Science.gov

Sample records for acceptable safety profile

  1. Science and Safety: 'Acceptable' Risk

    ERIC Educational Resources Information Center

    Science News, 1976

    1976-01-01

    Stresses ways to answer questions related to widespread publicity - are nuclear reactors safe, will dangerous research in genetic manipulation be banned? - with emphasis on true meaning of safety as related to risks. (EB)

  2. Safety profile of levetiracetam.

    PubMed

    Arroyo, Santiago; Crawford, Pamela

    2003-05-01

    A good balance between safety and tolerability is necessary for an antiepileptic drug (AED) to be successful in the management of patients with epilepsy. Levetiracetam is one of the new generation of AEDs licensed as an add-on therapy for the treatment of patients with partial-onset seizures. Leveti-racetam's mechanisms of action are not fully understood. Controlled clinical trials, open-label studies, and postmarketing surveillance indicate that leveti-racetam has a favorable safety profile characterized by little effect on vital signs or clinical laboratory values, reported adverse events that are mild to moderate, and no known drug-drug interactions. The tolerability of levetiracetam may extend to both pediatric and elderly patients based on analyses of small numbers of patients. Tolerability is maintained over the long term. Levetirac-etam does not appear to have a different safety profile in learning-disabled patients. Levetiracetam appears to have a good balance between tolerability and efficacy in the treatment of a wide variety of patients with partial epilepsy.

  3. [Safety profile of dolutegravir].

    PubMed

    Rivero, Antonio; Domingo, Pere

    2015-03-01

    Integrase inhibitors are the latest drug family to be added to the therapeutic arsenal against human immunodeficiency virus infection. Drugs in this family that do not require pharmacological boosting are characterized by a very good safety profile. The latest integrase inhibitor to be approved for use is dolutegravir. In clinical trials, dolutegravir has shown an excellent tolerability profile, both in antiretroviral-naïve and previously treated patients. Discontinuation rates due to adverse effects were 2% and 3%, respectively. The most frequent adverse effects were nausea, headache, diarrhea and sleep disturbance. A severe hypersensitivity reaction has been reported in only one patient. In patients coinfected with hepatropic viruses, the safety profile is similar to that in patients without coinfection. The lipid profile of dolutegravir is similar to that of raltegravir and superior to those of Atripla® and darunavir/ritonavir. Dolutegravir induces an early, predictable and non-progressive increase in serum creatinine of around 10% of baseline values in treatment-naïve patients and of 14% in treatment-experienced patients. This increase is due to inhibition of tubular creatinine secretion through the OCT2 receptor and does not lead to a real decrease in estimated glomerular filtration rate with algorithms that include serum creatinine. The effect of the combination of dolutegravir plus Kivexa(®) on biomarkers of bone remodeling is lower than that of Atripla(®). Dolutegravir has an excellent tolerability profile with no current evidence of long-term adverse effects. Its use is accompanied by an early and non-progressive increase in serum creatinine due to OCT2 receptor inhibition. In combination with abacavir/lamivudine, dolutegravir has a lower impact than enofovir/emtricitabine/efavirenz on bone remodelling markers.

  4. Laquinimod Safety Profile

    PubMed Central

    Comi, Giancarlo; Vollmer, Timothy L.; Montalban, Xavier; Kappos, Ludwig; Dadon, Yuval; Gorfine, Tali; Margalit, Maya; Sasson, Nissim; Rubinchick, Svetlana; Knappertz, Volker

    2017-01-01

    Background: Laquinimod 0.6 mg is a once-daily, oral, disease-modifying therapy in development for the treatment of multiple sclerosis (MS) that was investigated in two double-blind, placebo-controlled, phase 3 trials: ALLEGRO and BRAVO. Methods: Data from these studies were pooled to assess the safety profile of laquinimod versus placebo. Adverse events (AEs), laboratory value changes, and potential risks identified in preclinical studies were evaluated in participants in ALLEGRO and BRAVO treated with at least one dose of laquinimod or matching placebo (1:1 random assignment). Results: In total, 1988 patients received at least one dose of study drug (laquinimod: n = 983 [mean ± SD duration, 639 ± 190 days]; placebo: n = 1005 [mean ± SD duration, 627 ± 198 days]). Early terminations due to AEs were infrequent (laquinimod: 6.4%; placebo: 4.7%). Death was reported in four patients (laquinimod: n = 1; placebo: n = 3). Rates of serious AEs (including malignancies, infections, and cardiovascular AEs) were similar between groups. The most common AEs identified with laquinimod use were back and neck pain and appendicitis. Laquinimod was also associated with asymptomatic changes in liver enzyme levels, fibrinogen levels, and hematologic parameters that followed a consistent temporal pattern: mild, nonprogressive, and occurring within 90 days of treatment initiation, then stabilizing or reverting to baseline levels during continued treatment. Conclusions: Data from these pivotal laquinimod studies demonstrate a safety profile comprising benign or manageable AEs and asymptomatic laboratory findings with a clear temporal pattern. Potential risks noted in preclinical studies were not observed. PMID:28243182

  5. Nuclear safety technology and public acceptance

    NASA Astrophysics Data System (ADS)

    Kienle, F.

    1985-11-01

    In the years 1976 to 1982 officialdom intensified the safety regulations in German nuclear power plants out of all proportion, without actually bringing about a recognizable plus in safety or indeed a greater acceptance by the public of the peaceful use of nuclear energy. Although the risk to employees of nuclear power plants and to the population living in their vicinity is substantially smaller than the dangers of modern civilization, the general public still regards with concern the consequences of radioactive exposure and the hazards to later generations from long-life radionuclides. The task for the coming years must be to maintain the safety standard now attained, while simultaneously reducing those exaggerated individual requirements in order to establish a balance in safety precautions. Additionally, a proposal put forward by Sir Walter Marshall, Chairman of the CEGB, should be pursued, i.e., to put the presumed risks of nuclear energy into their correct perspective in the public eye using comprehensible comparisons such as the risks from active or passive smoking. This cannot be accomplished by quoting abstract statistics.

  6. Profile of the capsaicin 8% patch for the management of neuropathic pain associated with postherpetic neuralgia: safety, efficacy, and patient acceptability

    PubMed Central

    Laklouk, Muhammad; Baranidharan, Ganesan

    2016-01-01

    Capsaicin is a naturally occurring irritant active ingredient found in hot peppers. It is a ligand for transient receptor potential channel vanilloid receptors, which are found in nociceptive nerve terminals in the skin. Initial exposure to topical capsaicin leads to excitation of these receptors, release of vasoactive mediators, erythema, intense burning, pain, and thereafter desensitization of sensory neurons resulting in inhibition of pain transmission. Capsaicin 8% has been licensed for the treatment of postherpetic neuralgia pain in recent years. A single application of high-concentration capsaicin for 60 minutes for postherpetic neuralgia has been robustly evaluated. Capsaicin 8% patches are applied to the most painful areas of healthy skin and allowed to remain for 60 minutes. Treatment can be repeated every 90 days if the pain persists or returns. The patches are usually applied in specialist pain clinics where patients can be pretreated and monitored. Health care staff need to take certain precautions before administering these patches to avoid unintentional contact. Common adverse effects of the capsaicin 8% patch are transient mild-to-moderate self-limiting application-site burning, pain, erythema, pruritus, papules, swelling, dryness, and hypertension. To manage local pain from capsaicin application, the skin is pretreated with a local anesthetic such as topical lidocaine or an oral analgesic such as oxycodone for up to 5 days. A transient increase in pain is usually seen within 48 hours of patch application before the pain-relieving effect starts. Systemic absorption is minimal and clinically insignificant. The nature of administration and relatively high cost of capsaicin patches can significantly limit their use to a small number of patients with severe refractory symptoms. This review highlights recent evidence related to the use and effectiveness of the 8% capsaicin patch for Postherpetic Neuralgia and discusses its safety and side-effect profiles

  7. Profile of the capsaicin 8% patch for the management of neuropathic pain associated with postherpetic neuralgia: safety, efficacy, and patient acceptability.

    PubMed

    Laklouk, Muhammad; Baranidharan, Ganesan

    2016-01-01

    Capsaicin is a naturally occurring irritant active ingredient found in hot peppers. It is a ligand for transient receptor potential channel vanilloid receptors, which are found in nociceptive nerve terminals in the skin. Initial exposure to topical capsaicin leads to excitation of these receptors, release of vasoactive mediators, erythema, intense burning, pain, and thereafter desensitization of sensory neurons resulting in inhibition of pain transmission. Capsaicin 8% has been licensed for the treatment of postherpetic neuralgia pain in recent years. A single application of high-concentration capsaicin for 60 minutes for postherpetic neuralgia has been robustly evaluated. Capsaicin 8% patches are applied to the most painful areas of healthy skin and allowed to remain for 60 minutes. Treatment can be repeated every 90 days if the pain persists or returns. The patches are usually applied in specialist pain clinics where patients can be pretreated and monitored. Health care staff need to take certain precautions before administering these patches to avoid unintentional contact. Common adverse effects of the capsaicin 8% patch are transient mild-to-moderate self-limiting application-site burning, pain, erythema, pruritus, papules, swelling, dryness, and hypertension. To manage local pain from capsaicin application, the skin is pretreated with a local anesthetic such as topical lidocaine or an oral analgesic such as oxycodone for up to 5 days. A transient increase in pain is usually seen within 48 hours of patch application before the pain-relieving effect starts. Systemic absorption is minimal and clinically insignificant. The nature of administration and relatively high cost of capsaicin patches can significantly limit their use to a small number of patients with severe refractory symptoms. This review highlights recent evidence related to the use and effectiveness of the 8% capsaicin patch for Postherpetic Neuralgia and discusses its safety and side-effect profiles.

  8. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

    PubMed Central

    González-Rodríguez, Alexandre; Catalán, Rosa; Penadés, Rafael; Garcia-Rizo, Clemente; Bioque, Miquel; Parellada, Eduard; Bernardo, Miquel

    2015-01-01

    Background and objectives Short-term studies focused on once-monthly paliperidone palmitate (PP) at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations. Method Electronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available. Results Nineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically ill patients, as well as in acute and nonacute symptomatic schizophrenia patients, and a similar proportion of treatment-emergent adverse events between both groups were also noted. Conclusion Several studies have demonstrated that schizophrenia patients treated with PP show higher rates of improvement of psychotic symptoms compared to placebo, and similar efficacy and tolerability outcomes were noted when comparing PP to risperidone long-acting injectable or oral, paliperidone extended release. PMID:26082620

  9. Acceptance test report for the safety class shutdown system

    SciTech Connect

    Zuroff, W.F.

    1996-10-17

    This document provides the Acceptance Test Report for the successful testing of the Safety Shutdown Circuit. The test was done in accordance with the requirements that were defined in WHC-SD-WM-SCH-003, Interim Stabilization Safety Class Trip Circuit CGI Dedication Criteria. The actual test procedure document was contained in WHC-SD-WM-ATP-185, Acceptance Test Procedure for the Safety Class Shutdown System.

  10. Laser safety at high profile projects

    NASA Astrophysics Data System (ADS)

    Barat, K.

    2011-03-01

    Laser Safety at high profile laser facilities tends to be more controlled than in the standard laser lab found at a research institution. The reason for this is the potential consequences for such facilities from incidents. This ranges from construction accidents, to equipment damage to personnel injuries. No laser user wants to sustain a laser eye injury. Unfortunately, many laser users, most commonly experienced researchers and inexperienced graduate students, do receive laser eye injuries during their careers. . More unforgiveable is the general acceptance of this scenario, as part of the research & development experience. How do senior researchers, safety personnel and management stop this trend? The answer lies in a cultural change that involves institutional training, user mentoring, hazard awareness by users and administrative controls. None of these would inhibit research activities. As a matter of fact, proper implementation of these controls would increase research productivity. This presentation will review and explain the steps needed to steer an institution, research division, group or individual lab towards a culture that should nearly eliminate laser accidents. As well as how high profile facilities try to avoid laser injuries. Using the definition of high profile facility as one who's funding in the million to billions of dollars or Euros and derives form government funding.

  11. Safety and tolerance profile of venlafaxine.

    PubMed

    Danjou, P; Hackett, D

    1995-03-01

    Venlafaxine has been shown in clinical trials to be safe and well tolerated in patients with major depression. Data were pooled from 19 studies in which 2181 patients were given venlafaxine, 451 were given placebo and 591 were given a reference antidepressant (imipramine, trazodone, clomipramine, maprotiline, dothiepin or amineptine). Long-term safety was evaluated in 422 patients who were given venlafaxine for at least 1 year; as well, a total of 229 elderly patients have been treated with venlafaxine, including 66 who were given it for at least 1 year. The adverse events that occurred during short-term treatment in > or = 10% of patients were nausea, headache, insomnia, somnolence, dry mouth, dizziness, constipation, asthenia, sweating and nervousness. In comparator-controlled trials, the frequency of anticholinergic events with the reference agents was approximately twice that with venlafaxine. The safety profile and patient acceptability of venlafaxine are comparable to those of third-generation antidepressants, and possibly better than those of first-generation agents.

  12. Consumer acceptance and sensory profiling of reengineered kitoza products.

    PubMed

    Pintado, Ana I E; Monteiro, Maria J P; Talon, Régine; Leroy, Sabine; Scislowski, Valérie; Fliedel, Geneviève; Rakoto, Danielle; Maraval, Isabelle; Costa, Ana I A; Silva, Ana P; Pallet, Dominique; Tomlins, Keith; Pintado, Manuela M E

    2016-05-01

    Kitoza refers to a traditional way of preparing beef and pork in Madagascar. However, in order to improve some drawbacks previous identified, the product was submitted to a reengineering process. The acceptance and sensory profiling of improved Kitoza products among Portuguese consumers was investigated. A local smoked loin sausage was selected as basis for comparison. Firstly, a Focus Group study was performed to identify sensory descriptors for Kitoza products and explore product perception. Subsequently, a Flash Profile and a consumer sensory acceptance study were conducted. Flash Profile's results showed that beef- and pork-based Kitoza products investigated differed considerably in all sensory dimensions. The Portuguese sausage was characterized as having a more intense and lasting after taste, as well as displaying a higher degree of (meat) doneness. The acceptance study yielded higher overall liking ratings for pork- than for beef-based Kitoza, although the Portuguese sausage remained the most appreciated product.

  13. Enteral feeding pumps: efficacy, safety, and patient acceptability

    PubMed Central

    White, Helen; King, Linsey

    2014-01-01

    Enteral feeding is a long established practice across pediatric and adult populations, to enhance nutritional intake and prevent malnutrition. Despite recognition of the importance of nutrition within the modern health agenda, evaluation of the efficacy of how such feeds are delivered is more limited. The accuracy, safety, and consistency with which enteral feed pump systems dispense nutritional formulae are important determinants of their use and acceptability. Enteral feed pump safety has received increased interest in recent years as enteral pumps are used across hospital and home settings. Four areas of enteral feed pump safety have emerged: the consistent and accurate delivery of formula; the minimization of errors associated with tube misconnection; the impact of continuous feed delivery itself (via an enteral feed pump); and the chemical composition of the casing used in enteral feed pump manufacture. The daily use of pumps in delivery of enteral feeds in a home setting predominantly falls to the hands of parents and caregivers. Their understanding of the use and function of their pump is necessary to ensure appropriate, safe, and accurate delivery of enteral nutrition; their experience with this is important in informing clinicians and manufacturers of the emerging needs and requirements of this diverse patient population. The review highlights current practice and areas of concern and establishes our current knowledge in this field. PMID:25170284

  14. Enteral feeding pumps: efficacy, safety, and patient acceptability.

    PubMed

    White, Helen; King, Linsey

    2014-01-01

    Enteral feeding is a long established practice across pediatric and adult populations, to enhance nutritional intake and prevent malnutrition. Despite recognition of the importance of nutrition within the modern health agenda, evaluation of the efficacy of how such feeds are delivered is more limited. The accuracy, safety, and consistency with which enteral feed pump systems dispense nutritional formulae are important determinants of their use and acceptability. Enteral feed pump safety has received increased interest in recent years as enteral pumps are used across hospital and home settings. Four areas of enteral feed pump safety have emerged: the consistent and accurate delivery of formula; the minimization of errors associated with tube misconnection; the impact of continuous feed delivery itself (via an enteral feed pump); and the chemical composition of the casing used in enteral feed pump manufacture. The daily use of pumps in delivery of enteral feeds in a home setting predominantly falls to the hands of parents and caregivers. Their understanding of the use and function of their pump is necessary to ensure appropriate, safe, and accurate delivery of enteral nutrition; their experience with this is important in informing clinicians and manufacturers of the emerging needs and requirements of this diverse patient population. The review highlights current practice and areas of concern and establishes our current knowledge in this field.

  15. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children.

    PubMed

    Knuf, Markus; Pantazi-Chatzikonstantinou, Anna; Pfletschinger, Ulrich; Tichmann-Schumann, Irmingard; Maurer, Hartwig; Maurer, Lothar; Fischbach, Thomas; Zinke, Henrike; Pankow-Culot, Heidemarie; Papaevangelou, Vassiliki; Bianco, Veronique; Van der Wielen, Marie; Miller, Jacqueline M

    2011-06-06

    Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months. Pre-specified criteria for non-inferiority of immunogenicity following co-administration versus separate ACWY-TT and DTaP-HBV-IPV/Hib administration were reached. One month post-vaccination, ≥ 97.3% of ACWY-TT vaccinees had rSBA titres ≥ 1:8 (all serogroups). Seroprotection/seropositivity rates against DTaP-HBV-IPV/Hib antigens were ≥ 98.2%. The safety profile of co-administration was similar to that of DTaP-HBV-IPV/Hib alone. ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.

  16. Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer

    PubMed Central

    Lousberg, Laurence; Jerusalem, Guy

    2016-01-01

    Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus–exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile. PMID:28096680

  17. Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer.

    PubMed

    Lousberg, Laurence; Jerusalem, Guy

    2016-01-01

    Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus-exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile.

  18. Of Acceptable Risk: Science and the Determination of Safety.

    ERIC Educational Resources Information Center

    Lowrance, William W.

    This book looks at the problems of determination of safety and the underlying concept of safety itself. It is believed that if certain pervasive themes are properly appreciated, the whole field of safety will be better understood. The first chapter of the book sketches the general nature of safety decisions, defining safety as a measure of the…

  19. 49 CFR 174.9 - Safety and security inspection and acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Safety and security inspection and acceptance. 174... RAIL General Requirements § 174.9 Safety and security inspection and acceptance. (a) At each location... suspicious items or items that do not belong, and for other signs that the security of the car may have...

  20. Biologic Therapy in Psoriasis: Safety Profile.

    PubMed

    Campanati, Anna; Ganzetti, Giulia; Giuliodori, K; Molinelli, Elisa; Offidani, A

    2016-01-01

    This review focuses on the emerging concepts concerning the efficacy profile of biological drugs in psoriasis ranging from moderate to severe, and attempts to provide the most recent individual positioning of biologics in treating psoriasis. Biologic agents targeting towards specific immune mediators have emerged as treatment options for patients with moderate to-severe plaque psoriasis unresponsive or intolerant to traditional systemic agents. Data on the safety of biologics are available for up to 5 years in psoriasis and are on the whole reassuring. National registries are still evolving and will provide data on safety, to help the long-term monitoring of patients with psoriasis ongoing biological treatment. Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to relative lack of long-term safety data, especially for those who have been commercialized recently. Here, we have reviewed the long-term safety data obtained from National Registries, randomized controlled trials, open-label extension studies and meta-analyses on etanercept, infliximab, adalimumab, and ustekinumab in the treatment of adults with moderate to severe plaque psoriasis.

  1. The safety profile of drotrecogin alfa (activated)

    PubMed Central

    Fumagalli, Roberto; Mignini, Mariano A

    2007-01-01

    Continued safety assessment is essential for any newly approved therapy. Drotrecogin alfa (activated; DrotAA), which is approved for use in severe sepsis, has undergone clinical trials with corresponding safety analyses since 1995. However, the only comprehensive review of all trials is that reported in 2003 by Bernard and coworkers. This is an important review that focuses on the safety profile of DrotAA in all published studies (six randomized clinical trials and five national registry studies) and in previously unpublished data. DrotAA treatment is associated with an increased risk for bleeding (which in general is manageable). Nevertheless, the available evidence shows that any adverse effects of DrotAA are outweighed by its benefits in patients with severe sepsis who are at high risk for death. So far, more than 9,000 patients have been enrolled in clinical trials involving DrotAA, providing a valuable safety database. It is of note that although DrotAA does increase the risk of bleeding, this has not been associated with an overall increase in the rate of all severe adverse events. PMID:18269693

  2. Confinement and the safety factor profile

    SciTech Connect

    Batha, S.H.; Levinton, F.M.; Scott, S.D.

    1995-12-01

    The conjecture that the safety factor profile, q(r), controls the improvement in tokamak plasmas from poor confinement in the Low (L-) mode regime to improved confinement in the supershot regime has been tested in two experiments on the Tokamak Fusion Test Reactor (TFTR). First, helium was puffed into the beam-heated phase of a supershot discharge which induced a degradation from supershot to L-mode confinement in about 100 msec, far less than the current relaxation time. The q and shear profiles measured by a motional Stark effect polarimeter showed little change during the confinement degradation. Second, rapid current ramps in supershot plasmas altered the q profile, but were observed not to change significantly the energy confinement. Thus, enhanced confinement in supershot plasmas is not due to a particular q profile which has enhanced stability or transport properties. The discharges making a continuous transition between supershot and L-mode confinement were also used to test the critical-electron-temperature-gradient transport model. It was found that this model could not reproduce the large changes in electron and ion temperature caused by the change in confinement.

  3. Addressing patient safety through the use of 'criteria of acceptability' for medical radiation equipment.

    PubMed

    Gilley, Debbie Bray; Holmberg, Ola

    2013-02-01

    Patient safety should be considered in the use of ionising radiation equipment in medicine. The International Atomic Energy Agency (IAEA) establishes standards of safety and provides for the application of these standards, also in the area of medical use of radiation. Equipment acceptability, as it relates to radiation in medicine, is the need to satisfy the requirements or standards prior to the use of the device in patient imaging or treatment. Through IAEA activities in establishing and developing Safety Standards, Safety Reports and recommendations to regulatory authorities and end-users, it encourages the adoption of acceptability criteria that are relevant to the medical equipment and its use.

  4. [Demonstrating patient safety requires acceptance of a broader scientific palette].

    PubMed

    Leistikow, I

    2017-01-01

    It is high time the medical community recognised that patient-safety research can be assessed using other scientific methods than the traditional medical ones. There is often a fundamental mismatch between the methodology of patient-safety research and the methodology used to assess the quality of this research. One example is research into the reliability and validity of record review as a method for detecting adverse events. This type of research is based on logical positivism, while record review itself is based on social constructivism. Record review does not lead to "one truth": adverse events are not measured on the basis of the records themselves, but by weighing the probability of certain situations being classifiable as adverse events. Healthcare should welcome behavioural and social sciences to its scientific palette. Restricting ourselves to the randomised control trial paradigm is short-sighted and dangerous; it deprives patients of much-needed improvements in safety.

  5. Safety profile of lamotrigine in overdose

    PubMed Central

    Alabi, Akintunde; Todd, Adam; Husband, Andrew; Reilly, Joe

    2016-01-01

    Background: Lamotrigine is an anticonvulsant as well as a mood stabilizer. Apart from its established use in the treatment of epilepsy, there has been an expansion of its use in the treatment of mental disorders. Patients with epilepsy as well as those with mental disorders are at increased risk of deliberate drug overdoses. An evidence base for the safety profile of lamotrigine in overdose is an essential tool for prescribers. The objective of this study was to carry out a narrative synthesis of the existing evidence for the safety profile of lamotrigine in overdose. Methods: A systematic search was conducted of EMBASE (1974 to December 2015), MEDLINE (1946 to December 2015), PsycINFO (1806 to December 2015) and CINAHL (1981 to December 2015) databases. Studies were included in which there was a deliberate or accidental single drug overdose of lamotrigine, with its toxic effects described. Studies that did not involve an overdose were excluded. A narrative synthesis of the described toxic effects was carried out. Results: Out of 562 articles identified, 26 studies were included, mainly in the form of case reports and series. The most commonly described toxic effects of lamotrigine were on the central nervous system, specifically seizures, movement disorders and reduced consciousness. Other toxic effects included QTc interval and QRS complex prolongations, hypersensitivity reactions, serotonin syndrome as well as rhabdomyolysis possibly due to seizures and/or agitation. Deaths were recorded in two studies, with cardiovascular and neurological toxic effects described. Conclusions: Even though lamotrigine has been reported to be well tolerated, there is a risk of toxic effects which can be life threatening in overdose. This needs to be borne in mind when prescribing to patients at an increased risk of deliberate drug overdose. PMID:28008350

  6. Space Reactor Launch Safety--An Acceptably Low Risk

    SciTech Connect

    Weitzberg, Abraham; Wright, Steven

    2008-01-21

    Results from previous space reactor and radioisotope power source risk assessments were combined to provide a scoping assessment of the possible risks from the launch of a reactor power system for use on the surface of the moon or Mars. It is assumed that future reactor power system launches would be subject to the same rigorous safety analysis and launch approval process as past nuclear payload launches. Using the same methodology that has gained approval of past launches, it was determined that the mission risk would be 0.029 person-rem worldwide which translates to 1.5*10{sup -5} latent health effects. It is seen that the only significant sources of radiological risks from a non-operating reactor are possible inadvertent criticality accidents and the consequences of such events have been shown to be extremely low. Passive means such as spectral shift poisons or high reactor core length/diameter ratios have been shown to be able to reduce or eliminate the possibility of the more credible criticality accidents, such as flooding or sand burial. This paper advances the premise that, for design purposes, future space reactor surface-power designs should primarily address the credible accidents and not the hypothetical accidents. For launch accidents and other safety assessments, a probabilistic risk assessment approach will have to be used to assess the safety impact of all types of accidents, including the hypothetical accidents. With this approach, the design of the system will not be burdened with design features that are based on hypothetical criticality accidents having negligible risk. Moreover, there is little chance of convincingly demonstrating that these design features can substantially reduce or eliminated the risk associated with hypothetical criticality accidents.

  7. Efficacy, safety, and patient acceptability of the Essure™ procedure

    PubMed Central

    Lessard, Collette R; Hopkins, Matthew R

    2011-01-01

    The Essure™ system for permanent contraception was developed as a less invasive method of female sterilization. Placement of the Essure™ coil involves a hysteroscopic transcervical technique. This procedure can be done in a variety of settings and with a range of anesthetic options. More than eight years have passed since the US Food and Drug Administration approval of Essure™. Much research has been done to evaluate placement success, adverse outcomes, satisfaction, pain, and the contraceptive efficacy of the Essure™. The purpose of this review is to summarize the available literature regarding the efficacy, safety, and patient satisfaction with this new sterilization technique. PMID:21573052

  8. A Cross Sectional Study on Acceptability and Safety of IUCD among Postpartum Mothers at Tertiary Care Hospital, Telangana

    PubMed Central

    Jairaj, Sangeetha

    2016-01-01

    Introduction India is world’s 2nd largest populated country. It is first to introduce family planning services. IUCD is most effective, safe, long acting and do not interfere with coitus. Immediately or within 72 hours after delivery of placenta in a health care facility is convenient for those who are in outreach area, where family planning facilities are less available. Objectives To study the socio demographic profile of parturients attended to obstetric ward for delivery. To assess the acceptability and safety of IUCD among study population Materials and Methods A cross-sectional study was conducted among eligible postpartum women at Gandhi hospital secunderabad. Counseling was given about IUCD. After obtaining consent, Cu-T 380 was inserted in a 250 women, followed up to 6 weeks. The reasons for both acceptance and decline were recorded. Results Mean age of acceptance was 23.70±2.95 years. Majority were from urban area (79.75%). Acceptance was more in those who completed their secondary school level education (23.3%). Women undergoing caesarean section were accepting PPIUCD, more frequently than those who underwent normal vaginal delivery. Majority (67.12%) accepters told that they accepted IUCD because it is a reversible method. Main reported complications were pain abdomen (17.14%), bleeding (14.28%). Expulsion rate was 6.8%. Most common reason (40%) for removal of IUCD was inclination to other methods. Conclusion Even though expulsion rate high with, acceptance was high IUCD when it is inserted in postpartum period. PMID:26894092

  9. Occupational Therapy and Sensory Integration for Children with Autism: A Feasibility, Safety, Acceptability and Fidelity Study

    ERIC Educational Resources Information Center

    Schaaf, Roseann C.; Benevides, Teal W.; Kelly, Donna; Mailloux-Maggio, Zoe

    2012-01-01

    Objective: To examine the feasibility, safety, and acceptability of a manualized protocol of occupational therapy using sensory integration principles for children with autism. Methods: Ten children diagnosed with autism spectrum disorder ages 4-8 years received intensive occupational therapy intervention using sensory integration principles…

  10. 49 CFR 174.9 - Safety and security inspection and acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Safety and security inspection and acceptance. 174.9 Section 174.9 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS... security plan (see subpart I of part 172 of this subchapter) to address the security issues...

