photosensitive occipital epilepsy fills a diagnostic gap in adult first-seizure epileptology and is clinically important because of its good response to antiepileptic drug treatment and fair prognosis.
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Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.
2013-01-01
Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335
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Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I
2015-04-01
Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.
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OhioHealth web site wins awards. Draws leadership recognition for outstanding redesign.
Rees, Tom
2004-01-01
OhioHealth, Columbus, Ohio, has redesigned its web site, making it especially useful and appealing to women. For the collaborative effort, which included the Mayo Clinic and The VIA Group, Portland Maine, it has received numerous awards.
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Directory of Open Access Journals (Sweden)
Ian McGowan
Full Text Available The purpose of this study was to determine whether the development of a standardized approach to the collection of intestinal tissue from healthy volunteers, isolation of gut associated lymphoid tissue mucosal mononuclear cells (MMC, and characterization of mucosal T cell phenotypes by flow cytometry was sufficient to minimize differences in the normative ranges of flow parameters generated at two trial sites. Forty healthy male study participants were enrolled in Pittsburgh and Los Angeles. MMC were isolated from rectal biopsies using the same biopsy acquisition and enzymatic digestion protocols. As an additional comparator, peripheral blood mononuclear cells (PBMC were collected from the study participants. For quality control, cryopreserved PBMC from a single donor were supplied to both sites from a central repository (qPBMC. Using a jointly optimized standard operating procedure, cells were isolated from tissue and blood and stained with monoclonal antibodies targeted to T cell phenotypic markers. Site-specific flow data were analyzed by an independent center which analyzed all data from both sites. Ranges for frequencies for overall CD4+ and CD8+ T cells, derived from the qPBMC samples, were equivalent at both UCLA and MWRI. However, there were significant differences across sites for the majority of T cell activation and memory subsets in qPBMC as well as PBMC and MMC. Standardized protocols to collect, stain, and analyze MMC and PBMC, including centralized analysis, can reduce but not exclude variability in reporting flow data within multi-site studies. Based on these data, centralized processing, flow cytometry, and analysis of samples may provide more robust data across multi-site studies. Centralized processing requires either shipping of fresh samples or cryopreservation and the decision to perform centralized versus site processing needs to take into account the drawbacks and restrictions associated with each method.
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McGowan, Ian; Anton, Peter A; Elliott, Julie; Cranston, Ross D; Duffill, Kathryn; Althouse, Andrew D; Hawkins, Kevin L; De Rosa, Stephen C
2015-01-01
The purpose of this study was to determine whether the development of a standardized approach to the collection of intestinal tissue from healthy volunteers, isolation of gut associated lymphoid tissue mucosal mononuclear cells (MMC), and characterization of mucosal T cell phenotypes by flow cytometry was sufficient to minimize differences in the normative ranges of flow parameters generated at two trial sites. Forty healthy male study participants were enrolled in Pittsburgh and Los Angeles. MMC were isolated from rectal biopsies using the same biopsy acquisition and enzymatic digestion protocols. As an additional comparator, peripheral blood mononuclear cells (PBMC) were collected from the study participants. For quality control, cryopreserved PBMC from a single donor were supplied to both sites from a central repository (qPBMC). Using a jointly optimized standard operating procedure, cells were isolated from tissue and blood and stained with monoclonal antibodies targeted to T cell phenotypic markers. Site-specific flow data were analyzed by an independent center which analyzed all data from both sites. Ranges for frequencies for overall CD4+ and CD8+ T cells, derived from the qPBMC samples, were equivalent at both UCLA and MWRI. However, there were significant differences across sites for the majority of T cell activation and memory subsets in qPBMC as well as PBMC and MMC. Standardized protocols to collect, stain, and analyze MMC and PBMC, including centralized analysis, can reduce but not exclude variability in reporting flow data within multi-site studies. Based on these data, centralized processing, flow cytometry, and analysis of samples may provide more robust data across multi-site studies. Centralized processing requires either shipping of fresh samples or cryopreservation and the decision to perform centralized versus site processing needs to take into account the drawbacks and restrictions associated with each method.
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Fix my child: The importance of including siblings in clinical assessments.
Farnfield, Steve
2017-07-01
This study examined concordance in the attachment strategies of school-aged siblings with reference to environmental risk in terms of poverty and maltreatment. It also investigated the effect of child maltreatment and maternal mental illness on children's psychosocial functioning in terms of the Dynamic-Maturational Model of Attachment and Adaptation (DMM) including unresolved trauma and the DMM Depressed modifier. The attachment strategies of 30 sibling pairs, aged 5-14 years, were assessed using the School-age Assessment of Attachment (SAA). Unlike most previous studies, this study included siblings from large families of two to six children. The main finding was that as environmental risk increases, the diversity of sibling attachment strategies decreases with greater recourse to the DMM Type A3-6 and A/C strategies. Unlike previous studies, the highest level of concordance was found in sibling pairs with the opposite gender. Boys whose mothers had a history of mental illness were significantly more likely than girls to be assessed with the DMM-depression modifier. As danger increases, children in the same family experience more of the same childhood. Further research should focus on single case, intra-familial studies to build a systemic model of the shared environment. Research should also evaluate the effects of environmental risk compared with size of the sibling group on children's attachment strategies. The clinical implications point to the importance of assessing all children in the family using a model built around functional formulation rather than diagnosing the symptoms of a particular child.
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González, Eduardo; Sher, Anna A; Anderson, Robert M; Bay, Robin F; Bean, Daniel W; Bissonnete, Gabriel J; Bourgeois, Bérenger; Cooper, David J; Dohrenwend, Kara; Eichhorst, Kim D; El Waer, Hisham; Kennard, Deborah K; Harms-Weissinger, Rebecca; Henry, Annie L; Makarick, Lori J; Ostoja, Steven M; Reynolds, Lindsay V; Robinson, W Wright; Shafroth, Patrick B
2017-09-01
Most studies assessing vegetation response following control of invasive Tamarix trees along southwestern U.S. rivers have been small in scale (e.g., river reach), or at a regional scale but with poor spatial-temporal replication, and most have not included testing the effects of a now widely used biological control. We monitored plant composition following Tamarix control along hydrologic, soil, and climatic gradients in 244 treated and 172 reference sites across six U.S. states. This represents the largest comprehensive assessment to date on the vegetation response to the four most common Tamarix control treatments. Biocontrol by a defoliating beetle (treatment 1) reduced the abundance of Tamarix less than active removal by mechanically using hand and chain-saws (2), heavy machinery (3) or burning (4). Tamarix abundance also decreased with lower temperatures, higher precipitation, and follow-up treatments for Tamarix resprouting. Native cover generally increased over time in active Tamarix removal sites, however, the increases observed were small and was not consistently increased by active revegetation. Overall, native cover was correlated to permanent stream flow, lower grazing pressure, lower soil salinity and temperatures, and higher precipitation. Species diversity also increased where Tamarix was removed. However, Tamarix treatments, especially those generating the highest disturbance (burning and heavy machinery), also often promoted secondary invasions of exotic forbs. The abundance of hydrophytic species was much lower in treated than in reference sites, suggesting that management of southwestern U.S. rivers has focused too much on weed control, overlooking restoration of fluvial processes that provide habitat for hydrophytic and floodplain vegetation. These results can help inform future management of Tamarix-infested rivers to restore hydrogeomorphic processes, increase native biodiversity and reduce abundance of noxious species. © 2017 by the
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Thompson, Eric M.; Carkin, Bradley A.; Baise, Laurie G.; Kayen, Robert E.
2014-01-01
The geotechnical properties of the soils in and around Boston, Massachusetts, have been extensively studied. This is partly due to the importance of the Boston Blue Clay and the extent of landfill in the Boston area. Although New England is not a region that is typically associated with seismic hazards, there have been several historical earthquakes that have caused significant ground shaking (for example, see Street and Lacroix, 1979; Ebel, 1996; Ebel, 2006). The possibility of strong ground shaking, along with heightened vulnerability from unreinforced masonry buildings, motivates further investigation of seismic hazards throughout New England. Important studies that are pertinent to seismic hazards in New England include source-parameter studies (Somerville and others, 1987; Boore and others, 2010), wave-propagation studies (Frankel, 1991; Viegas and others, 2010), empirical ground-motion prediction equations (GMPE) for computing ground-motion intensity (Tavakoli and Pezeshk, 2005; Atkinson and Boore, 2006), site-response studies (Hayles and others, 2001; Ebel and Kim, 2006), and liquefaction studies (Brankman and Baise, 2008). The shear-wave velocity (VS) profiles collected for this report are pertinent to the GMPE, site response, and liquefaction aspects of seismic hazards in the greater Boston area. Besides the application of these data for the Boston region, the data may be applicable throughout New England, through correlations with geologic units (similar to Ebel and Kim, 2006) or correlations with topographic slope (Wald and Allen, 2007), because few VS measurements are available in stable tectonic regions.Ebel and Hart (2001) used felt earthquake reports to infer amplification patterns throughout the greater Boston region and noted spatial correspondence with the dominant period and amplification factors obtained from ambient noise (horizontal-to-vertical ratios) by Kummer (1998). Britton (2003) compiled geotechnical borings in the area and produced a
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The Spleen as an Optimal Site for Islet Transplantation and a Source of Mesenchymal Stem Cells
Directory of Open Access Journals (Sweden)
Naoaki Sakata
2018-05-01
Full Text Available This review demonstrates the unique potential of the spleen as an optimal site for islet transplantation and as a source of mesenchymal stem cells. Islet transplantation is a cellular replacement therapy used to treat severe diabetes mellitus; however, its clinical outcome is currently unsatisfactory. Selection of the most appropriate transplantation site is a major factor affecting the clinical success of this therapy. The spleen has long been studied as a candidate site for islet transplantation. Its advantages include physiological insulin drainage and regulation of immunity, and it has recently also been shown to contribute to the regeneration of transplanted islets. However, the efficacy of transplantation in the spleen is lower than that of intraportal transplantation, which is the current representative method of clinical islet transplantation. Safer and more effective methods of islet transplantation need to be established to allow the spleen to be used for clinical transplantation. The spleen is also of interest as a mesenchymal stem cell reservoir. Splenic mesenchymal stem cells contribute to the repair of damaged tissue, and their infusion may thus be a promising therapy for autoimmune diseases, including type 1 diabetes mellitus and Sjogren’s syndrome.
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The Spleen as an Optimal Site for Islet Transplantation and a Source of Mesenchymal Stem Cells.
Sakata, Naoaki; Yoshimatsu, Gumpei; Kodama, Shohta
2018-05-07
This review demonstrates the unique potential of the spleen as an optimal site for islet transplantation and as a source of mesenchymal stem cells. Islet transplantation is a cellular replacement therapy used to treat severe diabetes mellitus; however, its clinical outcome is currently unsatisfactory. Selection of the most appropriate transplantation site is a major factor affecting the clinical success of this therapy. The spleen has long been studied as a candidate site for islet transplantation. Its advantages include physiological insulin drainage and regulation of immunity, and it has recently also been shown to contribute to the regeneration of transplanted islets. However, the efficacy of transplantation in the spleen is lower than that of intraportal transplantation, which is the current representative method of clinical islet transplantation. Safer and more effective methods of islet transplantation need to be established to allow the spleen to be used for clinical transplantation. The spleen is also of interest as a mesenchymal stem cell reservoir. Splenic mesenchymal stem cells contribute to the repair of damaged tissue, and their infusion may thus be a promising therapy for autoimmune diseases, including type 1 diabetes mellitus and Sjogren’s syndrome.
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[The LESS (Laparo-endoscopic Single-Site) procedure in urology. Technical and clinical aspects].
Neri, F; Cindolo, L; Gidaro, S; Schips, L
2010-01-01
Minimally invasive urology is rapidly advancing, and single-site laparoscopic surgery is being explored clinically. Such laparoscopic procedures are technically challenging and require an experienced laparoscopic surgeon due to the lack of port placement triangulation and instrument clashing. In the last years several surgeons all over the world have explored the feasibility and safety of LESS using several and different ports, approaches and devices. Hundreds of procedures have been described with overall favorable intraoperative and postoperative outcomes. Our experience consists of more than 30 procedures successfully completed for adrenal, kidney disease and varicocele. To date, LESS could be considered feasible and effective using currently available devices, however it is to be considered as an initial status technique requiring further confirmatory studies and advanced laparoscopic skills.
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International Nuclear Information System (INIS)
Bicker, A.E.
1981-01-01
Among the several DOE sites that have been radiologically decontaminated under the auspices of the Nevada Operations Office are three whose physical characteristics are unique. These are the Tatum Dome Test Site (TDTS) near Hattiesburg, Mississippi; a location of mountainous terrain (Pahute Mesa) on the Nevada Test Site; and the GNOME site near Carlsbad, New Mexico. In each case the contamination, the terrain, and the climate conditions were different. This presentation includes a brief description of each site, the methods used to perform radiological surveys, the logistics required to support the decontamination (including health physics and sample analysis), and the specific techniques used to reduce or remove the contamination
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The fate of prospective spine studies registered on www.ClinicalTrials.gov.
Ohnmeiss, Donna D
2015-03-01
There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by
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Systematic Analysis of Splice-Site-Creating Mutations in Cancer
Directory of Open Access Journals (Sweden)
Reyka G. Jayasinghe
2018-04-01
Full Text Available Summary: For the past decade, cancer genomic studies have focused on mutations leading to splice-site disruption, overlooking those having splice-creating potential. Here, we applied a bioinformatic tool, MiSplice, for the large-scale discovery of splice-site-creating mutations (SCMs across 8,656 TCGA tumors. We report 1,964 originally mis-annotated mutations having clear evidence of creating alternative splice junctions. TP53 and GATA3 have 26 and 18 SCMs, respectively, and ATRX has 5 from lower-grade gliomas. Mutations in 11 genes, including PARP1, BRCA1, and BAP1, were experimentally validated for splice-site-creating function. Notably, we found that neoantigens induced by SCMs are likely several folds more immunogenic compared to missense mutations, exemplified by the recurrent GATA3 SCM. Further, high expression of PD-1 and PD-L1 was observed in tumors with SCMs, suggesting candidates for immune blockade therapy. Our work highlights the importance of integrating DNA and RNA data for understanding the functional and the clinical implications of mutations in human diseases. : Jayasinghe et al. identify nearly 2,000 splice-site-creating mutations (SCMs from over 8,000 tumor samples across 33 cancer types. They provide a more accurate interpretation of previously mis-annotated mutations, highlighting the importance of integrating data types to understand the functional and the clinical implications of splicing mutations in human disease. Keywords: splicing, RNA, mutations of clinical relevance
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Finney, Andrew; Healey, Emma; Jordan, Joanne L; Ryan, Sarah; Dziedzic, Krysia S
2016-07-08
The National Institute for Health and Care Excellence's Osteoarthritis (OA) guidelines recommended that future research should consider the benefits of combination therapies in people with OA across multiple joint sites. However, the clinical effectiveness of such approaches to OA management is unknown. This systematic review therefore aimed to identify the clinical and cost effectiveness of multidisciplinary approaches targeting multiple joint sites for OA in primary care. A systematic review of randomised controlled trials. Computerised bibliographic databases were searched (MEDLINE, EMBASE, CINAHL, PsychINFO, BNI, HBE, HMIC, AMED, Web of Science and Cochrane). Studies were included if they met the following criteria; a randomised controlled trial (RCT), a primary care population with OA across at least two different peripheral joint sites (multiple joint sites), and interventions undertaken by at least two different health disciplines (multidisciplinary). The Cochrane 'Risk of Bias' tool and PEDro were used for quality assessment of eligible studies. Clinical and cost effectiveness was determined by extracting and examining self-reported outcomes for pain, function, quality of life (QoL) and health care utilisation. The date range for the search was from database inception until August 2015. The search identified 1148 individual titles of which four were included in the review. A narrative review was conducted due to the heterogeneity of the included trials. Each of the four trials used either educational or exercise interventions facilitated by a range of different health disciplines. Moderate clinical benefits on pain, function and QoL were reported across the studies. The beneficial effects of exercise generally decreased over time within all studies. Two studies were able to show a reduction in healthcare utilisation due to a reduction in visits to a physiotherapist or a reduction in x-rays and orthopaedic referrals. The intervention that showed the most
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Region 9 NPL Sites (Superfund Sites 2013)
NPL site POINT locations for the US EPA Region 9. NPL (National Priorities List) sites are hazardous waste sites that are eligible for extensive long-term cleanup under the Superfund program. Eligibility is determined by a scoring method called Hazard Ranking System. Sites with high scores are listed on the NPL. The majority of the locations are derived from polygon centroids of digitized site boundaries. The remaining locations were generated from address geocoding and digitizing. Area covered by this data set include Arizona, California, Nevada, Hawaii, Guam, American Samoa, Northern Marianas and Trust Territories. Attributes include NPL status codes, NPL industry type codes and environmental indicators. Related table, NPL_Contaminants contains information about contaminated media types and chemicals. This is a one-to-many relate and can be related to the feature class using the relationship classes under the Feature Data Set ENVIRO_CONTAMINANT.
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Bjegovich-Weidman, Marija; Kahabka, Jill; Bock, Amy; Frick, Jacob; Kowalski, Helga; Mirro, Joseph
2012-03-01
Aurora Health Care (AHC) is the largest health care system in Wisconsin, with 14 acute care hospitals. In early 2010, a group of 18 medical oncologists became affiliated with AHC. This affiliation added 13 medical oncology infusion clinics to our existing 12 sites. In the era of health care reform and declining reimbursement, we need an objective method and criteria to evaluate our 25 outpatient medical oncology sites. We developed financial, clinical, and strategic tools for the evaluation and management of our cancer subservice lines and outpatient sites. The key to our success has been the direct involvement of stakeholders with a vested interest in the services in the selection of the criteria and evaluation process. We developed our objective metrics for evaluation based on strategic, financial, operational, and patient experience criteria. Strategic criteria included: population trends, full-time equivalent (FTE) medical oncologists/primary care physicians, FTE radiation oncologists, FTE oncologic surgeons, new annual cases of patients with cancer, and market share trends. Financial criteria per site included: physician work relative value units, staff FTE by type, staff salaries, and profit and loss. Operational criteria included: facility by type (clinic v hospital based), hours of operation, and facility detail (eg, No. of chairs, No. of procedure and examination rooms, square footage). Patient experience criteria included: nursing model primary/nurse navigators, multidisciplinary support at site, Press Ganey (South Bend, IN; health care performance improvement company) results, and employee engagement score. The outcome of our data analysis has resulted in the development of recommendations for AHC senior leadership and geographic market leadership to consider the consolidation of four sites (phase one, four sites; phase two, two sites) and priority strategic sites to address capacity issues that limit growth. The recommendations if implemented would
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Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies
2016-10-01
Physics of Cancer Metabolism This application seeks to put together a multidiscipline team of experts in various institutions in USA to assemble and...of this project is to build a research cohort of engaged volunteers that reflects the racial , ethnic, and socioeconomic diversity of New York City...assessed in a randomized, phase III clinical trial. Conflict of interest: Advisory Board: Joe O’Sullivan holds consulting/ advisory roles with Bayer
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Automatic web site authoring with SiteGuide
de Boer, V.; Hollink, V.; van Someren, M.W.; Kłopotek, M.A.; Przepiórkowski, A.; Wierzchoń, S.T.; Trojanowski, K.
2009-01-01
An important step in the design process for a web site is to determine which information is to be included and how the information should be organized on the web site’s pages. In this paper we describe ’SiteGuide’, a tool that automatically produces an information architecture for a web site that a
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Superfund Site Information - Site Sampling Data
U.S. Environmental Protection Agency — This asset includes Superfund site-specific sampling information including location of samples, types of samples, and analytical chemistry characteristics of...
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Preliminary siting characterization Salt Disposition Facility - Site B
International Nuclear Information System (INIS)
Wyatt, D.
2000-01-01
A siting and reconnaissance geotechnical program has been completed in S-Area at the Savannah River Site in South Carolina. This program investigated the subsurface conditions for the area known as ''Salt Disposition Facility (SDF), Site B'' located northeast of H-Area and within the S-Area. Data acquired from the Site B investigation includes both field exploration and laboratory test data
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Clinical neurogenetics: neuropathic lysosomal storage disorders.
Pastores, Gregory M; Maegawa, Gustavo H B
2013-11-01
The lysosomal storage disorders are a clinically heterogeneous group of inborn errors of metabolism, associated with the accumulation of incompletely degraded macromolecules within several cellular sites. Affected individuals present with a broad range of clinical problems, including hepatosplenomegaly and skeletal dysplasia. Onset of symptoms may range from birth to adulthood. Most are associated with neurologic features. Later-onset forms are often misdiagnosed as symptoms, which might include psychiatric manifestations, are slowly progressive, and may precede other neurologic or systemic features. Symptomatic care, which remains the mainstay for most subtypes, can lead to significant improvement in quality of life. Copyright © 2013 Elsevier Inc. All rights reserved.
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New Reactor Siting in Finland, Hanhikivi Site in Pyhaejoki - STUK preliminary safety assessment
International Nuclear Information System (INIS)
Nevalainen, Janne
2013-01-01
STUK has performed a preliminary assessment of the Decision-in-Principle on the Fennovoima application. A variety of factors must be considered in the selection of a site, including effects of the site on the plant design and the effects of the plant on the site environment. These include external hazards, both natural and human-induced. Since this is a new site, an extensive siting process is followed, that can include an EIA. A site survey is performed to identify candidate sites, after investigating a large region and rejecting unsuitable sites. The remaining sites are then screened and compared on the basis of safety and other considerations to select one or more preferred sites. Natural hazards include geology, seismology, hydrology and meteorology. Offshore ice will be a particular hazard for this plant, since the site is on average only 1.5 m above sea level. The design basis earthquake corresponds to a return frequency of 100,000 years, with 50 % confidence. The existing sites in southern Finland used a design peak ground acceleration of 0.1 g with the ground response spectrum maximum at 10 Hz. The candidate sites in northern Finland will require a peak ground acceleration of 0.2 g with the ground response spectrum maximum at 25 Hz
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DEFF Research Database (Denmark)
Kjeldsen, Marianne Kirstine; Bek, Dorte; Rasmussen, Erik Michael
2009-01-01
A line probe assay (GenoType MTBC) was evaluated for species differentiation within the Mycobacterium tuberculosis complex (MTBC). We included 387 MTBC isolates, 43 IS6110 low-copy MTBC isolates, 28 clinical specimens with varying microscopy grade, and 30 isolates of non-tuberculous mycobacteria...
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Comprehensive brachytherapy physical and clinical aspects
Baltas, Dimos; Meigooni, Ali S; Hoskin, Peter J
2013-01-01
Modern brachytherapy is one of the most important oncological treatment modalities requiring an integrated approach that utilizes new technologies, advanced clinical imaging facilities, and a thorough understanding of the radiobiological effects on different tissues, the principles of physics, dosimetry techniques and protocols, and clinical expertise. A complete overview of the field, Comprehensive Brachytherapy: Physical and Clinical Aspects is a landmark publication, presenting a detailed account of the underlying physics, design, and implementation of the techniques, along with practical guidance for practitioners. Bridging the gap between research and application, this single source brings together the technological basis, radiation dosimetry, quality assurance, and fundamentals of brachytherapy. In addition, it presents discussion of the most recent clinical practice in brachytherapy including prostate, gynecology, breast, and other clinical treatment sites. Along with exploring new clinical protocols, ...
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DEFF Research Database (Denmark)
Overgaard, Karsten; Rasmussen, Rune S; Johansen, Flemming F
2010-01-01
Reliable models are essential for translational stroke research to study the pathophysiology of ischaemic stroke in an effort to find therapies that may ultimately reduce oedema, infarction and mortality in the clinic. The purpose of this study was to investigate the relation between the site...
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Directory of Open Access Journals (Sweden)
Voytas Daniel F
2011-01-01
Full Text Available Abstract Background Zinc Finger Nucleases (ZFNs have tremendous potential as tools to facilitate genomic modifications, such as precise gene knockouts or gene replacements by homologous recombination. ZFNs can be used to advance both basic research and clinical applications, including gene therapy. Recently, the ability to engineer ZFNs that target any desired genomic DNA sequence with high fidelity has improved significantly with the introduction of rapid, robust, and publicly available techniques for ZFN design such as the Oligomerized Pool ENgineering (OPEN method. The motivation for this study is to make resources for genome modifications using OPEN-generated ZFNs more accessible to researchers by creating a user-friendly interface that identifies and provides quality scores for all potential ZFN target sites in the complete genomes of several model organisms. Description ZFNGenome is a GBrowse-based tool for identifying and visualizing potential target sites for OPEN-generated ZFNs. ZFNGenome currently includes a total of more than 11.6 million potential ZFN target sites, mapped within the fully sequenced genomes of seven model organisms; S. cerevisiae, C. reinhardtii, A. thaliana, D. melanogaster, D. rerio, C. elegans, and H. sapiens and can be visualized within the flexible GBrowse environment. Additional model organisms will be included in future updates. ZFNGenome provides information about each potential ZFN target site, including its chromosomal location and position relative to transcription initiation site(s. Users can query ZFNGenome using several different criteria (e.g., gene ID, transcript ID, target site sequence. Tracks in ZFNGenome also provide "uniqueness" and ZiFOpT (Zinc Finger OPEN Targeter "confidence" scores that estimate the likelihood that a chosen ZFN target site will function in vivo. ZFNGenome is dynamically linked to ZiFDB, allowing users access to all available information about zinc finger reagents, such as the
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Striated Muscle as Implantation Site for Transplanted Pancreatic Islets
Directory of Open Access Journals (Sweden)
Daniel Espes
2011-01-01
Full Text Available Islet transplantation is an attractive treatment for selected patients with brittle type 1 diabetes. In the clinical setting, intraportal transplantation predominates. However, due to extensive early islet cell death, the quantity of islets needed to restore glucose homeostasis requires in general a minimum of two donors. Moreover, the deterioration of islet function over time results in few insulin-independent patients after five-year followup. Specific obstacles to the success of islet transplantation include site-specific concerns for the liver such as the instant blood mediated inflammatory reaction, islet lipotoxicity, low oxygen tension, and poor revascularization, impediments that have led to the developing interest for alternative implantation sites over recent years. Within preclinical settings, several alternative sites have now been investigated and proven favorable in various aspects. Muscle is considered a very promising site and has physiologically properties and technical advantages that could make it optimal for islet transplantation.
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Mdala, Ibrahimu; Olsen, Ingar; Haffajee, Anne D; Socransky, Sigmund S; Thoresen, Magne; de Blasio, Birgitte Freiesleben
2014-09-01
To understand degeneration of healthy sites and identify factors associated with disease progression in patients with chronic periodontitis. Data on healthy sites from 163 American and Swedish subjects were analysed using two-three-state (health, gingivitis, chronic periodontitis) Markov models based on bleeding on probing (BOP), and either clinical attachment level (CAL) + BOP or pocket depth (PD) + BOP. In 2 years, 10% (CAL + BOP) and 3% (PD + BOP) of healthy sites developed chronic periodontitis. On average, healthy sites remained healthy for 32 months before transiting in both models. Most transitions (87-97%) from health were to the gingivitis state. The expected duration of the gingivitis lesion was 4-5 months and sites recovered with a high probability (96-98%). Disease severity as measured by number of sites with CAL/PD > 4 mm at baseline and smoking, were associated with fast progression from health to chronic periodontitis within 6 months as were gingival redness in the PD + BOP model only. With age, the rate of disease progression to gingivitis decreased. Transition probabilities for gingivitis and chronic periodontitis were higher with CAL + BOP than with PD + BOP. Smoking and disease severity were significant predictors for fast progression. © 2014 The Authors. Journal of Clinical Periodontology Published by John Wiley & Sons Ltd.
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Today, the U.S. Environmental Protection Agency released the list of Superfund sites that Administrator Pruitt has targeted for immediate and intense attention. The former Mohawk Tannery facility (a.k.a. Granite State Leathers) is one of the 21 sites on th
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Highly effective cystic fibrosis clinical research teams: critical success factors.
Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W
2014-08-01
Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.
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Nakayama, Akiyoshi; Nakaoka, Hirofumi; Yamamoto, Ken; Sakiyama, Masayuki; Shaukat, Amara; Toyoda, Yu; Okada, Yukinori; Kamatani, Yoichiro; Nakamura, Takahiro; Takada, Tappei; Inoue, Katsuhisa; Yasujima, Tomoya; Yuasa, Hiroaki; Shirahama, Yuko; Nakashima, Hiroshi
2016-01-01
Objective A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. Methods Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were replicated with 1396 cases and 1268 controls using a custom chip of 1961 single nucleotide polymorphisms (SNPs). We also first conducted GWASs of gout subtypes. Replication with Caucasian and New Zeala...
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Sonnemans, L J P; Vester, M E M; Kolsteren, E E M; Erwich, J J H M; Nikkels, P G J; Kint, P A M; van Rijn, R R; Klein, W M
2018-06-01
Clinical post-mortem radiology is a relatively new field of expertise and not common practice in most hospitals yet. With the declining numbers of autopsies and increasing demand for quality control of clinical care, post-mortem radiology can offer a solution, or at least be complementary. A working group consisting of radiologists, pathologists and other clinical medical specialists reviewed and evaluated the literature on the diagnostic value of post-mortem conventional radiography (CR), ultrasonography, computed tomography (PMCT), magnetic resonance imaging (PMMRI), and minimally invasive autopsy (MIA). Evidence tables were built and subsequently a Dutch national evidence-based guideline for post-mortem radiology was developed. We present this evaluation of the radiological modalities in a clinical post-mortem setting, including MIA, as well as the recently published Dutch guidelines for post-mortem radiology in foetuses, neonates, and children. In general, for post-mortem radiology modalities, PMMRI is the modality of choice in foetuses, neonates, and infants, whereas PMCT is advised in older children. There is a limited role for post-mortem CR and ultrasonography. In most cases, conventional autopsy will remain the diagnostic method of choice. Based on a literature review and clinical expertise, an evidence-based guideline was developed for post-mortem radiology of foetal, neonatal, and paediatric patients. What is Known: • Post-mortem investigations serve as a quality check for the provided health care and are important for reliable epidemiological registration. • Post-mortem radiology, sometimes combined with minimally invasive techniques, is considered as an adjunct or alternative to autopsy. What is New: • We present the Dutch guidelines for post-mortem radiology in foetuses, neonates and children. • Autopsy remains the reference standard, however minimal invasive autopsy with a skeletal survey, post-mortem computed tomography, or post
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Financial management of a large multisite randomized clinical trial.
Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G
2014-08-01
The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.
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Lindblad, Anne S; Manukyan, Zorayr; Purohit-Sheth, Tejashri; Gensler, Gary; Okwesili, Paul; Meeker-O'Connell, Ann; Ball, Leslie; Marler, John R
2014-04-01
Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification. To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections. An independent Analysis Center (AC) analyzed data from four anonymous new drug applications (NDAs) where FDA had performed site inspections overseen by FDA's Office of Scientific Investigations (OSI). FDA team members in the OSI chose the four NDAs from among all NDAs with data in Study Data Tabulation Model (SDTM) format. Two of the NDAs had data that OSI had deemed unreliable in support of the application after FDA site inspections identified serious data integrity problems. The other two NDAs had clinical data that OSI deemed reliable after site inspections. At the outset, the AC knew only that the experimental design specified two NDAs with significant problems. FDA gave the AC no information about which NDAs had problems, how many sites were inspected, or how many were found to have problems until after the AC analysis was complete. The AC evaluated randomization balance, enrollment patterns, study visit scheduling, variability of reported data, and last digit reference. The AC classified sites as 'High Concern', 'Moderate Concern', 'Mild Concern', or 'No Concern'. The AC correctly identified the two NDAs with data deemed unreliable by OSI. In addition, central data analysis correctly identified 5 of 6 (83%) sites for which FDA recommended rejection of data and 13 of 15 sites (87%) for which any regulatory deviations were
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African Journals Online (AJOL)
Surgical site infections (SSIs) are a worldwide problem that has ... deep tissue is found on clinical examination, re-opening, histopathological or radiological investigation ..... Esposito S, Immune system and SSI, Journal of Chemotherapy, 2001.
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Angelotti, Marietta; Bliss, Kathryn; Schiffman, Dana; Weaver, Erin; Graham, Laura; Lemme, Thomas; Pryor, Veronica; Gesten, Foster C
2015-06-01
Training in patient-centered medical home (PCMH) settings may prepare new physicians to measure quality of care, manage the health of populations, work in teams, and include cost information in decision making. Transforming resident clinics to PCMHs requires funding for additional staff, electronic health records, training, and other resources not typically available to residency programs. Describe how a 1115 Medicaid waiver was used to transform the majority of primary care training sites in New York State to the PCMH model and improve the quality of care provided. The 2013-2014 Hospital Medical Home Program provided awards to 60 hospitals and 118 affiliated residency programs (training more than 5000 residents) to transform outpatient sites into PCMHs and provide high-quality, coordinated care. Site visits, coaching calls, resident surveys, data reporting, and feedback were used to promote and monitor change in resident continuity and quality of care. Descriptive analyses measured improvements in these areas. A total of 156 participating outpatient sites (100%) received PCMH recognition. All sites enhanced resident education using PCMH principles through patient empanelment, development of quality dashboards, and transforming resident scheduling and training. Clinical quality outcomes showed improvement across the demonstration, including better performance on colorectal and breast cancer screening rates (rate increases of 13%, P≤.001, and 11%, P=.011, respectively). A 1115 Medicaid waiver is a viable mechanism for states to transform residency clinics to reflect new primary care models. The PCMH transformation of 156 sites led to improvements in resident continuity and clinical outcomes.
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2012-03-06
..., Take Care Corporation, Conestoga Rovers and Associates, Phillips Engineering, Rockwell Engineering, Excel Logistics, and American Food and Vending, Calhoun Spotting Service, and Job World working on-site...
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DEFF Research Database (Denmark)
Lifson, A; Rhame, F; Bellosa, W
2006-01-01
adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...
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Clinical applications of Gallium-68
International Nuclear Information System (INIS)
Banerjee, Sangeeta Ray; Pomper, Martin G.
