Sample records for search fda home
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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Price, performance, and the FDA approval process: the example of home HIV testing.
Paltiel, A David; Pollack, Harold A
2010-01-01
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.
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FDA Warns About Stem Cell Therapies
... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...
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Stone, Benjamin V; Forde, James C; Levit, Valerie B; Lee, Richard K; Te, Alexis E; Chughtai, Bilal
2016-11-01
In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. Google Trends™ was utilized to evaluate search engine trends for the term "pelvic organ prolapse" and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term "pelvic organ prolapse." The search results for the term "pelvic organ prolapse" were assessed for quality using the Health On the Net Foundation (HON) certification. There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r 2 = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information. Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.
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U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...
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Make Yourself At Home! Adolescents in Search of the Queer Spaces of Home
Directory of Open Access Journals (Sweden)
Kokkola, Lydia
2014-09-01
Full Text Available Home is often assumed to be a safe place, a place to which children can return after their adventures Away. For many gay and lesbian teens, both fictional and in real life, however, the space they share with their family of origin is not a place where they can feel at home. The heterosexual family home is often so hostile to queerly desiring teens that they are forced to leave in search of a place where they can feel at home. The queer spaces they enter in their search are usually considered risky spaces – public spaces, urban spaces, the bar and the street – unhomely spaces. In these temporary, in-between spaces, the queerly desiring teens in the novels examined in this paper form new family structures. Although all the Anglophone novels discussed in this article end on moments of up-lift and hope for the future, the association of the queerly desiring youngster with risky spaces suggests that the queer teens are themselves unheimlich (uncanny..
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The Einstein@Home search for gravitational waves and neutron stars
CERN. Geneva
2012-01-01
Einstein@Home is a volunteer distributed computing project with more than 300,000 participants. Like other volunteer computing projects, Einstein@Home harvests idle computer cycles from the the laptop and desktop computers of the general public. This provides enormous computing power, on the scale of some of the world's fastest supercomputers, but at very low cost. I describe the current status of the Einstein@Home search for new neutron stars, using data from the Laser Interferometer Gravitational-wave Observatory (LIGO), from the Arecibo and Parkes radio telescopes, and from the Fermi gamma-ray satellite. The sensitivity of these searches is limited by computing power, so the Einstein@Home approach allows the detection of weaker signals than more conventional approaches. In the past 18 months, Einstein@Home has discovered more than 20 new radio and gamma-ray pulsars, including a number of particularly interesting and exotic systems.
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Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S
2018-06-01
The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.
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Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D
2017-01-01
Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.
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Full Text Available ... Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Information by Audience For Women Women's Health Topics Women ...
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U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...
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Werthimer, Dan; Anderson, David; Bowyer, Stuart; Cobb, Jeff; Demorest, Paul
2002-01-01
We summarize results from two radio and two optical SETI programs based at the University of California, Berkeley. We discuss the most promising candidate signals from these searches and present plans for future SETI searches, including SERENDIP V and SETI@home II. The ongoing SERENDIP sky survey searches for radio signals at the 300 meter Arecibo Observatory. SERENDIP IV uses a 168 million channel spectrum analyser and a dedicated receiver to take data 24 hours a day, year round. The sky survey covers a 100 MHz band centered at the 21 cm line (1420 MHz) and declinations from -2 to +38 degrees. SETI@home uses desktop computers of 3.5 million volunteers to analyse 50 Terabytes of data taken at Arecibo. The SETI@home sky survey is 10 times more sensitive and searches a much wider variety of signal types than SERRENDIP IV but covers only a 2.5 MHz band. SETI@home is the planet's largest supercomputer, averaging 25 Tflops. SETI@home participants have contributed over a million years of computing time so far. The SEVENDIP optical pulse search looks for nS time scale pulses at optical wavelengths. It utilizes an automated 30 inch telescope, three ultra fast photo multiplier tubes and a coincidence detector. The target list includes F,G,K and M stars, globular cluster and galaxies. The SPOCK optical SETI program searches for narrow band continuous signals using spectra taken by Marcy and his colleagues in their planet search at Keck observatory.
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DEFF Research Database (Denmark)
Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P
2016-01-01
BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...
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Pure random search for ambient sensor distribution optimisation in a smart home environment.
Poland, Michael P; Nugent, Chris D; Wang, Hui; Chen, Liming
2011-01-01
Smart homes are living spaces facilitated with technology to allow individuals to remain in their own homes for longer, rather than be institutionalised. Sensors are the fundamental physical layer with any smart home, as the data they generate is used to inform decision support systems, facilitating appropriate actuator actions. Positioning of sensors is therefore a fundamental characteristic of a smart home. Contemporary smart home sensor distribution is aligned to either a) a total coverage approach; b) a human assessment approach. These methods for sensor arrangement are not data driven strategies, are unempirical and frequently irrational. This Study hypothesised that sensor deployment directed by an optimisation method that utilises inhabitants' spatial frequency data as the search space, would produce more optimal sensor distributions vs. the current method of sensor deployment by engineers. Seven human engineers were tasked to create sensor distributions based on perceived utility for 9 deployment scenarios. A Pure Random Search (PRS) algorithm was then tasked to create matched sensor distributions. The PRS method produced superior distributions in 98.4% of test cases (n=64) against human engineer instructed deployments when the engineers had no access to the spatial frequency data, and in 92.0% of test cases (n=64) when engineers had full access to these data. These results thus confirmed the hypothesis.
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Full Text Available ... of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...
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Full Text Available ... of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...
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Barbecue Basics: Tips to Prevent Foodborne Illness
Full Text Available ... of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...
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Animation of Antimicrobial Resistance
Full Text Available ... of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...
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FDA regulation of tobacco: blessing or curse for FDA professionals?
O'Reilly, James T
2009-01-01
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
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FDA Acronyms and Abbreviations
U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Full Text Available ... links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ...
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Full Text Available ... links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ...
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2013-03-05
... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...
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Full Text Available ... Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Special Features Don't ...
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Full Text Available ... Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ... Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures Surgery Devices ...
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Animation of Antimicrobial Resistance
Full Text Available ... Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ... Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of ...
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Full Text Available ... Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ... Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Information by Audience For Women ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ... Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Updates Fortify Your Knowledge About ...
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Barbecue Basics: Tips to Prevent Foodborne Illness
Full Text Available ... Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ... Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Updates Barbecue Basics: Tips to ...
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Barbecue Basics: Tips to Prevent Foodborne Illness
Full Text Available ... links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products ...
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FDA Peanut-Containing Product Recall
U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
International Nuclear Information System (INIS)
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
Energy Technology Data Exchange (ETDEWEB)
NONE
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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Stardust@home: An Interactive Internet-based Search for Interstellar Dust
Mendez, B. J.; Westphal, A. J.; Butterworth, A. L.; Craig, N.
2006-12-01
On January 15, 2006, NASA's Stardust mission returned to Earth after nearly seven years in interplanetary space. During its journey, Stardust encountered comet Wild 2, collecting dust particles from it in a special material called aerogel. At two other times in the mission, aerogel collectors were also opened to collect interstellar dust. The Stardust Interstellar Dust Collector is being scanned by an automated microscope at the Johnson Space Center. There are approximately 700,000 fields of view needed to cover the entire collector, but we expect only a few dozen total grains of interstellar dust were captured within it. Finding these particles is a daunting task. We have recruited many thousands of volunteers from the public to aid in the search for these precious pieces of space dust trapped in the collectors. We call the project Stardust@home. Through Stardust@home, volunteers from the public search fields of view from the Stardust aerogel collector using a web-based Virtual Microscope. Volunteers who discover interstellar dust particles have the privilege of naming them. The interest and response to this project has been extraordinary. Many people from all walks of life are very excited about space science and eager to volunteer their time to contribute to a real research project such as this. We will discuss the progress of the project and the education and outreach activities being carried out for it.
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THE EINSTEIN-HOME SEARCH FOR RADIO PULSARS AND PSR J2007+2722 DISCOVERY
Energy Technology Data Exchange (ETDEWEB)
Allen, B.; Knispel, B.; Aulbert, C.; Bock, O.; Eggenstein, H. B.; Fehrmann, H.; Machenschalk, B. [Max-Planck-Institut fuer Gravitationsphysik, D-30167 Hannover (Germany); Cordes, J. M.; Brazier, A.; Chatterjee, S. [Department of Astronomy, Cornell University, Ithaca, NY 14853 (United States); Deneva, J. S. [Arecibo Observatory, HC3 Box 53995, Arecibo, PR 00612 (United States); Hessels, J. W. T. [ASTRON, the Netherlands Institute for Radio Astronomy, Postbus 2, 7990 AA, Dwingeloo (Netherlands); Anderson, D. [Space Sciences Laboratory, University of California, Berkeley, CA 94720 (United States); Demorest, P. B. [NRAO (National Radio Astronomy Observatory), Charlottesville, VA 22903 (United States); Gotthelf, E. V. [Columbia Astrophysics Laboratory, Columbia University, New York, NY 10027 (United States); Hammer, D. [Department of Physics, University of Wisconsin-Milwaukee, Milwaukee, WI 53211 (United States); Kaspi, V. M. [Department of Physics, McGill University, Montreal, QC H3A2T8 (Canada); Kramer, M. [Max-Planck-Institut fuer Radioastronomie, D-53121 Bonn (Germany); Lyne, A. G. [Jodrell Bank Centre for Astrophysics, School of Physics and Astronomy, University of Manchester, Manchester, M13 9PL (United Kingdom); McLaughlin, M. A., E-mail: bruce.allen@aei.mpg.de [Department of Physics, West Virginia University, Morgantown, WV 26506 (United States); and others
2013-08-20
Einstein-Home aggregates the computer power of hundreds of thousands of volunteers from 193 countries, to search for new neutron stars using data from electromagnetic and gravitational-wave detectors. This paper presents a detailed description of the search for new radio pulsars using Pulsar ALFA survey data from the Arecibo Observatory. The enormous computing power allows this search to cover a new region of parameter space; it can detect pulsars in binary systems with orbital periods as short as 11 minutes. We also describe the first Einstein-Home discovery, the 40.8 Hz isolated pulsar PSR J2007+2722, and provide a full timing model. PSR J2007+2722's pulse profile is remarkably wide with emission over almost the entire spin period. This neutron star is most likely a disrupted recycled pulsar, about as old as its characteristic spin-down age of 404 Myr. However, there is a small chance that it was born recently, with a low magnetic field. If so, upper limits on the X-ray flux suggest but cannot prove that PSR J2007+2722 is at least {approx}100 kyr old. In the future, we expect that the massive computing power provided by volunteers should enable many additional radio pulsar discoveries.
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Full Text Available ... Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary ... exercising, and using FDA-approved medicines, insulin, and devices every day. FDA has lots of free information ...
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... AIDS Drugs Clinical Trials Apps skip to content Drugs Home Drugs Find information on FDA-approved HIV/ ... infection drugs and investigational HIV/AIDS drugs. Search Drugs Search drug Search Icon What's this? Close Popup ...
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Full Text Available ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers ...
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FDA abandons the Declaration of Helsinki: The effect on the ethics ...
African Journals Online (AJOL)
South African Journal of Bioethics and Law. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 5, No 2 (2012) >. Log in or Register to get access to full text downloads.
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FDA approved drugs as potential Ebola treatments [v2; ref status: indexed, http://f1000r.es/554
Directory of Open Access Journals (Sweden)
Sean Ekins
2015-03-01
Full Text Available In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available.
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21 CFR 60.34 - FDA action on petitions.
2010-04-01
... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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Real-World Evidence, Public Participation, and the FDA.
Schwartz, Jason L
2017-11-01
For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.
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... Videos for Educators Search English Español The Medical Home KidsHealth / For Parents / The Medical Home What's in ... for your child. What Does the Term "Medical Home" Mean? A medical home isn't a place ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & ...
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Full Text Available ... U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & ...
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Full Text Available ... U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & ...
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Full Text Available ... U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & ...
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Animation of Antimicrobial Resistance
Full Text Available ... U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow ... ol Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & ...
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Folbert, J.P.; Dagevos, J.C.
2001-01-01
De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de
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2010-04-21
...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...
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FDA and the Chemical Brain Drainers
DEFF Research Database (Denmark)
Grandjean, Philippe
2017-01-01
Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...
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FDA Recognized Consensus Standards
U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...
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21 CFR 60.10 - FDA assistance on eligibility.
2010-04-01
... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...
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... for Educators Search English Español Bringing Your Baby Home KidsHealth / For Parents / Bringing Your Baby Home What's ... recall your baby's seemingly endless crying episodes. The Home Front Introducing your baby to others at home ...
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New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.
English, Clayton; Aloi, Joseph J
2015-04-01
Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients
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Home-Explorer: Ontology-Based Physical Artifact Search and Hidden Object Detection System
Directory of Open Access Journals (Sweden)
Bin Guo
2008-01-01
Full Text Available A new system named Home-Explorer that searches and finds physical artifacts in a smart indoor environment is proposed. The view on which it is based is artifact-centered and uses sensors attached to the everyday artifacts (called smart objects in the real world. This paper makes two main contributions: First, it addresses, the robustness of the embedded sensors, which is seldom discussed in previous smart artifact research. Because sensors may sometimes be broken or fail to work under certain conditions, smart objects become hidden ones. However, current systems provide no mechanism to detect and manage objects when this problem occurs. Second, there is no common context infrastructure for building smart artifact systems, which makes it difficult for separately developed applications to interact with each other and uneasy for them to share and reuse knowledge. Unlike previous systems, Home-Explorer builds on an ontology-based knowledge infrastructure named Sixth-Sense, which makes it easy for the system to interact with other applications or agents also based on this ontology. The hidden object problem is also reflected in our ontology, which enables Home-Explorer to deal with both smart objects and hidden objects. A set of rules for deducing an object's status or location information and for locating hidden objects are described and evaluated.
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Directory of Open Access Journals (Sweden)
Gil Amarilyo
Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two
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Changes In Growth Culture FDA Activity Under Changing Growth Conditions
DEFF Research Database (Denmark)
Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.
1992-01-01
The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.
Ekins, Sean; Freundlich, Joel S; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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Subarray-based FDA radar to counteract deceptive ECM signals
Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang
2016-12-01
In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.
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Regulating nanomedicine - can the FDA handle it?
Bawa, Raj
2011-05-01
There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle
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Lee, Sung-Jae; Brooks, Ronald; Bolan, Robert K.; Flynn, Risa
2013-01-01
Men who have sex with men (MSM) in the United States represent a vulnerable population with lower rates of HIV testing. There are various specific attributes of HIV testing that may impact willingness to test (WTT) for HIV. Identifying specific attributes influencing patients’ decisions around WTT for HIV is critical to ensure improved HIV testing uptake. This study examined WTT for HIV by using conjoint analysis, an innovative method for systematically estimating consumer preferences across discrete attributes. WTT for HIV was assessed across eight hypothetical HIV testing scenarios varying across seven dichotomous attributes: location (home vs. clinic), price (free vs. $50), sample collection (finger prick vs. blood), timeliness of results (immediate vs. 1–2 weeks), privacy (anonymous vs. confidential), results given (by phone vs. in-person), and type of counseling (brochure vs. in-person). Seventy-five MSM were recruited from a community based organization providing HIV testing services in Los Angeles to participate in conjoint analysis. WTT for HIV score was based on a 100-point scale. Scores ranged from 32.2 to 80.3 for eight hypothetical HIV testing scenarios. Price of HIV testing (free vs. $50) had the highest impact on WTT (impact score=31.4, SD=29.2, p<.0001), followed by timeliness of results (immediate vs. 1–2 weeks) (impact score=13.9, SD=19.9, p=<.0001) and testing location (home vs. clinic) (impact score=10.3, SD=22.8, p=.0002). Impacts of other HIV testing attributes were not significant. Conjoint analysis method enabled direct assessment of HIV testing preferences and identified specific attributes that significantly impact WTT for HIV among MSM. This method provided empirical evidence to support the potential uptake of the newly FDA-approved over-the-counter HIV home-test kit with immediate results, with cautionary note on the cost of the kit. PMID:23651439
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76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry
2011-01-07
...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...
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21 CFR 312.86 - Focused FDA regulatory research.
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...
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Project Help Donate Porting Graphics Add-ons Science About SETI@home About Astropulse Science Community Message boards Questions and Answers Teams Profiles User search Web sites Pictures and music User University of California SETI@home and Astropulse are funded by grants from the National Science Foundation
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Gottlieb, the FDA and dumbing down medicine
Robbins RA
2017-01-01
No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...
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Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo
2018-02-01
This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.
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Mendez, Bryan J.; Westphal, A. J.; Butterworth, A. L.; Craig, N.
2006-12-01
On January 15, 2006, NASA’s Stardust mission returned to Earth after nearly seven years in interplanetary space. During its journey, Stardust encountered comet Wild 2, collecting dust particles from it in a special material called aerogel. At two other times in the mission, aerogel collectors were also opened to collect interstellar dust. The Stardust Interstellar Dust Collector is being scanned by an automated microscope at the Johnson Space Center. There are approximately 700,000 fields of view needed to cover the entire collector, but we expect only a few dozen total grains of interstellar dust were captured within it. Finding these particles is a daunting task. We have recruited many thousands of volunteers from the public to aid in the search for these precious pieces of space dust trapped in the collectors. We call the project Stardust@home. Through Stardust@home, volunteers from the public search fields of view from the Stardust aerogel collector using a web-based Virtual Microscope. Volunteers who discover interstellar dust particles have the privilege of naming them. The interest and response to this project has been extraordinary. Many people from all walks of life are very excited about space science and eager to volunteer their time to contribute to a real research project such as this. We will discuss the progress of the project and the education and outreach activities being carried out for it.
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... Page Search Home Health Conditions Genes Chromosomes & mtDNA Resources Help Me Understand Genetics Share: Email Facebook Twitter Genetics Home Reference provides consumer-friendly information about the effects of genetic variation on human health. Health Conditions More than 1,200 health ...
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Gottlieb, the FDA and dumbing down medicine
Directory of Open Access Journals (Sweden)
Robbins RA
2017-04-01
Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …
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42 CFR 405.203 - FDA categorization of investigational devices.
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...
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FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files
U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...
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Wood, Lauren N; Jamnagerwalla, Juzar; Markowitz, Melissa A; Thum, D Joseph; McCarty, Philip; Medendorp, Andrew R; Raz, Shlomo; Kim, Ja-Hong
2018-04-26
Uterine power morcellation, where the uterus is shred into smaller pieces, is a widely used technique for removal of uterine specimens in patients undergoing minimally invasive abdominal hysterectomy or myomectomy. Complications related to power morcellation of uterine specimens led to US Food and Drug Administration (FDA) communications in 2014 ultimately recommending against the use of power morcellation for women undergoing minimally invasive hysterectomy. Subsequently, practitioners drastically decreased the use of morcellation. We aimed to determine the effect of increased patient awareness on the decrease in use of the morcellator. Google Trends is a public tool that provides data on temporal patterns of search terms, and we correlated this data with the timing of the FDA communication. Weekly relative search volume (RSV) was obtained from Google Trends using the term “morcellation.” Higher RSV corresponds to increases in weekly search volume. Search volumes were divided into 3 groups: the 2 years prior to the FDA communication, a 1-year period following, and thereafter, with the distribution of the weekly RSV over the 3 periods tested using 1-way analysis of variance. Additionally, we analyzed the total number of websites containing the term “morcellation” over this time. The mean RSV prior to the FDA communication was 12.0 (SD 15.8), with the RSV being 60.3 (SD 24.7) in the 1-year after and 19.3 (SD 5.2) thereafter (PGoogle search activity about morcellation of uterine specimens increased significantly after the FDA communications. This trend indicates an increased public awareness regarding morcellation and its complications. More extensive preoperative counseling and alteration of surgical technique and clinician practice may be necessary. ©Lauren N Wood, Juzar Jamnagerwalla, Melissa A Markowitz, D Joseph Thum, Philip McCarty, Andrew R Medendorp, Shlomo Raz, Ja-Hong Kim. Originally published in JMIR Public Health and Surveillance (http
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FDA drug safety communications: a narrative review and clinical considerations for older adults.
Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A
2012-08-01
The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older
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Healthy public relations: the FDA's 1930s legislative campaign.
Kay, G
2001-01-01
In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.
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Animation of Antimicrobial Resistance
Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ...
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Barbecue Basics: Tips to Prevent Foodborne Illness
Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products Vaccines, ...
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Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... a vitamin can also cause problems with some medical tests or interfere with how some drugs work. ...
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Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ...
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Abbott, B. P.; Abbott, R.; Abbott, T. D.; Acernese, F.; Ackley, K.; Adams, C.; Adams, T.; Addesso, P.; Adhikari, R. X.; Adya, V. B.; Affeldt, C.; Afrough, M.; Agarwal, B.; Agatsuma, K.; Aggarwal, N.; Aguiar, O. D.; Aiello, L.; Ain, A.; Allen, B.; Allen, G.; Allocca, A.; Altin, P. A.; Amato, A.; Ananyeva, A.; Anderson, S. B.; Anderson, W. G.; Antier, S.; Appert, S.; Arai, K.; Araya, M. C.; Areeda, J. S.; Arnaud, N.; Ascenzi, S.; Ashton, G.; Ast, M.; Aston, S. M.; Astone, P.; Aufmuth, P.; Aulbert, C.; AultONeal, K.; Avila-Alvarez, A.; Babak, S.; Bacon, P.; Bader, M. K. M.; Bae, S.; Baker, P. T.; Baldaccini, F.; Ballardin, G.; Ballmer, S. W.; Banagiri, S.; Barayoga, J. C.; Barclay, S. E.; Barish, B. C.; Barker, D.; Barone, F.; Barr, B.; Barsotti, L.; Barsuglia, M.; Barta, D.; Bartlett, J.; Bartos, I.; Bassiri, R.; Basti, A.; Batch, J. C.; Baune, C.; Bawaj, M.; Bazzan, M.; Bécsy, B.; Beer, C.; Bejger, M.; Belahcene, I.; Bell, A. S.; Berger, B. K.; Bergmann, G.; Berry, C. P. L.; Bersanetti, D.; Bertolini, A.; Betzwieser, J.; Bhagwat, S.; Bhandare, R.; Bilenko, I. A.; Billingsley, G.; Billman, C. R.; Birch, J.; Birney, R.; Birnholtz, O.; Biscans, S.; Bisht, A.; Bitossi, M.; Biwer, C.; Bizouard, M. A.; Blackburn, J. K.; Blackman, J.; Blair, C. D.; Blair, D. G.; Blair, R. M.; Bloemen, S.; Bock, O.; Bode, N.; Boer, M.; Bogaert, G.; Bohe, A.; Bondu, F.; Bonnand, R.; Boom, B. A.; Bork, R.; Boschi, V.; Bose, S.; Bouffanais, Y.; Bozzi, A.; Bradaschia, C.; Brady, P. R.; Braginsky, V. B.; Branchesi, M.; Brau, J. E.; Briant, T.; Brillet, A.; Brinkmann, M.; Brisson, V.; Brockill, P.; Broida, J. E.; Brooks, A. F.; Brown, D. A.; Brown, D. D.; Brown, N. M.; Brunett, S.; Buchanan, C. C.; Buikema, A.; Bulik, T.; Bulten, H. J.; Buonanno, A.; Buskulic, D.; Buy, C.; Byer, R. L.; Cabero, M.; Cadonati, L.; Cagnoli, G.; Cahillane, C.; Calderón Bustillo, J.; Callister, T. A.; Calloni, E.; Camp, J. B.; Canizares, P.; Cannon, K. C.; Cao, H.; Cao, J.; Capano, C. D.; Capocasa, E.; Carbognani, F.; Caride, S.; Carney, M. F.; Casanueva Diaz, J.; Casentini, C.; Caudill, S.; Cavaglià, M.; Cavalier, F.; Cavalieri, R.; Cella, G.; Cepeda, C. B.; Cerboni Baiardi, L.; Cerretani, G.; Cesarini, E.; Chamberlin, S. J.; Chan, M.; Chao, S.; Charlton, P.; Chassande-Mottin, E.; Chatterjee, D.; Cheeseboro, B. D.; Chen, H. Y.; Chen, Y.; Cheng, H.-P.; Chincarini, A.; Chiummo, A.; Chmiel, T.; Cho, H. S.; Cho, M.; Chow, J. H.; Christensen, N.; Chu, Q.; Chua, A. J. K.; Chua, S.; Chung, A. K. W.; Chung, S.; Ciani, G.; Ciolfi, R.; Cirelli, C. E.; Cirone, A.; Clara, F.; Clark, J. A.; Cleva, F.; Cocchieri, C.; Coccia, E.; Cohadon, P.-F.; Colla, A.; Collette, C. G.; Cominsky, L. R.; Constancio, M.; Conti, L.; Cooper, S. J.; Corban, P.; Corbitt, T. R.; Corley, K. R.; Cornish, N.; Corsi, A.; Cortese, S.; Costa, C. A.; Coughlin, M. W.; Coughlin, S. B.; Coulon, J.-P.; Countryman, S. T.; Couvares, P.; Covas, P. B.; Cowan, E. E.; Coward, D. M.; Cowart, M. J.; Coyne, D. C.; Coyne, R.; Creighton, J. D. E.; Creighton, T. D.; Cripe, J.; Crowder, S. G.; Cullen, T. J.; Cumming, A.; Cunningham, L.; Cuoco, E.; Dal Canton, T.; Danilishin, S. L.; D'Antonio, S.; Danzmann, K.; Dasgupta, A.; Da Silva Costa, C. F.; Dattilo, V.; Dave, I.; Davier, M.; Davis, D.; Daw, E. J.; Day, B.; De, S.; DeBra, D.; Deelman, E.; Degallaix, J.; De Laurentis, M.; Deléglise, S.; Del Pozzo, W.; Denker, T.; Dent, T.; Dergachev, V.; De Rosa, R.; DeRosa, R. T.; DeSalvo, R.; Devenson, J.; Devine, R. C.; Dhurandhar, S.; Díaz, M. C.; Di Fiore, L.; Di Giovanni, M.; Di Girolamo, T.; Di Lieto, A.; Di Pace, S.; Di Palma, I.; Di Renzo, F.; Doctor, Z.; Dolique, V.; Donovan, F.; Dooley, K. L.; Doravari, S.; Dorrington, I.; Douglas, R.; Dovale Álvarez, M.; Downes, T. P.; Drago, M.; Drever, R. W. P.; Driggers, J. C.; Du, Z.; Ducrot, M.; Duncan, J.; Dwyer, S. E.; Edo, T. B.; Edwards, M. C.; Effler, A.; Eggenstein, H.-B.; Ehrens, P.; Eichholz, J.; Eikenberry, S. S.; Eisenstein, R. A.; Essick, R. C.; Etienne, Z. B.; Etzel, T.; Evans, M.; Evans, T. M.; Factourovich, M.; Fafone, V.; Fair, H.; Fairhurst, S.; Fan, X.; Farinon, S.; Farr, B.; Farr, W. M.; Fauchon-Jones, E. J.; Favata, M.; Fays, M.; Fehrmann, H.; Feicht, J.; Fejer, M. M.; Fernandez-Galiana, A.; Ferrante, I.; Ferreira, E. C.; Ferrini, F.; Fidecaro, F.; Fiori, I.; Fiorucci, D.; Fisher, R. P.; Flaminio, R.; Fletcher, M.; Fong, H.; Forsyth, P. W. F.; Forsyth, S. S.; Fournier, J.-D.; Frasca, S.; Frasconi, F.; Frei, Z.; Freise, A.; Frey, R.; Frey, V.; Fries, E. M.; Fritschel, P.; Frolov, V. V.; Fulda, P.; Fyffe, M.; Gabbard, H.; Gabel, M.; Gadre, B. U.; Gaebel, S. M.; Gair, J. R.; Gammaitoni, L.; Ganija, M. R.; Gaonkar, S. G.; Garufi, F.; Gaudio, S.; Gaur, G.; Gayathri, V.; Gehrels, N.; Gemme, G.; Genin, E.; Gennai, A.; George, D.; George, J.; Gergely, L.; Germain, V.; Ghonge, S.; Ghosh, Abhirup; Ghosh, Archisman; Ghosh, S.; Giaime, J. A.; Giardina, K. D.; Giazotto, A.; Gill, K.; Glover, L.; Goetz, E.; Goetz, R.; Gomes, S.; González, G.; Gonzalez Castro, J. M.; Gopakumar, A.; Gorodetsky, M. L.; Gossan, S. E.; Gosselin, M.; Gouaty, R.; Grado, A.; Graef, C.; Granata, M.; Grant, A.; Gras, S.; Gray, C.; Greco, G.; Green, A. C.; Groot, P.; Grote, H.; Grunewald, S.; Gruning, P.; Guidi, G. M.; Guo, X.; Gupta, A.; Gupta, M. K.; Gushwa, K. E.; Gustafson, E. K.; Gustafson, R.; Hall, B. R.; Hall, E. D.; Hammond, G.; Haney, M.; Hanke, M. M.; Hanks, J.; Hanna, C.; Hannuksela, O. A.; Hanson, J.; Hardwick, T.; Harms, J.; Harry, G. M.; Harry, I. W.; Hart, M. J.; Haster, C.-J.; Haughian, K.; Healy, J.; Heidmann, A.; Heintze, M. C.; Heitmann, H.; Hello, P.; Hemming, G.; Hendry, M.; Heng, I. S.; Hennig, J.; Henry, J.; Heptonstall, A. W.; Heurs, M.; Hild, S.; Hoak, D.; Hofman, D.; Holt, K.; Holz, D. E.; Hopkins, P.; Horst, C.; Hough, J.; Houston, E. A.; Howell, E. J.; Hu, Y. M.; Huerta, E. A.; Huet, D.; Hughey, B.; Husa, S.; Huttner, S. H.; Huynh-Dinh, T.; Indik, N.; Ingram, D. R.; Inta, R.; Intini, G.; Isa, H. N.; Isac, J.-M.; Isi, M.; Iyer, B. R.; Izumi, K.; Jacqmin, T.; Jani, K.; Jaranowski, P.; Jawahar, S.; Jiménez-Forteza, F.; Johnson, W. W.; Jones, D. I.; Jones, R.; Jonker, R. J. G.; Ju, L.; Junker, J.; Kalaghatgi, C. V.; Kalogera, V.; Kandhasamy, S.; Kang, G.; Kanner, J. B.; Karki, S.; Karvinen, K. S.; Kasprzack, M.; Katolik, M.; Katsavounidis, E.; Katzman, W.; Kaufer, S.; Kawabe, K.; Kéfélian, F.; Keitel, D.; Kemball, A. J.; Kennedy, R.; Kent, C.; Key, J. S.; Khalili, F. Y.; Khan, I.; Khan, S.; Khan, Z.; Khazanov, E. A.; Kijbunchoo, N.; Kim, Chunglee; Kim, J. C.; Kim, W.; Kim, W. S.; Kim, Y.-M.; Kimbrell, S. J.; King, E. J.; King, P. J.; Kirchhoff, R.; Kissel, J. S.; Kleybolte, L.; Klimenko, S.; Koch, P.; Koehlenbeck, S. M.; Koley, S.; Kondrashov, V.; Kontos, A.; Korobko, M.; Korth, W. Z.; Kowalska, I.; Kozak, D. B.; Krämer, C.; Kringel, V.; Krishnan, B.; Królak, A.; Kuehn, G.; Kumar, P.; Kumar, R.; Kumar, S.; Kuo, L.; Kutynia, A.; Kwang, S.; Lackey, B. D.; Lai, K. H.; Landry, M.; Lang, R. N.; Lange, J.; Lantz, B.; Lanza, R. K.; Lartaux-Vollard, A.; Lasky, P. D.; Laxen, M.; Lazzarini, A.; Lazzaro, C.; Leaci, P.; Leavey, S.; Lee, C. H.; Lee, H. K.; Lee, H. M.; Lee, H. W.; Lee, K.; Lehmann, J.; Lenon, A.; Leonardi, M.; Leroy, N.; Letendre, N.; Levin, Y.; Li, T. G. F.; Libson, A.; Littenberg, T. B.; Liu, J.; Lo, R. K. L.; Lockerbie, N. A.; London, L. T.; Lord, J. E.; Lorenzini, M.; Loriette, V.; Lormand, M.; Losurdo, G.; Lough, J. D.; Lovelace, G.; Lück, H.; Lumaca, D.; Lundgren, A. P.; Lynch, R.; Ma, Y.; Macfoy, S.; Machenschalk, B.; MacInnis, M.; Macleod, D. M.; Magaña Hernandez, I.; Magaña-Sandoval, F.; Magaña Zertuche, L.; Magee, R. M.; Majorana, E.; Maksimovic, I.; Man, N.; Mandic, V.; Mangano, V.; Mansell, G. L.; Manske, M.; Mantovani, M.; Marchesoni, F.; Marion, F.; Márka, S.; Márka, Z.; Markakis, C.; Markosyan, A. S.; Maros, E.; Martelli, F.; Martellini, L.; Martin, I. W.; Martynov, D. V.; Mason, K.; Masserot, A.; Massinger, T. J.; Masso-Reid, M.; Mastrogiovanni, S.; Matas, A.; Matichard, F.; Matone, L.; Mavalvala, N.; Mayani, R.; Mazumder, N.; McCarthy, R.; McClelland, D. E.; McCormick, S.; McCuller, L.; McGuire, S. C.; McIntyre, G.; McIver, J.; McManus, D. J.; McRae, T.; McWilliams, S. T.; Meacher, D.; Meadors, G. D.; Meidam, J.; Mejuto-Villa, E.; Melatos, A.; Mendell, G.; Mercer, R. A.; Merilh, E. L.; Merzougui, M.; Meshkov, S.; Messenger, C.; Messick, C.; Metzdorff, R.; Meyers, P. M.; Mezzani, F.; Miao, H.; Michel, C.; Middleton, H.; Mikhailov, E. E.; Milano, L.; Miller, A. L.; Miller, A.; Miller, B. B.; Miller, J.; Millhouse, M.; Minazzoli, O.; Minenkov, Y.; Ming, J.; Mishra, C.; Mitra, S.; Mitrofanov, V. P.; Mitselmakher, G.; Mittleman, R.; Moggi, A.; Mohan, M.; Mohapatra, S. R. P.; Montani, M.; Moore, B. C.; Moore, C. J.; Moraru, D.; Moreno, G.; Morriss, S. R.; Mours, B.; Mow-Lowry, C. M.; Mueller, G.; Muir, A. W.; Mukherjee, Arunava; Mukherjee, D.; Mukherjee, S.; Mukund, N.; Mullavey, A.; Munch, J.; Muniz, E. A. M.; Murray, P. G.; Napier, K.; Nardecchia, I.; Naticchioni, L.; Nayak, R. K.; Nelemans, G.; Nelson, T. J. N.; Neri, M.; Nery, M.; Neunzert, A.; Newport, J. M.; Newton, G.; Ng, K. K. Y.; Nguyen, T. T.; Nichols, D.; Nielsen, A. B.; Nissanke, S.; Nitz, A.; Noack, A.; Nocera, F.; Nolting, D.; Normandin, M. E. N.; Nuttall, L. K.; Oberling, J.; Ochsner, E.; Oelker, E.; Ogin, G. H.; Oh, J. J.; Oh, S. H.; Ohme, F.; Oliver, M.; Oppermann, P.; Oram, Richard J.; O'Reilly, B.; Ormiston, R.; Ortega, L. F.; O'Shaughnessy, R.; Ottaway, D. J.; Overmier, H.; Owen, B. J.; Pace, A. E.; Page, J.; Page, M. A.; Pai, A.; Pai, S. A.; Palamos, J. R.; Palashov, O.; Palomba, C.; Pal-Singh, A.; Pan, H.; Pang, B.; Pang, P. T. H.; Pankow, C.; Pannarale, F.; Pant, B. C.; Paoletti, F.; Paoli, A.; Papa, M. A.; Paris, H. R.; Parker, W.; Pascucci, D.; Pasqualetti, A.; Passaquieti, R.; Passuello, D.; Patricelli, B.; Pearlstone, B. L.; Pedraza, M.; Pedurand, R.; Pekowsky, L.; Pele, A.; Penn, S.; Perez, C. J.; Perreca, A.; Perri, L. M.; Pfeiffer, H. P.; Phelps, M.; Piccinni, O. J.; Pichot, M.; Piergiovanni, F.; Pierro, V.; Pillant, G.; Pinard, L.; Pinto, I. M.; Pitkin, M.; Poggiani, R.; Popolizio, P.; Porter, E. K.; Post, A.; Powell, J.; Prasad, J.; Pratt, J. W. W.; Predoi, V.; Prestegard, T.; Prijatelj, M.; Principe, M.; Privitera, S.; Prix, R.; Prodi, G. A.; Prokhorov, L. G.; Puncken, O.; Punturo, M.; Puppo, P.; Pürrer, M.; Qi, H.; Qin, J.; Qiu, S.; Quetschke, V.; Quintero, E. A.; Quitzow-James, R.; Raab, F. J.; Rabeling, D. S.; Radkins, H.; Raffai, P.; Raja, S.; Rajan, C.; Rakhmanov, M.; Ramirez, K. E.; Rapagnani, P.; Raymond, V.; Razzano, M.; Read, J.; Regimbau, T.; Rei, L.; Reid, S.; Reitze, D. H.; Rew, H.; Reyes, S. D.; Ricci, F.; Ricker, P. M.; Rieger, S.; Riles, K.; Rizzo, M.; Robertson, N. A.; Robie, R.; Robinet, F.; Rocchi, A.; Rolland, L.; Rollins, J. G.; Roma, V. J.; Romano, R.; Romel, C. L.; Romie, J. H.; Rosińska, D.; Ross, M. P.; Rowan, S.; Rüdiger, A.; Ruggi, P.; Ryan, K.; Rynge, M.; Sachdev, S.; Sadecki, T.; Sadeghian, L.; Sakellariadou, M.; Salconi, L.; Saleem, M.; Salemi, F.; Samajdar, A.; Sammut, L.; Sampson, L. M.; Sanchez, E. J.; Sandberg, V.; Sandeen, B.; Sanders, J. R.; Sassolas, B.; Sathyaprakash, B. S.; Saulson, P. R.; Sauter, O.; Savage, R. L.; Sawadsky, A.; Schale, P.; Scheuer, J.; Schmidt, E.; Schmidt, J.; Schmidt, P.; Schnabel, R.; Schofield, R. M. S.; Schönbeck, A.; Schreiber, E.; Schuette, D.; Schulte, B. W.; Schutz, B. F.; Schwalbe, S. G.; Scott, J.; Scott, S. M.; Seidel, E.; Sellers, D.; Sengupta, A. S.; Sentenac, D.; Sequino, V.; Sergeev, A.; Shaddock, D. A.; Shaffer, T. J.; Shah, A. A.; Shahriar, M. S.; Shao, L.; Shapiro, B.; Shawhan, P.; Sheperd, A.; Shoemaker, D. H.; Shoemaker, D. M.; Siellez, K.; Siemens, X.; Sieniawska, M.; Sigg, D.; Silva, A. D.; Singer, A.; Singer, L. P.; Singh, A.; Singh, R.; Singhal, A.; Sintes, A. M.; Slagmolen, B. J. J.; Smith, B.; Smith, J. R.; Smith, R. J. E.; Son, E. J.; Sonnenberg, J. A.; Sorazu, B.; Sorrentino, F.; Souradeep, T.; Spencer, A. P.; Srivastava, A. K.; Staley, A.; Steinke, M.; Steinlechner, J.; Steinlechner, S.; Steinmeyer, D.; Stephens, B. C.; Stone, R.; Strain, K. A.; Stratta, G.; Strigin, S. E.; Sturani, R.; Stuver, A. L.; Summerscales, T. Z.; Sun, L.; Sunil, S.; Sutton, P. J.; Swinkels, B. L.; Szczepańczyk, M. J.; Tacca, M.; Talukder, D.; Tanner, D. B.; Tápai, M.; Taracchini, A.; Taylor, J. A.; Taylor, R.; Theeg, T.; Thomas, E. G.; Thomas, M.; Thomas, P.; Thorne, K. A.; Thorne, K. S.; Thrane, E.; Tiwari, S.; Tiwari, V.; Tokmakov, K. V.; Toland, K.; Tonelli, M.; Tornasi, Z.; Torrie, C. I.; Töyrä, D.; Travasso, F.; Traylor, G.; Trifirò, D.; Trinastic, J.; Tringali, M. C.; Trozzo, L.; Tsang, K. W.; Tse, M.; Tso, R.; Tuyenbayev, D.; Ueno, K.; Ugolini, D.; Unnikrishnan, C. S.; Urban, A. L.; Usman, S. A.; Vahi, K.; Vahlbruch, H.; Vajente, G.; Valdes, G.; Vallisneri, M.; van Bakel, N.; van Beuzekom, M.; van den Brand, J. F. J.; Van Den Broeck, C.; Vander-Hyde, D. C.; van der Schaaf, L.; van Heijningen, J. V.; van Veggel, A. A.; Vardaro, M.; Varma, V.; Vass, S.; Vasúth, M.; Vecchio, A.; Vedovato, G.; Veitch, J.; Veitch, P. J.; Venkateswara, K.; Venugopalan, G.; Verkindt, D.; Vetrano, F.; Viceré, A.; Viets, A. D.; Vinciguerra, S.; Vine, D. J.; Vinet, J.-Y.; Vitale, S.; Vo, T.; Vocca, H.; Vorvick, C.; Voss, D. V.; Vousden, W. D.; Vyatchanin, S. P.; Wade, A. R.; Wade, L. E.; Wade, M.; Walet, R.; Walker, M.; Wallace, L.; Walsh, S.; Wang, G.; Wang, H.; Wang, J. Z.; Wang, M.; Wang, Y.-F.; Wang, Y.; Ward, R. L.; Warner, J.; Was, M.; Watchi, J.; Weaver, B.; Wei, L.-W.; Weinert, M.; Weinstein, A. J.; Weiss, R.; Wen, L.; Wessel, E. K.; Weßels, P.; Westphal, T.; Wette, K.; Whelan, J. T.; Whiting, B. F.; Whittle, C.; Williams, D.; Williams, R. D.; Williamson, A. R.; Willis, J. L.; Willke, B.; Wimmer, M. H.; Winkler, W.; Wipf, C. C.; Wittel, H.; Woan, G.; Woehler, J.; Wofford, J.; Wong, K. W. K.; Worden, J.; Wright, J. L.; Wu, D. S.; Wu, G.; Yam, W.; Yamamoto, H.; Yancey, C. C.; Yap, M. J.; Yu, Hang; Yu, Haocun; Yvert, M.; ZadroŻny, A.; Zanolin, M.; Zelenova, T.; Zendri, J.-P.; Zevin, M.; Zhang, L.; Zhang, M.; Zhang, T.; Zhang, Y.-H.; Zhao, C.; Zhou, M.; Zhou, Z.; Zhu, S. J.; Zhu, X. J.; Zucker, M. E.; Zweizig, J.; Anderson, D. P.; LIGO Scientific Collaboration; Virgo Collaboration
2017-12-01
We report results of a deep all-sky search for periodic gravitational waves from isolated neutron stars in data from the first Advanced LIGO observing run. This search investigates the low frequency range of Advanced LIGO data, between 20 and 100 Hz, much of which was not explored in initial LIGO. The search was made possible by the computing power provided by the volunteers of the Einstein@Home project. We find no significant signal candidate and set the most stringent upper limits to date on the amplitude of gravitational wave signals from the target population, corresponding to a sensitivity depth of 48.7 [1 /√{Hz }] . At the frequency of best strain sensitivity, near 100 Hz, we set 90% confidence upper limits of 1.8 ×1 0-25. At the low end of our frequency range, 20 Hz, we achieve upper limits of 3.9 ×1 0-24. At 55 Hz we can exclude sources with ellipticities greater than 1 0-5 within 100 pc of Earth with fiducial value of the principal moment of inertia of 1038 kg m2 .