  11. 49 CFR 174.9 - Safety and security inspection and acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 2 2013-10-01 2013-10-01 false Safety and security inspection and acceptance. 174.9 Section 174.9 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS... security plan (see subpart I of part 172 of this subchapter) to address the security issues...

  12. 49 CFR 174.9 - Safety and security inspection and acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 2 2014-10-01 2014-10-01 false Safety and security inspection and acceptance. 174.9 Section 174.9 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS... security plan (see subpart I of part 172 of this subchapter) to address the security issues...

  13. Ensuring an acceptable reliability and safety level for a launch complex

    NASA Astrophysics Data System (ADS)

    Kadzhaev, Vadim; Barmin, Igor; Denoyers, Jean-Yves; Ragot, Alain

    2011-04-01

    Some key aspects and criteria tasks for ensuring an acceptable reliability and safety level for complex technical systems are discussed in the view of successful operation of a launch complex, at the stage of Launch Vehicle (LV) preparation. The standards and principles of adequate characteristics for launch site core technological systems are defined. The tasks for evaluation the probability of faultless operation for the systems, their reliability a posteriori, and safety barriers formation are described. The model of the pre-launch phase is presented as a random process, in the form of "simple Poisson flow".

  14. Driver behaviour profiles for road safety analysis.

    PubMed

    Ellison, Adrian B; Greaves, Stephen P; Bliemer, Michiel C J

    2015-03-01

    Driver behaviour is a contributing factor in over 90 percent of road crashes. As a consequence, there is significant benefit in identifying drivers who engage in unsafe driving practices. Driver behaviour profiles (DBPs) are introduced here as an approach for evaluating driver behaviour as a function of the risk of a casualty crash. They employ data collected using global positioning system (GPS) devices, supplemented with spatiotemporal information. These profiles are comprised of common risk scores that can be used to compare drivers between each other and across time and space. The paper details the development of these DBPs and demonstrates their use as an input into modelling the factors that influence driver behaviour. The results show that even having controlled for the influence of the road environment, these factors remain the strongest predictors of driver behaviour suggesting different spatiotemporal environments elicit a variety of psychological responses in drivers. The approach and outcomes will be of interest to insurance companies in enhancing the risk-profiling of drivers with on-road driving and government through assessing the impacts of behaviour-change interventions.

  15. Profiling contextual factors which influence safety in heavy vehicle industries.

    PubMed

    Edwards, Jason R D; Davey, Jeremy; Armstrong, Kerry A

    2014-12-01

    A significant proportion of worker fatalities within Australia result from truck-related incidents. Truck drivers face a number of health and safety concerns. Safety culture, viewed here as the beliefs, attitudes and values shared by an organisation's workers, which interact with their surrounding context to influence behaviour, may provide a valuable lens for exploring safety-related behaviours in heavy vehicle operations. To date no major research has examined safety culture within heavy vehicle industries. As safety culture provides a means to interpret experiences and generate behaviour, safety culture research should be conducted with an awareness of the context surrounding safety. The current research sought to examine previous health and safety research regarding heavy vehicle operations to profile contextual factors which influence health and safety. A review of 104 peer-reviewed papers was conducted. Findings of these papers were then thematically analysed. A number of behaviours and scenarios linked with crashes and non-crash injuries were identified, along with a selection of health outcomes. Contextual factors which were found to influence these outcomes were explored. These factors were found to originate from government departments, transport organisations, customers and the road and work environment. The identified factors may provide points of interaction, whereby culture may influence health and safety outcomes.

  16. 41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... responsibility for determining the acceptability of each equivalent level of safety analysis? 102-80.125 Section... (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety Analysis § 102-80.125 Who has the responsibility...

  17. The cardiovascular safety profile of escitalopram.

    PubMed

    Thase, Michael E; Larsen, Klaus G; Reines, Elin; Kennedy, Sidney H

    2013-11-01

    The cardiovascular effects of escitalopram were examined in a large group of participants in double-blind, randomized, placebo-controlled studies. Escitalopram (n=3298) was administered at doses between 5 and 20mg/day. Patients were treated in acute (8-12 weeks) and long-term (24 weeks) studies. Assessment of cardiovascular safety included heart rate, blood pressure (BP), treatment-emergent adverse events (TEAEs) and electrocardiograms (ECGs). In the short-term, there was a small, but statistically significant 2 beats per minute decrease in heart rate with escitalopram compared with placebo. The difference compared to placebo in systolic or diastolic BP was not clinically or statistically significant. Valid ECG assessments at both baseline and last assessment were available for 2407 escitalopram patients and 1952 placebo patients. Escitalopram-placebo differences in mean changes in ECG values were not clinically meaningful. The mean difference to placebo in the corrected QT [Fridericia's (QTcF)] interval was 3.5 ms (all escitalopram doses); 1.3 ms (escitalopram 10mg) and 1.7 ms (escitalopram 20mg) (p=0.2836 for 10 versus 20 mg). One out of 2407 escitalopram patients had a QTcF interval >500 ms and a change from baseline >60 ms. The incidence and types of cardiac-associated adverse events were similar between patients treated for 8-12 weeks with placebo (2.2%) or escitalopram (1.9%) and for 24 weeks with placebo (2.7%) or escitalopram (2.3%). Analyses of data from long-term studies and studies of the elderly showed similar results. In conclusion, these data demonstrate that escitalopram, like other SSRIs, has a statistically significant effect on heart rate and no clinically meaningful effect on ECG values, BP, with a placebo-level incidence of cardiac-associated adverse events.

  18. Passion fruit juice with different sweeteners: sensory profile by descriptive analysis and acceptance.

    PubMed

    Rocha, Izabela Furtado de Oliveira; Bolini, Helena Maria André

    2015-03-01

    This study evaluated the effect of different sweeteners on the sensory profile, acceptance, and drivers of preference of passion fruit juice samples sweetened with sucrose, aspartame, sucralose, stevia, cyclamate/saccharin blend 2:1, and neotame. Sensory profiling was performed by 12 trained assessors using quantitative descriptive analysis (QDA). Acceptance tests (appearance, aroma, flavor, texture and overall impression) were performed with 124 consumers of tropical fruit juice. Samples with sucrose, aspartame and sucralose showed similar sensory profile (P < 0.05), without bitter taste, bitter aftertaste, and metallic taste, and samples with sucrose and sucralose did not differ from each other for the attribute sweet aftertaste. Passion fruit flavor affected positively and sweet aftertaste affected negatively the acceptance of the samples. Samples sweetened with aspartame, sucralose, and sucrose presented higher acceptance scores for the attributes flavor, texture, and overall impression, with no significant (P < 0.05) differences between them. Aspartame and sucralose can be good substitutes for sucrose in passion fruit juice.

  19. Passion fruit juice with different sweeteners: sensory profile by descriptive analysis and acceptance

    PubMed Central

    Rocha, Izabela Furtado de Oliveira; Bolini, Helena Maria André

    2015-01-01

    This study evaluated the effect of different sweeteners on the sensory profile, acceptance, and drivers of preference of passion fruit juice samples sweetened with sucrose, aspartame, sucralose, stevia, cyclamate/saccharin blend 2:1, and neotame. Sensory profiling was performed by 12 trained assessors using quantitative descriptive analysis (QDA). Acceptance tests (appearance, aroma, flavor, texture and overall impression) were performed with 124 consumers of tropical fruit juice. Samples with sucrose, aspartame and sucralose showed similar sensory profile (P < 0.05), without bitter taste, bitter aftertaste, and metallic taste, and samples with sucrose and sucralose did not differ from each other for the attribute sweet aftertaste. Passion fruit flavor affected positively and sweet aftertaste affected negatively the acceptance of the samples. Samples sweetened with aspartame, sucralose, and sucrose presented higher acceptance scores for the attributes flavor, texture, and overall impression, with no significant (P < 0.05) differences between them. Aspartame and sucralose can be good substitutes for sucrose in passion fruit juice. PMID:25838891

  20. Companies' opinions and acceptance of global food safety initiative benchmarks after implementation.

    PubMed

    Crandall, Phil; Van Loo, Ellen J; O'Bryan, Corliss A; Mauromoustakos, Andy; Yiannas, Frank; Dyenson, Natalie; Berdnik, Irina

    2012-09-01

    International attention has been focused on minimizing costs that may unnecessarily raise food prices. One important aspect to consider is the redundant and overlapping costs of food safety audits. The Global Food Safety Initiative (GFSI) has devised benchmarked schemes based on existing international food safety standards for use as a unifying standard accepted by many retailers. The present study was conducted to evaluate the impact of the decision made by Walmart Stores (Bentonville, AR) to require their suppliers to become GFSI compliant. An online survey of 174 retail suppliers was conducted to assess food suppliers' opinions of this requirement and the benefits suppliers realized when they transitioned from their previous food safety systems. The most common reason for becoming GFSI compliant was to meet customers' requirements; thus, supplier implementation of the GFSI standards was not entirely voluntary. Other reasons given for compliance were enhancing food safety and remaining competitive. About 54 % of food processing plants using GFSI benchmarked schemes followed the guidelines of Safe Quality Food 2000 and 37 % followed those of the British Retail Consortium. At the supplier level, 58 % followed Safe Quality Food 2000 and 31 % followed the British Retail Consortium. Respondents reported that the certification process took about 10 months. The most common reason for selecting a certain GFSI benchmarked scheme was because it was widely accepted by customers (retailers). Four other common reasons were (i) the standard has a good reputation in the industry, (ii) the standard was recommended by others, (iii) the standard is most often used in the industry, and (iv) the standard was required by one of their customers. Most suppliers agreed that increased safety of their products was required to comply with GFSI benchmarked schemes. They also agreed that the GFSI required a more carefully documented food safety management system, which often required

  1. A randomized, double-blind placebo-controlled study on acceptability, safety and efficacy of oral administration of sacha inchi oil (Plukenetia volubilis L.) in adult human subjects.

    PubMed

    Gonzales, Gustavo F; Gonzales, Carla

    2014-03-01

    The study was designed to assess acceptability and side-effects of consumption of sacha inchi oil, rich in α-linolenic acid and sunflower oil, rich in linoleic acid, in adult human subjects. Thirty subjects received 10 or 15ml daily of sacha inchi or sunflower oil for 4months. Acceptability was assessed with daily self-report and with a Likert test at the end of the study. Safety was assessed with self- recording of side-effects and with hepatic and renal markers. Primary efficacy variables were the change in lipid profile. Subjects reported low acceptability of sacha inchi oil at week-1 (37.5%). However, since week-6, acceptability was significantly increased to 81.25-93.75%. No differences were observed in acceptability with respect to sex or oil volume (P>0.05). Most frequent adverse effects during first weeks of consuming sacha inchi oil or sunflower oil were nauseas. The side-effects were reduced with time. Biochemical markers of hepatic and kidney function were maintained unchanged. Serum total cholesterol and LDL cholesterol levels and arterial blood pressure were lowered with both oils (P<0.05). Higher HDL-cholesterol was observed with sacha inchi oil at month-4. In conclusion, sacha inchi oil consumed has good acceptability after week-1 of consumption and it is safety.

  2. Orally disintegrating vardenafil tablets for the treatment of erectile dysfunction: efficacy, safety, and patient acceptability

    PubMed Central

    Green, Roger; Hicks, Rodney W

    2011-01-01

    Background: Erectile dysfunction (ED) is a well-documented medical condition that is expected to increase significantly over the next several decades, especially as men live longer and the prevalence of diabetes and cardiovascular diseases increase. Pharmacology agents are often the first line treatment approach. Newer solid dosage forms, known as orally disintegrating tablets (ODT), are now available as one treatment option. Objectives: To review the drug delivery mechanisms of ODTs in general and to review safety and efficacy of vardenafil ODT (a PDE-5 inhibitor) as a treatment option for management of ED. Method: Literature reviews were performed of pharmaceutical dosage forms and the POTENT I (n = 358 subjects) and POTENT II (n = 337 subjects) studies that investigated vardenafil ODT. Results: Vardenafil ODT has been successfully used in multiple age groups and in multiple settings with men from various ethnic backgrounds. Efficacy of vardenafil ODT, as measured using the International Index of Erectile Function (IIEF-EF) and from the Sexual Encounter Profile (SEP) was significantly greater than placebo (P < 0.0001) at 12 weeks. Safety profiles were similar to film-coated dosage forms with no patient deaths reported. Conclusion: Vardenafil ODT offers a convenient, ready-to-use approach for combating ED. Safety concerns are similar to other PDE-5 inhibitors and practitioners should counsel patients accordingly. PMID:21573049

  3. Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women

    PubMed Central

    Cranston, Ross D.; Mayer, Kenneth H.; Febo, Irma; Duffill, Kathryn; Siegel, Aaron; Engstrom, Jarret C.; Nikiforov, Alexyi; Park, Seo-Young; Brand, Rhonda M.; Jacobson, Cindy; Giguere, Rebecca; Dolezal, Curtis; Frasca, Timothy; Leu, Cheng-Shiun; Schwartz, Jill L.; Carballo-Diéguez, Alex

    2016-01-01

    Objectives The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. Methods MSM and TGW aged 18–30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel. Results 248 participants were enrolled into Stage 1A. Participants’ average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity. Conclusions In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population. Trial Registration ClinicalTrials.gov NCT01283360 PMID:27362788

  4. Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide

    PubMed Central

    Coggins, C; Blanchard, K; Alvarez, F; Brache, V; Weisberg, E; Kilmarx, P; Lacarra, M; Massai, R; Mishell, D; Salvatierra, A; Witwatwongwana, P; Elias, C; Ellertson, C

    2000-01-01

    Objective: We sought to determine the safety and acceptability of vaginal gel formulation PC-503 among low risk, abstinent women. The active ingredient was 2% pharmaceutical grade lambda carrageenan, a sulphated polymer that is generally recognised as safe by the US Food and Drug Administration. Methods: 35 women in five sites applied 5 ml of the PC-503 gel vaginally once a day for 7 days while abstaining from sexual intercourse. Visual vaginal examinations were performed on days 1, 4, and 8. STI testing and vaginal pool Gram stain preparations were done on days 1 and 8. Participants were asked about product acceptability. Results: 34 of the 35 women enrolled completed 7 days' use. Following product use, five reported mild symptoms including "bladder fullness," "genital warmth," or discomfort, and lower abdominal pain, and one had moderate pale yellow cervical discharge. Using the Nugent criteria, three women had bacterial vaginosis (BV) before and after use; three had BV before but not after, and two had BV after but not before. Most of the women found PC-503 to be pleasant or neutral in feel and smell and considered extra lubrication to be an advantage; however, one third found it to be messy. Conclusions: Vaginal use of PC-503 gel did not cause significant adverse effects in a small number of low risk, sexually abstinent women. Further testing in larger numbers of sexually active women is planned. A smaller volume of gel may be more acceptable to some women. Key Words: microbicide; carrageenan PMID:11221133

  5. Efficacy, safety, acceptability and affordability of cryotherapy: a review of current literature.

    PubMed

    McClung, E C; Blumenthal, P D

    2012-04-01

    As a result of widespread screening and treatment programs, the incidence of cervical cancer has decreased by as much as 75% in the developed world. Commonly used treatment modalities for precancerous lesions include cone biopsy, the Loop Electrosurgical Excision Procedure (LEEP), laser ablation and cryotherapy. In recent years LEEP has replaced cryotherapy as a commonly provided outpatient procedure in many places; however increased awareness of the burden of cervical cancer in the developing world and increased awareness of long term consequences of LEEP ‑ such as cervical insufficiency ‑ have renewed interest in cryotherapy. We reviewed current literature addressing the technique, efficacy, safety and acceptability of cryotherapy, as well as special topics such as cost effectiveness, HIV, and low resource settings. Among studies we reviewed, cure rates ranged from 56.8-96.6% among prospective controlled trials and from 70-95.5% among observational studies. Cryotherapy has very low complication rates and serious complications requiring medical intervention or affecting future reproductive outcomes are extremely rare. Side effects including vaginal discharge and cramping are temporary, generally self-limited, and well tolerated after anticipatory patient counseling. When surveyed, women find cryotherapy highly acceptable. Compared to other treatment modalities, cryotherapy is very affordable and feasible to integrate into cervical cancer screening and treatment programs.

  6. Safety, Effectiveness and Acceptability of the PrePex Device for Adult Male Circumcision in Kenya

    PubMed Central

    Feldblum, Paul J.; Odoyo-June, Elijah; Obiero, Walter; Bailey, Robert C.; Combes, Stephanie; Hart, Catherine; Jou Lai, Jaim; Fischer, Shelly; Cherutich, Peter

    2014-01-01

    Objective To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya. Methods We enrolled 427 men ages 18–49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain. Results Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%–8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30–0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family. Conclusions The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates. Trial Registration ClinicalTrials.gov NCT01711411 PMID:24788898

  7. [Safety profile of rilpivirine: general and neuropsychiatric tolerability, safety in patients with hepatitis B or C viruses, and lipid profile].

    PubMed

    López Cortés, Luis F; Martínez, Esteban; von Wichmann, Miguel Ángel

    2013-06-01

    Currently available data on the safety and tolerability of rilpivirine come from the product information document, a phase IIb, dose-finding clinical trial (TMC278-C204), the phase III ECHO and THRIVE clinical trials, and the preliminary data from the STaR and SPIRIT clinical trials, with a total of 1,728 patients. The comparator has usually been efavirenz. All studies have found a lower incidence and severity of neuropsychiatric adverse effects, a better lipid profile, and a lower number of patients with subclinical transaminase elevation in patients treated with rilpivirine. However, because of the relatively low number of patients coinfected with hepatitis B or C virus, definitive conclusions cannot be drawn. Similarly, experience in patients with mild or moderate liver failure is limited and there are no safety data in patients with advanced liver failure.

  8. KSC 50-MHz Doppler Radar Wind Profiler (DRWP) Operational Acceptance Test (OAT) Report

    NASA Technical Reports Server (NTRS)

    Barbre, Robert E.

    2015-01-01

    This report documents analysis results of the Kennedy Space Center updated 50-MHz Doppler Radar Wind Profiler (DRWP) Operational Acceptance Test (OAT). This test was designed to demonstrate that the new DRWP operates in a similar manner to the previous DRWP for use as a situational awareness asset for mission operations at the Eastern Range to identify rapid changes in the wind environment that weather balloons cannot depict. Data examination and two analyses showed that the updated DRWP meets the specifications in the OAT test plan and performs at least as well as the previous DRWP. Data examination verified that the DRWP provides complete profiles every five minutes from 1.8-19.5 km in vertical increments of 150 m. Analysis of 5,426 wind component reports from 49 concurrent DRWP and balloon profiles presented root mean square (RMS) wind component differences around 2.0 m/s. The DRWP's effective vertical resolution (EVR) was found to be 300 m for both the westerly and southerly wind component, which the best EVR possible given the DRWP's vertical sampling interval. A third analysis quantified the sensitivity to rejecting data that do not have adequate signal by assessing the number of first-guess propagations at each altitude. This report documents the data, quality control procedures, methodology, and results of each analysis. It also shows that analysis of the updated DRWP produced results that were at least as good as the previous DRWP with proper rationale. The report recommends acceptance of the updated DRWP for situational awareness usage as per the OAT's intent.

  9. Results of the NASA Kennedy Space Center 50-MHz Doppler Radar Wind Profiler Operational Acceptance Test

    NASA Technical Reports Server (NTRS)

    Barbre', Robert E., Jr.; Decker, Ryan K.; Leahy, Frank B.; Huddleston, Lisa

    2016-01-01

    This paper presents results of the new Kennedy Space Center (KSC) 50-MHz Doppler Radar Wind Profiler (DRWP) Operational Acceptance Test (OAT). The goal of the OAT was to verify the data quality of the new DRWP against the performance of the previous DRWP in order to use wind data derived by the new DRWP for space launch vehicle operations support at the Eastern Range. The previous DRWP was used as a situational awareness asset for mission operations to identify rapid changes in the wind environment that weather balloons cannot depict. The Marshall Space Flight Center's Natural Environments Branch assessed data from the new DRWP collected during Jan-Feb 2015 against a specified set of test criteria. Data examination verified that the DRWP provides complete profiles every five minutes from 1.8-19.5 km in vertical increments of 150 m. Analysis of 49 concurrent DRWP and balloon profiles presented root mean square wind component differences around 2.0 m/s. Evaluation of the DRWP's coherence between five-minute wind pairs found the effective vertical resolution to be Nyquist-limited at 300 m for both wind components. In addition, the sensitivity to rejecting data that do not have adequate signal was quantified. This paper documents the data, quality control procedures, methodology, and results of each analysis.

  10. Effect of organic acid treatments on microbial safety and overall acceptability of fresh-cut melon cubes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    There is much interest in developing effective minimal processing methodologies for fruits and vegetables that would enhance the microbial safety and not change overall acceptability. In this study, several organic acids (EDTA, nisin, sorbic acid and sodium lactate) generally regarded as safe (GRAS)...

  11. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa

    PubMed Central

    Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

    2016-01-01

    Background This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. Methods 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. Results No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. Conclusions The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of

  12. Long-term safety and efficacy profile of simvastatin.

    PubMed

    Boccuzzi, S J; Bocanegra, T S; Walker, J F; Shapiro, D R; Keegan, M E

    1991-11-01

    Simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor, has been administered to approximately 2,400 patients with primary hypercholesterolemia with a mean follow-up of 1 year in controlled clinical studies and their open extensions. Approximately 10% of this population received simvastatin for a period of greater than or equal to 2 years. The population on whom this safety analysis is based had a mean age of 50 years; 62% were men and approximately 27% had preexisting coronary artery disease. Simvastatin was titrated to the maximal daily dose of 40 mg each evening in 56% of the study population (last recorded dose). The most frequently reported drug-related clinical adverse experiences were constipation (2.5%), abdominal pain (2.2%), flatulence (2.0%) and headaches (1%). Persistent elevations of serum transaminase levels greater than 3 times the upper limit of normal were observed in only 1% of this cohort with only 0.1% of the total population requiring discontinuation of therapy. There were no clinically apparent episodes of hepatitis. Discontinuation of therapy due to myopathy was extremely rare (0.08%). Only minimal increases in the frequency of lens opacities (1%) were observed from baseline to the last lens examination during follow-up, consistent with the expected increase in lens opacity development due to normal aging. Patients who were greater than or equal to 65 years old had a clinical and laboratory safety profile comparable to the nonelderly population.(ABSTRACT TRUNCATED AT 250 WORDS)

  13. Safety and Acceptability of Community-Based Distribution of Injectable Contraceptives: A Pilot Project in Mozambique

    PubMed Central

    Jacinto, Ana; Mobaracaly, Mahomed Riaz; Ustáb, Momade Bay; Bique, Cassimo; Blazer, Cassandra; Weidert, Karen; Prata, Ndola

    2016-01-01

    ABSTRACT Mozambique has witnessed a climbing total fertility rate in the last 20 years. Nearly one-third of married women have an unmet need for family planning, but the supply of family planning services is not meeting the demand. This study aimed to explore the safety and effectiveness of training 2 cadres of community health workers—traditional birth attendants (TBAs) and agentes polivalentes elementares (APEs) (polyvalent elementary health workers)—to administer the injectable contraceptive depot-medroxyprogesterone acetate (DMPA), and to provide evidence to policy makers on the feasibility of expanding community-based distribution of DMPA in areas where TBAs and APEs are present. A total of 1,432 women enrolled in the study between February 2014 and April 2015. The majority (63% to 66%) of women in the study started using contraception for the first time during the study period, and most women (over 66%) did not report side effects at the 3-month and 6-month follow-up visits. Very few (less than 0.5%) experienced morbidities at the injection site on the arm. Satisfaction with the performance of TBAs and APEs was high and improved over the study period. Overall, the project showed a high continuation rate (81.1%) after 3 injections, with TBA clients having significantly higher continuation rates than APE clients after 3 months and after 6 months. Clients’ reported willingness to pay for DMPA (64%) highlights the latent demand for modern contraceptives. Given Mozambique’s largely rural population and critical health care workforce shortage, community-based provision of family planning in general and of injectable contraceptives in particular, which has been shown to be safe, effective, and acceptable, is of crucial importance. This study demonstrates that community-based distribution of injectable contraceptives can provide access to family planning to a large group of women that previously had little or no access. PMID:27651076

  14. Safety profile of bilastine: 2nd generation H1-antihistamines.

    PubMed

    Scaglione, F

    2012-12-01

    Bilastine is a new H1 antagonist with no sedative side effects, no cardiotoxic effects, and no hepatic metabolism. In addition, bilastine has proved to be effective for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. Pharmacological studies have shown that bilastine is highly selective for the H1 receptor in both in vivo and in vitro studies, and with no apparent affinity for other receptors. The absorption of bilastine is fast, linear and dose-proportional; it appears to be safe and well tolerated at all doses levels in healthy population. Multiple administration of bilastine has confirmed the linearity of the kinetic parameters. The distribution in the brain is undetectable. The safety profile in terms of adverse effects is very similar to placebo in all Phase I, II and III clinical trials. Bilastine (20 mg), unlike cetirizine, does not increase alcohol effects on the CNS. Bilastine 20 mg does not increase the CNS depressant effect of lorazepam. Bilastine 20 mg is similar to placebo in the driving test. Therefore, it meets the current criteria for medication used in the treatment of allergic rhinitis and urticaria.

  15. Outpatient renal needle biopsy of the transplanted kidney: safety profile.

    PubMed

    Petrone, H; Frapiccini, M G; Skare, R; Baran, M

    2011-11-01

    Since May 2005, we began performing renal graft biopsies as outpatient procedures when the patient's condition did not require hospitalization. To evaluate the safety profile of the 137 procedures performed in 111 patients, we performed a retrospective analysis of complications after all biopsies between 4 May 2005 and 6 January 6, 2011. The analysis focused on types of complications as well as needs for hospitalization with length of stay, for blood transfusion or for a further intervention. There were complications in 10.9% of procedures (n = 15) with 8% requiring hospitalization (n = 11). The complications were: gross hematuria (n = 10) including blockage of urinary flow (n = 2) with one subject requiring urologic intervention, and one patient experienced severe pain at the puncture site. Neither renal graft nor patient survival was threatened; there was no hemodynamic decompensation needing blood transfusions. The average hospital stay was 2.27 days (range = 1-8). Outpatient renal biopsies in 111 patients (137 procedures) had an 8% incidence of complications requiring admission and an average length of hospitalization of 2.27 days. Gross hematuria the most frequent problem, in no way compromised patient or graft survival showing it to be a safe outpatient procedure.

  16. Intraocular caspofungin: in vitro safety profile for human ocular cells.

    PubMed

    Kernt, M; Kampik, A

    2011-07-01

    Endogenous Candida endophthalmitis is sight-threatening, difficult to treat and sometimes leads to loss of the eye. Only a few therapeutic agents are available for its treatment. Caspofungin is the first of a new class of antifungal drugs (echinocandins) with a high activity against Candida species, the most common pathogens found in endogenous endophthalmitis. This study investigates the safety profile of caspofungin for intraocular application in a cell-culture model. Endothelial toxicity of caspofungin was evaluated in cultured human corneas. Possible toxic effects of caspofungin (5-300 μg ml(-1)) in corneal endothelial cells (CEC), primary human trabecular meshwork cells (TMC) and primary human retinal pigment epithelium (RPE) cells were evaluated after 24 h and under conditions of inflammatory stress by treatment with tumour necrosis factor-alpha (TNF-α), lipopolysaccharides (LPS) or interleukin-6 (IL-6) and hydrogen peroxide (H(2)O(2)). Toxicity was evaluated by tetrazolium dye-reduction assay; cell viability was quantified by a microscopic live-dead assay. No corneal endothelial toxicity could be detected after 30 days of treatment with 75 μg ml(-1) of caspofungin. Concentrations up to 75 μg ml(-1) had no influence on CEC, TMC or RPE cell proliferation, or on cell viability when administered for 24 h. Exposure to H(2)O(2) did not increase cellular toxicity of caspofungin at concentrations of 5-50 μg ml(-1). After preincubation with TNF-α, LPS or IL-6 for 24 h followed by treatment with caspofungin for 24 h, no significant decrease in cell proliferation or viability was observed. This study showed no significant toxicity for caspofungin on CEC, TMC or RPE cells, or human corneal endothelium when administered in therapeutic concentrations up to 50 μg ml(-1).

  17. Gastrointestinal safety profile of nabumetone: a meta-analysis.

    PubMed

    Huang, J Q; Sridhar, S; Hunt, R H

    1999-12-13

    Individual comparative studies suggest that nabumetone has a gastrointestinal (GI) safety profile superior to comparator NSAIDs but lack power to show a statistical difference. The aim of this study was to evaluate systematically the difference in GI adverse events--especially the rate of perforations, ulcers, and bleeds (PUBs)-- between studies, meta-analyses of comparative trials of nabumetone and conventional NSAIDs, and postmarketing, open-label studies of nabumetone meeting predefined inclusion and exclusion criteria. A fully recursive literature search identified 13 studies consisting of 29 treatment arms and 49,501 patients that met the predefined criteria. Tests for heterogeneity found no significant difference between studies of each subgroup. Overall, the dyspeptic symptoms flatulence, constipation, and diarrhea were the most commonly reported adverse events accounting for 98.6% of the total GI adverse events. Significantly more patients treated with a comparator NSAID experienced GI adverse events than did those taking nabumetone (P = 0.007). After adjustment for patient-exposure years, PUBs were 10 to 36 times more likely to develop in patients treated with a comparator NSAID than with nabumetone. This was consistently seen in patients in nonendoscopic (n = 7,468) and endoscopic studies (n = 244). In the analysis of postmarketing or open-label studies of nabumetone, only one PUB was reported per 500 patient-exposure years over 17,502 treatment years (n = 39,389). GI adverse event-related dropouts and hospitalizations were increased by 1.3- and 3.7-fold if patients were treated with a comparator NSAID than with nabumetone. Significantly fewer treatment-related GI adverse events, especially PUBs, are seen in patients treated with nabumetone than with a comparator NSAID. Nabumetone is very safe for the GI tract.