2013-01-01
Gallium-68 is a positron-emitting radioisotope that is produced from a 68 Ge/ 68 Ga generator. As such it is conveniently used, decoupling radiopharmacies from the need for a cyclotron on site. Gallium-68-labeled peptides have been recognized as a new class of radiopharmaceuticals showing fast target localization and blood clearance. 68 Ga-DOTATOC, 8 Ga-DOTATATE, 68 Ga-DOTANOC, are the most prominent radiopharmaceuticals currently in use for imaging and differentiating lesions of various somatostatin receptor subtypes, overexpressed in many neuroendocrine tumors. There has been a tremendous increase in the number of clinical studies with 68 Ga over the past few years around the world, including within the United States. An estimated ∼10,000 scans are being performed yearly in Europe at about 100 centers utilizing 68 Ga-labeled somatostatin analogs within clinical trials. Two academic sites within the US have also begun to undertake human studies. This review will focus on the clinical experience of selected, well-established and recently applied 68 Ga-labeled imaging agents used in nuclear medicine. - Highlights: ► A summary of the emerging clinical uses of 68 Ga-based radiopharmaceuticals is provided. ► 68 Ga-PET may prove as or more clinically robust than the corresponding 18 F-labeled agents. ► 68 Ga-radiopeptides were studied for targeting of somatostatin receptors subtypes. ► 68 Ga-DOTATOC, 68 Ga-DOTATATE, 68 Ga-DOTANOC, are currently in clinical trials
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The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors.
Smith-Gick, Jodi; Barnes, Nicola; Barone, Rocco; Bedford, Jeff; James, Jason R; Reisner, Stacy Frankovitz; Stephenson, Michael
2018-01-01
Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation.
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International Nuclear Information System (INIS)
Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young
2005-01-01
The purpose of this study was to establish a quality standard for mammographic equipment Korea and to eventually improve mammographic quality in clinics and hospitals throughout Korea by educating technicians and clinic personnel. For the phantom test and on site assessment, we visited 37 sites and examined 43 sets of mammographic equipment. Items that were examined include phantom test, radiation dose measurement, developer assessment, etc. The phantom images were assessed visually and by optical density measurements. For the clinical image assessment, clinical images from 371 sites were examined following the new Korean standard for clinical image evaluation. The items examined include labeling, positioning, contrast, exposure, artifacts, collimation among others. Quality standard of mammographic equipment was satisfied in all equipment on site visits. Average mean glandular dose was 114.9 mRad. All phantom image test scores were over 10 points (average, 10.8 points). However, optical density measurements were below 1.2 in 9 sets of equipment (20.9%). Clinical image evaluation revealed appropriate image quality in 83.5%, while images from non-radiologist clinics were adequate in 74.6% (91/122), which was the lowest score of any group. Images were satisfactory in 59.0% (219/371) based on evaluation by specialists following the new Korean standard for clinical image evaluation. Satisfactory images had a mean score of 81.7 (1 S.D. =8.9) and unsatisfactory images had a mean score of 61.9 (1 S.D = 11). The correlation coefficient between the two observers was 0.93 (ρ < 0.01) in 49 consecutive cases. The results of the phantom tests suggest that optical density measurements should be performed as part of a new quality standard for mammographic equipment. The new clinical evaluation criteria that was used in this study can be implemented with some modifications for future mammography quality control by the Korean government
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Directory of Open Access Journals (Sweden)
Gita eSuneja
2015-02-01
Full Text Available Introduction: The burden of cervical cancer is large and growing in developing countries, due in large part to limited access to screening services and lack of human papillomavirus (HPV vaccination. In spite of modern advances in diagnostic and therapeutic modalities, outcomes from cervical cancer have not markedly improved in recent years. Novel clinical trials are urgently needed to improve outcomes from cervical cancer worldwide. Methods: The Cervix Cancer Research Network (CCRN, a subsidiary of the Gynecologic Cancer InterGroup (GCIG, is a multi-national, multi-institutional consortium of physicians and scientists focused on improving cervical cancer outcomes worldwide by making cancer clinical trials available in low-, middle-, and high-income countries. Standard operating procedures for participation in CCRN include a pre-qualifying questionnaire to evaluate clinical activities and research infrastructure, followed by a site visit. Once a site is approved, they may choose to participate in one of four currently accruing clinical trials.Results: To date, 13 different CCRN site visits have been performed. Of these 13 sites visited, 10 have been approved as CCRN sites including Tata Memorial Hospital, India; Bangalore, India; Trivandrum, India; Ramathibodi, Thailand; Siriaj, Thailand; Pramongkutklao, Thailand; Ho Chi Minh, Vietnam; Blokhin Russian Cancer Research Center; the Hertzen Moscow Cancer Research Institute; and the Russian Scientific Center of Roentgenoradiology. The four currently accruing clinical trials are TACO, OUTBACK, INTERLACE, and SHAPE.Discussion: The CCRN has successfully enrolled 10 sites in developing countries to participate in four randomized clinical trials. The primary objectives are to provide novel therapeutics to regions with the greatest need and to improve the validity and generalizability of clinical trial results by enrolling a diverse sample of patients.
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Energy Technology Data Exchange (ETDEWEB)
Sakurai, Yasuhisa; Momose, Toshimitsu; Watanabe, Toshiaki; Ishikawa, Takashi; Iwata, Makoto (Tokyo Univ. (Japan). Faculty of Medicine); Bando, Mitsuaki
1991-05-01
Three patients with slowly progressive fluent aphasia are reported. One of the patients presented with memory disturbance. They were characterized clinically by having selective deficits in vocabulary, which resulted in impairment of confrontation naming, and auditory comprehension. MRI showed an atrophy not only in the left temporal lobe (including the superior, middle and inferior temporal gyri), hippocampus, parahippocampual gyrus, and fusiform gyrus, but also in the left parietal lobe. I-123 IMP SPECT and F-18 FDG PET were used to determine regional cerebral blood flow and regional cerebral metabolic rate, respectively. In addition to the decreased tracer uptake in the left temporal and/or parietal lobe, a decreased uptake was seen in the bilateral basal ganglia, the inner side of the temporal lobe (including the bilateral hippocampus), the right anterior temporal lobe, and the left thalamus. These findings may deny the previous thought that lesions are localized in slowly progressive fluent aphasia. Furthermore, noticeable difficulty in naming, i.e., patients unable to recognize the right answer, are considered attributable to widespread lesions from the whole left temporal lobe, including the hippocampus, to the right temporal lobe. (N.K.).
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SiteGuide: An example-based approach to web site development assistance
Hollink, V.; de Boer, V.; van Someren, M.; Filipe, J.; Cordeiro, J.
2009-01-01
We present ‘SiteGuide’, a tool that helps web designers to decide which information will be included in a new web site and how the information will be organized. SiteGuide takes as input URLs of web sites from the same domain as the site the user wants to create. It automatically searches the pages
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Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi
2016-07-11
Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to
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Correlation of bone quality in radiographic images with clinical bone quality classification
Energy Technology Data Exchange (ETDEWEB)
Kim, Hyun Woo; Huh, Kyung Hoe; Kim, Jeong Hwa; Yi, Won Jin; Heo, Min Suk; Lee, Sam Sun; Choi, Soon Chul [Seoul National University, Seoul (Korea, Republic of); Park, Kwan Soo [Inje University, Seoul (Korea, Republic of)
2006-03-15
To investigate the validity of digital image processing on panoramic radiographs in estimating bone quality before endosseous dental implant installation by correlating bone quality in radiographic images with clinical bone quality classification. An experienced surgeon assessed and classified bone quality for implant sites with tactile sensation at the time of implant placement. Including fractal dimension eighteen morphologic features of trabecular pattern were examined in each anatomical sites on panoramic radiographs. Finally bone quality of 67 implant sites were evaluated in 42 patients. Pearson correlation analysis showed that three morphologic parameters had weak linear negative correlation with clinical bone quality classification showing correlation coefficients of -0.276, -0.280, and -0.289, respectively (p<0.05). And other three morphologic parameters had obvious linear negative correlation with clinical bone quality classification showing correlation coefficients of -0.346, -0.488, and -0.343 respectively (p<0.05). Fractal dimension also had a linear correlating with clinical bone quality classification with correlation coefficients -0.506 significantly (P<0.05). This study suggests that fractal and morphometric analysis using digital panoramic radiographs can be used to evaluate bone quality for implant recipient sites.
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de Oña Navarro, Maria; Melón García, Santiago; Alvarez-Argüelles, Marta; Fernández-Verdugo, Ana; Boga Riveiro, Jose Antonio
2012-08-01
Although new influenza virus (IAn/H1N1) infections are mild and indistinguishable from any other seasonal influenza virus infections, there are few data on comparisons of the clinical features of infection with (IAn/H1N1) and with other respiratory viruses. The incidence, clinical aspects and temporal distribution of those respiratory viruses circulating during flu pandemic period were studied. Respiratory samples from patients with acute influenza-like symptoms were collected from May 2009 to December 2009. Respiratory viruses were detected by conventional culture methods and genome amplification techniques. Although IAn/H1N1 was the virus most frequently detected, several other respiratory viruses co-circulated with IAn/H1N1 during the pandemic period, especially rhinovirus. The similarity between clinical signs included in the clinical case definition for influenza and those caused by other respiratory viruses, particularly rhinovirus, suggest that a high percentage of viral infections were clinically diagnosed as case of influenza. Our study offers useful information to face future pandemics caused by influenza virus, indicating that differential diagnoses are required in order to not overestimate the importance of the pandemic. Copyright © 2011 Elsevier España, S.L. All rights reserved.
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Does Infection Site Matter? A Systematic Review of Infection Site Mortality in Sepsis.
Motzkus, Christine A; Luckmann, Roger
2017-09-01
Sepsis treatment protocols emphasize source control with empiric antibiotics and fluid resuscitation. Previous reviews have examined the impact of infection site and specific pathogens on mortality from sepsis; however, no recent review has addressed the infection site. This review focuses on the impact of infection site on hospital mortality among patients with sepsis. The PubMed database was searched for articles from 2001 to 2014. Studies were eligible if they included (1) one or more statistical models with hospital mortality as the outcome and considered infection site for inclusion in the model and (2) adult patients with sepsis, severe sepsis, or septic shock. Data abstracted included stage of sepsis, infection site, and raw and adjusted effect estimates. Nineteen studies were included. Infection sites most studied included respiratory (n = 19), abdominal (n = 19), genitourinary (n = 18), and skin and soft tissue infections (n = 11). Several studies found a statistically significant lower mortality risk for genitourinary infections on hospital mortality when compared to respiratory infections. Based on studies included in this review, the impact of infection site in patients with sepsis on hospital mortality could not be reliably estimated. Misclassification among infections and disease states remains a serious possibility in studies on this topic.
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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...
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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Customer Service/Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute ...
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Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... Customer Service/Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute ...
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Vaghardoost, Reza; Momeni, Mahnoush; Kazemikhoo, Nooshafarin; Mokmeli, Soheila; Dahmardehei, Mostafa; Ansari, Fereshteh; Nilforoushzadeh, Mohammad Ali; Sabr Joo, Parisa; Mey Abadi, Sara; Naderi Gharagheshlagh, Soheila; Sassani, Saeed
2018-04-01
Skin graft is a standard therapeutic technique in patients with deep ulcers, but managing donor site after grafting is very important. Although several modern dressings are available to enhance the comfort of donor site, using techniques that accelerate wound healing may enhance patient satisfaction. Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers, but there is not any report of using this method for healing of donor site in burn patients. The protocols and informed consent were reviewed according to Medical Ethics Board of Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1394.363) and Iranian Registry of Clinical Trials (IRCT2016020226069N2). Eighteen donor sites in 11 patients with grade 3 burn ulcer were selected. Donor areas were divided into 2 parts, for laser irradiation and control randomly. Laser area was irradiated by a red, 655-nm laser light, 150 mW, 2 J/cm 2 , on days 0 (immediately after surgery), 3, 5, and 7. Dressing and other therapeutic care for both sites were the same. The patients and the person who analyzed the results were blinded. The size of donor site reduced in both groups during the 7-day study period (P < 0.01) and this reduction was significantly greater in the laser group (P = 0.01). In the present study, for the first time, we evaluate the effects of LLLT on the healing process of donor site in burn patients. The results showed that local irradiation of red laser accelerates wound healing process significantly.
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Dedicated education unit: implementing an innovation in replication sites.
Moscato, Susan R; Nishioka, Vicki M; Coe, Michael T
2013-05-01
An important measure of an innovation is the ease of replication and achievement of the same positive outcomes. The dedicated education unit (DEU) clinical education model uses a collaborative academic-service partnership to develop an optimal learning environment for students. The University of Portland adapted this model from Flinders University, Australia, to increase the teaching capacity and quality of nursing education. This article identifies DEU implementation essentials and reports on the outcomes of two replication sites that received consultation support from the University of Portland. Program operation information, including education requirements for clinician instructors, types of patient care units, and clinical faculty-to-student ratios is presented. Case studies of the three programs suggest the DEU model is adaptable to a range of different clinical settings and continues to show promise as one strategy for addressing the nurse faculty shortage and strengthening academic-clinical collaborations while maintaining quality clinical education for students. Copyright 2013, SLACK Incorporated.
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DEFF Research Database (Denmark)
Christoffersen, Mette W; Brandt, Erik; Oehlenschläger, Jacob
2015-01-01
and matched 1:2 with patients subjected to CLC using pre-defined criteria. Follow-up data were obtained from the Danish National Patient Registry, mailed patient questionnaires, and clinical examination. A port-site hernia was defined as a repair for a port-site hernia or clinical hernia located at one......BACKGROUND: Conventional laparoscopic cholecystectomy (CLC) is regarded as the gold standard for cholecystectomy. However, single-incision laparoscopic cholecystectomy (SLC) has been suggested to replace CLC. This study aimed at comparing long-term incidences of port-site hernia and chronic pain...... after SLC versus CLC. METHODS: We conducted a matched cohort study based on prospective data (Jan 1, 2009-June 1, 2011) from the Danish Cholecystectomy Database with perioperative information and clinical follow-up. Consecutive patients undergoing elective SLC during the study period were included...
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Infections du site Operatoire en Chirurgie Orthopedique ...
African Journals Online (AJOL)
Mots clés: Infection site opératoire chirurgie orthopédique. English Title: Infections of the operative site in orthopedic surgery: clinical presentations, etiologies and management. English Abstract. Introduction: In orthopedic surgery, wound site infections constitute a difficult situation to the surgeon; and for the patient. The aim ...
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Directory of Open Access Journals (Sweden)
Caravatta Luciana
2012-06-01
Full Text Available Abstract Background Radiotherapy (RT is widely used in the treatment of pancreatic cancer. Currently, recommendation has been given for the delineation of the clinical target volume (CTV in adjuvant RT. Based on recently reviewed pathologic data, the aim of this study is to propose criteria for the CTV definition and delineation including elective nodal irradiation (ENI in the preoperative and definitive treatment of pancreatic cancer. Methods The anatomical structures of interest, as well as the abdominal vasculature were identified on intravenous contrast-enhanced CT scans of two different patients with pancreatic cancer of the head and the body. To delineate the lymph node area, a margin of 10 mm was added to the arteries. Results We proposed a set of guidelines for elective treatment of high-risk nodal areas and CTV delineation. Reference CT images were provided. Conclusions The proposed guidelines could be used for preoperative or definitive RT for carcinoma of the head and body of the pancreas. Further clinical investigations are needed to validate the defined CTVs.
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2011-04-07
... employed on-site at the Federal Way, Washington location of Weyerhaeuser Company, Corporate Headquarters... Company, Corporate Headquarters to be considered leased workers. Based on these findings, the Department... Federal Way, Washington location of Weyerhaeuser Company, Corporate Headquarters. The amended notice...
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2010-11-18
..., Accountants, Inc. and Accountant Temps Mountain View, CA; Amended Certification Regarding Eligibility To Apply... on-site leased workers from ATR International, Accountants, Inc., and Accountant Temps, Mountain View... a separate unemployment insurance (UI) tax account under the name Microsemi Corporation. Accordingly...
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DEFF Research Database (Denmark)
Salem, L C; Vogel, Asmus Mejling; Ebstrup, J
2015-01-01
OBJECTIVE: Our objective was to examine the quantity and profile of subjective cognitive complaints in young patients as compared with elderly patients referred to a memory clinic. METHODS: Patients were consecutively recruited from the Copenhagen University Hospital Memory Clinic at Rigshospitalet....... In total, 307 patients and 149 age-matched healthy controls were included. Patients were classified in 4 diagnostic groups: dementia, mild cognitive impairment, affective disorders and no cognitive impairment. Subjective memory was assessed with subjective memory complaints (SMC) scale. Global cognitive...... with dementia have a significantly higher level and a different profile of subjective cognitive complaints as compared with elderly patients with dementia. Furthermore, young patients, diagnosed with an affective disorder, had the highest level of subjective cognitive complaints of all patients in a memory...
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International Nuclear Information System (INIS)
Wang Guohui; Liang Peiyan; Cai Yanjun; Zhang Weiguang; Xie Chuanmiao; Wu Peihong
2008-01-01
Objective: Carcinoma of unknown primary (CUP) is not uncommon in usual clinical settings. They are, by definition, those cases with clinically suspected primary malignancy but not revealed by conventional investigation. The aim of this study was to investigate the efficacy of whole-body 18 F-fluoro- deoxyglucose (FDG) PET/CT in detecting a primary neoplasm for these patients. Methods: A totle of 150 patients with retrievable records from 169 CUP patients were selected within a group of consecutive 2589 patients from Jan. 2006 to Jun. 2007. All cases underwent whole-body FDG PET/CT scan. The final diagnoses were confirmed by pathologic results, other imaging modalities or clinical follow-up. Results: Among 150 patients, primary tumor sites were successfully detected by whole-body 18 F-FDG PET/CT scan in 70 cases (46.7%), of which 52 were pathologically confirmed and 18 by clinical follow-up. And 38 cases (54.3%) were lung cancer, 8 (11.4%) were nasopharyngeal carcinoma, 13 (18.6%) in digestive sys- tem, and 11 (15.7%) in other systems. Three clinically suspected CUP cases with negative 18 F-FDG PET/ CT were subsequently confirmed of benign processes by clinical follow-up. Six patients were wrongly diagnosed by 18 F-FDG PET/CT, and 15 patients did not have a confirmed diagnosis by the end of research. The primary cause of malignancy after 18 F-FDG PET/CT remained obscure in 56 patients, only 3 of whom be- came known during the course of clinical follow-up (nasopharyngeal bladder and esophageal carcinoma). Conclusion: 18 F-FDG PET/CT whole-body imaging plays an important role in patients with metastatic CUP. (authors)
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Nguyen, Naomi-Trang; Byarlay, Matthew R; Reinhardt, Richard A; Marx, David B; Meinberg, Trudy A; Kaldahl, Wayne B
2015-10-01
Numerous studies have documented the clinical outcomes of laser therapy for untreated periodontitis, but very few have reported on lasers treating inflamed pockets during maintenance therapy. The aim of this study is to compare the effectiveness of scaling and root planing (SRP) plus the adjunctive use of diode laser therapy to SRP alone on changes in the clinical parameters of disease and on the gingival crevicular fluid (GCF) inflammatory mediator interleukin-1β (IL-1β) in patients receiving regular periodontal maintenance therapy. This single-masked and randomized, controlled, prospective study includes 22 patients receiving regular periodontal maintenance therapy who had one or more periodontal sites with a probing depth (PD) ≥ 5 mm with bleeding on probing (BOP). Fifty-six sites were treated with SRP and adjunctive laser therapy (SRP + L). Fifty-eight sites were treated with SRP alone. Clinical parameters, including PD, clinical attachment level (CAL), and BOP, and GCF IL-1β levels were measured immediately before treatment (baseline) and 3 months after treatment. Sites treated with SRP + L and SRP alone resulted in statistically significant reductions in PD and BOP and gains in CAL. These changes were not significantly different between the two therapies. Similarly, differences in GCF IL-1β levels between SRP + L and SRP alone were not statistically significant. In periodontal maintenance patients, SRP + L did not enhance clinical outcomes compared to SRP alone in the treatment of inflamed sites with ≥ 5 mm PD.
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Social networking sites: a clinical dilemma?
Maughan, Daniel Lawrence; Economou, Alexis
2015-02-01
Social networking sites (SNS) are having an increasing influence on patients' lives and doctors are far from certain about how to deal with this new challenge. In our literature search, we could find no research on how doctors could engage positively with SNS to improve patient outcomes or create more patient-led care. We need to acknowledge the fact that a review of a patient's SNS page has the potential to enhance assessment and management, particularly where a corroborant history is hard to attain. As doctors, we need to think clearly about how to adapt our practice in light of this new form of communication; in particular, whether there is a case for engaging with SNS to improve patient care. 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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Nevada Test Site Environmental Report 2005, Attachment A - Site Description
International Nuclear Information System (INIS)
Cathy A. Wills
2006-01-01
This appendix to the ''Nevada Test Site Environmental Report 2005'', dated October 2006 (DOE/NV/11718--1214; DOE/NV/25946--007) expands on the general description of the Nevada Test Site (NTS) presented in the Introduction. Included are subsections that summarize the site?s geological, hydrological, climatological, and ecological setting. The cultural resources of the NTS are also presented. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NTS. An adequate knowledge of the site's environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NTS. The NTS environment contributes to several key features of the site which afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NTS operations. These key features include the general remote location of the NTS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This appendix complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report
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Nevada Test Site Environmental Report 2005, Attachment A - Site Description
Energy Technology Data Exchange (ETDEWEB)
Cathy A. Wills
2006-10-01
This appendix to the ''Nevada Test Site Environmental Report 2005'', dated October 2006 (DOE/NV/11718--1214; DOE/NV/25946--007) expands on the general description of the Nevada Test Site (NTS) presented in the Introduction. Included are subsections that summarize the site?s geological, hydrological, climatological, and ecological setting. The cultural resources of the NTS are also presented. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NTS. An adequate knowledge of the site's environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NTS. The NTS environment contributes to several key features of the site which afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NTS operations. These key features include the general remote location of the NTS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This appendix complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Site Selection for Surplus Plutonium Disposition Facilities at the Savannah River Site
International Nuclear Information System (INIS)
Wike, L.D.
2000-01-01
A site selection study was conducted to evaluate locations for the proposed Surplus Plutonium Disposition Facilities. Facilities to be located include the Mixed Oxide (MOX) Fuel Fabrication Facility, the Pit Disassembly and Conversion Facility (PDCF), and the Plutonium Immobilization Project (PIP) facility. Objectives of the study include: (1) Confirm that the Department of Energy (DOE) selected locations for the MOX and PDCF were suitable based on selected siting criteria, (2) Recommend a site in the vicinity of F Area that is suitable for the PIP, and (3) Identify alternative suitable sites for one or more of these facilities in the event that further geotechnical characterization or other considerations result in disqualification of a currently proposed site
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Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.
Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G
2016-06-01
Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.
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Directory of Open Access Journals (Sweden)
Drennan Judy
2011-05-01
Full Text Available Abstract Background The increasing popularity and use of the internet makes it an attractive option for providing health information and treatment, including alcohol/other drug use. There is limited research examining how people identify and access information about alcohol or other drug (AOD use online, or how they assess the usefulness of the information presented. This study examined the strategies that individuals used to identify and navigate a range of AOD websites, along with the attitudes concerning presentation and content. Methods Members of the general community in Brisbane and Roma (Queensland, Australia were invited to participate in a 30-minute search of the internet for sites related to AOD use, followed by a focus group discussion. Fifty one subjects participated in the study across nine focus groups. Results Participants spent a maximum of 6.5 minutes on any one website, and less if the user was under 25 years of age. Time spent was as little as 2 minutes if the website was not the first accessed. Participants recommended that AOD-related websites should have an engaging home or index page, which quickly and accurately portrayed the site's objectives, and provided clear site navigation options. Website content should clearly match the title and description of the site that is used by internet search engines. Participants supported the development of a portal for AOD websites, suggesting that it would greatly facilitate access and navigation. Treatment programs delivered online were initially viewed with caution. This appeared to be due to limited understanding of what constituted online treatment, including its potential efficacy. Conclusions A range of recommendations arise from this study regarding the design and development of websites, particularly those related to AOD use. These include prudent use of text and information on any one webpage, the use of graphics and colours, and clear, uncluttered navigation options
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[Organising an investigation site: a national training reference document].
Cornu, Catherine; David, Frédérique; Duchossoy, Luc; Hansel-Esteller, Sylvie; Bertoye, Pierre-Henri; Giacomino, Alain; Mouly, Stéphane; Diebolt, Vincent; Blazejewski, Sylvie
2014-01-01
Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation. This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation. The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials. © 2014 Société Française de Pharmacologie et de Thérapeutique.
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2010-07-01
... Manufacturing A, Austin, Texas. The notice was published in the Federal Register on May 28, 2010 (75 FR 30070...Logic, Inc., Austin, TX; Amended Certification Regarding Eligibility To Apply for Worker Adjustment..., Design Solutions, Inc., Veriseo, SilconElite and MicroLogic, Inc. were employed on-site at the Austin...
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Subsurface characterization and geohydrologic site evaluation West Chestnut Ridge site
International Nuclear Information System (INIS)
1984-01-01
The West Chestnut Ridge Site at the Oak Ridge National Laboratory is being considered for use as a repository for low-level radioactive waste. The purposes of this study were to provide a geohydrological characterization of the site for use in pathways analysis, and to provide preliminary geotechnical recommendations that would be used for development of a site utilization plan. Subsurface conditions were investigated at twenty locations and observation wells were installed. Field testing at each location included the Standard Penetration Test and permeability tests in soil and rock. A well pumping test was ocmpleted at one site. Laboratory testing included permeability, deformability, strength and compaction tests, as well as index and physical property tests. The field investigations showed that the subsurface conditions include residual soil overlying a weathered zone of dolomite which grades into relatively unweathered dolomite at depth. The thickness of residual soil is typically 80 ft (24 m) on the ridges, but can be as little as 10 ft (3 m) in the valleys. Trench excavations to depths of 30 ft (9 m) should not present serious slope stability problems above the water table. On-site soils can be used for liners or trench backfill but these soils may require moisture conditioning to achieve required densities. 19 figures, 8 tables
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Pimmer, Christoph; Linxen, Sebastian; Grohbiel, Urs
2012-01-01
This exploratory research investigates how students and professionals use social network sites (SNSs) in the setting of developing and emerging countries. Data collection included focus groups consisting of medical students and faculty as well as the analysis of a Facebook site centred on medical and clinical topics. The findings show how users,…
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Ferris, Maria; Norwood, Victoria; Radeva, Milena; Gassman, Jennifer J; Al-Uzri, Amira; Askenazi, David; Matoo, Tej; Pinsk, Maury; Sharma, Amita; Smoyer, William; Stults, Jenna; Vyas, Shefali; Weiss, Robert; Gipson, Debbie; Kaskel, Frederick; Friedman, Aaron; Moxey-Mims, Marva; Trachtman, Howard
2013-02-01
We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. © 2013 Wiley Periodicals, Inc.
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Nevada Test Site Environmental Report 2007 Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Cathy Wills
2008-09-01
This appendix expands on the general description of the Nevada Test Site (NTS) presented in the Introduction to the Nevada Test Site Environmental Report 2007 (U.S. Department of Energy [DOE], 2008). Included are subsections that summarize the site's geological, hydrological, climatological, and ecological setting. The cultural resources of the NTS are also presented. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NTS. An adequate knowledge of the site's environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NTS. The NTS environment contributes to several key features of the site which afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NTS operations. These key features include the general remote location of the NTS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Siting guidelines and their role in repository site selection
International Nuclear Information System (INIS)
Hanlon, C.L.
1985-01-01
The first requirement of the Nuclear Waste Policy Act was for the Secretary of Energy to issue general guidelines for siting repositories. The guidelines were to specify detailed geologic considerations that would be the primary criteria for the selection of sites in various host rocks, as well as factors that would qualify or disqualify any site from development as a repository. These guidelines were clearly intended to provide not only the framework for the siting program but also the stimulus for establishing effective communication and consultation among the parties involved in the program. The Act further required that the guidelines be a factor in the development of all future decision documents of the Office of Civilian Radioactive Waste Management, including the environmental assessments that would accompany the nomination of sites for characterization, the site-characterization plans that are to be prepared before the sinking of exploratory shafts at any candidate site, and the environmental impact statement that is to support the recommendation of a site for development as a repository. More than two years after its passage, the intention of the Act for the guidelines has been realized. Concurred in by the Nuclear Regulatory Commission on June 22, 1984, and issued by the Department in November 1984, the guidelines include postclosure technical guidelines that apply to conditions governing the long-term performance of the repository system; preclosure technical guidelines that apply to conditions governing the siting, construction, operation, and closure of the repository; and system guidelines whose objective is to ensure that the regulatory requirements of the Environmental Protection Agency and the Nuclear Regulatory Commission are met
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Energy Technology Data Exchange (ETDEWEB)
None
2003-06-27
This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 536: Area 3 Release Site, Nevada Test Site, Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 536 consists of a single Corrective Action Site (CAS): 03-44-02, Steam Jenny Discharge. The CAU 536 site is being investigated because existing information on the nature and extent of possible contamination is insufficient to evaluate and recommend corrective action alternatives for CAS 03-44-02. The additional information will be obtained by conducting a corrective action investigation (CAI) prior to evaluating CAAs and selecting the appropriate corrective action for this CAS. The results of this field investigation are to be used to support a defensible evaluation of corrective action alternatives in the corrective action decision document. Record of Technical Change No. 1 is dated 3-2004.
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Nottingham, Sara; Henning, Jolene
2014-01-01
Context Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). Objective To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Design Qualitative study. Setting One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. Patients or Other Participants A total of 4 ACIs with various experience levels and 4 second-year ATSs. Data Collection and Analysis Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. Results The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Conclusions Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form. PMID:24143902
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CERCLA site assessment workbook
International Nuclear Information System (INIS)
1994-08-01
This contains comments for each chapter of exercises (in Vol. 1) which illustrate how to conduct site assessments for CERCLA regulation. A through analysis of the exercises is provided so that work and solutions from Vol 1 can be critiqued and comments are also included on the strategy of site assessment whereas the exercises illustrate the principles involved. Covered exercises include the following: A preliminary assessment of a ground water site; waste characteristics and characterization of sources; documentation of observed releases and actual contamination of targets; the strategy of an SI at a surface water site; the soil exposure pathway; the air pathway
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Nevada National Security Site Environmental Report 2011 Attachment A: Site Description
International Nuclear Information System (INIS)
Wills, Cathy
2012-01-01
This attachment expands on the general description of the Nevada National Security Site (NNSS) presented in the Introduction to the Nevada National Security Site Environmental Report 2011. Included are subsections that summarize the site's geological, hydrological, climatological, and ecological setting and the cultural resources of the NNSS. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NNSS. An adequate knowledge of the site's environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NNSS. The NNSS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NNSS operations. These key features include the general remote location of the NNSS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Clinical and hormonal aspects of reproductive disorders in women from Semipalatinsk test site region
International Nuclear Information System (INIS)
Mamedalieva, N.M.; Moshcheeva, A.M.; Nauryzbaeva, B.U.
1997-01-01
90 women (62 during pregnancy and 28 out of pregnancy) from different districts of Semipalatinsk region were examined with aims of clinic-hormonal aspects study for reproductive disorders of pregnant from Semipalatinsk test site (STS) region. Age of examined women was within limits 18-40 years old. Patients have from 1 to 4 miscarriage abortions. Particular burdening of somatic, gynaecological and reproductive health of examined women is emphasized. Taking into consideration that among causes of reproductive disorders one of top places takes endocrine disorders the hormone background by content in blood of estradiol, progesterone and thyroid hormones was studied. It was determined, that hormonal disbalance or endocrine deficiency of women from STS during pregnancy and out the time does not guarantee normal course of hesitation process on the very early stages of development. When pregnancy was preserved the hormonal disbalance conducts to disfunction of fete-placental system. High frequency of both the obstetric and the perinatal pathology are caused by mentioned disfunctions
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International Nuclear Information System (INIS)
1993-01-01
In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation
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DEFF Research Database (Denmark)
Henriksen, N A; Meyhoff, C S; Wetterslev, J
2010-01-01
Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant...... diagnosed with SSI and a matched control group (N=46) without SSI according to the CDC criteria after laparotomy. Two blinded experienced surgeons evaluated the hospital records and determined whether patients had CRSSI, based on the following criteria: antibiotic treatment, surgical intervention, prolonged...... hospital stay or referral to an intensive care unit for SSI. The rate of CRSSI was 38 of 54 (70%) in patients with CDC-diagnosed SSI and none in patients without a CDC-diagnosed SSI. Sixty-one percent of the CDC-diagnosed SSIs were superficial, of which 48% were considered clinically relevant...
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Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe
2018-06-01
Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.
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Model for teaching population health and community-based care across diverse clinical experiences.
Van Dyk, Elizabeth J; Valentine-Maher, Sarah K; Tracy, Janet P
2015-02-01
The pillars constructivist model is designed to offer a unifying clinical paradigm to support consistent learning opportunities across diverse configurations of community and public health clinical sites. Thirty-six students and six faculty members participated in a mixed methods evaluation to assess the model after its inaugural semester of implementation. The evaluation methods included a rating scale that measures the model's ability to provide consistent learning opportunities at both population health and direct care sites, a case study to measure student growth within the five conceptual pillars, and a faculty focus group. Results revealed that the model served as an effective means of clinical education to support the use of multiple, small-scale public health sites. Although measurements of student growth within the pillars are inconclusive, the findings suggest efficacy. The authors recommend the continued use of the pillars constructivist model in baccalaureate programs, with further study of the author-designed evaluation tools. Copyright 2015, SLACK Incorporated.
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Raeder, Aggi
1997-01-01
Discussion of ways to promote sites on the World Wide Web focuses on how search engines work and how they retrieve and identify sites. Appropriate Web links for submitting new sites and for Internet marketing are included. (LRW)
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Site specific information in site selection
International Nuclear Information System (INIS)
Aeikaes, T.; Hautojaervi, A.