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Kim, Hyosun
2015-08-25
For the purpose of understanding the Food and Drug Administration's (FDA's) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. The FDA's warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of
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Home | SREL Herpetology Program
Savannah River Ecology Laboratory Herpetology Program Herp Home Research Publications Herps of SC /GA P.A.R.C. Outreach SREL Home powered by Google Search Herpetology at SREL The University of SREL herpetology research programs have always included faculty of the University of Georgia, post
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FDA Approves First Therapeutic Cancer Vaccine
Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.
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Predicting Drug Recalls From Internet Search Engine Queries.
Yom-Tov, Elad
2017-01-01
Batches of pharmaceuticals are sometimes recalled from the market when a safety issue or a defect is detected in specific production runs of a drug. Such problems are usually detected when patients or healthcare providers report abnormalities to medical authorities. Here, we test the hypothesis that defective production lots can be detected earlier by monitoring queries to Internet search engines. We extracted queries from the USA to the Bing search engine, which mentioned one of the 5195 pharmaceutical drugs during 2015 and all recall notifications issued by the Food and Drug Administration (FDA) during that year. By using attributes that quantify the change in query volume at the state level, we attempted to predict if a recall of a specific drug will be ordered by FDA in a time horizon ranging from 1 to 40 days in future. Our results show that future drug recalls can indeed be identified with an AUC of 0.791 and a lift at 5% of approximately 6 when predicting a recall occurring one day ahead. This performance degrades as prediction is made for longer periods ahead. The most indicative attributes for prediction are sudden spikes in query volume about a specific medicine in each state. Recalls of prescription drugs and those estimated to be of medium-risk are more likely to be identified using search query data. These findings suggest that aggregated Internet search engine data can be used to facilitate in early warning of faulty batches of medicines.
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Mining FDA drug labels for medical conditions.
Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre
2013-04-24
Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.
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Environmental assessments and findings of no significant impact--FDA. Notice.
1998-05-18
The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.
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21 CFR 516.34 - FDA recognition of exclusive marketing rights.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...
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Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations
Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.
2014-01-01
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family
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Gas separation performance of 6FDA-based polyimides with different chemical structures
Qiu, Wulin
2013-10-01
This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.
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Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations
Xu, Liren
2014-06-01
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.
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Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.
KuKanich, Butch; Warner, Matt; Hahn, Kevin
2017-02-01
OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.
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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar
2015-07-01
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.
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FDA-approved small-molecule kinase inhibitors
DEFF Research Database (Denmark)
Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig
2015-01-01
Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...
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Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H
2014-02-01
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.
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Alderdice, Fiona; Gargan, Phyl; McCall, Emma; Franck, Linda
2018-01-30
Online resources are a source of information for parents of premature babies when their baby is discharged from hospital. To explore what topics parents deemed important after returning home from hospital with their premature baby and to evaluate the quality of existing websites that provide information for parents post-discharge. In stage 1, 23 parents living in Northern Ireland participated in three focus groups and shared their information and support needs following the discharge of their infant(s). In stage 2, a World Wide Web (WWW) search was conducted using Google, Yahoo and Bing search engines. Websites meeting pre-specified inclusion criteria were reviewed using two website assessment tools and by calculating a readability score. Website content was compared to the topics identified by parents in the focus groups. Five overarching topics were identified across the three focus groups: life at home after neonatal care, taking care of our family, taking care of our premature baby, baby's growth and development and help with getting support and advice. Twenty-nine sites were identified that met the systematic web search inclusion criteria. Fifteen (52%) covered all five topics identified by parents to some extent and 9 (31%) provided current, accurate and relevant information based on the assessment criteria. Parents reported the need for information and support post-discharge from hospital. This was not always available to them, and relevant online resources were of varying quality. Listening to parents needs and preferences can facilitate the development of high-quality, evidence-based, parent-centred resources. © 2018 The Authors Health Expectations published by John Wiley & Sons Ltd.
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Evaluating eating behavior treatments by FDA standards
Directory of Open Access Journals (Sweden)
A. Janet eTomiyama
2014-01-01
Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.
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Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E
2015-10-01
The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.
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2011-05-24
... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...
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... Consumers Consumer Information by Audience For Kids For Kids Share Tweet Linkedin Pin it More sharing options ... Compliance Federal, State & Local Officials Consumers Health Professionals Science & Research Industry Scroll back to top Popular Content ...
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FDA actions against health economic promotions, 2002-2011.
Neumann, Peter J; Bliss, Sarah K
2012-01-01
To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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intersect as Attack Wing leaders change roles The 112th COS postured as cyber shield for Pa. infrastructure 111th Attack Wing 111th Attack Wing 21st Century Guard Airmen Home News Photos Art Video Resources - The Balance Search 111th Attack Wing: COMMUNITY/ENVIRO May 16, 2018; Pa. Department of Health update
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Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S
2011-01-01
Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements
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Directory of Open Access Journals (Sweden)
Deborah Korenstein
Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical
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FDA regulations for commercial food irradiation
International Nuclear Information System (INIS)
Takeguchi, C.A.
1985-01-01
The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed
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AF Branding & Trademark Licensing Join the Air Force Home About Us The Air Force Symbol Display Resources Document Library TM Connect Search AF Branding and Trademark Licensing Program: important links Legal Documents 10 U.S.C. § 2260 15 U.S.C. § 167;167; 1114-1125 DODI 5535.12, DoD Branding and
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FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.
Grant, Evita V
Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.
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Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?
Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.
2015-01-01
Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691
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Small-molecule kinase inhibitors: an analysis of FDA-approved drugs
DEFF Research Database (Denmark)
Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig
2016-01-01
Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...
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International Nuclear Information System (INIS)
Swedjemark, G.A.
1988-01-01
Local authorities in Sweden have made about 58,000 radon daughter measurements with the following aims: (1) to search for houses with high radon daughter levels, (2) to determine the level above which the house would be regarded as an insanitary dwelling, and (3) to check that the radon daughter concentrations in newly built houses are below the established limit. The sampling of dwellings is therefore not representative for Swedish homes. 5300 homes were found to have levels above the limit 400 Bq.m -3 EER. The highest level found was 28,000 Bq.m -3 . In about one third of the homes found to have levels exceeding the limit, measures had been carried out to decrease the radon daughter concentration. About half of the homes in which the levels were decreased had levels below the limit for rebuilding, e.g. 200 Bq.m -3 . Measurements in order to ascertain levels in newly built houses were made in about 1100 homes out of 200,000 built since 1981 which was the year in which requirements for newly built houses came into force. Of those built with radon-protective foundations, 94% had concentrations below the 70 Bq.m -3 EER limit, compared to 80% for traditional building techniques. (author)
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FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.
Wilson, Carolyn A; Simonyan, Vahan
2014-01-01
Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and
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Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen
2014-01-01
The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.
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FDA publishes checklist of Y2K high-risk devices.
1999-09-01
Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.
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[Outcomes after planned home births].
Blix, Ellen; Øian, Pål; Kumle, Merethe
2008-11-06
About 150 planned home births take place in Norway annually. Professionals have different opinions on whether such births are safe or not. The aim of the present study was to perform a systematic literature review on maternal and neonatal outcomes after planned home births. A review was performed of literature retrieved from searches in MEDLINE, PubMed, Embase, Cinahl and The Cochrane Library and relevant references found in the articles. The searches were limited to studies published in 1985 and later. 10 studies with data from 30 204 women who had planned and were selected to home birth at the onset of labour were included. Three of the studies had control groups including women with planned hospital births. All included studies were assessed to be of medium quality. Between 9.9 and 23.1 % of women and infants were transferred to hospital during labour or after birth. There were few caesarean sections, other interventions or complications in the studies assessed; the total perinatal mortality rate was 2.9/1000 and the intrapartum mortality rate 0.8/1000. There is no sound basis for discouraging low-risk women from planning a home birth. Results from the included studies do not directly apply to Norwegian conditions. Outcomes and transfers after planned home births should be systematically registered.
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High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations
Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.
2012-01-01
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
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High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations
Zhang, Chen
2012-02-01
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
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Dose Matters: FDA's Guidance on Children's X-rays
... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...
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Egyptian Journal of Medical Laboratory Sciences: Advanced Search
African Journals Online (AJOL)
Egyptian Journal of Medical Laboratory Sciences: Advanced Search. Journal Home > Egyptian Journal of Medical Laboratory Sciences: Advanced Search. Log in or Register to get access to full text downloads.
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Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O
2016-02-01
Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Propensity to Search: Common, Leisure, and Labor Models of Consumer Behavior
Directory of Open Access Journals (Sweden)
Sergey MALAKHOV
2015-05-01
Full Text Available The analysis of the propensity to search specifies the “common” or the ordinary model of consumer behavior based on the synthesis of the neoclassical approach with satisficing concept, and “leisure” and “labor” models of behavior that represent different combinations of conspicuous consumption, leisure, and labor. While the “common model” of behavior demonstrates a moderate propensity to search, “leisure” and “labor” models of consumer behavior exhibit vigorous propensities to search that results in purchase of unnecessary items and therefore in overconsumption. This trend is also presented in home production where vigorous propensity to search takes the form of the vigorous propensity to produce at home. The analysis of trends in allocation of time provides grounds for the assumption that men have more accentuated propensity to search and to produce at home than women that results in overconsumption of unnecessary items.
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Chambers, James D; May, Katherine E; Neumann, Peter J
2013-06-01
The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.
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Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.
Sarapa, Nenad
2007-09-01
The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.
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African Journals Online (AJOL)
Search Our Site With Google. Journal Home > Search Our Site With Google. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's ...
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No sisyphean task: how the FDA can regulate electronic cigarettes.
Paradise, Jordan
2013-01-01
The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009
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Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.
2014-01-01
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...
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Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S
2016-01-01
Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated
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Smart home technologies for health and social care support.
Martin, Suzanne; Kelly, Greg; Kernohan, W George; McCreight, Bernadette; Nugent, Christopher
2008-10-08
The integration of smart home technology to support health and social care is acquiring an increasing global significance. Provision is framed within the context of a rapidly changing population profile, which is impacting on the number of people requiring health and social care, workforce availability and the funding of healthcare systems. To explore the effectiveness of smart home technologies as an intervention for people with physical disability, cognitive impairment or learning disability, who are living at home, and to consider the impact on the individual's health status and on the financial resources of health care. We searched the following databases for primary studies: (a) the Cochrane Effective Practice and Organisation of Care (EPOC) Group Register, (b) the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, issue 1, 2007), and (c) bibliographic databases, including MEDLINE (1966 to March 2007), EMBASE (1980 to March 2007) and CINAHL (1982 to March 2007). We also searched the Database of Abstracts of Reviews of Effectiveness (DARE). We searched the electronic databases using a strategy developed by the EPOC Trials Search Co-ordinator. We included randomised controlled trials (RCTs), quasi-experimental studies, controlled before and after studies (CBAs) and interrupted time series analyses (ITS). Participants included adults over the age of 18, living in their home in a community setting. Participants with a physical disability, dementia or a learning disability were included. The included interventions were social alarms, electronic assistive devices, telecare social alert platforms, environmental control systems, automated home environments and 'ubiquitous homes'. Outcome measures included any objective measure that records an impact on a participant's quality of life, healthcare professional workload, economic outcomes, costs to healthcare provider or costs to participant. We included measures of service satisfaction
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Directory of Open Access Journals (Sweden)
Bander Balkhi
2018-02-01
Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.
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Content and Design Features of Academic Health Sciences Libraries' Home Pages.
McConnaughy, Rozalynd P; Wilson, Steven P
2018-01-01
The goal of this content analysis was to identify commonly used content and design features of academic health sciences library home pages. After developing a checklist, data were collected from 135 academic health sciences library home pages. The core components of these library home pages included a contact phone number, a contact email address, an Ask-a-Librarian feature, the physical address listed, a feedback/suggestions link, subject guides, a discovery tool or database-specific search box, multimedia, social media, a site search option, a responsive web design, and a copyright year or update date.
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African Journals Online (AJOL)
Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives. Journal Homepage Image. Chemsearch Journal is a peer – reviewed journal that publishes original research work, scientific papers and technical reports in all the field of Chemistry (pure science, agriculture, environmental science, ...
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How to find home backwards? Navigation during rearward homing of Cataglyphis fortis desert ants.
Pfeffer, Sarah E; Wittlinger, Matthias
2016-07-15
Cataglyphis ants are renowned for their impressive navigation skills, which have been studied in numerous experiments during forward locomotion. However, the ants' navigational performance during backward homing when dragging large food loads has not been investigated until now. During backward locomotion, the odometer has to deal with unsteady motion and irregularities in inter-leg coordination. The legs' sensory feedback during backward walking is not just a simple reversal of the forward stepping movements: compared with forward homing, ants are facing towards the opposite direction during backward dragging. Hence, the compass system has to cope with a flipped celestial view (in terms of the polarization pattern and the position of the sun) and an inverted retinotopic image of the visual panorama and landmark environment. The same is true for wind and olfactory cues. In this study we analyze for the first time backward-homing ants and evaluate their navigational performance in channel and open field experiments. Backward-homing Cataglyphis fortis desert ants show remarkable similarities in the performance of homing compared with forward-walking ants. Despite the numerous challenges emerging for the navigational system during backward walking, we show that ants perform quite well in our experiments. Direction and distance gauging was comparable to that of the forward-walking control groups. Interestingly, we found that backward-homing ants often put down the food item and performed foodless search loops around the left food item. These search loops were mainly centred around the drop-off position (and not around the nest position), and increased in length the closer the ants came to their fictive nest site. © 2016. Published by The Company of Biologists Ltd.
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In Search of Perfect Freedom | Houliston | Shakespeare in Southern ...
African Journals Online (AJOL)
Shakespeare in Southern Africa. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 26 (2014) >. Log in or Register to get access to full text downloads.
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Javitt, Gail H; Hudson, Kathy
2003-01-01
The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.
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Biometric Enhancement of Home and Office Security to Reduce ...
African Journals Online (AJOL)
West African Journal of Industrial and Academic Research. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 13, No 1 (2015) >. Log in or Register to get access to full text downloads.
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21 CFR 5.1110 - FDA public information offices.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...
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Alephweb: a search engine based on the federated structure ...
African Journals Online (AJOL)
Revue d'Information Scientifique et Technique. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 7, No 1 (1997) >. Log in or Register to get access to full text downloads.
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Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
Caliendo, Angela M; Hanson, Kimberly E
2016-04-01
Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.
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One and done: Reasons principal investigators conduct only one FDA-regulated drug trial
Directory of Open Access Journals (Sweden)
Amy Corneli, PhD, MPH
2017-06-01
Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.
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Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo, Richard A
2004-01-01
Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
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Medical student appraisal: searching on smartphones.
Khalifian, S; Markman, T; Sampognaro, P; Mitchell, S; Weeks, S; Dattilo, J
2013-01-01
The rapidly growing industry for mobile medical applications provides numerous smartphone resources designed for healthcare professionals. However, not all applications are equally useful in addressing the questions of early medical trainees. Three popular, free, mobile healthcare applications were evaluated along with a Google(TM) web search on both Apple(TM) and Android(TM) devices. Six medical students at a large academic hospital evaluated each application for a one-week period while on various clinical rotations. Google(TM) was the most frequently used search method and presented multimedia resources but was inefficient for obtaining clinical management information. Epocrates(TM) Pill ID feature was praised for its clinical utility. Medscape(TM) had the highest satisfaction of search and excelled through interactive educational features. Micromedex(TM) offered both FDA and off-label dosing for drugs. Google(TM) was the preferred search method for questions related to basic disease processes and multimedia resources, but was inadequate for clinical management. Caution should also be exercised when using Google(TM) in front of patients. Medscape(TM) was the most appealing application due to a broad scope of content and educational features relevant to medical trainees. Students should also be cognizant of how mobile technology may be perceived by their evaluators to avoid false impressions.
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We really need to talk: adapting FDA processes to rapid change.
Lykken, Sara
2013-01-01
The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.
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THPdb: Database of FDA-approved peptide and protein therapeutics.
Directory of Open Access Journals (Sweden)
Salman Sadullah Usmani
Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.
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Comparison of clinic-based versus home-based balance and agility ...
African Journals Online (AJOL)
South African Journal of Sports Medicine. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 23, No 3 (2011) >. Log in or Register to get access to full text downloads.
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Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma
International Nuclear Information System (INIS)
Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard
2012-01-01
Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.
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Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.
Sage, Adam; Blalock, Susan J; Carpenter, Delesha
This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.
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FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.
James, J S
1998-03-06
The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.
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Wil van Erp
2014-01-01
The purpose of this study is to explore why and how Management Accounting and Control Systems (MACS) enact and are enacted upon in the Dutch branch of nursing homes, homes for the elderly and home care. In search for answers, this study chooses an actor-network theory (ANT) perspective combined with
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A modified harmony search based method for optimal rural radial ...
African Journals Online (AJOL)
International Journal of Engineering, Science and Technology. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 2, No 3 (2010) >. Log in or Register to get access to full text downloads.
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Fisher, Neyman, and Bayes at FDA.
Rubin, Donald B
2016-01-01
The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.
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Three Drugs Approved for Urothelial Carcinoma by FDA.
2017-07-01
The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.
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Directory of Open Access Journals (Sweden)
Sean Ekins
2014-12-01
Full Text Available We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35. When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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Directory of Open Access Journals (Sweden)
Sean Ekins
2014-11-01
Full Text Available We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35. When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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Home media server content management
Tokmakoff, Andrew A.; van Vliet, Harry
2001-07-01
With the advent of set-top boxes, the convergence of TV (broadcasting) and PC (Internet) is set to enter the home environment. Currently, a great deal of activity is occurring in developing standards (TV-Anytime Forum) and devices (TiVo) for local storage on Home Media Servers (HMS). These devices lie at the heart of convergence of the triad: communications/networks - content/media - computing/software. Besides massive storage capacity and being a communications 'gateway', the home media server is characterised by the ability to handle metadata and software that provides an easy to use on-screen interface and intelligent search/content handling facilities. In this paper, we describe a research prototype HMS that is being developed within the GigaCE project at the Telematica Instituut . Our prototype demonstrates advanced search and retrieval (video browsing), adaptive user profiling and an innovative 3D component of the Electronic Program Guide (EPG) which represents online presence. We discuss the use of MPEG-7 for representing metadata, the use of MPEG-21 working draft standards for content identification, description and rights expression, and the use of HMS peer-to-peer content distribution approaches. Finally, we outline explorative user behaviour experiments that aim to investigate the effectiveness of the prototype HMS during development.
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Leonard, Elizabeth Weeks
2009-01-01
On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
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pSort search result - KOME | LSDB Archive [Life Science Database Archive metadata
Lifescience Database Archive (English)
Full Text Available switchLanguage; BLAST Search Image Search Home About Archive Update History Data ...name: kome_psort_search_result.zip File URL: ftp://ftp.biosciencedbc.jp/archive/kome/LATEST/kome_psort_searc...abase Description Download License Update History of This Database Site Policy | Contact Us pSort search result - KOME | LSDB Archive ...
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1995-02-01
The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.
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Wallach, Joshua D; Ciani, Oriana; Pease, Alison M; Gonsalves, Gregg S; Krumholz, Harlan M; Taylor, Rod S; Ross, Joseph S
2018-03-21
The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product's actual clinical effect. This study aims to compare the treatment effects among pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease with those observed among postapproval trials for the same indication. We searched Drugs@FDA and PubMed to identify published randomized superiority design pivotal trials for all novel drugs initially approved by the FDA between 2005 and 2012 based on surrogate markers as primary endpoints and published postapproval trials using the same surrogate markers or patient-relevant outcomes as endpoints. Summary ratio of odds ratios (RORs) and difference between standardized mean differences (dSMDs) were used to quantify the average difference in treatment effects between pivotal and matched postapproval trials. Between 2005 and 2012, the FDA approved 88 novel drugs for 90 indications based on one or multiple pivotal trials using surrogate markers of disease. Of these, 27 novel drugs for 27 indications were approved based on pivotal trials using surrogate markers as primary endpoints that could be matched to at least one postapproval trial, for a total of 43 matches. For nine (75.0%) of the 12 matches using the same non-continuous surrogate markers as trial endpoints, pivotal trials had larger treatment effects than postapproval trials. On average, treatment effects were 50% higher (more beneficial) in the pivotal than the postapproval trials (ROR 1.5; 95% confidence interval CI 1.01-2.23). For 17 (54.8%) of the 31 matches using the same continuous surrogate markers as trial endpoints, pivotal trials had larger treatment effects than the postapproval trials. On average, there was no difference in treatment effects between pivotal and postapproval trials (dSMDs 0.01; 95
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Genetics Home Reference: nonsyndromic hearing loss
... Centre for Genetics Education (Australia) Disease InfoSearch: Deafness Harvard Medical School Center for Hereditary Deafness Hereditary Hearing ... Available from http://www.ncbi.nlm.nih.gov/books/NBK1434/ Citation on ... Bulletins Genetics Home Reference Celebrates Its 15th Anniversary ...
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Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael
2013-01-22
The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5
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2011-10-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.
2014-01-01
BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval
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Huang, Fanghua
2010-04-01
Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.
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MedWatch, the FDA Safety Information and Adverse Event Reporting Program
... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...
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Directory of Open Access Journals (Sweden)
Gilhyang Kim
2016-11-01
Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.
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Care on demand in nursing homes: a queueing theoretic approach
Van Eeden, K.; Moeke, D.; Bekker, R.
2014-01-01
Nursing homes face ever-tightening healthcare budgets and are searching for ways to increase the efficiency of their healthcare processes without losing sight of the needs of their residents. Optimizing the allocation of care workers plays a key role in this search as care workers are responsible
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Timelines of translational science: From technology initiation to FDA approval.
Directory of Open Access Journals (Sweden)
Laura M McNamee
Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.
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FDA, CE mark or something else?-Thinking fast and slow.
Mishra, Sundeep
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.
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Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review
Directory of Open Access Journals (Sweden)
Juan Carlos Martínez-Aguayo
2016-06-01
Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.
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Zimmerman, Mark
2016-06-01
According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.
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HIV home testing – A problem or part of the solution? | Gardner ...
African Journals Online (AJOL)
South African Journal of Bioethics and Law. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 5, No 1 (2012) >. Log in or Register to get access to full text downloads.
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Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.
Bradford, W David; Kleit, Andrew N
2015-07-01
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.
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Nurse led home-based care for people with HIV/AIDS.
Wood, Elizabeth M; Zani, Babalwa; Esterhuizen, Tonya M; Young, Taryn
2018-03-27
Home-based care is used in many countries to increase quality of life and limit hospital stay, particularly where public health services are overburdened. Home-based care objectives for HIV/AIDS can include medical care, delivery of antiretroviral treatment and psychosocial support. This review assesses the effects of home-based nursing on morbidity in people infected with HIV/AIDS. The trials studied are in HIV positive adults and children, regardless of sex or setting and all randomised controlled. Home-based care provided by qualified nurses was compared with hospital or health-facility based treatment. The following electronic databases were searched from January 1980 to March 2015: AIDSearch, CINAHL, Cochrane Register of Controlled Trials, EMBASE, MEDLINE and PsycINFO/LIT, with an updated search in November 2016. Two authors independently screened titles and abstracts from the electronic search based on the study design, interventions and types of participant. For all selected abstracts, full text articles were obtained. The final study selection was determined with use of an eligibility form. Data extraction was performed independently from assessment of risk of bias. The results were analysed by narrative synthesis, in order to be able to obtain relevant effect measures plus 95% confidence intervals. Seven studies met the inclusion criteria. The trial size varied from 37 to 238 participants. Only one trial was conducted in children. Five studies were conducted in the USA and two in China. Four studies looked at home-based adherence support and the rest at providing home-based psychosocial support. Reported adherence to antiretroviral drugs improved with nurse-led home-based care but did not affect viral load. Psychiatric nurse support in those with existing mental health conditions improved mental health and depressive symptoms. Home-based psychological support impacted on HIV stigma, worry and physical functioning and in certain cases depressive symptoms
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Implementing guidelines in nursing homes: a systematic review.
Diehl, Heinz; Graverholt, Birgitte; Espehaug, Birgitte; Lund, Hans
2016-07-25
Research on guideline implementation strategies has mostly been conducted in settings which differ significantly from a nursing home setting and its transferability to the nursing home setting is therefore limited. The objective of this study was to systematically review the effects of interventions to improve the implementation of guidelines in nursing homes. A systematic literature search was conducted in the Cochrane Library, CINAHL, Embase, MEDLINE, DARE, HTA, CENTRAL, SveMed + and ISI Web of Science from their inception until August 2015. Reference screening and a citation search were performed. Studies were eligible if they evaluated any type of guideline implementation strategy in a nursing home setting. Eligible study designs were systematic reviews, randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted-time-series studies. The EPOC risk of bias tool was used to evaluate the risk of bias in the included studies. The overall quality of the evidence was rated using GRADE. Five cluster-randomised controlled trials met the inclusion criteria, evaluating a total of six different multifaceted implementation strategies. One study reported a small statistically significant effect on professional practice, and two studies demonstrated small to moderate statistically significant effects on patient outcome. The overall quality of the evidence for all comparisons was low or very low using GRADE. Little is known about how to improve the implementation of guidelines in nursing homes, and the evidence to support or discourage particular interventions is inconclusive. More implementation research is needed to ensure high quality of care in nursing homes. PROSPERO 2014: CRD42014007664.
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu
2008-03-01
To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.
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FDA Developments: Food Code 2013 and Proposed Trans Fat Determination
Grossman, M.R.
2014-01-01
268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the
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Klara, Kristina; Kim, Jeanie; Ross, Joseph S
2018-05-01
Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.
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America, you are digging your grave with your spoon--should the FDA tell you that on food labels?
Card, Melissa M
2013-01-01
R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.
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Home care technology through an ability expectation lens.
Wolbring, Gregor; Lashewicz, Bonnie
2014-06-20
Home care is on the rise, and its delivery is increasingly reliant on an expanding variety of health technologies ranging from computers to telephone "health apps" to social robots. These technologies are most often predicated on expectations that people in their homes (1) can actively interact with these technologies and (2) are willing to submit to the action of the technology in their home. Our purpose is to use an "ability expectations" lens to bring together, and provide some synthesis of, the types of utility and disadvantages that can arise for people with disabilities in relation to home care technology development and use. We searched the academic databases Scopus, Web of Science, EBSCO ALL, IEEE Xplore, and Compendex to collect articles that had the term "home care technology" in the abstract or as a topic (in the case of Web of Science). We also used our background knowledge and related academic literature pertaining to self-diagnosis, health monitoring, companionship, health information gathering, and care. We examined background articles and articles collected through our home care technology search in terms of ability expectations assumed in the presentation of home care technologies, or discussed in relation to home care technologies. While advances in health care support are made possible through emerging technologies, we urge critical examination of such technologies in terms of implications for the rights and dignity of people with diverse abilities. Specifically, we see potential for technologies to result in new forms of exclusion and powerlessness. Ableism influences choices made by funders, policy makers, and the public in the development and use of home health technologies and impacts how people with disabilities are served and how useful health support technologies will be for them. We urge continued critical examination of technology development and use according to ability expectations, and we recommend increasing incorporation of
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Pouwels, Koen; Van Grootheest, Kees
2013-01-01
The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of
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Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?
Rosania, Larry
2010-01-01
Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.
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6. Algorithms for Sorting and Searching
Indian Academy of Sciences (India)
Home; Journals; Resonance – Journal of Science Education; Volume 2; Issue 3. Algorithms - Algorithms for Sorting and Searching. R K Shyamasundar. Series Article ... Author Affiliations. R K Shyamasundar1. Computer Science Group, Tata Institute of Fundamental Research, Homi Bhabha Road, Mumbai 400 005, India ...
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Alaslai, Nasser Y.
2016-01-05
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
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Alaslai, Nasser Y.; Ghanem, Bader; Alghunaimi, Fahd; Litwiller, Eric; Pinnau, Ingo
2016-01-01
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
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Genetics Home Reference: critical congenital heart disease
... Facebook Twitter Home Health Conditions Critical congenital heart disease Critical congenital heart disease Printable PDF Open All Close All ... for Disease Control and Prevention: Congenital Heart Defects Disease InfoSearch: Congenital Heart Defects KidsHealth from Nemours Lucile Packard Children's ...
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A Good Year: FDA Approved Nine New Cancer Drugs in 2014
In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.
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Indian Academy of Sciences (India)
Home; Journals; Resonance – Journal of Science Education; Volume 21; Issue 7. The Search for ... https://www.ias.ac.in/article/fulltext/reso/021/07/0641-0652 ... In the first part of this article, we shall describethe different astronomical methods through whichthe extrasolar planets of various kinds are discovered.In the second ...
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Esterly, John S; Steadman, Emily; Scheetz, Marc H
2011-06-01
In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.
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Spanning the Home/Work Creative Space
DEFF Research Database (Denmark)
Davis, Lee N.; Davis, Jerome; Hoisl, Karin
the employee brings to work. Based on Woodman et al.’s (1993) “interactionist perspective” on organizational creativity, supplemented by literature on search and knowledge re/combination, we explore whether and how leisure time activities can span the creative space between the employee’s home and workplace...
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Pelletier, David L
2005-05-01
The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.
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Homing pigeons ( Columba livia f. domestica) can use magnetic cues for locating food
Thalau, Peter; Holtkamp-Rötzler, Elke; Fleissner, Gerta; Wiltschko, Wolfgang
2007-10-01
An experimental group of homing pigeons ( Columba livia f. domestica) learned to associate food with a magnetic anomaly produced by bar magnets that were fixed to the bowl in which they received their daily food ration in their home loft; the control group lacked this experience. Both groups were trained to search for two hidden food depots in a rectangular sand-filled arena without obvious visual cues; for the experimental birds, these depots were also marked with three 1.15 × 106 μT bar magnets. During the tests, there were two food depots, one marked with the magnets, the other unmarked; their position within the arena was changed from test to test. The experimental birds searched within 10 cm of the magnetically marked depot in 49% of the test sessions, whereas the control birds searched there in only 11% of the sessions. Both groups searched near the control depot in 11 and 13% of the sessions, respectively. The significant preference of the magnetically marked food depot by the experimental birds shows that homing pigeons cannot only detect a magnetic anomaly but can also use it as a cue for locating hidden food in an open arena.
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Search Results | Page 7 | IDRC - International Development ...
International Development Research Centre (IDRC) Digital Library (Canada)
2013-11-06
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Farris, April L
2010-01-01
As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.
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... Radiation-Emitting Products and Procedures Home, Business, and Entertainment Products Cell Phones Cell Phones Share Tweet Linkedin ... Follow FDA on Facebook View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination ...
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FDA, CE mark or something else?—Thinking fast and slow
Directory of Open Access Journals (Sweden)
Sundeep Mishra
2017-01-01
Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.
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Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates
This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.
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Home setting after stroke, facilitators and barriers: A systematic literature review.
Marcheschi, Elizabeth; Von Koch, Lena; Pessah-Rasmussen, Hélène; Elf, Marie
2018-07-01
This paper seeks to improve the understanding of the interaction between patients with stroke and the physical environment in their home settings. Stroke care is increasingly performed in the patient's home. Therefore, a systematic review was conducted to identify the existing knowledge about facilitators and barriers in the physical environment of home settings for the stroke rehabilitation process. Based upon Arksey and O'Malley's framework, a Boolean search strategy was performed in the databases; CINAHL, Medline, Web of Science and Scopus. Fifteen articles were retained from the literature search conducted between August and November 2016, and two researchers independently assessed their quality based on the Swedish Council on Health Technology Assessment guidelines. The results suggest that despite the healthcare system's ongoing shift towards home-based rehabilitation, the role played by the physical environment of home settings is still considered a side finding. Moreover, the research appears to focus mainly on how this environment supports mobility and activities of daily living, whereas information regarding the psychosocial and emotional processes that mediate the interaction between stroke survivors and their home setting are missing. A lack of information was also found with regard to the influence of different geographic locations on the stroke rehabilitation process. Future investigations are therefore needed to advance the understanding of the role played by the physical environment of home settings in supporting stroke recovery. © 2017 The Authors. Health and Social Care in the Community Published by John Wiley & Sons Ltd.
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Directory of Open Access Journals (Sweden)
Nguyen Diane
2013-01-01
Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by
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Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation
Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.
2017-11-01
Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction
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FDA Food Code recommendations: how do popular US baking shows measure up?
Directory of Open Access Journals (Sweden)
Valerie Cadorett
2018-05-01
Full Text Available The purpose of this study was to determine if popular US baking shows follow the FDA Food Code recommendations and critical food safety principles. This cross-sectional study examined a convenience sample of 75 episodes from three popular baking shows. The three shows were about competitively baking cupcakes, competitively baking cakes, and baking in a popular local bakery. Twenty-five episodes from each show were viewed. Coding involved tallying how many times 17 FDA Food Code recommendations were or were not followed. On each show, bare hands frequently came in contact with ready-to-eat food. On a per-hour basis, this occurred 80, 155, and 176 times on shows 1-3, respectively. Hands were washed before cooking three times on the three shows and never for the recommended 20 seconds. On each show, many people touched food while wearing jewelry other than a plain wedding band, for an average of at least 7 people per hour on each show. Shows 1-3 had high rates of long-haired bakers not wearing hair restraints (11.14, 6.57, and 14.06 per hour, respectively. Shows 1 and 2 had high rates of running among the bakers (22.29 and 10.57 instances per hour, respectively. These popular baking shows do not demonstrate proper food safety techniques put forth by the FDA and do not contribute the reduction of foodborne illnesses through proper food handling.
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FDA approves efavirenz. Food and Drug Administration.
Highleyman, L
1998-10-01
The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.
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Abdulhamid, Mahmoud A.
2017-10-12
A newly designed carbocyclic pseudo Tröger\\'s base diamine (CTB) monomer, 2,8-dimethyl-3,9-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (CTBDA) and its isomeric analogue 2,8-dimethyl-(1,7)(4,10)(3,9)-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6FDA-CTBDA) and 562 m2 g−1 (6FDA-iCTBDA). A 6FDA-based polyimide derived from 4,10-dimethyl-3,9-diamino-6H,12H-5,11-methanodibenzo[b,f][1,5]-diazocine (6FDA-TBDA) was made for comparison to investigate the effects of the basic tertiary nitrogen functionality in the Tröger\\'s base diamine on the polymer properties relative to the carbocyclic 6FDA-CTBDA analogue. 6FDA-TBDA displayed lower gas permeabilities but moderately higher gas-pair permselectivities than 6FDA-CTBDA. The enhanced permselectivity of 6FDA-TBDA resulted exclusively from higher diffusion-based selectivity. Direct gas sorption measurements demonstrated that the basicity in the Tröger\\'s base bridge moiety enhanced the sorption capacity of CO2 only slightly and had no effect on the CO2/CH4 solubility selectivity in 6FDA-TBDA vs. 6FDA-CTBDA.
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Virtual Visits in Home Health Care for Older Adults
Directory of Open Access Journals (Sweden)
Anne Marie Lunde Husebø
2014-01-01
Full Text Available Background. This review identifies the content of virtual visits in community nursing services to older adults and explores the manner in which service users and the nurses use virtual visits. Design. An integrative literature review. Method. Data collection comprised a literature search in three databases: Cinahl, Medline, and PubMed. In addition, a manual search of reference lists and expert consultation were performed. A total of 12 articles met the inclusion criteria. The articles were reviewed in terms of study characteristics, service content and utilization, and patient and health care provider experience. Results. Our review shows that in most studies the service is delivered on a daily basis and in combination with in-person visits. The findings suggest that older home-dwelling patients can benefit from virtual visits in terms of enhanced social inclusion and medication compliance. Service users and their nurses found virtual visits satisfactory and suitable for care delivery in home care to the elderly. Evidence for cost-saving benefits of virtual visits was not found. Conclusions. The findings can inform the planning of virtual visits in home health care as a complementary service to in-person visits, in order to meet the increasingly complex needs of older adults living at home.
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1999-05-14
The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.
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DEFF Research Database (Denmark)
Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.
1992-01-01
ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...
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Nields, Morgan W
2010-05-01
Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?
Brandt, Lawrence J
2008-05-01
The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.
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Directory of Open Access Journals (Sweden)
Franken SM
2016-05-01
Full Text Available Sylvie M Franken, Carlijn L Vierstra, Thomas RustemeyerDepartment of Dermatology, VU University Medical Centre, Amsterdam, the Netherlands Introduction: Although the treatment burden for phototherapy in the outpatient setting is considerable, prescription of home-based phototherapy has not been instigated. Home-based phototherapy seems more patient friendly in terms of avoiding the thrice-weekly hospital visits. So why are most treatments still given in a hospital setting? Is home-based treatment less effective? Are there financial barriers? Is the treatment not available? To answer these questions, a literature search was done. Methods: A literature search of PubMed, Embase, and Cochrane Library databases was performed, using the search terms “psoriasis” and “phototherapy”. Selection was based on two rounds; the first round involved screening the title and abstract of all records and second involved evaluating the full text of the remaining articles for eligibility according to inclusion and exclusion criteria. Results: In total, 23 publications were included with consensus of both researchers. Overall, the patients reported being very satisfied with home-based phototherapy. Results regarding effectivity in terms of improvement from disease severity and in quality of life were variable but generally positive. Reasons for reluctance varied from medicolegal and social aspects to lack of reimbursement and unfamiliarity on the side of the prescriber. Conclusion: In the treatment for psoriasis, home-based phototherapy is as effective and safe as phototherapy in an outpatient setting. Patients were more satisfied with home-based phototherapy. Factors that negatively influence the prescription of or choice for home-based phototherapy can be summarized in terms of lack of control, lack of knowledge, and lack of a good reimbursement system. Keywords: psoriasis, phototherapy, UVB, home-based, effectiveness, burden, costs, access
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The Utility of Home-Practice in Mindfulness-Based Group Interventions: A Systematic Review.
Lloyd, Annette; White, Ross; Eames, Catrin; Crane, Rebecca
2018-01-01
A growing body of research supports the efficacy of mindfulness-based interventions (MBIs). MBIs consider home-practice as essential to increasing the therapeutic effects of the treatment. To date however, the synthesis of the research conducted on the role of home-practice in controlled MBI studies has been a neglected area. This review aimed to conduct a narrative synthesis of published controlled studies, evaluating mindfulness-based group interventions, which have specifically measured home-practice. Empirical research literature published until June 2016 was searched using five databases. The search strategy focused on mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), and home-practice. Included studies met the following criteria: controlled trials, participants 18 years and above, evaluations of MBSR or MBCT, utilised standardised quantitative outcome measures and monitored home-practice using a self-reported measure. Fourteen studies met the criteria and were included in the review. Across all studies, there was heterogeneity in the guidance and resources provided to participants and the approaches used for monitoring home-practice. In addition, the guidance on the length of home-practice was variable across studies, which indicates that research studies and teachers are not adhering to the published protocols. Finally, only seven studies examined the relationship between home-practice and clinical outcomes, of which four found that home-practice predicted improvements on clinical outcome measures. Future research should adopt a standardised approach for monitoring home-practice across MBIs. Additionally, studies should assess whether the amount of home-practice recommended to participants is in line with MBSR/MBCT manualised protocols. Finally, research should utilise experimental methodologies to explicitly explore the relationship between home-practice and clinical outcomes.
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Directory of Open Access Journals (Sweden)
Hyosun Kim
2015-12-01
Full Text Available Background For the purpose of understanding the Food and Drug Administration’s (FDA’s concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014 regarding online promotional activities, were content-analyzed. Results Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the
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With Home Testing, Consumers Take Charge of Their Health
... There is no such requirement for consumers who purchase home tests, even the ones prescribed or recommended ... device, contact the Manufacturer and User Facility Device Experience Database (MAUDE) . An online search is available. You ...
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Clarkson, Paul; Hughes, Jane; Roe, Brenda; Giebel, Clarissa M; Jolley, David; Poland, Fiona; Abendstern, Michele; Chester, Helen; Challis, David
2018-03-01
The aim of this study was to explicate the outcomes of home support interventions for older people with dementia and/or their carers to inform clinical practice, policy and research. Most people with dementia receive support at home. However, components and effectiveness of home support interventions have been little explored. Systematic review with narrative summary. Electronic searches of published studies in English using PubMed, Cochrane Central Register of Controlled Trials, PsychINFO, CINAHL, Applied Social Science Index and CSA Social Services Abstracts. Databases and sources were searched from inception to April 2014 with no date restrictions to locate studies. The PRISMA statement was followed and established systematic review methods used. Using 14 components of care for people with dementia and their carers, identified previously, data across studies were synthesized. Interventions were grouped and described and effectiveness ratings applied. Qualitative studies were synthesized using key themes. Seventy studies (four qualitative) were included. Most were directed to carers and of high quality. Seven interventions for carers and two for people with dementia were identified, covering 81% of studies. Those relating to daily living, cognitive training and physical activity for people with dementia were absent. Measures of effectiveness were influenced mainly by the intensity (duration and frequency) of interventions. Those containing education, social support and behaviour management appeared most effective. These interventions reflect emergent patterns of home support. Research is required to identify effective interventions linked to the stage of dementia, which can be applied as part of routine clinical care. © 2017 John Wiley & Sons Ltd.
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Search Results | Page 24 | IDRC - International Development ...
International Development Research Centre (IDRC) Digital Library (Canada)
2007-01-01
Results 231 - 240 of 1368 ... Search. Home; South Asia .... Critical linkages between land use transition and human health in the Himalayan region. Published date. January 1, 2007. Papers. Civil society ISLAMIC CULTURE RADICALISM DEMOCRATIZATION ... Why studying attitudes and perceptions towards GMOs in India is ...
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Current and future state of FDA-CMS parallel reviews.
Messner, D A; Tunis, S R
2012-03-01
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.
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Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning
Taylor, Christy Marie
2013-01-01
In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…
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21 CFR 14.15 - Committees working under a contract with FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested...
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer In
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The rosiglitazone decision process at FDA and EMA : What should we learn?