  18. Sensory Profile and Consumer Acceptability of Prebiotic White Chocolate with Sucrose Substitutes and the Addition of Goji Berry (Lycium barbarum).

    PubMed

    Morais Ferreira, Janaína Madruga; Azevedo, Bruna Marcacini; Luccas, Valdecir; Bolini, Helena Maria André

    2017-03-01

    Functional food is a product containing nutrients that provide health benefits beyond basic nutrition. The objective of the present study was to evaluate the descriptive sensory profile and consumers' acceptance of functional (prebiotic) white chocolates with and without the addition of an antioxidant source (goji berry [GB]) and sucrose replacement. The descriptive sensory profile was determined by quantitative descriptive analysis (QDA) with trained assessors (n = 12), and the acceptance test was performed with 120 consumers. The correlation of descriptive and hedonic data was determined by partial least squares (PLS). The results of QDA indicated that GB reduces the perception of most aroma and flavor attributes, and enhances the bitter taste, bitter aftertaste, astringency, and most of the texture attributes. The consumers' acceptance of the chocolates was positive for all sensory characteristics, with acceptance scores above 6 on a 9-point scale. According to the PLS regression analysis, the descriptors cream color and cocoa butter flavor contributed positively to the acceptance of functional white chocolates. Therefore, prebiotic white chocolate with or without the addition of GB is innovative and can attract consumers, due to its functional properties, being a promising alternative for the food industry.

  19. 75 FR 9196 - Letter From Secretary of Energy Accepting Defense Nuclear Facilities Safety Board (Board...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    .... Comments may be sent to the address above. The text of the document is below. It may also be viewed at... (LANL), the first major upgrade to the Plutonium Facility's Safety Basis since 1996. The...

  20. Usability, Participant Acceptance, and Safety of a Prefilled Insulin Injection Device in a 3-Month Observational Survey in Everyday Clinical Practice in Australia

    PubMed Central

    Carter, John; Beilin, Jonathan; Morton, Adam; De Luise, Mario

    2009-01-01

    Background SoloSTAR® (SOL; sanofi-aventis, Paris, France) is a prefilled insulin pen device for the injection of insulin glargine and insulin glulisine. This is the first Australian survey to determine its usability, participant acceptance, and safety in clinical practice. Methods A 3-month, nonrandomized, noncomparative, observational survey in Australia was conducted in individuals with diabetes. Participants were given SOL pens containing glargine, the instruction leaflet, and a toll-free helpline number. Training was offered to all participants. Safety data, including product technical complaints (PTCs), were gathered from ongoing feedback given by the participant or health care professional (HCP) and by independent interviews conducted 6–10 weeks after study start. Results Some 2674 people consented to take part across 93 sites (150 HCPs), and 2029 participated in interviews. Of these, 52.6% had type 1 diabetes, 16.3% had manual dexterity problems, and 15.5% had poor eyesight not corrected by glasses. At the time of interview, 96.8% of participants were still using SOL. None of the eight PTCs reported were due to technical defects; most were related to handling errors. Some 62 participants reported 77 adverse events; none were related to a PTC. The vast majority of participants (95.4%) were “very satisfied” or “satisfied” with using SOL, and 89.7% of the participants had no questions or concerns using SOL on a daily basis. Similar positive findings were reported by participants with manual or dexterity impairments. Conclusions In this survey of everyday clinical practice, SOL had a good safety profile and was very well accepted by participants. PMID:20144398

  1. Children's Acceptance of Safety Guidelines after Exposure to Televised Dramas Depicting Accidents.

    ERIC Educational Resources Information Center

    Cantor, Joanne; Omdahl, Becky L.

    1999-01-01

    Presents a study where grade-school children were exposed to a scene from a movie involving one of two activities (either fire- or water-related activities) and involving one of two outcomes (fatal accidents or neutral events). Finds that watching the dramatized accidents increased students' estimated importance of adopting safety guidelines and…

  2. Treating atopic dermatitis: safety, efficacy, and patient acceptability of a ceramide hyaluronic acid emollient foam

    PubMed Central

    Pacha, Omar; Hebert, Adelaide A

    2012-01-01

    Advances in current understanding of the pathophysiology of atopic dermatitis have led to improved targeting of the structural deficiencies in atopic skin. Ceramide deficiency appears to be one of the major alterations in atopic dermatitis and the replenishment of this epidermal component through topically applied ceramide based emollients appears to be safe, well tolerated, and effective. Recently a ceramide hyaluronic acid foam has become commercially available and increasing evidence supports its safety and efficacy in patients who suffer from atopic dermatitis. PMID:22690129

  3. Desalinated versus recycled water: public perceptions and profiles of the accepters.

    PubMed

    Dolnicar, Sara; Schäfer, Andrea I

    2009-02-01

    Many countries' water resources are limited in both quantity and quality. While engineering solutions can now safely produce recycled and desalinated water from non-potable sources at a relatively low cost, the general public is sceptical about adopting these alternative water sources. Social scientists, policy makers and technical experts need to better understand what is causing this lack of acceptance by the general population and how acceptance levels for recycled and desalinated water can be increased. This study is the first to conduct a comparative analysis of knowledge, perceptions, and acceptability, and determine segments of residents who are more open-minded than the general population toward the use of recycled and desalinated water. The Australian population once perceived desalinated water as environmentally unfriendly, and recycled water as a public health hazard. The general level of knowledge about these two concepts as potential water sources has historically been low. After nearly five years of serious drought, accompanied by severe water restrictions across most of the country, and subsequent media attention on solutions to water scarcity, Australians now show more acceptance of desalinated water for close-to-body uses, and less resistance to recycled water for garden watering and cleaning uses. The types of people likely to be strong accepters of the two alternative water sources are distinctly different groups, and can be reached through different media mixes. This finding has significant implications for policy makers and water practitioners.

  4. Safety profile of Coartem®: the evidence base

    PubMed Central

    Falade, Catherine; Manyando, Christine

    2009-01-01

    This article reviews the comprehensive data on the safety and tolerability from over 6,300 patients who have taken artemether/lumefantrine (Coartem®) as part of Novartis-sponsored or independently-sponsored clinical trials. The majority of the reported adverse events seen in these studies are mild or moderate in severity and tend to affect the gastrointestinal or nervous systems. These adverse events, which are common in both adults and children, are also typical of symptoms of malaria or concomitant infections present in these patients. The wealth of safety data on artemether/lumefantrine has not identified any neurological, cardiac or haematological safety concerns. In addition, repeated administration is not associated with an increased risk of adverse drug reactions including neurological adverse events. This finding is especially relevant for children from regions with high malaria transmission rates who often receive many courses of anti-malarial medications during their lifetime. Data are also available to show that there were no clinically relevant differences in pregnancy outcomes in women exposed to artemether/lumefantrine compared with sulphadoxine-pyrimethamine during pregnancy. The six-dose regimen of artemether/lumefantrine is therefore well tolerated in a wide range of patient populations. In addition, post-marketing experience, based on the delivery of 250 million treatments as of July 2009, has not identified any new safety concerns for artemether/lumefantrine apart from hypersensitivity and allergies, known class effects of artemisinin derivatives. PMID:19818173

  5. Worldwide Status of Fresh Fruits Irradiation and Concerns about Quality, Safety, and Consumer Acceptance.

    PubMed

    Shahbaz, Hafiz Muhammad; Akram, Kashif; Ahn, Jae-Jun; Kwon, Joong-Ho

    2016-08-17

    Development of knowledge-based food preservation techniques have been a major focus of researchers in providing safe and nutritious food. Food irradiation is one of the most thoroughly investigated food preservation techniques, which has been shown to be effective and safe through extensive research. This process involves exposing food to ionizing radiations in order to destroy microorganisms or insects that might be present on and/or in the food. In addition, the effects of irradiation on the enzymatic activity and improvement of functional properties in food have also been well established. In the present review, the potential of food irradiation technology to address major problems, such as short shelf life, high-initial microbial loads, insect pest management (quarantine treatment) in supply chain, and safe consumption of fresh fruits was described. With improved hygienic quality, other uses, such as delayed ripening and enhanced physical appearance by irradiation were also discussed. Available data showed that the irradiation of fruits at the optimum dose can be a safe and cost-effective method, resulting in enhanced shelf life and hygienic quality with the least amount of compromise on the various nutritional attributes, whereas the consumer acceptance of irradiated fruits is a matter of providing the proper scientific information.

  6. Raising the profile of worker safety: highlights of the 2013 North American Agricultural Safety Summit.

    PubMed

    Nelson, William J; Heiberger, Scott; Lee, Barbara C

    2014-01-01

    The 2013 North American Agricultural Safety Summit, an unprecedented gathering of industry leaders and safety experts, was held September 25-27 in Minneapolis, MN. Hosted by the industry-led Agricultural Safety and Health Council of America (ASHCA), there were 250 attendees, 82 speakers, 76 abstracts with poster presentations, along with "best practices" videos, genius bars sessions, learning stations, exhibits, breakfast roundtable topics, and receptions. The event was a mix of knowledge, inspiration and networking to enable participants to influence the adoption of safety practices in their home/work settings. Given the agriculture industry's commitment to feed nine billion people, the projected world population by 2050, it is imperative that producers and agribusiness strive to do it safely, humanely and sustainably. Evaluation feedback was very positive, indicating ASHCA's original objectives for the Summit were achieved.

  7. Results of the Updated NASA Kennedy Space Center 50-MHz Doppler Radar Wind Profiler Operational Acceptance Test

    NASA Technical Reports Server (NTRS)

    Barbre', Robert E., Jr.; Deker, Ryan K.; Leahy, Frank B.; Huddleston, Lisa

    2016-01-01

    We present here the methodology and results of the Operational Acceptance Test (OAT) performed on the new Kennedy Space Center (KSC) 50-MHz Doppler Radar Wind Profiler (DRWP). On day-of-launch (DOL), space launch vehicle operators have used data from the DRWP to invalidate winds in prelaunch loads and trajectory assessments due to the DRWP's capability to quickly identify changes in the wind profile within a rapidly-changing wind environment. The previous DRWP has been replaced with a completely new system, which needs to undergo certification testing before being accepted for use in range operations. The new DRWP replaces the previous three-beam system made of coaxial cables and a copper wire ground plane with a four-beam system that uses Yagi antennae with enhanced beam steering capability. In addition, the new system contains updated user interface software while maintaining the same general capability as the previous system. The new DRWP continues to use the Median Filter First Guess (MFFG) algorithm to generate a wind profile from Doppler spectra at each range gate. DeTect (2015) contains further details on the upgrade. The OAT is a short-term test designed so that end users can utilize the new DRWP in a similar manner to the previous DRWP during mission operations at the Eastern Range in the midst of a long-term certification process. This paper describes the Marshall Space Flight Center Natural Environments Branch's (MSFC NE's) analyses to verify the quality and accuracy of the DRWP's meteorological data output as compared to the previous DRWP. Ultimately, each launch vehicle program has the responsibility to certify the system for their own use.

  8. Safety profile of Tysabri: international risk management plan.

    PubMed

    Iaffaldano, P; D'Onghia, M; Trojano, Maria

    2009-10-01

    Therapeutic monoclonal antibodies are potent new tools for a molecular targeted approach to modify the course of multiple sclerosis (MS). Natalizumab is a monoclonal antibody targeted against alpha-4 integrin that has proved to be very effective in the treatment of MS. It is well tolerated, although severe side effects have been reported that have conditioned its use as a second-line drug for the treatment of MS. The clinical benefit of natalizumab should be weighed carefully against the potential risk of serious adverse events. Therefore, risk management plans have already been developed in order to prevent or minimise risks relating to natalizumab. Data so far obtained from these observational programs confirm the already demonstrated risk-benefit profile of natalizumab in clinical trials.

  9. Safety profile of etifoxine: A French pharmacovigilance survey.

    PubMed

    Cottin, Judith; Gouraud, Aurore; Jean-Pastor, Marie-Josèphe; Dautriche, Anne Disson-; Boulay, Charlène; Geniaux, Hélène; Auffret, Marine; Bernard, Nathalie; Descotes, Jacques; Vial, Thierry

    2016-04-01

    Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADRs) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine-related ADR by reviewing Individual Case Safety Reports (ICSRs) recorded in France especially unexpected ADRs. Etifoxine-related ICSRs were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADRs (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS in 5, erythema multiforme in 10 and Stevens-Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness-like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADRs included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy-proven microscopic colitis of which one recurred after etifoxine re-administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADRs, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC) was based on these findings.

  10. Consumer acceptability and sensory profile of cooked broccoli with mustard seeds added to improve chemoprotective properties.

    PubMed

    Ghawi, Sameer Khalil; Shen, Yuchi; Niranjan, Keshavan; Methven, Lisa

    2014-09-01

    Broccoli, a rich source of glucosinolates, is a commonly consumed vegetable of the Brassica family. Hydrolysis products of glucosinolates, isothiocyanates, have been associated with health benefits and contribute to the flavor of Brassica. However, boiling broccoli causes the myrosinase enzyme needed for hydrolysis to denature. In order to ensure hydrolysis, broccoli must either be mildly cooked or active sources of myrosinase, such as mustard seed powder, can be added postcooking. In this study, samples of broccoli were prepared in 6 different ways; standard boiling, standard boiling followed by the addition of mustard seeds, sous vide cooking at low temperature (70 °C) and sous vide cooking at higher temperature (100 °C) and sous vide cooking at higher temperature followed by the addition of mustard seeds at 2 different concentrations. The majority of consumers disliked the mildly cooked broccoli samples (70 °C, 12 min, sous vide) which had a hard and stringy texture. The highest mean consumer liking was for standard boiled samples (100 °C, 7 min). Addition of 1% mustard seed powder developed sensory attributes, such as pungency, burning sensation, mustard odor, and flavor. One cluster of consumers (32%) found mustard seeds to be a good complement to cooked broccoli; however, the majority disliked the mustard-derived sensory attributes. Where the mustard seeds were partially processed, doubling the addition to 2% led to only the same level of mustard and pungent flavors as 1% unprocessed seeds, and mean consumer liking remained unaltered. This suggests that optimization of the addition level of partially processed mustard seeds may be a route to enhance bioactivity of cooked broccoli without compromising consumer acceptability.

  11. Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease.

    PubMed

    Sahni, J N; Czanner, G; Gutu, T; Taylor, S A; Bennett, K M; Wuerger, S M; Grierson, I; Murray-Dunning, C; Holland, M N; Harding, S P

    2017-01-01

    PurposeThe purpose of the study was to study the effect of an organic light-emitting diode sleep mask on daytime alertness, wellbeing, and retinal structure/function in healthy volunteers and in diabetic macular oedema (DMO).Patients and methodsHealthy volunteers in two groups, 18-30 yrs (A), 50-70 yrs (B) and people with DMO (C) wore masks (504 nm wavelength; 80 cd/m(2) luminance; ≤8 h) nightly for 3 months followed by a 1-month recovery period. Changes from baseline were measured for (means): psychomotor vigilance task (PVT) (number of lapses (NL), response time (RT)), sleep, depression, psychological wellbeing (PW), visual acuity, contrast sensitivity, colour, electrophysiology, microperimetry, and retinal thickness on OCT.ResultsOf 60 participants, 16 (27%) withdrew, 8 (13%) before month 1, due to sleep disturbances and mask intolerance. About 36/55 (65%) who continued beyond month 1 reported ≥1 adverse event. At month 3 mean PVT worsened in Group A (RT (7.65%, P<0.001), NL (43.3%, P=0.005)) and mean PW worsened in all groups (A 28.0%, P=0.01, B 21.2%, P=0.03, C 12.8%, P<0.05). No other clinically significant safety signal was detected. Cysts reduced/resolved in the OCT subfield of maximal pathology in 67% Group C eyes. Thinning was greater at 3 and 4 months for greater baseline thickness (central subfield P<0.001, maximal P<0.05).ConclusionSleep masks showed no major safety signal apart from a small impairment of daytime alertness and a moderate effect on wellbeing. Masks were acceptable apart from in some healthy participants. Preliminary data suggest a beneficial effect on retinal thickness in DMO. This novel therapeutic approach is ready for large clinical trials.

  12. Safety profile of grepafloxacin compared with other fluoroquinolones.

    PubMed

    Stahlmann, R; Schwabe, R

    1997-12-01

    Preclinical investigations with grepafloxacin showed that its toxicological profile is similar to that of other fluoroquinolones. The photosensitizing effect of grepafloxacin was relatively weak and similar to that of ciprofloxacin. Grepafloxacin did not cause convulsions in mice when administered in conjunction with the non-steroidal anti-inflammatory drug fenbufen. Intravenous injection of grepafloxacin caused transient dysrhythmias in rabbits at a dosage of 10 mg/kg and ventricular tachycardia at 30 mg/kg iv. Joint cartilage lesions were found in juvenile dogs after iv treatment with 100 mg/kg daily. Plasma concentrations (19-24 mg/L) under these conditions were approximately ten times above a therapeutic level. Data derived from patients who had been treated with grepafloxacin in phase II and phase III multiple-dose studies (400 mg, n = 1069; 600 mg, n = 925) were available for an analysis of the patients' tolerance of the drug. The most common adverse events observed for the 400 mg and 600 mg treatments during these studies were gastrointestinal reactions, such as nausea (11% and 15%, respectively), vomiting (1% and 6%) and diarrhoea (3% and 4%). In both groups a considerable number of patients (9% and 17%) reported an unpleasant taste; this was less common in the pooled controls (1%) after treatment with drugs such as doxycycline, ciprofloxacin, amoxycillin or cefixime. Headache occurred in 4% (400 mg) and 5% (600 mg) and insomnia in 1% (400 mg) or 2% (600 mg) of the patients. Similar incidences were found for photosensitivity (1% and 2%, respectively) and for rash (1% and 2%) in the 400 mg and 600 mg groups. So far, tolerance of the new compound seems to be similar to that of other fluoroquinolones. However, incidences of nausea, vomiting and unpleasant taste were rather high during the first clinical trials, particularly after treatment with 600 mg daily. Further data are necessary for a sound evaluation of the tolerance of grepafloxacin.

  13. The long-term efficacy and safety profile of barnidipine.

    PubMed

    Smilde, J G

    2000-11-01

    Two multicentre trials have investigated the efficacy and tolerability of treatment with once-daily barnidipine, in patients with mild to moderate essential hypertension. The long-term efficacy and safety of barnidipine were demonstrated in a long-term, multicentre, open-label study. In total, 106, 79 and 32 patients were followed for the first, second and third year, respectively. Patients received barnidipine at a dose titrated to achieve a sitting DBP > or = 90 mmHg or a decrease in sitting BDP > or = 10 mmHg. If necessary, another antihypertensive agent was added to achieve normalisation of blood pressure. In the first year, normalisation of blood pressure was achieved in 91% of patients. This was maintained in 91% and 81% of patients in the second and third years, respectively. At the end of treatment in both years, over 60% of patients remained on barnidipine monotherapy (10 or 20 mg/day). A low incidence of adverse events possibly or probably related to barnidipine (10 or 20 mg/day) monotherapy was reported in the first and second years with headache, peripheral oedema and palpitations the most commonly reported. In the third year of follow-up, only one adverse event, an ECG abnormality, was considered to be possibly related to the study medication. The effective 24 hour control of blood pressure with barnidipine monotherapy was confirmed in a randomised, double-blind, placebo-controlled, cross-over study of 20 patients. These patients were given 6 week regimens of both barnidipine (20 mg/day) and placebo. Office and 24 hour ambulatory blood pressures were recorded at the end of each treatment phase. Barnidipine lowered blood pressure to a significantly greater extent than placebo both at night and during the day. Adverse events were classified as mild or moderate and fewer adverse events were reported with barnidipine treatment compared with placebo. Barnidipine monotherapy (20 mg/day) is safe and effective in providing 24 hour control of blood pressure

  14. The effect of safety factor profile on transport in steady-state, high-performance scenarios

    DOE PAGES

    Holcomb, C. T.; Ferron, J. R.; Luce, T. C.; ...

    2012-03-09

    In this study, an analysis of the dependence of transport on the safety factor profile in high-performance, steady-state scenario discharges is presented. This is based on experimental scans of q95 and qmin taken with fixed βN, toroidal field, double-null plasma shape, divertor pumping, and electron cyclotron current drive input. The temperature and thermal diffusivity profiles were found to vary considerably with the q-profile, and these variations were significantly different for electrons and ions. With fixed q95, both temperature profiles increase and broaden as qmin is increased and the magnetic shear becomes low or negative in the inner half radius, butmore » these temperature profile changes are stronger for the electrons. Power balance calculations show the peak in the ion thermal diffusivity (χi) at ρ – 0.6 – 0.8 increases with q95 or qmin.« less

  15. Integrated safety profile of single-agent carfilzomib: experience from 526 patients enrolled in 4 phase II clinical studies.

    PubMed

    Siegel, David; Martin, Thomas; Nooka, Ajay; Harvey, R Donald; Vij, Ravi; Niesvizky, Ruben; Badros, Ashraf Z; Jagannath, Sundar; McCulloch, Leanne; Rajangam, Kanya; Lonial, Sagar

    2013-11-01

    Carfilzomib, a selective proteasome inhibitor, was approved in 2012 for the treatment of relapsed and refractory multiple myeloma. Safety data for single-agent carfilzomib have been analyzed for 526 patients with advanced multiple myeloma who took part in one of 4 phase II studies (PX-171-003-A0, PX-171-003-A1, PX-171-004, and PX-171-005). Overall analyses of adverse events and treatment modifications are presented, as well as specific analyses of adverse events by organ system. Overall, the most common adverse events of any grade included fatigue (55.5%), anemia (46.8%), and nausea (44.9%). In the grouped analyses, any grade adverse events were reported in 22.1% for any cardiac (7.2% cardiac failure), 69.0% for any respiratory (42.2% dyspnea), and 33.1% for any grouped renal impairment adverse event (24.1% increased serum creatinine). The most common non-hematologic adverse events were generally Grade 1 or 2 in severity, while Grade 3/4 adverse events were primarily hematologic and mostly reversible. There was no evidence of cumulative bone marrow suppression, either neutropenia or thrombocytopenia, and febrile neutropenia occurred infrequently (1.1%). Notably, the incidence of peripheral neuropathy was low overall (13.9%), including patients with baseline peripheral neuropathy (12.7%). Additionally, the incidence of discontinuations or dose reductions attributable to adverse events was low. These data demonstrate that single-agent carfilzomib has an acceptable safety profile in heavily pre-treated patients with relapsed/refractory multiple myeloma. The tolerable safety profile allows for administration of full-dose carfilzomib, both for extended periods and in a wide spectrum of patients with advanced multiple myeloma, including those with pre-existing comorbidities.

  16. [Genetically modified food (food derived from biotechnology): current and future trends in public acceptance and safety assessment].

    PubMed

    Nishiura, Hiroshi; Imai, Hirohisa; Nakao, Hiroyuki; Tsukino, Hiromasa; Kuroda, Yoshiki; Katoh, Takahiko

    2002-11-01

    Current and future trends regarding genetically modified (GM) crops and food stuffs were reviewed, with a particular focus on public acceptance and safety assessment. While GM foods, foods derived from biotechnology, are popular with growers and producers, they are still a matter of some concern among consumers. In fact, our recent surveys showed that Japanese consumers had become uneasy about the potential health risks of genetically modified foods. Many Japanese consumers have only vague ideas about the actual health risks, and they appear to be making decisions simply by rejecting GM food because of non-informed doubts. Although the debate about GM foods has increased in the mass media and scientific journals, few articles concerning direct studies on the potential toxicity or adverse health effects of GM foods have appeared. The roles of relevant international regulatory bodies in ensuring that GM crops and food are safe are therefore have summarized. Finally, the current debate on use of GM crops in agriculture and future trends for development of GM foods with enriched nutrients, better functionality, and medicinal ingredients, which will be of direct benefit to the consumer, are covered.

  17. The importance of being profiled: improving drug candidate safety and efficacy using ion channel profiling.

    PubMed

    Kaczorowski, Gregory J; Garcia, Maria L; Bode, Jacob; Hess, Stephen D; Patel, Umesh A

    2011-01-01

    Profiling of putative lead compounds against a representative panel of relevant enzymes, receptors, ion channels, and transporters is a pragmatic approach to establish a preliminary view of potential issues that might later hamper development. An early idea of which off-target activities must be minimized can save valuable time and money during the preclinical lead optimization phase if pivotal questions are asked beyond the usual profiling at hERG. The best data for critical evaluation of activity at ion channels is obtained using functional assays, since binding assays cannot detect all interactions and do not provide information on whether the interaction is that of an agonist, antagonist, or allosteric modulator. For ion channels present in human cardiac muscle, depending on the required throughput, manual-, or automated-patch-clamp methodologies can be easily used to evaluate compounds individually to accurately reveal any potential liabilities. The issue of expanding screening capacity against a cardiac panel has recently been addressed by developing a series of robust, high-throughput, cell-based counter-screening assays employing fluorescence-based readouts. Similar assay development approaches can be used to configure panels of efficacy assays that can be used to assess selectivity within a family of related ion channels, such as Nav1.X channels. This overview discusses the benefits of in vitro assays, specific decision points where profiling can be of immediate benefit, and highlights the development and validation of patch-clamp and fluorescence-based profiling assays for ion channels (for examples of fluorescence-based assays, see Bhave et al., 2010; and for high-throughput patch-clamp assays see Mathes, 2006; Schrøder et al., 2008).

  18. The Importance of Being Profiled: Improving Drug Candidate Safety and Efficacy Using Ion Channel Profiling

    PubMed Central

    Kaczorowski, Gregory J.; Garcia, Maria L.; Bode, Jacob; Hess, Stephen D.; Patel, Umesh A.

    2011-01-01

    Profiling of putative lead compounds against a representative panel of relevant enzymes, receptors, ion channels, and transporters is a pragmatic approach to establish a preliminary view of potential issues that might later hamper development. An early idea of which off-target activities must be minimized can save valuable time and money during the preclinical lead optimization phase if pivotal questions are asked beyond the usual profiling at hERG. The best data for critical evaluation of activity at ion channels is obtained using functional assays, since binding assays cannot detect all interactions and do not provide information on whether the interaction is that of an agonist, antagonist, or allosteric modulator. For ion channels present in human cardiac muscle, depending on the required throughput, manual-, or automated-patch-clamp methodologies can be easily used to evaluate compounds individually to accurately reveal any potential liabilities. The issue of expanding screening capacity against a cardiac panel has recently been addressed by developing a series of robust, high-throughput, cell-based counter-screening assays employing fluorescence-based readouts. Similar assay development approaches can be used to configure panels of efficacy assays that can be used to assess selectivity within a family of related ion channels, such as Nav1.X channels. This overview discusses the benefits of in vitro assays, specific decision points where profiling can be of immediate benefit, and highlights the development and validation of patch-clamp and fluorescence-based profiling assays for ion channels (for examples of fluorescence-based assays, see Bhave et al., 2010; and for high-throughput patch-clamp assays see Mathes, 2006; Schrøder et al., 2008). PMID:22171219

  19. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    PubMed

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  20. Adenovirus encoding human platelet-derived growth factor-B delivered to alveolar bone defects exhibits safety and biodistribution profiles favorable for clinical use.

    PubMed

    Chang, Po-Chun; Cirelli, Joni A; Jin, Qiming; Seol, Yang-Jo; Sugai, James V; D'Silva, Nisha J; Danciu, Theodora E; Chandler, Lois A; Sosnowski, Barbara A; Giannobile, William V

    2009-05-01

    Platelet-derived growth factor (PDGF) gene therapy offers promise for tissue engineering of tooth-supporting alveolar bone defects. To date, limited information exists regarding the safety profile and systemic biodistribution of PDGF gene therapy vectors when delivered locally to periodontal osseous defects. The aim of this preclinical study was to determine the safety profile of adenovirus encoding the PDGF-B gene (AdPDGF-B) delivered in a collagen matrix to periodontal lesions. Standardized alveolar bone defects were created in rats, followed by delivery of matrix alone or containing AdPDGF-B at 5.5 x 10(8) or 5.5 x 10(9) plaque-forming units/ml. The regenerative response was confirmed histologically. Gross clinical observations, hematology, and blood chemistries were monitored to evaluate systemic involvement. Bioluminescence and quantitative polymerase chain reaction were used to assess vector biodistribution. No significant histopathological changes were noted during the investigation. Minor alterations in specific hematological and blood chemistries were seen; however, most parameters were within the normal range for all groups. Bioluminescence analysis revealed vector distribution at the axillary lymph nodes during the first 2 weeks with subsequent return to baseline levels. AdPDGF-B was well contained within the localized osseous defect area without viremia or distant organ involvement. These results indicate that AdPDGF-B delivered in a collagen matrix exhibits acceptable safety profiles for possible use in human clinical studies.