1998-01-01
The programme for the siting of a deep repository for final disposal of spent nuclear fuel was started already in 1983 and is carried out today by Posiva Oy which continues the work started by Teollisuuden Voima Oy. The programme aims at site selection by the end of the year 2000. The programme has progressed in successive interim stages with defined goals. After an early phase for site identification, five sites were selected in 1987 for preliminary site characterisation. Three of these were selected and judged to be best suited for the more detailed characterisation in 1992. An additional new site was included into the programme based on a separate feasibility study in the beginning of 1997. Since the year 1983 several safety assessments together with technical plans of the facility have been completed. When approaching the site selection the needs for more detailed consideration of the site specific properties in the safety assessment have been increased. The Finnish regulator STUK has published a proposal for general safety requirements for the final disposal of spent nuclear fuel in Finland. This set of requirements has been projected to be used in conjunction of the decision making by the end 2000. Based on the site evaluation all sites can provide a stable environment and there is evidence that the requirements for the longevity of the canister can be fulfilled at each site. In this manner the four candidate sites do not differ too much from each other. The main difference between the sites is in the salinity of the deep groundwater. The significance of differences in the salinity for the long-term safety cannot be defined yet. The differences may contribute to the discussion of the longevity of the bentonite buffer and also to the modelling of the groundwater flow and transport. The use of the geosphere as a transport barrier is basically culminated on the questions about sparse but fast flow routes and 'how bad channeling can be'. To answer these questions
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Christie, Matthew C; Manger, Jules P; Khiyami, Abdulaziz M; Ornan, Afshan A; Wheeler, Karen M; Schenkman, Noah S
2016-01-01
Laparoscopic trocar-site hernias (TSH) are rare, with a reported incidence of 1% or less. The incidence of occult radiographically evident hernias has not been described after robot-assisted urologic surgery. We evaluated the incidence and risk factors of this problem. A single-institution retrospective review of robot-assisted urologic surgery was performed from April 2009 to December 2012. Patients with preoperative and postoperative CT were included for analysis. Imaging was reviewed by two radiologists and one urologist. One hundred four cases were identified, including 60 partial nephrectomy, 38 prostatectomy, and 6 cystectomy. Mean age was 58 years and mean body mass index (BMI) was 29 kg/m(2). The cohort was 77% male. Ten total hernias were identified by CT in 8 patients, 2 of which were clinically evident hernias. Excluding these two hernias, occult port-site hernias were identified radiographically in seven patients. Per-patient incidence of occult TSH was 6.7% (7/104), and per-port incidence was 1.4% (8/564). All hernias were midline and 30% contained bowel. Eight of the 10 occurred at 12 mm sites (p = 0.0065) and 3 of the 10 occurred at extended incisions. Age, gender, BMI, smoking status, diabetes mellitus, immunosuppressive drug therapy, ASA score, procedure, blood loss, prior abdominal surgery, and history of hernia were not significant risk factors. Specimen size >40 g (p = 0.024) and wound infection (p = 0.0052) were significant risk factors. While the incidence of clinically evident port-site hernia remains low in robot-assisted urologic surgery, the incidence of CT-detected occult hernia was 6.7% in this series. These occurred most often in sites extended for specimen extraction and at larger port sites. This suggests more attention should be paid to fascial closure at these sites.
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Quality of clinical trials: A moving target
Bhatt, Arun
2011-01-01
Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122
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Clinical magnetic resonance: imaging and spectroscopy
International Nuclear Information System (INIS)
Andrew, E.R.; Bydder, Graeme; Griffiths, John; Iles, Richard; Styles, Peter
1990-01-01
This book begins with a readable, comprehensive but non-mathematical introduction to the basic underlying principles of magnetic resonance. Further chapters include information on the theory and principles of MRI and MRS, the interpretation of MR images, the clinical applications and scope of MRI and MRS, practical aspects of spectroscopy and magnetic resonance, and also the practical problems associated with the siting, safety and operation of large MRI and MRS equipment. (author)
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Laparoendoscopic single site in pelvic surgery
Sanchez-Salas, Rafael; Clavijo, Rafael; Barret, Eric; Sotelo, Rene
2012-01-01
Laparoendoscopic single site (LESS) has recently gained momentum as feasible techniques for minimal access surgery. Our aim is to describe the current status of laparoendoscopic single site (LESS) in pelvic surgery. A comprehensive revision of the literature in LESS pelvic surgery was performed. References for this manuscript were obtained by performing a review of the available literature in PubMed from 01-01-01 to 30-11-11. References outside the search period were obtained selected manuscript΄s bibliography. Search terms included: pelvic anatomy, less in gynecology, single port colectomy, urological less, single port, single site, NOTES, LESS and single incision. 314 manuscripts were initially identified. Out of these, 46 manuscripts were selected based in their pelvic anatomy or surgical content; including experimental experience, clinical series and literature reviews. LESS drastically limit the surgeon's ability to perform in the operative field and the latter becomes hardened by the lack of space in anatomical location like the pelvis. Potential advantages of LESS are gained with the understanding that the surgical procedure is more technically challenging. Pelvic surgical procedures related to colorectal surgery, gynecology and urology have been performed with LESS technique and information available is mostly represented by case reports and short case series. Comparative series remain few. LESS pelvic surgery remain in its very beginning and due to the very specific anatomical conditions further development of LESS surgery in the mentioned area can be clearly be facilitated by using robotic technology. Standardization ad reproducibility of techniques are mandatory to further develop LESS in the surgical arena.. PMID:22557719
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Laparoendoscopic single site in pelvic surgery
Directory of Open Access Journals (Sweden)
Rafael Sanchez-Salas
2012-01-01
Full Text Available Laparoendoscopic single site (LESS has recently gained momentum as feasible techniques for minimal access surgery. Our aim is to describe the current status of laparoendoscopic single site (LESS in pelvic surgery. A comprehensive revision of the literature in LESS pelvic surgery was performed. References for this manuscript were obtained by performing a review of the available literature in PubMed from 01-01-01 to 30-11-11. References outside the search period were obtained selected manuscript΄s bibliography. Search terms included: pelvic anatomy, less in gynecology, single port colectomy, urological less, single port, single site, NOTES, LESS and single incision. 314 manuscripts were initially identified. Out of these, 46 manuscripts were selected based in their pelvic anatomy or surgical content; including experimental experience, clinical series and literature reviews. LESS drastically limit the surgeon′s ability to perform in the operative field and the latter becomes hardened by the lack of space in anatomical location like the pelvis. Potential advantages of LESS are gained with the understanding that the surgical procedure is more technically challenging. Pelvic surgical procedures related to colorectal surgery, gynecology and urology have been performed with LESS technique and information available is mostly represented by case reports and short case series. Comparative series remain few. LESS pelvic surgery remain in its very beginning and due to the very specific anatomical conditions further development of LESS surgery in the mentioned area can be clearly be facilitated by using robotic technology. Standardization ad reproducibility of techniques are mandatory to further develop LESS in the surgical arena..
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Nakayama, Akiyoshi; Nakaoka, Hirofumi; Yamamoto, Ken; Sakiyama, Masayuki; Shaukat, Amara; Toyoda, Yu; Okada, Yukinori; Kamatani, Yoichiro; Nakamura, Takahiro; Takada, Tappei; Inoue, Katsuhisa; Yasujima, Tomoya; Yuasa, Hiroaki; Shirahama, Yuko; Nakashima, Hiroshi; Shimizu, Seiko; Higashino, Toshihide; Kawamura, Yusuke; Ogata, Hiraku; Kawaguchi, Makoto; Ohkawa, Yasuyuki; Danjoh, Inaho; Tokumasu, Atsumi; Ooyama, Keiko; Ito, Toshimitsu; Kondo, Takaaki; Wakai, Kenji; Stiburkova, Blanka; Pavelka, Karel; Stamp, Lisa K; Dalbeth, Nicola; Sakurai, Yutaka; Suzuki, Hiroshi; Hosoyamada, Makoto; Fujimori, Shin; Yokoo, Takashi; Hosoya, Tatsuo; Inoue, Ituro; Takahashi, Atsushi; Kubo, Michiaki; Ooyama, Hiroshi; Shimizu, Toru; Ichida, Kimiyoshi; Shinomiya, Nariyoshi; Merriman, Tony R; Matsuo, Hirotaka
2017-05-01
A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were replicated with 1396 cases and 1268 controls using a custom chip of 1961 single nucleotide polymorphisms (SNPs). We also first conducted GWASs of gout subtypes. Replication with Caucasian and New Zealand Polynesian samples was done to further validate the loci identified in this study. In addition to the five loci we reported previously, further susceptibility loci were identified at a genome-wide significance level (pgout cases, and NIPAL1 and FAM35A for the renal underexcretion gout subtype. While NIPAL1 encodes a magnesium transporter, functional analysis did not detect urate transport via NIPAL1, suggesting an indirect association with urate handling. Localisation analysis in the human kidney revealed expression of NIPAL1 and FAM35A mainly in the distal tubules, which suggests the involvement of the distal nephron in urate handling in humans. Clinically ascertained male patients with gout and controls of Caucasian and Polynesian ancestries were also genotyped, and FAM35A was associated with gout in all cases. A meta-analysis of the three populations revealed FAM35A to be associated with gout at a genome-wide level of significance (p meta =3.58×10 -8 ). Our findings including novel gout risk loci provide further understanding of the molecular pathogenesis of gout and lead to a novel concept for the therapeutic target of gout/hyperuricaemia. 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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Kirkman, Matthew A; Pickles, Jessica C; Fairchild, Amy R; Avery, Aimee; Pietsch, Torsten; Jacques, Thomas S; Aquilina, Kristian
2018-05-30
Advances in molecular profiling have facilitated the emergence of newly defined entities of central nervous system tumor, including CNS high-grade neuroepithelial tumor with BCOR alteration (CNS HGNET-BCOR). Relatively little is known about the clinical behaviour of these newly-characterized tumors. We describe a pediatric male patient with CNS HGNET-BCOR who developed seeding of the tumor into the site of the surgical wound within months of surgery for resection of a residual posterior fossa tumor. This case emphasises three important points. First, CNS HGNET-BCOR can be aggressive tumors that necessitate close clinical and radiological surveillance. Second, surveillance imaging in such cases should incorporate the surgical incision site into the field of view, and this should be closely scrutinised to ensure the timely detection of wound site seeding. Third, wound site seeding may still occur despite the use of meticulous surgical techniques. Copyright © 2018. Published by Elsevier Inc.
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Stacchi, Claudio; Vercellotti, Tomaso; Torelli, Lucio; Furlan, Fabio; Di Lenarda, Roberto
2013-04-01
The objective of the present investigation was to longitudinally monitor stability changes of implants inserted using traditional rotary instruments or piezoelectric inserts, and to follow their variations during the first 90 days of healing. A randomized, controlled trial was conducted on 20 patients. Each patient received two identical, adjacent implants in the upper premolar area: the test site was prepared with piezosurgery, and the control site was prepared using twist drills. Resonance frequency analysis measurements were taken by a blinded operator on the day of surgery and after 7, 14, 21, 28, 42, 56, and 90 days. At 90 days, 39 out of 40 implants were osseointegrated (one failure in the control group). Both groups showed an initial decrease in mean implant stability quotient (ISQ) values: a shift in implant stability to increasing ISQ values occurred after 14 days in the test group and after 21 days in the control group. The lowest mean ISQ value was recorded at 14 days for test implants (97.3% of the primary stability) and at 21 days for the control implants (90.8% of the primary stability). ISQ variations with respect to primary stability differed significantly between the two groups during the entire period of observation: from day 14 to day 42, in particular, the differences were extremely significant (p < .0001). All 39 implants were in function successfully at the visit scheduled 1 year after insertion. The findings from this study suggest that ultrasonic implant site preparation results in a limited decrease of ISQ values and in an earlier shifting from a decreasing to an increasing stability pattern, when compared with the traditional drilling technique. From a clinical point of view, implants inserted with the piezoelectric technique demonstrated a short-term clinical success similar to those inserted using twist drills. © 2011 Wiley Periodicals, Inc.
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Searching your site`s management information systems
Energy Technology Data Exchange (ETDEWEB)
Marquez, W.; Rollin, C. [S.M. Stoller Corp., Boulder, CO (United States)
1994-12-31
The Department of Energy`s guidelines for the Baseline Environmental Management Report (BEMR) encourage the use of existing data when compiling information. Specific systems mentioned include the Progress Tracking System, the Mixed-Waste Inventory Report, the Waste Management Information System, DOE 4700.1-related systems, Programmatic Environmental Impact Statement (PEIS) data, and existing Work Breakdown Structures. In addition to these DOE-Headquarters tracking and reporting systems, there are a number of site systems that will be relied upon to produce the BEMR, including: (1) site management control and cost tracking systems; (2) commitment/issues tracking systems; (3) program-specific internal tracking systems; (4) Site material/equipment inventory systems. New requirements have often prompted the creation of new, customized tracking systems. This is a very time and money consuming process. As the BEMR Management Plan emphasizes, an effort should be made to use the information in existing tracking systems. Because of the wealth of information currently available from in-place systems, development of a new tracking system should be a last resort.
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DEFF Research Database (Denmark)
Danielsen, P.; Jorgensen, B.; Jorgensen, L.N.
2008-01-01
BACKGROUND: Autologous platelet-rich fibrin contains multiple growth factors. The aim of this randomized clinical trial was to study the effect of topical platelet-rich fibrin on epithelialization of donor sites and meshed split-thickness skin autografts. METHODS: Twenty consecutive leg ulcer pat...
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Nevada National Security Site Environmental Report 2011 Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Cathy Wills, ed.
2012-09-12
This attachment expands on the general description of the Nevada National Security Site (NNSS) presented in the Introduction to the Nevada National Security Site Environmental Report 2011. Included are subsections that summarize the site's geological, hydrological, climatological, and ecological setting and the cultural resources of the NNSS. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NNSS. An adequate knowledge of the site's environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NNSS. The NNSS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NNSS operations. These key features include the general remote location of the NNSS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Ayat-Isfahani, Farah; Pashang, Mina; Davoudi, Bita; Sadeghian, Saeed; Jalali, Arash
2017-03-01
Intravenous amiodarone is considered an effective treatment option for cardiac ventricular and atrial arrhythmias. Peripheral infusion of amiodarone may cause blood vessels irritation and phlebitis that is the most common complication of this drug by this route even when it is administered within recommended dosing limits. The effect of injection-site splinting on the occurrence of phlebitis among a group of cardiac arrhythmia patients receiving peripherally infused amiodarone. This research is a clinical trial on patients of Tehran Heart Center who were hospitalized due to cardiac arrhythmias. A sample of 60 patients with mean age 65 ± 14 years were randomly divided into control and test groups. In the experimental group with close splint and restrict the movement of the injection site until the end of the infusion and control groups without closing brace, at the same time received amiodarone. Injection protocol was similar for both groups. The results were analyzed with Spss18. The results of this research still significantly reduced the incidence of amiodarone injection-site phlebitis in the injection time (P = .005). Copyright © 2016 Society for Vascular Nursing, Inc. Published by Elsevier Inc. All rights reserved.
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Changes in information behavior in clinical teams after introduction of a clinical librarian service
Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean
2007-01-01
Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062
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2012-04-02
... Logistics, Eurest, Canteen, Kelly Services, Inc., Prodriver, Arkansas Warehouse, Inc., Andrews International... information shows that workers leased from Andrews International employed on-site at the Fort Smith, Arkansas...) tax account under the name U.S. Security. Accordingly, the Department is amending this certification...
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Individual-level outcomes from a national clinical leadership development programme.
Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina
2013-08-01
A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context.
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Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B
2018-03-01
The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.
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Angelo Troedhan; Izabela Schlichting; Andreas Kurrek; Marcel Wainwright
2014-01-01
Implant-Insertion-Torque-Value (ITV) proved to be a significant clinical parameter to predict long term implant success-rates and to decide upon immediate loading. The study evaluated ITVs, when four different and commonly used biomaterials were used in sinuslift-procedures compared to natural subantral bone in two-stage-implant-procedures. The tHUCSL-INTRALIFT-method was chosen for sinuslifting in 155 sinuslift-sites for its minimal invasive transcrestal approach and scalable augmentation vo...
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Nevada Test Site Environmental Report 2009, Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Cathy Wills, ed.
2010-09-13
This attachment expands on the general description of the Nevada Test Site (NTS) presented in the Introduction to the Nevada Test Site Environmental Report 2009. Included are subsections that summarize the site’s geological, hydrological, climatological, and ecological setting. The cultural resources of the NTS are also presented. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NTS. An adequate knowledge of the site’s environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NTS. The NTS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NTS operations. These key features include the general remote location of the NTS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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2010-05-20
... workers were sufficiently under the control of the subject firm to be considered leased workers. Based on... On-Site Leased Workers From Kelly Services, Summerton, SC; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974...
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2012-04-02
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-81,038] Ford Motor Company Twin... February 9, 2012, applicable to workers of Ford Motor Company, Twin Cities Assembly Plant, Vehicle..., and Pacer International were employed on-site at the St. Paul, Minnesota location of Ford Motor...
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Energy Technology Data Exchange (ETDEWEB)
1993-03-24
In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation.
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International Nuclear Information System (INIS)
Bruner, Deborah Watkins; Pugh, Stephanie L.; Yeager, Katherine A.; Bruner, Jesse; Curran, Walter
2015-01-01
Purpose: To assess how accrual to clinical trials is related to US minority population density relative to clinical trial site location and distance traveled to Radiation Therapy Oncology Group (RTOG) clinical trial sites. Methods and Materials: Data included member site address and ZIP codes, patient accrual, and patient race or ethnicity and ZIP code. Geographic Information System maps were developed for overall, Latino, and African American accrual to trials by population density. The Kruskal-Wallis test was used to assess differences in distance traveled by site, type of trial, and race or ethnicity. Results: From 2006 to 2009, 6168 patients enrolled on RTOG trials. The RTOG US site distribution is generally concordant with overall population density. Sites with highest accrual are located throughout the United States and parts of Canada and do not cluster, nor does highest minority accrual cluster in areas of highest US minority population density. Of the 4913 US patients with complete data, patients traveled a median of 11.6 miles to participate in clinical trials. Whites traveled statistically longer distances (12.9 miles; P<.0001) to participate, followed by Latinos (8.22 miles) and African Americans (5.85 miles). Patients were willing to drive longer distances to academic sites than community sites, and there was a trend toward significantly longer median travel for therapeutic versus cancer control or metastatic trials. Conclusions: Location matters, but only to a degree, for minority compared with nonminority participation in clinical trials. Geographic Information System tools help identify gaps in geographic access and travel burden for clinical trials participation. Strategies that emerged using these tools are discussed.
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Bruner, Deborah Watkins; Pugh, Stephanie L.; Yeager, Katherine A.; Bruner, Jesse; Curran, Walter
2015-01-01
Purpose To assess how accrual to clinical trials is related to U.S. minority population density relative to clinical trial site location and distance traveled to Radiation Therapy Oncology Group (RTOG) clinical trials sites. Methods Data included member site address and zip codes, patient accrual, and patient race/ethnicity and zip code. Geographic Information System (GIS) maps were developed for overall, Latino and African American accrual to trials by population density. The Kruskal-Wallis test was used to assess differences in distance traveled by site, type of trial and race/ethnicity. Results From 2006–2009, 6168 patients enrolled on RTOG trials. RTOG U.S. site distribution is generally concordant with overall population density. Sites with highest accrual are located throughout the U.S. and parts of Canada and do not cluster, nor does highest minority accrual cluster in areas of highest U.S. minority population density. Of the 4913 U.S. patients with complete data, patients traveled a median of 11.6 miles to participate in clinical trials. Whites traveled statistically longer distances (12.9 miles; p<0.0001) to participate followed by Latinos (8.22 miles), and African Americans (5.85 miles). Patients were willing to drive longer distances to academic sites than community sites and there was a trend toward significantly longer median travel for therapeutic vs cancer control or metastatic trials. Conclusions Location matters, but only to a degree, for minority compared to non-minority participation in clinical trials. GIS tools help identify gaps in geographic access and travel burden for clinical trials participation. Strategies that emerged using these tools are discussed. PMID:26281827
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Energy Technology Data Exchange (ETDEWEB)
Bruner, Deborah Watkins, E-mail: deborah.w.bruner@emory.edu [Emory University, Atlanta, Georgia (United States); Pugh, Stephanie L. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Yeager, Katherine A.; Bruner, Jesse; Curran, Walter [Emory University, Atlanta, Georgia (United States)
2015-11-01
Purpose: To assess how accrual to clinical trials is related to US minority population density relative to clinical trial site location and distance traveled to Radiation Therapy Oncology Group (RTOG) clinical trial sites. Methods and Materials: Data included member site address and ZIP codes, patient accrual, and patient race or ethnicity and ZIP code. Geographic Information System maps were developed for overall, Latino, and African American accrual to trials by population density. The Kruskal-Wallis test was used to assess differences in distance traveled by site, type of trial, and race or ethnicity. Results: From 2006 to 2009, 6168 patients enrolled on RTOG trials. The RTOG US site distribution is generally concordant with overall population density. Sites with highest accrual are located throughout the United States and parts of Canada and do not cluster, nor does highest minority accrual cluster in areas of highest US minority population density. Of the 4913 US patients with complete data, patients traveled a median of 11.6 miles to participate in clinical trials. Whites traveled statistically longer distances (12.9 miles; P<.0001) to participate, followed by Latinos (8.22 miles) and African Americans (5.85 miles). Patients were willing to drive longer distances to academic sites than community sites, and there was a trend toward significantly longer median travel for therapeutic versus cancer control or metastatic trials. Conclusions: Location matters, but only to a degree, for minority compared with nonminority participation in clinical trials. Geographic Information System tools help identify gaps in geographic access and travel burden for clinical trials participation. Strategies that emerged using these tools are discussed.
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Bruner, Deborah Watkins; Pugh, Stephanie L; Yeager, Katherine A; Bruner, Jesse; Curran, Walter
2015-11-01
To assess how accrual to clinical trials is related to US minority population density relative to clinical trial site location and distance traveled to Radiation Therapy Oncology Group (RTOG) clinical trial sites. Data included member site address and ZIP codes, patient accrual, and patient race or ethnicity and ZIP code. Geographic Information System maps were developed for overall, Latino, and African American accrual to trials by population density. The Kruskal-Wallis test was used to assess differences in distance traveled by site, type of trial, and race or ethnicity. From 2006 to 2009, 6168 patients enrolled on RTOG trials. The RTOG US site distribution is generally concordant with overall population density. Sites with highest accrual are located throughout the United States and parts of Canada and do not cluster, nor does highest minority accrual cluster in areas of highest US minority population density. Of the 4913 US patients with complete data, patients traveled a median of 11.6 miles to participate in clinical trials. Whites traveled statistically longer distances (12.9 miles; P<.0001) to participate, followed by Latinos (8.22 miles) and African Americans (5.85 miles). Patients were willing to drive longer distances to academic sites than community sites, and there was a trend toward significantly longer median travel for therapeutic versus cancer control or metastatic trials. Location matters, but only to a degree, for minority compared with nonminority participation in clinical trials. Geographic Information System tools help identify gaps in geographic access and travel burden for clinical trials participation. Strategies that emerged using these tools are discussed. Copyright © 2015 Elsevier Inc. All rights reserved.
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DEFF Research Database (Denmark)
Smed, Marie; Schultz, Carsten; Getz, Kenneth A.
2015-01-01
The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lacks......’ information transfer ability, their methods of communicating, are included. The model is studied on a unique dataset of 395 medical site representatives by applying Rasch scale modeling to differentiate the stickiness of the heterogenic information issues. The results reveal that economic measures...... a differentiated perspective on the potential for information transfer from site to producer. An exploration of the variation in stickiness of information, and therefore the complexity of information transfer in clinical trials, is the main aim of this study. To further enrich the model of the dispersed sites...
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Directory of Open Access Journals (Sweden)
Marta Gehring
2014-11-01
Full Text Available BackgroundItaly is Europe’s third largest pharmaceutical market, yet it ranks only ninth in the number of NIH-registered clinical trials per capita. The aim of our study was to explore stakeholders’ perception of Italy as place to undertake clinical trials, and to estimate the potential economic impact of selected reforms in terms of incremental trial activity.MethodsThe Survey of Attitudes towards Trials in Europe (SAT-EU Study was an anonymous, web-based survey which systematically assessed factors impacting clinical trial site selection in Europe. Estimates of Italian economic impact were developed in collaboration with AICRO (Association of Italian Contract Research Organisations.ResultsResponses were obtained from 485 professionals in 34 countries (15% residing in Italy representing over 100 institutions, spanning BioPharma Clinical Research Organizations (CROs, and Academic Clinical Trial Units (CTUs. Italy ranked tenth of twelve in terms of accessibility and transparency of information required to run clinical trials, and last with respect to predictability and speed of Ethics Committees. Costs of running clinical trials were not considered critical, whereas, fragmented and slow approval process was. Streamlined centralized trial authorization would translate into an estimated 1.1 billion Euros of incremental trial investments over three years. ConclusionsClinical trial professionals consider Italy’s governance of clinical research suboptimal, among the worst in Europe, and indicate that much could be done to make Italy more attractive for clinical trial investments. The present study also provides evidence about stakeholders’ willingness to invest in trials and its economic consequences provided effective reforms are put in place.
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Kazis, Lewis E; Sheridan, Robert L; Shapiro, Gabriel D; Lee, Austin F; Liang, Matthew H; Ryan, Colleen M; Schneider, Jeffrey C; Lydon, Martha; Soley-Bori, Marina; Sonis, Lily A; Dore, Emily C; Palmieri, Tina; Herndon, David; Meyer, Walter; Warner, Petra; Kagan, Richard; Stoddard, Frederick J; Murphy, Michael; Tompkins, Ronald G
2018-04-01
There has been little systematic examination of variation in pediatric burn care clinical practices and its effect on outcomes. As a first step, current clinical care processes need to be operationally defined. The highly specialized burn care units of the Shriners Hospitals for Children system present an opportunity to describe the processes of care. The aim of this study was to develop a set of process-based measures for pediatric burn care and examine adherence to them by providers in a cohort of pediatric burn patients. We conducted a systematic literature review to compile a set of process-based indicators. These measures were refined by an expert panel of burn care providers, yielding 36 process-based indicators in four clinical areas: initial evaluation and resuscitation, acute excisional surgery and critical care, psychosocial and pain control, and reconstruction and aftercare. We assessed variability in adherence to the indicators in a cohort of 1,076 children with burns at four regional pediatric burn programs in the Shriners Hospital system. The percentages of the cohort at each of the four sites were as follows: Boston, 20.8%; Cincinnati, 21.1%; Galveston, 36.0%; and Sacramento, 22.1%. The cohort included children who received care between 2006 and 2010. Adherence to the process indicators varied both across sites and by clinical area. Adherence was lowest for the clinical areas of acute excisional surgery and critical care, with a range of 35% to 48% across sites, followed by initial evaluation and resuscitation (range, 34%-60%). In contrast, the clinical areas of psychosocial and pain control and reconstruction and aftercare had relatively high adherence across sites, with ranges of 62% to 93% and 71% to 87%, respectively. Of the 36 process indicators, 89% differed significantly in adherence between clinical sites (p measures represents an important step in the assessment of clinical practice in pediatric burn care. Substantial variation was observed
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Evaluation of Amniotic Membrane Effectiveness in Skin Graft Donor Site Dressing in Burn Patients.
Salehi, Seyed Hamid; As'adi, Kamran; Mousavi, Seyed Jaber; Shoar, Saeed
2015-12-01
Although the recipient site in burn wounds is dressed with universally accepted materials, the ideal management of split-thickness skin donor sites remains controversial. The aim of our study is to compare two methods of wound dressing in donor sites of split-thickness skin graft in patients undergoing burn wound reconstructive surgery. Forty-two consecutive patients with second- and third-degree burns with a total body surface area between 20 and 40 % were enrolled in this randomized clinical trial conducted in Motahari Burn Hospital in Tehran, Iran. In each patient, two anatomic areas with similar features were randomly selected as intervention and control donor sites. The intervention site was dressed with amniotic membrane, whereas the control site was treated with Vaseline-impregnated gauze. Wounds were examined daily by expert surgeons to measure the clinical outcomes including duration of healing, severity of pain, and infection rate. The mean ± SD age of patients was 31.17 ± 13.72 years; furthermore, burn percentage had a mean ± SD of 31.19 ± 10.56. The mean ± SD of patients' cooperation score was 1.6 ± 0.79 in the intervention group compared with 2.93 ± 0.71 in the control group, revealing a statistically significant difference (P 0.05). Amniotic membrane as an alternative for dressing of skin graft donor sites provides significant benefits by increasing patients' comfort via diminishing the number of dressing changes and facilitating the process of wound healing.
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Feedback from performance assessment to site characterisation. The SITE-94 example
International Nuclear Information System (INIS)
Dverstorp, B.; Geier, J.
1999-01-01
Interaction and information exchange between site characterisation and performance assessment are key features of any successful radioactive waste management programme. Some examples are presented of the types of feedback that can be offered from performance assessment to site characterisation, based on SKI's most recent performance assessment project, SITE-94. SITE-94 in Sweden was an assessment of a hypothetical repository for spent nuclear fuel, based on real data gathered in the surface-based investigation of the Aespoe Hard Rock Laboratory site. Examples of feedback are given concerning quality control of data and site investigation procedures, identification of key parameters for the performance assessment, use of models for planning and evaluation of a site investigation, data sampling strategies, and guidance on future priorities for further development of site investigation methods. Because site characterisation serves multiple purposes, including provision of data for repository design and construction, it must account for and compromise among requirements from several lines of analyses in the performance assessment. (author)
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International Nuclear Information System (INIS)
Anon.
1978-01-01
This standard presents guidelines for evaluating site-related geotechnical parameters for nuclear power sites. Aspects considered include geology, ground water, foundation engineering, and earthwork engineering. These guidelines identify the basic geotechnical parameters to be considered in site evaluation, and in the design, construction, and performance of foundations and earthwork aspects for nuclear power plants. Also included are tabulations of typical field and laboratory investigative methods useful in identifying geotechnical parameters. Those areas where interrelationships with other standards may exist are indicated
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Single versus Two-Site Phacoemulsification and Mitomycin-C Trabeculectomy
Directory of Open Access Journals (Sweden)
Alireza Baradaran-Rafiee
2008-11-01
Full Text Available
PURPOSE: To compare the outcomes of single-site versus two-site mitomycin-C (MMC augmented phacotrabeculectomy. METHODS: This matched randomized clinical trial included 34 eyes of 30 patients with visually significant cataracts and poorly controlled glaucoma. Equal numbers of eyes were randomly assigned to the single-site and two-site groups. In the single-site approach, phacoemulsification was performed under a superior scleral tunnel followed by trabeculectomy. The two-site approach included a temporal clear corneal phaco-emulsification combined with a separate superior trabeculectomy. MMC 0.2 mg/ml was similarly applied for one minute in both groups. RESULTS: Patients were followed for a mean period of 13±1.4 (range, 12 to 15 months. Mean best corrected visual acuity one year after surgery was 0.6±0.4 LogMAR in the single-site group and 0.4±0.28 LogMAR in the two-site group (P=0.12. In the single-site group, mean preoperative intraocular pressure (IOP was 26.4±6.6 mmHg which was decreased to 14.8±2.5 mmHg, one year after the operation (P < 0.001. Corresponding figures for the two-site group were 22.9±3.3 and 13.6±1.7 mmHg respectively (P < 0.001. At final follow up no significant difference in IOP existed between the study groups. Mean number of anti-glaucoma medications was 0.06±0.24 in the two-site group vs 0
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Directory of Open Access Journals (Sweden)
Komal Puri
2013-01-01
Full Text Available Background: The aim of the present study was to evaluate and compare the clinical and microbiological effectiveness of Periochip TM as an adjunct to scaling and root planing (SRP with SRP alone in patients with chronic periodontitis. Materials and Methods: This randomized, split mouth, 3-month clinical and microbiological trial included 30 sites in 15 patients aged 30-50 years diagnosed with chronic periodontitis. In each patient, two bilateral pockets probing 5-7 mm were randomly assigned to test and control groups. The test group received SRP plus Periochip TM , whereas the control group received SRP alone. Clinical indices and anaerobic culture analysis was done at baseline, 1 month, and 3 months interval. Total bacterial count and analysis of four major periodontopathogenic bacteria Porphyromonas gingivalis (Pg, Prevotella intermedia (Pi, Aggregatibacter actinomycetemcomitans (Aa, and Fusobacterium nucleatum (Fn was done. Results: Significant improvement was obtained in all clinical variables in the test group as compared to the control group over the study period. Total colony counts were significantly reduced in the test group as compared to control over the period of time. At baseline Aa was recovered from 4 test group sites and 5 control group sites, Pg from 15 test group and 14 control group sites, Pi from 5 test group and 2 control group sites, Fn from 7 test and 7 control group sites. At 3 months, Aa was recovered from 1 test group and 4 control group sites, Pg from 4 test group and 8 control group sites, Pi from 1 test group and 1 control group site, Fn from 3 test and 4 control group sites. Conclusion: Periochip TM placement as an adjunct to SRP, showed promising results, when compared to SRP alone. Healthy microflora can be maintained for a longer period of time and delay in the repopulation by periodontopathic microorganisms was observed.
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Quality of clinical trials: A moving target
Directory of Open Access Journals (Sweden)
Arun Bhatt
2011-01-01
Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.
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Nevada Test Site Environmental Report 2008 Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Cathy A. Wills
2009-09-01
This attachment expands on the general description of the Nevada Test Site (NTS) presented in the Introduction to the Nevada Test Site Environmental Report 2008 (National Security Technologies, LLC [NSTec], 2009a). Included are subsections that summarize the site’s geological, hydrological, climatological, and ecological setting. The cultural resources of the NTS are also presented. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NTS. An adequate knowledge of the site’s environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NTS. The NTS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NTS operations. These key features include the general remote location of the NTS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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General aspects of siting and safety considerations
International Nuclear Information System (INIS)
Rutgers, E.
1980-01-01
The siting process from site selection to the different stages of review by the regulatory body is described. Special attention is payed to the role and responsibilities of the licensing authority. Next, the basic considerations involved in the siting process are reviewed. They include system planning, engineering, safety, environmental impact (including land use) and economics. Case studies illustrating different aspects of the siting process (e.g. site selection) are presented. (orig.)
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Directory of Open Access Journals (Sweden)
Rochira Vincenzo
2012-01-01
Full Text Available Abstract Introduction Pegvisomant-related lipohypertrophy may revert when changing the site of injection, but the lipohypertrophy may recur at the new site of injection. The strength of evidence, however, is weak and comes from information obtained from physical examination only. Case presentation We studied two Caucasian women with acromegaly, aged 51 and 71 years, with pegvisomant-related lipohypertrophy. Our two patients were evaluated at baseline, when the site of pegvisomant injection was the periumbilical abdominal region, and then four months after switching the injection site from the abdomen to both thighs. Both physical examination and radiological studies (magnetic resonance imaging and dual energy X-ray absorptiometry demonstrated that the abdominal lipohypertrophy progressively reverted in both patients after switching the site of injection to the thighs. However, lipohypertrophy reappeared at the new site of injection. The radiological outcome confirmed the reversibility of pegvisomant-related lipohypertrophy and strengthened the body of evidence on this issue. Conclusion In clinical practice, physical examination of the injection site or sites leads to an early detection of lipohypertrophy during pegvisomant treatment. Radiological procedures may be of help to confirm subcutaneous fat changes and for a precise monitoring of fat redistribution. Patients should get appropriate information about lipohypertrophy before starting pegvisomant treatment since the rotation of the site of injection may prevent lipohypertrophy.