Pouwels, Koen B.; van Grootheest, Kees
2012-01-01
In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased
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Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014
Directory of Open Access Journals (Sweden)
Benjamin Hixon
2017-02-01
Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties. Type: Original Research
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A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma
Directory of Open Access Journals (Sweden)
Fu-Shun Hsu
2017-01-01
Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.
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Predicting consumer behavior with Web search.
Goel, Sharad; Hofman, Jake M; Lahaie, Sébastien; Pennock, David M; Watts, Duncan J
2010-10-12
Recent work has demonstrated that Web search volume can "predict the present," meaning that it can be used to accurately track outcomes such as unemployment levels, auto and home sales, and disease prevalence in near real time. Here we show that what consumers are searching for online can also predict their collective future behavior days or even weeks in advance. Specifically we use search query volume to forecast the opening weekend box-office revenue for feature films, first-month sales of video games, and the rank of songs on the Billboard Hot 100 chart, finding in all cases that search counts are highly predictive of future outcomes. We also find that search counts generally boost the performance of baseline models fit on other publicly available data, where the boost varies from modest to dramatic, depending on the application in question. Finally, we reexamine previous work on tracking flu trends and show that, perhaps surprisingly, the utility of search data relative to a simple autoregressive model is modest. We conclude that in the absence of other data sources, or where small improvements in predictive performance are material, search queries provide a useful guide to the near future.
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Early Home Supported Discharge of Stroke Patients:
DEFF Research Database (Denmark)
Larsen, Torben; Olsen, T. Skyhøj; Sørensen, Jan
2006-01-01
OBJECTIVES: A comprehensive and systematic assessment (HTA) of early home-supported discharge by a multidisciplinary team that plans, coordinates, and delivers care at home (EHSD) was undertaken and the results were compared with that of conventional rehabilitation at stroke units. METHODS......: A systematic literature search for randomized trials (RCTs) on "early supported discharge" was closed in April 2005. RCTs on EHSD without information on (i) death or institution at follow-up, (ii) change in Barthél Index, (iii) length of hospital stay, (iv) intensity of home rehabilitation, or (v) baseline...... are discussed. CONCLUSIONS: EHSD is evidenced as a dominant health intervention. However, financial barriers between municipalities and health authorities have to be overcome. For qualitative reasons, a learning path of implementation is recommended where one stroke unit in a region initiates EHSD...
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The birth of a multicultural funeral home.
van der Pijl, Yvon
2017-01-01
In 2014, the Dutch Funeral Organization Yarden started with the participatory preparations for a multicultural funeral home. The project aims at a 24/7 service for the super-diverse population of Amsterdam and beyond. This article gives an ethnographic account of Yarden's efforts to capture cultural diversity. It explores how a multicultural gaze creates a power/knowledge dynamic producing new discourses and shaping new layers of significance. The study then turns into arguing that the birth of the multicultural home is, above all, a cultural, collaborative search leaving (counter-discursive) space for creativity, change, and cultural renewal of all actors involved.
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2017-11-22
This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.
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Home-based specialized palliative care in patients with advanced cancer
DEFF Research Database (Denmark)
Nordly, Mie; Vadstrup, Eva Soelberg; Sjøgren, Per
2016-01-01
OBJECTIVE: Due to an urgent need for specialized palliative care (SPC) for patients with advanced cancer, an overview of available information on organization and outcomes of home-based SPC would be valuable. Our systematic review aims to give an overview of available information...... on the organization and outcomes of home-based SPC for patients with advanced cancer. Outcomes related to place of death, survival time, quality of life, performance status, and symptom management are included. METHOD: A PICO process search strategy consisting of terms related to cancer, palliation, and home care...... for patients with advanced cancer, resulting in poor information and a lack of evidence. Generally, home-based SPC seems to have some positive effect on pain and dyspnea, but more high-quality studies are required....
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Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong
2017-10-01
Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.
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21 CFR 111.610 - What records must be made available to FDA?
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...
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Integration of new technology into clinical practice after FDA approval.
Govil, Ashul; Hao, Steven C
2016-10-01
Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.
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Hospital-based home care for children with cancer
DEFF Research Database (Denmark)
Hansson, Helena; Hallström, Inger; Kjaergaard, Hanne
2011-01-01
Hospital-based home care (HBHC) is widely applied in Pediatric Oncology. We reviewed the potential effect of HBHC on children's physical health and risk of adverse events, parental and child satisfaction, quality of life of children and their parents, and costs. A search of PubMed, CINAHL...
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Spanning the Creative Space between Home and Work
DEFF Research Database (Denmark)
Davis, Lee N.; Hoisl, Karin; Davis, Jerome
the employee brings to work. Based on Woodman et al.’s (1993) “interactionist perspective” on organizational creativity, supplemented by literature on search and knowledge/combination, we explore whether leisure time activities can span the creative space between the employee’s home and workplace – given...
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Preparation and production of a home builders' guide. Building and selling energy-efficient homes
Energy Technology Data Exchange (ETDEWEB)
Keast, D. N.; Mahoney, J. M.; McMahon, N. M.; Troy, M. H.; Wood, E. W.
1977-06-01
Procedures used in the preparation of a manual on the construction of energy-saving one- and two-family houses are described. Prior to writing the manual, builders were interviewed and a bibliographic search was conducted to obtain information on the design, construction and marketing of energy conserving homes. The packaging and distribution of the manual was planned. When written FEA will publish the manual. (ERA citation 04:044977)
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Stem-cell-derived products: an FDA update.
Moos, Malcolm
2008-12-01
The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.
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Home drinking in the UK: trends and causes.
Foster, John H; Ferguson, Colin S
2012-01-01
To explore the trend in the UK to consume alcohol at home rather than at licensed premises. A Medline search entering the terms 'home drinking', 'alcohol' and 'adult' covering the period 2000-2011 yielded 48 articles, of which 6 met the criteria to be included in the review. Grey literature including survey and market research data were reviewed. In the UK, since 1970 there has been trend for beer to be consumed at home more often than in licensed premises and that the overall trend towards greater home drinking has increased since 2000. The main reasons given are convenience, cost, safety, autonomy and stress relief. There has also been an increase in the practice known as 'pre-loading' (drinking before going out). Adults who drink mainly at home report that they are aware that they run a risk of higher overall alcohol consumption but tend to play down the possibility that increased consumption may lead to longer-term harm. Home drinking trends may have long-term public health consequences. Greater understanding of the drivers of this trend will help policy-makers to respond to these societal changes.
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FDA toxicity databases and real-time data entry
International Nuclear Information System (INIS)
Arvidson, Kirk B.
2008-01-01
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared
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Automatic extraction of drug indications from FDA drug labels.
Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong
2014-01-01
Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.
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Fatehi, Farhad; Gray, Leonard C; Wootton, Richard
2014-01-01
The way that PubMed results are displayed can be changed using the Display Settings drop-down menu in the result screen. There are three groups of options: Format, Items per page and Sort by, which allow a good deal of control. The results from several searches can be temporarily stored on the Clipboard. Records of interest can be selected on the results page using check boxes and can then be combined, for example to form a reference list. The Related Citations is a valuable feature of PubMed that can provide a set of similar articles when you have identified a record of interest among the results. You can easily search for RCTs or reviews using the appropriate filters or field tags. If you are interested in clinical articles, rather than basic science or health service research, then the Clinical Queries tool on the PubMed home page can be used to retrieve them.
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The determinants of home and nursing home death: a systematic review and meta-analysis.
Costa, Vania; Earle, Craig C; Esplen, Mary Jane; Fowler, Robert; Goldman, Russell; Grossman, Daphna; Levin, Leslie; Manuel, Douglas G; Sharkey, Shirlee; Tanuseputro, Peter; You, John J
2016-01-20
Most Canadians die in hospital, and yet, many express a preference to die at home. Place of death is the result of the interaction among sociodemographic, illness- and healthcare-related factors. Although home death is sometimes considered a potential indicator of end-of-life/palliative care quality, some determinants of place of death are more modifiable than others. The objective of this systematic review was to evaluate the determinants of home and nursing home death in adult patients diagnosed with an advanced, life-limiting illness. A systematic literature search was performed for studies in English published from January 1, 2004 to September 24, 2013 that evaluated the determinants of home or nursing home death compared to hospital death in adult patients with an advanced, life-limiting condition. The adjusted odds ratios, relative risks, and 95% confidence intervals of each determinant were extracted from the studies. Meta-analyses were performed if appropriate. The quality of individual studies was assessed using the Newcastle-Ottawa scale and the body of evidence was assessed according to the GRADE Working Group criteria. Of the 5,900 citations identified, 26 retrospective cohort studies were eligible. The risk of bias in the studies identified was considered low. Factors associated with an increased likelihood of home versus hospital death included multidisciplinary home palliative care, preference for home death, cancer as opposed to other diagnoses, early referral to palliative care, not living alone, having a caregiver, and the caregiver's coping skills. Knowledge about the determinants of place of death can be used to inform care planning between healthcare providers, patients and family members regarding the feasibility of dying in the preferred location and may help explain the incongruence between preferred and actual place of death. Modifiable factors such as early referral to palliative care, presence of a multidisciplinary home palliative care
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FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12
Trumbo, Paula R
2016-01-01
The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626
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1998-11-18
The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.
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Husebø, Anne Marie Lunde; Storm, Marianne; Våga, Bodil Bø; Rosenberg, Adriana; Akerjordet, Kristin
2018-04-01
To give an overview of empirical studies investigating nursing homes as a learning environment during nursing students' clinical practice. A supportive clinical learning environment is crucial to students' learning and for their development into reflective and capable practitioners. Nursing students' experience with clinical practice can be decisive in future workplace choices. A competent workforce is needed for the future care of older people. Opportunities for maximum learning among nursing students during clinical practice studies in nursing homes should therefore be explored. Mixed-method systematic review using PRISMA guidelines, on learning environments in nursing homes, published in English between 2005-2015. Search of CINAHL with Full Text, Academic Search Premier, MEDLINE and SocINDEX with Full Text, in combination with journal hand searches. Three hundred and thirty-six titles were identified. Twenty studies met the review inclusion criteria. Assessment of methodological quality was based on the Mixed Methods Appraisal Tool. Data were extracted and synthesised using a data analysis method for integrative reviews. Twenty articles were included. The majority of the studies showed moderately high methodological quality. Four main themes emerged from data synthesis: "Student characteristic and earlier experience"; "Nursing home ward environment"; "Quality of mentoring relationship and learning methods"; and "Students' achieved nursing competencies." Nursing home learning environments may be optimised by a well-prepared academic-clinical partnership, supervision by encouraging mentors and high-quality nursing care of older people. Positive learning experiences may increase students' professional development through achievement of basic nursing skills and competencies and motivate them to choose the nursing home as their future workplace. An optimal learning environment can be ensured by thorough preplacement preparations in academia and in nursing home wards
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR Staging
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer In
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Yang, Jianzhou; Xie, Rihua; Krewski, Daniel; Wang, Yongjin; Walker, Mark; Cao, Wenjun; Wen, Shi Wu
2014-01-01
Changing health care providers frequently breaks the continuity of care, which is associated with many health care problems. The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C, D and X drugs. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 were chosen for this study. The association between the number of changes in health care providers and with pregnancy exposure to category C, D, and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 568 women were included in this study. Rates of FDA C, D, and X drug uses were 14.35%, 17.07%, 21.72%, and 31.14%, in women with no change of provider, 1-2 changes, 3-5 changes, and more than 5 changes of health care providers. An association between the number of changes of health care providers and pregnancy exposure to FDA C, D, and X drugs existed in women without chronic diseases but not in women with chronic disease. Change of health care providers is associated with pregnancy exposure to FDA category C, D and X drugs in women without chronic diseases.
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Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D
2007-01-01
Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.
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Snowdon, John
2010-11-01
Although studies have shown the prevalence of depression in nursing homes to be high, under-recognition of depression in these facilities is widespread. Use of screening tests to enhance detection of depressive symptoms has been recommended. This paper aims to provoke discussion about optimal management of depression in nursing homes. The utility of the Cornell Scale for Depression in Dementia (CSDD) is considered. CSDD data relating to residents assessed in 2008-2009 were collected from three Sydney nursing homes. CSDD scores were available from 162 residents, though raters stated they were unable to score participants on at least one item in 47 cases. Scores of 13 or more were recorded for 23% of residents in these facilities, but in most of these cases little was documented in case files to show that the results had been discussed by staff, or that they led to interventions, or that follow-up testing was arranged. Results of CSDD testing should prompt care staff (including doctors) to consider causation of depression in cases where residents are identified as possibly depressed. In particular, there needs to be discussion of how to help residents to cope with disability, losses, and feelings of powerlessness. Research is needed, examining factors that might predict response to antidepressants, and what else helps. Accreditation of nursing homes could be made to depend partly on evidence that staff regularly search for, and (if found) ensure appropriate responses to, depression.
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Restraint use in older adults in home care: A systematic review.
Scheepmans, Kristien; Dierckx de Casterlé, Bernadette; Paquay, Louis; Milisen, Koen
2018-03-01
To get insight into restraint use in older adults receiving home care and, more specifically, into the definition, prevalence and types of restraint, as well as the reasons for restraint use and the people involved in the decision-making process. Systematic review. Four databases (i.e. Pubmed, CINAHL, Embase, Cochrane Library) were systematically searched from inception to end of April 2017. The study encompassed qualitative and quantitative research on restraint use in older adults receiving home care that reported definitions of restraint, prevalence of use, types of restraint, reasons for use or the people involved. We considered publications written in English, French, Dutch and German. One reviewer performed the search and made the initial selection based on titles and abstracts. The final selection was made by two reviewers working independently; they also assessed study quality. We used an integrated design to synthesise the findings. Eight studies were reviewed (one qualitative, seven quantitative) ranging in quality from moderate to high. The review indicated there was no single, clear definition of restraint. The prevalence of restraint use ranged from 5% to 24.7%, with various types of restraint being used. Families played an important role in the decision-making process and application of restraints; general practitioners were less involved. Specific reasons, other than safety for using restraints in home care were noted (e.g. delay to nursing home admission; to provide respite for an informal caregiver). Contrary to the current socio demographical evolutions resulting in an increasing demand of restraint use in home care, research on this subject is still scarce and recent. The limited evidence however points to the challenging complexity and specificity of home care regarding restraint use. Given these serious challenges for clinical practice, more research about restraint use in home care is urgently needed. Copyright © 2017. Published by Elsevier
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Directory of Open Access Journals (Sweden)
Hafiz Majid Hussain
2018-01-01
Full Text Available The traditional power grid is inadequate to overcome modern day challenges. As the modern era demands the traditional power grid to be more reliable, resilient, and cost-effective, the concept of smart grid evolves and various methods have been developed to overcome these demands which make the smart grid superior over the traditional power grid. One of the essential components of the smart grid, home energy management system (HEMS enhances the energy efficiency of electricity infrastructure in a residential area. In this aspect, we propose an efficient home energy management controller (EHEMC based on genetic harmony search algorithm (GHSA to reduce electricity expense, peak to average ratio (PAR, and maximize user comfort. We consider EHEMC for a single home and multiple homes with real-time electricity pricing (RTEP and critical peak pricing (CPP tariffs. In particular, for multiple homes, we classify modes of operation for the appliances according to their energy consumption with varying operation time slots. The constrained optimization problem is solved using heuristic algorithms: wind-driven optimization (WDO, harmony search algorithm (HSA, genetic algorithm (GA, and proposed algorithm GHSA. The proposed algorithm GHSA shows higher search efficiency and dynamic capability to attain optimal solutions as compared to existing algorithms. Simulation results also show that the proposed algorithm GHSA outperforms the existing algorithms in terms of reduction in electricity cost, PAR, and maximize user comfort.
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Migrant Home Attendants: Regulation and Practice in 7 Countries
Garms-Homolová, Vjenka; Bentwich, Miriam
2013-01-01
We compared regulation and working and living conditions of foreign home attendants in 7 countries (Canada, Germany, Israel, Singapore, Spain, United Kingdom, United States). We conducted a literature search in the PSYCinfo, MEDLINE, and Google Scholar databases for 2002 to 2012. We found substantial between-country differences in the legal status of migrant caregivers and regulations regarding working and living conditions and drew 3 conclusions. Improving regulations will likely improve not only the well-being of foreign home attendants but also the care they provide. Countries in which many foreign home attendants work without specific legal entry programs should rethink their policies. Finally, requiring an employer’s recommendation to obtain permanent residency may constrain foreign workers from registering complaints or leaving suboptimal employment situations. PMID:24134377
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Peeters, J.M.; Mistiaen, P.; Francke, A.L.
2011-01-01
We conducted a systematic review of video communication in home care to provide insight into the ratio between the costs and financial benefits (i.e. cost savings). Four databases (PUBMED, EMBASE, COCHRANE LIBRARY, CINAHL) were searched for studies on video communication for patients living at home
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Home, Office of Public Advocacy, Department of Administration, State of
Visiting Alaska State Employees State of Alaska Department of Administration Division of Office of Public Advocacy Alaska Department of Administration, Office of Public Advocacy Home Programs Sections Forms Vendor Support Search Office of Public Advocacy State of Alaska Administration > Office of Public Advocacy
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Home care in Europe: a systematic literature review
2011-01-01
Background Health and social services provided at home are becoming increasingly important. Hence, there is a need for information on home care in Europe. The objective of this literature review was to respond to this need by systematically describing what has been reported on home care in Europe in the scientific literature over the past decade. Methods A systematic literature search was performed for papers on home care published in English, using the following data bases: Cinahl, the Cochrane Library, Embase, Medline, PsycINFO, Sociological Abstracts, Social Services Abstracts, and Social Care Online. Studies were only included if they complied with the definition of home care, were published between January 1998 and October 2009, and dealt with at least one of the 31 specified countries. Clinical interventions, instrument developments, local projects and reviews were excluded. The data extracted included: the characteristics of the study and aspects of home care 'policy & regulation', 'financing', 'organisation & service delivery', and 'clients & informal carers'. Results Seventy-four out of 5,133 potentially relevant studies met the inclusion criteria, providing information on 18 countries. Many focused on the characteristics of home care recipients and on the organisation of home care. Geographical inequalities, market forces, quality and integration of services were also among the issues frequently discussed. Conclusions Home care systems appeared to differ both between and within countries. The papers included, however, provided only a limited picture of home care. Many studies only focused on one aspect of the home care system and international comparative studies were rare. Furthermore, little information emerged on home care financing and on home care in general in Eastern Europe. This review clearly shows the need for more scientific publications on home care, especially studies comparing countries. A comprehensive and more complete insight into the
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Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.
Directory of Open Access Journals (Sweden)
Sarah D Kowitt
Full Text Available Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125 and adults (N = 5,014, we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC, Food and Drug Administration (FDA, and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA. In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.
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Research and implementation of geographic information service mode in digital home
Lei, B.; Liu, K.; Gan, Y.; Zhong, M.
2014-04-01
Accompanying infrastructure improvements and networking technology innovation, the development of digital home service industry has gotten more and more attention. However, the digital home service levels have not sufficiently met rising demand from users. Therefore, it is urgent to propose and develop new service modes for the digital home. Geographic information services can provide various spatial information services such as map search, spatial information query. It has become an inevitable trend to implement geographic information services in the digital home. This paper proposes three new geographic information services modes for the digital home after sufficient requirement analysis: pushed information service mode, interactive information service mode, personalized information service mode. The key technologies to implement geographic information services on digital televisions are studied, involving digital television middleware technology, network transmission technology and visualization technology. According to the service modes' characteristics mentioned above, a service system in the digital home is established to implement geographic information services on the basis of digital television. The implementation of geographic information services in the digital home not only enriches the digital home services content, but also promotes geographic information from specialization to public popularity.
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Planned and unplanned deliveries at home: implications of a changing ratio.
Murphy, J F; Dauncey, M; Gray, O P; Chalmers, I
1984-05-12
The observation that perinatal mortality among babies delivered at home has tended to increase beyond that among babies delivered in consultant obstetric units has caused alarm and prompted recommendations that delivery at home should be further phased out. With data derived from the Cardiff Births Survey the possibility was investigated that this trend might reflect a changing ratio of planned to unplanned domiciliary births. At the beginning of the 1970s deliveries at home that were planned to be so outnumbered those that were not by nearly five to one. By 1979 unplanned deliveries at home outnumbered planned deliveries. The characteristics of the mothers, the health care they received, and the outcome of delivery differed strikingly between planned and unplanned deliveries at home. It is concluded, firstly, that every year the maternity services must try to meet the various needs of about 2000 women in England and Wales who give birth at home without planning to do so; and, secondly, that the heterogeneity of births at home and in hospital will continue to obstruct the search for unbiased estimates of the risks attributable to delivery in specialist obstetric units, general practitioner units, and at home.
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Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.
Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R
2012-01-01
Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.
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Investigating Intrinsic and Extrinsic Variables During Simulated Internet Search
Liechty, Molly M.; Madhavan, Poornima
2011-01-01
Using an eye tracker we examined decision-making processes during an internet search task. Twenty experienced homebuyers and twenty-five undergraduates from Old Dominion University viewed homes on a simulated real estate website. Several of the homes included physical properties that had the potential to negatively impact individual perceptions. These negative externalities were either easy to change (Level 1) or impossible to change (Level 2). Eye movements were analyzed to examine the relationship between participants' "stated preferences"[verbalized preferences], "revealed preferences" [actual decisions[, and experience. Dwell times, fixation durations/counts, and saccade counts/amplitudes were analyzed. Results revealed that experienced homebuyers demonstrated a more refined search pattern than novice searchers. Experienced homebuyers were also less impacted by negative externalities. Furthermore, stated preferences were discrepant from revealed preferences; although participants initially stated they liked/disliked a graphic, their eye movement patterns did not reflect this trend. These results have important implications for design of user-friendly web interfaces.
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Early Home Supported Discharge of Stroke Patients:
DEFF Research Database (Denmark)
Larsen, Torben; Olsen, T. Skyhøj; Sørensen, Jan
2006-01-01
: A systematic literature search for randomized trials (RCTs) on "early supported discharge" was closed in April 2005. RCTs on EHSD without information on (i) death or institution at follow-up, (ii) change in Barthél Index, (iii) length of hospital stay, (iv) intensity of home rehabilitation, or (v) baseline...... data are excluded. Seven RCTs on EHSD with 1,108 patients followed 3-12 months after discharge are selected for statistical meta-analysis of outcomes. The costs are calculated as a function of the average number of home training sessions. Economic evaluation is organized as a test of dominance (both...... of death is not significant. Length of stay is significantly reduced by 10 days (CI, 2.6-18 days). All outcomes have a nonsignificant positive covariance. The median number of home sessions is eleven, and the average cost per EHSD is 1,340 USD. The "action mechanism" and financial barriers to EHSD...
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Technologies for an aging society: a systematic review of "smart home" applications.
Demiris, G; Hensel, B K
2008-01-01
A "smart home" is a residence wired with technology features that monitor the well-being and activities of their residents to improve overall quality of life, increase independence and prevent emergencies. This type of informatics applications targeting older adults, people with disabilities or the general population is increasingly becoming the focus of research worldwide. The aim of this study was to provide a comprehensive review of health related smart home projects and discuss human factors and other challenges. To cover not only the medical but also the social sciences and electronics literature, we conducted extensive searches across disciplines (e.g., Medline, Embase, CINAHL, PsycINFO, Electronics and Communications Abstracts, Web of Science etc.). In order to be inclusive of all new initiatives and efforts in this area given the innovativeness of the concept, we manually searched for relevant references in the retrieved articles as well as published books on smart homes and gerontechnology. A total of 114 publications (including papers, abstracts and web pages) were identified and reviewed to identify the overarching projects. Twenty one smart home projects were identified (71% of the projects include technologies for functional monitoring, 67% for safety monitoring, 47% for physiological monitoring, 43% for cognitive support or sensory aids, 19% for monitoring security and 19% to increase social interaction). Evidence for their impact on clinical outcomes is lacking. The field of smart homes is a growing informatics domain. Several challenges including not only technical but also ethical ones need to be addressed.
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Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza
2007-01-01
The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.
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21 CFR 1.378 - What criteria does FDA use to order a detention?
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...
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Abdulhamid, Mahmoud A.; Ma, Xiaohua; Miao, Xiaohe; Pinnau, Ingo
2017-01-01
,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6
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Mining FDA drug labels using an unsupervised learning technique--topic modeling.
Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida
2011-10-18
The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific
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Mining FDA drug labels using an unsupervised learning technique - topic modeling
2011-01-01
Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that
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Vandenberg, Ann E.; van Beijnum, Bernhard J.F.; Overdevest, Vera G.P.; Capezuti, Elizabeth; Johnson II, Theodore M.
2017-01-01
Falls remain a major geriatric problem, and the search for new solutions continues. We investigated how existing fall prevention technology was experienced within nursing home nurses' environment and workflow. Our NIH-funded study in an American nursing home was followed by a cultural learning
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Vandenberg, Ann E.; van Beijnum, Bernhard J.F.; Overdevest, Vera G.P.; Capezuti, Elizabeth; Johnson II, Theodore M.
2017-01-01
Falls remain a major geriatric problem, and the search for new solutions continues. We investigated how existing fall prevention technology was experienced within nursing home nurses' environment and workflow. Our NIH-funded study in an American nursing home was followed by a cultural learning
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Association between eating out of home and body weight.
Bezerra, Ilana N; Curioni, Cintia; Sichieri, Rosely
2012-02-01
Eating outside of the home environment on a frequent basis has been associated with weight gain. Food choices when eating out are usually high in energy content, which contributes to excessive energy intake; however, the available data on out-of-home eating and obesity are far from conclusive. This systematic review assesses the association between out-of-home eating and body weight in adults over 18 years of age. The literature databases searched included Medline, Embase, Lilacs, The Cochrane Library, and the ISI Web of Knowledge. The review includes a comprehensive quality assessment of all included observational studies, 20 cross-sectional studies, and 8 prospective cohort studies. All but one of the prospective cohort studies and about half of the cross-sectional analyses found a positive association between out-of-home eating and body weight. However, many methodological differences among the studies were found, such as the definition of out-of-home eating and its assessment, which limits comparisons. The results of the present analysis suggest that in future studies fast-food restaurants and other out-of-home dining venues should be analyzed separately, assessments based on a single 24-h recall should be avoided, and controls for at-home choices (which were not included in any of the studies reviewed) are necessary to evaluate this association. © 2012 International Life Sciences Institute.
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Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton
2012-01-01
Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.
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Directory of Open Access Journals (Sweden)
Sequeiros Iara
2009-01-01
Full Text Available There is a worldwide drive for the home management of chronic respiratory diseases. With the widespread use of home intravenous (IV treatment for cystic fibrosis (CF pulmonary exacerbations (PExs, evidence pointing to an inferior outcome of care for home-treated patients in comparison to hospital-treated patients is a cause of concern. Currently, patients who self-administer IV antibiotics at home are provided with equipment and instructions on the use of antibiotics. Policies vary; but in most UK centers, these patients are then followed up by the multidisciplinary team only on days 1, 7 and 14 of the treatment course. We aimed to review the current published literature in search for evidence for the value and the shortfalls of self-administered IV treatment at home for acute PExs in CF patients in comparison to conventional hospital treatment. We searched the electronic database system Medline for published papers regarding studies comparing home- and hospital-based IV antibiotic treatment for both adult and pediatric CF patients. Sixteen studies were identified and grouped into those that showed a similar outcome between home and hospital treatment and those that showed an inferior outcome for home management. Most studies were retrospective or inadequately powered to provide clear answers. Ideally, outcome of care for home treatment should be at least equal to outcome for hospital treatment. Extensive efforts should be made to standardize therapies preserving the advantages of home management and addressing the perceived reasons for an inferior outcome. Until further studies provide definitive answers, treatment at home should be reserved for adequately selected patients and individualized depending on the unique settings of each CF center and specific patients′ requirements. There is great need for a prospective randomized controlled trial comparing home and hospital treatments in order to clarify this matter.
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Early discharge hospital at home.
Gonçalves-Bradley, Daniela C; Iliffe, Steve; Doll, Helen A; Broad, Joanna; Gladman, John; Langhorne, Peter; Richards, Suzanne H; Shepperd, Sasha
2017-06-26
Early discharge hospital at home is a service that provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care. This is an update of a Cochrane review. To determine the effectiveness and cost of managing patients with early discharge hospital at home compared with inpatient hospital care. We searched the following databases to 9 January 2017: the Cochrane Effective Practice and Organisation of Care Group (EPOC) register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and EconLit. We searched clinical trials registries. Randomised trials comparing early discharge hospital at home with acute hospital inpatient care for adults. We excluded obstetric, paediatric and mental health hospital at home schemes. DATA COLLECTION AND ANALYSIS: We followed the standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the body of evidence for the most important outcomes. We included 32 trials (N = 4746), six of them new for this update, mainly conducted in high-income countries. We judged most of the studies to have a low or unclear risk of bias. The intervention was delivered by hospital outreach services (17 trials), community-based services (11 trials), and was co-ordinated by a hospital-based stroke team or physician in conjunction with community-based services in four trials.Studies recruiting people recovering from strokeEarly discharge hospital at home probably makes little or no difference to mortality at three to six months (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.57 to 1.48, N = 1114, 11 trials, moderate-certainty evidence) and may make little or no difference to the risk of hospital readmission (RR 1.09, 95% CI 0.71 to 1.66, N = 345, 5 trials, low-certainty evidence). Hospital at home may lower the risk of living in institutional setting at six months (RR 0.63, 96% CI
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An ethical analysis of a home visit case study.
Pibernat, Artur Dalfó; Vidal, Jessica Rosell; Pibernat, Enric Dalfó; Rodríguez, Francisco Javier Pelegrina; Colomer, Gerard; Cid, Maria Feijoo
2017-12-01
This article will explore a clinical case study of a home visit carried out by the case manager nurse. In this case, we will discuss the dilemma of finding the balance between autonomy and beneficence from the perspective of principlist ethics, virtue ethics and the 'ethics of care'. The main conflict in this case study deals with all proposals are unsuitable and it is not necessary for a nurse to pay him a home visit, whereas for the healthcare system it is considered necessary. We could conclude that, during the home visit, the case manager aspires to achieve excellence, and throughout his clinical relationship with Francesc, searches for a series of virtues, respecting certain fundamental principles. In this way, the case managers ensure that Jaume's care is more humanised. The case has been anonymised and confidentiality maintained.
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The impact of work culture on quality of care in nursing homes--a review study.
André, Beate; Sjøvold, Endre; Rannestad, Toril; Ringdal, Gerd I
2014-09-01
The main aim of this review study was to identify which factors that characterise the relationship between work culture and quality of care in nursing homes. This review study was structured through systematic search methods to identify articles that describe the relationship between work culture and quality of care in nursing homes. The database search yielded 14510 hits. Closer examination showed that 10401 of these hits were duplicates. Of the remaining 4109 articles, only 10 were related to our aim for the study. A qualitative method were used to explain and understand phenomena of work culture and quality if care in nursing homes. Nine out of 10 articles in this review study emphasise the importance of leadership style and supportive management to increase quality of care in nursing homes. Increased empowerment, participation and influence were important factors for improving quality of care. Significant associations between work culture and quality of care and between empowerment and quality of care were reported. Nursing management and leaders must take in consideration that work culture is crucial for improving quality of care in nursing homes, and this study can be used to increase the focus on the work culture among healthcare personnel in nursing homes. Changes are necessary to increase healthcare personnel's job satisfaction, empowerment, autonomy and influence in nursing homes. Giving empowerment to the healthcare personnel working in nursing homes is both an organisational and an interpersonal issue. Being given empowerment and influence over their own work situation, the healthcare workers can be more committed and involved in the goal of obtaining best possible care to the residents. © 2013 Nordic College of Caring Science.
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Quality of information accompanying on-line marketing of home diagnostic tests.
Datta, Adrija K; Selman, Tara J; Kwok, Tony; Tang, Teresa; Khan, Khalid S
2008-01-01
To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. A cross-sectional analysis of a database developed from searching targeted websites. Data sources were websites written in English which marketed medical home diagnostic tests. A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers.
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Palley, H A
1995-01-01
The central issue facing federal regulation of breast implants is that while such devices are not functionally necessary or needed for survival, the side effects may be harmful and have not been proven unharmful. The Medical Device Amendments of 1976 appear to require such evidence prior to the FDA permitting the unrestricted marketing of these devices. However, only recently have such requirements been imposed by the FDA. The author examines the FDA's decision-making process, particularly as applied to silicone breast implants, and the factors that appears to have affected such decisions. In pursuing this study, the activities of a number of interest-group actors, as well as congressional responses and the role of federal bureaucratic actors, were examined. In 1992, the FDA established a regulatory protocol that effectively withdrew most silicone breast implants from the market for the purpose of breast augmentation and allows for the monitoring of the impact of new implants on women's health. This increase concern for determining the safety of breast implants is due to a number of factors, which are examined in this article.
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Kojima, Gotaro
Frailty has been recognized as a medical syndrome characterized by decreased physiological reserve and vulnerability to poor resolution of homeostasis. Frailty is common in nursing homes and as many as 90% of nursing home patients are frail or prefrail. Previous studies have examined frailty as a risk factor for nursing home placement and yielded inconsistent results. The current study aims to systematically review the literature and to conduct a meta-analysis to combine the risk measures to provide the evidence on frailty as a predictor of nursing home placement among community-dwelling older adults. A systematic literature search was performed in July 2015 using 6 databases (Scopus, Embase, CINAHL Plus, MEDLINE, PsycINFO, and the Cochrane Library). Any cohort studies examining associations between frailty and risk of subsequent nursing home placement among community-dwelling older adults published from 2000 to July 2015 were potentially eligible. The numbers of those who were admitted to nursing homes and who were not, according to frailty categories, were used to calculate pooled odds ratio (OR) using fixed-effect models. The included studies were assessed for heterogeneity, methodological quality, and publication bias. The systematic literature search and hand-search identified 885 potentially relevant studies, among which 5 studies including 3528 community-dwelling older adults were selected for this review. Meta-analyses were performed using data from these studies and showed that both frailty and prefrailty significantly predicted nursing home placement (5 studies: pooled OR = 5.58, 95% confidence interval [CI] = 2.94-10.60, P dwelling older adults. It is noteworthy that adherence to the exercise programs was high and adverse events were not reported in most of the trials. These findings suggest that physical exercise can potentially prevent or reverse frailty and may lead to decreased risks of nursing home placement in older adults. This systematic review
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21 CFR 1.406 - How will FDA handle classified information in an informal hearing?
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...
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21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...
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Directory of Open Access Journals (Sweden)
Taherh Hadian
2018-01-01
Full Text Available Background: Adolescence pregnancy is high risk both for mother and child. This systematic review aimed to determine the effect of home visiting on maternal and neonatal outcomes in adolescent mothers.Materials and Methods: This systematic review was performed by searching English databases including Cochran library, PubMed, Google scholar, Scopus, web of science, Embase, Ovid and Persian databases including SID, Magiran, and Barakat Knowledge Network System without time limitation. The search terms included "adolescent or teen pregnancy", "adolescent or teen mothers", "home visiting", "home visitation" and "home visit". Results: According to databases search, 967 papers were found that among them 913 papers were not related. Among 54 related papers, 44 abstracts and 10 full texts were studied. At the end, 7 RCT included in this systematic review. The meta-analysis result done on 375 person indicated that mental health in the home visiting group was significantly better than the control group (routine care or cares except considered intervention (standard mean difference: -0.33; 95%CI: -0.57 to -0.10; p=0.006, I2=0%. Also, meta-analysis done on 185 persons showed that there was no significant difference between two groups in terms of repeat pregnancy (odds ratio: 0.83; 95% CI: 0.33 to 2.03; p=0.67; I2=50% and repeat birth (odds ratio: 0.90; 95%CI: 0.35 to 2.31; P= 0.820, I2=0%. Conclusion: Results indicates that home visiting can improve mental health but does not have any effect on repeat pregnancy and repeat birth. Clinical trials with accurate methodology by controlling effect of number and duration of home visiting are recommended.
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Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J
This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units , which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5 to 2.1 standard deviation (SD) of the percent label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3 to 9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting can have an effect on the amount of drug present in a split tablet and available for absorption. Tablet splitting has become a very common practice in the United States and throughout the
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Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.
2012-01-01
Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874
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Zelko, Erika; Klemenc-Ketis, Zalika; Tusek-Bunc, Ksenija
2016-04-01
We wanted to systematically review the available evidence to evaluate the drug adherence in elderly with polypharmacy living at home. We performed a literature search using MEDLINE, ISI Web of Science, ProQuest, EMBASE, SCOPUS, Springer Link, Sage Journals and CINAHL. We used the following terms: Medication Adherence, Medication Compliance, Polypharmacy, and Elderly. The search was limited to English-language articles. We included only clinical trials, systematic reviews, meta-analysis and cross-sectional studies. A total of seven articles were included in this systematic review after applying the search strategy. Six studies dealt with the prevalence of medication adherence and its correlates in patients aged 65 years or more with polypharmacy. Two studies dealt with the effect of various interventions on medication adherence in patients aged 65 years or more with polypharmacy. The available literature on the polypharmacy and drug adherence in elderly living at home is scarce and further studies are needed.
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Socio-Economic Factors Affecting Home Internet Usage Patterns in Central Queensland
Directory of Open Access Journals (Sweden)
Wal J. Taylor
2003-01-01
Full Text Available Governments and other policy makers are concerned with the gap in home Internet usage between people from metropolitan and rural areas. A survey conducted in Central Queensland, Australia examined differences in home Internet usage patterns between young and old, male and female, people in urban and rural areas, married and unmarried, well-educated and less educated, rich and poor, and employed and unemployed and found significant differences. These results highlight areas for further research and provide a basis for government agencies and industries to consider these associations in future policy formulation for regional development using ICT. The research suggested that further research should be conducted to monitor consuming behaviors of the youngest age group in Internet use for entertainment and information search in order to detect possible Internet overuse or addiction. In addition, further research should be conducted to find out what people search for on the Internet, and if for employment opportunities, financial incentives are suggested for the unemployed people.
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Directory of Open Access Journals (Sweden)
Sophie Orton
Full Text Available Children's exposure to secondhand smoke (SHS has been causally linked to a number of childhood morbidities and mortalities. Over 50% of UK children whose parents are smokers are regularly exposed to SHS at home. No previous review has identified the factors associated with children's SHS exposure in the home.To identify by systematic review, the factors which are associated with children's SHS exposure in the home, determined by parent or child reports and/or biochemically validated measures including cotinine, carbon monoxide or home air particulate matter.Electronic searches of MEDLINE, EMBASE, PsychINFO, CINAHL and Web of Knowledge to July 2014, and hand searches of reference lists from publications included in the review were conducted.Forty one studies were included in the review. Parental smoking, low socioeconomic status and being less educated were all frequently and consistently found to be independently associated with children's SHS exposure in the home. Children whose parents held more negative attitudes towards SHS were less likely to be exposed. Associations were strongest for parental cigarette smoking status; compared to children of non-smokers, those whose mothers or both parents smoked were between two and 13 times more likely to be exposed to SHS.Multiple factors are associated with child SHS exposure in the home; the best way to reduce child SHS exposure in the home is for smoking parents to quit. If parents are unable or unwilling to stop smoking, they should instigate smoke-free homes. Interventions targeted towards the socially disadvantaged parents aiming to change attitudes to smoking in the presence of children and providing practical support to help parents smoke outside the home may be beneficial.
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Home safe home: Evaluation of a childhood home safety program.
Stewart, Tanya Charyk; Clark, Andrew; Gilliland, Jason; Miller, Michael R; Edwards, Jane; Haidar, Tania; Batey, Brandon; Vogt, Kelly N; Parry, Neil G; Fraser, Douglas D; Merritt, Neil
2016-09-01
The London Health Sciences Centre Home Safety Program (HSP) provides safety devices, education, a safety video, and home safety checklist to all first-time parents for the reduction of childhood home injuries. The objective of this study was to evaluate the HSP for the prevention of home injuries in children up to 2 years of age. A program evaluation was performed with follow-up survey, along with an interrupted time series analysis of emergency department (ED) visits for home injuries 5 years before (2007-2013) and 2 years after (2013-2015) implementation. Spatial analysis of ED visits was undertaken to assess differences in home injury rates by dissemination areas controlling differences in socioeconomic status (i.e., income, education, and lone-parent status) at the neighborhood level. A total of 3,458 first-time parents participated in the HSP (a 74% compliance rate). Of these, 20% (n = 696) of parents responded to our questionnaire, with 94% reporting the program to be useful (median, 6; interquartile range, 2 on a 7-point Likert scale) and 81% learning new strategies for preventing home injuries. The median age of the respondent's babies were 12 months (interquartile range, 1). The home safety check list was used by 87% of respondents to identify hazards in their home, with 95% taking action to minimize the risk. The time series analysis demonstrated a significant decline in ED visits for home injuries in toddlers younger than2 years of age after HSP implementation. The declines in ED visits for home injuries remained significant over and above each socioeconomic status covariate. Removing hazards, supervision, and installing safety devices are key facilitators in the reduction of home injuries. Parents found the HSP useful to identify hazards, learn new strategies, build confidence, and provide safety products. Initial finding suggests that the program is effective in reducing home injuries in children up to 2 years of age. Therapeutic/care management study
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Searching Online Chemical Data Repositories via the ChemAgora Portal.
Zanzi, Antonella; Wittwehr, Clemens
2017-12-26
ChemAgora, a web application designed and developed in the context of the "Data Infrastructure for Chemical Safety Assessment" (diXa) project, provides search capabilities to chemical data from resources available online, enabling users to cross-reference their search results with both regulatory chemical information and public chemical databases. ChemAgora, through an on-the-fly search, informs whether a chemical is known or not in each of the external data sources and provides clikable links leading to the third-party web site pages containing the information. The original purpose of the ChemAgora application was to correlate studies stored in the diXa data warehouse with available chemical data. Since the end of the diXa project, ChemAgora has evolved into an independent portal, currently accessible directly through the ChemAgora home page, with improved search capabilities of online data sources.
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The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In
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21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements.... Examples of § 201.66 Standard Labeling and Modified Labeling Formats A. Section 201.66 Standard Labeling...
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2010-05-21
...] FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U...: Notice of availability; request for comments. SUMMARY: As part of the second phase of the Transparency... Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and...
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Home-based versus centre-based cardiac rehabilitation.