  1. Atorvastatin calcium encapsulated eudragit nanoparticles with enhanced oral bioavailability, safety and efficacy profile.

    PubMed

    Kumar, Nagendra; Chaurasia, Sundeep; Patel, Ravi R; Khan, Gayasuddin; Kumar, Vikas; Mishra, Brahmeshwar

    2017-03-01

    Atorvastatin calcium (ATR), a second generation statin drug, was encapsulated in eudragit RSPO-based polymeric nanoparticles. The effect of independent variables (polymer content, stabilizer concentration, volume of chloroform and homogenization speed) on response variables (mean diameter particle size and entrapment efficiency) were investigated by employing central composite experimental design. All the independent variables were found to be significant for determining the response variables. Solid-state characterization study indicated the absence of physicochemical interaction between drug and polymer in formulation. Morphological study exhibited homogenous spherical shape of formulated nanoparticles. In vitro release study in phosphate buffer (pH 7.4) demonstrated sustained release profile over 24 h. Pharmacokinetic study in Charles Foster rats showed significant enhancement in oral bioavailability as compared to pure drug suspension. Efficacy study (lipid profile and blood glucose level) significantly justified the effectiveness of formulation having 50% less dose of ATR as compared to pure drug suspension. The effectiveness of formulation was further justified with an improved plasma safety profile of treated rats. Hence, ATR encapsulated eudragit RSPO nanoparticles can serve as potential drug delivery approach to enhance drug bioavailability, efficacy and safety profiles to alter existing marketed drug products.

  2. Microstructure and mechanical properties of high strength Al—Mg—Si—Cu profiles for safety parts

    NASA Astrophysics Data System (ADS)

    Österreicher, J. A.; Schiffl, A.; Falkinger, G.; Bourret, G. R.

    2016-03-01

    Aluminium extrudate used for safety parts in cars need to exhibit high yield strength and ductility, a combination that is not easily achieved. In this work, the mechanical properties and microstructure of profiles with a yield strength greater than 280MPa achieved by two different artificial ageing treatments were studied. Profiles from one of the heat treatments performed well in quasi-static compression testing while those from the other heat treatment clearly failed. The batch of profiles that failed showed higher uniform elongation in tensile testing but a lower reduction in area. However, the difference in bending angles in the three-point-bending test were not as pronounced. Microscopic investigation of polished sections and fracture surfaces revealed that failure is dominated by the fracture of intermetallic phases resulting in voids. The growth and coalescence of these voids is facilitated by another population of smaller voids within the matrix, presumably nucleating at secondary phases.

  3. Providing newborn resuscitation at the mother’s bedside: assessing the safety, usability and acceptability of a mobile trolley

    PubMed Central

    2014-01-01

    Background Deferring cord clamping at very preterm births may be beneficial for babies. However, deferring cord clamping should not mean that newborn resuscitation is deferred. Providing initial care at birth at the mother’s bedside would allow parents to be present during resuscitation, and would potentially allow initial care to be given with the cord intact. The aim of this study was to evaluate the usability of a new mobile trolley for providing newborn resuscitation by describing the range of resuscitation procedures performed on a group of babies, to assess the acceptability to clinicians compared with standard equipment, based on a questionnaire survey, to assess safety from post resuscitation temperature measurements and serious adverse event reports and to assess whether the trolley allowed resuscitation with the umbilical cord intact by assessing the proportion of babies that could be placed on the trolley to allow resuscitation with the cord intact. Methods The trolley was used when the attendance of a clinician trained in newborn life support was required at a birth. Clinicians were asked to complete a questionnaire about their experience of using the trolley. Serious adverse events were reported. Results 78 babies were managed on the trolley. Median (range) gestation was 34 weeks (24 to 41 weeks). Median (range) birth weight was2470 grams (520 to 4080 grams). The full range of resuscitation procedures has been successfully provided, although only one baby required emergency umbilical venous catheterisation. 77/78 babies had a post resuscitation temperature above 36°C. There were no adverse events. Most clinicians rated the trolley as ‘the same’, ‘better’ or ’much better’ than conventional resuscitation equipment. In most situations, the baby could be resuscitated with umbilical cord intact, although on 18 occasions the cord was too short to reach the trolley. Conclusions Immediate stabilisation at birth and resuscitation can be

  4. Longitudinal Stability of Social Competence Indicators in a Portuguese Sample: Q-Sort Profiles of Social Competence, Measures of Social Engagement, and Peer Sociometric Acceptance

    ERIC Educational Resources Information Center

    Santos, António J.; Vaughn, Brian E.; Peceguina, Inês; Daniel, João R.

    2014-01-01

    This study examines the temporal stability (over 3 years) of individual differences in 3 domains relevant to preschool children's social competence: social engagement/motivation, profiles of behavior and personality attributes characteristic of socially competent young children, and peer acceptance. Each domain was measured with multiple…

  5. Short communication: Influence of long-chain inulin and Lactobacillus paracasei subspecies paracasei on the sensory profile and acceptance of a traditional yogurt.

    PubMed

    Pimentel, T C; Cruz, A G; Prudencio, S H

    2013-10-01

    The objectives of this study were to evaluate the influence of the addition of long-chain inulin as a fat replacer and prebiotic agent (20g/L) and (or) probiotic Lactobacillus paracasei ssp. paracasei on the sensory profile and acceptance of yogurts, and to assess the influence of descriptive attributes on the sensory acceptance of the products. The addition of inulin to low-fat yogurt improved its brightness and firmness, which was similar to the full-fat yogurt. However, the use of long-chain inulin increased the separation of serum and no influence on creaminess was observed. Regarding the product's acceptability, the low-fat yogurt with added inulin presented similar acceptance compared with the full-fat yogurt. The addition of Lb. paracasei ssp. paracasei did not affect the sensory profile and acceptance of the low-fat yogurt. Using external preference mapping, it was possible to verify that the sensory acceptance was driven positively by the sweetness and creaminess and negatively driven by firmness (appearance and texture) and homogeneity (appearance). It was possible to formulate low-fat yogurts with added probiotics that presented similar sensory characteristics to those of full-fat yogurts, and this was due to the addition of the long-chain inulin as a fat replacer.

  6. Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

    PubMed

    Würtzen, G

    1993-01-01

    The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

  7. Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

    PubMed Central

    Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

    2012-01-01

    Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006–2008 and DDW 2008–2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Results Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT4 agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT4 agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT1 receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT4 agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT4 agonists with no hERG or 5-HT1 affinity (renzapride, clebopride, mosapride). Conclusions 5-HT4 agonists for GI disorders differ in chemical structure and selectivity for 5-HT4 receptors. Selectivity for 5-HT4 over non-5-HT4 receptors may influence the agent's safety and overall risk–benefit profile. Based on available evidence, highly selective 5-HT4 agonists may offer improved safety to treat patients with impaired GI motility. PMID:22356640

  8. Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

    PubMed Central

    2016-01-01

    Rift Valley Fever (RVF) is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA), a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control. PMID:27689098

  9. The effect of safety factor profile on transport in steady-state, high-performance scenarios

    SciTech Connect

    Holcomb, C. T.; Ferron, J. R.; Luce, T. C.; DeBoo, J. C.; Park, J. M.; White, A. E.; Turco, F.; Rhodes, T. L.; Doyle, E. J.; Schmitz, L.; Van Zeeland, M. A.; McKee, G. R.

    2012-03-09

    In this study, an analysis of the dependence of transport on the safety factor profile in high-performance, steady-state scenario discharges is presented. This is based on experimental scans of q95 and qmin taken with fixed βN, toroidal field, double-null plasma shape, divertor pumping, and electron cyclotron current drive input. The temperature and thermal diffusivity profiles were found to vary considerably with the q-profile, and these variations were significantly different for electrons and ions. With fixed q95, both temperature profiles increase and broaden as qmin is increased and the magnetic shear becomes low or negative in the inner half radius, but these temperature profile changes are stronger for the electrons. Power balance calculations show the peak in the ion thermal diffusivity (χi) at ρ – 0.6 – 0.8 increases with q95 or qmin.

  10. New geometric design consistency model based on operating speed profiles for road safety evaluation.

    PubMed

    Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo

    2013-12-01

    To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment.

  11. Omic profiling for drug safety assessment: current trends and public-private partnerships.

    PubMed

    Gallagher, William M; Tweats, David; Koenig, Jochen

    2009-04-01

    The drug development process is currently being hindered by non-optimal prediction of toxicity. Advances in molecular profiling approaches, such as transcriptomics, proteomics and metabolomics, offer the potential to provide a more comprehensive insight into toxicological effects than hitherto possible. These new technologies present their own challenges, however, particularly in relation to standardization and assessment. The focus of this article is on describing the current trends concerning the application of omic approaches in drug safety assessment, with specific emphasis on the role of public-private partnerships in advancing this emerging arena.

  12. Glargine and detemir: Safety and efficacy profiles of the long-acting basal insulin analogs

    PubMed Central

    Poon, Kitty; King, Allen B

    2010-01-01

    Diabetes mellitus is a growing public health concern in the US and worldwide. Insulin therapy is the cornerstone of diabetes therapy, and the use of basal insulins will increase as clinicians strive to help their patients reach glycemic goals. Basal insulins have been continually improved upon over the years, and the long-acting basal insulin analogs, glargine and detemir, have many pharmacokinetic and pharmacodynamic advantages over neutral protamine Hagedorn insulin, namely, less variable absorption profiles, a less pronounced peak in effect, and a longer duration of action. Overall, glargine and detemir do not differ greatly in their safety and efficacy profiles. Major differences between the two include lower within-subject variability, lower risk of hypoglycemia, and a weight-sparing effect with insulin detemir. This review summarizes data from the key pharmacokinetic and pharmacodynamic studies, as well as clinical and observational studies to elucidate the role of each basal insulin analog in therapy. PMID:21701633

  13. Safety profile and protocol prevention of adverse reactions to uroangiographic contrast media in diagnostic imaging.

    PubMed

    Rossi, C; Reginelli, A; D'Amora, M; Di Grezia, G; Mandato, Y; D'Andrea, A; Brunese, L; Grassi, R; Rotondi, A

    2014-01-01

    The purpose of the study is to examine the incidence of adverse reactions caused by non-ionic contrast media in selected patients after desensitization treatment and to evaluate the safety profile of organ iodine contrast media (i.c.m.) in a multistep prevention protocol. In a population of 2000 patients that had received a CT scan, 100 patients with moderate/high risk for adverse reactions against iodinated contrast agents followed a premedication protocol and all adverse reactions are reported and classified as mild, moderate or severe. 1.7 percent of the pre-treated patients reported a mild, immediate type reaction to iodine contrast; of these five patients with allergy 0.71 percent had received iomeprol, 0.35 percent received ioversol and 0.71 percent received iopromide. The incidence of adverse reactions was reported to be higher (4 out of 5 patients) among those that referred a history of hypersensitivity against iodinated i.c.m. Although intravenous contrast materials have greatly improved, especially in terms of their safety profile, they should not be administered if there isn't a clear or justified indication. In conclusion, even if we know that the majority of these reactions are idiosyncratic and unpredictable we propose, with the aim of improving our knowledge on this subject, a multicenter study, based on skin allergy tests (prick test, patch test, intradermal reaction) in selected patients that have had previous experiences of hypersensitivity against parenteral organ iodine contrast media.

  14. Grepafloxacin: a review of its safety profile based on clinical trials and postmarketing surveillance.

    PubMed

    Lode, H; Vogel, F; Elies, W

    1999-01-01

    The safety profile of grepafloxacin has been characterized in a number of preclinical and clinical studies. Preclinical investigations have shown that its toxicologic profile is similar to that of other fluoroquinolones, and phase I studies in humans have confirmed these data. A photosensitivity study demonstrated equivalence with ciprofloxacin, and a study in elderly patients taking the highest clinical dose of grepafloxacin indicated that prolongation of the QTc interval by grepafloxacin was less than 2 ms, 15 times less than that observed in a study of erythromycin. In phase II and III clinical investigations conducted in the United States and the United Kingdom, safety data have been gathered from more than 3000 patients with either community-acquired pneumonia or acute bacterial exacerbations of chronic bronchitis. The most common adverse events with grepafloxacin 400 or 600 mg were gastrointestinal, such as nausea, vomiting, and diarrhea. The frequency of these adverse events was similar to that seen with ciprofloxacin. Significantly more patients reported a mild, unpleasant metallic taste with grepafloxacin than with ciprofloxacin, but <1% of patients withdrew from therapy because of this. Headache was observed significantly more often in ciprofloxacin-treated patients than in grepafloxacin-treated patients. Recent postmarketing data confirm the good tolerability and safety profile of grepafloxacin. These data, from a case-report study of more than 9000 patients in Germany, demonstrated that only 2.3% of patients reported adverse events when grepafloxacin was used in routine clinical practice. The most frequently reported events were nausea (0.8%) and gastrointestinal symptoms (0.4%). Dizziness was reported by only 0.3% of patients, and only 4 patients (0.04%) reported photosensitization. Adverse events did not appear to be either dose dependent or related to diagnosis. More than 400,000 patients world-wide have received grepafloxacin treatment. No new

  15. First-in-Human Trial of MIV-150 and Zinc Acetate Coformulated in a Carrageenan Gel: Safety, Pharmacokinetics, Acceptability, Adherence, and Pharmacodynamics

    PubMed Central

    Hoesley, Craig J.; Plagianos, Marlena; Hoskin, Elena; Zhang, Shimin; Teleshova, Natalia; Alami, Mohcine; Novak, Lea; Kleinbeck, Kyle R.; Katzen, Lauren L.; Zydowsky, Thomas M.; Fernández-Romero, José A.; Creasy, George W.

    2016-01-01

    Objective: To evaluate the safety and pharmacokinetics of MIV-150 and zinc acetate in a carrageenan gel (PC-1005). Acceptability, adherence, and pharmacodynamics were also explored. Design: A 3-day open-label safety run-in (n = 5) preceded a placebo-controlled, double-blind trial in healthy, HIV-negative, abstinent women randomized (4:1) to vaginally apply 4 mL of PC-1005 or placebo once daily for 14 days. Methods: Assessments included physical examinations, safety labs, colposcopy, biopsies, cervicovaginal lavages (CVLs), and behavioral questionnaires. MIV-150 (plasma, CVL, tissue), zinc (plasma, CVL), and carrageenan (CVL) concentrations were determined with LC-MS/MS, ICP-MS, and ELISA, respectively. CVL antiviral activity was measured using cell-based assays. Safety, acceptability, and adherence were analyzed descriptively. Pharmacokinetic parameters were calculated using noncompartmental techniques and actual sampling times. CVL antiviral EC50 values were calculated using a dose–response inhibition analysis. Results: Participants (n = 20) ranged from 19–44 years old; 52% were black or African American. Among those completing the trial (13/17, PC-1005; 3/3, placebo), 11/17 reported liking the gel overall; 7 recommended reducing the volume. Adverse events, which were primarily mild and/or unrelated, were comparable between groups. Low systemic MIV-150 levels were observed, without accumulation. Plasma zinc levels were unchanged from baseline. Seven of seven CVLs collected 4-hour postdose demonstrated antiviral (HIV, human papillomavirus) activity. High baseline CVL anti–herpes-simplex virus type-2 (HSV-2) activity precluded assessment of postdose activity. Conclusions: PC-1005 used vaginally for 14 days was well tolerated. Low systemic levels of MIV-150 were observed. Plasma zinc levels were unchanged. Postdose CVLs had anti-HIV and anti–human papillomavirus activity. These data warrant further development of PC-1005 for HIV and sexually transmitted

  16. Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma.

    PubMed

    Weber, Jeffrey S; Hodi, F Stephen; Wolchok, Jedd D; Topalian, Suzanne L; Schadendorf, Dirk; Larkin, James; Sznol, Mario; Long, Georgina V; Li, Hewei; Waxman, Ian M; Jiang, Joel; Robert, Caroline

    2017-03-01

    Purpose We conducted a retrospective analysis to assess the safety profile of nivolumab monotherapy in patients with advanced melanoma and describe the management of adverse events (AEs) using established safety guidelines. Patients and Methods Safety data were pooled from four studies, including two phase III trials, with patients who received nivolumab 3 mg/kg once every 2 weeks. We evaluated rate of treatment-related AEs, time to onset and resolution of select AEs (those with potential immunologic etiology), and impact of select AEs and suppressive immune-modulating agents (IMs) on antitumor efficacy. Results Among 576 patients, 71% (95% CI, 67% to 75%) experienced any-grade treatment-related AEs (most commonly fatigue [25%], pruritus [17%], diarrhea [13%], and rash [13%]), and 10% (95% CI, 8% to 13%) experienced grade 3 to 4 treatment-related AEs. No drug-related deaths were reported. Select AEs (occurring in 49% of patients) were most frequently skin related, GI, endocrine, and hepatic; grade 3 to 4 select AEs occurred in 4% of patients. Median time to onset of select AEs ranged from 5 weeks for skin to 15 weeks for renal AEs. Approximately 24% of patients received systemic IMs to manage select AEs, which in most cases resolved. Adjusting for number of doses, objective response rate (ORR) was significantly higher in patients who experienced treatment-related select AEs of any grade compared with those who did not. ORRs were similar in patients who did and patients who did not receive systemic IMs. Conclusion Treatment-related AEs with nivolumab monotherapy were primarily low grade, and most resolved with established safety guidelines. Use of IMs did not affect ORR, although treatment-related select AEs of any grade were associated with higher ORR, but no progression-free survival benefit.

  17. Inventory of Safety-related Codes and Standards for Energy Storage Systems with some Experiences related to Approval and Acceptance

    SciTech Connect

    Conover, David R.

    2014-09-11

    The purpose of this document is to identify laws, rules, model codes, codes, standards, regulations, specifications (CSR) related to safety that could apply to stationary energy storage systems (ESS) and experiences to date securing approval of ESS in relation to CSR. This information is intended to assist in securing approval of ESS under current CSR and to identification of new CRS or revisions to existing CRS and necessary supporting research and documentation that can foster the deployment of safe ESS.

  18. Offer/Acceptance Ratio.

    ERIC Educational Resources Information Center

    Collins, Mimi

    1997-01-01

    Explores how human resource professionals, with above average offer/acceptance ratios, streamline their recruitment efforts. Profiles company strategies with internships, internal promotion, cooperative education programs, and how to get candidates to accept offers. Also discusses how to use the offer/acceptance ratio as a measure of program…

  19. Safety, Acceptability, and Use of a Smartphone App, BlueIce, for Young People Who Self-Harm: Protocol for an Open Phase I Trial

    PubMed Central

    2016-01-01

    Background Up to 18% of adolescents will engage in an act of self-harm before young adulthood, with the majority of acts occurring in private. Mobile apps may offer a way of providing support for young people at times of distress to prevent self-harm. Objective This is a proof-of-concept study designed to explore the safety, acceptability, feasibility, and usability of a smartphone app, BlueIce, with young people who are self-harming. Methods In this phase I open trial we will evaluate BlueIce, a smartphone app developed and coproduced with young people with lived experience of self-harm. BlueIce includes a mood-monitoring diary, selection of mood-lifting techniques based on cognitive behavior therapy and dialectical behavior therapy, and direct access to emergency telephone numbers. We will recruit young people (n=50) attending specialist child and adolescent mental health services with a current or past history of self-harm to trial BlueIce as an adjunct to their usual care. Questionnaires and interviews will be completed at baseline, postfamiliarization (2 weeks), and at follow-up (12 weeks after baseline) to assess safety, app use, and acceptability. Interviews will be undertaken with clinicians to assess the feasibility of BlueIce within a clinical setting. Results Recruitment occurred between May and November 2016. The recruitment target was 50, and by the beginning of November 54 young people had been referred. Conclusions This study is the first to evaluate an app specifically developed with young people for young people (under the age of 18 years) who self-harm. It will determine whether BlueIce is acceptable, how often it is used, and whether it is safe and does not have any unintentional adverse effects. This information will determine whether a feasibility trial to test recruitment, randomization, retention, and appropriate outcome measures should be pursued. PMID:27852560

  20. The affective profiles, psychological well-being, and harmony: environmental mastery and self-acceptance predict the sense of a harmonious life.

    PubMed

    Garcia, Danilo; Al Nima, Ali; Kjell, Oscar N E

    2014-01-01

    Background. An important outcome from the debate on whether wellness equals happiness, is the need of research focusing on how psychological well-being might influence humans' ability to adapt to the changing environment and live in harmony. To get a detailed picture of the influence of positive and negative affect, the current study employed the affective profiles model in which individuals are categorised into groups based on either high positive and low negative affect (self-fulfilling); high positive and high negative affect (high affective); low positive and low negative affect (low affective); and high negative and low positive affect (self-destructive). The aims were to (1) investigate differences between affective profiles in psychological well-being and harmony and (2) how psychological well-being and its dimensions relate to harmony within the four affective profiles. Method. 500 participants (mean age = 34.14 years, SD. = ±12.75 years; 187 males and 313 females) were recruited online and required to answer three self-report measures: The Positive Affect and Negative Affect Schedule; The Scales of Psychological Well-Being (short version) and The Harmony in Life Scale. We conducted a Multivariate Analysis of Variance where the affective profiles and gender were the independent factors and psychological well-being composite score, its six dimensions as well as the harmony in life score were the dependent factors. In addition, we conducted four multi-group (i.e., the four affective profiles) moderation analyses with the psychological well-being dimensions as predictors and harmony in life as the dependent variables. Results. Individuals categorised as self-fulfilling, as compared to the other profiles, tended to score higher on the psychological well-being dimensions: positive relations, environmental mastery, self-acceptance, autonomy, personal growth, and purpose in life. In addition, 47% to 66% of the variance of the harmony in life was explained by the

  1. The affective profiles, psychological well-being, and harmony: environmental mastery and self-acceptance predict the sense of a harmonious life

    PubMed Central

    Al Nima, Ali; Kjell, Oscar N.E.

    2014-01-01

    Background. An important outcome from the debate on whether wellness equals happiness, is the need of research focusing on how psychological well-being might influence humans’ ability to adapt to the changing environment and live in harmony. To get a detailed picture of the influence of positive and negative affect, the current study employed the affective profiles model in which individuals are categorised into groups based on either high positive and low negative affect (self-fulfilling); high positive and high negative affect (high affective); low positive and low negative affect (low affective); and high negative and low positive affect (self-destructive). The aims were to (1) investigate differences between affective profiles in psychological well-being and harmony and (2) how psychological well-being and its dimensions relate to harmony within the four affective profiles. Method. 500 participants (mean age = 34.14 years, SD. = ±12.75 years; 187 males and 313 females) were recruited online and required to answer three self-report measures: The Positive Affect and Negative Affect Schedule; The Scales of Psychological Well-Being (short version) and The Harmony in Life Scale. We conducted a Multivariate Analysis of Variance where the affective profiles and gender were the independent factors and psychological well-being composite score, its six dimensions as well as the harmony in life score were the dependent factors. In addition, we conducted four multi-group (i.e., the four affective profiles) moderation analyses with the psychological well-being dimensions as predictors and harmony in life as the dependent variables. Results. Individuals categorised as self-fulfilling, as compared to the other profiles, tended to score higher on the psychological well-being dimensions: positive relations, environmental mastery, self-acceptance, autonomy, personal growth, and purpose in life. In addition, 47% to 66% of the variance of the harmony in life was explained by

  2. Scientific evaluation of the data-derived safety factors for the acceptable daily intake. Case study: diethylhexylphthalate.

    PubMed

    Morgenroth, V

    1993-01-01

    Diethylhexylphthalate causes peroxisome proliferation and is hepatocarcinogenic in rodents; it also displays reproductive and developmental toxicity in a variety of mammalian and non-mammalian species. These manifestations of toxicity have each been separately evaluated for the development of a data-derived safety factor and Tolerable Daily Intake (TDI). Using hepatocarcinogenicity as the pivotal study, the nature of toxicity factor of 10 is applicable and there are no adequate studies demonstrating a No-Observed-Adverse-Effect Level (NOAEL). If studies of less statistical sensitivity are used to derive the NOAEL and a factor of 0.1 is used for the relative sensitivity to humans of peroxisome proliferation (assuming this is linked mechanistically to carcinogenesis), a TDI of 1 mg/kg bw is obtained. The data-derived safety factor using peroxisomal proliferation as the pivotal end-point is 6.25, since the factor from trans-species toxicodynamics is 0.01, and the TDI derived from the NOAEL for peroxisome proliferation is thus 8 mg/kg bw. If teratogenicity is used as the pivotal study, the nature of toxicity attracts a factor of 10 and all the other aspects take default values because of the limited availability of relevant toxicodynamic and toxicokinetic data. The TDI derived from the NOAEL for teratogenicity is then 0.04 mg/kg bw and this confirms teratogenicity as the limiting aspect of toxicity defining the TDI. It also identifies the fact that appropriate toxicokinetic and toxicodynamic data related to the pregnant animal and fetus would facilitate a re-evaluation of the safety factor and TDI by replacing the current default values by data-derived values.

  3. Safety profiling of pioglitazone and telmisartan combination by sub-chronic toxicity study in rat.

    PubMed

    Sengupta, Pinaki; Das, Arindam; Ibrahim, Fuzianna; Mandal, Uttam Kumar; Chatterjee, Bappaditya; Mahmood, Syed; Das, Sreemoy Kanti; Kifayatullah, Muhammad

    2016-11-01

    It has been reported that the major cause of mortality in diabetes is cardiovascular diseases and contribution of hypertension is significant in this context. Pioglitazone, a thiazolidinedione class of therapeutic agent is used to treat type 2 diabetes mellitus. Telmisartan, an angiotensin receptor blocker antihypertensive has been reported to have beneficial effect if co-administered with pioglitazone for the management of diabetes complications. The present research work aims to evaluate the safety/toxicity profile of this combination in rat model. The investigation was carried out after co-administering the drugs to the rats for 28 days at three dose levels of 50, 100 and 150 mg/kg covering low to high dose ranges. Various hematological and biochemical parameters were studied in addition to the histopathology of the major organs in order to evaluate the toxicity profile of the combination. Absence of mortality and histopathological changes as well as unaltered hematological and biochemical parameters was observed. This preliminary investigation concludes that the combination of pioglitazone and telmisartan can primarily be stated as safe in animals, even at the dose level which is several folds higher than the intended human dose. Thus, this combination can be explored in future to develop a rational therapy regimen to treat hypertensive diabetic patients.

  4. Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe

    PubMed Central

    Mavhu, Webster; Ncube, Getrude; Xaba, Sinokuthemba; Madidi, Ngonidzashe; Keatinge, Jo; Dhodho, Efison; Samkange, Christopher A.; Tshimanga, Mufuta; Mangwiro, Tonderayi; Mugurungi, Owen; Njeuhmeli, Emmanuel; Cowan, Frances M.

    2016-01-01

    Background: Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe. Methods: The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. Results: A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal. Conclusions: Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery. PMID:27331593

  5. Effect of Vitamin D3 Fortification and Saskatoon Berry Syrup Addition on the Flavor Profile, Acceptability, and Antioxidant Properties of Rooibos Tea (Aspalathus linearis).

    PubMed

    Grant, Jennifer; Ryland, Donna; Isaak, Cara K; Prashar, Suvira; Siow, Yaw L; Taylor, Carla G; Aliani, Michel

    2017-03-01

    The unique characteristics and healthful reputation of caffeine-free rooibos tea (RT) make it an ideal carrier for vitamin D3 supplementation, and a potential base for the addition of Saskatoon berry syrup (SBS), a natural flavor additive. The objective of this study was to determine the effect of vitamin D3 fortification and SBS addition on the flavor profile, consumer acceptability, and antioxidant properties of RT. Six formulations (RT, RT with SBS, RT with SBS and vitamin D3 , RT with vitamin D3 , green tea [GT], and GT with SBS) were evaluated by 12 trained panelists and 114 consumers. The formulations were also assessed for antioxidant capacity, physical characteristics, and untargeted phytochemical content. Sensory results revealed that the mean intensity values for berry and sweet attributes were significantly higher (P < 0.05) while bitter and astringent attributes were significantly lower when SBS was added to RT samples compared to those without syrup. Acceptability of flavor, aftertaste, and overall acceptability were also significantly higher for the RT with SBS. The addition of SBS to RT significantly increased the antioxidant capacities which may increase the related health benefits of RT. SBS contributed several polyphenols, particularly flavonoids, to the tea. Vitamin D3 added to RT formulations did not significantly affect the sensory attributes, acceptability, or antioxidant content. For the development of a functional vitamin D3 fortified iced-tea beverage that can be consumed as part of the daily diet, SBS could be a favorable flavoring additive that may provide additional health benefits.

  6. "Would you accept having your DNA profile inserted in the National Forensic DNA database? Why?" Results of a questionnaire applied in Portugal.