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Allegheny County Illegal Dump Sites
Allegheny County / City of Pittsburgh / Western PA Regional Data Center — The Illegal Dump Site dataset includes information on illegal dump sites, their type of trash, and the estimate tons of trash at each site. The information was...
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Liu, B; Hao, X; Goan, M
2000-05-01
To investigate the blood supply patterns and the clinical liability of a leg flap pedicle-included with cutaneous nerve and its concomitant vessels. Fresh cadaver legs with thirty-two in infants and two in adults were anatomically examined after the intravenous injection of the red Chlorinated Poly Vingl Choride (CPVC). Five patients with the soft tissue defects were selected for the treatment with the flap pedicle-included with the cutaneous nerve and its concomitant vessels. Four main cutaneous nerves were found in the leg after they perforated the deep fascia out. They were companioned with their concomitant vessels with different blood-supply pateeerns, which the upper part of the leg was in an axial pattern and the lower part was in a "chain-type anastomosing" pattern. Following the above-mentioned findings, five cases were successfully treated with this led flap. The leg flap should be designed along the cutaneous nerve and its concomitant vessels. When the flap is applied in the area of blood supply with "chain-type anastomosing" pattern, the deep fascia should also be included in the flap.
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2000-06-23
CDC-funded human immunodeficiency virus (HIV) counseling, testing, and referral sites are an integral part of national HIV prevention efforts (1). Voluntary counseling, testing, and referral opportunities are offered to persons at risk for HIV infection at approximately 11,000 sites, including dedicated HIV counseling and testing sites, sexually transmitted disease (STD) clinics, drug-treatment centers, hospitals, and prisons. Services also are offered to women in family planning and prenatal/obstetric clinics to increase HIV prevention efforts among women and decrease the risk for perinatal HIV transmission. To increase use of HIV counseling, testing, and referral services by those at risk for HIV infection, in 1995, the National Association of People with AIDS designated June 27 each year as National HIV Testing Day. This report compares use of CDC-funded counseling, testing, and referral services the week before and the week of June 27 from 1994 through 1998 and documents the importance of a national public health campaign designed to increase knowledge of HIV serostatus.
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Clinical EPR: Unique Opportunities and Some Challenges
Swartz, Harold M.; Williams, Benjamin B.; Zaki, Bassem I.; Hartford, Alan C.; Jarvis, Lesley A.; Chen, Eunice; Comi, Richard J.; Ernstoff, Marc S.; Hou, Huagang; Khan, Nadeem; Swarts, Steven G.; Flood, Ann B.; Kuppusamy, Periannan
2014-01-01
Electron paramagnetic resonance (EPR) spectroscopy has been well established as a viable technique for measurement of free radicals and oxygen in biological systems, from in vitro cellular systems to in vivo small animal models of disease. However, the use of EPR in human subjects in the clinical setting, although attractive for a variety of important applications such as oxygen measurement, is challenged with several factors including the need for instrumentation customized for human subjects, probe and regulatory constraints. This paper describes the rationale and development of the first clinical EPR systems for two important clinical applications, namely, measurement of tissue oxygen (oximetry), and radiation dose (dosimetry) in humans. The clinical spectrometers operate at 1.2 GHz frequency and use surface loop resonators capable of providing topical measurements up to 1 cm depth in tissues. Tissue pO2 measurements can be carried out noninvasively and repeatedly after placement of an oxygen-sensitive paramagnetic material (currently India ink) at the site of interest. Our EPR dosimetry system is capable of measuring radiation-induced free radicals in the tooth of irradiated human subjects to determine the exposure dose. These developments offer potential opportunities for clinical dosimetry and oximetry, which include guiding therapy for individual patients with tumors or vascular disease, by monitoring of tissue oxygenation. Further work is in progress to translate this unique technology to routine clinical practice. PMID:24439333
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Should clinical case definitions of influenza in hospitalized older adults include fever?
Falsey, Ann R; Baran, Andrea; Walsh, Edward E
2015-08-01
Influenza is a major cause of morbidity and mortality in elderly persons. Fever is included in all standard definitions of influenza-like illness (ILI), yet older patients may have diminished febrile response to infection. Therefore, we examined the utility of various thresholds to define fever for case definitions of influenza in persons ≥ 65 years of age. Data from two prospective surveillance studies for respiratory viral infection in adults hospitalized with acute cardiopulmonary illnesses with or without fever were examined. The highest temperature reported prior to admission or measured during the first 24 h after admission was recorded. The diagnosis of influenza was made by a combination of viral culture, reverse-transcription polymerase chain reaction, antigen testing, and serology. A total of 2410 subjects (66% ≥ 65 years of age) were enrolled; 281 had influenza (261 influenza A, 19 influenza B, and one mixed influenza A and B). The commonly used definition of ILI (fever ≥ 37·8°C and cough) resulted in 57% sensitivity and 71% specificity in older adults. Receiver operating characteristic curves examining the various temperature thresholds combined with cough and/or sore throat showed the optimal balance between sensitivity and specificity to be 37·9°C (AUC 0·71) and 37·3°C (AUC 0·66), in younger and older persons, respectively. Clinical decision rules using the presence of cough and fever may be helpful when screening for influenza or empiric antiviral treatment when rapid influenza testing is not available; however, lower fever thresholds may be considered for elderly subjects. © 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.
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Closure Report for Corrective Action Unit 537: Waste Sites, Nevada Test Site, Nevada
International Nuclear Information System (INIS)
NSTec Environmental Restoration
2007-01-01
Corrective Action Unit (CAU) 537 is identified in the ''Federal Facility Agreement and Consent Order'' (FFACO) of 1996 as Waste Sites. CAU 537 is located in Areas 3 and 19 of the Nevada Test Site, approximately 65 miles northwest of Las Vegas, Nevada, and consists of the following two Corrective Action Sites (CASs): CAS 03-23-06, Bucket; Yellow Tagged Bags; and CAS 19-19-01, Trash Pit. CAU 537 closure activities were conducted in April 2007 according to the FFACO and Revision 3 of the Sectored Clean-up Work Plan for Housekeeping Category Waste Sites (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2003). At CAS 03-23-06, closure activities included removal and disposal of a 15-foot (ft) by 15-ft by 8-ft tall wooden shed containing wood and metal debris and a 5-gallon plastic bucket containing deteriorated plastic bags with yellow radioactive contamination tape. The debris was transported to the Area 9 U10c Landfill for disposal after being screened for radiological contamination according to the ''NV/YMP Radiological Control Manual'' (NNSA/NSO, 2004). At CAS 19-19-01, closure activities included segregation, removal, and disposal of non-friable, non-regulated asbestos-containing material (ACM) and construction debris. The ACM was determined to be non-friable by waste characterization samples collected prior to closure activities. The ACM was removed and double-bagged by licensed, trained asbestos workers and transported to the Area 9 U10c Landfill for disposal. Construction debris was transported in end-dump trucks to the Area 9 U10c Landfill for disposal. Closure activities generated sanitary waste/construction debris and ACM. Waste generated during closure activities was appropriately managed and disposed. Waste characterization sample results are included as Appendix A of this report, and waste disposition documentation is included as Appendix B of this report. Copies of the Sectored Housekeeping Site Closure
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Jeong, Sohyun; Sohn, Minji; Kim, Jae Hyun; Ko, Minoh; Seo, Hee-Won; Song, Yun-Kyoung; Choi, Boyoon; Han, Nayoung; Na, Han-Sung; Lee, Jong Gu; Kim, In-Wha; Oh, Jung Mi; Lee, Euni
2017-06-21
Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.
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WE-G-BRA-05: IROC Houston On-Site Audits and Parameters That Affect Performance
International Nuclear Information System (INIS)
Kry, S; Dromgoole, L; Alvarez, P; Lowenstein, J; Molineu, A; Taylor, P; Followill, D
2015-01-01
Purpose: To highlight the IROC Houston on-site dosimetry audit program, and to investigate the impact of clinical conditions on the frequency of errors/recommendations noted by IROC Houston. Methods: The results of IROC Houston on-site audits from 2000-present were abstracted and compared to clinical parameters, this included 409 institutions and 1020 linacs. In particular, we investigated the frequency of recommendations versus year, and the impact of repeat visits on the number of recommendations. We also investigated the impact on the number of recommendations of several clinical parameters: the number and age of the linacs, the linac/TPS combination, and the scope of the QA program. Results: The number of recommendations per institution (3.1 average) has shown decline between 2000 and present, although the number of recommendations per machine (0.89) has not changed. Previous IROC Houston site visits did not Result in fewer recommendations on a repeat visit, but IROC Houston tests have changed substantially during the last 15 years as radiotherapy technology has changed. There was no impact on the number of recommendations based on the number of machines at the institution or the age of a given machine. The fewest recommendations were observed for Varian-Eclipse combinations (0.71 recs/machine), while Elekta- Pinnacle combinations yielded the most (1.62 recs/machine). Finally, in the TG-142 era (post-2010), those institutions that had a QA recommendation (n=77) had significantly more other recommendations (1.83 per institution) than those that had no QA rec (n=12, 1.33 per institution). Conclusion: Establishing and maintaining a successful radiotherapy program is challenging and areas of improvement can routinely be identified. Clinical conditions such as linac-TPS combinations and the establishment of a good QA program impact the frequency of errors/deficiencies identified by IROC Houston during their on-site review process
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WE-G-BRA-05: IROC Houston On-Site Audits and Parameters That Affect Performance
Energy Technology Data Exchange (ETDEWEB)
Kry, S; Dromgoole, L; Alvarez, P; Lowenstein, J; Molineu, A; Taylor, P; Followill, D [UT MD Anderson Cancer Center, Houston, TX (United States)
2015-06-15
Purpose: To highlight the IROC Houston on-site dosimetry audit program, and to investigate the impact of clinical conditions on the frequency of errors/recommendations noted by IROC Houston. Methods: The results of IROC Houston on-site audits from 2000-present were abstracted and compared to clinical parameters, this included 409 institutions and 1020 linacs. In particular, we investigated the frequency of recommendations versus year, and the impact of repeat visits on the number of recommendations. We also investigated the impact on the number of recommendations of several clinical parameters: the number and age of the linacs, the linac/TPS combination, and the scope of the QA program. Results: The number of recommendations per institution (3.1 average) has shown decline between 2000 and present, although the number of recommendations per machine (0.89) has not changed. Previous IROC Houston site visits did not Result in fewer recommendations on a repeat visit, but IROC Houston tests have changed substantially during the last 15 years as radiotherapy technology has changed. There was no impact on the number of recommendations based on the number of machines at the institution or the age of a given machine. The fewest recommendations were observed for Varian-Eclipse combinations (0.71 recs/machine), while Elekta- Pinnacle combinations yielded the most (1.62 recs/machine). Finally, in the TG-142 era (post-2010), those institutions that had a QA recommendation (n=77) had significantly more other recommendations (1.83 per institution) than those that had no QA rec (n=12, 1.33 per institution). Conclusion: Establishing and maintaining a successful radiotherapy program is challenging and areas of improvement can routinely be identified. Clinical conditions such as linac-TPS combinations and the establishment of a good QA program impact the frequency of errors/deficiencies identified by IROC Houston during their on-site review process.
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Triple Active Antiretroviral Regimen Including Enfuvirtide Via the Biojector is Effective and Safe
Directory of Open Access Journals (Sweden)
Mona Loutfy
2007-01-01
Full Text Available For full HIV virological suppression, three fully active antiretroviral agents are required. New drug classes should be included to ensure that agents are fully active. The addition of enfuvirtide and efavirenz to the present patient’s new antiretroviral regimen ensured that two fully active agents were in use in the setting of a moderate degree of nucleoside resistance and a high level of protease resistance, and where non-nucleoside reverse transcriptase inhibitors were still fully active. Both viral load and CD4 count responded favourably to this regimen. The patient received support from physicians and clinic staff in the introduction and use of enfuvirtide. To reduce injection site reactions, a needle-free injection system (Biojector proved effective.
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Small Wind Site Assessment Guidelines
Energy Technology Data Exchange (ETDEWEB)
Olsen, Tim [Advanced Energy Systems LLC, Eugene, OR (United States); Preus, Robert [National Renewable Energy Lab. (NREL), Golden, CO (United States)
2015-09-01
Site assessment for small wind energy systems is one of the key factors in the successful installation, operation, and performance of a small wind turbine. A proper site assessment is a difficult process that includes wind resource assessment and the evaluation of site characteristics. These guidelines address many of the relevant parts of a site assessment with an emphasis on wind resource assessment, using methods other than on-site data collection and creating a small wind site assessment report.
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Umatilla Satellite and Release Sites Project : Final Siting Report.
Energy Technology Data Exchange (ETDEWEB)
Montgomery, James M.
1992-04-01
This report presents the results of site analysis for the Umatilla Satellite and Release Sites Project. The purpose of this project is to provide engineering services for the siting and conceptual design of satellite and release facilities for the Umatilla Basin hatchery program. The Umatilla Basin hatchery program consists of artificial production facilities for salmon and steelhead to enhance production in the Umatilla River as defined in the Umatilla master plan approved in 1989 by the Northwest Power Planning Council. Facilities identified in the master plan include adult salmon broodstock holding and spawning facilities, facilities for recovery, acclimation, and/or extended rearing of salmon juveniles, and development of river sites for release of hatchery salmon and steelhead. The historic and current distribution of fall chinook, summer chinook, and coho salmon and steelhead trout was summarized for the Umatilla River basin. Current and future production and release objectives were reviewed. Twenty seven sites were evaluated for the potential and development of facilities. Engineering and environmental attributes of the sites were evaluated and compared to facility requirements for water and space. Site screening was conducted to identify the sites with the most potential for facility development. Alternative sites were selected for conceptual design of each facility type. A proposed program for adult holding facilities, final rearing/acclimation, and direct release facilities was developed.
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McAlearney, Ann Scheck; Song, Paula H; Reiter, Kristin L
2012-11-01
The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Interviewees expressed both "altruistic" and "self-interested" motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. Copyright © 2012 Elsevier Inc. All rights reserved.
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Directory of Open Access Journals (Sweden)
Adoke Yeka
2005-07-01
Full Text Available BACKGROUND: Drug resistance in Plasmodium falciparum poses a major threat to malaria control. Combination antimalarial therapy including artemisinins has been advocated recently to improve efficacy and limit the spread of resistance, but artemisinins are expensive and relatively untested in highly endemic areas. We compared artemisinin-based and other combination therapies in four districts in Uganda with varying transmission intensity. METHODS AND FINDINGS: We enrolled 2,160 patients aged 6 mo or greater with uncomplicated falciparum malaria. Patients were randomized to receive chloroquine (CQ + sulfadoxine-pyrimethamine (SP; amodiaquine (AQ + SP; or AQ + artesunate (AS. Primary endpoints were the 28-d risks of parasitological failure either unadjusted or adjusted by genotyping to distinguish recrudescence from new infections. A total of 2,081 patients completed follow-up, of which 1,749 (84% were under the age of 5 y. The risk of recrudescence after treatment with CQ + SP was high, ranging from 22% to 46% at the four sites. This risk was significantly lower (p < 0.01 after AQ + SP or AQ + AS (7%-18% and 4%-12%, respectively. Compared to AQ + SP, AQ + AS was associated with a lower risk of recrudescence but a higher risk of new infection. The overall risk of repeat therapy due to any recurrent infection (recrudescence or new infection was similar at two sites and significantly higher for AQ + AS at the two highest transmission sites (risk differences = 15% and 16%, p < 0.003. CONCLUSION: AQ + AS was the most efficacious regimen for preventing recrudescence, but this benefit was outweighed by an increased risk of new infection. Considering all recurrent infections, the efficacy of AQ + SP was at least as efficacious at all sites and superior to AQ + AS at the highest transmission sites. The high endemicity of malaria in Africa may impact on the efficacy of artemisinin-based combination therapy. The registration number for this trial is ISRCTN
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Yeka, Adoke; Banek, Kristin; Bakyaita, Nathan; Staedke, Sarah G; Kamya, Moses R; Talisuna, Ambrose; Kironde, Fred; Nsobya, Samuel L; Kilian, Albert; Slater, Madeline; Reingold, Arthur; Rosenthal, Philip J; Wabwire-Mangen, Fred; Dorsey, Grant
2005-01-01
Background Drug resistance in Plasmodium falciparum poses a major threat to malaria control. Combination antimalarial therapy including artemisinins has been advocated recently to improve efficacy and limit the spread of resistance, but artemisinins are expensive and relatively untested in highly endemic areas. We compared artemisinin-based and other combination therapies in four districts in Uganda with varying transmission intensity. Methods and Findings We enrolled 2,160 patients aged 6 mo or greater with uncomplicated falciparum malaria. Patients were randomized to receive chloroquine (CQ) + sulfadoxine-pyrimethamine (SP); amodiaquine (AQ) + SP; or AQ + artesunate (AS). Primary endpoints were the 28-d risks of parasitological failure either unadjusted or adjusted by genotyping to distinguish recrudescence from new infections. A total of 2,081 patients completed follow-up, of which 1,749 (84%) were under the age of 5 y. The risk of recrudescence after treatment with CQ + SP was high, ranging from 22% to 46% at the four sites. This risk was significantly lower (p AQ + SP or AQ + AS (7%–18% and 4%–12%, respectively). Compared to AQ + SP, AQ + AS was associated with a lower risk of recrudescence but a higher risk of new infection. The overall risk of repeat therapy due to any recurrent infection (recrudescence or new infection) was similar at two sites and significantly higher for AQ + AS at the two highest transmission sites (risk differences = 15% and 16%, pAQ + AS was the most efficacious regimen for preventing recrudescence, but this benefit was outweighed by an increased risk of new infection. Considering all recurrent infections, the efficacy of AQ + SP was at least as efficacious at all sites and superior to AQ + AS at the highest transmission sites. The high endemicity of malaria in Africa may impact on the efficacy of artemisinin-based combination therapy. The registration number for this trial is ISRCTN67520427 (http
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Thomas, D; Delgado, A; Louison, B; Lefrancois, T; Shaw, J
2013-07-01
Vaccination of domestic pets is an important component of rabies control and prevention in countries where the disease is maintained in a wildlife reservoir. In Grenada, vaccine coverage rates were low, despite extensive public education and advertising of government-sponsored vaccine clinics where rabies vaccine is administered to animals at no cost to animal owners. Information was needed on reasons for decreased dog owner participation in government-funded rabies vaccination clinics. A total of 120 dog owners from 6 different parishes were asked to complete a questionnaire assessing their currently held beliefs about rabies vaccination and perception of the risk posed by rabies. Over 70% of respondents believed that problems in the organization and management of clinic sites could allow for fighting between dogs or disease spread among dogs, while 35% of owners did not believe that they had the ability or adequate help to bring their dogs to the clinic sites. Recommendations for improving vaccine coverage rates included: improved scheduling of clinic sites and dates; increased biosecurity at clinic locations; focused advertising on the availability of home visits, particularly for aggressive dogs or dogs with visible skin-related diseases such as mange; and the recruitment of community volunteers to assist with bringing dogs to the clinic sites. Copyright © 2013. Published by Elsevier B.V.
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Pain in donor site after BTB-ACL reconstruction with PRGF: a randomized trial.
Seijas, Roberto; Cuscó, Xavier; Sallent, Andrea; Serra, Iván; Ares, Oscar; Cugat, Ramón
2016-06-01
Anterior cruciate ligament (ACL) tears are highly incident injuries in young athletes within our work area. The use of the patellar graft, despite being the treatment of choice, presents post-operative problems such as anterior knee pain, which limits its use and leads to preference being taken for alternative grafts. Our aim was to evaluate if the application of PRGF reduces anterior knee pain in donor site in BTB-ACL reconstruction. 43 patients were included in the double-blinded and randomized clinical trial comparing two patient groups who underwent ACL reconstruction using patellar tendon graft, comparing anterior knee pain with and without the application of PRGF at the donor site after harvesting the graft. The PRGF group showed decreased donor site pain in comparison to the control group, with significant differences in the first two months of follow-up. The application of PRGF decreased donor site pain compared to the control group.
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Disclosure of investigators' recruitment performance in multicenter clinical trials
DEFF Research Database (Denmark)
Dal-Ré, Rafael; Moher, David; Gluud, Christian
2011-01-01
Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....
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Wrong site surgery! How can we stop it?
Directory of Open Access Journals (Sweden)
Vishwanath Hanchanale
2014-01-01
Full Text Available Introduction: "Primum non nocere" (first do no harm: Hippocrates (c. 460 BC-377 BC. Wrong site surgery is the fourth commonest sentinel event after patient suicide, operative and post-operative complications, and medication errors. Misinterpretation of the clinic letters or radiology reports is the commonest reason for the wrong site being marked before surgery. Materials and Methods: We analyzed 50 cases each of operations carried out on the kidney, ureter, and the testis. The side mentioned on clinic letters, the consent form, and radiology reports lists were also studied. The results were analyzed in detail to determine where the potential pitfalls were likely to arise. Results: A total of 803 clinic letters from 150 cases were reviewed. The side of disease was not documented in 8.71% and five patients had the wrong side mentioned in one of their clinic letters. In the radiology reports, the side was not mentioned in three cases and it was reported wrongly in two patients. No wrong side was ever consented for and no wrong side surgery was performed. Conclusion: The side of surgery was not always indicated in clinic letter, theatre list, or the consent form despite the procedure being carried on a bilateral organ. As misinterpretation is a major cause of wrong side surgery, it is prudent that the side is mentioned every time in every clinic letter, consent form, and on the theatre list. The WHO surgical safety checklist has already been very effective in minimizing the wrong site surgery in the National Health Service.
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Site enforcement tracking system (SETS): PRP listing by site for region 9
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Site enforcement tracking system (SETS): PRP listing by site for region 8
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Site enforcement tracking system (SETS): PRP listing by site for region 10
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Site enforcement tracking system (SETS): PRP listing by site for region 3
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Site enforcement tracking system (SETS): PRP listing by site for region 2
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Site enforcement tracking system (SETS): PRP listing by site for region 5
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Site enforcement tracking system (SETS): PRP listing by site for region 6
International Nuclear Information System (INIS)
1993-04-01
When expending Superfund monies at a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) site, EPA must conduct a search to identify parties with potential financial responsibility for remediation of uncontrolled hazardous waste sites. EPA regional Superfund Waste Management Staff issue a notice letter to the potentially responsible party (PRP). Data from the notice letter is used to form the Site Enforcement Tracking System (SETS). The data includes PRP name and address, a company contact person, the date the notice was issued, and the related CERCLA site name and identification number
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Basics of clinical diagnosis in implant dentistry
Directory of Open Access Journals (Sweden)
Manu Rathee
2015-01-01
Full Text Available Implant-based prosthetic rehabilitation requires an understanding of associated anatomical structures. The ultimate predictability of an implant site is determined by the existing anatomy as related to dentition and the associated hard and soft tissues. Meticulous clinical assessment helps in determining the suitability of the potential site for implant placement. The purpose of this article is to present the clinical assessment for dental implants' placement to modulate peri-implant tissue characteristics in individual clinical need.
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Directory of Open Access Journals (Sweden)
Talebizadeh Zohreh
2009-09-01
Full Text Available Abstract Background Autism is a highly heritable complex neurodevelopmental disorder, therefore identifying its genetic basis has been challenging. To date, numerous susceptibility genes and chromosomal abnormalities have been reported in association with autism, but most discoveries either fail to be replicated or account for a small effect. Thus, in most cases the underlying causative genetic mechanisms are not fully understood. In the present work, the Autism Genetic Database (AGD was developed as a literature-driven, web-based, and easy to access database designed with the aim of creating a comprehensive repository for all the currently reported genes and genomic copy number variations (CNVs associated with autism in order to further facilitate the assessment of these autism susceptibility genetic factors. Description AGD is a relational database that organizes data resulting from exhaustive literature searches for reported susceptibility genes and CNVs associated with autism. Furthermore, genomic information about human fragile sites and noncoding RNAs was also downloaded and parsed from miRBase, snoRNA-LBME-db, piRNABank, and the MIT/ICBP siRNA database. A web client genome browser enables viewing of the features while a web client query tool provides access to more specific information for the features. When applicable, links to external databases including GenBank, PubMed, miRBase, snoRNA-LBME-db, piRNABank, and the MIT siRNA database are provided. Conclusion AGD comprises a comprehensive list of susceptibility genes and copy number variations reported to-date in association with autism, as well as all known human noncoding RNA genes and fragile sites. Such a unique and inclusive autism genetic database will facilitate the evaluation of autism susceptibility factors in relation to known human noncoding RNAs and fragile sites, impacting on human diseases. As a result, this new autism database offers a valuable tool for the research
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Hall, Katherine C; Diffenderfer, Sandy K; Stidham, April; Mullins, Christine M
2018-04-19
In the 1990s, dedicated education units transformed undergraduate preceptorships, but graduate preceptorships remain static. The dyadic nurse practitioner preceptorship model supports an environment where faculty, students, and preceptors may overlook nuances that affect the teaching-learning process. This article describes an innovative clinical education model, Student and Preceptor Advancement in a Dedicated Education Site, designed to improve preceptorships for advanced practice nurses. The focus is on adaptations made to facilitate use in advanced practice nursing programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
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International Nuclear Information System (INIS)
Olsen, C.W.
1983-07-01
The conditions and criteria for selecting a site for a nuclear weapons test at the Nevada Test Site are summarized. Factors considered are: (1) scheduling of drill rigs, (2) scheduling of site preparation (dirt work, auger hole, surface casing, cementing), (3) schedule of event (when are drill hole data needed), (4) depth range of proposed W.P., (5) geologic structure (faults, Pz contact, etc.), (6) stratigraphy (alluvium, location of Grouse Canyon Tuff, etc.), (7) material properties (particularly montmorillonite and CO 2 content), (8) water table depth, (9) potential drilling problems (caving), (10) adjacent collapse craters and chimneys, (11) adjacent expended but uncollapsed sites, (12) adjacent post-shot or other small diameter holes, (13) adjacent stockpile emplacement holes, (14) adjacent planned events (including LANL), (15) projected needs of Test Program for various DOB's and operational separations, and (16) optimal use of NTS real estate
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Evaluation of a morphing based method to estimate muscle attachment sites of the lower extremity.
Pellikaan, P; van der Krogt, M M; Carbone, V; Fluit, R; Vigneron, L M; Van Deun, J; Verdonschot, N; Koopman, H F J M
2014-03-21
To generate subject-specific musculoskeletal models for clinical use, the location of muscle attachment sites needs to be estimated with accurate, fast and preferably automated tools. For this purpose, an automatic method was used to estimate the muscle attachment sites of the lower extremity, based on the assumption of a relation between the bone geometry and the location of muscle attachment sites. The aim of this study was to evaluate the accuracy of this morphing based method. Two cadaver dissections were performed to measure the contours of 72 muscle attachment sites on the pelvis, femur, tibia and calcaneus. The geometry of the bones including the muscle attachment sites was morphed from one cadaver to the other and vice versa. For 69% of the muscle attachment sites, the mean distance between the measured and morphed muscle attachment sites was smaller than 15 mm. Furthermore, the muscle attachment sites that had relatively large distances had shown low sensitivity to these deviations. Therefore, this morphing based method is a promising tool for estimating subject-specific muscle attachment sites in the lower extremity in a fast and automated manner. Copyright © 2013 Elsevier Ltd. All rights reserved.
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International Nuclear Information System (INIS)
Pucar, Darko; Hricak, Hedvig; Shukla-Dave, Amita; Kuroiwa, Kentaro; Drobnjak, Marija; Eastham, James; Scardino, Peter T.; Zelefsky, Michael J.
2007-01-01
Purpose: To determine whether prostate cancer local recurrence after radiation therapy (RT) occurs at the site of primary tumor by retrospectively comparing the tumor location on pre-RT and post-RT magnetic resonance imaging (MRI) and using step-section pathology after salvage radical prostatectomy (SRP) as the reference standard. Methods and Materials: Nine patients with localized prostate cancer were treated with intensity modulated RT (69-86.4 Gy), and had pre-RT and post-RT prostate MRI, biopsy-proven local recurrence, and SRP. The location and volume of lesions on pre-RT and post-RT MRI were correlated with step-section pathology findings. Tumor foci >0.2 cm 3 and/or resulting in extraprostatic disease on pathology were considered clinically significant. Results: All nine significant tumor foci (one in each patient; volume range, 0.22-8.63 cm 3 ) were detected both on pre-RT and post-RT MRI and displayed strikingly similar appearances on pre-RT and post-RT MRI and step-section pathology. Two clinically insignificant tumor foci (≤0.06 cm 3 ) were not detected on imaging. The ratios between tumor volumes on pathology and on post-RT MRI ranged from 0.52 to 2.80. Conclusions: Our study provides a direct visual confirmation that clinically significant post-RT local recurrence occurs at the site of primary tumor. Our results are in agreement with reported clinical and pathologic results and support the current practice of boosting the radiation dose within the primary tumor using imaging guidance. They also suggest that monitoring of primary tumor with pre-RT and post-RT MRI could lead to early detection of local recurrence amenable to salvage treatment
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Bauermeister, José A; Pingel, Emily S; Jadwin-Cakmak, Laura; Meanley, Steven; Alapati, Deepak; Moore, Michael; Lowther, Matthew; Wade, Ryan; Harper, Gary W
2015-10-01
Young men who have sex with men (YMSM) are at increased risk for HIV and STI infection. While encouraging HIV and STI testing among YMSM remains a public health priority, we know little about the cultural competency of providers offering HIV/STI tests to YMSM in public clinics. As part of a larger intervention study, we employed a mystery shopper methodology to evaluate the LGBT cultural competency and quality of services offered in HIV and STI testing sites in Southeast Michigan (n = 43).We trained and deployed mystery shoppers (n = 5) to evaluate the HIV and STI testing sites by undergoing routine HIV/STI testing. Two shoppers visited each site, recording their experiences using a checklist that assessed 13 domains, including the clinic's structural characteristics and interactions with testing providers. We used the site scores to examine the checklist's psychometric properties and tested whether site evaluations differed between sites only offering HIV testing (n = 14) versus those offering comprehensive HIV/STI testing (n = 29). On average, site scores were positive across domains. In bivariate comparisons by type of testing site, HIV testing sites were more likely than comprehensive HIV/STI testing clinics to ascertain experiences of intimate partner violence, offer action steps to achieve safer sex goals, and provide safer sex education. The developed checklist may be used as a quality assurance indicator to measure HIV/STI testing sites' performance when working with YMSM. Our findings also underscore the need to bolster providers' provision of safer sex education and behavioral counseling within comprehensive HIV/STI testing sites.
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Real-Time Enrollment Dashboard For Multisite Clinical Trials.
Mattingly, William A; Kelley, Robert R; Wiemken, Timothy L; Chariker, Julia H; Peyrani, Paula; Guinn, Brian E; Binford, Laura E; Buckner, Kimberley; Ramirez, Julio
2015-10-30
Achieving patient recruitment goals are critical for the successful completion of a clinical trial. We designed and developed a web-based dashboard for assisting in the management of clinical trial screening and enrollment. We use the dashboard to assist in the management of two observational studies of community-acquired pneumonia. Clinical research associates and managers using the dashboard were surveyed to determine its effectiveness as compared with traditional direct communication. The dashboard has been in use since it was first introduced in May of 2014. Of the 23 staff responding to the survey, 77% felt that it was easier or much easier to use the dashboard for communication than to use direct communication. We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are a useful tool for clinical trial management. They can be used as a standalone trial information tool or included into a larger management system.
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2011-05-20
... Resources, Systems Pros, Total Tech Services, Triple Crown Consulting, and Ingenium Technology, Inc... Resources, PDS Technical Service, Superior Technical Resources, Systems Pros, Total Tech Services, and... subject firm. The company reports that workers leased from Ingenium Technology, Inc. were employed on-site...
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Lee, Hye-Joo; Shin, Wonkyo; Jang, Yun Jeong; Choi, Chel Hun; Lee, Jeong-Won; Bae, Duk-Soo; Kim, Byoung-Gie
2018-05-01
Placental site trophoblastic tumor (PSTT) is the rarest form of gestational trophoblastic disease (GTD) and the optimum management is still controversial. In this study, we analyzed the clinical features, treatment, and outcomes of 6 consecutive patients with PSTT treated in our institution. The electronic medical record database of Samsung Medical Center was screened to identify patients with PSTT from 1994 to 2017. Medical records for the details of each patient's clinical features and treatment were extracted and reviewed. This study was approved Institutional Review Board of our hospital. A total of 418 cases of GTD, 6 (1.4%) patients with PSTT were identified. The median age of the patients was 31 years. The antecedent pregnancy was term in all 5 cases with available antecedent pregnancy information and the median interval from pregnancy to diagnosis of PSTT was 8 months. The median titer of serum beta human chorionic gonadotropin (β-hCG) at diagnosis was 190.9 mIU/mL. Five (83.3%) patients presented with irregular vaginal bleeding and one (16.7%) had amenorrhea. All patients had disease confined to the uterus without metastasis at diagnosis and were successfully treated by hysterectomy alone. All of them were alive without disease during the follow-up period. In this study, we observed low level serum β-hCG titer and irregular vaginal bleeding with varying interval after antecedent term pregnancy were most common presenting features of PSTT. In addition, we demonstrated hysterectomy alone was successful for the treatment of stage I disease of PSTT.
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Takahashi, Arata; Kumamaru, Hiraku; Tomotaki, Ai; Matsumura, Goki; Fukuchi, Eriko; Hirata, Yasutaka; Murakami, Arata; Hashimoto, Hideki; Ono, Minoru; Miyata, Hiroaki
2018-03-01
Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.