Taylor, Rod S; Dalal, Hayes; Jolly, Kate; Moxham, Tiffany; Zawada, Anna
2010-01-20
The burden of cardiovascular disease world-wide is one of great concern to patients and health care agencies alike. Traditionally centre-based cardiac rehabilitation (CR) programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation. To determine the effectiveness of home-based cardiac rehabilitation programmes compared with supervised centre-based cardiac rehabilitation on mortality and morbidity, health-related quality of life and modifiable cardiac risk factors in patients with coronary heart disease. We updated the search of a previous review by searching the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2007, Issue 4), MEDLINE, EMBASE and CINAHL from 2001 to January 2008. We checked reference lists and sought advice from experts. No language restrictions were applied. Randomised controlled trials (RCTs) that compared centre-based cardiac rehabilitation (e.g. hospital, gymnasium, sports centre) with home-based programmes, in adults with myocardial infarction, angina, heart failure or who had undergone revascularisation. Studies were selected independently by two reviewers, and data extracted by a single reviewer and checked by a second one. Authors were contacted where possible to obtain missing information. Twelve studies (1,938 participants) met the inclusion criteria. The majority of studies recruited a lower risk patient following an acute myocardial infarction (MI) and revascularisation. There was no difference in outcomes of home- versus centre-based cardiac rehabilitation in mortality risk ratio (RR) was1.31 (95% confidence interval (C) 0.65 to 2.66), cardiac events, exercise capacity standardised mean difference (SMD) -0.11 (95% CI -0.35 to 0.13), as well as in modifiable risk factors (systolic blood pressure; diastolic blood pressure; total cholesterol
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Hughes, Carmel; Smith, Michael; Tunney, Michael; Bradley, Marie C
2011-12-07
Nursing homes for older people provide an environment likely to promote the acquisition and spread of meticillin-resistant Staphylococcus aureus (MRSA), putting residents at increased risk of colonisation and infection. It is recognised that infection prevention and control strategies are important in preventing and controlling MRSA transmission. To determine the effects of infection prevention and control strategies for preventing the transmission of MRSA in nursing homes for older people. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2011, Issue 2), the Cochrane Wounds Group Specialised Register (searched May 27th, 2011). We also searched Ovid MEDLINE (from 1950 to April Week 2 2011), OVID MEDLINE (In-process and Other Non-Indexed Citations, April 26th 2011) Ovid EMBASE (1980 to 2011 Week 16), EBSCO CINAHL (1982 to April 21st 2011), DARE (1992 to 2011, week 16), Web of Science (1981 to May 2011), and the Health Technology Assessment (HTA) website (1988 to May 2011). Research in progress was sought through Current Clinical Trials (www.controlled-trials.com), Medical Research Council Research portfolio, and HSRPRoj (current USA projects). All randomised and controlled clinical trials, controlled before and after studies and interrupted time series studies of infection prevention and control interventions in nursing homes for older people were eligible for inclusion. Two review authors independently reviewed the results of the searches. Another review author appraised identified papers and undertook data extraction which was checked by a second review author. For this second update only one study was identified, therefore it was not possible to undertake a meta-analysis. A cluster randomised controlled trial in 32 nursing homes evaluated the effect of an infection control education and training programme on MRSA prevalence. The primary outcome was MRSA prevalence in residents and staff, and a change in infection
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Optimally setting up directed searches for continuous gravitational waves in Advanced LIGO O1 data
Ming, Jing; Papa, Maria Alessandra; Krishnan, Badri; Prix, Reinhard; Beer, Christian; Zhu, Sylvia J.; Eggenstein, Heinz-Bernd; Bock, Oliver; Machenschalk, Bernd
2018-02-01
In this paper we design a search for continuous gravitational waves from three supernova remnants: Vela Jr., Cassiopeia A (Cas A) and G347.3. These systems might harbor rapidly rotating neutron stars emitting quasiperiodic gravitational radiation detectable by the advanced LIGO detectors. Our search is designed to use the volunteer computing project Einstein@Home for a few months and assumes the sensitivity and duty cycles of the advanced LIGO detectors during their first science run. For all three supernova remnants, the sky positions of their central compact objects are well known but the frequency and spin-down rates of the neutron stars are unknown which makes the searches computationally limited. In a previous paper we have proposed a general framework for deciding on what target we should spend computational resources and in what proportion, what frequency and spin-down ranges we should search for every target, and with what search setup. Here we further expand this framework and apply it to design a search directed at detecting continuous gravitational wave signals from the most promising three supernova remnants identified as such in the previous work. Our optimization procedure yields broad frequency and spin-down searches for all three objects, at an unprecedented level of sensitivity: The smallest detectable gravitational wave strain h0 for Cas A is expected to be 2 times smaller than the most sensitive upper limits published to date, and our proposed search, which was set up and ran on the volunteer computing project Einstein@Home, covers a much larger frequency range.
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Quality of information accompanying on-line marketing of home diagnostic tests
Datta, Adrija K; Selman, Tara J; Kwok, Tony; Tang, Teresa; Khan, Khalid S
2008-01-01
Objective To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. Design A cross-sectional analysis of a database developed from searching targeted websites. Setting Data sources were websites written in English which marketed medical home diagnostic tests. Main outcome measures A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. Results 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. Conclusions The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers. PMID:18263912
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de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard
2015-08-15
On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.
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Search for anomalous W t b couplings in single top quark production ...
Indian Academy of Sciences (India)
Pramana – Journal of Physics. Current Issue : Vol. 90, Issue 4 · Current Issue Volume 90 | Issue 4. April 2018. Home · Volumes & Issues · Special Issues · Forthcoming Articles · Search · Editorial Board · Information for Authors · Subscription ...
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Doblin, Rick
2002-01-01
The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.
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Directory of Open Access Journals (Sweden)
Freeman Michael
2012-03-01
Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster
By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.
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21 CFR 814.44 - Procedures for review of a PMA.
2010-04-01
... labeling before marketing. FDA will also give the public notice of the order, including notice of and... approval will be placed on FDA's home page on the Internet (http://www.fda.gov), and it will state that a... health, is available on the Internet and has been placed on public display, and that copies are available...
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Carpentier, Francesca Renee Dillman
2016-02-09
This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim's article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim's rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA's attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. © 2016 by Kerman University of Medical Sciences.
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Organizational home care models across Europe: A cross sectional study.
Van Eenoo, Liza; van der Roest, Henriëtte; Onder, Graziano; Finne-Soveri, Harriet; Garms-Homolova, Vjenka; Jonsson, Palmi V; Draisma, Stasja; van Hout, Hein; Declercq, Anja
2018-01-01
Decision makers are searching for models to redesign home care and to organize health care in a more sustainable way. The aim of this study is to identify and characterize home care models within and across European countries by means of structural characteristics and care processes at the policy and the organization level. At the policy level, variables that reflected variation in health care policy were included based on a literature review on the home care policy for older persons in six European countries: Belgium, Finland, Germany, Iceland, Italy, and the Netherlands. At the organizational level, data on the structural characteristics and the care processes were collected from 36 home care organizations by means of a survey. Data were collected between 2013 and 2015 during the IBenC project. An observational, cross sectional, quantitative design was used. The analyses consisted of a principal component analysis followed by a hierarchical cluster analysis. Fifteen variables at the organizational level, spread across three components, explained 75.4% of the total variance. The three components made it possible to distribute home care organizations into six care models that differ on the level of patient-centered care delivery, the availability of specialized care professionals, and the level of monitoring care performance. Policy level variables did not contribute to distinguishing between home care models. Six home care models were identified and characterized. These models can be used to describe best practices. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Does smart home technology prevent falls in community-dwelling older adults: a literature review.
Pietrzak, Eva; Cotea, Cristina; Pullman, Stephen
2014-01-01
Falls in older Australians are an increasingly costly public health issue, driving the development of novel modes of intervention, especially those that rely on computer-driven technologies. The aim of this paper was to gain an understanding of the state of the art of research on smart homes and computer-based monitoring technologies to prevent and detect falls in the community-dwelling elderly. Cochrane, Medline, Embase and Google databases were searched for articles on fall prevention in the elderly using pre-specified search terms. Additional papers were searched for in the reference lists of relevant reviews and by the process of 'snowballing'. Only studies that investigated outcomes related to falling such as fall prevention and detection, change in participants' fear of falling and attitudes towards monitoring technology were included. Nine papers fulfilled the inclusion criteria. The following outcomes were observed: (1) older adults' attitudes towards fall detectors and smart home technology are generally positive; (2) privacy concerns and intrusiveness of technology were perceived as less important to participants than their perception of health needs and (3) unfriendly and age-inappropriate design of the interface may be one of the deciding factors in not using the technology. So far, there is little evidence that using smart home technology may assist in fall prevention or detection, but there are some indications that it may increase older adults' confidence and sense of security, thus possibly enabling aging in place.
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A Systematic Review of Home-Based Childhood Obesity Prevention Studies
Fawole, Oluwakemi; Segal, Jodi; Wilson, Renee F.; Cheskin, Lawrence J.; Bleich, Sara N.; Wu, Yang; Lau, Brandyn; Wang, Youfa
2013-01-01
BACKGROUND AND OBJECTIVES: Childhood obesity is a global epidemic. Despite emerging research about the role of the family and home on obesity risk behaviors, the evidence base for the effectiveness of home-based interventions on obesity prevention remains uncertain. The objective was to systematically review the effectiveness of home-based interventions on weight, intermediate (eg, diet and physical activity [PA]), and clinical outcomes. METHODS: We searched Medline, Embase, PsychInfo, CINAHL, clinicaltrials.gov, and the Cochrane Library from inception through August 11, 2012. We included experimental and natural experimental studies with ≥1-year follow-up reporting weight-related outcomes and targeting children at home. Two independent reviewers screened studies and extracted data. We graded the strength of the evidence supporting interventions targeting diet, PA, or both for obesity prevention. RESULTS: We identified 6 studies; 3 tested combined interventions (diet and PA), 1 used diet intervention, 1 combined intervention with primary care and consumer health informatics components, and 1 combined intervention with school and community components. Select combined interventions had beneficial effects on fruit/vegetable intake and sedentary behaviors. However, none of the 6 studies reported a significant effect on weight outcomes. Overall, the strength of evidence is low that combined home-based interventions effectively prevent obesity. The evidence is insufficient for conclusions about home-based diet interventions or interventions implemented at home in association with other settings. CONCLUSIONS: The strength of evidence is low to support the effectiveness of home-based child obesity prevention programs. Additional research is needed to test interventions in the home setting, particularly those incorporating parenting strategies and addressing environmental influences. PMID:23753095
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Search for a SM Higgs boson in dilepton plus missing transverse ...
Indian Academy of Sciences (India)
Home; Journals; Pramana – Journal of Physics; Volume 79; Issue 5. Search for a SM Higgs boson in dilepton plus missing transverse energy final state with the DØ detector at s = 1.96 TeV. Ruchika Nayyar Kirti Ranjan. Poster Presentations Volume 79 Issue 5 November 2012 pp 1289-1292 ...
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21 CFR 1.405 - When does FDA have to issue a decision on an appeal?
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an appeal? 1.405 Section 1.405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal...
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2016 in review: FDA approvals of new molecular entities.
Griesenauer, Rebekah H; Kinch, Michael S
2017-11-01
An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Animation of Antimicrobial Resistance
Full Text Available ... Skip to common links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search ... & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet ...
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Full Text Available ... Skip to common links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search ... Health Topics Women and Diabetes Share Tweet Linkedin Pin ...
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Search, Memory, and Choice Error: An Experiment.
Sanjurjo, Adam
2015-01-01
Multiple attribute search is a central feature of economic life: we consider much more than price when purchasing a home, and more than wage when choosing a job. An experiment is conducted in order to explore the effects of cognitive limitations on choice in these rich settings, in accordance with the predictions of a new model of search memory load. In each task, subjects are made to search the same information in one of two orders, which differ in predicted memory load. Despite standard models of choice treating such variations in order of acquisition as irrelevant, lower predicted memory load search orders are found to lead to substantially fewer choice errors. An implication of the result for search behavior, more generally, is that in order to reduce memory load (thus choice error) a limited memory searcher ought to deviate from the search path of an unlimited memory searcher in predictable ways-a mechanism that can explain the systematic deviations from optimal sequential search that have recently been discovered in peoples' behavior. Further, as cognitive load is induced endogenously (within the task), and found to affect choice behavior, this result contributes to the cognitive load literature (in which load is induced exogenously), as well as the cognitive ability literature (in which cognitive ability is measured in a separate task). In addition, while the information overload literature has focused on the detrimental effects of the quantity of information on choice, this result suggests that, holding quantity constant, the order that information is observed in is an essential determinant of choice failure.
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Search, Memory, and Choice Error: An Experiment.
Directory of Open Access Journals (Sweden)
Adam Sanjurjo
Full Text Available Multiple attribute search is a central feature of economic life: we consider much more than price when purchasing a home, and more than wage when choosing a job. An experiment is conducted in order to explore the effects of cognitive limitations on choice in these rich settings, in accordance with the predictions of a new model of search memory load. In each task, subjects are made to search the same information in one of two orders, which differ in predicted memory load. Despite standard models of choice treating such variations in order of acquisition as irrelevant, lower predicted memory load search orders are found to lead to substantially fewer choice errors. An implication of the result for search behavior, more generally, is that in order to reduce memory load (thus choice error a limited memory searcher ought to deviate from the search path of an unlimited memory searcher in predictable ways-a mechanism that can explain the systematic deviations from optimal sequential search that have recently been discovered in peoples' behavior. Further, as cognitive load is induced endogenously (within the task, and found to affect choice behavior, this result contributes to the cognitive load literature (in which load is induced exogenously, as well as the cognitive ability literature (in which cognitive ability is measured in a separate task. In addition, while the information overload literature has focused on the detrimental effects of the quantity of information on choice, this result suggests that, holding quantity constant, the order that information is observed in is an essential determinant of choice failure.
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Zubair, Maria; Chadborn, Neil H; Gladman, John R F; Dening, Tom; Gordon, Adam L; Goodman, Claire
2017-10-10
Care home residents are relatively high users of healthcare resources and may have complex needs. Comprehensive geriatric assessment (CGA) may benefit care home residents and improve efficiency of care delivery. This is an approach to care in which there is a thorough multidisciplinary assessment (physical and mental health, functioning and physical and social environments) and a care plan based on this assessment, usually delivered by a multidisciplinary team. The CGA process is known to improve outcomes for community-dwelling older people and those in receipt of hospital care, but less is known about its efficacy in care home residents. Realist review was selected as the most appropriate method to explore the complex nature of the care home setting and multidisciplinary delivery of care. The aim of the realist review is to identify and characterise a programme theory that underpins the CGA intervention. The realist review will extract data from research articles which describe the causal mechanisms through which the practice of CGA generates outcomes. The focus of the intervention is care homes, and the outcomes of interest are health-related quality of life and satisfaction with services; for both residents and staff. Further outcomes may include appropriate use of National Health Service services and resources of older care home residents. The review will proceed through three stages: (1) identifying the candidate programme theories that underpin CGA through interviews with key stakeholders, systematic search of the peer-reviewed and non-peer-reviewed evidence, (2) identifying the evidence relevant to CGA in UK care homes and refining the programme theories through refining and iterating the systematic search, lateral searches and seeking further information from study authors and (3) analysis and synthesis of evidence, involving the testing of the programme theories. The PEACH project was identified as service development following submission to the UK Health
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Families' engagement with young children's science and technology learning at home
Hall, Robin L.; Schaverien, Lynette
2001-07-01
There is accumulating evidence of the worth of involving families in young children's learning in informal contexts. By exploring families' engagement with their children's science and technology learning at home over a 6-month period, the present investigation sought to illuminate both the nature and the educational significance of what families do. Initially, in order to seed scientific and technological inquiry in homes, kindergarten and year-one children investigated flashlights with family members at school. Each day, equipment was available to take home. Using established anthropological methods, one of the researchers investigated children's further inquiries beyond the classroom in diverse ways; for example, by visiting homes and conversing via telephone and facsimile. The findings showed that families engaged with children's inquiries at home in many ways - by providing resources, conversing, and investigating collaboratively with children. Moreover, when families pursued inquiries together and when children conducted their own sustained intellectual searches, children's ideas deepened. Such evidence of the educational significance of what families do suggests that early science and technology education might be made more effective if it were aligned with the ways people learn together outside formal institutions.
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1995-04-01
Advantage 24 is a new contraceptive gel that makes use of bioadhesive technology to offer 24 hours of protection relying on the spermicide nonoxynol-9 (N-9) in lower concentrations. If a proposed US Food and Drug Administration (FDA) rule is enforced N-9 may be examined closely. The manufacturer, Whitehall-Robins Healthcare in New Jersey, stopped production of the Today contraceptive sponge because of the costs of complying with FDA standards. The Advantage 24 gel costs twice as much as the sponge. It is made in Switzerland and distributed by an Illinois company. Any vaginal contraceptive containing N-9 would be approved by the FDA as long as it complied with guidelines laid down in an FDA monograph. However, the registration of the gel could not be confirmed. The product uses a bioadhesive technology concept that natural substances adhere to epithelial and mucosal tissues in the body. Polycarbofil is mixed with water, N-9, and mineral oil to create an emulsion that allows for a time-release mechanism, but at any given time only 2 mg of N-9 is available to kill sperm. The final formula for Advantage 24 is 52.5 mg per dose. Too much N-9 can be toxic, as demonstrated by the Today sponge, which contained 1000 mg of N-9. In Kenya prostitutes using it frequently experienced 3 times as many genital lesions as those using a placebo. A study of Advantage 24 by a Miami laboratory involved 250 women, 22-45 years old, who had had prior tubal ligations. When the gel was applied 15-30 minutes before intercourse the efficacy rate was 98%; it was 91% for those applying it 12 hours before; and it was 86% when the gel was applied 24 hours ahead of time. FDA compliance officers are intrigued about the claim that the gel lasts 24 hours. However, if the claim is held up by research data, women will have an easily available, portable, efficient, aesthetic, and highly effective contraceptive.
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Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J
2017-08-01
We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.
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Ghanem, Bader
2016-04-30
Two novel Tröger\\'s base-based di-o-substituted diamine monomers were synthesized and used to prepare two intrinsically microporous 6FDA-based polyimides (PIM-PI-TB-1 and PIM-PI-TB-2) with high molecular weight, high thermal stability and excellent solubility in common organic solvents. Compared to previously reported methods for preparing TB-based diamines, which are based on reduction of dimerized nitro-substituted anilines or condensation of phenylenediamine derivatives with dianhydrides, the novel protocol can be used to prepare different functionalized TB-based diamine monomers from a wide variety of aniline derivatives. PIM-PI-TB-1 (made from 6FDA and dibromo-tetramethyl-substituted TB diamine) and PIM-PI-TB-2 (made from 6FDA and tetramethyl-substituted TB diamine) are intrinsically microporous polymers with high BET surface areas of 440 m2/g and 580 m2/g, respectively. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 bar for fresh and 180 days aged films. Both TB-based polyimides exhibited high gas permeability with moderate selectivity. The gas permeability dropped significantly coupled with a moderate increase in selectivity after long-term physical aging of 180 days.
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Ghanem, Bader; Alaslai, Nasser Y.; Miao, Xiaohe; Pinnau, Ingo
2016-01-01
Two novel Tröger's base-based di-o-substituted diamine monomers were synthesized and used to prepare two intrinsically microporous 6FDA-based polyimides (PIM-PI-TB-1 and PIM-PI-TB-2) with high molecular weight, high thermal stability and excellent solubility in common organic solvents. Compared to previously reported methods for preparing TB-based diamines, which are based on reduction of dimerized nitro-substituted anilines or condensation of phenylenediamine derivatives with dianhydrides, the novel protocol can be used to prepare different functionalized TB-based diamine monomers from a wide variety of aniline derivatives. PIM-PI-TB-1 (made from 6FDA and dibromo-tetramethyl-substituted TB diamine) and PIM-PI-TB-2 (made from 6FDA and tetramethyl-substituted TB diamine) are intrinsically microporous polymers with high BET surface areas of 440 m2/g and 580 m2/g, respectively. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 bar for fresh and 180 days aged films. Both TB-based polyimides exhibited high gas permeability with moderate selectivity. The gas permeability dropped significantly coupled with a moderate increase in selectivity after long-term physical aging of 180 days.
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End-of-life expectations and experiences among nursing home patients and their relatives
DEFF Research Database (Denmark)
Fosse, Anette; Schaufel, Margrethe Aase; Ruths, Sabine
2014-01-01
. CONCLUSION: Nursing home patients and their relatives wanted doctors more involved in end-of-life care. They expected doctors to acknowledge their preferences and provide guidance and symptom relief. PRACTICE IMPLICATIONS: High-quality end-of-life care in nursing homes relies on organization, funding......OBJECTIVE: Synthesize research about patients' and relatives' expectations and experiences on how doctors can improve end-of-life care in nursing homes. METHODS: We systematically searched qualitative studies in English in seven databases (Medline, Embase, PsycINFO, CINAHL, Ageline, Cochrane...... decision-makers reported uncertainty and distress when guidance from health personnel was lacking. They worried about staff shortage and emphasized doctor availability. Relatives and health personnel seldom recognized patients' ability to consent, and patients' preferences were not always recognized...
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Yu, Sheila; Escobedo, Patricia; Garcia, Robert; Cruz, Tess Boley; Unger, Jennifer B; Baezconde-Garbanati, Lourdes; Meza, Leah; Sussman, Steve
2018-02-11
After proposing the "Deeming Rule" in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles-area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA's soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015-2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.
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The FDA Food Safety and Modernization Act and the Exemption for Small Firms
Pouliot, Sebastien
2011-01-01
The FDA Food Safety Modernization Act of 2010 is new legislation that mandates, among other things, new food safety standards. The act includes a clause that exempts small firms from new regulatory requirements. This paper investigates the effects of a small firm exemption from more stringent food safety standards. The model compares food safety, total output and the number of market participants for different food safety regulation with and without an exemption for small firms. The numerical...
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Stip, Emmanuel; Rialle, Vincent
2005-04-01
In light of the advent of new technologies, we proposed to reexamine certain challenges posed by cognitive remediation and social reintegration (that is, deinstitutionalization) of patients with severe and persistent mental disorders. We reviewed literature on cognition, remediation, smart homes, as well as on objects and utilities, using medical and computer science electronic library and Internet searches. These technologies provide solutions for disabled persons with respect to care delivery, workload reduction, and socialization. Examples include home support, video conferencing, remote monitoring of medical parameters through sensors, teledetection of critical situations (for example, a fall or malaise), measures of daily living activities, and help with tasks of daily living. One of the key concepts unifying all these technologies is the health-smart home. We present the notion of the health-smart home in general and then examine it more specifically in relation to schizophrenia. Management of people with schizophrenia with cognitive deficits who are being rehabilitated in the community can be improved with the use of technology; however, such technology has ethical ramifications.
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Transfer to hospital in planned home births: a systematic review.
Blix, Ellen; Kumle, Merethe; Kjærgaard, Hanne; Øian, Pål; Lindgren, Helena E
2014-05-29
There is concern about the safety of homebirths, especially in women transferred to hospital during or after labour. The scope of transfer in planned home births has not been assessed in a systematic review. This review aimed to describe the proportions and indications for transfer from home to hospital during or after labour in planned home births. The databases Pubmed, Embase, Cinahl, Svemed+, and the Cochrane Library were searched using the MeSH term "home childbirth". Inclusion criteria were as follows: the study population was women who chose planned home birth at the onset of labour; the studies were from Western countries; the birth attendant was an authorised midwife or medical doctor; the studies were published in 1985 or later, with data not older than from 1980; and data on transfer from home to hospital were described. Of the 3366 titles identified, 83 full text articles were screened, and 15 met the inclusion criteria. Two of the authors independently extracted the data. Because of the heterogeneity and lack of robustness across the studies, there were considerable risks for bias if performing meta-analyses. A descriptive presentation of the findings was chosen. Fifteen studies were eligible for inclusion, containing data from 215,257 women. The total proportion of transfer from home to hospital varied from 9.9% to 31.9% across the studies. The most common indication for transfer was labour dystocia, occurring in 5.1% to 9.8% of all women planning for home births. Transfer for indication for foetal distress varied from 1.0% to 3.6%, postpartum haemorrhage from 0% to 0.2% and respiratory problems in the infant from 0.3% to 1.4%. The proportion of emergency transfers varied from 0% to 5.4%. Future studies should report indications for transfer from home to hospital and provide clear definitions of emergency transfers.
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Challenges and Strategies in Providing Home Based Primary Care for Refugees in the US.
Febles, C; Nies, M A; Fanning, K; Tavernier, S S
2017-12-01
The recent crisis in the Middle East has prompted the exodus of millions of refugees from the region who are at present seeking shelter across Europe and in the United States. Among the most immediate needs of refugees upon arrival in a host country is health care, and it is one of the most sustained interactions they experience. Home visits are a common form of primary care for refugees. The authors review the literature to identify themes related to challenges and strategies for providing home based primary care to refugees. The literature review was performed by searching cross-disciplinary databases utilizing Onesearch, but focusing primarily on results produced through CINAHL, EBSCOHOST, and Pub Med databases. To maximize the number of studies included, there was no time frame placed upon publication dates of articles within the search. A total of 55 articles were included in this paper.
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The history and contemporary challenges of the US Food and Drug Administration.
Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric
2007-01-01
The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces
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Does smart home technology prevent falls in community-dwelling older adults: a literature review
Directory of Open Access Journals (Sweden)
Eva Pietrzak
2014-04-01
Full Text Available Background: Falls in older Australians are an increasingly costly public health issue, driving the development of novel modes of intervention, especially those that rely on computer-driven technologies. Objective: The aim of this paper was to gain an understanding of the state of the art of research on smart homes and computer-based monitoring technologies to prevent and detect falls in the community-dwelling elderly. Method: Cochrane, Medline, Embase and Google databases were searched for articles on fall prevention in the elderly using pre-specified search terms. Additional papers were searched for in the reference lists of relevant reviews and by the process of ‘snowballing’. Only studies that investigated outcomes related to falling such as fall prevention and detection, change in participants’ fear of falling and attitudes towards monitoring technology were included. Results: Nine papers fulfilled the inclusion criteria. The following outcomes were observed: (1 older adults’ attitudes towards fall detectors and smart home technology are generally positive; (2 privacy concerns and intrusiveness of technology were perceived as less important to participants than their perception of health needs and (3 unfriendly and age-inappropriate design of the interface may be one of the deciding factors in not using the technology. Conclusion: So far, there is little evidence that using smart home technology may assist in fall prevention or detection, but there are some indications that it may increase older adults’ confidence and sense of security, thus possibly enabling aging in place.
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FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers
Do, Kathy T.
2015-01-01
Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154
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FDA advisory committees meet January 26 on Salk HIV-1 immunogen.
1995-01-06
Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment.
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Rainey, Emily; Simonsen, Sara; Stanford, Joseph; Shoaf, Kimberley; Baayd, Jami
2017-06-01
The United Kingdom's National Institute for Health and Care Excellence (NICE) recently published recommendations that support planned home birth for low-risk women. The American College of Obstetricians and Gynecologists (ACOG) remains wary of planned home birth, asserting that hospitals and birthing centers are the safest birth settings. Our objective was to examine opinions of obstetricians in Salt Lake City, Utah about home birth in the context of rising home birth rates and conflicting guidelines. Participants were recruited through online searches of Salt Lake City obstetricians and through snowball sampling. We conducted individual interviews exploring experiences with and attitudes toward planned home birth and the ACOG/NICE guidelines. Fifteen obstetricians who varied according to years of experience, location of medical training, sex, and subspecialty (resident, OB/GYN, maternal-fetal medicine specialist) were interviewed. Participants did not recommend home birth but supported a woman's right to choose her birth setting. Obstetrician opinions about planned home birth were shaped by misconceptions of home birth benefits, confusion surrounding the scope of care at home and among home birth providers, and negative transfer experiences. Participants were unfamiliar with the literature on planned home birth and/or viewed the evidence as unreliable. Support for ACOG guidelines was high, particularly in the context of the United States health care setting. Physician objectivity may be limited by biases against home birth, which stem from limited familiarity with published evidence, negative experiences with home-to-hospital transfers, and distrust of home birth providers in a health care system not designed to support home birth. © 2017 Wiley Periodicals, Inc.
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Romero, Klaus; Sinha, Vikram; Allerheiligen, Sandra; Danhof, Meindert; Pinheiro, Jose; Kruhlak, Naomi; Wang, Yaning; Wang, Sue-Jane; Sauer, John-Michael; Marier, J. F.; Corrigan, Brian; Rogers, James; Heerspink, H. J. Lambers; Gumbo, Tawanda; Vis, Peter; Watkins, Paul; Morrison, Tina; Gillespie, William; Gordon, Mark Forrest; Stephenson, Diane; Hanna, Debra; Pfister, Marc; Lalonde, Richard; Colatsky, Thomas
2014-01-01
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for
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An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings. In making this workshop unique, a case study approach was used to discuss issues related to
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2011-07-14
...., Bldg. 51, rm. 2201, Silver Spring, MD 20993- 0002, or Office of Communication, Outreach and Development... help make critical treatment decisions. FDA oversight of companion diagnostics will protect patients... current thinking on companion diagnostic devices. It does not create or confer any rights for or on any...
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2011-03-14
... Act: Title III--A New Paradigm for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS... announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title III--A New Paradigm for... provided. Request special accommodations due By March 22, 2011.... Patricia M. Kuntze, 301- to disability...
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Tippett, Elizabeth C; Chen, Brian K
2015-12-01
Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.
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Njoku, Nkechi C.
2016-01-01
Impact of home video/movie industry on the moral behaviour of secondary school students is a search for the impact of home video in moral upbringing of school children. The study adopted a survey design approach of investigation: The area of study is Ebonyi State and the population comprised all the 322 CRS teachers in the state. 200 teachers were…
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In-Home Care for Optimizing Chronic Disease Management in the Community
2013-01-01
Background The emerging attention on in-home care in Canada assumes that chronic disease management will be optimized if it takes place in the community as opposed to the health care setting. Both the patient and the health care system will benefit, the latter in terms of cost savings. Objectives To compare the effectiveness of care delivered in the home (i.e., in-home care) with no home care or with usual care/care received outside of the home (e.g., health care setting). Data Sources A literature search was performed on January 25, 2012, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 2006, until January 25, 2012. Review Methods An evidence-based analysis examined whether there is a difference in mortality, hospital utilization, health-related quality of life (HRQOL), functional status, and disease-specific clinical measures for in-home care compared with no home care for heart failure, atrial fibrillation, coronary artery disease, stroke, chronic obstructive pulmonary disease, diabetes, chronic wounds, and chronic disease / multimorbidity. Data was abstracted and analyzed in a pooled analysis using Review Manager. When needed, subgroup analysis was performed to address heterogeneity. The quality of evidence was assessed by GRADE. Results The systematic literature search identified 1,277 citations from which 12 randomized controlled trials met the study criteria. Based on these, a 12% reduced risk for in-home care was shown for the outcome measure of combined events including all-cause mortality and hospitalizations (relative risk [RR]: 0.88; 95% CI: 0.80–0.97). Patients receiving in-home care had an average of 1 less unplanned hospitalization (mean difference [MD]: –1.03; 95% CI: –1.53 to –0.53) and an average of 1 less
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Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle
2014-12-01
The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition. Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics.
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Abbott, B. P.; Abbott, R.; Abbott, T. D.; Acernese, F.; Ackley, K.; Adams, C.; Adams, T.; Addesso, P.; Adhikari, R. X.; Adya, V. B.; Affeldt, C.; Afrough, M.; Agarwal, B.; Agatsuma, K.; Aggarwal, N.; Aguiar, O. D.; Aiello, L.; Ain, A.; Allen, B.; Allen, G.; Allocca, A.; Altin, P. A.; Amato, A.; Ananyeva, A.; Anderson, S. B.; Anderson, W. G.; Antier, S.; Appert, S.; Arai, K.; Araya, M. C.; Areeda, J. S.; Arnaud, N.; Ascenzi, S.; Ashton, G.; Ast, M.; Aston, S. M.; Astone, P.; Aufmuth, P.; Aulbert, C.; AultONeal, K.; Avila-Alvarez, A.; Babak, S.; Bacon, P.; Bader, M. K. M.; Bae, S.; Baker, P. T.; Baldaccini, F.; Ballardin, G.; Ballmer, S. W.; Banagiri, S.; Barayoga, J. C.; Barclay, S. E.; Barish, B. C.; Barker, D.; Barone, F.; Barr, B.; Barsotti, L.; Barsuglia, M.; Barta, D.; Bartlett, J.; Bartos, I.; Bassiri, R.; Basti, A.; Batch, J. C.; Baune, C.; Bawaj, M.; Bazzan, M.; Becsy, B.; Beer, C.; Bejger, M.; Belahcene, I.; Bell, A. S.; Berger, B. K.; Bergmann, G.; Berry, C. P. L.; Bersanetti, D.; Bertolini, A.; Betzwieser, J.; Bhagwat, S.; Bhandare, R.; Bilenko, I. A.; Billingsley, G.; Billman, C. R.; Birch, J.; Birney, R.; Birnholtz, O.; Biscans, S.; Bisht, A.; Bitossi, M.; Biwer, C.; Bizouard, M. A.; Blackburn, J. K.; Blackman, J.; Blair, C. D.; Blair, D. G.; Blair, R. M.; Bloemen, S.; Bock, O.; Bode, N.; Boer, M.; Bogaert, G.; Bohe, A.; Bondu, F.; Bonnand, R.; Boom, B. A.; Bork, R.; Boschi, V.; Bose, S.; Bouffanais, Y.; Bozzi, A.; Bradaschia, C.; Brady, P. R.; Braginsky, V. B.; Branchesi, M.; Brau, J. E.; Briant, T.; Brillet, A.; Brinkmann, M.; Brisson, V.; Brockill, P.; Broida, J. E.; Brooks, A. F.; Brown, D. A.; Brown, D. D.; Brown, N. M.; Brunett, S.; Buchanan, C. C.; Buikema, A.; Bulik, T.; Bulten, H. J.; Buonanno, A.; Buskulic, D.; Buy, C.; Byer, R. L.; Cabero, M.; Cadonati, L.; Cagnoli, G.; Cahillane, C.; Bustillo, J. Calderon; Callister, T. A.; Calloni, E.; Camp, J. B.; Canizares, P.; Cannon, K. C.; Cao, H.; Cao, J.; Capano, C. D.; Capocasa, E.; Carbognani, F.; Caride, S.; Carney, M. F.; Diaz, J. Casanueva; Casentini, C.; Caudill, S.; Cavaglia, M.; Cavalier, F.; Cavalieri, R.; Cella, G.; Cepeda, C. B.; Baiardi, L. Cerboni; Cerretani, G.; Cesarini, E.; Chamberlin, S. J.; Chan, M.; Chao, S.; Charlton, P.; Chassande-Mottin, E.; Chatterjee, D.; Cheeseboro, B. D.; Chen, H. Y.; Chen, Y.; Cheng, H. -P.; Chincarini, A.; Chiummo, A.; Chmiel, T.; Cho, H. S.; Cho, M.; Chow, J. H.; Christensen, N.; Chu, Q.; Chua, A. J. K.; Chua, S.; Chung, A. K. W.; Chung, S.; Ciani, G.; Ciolfi, R.; Cirelli, C. E.; Cirone, A.; Clara, F.; Clark, J. A.; Cleva, F.; Cocchieri, C.; Coccia, E.; Cohadon, P. -F.; Colla, A.; Collette, C. G.; Cominsky, L. R.; Constancio, M., Jr.; Conti, L.; Cooper, S. J.; Corban, P.; Corbitt, T. R.; Corley, K. R.; Cornish, N.; Corsi, A.; Cortese, S.; Costa, C. A.; Coughlin, M. W.; Coughlin, S. B.; Coulon, J. -P.; Countryman, S. T.; Couvares, P.; Covas, P. B.; Cowan, E. E.; Coward, D. M.; Cowart, M. J.; Coyne, D. C.; Coyne, R.; Creighton, J. D. E.; Creighton, T. D.; Cripe, J.; Crowder, S. G.; Cullen, T. J.; Cumming, A.; Cunningham, L.; Cuoco, E.; Dal Canton, T.; Danilishin, S. L.; D'Antonio, S.; Danzmann, K.; Dasgupta, A.; Costa, C. F. Da Silva; Dattilo, V.; Dave, I.; Davier, M.; Davis, D.; Daw, E. J.; Day, B.; De, S.; DeBra, D.; Deelman, E.; Degallaix, J.; De Laurentis, M.; Deleglise, S.; Del Pozzo, W.; Denker, T.; Dent, T.; Dergachev, V.; De Rosa, R.; DeRosa, R. T.; DeSalvo, R.; Devenson, J.; Devine, R. C.; Dhurandhar, S.; Diaz, M. C.; Di Fiore, L.; Di Giovanni, M.; Di Girolamo, T.; Di Lieto, A.; Di Pace, S.; Di Palma, I.; Di Renzo, F.; Doctor, Z.; Dolique, V.; Donovan, F.; Dooley, K. L.; Doravari, S.; Dorrington, I.; Douglas, R.; Alvarez, M. Dovale; Downes, T. P.; Drago, M.; Drever, R. W. P.; Driggers, J. C.; Du, Z.; Ducrot, M.; Duncan, J.; Dwyer, S. E.; Edo, T. B.; Edwards, M. C.; Effler, A.; Eggenstein, H. -B.; Ehrens, P.; Eichholz, J.; Eikenberry, S. S.; Eisenstein, R. A.; Essick, R. C.; Etienne, Z. B.; Etzel, T.; Evans, M.; Evans, T. M.; Factourovich, M.; Fafone, V.; Fair, H.; Fairhurst, S.; Fan, X.; Farinon, S.; Farr, B.; Farr, W. M.; Fauchon-Jones, E. J.; Favata, M.; Fays, M.; Fehrmann, H.; Feicht, J.; Fejer, M. M.; Fernandez-Galiana, A.; Ferrante, I.; Ferreira, E. C.; Ferrini, F.; Fidecaro, F.; Fiori, I.; Fiorucci, D.; Fisher, R. P.; Flaminio, R.; Fletcher, M.; Fong, H.; Forsyth, P. W. F.; Forsyth, S. S.; Fournier, J. -D.; Frasca, S.; Frasconi, F.; Frei, Z.; Freise, A.; Frey, R.; Frey, V.; Fries, E. M.; Fritschel, P.; Frolov, V. V.; Fulda, P.; Fyffe, M.; Gabbard, H.; Gabel, M.; Gadre, B. U.; Gaebel, S. M.; Gair, J. R.; Gammaitoni, L.; Ganija, M. R.; Gaonkar, S. G.; Garufi, F.; Gaudio, S.; Gaur, G.; Gayathri, V.; Gehrels, N.; Gemme, G.; Genin, E.; Gennai, A.; George, D.; George, J.; Gergely, L.; Germain, V.; Ghonge, S.; Ghosh, Abhirup; Ghosh, Archisman; Ghosh, S.; Giaime, J. A.; Giardina, K. D.; Giazotto, A.; Gill, K.; Glover, L.; Goetz, E.; Goetz, R.; Gomes, S.; Gonzalez, G.; Castro, J. M. Gonzalez; Gopakumar, A.; Gorodetsky, M. L.; Gossan, S. E.; Gosselin, M.; Gouaty, R.; Grado, A.; Graef, C.; Granata, M.; Grant, A.; Gras, S.; Gray, C.; Greco, G.; Green, A. C.; Groot, P.; Grote, H.; Grunewald, S.; Gruning, P.; Guidi, G. M.; Guo, X.; Gupta, A.; Gupta, M. K.; Gushwa, K. E.; Gustafson, E. K.; Gustafson, R.; Hall, B. R.; Hall, E. D.; Hammond, G.; Haney, M.; Hanke, M. M.; Hanks, J.; Hanna, C.; Hannuksela, O. A.; Hanson, J.; Hardwick, T.; Harms, J.; Harry, G. M.; Harry, I. W.; Hart, M. J.; Haster, C. -J.; Haughian, K.; Healy, J.; Heidmann, A.; Heintze, M. C.; Heitmann, H.; Hello, P.; Hemming, G.; Hendry, M.; Heng, I. S.; Hennig, J.; Henry, J.; Heptonstall, A. W.; Heurs, M.; Hild, S.; Hoak, D.; Hofman, D.; Holt, K.; Holz, D. E.; Hopkins, P.; Horst, C.; Hough, J.; Houston, E. A.; Howell, E. J.; Hu, Y. M.; Huerta, E. A.; Huet, D.; Hughey, B.; Husa, S.; Huttner, S. H.; Huynh-Dinh, T.; Indik, N.; Ingram, D. R.; Inta, R.; Intini, G.; Isa, H. N.; Isac, J. -M.; Isi, M.; Iyer, B. R.; Izumi, K.; Jacqmin, T.; Jani, K.; Jaranowski, P.; Jawahar, S.; Jimenez-Forteza, F.; Johnson, W. W.; Jones, D. I.; Jones, R.; Jonker, R. J. G.; Ju, L.; Junker, J.; Kalaghatgi, C. V.; Kalogera, V.; Kandhasamy, S.; Kang, G.; Kanner, J. B.; Karki, S.; Karvinen, K. S.; Kasprzack, M.; Katolik, M.; Katsavounidis, E.; Katzman, W.; Kaufer, S.; Kawabe, K.; Kefelian, F.; Keitel, D.; Kemball, A. J.; Kennedy, R.; Kent, C.; Key, J. S.; Khalili, Y.; Khan, I.; Khan, S.; Khan, Z.; Khazanov, E. A.; Kijbunchoo, N.; Kim, Chunglee; Kim, J. C.; Kim, W.; Kim, W. S.; Kim, Y. -M.; Kimbrell, S. J.; King, E. J.; King, P. J.; Kirchhoff, R.; Kissel, J. S.; Kleybolte, L.; Klimenko, S.; Koch, P.; Koehlenbeck, S. M.; Koley, S.; Kondrashov, V.; Kontos, A.; Korobko, M.; Korth, W. Z.; Kowalska, I.; Kozak, D. B.; Kraemer, C.; Kringel, V.; Krishnan, B.; Krolak, A.; Kuehn, G.; Kumar, P.; Kumar, R.; Kumar, S.; Kuo, L.; Kutynia, A.; Kwang, S.; Lackey, B. D.; Lai, K. H.; Landry, M.; Lang, R. N.; Lange, J.; Lantz, B.; Lanza, R. K.; Lartaux-Vollard, A.; Lasky, P. D.; Laxen, M.; Lazzarini, A.; Lazzaro, C.; Leaci, P.; Leavey, S.; Lee, C. H.; Lee, H. K.; Lee, H. M.; Lee, H. W.; Lee, K.; Lehmann, J.; Lenon, A.; Leonardi, M.; Leroy, N.; Letendre, N.; Levin, Y.; Li, T. G. F.; Libson, A.; Littenberg, T. B.; Liu, J.; Lo, R. K. L.; Lockerbie, N. A.; London, L. T.; Lord, J. E.; Lorenzini, M.; Loriette, V.; Lormand, M.; Losurdo, G.; Lough, J. D.; Lovelace, G.; Lueck, H.; Lumaca, D.; Lundgren, A. P.; Lynch, R.; Ma, Y.; Macfoy, S.; Machenschalk, B.; MacInnis, M.; Macleod, D. M.; Hernandez, I. Magana; Magana-Sandoval, F.; Zertuche, L. Magana; Magee, R. M.; Majorana, E.; Maksimovic, I.; Man, N.; Mandic, V.; Mangano, V.; Mansell, G. L.; Manske, M.; Mantovani, M.; Marchesoni, F.; Marion, F.; Marka, S.; Marka, Z.; Markakis, C.; Markosyan, A. S.; Maros, E.; Martelli, F.; Martellini, L.; Martin, I. W.; Martynov, D. V.; Mason, K.; Masserot, A.; Massinger, T. J.; Masso-Reid, M.; Mastrogiovanni, S.; Matas, A.; Matichard, F.; Matone, L.; Mavalvala, N.; Mayani, R.; Mazumder, N.; McCarthy, R.; McClelland, D. E.; McCormick, S.; McCuller, L.; McGuire, S. C.; McIntyre, G.; McIver, J.; McManus, D. J.; McRae, T.; McWilliams, S. T.; Meacher, D.; Meadors, G. D.; Meidam, J.; Mejuto-Villa, E.; Melatos, A.; Mendell, G.; Mercer, R. A.; Merilh, E. L.; Merzougui, M.; Meshkov, S.; Messenger, C.; Messick, C.; Metzdorff, R.; Meyers, P. M.; Mezzani, F.; Miao, H.; Michel, C.; Middleton, H.; Mikhailov, E. E.; Milano, L.; Miller, A. L.; Miller, A.; Miller, B. B.; Miller, J.; Millhouse, M.; Minazzoli, O.; Minenkov, Y.; Ming, J.; Mishra, C.; Mitra, S.; Mitrofanov, V. P.; Mitselmakher, G.; Mittleman, R.; Moggi, A.; Mohan, M.; Mohapatra, S. R. P.; Montani, M.; Moore, B. C.; Moore, C. J.; Moraru, D.; Moreno, G.; Morriss, S. R.; Mours, B.; Mow-Lowry, C. M.; Mueller, G.; Muir, A. W.; Mukherjee, Arunava; Mukherjee, D.; Mukherjee, S.; Mukund, N.; Mullavey, A.; Munch, J.; Muniz, E. A. M.; Murray, P. G.; Napier, K.; Nardecchia, I.; Naticchioni, L.; Nayak, R. K.; Nelemans, G.; Nelson, T. J. N.; Neri, M.; Nery, M.; Neunzert, A.; Newport, J. M.; Newton, G.; Ng, K. K. Y.; Nguyen, T. T.; Nichols, D.; Nielsen, A. B.; Nissanke, S.; Nitz, A.; Noack, A.; Nocera, F.; Nolting, D.; Normandin, M. E. N.; Nuttall, L. K.; Oberling, J.; Ochsner, E.; Oelker, E.; Ogin, G. H.; Oh, J. J.; Oh, S. H.; Ohme, F.; Oliver, M.; Oppermann, P.; Oram, Richard J.; O'Reilly, B.; Ormiston, R.; Ortega, L. F.; O'Shaughnessy, R.; Ottaway, D. J.; Overmier, H.; Owen, B. J.; Pace, A. E.; Page, J.; Page, M. A.; Pai, A.; Pai, S. A.; Palamos, J. R.; Palashov, O.; Palomba, C.; Pal-Singh, A.; Pan, H.; Pang, B.; Pang, P. T. H.; Pankow, C.; Pannarale, F.; Pant, B. C.; Paoletti, F.; Paoli, A.; Papa, M. A.; Paris, H. R.; Parker, W.; Pascucci, D.; Pasqualetti, A.; Passaquieti, R.; Passuello, D.; Patricelli, B.; Pearlstone, B. L.; Pedraza, M.; Pedurand, R.; Pekowsky, L.; Pele, A.; Penn, S.; Perez, C. J.; Perreca, A.; Perri, L. M.; Pfeiffer, H. P.; Phelps, M.; Piccinni, O. J.; Pichot, M.; Piergiovanni, F.; Pierro, V.; Pillant, G.; Pinard, L.; Pinto, I. M.; Pitkin, M.; Poggiani, R.; Popolizio, P.; Porter, E. K.; Post, A.; Powell, J.; Prasad, J.; Pratt, J. W. W.; Predoi, V.; Prestegard, T.; Prijatelj, M.; Principe, M.; Privitera, S.; Prix, R.; Prodi, G. A.; Prokhorov, L. G.; Puncken, O.; Punturo, M.; Puppo, P.; Puerrer, M.; Qi, H.; Qin, J.; Qiu, S.; Quetschke, V.; Quintero, E. A.; Quitzow-James, R.; Raab, F. J.; Rabeling, D. S.; Radkins, H.; Raffai, P.; Raja, S.; Rajan, C.; Rakhmanov, M.; Ramirez, K. E.; Rapagnani, P.; Raymond, V.; Razzano, M.; Read, J.; Regimbau, T.; Rei, L.; Reid, S.; Reitze, D. H.; Rew, H.; Reyes, S. D.; Ricci, F.; Ricker, P. M.; Rieger, S.; Riles, K.; Rizzo, M.; Robertson, N. A.; Robie, R.; Robinet, F.; Rocchi, A.; Rolland, L.; Rollins, J. G.; Roma, V. J.; Romano, R.; Romel, C. L.; Romie, J. H.; Rosinska, D.; Ross, M. P.; Rowan, S.; Ruediger, A.; Ruggi, P.; Ryan, K.; Rynge, M.; Sachdev, S.; Sadecki, T.; Sadeghian, L.; Sakellariadou, M.; Salconi, L.; Saleem, M.; Salemi, F.; Samajdar, A.; Sammut, L.; Sampson, L. M.; Sanchez, E. J.; Sandberg, V.; Sandeen, B.; Sanders, J. R.; Sassolas, B.; Sathyaprakash, B. S.; Saulson, P. R.; Sauter, O.; Savage, R. L.; Sawadsky, A.; Schale, P.; Scheuer, J.; Schmidt, E.; Schmidt, J.; Schmidt, P.; Schnabel, R.; Schofield, R. M. S.; Schoenbeck, A.; Schreiber, E.; Schuette, D.; Schulte, B. W.; Schutz, B. F.; Schwalbe, S. G.; Scott, J.; Scott, S. M.; Seidel, E.; Sellers, D.; Sengupta, A. S.; Sentenac, D.; Sequino, V.; Sergeev, A.; Shaddock, D. A.; Shaffer, T. J.; Shah, A. A.; Shahriar, M. S.; Shao, L.; Shapiro, B.; Shawhan, P.; Sheperd, A.; Shoemaker, D. H.; Shoemaker, D. M.; Siellez, K.; Siemens, X.; Sieniawska, M.; Sigg, D.; Silva, A. D.; Singer, A.; Singer, L. P.; Singh, A.; Singh, R.; Singhal, A.; Sintes, A. M.; Slagmolen, B. J. J.; Smith, B.; Smith, R. J. E.; Smith, R. J. E.; Son, E. J.; Sonnenberg, J. A.; Sorazu, B.; Sorrentino, F.; Souradeep, T.; Spencer, A. P.; Srivastava, A. K.; Staley, A.; Steinke, M.; Steinlechner, J.; Steinlechner, S.; Steinmeyer, D.; Stephens, B. C.; Stone, R.; Strain, K. A.; Stratta, G.; Strigin, S. E.; Sturani, R.; Stuver, A. L.; Summerscales, T. Z.; Sun, L.; Sunil, S.; Sutton, P. J.; Swinkels, B. L.; Szczepanczyk, M. J.; Tacca, M.; Talukder, D.; Tanner, D. B.; Tapai, M.; Taracchini, A.; Taylor, J. A.; Taylor, R.; Theeg, T.; Thomas, E. G.; Thomas, M.; Thomas, P.; Thorne, K. A.; Thorne, K. S.; Thrane, E.; Tiwari, S.; Tiwari, V.; Tokmakov, K. V.; Toland, K.; Tonelli, M.; Tornasi, Z.; Torrie, C. I.; Toyra, D.; Travasso, F.; Traylor, G.; Trifiro, D.; Trinastic, J.; Tringali, M. C.; Trozzo, L.; Tsang, K. W.; Tse, M.; Tso, R.; Tuyenbayev, D.; Ueno, K.; Ugolini, D.; Unnikrishnan, C. S.; Urban, A. L.; Usman, S. A.; Vahi, K.; Vahlbruch, H.; Vajente, G.; Valdes, G.; Vallisneri, M.; van Bakel, N.; van Beuzekom, M.; van den Brand, J. F. J.; Van Den Broeck, C.; Vander-Hyde, D. C.; van der Schaaf, L.; van Heijningen, J. V.; van Veggel, A. A.; Vardaro, M.; Varma, V.; Vass, S.; Vasuth, M.; Vecchio, A.; Vedovato, G.; Veitch, J.; Veitch, P. J.; Venkateswara, K.; Venugopalan, G.; Verkindt, D.; Vetrano, F.; Vicere, A.; Viets, A. D.; Vinciguerra, S.; Vine, D. J.; Vinet, J. -Y.; Vitale, S.; Vo, T.; Vocca, H.; Vorvick, C.; Voss, D. V.; Vousden, W. D.; Vyatchanin, S. P.; Wade, A. R.; Wade, L. E.; Wade, M.; Walet, R.; Walker, M.; Wallace, L.; Walsh, S.; Wang, G.; Wang, H.; Wang, J. Z.; Wang, M.; Wang, Y. -F.; Wang, Y.; Ward, R. L.; Warner, J.; Was, M.; Watchi, J.; Weaver, B.; Wei, L. -W.; Weinert, M.; Weinstein, A. J.; Weiss, R.; Wen, L.; Wessel, E. K.; Wessels, P.; Westphal, T.; Wette, K.; Whelan, J. T.; Whiting, B. F.; Whittle, C.; Williams, D.; Williams, R. D.; Williamson, A. R.; Willis, J. L.; Willke, B.; Wimmer, M. H.; Winkler, W.; Wipf, C. C.; Wittel, H.; Woan, G.; Woehler, J.; Wofford, J.; Wong, K. W. K.; Worden, J.; Wright, J. L.; Wu, D. S.; Wu, G.; Yam, W.; Yamamoto, H.; Yancey, C. C.; Yap, M. J.; Yu, Hang; Yu, Haocun; Yvert, M.; Zadrozny, A.; Zanolin, M.; Zelenova, T.; Zendri, J. -P.; Zevin, M.; Zhang, L.; Zhang, M.; Zhang, T.; Zhang, Y. -H.; Zhao, C.; Zhou, M.; Zhou, Z.; Zhu, S. J.; Zhu, X. J.; Zucker, M. E.; Zweizig, J.; Anderson, D. P.