    PubMed

    Machado, Helena; Silva, Susana

    2014-01-01

    The creation and expansion of forensic DNA databases might involve potential threats to the protection of a range of human rights. At the same time, such databases have social benefits. Based on data collected through an online questionnaire applied to 628 individuals in Portugal, this paper aims to analyze the citizens' willingness to donate voluntarily a sample for profiling and inclusion in the National Forensic DNA Database and the views underpinning such a decision. Nearly one-quarter of the respondents would indicate 'no', and this negative response increased significantly with age and education. The overriding willingness to accept the inclusion of the individual genetic profile indicates an acknowledgement of the investigative potential of forensic DNA technologies and a relegation of civil liberties and human rights to the background, owing to the perceived benefits of protecting both society and the individual from crime. This rationale is mostly expressed by the idea that all citizens should contribute to the expansion of the National Forensic DNA Database for reasons that range from the more abstract assumption that donating a sample for profiling would be helpful in fighting crime to the more concrete suggestion that everyone (criminals and non-criminals) should be in the database. The concerns with the risks of accepting the donation of a sample for genetic profiling and inclusion in the National Forensic DNA Database are mostly related to lack of control and insufficient or unclear regulations concerning safeguarding individuals' data and supervising the access and uses of genetic data. By providing an empirically-grounded understanding of the attitudes regarding willingness to donate voluntary a sample for profiling and inclusion in a National Forensic DNA Database, this study also considers the citizens' perceived benefits and risks of operating forensic DNA databases. These collective views might be useful for the formation of international common

  7. Safety profile of different low-molecular weight heparins used at therapeutic dose.

    PubMed

    Gouin-Thibault, Isabelle; Pautas, Eric; Siguret, Virginie

    2005-01-01

    Low-molecular weight heparins (LMWHs) have been shown to be as safe and effective as unfractionated heparin (UFH) for the treatment of acute venous thrombosis and non-life-threatening pulmonary embolism. Different reports have shown that LMWHs may also be used to treat patients with unstable angina or non-Q-wave infarction. The safety of LMWHs used at therapeutic dose has been widely studied in pivotal clinical trials and analysed in several meta-analyses. However, despite the wide development and use of LMWHs, several issues regarding the safety and optimal use of LMWHs remain unanswered. The main adverse effect of LMWHs is bleeding and it is uncertain whether a weight-adjusted dosage regimen without laboratory monitoring can be used in patients with a high risk of bleeding, such as patients with renal failure, elderly patients, obese patients or pregnant women. These patients are usually excluded from clinical trials and only a few studies, not sufficiently powered to estimate efficacy and safety, have been carried out in these special populations. Most of the available data comes from pharmacokinetic or population pharmacodynamic studies or clinical reports. Results in patients with renal impairment who are not undergoing haemodialysis suggest that a reduction in calculated creatinine clearance levels is associated with an increased risk of accumulation of anti-Xa activity, the extent of which differs depending on the individual LMWH and the extent to which the compound is cleared by the kidney. The limited data available regarding the use of therapeutic doses of LMWHs in obese patients suggest that there is no need to cap the dose at a maximal allowable dose. Long-term (3-month) treatment with LMWHs appears to be as effective and safe as oral anticoagulant therapy for the treatment of venous thromboembolism. It appears that each LMWH is a distinct compound with unique pharmacokinetic and pharmacodynamic profiles. Until more data are available regarding these

  8. Curcuma longa L. as a Therapeutic Agent in Intestinal Motility Disorders. 2: Safety Profile in Mouse

    PubMed Central

    Micucci, Matteo; Aldini, Rita; Cevenini, Monica; Colliva, Carolina; Spinozzi, Silvia; Roda, Giulia; Montagnani, Marco; Camborata, Cecilia; Camarda, Luca; Chiarini, Alberto; Mazzella, Giuseppe; Budriesi, Roberta

    2013-01-01

    Background Curcuma extract exerts a myorelaxant effect on the mouse intestine. In view of a possible use of curcuma extract in motor functional disorders of the gastrointestinal tract, a safety profile study has been carried out in the mouse. Methods Thirty mice were used to study the in vitro effect of curcuma on gallbladder, bladder, aorta and trachea smooth muscular layers and hearth inotropic and chronotropic activity. The myorelaxant effect on the intestine was also thoroughly investigated. Moreover, curcuma extract (200 mg/Kg/day) was orally administered to twenty mice over 28 days and serum liver and lipids parameters were evaluated. Serum, bile and liver bile acids qualitative and quantitative composition was were also studied. Results In the intestine, curcuma extract appeared as a not competitive inhibitor through cholinergic, histaminergic and serotoninergic receptors and showed spasmolytic effect on K+ induced contraction at the level of L type calcium channels. No side effect was observed on bladder, aorta, trachea and heart when we used a dose that is effective on the intestine. An increase in gallbladder tone and contraction was observed. Serum liver and lipids parameters were normal, while a slight increase in serum and liver bile acids concentration and a decrease in bile were observed. Conclusions Although these data are consistent with the safety of curcuma extract as far as its effect on the smooth muscular layers of different organs and on the heart, the mild cholestatic effect observed in absence of alteration of liver function tests must be further evaluated and the effective dose with minimal side effects considered. PMID:24260512

  9. A comparative study of the safety, effectiveness and acceptability of two foaming vaginal tablets (nonoxynol-9 versus menfegol) in Thai women.

    PubMed

    Chompootaweep, S; Dusitsin, N

    1990-05-01

    Two foaming vaginal tablets containing nonoxynol-9 (OVT-n) or menfegol (OVT-m) were studied to evaluate safety, effectiveness and acceptability. The study was conducted at the Chulalongkorn University, Institute of Health Research, Bangkok, Thailand. One-hundred-two women randomly assigned to one of the two types of tablets were scheduled for follow-up visits at 1, 3, 6 and 12 months. Although there were differences between the two groups in the gross cumulative 12-month life table rates and 12-month continuation rates, these differences were not statistically significant. Twelve-month discontinuation rates for accidental pregnancy were 31.7 per 100 women for OVT-n group and 25.3 per 100 women for the OVT-m group. Seventeen of the total 22 pregnancies occurred due to use failure. This study indicates that the regular and proper use of OVT-n or OVT-m tablets are comparable and are a safe means of birth control. Although a few product-related (burning) or medical complaints were reported by both groups of tablet users, it seems that the vaginal contraceptive is an acceptable method for fertility control in a suitable population who will use it regularly and properly.

  10. Control of the tokamak safety factor profile with time-varying constraints using MPC

    NASA Astrophysics Data System (ADS)

    Maljaars, E.; Felici, F.; de Baar, M. R.; van Dongen, J.; Hogeweij, G. M. D.; Geelen, P. J. M.; Steinbuch, M.

    2015-02-01

    A controller is designed for the tokamak safety factor profile that takes real-time-varying operational and physics limits into account. This so-called model predictive controller (MPC) employs a prediction model in order to compute optimal control inputs that satisfy the given limits. The use of linearized models around a reference trajectory results in a quadratic programming problem that can easily be solved online. The performance of the controller is analysed in a set of ITER L-mode scenarios simulated with the non-linear plasma transport code RAPTOR. It is shown that the controller can reduce the tracking error due to an overestimation or underestimation of the modelled transport, while making a trade-off between residual error and amount of controller action. It is also shown that the controller can account for a sudden decrease in the available actuator power, while providing warnings ahead of time about expected violations of operational and physics limits. This controller can be extended and implemented in existing tokamaks in the near future.

  11. Effectiveness and safety profile of 40% trichloroacetic acid and cryotherapy for plantar warts.

    PubMed

    Cengiz, Fatma Pelin; Emiroglu, Nazan; Su, Ozlem; Onsun, Nahide

    2016-09-01

    Plantar warts are one of the most common infectious skin disease caused by the human papillomavirus. In this study, cryotherapy with liquid nitrogen delivered by the physician, up to four treatments 2 weeks apart. Forty percent trichloroacetic acid (TCA) was applied to warts weekly up to four treatments. At the end of 4 weeks, the clinical improvement of the TCA group (n = 30) was six patients (20%) with no change, one patient (3.3%) with a mild response, 13 patients (43.3%) with a moderate response and 10 patients (33.3%) with a good response. In the cryotherapy group, clinical responses were 12 patients (40%) with no change, four patients (13.3%) with a mild response, 12 patients (40%) with a moderate response and two patients (6.7%) with a good response. There was a statistically significant difference in improvement between the two treatment groups (P = 0.027). According to our results, TCA 40% is more effective for clearance of plantar warts with significantly improved long-term safety profile.

  12. Computer-aided design of carbon nanotubes with the desired bioactivity and safety profiles.

    PubMed

    Fourches, Denis; Pu, Dongqiuye; Li, Liwen; Zhou, Hongyu; Mu, Qingxin; Su, Gaoxing; Yan, Bing; Tropsha, Alexander

    2016-01-01

    Growing experimental evidences suggest the existence of direct relationships between the surface chemistry of nanomaterials and their biological effects. Herein, we have employed computational approaches to design a set of biologically active carbon nanotubes (CNTs) with controlled protein binding and cytotoxicity. Quantitative structure-activity relationship (QSAR) models were built and validated using a dataset of 83 surface-modified CNTs. A subset of a combinatorial virtual library of 240 000 ligands potentially attachable to CNTs was selected to include molecules that were within the chemical similarity threshold with respect to the modeling set compounds. QSAR models were then employed to virtually screen this subset and prioritize CNTs for chemical synthesis and biological evaluation. Ten putatively active and 10 putatively inactive CNTs decorated with the ligands prioritized by virtual screening for either protein-binding or cytotoxicity assay were synthesized and tested. We found that all 10 putatively inactive and 7 of 10 putatively active CNTs were confirmed in the protein-binding assay, whereas all 10 putatively inactive and 6 of 10 putatively active CNTs were confirmed in the cytotoxicity assay. This proof-of-concept study shows that computational models can be employed to guide the design of surface-modified nanomaterials with the desired biological and safety profiles.

  13. Computer-Aided Design of Carbon Nanotubes with the Desired Bioactivity and Safety Profiles

    PubMed Central

    Fourches, Denis; Pu, Dongqiuye; Li, Liwen; Zhou, Hongyu; Mu, Qingxin; Su, Gaoxing; Yan, Bing; Tropsha, Alexander

    2016-01-01

    Growing experimental evidences suggest the existence of direct relationships between the surface chemistry of nanomaterials and their biological effects. Herein, we have employed computational approaches to design a set of biologically active Carbon Nanotubes (CNTs) with controlled protein binding and cytotoxicity. Quantitative Structure-Activity Relationships (QSAR) models were built and validated using a dataset of 83 surface-modified CNTs. A subset of a combinatorial virtual library of 240,000 ligands potentially attachable to CNTs was selected to include molecules that were within the chemical similarity threshold with respect to the modeling set compounds. QSAR models were then employed to virtually screen this subset and prioritize CNTs for chemical synthesis and biological evaluation. Ten putatively active and ten putatively inactive CNTs decorated with the ligands prioritized by virtual screening for either protein binding or cytotoxicity assays were synthesized and tested. We found that all 10 putatively inactive and 7 out of 10 putatively active CNTs were confirmed in the protein binding assay, whereas all 10 putatively inactive and 6 out of 10 putatively active CNTs were confirmed in the cytotoxicity assay. This proof-of-concept study shows that computational models can be employed to guide the design of surface-modified nanomaterials with the desired biological and safety profiles. PMID:26525350

  14. Evaluation of antidiabetic, antioxidant effect and safety profile of gomutra ark in Wistar albino rats

    PubMed Central

    Sachdev, Devender O.; Gosavi, Devesh D.; Salwe, Kartik J.

    2012-01-01

    The effect of Gomutra ark (GoA) on experimental alloxan-induced diabetes in rats was studied. For this purpose, Wistar albino rats of either sex weighing 200-250 g were used. The biochemical parameters like blood sugar, vitamin C, and malondialdehyde release were measured. The safety profile of GoA was evaluated using acute and chronic toxicity studies. GoA significantly lowers blood glucose in diabetic rats although the observed effect was found to be less than glibenclamide. It significantly lowers the level of malondialdehyde and vitamin C in diabetic rats. No toxicity was observed even when cow urine was given 32 times of the study dose in acute toxicity and no significant changes were seen when it was used chronically, which suggests that cow urine is having a very high therapeutic index. This study supports the traditional use of GoA in diabetes and is having a high therapeutic index and is safe for chronic use. However, further studies are needed to elucidate the mechanism of action of Gomutra ark. PMID:23284212

  15. Safety Profiles of Tripterygium wilfordii Hook F: A Systematic Review and Meta-Analysis

    PubMed Central

    Zhang, Chi; Sun, Ping-Ping; Guo, Hong-Tao; Liu, Yan; Li, Jian; He, Xiao-Juan; Lu, Ai-Ping

    2016-01-01

    Objective: Tripterygium wilfordii Hook F (TwHF) is a widely used and effective treatment for inflammatory diseases. There have been concerns about its toxicity but no adequate synthesis of the evidence for adverse events (AEs). We aimed to undertake a clinically informative, systematic safety profile of TwHF. Methods: We undertook a systematic review and meta-analysis of experimental studies and observational studies. We searched electronic databases and conference abstracts. Safety outcomes were rates of common AEs. Results: We screened 4137 abstracts for eligibility and included 594 studies in the analysis. The overall incidence of AEs was 26.7% (95% CI 24.8%, 28.8%) in 23,256 TwHF users. The estimates did vary markedly when stratified by specific study types. The incidence of gastrointestinal symptoms, adverse reproductive outcomes, adverse skin reactions, hematologic events and cardiovascular events were 13.3% (95% CI 11.9%, 14.9%), 11.7% (95% CI 10.3%, 13.3%), 7.8% (95% CI 6.3–9.5%), 6.5% (95% CI 5.7–7.4 %) and 4.9% (95% CI 1.6 %, 14.3 %), respectively. The prevalence of irregular menstruation (IM) was increased in patients taking TwHF compared with those given control (odds ratio [OR] 4.65, 95% CI 3.08 to 7.03). TwHF use has lower risk of weight gain (OR 0.12 [95% CI 0.04 to 0.39]) and hair loss (OR 0.37 [95% CI 0.18 to 0.78]). Furthermore, long-term aspirin use (>6 months) has a higher AEs incidence (31.0% [95% CI 24.5%–38.5%]). Conclusion: Our findings suggest that more than one in four patients who were taking TwHF had experienced AEs. A clear need exists for improved understanding of contributing risk factors, as well as of prevention and management strategies to improve patients' tolerance for TwHF. PMID:27877128

  16. Safety and effectiveness profile of raloxifene in long-term, prospective, postmarketing surveillance.

    PubMed

    Iikuni, Noriko; Hamaya, Etsuro; Nihojima, Shigeru; Yokoyama, Shunji; Goto, Wakana; Taketsuna, Masanori; Miyauchi, Akimitsu; Sowa, Hideaki

    2012-11-01

    This large-scale postmarketing surveillance of raloxifene (60 mg/day) was conducted to assess the safety and effectiveness of raloxifene for long-term use in postmenopausal Japanese women with osteoporosis. The baseline examination included 6,967 women (mean age, 70.4 years). Participants completed observation after 6, 12, 24, and 36 months of therapy. Adverse drug reactions (ADR) were reported in 776 participants (11.14 %), with a total of 87 serious ADR cases occurring in 76 participants (1.09 %). The most frequently reported ADRs were edema peripheral (45/6,967, 0.65 %) and venous thromboembolism (11/6,967, 0.16 %). Of the 6,967 participants, 2,784 were included in the effectiveness analysis. Lumbar spine bone mineral density (BMD) increased significantly (p < 0.001, paired t test) compared with baseline at 6, 12, 24, and 36 months (2.51 %, 2.85 %, 4.76 %, and 3.51 %, respectively). Significant decreases in serum and urinary cross-linked amino-terminal telopeptide of type I collagen (NTX) and urinary deoxypyridinoline levels from baseline were observed at 3 months, followed by a significant decrease of serum bone alkaline phosphatase at 6 months [p < 0.001 for all comparisons except serum NTX (p = 0.011), Wilcoxon signed-rank test]. Early reductions in the biochemical markers of bone turnover (BTM) observed at 3 months with raloxifene treatment correlated negatively with subsequent increases in lumbar spine BMD at 1 year (r = -0.347, p = 0.008). The incidence of any new clinical fractures within 3 years was 1.18 % (82/6,967 participants). In summary, no new signals in safety were observed in the daily use of raloxifene. Moreover, the effectiveness profile of raloxifene was confirmed in practical use by this large-scale, long-term, postmarketing surveillance.

  17. Safety, Acceptability, and Feasibility of Early Infant Male Circumcision Conducted by Nurse-Midwives Using the AccuCirc Device: Results of a Field Study in Zimbabwe

    PubMed Central

    Mavhu, Webster; Larke, Natasha; Hatzold, Karin; Ncube, Getrude; Weiss, Helen A; Mangenah, Collin; Chonzi, Prosper; Mugurungi, Owen; Mufuka, Juliet; Samkange, Christopher A; Gwinji, Gerald; Cowan, Frances M; Ticklay, Ismail

    2016-01-01

    ABSTRACT Background: For prevention of HIV, early infant male circumcision (EIMC) needs to be scaled up in countries with high HIV prevalence. Routine EIMC will maintain the HIV prevention gains anticipated from current adult male circumcision initiatives. We present here the results of a field study of EIMC conducted in Zimbabwe. Methods: The study was observational and based on the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices. We recruited parents of newborn male infants between August 2013 and July 2014 from 2 clinics. Nurse-midwives used the AccuCirc device to circumcise eligible infants. We followed participants for 14 days after EIMC. Outcome measures were EIMC safety, acceptability, and feasibility. Results: We enrolled 500 male infants in the field study (uptake 11%). The infants were circumcised between 6 and 60 days postpartum. The procedure took a median of 17 minutes (interquartile range of 5 to 18 minutes). Mothers’ knowledge of male circumcision was extensive. Of the 498 mothers who completed the study questionnaire, 91% knew that male circumcision decreases the risk of HIV acquisition, and 83% correctly stated that this prevention is partial. Asked about their community’s perception of EIMC, 40% felt that EIMC will likely be viewed positively in their community; 13% said negatively; and 47% said the perception could be both ways. We observed 7 moderate or severe adverse events (1.4%; 95% confidence interval, 0.4% to 2.4%). All resolved without lasting effects. Nearly all mothers (99%) reported great satisfaction with the outcome, would recommend EIMC to other parents, and would circumcise their next sons. Conclusion: This first field study in sub-Saharan Africa of the AccuCirc device for EIMC demonstrated that EIMC conducted by nurse-midwives with this device is safe, feasible, and acceptable to parents. PMID:27413083

  18. Safety Profile of Nifurtimox and Treatment Interruption for Chronic Chagas Disease in Colombian Adults

    PubMed Central

    Olivera, Mario Javier; Cucunubá, Zulma M.; Álvarez, Carlos Arturo; Nicholls, Rubén Santiago

    2015-01-01

    Nifurtimox (NFX) is one of the approved drugs used to treat Chagas disease. Safety profile studies and models on risk factors for treatment interruption in adults are scarce in Latin America. This study evaluated retrospectively the medical records of adult Chagas disease patients treated with NFX between 2007 and 2012 in Bogotá, Colombia. An accelerated failure time model was used, and associations were expressed as time ratio (TR). In total, 76 adult patients with NFX were included: 60 (79.0%) completed 60 days of treatment, 61 (80.3%) presented adverse drug reactions (ADRs), and 16 (21.0%) required treatment interruption. The predominant symptoms were epigastric pain (23.7%), nauseas (18.4%), sleep disturbances (18.4%), loss of appetite (17.1%), and temporary loss of memory (15.2%). ADRs were classified as mild (64.5%), moderate (30.4%), and severe (5.1%). Time of treatment was significantly longer when presenting ≤ 3 ADRs (TR: 1.78; 95% CI: 1.04–3.03), presence of non-severe ADRs (TR: 6.52; 95% CI: 3.24–13.1), doses of NFX ≤ 8 mg/kg/day (TR: 1.78; 95% CI: 0.90–3.49), and age < 48 years (TR: 1.57; 95% CI: 0.90–2.74). Treatment with NFX in adults caused a high frequency of ADRs, but most of the cases were mild and did not require treatment interruption. Severity and number of ADRs were the main predictors for treatment interruption. PMID:26392162

  19. Evaluation of bioavailability, efficacy, and safety profile of doxorubicin-loaded solid lipid nanoparticles

    NASA Astrophysics Data System (ADS)

    Patro, Nagaraju M.; Devi, Kshama; Pai, Roopa S.; Suresh, Sarasija

    2013-12-01

    We investigated the bioavailability, efficacy, and toxicity of doxorubicin-loaded solid lipid nanoparticles (DOX-SLNs) prepared by a simple modified double-emulsification method. A 3-factor, 3-level Box-Behnken statistical design was adopted in the optimization of DOX-SLN formulation considering dependent factors particle size and entrapment efficiency. Optimized SLN formulation composed of lipid (2 %) consisting of soya lecithin and Precirol ATO 5 (1:3) with Pluronic F68 (0.3 %) resulted in 217.36 ± 3.31 nm particle size and 59.45 ± 1.75 % entrapment efficiency. DOX-SLN exhibited significant enhancement ( p < 0.05) in bioavailability as compared with free DOX in Sprague-Dawley (SD) rats. DOX-SLN exhibited higher peak plasma concentration (6.761 ± 0.08 vs. 2.412 ± 0.04 μg/ml), increased AUC (61.368 ± 3.54 vs. 5.812 ± 0.49 μg/ml h), decreased clearance (36 ± 0.01 vs. 619 ± 0.005 mL/h kg), and volume of distribution (733 ± 0.092 vs. 2,064 ± 0.061 mL/kg) when compared to free DOX. The collective results of cardiac and kidney enzyme assay, antioxidant enzyme levels, hematological parameters, effect on body weight and tumor volume, tumor necrosis factor-α level, histopathological examination, and survival analysis confirmed the improved efficacy and safety profile of DOX-SLN in 7,12-dimethyl benzanthracene-induced breast cancer in SD rats.

  20. Pharmacodynamics, pharmacokinetics and safety profile of the new platelet-activating factor antagonist apafant in man.

    PubMed

    Brecht, H M; Adamus, W S; Heuer, H O; Birke, F W; Kempe, E R

    1991-01-01

    Platelet-activating factor (PAF) is a unique phospholipid mediator with multifunctional properties. Evidence generated in experimental studies suggests that PAF plays a pathogenetic role in anaphylactic, inflammatory and immunogenic reactions. Apafant (WEB 2086, CAS 105219-56-5), a novel synthetic PAF receptor antagonist, was administered to a total of 101 healthy volunteers within 5 studies to investigate its pharmacologic activity, pharmacokinetic behaviour and safety profile. Pharmacologic activity was monitored by inhibition of 5 x 10(-8) mol/l PAF-induced platelet aggregation ex vivo. The following treatment schedules were studied: oral single dose 1.25 to 400 mg; oral multiple dose 100 mg t.i.d. over 7 days; i.v. infusion 0.5 to 50 mg (over 30 min); inhalative administration up to 1.0 mg. PAF induced platelet aggregation was virtually completely inhibited by single oral doses of 20 mg upwards, throughout during the multiple oral dose study, at all dose levels tested in the i.v. study and (significantly but not completely) at 0.5 and 1.0 mg in the inhalative study. Following oral administrations (capsules) apafant is absorbed rapidly (tmax 1 to 2 h), there is linear pharmacokinetics for the mean plasma concentrations of apafant measured by RIA as well as for the areas under the curve (AUCs). Approximately 60% of apafant is bound to plasma protein, the mean volume of distribution is 28 l, about 44% of an oral dose is excreted in the urine, the mean renal clearance is 192 ml/min. No accumulation of the drug occurred in volunteers with normal kidney function. No clinically relevant drug related adverse events or changes in laboratory or vital parameters such as blood pressure, heart rate, respiratory rate and ECG were observed.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Nonclinical Safety Profile of BMS-986001, a Nucleoside Transcriptase Inhibitor for Combination Retroviral Therapy.

    PubMed

    Mausumee, Guha; Frank, Simutis; Shawn, Clark; Dara, Hawthorne; Zhao, Yue; Soleil, Piche Marie; Sanderson, Thomas P; Michael, Graziano; Marc, Davies

    2014-05-01

    Nucleoside reverse transcriptase inhibitors (NRTIs)/nucleotide reverse transcriptase inhibitors are key components of combination antiretroviral therapy for HIV infection. First-generation NRTIs are associated with mitochondrial toxicity in patients, mainly due to inhibition of human DNA polymerase γ (hDNA polγ) that manifests as adverse events such as lipodystrophy, lactic acidosis, myopathy, cardiomyopathy, or nephropathy in patients. In chronic nonclinical studies in rodents and nonrodents, eukaryotic (host) mitochondrial toxicity manifests as some drug-specific toxicities similar to human toxicity. BMS-986001, a novel thymidine analog with minimal hDNA polγ inhibition, has demonstrated antiretroviral activity in early clinical studies. The primary toxicity of BMS-986001 in rats and monkeys is bone marrow dyserythropoiesis with associated decreases in red blood cell mass. Additionally, at high doses, severe platelet reductions accompanied by cutaneous petechiae began during weeks 8 and 11 in 3 of 60 monkeys in chronic toxicity studies. In a 6-month study, platelet reductions required euthanasia of the 2 affected monkeys (300 mg/kg/d) at week 14, but with dose reduction (200 mg/kg/d) remaining monkeys had no platelet changes. One affected monkey (200 mg/kg/d) in a 9-month study completed dosing and its platelet counts recovered during a 1-month recovery. Formation of platelet-bound immunoglobulin in the presence of BMS-986001, together with rapid and complete platelet recovery in the absence of BMS-986001, suggested that platelet decreases in monkeys may be immune mediated. No findings indicative of mitochondrial toxicity were observed in rats or monkeys given BMS-986001, suggesting an improved safety profile compared to marketed NRTI or tenofovir disoproxil fumarate.

  2. Profile of ranibizumab: efficacy and safety for the treatment of wet age-related macular degeneration

    PubMed Central

    Chen, Youxin; Han, Fei

    2012-01-01

    Wet age-related macular degeneration (AMD) causes severe vision loss due to the development of choroidal neovascularization (CNV). The critical role of vascular endothelial growth factor in the pathogenesis of CNV is well understood. Ranibizumab plays an inhibitory role with CNV and reduces vascular permeability by binding to vascular endothelial growth factor. Intravitreal ranibizumab reduces the risk of visual acuity (VA) loss and increases the chance of VA gain compared with no treatment or photodynamic therapy for CNV in AMD. Some high-quality research has shown that the optimal timing for ranibizumab treating wet AMD is the first 3 months. It is recommended that ranibizumab is intravitreally injected monthly in the initiation for at least 3 months. Subsequent managing of regimens should be made dependent on the VA change, fundus examination, and image of optical coherence topography. An individualized strategy or combined method with photodynamic therapy is beneficial to the active lesion in the consecutive treatment of ranibizumab for CNV, and may be a good choice in order to decrease injection times. Regarding the safety profile, ranibizumab has been well tolerated in clinical trials. The principal ocular adverse event detected in clinical trials is a low frequency of ocular inflammation. Key serious ocular adverse events occurred in <5% of ranibizumab-treated patients in large-scale clinical trials. It appears unlikely that treatment with ranibizumab increases the risk of vascular events significantly. Less frequent injections on an as-needed schedule, based on monthly monitoring may have the most optimal risk:benefit ratio. PMID:22911433

  3. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  4. The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

    PubMed

    Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

    2016-01-01

    With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy.

  5. Longitudinal stability of social competence indicators in a Portuguese sample: Q-sort profiles of social competence, measures of social engagement, and peer sociometric acceptance.

    PubMed

    Santos, António J; Vaughn, Brian E; Peceguina, Inês; Daniel, João R

    2014-03-01

    This study examines the temporal stability (over 3 years) of individual differences in 3 domains relevant to preschool children's social competence: social engagement/motivation, profiles of behavior and personality attributes characteristic of socially competent young children, and peer acceptance. Each domain was measured with multiple indicators. Sociometric status categories (Asher & Dodge, 1986) and reciprocated friendships were derived from sociometric data. Composites for social competence domains were significantly associated across all time points. Within age-periods, social competence domains were associated with both sociometric and friendship status categories; however, neither sociometric status nor reciprocated friendships were stable over time. Nevertheless, analyses examining the social competence antecedents to reciprocated friendship at age-4 and age-5 suggested that more socially competent children in the prior year were more likely to have a reciprocated friendship in the current year. Popular and rejected sociometric status categories were also associated with social competence indicators in prior years, but this was most clearly seen at age-5.