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Nevada National Security Site Environmental Report 2010, Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
C. Wills, ed.
2011-09-13
Introduction to the Nevada National Security Site Environmental Report 2010. Included are subsections that summarize the site’s geological, hydrological, climatological, and ecological setting and the cultural resources of the NNSS. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NNSS. An adequate knowledge of the site’s environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NNSS. The NNSS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NNSS operations. These key features include the general remote location of the NNSS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Directory of Open Access Journals (Sweden)
Katrin Weier
Full Text Available The cerebellum is known to be involved not only in motor but also cognitive and affective processes. Structural changes in the cerebellum in relation to cognitive dysfunction are an emerging topic in the field of neuro-psychiatric disorders. In Multiple Sclerosis (MS cerebellar motor and cognitive dysfunction occur in parallel, early in the onset of the disease, and the cerebellum is one of the predilection sites of atrophy. This study is aimed at determining the relationship between cerebellar volumes, clinical cerebellar signs, cognitive functioning and fatigue in MS. Cerebellar volumetry was conducted using T1-weighted MPRAGE magnetic resonance imaging of 172 MS patients. All patients underwent a clinical and brief neuropsychological assessment (information processing speed, working memory, including fatigue testing. Patients with and without cerebellar signs differed significantly regarding normalized cerebellar total volume (nTCV, normalized brain volume (nBV and whole brain T2 lesion volume (LV. Patients with cerebellar dysfunction likewise performed worse in cognitive tests. A regression analysis indicated that age and nTCV explained 26.3% of the variance in SDMT (symbol digit modalities test performance. However, only age, T2 LV and nBV remained predictors in the full model (r(2 = 0.36. The full model for the prediction of PASAT (Paced Auditory Serial Addition Test scores (r(2 = 0.23 included age, cerebellar and T2 LV. In the case of fatigue, only age and nBV (r(2 = 0.17 emerged as significant predictors. These data support the view that cerebellar abnormalities contribute to disability, including cognitive impairment in MS. However, this contribution does not seem to be independent of, and may even be dominated by wider spread MS pathology as reflected by nBV and T2 LV.
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Facility siting as a decision process at the Savannah River Site
International Nuclear Information System (INIS)
Wike, L.D.
1995-01-01
Site selection for new facilities at Savannah River Site (SRS) historically has been a process dependent only upon specific requirements of the facility. While this approach is normally well suited to engineering and operational concerns, it can have serious deficiencies in the modern era of regulatory oversight and compliance requirements. There are many issues related to the site selection for a facility that are not directly related to engineering or operational requirements; such environmental concerns can cause large schedule delays and budget impact,s thereby slowing or stopping the progress of a project. Some of the many concerns in locating a facility include: waste site avoidance, National Environmental Policy Act requirements, Clean Water Act, Clean Air Act, wetlands conservation, US Army Corps of Engineers considerations, US Fish and Wildlife Service statutes including threatened and endangered species issues, and State of South Carolina regulations, especially those of the Department of Health and Environmental Control. In addition, there are SRS restrictions on research areas set aside for National Environmental Research Park (NERP), Savannah River Ecology Laboratory, Savannah River Forest Station, University of South Carolina Institute of Archaeology and Anthropology, Southeastern Forest Experimental Station, and Savannah River Technology Center (SRTC) programs. As with facility operational needs, all of these siting considerations do not have equal importance. The purpose of this document is to review recent site selection exercises conducted for a variety of proposed facilities, develop the logic and basis for the methods employed, and standardize the process and terminology for future site selection efforts
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Nevada National Security Site Environmental Report 2012 Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Wills, Cathy A
2013-09-11
This attachment expands on the general description of the Nevada National Security Site (NNSS) presented in the Introduction to the Nevada National Security Site Environmental Report 2012 (National Security Technologies, LLC [NSTec], 2013). Included are subsections that summarize the site’s geological, hydrological, climatological, and ecological setting and the cultural resources of the NNSS. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NNSS. An adequate knowledge of the site’s environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NNSS. The NNSS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NNSS operations. These key features include the general remote location of the NNSS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Nevada National Security Site Environmental Report 2016, Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Wills, Cathy [National Security Technologies, LLC. (NSTec), Mercury, NV (United States)
2017-09-07
This attachment expands on the general description of the Nevada National Security Site (NNSS) presented in the Introduction to the Nevada National Security Site Environmental Report 2016 (prepared by National Security Technologies, LLC [NSTec], 2017). Included are subsections that summarize the site’s geological, hydrological, climatological, and ecological settings and the cultural resources of the NNSS. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NNSS. An adequate knowledge of the site’s environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NNSS. The NNSS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NNSS operations. These key features include the general remote location of the NNSS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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Nevada National Security Site Environmental Report 2013 Attachment A: Site Description
Energy Technology Data Exchange (ETDEWEB)
Wills, C.
2014-09-09
This attachment expands on the general description of the Nevada National Security Site (NNSS) presented in the Introduction to the Nevada National Security Site Environmental Report 2012 (National Security Technologies, LLC [NSTec], 2013). Included are subsections that summarize the site’s geological, hydrological, climatological, and ecological setting and the cultural resources of the NNSS. The subsections are meant to aid the reader in understanding the complex physical and biological environment of the NNSS. An adequate knowledge of the site’s environment is necessary to assess the environmental impacts of new projects, design and implement environmental monitoring activities for current site operations, and assess the impacts of site operations on the public residing in the vicinity of the NNSS. The NNSS environment contributes to several key features of the site that afford protection to the inhabitants of adjacent areas from potential exposure to radioactivity or other contaminants resulting from NNSS operations. These key features include the general remote location of the NNSS, restricted access, extended wind transport times, the great depths to slow-moving groundwater, little or no surface water, and low population density. This attachment complements the annual summary of monitoring program activities and dose assessments presented in the main body of this report.
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McAlearney, Ann Scheck; Song, Paula H.; Reiter, Kristin L.
2012-01-01
Background The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute’s Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. Objectives This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. Research Methods We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Results Interviewees expressed both “altruistic” and “self-interested” motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. Conclusion The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. PMID:22925970
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The Savannah River site`s groundwater monitoring program: second quarter 1997
Energy Technology Data Exchange (ETDEWEB)
Rogers, C.D. [Westinghouse Savannah River Company, AIKEN, SC (United States)
1997-11-01
The Environmental Protection Department/Environmental Monitoring Section (EPD/EMS) administers the Savannah River Site`s (SRS) Groundwater Monitoring Program. During second quarter 1997, EPD/EMS conducted extensive sampling of monitoring wells. A detailed explanation of the flagging criteria is presented in the Flagging Criteria section of this document. Analytical results from second quarter 1997 are included in this report.
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Directory of Open Access Journals (Sweden)
Richard C Wang
Full Text Available One of the main reasons for disease recurrence in the curative breast cancer treatment setting is the development of drug resistance. Microtubule targeted agents (MTAs are among the most commonly used drugs for the treatment of breaset cancer and therefore overcoming taxane resistance is of primary clinical importance. Our group has previously demonstrated that the microtubule dynamics of docetaxel-resistant MCF-7TXT cells are insensitivity to docetaxel due to the distinct expression profiles of β-tubulin isotypes in addition to the high expression of p-glycoprotein (ABCB1. In the present investigation we examined whether taxane-resistant breast cancer cells are more sensitive to microtubule destabilizing agents including vinca alkaloids and colchicine-site binding agents (CSBAs than the non-resistant cells.Two isogenic MCF-7 breast cancer cell lines were selected for resistance to docetaxel (MCF-7TXT and the wild type parental cell line (MCF-7CC to examine if taxane-resistant breast cancer cells are sensitive to microtubule-destabilizing agents including vinca alkaloids and CSBAs. Cytotoxicity assays, immunoblotting, indirect immunofluorescence and live imaging were used to study drug resistance, apoptosis, mitotic arrest, microtubule formation, and microtubule dynamics.MCF-7TXT cells were demonstrated to be cross resistant to vinca alkaloids, but were more sensitive to treatment with colchicine compared to parental non-resistant MCF-7CC cells. Cytotoxicity assays indicated that the IC50 of MCF-7TXT cell to vinorelbine and vinblastine was more than 6 and 3 times higher, respectively, than that of MCF-7CC cells. By contrast, the IC50 of MCF-7TXT cell for colchincine was 4 times lower than that of MCF-7CC cells. Indirect immunofluorescence showed that all MTAs induced the disorganization of microtubules and the chromatin morphology and interestingly each with a unique pattern. In terms of microtubule and chromain morphology, MCF-7TXT cells were
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Smith, Carol E; Piamjariyakul, Ubolrat; Werkowitch, Marilyn; Yadrich, Donna Macan; Thompson, Noreen; Hooper, Dedrick; Nelson, Eve-Lynn
2016-01-01
This article describes a method to translate an evidence based health care intervention to the mobile environment. This translation assisted patient participants to: avoid life threatening infections; monitor emotions and fatigue; keep involved in healthy activities. The mobile technology also decreased costs by reducing for example travel to visit health care providers. Testing of this translation method and its use by comparison groups of patients adds to the knowledge base for assessing technology for its impact on health outcome measures. The challenges and workflow of designing materials for the mobile format are described. Transitioning clinical trial verified interventions, previously provided in person to patients, onto tablet and internet platforms is an important process that must be evaluated. In this study, our evidence based guide’s intravenous (IV) homeCare interventions (IVhomeCare) were delivered via Apple iPad mini™ tablet audiovisual instruction / discussion sessions and on a website. Each iPad audiovisual session (n = 41), included three to five families, a mental health specialist, and healthcare professionals. Patients and their family caregivers readily learned to use the wireless mobile tablets, and the IVhomeCare interventions, as described here, were successfully translated onto these mobile technology platforms. Using Likert scale responses on a questionnaire (1 = not helpful and 5 = very helpful) participants indicated that they gained problem solving skills for home care through iPad group discussion (M = 4.60, SD = 0.60). The firewall protected videoconferencing in real time with multiple healthcare professionals effectively allowed health history taking and visual inspection of the patient’s IV insertion site for signs of infection. Supportive interactions with peer families on videoconferencing were documented during discussions. Discussion topics included low moods, fatigue, infection worry, how to maintain independence, and
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Site investigations: Strategy for rock mechanics site descriptive model
International Nuclear Information System (INIS)
Andersson, Johan; Christiansson, Rolf; Hudson, John
2002-05-01
As a part of the planning work for the Site Investigations, SKB has developed a Rock Mechanics Site Descriptive Modelling Strategy. Similar strategies are being developed for other disciplines. The objective of the strategy is that it should guide the practical implementation of evaluating site specific data during the Site Investigations. It is also understood that further development may be needed. This methodology enables the crystalline rock mass to be characterised in terms of the quality at different sites, for considering rock engineering constructability, and for providing the input to numerical models and performance assessment calculations. The model describes the initial stresses and the distribution of deformation and strength properties of the intact rock, of fractures and fracture zones, and of the rock mass. The rock mass mechanical properties are estimated by empirical relations and by numerical simulations. The methodology is based on estimation of mechanical properties using both empirical and heroretical/numerical approaches; and estimation of in situ rock stress using judgement and numerical modelling, including the influence of fracture zones. These approaches are initially used separately, and then combined to produce the required characterisation estimates. The methodology was evaluated with a Test Case at the Aespoe Hard Rock Laboratory in Sweden. The quality control aspects are an important feature of the methodology: these include Protocols to ensure the structure and coherence of the procedures used, regular meetings to enhance communication, feedback from internal and external reviewing, plus the recording of an audit trail of the development steps and decisions made. The strategy will be reviewed and, if required, updated as appropriate
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Site investigations: Strategy for rock mechanics site descriptive model
Energy Technology Data Exchange (ETDEWEB)
Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden); Christiansson, Rolf [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Hudson, John [Rock Engineering Consultants, Welwyn Garden City (United Kingdom)
2002-05-01
As a part of the planning work for the Site Investigations, SKB has developed a Rock Mechanics Site Descriptive Modelling Strategy. Similar strategies are being developed for other disciplines. The objective of the strategy is that it should guide the practical implementation of evaluating site specific data during the Site Investigations. It is also understood that further development may be needed. This methodology enables the crystalline rock mass to be characterised in terms of the quality at different sites, for considering rock engineering constructability, and for providing the input to numerical models and performance assessment calculations. The model describes the initial stresses and the distribution of deformation and strength properties of the intact rock, of fractures and fracture zones, and of the rock mass. The rock mass mechanical properties are estimated by empirical relations and by numerical simulations. The methodology is based on estimation of mechanical properties using both empirical and heroretical/numerical approaches; and estimation of in situ rock stress using judgement and numerical modelling, including the influence of fracture zones. These approaches are initially used separately, and then combined to produce the required characterisation estimates. The methodology was evaluated with a Test Case at the Aespoe Hard Rock Laboratory in Sweden. The quality control aspects are an important feature of the methodology: these include Protocols to ensure the structure and coherence of the procedures used, regular meetings to enhance communication, feedback from internal and external reviewing, plus the recording of an audit trail of the development steps and decisions made. The strategy will be reviewed and, if required, updated as appropriate.
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2010-08-23
... produce performance coating solutions for vehicles. The company reports that workers leased from DuPont Performance Coatings, a wholly-owned subsidiary of E.I. DuPont de Nemours Company, OEM, were employed on-site..., C R Associates, Syncreon, Robinson Solutions and Dupont Performance Coatings Fenton, MO; Amended...
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2010-03-12
... Qimonda AG Sandston, VA; Amended Certification Regarding Eligibility To Apply for Worker Adjustment..., Sandston, Virginia. The notice was published in the Federal Register on December 30, 2008 (73 FR 79914... division of Select Staffing were employed on-site at the Sandston, Virginia location of Qimonda 200MM...
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Scar evaluation of split thickness skin graft donor site
Directory of Open Access Journals (Sweden)
Jani Muha
2014-12-01
Full Text Available BACKGROUND. Split thickness skin graft harvesting causes a certain degree of scaring on the donor site. Donor site scar can cause aesthetic and functional sequelae on the patient's body. Our goal was to study the process of donor site selection, and then evaluate donor site scars and their impact on patients. PATIENTS AND METHODS. This retrospective study included 45 patients aged 5 to 61 years (in average 36, who have been treated with STSG in the 2004–2010 period. 57.8% of them were men. On a follow-up visit, we photographed healed skin defects and donor sites. We then determined and compared the surface areas of skin defect and the donor site using the Adobe® Illustrator® CS5 computer program. Donor site scars were assessed according to the Vancouver scar scale (VSS. We examined scar’s light touch sensitivity with monofilaments and skin colouring compared to adjacent healthy skin using colorimeter. Patients were also interviewed about their treatment course in a form of a standardized questionnaire. RESULTS. Our research has revealed that 20.0% of patients participated in the decision making process of choosing the donor site, while in 80.0% the donor site was chosen by the surgeon himself. 6.7% of patients were not satisfied with their donor site. Most of the patients (37/45 had donor sites on their thighs. In average, the donor site surface area was 94% bigger than the skin defect area. We found statistically significant differences in VSS values, light touch sensitivity and skin colouring between donor site scaring and adjacent healthy skin. CONCLUSIONS. Donor site scar can represent a lasting aesthetic and functional disability for patients. Our research has shown that most of the patients do not participate in the donor site selection process, but are satisfied with their donor site. In most cases, STGSs are harvested from the thigh, other anatomical regions, where scarring would be aesthetically less obtrusive, are underused
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Energy Technology Data Exchange (ETDEWEB)
Soederbaeck, Bjoern [ed.
2008-06-15
The Swedish Nuclear Fuel and Waste Management Company (SKB) is undertaking site characterization at two different locations, the Forsmark and Laxemar-Simpevarp areas, with the objective of siting a geological repository for spent nuclear fuel. The site investigations started in 2002 and were completed in 2007. The analysis and modelling of data from the site investigations, which have taken place during and after these investigations, provide a foundation for the development of an integrated, multidisciplinary site descriptive model (SDM) for each of the two sites. A site descriptive model constitutes a description of the site and its regional setting, covering the current state of the geosphere and the biosphere, as well as those natural processes that affect or have affected their long-term development. Hitherto, a number of reports presenting preliminary site descriptive models for Forsmark and Laxemar-Simpevarp have been published. In these reports, the evolutionary and historical aspects of the site were included in a separate chapter. The present report comprises a further elaboration of the evolutionary and historical information included in the preliminary SDM reports, but presented here in a separate, supplementary report to the final site description, SDM-Site. The report is common to the two investigated areas, and the overall objective is to describe the long-term geological evolution, the palaeoclimate, and the post-glacial development of ecosystems and of the human population at the two sites. The report largely consists of a synthesis of information derived from the scientific literature and other sources not related to the site investigations. However, considerable information from the site investigations that has contributed to our understanding of the past development at each site is also included. This unique synthesis of both published information in a regional perspective and new site-specific information breaks new ground in our understanding
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International Nuclear Information System (INIS)
Soederbaeck, Bjoern
2008-06-01
The Swedish Nuclear Fuel and Waste Management Company (SKB) is undertaking site characterization at two different locations, the Forsmark and Laxemar-Simpevarp areas, with the objective of siting a geological repository for spent nuclear fuel. The site investigations started in 2002 and were completed in 2007. The analysis and modelling of data from the site investigations, which have taken place during and after these investigations, provide a foundation for the development of an integrated, multidisciplinary site descriptive model (SDM) for each of the two sites. A site descriptive model constitutes a description of the site and its regional setting, covering the current state of the geosphere and the biosphere, as well as those natural processes that affect or have affected their long-term development. Hitherto, a number of reports presenting preliminary site descriptive models for Forsmark and Laxemar-Simpevarp have been published. In these reports, the evolutionary and historical aspects of the site were included in a separate chapter. The present report comprises a further elaboration of the evolutionary and historical information included in the preliminary SDM reports, but presented here in a separate, supplementary report to the final site description, SDM-Site. The report is common to the two investigated areas, and the overall objective is to describe the long-term geological evolution, the palaeoclimate, and the post-glacial development of ecosystems and of the human population at the two sites. The report largely consists of a synthesis of information derived from the scientific literature and other sources not related to the site investigations. However, considerable information from the site investigations that has contributed to our understanding of the past development at each site is also included. This unique synthesis of both published information in a regional perspective and new site-specific information breaks new ground in our understanding
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Site Environmental Report, 1993
Energy Technology Data Exchange (ETDEWEB)
1994-06-01
The Site Environmental Report (SER) is prepared annually in accordance with DOE Order 5400.1, ``General Environmental Protection Program.`` This 1993 SER provides the general public as well as scientists and engineers with the results from the site`s ongoing Environmental Monitoring Program. Also included in this report is information concerning the site`s progress toward achieving full compliance with requirements set forth by DOE, US Environmental Protection Agency (USEPA), and Ohio EPA (OEPA). For some readers, the highlights provided in the Executive Summary may provide sufficient information. Many readers, however, may wish to read more detailed descriptions of the information than those which are presented here.
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Localized scleroderma: a clinical study at a single center in Korea.
Noh, Jung Won; Kim, Jinseok; Kim, Jae-Wang
2013-08-01
Localized scleroderma (morphea) is a rare autoimmune disease limited to the skin, characterized by cutaneous fibrosing and obstructive vasculopathy. Localized scleroderma may invade into the subcutaneous fat layer and cause permanent functional disability. Because of its rarity, there have been few clinical surveys of patients with localized scleroderma in Korea. The aim of this study was to elucidate the clinical presentation, serological data, and clinical outcomes of localized scleroderma. This was a retrospective survey conducted by reviewing available medical records during a 7 year-period from 2004 to 2010 in a single medical center in Jeju Island, South Korea. In total 43 patients with localized scleroderma were included. Localized scleroderma occurred primarily in females (female to male ratio 2.6 : 1.0). Most patients were between 10 and 29 years of age and the mean age at diagnosis was 26.2 years. Plaque (51.2%) and linear morphea (37.2%) were most common. No case was associated with systemic scleroderma (systemic sclerosis). The most common site of plaque morphea was the trunk (47.8%). In the linear type, the most common site was head-neck (52.9%). Fluorescent antinuclear antibody was positive in 23.3% of all cases. Treatment included systemic corticosteroids, colchicine, anti-malarial agents, D-penicillamine or intralesional triamcinolone injection. Clinical improvement, including significant and partial response, was seen in only 62.8% of treated patients. Localized scleroderma is a chronic inflammatory condition confined to the skin. In order to exclude other conditions, thorough history taking, physical examination, serologic studies and histopathologic examinations should be conducted. © 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.
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Kuranishi, Fumito; Imaoka, Yuki; Sumi, Yuusuke; Uemae, Yoji; Yasuda-Kurihara, Hiroko; Ishihara, Takeshi; Miyazaki, Tsubasa; Ohno, Tadao
2018-01-01
No effective treatment has been developed for bone-metastatic breast cancer. We found 3 cases with clinical complete response (cCR) of the bone metastasis and longer overall survival of the retrospectively examined cohort treated comprehensively including autologous formalin-fixed tumor vaccine (AFTV). AFTV was prepared individually for each patient from their own formalin-fixed and paraffin-embedded breast cancer tissues. Three patients maintained cCR status of the bone metastasis for 17 months or more. Rate of cCR for 1 year or more appeared to be 15% (3/20) after comprehensive treatments including AFTV. The median overall survival time (60.0 months) and the 3- to 8-year survival rates after diagnosis of bone metastasis were greater than those of historical control cohorts in Japan (1988-2002) and in the nationwide population-based cohort study of Denmark (1999-2007). Bone-metastatic breast cancer may be curable after comprehensive treatments including AFTV, although larger scale clinical trial is required.
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Integrative Analysis of CRISPR/Cas9 Target Sites in the Human HBB Gene
Directory of Open Access Journals (Sweden)
Yumei Luo
2015-01-01
Full Text Available Recently, the clustered regularly interspaced short palindromic repeats (CRISPR system has emerged as a powerful customizable artificial nuclease to facilitate precise genetic correction for tissue regeneration and isogenic disease modeling. However, previous studies reported substantial off-target activities of CRISPR system in human cells, and the enormous putative off-target sites are labor-intensive to be validated experimentally, thus motivating bioinformatics methods for rational design of CRISPR system and prediction of its potential off-target effects. Here, we describe an integrative analytical process to identify specific CRISPR target sites in the human β-globin gene (HBB and predict their off-target effects. Our method includes off-target analysis in both coding and noncoding regions, which was neglected by previous studies. It was found that the CRISPR target sites in the introns have fewer off-target sites in the coding regions than those in the exons. Remarkably, target sites containing certain transcriptional factor motif have enriched binding sites of relevant transcriptional factor in their off-target sets. We also found that the intron sites have fewer SNPs, which leads to less variation of CRISPR efficiency in different individuals during clinical applications. Our studies provide a standard analytical procedure to select specific CRISPR targets for genetic correction.
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Mdala, Ibrahimu; Olsen, Ingar; Haffajee, Anne D; Socransky, Sigmund S; Thoresen, Magne; de Blasio, Birgitte Freiesleben
2014-01-01
Aim To understand degeneration of healthy sites and identify factors associated with disease progression in patients with chronic periodontitis. Material and Methods Data on healthy sites from 163 American and Swedish subjects were analysed using two-three-state (health, gingivitis, chronic periodontitis) Markov models based on bleeding on probing (BOP), and either clinical attachment level (CAL) + BOP or pocket depth (PD) + BOP. Results In 2 years, 10% (CAL + BOP) and 3% (PD + BOP) of healthy sites developed chronic periodontitis. On average, healthy sites remained healthy for 32 months before transiting in both models. Most transitions (87–97%) from health were to the gingivitis state. The expected duration of the gingivitis lesion was 4–5 months and sites recovered with a high probability (96–98%). Disease severity as measured by number of sites with CAL/PD > 4 mm at baseline and smoking, were associated with fast progression from health to chronic periodontitis within 6 months as were gingival redness in the PD + BOP model only. With age, the rate of disease progression to gingivitis decreased. Conclusion Transition probabilities for gingivitis and chronic periodontitis were higher with CAL + BOP than with PD + BOP. Smoking and disease severity were significant predictors for fast progression. PMID:24888705
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Energy Technology Data Exchange (ETDEWEB)
Heffner, J.D. [ed.] [Exploration Resources, Inc., Athens, GA (United States)
1991-11-01
This report provides information regarding the status of and groundwater quality at the waste sites at the Department of Energy`s (DOE) Savannah River Site (SRS). Specific information provided for each waste site at SRS includes its location, size, inventory (when known), and history. Many waste sites at SRS are considered to be of little environmental concern because they contain nontoxic or inert material such as construction rubble and debris. Other waste sites, however, either are known to have had an effect on groundwater quality or are suspected of having the potential to affect groundwater. Monitoring wells have been installed at most of these sites; monitoring wells are scheduled for installation at the remaining sites. Results of the groundwater analyses from these monitoring wells, presented in the appendices, are used in the report to help identify potential contaminants of concern, if any, at each waste site. The list of actions proposed for each waste site in Christensen and Gordon`s 1983 report are summarized, and an update is provided for each site. Planned actions for the future are also outlined.
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2010-03-12
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-70,151] Smith and Nephew, Inc... November 5, 2009, applicable to workers of Smith and Nephew, Inc., Wound Management-Largo Division, Largo... workers leased from Adecco were employed on-site at the Largo, Florida location of Smith and Nephew, Inc...
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S. Mark Nelson; Rick Wydoski
2013-01-01
We studied butterfly assemblages at six types of riparian landscapes in five different watersheds in the southwestern United States (n=34 sites). Sites included exotic-invasive Tamarix ramosissima (tamarisk) dominated sites; sites where tamarisk was controlled, but not actively revegetated; sites revegetated with upland plants; sites where control was followed with riparian plant revegetation; native riparian vegetation sites; and sites that were a mixture of native and tamarisk vegetations. ...
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Pechak, Celia; Black, Jill D
2013-12-01
The influence of internationalization on physiotherapist education in at least North American-based programmes has become more apparent. Faculty and students have been involved in various international activities. One category of activities includes international clinical education (ICE), where students earn clinical education credit for their learning activities at international sites. Although this educational strategy appears to be increasingly used in at least the United States and Canada, the related literature is limited in scope. The purpose of this portion of the present study was to investigate the benefits and challenges of ICE for US-based students, US-based physiotherapy programmes and international partners from the perspective of US-based faculty sending students for clinical education internationally. Content analysis was used for this qualitative study. Fifteen US-based faculty members who had experience in sending physiotherapist students for ICE were recruited. The primary researcher conducted semi-structured phone interviews, averaging approximately 60 minutes in length. The primary and secondary researchers completed data analysis using NVivo 8 software (QSR International Inc., Cambridge, MA). Benefits of ICE to the students included exposure to alternate health systems, broadening of student perspectives and clinical competence. Challenges consisted of funding and possible language barrier. Increased visibility, expanded global perspective and faculty collaborations were benefits to the programme. Ensuring a quality learning experience was the greatest programme challenge. Benefits to the international site included education and faculty collaborations/exchanges; challenges were language, student clinical preparation and unfamiliarity with the student evaluation tool. Because the sample was limited to 15 US-based faculty members, the results may not be relevant to all programmes inside or outside of the United States. Additionally, the study
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Systematic Analysis of Splice-Site-Creating Mutations in Cancer.
Jayasinghe, Reyka G; Cao, Song; Gao, Qingsong; Wendl, Michael C; Vo, Nam Sy; Reynolds, Sheila M; Zhao, Yanyan; Climente-González, Héctor; Chai, Shengjie; Wang, Fang; Varghese, Rajees; Huang, Mo; Liang, Wen-Wei; Wyczalkowski, Matthew A; Sengupta, Sohini; Li, Zhi; Payne, Samuel H; Fenyö, David; Miner, Jeffrey H; Walter, Matthew J; Vincent, Benjamin; Eyras, Eduardo; Chen, Ken; Shmulevich, Ilya; Chen, Feng; Ding, Li
2018-04-03
For the past decade, cancer genomic studies have focused on mutations leading to splice-site disruption, overlooking those having splice-creating potential. Here, we applied a bioinformatic tool, MiSplice, for the large-scale discovery of splice-site-creating mutations (SCMs) across 8,656 TCGA tumors. We report 1,964 originally mis-annotated mutations having clear evidence of creating alternative splice junctions. TP53 and GATA3 have 26 and 18 SCMs, respectively, and ATRX has 5 from lower-grade gliomas. Mutations in 11 genes, including PARP1, BRCA1, and BAP1, were experimentally validated for splice-site-creating function. Notably, we found that neoantigens induced by SCMs are likely several folds more immunogenic compared to missense mutations, exemplified by the recurrent GATA3 SCM. Further, high expression of PD-1 and PD-L1 was observed in tumors with SCMs, suggesting candidates for immune blockade therapy. Our work highlights the importance of integrating DNA and RNA data for understanding the functional and the clinical implications of mutations in human diseases. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
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Site characterization and validation
International Nuclear Information System (INIS)
Olsson, O.; Eriksson, J.; Falk, L.; Sandberg, E.
1988-04-01
The borehole radar investigation program of the SCV-site (Site Characterization and Validation) has comprised single hole reflection measurements with centre frequencies of 22, 45, and 60 MHz. The radar range obtained in the single hole reflection measurements was approximately 100 m for the lower frequency (22 MHz) and about 60 m for the centre frequency 45 MHz. In the crosshole measurements transmitter-receiver separations from 60 to 200 m have been used. The radar investigations have given a three dimensional description of the structure at the SCV-site. A generalized model of the site has been produced which includes three major zones, four minor zones and a circular feature. These features are considered to be the most significant at the site. Smaller features than the ones included in the generalized model certainly exist but no additional features comparable to the three major zones are thought to exist. The results indicate that the zones are not homogeneous but rather that they are highly irregular containing parts of considerably increased fracturing and parts where their contrast to the background rock is quite small. The zones appear to be approximately planar at least at the scale of the site. At a smaller scale the zones can appear quite irregular. (authors)
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Hickson, Evelyn; Harris, Jeanette; Brett, David
2015-04-01
Surgical site infections (SSI) are a substantial concern for cesarean deliveries in which a surgical site complication is most unwelcome for a mother with a new infant. Steps taken pre- and post-operatively to reduce the number of complications may be of substantial benefit clinically, economically, and psychologically. A risk-based approach to incision management was developed and implemented for all cesarean deliveries at our institution. A number of incremental interventions for low-risk and high-risk patients including pre-operative skin preparations, standardized pre- and post-operative protocols, post-operative nanocrystalline silver anti-microbial barrier dressings, and incisional negative pressure wound therapy (NPWT) were implemented sequentially over a 5-y period. A systematic clinical chart review of 4,942 patients spanning all cesarean deliveries between 2007-2012 was performed to determine what effects the interventions had on the rate of SSI for cesarean deliveries. The percentage of SSI was reduced from 2.13% (2007) to 0.10% (2012) (poperative SSIs were avoided: A total cost saving of nearly $5,000,000. Applying a clinical algorithm for assessing the risk of surgical site complication and making recommendations on pre-operative and post-operative incision management can result in a substantial and sustainable reduction in cesarean SSI.
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SITE: a methodology for assessment of energy facility siting patterns. Regional studies program
International Nuclear Information System (INIS)
Frigerio, N.A.; Habegger, L.J.; King, R.F.; Hoover, L.J.; Clark, N.A.; Cobian, J.M.
1975-08-01
The timely development of the nation's energy production capacity in a manner that minimizes potential adverse local and regional impacts associated with energy facilities requires the use of sophisticated techniques for evaluation of siting alternatives and fuel cycle options. This report is a documentation of the computerized SITE methodology that has been developed for evaluating health, environmental, and socioeconomic impacts related to utilization of alternate sites for energy production within a region of interest. The cost, impact, and attribute vectors, which are generated and displayed on density maps, can be used in a multiparameter overlay process to identify preferable siting areas. The assessment of clustered facilities in energy centers is also possible within the SITE analysis framework. An application of the SITE methodology to Northern Illinois is presented. Also included is a description of the ongoing extension of SITE for the accumulative evaluation of alternative regional energy siting patterns and fuel cycle options. An appendix provides documentation and user information for the SITE computer program
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International Nuclear Information System (INIS)
Jeong, Hwan Seok; You Dong Soo
1998-01-01
This study was designed to reveal the correlationship between the internal derangement state of TMJ and clinical characteristics including pain and mandibular dysfuntion. One hundred and twenty five subjects with TMJ signs and symptoms were chosen for two years. The level of pain and mandibular dysfuntion were evaluated by Visual Analog Scale (VAS) and Craniomandibular Index (CMI). The diagnostic categories of TMJ internal derangement were determined by arthrography and they included normal disc position, anterior disc displacement with reduction (ADDR), rotational disc displacement with reduction (RDDR), andterior disc displacement without reduction (ADDNR), and rotational disc displacement without reduction (RDDNR). Also disc perforation was used as a criteria to divide the diagnostic subgroups. The obtained results were as follows ; 1. The patient distribution of each group was 5 in normal disc position (4%), 40 in ADDR (32%), 30 in RDDR (24%), 34 in ADDNR (27%), and 16 in RDDNR (13%). 2. Perforation was observed in 8% of ADDR, 10% of RDDR, 32% of ADDNR, and 19% of RDDNR. 3. CMI of perforation group was higher than that of reduction or normal group(p 0.05).
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Site environmental report summary
International Nuclear Information System (INIS)
1992-01-01
In this summary of the Fernald 1992 Site Environmental Report the authors will describe the impact of the Fernald site on man and the environment and provide results from the ongoing Environmental Monitoring Program. Also included is a summary of the data obtained from sampling conducted to determine if the site complies with DOE, US Environmental Protection Agency (USEPA), and Ohio EPA (OEPA) requirements. These requirements are set to protect both man and the environment
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Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua
2017-12-01
Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. This study contributed a new data processing framework to extract and integrate
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Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua
2018-01-01
Background Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. Objective In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. Methods The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. Results The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. Conclusion This study contributed a new
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Site 300 City Water Master Plan
Energy Technology Data Exchange (ETDEWEB)
Shaw, Jeff [Stantec Consulting Services Inc., Irvine, CA (United States)
2017-03-13
Lawrence Livermore National Laboratory (LLNL), a scientific research facility, operates an experimental test site known as Site 300. The site is located in a remote area of southeastern Alameda County, California, and consists of about 100 facilities spread across 7,000-acres. The Site 300 water system includes groundwater wells and a system of storage tanks, booster pumps, and underground piping to distribute water to buildings and significant areas throughout the site. Site 300, which is classified as a non-transient non-community (NTNC) water system, serves approximately 110 employees through 109 service connections. The distribution system includes approximately 76,500-feet of water mains varying from 4- to 10-inches in diameter, mostly asbestos cement (AC) pipe, and eleven water storage tanks. The water system is divided into four pressure zones fed by three booster pump stations to tanks in each zone.