2017-01-01
We report results of a deep all-sky search for periodic gravitational waves from isolated neutron stars in data from the first Advanced LIGO observing run. This search investigates the low frequency range of Advanced LIGO data, between 20 and 100 Hz, much of which was not explored in initial LIGO.
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Ronquillo, Jay G; Zuckerman, Diana M
2017-09-01
Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review
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Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar
2017-01-01
Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer-Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that
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Kneale, Laura; Choi, Yong; Demiris, George
2016-01-01
Home health nurses and clients experience unmet information needs when transitioning from hospital to home health. Personal health records (PHRs) support consumer-centered information management activities. Previous work has assessed PHRs associated with healthcare providers, but these systems leave home health nurses unable to access necessary information. To evaluate the ability of publically available PHRs to accept, manage, and share information from a home health case study. Two researchers accessed the publically available PHRs on myPHR.com, and attempted to enter, manage, and share the case study data. We qualitatively described the PHR features, and identified gaps between the case study information and PHR functionality. Eighteen PHRs were identified in our initial search. Seven systems met our inclusion criteria, and are included in this review. The PHRs were able to accept basic medical information. Gaps occurred when entering, managing, and/or sharing data from the acute care and home health episodes. The PHRs that were reviewed were unable to effectively manage the case study information. Therefore, increasing consumer health literacy through these systems may be difficult. The PHRs that we reviewed were also unable to electronically share their data. The gap between the existing functionality and the information needs from the case study may make these PHRs difficult to use for home health environments. Additional work is needed to increase the functionality of the PHR systems to better fit the data needs of home health clients.
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Miller, Jennifer E; Korn, David; Ross, Joseph S
2015-01-01
Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve
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How popular is waterpipe tobacco smoking? Findings from internet search queries.
Salloum, Ramzi G; Osman, Amira; Maziak, Wasim; Thrasher, James F
2015-09-01
Waterpipe tobacco smoking (WTS), a traditional tobacco consumption practice in the Middle East, is gaining popularity worldwide. Estimates of population-level interest in WTS over time are not documented. We assessed the popularity of WTS using World Wide Web search query results across four English-speaking countries. We analysed trends in Google search queries related to WTS, comparing these trends with those for electronic cigarettes between 2004 and 2013 in Australia, Canada, the UK and the USA. Weekly search volumes were reported as percentages relative to the week with the highest volume of searches. Web-based searches for WTS have increased steadily since 2004 in all four countries. Search volume for WTS was higher than for e-cigarettes in three of the four nations, with the highest volume in the USA. Online searches were primarily targeted at WTS products for home use, followed by searches for WTS cafés/lounges. Online demand for information on WTS-related products and venues is large and increasing. Given the rise in WTS popularity, increasing evidence of exposure-related harms, and relatively lax government regulation, WTS is a serious public health concern and could reach epidemic levels in Western societies. 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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Home birth integration into the health care systems of eleven international jurisdictions.
Comeau, Amanda; Hutton, Eileen K; Simioni, Julia; Anvari, Ella; Bowen, Megan; Kruegar, Samantha; Darling, Elizabeth K
2018-02-13
The purpose of this study was to develop assessment criteria that could be used to examine the level of integration of home birth within larger health care systems in developed countries across 11 international jurisdictions. An expert panel developed criteria and a definition to assess home birth integration within health care systems. We selected jurisdictions based on the publications that were eligible for inclusion in our systematic review and meta-analysis on planned place of birth. We sent the authors of the included publications a questionnaire about home birth practitioners and practices in their respective health care system at the time of their studies. We searched published peer-reviewed, non-peer-reviewed, and gray literature, and the websites of professional bodies to document information about home birth integration in each jurisdiction based on our criteria. Where information was lacking, we contacted experts in the field from the relevant jurisdiction. Home birth is well integrated into the health care system in British Columbia (Canada), England, Iceland, the Netherlands, New Zealand, Ontario (Canada), and Washington State (USA). Home birth is less well integrated into the health care system in Australia, Japan, Norway, and Sweden. This paper is the first to propose criteria for the evaluation of home birth integration within larger maternity care systems. Application of these criteria across 11 international jurisdictions indicates differences in the recognition and training of home birth practitioners, in access to hospital facilities, and in the supplies and equipment available at home births, which give rise to variation in the level of integration across different settings. Standardized criteria for the evaluation of systems integration are essential for interpreting planned home birth outcomes that emerge from contextual differences. © 2018 Wiley Periodicals, Inc.
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Directory of Open Access Journals (Sweden)
Isidro Palos
2017-06-01
Full Text Available Chagas disease (CD is a neglected disease caused by the parasite Trypanosoma cruzi, which affects underdeveloped countries. The current drugs of choice are nifurtimox and benznidazole, but both have severe adverse effects and less effectivity in chronic infections; therefore, the need to discover new drugs is essential. A computer-guided drug repositioning method was applied to identify potential FDA drugs (approved and withdrawn as cruzain (Cz inhibitors and trypanocidal effects were confirmed by in vitro and in vivo studies. 3180 FDA drugs were virtually screened using a structure-based approach. From a first molecular docking analysis, a set of 33 compounds with the best binding energies were selected. Subsequent consensus affinity binding, ligand amino acid contact clustering analysis, and ranked position were used to choose four known pharmacological compounds to be tested in vitro. Mouse blood samples infected with trypomastigotes from INC-5 and NINOA strains were used to test the trypanocidal effect of four selected compounds. Among these drugs, one fibrate antilipemic (etofyllin clofibrate and three β-lactam antibiotics (piperacillin, cefoperazone, and flucloxacillin showed better trypanocidal effects (LC50 range 15.8–26.1 μg/mL in comparison with benznidazole and nifurtimox (LC50 range 33.1–46.7 μg/mL. A short-term in vivo evaluation of these compounds showed a reduction of parasitemia in infected mice (range 90–60% at 6 h, but this was low compared to benznidazole (50%. This work suggests that four known FDA drugs could be used to design and obtain new trypanocidal agents.
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Sexual Abuse of Older Nursing Home Residents: A Literature Review
Directory of Open Access Journals (Sweden)
Wenche Malmedal
2015-01-01
Full Text Available Despite an increasing literature related to elder abuse, sexual abuse of older persons in general and of vulnerable adults living in nursing homes in particular is still sparsely described. The purpose of this study was to assess the state of knowledge on the subject of sexual abuse against older nursing home residents through a literature review. Systematic searches in reference databases including Cinahl, Medline, OVID Nursing Database, ISI Web of Science, PsycINFO, Cochrane Library, and SveMed + were conducted. Through several phases of selection of the articles, using strict inclusion and exclusion criteria, six articles were chosen for a deeper examination. Findings from the review show that sexual abuse occurs in nursing homes and that both older women and men are victims of sexual abuse. Perpetrators appear mainly to be staff and other residents and mainly to be men, but also women abuse both older men and older women. Findings from the literature review show that there is a need for knowledge and further research on the topic of sexual abuse against older residents in nursing homes. Furthermore, there is a need for good policies and reporting systems, as an important step in seriously addressing sexual abuse against older persons.
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Design of the smart home system based on the optimal routing algorithm and ZigBee network.
Directory of Open Access Journals (Sweden)
Dengying Jiang
Full Text Available To improve the traditional smart home system, its electric wiring, networking technology, information transmission and facility control are studied. In this paper, we study the electric wiring, networking technology, information transmission and facility control to improve the traditional smart home system. First, ZigBee is used to replace the traditional electric wiring. Second, a network is built to connect lots of wireless sensors and facilities, thanks to the capability of ZigBee self-organized network and Genetic Algorithm-Particle Swarm Optimization Algorithm (GA-PSOA to search for the optimal route. Finally, when the smart home system is connected to the internet based on the remote server technology, home environment and facilities could be remote real-time controlled. The experiments show that the GA-PSOA reduce the system delay and decrease the energy consumption of the wireless system.
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Design of the smart home system based on the optimal routing algorithm and ZigBee network.
Jiang, Dengying; Yu, Ling; Wang, Fei; Xie, Xiaoxia; Yu, Yongsheng
2017-01-01
To improve the traditional smart home system, its electric wiring, networking technology, information transmission and facility control are studied. In this paper, we study the electric wiring, networking technology, information transmission and facility control to improve the traditional smart home system. First, ZigBee is used to replace the traditional electric wiring. Second, a network is built to connect lots of wireless sensors and facilities, thanks to the capability of ZigBee self-organized network and Genetic Algorithm-Particle Swarm Optimization Algorithm (GA-PSOA) to search for the optimal route. Finally, when the smart home system is connected to the internet based on the remote server technology, home environment and facilities could be remote real-time controlled. The experiments show that the GA-PSOA reduce the system delay and decrease the energy consumption of the wireless system.
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Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana
2015-01-01
The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.
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Carnahan, Ryan M; Letuchy, Elena M
2018-01-01
Nursing home quality measures include the proportion of residents who receive antipsychotics. Residents with bipolar disorder are included even though antipsychotics are FDA-approved for this indication. We evaluated how including residents with bipolar disorder impacted the antipsychotic use quality measure for long-stay residents. We evaluated the agreement of minimum data set (MDS) bipolar disorder diagnoses with Medicare data, whether dementia was diagnosed before bipolar disorder, and how less-specific bipolar disorder diagnoses impacted findings. Cross-sectional study. Nursing homes in Iowa. 21,955 long-stay nursing home residents in the first quarter of 2014. We identified antipsychotic use and bipolar disorder using MDS data. We compared MDS bipolar disorder diagnoses with Chronic Conditions Warehouse (CCW) "ever" bipolar disorder indicators, and prior year claims. We compared CCW condition onset dates to identify bipolar disorder diagnosed after dementia. The mean (SD) proportion receiving antipsychotics was 19.6% (11.1%) with bipolar disorder and 18.3% (10.8%) without. The positive predictive value (PPV) of MDS bipolar disorder diagnoses was 80.2% versus CCW lifetime indicators, and 74.6% versus claims. PPV decreased by 27.1% when "bipolar disorder, unspecified" and "other bipolar disorders" diagnoses were excluded. Nearly three-quarters of residents with bipolar disorder had dementia. Over half of those with dementia had dementia first per CCW records. This proportion was lower among those with more specific bipolar disorder diagnoses or MDS bipolar disorder indicators. Bipolar disorder in nursing home residents is often first diagnosed after dementia using nonspecific diagnoses. This practice deserves further evaluation. Copyright © 2017 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.
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Oral health educational interventions for nursing home staff and residents.
Albrecht, Martina; Kupfer, Ramona; Reissmann, Daniel R; Mühlhauser, Ingrid; Köpke, Sascha
2016-09-30
Associations between nursing home residents' oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents' oral health. To assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents. We searched the Cochrane Oral Health Trials Register (to 18 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 12), MEDLINE Ovid (1946 to 18 January 2016), Embase Ovid (1980 to 18 January 2016), CINAHL EBSCO (1937 to 18 January 2016), and Web of Science Conference Proceedings (1990 to 18 January 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 18 January 2016. In addition, we searched reference lists of identified articles and contacted experts in the field. We placed no restrictions on language or date of publication when searching the electronic databases. Randomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention. Two review authors independently screened articles retrieved from the searches for relevance, extracted data from included studies, assessed risk of bias for each included study, and evaluated the overall quality of the evidence. We retrieved data about the development and evaluation processes of complex interventions on the basis of the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). We contacted authors of relevant studies for additional information. We included nine RCTs involving
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Poss, Jeffrey W; Sinn, Chi-Ling Joanna; Grinchenko, Galina; Blums, Jane; Peirce, Tom; Hirdes, John
2017-02-01
We examine recipients of publicly funded ongoing care in a single Ontario jurisdiction who reside in three different settings: long-stay home care patients in private homes and apartments, other patients in retirement homes and residents of long-term care homes, using interRAI assessment instruments. Among home care patients, those in retirement homes have higher proportions of dementia and moderate cognitive impairment, less supportive informal care systems as well as more personal care and nursing services above those provided by the public home care system, more frequent but shorter home support visits and lower than expected public home care expenditures. These lower expenditures may be because of efficiency of care delivery or by retirement homes providing some services otherwise provided by the public home care system. Although persons in each setting are mostly older adults with high degrees of frailty and medical complexity, long-term care home residents show distinctly higher needs. We estimate that 40% of retirement home residents are long-stay home care patients, and they comprise about one in six of this Community Care Access Centre's long-stay patients. Copyright © 2017 Longwoods Publishing.
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Mukamel, Dana B; Spector, William D; Zinn, Jacqueline; Weimer, David L; Ahn, Richard
2010-10-01
Nursing Home Compare first published clinical quality measures at the end of 2002. It is a quality report card that for the first time offers consumers easily accessible information about the clinical quality of nursing homes. It led to changes in consumers' demand, increasing the relative importance of clinical versus hotel aspects of quality in their search and choice of a nursing home. To examine the hypothesis that nursing homes responding to these changes in demand shifted the balance of resources from hotel to clinical activities. The study included 10,022 free-standing nursing homes nationwide during 2001 to 2006. RESEARCH DESIGN AND DATA: A retrospective multivariate statistical analysis of trends in the ratio of clinical to hotel expenditures, using Medicare cost reports, Minimum Data Set and Online Survey, Certification and Reporting data, controlling for changes in residents' acuity and facility fixed effects. Inference is based on robust standard errors. The ratio of clinical to hotel expenditures averaged 1.78. It increased significantly (P hotel expenditures following publication of the report card suggests that nursing homes responded as expected to the changes in the elasticity of demand with respect to clinical quality brought about by the public reporting of clinical quality measures. The response was stronger among nursing homes facing stronger incentives.
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Network computing with Einstein@home and climateprediction.net
CERN. Geneva; Christensen, Carl; Massey, Neil; Aina, Tolu; Marquina, Miguel Angel
2005-01-01
Einstein@Home is a project developed to search data from the Laser Interferometer Gravitational wave Observatory (LIGO) in the US and from the GEO 600 gravitational wave observatory in Germany for signals coming from extremely dense, rapidly rotating stars. Such sources are believed to be either quark stars or neutron stars, and a subclass of these are already observed by conventional means as pulsars or X-ray emitting celestial objects. Einstein@home is an official project of the Year of Physics. 2. climateprediction.net aims to investigate the approximations that have to be made in state-of-the-art climate models by running such models thousands of times under a range of approximations. This will help understand how sensitive different models are to small changes in, for example, the carbon dioxide and the sulphur cycle. This will contribute to exploring how climate may change in the next century under a wide range of different scenarios.
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A tabu-search for minimising the carry-over effects value of a round ...
African Journals Online (AJOL)
the tournament occurs when a team plays two consecutive home games or two ...... The initial solution for the tabu-search algorithm was generated randomly by ... at random on each level of the tree. ..... f e g j 9 7 6 1 5 c 0 a i 2 l 3 k d 4 h b 8.
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The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.
Shorter, Edward
2008-01-01
The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.
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Emmerson, Kellie B; Harding, Katherine E; Taylor, Nicholas F
2017-08-01
To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. A community rehabilitation programme within a large metropolitan health service. Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. A total of 62 participants were allocated to the intervention ( n = 30) and control groups ( n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI -12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI -0.1 to 0.1). There were no between-group differences in how participants found instructions ( p = 0.452), whether they remembered to do their exercises ( p = 0.485), or whether they enjoyed doing their exercises ( p = 0.864). The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx.
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Young, Camilla; Hall, Amanda M; Gonçalves-Bradley, Daniela C; Quinn, Terry J; Hooft, Lotty; van Munster, Barbara C; Stott, David J
2017-04-03
Changing population demographics have led to an increasing number of functionally dependent older people who require care and medical treatment. In many countries, government policy aims to shift resources into the community from institutional care settings with the expectation that this will reduce costs and improve the quality of care compared. To assess the effects of long-term home or foster home care versus institutional care for functionally dependent older people. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Library, MEDLINE, Embase, CINAHL, and two trials registers to November 2015. We included randomised and non-randomised trials, controlled before-after studies and interrupted time series studies complying with the EPOC study design criteria and comparing the effects of long-term home care versus institutional care for functionally dependent older people. Two reviewers independently extracted data and assessed the risk of bias of each included study. We reported the results narratively, as the substantial heterogeneity across studies meant that meta-analysis was not appropriate. We included 10 studies involving 16,377 participants, all of which were conducted in high income countries. Included studies compared community-based care with institutional care (care homes). The sample size ranged from 98 to 11,803 (median N = 204). There was substantial heterogeneity in the healthcare context, interventions studied, and outcomes assessed. One study was a randomised trial (N = 112); other included studies used designs that had potential for bias, particularly due lack of randomisation, baseline imbalances, and non-blinded outcome assessment. Most studies did not select (or exclude) participants for any specific disease state, with the exception of one study that only included patients if they had a stroke. All studies had methodological limitations, so readers should interpret results with caution.It is uncertain
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Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S
2017-10-01
Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to
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DEFF Research Database (Denmark)
Winther, Ida Wentzel
2009-01-01
What is home? A building, a physical and mental phenomenon, or a concept? There are many homes and ways `to home oneself´. Many of us quite often dwell in other places than at home (as professional commuters between two places, as travellers staying in hotels, as children of divorced parents...
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Search for 12 C+ 12 C clustering in 24 Mg ground state
Indian Academy of Sciences (India)
Home; Journals; Pramana – Journal of Physics; Volume 88; Issue 2. Search for 12C+12C clustering in 24Mg ground state. B N JOSHI ARUN K JAIN D C BISWAS B V JOHN Y K GUPTA L S DANU R P VIND G K PRAJAPATI S MUKHOPADHYAY A SAXENA. Regular Volume 88 Issue 2 February 2017 Article ID 29 ...
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Family and home characteristics correlate with mold in homes.
Reponen, Tiina; Levin, Linda; Zheng, Shu; Vesper, Stephen; Ryan, Patrick; Grinshpun, Sergey A; LeMasters, Grace
2013-07-01
Previously, we demonstrated that infants residing in homes with higher Environmental Relative Moldiness Index were at greater risk for developing asthma by age seven. The purpose of this analysis was to identify the family and home characteristics associated with higher moldiness index values in infants' homes at age one. Univariate linear regression of each characteristic determined that family factors associated with moldiness index were race and income. Home characteristics associated with the moldiness index values were: air conditioning, carpet, age of the home, season of home assessment, and house dust mite allergen. Parental history of asthma, use of dehumidifier, visible mold, dog and cat allergen levels were not associated with moldiness index. Results of multiple linear regression showed that older homes had 2.9 units higher moldiness index (95% confidence interval [CI]=0.4, 5.4), whereas homes with central air conditioning had 2.5 units lower moldiness index (95% CI=-4.7, -0.4). In addition, higher dust mite allergen levels and carpeting were positively and negatively associated with higher moldiness index, respectively. Because older homes and lack of air conditioning were also correlated with race and lower income, whereas carpeting was associated with newer homes, the multivariate analyses suggests that lower overall socioeconomic position is associated with higher moldiness index values. This may lead to increased asthma risk in homes inhabited by susceptible, vulnerable population subgroups. Further, age of the home was a surrogate of income, race and carpeting in our population; thus the use of these factors should carefully be evaluated in future studies. Copyright © 2013 Elsevier Inc. All rights reserved.
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Directory of Open Access Journals (Sweden)
Chatterjee S
2012-12-01
Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.
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Key issues in human resource planning for home support workers in Canada.
Keefe, Janice M; Knight, Lucy; Martin-Matthews, Anne; Légaré, Jacques
2011-01-01
This paper is a synthesis of research on recruitment and retention challenges for home support workers (HSWs) in Canada. Home support workers (HSWs) provide needed support with personal care and daily activities to older persons living in the community. Literature (peer reviewed, government, and non-government documents) published in the past decade was collected from systematic data base searches between January and September 2009, and yielded over 100 references relevant to home care human resources for older Canadians. Four key human resource issues affecting HSWs were identified: compensation, education and training, quality assurance, and working conditions. To increase the workforce and retain skilled employees, employers can tailor their marketing strategies to specific groups, make improvements in work environment, and learn about what workers value and what attracts them to home support work. Understanding these HR issues for HSWs will improve recruitment and retention strategies for this workforce by helping agencies to target their limited resources. Given the projected increase in demand for these workers, preparations need to begin now and consider long-term strategies involving multiple policy areas, such as health and social care, employment, education, and immigration.
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Uterotonic use at home births in low-income countries: a literature review.
Flandermeyer, Dawn; Stanton, Cynthia; Armbruster, Deborah
2010-03-01
This literature review compiles data on rates of use, indications, types of provider, mode of administration, and dose of uterotonics used for home births in low-income countries, and identifies gaps meriting further research. Published and unpublished English language articles from 1995 through 2008 pertaining to home use of uterotonics were identified via electronic searches of medical and social science databases. In addition, bibliographies of articles were examined for eligible studies. Data were abstracted and analyzed by the objectives outlined for this review. Twenty-three articles met the inclusion/exclusion criteria. Use rates of uterotonics at home births ranged widely from 1% to 69%, with the large majority of observations from South Asia. Descriptive studies suggest that home use of uterotonics before delivery of the baby are predominantly administered by nonprofessionals to accelerate labor, and are not perceived as unsafe. To achieve maximum benefit and minimal harm, programs that increase access to uterotonics for postpartum hemorrhage prevention must take into account existing practices among pregnant women. Further research regarding access to uterotonics and intervention studies for provider behavior change regarding uterotonic use is warranted.
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Weaver, Meaghann S; Wichman, Brittany; Bace, Sue; Schroeder, Denice; Vail, Catherine; Wichman, Chris; Macfadyen, Andrew
2018-06-01
The national nursing shortage translates into a gap in home nursing care available to children with complex, chronic medical conditions and their family caregivers receiving palliative care consultations. A total of 38 home health nursing surveys were completed by families receiving pediatric palliative care consultation services at a freestanding children's hospital in the Midwest. The gap in the average number of nursing hours allotted versus received was 40 h/wk per family, primarily during evening hours. Parents missed an average of 23 hours of employment per week to provide hands-on nursing care at home, ranking stress regarding personal employment due to nursing shortage at 6.2/10. Families invested an average of 10 h/mo searching for additional nursing coverage and often resorted to utilizing more than 6 different home nurse coverage personnel per month. Families reported multiple delays to hospital discharges (mean, 15 days per delay) due to inability to find home nursing coverage. Respiratory technology and lack of Medicaid coverage ( P home nursing access. This study examines how the pediatric home nursing shortage translates into a lived experience for families with children with complex medical conditions receiving palliative care.
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Directory of Open Access Journals (Sweden)
Sheila Yu
2018-02-01
Full Text Available After proposing the “Deeming Rule” in 2014, the U.S. Food and Drug Administration (FDA began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles–area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations at two time points one year apart to better understand what vape shop retailers would do given FDA’s soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014 and Year 2 surveying 61 shops (2015–2016. Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2 were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule. Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc. over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.
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Stamuli, Eugena; Richardson, Gerry; Duffy, Steven; Robling, Michael; Hood, Kerry
2015-09-01
A systematic review of the economic evidence on home visitation programmes for young or vulnerable pregnant women was undertaken to provide a summary of the existing literature of these interventions. Relevant studies were identified from a number of sources including large databases, free text search on Google Scholar as well as hand-searching of the obtained references. The search yielded a large number of papers, of which 12 were considered appropriate to be included in the review. These were either full or partial economic evaluations: four studies were cost-benefit analyses, three were cost-effectiveness analyses and the remaining were costing studies. The review highlighted the paucity of good quality economic evaluations in the area of home visiting programmes for young or vulnerable pregnant women. Methods varied substantially between the studies spanning from differing data sources (e.g. single randomized trials or meta-analyses) to different perspectives taken, cost items and outcomes included in the analysis. It is difficult to establish a coherent body of economic evidence for these interventions and draw a firm conclusion on their value for money. Home visiting programmes are complex interventions, with impact on the lives of mothers and their children. The funding of such interventions should be based on rigorous effectiveness and economic evidence. There is a need for well-designed economic evaluations which will follow the appropriate methodological guidelines and also take into account the complexity of such interventions. These analyses should preferably consider multiple perspectives and allow for the fact that the majority of the benefits accrue in the long-term future. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Holden, Mark
2015-01-01
This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.
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24 CFR 982.612 - Group home: State approval of group home.
2010-04-01
... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Group home: State approval of group... Types Group Home § 982.612 Group home: State approval of group home. A group home must be licensed..., Retardation, or Social Services) as a group home for elderly persons or persons with disabilities. ...
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ThinkHome Energy Efficiency in Future Smart Homes
Christian Reinisch; Mario J. Kofler; Félix Iglesias; Wolfgang Kastner
2011-01-01
Abstract Smart homes have been viewed with increasing interest by both home owners and the research community in the past few years. One reason for this development is that the use of modern automation technology in the home or building promises considerable savings of energy, therefore, simultaneously reducing the operational costs of the building over its whole lifecycle. However, the full potential of smart homes still lies fallow, due to the complexity and diversity of the systems, badly ...
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A systematic review--physical activity in dementia: the influence of the nursing home environment.
Anderiesen, Hester; Scherder, Erik J A; Goossens, Richard H M; Sonneveld, Marieke H
2014-11-01
Most older persons with dementia living in nursing homes spend their days without engaging in much physical activity. This study therefore looked at the influence that the environment has on their level of physical activity, by reviewing empirical studies that measured the effects of environmental stimuli on the physical activity of nursing home residents suffering from dementia. The electronic databases PubMed, PsycINFO, EMBASE, CINAHL and the Cochrane Library were used for the search. The search covered studies published between January 1993 and December 2012, and revealed 3187 abstracts. 326 studies were selected as potentially relevant; of these, 24 met all the inclusion criteria. Positive results on the residents' levels of physical activity were found for music, a homelike environment and functional modifications. Predominantly positive results were also found for the small-scale group living concepts. Mixed results were found for bright or timed light, the multisensory environment and differences in the building footprint. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.
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Directory of Open Access Journals (Sweden)
María Sanz-Lorente
2017-04-01
Full Text Available Objective: To evaluate the documental quality of websites related to Home Care Services. Method: This is a descriptive cross-sectional study of websites based on Home Care Services, using searches on Google to access the study population. The “fallacy sample” of this search engine was take into account. The quality was studied thought the 8 variables of the Credibility Indicator (CI. Results: A total of 215 active websites, mainly belonging to the media, were evaluated. None of the websites met all 8 items in the CI. Mean of 2,12 ± 0,07; Minimum of 0 and Maximum of 5; Median equal to 3. Within the studied websites, 74 (34,42% presented both authorship and affiliation. There was an association between the CI accomplishment and websites that had these 2 variables (p <0.001. Conclusions: The quality of websites covering issues of Hospital-Based Home Care services is still poor. It is confirmed that identifying authorship and affiliation is an important factor in predicting the quality of the information. The Credibility Indicator is a useful aid when determining the quality of a website.
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Einstein@Home discovers a radio-quiet gamma-ray millisecond pulsar.
Clark, Colin J; Pletsch, Holger J; Wu, Jason; Guillemot, Lucas; Kerr, Matthew; Johnson, Tyrel J; Camilo, Fernando; Salvetti, David; Allen, Bruce; Anderson, David; Aulbert, Carsten; Beer, Christian; Bock, Oliver; Cuéllar, Andres; Eggenstein, Heinz-Bernd; Fehrmann, Henning; Kramer, Michael; Kwang, Shawn A; Machenschalk, Bernd; Nieder, Lars; Ackermann, Markus; Ajello, Marco; Baldini, Luca; Ballet, Jean; Barbiellini, Guido; Bastieri, Denis; Bellazzini, Ronaldo; Bissaldi, Elisabetta; Blandford, Roger D; Bloom, Elliott D; Bonino, Raffaella; Bottacini, Eugenio; Brandt, Terri J; Bregeon, Johan; Bruel, Philippe; Buehler, Rolf; Burnett, Toby H; Buson, Sara; Cameron, Rob A; Caputo, Regina; Caraveo, Patrizia A; Cavazzuti, Elisabetta; Cecchi, Claudia; Charles, Eric; Chekhtman, Alexandre; Ciprini, Stefano; Cominsky, Lynn R; Costantin, Denise; Cutini, Sara; D'Ammando, Filippo; De Luca, Andrea; Desiante, Rachele; Di Venere, Leonardo; Di Mauro, Mattia; Di Lalla, Niccolò; Digel, Seth W; Favuzzi, Cecilia; Ferrara, Elizabeth C; Franckowiak, Anna; Fukazawa, Yasushi; Funk, Stefan; Fusco, Piergiorgio; Gargano, Fabio; Gasparrini, Dario; Giglietto, Nico; Giordano, Francesco; Giroletti, Marcello; Gomez-Vargas, Germán A; Green, David; Grenier, Isabelle A; Guiriec, Sylvain; Harding, Alice K; Hewitt, John W; Horan, Deirdre; Jóhannesson, Guðlaugur; Kensei, Shiki; Kuss, Michael; La Mura, Giovanni; Larsson, Stefan; Latronico, Luca; Li, Jian; Longo, Francesco; Loparco, Francesco; Lovellette, Michael N; Lubrano, Pasquale; Magill, Jeffrey D; Maldera, Simone; Manfreda, Alberto; Mazziotta, Mario N; McEnery, Julie E; Michelson, Peter F; Mirabal, Nestor; Mitthumsiri, Warit; Mizuno, Tsunefumi; Monzani, Maria Elena; Morselli, Aldo; Moskalenko, Igor V; Nuss, Eric; Ohsugi, Takashi; Omodei, Nicola; Orienti, Monica; Orlando, Elena; Palatiello, Michele; Paliya, Vaidehi S; de Palma, Francesco; Paneque, David; Perkins, Jeremy S; Persic, Massimo; Pesce-Rollins, Melissa; Porter, Troy A; Principe, Giacomo; Rainò, Silvia; Rando, Riccardo; Ray, Paul S; Razzano, Massimiliano; Reimer, Anita; Reimer, Olaf; Romani, Roger W; Saz Parkinson, Pablo M; Sgrò, Carmelo; Siskind, Eric J; Smith, David A; Spada, Francesca; Spandre, Gloria; Spinelli, Paolo; Thayer, Jana B; Thompson, David J; Torres, Diego F; Troja, Eleonora; Vianello, Giacomo; Wood, Kent; Wood, Matthew
2018-02-01
Millisecond pulsars (MSPs) are old neutron stars that spin hundreds of times per second and appear to pulsate as their emission beams cross our line of sight. To date, radio pulsations have been detected from all rotation-powered MSPs. In an attempt to discover radio-quiet gamma-ray MSPs, we used the aggregated power from the computers of tens of thousands of volunteers participating in the Einstein@Home distributed computing project to search for pulsations from unidentified gamma-ray sources in Fermi Large Area Telescope data. This survey discovered two isolated MSPs, one of which is the only known rotation-powered MSP to remain undetected in radio observations. These gamma-ray MSPs were discovered in completely blind searches without prior constraints from other observations, raising hopes for detecting MSPs from a predicted Galactic bulge population.
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Parker, G; Spiers, G; Gridley, K; Atkin, K; Birks, Y; Lowson, K; Light, K
2013-01-01
Promoting 'care closer to home' for ill children is a policy and practice objective internationally. Progress towards this goal is hampered by a perceived lack of evidence on effectiveness and costs. The aim of the work reported here was to establish the strength of current international evidence on the effectiveness and costs of paediatric home care by updating and extending an earlier systematic review. A systematic review following Centre for Reviews and Dissemination guidelines involved updating electronic searches, and extending them to cover paediatric home care for short-term acute conditions. Twenty-one databases were searched from 1990 to April 2007. Hand searching was also carried out. Pairs of team members, guided by an algorithm, selected randomized controlled trials (RCTs), other comparative studies and studies including health economics data. A third reviewer resolved any disagreements. The quality of RCTs was assessed, but a 'best-evidence' approach was taken overall. Data were extracted into specifically designed spreadsheets and a second team member checked all data. Narrative synthesis was used throughout. This paper reports findings from RCTs and studies with health economics data. In total, 16 570 publications were identified after de-duplication. Eleven new RCTs (reported in 17 papers) and 20 papers with health economics data were included and reviewed. Evidence on costs and effectiveness of paediatric home care has not grown substantially since the previous review, but this updated review adds weight to the conclusion that it can deliver equivalent clinical outcomes for children and not impose a greater burden on families. Indeed, in some cases, there is evidence of reduced burden and costs for families compared with hospital care. There is also growing evidence, albeit based on weaker evidence, that paediatric home care may reduce costs for health services, particularly for children with complex and long-term needs. © 2012 Blackwell
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2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited...