  6. Safety profile of solid lipid nanoparticles loaded with rosmarinic acid for oral use: in vitro and animal approaches.

    PubMed

    Madureira, Ana Raquel; Nunes, Sara; Campos, Débora A; Fernandes, João C; Marques, Cláudia; Zuzarte, Monica; Gullón, Beatriz; Rodríguez-Alcalá, Luís M; Calhau, Conceição; Sarmento, Bruno; Gomes, Ana Maria; Pintado, Maria Manuela; Reis, Flávio

    2016-01-01

    Rosmarinic acid (RA) possesses several protective bioactivities that have attracted increasing interest by nutraceutical/pharmaceutical industries. Considering the reduced bioavailability after oral use, effective (and safe) delivery systems are crucial to protect RA from gastrointestinal degradation. This study aims to characterize the safety profile of solid lipid nanoparticles produced with Witepsol and Carnauba waxes and loaded with RA, using in vitro and in vivo approaches, focused on genotoxicity and cytotoxicity assays, redox status markers, hematological and biochemical profile, liver and kidney function, gut bacterial microbiota, and fecal fatty acids composition. Free RA and sage extract, empty nanoparticles, or nanoparticles loaded with RA or sage extract (0.15 and 1.5 mg/mL) were evaluated for cell (lymphocytes) viability, necrosis and apoptosis, and antioxidant/prooxidant effects upon DNA. Wistar rats were orally treated for 14 days with vehicle (control) and with Witepsol or Carnauba nanoparticles loaded with RA at 1 and 10 mg/kg body weight/d. Blood, urine, feces, and several tissues were collected for analysis. Free and loaded RA, at 0.15 mg/mL, presented a safe profile, while genotoxic potential was found for the higher dose (1.5 mg/mL), mainly by necrosis. Our data suggest that both types of nanoparticles are safe when loaded with moderate concentrations of RA, without in vitro genotoxicity and cytotoxicity and with an in vivo safety profile in rats orally treated, thus opening new avenues for use in nutraceutical applications.

  7. Safety profile of solid lipid nanoparticles loaded with rosmarinic acid for oral use: in vitro and animal approaches

    PubMed Central

    Madureira, Ana Raquel; Nunes, Sara; Campos, Débora A; Fernandes, João C; Marques, Cláudia; Zuzarte, Monica; Gullón, Beatriz; Rodríguez-Alcalá, Luís M; Calhau, Conceição; Sarmento, Bruno; Gomes, Ana Maria; Pintado, Maria Manuela; Reis, Flávio

    2016-01-01

    Rosmarinic acid (RA) possesses several protective bioactivities that have attracted increasing interest by nutraceutical/pharmaceutical industries. Considering the reduced bioavailability after oral use, effective (and safe) delivery systems are crucial to protect RA from gastrointestinal degradation. This study aims to characterize the safety profile of solid lipid nanoparticles produced with Witepsol and Carnauba waxes and loaded with RA, using in vitro and in vivo approaches, focused on genotoxicity and cytotoxicity assays, redox status markers, hematological and biochemical profile, liver and kidney function, gut bacterial microbiota, and fecal fatty acids composition. Free RA and sage extract, empty nanoparticles, or nanoparticles loaded with RA or sage extract (0.15 and 1.5 mg/mL) were evaluated for cell (lymphocytes) viability, necrosis and apoptosis, and antioxidant/prooxidant effects upon DNA. Wistar rats were orally treated for 14 days with vehicle (control) and with Witepsol or Carnauba nanoparticles loaded with RA at 1 and 10 mg/kg body weight/d. Blood, urine, feces, and several tissues were collected for analysis. Free and loaded RA, at 0.15 mg/mL, presented a safe profile, while genotoxic potential was found for the higher dose (1.5 mg/mL), mainly by necrosis. Our data suggest that both types of nanoparticles are safe when loaded with moderate concentrations of RA, without in vitro genotoxicity and cytotoxicity and with an in vivo safety profile in rats orally treated, thus opening new avenues for use in nutraceutical applications. PMID:27536103

  8. Food safety knowledge and practices of abattoir and butchery shops and the microbial profile of meat in Mekelle City, Ethiopia

    PubMed Central

    Haileselassie, Mekonnen; Taddele, Habtamu; Adhana, Kelali; Kalayou, Shewit

    2013-01-01

    Objective To assess the food safety knowledge and practices in meat handling, and to determine microbial load and pathogenic organisms in meat at Mekelle city. Methods A descriptive survey design was used to answer questions concerning the current status of food hygiene and sanitation practiced in the abattoir and butcher shops. Workers from the abattoir and butcher shops were interviewed through a structured questionnaire to assess their food safety knowledge. Bacterial load was assessed by serial dilution method and the major bacterial pathogens were isolated by using standard procedures. Results 15.4% of the abattoir workers had no health certificate and there was no hot water, sterilizer and cooling facility in the abattoir. 11.3% of the butchers didn't use protective clothes. There was a food safety knowledge gap within the abattoir and butcher shop workers. The mean values of bacterial load of abattoir meat, butcher shops and street meat sale was found to be 1.1×105, 5.6×105 and 4.3×106 cfu/g, respectively. The major bacterial pathogens isolated were Escherichia coli, Staphylococcus aureus and Bacillus cereus. Conclusions The study revealed that there is a reasonable gap on food safety knowledge by abattoir and butcher shop workers. The microbial profile was also higher compared to standards set by World Health Organization. Due attention should be given by the government to improve the food safety knowledge and the quality standard of meat sold in the city. PMID:23646306

  9. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    PubMed

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-02-21

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

  10. Nabumetone: therapeutic use and safety profile in the management of osteoarthritis and rheumatoid arthritis.

    PubMed

    Hedner, Thomas; Samulesson, Ola; Währborg, Peter; Wadenvik, Hans; Ung, Kjell-Arne; Ekbom, Anders

    2004-01-01

    Nabumetone is a nonsteroidal anti-inflammatory prodrug, which exerts its pharmacological effects via the metabolite 6-methoxy-2-naphthylacetic acid (6-MNA). Nabumetone itself is non-acidic and, following absorption, it undergoes extensive first-pass metabolism to form the main circulating active metabolite (6-MNA) which is a much more potent inhibitor of preferentially cyclo-oxygenase (COX)-2. The three major metabolic pathways of nabumetone are O-demethylation, reduction of the ketone to an alcohol, and an oxidative cleavage of the side-chain occurs to yield acetic acid derivatives. Essentially no unchanged nabumetone and < 1% of the major 6-MNA metabolite are excreted unchanged in the urine from which 80% of the dose can be recovered and another 10% in faeces. Nabumetone is clinically used mainly for the management of patients with osteoarthritis (OA) or rheumatoid arthritis (RA) to reduce pain and inflammation. The clinical efficacy of nabumetone has also been evaluated in patients with ankylosing spondylitis, soft tissue injuries and juvenile RA. The optimum oral dosage of nabumetone for OA patients is 1 g once daily, which is well tolerated. The therapeutic response is superior to placebo and similar to nonselective COX inhibitors. In RA patients, nabumetone 1 g at bedtime is optimal, but an additional 0.5-1 g can be administered in the morning for patients with persistent symptoms. In RA, nabumetone has shown a comparable clinical efficacy to aspirin (acetylsalicylic acid), diclofenac, piroxicam, ibuprofen and naproxen. Clinical trials and a decade of worldwide safety data and long-term postmarketing surveillance studies show that nabumetone is generally well tolerated. The most frequent adverse effects are those commonly seen with COX inhibitors, which include diarrhoea, dyspepsia, headache, abdominal pain and nausea. In common with other COX inhibitors, nabumetone may increase the risk of GI perforations, ulcerations and bleedings (PUBs). However, several

  11. Use of speed profile as surrogate measure: Effect of traffic calming devices on crosstown road safety performance.

    PubMed

    Moreno, Ana Tsui; García, Alfredo

    2013-12-01

    Urban road safety management is usually characterized by the lack of sufficient, good quality crash data and low budgets to obtain it even though many traffic accidents occur there. For example, 54 percent of road crashes in Spain take place in urban areas, and 10 percent of urban fatal crashes occur on crosstown roads, which are rural roads that traverse small communities. Traffic calming measures (TCMs) are often implemented on these parts of rural roads that traverse small communities in order to reduce both the frequency and severity of crashes by lowering speeds, but evaluation of their effectiveness has been limited. The objective of this study was to develop a methodology using continuous speed profiles to evaluate the safety effectiveness of TCMs on crosstown roads as part of an integrated system in the absence of historical data. Given the strong relationship between speed and crash experience, safety performance can be related to speed. Consequently, speed can be used indirectly as a surrogate safety measure in the absence of crash and speed data. Two indexes were defined in this study as surrogate safety measures based on the continuous speed profile: Ra and Ea. Ra represents the absolute accumulated speed variations relative to the average speed and is inversely related to accumulated speed uniformity; and Ea represents the accumulated speed variations above the speed limit and is directly related to accumulated speeding. Naturalistic data were collected using GPS trackers for 12 scenarios with different TCM spacings. Then, the indexes were applied to individual observed speed profiles (individual analysis) as well as the operating speed profile (global analysis). The values obtained from individual and global analysis were statistically different. Spacing lower than 110m, which was found optimal from previous research, did not allow drivers to modify their speeds as the accumulated speed uniformity was quite similar regardless of the average operating

  12. Safety assessment of genetically modified rice expressing human serum albumin from urine metabonomics and fecal bacterial profile.

    PubMed

    Qi, Xiaozhe; Chen, Siyuan; Sheng, Yao; Guo, Mingzhang; Liu, Yifei; He, Xiaoyun; Huang, Kunlun; Xu, Wentao

    2015-02-01

    The genetically modified (GM) rice expressing human serum albumin (HSA) is used for non-food purposes; however, its food safety assessment should be conducted due to the probability of accidental mixture with conventional food. In this research, Sprague Dawley rats were fed diets containing 50% (wt/wt) GM rice expressing HSA or non-GM rice for 90 days. Urine metabolites were detected by (1)H NMR to examine the changes of the metabolites in the dynamic process of metabolism. Fecal bacterial profiles were detected by denaturing gradient gel electrophoresis to reflect intestinal health. Additionally, short chain fatty acids and fecal enzymes were investigated. The results showed that compared with rats fed the non-GM rice, some significant differences were observed in rats fed with the GM rice; however, these changes were not significantly different from the control diet group. Additionally, the gut microbiota was associated with blood indexes and urine metabolites. In conclusion, the GM rice diet is as safe as the traditional daily diet. Furthermore, urine metabonomics and fecal bacterial profiles provide a non-invasive food safety assessment rat model for genetically modified crops that are used for non-food/feed purposes. Fecal bacterial profiles have the potential for predicting the change of blood indexes in future.

  13. Condoms and Contexts: Profiles of Sexual Risk and Safety Among Young Heterosexually Active Men

    PubMed Central

    Masters, N. Tatiana; Casey, Erin; Beadnell, Blair; Morrison, Diane M.; Hoppe, Marilyn J.; Wells, Elizabeth A.

    2014-01-01

    Heterosexual men’s sexual safety behavior is important to controlling the U.S. epidemic of sexually transmitted infections (STIs), including HIV. While sexual safety is often treated as a single behavior, such as condom use, it can also be conceptualized as resulting from multiple factors. Doing so can help us achieve more nuanced understandings of sexual risk and safety within partner-related contexts. We used Latent Class Analysis with data collected online from 18-25 year old heterosexually active U.S. men (n = 432) to empirically derive a typology of the patterns of sexual safety strategies they employ. Indicators were sexual risk reduction strategies used in the past year with the most recent female sex partner: Condom use, discussing sexual histories, STI testing, agreeing to be monogamous, and discussing birth control. We identified four subgroups: Risk Takers (12%), Condom Reliers (25%), Multistrategists (28%), and Relationship Reliers (35%). Partner-related context factors – number of past-year sex partners, relationship commitment, and sexual concurrency – predicted subgroup membership. Findings support tailoring STI prevention to men’s sexual risk-safety subgroups. Interventions should certainly continue to encourage condom use, but should also include information on how partner-related context factors and alternate sexual safety strategies can help men reduce risk for themselves and their partners. PMID:25256019

  14. Condoms and Contexts: Profiles of Sexual Risk and Safety Among Young Heterosexually Active Men.

    PubMed

    Masters, N Tatiana; Casey, Erin; Beadnell, Blair; Morrison, Diane M; Hoppe, Marilyn J; Wells, Elizabeth A

    2015-01-01

    Heterosexual men's sexual safety behavior is important to controlling the U.S. epidemic of sexually transmitted infections (STIs), including human immunodeficiency virus (HIV). While sexual safety is often treated as a single behavior, such as condom use, it can also be conceptualized as resulting from multiple factors. Doing so can help us achieve more nuanced understandings of sexual risk and safety within partner-related contexts. We used latent class analysis with data collected online from 18- to 25-year-old heterosexually active U.S. men (n = 432) to empirically derive a typology of the patterns of sexual safety strategies they employed. Indicators were sexual risk-reduction strategies used in the past year with the most recent female sex partner: condom use, discussing sexual histories, STI testing, agreeing to be monogamous, and discussing birth control. We identified four subgroups: Risk Takers (12%), Condom Reliers (25%), Multistrategists (28%), and Relationship Reliers (35%). Partner-related context factors--number of past-year sex partners, relationship commitment, and sexual concurrency--predicted subgroup membership. Findings support tailoring STI prevention to men's sexual risk-safety subgroups. Interventions should certainly continue to encourage condom use but should also include information on how partner-related context factors and alternate sexual safety strategies can help men reduce risk for themselves and their partners.

  15. Efficacy and safety profiles of manidipine compared with amlodipine: A meta-analysis of head-to-head trials

    PubMed Central

    RICHY, FLORENT F; LAURENT, STEPHANE

    2011-01-01

    The aim of this meta-analysis was to compare the efficacy and safety profile of manidipine 20 mg with that of amlodipine 10 mg. A systematic research of quantitative data produced or published between 1995 and 2009 was performed. Head-to-head randomized controlled trials (RCTs) of 12 months minimum duration reporting comparative efficacy (changes in systolic and diastolic blood pressure) and safety (total adverse events and ankle oedema), were included. Four high-quality RCTs, accounting for 838 patients (436 received manidipine and 402 received amlodipine) were included. The effi cacy of manidipine and amlodipine was statistically equivalent: effect size for DBP =−0.08 (p = 0.22) and SBP =−0.01 (p =0.83).The global safety of manidipine was signifi cantly better than amlodipine: the relative risk (RR) for adverse event was 0.69 (0.56 – 0.85), and particularly for ankle oedema RR was 0.35 (0.22 – 0.54). Publication bias was not signifi cant and the robustness of the analyses was good. These data suggest a better efficacy/safety ratio of manidipine over amlodipine. PMID:20945994

  16. Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update

    PubMed Central

    Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

    2016-01-01

    Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making. PMID:27354959

  17. Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update.

    PubMed

    Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

    2016-06-22

    Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making.

  18. Safety profile of Cerebrolysin: clinical experience from dementia and stroke trials.

    PubMed

    Thome, J; Doppler, E

    2012-04-01

    The safety of Cerebrolysin has been shown through many years of clinical use, observations from postmarketing surveillance studies, and safety data from randomized, controlled clinical trials. The reported events showed that adverse reactions to Cerebrolysin were generally mild and transient. Most common adverse events included vertigo, agitation and feeling hot. In the controlled clinical trials analyzed for this report, the incidence of adverse events was similar in Cerebrolysin- and placebo-treated groups. Cerebrolysin seems to be safe when used in combination with recombinant tissue-type plasminogen activator or cholinesterase inhibitors such as donepezil or rivastigmine. To our knowledge, Cerebrolysin was not associated with major changes in vital signs or laboratory parameters.

  19. A practical profile of integrated safety assessment of near-surface disposal of radwaste at PINSTECH.

    PubMed

    Jan, F; Ahmad, S S; Hasany, S M; Aslam, M

    2007-06-01

    Near-surface or shallow land disposal of radioactive waste has been the primary practice at the Pakistan Institute of Nuclear Science and Technology (PINSTECH). The adopted choice of this mode of disposal has been based on a study of the site and the quality and quantity of waste generated at the 5 MW reactor with HEU fuel. Specific measures regarding the radiation safety of the workers and environmental protection have been adopted. The waste disposal operations are conducted to meet local regulatory requirements, IAEA recommendations and internationally endorsed principles such as ALARA (as low as reasonably achievable - economic, social and other relevant factors being considered). The data obtained through the years of operational and management experience have manifested the robustness of the disposal system and reliability of the disposal criterion, and have also served to further refine the latter. Consequently, confidence in the current shallow-land-burial practices has increased. Radiological safety of these practices has been assessed by addressing different aspects of the safety and disposal system. These parameters, as indices of a non-exclusive and operational safety model, are presented.

  20. Safety evaluation of chemicals in food: toxicological data profiles for pesticides

    PubMed Central

    Vettorazzi, G.; Miles-Vettorazzi, P.

    1975-01-01

    The sources of the scientific information used over the past several years by the Joint FAO/WHO Meetings on Pesticide Residues in carrying out toxicological evaluations are classified systematically according to compound and subject for the first time in this paper. It is hoped that those engaged in the toxicological assessment of pesticide chemicals, for the purpose of standardizing pesticide tolerances or for developing criteria of acceptability, will profit from this classification. PMID:779805

  1. Long-Term Efficacy and Safety Profile of Lanthanum Carbonate: Results for up to 6 Years of Treatment

    PubMed Central

    Hutchison, Alastair J.; Barnett, M. Edwina; Krause, Rolfdieter; Kwan, Jonathan T.C.; Siami, Ghodrat A.

    2008-01-01

    Background/Aims Lanthanum carbonate (LC, FOSRENOL®) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. Methods Patients from four previous trials entered this study. Results Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium × phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. Conclusions LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs. PMID:18667837

  2. Myrrh and trematodoses in Egypt: an overview of safety, efficacy and effectiveness profiles.

    PubMed

    Abdul-Ghani, Rashad A; Loutfy, Naguiba; Hassan, Azza

    2009-09-01

    Myrrh is an herbal product that has been used since ancient ages for traditional medication and other purposes. The revolution of myrrh as an antiparasitic agent in Egypt began in the 1990s through scientific evidence-based research. The human trematode infections in Egypt were the main focus of research with stories of success and disagreement, at times. The present paper reviewed the antiparasitary activity of myrrh with stress on its possible mode of action, its safety, efficacy and effectiveness on trematode infections in experimental studies and clinical trials in Egypt as well as its molluscicidal effects on the intermediate hosts of trematodes.

  3. Profiles.

    ERIC Educational Resources Information Center

    School Arts, 1979

    1979-01-01

    Profiles seven Black, Native American, and Chicano artists and art teachers: Hale A. Woodruff, Allan Houser, Luis Jimenez, Betrand D. Phillips, James E. Pate, I, and Fernando Navarro. This article is part of a theme issue on multicultural art. (SJL)

  4. Safety profile of sural nerve in posterolateral approach to the ankle joint: MRI study.

    PubMed

    Ellapparadja, Pregash; Husami, Yaya; McLeod, Ian

    2014-05-01

    The posterolateral approach to ankle joint is well suited for ORIF of posterior malleolar fractures. There are no major neurovascular structures endangering this approach other than the sural nerve. The sural nerve is often used as an autologous peripheral nerve graft and provides sensation to the lateral aspect of the foot. The aim of this paper is to measure the precise distance of the sural nerve from surrounding soft tissue structures so as to enable safe placement of skin incision in posterolateral approach. This is a retrospective image review study involving 64 MRI scans. All measurements were made from Axial T1 slices. The key findings of the paper is the safety window for the sural nerve from the lateral border of tendoachilles (TA) is 7 mm, 1.3 cm and 2 cm at 3 cm above ankle joint, at the ankle joint and at the distal tip of fibula respectively. Our study demonstrates the close relationship of the nerve in relation to TA and fibula in terms of exact measurements. The safety margins established in this study should enable the surgeon in preventing endangerment of the sural nerve encountered in this approach.

  5. Inhibition of EGF Uptake by Nephrotoxic Antisense Drugs In Vitro and Implications for Preclinical Safety Profiling.

    PubMed

    Moisan, Annie; Gubler, Marcel; Zhang, Jitao David; Tessier, Yann; Dumong Erichsen, Kamille; Sewing, Sabine; Gérard, Régine; Avignon, Blandine; Huber, Sylwia; Benmansour, Fethallah; Chen, Xing; Villaseñor, Roberto; Braendli-Baiocco, Annamaria; Festag, Matthias; Maunz, Andreas; Singer, Thomas; Schuler, Franz; Roth, Adrian B

    2017-03-17

    Antisense oligonucleotide (AON) therapeutics offer new avenues to pursue clinically relevant targets inaccessible with other technologies. Advances in improving AON affinity and stability by incorporation of high affinity nucleotides, such as locked nucleic acids (LNA), have sometimes been stifled by safety liabilities related to their accumulation in the kidney tubule. In an attempt to predict and understand the mechanisms of LNA-AON-induced renal tubular toxicity, we established human cell models that recapitulate in vivo behavior of pre-clinically and clinically unfavorable LNA-AON drug candidates. We identified elevation of extracellular epidermal growth factor (EGF) as a robust and sensitive in vitro biomarker of LNA-AON-induced cytotoxicity in human kidney tubule epithelial cells. We report the time-dependent negative regulation of EGF uptake and EGF receptor (EGFR) signaling by toxic but not innocuous LNA-AONs and revealed the importance of EGFR signaling in LNA-AON-mediated decrease in cellular activity. The robust EGF-based in vitro safety profiling of LNA-AON drug candidates presented here, together with a better understanding of the underlying molecular mechanisms, constitutes a significant step toward developing safer antisense therapeutics.

  6. Transcriptome profiling of patient-specific human iPSC-cardiomyocytes predicts individual drug safety and efficacy responses in vitro

    PubMed Central

    Matsa, Elena; Burridge, Paul W.; Yu, Kun-Hsing; Ahrens, John H.; Termglinchan, Vittavat; Wu, Haodi; Liu, Chun; Shukla, Praveen; Sayed, Nazish; Churko, Jared M.; Shao, Ningyi; Woo, Nicole A.; Chao, Alexander S.; Gold, Joseph D.; Karakikes, Ioannis; Snyder, Michael P.; Wu, Joseph C.

    2016-01-01

    SUMMARY Understanding individual susceptibility to drug-induced cardiotoxicity is key to improving patient safety and preventing drug attrition. Human induced pluripotent stem cells (hiPSCs) enable the study of pharmacological and toxicological responses in patient-specific cardiomyocytes (CMs), and may serve as preclinical platforms for precision medicine. Transcriptome profiling in hiPSC-CMs from seven individuals lacking known cardiovascular disease-associated mutations, and in three isogenic human heart tissue and hiPSC-CM pairs, showed greater inter-patient variation than intra-patient variation, verifying that reprogramming and differentiation preserve patient-specific gene expression, particularly in metabolic and stress-response genes. Transcriptome-based toxicology analysis predicted and risk-stratified patient-specific susceptibility to cardiotoxicity, and functional assays in hiPSC-CMs using tacrolimus and rosiglitazone, drugs targeting pathways predicted to produce cardiotoxicity, validated inter-patient differential responses. CRISPR/Cas9-mediated pathway correction prevented drug-induced cardiotoxicity. Our data suggest that hiPSC-CMs can be used in vitro to predict and validate patient-specific drug safety and efficacy, potentially enabling future clinical approaches to precision medicine. PMID:27545504

  7. Safety Profile of Finasteride: Distribution of Adverse Effects According to Structural and Informational Dichotomies of the Mind/Brain.

    PubMed

    Motofei, Ion G; Rowland, David L; Manea, Mirela; Georgescu, Simona R; Păunică, Ioana; Sinescu, Ioanel

    2017-02-04

    Finasteride is currently used extensively for male androgenic alopecia and benign prostatic hyperplasia; however, some adverse effects are severe and even persistent after treatment cessation, the so-called 'post-finasteride syndrome'. The following most severe adverse effects-sexual dysfunction and depression-often occur together and may potentiate one other, a fact that could explain (at least in part) the magnitude and persistence of finasteride adverse effects. This paper presents the pharmacological action of finasteride and the corresponding adverse effects, the biological base explaining the occurrence, persistence and distribution of these adverse effects, and a possible therapeutic solution for post-finasteride syndrome. The distribution of finasteride adverse effects is presented within a comprehensive and modern neuro-endocrine perspective related to structural and informational dichotomies of the brain. Understanding the variation of finasteride side effects among different populations would be necessary not only to delineate the safety profile of finasteride for different subgroups of men (a subject may or may not be affected by a certain anti-hormonal compound dependent on the individual neuro-endocrine profile), but also as a possible premise for a therapeutic approach of finasteride adverse effects. Such therapeutic approach should include administration of exogenous hormones, which are deficient in men with post-finasteride syndrome, namely dihydrotestosterone (in right-handed men) or progesterone/dihydroprogesterone (in left-handed subjects).

  8. Safety and efficacy of hydroalcoholic extract from Lawsonia inermis leaves on lipid profile in alloxan-induced diabetic rats

    PubMed Central

    Singh, Surender; Verma, Nishikant; Karwasra, Ritu; Kalra, Prerna; Kumar, Rohit; Gupta, Yogendra Kumar

    2015-01-01

    Introduction: Dyslipidemia is one of the most common risk factor for cardiac-related disorders in diabetes mellitus. Diabetic dyslipidemia is characterized by hypertriglyceridemia, low high density lipoprotein and elevated low density lipoprotein concentration. Aim: To explore the effect of Lawsonia inermis hydroalcoholic extract (LIHE) for diabetic dyslipidemic activity along with its safety profile. Materials and Methods: LIHE administered at doses of 100, 200 and 400 mg/kg in rats after induction of hyperglycemia by alloxan. Insulin (1 IU/kg), glibenclamide (2.5 mg/kg), and metformin (100 mg/kg) were used as positive control and 1% gum acacia as normal control. Statistical analysis was performed using one-way analysis of variance, followed by Dunnett's t-test. Results: The percentage reduction in blood glucose level of LIHE at dose of 400 mg/kg was 39.08% on day 21 when compared to baseline (day 0), which is comparable to glibenclamide (44.77%) and metformin (46.30%). Decrease in blood glucose level exhibited significant improvement in lipid profile, plasma albumin, total plasma protein and serum creatinine. Conclusion: Results of this study demonstrated that LIHE significantly improved lipid and lipoprotein pattern observed in diabetic rats and this could be due to improvement in insulin secretion or action, thus has potential to be used in treatment of diabetes mellitus associated dyslipidemia. PMID:26730149

  9. Modeling of DIII-D Discharges With Feedback Control of the Safety Factor Profile Evolution

    NASA Astrophysics Data System (ADS)

    Ferron, J. R.; Gohil, P.; Greenfield, C. M.; Luce, T. C.; Petty, C. C.; Politzer, P. A.; Wade, M. R.; Basiuk, V.; Imbeaux, F.; Casper, T. A.; Murakami, M.; Ou, Y.; Schuster, E.; Gao, Q.; Wang, A.

    2006-10-01

    Closed loop control of the q evolution is implemented by modifying the rate of relaxation of the current density through changes in the conductivity using neutral beam or electron cyclotron power for electron heating. Comparisons between the experimental q evolution and transport code (ONETWO, TRANSP, CRONOS, CORSICA) modeling are being used to develop the physics model of the control process. We find that the neutral beam current drive profile in the simulation must peak near the mid-radius, instead of near the axis as predicted by NBCD theory, in order for the predicted q evolution to match the experiment. Alfvén eigenmode type fluctuations observed in the experiment could have provided a mechanism for fast ion transport. A simplified physics model is being developed for use in design of a model-based q evolution controller which will be tested in CRONOS simulations and in the experiment.

  10. Practice-Based Evidence: Profiling the Safety of Cilostazol by Text-Mining of Clinical Notes

    PubMed Central

    Iyer, Srinivasan V.; LePendu, Paea; Olson, Cliff; Shah, Nigam H.