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Lacaria, Melanie; Srour, Myriam; Michaud, Jacques L; Doja, Asif; Miller, Elka; Schwartzentruber, Jeremy; Goldsmith, Claire; Majewski, Jacek; Boycott, Kym M
2017-06-01
Distal deletion of the long arm of chromosome 10 is associated with a dysmorphic craniofacial appearance, microcephaly, behavioral issues, developmental delay, intellectual disability, and ocular, urogenital, and limb abnormalities. Herein, we present clinical, molecular, and cytogenetic investigations of four patients, including two siblings, with nearly identical terminal deletions of 10q26.3, all of whom have an atypical presentation of this syndrome. Their prominent features include ataxia, mild-to-moderate intellectual disability, and hyperemia of the hands and feet, and they do not display many of the other features commonly associated with deletions of this region. These results point to a novel gene locus associated with ataxia and highlight the variability of the clinical presentation of patients with deletions of this region. © 2017 Wiley Periodicals, Inc.
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Do we have to Include HCI Issues in Clinical Trials of Medical Devices?
DEFF Research Database (Denmark)
Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne
2017-01-01
Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...
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International Nuclear Information System (INIS)
1987-06-01
The Cultural Resources Site Study Plan describes a field program to identify and evaluate the archaeological, historical, and Native American Indian resources of the site on local and regional perspectives; monitor and manage discovered cultural resources; and establish a worker education program. The archaeological field program consists of three pedestrian surveys: Survey 1 includes two EDBH seismic survey lines and the area within the exploratory shaft facility (ESF); Survey 2 includes the remainder of the site plus a 1/4 to 3/4-mi border area; and Survey 3 includes an assortment of offsite areas. The historical studies will identify and evaluate known and discovered historical sites and structures and the Native American Indian will identify and evaluate cultural and religious concerns expressed by Indian tribal groups. Prehistoric and historic sites will be evaluated to determine if they meet eligibility criteria for listing on the National Register of Historic Places. This site study plan describes the need for each study; its design and design rationale; analysis, management, and use of data; schedule of field activities; organization of field personnel and sample management; and quality assurance requirements. The cultural resource studies will provide data for satisfying the Programmatic Agreement, engineering design needs, and SRP requirements for permits and approvals, and for minimizing effects to any cultural properties discovered during site characterization. 75 refs., 10 figs., 2 tabs
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Site locality identification study: Hanford Site. Volume I. Methodology, guidelines, and screening
International Nuclear Information System (INIS)
1980-07-01
Presented in this report are the results of the site locality identification study for the Hanford Site using a screening process. To enable evaluation of the entire Hanford Site, the screening process was applied to a somewhat larger area; i.e., the Pasco Basin. The study consisted of a series of screening steps that progressively focused on smaller areas which are within the Hanford Site and which had a higher potential for containing suitable repository sites for nuclear waste than the areas not included for further study. Five site localities, designated H-1, H-2, H-3, H-4, H-5 (Figure A), varying in size from approximately 10 to 50 square miles, were identified on the Hanford Site. It is anticipated that each site locality may contain one or more candidate sites suitable for a nuclear waste repository. The site locality identification study began with definition of objectives and the development of guidelines for screening. Three objectives were defined: (1) maximize public health and safety; (2) minimize adverse environmental and socioeconomic impacts; and (3) minimize system costs. The screening guidelines have numerical values that provided the basis for the successive reduction of the area under study and to focus on smaller areas that had a higher likelihood of containing suitable sites
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Site selection for nuclear power plants
International Nuclear Information System (INIS)
Ehjchkholz, D.
1980-01-01
Problem of NPP site selection in the USA including engineering factors, radiation and environmental protection factors is stated in detail. Floating and underground sites are considered especially. The attention in paid to waste storage and risk criterium in siting [ru
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Energy Technology Data Exchange (ETDEWEB)
La Pointe, Paul; Fox, Aaron (Golder Associates Inc (United States)); Hermanson, Jan; Oehman, Johan (Golder Associates AB, Stockholm (Sweden))
2008-12-15
The Swedish Nuclear Fuel and Waste Management Company (SKB) is performing site characterization at two different locations, Forsmark and Laxemar, in order to locate a site for a final geologic repository for spent nuclear fuel. The program is built upon the development of Site Descriptive Models (SDMs) at specific timed data freezes. Each SDM is formed from discipline-specific reports from across the scientific spectrum. This report describes the methods, analyses, and conclusions of the modelling team in the production of the SDM-Site Laxemar geological discrete-fracture network (DFN) model. The DFN builds upon the work of other geological models, including the deformation zone and rock domain models. The geological DFN is a statistical model for stochastically simulating rock fractures and minor deformation zones at a scale of less than 1,000 m (the lower cut-off of the DZ models). The geological DFN is valid within six distinct fracture domains inside the Laxemar local model subarea: FSM{sub C}, FSM{sub E}W007, FSM{sub N}, FSM{sub N}E005, FSM{sub S}, and FSM{sub W}. The models are built using data from detailed surface outcrop maps, geophysical lineament maps, and the cored borehole record at Laxemar. The conceptual model for the SDM-Site Laxemar geological DFN model revolves around the identification of fracture domains based on relative fracture set intensities, orientation clustering, and the regional tectonic framework (including deformation zones). A single coupled fracture size/fracture intensity concept (the Base Model) based on a Pareto (power-law) distribution for fracture sizes was chosen as the recommended parameterisation. A slew of alternative size-intensity models were also carried through the fracture analyses and into the uncertainty and model verification analyses. Uncertainty is modelled by analysing the effects on fracture intensity (P32) that alternative model cases can have. Uncertainty is parameterised as a ratio between the P32 of the
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International Nuclear Information System (INIS)
La Pointe, Paul; Fox, Aaron; Hermanson, Jan; Oehman, Johan
2008-10-01
The Swedish Nuclear Fuel and Waste Management Company (SKB) is performing site characterization at two different locations, Forsmark and Laxemar, in order to locate a site for a final geologic repository for spent nuclear fuel. The program is built upon the development of Site Descriptive Models (SDMs) at specific timed data freezes. Each SDM is formed from discipline-specific reports from across the scientific spectrum. This report describes the methods, analyses, and conclusions of the modelling team in the production of the SDM-Site Laxemar geological discrete-fracture network (DFN) model. The DFN builds upon the work of other geological models, including the deformation zone and rock domain models. The geological DFN is a statistical model for stochastically simulating rock fractures and minor deformation zones at a scale of less than 1,000 m (the lower cut-off of the DZ models). The geological DFN is valid within six distinct fracture domains inside the Laxemar local model subarea: FSM C , FSM E W007, FSM N , FSM N E005, FSM S , and FSM W . The models are built using data from detailed surface outcrop maps, geophysical lineament maps, and the cored borehole record at Laxemar. The conceptual model for the SDM-Site Laxemar geological DFN model revolves around the identification of fracture domains based on relative fracture set intensities, orientation clustering, and the regional tectonic framework (including deformation zones). A single coupled fracture size/fracture intensity concept (the Base Model) based on a Pareto (power-law) distribution for fracture sizes was chosen as the recommended parameterisation. A slew of alternative size-intensity models were also carried through the fracture analyses and into the uncertainty and model verification analyses. Uncertainty is modelled by analysing the effects on fracture intensity (P32) that alternative model cases can have. Uncertainty is parameterised as a ratio between the P32 of the alternative model and the P
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Clinical trials in the Middle East and North Africa (MENA) Region: grandstanding or grandeur?
Nair, Satish Chandrasekhar; Ibrahim, Halah; Celentano, David D
2013-11-01
Nearly 31% of the world's clinical trials are conducted outside the US and 25% of the new drug applications include data from international sites. The high population growth, demand for medication, increased prevalence of life-style related and rare genetic diseases in the MENA countries should be associated with a consequent scale-up of clinical trials in these countries. However, the region sponsors under 1% of global clinical trials. Determinants including the regulatory environment, patient protection, physician-preparedness, types of diseases, costs of trials and pace of subject recruitment, were analyzed to identify critical factors that influence barriers to the conduct clinical trials in MENA. Strategic planning by the CRO can help overcome challenges related to regulatory and oversight requirements. Barriers related to trial quality and subject protection can be mitigated by risk-based monitoring. Growing healthcare infrastructure and communication technologies provide clear advantages for subject recruitment. Low operating costs combined with the increase in pharmaceutical sales provide incentives for the future conduct of clinical trials. Although the opportunities and challenges cited are common to the MENA region, further studies are needed to assess other potential contributing variables for the conduct of clinical trials specific to each MENA country. Challenges in drug importation and site oversight can be overcome with systematic interventions. Social media network and community awareness programs can assist reductions in barriers in obtaining effective informed consents. Increasing pharmaceutical sales, population growth, high prevalence of genetic and life-style related diseases and reduced clinical trial development costs offer expanding opportunities for future clinical trials in MENA. Copyright © 2013 Elsevier Inc. All rights reserved.
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International Nuclear Information System (INIS)
Borofka, B.P.
1999-01-01
Wisconsin Electric Power Company, which recently celebrated its 100th anniversary, has actively promoted the redevelopment of its former sites as well as those of its customers. Serving Milwaukee and southeast Wisconsin, Wisconsin Electric's (WE) sites include former power plants, landfills, right-of-ways, and manufactured gas plant sites. In setting an example for others, as well as seeking to maximize the economic value of these sites, WE has either redeveloped or promoted the redevelopment of these sites by others. Examples include the East Wells Power Plant (now home of the Milwaukee Repertory Theater), the Lakeside Power Plant Site (now the home of Harnischfeger Corporation's headquarters), and the Commerce Street Power Plant located on the Milwaukee River near downtown Milwaukee. In each case the company evaluated the potential environmental liabilities against the unrealized asset value derived from facility location, site size, architectural uniqueness, or other characteristics. At the Commerce Street Power Plant, walking distance to the downtown Milwaukee business district combined with river frontage, were significant site values leveraged against a $5 million asbestos and lead-based paint removal project done to prepare the plant for marketing. More recently, WE has used its experience in promoting the redevelopment of the Menomonee River Valley, the original core of Milwaukee's industrial community, and in advancing a more practical regulatory approach to redeveloping older sites. Finally, the company is working with a non-profit community health clinic, community groups and local foundations in linking these redevelopment activities with the economic and physical health of inner city residents
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Energy Technology Data Exchange (ETDEWEB)
U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office
2004-04-01
This Corrective Action Decision Document identifies the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's corrective action alternative recommendation for each of the corrective action sites (CASs) within Corrective Action Unit (CAU) 204: Storage Bunkers, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. An evaluation of analytical data from the corrective action investigation, review of current and future operations at each CAS, and a detailed comparative analysis of potential corrective action alternatives were used to determine the appropriate corrective action for each CAS. There are six CASs in CAU 204, which are all located between Areas 1, 2, 3, and 5 on the NTS. The No Further Action alternative was recommended for CASs 01-34-01, 02-34-01, 03-34-01, and 05-99-02; and a Closure in Place with Administrative Controls recommendation was the preferred corrective action for CASs 05-18-02 and 05-33-01. These alternatives were judged to meet all requirements for the technical components evaluated as well as applicable state and federal regulations for closure of the sites and will eliminate potential future exposure pathways to the contaminated media at CAU 204.
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Site locality identification study: Hanford Site. Volume II. Data cataloging
International Nuclear Information System (INIS)
1980-07-01
Data compilation and cataloging for the candidate site locality identification study were conducted in order to provide a retrievable data cataloging system for the present siting study and future site evaluation and licensng processes. This task occurred concurrently with and also independently of other tasks of the candidate site locality identification study. Work in this task provided the data utilized primarily in the development and application of screening and ranking processes to identify candidate site localities on the Hanford Site. The overall approach included two steps: (1) data acquisition and screening; and (2) data compilation and cataloging. Data acquisition and screening formed the basis for preliminary review of data sources with respect to their probable utilization in the candidate site locality identification study and review with respect to the level of completeness and detail of the data. The important working assumption was that the data to be used in the study be based on existing and available published and unpublished literature. The data compilation and cataloging provided the basic product of the Task; a retrievable data cataloging system in the form of an annotated reference list and key word index and an index of compiled data. The annotated reference list and key word index are cross referenced and can be used to trace and retrieve the data sources utilized in the candidate site locality identification study
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Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.
Nyaoke, Borna A; Mutua, Gaudensia N; Sajabi, Rose; Nyasani, Delvin; Mureithi, Marianne W; Anzala, Omu A
2017-01-01
1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests. A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site. Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research. The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials.
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Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.
Directory of Open Access Journals (Sweden)
Borna A Nyaoke
Full Text Available 1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests.A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site.Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research.The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine
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A new in situ model to study erosive enamel wear, a clinical pilot study.
Ruben, J.L.; Truin, G.J.; Bronkhorst, E.M.; Huysmans, M.C.D.N.J.M.
2017-01-01
OBJECTIVES: To develop an in situ model for erosive wear research which allows for more clinically relevant exposure parameters than other in situ models and to show tooth site-specific erosive wear effect of an acid challenge of orange juice on enamel. METHODS: This pilot study included 6
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Takahashi, K; Sengoku, S; Kimura, H
2011-02-01
A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.
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Novel BRCA1 splice-site mutation in ovarian cancer patients of Slavic origin.
Krivokuca, Ana; Dragos, Vita Setrajcic; Stamatovic, Ljiljana; Blatnik, Ana; Boljevic, Ivana; Stegel, Vida; Rakobradovic, Jelena; Skerl, Petra; Jovandic, Stevo; Krajc, Mateja; Magic, Mirjana Brankovic; Novakovic, Srdjan
2018-04-01
Mutations in breast cancer susceptibility gene 1 (BRCA1) lead to defects in a number of cellular pathways including DNA damage repair and transcriptional regulation, resulting in the elevated genome instability and predisposing to breast and ovarian cancers. We report a novel mutation LRG_292t1:c.4356delA,p.(Ala1453Glnfs*3) in the 12th exon of BRCA1, in the splice site region near the donor site of intron 12. It is a frameshift mutation with the termination codon generated on the third amino acid position from the site of deletion. Human Splice Finder 3.0 and MutationTaster have assessed this variation as disease causing, based on the alteration of splicing, creation of premature stop codon and other potential alterations initiated by nucleotide deletion. Among the most important alterations are frameshift and splice site changes (score of the newly created donor splice site: 0.82). c.4356delA was associated with two ovarian cancer cases in two families of Slavic origin. It was detected by next generation sequencing, and confirmed with Sanger sequencing in both cases. Because of the fact that it changes the reading frame of the protein, novel mutation c.4356delA p.(Ala1453Glnfs*3) in BRCA1 gene might be of clinical significance for hereditary ovarian cancer. Further functional as well as segregation analyses within the families are necessary for appropriate clinical classification of this variant. Since it has been detected in two ovarian cancer patients of Slavic origin, it is worth investigating founder effect of this mutation in Slavic populations.
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Energy Technology Data Exchange (ETDEWEB)
NNSA/NSO
2002-12-12
The Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 204 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 204 is located on the Nevada Test Site approximately 65 miles northwest of Las Vegas, Nevada. This CAU is comprised of six Corrective Action Sites (CASs) which include: 01-34-01, Underground Instrument House Bunker; 02-34-01, Instrument Bunker; 03-34-01, Underground Bunker; 05-18-02, Chemical Explosives Storage; 05-33-01, Kay Blockhouse; 05-99-02, Explosive Storage Bunker. Based on site history, process knowledge, and previous field efforts, contaminants of potential concern for Corrective Action Unit 204 collectively include radionuclides, beryllium, high explosives, lead, polychlorinated biphenyls, total petroleum hydrocarbons, silver, warfarin, and zinc phosphide. The primary question for the investigation is: ''Are existing data sufficient to evaluate appropriate corrective actions?'' To address this question, resolution of two decision statements is required. Decision I is to ''Define the nature of contamination'' by identifying any contamination above preliminary action levels (PALs); Decision II is to ''Determine the extent of contamination identified above PALs. If PALs are not exceeded, the investigation is completed. If PALs are exceeded, then Decision II must be resolved. In addition, data will be obtained to support waste management decisions. Field activities will include radiological land area surveys, geophysical surveys to identify any subsurface metallic and nonmetallic debris, field screening for applicable contaminants of potential concern, collection and analysis of surface and subsurface soil samples from biased locations
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Fujise, Osamu; Miura, Mayumi; Hamachi, Takafumi; Maeda, Katsumasa
2006-08-01
Porphyromonas gingivalis is considered a critical pathogen of periodontal diseases including recurrent periodontitis. The profound effects of active periodontal treatment (APT) on P. gingivalis elimination were previously demonstrated and revealed that the subsequent P. gingivalis-free or -suppressed status seems to be maintained during early periodontal maintenance (PMT). The aim of the present study was to show the occurrence of microbial recolonization during this early PMT period. In total, 128 sites from 11 generalized chronic periodontitis patients and one generalized aggressive periodontitis patient underwent clinical and microbiologic examination at baseline (Exam-I), after APT (Exam-II), and in PMT (Exam-III). Exam-III was carried out an average of 4.5 +/- 3.5 months after Exam-II. Detection and quantification of putative pathogens were performed using a polymerase chain reaction-based method. The PMT used was effective in maintaining the clinical conditions improved by APT. However, in microbiological examinations, Exam-III showed higher detection frequency and levels of P. gingivalis than Exam-II. This suggests that a P. gingivalis recolonization started in the early PMT period. P. gingivalis-increased sites then showed significantly more severe signs of periodontitis in Exam-I than P. gingivalis-stable sites (bleeding on probing frequency: 76.7% versus 56.5%; suppuration frequency: 41.9% versus 12.9%). On the other hand, in Exam-II, no significant differences of clinical parameters were noted between P. gingivalis-increased and -stable sites. Severe periodontitis sites before APT seemed to place them at risk of P. gingivalis recolonization in the early PMT period, and this microbial restoration could be a cause of recurrent periodontitis.
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1984 state-by-state assessment of low-level radioactive wastes shipped to commercial disposal sites
International Nuclear Information System (INIS)
1985-12-01
The 1984 report uses the volume of low-level waste reported as received at each commercial disposal site as the national baseline figure. A volume of 75,429 m 3 of radioactive waste containing 600,909 Ci of activity was reported disposed at the commercial sites in 1984. The distribution of these waste volumes by disposal site is presented in Table 1. Table 2 displays typical radionuclides in low-level wastes by sector. Table 3 presents predominant waste forms associated with low-level waste by sector. The total volume and curie values tabulated for each state were obtained directly from the commercial disposal site operators. The total is the sum of the volume and radioactivity reported by Chem Nuclear and US Ecology for each state. Figure 1 displays the disposal capacity remaining at Barnwell, Richland, and Beatty commercial disposal sites as of December 31, 1984. Summary information on commercial nuclear power plant wastes was obtained from semiannual waste and effluent reports submitted to the NRC in accordance with the NRC Regulatory Guide 1.21. Where reported data were not available, data were obtained by communication with the utility. Non-reactor waste volumes are actual amounts recorded as received at the commercial waste repositories in 1984. Waste categories are defined as academic, medical, government, and industrial. Academic includes university hospitals and medical and nonmedical research facilities. The medical category includes hospitals and clinics, research facilities, and private medical offices. The industrial category includes private entities such as research and development companies, manufacturers, nondestructive testing, mining, and radiopharmaceutical manufacturers. Government includes state and federal agencies. Data from previous publications were also used as a comparison. 11 refs., 1 fig., 3 tabs
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Socioeconomic Site Study Plan: Draft
International Nuclear Information System (INIS)
1987-07-01
Social and economic issues and concerns of the Deak Smith County site area will be evaluated during site characterization. Effects that the area could experience from a repository project include demographic, economic, community service, fiscal, and social impacts. The Socioeconomic Site Study Plan is designed to provide a strategy to assess the potential for those impacts. The Socioeconomic Site Study Plan is structured to provide an overview of the socioeconomic program requirements, objectives, and activities to be conducted during site characterization. This report will describe the study design and its rationale; data collection, management, and reporting; program schedules and milestones; site study organization and management; and quality assurance issues. 43 refs
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Immediate placement of implants into infected sites: a systematic review.
Chrcanovic, Bruno Ramos; Martins, Maximiliano Delany; Wennerberg, Ann
2015-01-01
Traditionally, before placing dental implants, the compromised teeth are removed and the extraction sockets are left to heal for several months. To preserve the alveolar bone level from the collapse caused by healing and to reduce treatment time in situations in which tooth extraction precedes implant placement, some clinicians began to install the implant immediately into the postextraction socket without waiting for the site to heal. The purpose of this study was to review the literature regarding treatment outcomes of immediate implant placement into sites exhibiting pathology after clinical procedures to perform the decontamination of the implant's site. The following questions were raised: Does the presence of periodontal or endodontic infection affect immediate implant placement success? What is suggested to address the infection in the socket prior to immediate placement? An electronic search in PubMed (U.S. National Library of Medicine, Bethesda, MD, USA) was undertaken in March 2013. The titles and abstracts from these results were read to identify studies within the selection criteria. Eligibility criteria included both animal and human studies, and excluded any review and case reports articles. The publication's intervention had to have been implant placement into a site classified as having an infection (periapical, endodontic, perioendodontic, and periodontal). The search strategy initially yielded 706 references. Thirty-two studies were identified within the selection criteria, from which nine were case reports and review articles and were excluded. Additional hand-searching of the reference lists of selected studies yielded five additional papers. The high survival rate obtained in several studies supports the hypothesis that implants may be successfully osseointegrated when placed immediately after extraction of teeth presenting endodontic and periodontal lesions, provided that appropriate clinical procedures are performed before the implant
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Siting of nuclear facilities. Selections from Nuclear Safety
Energy Technology Data Exchange (ETDEWEB)
Buchanan, J.R.
1976-07-01
The report presented siting policy and practice for nuclear power plants as developed in the U.S. and abroad. Twenty-two articles from Nuclear Safety on this general topic are reprinted since they provide a valuable reference source. The appendices also include reprints of some relevant regulatory rules and guides on siting. Advantages and disadvantages of novel siting concepts such as underground containment, offshore siting, and nuclear energy parks are addressed. Other topics include site criteria, risk criteria, and nuclear ship criteria.
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Siting of nuclear facilities. Selections from Nuclear Safety
International Nuclear Information System (INIS)
Buchanan, J.R.
1976-07-01
The report presented siting policy and practice for nuclear power plants as developed in the U.S. and abroad. Twenty-two articles from Nuclear Safety on this general topic are reprinted since they provide a valuable reference source. The appendices also include reprints of some relevant regulatory rules and guides on siting. Advantages and disadvantages of novel siting concepts such as underground containment, offshore siting, and nuclear energy parks are addressed. Other topics include site criteria, risk criteria, and nuclear ship criteria
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Antibiotic prophylaxis for surgical site infection in people undergoing liver transplantation.
Almeida, Ricardo A M B; Hasimoto, Claudia N; Kim, Anna; Hasimoto, Erica N; El Dib, Regina
2015-12-05
met the inclusion criteria after randomisation, and hence were included in the analyses. Most probably, the 17 excluded participants were high-risk liver transplant recipients. Trial authors concluded that they could find no differences between the two antibiotic regimens - ceftriaxone plus metronidazole versus ampicillin-sulbactam plus ceftizoxime - when given to liver transplant recipients. Review authors could not reconfirm the analyses because, as it has been mentioned, trial authors provided no trial data for analyses. Benefits and harms of antibiotic prophylactic regimens for surgical site infection in liver transplantation remain unclear. Additional well-conducted randomised clinical trials adhering to SPIRIT (Spirit Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) guidelines are needed to determine the exact role of antibiotic prophylactic regimens in patients undergoing liver transplantation.
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Vaduganathan, Muthiah; Butler, Javed; Roessig, Lothar; Fonarow, Gregg C; Greene, Stephen J; Metra, Marco; Cotter, Gadi; Kupfer, Stuart; Zalewski, Andrew; Sato, Naoki; Filippatos, Gerasimos; Gheorghiade, Mihai
2015-07-01
With one possible exception, the last decade of clinical trials in hospitalized heart failure (HHF) patients has failed to demonstrate improvement in long-term clinical outcomes. This trend necessitates a need to evaluate optimal drug development strategies and standards of trial conduct. It has become increasingly important to recognize the heterogeneity among HHF patients and the differential characterization of novel drug candidates. Targeting these agents to specific subpopulations may afford optimal net response related to the particular mode of action of the drug. Analyses of previous trials demonstrate profound differences in the baseline characteristics of patients enrolled across global regions and participating sites. Such differences may influence risks for events and interpretation of results. Therefore, the actual execution of trials and the epidemiology of HHF populations at the investigative sites must be taken into consideration. Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct. Observational data prior to study initiation may enable sites to feedback and engage in protocol development to allow for feasible and valid clinical trial conduct. This site-centered, epidemiology-based network environment may facilitate studies in specific patient populations and promote optimal data collection and clear interpretation of drug safety and efficacy. This review summarizes the roundtable discussion held by a multidisciplinary team of representatives from academia, National Institutes of Health, industry, regulatory agencies, payers, and contract and academic research organizations to answer the question: Who should be targeted for novel therapies in HHF?
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Directory of Open Access Journals (Sweden)
Fumito Kuranishi
2018-01-01
Full Text Available Introduction. No effective treatment has been developed for bone-metastatic breast cancer. We found 3 cases with clinical complete response (cCR of the bone metastasis and longer overall survival of the retrospectively examined cohort treated comprehensively including autologous formalin-fixed tumor vaccine (AFTV. Patients and Methods. AFTV was prepared individually for each patient from their own formalin-fixed and paraffin-embedded breast cancer tissues. Results. Three patients maintained cCR status of the bone metastasis for 17 months or more. Rate of cCR for 1 year or more appeared to be 15% (3/20 after comprehensive treatments including AFTV. The median overall survival time (60.0 months and the 3- to 8-year survival rates after diagnosis of bone metastasis were greater than those of historical control cohorts in Japan (1988–2002 and in the nationwide population-based cohort study of Denmark (1999–2007. Conclusion. Bone-metastatic breast cancer may be curable after comprehensive treatments including AFTV, although larger scale clinical trial is required.
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Money and morals: ending clinical trials for financial reasons.
Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas
2015-01-01
Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic.
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Australian clinical dosimetry service at ARPANSA
International Nuclear Information System (INIS)
McDonald, Abel; Williams, Ivan
2010-01-01
Full text: Earlier this year, the Australian Health Ministers' Advisory Council accepted the Federal Government's offer to fund the establishment and operation for 3 years of an Australian Clinical Dosimetry Service (ACDS). The service will be located within the Australian Radiation Protection and Nuclear Safety Agency in Yallambie, Victoria and will commence operation at the beginning of 20II. The purpose of the ACDS is to make available independent checks and auditing services to all Australian radiotherapy services. These services will range form postal audits to site visits, and include treatment dose assessments using phantoms (Level III audits). There will be a Clinical Advisory Group to oversee the development of the service, so the ACPSEM and other professional groups will playa key role in developing the ACDS. In consultation with radiotherapy facilities, the ACDS will establish an Audit Panel which will be made up of local staff to assist with on site work and minimise travel costs. The results of all measurements made by the ACDS will be confi dential: only de-identified data would be publicly reported. The service will be free to participating facilities in the first 3 years. An independent review will be conducted in the third year to determine the ongoing arrangements for the service.
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Johnston, Bridget; Patterson, Anne; Bird, Lydia; Wilson, Eleanor; Almack, Kathryn; Mathews, Gillian; Seymour, Jane
2018-02-23
The Midhurst Macmillan Specialist Palliative Care at Home Service was founded in 2006 to improve community-based palliative care provision. Principal components include; early referral; home-based clinical interventions; close partnership working; and flexible teamwork. Following a successful introduction, the model was implemented in six further sites across England. This article reports a mixed methods evaluation of the implementation across these 'Innovation Centres'. The evaluation aimed to assess the process and impact on staff, patients and carers of providing Macmillan Specialist Care at Home services across the six sites. The study was set within a Realist Evaluation framework and used a longitudinal, mixed methods research design. Data collection over 15 months (2014-2016) included: Quantitative outcome measures - Palliative Performance Scale [PPS] and Palliative Prognostic Index [PPI] (n = 2711); Integrated Palliative Outcome Scales [IPOS] (n = 1157); Carers Support Needs Assessment Tool [CSNAT] (n = 241); Views of Informal Carers -Evaluation of Services [VOICES-SF] (n = 102); a custom-designed Service Data Tool [SDT] that gathered prospective data from each site (n = 88). Qualitative data methods included: focus groups with project team and staff (n = 32 groups with n = 190 participants), and, volunteers (n = 6 groups with n = 32 participants). Quantitative data were analysed using SPPS Vs. 21 and qualitative data was examined via thematic analysis. Comparison of findings across the six sites revealed the impact of their unique configurations on outcomes, compounded by variations in stage and mode of implementation. PPS, PPI and IPOS data revealed disparity in early referral criteria, complicated by contrasting interpretations of palliative care. The qualitative analysis, CSNAT and VOICES-SF data confirmed the value of the Macmillan model of care but uptake of specialist home-based clinical interventions was limited. The
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International Nuclear Information System (INIS)
1992-10-01
The US Environmental Protection Agency (EPA) has established health and environmental protection regulations to correct and prevent groundwater contamination resulting from processing activities at inactive uranium milling sites (40 CFR 192). The US Department of Energy (DOE) is responsible for assessing the inactive uranium processing sites. The DOE has determined this assessment shall include information on hydrogeologic site characterization. This document contains appendices to Attachment 3, Groundwater Hydrology Report included are calculations
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Nanoparticles for Site Specific Genome Editing
McNeer, Nicole Ali
Triplex-forming peptide nucleic acids (PNAs) can be used to coordinate the recombination of short 50-60 by "donor DNA" fragments into genomic DNA, resulting in site-specific correction of genetic mutations or the introduction of advantageous genetic modifications. Site-specific gene editing in hematopoietic stem and progenitor cells (HSPCs) could result in treatment or cure of inherited disorders of the blood such as beta-thalassemia. Gene editing in HSPCs and differentiated T cells could help combat HIV/AIDs by modifying receptors, such as CCR5, necessary for R5-tropic HIV entry. However, translation of genome modification technologies to clinical practice is limited by challenges in intracellular delivery, especially in difficult-to-transfect hematolymphoid cells. In vivo gene editing could also provide novel treatment for systemic monogenic disorders such as cystic fibrosis, an autosomal recessive disorder caused by mutations in the cystic fibrosis transmembrane receptor. Here, we have engineered biodegradable nanoparticles to deliver oligonucleotides for site-specific genome editing of disease-relevant genes in human cells, with high efficiency, low toxicity, and editing of clinically relevant cell types. We designed nanoparticles to edit the human beta-globin and CCR5 genes in hematopoietic cells. We show that poly(lactic-co-glycolic acid) (PLGA) nanoparticles can delivery PNA and donor DNA for site-specific gene modification in human hematopoietic cells in vitro and in vivo in NOD-scid IL2rgammanull mice. Nanoparticles delivered by tail vein localized to hematopoietic compartments in the spleen and bone marrow of humanized mice, resulting in modification of the beta-globin and CCR5 genes. Modification frequencies ranged from 0.005 to 20% of cells depending on the organ and cell type, without detectable toxicity. This project developed highly versatile methods for delivery of therapeutics to hematolymphoid cells and hematopoietic stem cells, and will help to
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Ecological restoration of Central European mining sites: a summary of a multi-site analysis
Energy Technology Data Exchange (ETDEWEB)
Prach, K.; Rehounkova, K.; Rehounek, J.; Konvalinkova, P. [University of South Bohemia, Ceske Budejovice (Czech Republic)
2011-07-01
Sites disturbed by mining were surveyed in the Czech Republic, central Europe. The sites included spoil heaps from coal mining, sand and gravel pits, extracted peatlands and stone quarries. The following main conclusions emerged: I) potential for spontaneous succession to be used in restoration projects is between 95 and 100% of the total area disturbed; ii) mining sites, if mining is properly designed and then the sites are left to spontaneous succession, often act as refugia for endangered and retreating organisms, and may contribute substantially to local biodiversity.
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Regional energy facility siting analysis
International Nuclear Information System (INIS)
Eberhart, R.C.; Eagles, T.W.
1976-01-01
Results of the energy facility siting analysis portion of a regional pilot study performed for the anticipated National Energy Siting and Facility Report are presented. The question of cell analysis versus site-specific analysis is explored, including an evaluation of the difference in depth between the two approaches. A discussion of the possible accomplishments of regional analysis is presented. It is concluded that regional sitting analysis could be of use in a national siting study, if its inherent limits are recognized
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Golden Eagle Territories and Ecology at Site 300
Energy Technology Data Exchange (ETDEWEB)
Fratanduono, M. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)
2015-09-29
Garcia and Associates (GANDA) was contracted by the Lawrence Livermore National Laboratory (LLNL) to collect information on golden eagle (Aquila chrysaetos) use of Site 300. During 2014, we conducted surveys at Site 300 and for an area including a 10-mile radius of Site 300. Those surveys documented 42 golden eagle territories including two territories that overlapped with Site 300. These were named ‘Tesla’ and ‘Linac Road’. In 2015, we conducted surveys to refine the territory boundaries of golden eagle territories that overlapped with Site 300 and to document eagle activity at Site 300.