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Abbott, B. P.; Abbott, R.; Abbott, T. D.; Abernathy, M. R.; Acemese, F.; Ackley, K.; Adams, C.; Phythian-Adams, A.T.; Addesso, P.; Adhikari, R. X.; Adya, V. B.; Affeldt, C.; Agathos, M.; Agatsuma, K.; Aggarwa, N.; Aguiar, O. D.; Aiello, L.; Ain, A.; Allen, B.; Allocca, A.; Altin, P. A.; Anderson, S. B.; Anderson, W. G.; Arai, K.; Araya, M. C.; Arceneaux, C. C.; Areeda, J. S.; Arnaud, N.; Arun, K. G.; Ascenzi, S.; Ashton, G.; Ast, M.; Aston, S. M.; Astone, P.; Aufmuth, P.; Aulbert, C.; Babak, S.; Bacon, P.; Bader, M. K. M.; Baker, P. T.; Baldaccini, F.; Ballardin, G.; Ballmer, S. W.; Barayoga, J. C.; Barclay, S. E.; Barish, B. C.; Arker, Bd.; Barone, F.; Barr, B.; Barsotti, L.; Barsuglia, M.; Barta, D.; Bartlett, J.; Bartos, I.; Bassiri, R.; Basti, A.; Batch, J. C.; Baune, C.; Bavigadda, V.; Bazzan, M.; Bejger, M.; Be, A. S.; Berger, B. K.; Bergmann, G.; Berry, C. P. L.; Bersanetti, D.; Bertolini, A.; Betzwieser, J.; Bhagwat, S.; Bhandare, R.; Bilenko, I. A.; Billingsley, G.; Birch, M.J.; Birney, R.; Biscans, S.; Bisht, A.; Bitoss, M.; Biwer, C.; Bizouard, M. A.; Blackburn, J. K.; Blair, C. D.; Blair, D. G.; Blair, R. M.; Bloemen, S.; Bock, O.; Boer, M.; Bogaert, J.G.; Bogan, C.; Bohe, A.; Bond, C.; Bondu, F.; Bonnand, R.; Boom, B. A.; Bork, R.; Boschi, V.; Bose, S.; Boutfanais, Y.; Bozzi, A.; Bradaschia, C.; Brady, P. R.; Braginsky, V. B.; Branchesi, M.; Brau, J. E.; Briant, T.; Brillet, A.; Brinkmann, M.; Brisson, V.; Brockill, P.; Broida, J. E.; Brooks, A. F.; Brown, A.D.; Brown, D.; Brown, N. M.; Brunett, S.; Buchanan, C. C.; Buikema, A.; Bulik, O.; Bulten, H. J.; Buonanno, A.; Buskulic, D.; Buy, C.; Byer, R. L.; Cabero, M.; Cadonati, L.; Cagnoli, C.; Cahillane, C.; Bustillo, J. Calderon; Callister, T. A.; Calloni, E.; Camp, J. B.; Cannon, K. C.; Cao, J.; Capano, C. D.; Capocasa, E.; Carbognani, F.; Caride, S.; Diaz, J. Casanueva; Casentini, C.; Caudill, S.; Cavaglia, M.; Cavalier, F.; Cavalieri, R.; Cella, G.; Cepeda, C. B.; Baiardi, L. Cerboni; Cerretani, G.; Cesarini, E.; Chamberlin, S. J.; Chan, M.; Chao, D. S.; Charlton, P.; Chassande-Mottin, E.; Cheeseboro, B. D.; Chen, H. Y.; Chen, Y; Cheng, C.; Chincarini, A.; Chiummo, A.; Cho, H. S.; Cho, M.; Chow, J. H.; Christensen, N.; Chu, Q.; Chua, S. S. Y.; Chung, S.; Ciani, G.; Clara, F.; Clark, J. A.; Cleva, F.; Coccia, E.; Cohadon, P. -F.; Colla, A.; Collette, C. G.; Cominsky, L.; Constancio, M., Jr.; Conte, A.; Conti, L.; Cook, D.; Corbitt, T. R.; Cornish, N.; Corsi, A.; Cortese, S.; Costa, C. A.; Coughlin, M. W.; Coughlin, S. B.; Coulon, J. -P.; Countryman, S. T.; Couvares, P.; Cowan, E. E.; Coward, D. M.; Cowart, M. J.; Coyne, D. C.; Coyne, R.; Craig, K.; Creighton, J. D. E.; Creighton, T. D.; Cripe, J.; Crowder, S. G.; Cumming, A.; Cunningham, Laura; Cuoco, E.; Dal Canton, T.; Danilishin, S. L.; D'Antonio, S.; Danzmann, K.; Darman, N. S.; Dasgupta, A.; Costa, C. F. Da Silva; Dattilo, V.; Dave, I.; Davier, M.; Davies, G. S.; Daw, E. J.; Day, R.; De, S.; DeBra, D.; Debreczeni, G.; Degallaix, J.; De laurentis, M.; Deleglise, S.; Del Pozzo, W.; Denker, T.; Dent, T.; Dergachev, V.A.; De Rosa, R.; DeRosa, R. T.; DeSalvo, R.; Devine, R. C.; Dhurandhar, S.; Diaz, M. C.; Di Fiore, L.; Giovanni, M. Di; Di Girolamo, T.; Di Lieto, A.; Di Pace, S.; Di Palma, I.; Di Virgilio, A.; Dolique, V.; Donovan, F.; Dooley, K. L.; Doravari, S.; Douglas, R.; Downes, T. P.; Drago, M.; Dreyer, R. W. P.; Driggers, J. C.; Ducrot, M.; Dwyer, S. E.; Edo, T. B.; Edwards, M. C.; Effler, A.; Egizenstein, H. -B.; Ehrens, P.; Eichholel, J.; Eikenberry, S. S.; Engels, W.; Essick, R. C.; Etzel, T.; Evans, M.; Evans, T. M.; Everett, R.; Factourovich, M.; Fafone, O.; Fair, H.; Fairhurst, S.; Fan, X.; Fang, Q.; Farinon, S.; Farr, B.; Far, W. M.; Favata, M.; Fays, M.; Fehrmann, H.; Fejer, M. M.; Fenyvesi, E.; Ferrante, I.; Ferreira, E. C.; Ferrini, F.; Fidecaro, F.; Fiori, I.; Fiorucci, D.; Fisher, R. P.; Flaminio, R.; Fletcher, M.M.; Fournier, J. -D.; Frasca, J. -D; Frasconi, F.; Frei, Z.; Freise, A.; Frey, R.; Frey, V.; Fritsche, P.; Frolov, V. V.; Fulda, P.; Fyffe, M.; Gabbard, H. A. G.; Gair, J. R.; Gammaitoni, L.; Gaonkar, S. G.; Garuti, F.; Gaur, G.; Gehrels, N.; Gemme, G.; Geng, P.; Genin, E.; Gennai, A.; George, J.; Gergely, L.; Germain, V.; Ghosh, Abhirup; Ghosh, Archisman; Ghosh, S.; Giaime, J. A.; Giardina, K. D.; Giazotto, A.; Gi, K.; Glaetke, A.; Goetz, E.; Goetz, R.; Gondan, L.; Gonzalez, Idelmis G.; Castro, J. M. Gonzalez; Gopakumar, A.; Gordon, N. A.; Gorodetsky, M. L.; Gossan, S. E.; Lee-Gosselin, M.; Gouaty, R.; Grado, A.; Graef, C.; Graff, P. B.; Granata, M.; Granta, A.; Gras, S.; Cray, C.; Greco, G.; Green, A. C.; Groot, P.; Grote, H.; Grunewald, S.; Guidi, G. M.; Guo, X.; Gupta, A.; Gupta, M. K.; Gushwa, K. E.; Gustafson, E. K.; Gustafson, R.; Hacker, J. J.; Hall, B. R.; Hall, E. D.; Hammond, G.; Haney, M.; Hanke, M. M.; Hanks, J.; Hanna, C.; Hanson, J.; Hardwick, T.; Harms, J.; Harry, G. M.; Harry, I. W.; Hart, M. J.; Hartman, M. T.; Haster, C. -J.; Haughian, K.; Heidmann, A.; Heintze, M. C.; Heitmann, H.; Hello, P.; Hemming, G.; Hendry, M.; Heng, S.; Hennig, J.; Henry, J.A.; Heptonsta, A. W.; Heurs, M.; Hild, S.; Hoak, D.; Hofman, D.; Holt, K.; Holz, D. E.; Hopkins, P.; Hough, J.; Houston, E. A.; Howel, E. J.; Hu, Y. M.; Huang, O.; Huerta, E. A.; Huet, D.; Hughey, B.; Husa, S.; Huttner, S. H.; Huynh-Dinh, T.; Indik, N.; Ingram, D. R.; Inta, R.; Isa, H. N.; Isac, J. -M.; Isi, M.; Isogai, T.; Lyer, B. R.; Fzumi, K.; Jaccimin, T.; Jang, D.H.; Jani, K.; Jaranowski, P.; Jawahar, S.; Jian, L.; Jimenez-Forteza, F.; Johnson, W.; Jones, I.D.; Jones, R.; Jones, R.; Jonker, R. J. G.; Ju, L.; Wads, k; Kalaghatgi, C. V.; Kalogera, V.; Kandhasamy, S.; Kang, G.; Kanner, J. B.; Kapadia, S. J.; Karki, S.; Karvinen, K. S.; Kasprzack, M.; Katsavounidis, E.; Katzman, W.; Kaufer, S.; Kaur, T.; Kawabe, K.; Kefelian, F.; Keh, M. S.; Keite, D.; Kelley, D. B.; Kells, W.; Kennedy, R.E.; Key, J. S.; Khalili, F. Y.; Khan, I.; Khan, S.; Khan, Z.; Khazanov, E. A.; Kijbunchoo, N.; Kim, Chi-Woong; Kim, Chunglee; Kim, J.; Kim, K.; Kim, Namjun; Kim, W.; Kimbre, S. J.; King, E. J.; King, P. J.; Kisse, J. S.; Klein, B.; Kleybolte, L.; Klimenko, S.; Koehlenbeck, S. M.; Koley, S.; Kondrashov, V.; Kontos, A.; Korobko, M.; Korth, W. Z.; Kowalska, I.; Kozak, D. B.; Kringe, V.; Krishnan, B.; Krolak, A.; Krueger, C.; Kuehn, G.; Kumar, P.; Kumar, R.; Kuo, L.; Kutynia, A.; Lackey, B. D.; Landry, M.; Lange, J.; Lantz, B.; Lasky, P. D.; Laxen, M.; Lazzaro, C.; Leaci, P.; Leavey, S.; Lebigot, E. O.; Lee, C. H.; Lee, K.H.; Lee, M.H.; Lee, K.; Lenon, A.; Leonardi, M.; Leong, J. R.; Leroy, N.; Letendre, N.; Levin, Y.; Lewis, J. B.; Li, T. G. F.; Libson, A.; Littenberg, T. B.; Lockerbie, N. A.; Lombardi, A. L.; London, L. T.; Lord, J. E.; Lorenzini, M.; Loriette, V.; Lormand, M.; Losurdo, G.; Lough, J. D.; Liick, H.; Lundgren, A. P.; Lynch, R.; Ivia, Y.; Machenschalk, B.; Maclnnis, M.; Macleod, D. M.; Magafia-Sandoval, F.; Zertuche, L. Magafia; Magee, R. M.; Majorana, E.; Maksimovic, I.; Malvezzi, V.; Man, N.; Mandic, V.; Mangano, V.; Manse, G. L.; Manske, M.; Mantovani, M.; Marchesoni, F.; Marion, F.; Marka, S.; Marka, Z.; Markosyan, A. S.; Maros, E.; Martelli, F.; Martellini, L.; Martin, I. W.; Martynov, D. V.; Marx, J. N.; Mason, K.; Masserot, A.; Massinger, T. J.; Masso-Reid, M.; Mastrogiovanni, S.; Matiehard, F.; Matone, L.; Mavalvala, N.; Mazumder, N.; McCarthy, R.; McClelland, D. E.; McCormick, S.; McGuire, S. C.; McIntyre, G.; McIver, J.; McManus, D. J.; McRae, T.; McWilliams, S. T.; Meacher, D.; Meadors, G. D.; Meidam, J.; Melatos, A.; Mende, G.; Mercer, R. A.; Merilh, E. L.; Merzougui, M.; Meshkov, S.; Messenger, C.; Messick, C.; Metzdorff, R.; Meyers, P. M.; Mezzani, F.; Miao, H.; Miche, C.; Middleton, H.; Mikhailov, E. E.; Milano, L.; Miller, A. L.; Miller, A.; Miller, B. B.; Miller, J.; Millhouse, M.; Minenkov, Y.; Ming, J.; Mirshekari, S.; Mishra, C.; Mitra, S.; Mitrofanov, V. P.; Mitselmakher, G.; Mittleman, R.; Moggi, A.; Mohan, M.; Mohapatra, S. R. P.; Montani, M.; Moore, B.C.; Moore, C. J.; Moraru, D.; Moreno, G.; Morriss, S. R.; Mossavi, K.; Mours, B.; Mow-Lowry, C. M.; Mueller, G.; Muir, A. W.; Mukherjee, Arunava; Mukherjee, S.D.; Mukherjee, S.; Mukund, N.; Mullavey, A.; Munch, J.; Murphy, D. J.; Murray, P.G.; Mytidis, A.; Nardecehia, I.; Naticchioni, L.; Nayak, R. K.; Nedkova, K.; Nelemans, G.; Nelson, T. J. N.; Gutierrez-Neri, M.; Neunzert, A.; Newton, G.; Nguyen, T. T.; Nielsen, A. B.; Nissanke, S.; Nitz, A.; Nocera, F.; Nolting, D.; Normandin, M. E. N.; Nuttall, L. K.; Oberling, J.; Ochsner, E.; O'Dell, J.; Oelker, E.; Ogin, G. H.; Oh, J. J.; Hang, S.; Ohme, F.; Oliver, M.; Oppermann, P.; Ram, Richard J.; O'Reilly, B.; O'Shaughnessy, R.; Ottaway, D. J.; Overmier, H.; Owen, B. J.; Pai, A.; Pai, S. A.; Palamos, J. R.; Palashov, O.; Palomba, C.; Pal-Singh, A.; Pan, H.; Pankow, C.; Pannarale, F.; Pant, B. C.; Paoletti, F.; Paoli, A.; Papa, M. A.; Paris, H. R.; Parker, W.S; Pascucci, D.; Pasqualetti, A.; Passaquieti, R.; Passuello, D.; Patricelli, B.; Patrick, Z.; Pearlstone, B. L.; Pedraza, M.; Pedurand, R.; Pekowsky, L.; Pele, A.; Penn, S.; Perreca, A.; Perri, L. M.; Phelps, M.; Piccinni, . J.; Pichot, M.; Piergiovanni, F.; Pierro, V.; Pillant, G.; Pinard, L.; Pinto, I. M.; Pitkin, M.; Poe, M.; Poggiani, R.; Popolizio, P.; Post, A.; Powel, J.; Prasad, J.; Predoi, V.; Prestegard, T.; Price, L. R.; Prijatelj, M.; Principe, M.; Privitera, S.; Prix, R.; Prodi, G. A.; Prokhorov, L. G.; Puncken, .; Punturo, M.; Purrer, PuppoM.; Qi, H.; Qin, J.; Qiu, S.; Quetschke, V.; Quintero, E. A.; Quitzow-James, R.; Raab, F. J.; Rabeling, D. S.; Radkins, H.; Raffai, P.; Raja, S.; Rajan, C.; Rakhmanov, M.; Rapagnani, P.; Raymond, V.; Razzano, M.; Re, V.; Read, J.; Reed, C. M.; Regimbau, T.; Rei, L.; Reid, S.; Reitze, D. H.; Rew, H.; Reyes, S. D.; Ricci, F.; Riles, K.; Rizzo, M.; Robertson, N. A.; Robie, R.; Robinet, F.; Rocchi, A.; Rolland, L.; Rollins, J. G.; Roma, V. J.; Romano, R.; Romanov, G.; Romie, J. H.; Rowan, RosiliskaS.; Ruggi, RiidigerP.; Ryan, K.; Sachdev, Perminder S; Sadecki, T.; Sadeghian, L.; Sakellariadou, M.; Salconi, L.; Saleem, M.; Salemi, F.; Samajdar, A.; Sammut, L.; Sanchez, E. J.; Sandberg, V.; Sandeen, B.; Sanders, J. R.; Sassolas, B.; Saulson, P. R.; Sauter, E. S.; Savage, R. L.; Sawadsky, A.; Schale, P.; Schilling, R.; Schmidt, J; Schmidt, P.; Schnabe, R.; Schofield, R. M. S.; Schonbeck, A.; Schreiber, K.E.C.; Schuette, D.; Schutz, B. F.; Scott, J.; Scott, S. M.; Sellers, D.; Sengupta, A. S.; Sentenac, D.; Sequino, V.; Sergeev, A.; Setyawati, Y.; Shaddock, D. A.; Shaffer, T. J.; Shahriar, M. S.; Shaltev, M.; Shapiro, B.; Shawhan, P.; Sheperd, A.; Shoemaker, D. H.; Shoemaker, D. M.; Sielleez, K.; Siemens, X.; Sieniawska, M.; Sigg, D.; Silva, António Dias da; Singer, A.; Singer, L. P.; Singh, A.; Singh, R.; Singhal, A.; Sintes, A. M.; Slagmolen, B. J. J.; Smith, R. J. E.; Smith, N.D.; Smith, R. J. E.; Son, E. J.; Sorazus, B.; Sorrentino, F.; Souradeep, T.; Srivastava, A. K.; Staley, A.; Steinke, M.; Steinlechner, J.; Steinlechner, S.; Steinmeyer, D.; Stephens, B. C.; Stone, R.; Strain, K. A.; Straniero, N.; Stratta, G.; Strauss, N. A.; Strigin, S. E.; Sturani, R.; Stuver, A. L.; Summerscales, T. Z.; Sunil, Suns; Sutton, P. J.; Swinkels, B. L.; Szczepariczyk, M. J.; Tacca, M.; Talukder, D.; Tanner, D. B.; Tapai, M.; Tarabrin, S. P.; Taracchini, A.; Taylor, W.R.; Theeg, T.; Thirugnanasambandam, M. P.; Thomas, E. G.; Thomas, M.; Thomas, P.; Thorne, K. A.; Thrane, E.; Tiwari, S.; Tiwari, V.; Tokmakov, K. V.; Toland, K.; Tomlinson, C.; Tonelli, M.; Tomasi, Z.; Torres, C. V.; Tome, C.; Tot, D.; Travasso, F.; Traylor, G.; Trifire, D.; Tringali, M. C.; Trozz, L.; Tse, M.; Turconi, M.; Tuyenbayev, D.; Ugolini, D.; Unnikrishnan, C. S.; Urban, A. L.; Usman, S. A.; Vahlbruch, H.; Valente, G.; Valdes, G.; van Bake, N.; Van Beuzekom, Martin; Van den Brand, J. F. J.; Van Den Broeck, C.F.F.; Vander-Hyde, D. C.; van der Schaaf, L.; Van Heilningen, J. V.; Van Vegge, A. A.; Vardaro, M.; Vass, S.; Vaslith, M.; Vaulin, R.; Vecchio, A.; Vedovato, G.; Veitch, J.; Veitch, P.J.; Venkateswara, K.; Verkindt, D.; Vetrano, F.; Vicere, A.; Vinciguerra, S.; Vine, D. J.; Vinet, J. -Y.; Vitale, S.; Vo, T.; Vocca, H.; Vorvick, C.; Voss, D. V.; Vousden, W. D.; Vyatchanin, S. P.; Wade, A. R.; Wade, L. E.; Wade, MT; Walker, M.; Wallace, L.; Walsh, S.; Vvang, G.; Wang, O.; Wang, X.; Wiang, Y.; Ward, R. L.; Wiarner, J.; Was, M.; Weaver, B.; Wei, L. -W.; Weinert, M.; Weinstein, A. J.; Weiss, R.; Wen, L.; Weliels, P.; Westphal, T.; Wette, K.; Whelan, J. T.; Whiting, B. F.; Williams, D.R.; Williamson, A. R.; Willis, J. L.; WilIke, B.; Wimmer, M. H.; Whinkler, W.; Wipf, C. C.; De Witte, H.; Woan, G.; Woehler, J.; Worden, J.; Wright, J.L.; Wu, D. S.; Wu, G.; Yablon, J.; Yam, W.; Yamamoto, H.; Yancey, C. C.; Yu, H.; Yvert, M.; Zadrozny, A.; Zangrando, L.; Zanolin, M.; Zendri, J. P.; Zevin, M.; Zhang, L.; Zhang, M.; Zhang, Y.; Zhao, C.; Zhou, M.; Zhou, Z.; Zhu, S.J.; Zhu, X.; Zucker, M. E.; Zuraw, S. E.; Zweizig, J.
2016-01-01
We report results of a deep all-sky search for periodic gravitational waves from isolated neutron stars in data from the S6 LIGO science run. The search was possible thanks to the computing power provided by the volunteers of the Einstein@Home distributed computing project. We find no significant
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... Home › Aging & Health A to Z › Nursing Homes Font size A A A Print Share Glossary Basic ... Reason For Living in A Nursing Home Some type of disability with activities of daily living (ADLs) ...
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Taherh Hadian; Mojgan Mirghafourvand; Sakineh Mohammad-Alizadeh Charandabi; Solmaz Ghanbari; Jila Nahaeii; Shahla Meedya
2018-01-01
Background: Adolescence pregnancy is high risk both for mother and child. This systematic review aimed to determine the effect of home visiting on maternal and neonatal outcomes in adolescent mothers.Materials and Methods: This systematic review was performed by searching English databases including Cochran library, PubMed, Google scholar, Scopus, web of science, Embase, Ovid and Persian databases including SID, Magiran, and Barakat Knowledge Network System without time limitation. The search...
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Wang, Kejian; Wan, Mei; Wang, Rui-Sheng; Weng, Zuquan
2016-04-01
Drug repositioning refers to the process of developing new indications for existing drugs. As a phenotypic indicator of drug response in humans, clinical side effects may provide straightforward signals and unique opportunities for drug repositioning. We aimed to identify drugs frequently associated with hypotension adverse reactions (ie, the opposite condition of hypertension), which could be potential candidates as antihypertensive agents. We systematically searched the electronic records of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) through the openFDA platform to assess the association between hypotension incidence and antihypertensive therapeutic effect regarding a list of 683 drugs. Statistical analysis of FAERS data demonstrated that those drugs frequently co-occurring with hypotension events were more likely to have antihypertensive activity. Ranked by the statistical significance of frequent hypotension reporting, the well-known antihypertensive drugs were effectively distinguished from others (with an area under the receiver operating characteristic curve > 0.80 and a normalized discounted cumulative gain of 0.77). In addition, we found a series of antihypertensive agents (particularly drugs originally developed for treating nervous system diseases) among the drugs with top significant reporting, suggesting the good potential of Web-based and data-driven drug repositioning. We found several candidate agents among the hypotension-related drugs on our list that may be redirected for lowering blood pressure. More important, we showed that a pharmacovigilance system could alternatively be used to identify antihypertensive agents and sustainably create opportunities for drug repositioning.
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... are part of home healthcare agencies. You may benefit from home care if you are dealing with ... it will trigger an emergency response or checkup phone call. Newer technologies ... or mobile testing technology (home diagnostics), including x-rays and ...
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Jusoh, Norwahyu; Fong Yeong, Yin; Keong Lau, Kok; Shariff, Azmi Mohd
2017-08-01
In the present work, zeolite T and aminosilane grafted zeolite T are embedded into 6FDA-durene polyimide phase for the fabrication of mixed matrix membranes (MMMs). FESEM images demonstrated that the improvement of interfacial adhesion between zeolite and polymer phases in MMM loaded with aminosilane grafted zeolite T was not significant as compared to zeolite T/6FDA-durene MMM. From the gas permeation test, CO2/CH4 selectivity up to 26.4 was achieved using MMM containing aminosilane grafted zeolite T, while MMM loaded with ungrafted zeolite T showed CO2/CH4 selectivity of 19.1. In addition, MMM incorporated with aminosilane grafted zeolite T particles successfully lies on Robeson upper bound 2008, which makes it an attractive candidate for CO2/CH4 separation.
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Anwer, Shahnawaz; Alghadir, Ahmad; Brismée, Jean-Michel
2016-01-01
The Osteoarthritis Research Society International recommended that nonpharmacological methods include patient education programs, weight reduction, coping strategies, and exercise programs for the management of knee osteoarthritis (OA). However, neither a systematic review nor a meta-analysis has been published regarding the effectiveness of home exercise programs for the management of knee OA. The purpose of this systematic review was to examine the evidence regarding the effect of home exercise programs with and without supervised clinic-based exercises in the management of knee OA. We searched PubMed, CINAHL, Embase, Scopus, and PEDro for research articles published prior to September 2014 using key words such as pain, exercise, home exercise program, rehabilitation, supervised exercise program, and physiotherapy in combination with Medical Subject Headings "Osteoarthritis knee." We selected randomized and case-controlled trials published in English language. To verify the quality of the selected studies, we applied the PEDro Scale. Two evaluators individually selected the studies based on titles, excluding those articles that were not related to the objectives of this review. One evaluator extracted data from the included studies. A second evaluator independently verified extracted data for accuracy. A total of 31 studies were found in the search. Of these, 19 studies met the inclusion criteria and were further analyzed. Seventeen of these 19 studies reached high methodological quality on the PEDro scale. Although the methods and home exercise program interventions varied widely in these studies, most found significant improvements in pain and function in individuals with knee OA. The analysis indicated that both home exercise programs with and without supervised clinic-based exercises were beneficial in the management of knee OA. The large evidence of high-quality trials supports the effectiveness of home exercise programs with and without supervised clinic
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Aspden, Trefor; Bradshaw, Siobhan A; Playford, E Diane; Riazi, Afsane
2014-09-01
the aims of this review were (i) to identify quality-of-life (QoL) measures which have had their measurement properties validated in people residing in care homes or nursing homes, and to critically compare and summarise these instruments and (ii) to make recommendations for measurement instruments. bibliographic databases PsycINFO, PubMed, Cochrane, CINAHL and Embase were searched for articles evaluating measurement properties of QoL instruments in people residing in care homes. Methodological quality of studies was assessed using the consensus-based standards for the selection of health measurement instruments checklist. Measurement properties of instruments were appraised using a systematic checklist. the search strategy resulted in 3252 unique citations, of which 15 articles were included in this review. These articles assessed 13 instruments, 8 of which were dementia or Alzheimer specific instruments. The QUALIDEM, a dementia-specific observational instrument, had the widest array of information available on its measurement properties, which were mostly satisfactory. Most measurement instruments lacked information on hypotheses testing and content validity. Information on responsiveness and measurement error was not available for any instrument. for people with dementia living in care homes, the QUALIDEM is recommended for measuring QoL. For residents without dementia, we recommend Kane et al.'s Psychosocial Quality of Life Domains questionnaire. Studies of higher methodological quality, assessing a wider range of measurement properties are needed to allow a more fully informed choice of QoL instrument. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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Driver, Vickie R; Gould, Lisa J; Dotson, Peggy; Gibbons, Gary W; Li, William W; Ennis, William J; Kirsner, Robert S; Eaglstein, William H; Bolton, Laura L; Carter, Marissa J
2017-05-01
Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory
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Tree Alignment Based on Needleman-Wunsch Algorithm for Sensor Selection in Smart Homes.
Chua, Sook-Ling; Foo, Lee Kien
2017-08-18
Activity recognition in smart homes aims to infer the particular activities of the inhabitant, the aim being to monitor their activities and identify any abnormalities, especially for those living alone. In order for a smart home to support its inhabitant, the recognition system needs to learn from observations acquired through sensors. One question that often arises is which sensors are useful and how many sensors are required to accurately recognise the inhabitant's activities? Many wrapper methods have been proposed and remain one of the popular evaluators for sensor selection due to its superior accuracy performance. However, they are prohibitively slow during the evaluation process and may run into the risk of overfitting due to the extent of the search. Motivated by this characteristic, this paper attempts to reduce the cost of the evaluation process and overfitting through tree alignment. The performance of our method is evaluated on two public datasets obtained in two distinct smart home environments.
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Dikkers, J.S.E.; Geurts, S.A.E.; Dulk, L. den; Peper, A.B.; Kompier, M.A.J.
2004-01-01
In the present study, we examined the associations among work-home culture (WHC), the utilization of work-home arrangements (WHAs), and work-home interference (WHI) among 638 workers from a Dutch financial consultancy firm. We (a) developed a typology of WHC, (b) examined whether the utilization of
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Associations Between Home Death and the Use and Type of Care at Home.
McEwen, Rebecca; Asada, Yukiko; Burge, Frederick; Lawson, Beverley
2018-01-01
Despite wishes for and benefits of home deaths, a discrepancy between preferred and actual location of death persists. Provision of home care may be an effective policy response to support home deaths. Using the population-based mortality follow-back study conducted in Nova Scotia, we investigated the associations between home death and formal care at home and between home death and the type of formal care at home. We found (1) the use of formal care at home at the end of life was associated with home death and (2) the use of formal home support services at home was associated with home death among those whose symptoms were well managed.
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Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays
Directory of Open Access Journals (Sweden)
Majid Moshirfar
2017-09-01
Full Text Available AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA, adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE, and achieved monocular uncorrected near visual acuity (UNVA at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40 or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20 or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.
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Directory of Open Access Journals (Sweden)
Fix Brian V
2011-12-01
Full Text Available Abstract Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA. The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.
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Intimacy between care home residents with dementia: Findings from a review of the literature.
Wiskerke, Esther; Manthorpe, Jill
2016-07-13
There is limited research on what family members and frontline care home staff consider to be the best responses to the sexual expression of a person with dementia, whilst at the same time respecting relatives' feelings, managing their possible distress and conflict, and how good practice should be reflected in care home policy and practice guidance. This literature review explored what is known of the views of relatives and care workers of new relationships or sexual intimacy between care home residents with dementia, whilst still married to another person. It reports the findings of searches of three databases undertaken in August 2014 (Medline, Embase and PsychINFO). Nine papers were found relevant to the research question. The following themes emerged from a synthesis of the papers located: sexuality in old age, dementia and sexuality, hyper-sexuality, views regarding sexuality of older people living in care homes, the law, ethics and consent, relationships and communication between care home and relatives, and new relationships or intimacy between residents with dementia. While studies of residents' expression of sexuality and their engaging in sexual behaviour with other resident(s) may be challenging to manage in care home settings and can be emotionally painful or uncomfortable for families, the review found that studies are few in number and span emotional intimacy and distressing behaviour. © The Author(s) 2016.
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Military Commission Seal VWAP Login Home Go ABOUT US Organization Overview Organizational Chart Families VWAP Login CCTV Sites Travel Media MC News CCTV Sites Travel Today at OMC Home Today at OMC Daily
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DEFF Research Database (Denmark)
Agar, John W; Perkins, Anthony; Heaf, James G
2015-01-01
We describe the infrastructure that is necessary for hemodialysis in the home focusing on physical requirements, the organization of plumbing and water, and the key features that should guide the selection of machines that are suitable for home use.......We describe the infrastructure that is necessary for hemodialysis in the home focusing on physical requirements, the organization of plumbing and water, and the key features that should guide the selection of machines that are suitable for home use....
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DEFF Research Database (Denmark)
Madsen, Per Printz
2009-01-01
In the last couple of year's computer based home control systems are getting more and more common in modern homes. For instance these systems take care of light control, heat control and security systems. The latest trend is to use wireless communication like Z-Wave and ZigBee to interconnect...... different components in these systems. One of the characteristics is that each system, like for instance heat and light, has their own specific way of using the communication system. This paper describes a way to connect different home control systems through an intelligent gateway, called a Home......Port. The HomePort consists of a number of Subsystem communication drivers, a virtual communication layer, an interpreter and a PC- based compiler for a high level control language, called GIL (Gateway intelligence language). The focus in this paper will be on the upper two layers in the Home...
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DOE Zero Energy Ready Home Case Study: Thrive Home Builders, Lowry Plan
Energy Technology Data Exchange (ETDEWEB)
Pacific Northwest National Laboratory
2017-09-01
Thrive Home Builders built this 4,119-ft2 home at the Lowry development in Denver, Colorado, to the high-performance criteria of the U.S. Department of Energy’s Zero Energy Ready Home Program. Despite the dense positioning of the homes, mono-plane roof designs afforded plenty of space for the 8.68 kW of photovoltaic panels. With the PV, the home achieves a Home Energy Rating System (HERS) score of 4 and the home owners should enjoy energy bills of about $-11 a year. Without the PV, the home would score a HERS 38 (far lower than the HERS 80 to 100 of typical new homes).
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Multidisciplinary nutritional support for undernutrition in nursing home and home-care
DEFF Research Database (Denmark)
Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe
2016-01-01
Objective To assess the effect of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care identified with the validated Eating Validation Scheme (EVS). Methods An 11 wk cluster randomized trial with a home-care (3 clusters) or nursing home (3 clusters.......3] versus 1.3 [0.5], P = 0.021) was observed. There was a almost significant difference in mortality (2% versus 13%, P = 0.079). Conclusions Multidisciplinary nutritional support in older adults in nursing home and home-care could have a positive effect on quality of life, muscle strength, and oral care....... means of EuroQol-5D-3L), physical performance (30-seconds chair stand), nutritional status (weight and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (participants from home-care), and mortality. Results Respectively, 55 (46 from 2 home...
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Directory of Open Access Journals (Sweden)
Francesca Renee Dillman Carpentier
2016-04-01
Full Text Available This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media.
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Home Rx: The Health Benefits of Home Performance
Energy Technology Data Exchange (ETDEWEB)
Wilson, Jonathan [National Center for Healthy Housing (NCHH), Columbia, MD (United States); Jacobs, David [National Center for Healthy Housing (NCHH), Columbia, MD (United States); Reddy, Amanda [National Center for Healthy Housing (NCHH), Columbia, MD (United States); Tohn, Ellen [Tohn Environmental Strategies, Wayland, MA (United States); Cohen, Jonathan [Dept. of Energy (DOE), Washington DC (United States); Jacobsohn, Ely [Dept. of Energy (DOE), Washington DC (United States)
2016-12-01
Evidence in a new, groundbreaking U.S. Department of Energy report, Home Rx: The Health Benefits of Home Performance, shows that home performance upgrades can improve the quality of a home’s indoor environment by reducing the prevalence of harmful indoor air pollutants and contaminants. Until recently, no systematic review of this evidence had been conducted, limiting full understanding of the link between home performance and health. This new report summarizes current knowledge and identifies research gaps. The design characteristics and results of each of the 40 studies considered in the report are summarized in a searchable matrix.
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FDA-Approved Natural Polymers for Fast Dissolving Tablets
Directory of Open Access Journals (Sweden)
Md Tausif Alam
2014-01-01
Full Text Available Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing, in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.
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Müller, Christian; Lautenschläger, Sindy; Meyer, Gabriele; Stephan, Astrid
2017-06-01
During the transition of people with dementia from home to nursing home family caregivers often feel burdened. We aimed to 1) identify interventions which support people with dementia and their caregivers in the transition from home care to nursing home care, 2) synthesize the evidence for efficacy of these interventions, and 3) examine whether the identified interventions have been systematically developed, evaluated and implemented according to the Medical Research Council guidance on complex interventions. A systematic review of randomised controlled trials was conducted according to the recommendations specified in the Cochrane Handbook for Intervention Reviews. The review protocol was registered in PROSPERO (2015: CRD42015019839). Reporting follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. MEDLINE, CENTRAL, PsycINFO, CINAHL, OTseeker, and PEDro, were searched. Other sources included Google Scholar, and ALOIS. Two reviewers independently assessed the eligibility of the articles. Data extraction was performed by one reviewer and verified independently by another. The Cochrane Risk of Bias tool was used for critical appraisal. Development and evaluation of the identified interventions were assessed, taking the Medical Research Council guidance into account. Review findings were synthesized narratively. The search yielded 1278 records. Five studies were included, all conducted in the United States (4 RCTs and 1 cRCT with a total of 695 participants). The psychosocial interventions were individual and family counseling via telephone or ad hoc all of which addressed only informal caregivers. The intervention components, content and mode of delivery differed widely with inconsistent results. Significant intervention effects were found for the reduction of caregivers' depressive symptoms, burden, feeling of guilt, emotional distress, overload, and interactions with staff. Other outcomes, i.e. stress, placement
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ThinkHome Energy Efficiency in Future Smart Homes
Directory of Open Access Journals (Sweden)
Reinisch Christian
2011-01-01
Full Text Available Abstract Smart homes have been viewed with increasing interest by both home owners and the research community in the past few years. One reason for this development is that the use of modern automation technology in the home or building promises considerable savings of energy, therefore, simultaneously reducing the operational costs of the building over its whole lifecycle. However, the full potential of smart homes still lies fallow, due to the complexity and diversity of the systems, badly engineered and configured installations, as well as the frequent problem of suboptimal control strategies. Summarized, these problems converge to two undesirable conditions in the "not-so-smart" home: energy consumption is still higher than actually necessary and users are unable to yield full comfort in their automated homes. This work puts its focus on alleviating the current problems by proposing a comprehensive system concept, that shall ensure that smart homes can keep their promise in the future. The system operates on an extensive knowledge base that stores all information needed to fulfill the goals of energy efficiency and user comfort. Its intelligence is implemented as and within a multiagent system that also caters for the system's openness to the outside world. As a first evaluation, a profile-based control strategy for thermal comfort is developed and verified by means of simulation.
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The Stardust Interstellar Dust Collector and Stardust@home
Westphal, A. J.; Anderson, D.; Bastien, R.; Butterworth, A.; Frank, D.; Gainsforth, Z.; Kelley, N.; Lettieri, R.; Mendez, B.; Prasad, R.; Tsitrin, S.; von Korff, J.; Warren, J.; Wertheimer, D.; Zhang, A.; Zolensky, M.
2006-12-01
The Stardust sample return mission is effectively two missions in one. Stardust brought back to earth for analytical study the first solid samples from a known solar system body beyond the moon, comet Wild2. The first results of the analyses of these samples are reported elsewhere in this session. In a separate aerogel collector, Stardust also captured and has returned the first samples of contemporary interstellar dust. Landgraf et al. [1] has estimated that ~ 50 interstellar dust particles in the micron size range have been captured in the Stardust Interstellar Dust Collector. Their state after capture is unknown. Before analysis of these particles can begin, they must be located in the collector. Here we describe the current status of Stardust@home, the massively distributed public search for these tiny interstellar dust particles. So far more than 13,000 volunteers have collectively performed more than 10,000,000 searches in stacks of digital images of ~10% of the collector. We report new estimates of the flux of interplanetary dust at ~2 AU based on the results of this search, and will compare with extant models[2]. References: [1] Landgraf et al., (1999) Planet. Spac. Sci. 47, 1029. [2] Staubach et al. (2001) in Interplanetary Dust, E. Grün, ed., Astron. &Astro. Library, Springer, 2001.