    2013-01-01

    Background Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). Methods and Results We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1∶5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. Conclusions This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover ‘natural experiments’ such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy. PMID:23717437

  11. Toxicity and Safety Profiles of Methanolic Extract of Pistacia integerrima J. L. Stewart ex Brandis (PI) for Wistar Rats

    PubMed Central

    Sharwan, Gotmi; Jain, Parag; Pandey, Ravindra; Shukla, Shiv Shankar

    2016-01-01

    Objectives: The goals of this research were to evaluate acute (single-dose) and sub-acute (repeated-dose) toxicity profiles of methanolic extract of Pistacia integerrima J. L. Stewart ex Brandis (PI) for Wistar rats and to assess the safety profile of PI by observing physiological changes, mortality, changes in body weight, the histopathology of body organs, the hematology and the biochemistry of the animals. Methods: The toxicity profile of PI was evaluated using Wistar rats of both sexes. Animals were divided into four groups: Group 1; control group (normal saline), Group 2; PI-1 (250 mg/kg), Group 3; PI-2 (500 mg/kg), Group 4; PL-3 (1,000 mg/kg). An acute-toxicity study in which animals received a single dose of PI extract (2,000 mg/ kg) and were then observed for 14 days for changes in skin, fur, eye color, mucous membrane secretions and excretions, gait, posture, and tonic or clonic movements was performed according to guideline 425 of the Organization of Economic and Corporation Development (OECD). In the repeated-dose toxicity study (OECD – 407) animals received a daily dose of PI extract for 28 days (4 weeks). The parameters observed in this study include body weight, hematology and biochemistry of the animals. Results: In the acute toxicity study, no mortalities or changes in behavior were noted in the animals. The repeated-dose toxicity study was also devoid of any toxicity in the animals during the 28 days of testing with PI extract. The extract did not alter- the body weight, hematology or biochemistry of the animals. The methanolic extract of PI was to be found safe to the no-observed-adverse-effect-level (NOAEL) for the single- dose and repeated-dose toxicity tests in rats. Conclusion: The methanolic extract of PI was devoid of toxicity; hence, it can be used for various ayurvedic preparations and treatments of diseases. PMID:27695635

  12. Safety and efficacy profile of lenvatinib in cancer therapy: a systematic review and meta-analysis

    PubMed Central

    Hu, Yuanyuan; Guo, Linghong; Chen, Bo; Shen, Kai; Xiao, Yue

    2016-01-01

    To systematically review the safety and efficacy of lenvatinib in the treatment of patients, we retrieved all the relevant clinical trials on the adverse events (AEs) and survival outcomes of lenvatinib through PubMed, Medline, Embase, Web of Science and Cochrane Collaboration's Central register of controlled trial. Fourteen eligible studies involving a total of 978 patients were included in our analysis. The most common all-grade AEs observed in patients treated with lenvatinib were hematuria (56.6%), fatigue (52.2%) and decreased appetite (50.5%). The most frequently observed grade ≥3 AEs were thrombocytopenia (25.4%), hypertension (17.7%) and edema peripheral (15.5%). The incidences of both all-grade and high-grade hypertension were significantly increased. Meanwhile, the controlled trial suggested that progression free survival (PFS) was significantly longer in the lenvatinib group than the placebo group. Subgroup analyses showed that mean PFS for renal cell carcinoma was 10.933±1.828 months (95% CI 7.350-14.515, p < 0.001), and that for thyroid cancer was 18.344±0.083 months (95% CI 18.181-18.506, p < 0.001). In conclusion, lenvatinib is an effective agent in thyroid cancer. Early monitoring and effective management of side effects are crucial for the safe use of this drug. PMID:27329593

  13. Safety and efficacy profile of lenvatinib in cancer therapy: a systematic review and meta-analysis.

    PubMed

    Zhu, Chenjing; Ma, Xuelei; Hu, Yuanyuan; Guo, Linghong; Chen, Bo; Shen, Kai; Xiao, Yue

    2016-07-12

    To systematically review the safety and efficacy of lenvatinib in the treatment of patients, we retrieved all the relevant clinical trials on the adverse events (AEs) and survival outcomes of lenvatinib through PubMed, Medline, Embase, Web of Science and Cochrane Collaboration's Central register of controlled trial. Fourteen eligible studies involving a total of 978 patients were included in our analysis. The most common all-grade AEs observed in patients treated with lenvatinib were hematuria (56.6%), fatigue (52.2%) and decreased appetite (50.5%). The most frequently observed grade ≥3 AEs were thrombocytopenia (25.4%), hypertension (17.7%) and edema peripheral (15.5%). The incidences of both all-grade and high-grade hypertension were significantly increased. Meanwhile, the controlled trial suggested that progression free survival (PFS) was significantly longer in the lenvatinib group than the placebo group. Subgroup analyses showed that mean PFS for renal cell carcinoma was 10.933±1.828 months (95% CI 7.350-14.515, p < 0.001), and that for thyroid cancer was 18.344±0.083 months (95% CI 18.181-18.506, p < 0.001). In conclusion, lenvatinib is an effective agent in thyroid cancer. Early monitoring and effective management of side effects are crucial for the safe use of this drug.

  14. Glucagon in artificial pancreas systems: Potential benefits and safety profile of future chronic use.

    PubMed

    Taleb, Nadine; Haidar, Ahmad; Messier, Virginie; Gingras, Véronique; Legault, Laurent; Rabasa-Lhoret, Rémi

    2017-01-01

    The role of glucagon in the pathophysiology of diabetes has long been recognized, although its approved clinical use has so far been limited to the emergency treatment of severe hypoglycaemia. A novel use of glucagon as intermittent mini-boluses is proposed in the dual-hormone version (insulin and glucagon) of the external artificial pancreas. Short-term studies suggest that the incorporation of glucagon into artificial pancreas systems has the potential to further decrease hypoglycaemic risk and improve overall glucose control; however, the potential long-term safety and benefits also need to be investigated given the recognized systemic effects of glucagon. In the present report, we review the available animal and human data on the physiological functions of glucagon, as well as its pharmacological use, according to dosing and duration (acute and chronic). Along with its main role in hepatic glucose metabolism, glucagon affects the cardiovascular, renal, pulmonary and gastrointestinal systems. It has a potential role in weight reduction through its central satiety function and its role in increasing energy expenditure. Most of the pharmacological studies investigating the effects of glucagon have used doses exceeding 1 mg, in contrast to the mini-boluses used in the artificial pancreas. The available data are reassuring but comprehensive human studies using small but chronic glucagon doses that are close to the physiological ranges are lacking. We propose a list of variables that could be monitored during long-term trials of the artificial pancreas. Such trials should address the questions about the risk-benefit ratio of chronic glucagon use.

  15. Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United States

    PubMed Central

    Forsyth, Colin J.; Hernandez, Salvador; Olmedo, Wilman; Abuhamidah, Adieb; Traina, Mahmoud I.; Sanchez, Daniel R.; Soverow, Jonathan; Meymandi, Sheba K.

    2016-01-01

    Background. Nifurtimox is 1 of only 2 medications available for treating Chagas disease (CD) and currently the only drug available in the United States, but its safety and tolerance have not been extensively studied. This is the first study to evaluate tolerance of nifurtimox in US patients with CD. Methods. This investigation assessed side effects in a sample of 53 patients with CD, all Latin American immigrants, who underwent treatment with nifurtimox (8–10 mg/kg in 3 daily doses for 12 weeks) from March 2008 to July 2012. The frequency and severity of adverse events (AEs) was recorded. Results. A total of 435 AEs were recorded; 93.8% were mild, 3.0% moderate, and 3.2% severe. Patients experienced a mean of 8.2 AEs; the most frequent were anorexia (79.2%), nausea (75.5%), headache (60.4%), amnesia (58.5%), and >5% weight loss (52.8%). Eleven patients (20.8%) were unable to complete treatment. Experiencing a moderate or severe AE (odds ratio [OR], 3.82; P < .05) and Mexican nationality (OR, 2.29; P < .05) were significant predictors of treatment discontinuation, but sex and cardiac progression at baseline were not. Patients who did not complete treatment experienced nearly 3 times more AEs per 30-day period (P = .05). Conclusions. Nifurtimox produces frequent side effects, but the majority are mild and can be managed with dose reduction and/or temporary suspension of medication. The high frequency of gastrointestinal symptoms and weight loss mirrors results from prior investigations. Special attention should be paid during the early stages of treatment to potentially severe symptoms including depression, rash, and anxiety. PMID:27432838

  16. Beliefs and behaviours relevant to the road safety effects of profile lane-marking.

    PubMed

    Hatfield, Julie; Murphy, Susanne; Job, R F Soames

    2008-11-01

    Audio-tactile lane-marking (ATLM) is designed to alert inattentive drivers when they deviate from their lane, and appears to reduce crashes. Research into cognitive-behavioural mechanisms underlying, or possibly undermining, the efficacy of ATLM, is limited. We surveyed 775 randomly selected drivers (42% female, up to 75+ years) regarding the profile line-marking (PLM) employed in Australia (and in some European countries). Respondents perceived advantages of PLM in terms of lane-keeping and visibility. Respondents reported avoiding edge-line PLM, so that it may result in driving too close to untreated centre-line. Findings generally allayed concerns, on the basis of risk homeostasis theory, that PLM may increase risky driving. Perceived efficacy of PLM was not associated with increased drink-driving or speeding, but was associated with increased driving while fatigued. Findings suggest that the efficacy of PLM may be increased by employing PLM on both edge- and centre-lines, by exaggerating the audio-tactile effects of PLM that cause drivers to avoid it, and by discouraging the belief that it is safe to drive while fatigued when PLM is present.

  17. Experiences and Acceptance of Intimate Partner Violence: Associations with STI Symptoms and Ability to Negotiate Sexual Safety among Young Liberian Women

    PubMed Central

    Callands, Tamora A.; Sipsma, Heather L.; Betancourt, Theresa S.; Hansen, Nathan B.

    2013-01-01

    Women who experience intimate partner violence may be at elevated risk for poor sexual health outcomes including sexual transmitted infections (STIs). This association however, has not been consistently demonstrated in low-income or post-conflict countries; furthermore, the role that attitudes towards intimate partner violence play in sexual health outcomes and behaviour has rarely been examined. We examined associations between intimate partner violence experiences, accepting attitudes towards physical intimate partner violence, and sexual health and behavioural outcomes among 592 young women in post-conflict Liberia. Participants’ experiences with either moderate or severe physical violence or sexual violence were common. Additionally, accepting attitudes towards physical intimate partner violence were positively associated with reporting STI symptoms, intimate partner violence experiences and the ability to negotiate safe sex. Findings suggest that for sexual health promotion and risk reduction intervention efforts to achieve full impact, interventions must address the contextual influence of violence, including individual attitudes toward intimate partner violence. PMID:23586393

  18. Safety, efficacy and acceptability of outpatient mifepristone-misoprostol medical abortion through 70 days since last menstrual period in public sector facilities in Mexico City.

    PubMed

    Sanhueza Smith, Patricio; Peña, Melanie; Dzuba, Ilana G; García Martinez, María Laura; Aranguré Peraza, Ana Gabriela; Bousiéguez, Manuel; Shochet, Tara; Winikoff, Beverly

    2015-02-01

    Extensive evidence exists regarding the efficacy and acceptability of medical abortion through 63 days since last menstrual period (LMP). In Mexico City's Secretariat of Health (SSDF) outpatient facilities, mifepristone-misoprostol medical abortion is the first-line approach for abortion care in this pregnancy range. Recent research demonstrates continued high rates of complete abortion through 70 days LMP. To expand access to legal abortion services in Mexico City (where abortion is legal through 12 weeks LMP), this study sought to assess the efficacy and acceptability of the standard outpatient approach through 70 days in two SSDF points of service. One thousand and one women seeking pregnancy termination were enrolled and given 200 mg mifepristone followed by 800 μg misoprostol 24-48 hours later. Women were asked to return to the clinic one week later for evaluation. The great majority of women (93.3%; 95% CI: 91.6-94.8) had complete abortions. Women with pregnancies ≤ 8 weeks LMP had significantly higher success rates than women in the 9th or 10th weeks (94.9% vs. 90.5%; p = 0.01). The difference in success rates between the 9th and 10th weeks was not significant (90.0% vs. 91.2%; p = 0.71). The majority of women found the side effects (82.9%) and the use of misoprostol (84.4%) to be very acceptable or acceptable. This study provides additional evidence supporting an extended outpatient medical abortion regimen through 10 weeks LMP.

  19. Transarterial Chemoembolization for Hepatocellular Carcinoma with a New Generation of Beads: Clinical–Radiological Outcomes and Safety Profile

    SciTech Connect

    Spreafico, Carlo Cascella, Tommaso; Facciorusso, Antonio Sposito, Carlo; Rodolfo, Lanocita Morosi, Carlo Civelli, Enrico M. Vaiani, Marta; Bhoori, Sherrie; Pellegrinelli, Alessandro; Marchianò, Alfonso; Mazzaferro, Vincenzo

    2015-02-15

    PurposeTo evaluate the short-term safety and efficacy of the new generation of 70–150 µm drug-eluting beads (M1 DEB) in patients with hepatocellular carcinoma undergoing transarterial chemoembolization (TACE) as a primary therapy or as a bridge to liver transplantation (LT).MethodsForty-five consecutive patients underwent TACE with M1 DEB loaded with doxorubicin (DEBDOX/M1). Clinical data were recorded at 12, 24, and 48 h, 7 and 30 days after treatment. Response was assessed by computed tomographic scan according to the modified response evaluation criteria in solid tumors criteria, and a second DEBDOX/M1 TACE was scheduled within 6 weeks in case of a noncomplete response.ResultsAll patients had well-compensated cirrhosis (97.7 % Child A, 44.4 % hepatitis C virus, median age 61 years). Twenty patients (44.4 %) had Barcelona Clinic for Liver Cancer class B disease; the median number of nodules and their sum of diameters were 2 (range 1–6) and 43 mm (range 10–190), respectively. The mean number of TACE procedures per patient was 1.4. Objective response rate (complete + partial response) was 77.7 % with a median time to best response of 3 months (95 % confidence interval 2–4). In 13 patients, DEBDOX/M1 TACE served as a bridge/downstaging to LT/surgery. Pathology showed that more than 90 % necrosis was achieved in 10 of 28 nodules. DEBDOX/M1 TACE was well tolerated, and the grade 3/4 adverse event rate was low (1 of 65 procedures).ConclusionDEBDOX/M1 TACE is an effective procedure with a favorable safety profile and promising results in terms of objective response rate, tumor downstaging, and necrosis.

  20. Improving eye safety in citrus harvest crews through the acceptance of personal protective equipment, community-based participatory research, social marketing, and community health workers.

    PubMed

    Tovar-Aguilar, J Antonio; Monaghan, Paul F; Bryant, Carol A; Esposito, Andrew; Wade, Mark; Ruiz, Omar; McDermott, Robert J

    2014-01-01

    For the last 10 years, the Partnership for Citrus Workers Health (PCWH) has been an evidence-based intervention program that promotes the adoption of protective eye safety equipment among Spanish-speaking farmworkers of Florida. At the root of this program is the systematic use of community-based preventive marketing (CBPM) and the training of community health workers (CHWs) among citrus harvester using popular education. CBPM is a model that combines the organizational system of community-based participatory research (CBPR) and the strategies of social marketing. This particular program relied on formative research data using a mixed-methods approach and a multilevel stakeholder analysis that allowed for rapid dissemination, effective increase of personal protective equipment (PPE) usage, and a subsequent impact on adoptive workers and companies. Focus groups, face-to-face interviews, surveys, participant observation, Greco-Latin square, and quasi-experimental tests were implemented. A 20-hour popular education training produced CHWs that translated results of the formative research to potential adopters and also provided first aid skills for eye injuries. Reduction of injuries is not limited to the use of safety glasses, but also to the adoption of timely intervention and regular eye hygiene. Limitations include adoption in only large companies, rapid decline of eye safety glasses without consistent intervention, technological limitations of glasses, and thorough cost-benefit analysis.

  1. Recent RF Experiments and Application of RF Waves to Real-Time Control of Safety Factor Profile in JT-60U

    SciTech Connect

    Suzuki, T.; Isayama, A.; Ide, S.; Fujita, T.; Oikawa, T.; Sakata, S.; Sueoka, M.; Hosoyama, H.; Seki, M.

    2005-09-26

    Two topics of applications of RF waves to current profile control in JT-60U are presented; application of lower-hybrid (LH) waves to safety factor profile control and electron cyclotron (EC) waves to neo-classical tearing mode (NTM) control. A real-time control system of safety factor (q) profile was developed. This system, for the first time, enables 1) real time evaluation of q profile using local magnetic pitch angle measurement by motional Stark effect (MSE) diagnostic and 2) control of current drive (CD) location ({rho}CD) by controlling the parallel refractive index N parallel of LH waves through control of phase difference ({delta}{phi}) of LH waves between multi-junction launcher modules. The method for real-time q profile evaluation was newly developed, without time-consuming reconstruction of equilibrium, so that the method requires less computational time. Safety factor profile by the real-time calculation agrees well with that by equilibrium reconstruction with MSE. The control system controls {rho}CD through {delta}{phi} in such a way to decrease the largest residual between the real-time evaluated q profile q(r) and its reference profile qref(r). The real-time control system was applied to a positive shear plasma (q(0){approx}1). The reference q profile was set to monotonic positive shear profile having qref(0)=1.3. The real-time q profile approached to the qref(r) during application of real-time control, and was sustained for 3s, which was limited by the duration of the injected LH power. Temporal evolution of current profile was consistent with relaxation of inductive electric field induced by theoretical LH driven current. An m/n=3/2 NTM that appeared at {beta}N{approx}3 was completely stabilized by ECCD applied to a fully-developed NTM. Precise ECCD at NTM island was essential for the stabilization. ECCD that was applied to resonant rational surface (q=3/2) before an NTM onset suppressed appearance of NTM. In order to keep NTM intensity below a

  2. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    1992-08-01

    The principal safety objectives and safety assurance strategies of the Hermes space vehicle program are discussed. The highlights of the Hermes safety assurance strategy are reviewed with particular reference to risk identification, risk evaluation, risk reduction, and risk acceptance. The application of the safety assurance strategy to Phase I definition studies and safety objectives of the Hermes X 2000 mission are then discussed.

  3. Discovery of quinone-directed antitumor agents selectively bioactivated by NQO1 over CPR with improved safety profile.

    PubMed

    Bian, Jinlei; Li, Xiang; Wang, Nan; Wu, Xingsen; You, Qidong; Zhang, Xiaojin

    2017-03-31

    In this work, we mainly focused on discovering compounds with good selectivity for NQO1 over CPR. The NQO1-mediated two-electron reduction of compounds would kill cancer cells selectively, while CPR-mediated one-electron reduction would induce potential hepatotoxicity. Several novel quinone-directed antitumor agents were discovered as specific NQO1 substrates through structure-activity relationship studies. Among them, compound 3,7,8-trimethylnaphtho[1,2-b]furan-4,5-dione (12b) emerged as the most specific substrate of the two-electron oxidoreductase NQO1 and could hardly be reduced by CPR. It afforded the highest selectivity between NQO1/CPR (selectivity ratio = 6.37), much higher than the control β-lapachone (selectivity ratio = 1.36), indicated 12b may possess superior safety profile. The electrochemical studies provided a reasonable explanation to the good selectivity toward NQO1. Molecular docking studies supported that 12b was capable of forming additional C-H … π interactions with Trp105 and Phe178 residues compared to the control β-lap. In addition, compound 12b was shown to kill cancer cells efficiently both in vitro and in vivo model. This work gave us a promising and novel scaffold for further investigation.

  4. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics.

    PubMed

    Brunstein, Claudio G; Miller, Jeffrey S; Cao, Qing; McKenna, David H; Hippen, Keli L; Curtsinger, Julie; Defor, Todd; Levine, Bruce L; June, Carl H; Rubinstein, Pablo; McGlave, Philip B; Blazar, Bruce R; Wagner, John E

    2011-01-20

    Acute graft-versus-host disease (aGVHD) is associated with high risk of morbidity and mortality and is a common complication after double umbilical cord blood (UCB) transplantation. To reduce these risks, we established a method of CD4(+)CD25(+)FoxP3(+) T regulatory cell (Treg) enrichment from cryopreserved UCB followed by a 18 (+) 1-day expansion culture including anti-CD3/anti-CD28 antibody-coated beads and recombinant human interleukin-2. In a "first-in-human" clinical trial, we evaluated the safety profile of UCB Treg in 23 patients. Patients received a dose of 0.1-30 × 10(5)UCB Treg/kg after double UCB transplantation. The targeted Treg dose was achieved in 74% of cultures, with all products being suppressive in vitro (median 86% suppression at a 1:4 ratio). No infusional toxicities were observed. After infusion, UCB Treg could be detected for 14 days, with the greatest proportion of circulating CD4(+)CD127(-)FoxP3(+) cells observed on day (+)2. Compared with identically treated 108 historical controls without Treg, there was a reduced incidence of grade II-IV aGVHD (43% vs 61%, P = .05) with no deleterious effect on risks of infection, relapse, or early mortality. These results set the stage for a definitive study of UCB Treg to determine its potency in preventing allogeneic aGVHD. This study is registered at http://www.clinicaltrials.gov as NCT00602693.

  5. Safety Profile of Liver FibroScan in Patients with Cardiac Pacemakers or Implantable Cardioverter-Defibrillators

    PubMed Central

    Pranke, Stephanie; Rashidi, Farid; Nosib, Shravan; Worobetz, Lawrence

    2017-01-01

    Background. Emerging evidence suggests that nonalcoholic fatty liver disease (NAFLD) is associated with coronary artery diseases and arrhythmias. The FibroScan (Echosens, France), a widely available, noninvasive device, is able to detect liver fibrosis and steatosis within this patient population. However, the FibroScan is currently contraindicated in patients with cardiac pacemakers (PM) or implantable cardioverter-defibrillators (ICD). Objective. To determine the safety profile of FibroScan testing in patients with PM or ICD. Methods. Consecutive outpatients undergoing routine device interrogations at a tertiary level teaching hospital underwent simultaneous liver stiffness measurements. PM or ICD performance data, device types, patient demographics, medical history, and previous laboratory and conventional liver imaging results were collected. Results. Analysis of 107 subjects with 33 different types of implanted cardiac devices, from 5 different companies (Medtronic, Sorin, ELA Medical, Boston Scientific, and St. Jude), did not demonstrate any adverse events as defined by abnormal device sensing/pacing or ICD firing. This population included high risk subjects undergoing active pacing (n = 53) and with right pectoral PM placement (n = 1). None of the subjects had any clinical signs of decompensated congestive heart failure or cirrhosis during the exam. Conclusion. TE with FibroScan can be safely performed in patients with PM or ICD. PMID:28349045

  6. Intra-articular administration of lidocaine in anaesthetized dogs: pharmacokinetic profile and safety on cardiovascular and nervous systems.

    PubMed

    Di Salvo, A; Bufalari, A; De Monte, V; Cagnardi, P; Marenzoni, M L; Catanzaro, A; Vigorito, V; Della Rocca, G

    2015-08-01

    The intra-articular administration of lidocaine is a frequent practice in human orthopaedic surgical procedures, but an eventual absorption of the drug into the bloodstream can lead to toxicity, mainly concerning the central nervous system and the cardiovascular systems. The purpose of this study was to determine the pharmacokinetic profile and the safety, in terms of cardiovascular and CNS toxicity, of lidocaine after intra-articular administration to anesthetized dogs undergoing arthroscopy. Lidocaine 2% was administered to eight dogs before surgery in differing amounts, depending on the volume of the joints involved, and blood samples were taken at predetermined time points. The maximum serum concentration of lidocaine ranged from 0.50 to 3.01 μg/mL (mean ± SD: 2.18 ± 0.91 μg/mL), and the time to reach it was 28.75 ± 15.74 min. No signs of cardiac toxicity were detected during the entire procedure, and possible signs of CNS toxicity were masked by the anaesthesia. However, concentrations reported in literature as responsible for neurotoxicity in dog were achieved in three of eight investigated subjects. Pending further studies, veterinarians should consider the possibility of side effects occurring following the intra-articular administration of local anaesthetics.

  7. Hepatic safety profile of darunavir with low-dose ritonavir (DRV/r) in HIV/HCV coinfected and HIV monoinfected patients.

    PubMed

    Morsica, Giulia; Bianchi, Giampaolo; Bagaglio, Sabrina; Conte, Camilla; Salpietro, Stefania; Porrino, Lucy; Uberti-Foppa, Caterina

    2011-07-01

    The hepatic safety profile of ART including DRV/r was retrospectively evaluated in antiretroviral-experienced HIV-infected patients (18 HIV/HCV coinfected, group A and 29 infected with HIV alone, group B) during a 72 week study. During the study, liver enzyme values were higher in group A, but in the case of abnormal transaminase levels, the median values did not exceed 1.6xULN. This study showed evidence of long-lasting hepatic safety of ART including PI DRV/r in HIV/HCV coinfected and in HIV monoinfected persons.

  8. Safety profile of dalfampridine extended release in multiple sclerosis: 5-year postmarketing experience in the United States

    PubMed Central

    Jara, Michele; Aquilina, Thomas; Aupperle, Peter; Rabinowicz, Adrian L

    2015-01-01

    Background Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine outside the US), 10 mg twice daily, was approved by the US Food and Drug Administration (FDA) in January 2010 to improve walking in people with multiple sclerosis, as determined by an increase in walking speed. Objective To provide a descriptive analysis of reported adverse events (AEs) for commercially available dalfampridine-ER from March 2010 through March 31, 2015. Methods Five-year postmarketing data for dalfampridine-ER were available from the exposure of approximately 107,000 patients in the US (103,700 patient-years). Commonly reported AEs (≥2% of all reported AEs) and serious AEs were determined. The incidence of reported seizures was determined and the events were further investigated. Results Among the 107,000 patients exposed to dalfampridine-ER (70% female; mean age 52.1), the most common AEs were dizziness (3.7%), insomnia (3.2%), balance disorder (3%), fall (2.4%), headache (2.4%), nausea (2.1%), and urinary tract infection (2%). Other common AEs were drug ineffectiveness (5.8%), gait disturbance (4.6%), and inappropriate dosing (3.1%). Serious AEs included rare anaphylactic reactions (five cases) and drug hypersensitivity reactions (eight cases). A total of 657 seizure cases were reported (6.3/1,000 patient-years); of these, 324 were medically confirmed (3.1/1,000 patient-years). Incidence of reported seizures was stable over time. Duration of treatment prior to a seizure ranged from a single dose to >4 years; 12% of the seizures occurred within a week of starting treatment. Conclusion The 5-year US postmarketing safety data of dalfampridine-ER is consistent with the safety profile observed in clinical trials. Incidence of reported seizures remained stable over time. Since commercial availability in March 2010, a warning regarding the risk of anaphylaxis and severe allergic reactions was added to the US prescribing information

  9. UGV acceptance testing

    NASA Astrophysics Data System (ADS)

    Kramer, Jeffrey A.; Murphy, Robin R.

    2006-05-01

    With over 100 models of unmanned vehicles now available for military and civilian safety, security or rescue applications, it is important to for agencies to establish acceptance testing. However, there appears to be no general guidelines for what constitutes a reasonable acceptance test. This paper describes i) a preliminary method for acceptance testing by a customer of the mechanical and electrical components of an unmanned ground vehicle system, ii) how it has been applied to a man-packable micro-robot, and iii) discusses the value of testing both to ensure that the customer has a workable system and to improve design. The test method automated the operation of the robot to repeatedly exercise all aspects and combinations of components on the robot for 6 hours. The acceptance testing process uncovered many failures consistent with those shown to occur in the field, showing that testing by the user does predict failures. The process also demonstrated that the testing by the manufacturer can provide important design data that can be used to identify, diagnose, and prevent long-term problems. Also, the structured testing environment showed that sensor systems can be used to predict errors and changes in performance, as well as uncovering unmodeled behavior in subsystems.

  10. Building America Top Innovations 2014 Profile: ASHRAE Standard 62.2. Ventilation and Acceptable Indoor Air Quality in Low-Rise Residential Buildings

    SciTech Connect

    none,

    2014-11-01

    This 2014 Top Innovations profile describes Building America research and support in developing and gaining adoption of ASHRAE 62.2, a residential ventilation standard that is critical to transforming the U.S. housing industry to high-performance homes.

  11. Effects of a Follow-On Formula Containing Isomaltulose (Palatinose™) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial

    PubMed Central

    Fleddermann, M.; Rauh-Pfeiffer, A.; Demmelmair, H.; Holdt, L.; Teupser, D.; Koletzko, B.

    2016-01-01

    Effects of the dietary glycaemic load on postprandial blood glucose and insulin response might be of importance for fat deposition and risk of obesity. We aimed to investigate the metabolic effects, acceptance and tolerance of a follow-on formula containing the low glycaemic and low insulinaemic carbohydrate isomaltulose replacing high glycaemic maltodextrin. Healthy term infants aged 4 to 8 completed months (n = 50) were randomized to receive the intervention follow-on formula (IF, 2.1g isomaltulose (Palatinose™)/100mL) or an isocaloric conventional formula (CF) providing 2.1g maltodextrin/100mL for four weeks. Plasma insulinaemia 60min after start of feeding (primary outcome) was not statistically different, while glycaemia adjusted for age and time for drinking/volume of meal 60min after start of feeding was 122(105,140) mg/dL in IF (median, interquartile range) and 111(100,123) in CF (p = 0.01). Urinary c-peptide:creatinine ratio did not differ (IF:81.5(44.7, 96.0) vs. CF:56.8(37.5, 129),p = 0.43). Urinary c-peptide:creatinine ratio was correlated total intake of energy (R = 0.31,p = 0.045), protein (R = 0.42,p = 0.006) and fat (R = 0.40,p = 0.01) but not with carbohydrate intake (R = 0.22,p = 0.16). Both formulae were well accepted without differences in time of crying, flatulence, stool characteristics and the occurrence of adverse events. The expected lower postprandial plasma insulin and blood glucose level due to replacement of high glycaemic maltodextrin by low glycaemic isomaltulose were not observed in the single time-point blood analysis. In infants aged 4 to 8 completed months fed a liquid formula, peak blood glucose might be reached earlier than 60min after start of feeding. Non-invasive urinary c-peptide measurements may be a suitable marker of nutritional intake during the previous four days in infants. Trial registration: ClinicalTrials.gov NCT01627015 PMID:26987056

  12. A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project

    PubMed Central

    Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M.; Corripio, Iluminada; Aguilar, Eduardo J.; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J.

    2016-01-01

    Background: The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Methods: Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. Results: The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, P<.001). Conclusions: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. PMID:26506856

  13. Baby-Crying Acceptance

    NASA Astrophysics Data System (ADS)

    Martins, Tiago; de Magalhães, Sérgio Tenreiro

    The baby's crying is his most important mean of communication. The crying monitoring performed by devices that have been developed doesn't ensure the complete safety of the child. It is necessary to join, to these technological resources, means of communicating the results to the responsible, which would involve the digital processing of information available from crying. The survey carried out, enabled to understand the level of adoption, in the continental territory of Portugal, of a technology that will be able to do such a digital processing. It was used the TAM as the theoretical referential. The statistical analysis showed that there is a good probability of acceptance of such a system.