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International Nuclear Information System (INIS)
Khanlari, Mahsa; Daneshbod, Yahya; Shaterzadeh Yazdi, Hanieh; Shirian, Sadegh; Negahban, Shahrzad; Aledavood, Azita; Oryan, Ahmad; Khademi, Bijan; Daneshbod, Khosrow; Field, Andrew
2015-01-01
The diagnostic accuracy of fine needle aspiration cytology (FNAC) of head and neck lesions is relatively high, but cytologic interpretation might be confusing if the sample is lacking typical cytologic features according to labeled site by physician. These errors may have an impact on pathology search engines, healthcare costs or even adverse outcomes. The cytology archive database of multiple institutions in southern Iran and Australia covering the period 2001–2011, were searched using keywords: salivary gland, head, neck, FNAC, and cytology. All the extracted reports were reviewed. The reports which showed discordance between the clinician's impression of the organ involved and subsequent fine needle biopsy request, and the eventual cytological diagnosis were selected. The cytological diagnosis was confirmed by histology or cell block, with assistance from imaging, clinical outcome, physical examination, molecular studies, or microbiological culture. The total number of 10,200 head and neck superficial FNAC were included in the study, from which 48 cases showed discordance between the clinicians request and the actual site of pathology. Apart from the histopathology, the imaging, clinical history, physical examination, immunohistochemical study, microbiologic culture and molecular testing helped to finalize the target organ of pathology in 23, 6, 7, 8, 2, and 1 cases respectively. The commonest discrepancies were for FNAC of “salivary gland” [total: 20 with actual final pathology in: bone (7), soft tissue (5), lymph node (3), odontogenic (3) and skin (2)], “lymph node” [total: 12 with final pathology in: soft tissue (3), skin (3), bone (1) and brain (1)], “soft tissue” [total: 11 with final pathology in: bone (5), skin (2), salivary gland (1), and ocular region (1)] and “skin” [total: 5 with final pathology in: lymph node (2), bone (1), soft tissue (1) and salivary gland (1)]. The primary physician requesting FNAC of head and neck lesions
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Clinical Chemistry of Patients With Ebola in Monrovia, Liberia.
de Wit, Emmie; Kramer, Shelby; Prescott, Joseph; Rosenke, Kyle; Falzarano, Darryl; Marzi, Andrea; Fischer, Robert J; Safronetz, David; Hoenen, Thomas; Groseth, Allison; van Doremalen, Neeltje; Bushmaker, Trenton; McNally, Kristin L; Feldmann, Friederike; Williamson, Brandi N; Best, Sonja M; Ebihara, Hideki; Damiani, Igor A C; Adamson, Brett; Zoon, Kathryn C; Nyenswah, Tolbert G; Bolay, Fatorma K; Massaquoi, Moses; Sprecher, Armand; Feldmann, Heinz; Munster, Vincent J
2016-10-15
The development of point-of-care clinical chemistry analyzers has enabled the implementation of these ancillary tests in field laboratories in resource-limited outbreak areas. The Eternal Love Winning Africa (ELWA) outbreak diagnostic laboratory, established in Monrovia, Liberia, to provide Ebola virus and Plasmodium spp. diagnostics during the Ebola epidemic, implemented clinical chemistry analyzers in December 2014. Clinical chemistry testing was performed for 68 patients in triage, including 12 patients infected with Ebola virus and 18 infected with Plasmodium spp. The main distinguishing feature in clinical chemistry of Ebola virus-infected patients was the elevation in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyltransferase levels and the decrease in calcium. The implementation of clinical chemistry is probably most helpful when the medical supportive care implemented at the Ebola treatment unit allows for correction of biochemistry derangements and on-site clinical chemistry analyzers can be used to monitor electrolyte balance. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.
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Five Fabulous Literacy-Oriented Web Sites.
Kurlychek, Ken
1997-01-01
Profiles six noteworthy web sites on literacy-related information, including sites that deal with issues addressing literacy and deafness, literacy development, family literacy program development, evaluation of family literacy programs, and encouraging young children with deafness to read. Online addresses of the web sites are provided. (CR)
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Communities of clinical practice: the social organization of clinical learning.
Egan, Tony; Jaye, Chrystal
2009-01-01
The social organization of clinical learning is under-theorized in the sociological literature on the social organization of health care. Professional scopes of practice and jurisdictions are formally defined by professional principles and standards and reflected in legislation; however, these are mediated through the day-to-day clinical activities of social groupings of clinical teams. The activities of health service providers typically occur within communities of clinical practice. These are also major sites for clinical curriculum delivery, where clinical students learn not only clinical skills but also how to be health professionals. In this article, we apply Wenger's model of social learning within organizations to curriculum delivery within a health service setting. Here, social participation is the basis of learning. We suggest that it offers a powerful framework for recognizing and explaining paradox and incongruence in clinical teaching and learning, and also for recognizing opportunities, and devising means, to add value to students' learning experiences.
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Cost analysis of a novel HIV testing strategy in community pharmacies and retail clinics.
Lecher, Shirley Lee; Shrestha, Ram K; Botts, Linda W; Alvarez, Jorge; Moore, James H; Thomas, Vasavi; Weidle, Paul J
2015-01-01
To document the cost of implementing point-of-care (POC) human immunodeficiency virus (HIV) rapid testing in busy community pharmacies and retail clinics. Providing HIV testing services in community pharmacies and retail clinics is an innovative way to expand HIV testing. The cost of implementing POC HIV rapid testing in a busy retail environment needs to be documented to provide program and policy leaders with adequate information for planning and budgeting. Cost analysis from a pilot project that provided confidential POC HIV rapid testing services in community pharmacies and retail clinics. The pharmacy sites were operated under several different ownership structures (for-profit, nonprofit, sole proprietorship, corporation, public, and private) in urban and rural areas. We included data from the initial six sites that participated in the project. We collected the time spent by pharmacy and retail clinic staff for pretest and posttest counseling in an activity log for time-in-motion for each interaction. Pharmacists and retail clinic staff. HIV rapid testing. The total cost was calculated to include costs of test kits, control kits, shipping, test supplies, training, reporting, program administration, and advertising. The six sites trained 22 staff to implement HIV testing. A total of 939 HIV rapid tests were conducted over a median time of 12 months, of which 17 were reactive. Median pretest counseling time was 2 minutes. Median posttest counseling time was 2 minutes for clients with a nonreactive test and 10 minutes for clients with a reactive test. The average cost per person tested was an estimated $47.21. When we considered only recurrent costs, the average cost per person tested was $32.17. Providing POC HIV rapid testing services required a modest amount of staff time and costs that are comparable to other services offered in these settings. HIV testing in pharmacies and retail clinics can provide an additional alternative venue for increasing the
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International Nuclear Information System (INIS)
1987-10-01
The Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) requires the Department of Energy (DOE) to provide technical assistance to ''...those compact regions, host States and nonmember States determined by the Secretary to require assistance.'' Technical assistance has been defined to include, but not be limited to, ''technical guidelines for site selection.'' This site selection workshop was developed to assist States and Compacts in developing new low-level radioactive waste (LLW) disposal sites in accordance with the requirements of the LLRWPAA. The workshop comprises a series of lectures, discussion topics, and exercises, supported by this Site Selection Workshop Handbook, designed to examine various aspects of a comprehensive site selection program. It is not an exhaustive treatment of all aspects of site selection, nor is it prescriptive. The workshop focuses on the major elements of site selection and the tools that can be used to implement the site selection program
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Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate.
Mackay, Christine B; Antonelli, Kaitlyn R; Bruinooge, Suanna S; Saint Onge, Jarron M; Ellis, Shellie D
2017-08-01
The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers' efforts to accrue patients to clinical trials has not been well described. First, members of cancer research centers and community-based institutions (n = 252) were surveyed to assess the status of insurance denials, and then, a focused survey (n = 77) collected denial details. Univariate and multivariate analyses were used to examine associations between the receipt of denials and site characteristics. Overall, 62.7% of the initial survey respondents reported at least 1 insurance denial during 2014. Sites using a precertification process were 3.04 times more likely to experience denials (95% confidence interval, 1.55-5.99; P ≤ .001), and similar rates of denials were reported from sites located in states with preexisting clinical trial coverage laws versus states without them (82.3% vs 85.1%; χ = 50.7; P ≤ .001). Among the focused survey sites, academic centers reported denials more often than community sites (71.4% vs 46.4%). The failure of plans to cover trial participation was cited as the most common reason provided for denials (n = 33 [80.5%]), with nearly 80% of sites (n = 61) not receiving a coverage response from the insurer within 72 hours. Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts
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International Nuclear Information System (INIS)
1992-09-01
The purpose of this volume is to report the results of the comparison of the ALWR plan parameters envelope with values of site characteristics developed for our hypothetical sites that generally represent conditions encountered within the United States. This effort is not intended to identify or address the suitability of any existing site, site area, or region in the United States. Also included in this volume is Appendix F, SERCH Summaries Regarding Siting
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Replacement Power Facility site selection report
Energy Technology Data Exchange (ETDEWEB)
Wike, L.D.; Toole, G.L.; Specht, W.L.
1992-06-01
The Department of Energy (DOE) has proposed the construction and operation of a Replacement Power Facility (RPF) for supplementing and replacing existing sources of steam and possibly electricity at the Savannah River Site (SRS). DOE is preparing an Environmental Impact Statement (EIS) for this project As part of the impact analysis of the proposed action, the EIS will include a detailed description of the environment where the RPF will be constructed. This description must be specific to the recommended site at SRS, which contains more than 300 square miles of land including streams, lakes, impoundments, wetlands, and upland areas. A formal site-selection process was designed and implemented to identify the preferred RPF site.
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Evolution of the clinical trial landscape in Asia Pacific
Directory of Open Access Journals (Sweden)
Yathindranath S
2014-07-01
Full Text Available Shourav Yathindranath,1 Amar Kureishi,2 Simranjit Singh,3 Spencer Yeow,3 Grace Geng,4 Karen Wai,1 Audrey Ho,1 Elvira Zenaida Lansang,1 Ken J Lee5 1Feasibility and Site Identification Asia, 2Drug Development Asia, 3Strategic Planning Asia, Quintiles East Asia Private Limited, Singapore; 4People’s Republic of China Site Services, Quintiles, Beijing, People’s Republic of China; 5Asia Site Services, Quintiles East Asia Private Limited, Singapore Introduction: Asia Pacific has and continues to be one of the fastest-growing pharmaceutical markets in the world. This growth has a carry-over effect of driving pharmaceutical research and development investment in the region. Coupled with this, there have been multiple initiatives conducted by governments and other research focused organizations and societies in the region to help support this growth in research. In this report, we discuss the latest developments in pharmaceutical research and development in Asia Pacific and how these various initiatives have made an impact. Methods: An extensive search of the major clinical trial registries, along with the literature and Internet review of the recent developments in clinical trials, was performed comparing two time periods – 2009–2010 and 2011–2012. Results: In overall numbers, the clinical trial industry in Asia Pacific has remained stable when comparing the two time periods, with stable volumes of clinical trial numbers and site numbers. However, on closer inspection, a dynamic change in geography, nature, and therapeutic areas of the trials being conducted is observed. Japan, South Korea, People’s Republic of China, and Taiwan continue to be major clinical trial destinations. Developing countries, such as Indonesia, Vietnam, and Philippines, have seen rising standards of living and medical care; this is starting to impact their contribution to trials. Also, there are an increasing number of local trials in Asia Pacific with a bigger role
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Directory of Open Access Journals (Sweden)
Q Xu
2014-12-01
Full Text Available Objective: To analyse the clinicopathologic characteristics of visceral metastatic carcinoma of unknown primary site (VMCUP, discuss the relationship between its treatment and prognosis, and provide the basis for individualized clinical diagnosis and treatment. Methods: A retrospective analysis on clinical pathologic data was performed on 21 VMCUP cases from Fujian Union Hospital from January 2007 to January 2012. Follow-up visits on patients were made and analysis of their survival conditions and relevant influencing factors were collated. Results: The gender distribution of the 21 VMCUP cases was 1:1.1; the median age was 63 years and the pathology type was dominated by adenocarcinoma. The median survival time and survival rate in patients accepting treatment were evidently higher than those in patients not accepting treatment. The median survival time of those patients receiving more than one treatment procedure was higher than in those patients only receiving chemotherapy. Among those patients who received comprehensive therapy, the median survival time in those mainly receiving operative therapy was also higher than in those only receiving chemotherapy (p two cycles or > four cycles was evidently longer than those receiving chemotherapy ≤ two cycles or ≤ four cycles separately. For those choosing paclitaxel in combination with platinum as first-line chemotherapy, their median survival time was longer than those primarily taking fluorouracil (p 0.05 in the median survival times among groups receiving the same treatment but with different age, gender or pathological types. It was indicated by multiple-factor analysis that the chemotherapeutics, chemotherapy times and treatment methods were prognostic factors affecting the survival of VMCUP. Conclusion: The overall progression of VMCUP patients deteriorates quickly, with a poor prognosis and without a standard treatment pattern. Appropriate chemotherapy, surgery and radiotherapy, however
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Zipfel, Jonathan; Kastler, Adrian; Tatu, Laurent; Behr, Julien; Kechidi, Rachid; Kastler, Bruno
2016-01-01
Two studies recently reported that computed tomography (CT) guided infiltration of the greater occipital nerve at its intermediate site allows a high efficacy rate with long-lasting pain relief following procedure in occipital neuralgia and in various craniofacial pain syndromes. The purpose of our study was to evaluate the technical feasibility and safety of ultrasound-guided intermediate site greater occipital nerve infiltration. Retrospective study. This study was conducted at the imaging department of a 1,409 bed university hospital. Local institutional review board approval was obtained and written consent was waived. In this retrospective study, 12 patients suffering from refractory occipital neuralgia or craniofacial pain syndromes were included between April and October 2014. They underwent a total of 21 ultrasound-guided infiltrations. Infiltration of the greater occipital nerve was performed at the intermediate site of the greater occipital nerve, at its first bend between obliqus capitis inferior and semispinalis capitis muscles with local anestetics and cortivazol. Technical success was defined as satisfactory diffusion of added iodinated contrast media in the fatty space between these muscles depicted on control CT scan. We also reported first data of immediate block test efficacy and initial clinical efficacy at 7 days, one month, and 3 months, defined by a decrease of at least 50% of visual analog scale (VAS) scores. Technical success rate was 95.24%. Patients suffered from right unilateral occipital neuralgia in 3 cases, left unilateral occipital neuralgia in 2 cases, bilateral occipital neuralgia in 2 cases, migraine in one case, cervicogenic headache in one case, tension-type headache in 2 cases, and cluster headache in one case. Block test efficacy was found in 93.3% (14/15) cases. Clinical efficacy was found in 80% of cases at 7 days, in 66.7% of cases at one month and in 60% of cases at 3 months. No major complications were noted. Some of the
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Vidal-Acuña, M Reyes; Ruiz-Pérez de Pipaón, Maite; Torres-Sánchez, María José; Aznar, Javier
2017-12-08
An expanded library of matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) has been constructed using the spectra generated from 42 clinical isolates and 11 reference strains, including 23 different species from 8 sections (16 cryptic plus 7 noncryptic species). Out of a total of 379 strains of Aspergillus isolated from clinical samples, 179 strains were selected to be identified by sequencing of beta-tubulin or calmodulin genes. Protein spectra of 53 strains, cultured in liquid medium, were used to construct an in-house reference database in the MALDI-TOF MS. One hundred ninety strains (179 clinical isolates previously identified by sequencing and the 11 reference strains), cultured on solid medium, were blindy analyzed by the MALDI-TOF MS technology to validate the generated in-house reference database. A 100% correlation was obtained with both identification methods, gene sequencing and MALDI-TOF MS, and no discordant identification was obtained. The HUVR database provided species level (score of ≥2.0) identification in 165 isolates (86.84%) and for the remaining 25 (13.16%) a genus level identification (score between 1.7 and 2.0) was obtained. The routine MALDI-TOF MS analysis with the new database, was then challenged with 200 Aspergillus clinical isolates grown on solid medium in a prospective evaluation. A species identification was obtained in 191 strains (95.5%), and only nine strains (4.5%) could not be identified at the species level. Among the 200 strains, A. tubingensis was the only cryptic species identified. We demonstrated the feasibility and usefulness of the new HUVR database in MALDI-TOF MS by the use of a standardized procedure for the identification of Aspergillus clinical isolates, including cryptic species, grown either on solid or liquid media. © The Author 2017. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For
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Site observational work plan for the UMTRA Project Site at Riverton, Wyoming. Revision 3/95
International Nuclear Information System (INIS)
1995-03-01
Ground water compliance for the Uranium Mill Tailings Remedial Action (UMTRA) Project sites, including the Riverton, Wyoming, site, is governed by the Uranium Mill Tailings Radiation Control Act and the US Environmental Protection Agency's Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings. The compliance strategy proposed for this site is natural flushing in conjunction with institutional controls. The essential premise of natural flushing is that ground water movement and natural attenuation processes will reduce the detected contamination to background levels or alternate concentration limits that do not pose a risk to human health or the environment within 100 years. This document contains the following sections. Section 2.0 of this SOWP describes the requirements for meeting standards at UMTRA Project sites. Section 3.0 provides site-specific data and the related conceptual model. Section 4.0 provides the justification for the recommended ground water compliance strategy for the Riverton site. Section 5.0 provides the justification and process for collection and assessment of additional required data. Section 6.0 provides a list of the references cited. The appendixes include data on monitor wells and lithography, ground water, surface water, and sediment quality
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Remediation management of complex sites using an adaptive site management approach.
Price, John; Spreng, Carl; Hawley, Elisabeth L; Deeb, Rula
2017-12-15
Complex sites require a disproportionate amount of resources for environmental remediation and long timeframes to achieve remediation objectives, due to their complex geologic conditions, hydrogeologic conditions, geochemical conditions, contaminant-related conditions, large scale of contamination, and/or non-technical challenges. A recent team of state and federal environmental regulators, federal agency representatives, industry experts, community stakeholders, and academia worked together as an Interstate Technology & Regulatory Council (ITRC) team to compile resources and create new guidance on the remediation management of complex sites. This article summarizes the ITRC team's recommended process for addressing complex sites through an adaptive site management approach. The team provided guidance for site managers and other stakeholders to evaluate site complexities and determine site remediation potential, i.e., whether an adaptive site management approach is warranted. Adaptive site management was described as a comprehensive, flexible approach to iteratively evaluate and adjust the remedial strategy in response to remedy performance. Key aspects of adaptive site management were described, including tools for revising and updating the conceptual site model (CSM), the importance of setting interim objectives to define short-term milestones on the journey to achieving site objectives, establishing a performance model and metrics to evaluate progress towards meeting interim objectives, and comparing actual with predicted progress during scheduled periodic evaluations, and establishing decision criteria for when and how to adapt/modify/revise the remedial strategy in response to remedy performance. Key findings will be published in an ITRC Technical and Regulatory guidance document in 2017 and free training webinars will be conducted. More information is available at www.itrc-web.org. Copyright © 2017 Elsevier Ltd. All rights reserved.
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1994 Site environmental report
Energy Technology Data Exchange (ETDEWEB)
NONE
1995-07-01
The Fernald site is a Department of Energy (DOE)-owned facility that produced high-quality uranium metals for military defense for nearly 40 years. DOE suspended production at the site in 1989 and formally ended production in 1991. Although production activities have ceased, the site continues to examine the air and liquid pathways as possible routes through which pollutants from past operations and current remedial activities may leave the site. The Site Environmental Report (SER) is prepared annually in accordance with DOE Order 5400.1, General Environmental Protection Program. This 1994 SER provides the general public as well as scientists and engineers with the results from the site`s ongoing Environmental Monitoring Program. Also included in this report is information concerning the site`s progress toward achieving full compliance with requirements set forth by DOE, U.S. Environmental Protection Agency (USEPA), and Ohio EPA (OEPA). For some readers, the highlights provided in this Executive Summary may provide sufficient information. Many readers, however, may wish to read more detailed descriptions of the information than those which are presented here. All information presented in this summary is discussed more fully in the main body of this report.
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International Nuclear Information System (INIS)
Carlson, R.A.
2005-01-01
The 600-233 waste site consisted of three small-diameter pipelines within the 600-232 waste site, including previously unknown diesel fuel supply lines discovered during site remediation. The 600-233 waste site has been remediated to achieve the remedial action objectives specified in the Remaining Sites ROD. The results of verification sampling show that residual contaminant concentrations do not preclude any future uses and allow for unrestricted use of shallow zone soils. The results also demonstrate that residual contaminant concentrations are protective of groundwater and the Columbia River
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Energy Technology Data Exchange (ETDEWEB)
U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office
2003-07-16
This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 322, Areas 1 and 3 Release Sites and Injection Wells, Nevada Test Site, Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 322 consists of three Corrective Action Sites (CASs): 01-25-01, AST Release (Area 1); 03-25-03, Mud Plant AST Diesel Release (Area 3); 03-20-05, Injection Wells (Area 3). Corrective Action Unit 322 is being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives. The investigation of three CASs in CAU 322 will determine if hazardous and/or radioactive constituents are present at concentrations and locations that could potentially pose a threat to human health and the environment. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.
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Directory of Open Access Journals (Sweden)
Daniel Ortiz
2016-01-01
Full Text Available Purpose: Access site complications following peripheral vascular intervention (PVI are associated with prolonged hospitalization and increased mortality. Prediction of access site complication risk may optimize PVI care; however, there is no tool designed for this. We aimed to create a clinical scoring tool to stratify patients according to their risk of developing access site complications after PVI. Methods: The Society for Vascular Surgery’s Vascular Quality Initiative database yielded 27,997 patients who had undergone PVI at 131 North American centers. Clinically and statistically significant preprocedural risk factors associated with in-hospital, post-PVI access site complications were included in a multivariate logistic regression model, with access site complications as the outcome variable. A predictive model was developed with a random sample of 19,683 (70% PVI procedures and validated in 8,314 (30%. Results: Access site complications occurred in 939 (3.4% patients. The risk tool predictors are female gender, age > 70 years, white race, bedridden ambulatory status, insulin-treated diabetes mellitus, prior minor amputation, procedural indication of claudication, and nonfemoral arterial access site (model c-statistic = 0.638. Of these predictors, insulin-treated diabetes mellitus and prior minor amputation were protective of access site complications. The discriminatory power of the risk model was confirmed by the validation dataset (c-statistic = 0.6139. Higher risk scores correlated with increased frequency of access site complications: 1.9% for low risk, 3.4% for moderate risk and 5.1% for high risk. Conclusions: The proposed clinical risk score based on eight preprocedural characteristics is a tool to stratify patients at risk for post-PVI access site complications. The risk score may assist physicians in identifying patients at risk for access site complications and selection of patients who may benefit from bleeding avoidance
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Site Rehabilitation Completion Report with No Further Action Proposal for the Northeast Site
Energy Technology Data Exchange (ETDEWEB)
Daniel, Joe [Stoller Newport News Technology, Inc., Grand Junction, CO (United States); Tabor, Charles [Stoller Newport News Technology, Inc., Grand Junction, CO (United States); Survochak, Scott [U.S. Department of Energy, Office of Legacy Management, Grand Junction, CO (United States)
2013-05-01
The purpose of this Site Rehabilitation Completion Report is to present the post-active-remediation monitoring results for the Northeast Site and to propose No Further Action with Controls. This document includes information required by Chapter 62-780.750(4)(d), 62-780.750(6), and 62-780.600(8)(a)27 Florida Administrative Code (F.A.C.). The Closure Monitoring Plan for the Northeast Site and 4.5 Acre Site (DOE 2009a) describes the approach for post-active-remediation monitoring. The Young - Rainey Science, Technology, and Research Center (STAR Center) is a former U.S. Department of Energy (DOE) facility constructed in the mid-1950s. The 99-acre STAR Center is located in Largo, Florida. The Northeast Site is located in the northeast corner of the STAR Center. The Northeast Site meets all the requirements for an RMO II closure—No Further Action with Controls. DOE is nearing completion of a restrictive covenant for the Northeast Site. DOE has completed post-active-remediation monitoring at the Northeast Site as of September 2012. No additional monitoring will be conducted.
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U.S. Environmental Protection Agency — This asset includes a number of individual data sets related to site-specific information for Superfund, which is governed under the Comprehensive Environmental...
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Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages
International Nuclear Information System (INIS)
Chiramel, George Koshy; Keshava, Shyamkumar Nidugala; Moses, Vinu; Kekre, Nitin; Tamilarasi, V; Devasia, Anthony
2015-01-01
To evaluate the effectiveness of endovascular management in iatrogenic renal injuries with regard to clinical status on follow-up and requirements for repeat angiography and embolization. This retrospective study included patients who were referred for endovascular management of significant hemorrhage following an iatrogenic injury. Data was recorded from the Picture Archiving and Communication system (PACS) and electronic medical records. The site and type of iatrogenic injury, imaging findings, treatment, angiography findings, embolization performed, clinical status on follow-up, and requirement for repeat embolization were recorded. The outcomes were clinical resolution, nephrectomy, or death. Clinical findings were recorded on follow-up visits to the clinic. Statistical analysis was performed using descriptive statistics. Seventy patients were included in this study between January 2000 and June 2012. A bleeding lesion (a pseudoaneurysm or arteriovenous fistula) was detected during the first angiogram in 55 patients (78.6%) and was selectively embolized. Fifteen required a second angiography as there was no clinical improvement and five required a third angiography. Overall, 66 patients (94.3%) showed complete resolution and 4 patients (5.7%) died. Three patients (4.3%) underwent nephrectomy for clinical stabilization even after embolization. There were no major complications. The two minor complications resolved spontaneously. Angiography and embolization is the treatment of choice in iatrogenic renal hemorrhage. Upto 20% of initial angiograms may not reveal the bleed and repeat angiography is required to identify a recurrent or unidentified bleed. The presence of multiple punctate bleeders on angiography suggests an enlarging subcapsular hematoma and requires preoperative embolization and nephrectomy
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DEFF Research Database (Denmark)
Meyhoff, Christian S; Wetterslev, Jørn; Jorgensen, Lars N
2009-01-01
Control and Prevention. Secondary outcomes included atelectasis, pneumonia, respiratory failure, and mortality. RESULTS: Surgical site infection occurred in 131 of 685 patients (19.1%) assigned to receive 80% oxygen vs 141 of 701 (20.1%) assigned to receive 30% oxygen (odds ratio [OR], 0.94; 95...
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National Ignition Facility site requirements
International Nuclear Information System (INIS)
1996-07-01
The Site Requirements (SR) provide bases for identification of candidate host sites for the National Ignition Facility (NIF) and for the generation of data regarding potential actual locations for the facilities. The SR supplements the NIF Functional Requirements (FR) with information needed for preparation of responses to queries for input to HQ DOE site evaluation. The queries are to include both documents and explicit requirements for the potential host site responses. The Sr includes information extracted from the NIF FR (for convenience), data based on design approaches, and needs for physical and organization infrastructure for a fully operational NIF. The FR and SR describe requirements that may require new construction or may be met by use or modification of existing facilities. The SR do not establish requirements for NIF design or construction project planning. The SR document does not constitute an element of the NIF technical baseline
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2010-09-21
.... The workers are engaged in activities related to information technology (IT) outsourcing services. New information shows that workers leased from Compuware Corporation were employed on-site at the Detroit...
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Kharbanda, Elyse O; Nordin, James D; Sinaiko, Alan R; Ekstrom, Heidi L; Stultz, Jerry M; Sherwood, Nancy E; Fontaine, Patricia L; Asche, Steve E; Dehmer, Steven P; Amundson, Jerry H; Appana, Deepika X; Bergdall, Anna R; Hayes, Marcia G; O'Connor, Patrick J
2015-01-01
Blood pressure (BP) is routinely measured in children and adolescents during primary care visits. However, elevated BP or hypertension is frequently not diagnosed or evaluated further by primary care providers. Barriers to recognition include lack of clinician buy-in, competing priorities, and complexity of the standard BP tables. We have developed and piloted TeenBP- a web-based, electronic health record (EHR) linked system designed to improve recognition of prehypertension and hypertension in adolescents during primary care visits. Important steps in developing TeenBP included the following: review of national BP guidelines, consideration of clinic workflow, engagement of clinical leaders, and evaluation of the impact on clinical sites. Use of a web-based platform has facilitated updates to the TeenBP algorithm and to the message content. In addition, the web-based platform has allowed for development of a sophisticated display of patient-specific information at the point of care. In the TeenBP pilot, conducted at a single pediatric and family practice site with six clinicians, over a five-month period, more than half of BPs in the hypertensive range were clinically recognized. Furthermore, in this small pilot the TeenBP clinical decision support (CDS) was accepted by providers and clinical staff. Effectiveness of the TeenBP CDS will be determined in a two-year cluster-randomized clinical trial, currently underway at 20 primary care sites. Use of technology to extract and display clinically relevant data stored within the EHR may be a useful tool for improving recognition of adolescent hypertension during busy primary care visits. In the future, the methods developed specifically for TeenBP are likely to be translatable to a wide range of acute and chronic issues affecting children and adolescents.
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International Nuclear Information System (INIS)
2016-07-01
The objective of this publication is to provide the state-of-the-art practice and detailed technical elements related to ground motion evaluation by ground motion prediction equations (GMPEs) and site response in the context of seismic hazard assessments as recommended in IAEA Safety Standards Series No. SSG-9, Seismic Hazards in Site Evaluation for Nuclear Installations. The publication includes the basics of GMPEs, ground motion simulation, selection and adjustment of GMPEs, site characterization, and modelling of site response in order to improve seismic hazard assessment. The text aims at delineating the most important aspects of these topics (including current practices, criticalities and open problems) within a coherent framework. In particular, attention has been devoted to filling conceptual gaps. It is written as a reference text for trained users who are responsible for planning preparatory seismic hazard analyses for siting of all nuclear installations and/or providing constraints for anti-seismic design and retrofitting of existing structures
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Nanofibrillar cellulose wound dressing in skin graft donor site treatment.
Hakkarainen, T; Koivuniemi, R; Kosonen, M; Escobedo-Lucea, C; Sanz-Garcia, A; Vuola, J; Valtonen, J; Tammela, P; Mäkitie, A; Luukko, K; Yliperttula, M; Kavola, H
2016-12-28
Although new therapeutic approaches for burn treatment have made progress, there is still need for better methods to enhance wound healing and recovery especially in severely burned patients. Nanofibrillar cellulose (NFC) has gained attention due to its renewable nature, good biocompatibility and excellent physical properties that are of importance for a range of applications in pharmaceutical and biomedical fields. In the present study, we investigated the potential of a wood based NFC wound dressing in a clinical trial on burn patients. Previously, we have investigated NFC as a topical functionalized wound dressing that contributes to improve wound healing in mice. Wood based NFC wound dressing was tested in split-thickness skin graft donor site treatment for nine burn patients in clinical trials at Helsinki Burn Centre. NFC dressing was applied to split thickness skin graft donor sites. The dressing gradually dehydrated and attached to donor site during the first days. During the clinical trials, physical and mechanical properties of NFC wound dressing were optimized by changing its composition. From patient 5 forward, NFC dressing was compared to commercial lactocapromer dressing, Suprathel® (PMI Polymedics, Germany). Epithelialization of the NFC dressing-covered donor site was faster in comparison to Suprathel®. Healthy epithelialized skin was revealed under the detached NFC dressing. NFC dressing self-detached after 11-21days for patients 1-9, while Suprathel® self-detached after 16-28days for patients 5-9. In comparison studies with patients 5-9, NFC dressing self-detached on average 4days earlier compared with Suprathel®. Lower NFC content in the material was evaluated to influence the enhanced pliability of the dressing and attachment to the wound bed. No allergic reaction or inflammatory response to NFC was observed. NFC dressing did not cause more pain for patients than the traditional methods to treat the skin graft donor sites. Based on the
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The Savannah River Site`s Groundwater Monitoring Program: Third quarter 1992
Energy Technology Data Exchange (ETDEWEB)
Rogers, C.D. [Westinghouse Savannah River Co., Aiken, SC (United States)
1993-02-04
The Environmental Protection Department/Environmental Monitoring Section (EPD/EMS) administers the Savannah River Site`s (SRS) Groundwater Monitoring Program. During third quarter 1992, EPD/EMS conducted extensive sampling of monitoring wells. Table 1 lists those well series with constituents in the groundwater above Flag 2 during third quarter 1992, organized by location. Results from all laboratory analyses are used to generate this table. Specific conductance and pH data from the field also are included in this table.
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Skin Substitutes: A Brief Review of Types and Clinical Applications
Alrubaiy, Laith; Al-Rubaiy, Kathem K.
2009-01-01
Replacing skin defects has witnessed several developments over the centuries. It started with the introduction of skin grafting by Reverdin in 1871. Since then, varieties of skin grafting techniques have been used successfully. Despite being clinically useful, skin grafts have many limitations including the availability of the donor site especially in circumstances of extensive skin loss, immune rejection in allogenic skin grafts, pain, scarring, slow healing and infection.1,2 For these reaso...
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International Nuclear Information System (INIS)
Evans, Suzanne B.; Kaufman, Seth A.; Price, Lori Lyn; Cardarelli, Gene; Dipetrillo, Thomas A.; Wazer, David E.
2006-01-01
Purpose: To investigate the incidence of, and possible factors associated with, seroma formation after intraoperative placement of the MammoSite catheter for accelerated partial breast irradiation. Methods and Materials: This study evaluated 38 patients who had undergone intraoperative MammoSite catheter placement at lumpectomy or reexcision followed by accelerated partial breast irradiation with 34 Gy in 10 fractions. Data were collected regarding dosimetric parameters, including the volume of tissue enclosed by the 100%, 150%, and 200% isodose shells, dose homogeneity index, and maximal dose at the surface of the applicator. Clinical and treatment-related factors were analyzed, including patient age, patient weight, history of diabetes and smoking, use of reexcision, interval between surgery and radiotherapy, total duration of catheter placement, total excised specimen volume, and presence or absence of postprocedural infection. Seroma was verified by clinical examination, mammography, and/or ultrasonography. Persistent seroma was defined as seroma that was clinically detectable >6 months after radiotherapy completion. Results: After a median follow-up of 17 months, the overall rate of any detectable seroma was 76.3%. Persistent seroma (>6 months) occurred in 26 (68.4%) of 38 patients, of whom 46% experienced at least modest discomfort at some point during follow-up. Of these symptomatic patients, 3 required biopsy or complete cavity excision, revealing squamous metaplasia, foreign body giant cell reaction, fibroblasts, and active collagen deposition. Of the analyzed dosimetric, clinical, and treatment-related variables, only body weight correlated positively with the risk of seroma formation (p = 0.04). Postprocedural infection correlated significantly (p = 0.05) with a reduced risk of seroma formation. Seroma was associated with a suboptimal cosmetic outcome, because excellent scores were achieved in 61.5% of women with seroma compared with 83% without seroma
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International Nuclear Information System (INIS)
Wickline, Alfred
2005-01-01
This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 137: Waste Disposal Sites. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 137 contains sites that are located in Areas 1, 3, 7, 9, and 12 of the Nevada Test Site (NTS), which is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 137 is comprised of the eight corrective action sites (CASs) shown on Figure 1-1 and listed below: (1) CAS 01-08-01, Waste Disposal Site; (2) CAS 03-23-01, Waste Disposal Site; (3) CAS 03-23-07, Radioactive Waste Disposal Site; (4) CAS 03-99-15, Waste Disposal Site; (5) CAS 07-23-02, Radioactive Waste Disposal Site; (6) CAS 09-23-07, Radioactive Waste Disposal Site; (7) CAS 12-08-01, Waste Disposal Site; and (8) CAS 12-23-07, Waste Disposal Site. The Corrective Action Investigation (CAI) will include field inspections, radiological surveys, geophysical surveys, sampling of environmental media, analysis of samples, and assessment of investigation results, where appropriate. Data will be obtained to support corrective action alternative evaluations and waste management decisions. The CASs in CAU 137 are being investigated because hazardous and/or radioactive constituents may be present in concentrations that could potentially pose a threat to human health and the environment. Existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives for the CASs. Additional information will be generated by conducting a CAI before evaluating and selecting corrective action
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Participant verification: prevention of co-enrolment in clinical trials in South Africa.