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An configuration method of patient service cloud for the home patient with multi sensor network
International Nuclear Information System (INIS)
Noji, Tamotsu; Arino, Masashi; Saito, Mayuko; Horii, Minoru; Ogino, Tadashi; Suto, Yasuzo; Sasaki, Hitoshi; Mansei, Kouiti
2010-01-01
We are advancing the research of patient service cloud in the global medical collaboration network system based on 3D electronic referral letters. In this paper it proposes one configuration method of private cloud that aims at the home care patient's health care and independence support based on voice navigation system (VONAVS). We evaluate 3D image compression rate, try image compositing Cloud's configuration by the multi sensor network, and search for the configuration method of the remote image diagnosis. The proposed configuration method expands the possibility to the global medical collaboration network system for new large areas such as a telemedicine, an emergency care, and home medical care. (author)
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International Nuclear Information System (INIS)
Taylor, David J; Parsons, Christine E; Han, Haiyong; Jayaraman, Arul; Rege, Kaushal
2011-01-01
Tumor Necrosis Factor-α Related Apoptosis Inducing Ligand (TRAIL) and agonistic antibodies to death receptor 4 and 5 are promising candidates for cancer therapy due to their ability to induce apoptosis selectively in a variety of human cancer cells, while demonstrating little cytotoxicity in normal cells. Although TRAIL and agonistic antibodies to DR4 and DR5 are considered safe and promising candidates in cancer therapy, many malignant cells are resistant to DR-mediated, TRAIL-induced apoptosis. In the current work, we screened a small library of fifty-five FDA and foreign-approved anti-neoplastic drugs in order to identify candidates that sensitized resistant prostate and pancreatic cancer cells to TRAIL-induced apoptosis. FDA-approved drugs were screened for their ability to sensitize TRAIL resistant prostate cancer cells to TRAIL using an MTT assay for cell viability. Analysis of variance was used to identify drugs that exhibited synergy with TRAIL. Drugs demonstrating the highest synergy were selected as leads and tested in different prostate and pancreatic cancer cell lines, and one immortalized human pancreatic epithelial cell line. Sequential and simultaneous dosing modalities were investigated and the annexin V/propidium iodide assay, in concert with fluorescence microscopy, was employed to visualize cells undergoing apoptosis. Fourteen drugs were identified as having synergy with TRAIL, including those whose TRAIL sensitization activities were previously unknown in either prostate or pancreatic cancer cells or both. Five leads were tested in additional cancer cell lines of which, doxorubicin, mitoxantrone, and mithramycin demonstrated synergy in all lines. In particular, mitoxantrone and mithramycin demonstrated significant synergy with TRAIL and led to reduction of cancer cell viability at concentrations lower than 1 μM. At these low concentrations, mitoxantrone demonstrated selectivity toward malignant cells over normal pancreatic epithelial cells
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Directory of Open Access Journals (Sweden)
Taylor David J
2011-11-01
Full Text Available Abstract Background Tumor Necrosis Factor-α Related Apoptosis Inducing Ligand (TRAIL and agonistic antibodies to death receptor 4 and 5 are promising candidates for cancer therapy due to their ability to induce apoptosis selectively in a variety of human cancer cells, while demonstrating little cytotoxicity in normal cells. Although TRAIL and agonistic antibodies to DR4 and DR5 are considered safe and promising candidates in cancer therapy, many malignant cells are resistant to DR-mediated, TRAIL-induced apoptosis. In the current work, we screened a small library of fifty-five FDA and foreign-approved anti-neoplastic drugs in order to identify candidates that sensitized resistant prostate and pancreatic cancer cells to TRAIL-induced apoptosis. Methods FDA-approved drugs were screened for their ability to sensitize TRAIL resistant prostate cancer cells to TRAIL using an MTT assay for cell viability. Analysis of variance was used to identify drugs that exhibited synergy with TRAIL. Drugs demonstrating the highest synergy were selected as leads and tested in different prostate and pancreatic cancer cell lines, and one immortalized human pancreatic epithelial cell line. Sequential and simultaneous dosing modalities were investigated and the annexin V/propidium iodide assay, in concert with fluorescence microscopy, was employed to visualize cells undergoing apoptosis. Results Fourteen drugs were identified as having synergy with TRAIL, including those whose TRAIL sensitization activities were previously unknown in either prostate or pancreatic cancer cells or both. Five leads were tested in additional cancer cell lines of which, doxorubicin, mitoxantrone, and mithramycin demonstrated synergy in all lines. In particular, mitoxantrone and mithramycin demonstrated significant synergy with TRAIL and led to reduction of cancer cell viability at concentrations lower than 1 μM. At these low concentrations, mitoxantrone demonstrated selectivity toward
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Einstein@Home discovers a radio-quiet gamma-ray millisecond pulsar
Clark, Colin J.; Pletsch, Holger J.; Wu, Jason; Guillemot, Lucas; Kerr, Matthew; Johnson, Tyrel J.; Camilo, Fernando; Salvetti, David; Allen, Bruce; Anderson, David; Aulbert, Carsten; Beer, Christian; Bock, Oliver; Cuéllar, Andres; Eggenstein, Heinz-Bernd; Fehrmann, Henning; Kramer, Michael; Kwang, Shawn A.; Machenschalk, Bernd; Nieder, Lars; Ackermann, Markus; Ajello, Marco; Baldini, Luca; Ballet, Jean; Barbiellini, Guido; Bastieri, Denis; Bellazzini, Ronaldo; Bissaldi, Elisabetta; Blandford, Roger D.; Bloom, Elliott D.; Bonino, Raffaella; Bottacini, Eugenio; Brandt, Terri J.; Bregeon, Johan; Bruel, Philippe; Buehler, Rolf; Burnett, Toby H.; Buson, Sara; Cameron, Rob A.; Caputo, Regina; Caraveo, Patrizia A.; Cavazzuti, Elisabetta; Cecchi, Claudia; Charles, Eric; Chekhtman, Alexandre; Ciprini, Stefano; Cominsky, Lynn R.; Costantin, Denise; Cutini, Sara; D’Ammando, Filippo; De Luca, Andrea; Desiante, Rachele; Di Venere, Leonardo; Di Mauro, Mattia; Di Lalla, Niccolò; Digel, Seth W.; Favuzzi, Cecilia; Ferrara, Elizabeth C.; Franckowiak, Anna; Fukazawa, Yasushi; Funk, Stefan; Fusco, Piergiorgio; Gargano, Fabio; Gasparrini, Dario; Giglietto, Nico; Giordano, Francesco; Giroletti, Marcello; Gomez-Vargas, Germán A.; Green, David; Grenier, Isabelle A.; Guiriec, Sylvain; Harding, Alice K.; Hewitt, John W.; Horan, Deirdre; Jóhannesson, Guðlaugur; Kensei, Shiki; Kuss, Michael; La Mura, Giovanni; Larsson, Stefan; Latronico, Luca; Li, Jian; Longo, Francesco; Loparco, Francesco; Lovellette, Michael N.; Lubrano, Pasquale; Magill, Jeffrey D.; Maldera, Simone; Manfreda, Alberto; Mazziotta, Mario N.; McEnery, Julie E.; Michelson, Peter F.; Mirabal, Nestor; Mitthumsiri, Warit; Mizuno, Tsunefumi; Monzani, Maria Elena; Morselli, Aldo; Moskalenko, Igor V.; Nuss, Eric; Ohsugi, Takashi; Omodei, Nicola; Orienti, Monica; Orlando, Elena; Palatiello, Michele; Paliya, Vaidehi S.; de Palma, Francesco; Paneque, David; Perkins, Jeremy S.; Persic, Massimo; Pesce-Rollins, Melissa; Porter, Troy A.; Principe, Giacomo; Rainò, Silvia; Rando, Riccardo; Ray, Paul S.; Razzano, Massimiliano; Reimer, Anita; Reimer, Olaf; Romani, Roger W.; Saz Parkinson, Pablo M.; Sgrò, Carmelo; Siskind, Eric J.; Smith, David A.; Spada, Francesca; Spandre, Gloria; Spinelli, Paolo; Thayer, Jana B.; Thompson, David J.; Torres, Diego F.; Troja, Eleonora; Vianello, Giacomo; Wood, Kent; Wood, Matthew
2018-01-01
Millisecond pulsars (MSPs) are old neutron stars that spin hundreds of times per second and appear to pulsate as their emission beams cross our line of sight. To date, radio pulsations have been detected from all rotation-powered MSPs. In an attempt to discover radio-quiet gamma-ray MSPs, we used the aggregated power from the computers of tens of thousands of volunteers participating in the Einstein@Home distributed computing project to search for pulsations from unidentified gamma-ray sources in Fermi Large Area Telescope data. This survey discovered two isolated MSPs, one of which is the only known rotation-powered MSP to remain undetected in radio observations. These gamma-ray MSPs were discovered in completely blind searches without prior constraints from other observations, raising hopes for detecting MSPs from a predicted Galactic bulge population. PMID:29503868
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DEFF Research Database (Denmark)
Møller, Kristian; Klausen, Maja
2018-01-01
The chapter draw from critical mediatization theory, critical intimacy theory, and cultural gerontology and asks: How do elderly people practice their mediatized homes? Which roles do media play in constituting and disturbing the flows of bodies into the home? Moreover: how do dominant...... in the making of the mediatized home space. We conclude by returning to the research questions and making explicit how researching flows of bodies that in many ways inhabit homes of the in-between contributes to both gerontological and geomediatization research agendas....
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Stroke and Nursing Home care: a national survey of nursing homes.
LENUS (Irish Health Repository)
Cowman, Seamus
2010-01-01
BACKGROUND: Although stroke is recognised as a major factor in admission to nursing home care, data is lacking on the extent and nature of the disabilities and dependency in nursing homes arising from stroke. A national study conducted in nursing homes can quantify the number of residents with stroke in nursing homes, their disability and levels of dependency. METHODS: A cross-sectional survey research design was used. A total of 572 public and private nursing homes were identified nationally and a stratified random selection of 60 nursing homes with 3,239 residents was made. In half of the nursing homes (n = 30) efforts were made to interview all residents with stroke Survey instruments were used to collect data from residents with stroke and nursing home managers on demography, patient disability, and treatment. RESULTS: Across all nursing homes (n = 60), 18% (n = 570) of the residents had previously had a stroke. In homes (n = 30), where interviews with residents with stroke (n = 257), only 7% (n = 18) residents were capable of answering for themselves and were interviewed. Data on the remaining 93% (n = 239) residents were provided by the nursing home manager. Nurse Managers reported that 73% of residents with stroke had a high level of dependency. One in two residents with stroke was prescribed antidepressants or sedative medication. Only 21% of stroke residents were prescribed anticoagulants, 42% antiplatelets, and 36% cholesterol lowering medications. Stroke rehabilitation guidelines were lacking and 68% reported that there was no formal review process in place. CONCLUSIONS: This study provides seminal findings on stroke and nursing home services in Ireland. We now know that one in six nursing home residents in a national survey are residents with a stroke, and have a wide range of disabilities. There is currently little or no structured care (beyond generic care) for stroke survivors who reside in nursing homes in Ireland.
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Home Automation : Smart home technology and template house design
Zheng, Zeya
2013-01-01
In this thesis, home automation’s general knowledge, technology information and each component will be introduced to the reader in the first half of the whole thesis. In the second half, thesis includes the Home Automation template design and market competitiveness analysis. The author assumes that the reader is going to spend lots of money to have a smart home. In this situation, the author introduces the home automation to the reader at each component. So the reader in this thesis actu...
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Howell, Doris M.; Abernathy, Tom; Cockerill, Rhonda; Brazil, Kevin; Wagner, Frank; Librach, Larry
2011-01-01
Purpose: Empirical understanding of predictors for home care service use and death at home is important for healthcare planning. Few studies have examined these predictors in the context of the publicly funded Canadian home care system. This study examined predictors for home care use and home death in the context of a “gold standard” comprehensive palliative home care program pilot in Ontario where patients had equal access to home care services. Methods: Secondary clinical and administrative data sources were linked using a unique identifier to examine multivariate factors (predisposing, enabling, need) on total home care expenditures and home death for a cohort of cancer patients enrolled in the HPCNet pilot. Results: Subjects with gastrointestinal symptoms (OR: 1.64; p=0.03) and those with higher income had increased odds of dying at home (OR: 1.14; phome care expenditures. Conclusions: Predictors of home death found in earlier studies appeared less important in this comprehensive palliative home care pilot. An income effect for home death observed in this study requires examination in future controlled studies. Relevance: Access to palliative home care that is adequately resourced and organized to address the multiple domains of issues that patients/families experience at the end of life has the potential to enable home death and shift care appropriately from limited acute care resources. PMID:22294993
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Nago, Eunice S; Lachat, Carl K; Dossa, Romain A M; Kolsteren, Patrick W
2014-01-01
In the present review, the association of out-of-home eating with anthropometric changes was examined. Peer-reviewed studies in eight databases were searched, and 15 prospective studies were included in the review. The quality of the data was assessed by considering risks of bias in sample selection, data collection methods, and the appropriateness of statistical tests. From this, seven studies, which used relatively large samples or had a follow-up period longer than 10 years, were retained for further analysis. It was concluded that eating out-of-home frequently, in the broad sense, is positively associated with the risk of becoming overweight or obese and weight change. With regard to specific out-of-home sources, the review shows that eating at fast-food outlets is associated with a greater increase in body weight and waist circumference over time than eating at restaurants and takeaway foods positively predict BMI change in women. More research is needed on out-of-home foods other than fast-foods and restaurant foods, such as street, canteen, and school foods.
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Rosen, Laura J; Myers, Vicki; Winickoff, Jonathan P; Kott, Jeff
2015-12-18
Smoke-free homes can help protect children from tobacco smoke exposure (TSE). The objective of this study was to conduct a meta-analysis to quantify effects of interventions on changes in tobacco smoke pollution in the home, as measured by air nicotine and particulate matter (PM). We searched MEDLINE, PubMed, Web of Science, PsycINFO, and Embase. We included controlled trials of interventions which aimed to help parents protect children from tobacco smoke exposure. Two reviewers identified relevant studies, and three reviewers extracted data. Seven studies were identified. Interventions improved tobacco smoke air pollution in homes as assessed by nicotine or PM. (6 studies, N = 681, p = 0.02). Analyses of air nicotine and PM separately also showed some benefit (Air nicotine: 4 studies, N = 421, p = 0.08; PM: 3 studies, N = 340, p = 0.02). Despite improvements, tobacco smoke pollution was present in homes in all studies at follow-up. Interventions designed to protect children from tobacco smoke are effective in reducing tobacco smoke pollution (as assessed by air nicotine or PM) in homes, but contamination remains. The persistence of significant pollution levels in homes after individual level intervention may signal the need for other population and regulatory measures to help reduce and eliminate childhood tobacco smoke exposure.
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SEARCH: Spatially Explicit Animal Response to Composition of Habitat.
Pauli, Benjamin P; McCann, Nicholas P; Zollner, Patrick A; Cummings, Robert; Gilbert, Jonathan H; Gustafson, Eric J
2013-01-01
Complex decisions dramatically affect animal dispersal and space use. Dispersing individuals respond to a combination of fine-scale environmental stimuli and internal attributes. Individual-based modeling offers a valuable approach for the investigation of such interactions because it combines the heterogeneity of animal behaviors with spatial detail. Most individual-based models (IBMs), however, vastly oversimplify animal behavior and such behavioral minimalism diminishes the value of these models. We present program SEARCH (Spatially Explicit Animal Response to Composition of Habitat), a spatially explicit, individual-based, population model of animal dispersal through realistic landscapes. SEARCH uses values in Geographic Information System (GIS) maps to apply rules that animals follow during dispersal, thus allowing virtual animals to respond to fine-scale features of the landscape and maintain a detailed memory of areas sensed during movement. SEARCH also incorporates temporally dynamic landscapes so that the environment to which virtual animals respond can change during the course of a simulation. Animals in SEARCH are behaviorally dynamic and able to respond to stimuli based upon their individual experiences. Therefore, SEARCH is able to model behavioral traits of dispersing animals at fine scales and with many dynamic aspects. Such added complexity allows investigation of unique ecological questions. To illustrate SEARCH's capabilities, we simulated case studies using three mammals. We examined the impact of seasonally variable food resources on the weight distribution of dispersing raccoons (Procyon lotor), the effect of temporally dynamic mortality pressure in combination with various levels of behavioral responsiveness in eastern chipmunks (Tamias striatus), and the impact of behavioral plasticity and home range selection on disperser mortality and weight change in virtual American martens (Martes americana). These simulations highlight the relevance of
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Kim, Dasom; Lee, Insook
2017-10-01
This study was intended to integrate the evidence of home care service intervention for mothers and children in vulnerable groups through an integrative literature review. We searched the MEDLINE (PubMED), EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, DBpia databases. The quality of the articles was assessed by one doctoral researcher and verified by one professor of community health nursing who had participated in the systematic review of literature. A framework was developed to identify the intervention patterns in the selected papers and categorize various elements. The extracted intervention elements were grouped into potential themes, which were verified by assessors on whether they clearly reflected the interventions in the papers. Among 878 searched papers, we selected 16 papers after excluding literature that does not satisfy the selection criteria and quality evaluation. The intervention elements of 16 selected papers were categorized into six themes. The extracted intervention elements were divided into the themes of Patient-specific/Situation-specific care planning and intervention, Emphasis on self care competency, Intense home visit by developmental milestone, Reinforcing and modeling mother-child attachment, Communication and interaction across the intervention, Linkage with community resource and multidisciplinary approach. As a result of the analysis of proper interventions of home care services for mothers and children in vulnerable groups, it was found that it is necessary to consider indispensable intervention elements that can standardize the quality of home care services, and conduct studies on developing intervention programs based on the elements. © 2017 Korean Society of Nursing Science
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Eldercare at Home: Choosing a Nursing Home
... required, these services can be provided by a separate home health agency as directed by a doctor or ... complaints made by or on behalf of nursing home residents and work to resolve the problems. If they are unable ...
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Kodra, Suela
2016-01-01
Smart Home is an intelligent home equipped with devices and communications systems that enables the residents to connect and control their home appliances and systems. This technology has changed the way a consumer interacts with his home, enabling more control and convenience. Another advantage of this technology is the positive impact it has on savings on energy and other resources. However, despite the consumer's excitement about smart home, security and privacy have shown to be the strong...
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Racial and ethnic disparities in the healing of pressure ulcers present at nursing home admission.
Bliss, Donna Z; Gurvich, Olga; Savik, Kay; Eberly, Lynn E; Harms, Susan; Mueller, Christine; Garrard, Judith; Cunanan, Kristen; Wiltzen, Kjerstie
2017-09-01
Pressure ulcers increase the risk of costly hospitalization and mortality of nursing home residents, so timely healing is important. Disparities in healthcare have been identified in the nursing home population but little is known about disparities in the healing of pressure ulcers. To assess racial and ethnic disparities in the healing of pressure ulcers present at nursing home admission. Multi-levels predictors, at the individual resident, nursing home, and community/Census tract level, were examined in three large data sets. Minimum Data Set records of older individuals admitted to one of 439 nursing homes of a national, for-profit chain over three years with a stages 2-4 pressure ulcer (n=10,861) were searched to the 90-day assessment for the first record showing pressure ulcer healing. Predictors of pressure ulcer healing were analyzed for White admissions first using logistic regression. The Peters-Belson method was used to assess racial or ethnic disparities among minority group admissions. A significantly smaller proportion of Black nursing home admissions had their pressure ulcer heal than expected had they been part of the White group. There were no disparities in pressure ulcer healing disadvantaging other minority groups. Significant predictors of a nonhealing of pressure ulcer were greater deficits in activities of daily living and pressure ulcer severity. Reducing disparities in pressure ulcer healing is needed for Blacks admitted to nursing homes. Knowledge of disparities in pressure ulcer healing can direct interventions aiming to achieve equity in healthcare for a growing number of minority nursing home admissions. Copyright © 2017 Elsevier B.V. All rights reserved.
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Directory of Open Access Journals (Sweden)
Uebbing L
2017-04-01
Full Text Available Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, 3Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt, Germany; 4Global Research and Development, AbbVie Inc., North Chicago, IL, USA *These authors contributed equally to this work Abstract: Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is
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International Nuclear Information System (INIS)
Denney, Bruce
1989-01-01
Full text: A review of the Food and Drug Administration's (FDA) rationale and methods for determining protective action guidelines (PAGs) and derived response levels (DRLs) (FDAa82, FDAb82) for human food and animal feed reveals the presence of ambiguous and contradictory information that should be clarified in order to improve the usefulness of the guidance. The differences in the criteria used to determine the Preventative and Emergency PAGs and DRLs, for example, are striking. The Preventative PAGs (and DRLs) are based on accepted health physics principles, e.g. risk factors, avoidance of fetal health effects, agricultural models, etc. The Emergency PAGs (and DRLs), however, are based solely on a traditional safety factor of ten. This difference in rationale becomes more conspicuous when the protective actions for these PAGs are compared: preventative protective actions involve low impact actions, e.g. removal of cattle from pasture, storage to allow for radioactive decay, etc., while emergency protective actions involve high impact actions e.g. isolating and condemning food products. These differences result in a contradiction: high impact actions, which may cause considerable problems and loss of income for farmers and food processors, are based on non-technical premises ('tradition'), while the low impact actions, which may only result in minor inconveniences to farmers and food processors, are based on solid scientific principles. Justifying or explaining these differences to farmers or to the media may be very difficult. Clearly there exists a need to review the basis and rationale upon which the Emergency PAGs and DRLs were derived in order to provide a more scientific explanation for their choice and use. In the FDA guidance (FDAa82), references are also made to ALARA and to the use of low-impact actions at doses lower than the PAGs. Although the FDA accepts and endorses the concept of keeping doses as low as reasonably achievable, the FDA does not
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Adaptive clustering procedure for continuous gravitational wave searches
Singh, Avneet; Papa, Maria Alessandra; Eggenstein, Heinz-Bernd; Walsh, Sinéad
2017-10-01
In hierarchical searches for continuous gravitational waves, clustering of candidates is an important post-processing step because it reduces the number of noise candidates that are followed up at successive stages [J. Aasi et al., Phys. Rev. Lett. 88, 102002 (2013), 10.1103/PhysRevD.88.102002; B. Behnke, M. A. Papa, and R. Prix, Phys. Rev. D 91, 064007 (2015), 10.1103/PhysRevD.91.064007; M. A. Papa et al., Phys. Rev. D 94, 122006 (2016), 10.1103/PhysRevD.94.122006]. Previous clustering procedures bundled together nearby candidates ascribing them to the same root cause (be it a signal or a disturbance), based on a predefined cluster volume. In this paper, we present a procedure that adapts the cluster volume to the data itself and checks for consistency of such volume with what is expected from a signal. This significantly improves the noise rejection capabilities at fixed detection threshold, and at fixed computing resources for the follow-up stages, this results in an overall more sensitive search. This new procedure was employed in the first Einstein@Home search on data from the first science run of the advanced LIGO detectors (O1) [LIGO Scientific Collaboration and Virgo Collaboration, arXiv:1707.02669 [Phys. Rev. D (to be published)
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Stroke and Nursing Home care: a national survey of nursing homes
Directory of Open Access Journals (Sweden)
McGee Hannah
2010-01-01
Full Text Available Abstract Background Although stroke is recognised as a major factor in admission to nursing home care, data is lacking on the extent and nature of the disabilities and dependency in nursing homes arising from stroke. A national study conducted in nursing homes can quantify the number of residents with stroke in nursing homes, their disability and levels of dependency. Methods A cross-sectional survey research design was used. A total of 572 public and private nursing homes were identified nationally and a stratified random selection of 60 nursing homes with 3,239 residents was made. In half of the nursing homes (n = 30 efforts were made to interview all residents with stroke Survey instruments were used to collect data from residents with stroke and nursing home managers on demography, patient disability, and treatment. Results Across all nursing homes (n = 60, 18% (n = 570 of the residents had previously had a stroke. In homes (n = 30, where interviews with residents with stroke (n = 257, only 7% (n = 18 residents were capable of answering for themselves and were interviewed. Data on the remaining 93% (n = 239 residents were provided by the nursing home manager. Nurse Managers reported that 73% of residents with stroke had a high level of dependency. One in two residents with stroke was prescribed antidepressants or sedative medication. Only 21% of stroke residents were prescribed anticoagulants, 42% antiplatelets, and 36% cholesterol lowering medications. Stroke rehabilitation guidelines were lacking and 68% reported that there was no formal review process in place. Conclusions This study provides seminal findings on stroke and nursing home services in Ireland. We now know that one in six nursing home residents in a national survey are residents with a stroke, and have a wide range of disabilities. There is currently little or no structured care (beyond generic care for stroke survivors who reside in nursing homes in Ireland.
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QUADrATiC: scalable gene expression connectivity mapping for repurposing FDA-approved therapeutics.
O'Reilly, Paul G; Wen, Qing; Bankhead, Peter; Dunne, Philip D; McArt, Darragh G; McPherson, Suzanne; Hamilton, Peter W; Mills, Ken I; Zhang, Shu-Dong
2016-05-04
Gene expression connectivity mapping has proven to be a powerful and flexible tool for research. Its application has been shown in a broad range of research topics, most commonly as a means of identifying potential small molecule compounds, which may be further investigated as candidates for repurposing to treat diseases. The public release of voluminous data from the Library of Integrated Cellular Signatures (LINCS) programme further enhanced the utilities and potentials of gene expression connectivity mapping in biomedicine. We describe QUADrATiC ( http://go.qub.ac.uk/QUADrATiC ), a user-friendly tool for the exploration of gene expression connectivity on the subset of the LINCS data set corresponding to FDA-approved small molecule compounds. It enables the identification of compounds for repurposing therapeutic potentials. The software is designed to cope with the increased volume of data over existing tools, by taking advantage of multicore computing architectures to provide a scalable solution, which may be installed and operated on a range of computers, from laptops to servers. This scalability is provided by the use of the modern concurrent programming paradigm provided by the Akka framework. The QUADrATiC Graphical User Interface (GUI) has been developed using advanced Javascript frameworks, providing novel visualization capabilities for further analysis of connections. There is also a web services interface, allowing integration with other programs or scripts. QUADrATiC has been shown to provide an improvement over existing connectivity map software, in terms of scope (based on the LINCS data set), applicability (using FDA-approved compounds), usability and speed. It offers potential to biological researchers to analyze transcriptional data and generate potential therapeutics for focussed study in the lab. QUADrATiC represents a step change in the process of investigating gene expression connectivity and provides more biologically-relevant results than
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Search for the neutrinoless ββ decay in 76Ge with the GERDA experiment
International Nuclear Information System (INIS)
Cattadori, C.; Knapp, M.; Kröninger, K.; Liu, X.; Pandola, L.; Pullia, A.; Tomei, C.; Ur, C.; Zocca, F.
2011-01-01
The GERmanium Detector Array, GERDA, [Gerda Collaboration, Abt I et al., Proposal, a (http://www.mpi-hd.mpg.de/ge76/home.html)] is designed to search for neutrinoless double beta (0νββ)-decay of 76 Ge. The importance of such a search is emphasized by the evidence of a non-zero neutrino mass from flavour oscillation experiments and by the recent claim [Klapdor-Kleingrothaus H V et al., Phys. Lett. B 586, 198 (2004)] based on data of the Heidelberg-Moscow experiment. GERDA will be installed in the Hall A of the Gran Sasso underground Laboratory (LNGS), Italy. The construction of GERDA will start in 2006.
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Medicare home health utilization as a function of nursing home market factors.
Swan, J H; Benjamin, A E
1990-01-01
Rapid increases in the size and costs of the home health market, unknown impacts of Medicare's DRG hospital reimbursement on the posthospital market, and general lack of knowledge about factors that explain interstate variation in home health utilization all suggest the importance of developing and testing models of Medicare home health use. This article proposes and tests a model of state home health utilization as a function of the nursing home market. This model proposes that home health u...
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Specialist home-based nursing services for children with acute and chronic illnesses.
Parab, Chitra S; Cooper, Carolyn; Woolfenden, Susan; Piper, Susan M
2013-06-15
Specialist paediatric home-based nursing services have been proposed as a cost-effective means of reducing distress resulting from hospital admissions, while enhancing primary care and reducing length of hospital stay. This review is an update of our original review, which was published in 2006. To evaluate specialist home-based nursing services for children with acute and chronic illnesses. We searched the following databases in February 2012: the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2012 Issue 2, Ovid MEDLINE, EMBASE, PsycINFO, CINAHL and Sociological Abstracts. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. No language restrictions were applied. Randomised controlled trials (RCTs) of children from birth to age 18 years with acute or chronic illnesses allocated to specialist home-based nursing services compared with conventional health care. Outcomes included utilisation of health care, physical and mental health, satisfaction, adverse health outcomes and costs. Two review authors extracted data from the studies independently and resolved any discrepancies by recourse to a third author. Meta-analysis was not appropriate because of the clinical diversity of the studies and the lack of common outcome measures. We screened 4226 titles to yield seven RCTs with a total of 840 participants. Participants, interventions and outcomes were diverse. No significant differences were reported in health outcomes; two studies reported a reduction in the hospital stay with no difference in the hospital readmission rates. Three studies reported a reduction in parental anxiety and improvement in child behaviours was reported in three studies. Overall increased parental satisfaction was reported in three studies. Also, better parental coping and family functioning was reported in one study. By contrast, one study each reported no impact on parental burden of care or on functional status of
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SpaceScience@Home: Authentic Research Projects that Use Citizen Scientists
Méndez, B. J. H.
2008-06-01
In recent years, several space science research projects have enlisted the help of large numbers of non-professional volunteers, ``citizen scientists'', to aid in performing tasks that are critical to a project, but require more person-time (or computing time) than a small professional research team can practically perform themselves. Examples of such projects include SETI@home, which uses time from volunteers computers to process radio-telescope observation looking for signals originating from extra-terrestrial intelligences; Clickworkers, which asks volunteers to review images of the surface of Mars to identify craters; Spacewatch, which used volunteers to review astronomical telescopic images of the sky to identify streaks made by possible Near Earth Asteroids; and Stardust@home, which asks volunteers to review ``focus movies'' taken of the Stardust interstellar dust aerogel collector to search for possible impacts from interstellar dust particles. We shall describe these and other similar projects and discuss lessons learned from carrying out such projects, including the educational opportunities they create.
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An analysis of FDA-approved drugs: natural products and their derivatives.
Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton
2016-02-01
Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.
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The Sweet-Home speech and multimodal corpus for home automation interaction
Vacher , Michel; Lecouteux , Benjamin; Chahuara , Pedro; Portet , François; Meillon , Brigitte; Bonnefond , Nicolas
2014-01-01
International audience; Ambient Assisted Living aims at enhancing the quality of life of older and disabled people at home thanks to Smart Homes and Home Automation. However, many studies do not include tests in real settings, because data collection in this domain is very expensive and challenging and because of the few available data sets. The SWEET-H OME multimodal corpus is a dataset recorded in realistic conditions in D OMUS, a fully equipped Smart Home with microphones and home automati...
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Hughes, Carmel; Tunney, Michael; Bradley, Marie C
2013-11-19
Nursing homes for older people provide an environment likely to promote the acquisition and spread of meticillin-resistant Staphylococcus aureus (MRSA), putting residents at increased risk of colonisation and infection. It is recognised that infection prevention and control strategies are important in preventing and controlling MRSA transmission. To determine the effects of infection prevention and control strategies for preventing the transmission of MRSA in nursing homes for older people. In August 2013, for this third update, we searched the Cochrane Wounds Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Database of Abstracts of Reviews of Effects (DARE, The Cochrane Library), Ovid MEDLINE, OVID MEDLINE (In-process and Other Non-Indexed Citations), Ovid EMBASE, EBSCO CINAHL, Web of Science and the Health Technology Assessment (HTA) website. Research in progress was sought through Current Clinical Trials, Gateway to Reseach, and HSRProj (Health Services Research Projects in Progress). All randomised and controlled clinical trials, controlled before and after studies and interrupted time series studies of infection prevention and control interventions in nursing homes for older people were eligible for inclusion. Two review authors independently reviewed the results of the searches. Another review author appraised identified papers and undertook data extraction which was checked by a second review author. For this third update only one study was identified, therefore it was not possible to undertake a meta-analysis. A cluster randomised controlled trial in 32 nursing homes evaluated the effect of an infection control education and training programme on MRSA prevalence. The primary outcome was MRSA prevalence in residents and staff, and a change in infection control audit scores which measured adherence to infection control standards. At the end of the 12 month study, there was no change in MRSA
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Smoke-Free Homes and Home Exposure to Secondhand Smoke in Shanghai, China
Directory of Open Access Journals (Sweden)
Pinpin Zheng
2014-11-01
Full Text Available Few studies have examined home exposure to secondhand smoke (SHS in China. This study aimed to document: (1 the prevalence and correlates of exposure to SHS in homes (in adult non-smokers in Shanghai, and (2 enforcement of rules, harm reduction behaviors, and self-efficacy for maintaining smoke-free homes in Shanghai. A total of 500 participants were recruited using a multistage proportional random sampling design in an urban and suburban district to complete a survey. Among the total 355 nonsmokers, 127 (35.8% participants reported being exposed to SHS in the past 7 days. Participants living with smokers in the home, with no smoking restriction at home, and having children younger than 18 were more likely to be exposed to SHS at home. Higher self-efficacy in maintaining a smoke-free home was negatively associated with home SHS exposure. Having visitors who smoke was the greatest policy enforcement challenge. Ineffective measures such as opening windows were more commonly used in homes with partial bans. Educational initiatives to protect against SHS exposure in the home should promote smoke-free homes, address challenges to implementing such policies, and address misconceptions regarding the effectiveness of supposed harm reduction behaviors.
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Energy Technology Data Exchange (ETDEWEB)
none,
2014-09-01
This builder won a Custom Builder honor in the 2014 Housing Innovation Awards for this showcase home that serves as an energy-efficient model home for the custom home builder: 1,300 visitors toured the home, thousands more learned about the home’s advanced construction via the webpage, YouTube, Twitter, Facebook, Instagram, and Pinterest.
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Department of Housing and Urban Development — The HOME Investment Partnership Program (HOME) is authorized under Title II of the Cranston-Gonzalez National Affordable Housing Act. HOME provides formula grants to...
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The effectiveness of home hand exercise programmes in rheumatoid arthritis: a systematic review.
Hammond, Alison; Prior, Yeliz
2016-09-01
Rheumatoid arthritis (RA) commonly reduces hand function. We systematically reviewed trials to investigate effects of home hand exercise programmes on hand symptoms and function in RA. We searched: Medline (1946-), AMED, CINAHL, Physiotherapy Evidence Database, OT Seeker, the Cochrane Library, ISI Web of Science from inception to January 2016. Nineteen trials were evaluated. Only three were randomized controlled trials with a low risk of bias (n = 665). Significant short-term improvements occurred in hand function, pain and grip strength, with long-term improvements in hand and upper limb function and pinch strength. Heterogeneity of outcome measures meant meta-analysis was not possible. Evaluation of low and moderate risk of bias trials indicated high-intensity home hand exercise programmes led to better short-term outcomes than low-intensity programmes. Such programmes are cost-effective. Further research is required to evaluate methods of helping people with RA maintain long-term home hand exercise. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Smart Cities - Smart Homes and Smart Home Technology
Faanes, Erlend Kydland
2014-01-01
This master’s thesis consists of two articles where the first article is theoretical and the second is the empirical study. Article I The purpose with this paper is to explore and illuminate how smart home and smart home technology can contribute to enhance health and Quality of Life in elderly citizens and allow them to live longer in their home. The paper provides a brief introduction to health promotion and highlights the thesis theoretical framework and foundation of Aaron Antonov...
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Nursing perception of patient transitions from hospitals to home with home health.
Smith, Shannon Bright; Alexander, Judith W
2012-01-01
The study's purpose was to determine nurses' opinions of sending patients from the hospital to home with home health services. The study occurred in the Charleston, South Carolina, Tricounty area (Berkeley, Charleston, and Dorchester counties). Home health agencies and hospitals were invited to participate. The study used a survey design to gather information on nursing perceptions of current practices and needed changes to improve transition of patients. The population was nurses (licensed practical nurses (LPNs) and registered nurses (RNs)) employed at inpatient hospitals or home health agencies in the area. Thirty-four RNs responded with no LPNs respondents. Agency administrators/chief nursing officers agreed for their agencies to participate and distributed the survey using a Research Electronic Data Capture (REDCap) Internet-based survey tool. Using the survey results and information from a literature review, the study developed a list of propositions, which participating administrators reviewed, for improving transitions to home. Both home health and hospital nurses reported a need to improve the process of sending patients from hospital to home with home health services. This study provides hospitals and home health agencies with propositions to facilitate the establishment of a process to communicate effectively patients care needs and streamline the discharging patients from the hospital to home health care; thus, improving patient transition. Case managers and discharge planners will need interagency collaboration along with evidence-based interventions to transition patients from the hospital to home with home health services with various populations. Direct patient care nurses in both hospital and home health settings should share the same accountability as case managers to ensure successful transitions.
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Representing in-home and out-of-home energy consumption behavior in Beijing
International Nuclear Information System (INIS)
Yu Biying; Zhang Junyi; Fujiwara, Akimasa
2011-01-01
It is expected that in-home and out-of-home energy consumption behavior in a household might be correlated with each other, probably due to the existence of household budget constraints. Ownership and usage of energy-saving technologies for in-home appliances (or vehicles) might lead to the increase in out-of-home (or in-home) energy consumption. It is therefore necessary to jointly represent in-home and out-of-home energy consumption in the same modeling framework. With this consideration, we first build a new type of energy consumption model based on the Multiple Discrete-Continuous Extreme Value (MDCEV) modeling framework. Next, we conducted a questionnaire survey in Beijing in 2009 and successfully collected the information about households' energy consumption, ownership/usage of in-home appliances and vehicles, and households' and their members' attributes from 1014 households. Throughout an empirical analysis, it is confirmed that the MDCEV model is effective to simultaneously describe the in-home and out-of-home energy consumption behavior. In addition, it is revealed that a set of household and personal attributes affect the ownership and usage of in-home appliances and vehicles. Furthermore, it is shown that the unobserved factors play a much more important role in explaining energy consumption behavior than the observed attributes of households and their members. - Highlights: → Representing in-home and out-of-home energy consumption behavior jointly. → MDCEV model is built to describe household energy consumption behavior. → Log-linear competitive relationships are found among expenditures of end-uses. → Model results provide some insights about the influence of varied observed factors. → Unobserved factors are more important in explaining energy consumption behavior.
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Home Health Compare: Find a Home Health Agency
... page could not be loaded. The Medicare.gov Home page currently does not fully support browsers with " ... widget - Select to show Back to top Footer Home A federal government website managed and paid for ...
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Tafuri, G; Stolk, P; Trotta, F; Putzeist, M; Leufkens, H G; Laing, R O; De Allegri, M
2014-01-01
The process leading to a regulatory outcome is guided by factors both related and unrelated to the data package, defined in this analysis as 'formal and informal factors', respectively. The aim of this qualitative study was to analyse which formal and informal factors drive the decision-making process of the European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulators with regard to anticancer drugs, using in-depth semi-structured interviews with regulators of the two agencies. In line with the theory and practice of qualitative research, no set sample size was defined a priori. Respondent enrolment continued until saturation and redundancy were reached. Data were collected through means of in-depth semi-structured interviews conducted either in a face-to-face setting or via Skype(®) with each regulator. The interviews were audio-recorded and verbatim transcribed. The analysis was manually carried out on the transcribed text. Data were independently coded and categorized by two researchers. Interpretation of the findings emerged through a process of triangulation between the two. Seven EMA and six FDA regulators, who had extensive experience with making decisions about anticancer medicines, were interviewed between April and June 2012. There is an open dialogue between the FDA and EMA, with the two moving closer and exchanging information, not opinions. Differences in decision-making between the agencies may be due to a different evaluation of end points. Different interaction modalities with industry and patients represent an additional source of divergence with a potential impact on decision-making. The key message of our respondents was that the agencies manage uncertainty in a different way: unlike the EMA, the FDA has a prevailing attitude to take risks in order to guarantee quicker access to new treatments. Although formal factors are the main drivers for regulatory decisions, the influence of informal factors plays an important role in
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... Home Health Insights Exercise & Weight Exercise at Home Exercise at Home Make an Appointment Ask a Question ... with the movement and contact your provider. Posture Exercises Better posture means better breathing and movement. Axial ...
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DEFF Research Database (Denmark)
Hansen, Ellen Kathrine; Olesen, Gitte Gylling Hammershøj; Mullins, Michael
2013-01-01
The article places focus on how smart technologies integrated in a one family- home and particular the window offer unique challenges and opportunities for designing buildings with the best possible environments for people and nature. Toward an interdisciplinary approach, we address the interaction...... between daylight defined in technical terms and daylight defined in aesthetic, architectural terms. Through field-tests of a Danish carbon-neutral home and an analysis of five key design parameters, we explore the contradictions and potentials in smart buildings, using the smart window as example of how...... to the energy design is central. The study illuminates an approach of the design of smart houses as living organisms by connecting technology with the needs of the occupants with the power and beauty of daylight....
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Bringing Work Home: Take-Home Pesticide Exposure Among Farm Families
Curwin, B.D.
2006-01-01
In this thesis take-home pesticide exposure among farm families, with an emphasis on herbicides, was investigated. Take-home exposure occurs when a worker unwittingly brings home a substance on his or her clothing or shoes, thereby potentially exposing his or her family. The pesticides investigated
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Burns, Suzanne Perea; Pickens, Noralyn Davel; Dawson, Deirdre R; Perea, Jaimee D; Vas, Asha K; Marquez de la Plata, Carlos; Neville, Marsha
2018-02-06
Adults with stroke frequently experience executive dysfunction. Despite the range of assessments that examine the effects of executive dysfunction on daily tasks, there remains a paucity of literature that examines the influence of the environment on performance in the community. The MET-Home is an ecologically valid assessment for examining post-stroke executive dysfunction in the home environment. This qualitative study explores the relationship between the environment and MET-Home performance among home-dwelling adults with stroke and matched controls. Using a descriptive qualitative approach, we analysed video, interview, and observation notes from a MET-Home validation study. An overarching theme of interplay between everyday task performance and the home environment produced further themes: naturalistically emerging supports and barriers and environment as strategy. Within naturalistically emerging supports and barriers, five contextual sub-themes were discovered: physical environment, social environment, temporal context, virtual context, and personal context. Within environment as strategy, we identified four sub-themes: reducing distractions, using everyday technologies, planning in context, and seeking social support. These findings extend the conceptualisation of how we evaluate executive dysfunction in the context of the community to also consider the inherent influence of the environment.
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The energy landscape of a selective tumor-homing pentapeptide
Zanuy, David; Flores-Ortega, Alejandra; Casanovas, Jordi; Curco, David; Nussinov, Ruth; Aleman, Carlos
2009-01-01
Recently, a potentially powerful strategy based on the of phage-display libraries has been presented to target tumors via homing peptides attached to nanoparticles. The Cys-Arg-Glu-Lys-Ala (CREKA) peptide sequence has been identified as a tumor-homing peptide that binds to clotted plasmas proteins present in tumor vessels and interstitium. The aim of this work consists of mapping the conformational profile of CREKA to identify the bioactive conformation. For this purpose, a conformational search procedure based on modified Simulated Annealing combined with Molecular Dynamics was applied to three systems that mimic the experimentally used conditions: (i) the free peptide; (ii) the peptide attached to a nanoparticle; and (iii) the peptide inserted in a phage display protein. In addition, the free peptide was simulated in an ionized aqueous solution environment, which mimics the ionic strength of the physiological medium. Accessible minima of all simulated systems reveal a multiple interaction pattern involving the ionized side chains of Arg, Glu and Lys, which induces a β-turn motif in the backbone observed in all simulated CREKA systems. PMID:18588341
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Directory of Open Access Journals (Sweden)
Laura J. Rosen
2015-12-01
Full Text Available Introduction: Smoke-free homes can help protect children from tobacco smoke exposure (TSE. The objective of this study was to conduct a meta-analysis to quantify effects of interventions on changes in tobacco smoke pollution in the home, as measured by air nicotine and particulate matter (PM. Methods: We searched MEDLINE, PubMed, Web of Science, PsycINFO, and Embase. We included controlled trials of interventions which aimed to help parents protect children from tobacco smoke exposure. Two reviewers identified relevant studies, and three reviewers extracted data. Results: Seven studies were identified. Interventions improved tobacco smoke air pollution in homes as assessed by nicotine or PM. (6 studies, N = 681, p = 0.02. Analyses of air nicotine and PM separately also showed some benefit (Air nicotine: 4 studies, N = 421, p = 0.08; PM: 3 studies, N = 340, p = 0.02. Despite improvements, tobacco smoke pollution was present in homes in all studies at follow-up. Conclusions: Interventions designed to protect children from tobacco smoke are effective in reducing tobacco smoke pollution (as assessed by air nicotine or PM in homes, but contamination remains. The persistence of significant pollution levels in homes after individual level intervention may signal the need for other population and regulatory measures to help reduce and eliminate childhood tobacco smoke exposure.
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Mills, Susanna; White, Martin; Brown, Heather; Wrieden, Wendy; Kwasnicka, Dominika; Halligan, Joel; Robalino, Shannon; Adams, Jean
2017-04-01
Many dietary interventions assume a positive influence of home cooking on diet, health and social outcomes, but evidence remains inconsistent. We aimed to systematically review health and social determinants and outcomes of home cooking. Given the absence of a widely accepted, established definition, we defined home cooking as the actions required for preparing hot or cold foods at home, including combining, mixing and often heating ingredients. Nineteen electronic databases were searched for relevant literature. Peer-reviewed studies in English were included if they focussed mainly on home cooking, and presented post 19 th century observational or qualitative data on participants from high/very high human development index countries. Interventional study designs, which have previously been reviewed, were excluded. Themes were summarised using narrative synthesis. From 13,341 unique records, 38 studies - primarily cross-sectional in design - met the inclusion criteria. A conceptual model was developed, mapping determinants of home cooking to layers of influence including non-modifiable, individual, community and cultural factors. Key determinants included female gender, greater time availability and employment, close personal relationships, and culture and ethnic background. Putative outcomes were mostly at an individual level and focused on potential dietary benefits. Findings show that determinants of home cooking are more complex than simply possessing cooking skills, and that potential positive associations between cooking, diet and health require further confirmation. Current evidence is limited by reliance on cross-sectional studies and authors' conceptualisation of determinants and outcomes. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.
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Intimacy and sexuality of nursing home residents with dementia: a systematic review.
Roelofs, Tineke S M; Luijkx, Katrien G; Embregts, Petri J C M
2015-03-01
Considering people with dementia, increasing cognitive, physical, and environmental impairments can impede the capacity to express and experience intimacy and sexuality. When a move to a residential (nursing) home becomes inevitable, increasing dependency can influence this even more. The aim of the review is to provide a structured overview of all elements of intimacy across the full spectrum of intimacy and sexuality in people with dementia, living in specialist residential care. A systematic search and review were conducted. Research published between 1990 and 2013 was identified in the electronic databases: Pubmed, PsychInfo, and Medline. Inclusion and exclusion criteria were predefined. Selected studies were assessed on quality, using the Mixed METHODS Appraisal Tool. Twelve of the 215 initially retrieved unique research publications were selected. A varied range of studies were found; these studies differed in design, research quality, searched population, and research theme. Different themes emerged: intimate and sexual behavior, knowledge and attitudes, capacity to consent and care culture, and staff training and guidelines. Although results were found in a wide range of intimate and sexual behavior, knowledge, attitudes and needs of others, and descriptions of culture in residential and nursing homes, the perspective of residents was lacking in literature. Also a "protective" care paradigm was found throughout. Future research is needed to highlight resident perspective and develop training opportunities and guidelines for care staff.
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Directory of Open Access Journals (Sweden)
Barbara Gomes
Full Text Available BACKGROUND: Extensive evidence shows that well over 50% of people prefer to be cared for and to die at home provided circumstances allow choice. Despite best efforts and policies, one-third or less of all deaths take place at home in many countries of the world. OBJECTIVES: 1. to quantify the effect of home palliative care services for adult patients with advanced illness and their family caregivers on patients' odds of dying at home; 2. to examine the clinical effectiveness of home palliative care services on other outcomes for patients and their caregivers such as symptom control, quality of life, caregiver distress and satisfaction with care; 3. to compare the resource use and costs associated with these services; 4. to critically appraise and summarize the current evidence on cost-effectiveness. METHODS: Search methods: We searched 12 electronic databases up to November 2012. We checked the reference lists of all included studies, 49 relevant systematic reviews, four key textbooks and recent conference abstracts. We contacted 17 experts and researchers for unpublished data. Selection criteria: We included randomised controlled trials (RCTs, controlled clinical trials (CCTs, controlled before and after studies (CBAs and interrupted time series (ITSs evaluating the impact of home palliative care services on outcomes for adults with advanced illness or their family caregivers, or both. Data collection and analysis: One review author assessed the identified titles and abstracts. Two independent reviewers performed assessment of all potentially relevant studies, data extraction and assessment of methodological quality. We carried out meta-analysis where appropriate and calculated numbers needed to treat to benefit (NNTBs for the primary outcome (death at home. MAIN RESULTS: We identified 23 studies (16 RCTs, 6 of high quality, including 37,561 participants and 4042 family caregivers, largely with advanced cancer but also congestive heart failure
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Biosimilars: More Treatment Choices and Innovation
... ol Search FDA Submit search ... Information Biosimilar products provide more treatment options to patients, potentially lowering treatment costs and increasing access to lifesaving medications. The U.S. ...
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Search for a cure: narratives of Thai family caregivers living with a person with AIDS.
Nilmanat, Kittikorn; Street, Annette
2004-09-01
Facing an incurable prognosis Thai families search for a cure for AIDS using all possible means available to them. This paper reports a longitudinal narrative case study of eight family caregivers caring for a relative with AIDS in rural Southern Thailand. The paper demonstrates how the caregivers living with a person with AIDS made sense of illness episodes, and how they chose and evaluated particular treatments and care. Caregivers moved between modern medicine, traditional/folk medicine, supernatural healing rites, religious performances, and home remedies in their search for a cure. The findings indicate that a more holistic and palliative approach is needed toward AIDS care.
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Smart homes and home health monitoring technologies for older adults: A systematic review.
Liu, Lili; Stroulia, Eleni; Nikolaidis, Ioanis; Miguel-Cruz, Antonio; Rios Rincon, Adriana
2016-07-01
Around the world, populations are aging and there is a growing concern about ways that older adults can maintain their health and well-being while living in their homes. The aim of this paper was to conduct a systematic literature review to determine: (1) the levels of technology readiness among older adults and, (2) evidence for smart homes and home-based health-monitoring technologies that support aging in place for older adults who have complex needs. We identified and analyzed 48 of 1863 relevant papers. Our analyses found that: (1) technology-readiness level for smart homes and home health monitoring technologies is low; (2) the highest level of evidence is 1b (i.e., one randomized controlled trial with a PEDro score ≥6); smart homes and home health monitoring technologies are used to monitor activities of daily living, cognitive decline and mental health, and heart conditions in older adults with complex needs; (3) there is no evidence that smart homes and home health monitoring technologies help address disability prediction and health-related quality of life, or fall prevention; and (4) there is conflicting evidence that smart homes and home health monitoring technologies help address chronic obstructive pulmonary disease. The level of technology readiness for smart homes and home health monitoring technologies is still low. The highest level of evidence found was in a study that supported home health technologies for use in monitoring activities of daily living, cognitive decline, mental health, and heart conditions in older adults with complex needs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
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DEFF Research Database (Denmark)
Kofod, Jens Erik; Birkemose, A.
2004-01-01
Undernutrition is present among 33% of nursing home residents in Denmark. Hence, it is relevant to examine the meal situation at nursing homes to single out factors that may increase or reduce the residents' food intake. in the ongoing Danish nursing home debate it is claimed that a new type...... of nursing home improves the residents' meal situation with a positive effect on nutrition. The aim of this work is to test the general hypothesis that (i) residents appreciate the meal situation in these nursing homes and (ii) nutritional status of the residents is improved in this type of nursing home....... This study was carried out in four Danish nursing homes at various locations in Denmark. The methods used are qualitative interviews and observations at four nursing homes in combination with measurement of body mass index (BMI) at two of the four nursing homes. Undernutrition is defined as a BMI below 20...
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Home care is care that allows a person with special needs stay in their home. It might be for people who are getting ... are chronically ill, recovering from surgery, or disabled. Home care services include Personal care, such as help ...
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Attitudes of palliative home care physicians towards palliative sedation at home in Italy.
Mercadante, Sebastiano; Masedu, Francesco; Mercadante, Alessandro; Marinangeli, Franco; Aielli, Federica
2017-05-01
Information about the attitudes towards palliative sedation (PS) at home is limited. The aim of this survey was to assess the attitudes of palliative care physicians in Italy regarding PS at home. A questionnaire was submitted to a sample of palliative care physicians, asking information about their activity and attitudes towards PS at home. This is a survey of home care physicians in Italy who were involved in end-of-life care decisions at home. One hundred and fifty participants responded. A large heterogeneity of home care organizations that generate some problems was found. Indications, intention and monitoring of PS seem to be appropriate, although some cultural and logistic conditions were limiting the use of PS. Specialized home care physicians are almost involved to start PS at home. Midazolam was seldom available at home and opioids were more frequently used. These data should prompt health care agencies to make a minimal set of drugs easily available for home care. Further research is necessary to compare attitudes in countries with different sociocultural profiles.
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24 CFR 982.610 - Group home: Who may reside in a group home.
2010-04-01
... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Group home: Who may reside in a group home. 982.610 Section 982.610 Housing and Urban Development Regulations Relating to Housing and... Housing Types Group Home § 982.610 Group home: Who may reside in a group home. (a) An elderly person or a...
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DEFF Research Database (Denmark)
Borlund, Pia; Dreier, Sabine
2014-01-01
We report a naturalistic interactive information retrieval (IIR) study of 18 ordinary users in the age of 20–25 who carry out everyday-life information seeking (ELIS) on the Internet with respect to the three types of information needs identified by Ingwersen (1986): the verificative information...... need (VIN), the conscious topical information need (CIN), and the muddled topical information need (MIN). The searches took place in the private homes of the users in order to ensure as realistic searching as possible. Ingwersen (1996) associates a given search behaviour to each of the three types...... of information needs, which are analytically deduced, but not yet empirically tested. Thus the objective of the study is to investigate whether empirical data does, or does not, conform to the predictions derived from the three types of information needs. The main conclusion is that the analytically deduced...
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Koonen, A.M.J.
2013-01-01
This article consists of a collection of slides from the author's conference presentation. Some of the specific areas/topics discussed include: Convergence in home networks, home service scenarios; Home wired network architectures, CapEx and OpEx; Residential Gateway; Optical fiber types;
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Searches for the Standard Model Higgs boson at the Tevatron collider
Energy Technology Data Exchange (ETDEWEB)
Fisher, Wade C. [Michigan State Univ., East Lansing, MI (United States). Dept. of Physics and Astronomy; Junk, Thomas R. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States)
2016-01-01
During Run II of the Tevatron collider, which took place from 2001 until 2011, the CDF and D0 detectors each collected approximately 10 fb -1 of
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Finigan, Valerie; Chadderton, Diane
2015-06-01
The birth of a baby is a family experience. However, in the United Kingdom birth often occurs outside the family environment, in hospital. Both home and hospital births have risks and benefits, but research shows that, for most women, it is as safe to give birth at home as it is in hospital. Women report home-birth to be satisfying with lowered risks of intervention and less likelihood of being separated from their family. It is also more cost effective for the National Health Service. Yet, whilst midwives are working hard to promote home birth as an option, it remains controversial. The aim of this paper is to raise awareness of the safety of home birth and the needs of women and midwives when a home birth is chosen. It provides an overview of care required and the role of the midwife in the ensuring care is woman-centred and personalised.
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Socioeconomic disparities in home health care service access and utilization: a scoping review.
Goodridge, Donna; Hawranik, Pamela; Duncan, Vicky; Turner, Hollie
2012-10-01
Home health care services are expanding at a rapid pace in order to meet the needs of the growing population of older adults and those with chronic illnesses. Because of current restrictions on home health care as an insured service in some countries, individuals may be required to pay for some or all of their home care services out of pocket. These payments may potentially limit access to needed home care services for persons in the lowest socioeconomic strata. Previous research demonstrates a clear socioeconomic gradient in access to acute and primary care services, where those most in need of services are the most disadvantaged and under-serviced. There has been little attention paid thus far, however, to the way in which socioeconomic status may affect the receipt of home health care services. To determine what is known from existing literature about socioeconomic disparities in home health care access and utilization. A scoping review was used to map the extent and nature of the literature in this area. A search of the databases CINAHL, Medline, SocIndex and Sociological Abstracts as well as Dissertations International. A total of 206 potentially relevant articles were published between 2000 and April 2011. Two reviewers independently reviewed the articles, leaving 15 research articles to be included in the scoping review. The majority of articles reported secondary analyses of administrative datasets related to utilization of home health care. Several studies examined access and utilization using qualitative approaches. The distinction between professional and supportive home care services was not always clear in the articles. Individual and composite measures of socioeconomic status were reported, with the most frequently used indicator being income. Several studies used more complex composite ecological indicators of socieconomic status. There was general agreement that utilization of home health services favored persons with greater economic disadvantage
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78 FR 23508 - Use of Certain Symbols in Labeling
2013-04-19
... labeling is false or misleading (section 502(a)), if the required information on the labeling fails to.../search.cfm for the most recent FDA listing of recognized consensus standards. In ``Guidance for Industry... Consensus Standards for Recognition,'' FDA set forth its procedures for recognition of consensus standards...
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Stickel, L.F.; King, John A.
1968-01-01
The concept of home range was expressed by Seton (1909) in the term 'home region,' which Burr (1940, 1943) clarified with a definition of home range and exemplified in a definitive study of Peromyscus in the field. Burt pointed out the ever-changing characteristics of home-range area and the consequent absence of boundaries in the usual sense--a finding verified by investigators thereafter. In the studies summarized in this paper, sizes of home ranges of Peromyscus varied within two magnitudes, approximately from 0.1 acre to ten acres, in 34 studies conducted in a variety of habitats from the seaside dunes of Florida to the Alaskan forests. Variation in sizes of home ranges was correlated with both environmental and physiological factors; with habitat it was conspicuous, both in the same and different regions. Food supply also was related to size of home range, both seasonally and in relation to habitat. Home ranges generally were smallest in winter and largest in spring, at the onset of the breeding season. Activity and size also were affected by changes in weather. Activity was least when temperatures were low and nights were bright. Effects of rainfall were variable. Sizes varied according to sex and age; young mice remained in the parents' range until they approached maturity, when they began to travel more widely. Adult males commonly had larger home ranges than females, although there were a number of exceptions. An inverse relationship between population density and size of home range was shown in several studies and probably is the usual relationship. A basic need for activity and exploration also appeared to influence size of home range. Behavior within the home range was discussed in terms of travel patterns, travels in relation to home sites and refuges, territory, and stability of size of home range. Travels within the home range consisted of repeated use of well-worn trails to sites of food, shelter, and refuge, plus more random exploratory travels
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DOE Challenge Home Case Study: e2 Homes – Winter Park, Florida
Energy Technology Data Exchange (ETDEWEB)
none,
2013-01-01
This Challenge Home case study describes the first certified DOE Challenge Home as constructed by e2 Homes. Completed in May 2012, the “Wilson Residence” in Winter Park, Florida, is a 4,305-ft2 custom home that scores a HERS 57 without solar and a better than zero net-energy HERS -7 with solar.
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Energy Technology Data Exchange (ETDEWEB)
Anderson, R.; Christensen, C.; Horowitz, S.
2006-08-01
An optimization method based on the evaluation of a broad range of different combinations of specific energy efficiency and renewable-energy options is used to determine the least-cost pathway to the development of new homes with zero peak cooling demand. The optimization approach conducts a sequential search of a large number of possible option combinations and uses the most cost-effective alternatives to generate a least-cost curve to achieve home-performance levels ranging from a Title 24-compliant home to a home that uses zero net source energy on an annual basis. By evaluating peak cooling load reductions on the least-cost curve, it is then possible to determine the most cost-effective combination of energy efficiency and renewable-energy options that both maximize annual energy savings and minimize peak-cooling demand.
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Hazarika, Maitreyee; Chuk, Meredith K; Theoret, Marc R; Mushti, Sirisha; He, Kun; Weis, Shawna L; Putman, Alexander H; Helms, Whitney S; Cao, Xianhua; Li, Hongshan; Zhao, Hong; Zhao, Liang; Welch, Joel; Graham, Laurie; Libeg, Meredith; Sridhara, Rajeshwari; Keegan, Patricia; Pazdur, Richard
2017-07-15
On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks with at least 6-month follow-up in an ongoing, randomized, open-label, active-controlled clinical trial. The ORR as assessed by a blinded independent review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5-40.8). Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ to 10+ months. In 13 patients, the response duration was 6 months or longer. The risks of nivolumab, including clinically significant immune-mediated adverse reactions (imARs), were assessed in 268 patients who received at least one dose of nivolumab. The FDA review considered whether the ORR and durations of responses were reasonably likely to predict clinical benefit, the adequacy of the safety database, and systematic approaches to the identification, description, and patient management for imARs in product labeling. Clin Cancer Res; 23(14); 3484-8. ©2017 AACR . ©2017 American Association for Cancer Research.
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The Battlefield of IoT: Competitive and Cooperative Relationship Among Smart Home Vendors
Huang, Kuang-Chiu; Lin, Yu-Cheng
2017-01-01
The integration between electronic devices and networking enable convenient, comfortable, efficient and secure life. So there are a variety of smart home hubs and accessories migrating to daily life with all kinds of possibilities and extending the scope and coverage of Internet of Things (IoT). For an example, Amazon’s Echo launched in June 2015 and offers amazing capabilities. Its artificial intelligence voice assistant Alexa is a breakthrough invention, and people can not only search infor...
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ConductHome: Gesture Interface Control of Home Automation Boxes
J. Branstett; V. Gagneux; A. Leleu; B. Levadoux; J. Pascale
2015-01-01
This paper presents the interface ConductHome which controls home automation systems with a Leap Motion using "invariant gesture protocols". This interface is meant to simplify the interaction of the user with its environment. A hardware part allows the Leap Motion to be carried around the house. A software part interacts with the home automation box and displays the useful information for the user. An objective of this work is the development of a natural/invariant/simpl...
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Home versus in-patient treatment for deep vein thrombosis.
Othieno, Richard; Okpo, Emmanuel; Forster, Rachel
2018-01-09
Deep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein, which can occur after surgery, after trauma, or when a person has been immobile for a long time. Clots can dislodge and block blood flow to the lungs (pulmonary embolism (PE)), causing death. DVT and PE are known by the term venous thromboembolism (VTE). Heparin (in the form of unfractionated heparin (UFH)) is a blood-thinning drug used during the first three to five days of DVT treatment. Low molecular weight heparins (LMWHs) allow people with DVT to receive their initial treatment at home instead of in hospital. This is an update of a review first published in 2001 and updated in 2007. To compare the incidence and complications of venous thromboembolism (VTE) in patients treated at home versus patients treated with standard in-patient hospital regimens. Secondary objectives included assessment of patient satisfaction and cost-effectiveness of treatment. For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (last searched 16 March 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2), and trials registries. We also checked the reference lists of relevant publications. Randomised controlled trials (RCTs) examining home versus hospital treatment for DVT, in which DVT was clinically confirmed and was treated with LMWHs or UFH. One review author selected material for inclusion, and another reviewed the selection of trials. Two review authors independently extracted data and assessed included studies for risk of bias. Primary outcomes included combined VTE events (PE and recurrent DVT), gangrene, heparin complications, and death. Secondary outcomes were patient satisfaction and cost implications. We performed meta-analysis using fixed-effect models with risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous data. We included in this review seven RCTs involving 1839 randomised
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Lin, Yanxia; Myall, Michelle; Jarrett, Nikki
2017-12-01
To understand how decisions are made to transfer dying patients home from critical care units. Many people prefer a home death, but a high proportion die in critical care units. Transferring dying patients home is recognized to be complex but transfer decision-making itself remains unclear. Integrative review. Seven bibliographic databases (origin-2015), grey literature and reference lists were searched. An integrative review method was used to synthesize data from diverse sources. Papers were selected through title and abstract screening and full-text reviewing, using inclusion and exclusion criteria derived from review questions. Following quality appraisal, data were extracted and synthesized using normalization process theory as a framework. The number of patients transferred home ranged from 1-346, with most papers reporting on the transfer of one or two patients. Four themes regarding transfer decision-making work were generated: divergent views and practice, multiple stakeholders' involvement in decision-making, collective work and limited understanding of individuals' experiences. The practice of transferring patients home to die and its decision-making varies internationally and is usually influenced by the care system, culture or religion. It is less common to transfer patients home to die from critical care units in western societies. A better understanding of the decision-making work was obtained but mainly from the perspective of hospital-based healthcare professionals. Further research is needed to develop decision-making practice guidance to facilitate patients' wishes to die at home. © 2017 John Wiley & Sons Ltd.
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The Search Performance Evaluation and Prediction in Exploratory Search
LIU, FEI
2016-01-01
The exploratory search for complex search tasks requires an effective search behavior model to evaluate and predict user search performance. Few studies have investigated the relationship between user search behavior and search performance in exploratory search. This research adopts a mixed approach combining search system development, user search experiment, search query log analysis, and multivariate regression analysis to resolve the knowledge gap. Through this study, it is shown that expl...
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Cost-effectiveness implications based on a comparison of nursing home and home health case mix.
Kramer, A M; Shaughnessy, P W; Pettigrew, M L
1985-01-01
Case-mix differences between 653 home health care patients and 650 nursing home patients, and between 455 Medicare home health patients and 447 Medicare nursing home patients were assessed using random samples selected from 20 home health agencies and 46 nursing homes in 12 states in 1982 and 1983. Home health patients were younger, had shorter lengths of stay, and were less functionally disabled than nursing home patients. Traditional long-term care problems requiring personal care were more...
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The Center for Cancer Research’s ability to rapidly deploy integrated basic and clinical research teams at a single site facilitated the rapid FDA approval of the immunotherapy drug avelumab for metastatic Merkel cell carcinoma, a rare, aggressive form of skin cancer. Learn more...
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Investigating drug repositioning opportunities in FDA drug labels through topic modeling.
Bisgin, Halil; Liu, Zhichao; Kelly, Reagan; Fang, Hong; Xu, Xiaowei; Tong, Weida
2012-01-01
Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not have a Boxed Warning. In
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Human Resources Division
2002-01-01
Administrative procedures for : Travel to the home station and home leave (hl) Additional travel to the home station (at) Travel to the home station and home leave for family reasons (hlf) As part of the process of simplifying administrative procedures, HR and AS Divisions have devised a new, virtually automatic procedure for payment of travel expenses to the home station. The changes are aimed at rationalising administrative procedures and not at reducing benefits. The conditions of eligibility are unchanged. The new procedure, which will be operational with effect from 1st June 2002, will greatly simplify the administrative processing of claims for travel expenses and the recording of home leaves. Currently, requests for payment are introduced manually into the Advances and Claims system (AVCL) by divisional secretariats. All travel to the home station starting prior to 1st June 2002 will be processed according to the existing system whereas that starting on 1st June and after will be processed accordi...
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One visual search, many memory searches: An eye-tracking investigation of hybrid search.
Drew, Trafton; Boettcher, Sage E P; Wolfe, Jeremy M
2017-09-01
Suppose you go to the supermarket with a shopping list of 10 items held in memory. Your shopping expedition can be seen as a combination of visual search and memory search. This is known as "hybrid search." There is a growing interest in understanding how hybrid search tasks are accomplished. We used eye tracking to examine how manipulating the number of possible targets (the memory set size [MSS]) changes how observers (Os) search. We found that dwell time on each distractor increased with MSS, suggesting a memory search was being executed each time a new distractor was fixated. Meanwhile, although the rate of refixation increased with MSS, it was not nearly enough to suggest a strategy that involves repeatedly searching visual space for subgroups of the target set. These data provide a clear demonstration that hybrid search tasks are carried out via a "one visual search, many memory searches" heuristic in which Os examine items in the visual array once with a very low rate of refixations. For each item selected, Os activate a memory search that produces logarithmic response time increases with increased MSS. Furthermore, the percentage of distractors fixated was strongly modulated by the MSS: More items in the MSS led to a higher percentage of fixated distractors. Searching for more potential targets appears to significantly alter how Os approach the task, ultimately resulting in more eye movements and longer response times.
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Dikkers, J.S.E.; Geurts, S.A.E.; Dulk, L. den; Peper, A.B.; Taris, T.W.; Kompier, M.A.J.
2007-01-01
This study examined the associations of work–home culture with (a) demographic and organizational characteristics, (b) the use of work–home arrangements, and (c) negative and positive work–home interaction, among 1,179 employees from one public and two private organizations. Substantial support was
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Dikkers, J.S.E.; Geurts, S.A.E.; den Dulk, L.; Peper, B.; Taris, T.W.; Kompier, M.A.J.
2007-01-01
This study examined the associations of work-home culture with (a) demographic and organizational characteristics, (b) the use of work-home arrangements, and (c) negative and positive work-home interaction, among 1,179 employees from one public and two private organizations. Substantial support was
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Cloud4Psi: cloud computing for 3D protein structure similarity searching.
Mrozek, Dariusz; Małysiak-Mrozek, Bożena; Kłapciński, Artur
2014-10-01
Popular methods for 3D protein structure similarity searching, especially those that generate high-quality alignments such as Combinatorial Extension (CE) and Flexible structure Alignment by Chaining Aligned fragment pairs allowing Twists (FATCAT) are still time consuming. As a consequence, performing similarity searching against large repositories of structural data requires increased computational resources that are not always available. Cloud computing provides huge amounts of computational power that can be provisioned on a pay-as-you-go basis. We have developed the cloud-based system that allows scaling of the similarity searching process vertically and horizontally. Cloud4Psi (Cloud for Protein Similarity) was tested in the Microsoft Azure cloud environment and provided good, almost linearly proportional acceleration when scaled out onto many computational units. Cloud4Psi is available as Software as a Service for testing purposes at: http://cloud4psi.cloudapp.net/. For source code and software availability, please visit the Cloud4Psi project home page at http://zti.polsl.pl/dmrozek/science/cloud4psi.htm. © The Author 2014. Published by Oxford University Press.
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African Journals Online (AJOL)
Sitwala
determine factors associated with home deliveries. Main outcome ... deliver at home than a health facility compared to those who .... regression analysis, women who had four years of schooling or .... by report bias, the burden of home deliveries is a real challenge .... Journal of Econometrics 1987; 36: 185-204. 14. Michelo ...
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release announcing Home Energy Saver and a Q-and-A. The "About" page should tell you everything you need to know about using Home Energy Saver. If you have any questions, please email the project leader, Dr. Evan Mills. News Releases Microsoft Licenses Berkeley Lab's Home Energy Saver Code for Its
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DOE Zero Energy Ready Home Case Study: Garbett Homes, Herriman, Utah
Energy Technology Data Exchange (ETDEWEB)
none,
2013-09-01
As the first net zero-energy production home certified in Utah, this house incorporates two 94% efficient tankless water heaters and two roof-mounted solar panels that preheat the home's water supply. This home won a 2013 Housing Innovation Award in the production builder category.
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Work-home interference in relation to work, organizational, and home characteristics
Dikkers, J.S.E.
2008-01-01
In this thesis we examine work-home interference in relation to work, organizational, and home characteristics. The study is guided by the following three research questions: i) how are workload and negative WHI temporally related? (research question 1); ii) is work-home culture related to the use
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The 2014 FDA assessment of commercial fish: practical considerations for improved dietary guidance.
McGuire, Jennifer; Kaplan, Jason; Lapolla, John; Kleiner, Rima
2016-07-13
The U.S. Food and Drug Administration (FDA) recently released its report: A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children). By evaluating the benefits and potential concerns of eating fish during pregnancy and breastfeeding, the analysis suggests that pregnant women consuming two seafood meals (8-12 oz) per week could provide their child with an additional 3.3 IQ points by age 9. Recent insights from behavioral economics research indicate that other factors, such as concerns about price and methylmercury (MeHg) exposure, appear to reduce fish consumption in many individuals.To assess the net effects of eating commercial fish during pregnancy, we compared the consumption of select fish species necessary to achieve IQ benefits with the amount necessary to have adverse developmental effects due to MeHg exposure. For the species or market types evaluated, the number of servings necessary to reach MeHg exposure to observe an adverse effect was at least twice that the amount estimated to achieve peak developmental benefit. We then reported average costs of fresh and canned or pouched fish, and calculated the cost per week for pregnant women to achieve maximum IQ benefits for their gestating child. Canned light tuna was the least expensive option at $1.83 per week to achieve maximum IQ benefit.Due to their relatively low cost, canned and pouched fish products eaten with enough regularity are likely to provide peak cognitive benefits. Because of its popularity, canned and pouched tuna could provide some of the largest cognitive benefits from fish consumption in the U.S. Future FDA consumer advice and related educational initiatives could benefit from a broader perspective that highlights the importance of affordable and accessible fish choices. These observations underscore the importance of clear public health messaging that address both health
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Does hospital at home for palliative care facilitate death at home? Randomised controlled trial
Grande, Gunn E; Todd, Chris J; Barclay, Stephen I G; Farquhar, Morag C
1999-01-01
Objective To evaluate the impact on place of death of a hospital at home service for palliative care. Design Pragmatic randomised controlled trial. Setting Former Cambridge health district. Participants 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. Intervention Hospital at home versus standard care. Main outcome measures Place of death. Results Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. Conclusion In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting. Key messagesTerminally ill patients allocated to hospital at home were no more likely to die at home than patients receiving standard careAlthough the subsample of patients actually admitted to hospital at home did show a significant increase in likelihood of dying at home, whether this was due to the service itself or the characteristics of patients admitted to hospital at home could not be determinedThe need to
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Second-home electricity consumption
International Nuclear Information System (INIS)
Andersen, Frits M.; Christensen, Morten S.; Jensen, Ole Michael; Kofoed, Niels-Ulrik; Morthorst, Poul Erik
2008-01-01
In Denmark, electricity consumption in first and second homes has developed quite differently. Since 1990, electricity consumption in ordinary residences has grown moderately, while consumption in weekend and second homes has increased considerably. In turn, this development has been blamed on a growing number of luxury cottages, new legislation permitting senior citizens to have their permanent address in their second home and a growing number of electric appliances. In order to examine the growing electricity consumption in second homes and to estimate future demand, a multidisciplinary study combining top-down and bottom-up analyses was conducted, i.e., combining models using aggregated economic parameters and feasibility studies using technical parameters, respectively. The top-down estimation showed that changes in electricity consumption in second homes correlate to changes in income. The bottom-up estimation showed that consumption was mainly affected by the frequency with which second homes were used in the winter time. This indicates that additional second homes, increased full-time use and intensified use of electric appliances are the main reasons for the observed increases in electricity consumption. Luxury tourism use and senior citizens' that use a few per cent of the second homes as their home contribute to a minor degree to the overall increase of electricity consumption. Scenarios show that this development may accelerate with increased leisure time, increased use and more permanent settlement in second homes
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SearchResultFinder: federated search made easy
Trieschnigg, Rudolf Berend; Tjin-Kam-Jet, Kien; Hiemstra, Djoerd
Building a federated search engine based on a large number existing web search engines is a challenge: implementing the programming interface (API) for each search engine is an exacting and time-consuming job. In this demonstration we present SearchResultFinder, a browser plugin which speeds up
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DEFF Research Database (Denmark)
Nielsen, Rikke Skovgaard
2015-01-01
The paper focuses on ethnic differences in the timing and patterns of leaving the parental home. Leaving home is a key transition in the life course of the individual, and extensive research has been conducted on the timing and patterns of leaving it. However, ethnic differences in these patterns...... of leaving home. Results showed that while some differences disappeared when controlling for covariates, others persisted, thus indicating ethnic differences in home-leaving patterns. A strong link between leaving home and marriage was substantiated for Turks, but not for Somalis. The home-leaving patterns...... of Somalis were much more similar to those of Danes. Overall, Turkish descendants were similar to Turkish immigrants but with some differentiation. The analyses identified the existence of ethnic differences in home-leaving patterns but also found evidence of a shift towards less traditional patterns, i...
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Obesity and Nursing Home Care in the United States: A Systematic Review.
Harris, John Alexander; Castle, Nicholas George
2017-12-14
Obesity is increasing among people residing in nursing homes, and resident obesity substantially affects services needed, equipment and facilities provided, and morbidity in this setting. The purpose of this article is to describe the scope and depth of evidence regarding the impact of obesity among nursing home residents in the United States. A systematic literature review was performed in PubMed, EMBASE, CINAHL, and Web of Science databases as well as additional hand-searched documents. Included articles were published from 1997 to March 2017. The characteristics and content of the included articles were systematically reviewed and reported. Twenty-eight studies met inclusion criteria for review. The median study size was 636 residents (interquartile range 40-11,248); 18 (64%) studies were retrospective and 10 (36%) were prospective in nature. Ten (36%) studies examined medical and functional morbidity, 10 (36%) examined health system effects, and 5 (18%) examined the risk of admission to nursing homes. Most studies found that obesity poses serious issues to resident health and the provision of health care, as well as broad health system and nursing challenges in the provision of high-quality nursing home care and services. Although obesity affects about one in four nursing home residents in the United States, relatively limited evidence exists on the complex challenges of obesity for their residents and their care. A continued focus on resident quality of life, health system improvement, and nursing best practices for properly caring for individuals with obesity is needed. © The Author(s) 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Beyond Home Automation: Designing More Effective Smart Home Systems
Carner, Paolo
2009-01-01
This paper outlines a Smart Home Proof-of-Concept system that uses a Bayesian Network to predict the likelihood of a monitored event to occur. Firstly, this paper will provide an introduction to the concept of a smart home system; then it will outline how Artificial Intelligence concepts can be used to make such systems more effective. Finally, it will detail the implementation of a smart home system, which uses an inference engine to determine the likelihood of a fire. The system prototype h...
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Schedules for home visits in the early postpartum period.
Yonemoto, Naohiro; Dowswell, Therese; Nagai, Shuko; Mori, Rintaro
2017-08-02
Maternal complications including psychological and mental health problems and neonatal morbidity have been commonly observed in the postpartum period. Home visits by health professionals or lay supporters in the weeks following the birth may prevent health problems from becoming chronic with long-term effects on women, their babies, and their families. To assess outcomes for women and babies of different home-visiting schedules during the early postpartum period. The review focuses on the frequency of home visits, the duration (when visits ended) and intensity, and on different types of home-visiting interventions. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 January 2013) and reference lists of retrieved articles. Randomised controlled trials (RCTs) (including cluster-RCTs) comparing different types of home-visiting interventions enrolling participants in the early postpartum period (up to 42 days after birth). We excluded studies in which women were enrolled and received an intervention during the antenatal period (even if the intervention continued into the postnatal period) and studies recruiting only women from specific high-risk groups. (e.g. women with alcohol or drug problems). Study eligibility was assessed by at least two review authors. Data extraction and assessment of risk of bias were carried out independently by at least two review authors. Data were entered into Review Manager software. We included data from 12 randomised trials with data for more than 11,000 women. The trials were carried out in countries across the world, and in both high- and low-resource settings. In low-resource settings women receiving usual care may have received no additional postnatal care after early hospital discharge.The interventions and control conditions varied considerably across studies with trials focusing on three broad types of comparisons: schedules involving more versus fewer postnatal home visits (five studies), schedules
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Birchley, Giles; Huxtable, Richard; Murtagh, Madeleine; ter Meulen, Ruud; Flach, Peter; Gooberman-Hill, Rachael
2017-01-01
Background Smart-home technologies, comprising environmental sensors, wearables and video are attracting interest in home healthcare delivery. Development of such technology is usually justified on the basis of the technology?s potential to increase the autonomy of people living with long-term conditions. Studies of the ethics of smart-homes raise concerns about privacy, consent, social isolation and equity of access. Few studies have investigated the ethical perspectives of smart-home engine...
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Google's pagerank and beyond the science of search engine rankings
Langville, Amy N
2006-01-01
Why doesn't your home page appear on the first page of search results, even when you query your own name? How do other Web pages always appear at the top? What creates these powerful rankings? And how? The first book ever about the science of Web page rankings, Google's PageRank and Beyond supplies the answers to these and other questions and more. The book serves two very different audiences: the curious science reader and the technical computational reader. The chapters build in mathematical sophistication, so that the first five are accessible to the general academic reader. While other cha
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[The status of diabetic adolescents in search of apprenticeship].
Schoberberger, C; Schober, E; Frisch, H
1984-01-01
Chronic diseases like diabetes may be a disadvantage in several professions. The aim of the study was to analyse the situation of juvenile diabetics searching for apprenticeship in Austria. 177 individuals (30 adolescent diabetics, 50 healthy adolescents of the same age and 97 masters) were asked by a special questionnaire about their opinions concerning employment and professional changes of juvenile diabetics. Following dimensions were tested: subjective knowledge about juvenile diabetes, objective knowledge about juvenile diabetes, physical capacity, psychological factors, life expectation, stay at home because of illness--admittance to hospital, diabetes--profession, exceptions necessary at work because of diabetes, attitude of the state towards the professional situation of the diabetics.
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At Home in the Office. A Guide for the Home Worker.
Thomas, Neil; And Others
This guide provides information to persons interested in establishing a work-at-home program, specifically those in clerical or support staff positions who use modern automated office equipment. The text is divided into two sections. The Home Worker section provides a summary of the At Home in the Office Project, personality characteristics…
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Evolution of Home Automation Technology
Mohd. Rihan; M. Salim Beg
2009-01-01
In modern society home and office automation has becomeincreasingly important, providing ways to interconnectvarious home appliances. This interconnection results infaster transfer of information within home/offices leading tobetter home management and improved user experience.Home Automation, in essence, is a technology thatintegrates various electrical systems of a home to provideenhanced comfort and security. Users are grantedconvenient and complete control over all the electrical homeappl...
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More Than Four Walls: The Meaning of Home in Home Birth Experiences
Directory of Open Access Journals (Sweden)
Emily Burns
2015-04-01
Full Text Available The “home versus hospital” as places of birth debate has had a long and at times vicious history. From academic literature to media coverage, the two have often been pitted against each other not only as opposing physical spaces, but also as opposing ideologies of birth. The hospital has been heavily critiqued as a site of childbirth since the 1960s, with particular focus on childbirth and medicalisation. The focus of much of the hospital and home birthing research exists on a continuum of medicalisation, safety, risk, agency, and maternal and neonatal health and wellbeing. While the hospital birthing space has been interrogated, a critique of home birthing space has remained largely absent from the social sciences. The research presented in this article unpacks the complex relationship between home birthing women and the spaces in which they birth. Using qualitative data collected with 59 home birthing women in Australia in 2010, between childbearing and the home should not be considered as merely an alternative to hospital births, but rather as an experience that completely renegotiates the home space. Home, for the participants in this study, is a dynamic, changing, and even spiritual element in the childbirth experience, and not simply the building in which it occurs.
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Second-home electricity consumption
Energy Technology Data Exchange (ETDEWEB)
Andersen, Frits M.; Morthorst, Poul Erik [Risoe, Systems Analysis Department, Technical University of Denmark, P.O. Box 49, DK-4000 Roskilde (Denmark); Christensen, Morten S.; Kofoed, Niels-Ulrik [Esbensen Consulting Engineers, Carl Jacobsens Vej 25D, DK-2500 Valby (Denmark); Jensen, Ole Michael [Danish Building Research Institute, Department of Energy and Environment, University of Aalborg, P.O. Box 119, DK-2970 Horsholm (Denmark)
2008-01-15
In Denmark, electricity consumption in first and second homes has developed quite differently. Since 1990, electricity consumption in ordinary residences has grown moderately, while consumption in weekend and second homes has increased considerably. In turn, this development has been blamed on a growing number of luxury cottages, new legislation permitting senior citizens to have their permanent address in their second home and a growing number of electric appliances. In order to examine the growing electricity consumption in second homes and to estimate future demand, a multidisciplinary study combining top-down and bottom-up analyses was conducted, i.e., combining models using aggregated economic parameters and feasibility studies using technical parameters, respectively. The top-down estimation showed that changes in electricity consumption in second homes correlate to changes in income. The bottom-up estimation showed that consumption was mainly affected by the frequency with which second homes were used in the winter time. This indicates that additional second homes, increased full-time use and intensified use of electric appliances are the main reasons for the observed increases in electricity consumption. Luxury tourism use and senior citizens' that use a few per cent of the second homes as their home contribute to a minor degree to the overall increase of electricity consumption. Scenarios show that this development may accelerate with increased leisure time, increased use and more permanent settlement in second homes. (author)
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Lutgring, Joseph D; Machado, María-José; Benahmed, Faiza H; Conville, Patricia; Shawar, Ribhi M; Patel, Jean; Brown, Allison C
2018-02-01
The FDA-CDC Antimicrobial Resistance Isolate Bank was created in July 2015 as a publicly available resource to combat antimicrobial resistance. It is a curated repository of bacterial isolates with an assortment of clinically important resistance mechanisms that have been phenotypically and genotypically characterized. In the first 2 years of operation, the bank offered 14 panels comprising 496 unique isolates and had filled 486 orders from 394 institutions throughout the United States. New panels are being added. Copyright © 2018 American Society for Microbiology.
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DOE Zero Energy Ready Home Case Study: Amaris Homes, Afton Model
Energy Technology Data Exchange (ETDEWEB)
Pacific Northwest National Laboratory
2017-09-01
Amaris Homes built this 3,734-ft2 home in Afton, Minnesota, to the performance criteria of the DOE Zero Energy Ready Home (ZERH) program. A high-efficiency gas boiler provides hot water for the zoned radiant floor system as well as for faucets and showers. A high-efficiency heat pump provides zoned cooling.
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Home treatment for mental health problems: a systematic review.
Burns, T; Knapp, M; Catty, J; Healey, A; Henderson, J; Watt, H; Wright, C
2001-01-01
This review investigates the effectiveness of 'home treatment' for mental health problems in terms of hospitalisation and cost-effectiveness. For the purposes of this review, 'home treatment' is defined as a service that enables the patient to be treated outside hospital as far as possible and remain in their usual place of residence. METHODS - SYSTEMATIC LITERATURE SEARCH: 'Home treatment' excluded studies focused on day, residential and foster care. The review was based on Cochrane methodology, but non-randomised studies were included if they compared two services; these were only analysed if they provided evidence of the groups' baseline clinical comparability. METHODS - REVIEW OF ECONOMIC EVALUATIONS: Economic evaluations among the studies found were reviewed against established criteria. METHODS - IDENTIFICATION OF SERVICE COMPONENTS: A three-round Delphi exercise ascertained the degree of consensus among expert psychiatrists concerning the important components of community-based services that enable them to treat patients outside hospital. The identified components were used to construct the follow-up questionnaire. METHODS - FOLLOW-UP OF AUTHORS: As a supplement to the information available in the papers, authors of all the studies were followed up for data on service components, sustainability of programmes and service utilisation. METHODS - DATA ANALYSIS: The outcome measure was mean days in hospital per patient per month over the follow-up period. (1) Comparative analysis - compared experimental to control services. It analysed all studies with available data, divided into 'inpatient-control' and 'community-control' studies, and tested for associations between service components and difference in hospital days. (2) Experimental services analysis - analysed only experimental service data and tested for associations between service components and hospital days. RESULTS - SYSTEMATIC LITERATURE SEARCH: A total of 91 studies were found, conducted over a 30
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Posner, Kelly; Oquendo, Maria A; Gould, Madelyn; Stanley, Barbara; Davies, Mark
2007-07-01
To evaluate the link between antidepressants and suicidal behavior and ideation (suicidality) in youth, adverse events from pediatric clinical trials were classified in order to identify suicidal events. The authors describe the Columbia Classification Algorithm for Suicide Assessment (C-CASA), a standardized suicidal rating system that provided data for the pediatric suicidal risk analysis of antidepressants conducted by the Food and Drug Administration (FDA). Adverse events (N=427) from 25 pediatric antidepressant clinical trials were systematically identified by pharmaceutical companies. Randomly assigned adverse events were evaluated by three of nine independent expert suicidologists using the Columbia classification algorithm. Reliability of the C-CASA ratings and agreement with pharmaceutical company classification were estimated. Twenty-six new, possibly suicidal events (behavior and ideation) that were not originally identified by pharmaceutical companies were identified in the C-CASA, and 12 events originally labeled as suicidal by pharmaceutical companies were eliminated, which resulted in a total of 38 discrepant ratings. For the specific label of "suicide attempt," a relatively low level of agreement was observed between the C-CASA and pharmaceutical company ratings, with the C-CASA reporting a 50% reduction in ratings. Thus, although the C-CASA resulted in the identification of more suicidal events overall, fewer events were classified as suicide attempts. Additionally, the C-CASA ratings were highly reliable (intraclass correlation coefficient [ICC]=0.89). Utilizing a methodical, anchored approach to categorizing suicidality provides an accurate and comprehensive identification of suicidal events. The FDA's audit of the C-CASA demonstrated excellent transportability of this approach. The Columbia algorithm was used to classify suicidal adverse events in the recent FDA adult antidepressant safety analyses and has also been mandated to be applied to all