Harichund, C; Haripersad, K; Ramjee, R
2013-05-15
As KwaZulu-Natal Province is the epicentre of the HIV epidemic in both South Africa (SA) and globally, it is an ideal location to conduct HIV prevention and therapeutic trials. Numerous prevention trials are currently being conducted here; the potential for participant co-enrolment may compromise the validity of these studies and is therefore of great concern. To report the development and feasibility of a digital, fingerprint-based participant identification method to prevent co-enrolment at multiple clinical trial sites. The Medical Research Council (MRC) HIV Prevention Research Unit (HPRU) developed the Biometric Co-enrolment Prevention System (BCEPS), which uses fingerprint-based biometric technology to identify participants. A trial website was used to determine the robustness and usability of the system. After successful testing, the BCEPS was piloted in July 2010 across 7 HPRU clinical research sites. The BCEPS was pre-loaded with study names and clinical trial sites, with new participant information loaded at first visit to a trial site. We successfully implemented the BCEPS at the 7 HPRU sites. Using the BCEPS, we performed real-time 'flagging' of women who were already enrolled in another study as they entered a trial at an HPRU site and, where necessary, excluded them from participation on site. This system has promise in reducing co-enrolment in clinical trials and represents a valuable tool for future implementation by all groups conducting trials. The MRC is currently co-ordinating this effort with clinical trial sites nationally.
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International Nuclear Information System (INIS)
Yaffee, S.L.; Miller, C.A.
1974-11-01
The ''AEC-Maryland Regional Siting Factors Study'' examines the process of siting in a regional context. It is developing an analysis method to delineate candidate areas for siting of several power plant technology packages, including both fossil-fueled and nuclear options. Tools that are being used include simulation modeling, economic and demographic forecasting, spatial analysis, and computer graphics and numerical manipulation. The approach will describe the trade-offs incurred if a power plant is located in one candidate area rather than in another. In FY 1974, a suitability analysis method was developed which uses engineering and environmental parameters to define a level of environmental cost incurred if a segment of land is used to site a specific technology package. (U.S.)
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The Savannah River Site`s Groundwater Monitoring Program. Fourth quarter, 1990
Energy Technology Data Exchange (ETDEWEB)
1991-06-18
This report summarizes the Savannah River Site (SRS) groundwater monitoring program conducted in the fourth quarter of 1990. It includes the analytical data, field data, well activity data, and other documentation for this program, provides a record of the program`s activities and rationale, and serves as an official document of the analytical results. The groundwater monitoring program includes the following activities: installation, maintenance, and abandonment of monitoring wells, environmental soil borings, development of the sampling and analytical schedule, collection and analyses of groundwater samples, review of analytical and other data, maintenance of the databases containing groundwater monitoring data, quality assurance (QA) evaluations of laboratory performance, and reports of results to waste-site facility custodians and to the Environmental Protection Section (EPS) of EPD.
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Chen, Jing; Li, Tiancheng; Zhou, Xuedong; Cheng, Lei; Huo, Yuanyuan; Zou, Jing; Li, Yuqing
2017-11-01
The aim of this study was to analyze the characteristics of the clustered regularly interspaced short palindromic repeats (CRISPR) sites in 45 clinical Streptococcus mutans strains and their relationship to the clinical manifestations of early childhood caries (ECC). Forty-five S. mutans strains were isolated from the plaque samples taken from sixty-three children. CRISPR sites were sequenced and BLAST was used to compare these sites to those in the CRISPRTarget database. The association between the distribution of CRISPR sites and the manifestation of caries was analyzed by Chi-Square test. Further, biofilm formation (by crystal violet staining) and the synthesis of polysaccharide (by anthrone-sulfuric method) of all clinical isolated S. mutans strains with both CRISPR sites and no CRISPR site were comapared. Finally, acidogenicity and acidurity of two typical strains were determined using pH drop and acid tolerance assays. Biofilm formation and EPS synthesis by two typical strains were compared by 3D CLSM (Confocal Laser Scanning Microscope) assays and the expression of gtf genes were evaluated using qPCR. We found that most of the spacers in the clinical S. mutans strains were derived from Streptococcus phages APCM01 and M102. The number of CRISPR sites in these strains was associated with the clinical manifestations of ECC. Moreover, we found that the biofilm formation and EPS synthesis ability of the S. mutans strains with both CRISPR sites was significant improved. An association was found between the distribution of CRISPR sites and the clinical manifestations of caries. The CRISPR sites might contribute to the cariogenic potential of S. mutans. Copyright © 2017 Elsevier Ltd. All rights reserved.
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2013-04-30
..., USA, Inc., Oncology Care Systems (Radiation Oncology), Including On-Site Leased Workers From Source... Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), including on- site leased... of February 2013, Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology...
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International Nuclear Information System (INIS)
Mitchell, J.S.; Hlasivec, Z.
1984-01-01
It is generally accepted that the clinical radiotherapeutic oncologist must be a well educated doctor, with wide knowledge and experience, able to deal with the many difficult problems that can arise in connection with radiotherapy, curative, palliative or prophylactic. The management, treatment and care of the individual patient with malignant disease is a major task of medicine, requiring up-to-date knowledge in a number of rapidly advancing fields. To be efficient, it is essential for the clinical radiation oncologist to continue his education throughout his life, by reading the literature, attending lectures, conferences and advanced 'refresher' courses, and by visiting other centres. The clinical radiation oncologist will discover that it is wise, where at all possible, to spend a proportion of his time working with other specialists on clinical trials and research, with formal publication of the results. The disciplines of such work will deepen his understanding, not only of his own speciality, but of the whole field of oncology, and will further co-operation between the many different specialists on whose combined efforts the cure of each individual patient and the advances in the treatment of cancer must ultimately depend
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Spinozzi, Giulio; Calabria, Andrea; Brasca, Stefano; Beretta, Stefano; Merelli, Ivan; Milanesi, Luciano; Montini, Eugenio
2017-11-25
Bioinformatics tools designed to identify lentiviral or retroviral vector insertion sites in the genome of host cells are used to address the safety and long-term efficacy of hematopoietic stem cell gene therapy applications and to study the clonal dynamics of hematopoietic reconstitution. The increasing number of gene therapy clinical trials combined with the increasing amount of Next Generation Sequencing data, aimed at identifying integration sites, require both highly accurate and efficient computational software able to correctly process "big data" in a reasonable computational time. Here we present VISPA2 (Vector Integration Site Parallel Analysis, version 2), the latest optimized computational pipeline for integration site identification and analysis with the following features: (1) the sequence analysis for the integration site processing is fully compliant with paired-end reads and includes a sequence quality filter before and after the alignment on the target genome; (2) an heuristic algorithm to reduce false positive integration sites at nucleotide level to reduce the impact of Polymerase Chain Reaction or trimming/alignment artifacts; (3) a classification and annotation module for integration sites; (4) a user friendly web interface as researcher front-end to perform integration site analyses without computational skills; (5) the time speedup of all steps through parallelization (Hadoop free). We tested VISPA2 performances using simulated and real datasets of lentiviral vector integration sites, previously obtained from patients enrolled in a hematopoietic stem cell gene therapy clinical trial and compared the results with other preexisting tools for integration site analysis. On the computational side, VISPA2 showed a > 6-fold speedup and improved precision and recall metrics (1 and 0.97 respectively) compared to previously developed computational pipelines. These performances indicate that VISPA2 is a fast, reliable and user-friendly tool for
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DOE site performance assessment activities
International Nuclear Information System (INIS)
1990-07-01
Information on performance assessment capabilities and activities was collected from eight DOE sites. All eight sites either currently dispose of low-level radioactive waste (LLW) or plan to dispose of LLW in the near future. A survey questionnaire was developed and sent to key individuals involved in DOE Order 5820.2A performance assessment activities at each site. The sites surveyed included: Hanford Site (Hanford), Idaho National Engineering Laboratory (INEL), Los Alamos National Laboratory (LANL), Nevada Test Site (NTS), Oak Ridge National Laboratory (ORNL), Paducah Gaseous Diffusion Plant (Paducah), Portsmouth Gaseous Diffusion Plant (Portsmouth), and Savannah River Site (SRS). The questionnaire addressed all aspects of the performance assessment process; from waste source term to dose conversion factors. This report presents the information developed from the site questionnaire and provides a comparison of site-specific performance assessment approaches, data needs, and ongoing and planned activities. All sites are engaged in completing the radioactive waste disposal facility performance assessment required by DOE Order 5820.2A. Each site has achieved various degrees of progress and have identified a set of critical needs. Within several areas, however, the sites identified common needs and questions
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Liu, X; Wen, M K; Liu, H Y; Sun, D W; Lang, J H; Fan, Q B; Shi, H H
2017-10-25
Objective: To investigate clinical outcomes of laparoendoscopic single-site ovarian cystectomy compared with traditional multi-port laparoscopic ovarian cystectomy. Methods: Data of 81 patients with ovarian cystectomy from January 2016 to May 2017, the single-site group ( n= 40) and the multi-port group ( n= 41) in Peking Union Medical College Hospital were retrospectively collected. The outcomes of single-site and multi-port groups were analyzed and compared, including: postoperative fever, operation time, blood loss, hemoglobin change, surgical complications, postoperative pain score, postoperative analgesic requirements, body image scale and cosmetic score, length of hospital stay, postoperative total cost. Results: No complication was found in two groups. No difference was found in postoperative fever, blood loss, hemoglobin change, postoperative pain score, length of hospital stay, and total cost between the two groups (all P> 0.05). Operation time was (50±20) minutes in single-site group, and (40±15) minutes in multi-port group; postoperative analgesic requirements was 28%(11/40) in single-site group, and 7%(4/41) in multi-port group; cosmetic score was 22.6±2.6 in single-site group, and 17.3±2.6 in multi-port group; body image scale was 5.7±1.2 in single-site group, and 6.2±1.2 in multi-port group; these four clinical parameters were statistical differences (all P< 0.05). Conculsion: Laparoendoscopic single-site ovarian cystectomy is feasible and safe, although it could't relieve the postoperative pian, it do offer a higher cosmetic satisfaction.
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International Nuclear Information System (INIS)
1991-09-01
The US Environmental Protection Agency (EPA) has established health and environmental regulations to correct and prevent groundwater contamination resulting from former uranium processing activities at inactive uranium processing sites (40 CFR 192). According to the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA), the US Department of Energy (DOE) is responsible for assessing the inactive uranium processing sites. The DOE has decided that each assessment shall include information on hydrogeologic site characterization. The water resources protection strategy that describes how the proposed action will comply with the EPA groundwater protection standards is presented in Attachment 4. Site characterization activities discussed in this section include: Definition of the hydrogeologic characteristics of the environment, including hydrostratigraphy, aquifer parameters, areas of aquifer recharge and discharge, potentiometric surfaces, and groundwater velocities. Definition of background groundwater quality and comparison with the proposed EPA groundwater protection standards. Evaluation of the physical and chemical characteristics of the contaminant source and/or residual radioactive materials. Definition of existing groundwater contamination by comparison with the EPA groundwater protection standards. Description of the geochemical processes that affect the downward migration of the source contaminants at the processing site. Description of water resource utilization, including availability, current and future use and value, and alternate water supplies
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Skin cancer of the head and neck with clinical perineural invasion
International Nuclear Information System (INIS)
McCord, Mark W.; Mendenhall, William M.; Parsons, James T.; Amdur, Robert J.; Stringer, Scott P.; Cassisi, Nicholas J.; Million, Rodney R.
2000-01-01
Purpose: To review treatment and outcomes in 62 patients with clinical and/or gross evidence of perineural invasion from skin cancer of the head and neck. Methods and Materials: Sixty-two patients received radiotherapy at the University of Florida as part or all of their treatment between January 1965 and April 1995. All patients had clinical signs and symptoms of perineural involvement and/or documentation of tumor extending to grossly involve nerve(s). Twenty-one patients underwent therapy for previously untreated lesions, including 12 who received radiotherapy alone and nine who had surgery with postoperative radiotherapy. Forty-one patients underwent therapy for recurrent lesions, including 18 treated with radiotherapy alone and 23 who received preoperative or postoperative radiotherapy. Results: Factors on multivariate analysis that predicted local control included patient age, previously untreated vs. recurrent lesions, presence of clinical symptoms, and extent of radiotherapy fields. Recurrence patterns were predominantly local; 26 of 31 patients (84%) who developed local recurrence after treatment had recurrent cancer limited to the primary site. Conclusions: Many patients with skin cancer and symptomatic perineural invasion have disease that is incompletely resectable. Approximately half these patients will be cured with aggressive irradiation alone or combined with surgery. Age, prior treatment, and clinical symptoms influence the likelihood of cure
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Person, Benjamin; Ifargan, Ruth; Lachter, Jesse; Duek, Simon D; Kluger, Yoram; Assalia, Ahmad
2012-07-01
Preoperative stoma site marking and counseling aim to improve patients' rehabilitation and adaptation to a new medical condition. Objective studies are needed to provide evidence of the impact of care by stoma therapists. Key quality indicators include patients' quality of life, independence, and complication rates as affected by the variable modes of stoma site marking and planning. The aim of this study was to evaluate the impact of preoperative stoma site marking on patients' quality of life, independence, and complication rates. : A validated stoma quality-of-life questionnaire was used as the main assessment tool. Complications were noted on regular postoperative visits. This is a single-center, clinical study. The study was conducted at the Rambam Health Care Campus in Haifa, Israel. Rambam Health Care Campus is a tertiary university hospital. All patients who underwent an elective stoma creation between 2006 and 2008 were included. Evaluated parameters included demographics, stoma type, marking status, complication rates, quality of life, and independence parameters. : One hundred five patients (60 men and 45 women) were included, of whom 52 (49.5%) were preoperatively marked and 53 (50.5%) were not marked. Sixty stomas (57%) were permanent, and 45 (43%) stomas were temporary. The quality of life of patients whose stoma sites were preoperatively marked was significantly better than that of the unmarked patients (p stoma type. Preoperative stoma site marking is crucial for improving patients' postoperative quality of life, promoting their independence, and reducing the rates of postoperative complications. The role of the enterostomal therapist is very important in the ostomates' pre- and postoperative care.
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International Nuclear Information System (INIS)
1991-12-01
Detailed investigations of geologic, geomorphic, and seismic conditions at the Bodo Canyon disposal site were conducted. The purpose of these investigations was basic site characterization and identification of potential geologic hazards that could affect long-term site stability. Subsequent engineering studies, such as analyses of hydrologic and liquefaction hazards, used the data developed in these studies. The geomorphic analysis was employed in the design of effective erosion protection. Studies of the regional and local seismotectonic setting, which included a detailed search for possible capable faults within a 65 kilometer radius of the site, provided the basis for seismic design parameters. The scope of work performed included the following: Compilation and analysis of previous published and unpublished geologic literature and maps; Review of historical and instrumental earthquake data; Review of site-specific subsurface geologic data, including lithologic and geophysical logs of exploratory boreholes advanced in the site area; Photogeologic interpretations of existing conventional aerial photographs; and, Ground reconnaissance and mapping of the site region
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Parotid lymphomas - clinical and computed tomogrphic imaging ...
African Journals Online (AJOL)
Parotid lymphomas - clinical and computed tomogrphic imaging features. ... South African Journal of Surgery ... Lymphoma has a clinical presentation similar ... CT scanning is a useful adjunctive investigation to determine the site and extent of ...
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Selection of the Mars Science Laboratory landing site
Golombek, M.; Grant, J.; Kipp, D.; Vasavada, A.; Kirk, Randolph L.; Fergason, Robin L.; Bellutta, P.; Calef, F.; Larsen, K.; Katayama, Y.; Huertas, A.; Beyer, R.; Chen, A.; Parker, T.; Pollard, B.; Lee, S.; Hoover, R.; Sladek, H.; Grotzinger, J.; Welch, R.; Dobrea, E. Noe; Michalski, J.; Watkins, M.
2012-01-01
The selection of Gale crater as the Mars Science Laboratory landing site took over five years, involved broad participation of the science community via five open workshops, and narrowed an initial >50 sites (25 by 20 km) to four finalists (Eberswalde, Gale, Holden and Mawrth) based on science and safety. Engineering constraints important to the selection included: (1) latitude (±30°) for thermal management of the rover and instruments, (2) elevation (surface that is safe for landing and roving and not dominated by fine-grained dust. Science criteria important for the selection include the ability to assess past habitable environments, which include diversity, context, and biosignature (including organics) preservation. Sites were evaluated in detail using targeted data from instruments on all active orbiters, and especially Mars Reconnaissance Orbiter. All of the final four sites have layered sedimentary rocks with spectral evidence for phyllosilicates that clearly address the science objectives of the mission. Sophisticated entry, descent and landing simulations that include detailed information on all of the engineering constraints indicate all of the final four sites are safe for landing. Evaluation of the traversabilty of the landing sites and target “go to” areas outside of the ellipse using slope and material properties information indicates that all are trafficable and “go to” sites can be accessed within the lifetime of the mission. In the final selection, Gale crater was favored over Eberswalde based on its greater diversity and potential habitability.
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The commissioning of CMS sites: Improving the site reliability
International Nuclear Information System (INIS)
Belforte, S; Fisk, I; Flix, J; Hernandez, J M; Klem, J; Letts, J; Magini, N; Saiz, P; Sciaba, A
2010-01-01
The computing system of the CMS experiment works using distributed resources from more than 60 computing centres worldwide. These centres, located in Europe, America and Asia are interconnected by the Worldwide LHC Computing Grid. The operation of the system requires a stable and reliable behaviour of the underlying infrastructure. CMS has established a procedure to extensively test all relevant aspects of a Grid site, such as the ability to efficiently use their network to transfer data, the functionality of all the site services relevant for CMS and the capability to sustain the various CMS computing workflows at the required scale. This contribution describes in detail the procedure to rate CMS sites depending on their performance, including the complete automation of the program, the description of monitoring tools, and its impact in improving the overall reliability of the Grid from the point of view of the CMS computing system.
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Introduction to the Hanford Site
Energy Technology Data Exchange (ETDEWEB)
Cushing, C.E.
1995-06-01
This section of the 1994 Hanford Site Environmental Report discusses the Site mission and provides general information about the site. The U.S. DOE has established a new mission for Hanford including: Management of stored wastes, environmental restoration, research and development, and development of new technologies. The Hanford Reservation is located in south central Washington State just north of the confluence of the Snake and Yakima Rivers with the Columbia River. The approximately 1,450 square kilometers which comprises the Hanford Site, with restricted public access, provides a buffer for the smaller areas within the site which have historically been used for the production of nuclear materials, radioactive waste storage, and radioactive waste disposal.
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Introduction to the Hanford Site
International Nuclear Information System (INIS)
Cushing, C.E.
1995-01-01
This section of the 1994 Hanford Site Environmental Report discusses the Site mission and provides general information about the site. The U.S. DOE has established a new mission for Hanford including: Management of stored wastes, environmental restoration, research and development, and development of new technologies. The Hanford Reservation is located in south central Washington State just north of the confluence of the Snake and Yakima Rivers with the Columbia River. The approximately 1,450 square kilometers which comprises the Hanford Site, with restricted public access, provides a buffer for the smaller areas within the site which have historically been used for the production of nuclear materials, radioactive waste storage, and radioactive waste disposal
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Site identification presentation: Basalt Waste Isolation Project
International Nuclear Information System (INIS)
1979-11-01
The final step in the site identification process for the Basalt Waste Isolation Project is described. The candidate sites are identified. The site identification methodology is presented. The general objectives which must be met in selecting the final site are listed. Considerations used in the screening process are also listed. Summary tables of the guidelines used are included
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7 CFR 205.403 - On-site inspections.
2010-01-01
..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Certification § 205.403 On-site inspections. (a) On-site inspections. (1... site that produces or handles organic products and that is included in an operation for which...
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Environmental assessment, Richton Dome site, Mississippi
International Nuclear Information System (INIS)
1986-05-01
The Nuclear Waste Policy Act of 1982 (42 USC Sections 10101-10226) requires the environmental assessment of a potential site to include a statement of the basis for the nomination of a site as suitable for characterization. Volume 2 of this environmental assessment provides a detailed evaluation of the Richton Dome Site and its suitability as the site for a radioactive waste disposal facility under DOE siting guidelines, as well as a comparison of the Richton Dome site with other proposed sites. Evaluation of the Richton Dome site is based on the reference repository design, but the evaluation will not change if based on the Mission Plan repository concept. The comparative evaluation of proposed sites is required under DOE guidelines, but is not intended to directly support the subsequent recommendation of three sites for characterization as candidate sites. 428 refs., 24 figs., 62 tabs
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A multisite study of the clinical diagnosis of different autism spectrum disorders.
Lord, Catherine; Petkova, Eva; Hus, Vanessa; Gan, Weijin; Lu, Feihan; Martin, Donna M; Ousley, Opal; Guy, Lisa; Bernier, Raphael; Gerdts, Jennifer; Algermissen, Molly; Whitaker, Agnes; Sutcliffe, James S; Warren, Zachary; Klin, Ami; Saulnier, Celine; Hanson, Ellen; Hundley, Rachel; Piggot, Judith; Fombonne, Eric; Steiman, Mandy; Miles, Judith; Kanne, Stephen M; Goin-Kochel, Robin P; Peters, Sarika U; Cook, Edwin H; Guter, Stephen; Tjernagel, Jennifer; Green-Snyder, Lee Anne; Bishop, Somer; Esler, Amy; Gotham, Katherine; Luyster, Rhiannon; Miller, Fiona; Olson, Jennifer; Richler, Jennifer; Risi, Susan
2012-03-01
Best-estimate clinical diagnoses of specific autism spectrum disorders (autistic disorder, pervasive developmental disorder-not otherwise specified, and Asperger syndrome) have been used as the diagnostic gold standard, even when information from standardized instruments is available. To determine whether the relationships between behavioral phenotypes and clinical diagnoses of different autism spectrum disorders vary across 12 university-based sites. Multisite observational study collecting clinical phenotype data (diagnostic, developmental, and demographic) for genetic research. Classification trees were used to identify characteristics that predicted diagnosis across and within sites. Participants were recruited through 12 university-based autism service providers into a genetic study of autism. A total of 2102 probands (1814 male probands) between 4 and 18 years of age (mean [SD] age, 8.93 [3.5] years) who met autism spectrum criteria on the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule and who had a clinical diagnosis of an autism spectrum disorder. Best-estimate clinical diagnoses predicted by standardized scores from diagnostic, cognitive, and behavioral measures. Although distributions of scores on standardized measures were similar across sites, significant site differences emerged in best-estimate clinical diagnoses of specific autism spectrum disorders. Relationships between clinical diagnoses and standardized scores, particularly verbal IQ, language level, and core diagnostic features, varied across sites in weighting of information and cutoffs. Clinical distinctions among categorical diagnostic subtypes of autism spectrum disorders were not reliable even across sites with well-documented fidelity using standardized diagnostic instruments. Results support the move from existing subgroupings of autism spectrum disorders to dimensional descriptions of core features of social affect and fixated, repetitive behaviors
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Pasquali, Sara K.; Burstein, Danielle S.; Benjamin, Daniel K.; Smith, P. Brian; Li, Jennifer S.
2010-01-01
Background Recent studies have examined the globalization of clinical research. These studies focused on adult trials, and the globalization of pediatric research has not been examined to date. We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Program, which provides economic incentives to pharmaceutical companies to conduct drug studies in children. Methods Published studies containing the main results of trials conducted from 1998–2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported. Results Overall, 174 trials were included (sample size 8–27,065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of those that did report this information, 65% were conducted in at least one country outside the US, and 11% did not have any sites in the US. Fifty-four different countries were represented and 38% of trials enrolled patients in at least one site located in a developing/transition country, including more than one third of infectious disease, cardiovascular, and allergy/immunology trials. Conclusions The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside of the US, and over a third of trials enrolled patients in developing/transition countries. While there are many potential benefits to the globalization of pediatric research, this trend also raises certain scientific and ethical concerns which require further evaluation. PMID:20732941
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Allegheny County / City of Pittsburgh / Western PA Regional Data Center — Information pertaining to Summer Meal Sites, as collected by Citiparks in the City of Pittsburgh Department of Parks and Recreation. This dataset includes the...
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International Nuclear Information System (INIS)
Ojiri, Hiroya; Mendenhall, William M.; Mancuso, Anthony A.
2002-01-01
Purpose: To determine whether findings on CT studies, done 6 weeks after radiotherapy (RT), can predict the likelihood of ultimate control at the primary site in oropharyngeal carcinoma. Methods and Materials: Forty-six patients with oropharyngeal squamous cell carcinoma underwent RT with curative intent. A minimal 2-year clinical follow-up after RT was required. The primary site CT findings were graded for risk of recurrence on a modified 3-point scale as follows: Grade 0, no detectable focal abnormalities; Grade 1, anatomic asymmetry or focal mass 10 mm (2a) or 10 mm at the primary site, the likelihood of local control is high (93%). The study results indicate that CT findings, based on this relatively small series, may not add incremental information beyond that of clinical examination for predicting local control but may be useful as a baseline if imaging surveillance is contemplated
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Cholera Incidence and Mortality in Sub-Saharan African Sites during Multi-country Surveillance.
Sauvageot, Delphine; Njanpop-Lafourcade, Berthe-Marie; Akilimali, Laurent; Anne, Jean-Claude; Bidjada, Pawou; Bompangue, Didier; Bwire, Godfrey; Coulibaly, Daouda; Dengo-Baloi, Liliana; Dosso, Mireille; Orach, Christopher Garimoi; Inguane, Dorteia; Kagirita, Atek; Kacou-N'Douba, Adele; Keita, Sakoba; Kere Banla, Abiba; Kouame, Yao Jean-Pierre; Landoh, Dadja Essoya; Langa, Jose Paulo; Makumbi, Issa; Miwanda, Berthe; Malimbo, Muggaga; Mutombo, Guy; Mutombo, Annie; NGuetta, Emilienne Niamke; Saliou, Mamadou; Sarr, Veronique; Senga, Raphael Kakongo; Sory, Fode; Sema, Cynthia; Tante, Ouyi Valentin; Gessner, Bradford D; Mengel, Martin A
2016-05-01
Cholera burden in Africa remains unknown, often because of weak national surveillance systems. We analyzed data from the African Cholera Surveillance Network (www.africhol.org). During June 2011-December 2013, we conducted enhanced surveillance in seven zones and four outbreak sites in Togo, the Democratic Republic of Congo (DRC), Guinea, Uganda, Mozambique and Cote d'Ivoire. All health facilities treating cholera cases were included. Cholera incidences were calculated using culture-confirmed cholera cases and culture-confirmed cholera cases corrected for lack of culture testing usually due to overwhelmed health systems and imperfect test sensitivity. Of 13,377 reported suspected cases, 34% occurred in Conakry, Guinea, 47% in Goma, DRC, and 19% in the remaining sites. From 0-40% of suspected cases were aged under five years and from 0.3-86% had rice water stools. Within surveillance zones, 0-37% of suspected cases had confirmed cholera compared to 27-38% during outbreaks. Annual confirmed incidence per 10,000 population was cholera incidence, age distribution, clinical presentation, culture confirmation, and testing frequency. These results can help guide preventive activities, including vaccine use.
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Hanford Site Waste Management Plan
International Nuclear Information System (INIS)
1988-12-01
The Hanford Site Waste Management Plan (HWMP) was prepared in accordance with the outline and format described in the US Department of Energy Orders. The HWMP presents the actions, schedules, and projected costs associated with the management and disposal of Hanford defense wastes, both radioactive and hazardous. The HWMP addresses the Waste Management Program. It does not include the Environmental Restoration Program, itself divided into the Environmental Restoration Remedial Action Program and the Decontamination and Decommissioning Program. The executive summary provides the basis for the plans, schedules, and costs within the scope of the Waste Management Program at Hanford. It summarizes fiscal year (FY) 1988 including the principal issues and the degree to which planned activities were accomplished. It further provides a forecast of FY 1989 including significant milestones. Section 1 provides general information for the Hanford Site including the organization and administration associated with the Waste Management Program and a description of the Site focusing on waste management operations. Section 2 and Section 3 describe radioactive and mixed waste management operations and hazardous waste management, respectively. Each section includes descriptions of the waste management systems and facilities, the characteristics of the wastes managed, and a discussion of the future direction of operations
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Evaluation of breastfeeding Web sites for patient education.
Dornan, Barbara A; Oermann, Marilyn H
2006-01-01
To evaluate the quality of Web sites on breastfeeding for patient education. Descriptive study of 30 Web sites on breastfeeding for patient education, evaluated based on the Health Information Technology Institute (HITI) criteria, readability, and eight content criteria from the American Academy of Pediatrics (AAP) policy statement on breastfeeding. The mean Flesch-Kincaid Grade Level for readability of the 30 sites was 9.2. Seven of the sites included all eight of the content criteria from the AAP, and three sites did not include any of the information recommended by the AAP content criteria. Nurses should be able to recommend best patient education materials for their patients. The five best Web sites for breastfeeding education are identified for patient teaching, and the HITI criteria are explained for nurses to learn how to evaluate Web sites for themselves and their patients.
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Geo-Proxy-Based Site Classification for Regional Zonation of Seismic Site Effects in South Korea
Directory of Open Access Journals (Sweden)
Chang-Guk Sun
2018-02-01
Full Text Available Seismic site effects and topographic effects related to ground motion occur during an earthquake due to site-specific geotechnical or geological characteristics, including the geological or geographical structure and the characteristics of near-surface sub-soil layers. Site-specific site effects due to geological conditions have been confirmed in recent earthquake events. Earthquake-induced damage has mainly occurred at accumulated soft soil layers under basins or along coasts and rivers. An alternative method has recently been proposed for evaluating regional seismic site effects and amplification factors using digital elevation models (DEM. High-quality DEMs at high resolutions may be employed to resolve finer-scale variations in topographic gradients and consequently, correlated site response parameters. Because there are many regions in South Korea lacking borehole datasets, which are insufficient for site classification only using borehole datasets, a DEM-based proxy for seismic zonation can be effective. Thus, in this study, geo-proxy-based site classification was proposed based on empirical correlations with site response parameters and conducted for regional zonation of seismic site effects to identify the amplification of characteristics in the western metropolitan areas of South Korea, depending on the site-specific geo-spatial conditions.
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In-situ and on-site technologies; An overview
Energy Technology Data Exchange (ETDEWEB)
Freestone, F J [Technical Support Branch, ORD, RREL, U.S. EPA, Edison, New Jersey (US)
1990-01-01
A broad analysis of and perspective on the characteristics and measured performance of in-situ and on-site treatment technologies available for remediation of contaminated soils, groundwater and associated debris at hazardous waste sites. Included in the analysis is information from U.S. and European sources. Available data are appended from nine recently completed field demonstrations from the U.S. Environmental Protection Agency (EPA) Superfund Innovative Technology Evaluation (SITE) program. The most frequently applied technology areas appear to be on-site thermal treatment for organics, on-site and in-situ solidification/stabilization technologies for most inorganics and metals, traditional on-site water treatment techniques, and soil vapor extraction for volatile organic compounds. Rapidly developing areas include bioremediation technologies, and concentration technologies. Two of the weakest areas include materials handling for such situations as excavating buried drums and soils with volatiles safely, and performing physical and chemical site characterization using technology-sensitive parameters. An area worthy of international cooperatin is that of performing benchscale screening and treatability studies, including the specification of key parameters needing measurement, techniques for such measurement and for interpretation, storage and retrieval of resulting data. We are in the process of evaluating existing treatability study data on soils and debris, and will be installing that data onto an on-line information system available to the public world-wide. (AB) 10 refs.
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Directory of Open Access Journals (Sweden)
Scott Shannon D
2011-12-01
Full Text Available Abstract Background Canada is among the most prosperous nations in the world, yet the health and wellness outcomes of Canadian children are surprisingly poor. There is some evidence to suggest that these poor health outcomes are partly due to clinical practice variation, which can stem from failure to apply the best available research evidence in clinical practice, otherwise known as knowledge translation (KT. Surprisingly, clinical practice variation, even for common acute paediatric conditions, is pervasive. Clinical practice variation results in unnecessary medical treatments, increased suffering, and increased healthcare costs. This study focuses on improving health outcomes for common paediatric acute health concerns by evaluating strategies that improve KT and reduce clinical practice variation. Design/Methods Using a multiple case study design, qualitative and quantitative data will be collected from four emergency departments in western Canada. Data sources will include: pre- and post-implementation focus group data from multidisciplinary healthcare professionals; individual interviews with the local champions, KT intervention providers, and unit/site leaders/managers; Alberta Context Tool (ACT survey data; and aggregated patient outcome data. Qualitative and quantitative data will be systematically triangulated, and matrices will be built to do cross-case comparison. Explanations will be built about the success or lack of success of the clinical practice guidelines (CPG and clinical pathways (CPs uptake based upon the cross-case comparisons. Significance This study will generate new knowledge about the potential causal mechanisms and factors which shape implementation. Future studies will track the impact of the CPG/CPs implementation on children's health outcome, and healthcare costs.
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A data base for low-level radioactive waste disposal sites
International Nuclear Information System (INIS)
Daum, M.L.; Moskowitz, P.D.
1989-07-01
A computerized database was developed to assist the US Environmental Protection Agency (EPA) in evaluating methods and data for characterizing health hazards associated with land and ocean disposal options for low-level radioactive wastes. The data cover 1984 to 1987. The types of sites considered include Nuclear Regulatory Commission (NRC) licensed commercial disposal sites, EPA National Priority List (NPL) sites, US Department of Energy (DOE) Formerly Utilized Sites Remedial Action Project (FUSRAP) and DOE Surplus Facilities Management Program (SFMP) sites, inactive US ocean disposal sites, and DOE/Department of Defense facilities. Sources of information include reports from EPA, the US Department of Energy (DOE) and the Nuclear Regulatory Commission (NRC), as well as direct communication with individuals associated with specific programs. The data include site descriptions, waste volumes and activity levels, and physical and radiological characterization of low-level wastes. Additional information on mixed waste, packaging forms, and disposal methods were compiled, but are not yet included in the database. 55 refs., 4 figs., 2 tabs