  14. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

    PubMed Central

    Festin, Mario P.R.; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M. Valeria; Kapp, Nathalie

    2016-01-01

    STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability

  15. Identification of the significant factors in food safety using global sensitivity analysis and the accept-and-reject algorithm: application to the cold chain of ham.

    PubMed

    Duret, Steven; Guillier, Laurent; Hoang, Hong-Minh; Flick, Denis; Laguerre, Onrawee

    2014-06-16

    Deterministic models describing heat transfer and microbial growth in the cold chain are widely studied. However, it is difficult to apply them in practice because of several variable parameters in the logistic supply chain (e.g., ambient temperature varying due to season and product residence time in refrigeration equipment), the product's characteristics (e.g., pH and water activity) and the microbial characteristics (e.g., initial microbial load and lag time). This variability can lead to different bacterial growth rates in food products and has to be considered to properly predict the consumer's exposure and identify the key parameters of the cold chain. This study proposes a new approach that combines deterministic (heat transfer) and stochastic (Monte Carlo) modeling to account for the variability in the logistic supply chain and the product's characteristics. The model generates a realistic time-temperature product history , contrary to existing modeling whose describe time-temperature profile Contrary to existing approaches that use directly a time-temperature profile, the proposed model predicts product temperature evolution from the thermostat setting and the ambient temperature. The developed methodology was applied to the cold chain of cooked ham including, the display cabinet, transport by the consumer and the domestic refrigerator, to predict the evolution of state variables, such as the temperature and the growth of Listeria monocytogenes. The impacts of the input factors were calculated and ranked. It was found that the product's time-temperature history and the initial contamination level are the main causes of consumers' exposure. Then, a refined analysis was applied, revealing the importance of consumer behaviors on Listeria monocytogenes exposure.

  16. Safety profile and probe placement accuracy of intraspinal pressure monitoring for traumatic spinal cord injury: Injured Spinal Cord Pressure Evaluation study.

    PubMed

    Phang, Isaac; Zoumprouli, Argyro; Saadoun, Samira; Papadopoulos, Marios C

    2016-09-01

    OBJECTIVE A novel technique for monitoring intraspinal pressure and spinal cord perfusion pressure in patients with traumatic spinal cord injury was recently described. This is analogous to monitoring intracranial pressure and cerebral perfusion pressure in patients with traumatic brain injury. Because intraspinal pressure monitoring is a new technique, its safety profile and impact on early patient care and long-term outcome after traumatic spinal cord injury are unknown. The object of this study is to review all patients who had intraspinal pressure monitoring to date at the authors' institution in order to define the accuracy of intraspinal pressure probe placement and the safety of the technique. METHODS At the end of surgery to fix spinal fractures, a pressure probe was inserted intradurally to monitor intraspinal pressure at the injury site. Postoperatively, CT scanning was performed within 48 hours and MRI at 2 weeks and 6 months. Neurointensive care management and complications were reviewed. The American Spinal Injury Association Impairment Scale (AIS) grade was determined on admission and at 2 to 4 weeks and 12 to 18 months postoperation. RESULTS To date, 42 patients with severe traumatic spinal cord injuries (AIS Grades A-C) had undergone intraspinal pressure monitoring. Monitoring started within 72 hours of injury and continued for up to a week. Based on postoperative CT and MRI, the probe position was acceptable in all patients, i.e., the probe was located at the site of maximum spinal cord swelling. Complications were probe displacement in 1 of 42 patients (2.4%), CSF leakage that required wound resuturing in 3 of 42 patients (7.1%), and asymptomatic pseudomeningocele that was diagnosed in 8 of 42 patients (19.0%). Pseudomeningocele was diagnosed on MRI and resolved within 6 months in all patients. Based on the MRI and neurological examination results, there were no serious probe-related complications such as meningitis, wound infection, hematoma

  17. Simplicity, safety, and acceptability of insulin pen use versus the conventional vial/syringe device in patients with type 1 and type 2 diabetes mellitus in Lebanon

    PubMed Central

    Ramadan, Wijdan H; Khreis, Noura A; Kabbara, Wissam K

    2015-01-01

    Background The aim of the study was to evaluate the simplicity, safety, patients’ preference, and convenience of the administration of insulin using the pen device versus the conventional vial/syringe in patients with diabetes. Methods This observational study was conducted in multiple community pharmacies in Lebanon. The investigators interviewed patients with diabetes using an insulin pen or conventional vial/syringe. A total of 74 questionnaires were filled over a period of 6 months. Answers were entered into the Statistical Package for Social Sciences (SPSS) software and Excel spreadsheet. t-test, logistic regression analysis, and correlation analysis were used in order to analyze the results. Results A higher percentage of patients from the insulin pen users group (95.2%) found the method easy to use as compared to only 46.7% of the insulin conventional users group (P 0.001, relative risk [RR]: 2.041, 95% confidence interval [CI]: 1.178–3.535). Moreover, 61.9% and 26.7% of pen users and conventional users, respectively, could read the scale easily (P 0.037, RR 2.321, 95% CI: 0.940–5.731), while 85.7% of pen users found it more convenient shifting to pen and 86.7% of the conventional users would want to shift to pen if it had the same cost. Pain perception was statistically different between the groups. A much higher percentage (76.2%) of pen users showed no pain during injection compared to only 26.7% of conventional users (P 0.003, RR 2.857, 95% CI: 1.194–6.838). Conclusion The insulin pen was significantly much easier to use and less painful than the conventional vial/syringe. Proper education on the methods of administration/storage and disposal of needles/syringes is needed in both groups. PMID:25848231

  18. Comparison on the Effects and Safety of Tualang Honey and Tribestan in Sperm Parameters, Erectile Function, and Hormonal Profiles among Oligospermic Males

    PubMed Central

    Ismail, Shaiful Bahari; Bakar, Mohd. Bustamanizan; Nik Hussain, Nik Hazlina; Sulaiman, Siti Amrah; Jaafar, Hasnan; Draman, Samsul; Ramli, Roszaman; Wan Yusoff, Wan Zahanim

    2014-01-01

    Introduction. This study aims to evaluate the effectiveness of Tualang honey on sperm parameters, erectile function, and hormonal and safety profiles. Methodology. A randomized control trial was done using Tualang honey (20 grams) and Tribestan (750 mg) over a period of 12 weeks. Sperm parameters including sperm concentration, motility, and morphology were analyzed and erectile function was assessed using IIEF-5 questionnaire. Hormonal profiles of testosterone, FSH, and LH were studied. The volunteers were randomized into two groups and the outcomes were analyzed using SPSS version 18. Results. A total of 66 participants were involved. A significant increment of mean sperm concentration (P < 0.001), motility (P = 0.015) and morphology (P = 0.008) was seen in Tualang honey group. In Tribestan group, a significant increment of mean sperm concentration (P = 0.007), and morphology (P = 0.009) was seen. No significant differences of sperm concentration, motility, and morphology were seen between Tualang honey and Tribestan group and similar results were also seen in erectile function and hormonal profile. All safety profiles were normal and no adverse event was reported. Conclusion. Tualang honey effect among oligospermic males was comparable with Tribestan in improving sperm concentration, motility, and morphology. The usage of Tualang honey was also safe with no reported adverse event. PMID:25505918

  19. Acceptance speech.

    PubMed

    Yusuf, C K

    1994-01-01

    I am proud and honored to accept this award on behalf of the Government of Bangladesh, and the millions of Bangladeshi children saved by oral rehydration solution. The Government of Bangladesh is grateful for this recognition of its commitment to international health and population research and cost-effective health care for all. The Government of Bangladesh has already made remarkable strides forward in the health and population sector, and this was recognized in UNICEF's 1993 "State of the World's Children". The national contraceptive prevalence rate, at 40%, is higher than that of many developed countries. It is appropriate that Bangladesh, where ORS was discovered, has the largest ORS production capacity in the world. It was remarkable that after the devastating cyclone in 1991, the country was able to produce enough ORS to meet the needs and remain self-sufficient. Similarly, Bangladesh has one of the most effective, flexible and efficient control of diarrheal disease and epidemic response program in the world. Through the country, doctors have been trained in diarrheal disease management, and stores of ORS are maintained ready for any outbreak. Despite grim predictions after the 1991 cyclone and the 1993 floods, relatively few people died from diarrheal disease. This is indicative of the strength of the national program. I want to take this opportunity to acknowledge the contribution of ICDDR, B and the important role it plays in supporting the Government's efforts in the health and population sector. The partnership between the Government of Bangladesh and ICDDR, B has already borne great fruit, and I hope and believe that it will continue to do so for many years in the future. Thank you.

  20. The safety profile of Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY)

    PubMed Central

    Rinderknecht, Stephen; Bryant, Kristina; Nolan, Terry; Pavia-Ruz, Noris; Doniz, Carlos Aranza; Weber, Miguel Angel Rodriguez; Cohen, Christopher; Aris, Emmanuel; Mesaros, Narcisa; Miller, Jacqueline M.

    2012-01-01

    The safety profile of HibMenCY was compared with licensed Hib conjugate vaccines in a pooled analysis that included more than 8,500 subjects who were administered a four-dose series of HibMenCY or commercially available Hib vaccines at 2, 4, 6 and 12–15 mo of age in two primary vaccination and two fourth dose phase 3 studies. In all studies, HibMenCY or Hib vaccine was co-administered with age-appropriate, routinely recommended vaccines. In one primary and one fourth dose study (n = 4180), local and general symptoms were solicited using diary cards for 4 d after each dose. Serious adverse events (SAEs) and the occurrence of adverse events (AEs) indicating new onset of chronic disease (NOCD), rash, and conditions prompting Emergency Room (ER) visits were reported from dose 1 until 6 mo after dose 4. The incidences of solicited local and general symptoms were similar following HibMenCY and commercially available Hib vaccines. For some solicited symptoms (pain at the injection site and irritability), rates were lower in the HibMenCY group compared with the Hib control group (p value < 0.05). There were no statistically significant differences between groups in the incidences of SAEs, NOCDs, rash, or AEs leading to ER visits, with the exceptions of anemia and viral gastroenteritis, which occurred significantly less frequently in those receiving HibMenCY than those receiving commercially available Hib vaccines. In this pooled safety analysis, the safety profile of HibMenCY was similar to the safety profile of licensed monovalent Hib vaccines, despite the addition of meningococcal antigens.   These studies are registered at www.clinicaltrials.gov NCT00345579 (primary vaccination study), NCT00345683 (fourth dose vaccination study) and NCT00289783 (primary and fourth dose vaccination studies) PMID:22327493

  1. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service any component until it passes all applicable inspections and tests prescribed by this subpart and...

  2. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service any component until it passes all applicable inspections and tests prescribed by this subpart and...

  3. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service any component until it passes all applicable inspections and tests prescribed by this subpart and...

  4. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service any component until it passes all applicable inspections and tests prescribed by this subpart and...

  5. Establishment of an equivalence acceptance criterion for accelerated stability studies.

    PubMed

    Burdick, Richard K; Sidor, Leslie

    2013-01-01

    In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and efficacy, an equivalence acceptance criterion is proposed that is based on the statistical concept of effect size. As with all statistical tests of equivalence, it is important to collect input from appropriate subject-matter experts when defining the acceptance criterion.

  6. Profiles of Bullying Victimization, Discrimination, Social Support, and School Safety: Links with Latino/a Youth Acculturation, Gender, Depressive Symptoms, and Cigarette Use

    PubMed Central

    Lorenzo-Blanco, Elma I.; Unger, Jennifer B.; Oshri, Assaf; Baezconde-Garbanati, Lourdes; Soto, Daniel

    2016-01-01

    Latino/a youth are at risk for symptoms of depression and cigarette smoking but this risk varies by acculturation and gender. To understand why some youth are at greater risk than others, we identified profiles of diverse community experiences (perceived discrimination, bullying victimization, social support, perceived school safety) and examined associations between profiles of community experience and depressive symptoms, cigarette smoking, acculturation, and gender. Data came from Project Red (Reteniendo y Entendiendo Diversidad para Salud), a school-based longitudinal study of acculturation among 1919 Latino/a adolescents (52% female; 84% 14 years old; 87% U.S. born). Latent profile analysis (LPA) revealed four distinct profiles of community experience which varied by gender and acculturation. Boys were overrepresented in profile groups with high perceived discrimination, some bullying, and lack of positive experiences, while girls were overrepresented in groups with high bullying victimization in the absence and presence of other community experiences. Youth low on both U.S. and Latino/a cultural orientation described high perceived discrimination and lacked positive experiences, and were predominantly male. Profiles characterized by high perceived discrimination and/or high bullying victimization in the absence of positive experiences had higher levels of depressive symptoms and higher risk of smoking, relative to the other groups. Findings suggest that acculturation comes with diverse community experiences that vary by gender and relate to smoking and depression risk. Results from this research can inform the development of tailored intervention and prevention strategies to reduce depression and/or smoking for Latino/a youth at risk for depression and/or smoking. PMID:26752445

  7. Profiles of bullying victimization, discrimination, social support, and school safety: Links with Latino/a youth acculturation, gender, depressive symptoms, and cigarette use.

    PubMed

    Lorenzo-Blanco, Elma I; Unger, Jennifer B; Oshri, Assaf; Baezconde-Garbanati, Lourdes; Soto, Daniel

    2016-01-01

    Latino/a youth are at risk for symptoms of depression and cigarette smoking but this risk varies by acculturation and gender. To understand why some youth are at greater risk than others, we identified profiles of diverse community experiences (perceived discrimination, bullying victimization, social support, perceived school safety) and examined associations between profiles of community experience and depressive symptoms, cigarette smoking, acculturation, and gender. Data came from Project Red (Reteniendo y Entendiendo Diversidad para Salud), a school-based longitudinal study of acculturation among 1,919 Latino/a adolescents (52% female; 84% 14 years old; 87% U.S. born). Latent profile analysis (LPA) revealed 4 distinct profiles of community experience that varied by gender and acculturation. Boys were overrepresented in profile groups with high perceived discrimination, some bullying, and lack of positive experiences, while girls were overrepresented in groups with high bullying victimization in the absence and presence of other community experiences. Youth low on both U.S. and Latino/a cultural orientation described high perceived discrimination and lacked positive experiences, and were predominantly male. Profiles characterized by high perceived discrimination and /or high bullying victimization in the absence of positive experiences had higher levels of depressive symptoms and higher risk of smoking, relative to the other groups. Findings suggest that acculturation comes with diverse community experiences that vary by gender and relate to smoking and depression risk. Results from this research can inform the development of tailored intervention and prevention strategies to reduce depression and/or smoking for Latino/a youth.

  8. Acceptance of Safety and Mission Success Risks

    NASA Technical Reports Server (NTRS)

    Groen, Frank

    2015-01-01

    NASA has developed an objectives based hierarchy for guiding Reliability and Maintainability (RM) activities. This presentation overviews the hierarchy and proposes to the international trilateral partners to formulate a task force to consider the elements of the NASA RM framework, as captured in the hierarchy of RM considerations, to identify commonalities and differences in the way RM is addressed by the flight projects among the partners.

  9. School Bus Safety: An Acceptable Level.

    ERIC Educational Resources Information Center

    Lovett, Steve

    1986-01-01

    Any district board of education considering seat belt installation on large school buses should examine all the research available prior to making a final decision. New Jersey's Guide for Analyzing a Pupil Transportation Program is provided. (MLF)

  10. Hanford Site liquid waste acceptance criteria

    SciTech Connect

    LUECK, K.J.

    1999-09-11

    This document provides the waste acceptance criteria for liquid waste managed by Waste Management Federal Services of Hanford, Inc. (WMH). These waste acceptance criteria address the various requirements to operate a facility in compliance with applicable environmental, safety, and operational requirements. This document also addresses the sitewide miscellaneous streams program.

  11. Physics-based control-oriented modeling and robust feedback control of the plasma safety factor profile and stored energy dynamics in ITER

    NASA Astrophysics Data System (ADS)

    Barton, Justin E.; Besseghir, Karim; Lister, Jo; Schuster, Eugenio

    2015-11-01

    Many challenging plasma control problems still need to be addressed in order for the ITER plasma control system (PCS) to be able to maintain the plasma within a predefined operational space and optimize the plasma state evolution in the tokamak, which will greatly aid in the successful achievement of ITER’s goals. Firstly in this work, a general control-oriented, physics-based modeling approach is developed to obtain first-principles-driven (FPD) models of the plasma magnetic profile and stored energy evolutions valid for high performance, high confinement (H-mode) scenarios, with the goal of developing model-based closed-loop algorithms to control the safety factor profile (q profile) and stored energy evolutions in the tokamak. The FPD model is tailored to H-mode burning plasma scenarios in ITER by employing the DINA-CH & CRONOS free-boundary tokamak simulation code, and the FPD model’s prediction capabilities are demonstrated by comparing the prediction to data obtained from DINA-CH & CRONOS. Secondly, a model-based feedback control algorithm is designed to simultaneously track target q profile and stored energy evolutions in H-mode burning plasma scenarios in ITER by embedding the developed FPD model of the magnetic profile evolution into the control design process. The feedback controller is designed to ensure that the closed-loop system is robust to uncertainties in the electron density, electron temperature and plasma resistivity, and is tested in simulations with the developed FPD model. The effectiveness of the controller is demonstrated by first tracking nominal q profile and stored energy target evolutions, and then modulating the generated fusion power while maintaining the q profile in a stationary condition. In the process, many key practical issues for plasma profile control in ITER are investigated, which will be useful for the development of the ITER PCS that has recently been initiated. Some of the more pertinent investigated issues are the

  12. Integrating comparative expression profiling data with association of SNPs to Salmonella shedding for improved food safety and porcine disease resistance

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Salmonella in swine is a major food safety problem, as a majority of U.S. swine herds are Salmonella-positive. Salmonella can be shed from colonized swine and contaminate a) neighboring pigs; b) slaughter plants and pork products; c) edible crops when swine manure is used as a fertilizer; and d) wat...

  13. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Construction acceptance. 193.2303 Section 193.2303 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS...

  14. Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial

    PubMed Central

    Täubel, Jörg; Ferber, Georg; Fernandes, Sara; Lorch, Ulrike; Santamaría, Eva; Izquierdo, Iñaki

    2016-01-01

    Introduction Rupatadine is a marketed second generation antihistamine, with anti-PAF activity, indicated for symptomatic treatment of allergic rhinitis and urticaria. This study was conducted to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of rupatadine in healthy Japanese subjects after single and multiple oral doses. Methods In this randomised, double-blind, placebo-controlled study, 27 male and female healthy Japanese subjects were administered single and multiple escalating rupatadine dose of 10, 20 and 40 mg or placebo. Blood samples were collected at different time points for PK measurements and subjects were assessed for safety and tolerability. The effect of rupatadine on cognitive functioning was evaluated by means of computerized cognitive tests: rapid visual information processing (RVP), reaction time (RT), spatial working memory (SWM) and visual analogue scales (VAS). Results Exposure to rupatadine as measured by Cmax and AUC was found to increase in a dose dependent manner over the dose range of 10–40 mg for both single and multiple dose administration. The safety assessments showed that all treatment related side effects were of mild intensity and there were no serious adverse events (SAEs) or withdrawals due to treatment–emergent adverse events (TEAEs) in this study. The therapeutic dose of rupatadine did not show any CNS impairment in any of the cognitive tests. Conclusions This study demonstrated that rupatadine is safe and well tolerated by Japanese healthy subjects. The PK-PD profile confirmed previous experience with rupatadine. PMID:27632557

  15. Safety and efficacy of low-profile balloons in native coarctation and recoarctation balloon angioplasty for infants.

    PubMed

    Dilawar, Muhammad; El Said, Howaida Galal; El-Sisi, Amal; Ahmad, Zaheer

    2009-05-01

    Background Traditionally, high-profile/high-pressure balloons have been used for angioplasties, whereas low-profile/low-pressure balloons have been used for valvuloplasties. High-profile balloons require larger introducing sheaths, which can be a limiting factor for percutaneous catheter interventions in infants. This report aims to report the author's experience with the efficacy of low-profile balloons using smaller introducing sheaths for coarctation balloon angioplasty in infants. Methods From April 2004 to April 2008, 15 infants, representing both native coarctation and recoarctation indications, underwent coarctation balloon angioplasty and were retrospectively reviewed. The arterial access was achieved using 4-Fr (Cook) introducing sheaths and Tyshak (NuMED, Hallenweg-Netherlands) balloons 5 to 8 mm in diameter for coarctation angioplasty in the study group. Results In this study, 15 infants (7 with native coarctation and 8 with postoperative recoarctation) underwent balloon angioplasty. These infants ranged in age from 2 to 9 months (median, 4 months) and in weight from 3.5 to 10.8 kg (median, 5.7 kg). The peak-to-peak coarctation gradient was reduced from 46.2 +/- 28 mmHg before angioplasty to 10 +/- 8 mmHg afterward (p = 0.001). The angiographic diameter of the coarctation segment was increased from 2.4 +/- 1.0 mm before angioplasty to 5 +/- 0.8 mm afterward (p = 0.001). There were no immediate major or minor complications. During a follow-up period up to 48 months, only one patient from the native coarctation group experienced recoarctation and underwent successful reballooning, and none of the patients experienced aneurysms. Conclusion This study shows that the use of low-profile/low-pressure balloons is an effective treatment for infants. Furthermore, low-profile balloons required smaller introducing sheaths, which provides a clear advantage of minimizing vascular complications with coarctation ballooning in younger infants.

  16. The safety and tolerability profile of therapies for the prevention and treatment of osteoporosis in postmenopausal women.

    PubMed

    Komm, Barry S; Morgenstern, Diana; A Yamamoto, Luis; Jenkins, Simon N

    2015-01-01

    At a time when the prevalence of osteoporosis and related fractures is increasing, initiation and continuation of pharmacologic therapies for prevention and treatment of postmenopausal osteoporosis have declined. This decline has been at least in part attributable to concerns about safety of these agents, such as atypical fractures with bisphosphonates and breast cancer with estrogen/progestin therapy, particularly when they are used long term by older women. However, in many cases, absolute risk of serious adverse effects is small and should be balanced against the larger potential for fracture reduction. Here, we review the safety and tolerability of available therapies for postmenopausal osteoporosis. Taking into consideration their relative efficacy, we also provide strategies for optimization of the risk:benefit ratio.

  17. Acceptability, Safety, and Efficacy of Oral Administration of Extracts of Black or Red Maca (Lepidium meyenii) in Adult Human Subjects: A Randomized, Double-Blind, Placebo-Controlled Study.

    PubMed

    Gonzales-Arimborgo, Carla; Yupanqui, Irma; Montero, Elsa; Alarcón-Yaquetto, Dulce E; Zevallos-Concha, Alisson; Caballero, Lidia; Gasco, Manuel; Zhao, Jianping; Khan, Ikhlas A; Gonzales, Gustavo F

    2016-08-18

    The plant maca, grown at 4000 m altitude in the Peruvian Central Andes, contains hypocotyls that have been used as food and in traditional medicine for centuries. The aim of this research was to provide results on some health effects of oral administration of spray-dried extracts of black or red maca (Lepidium meyenii) in adult human subjects living at low (LA) and high altitude (HA). A total of 175 participants were given 3 g of either placebo, black, or red maca extract daily for 12 weeks. Primary outcomes were changes in sexual desire, mood, energy, health-related quality of life score (HRQL), and chronic mountain sickness (CMS) score, or in glycaemia, blood pressure, and hemoglobin levels. Secondary outcomes were acceptability and safety, assessed using the Likert test and side effect self-recording, respectively, and the effect of altitude. At low altitude, 32, 30, and 32 participants started the study receiving placebo, red maca, or black maca, respectively. At high altitudes, 33, 35, and 31 participants started the study receiving placebo, red maca, and black maca, respectively. Consumption of spray-dried extracts of red and black maca resulted in improvement in mood, energy, and health status, and reduced CMS score. Fatty acids and macamides were higher in spray-dried extracts of black maca than in red maca. GABA predominated in spray-dried extracts of red maca. Effects on mood, energy, and CMS score were better with red maca. Black maca and, in smaller proportions, red maca reduced hemoglobin levels only in highlanders with abnormally high hemoglobin levels; neither variety of maca reduced hemoglobin levels in lowlanders. Black maca reduced blood glucose levels. Both varieties produced similar responses in mood, and HRQL score. Maca extracts consumed at LA or HA had good acceptability and did not show serious adverse effects. In conclusion, maca extract consumption relative to the placebo improved quality of life parameters. Differences in the level of

  18. Acceptability, Safety, and Efficacy of Oral Administration of Extracts of Black or Red Maca (Lepidium meyenii) in Adult Human Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

    PubMed Central

    Gonzales-Arimborgo, Carla; Yupanqui, Irma; Montero, Elsa; Alarcón-Yaquetto, Dulce E.; Zevallos-Concha, Alisson; Caballero, Lidia; Gasco, Manuel; Zhao, Jianping; Khan, Ikhlas A.; Gonzales, Gustavo F.

    2016-01-01

    The plant maca, grown at 4000 m altitude in the Peruvian Central Andes, contains hypocotyls that have been used as food and in traditional medicine for centuries. The aim of this research was to provide results on some health effects of oral administration of spray-dried extracts of black or red maca (Lepidium meyenii) in adult human subjects living at low (LA) and high altitude (HA). A total of 175 participants were given 3 g of either placebo, black, or red maca extract daily for 12 weeks. Primary outcomes were changes in sexual desire, mood, energy, health-related quality of life score (HRQL), and chronic mountain sickness (CMS) score, or in glycaemia, blood pressure, and hemoglobin levels. Secondary outcomes were acceptability and safety, assessed using the Likert test and side effect self-recording, respectively, and the effect of altitude. At low altitude, 32, 30, and 32 participants started the study receiving placebo, red maca, or black maca, respectively. At high altitudes, 33, 35, and 31 participants started the study receiving placebo, red maca, and black maca, respectively. Consumption of spray-dried extracts of red and black maca resulted in improvement in mood, energy, and health status, and reduced CMS score. Fatty acids and macamides were higher in spray-dried extracts of black maca than in red maca. GABA predominated in spray-dried extracts of red maca. Effects on mood, energy, and CMS score were better with red maca. Black maca and, in smaller proportions, red maca reduced hemoglobin levels only in highlanders with abnormally high hemoglobin levels; neither variety of maca reduced hemoglobin levels in lowlanders. Black maca reduced blood glucose levels. Both varieties produced similar responses in mood, and HRQL score. Maca extracts consumed at LA or HA had good acceptability and did not show serious adverse effects. In conclusion, maca extract consumption relative to the placebo improved quality of life parameters. Differences in the level of

  19. Hand Safety

    MedlinePlus

    ... Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring ... Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring ...

  20. European consumer response to packaging technologies for improved beef safety.

    PubMed

    Van Wezemael, Lynn; Ueland, Øydis; Verbeke, Wim

    2011-09-01

    Beef packaging can influence consumer perceptions of beef. Although consumer perceptions and acceptance are considered to be among the most limiting factors in the application of new technologies, there is a lack of knowledge about the acceptability to consumers of beef packaging systems aimed at improved safety. This paper explores European consumers' acceptance levels of different beef packaging technologies. An online consumer survey was conducted in five European countries (n=2520). Acceptance levels among the sample ranged between 23% for packaging releasing preservative additives up to 73% for vacuum packaging. Factor analysis revealed that familiar packaging technologies were clearly preferred over non-familiar technologies. Four consumer segments were identified: the negative (31% of the sample), cautious (30%), conservative (17%) and enthusiast (22%) consumers, which were profiled based on their attitudes and beef consumption behaviour. Differences between consumer acceptance levels should be taken into account while optimising beef packaging and communicating its benefits.

  1. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects.

    PubMed

    Ciprero, Karen; Zykov, Kirill A; Briko, Nikolay I; Shekar, Tulin; Sterling, Tina M; Bitieva, Elizaveta; Stek, Jon E; Musey, Luwy

    2016-08-02

    Pneumococcal infection is a major cause of pneumonia, bacteremia, and meningitis. Incidence of pneumococcal disease (PD) varies worldwide. The 23-valent pneumococcal polysaccharide vaccine (PPV23) displays an acceptable safety profile and has been demonstrated cost-effective in reducing burden of PD.

  2. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease.

    PubMed

    Seiple, William; Jennings, Danna; Rosen, Richard B; Borchert, Leona; Canale, Lee; Fagan, Nora; Gordon, Mark Forrest

    2016-01-01

    Background. Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n = 121) or ropinirole (n = 125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71-1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year, -4.1 ± 8.9, and 2 years, -0.7 ± 10.1, and ropinirole: 1 year, -3.7 ± 8.2, and 2 years, -1.7 ± 10.5) and Hoehn-Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.

  3. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease

    PubMed Central

    Jennings, Danna; Borchert, Leona; Canale, Lee; Fagan, Nora

    2016-01-01

    Background. Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n = 121) or ropinirole (n = 125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71–1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year, −4.1 ± 8.9, and 2 years, −0.7 ± 10.1, and ropinirole: 1 year, −3.7 ± 8.2, and 2 years, −1.7 ± 10.5) and Hoehn–Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300. PMID:28078162

  4. Safety Profile of the Merck Human Immunodeficiency Virus-1 Clade B gag DNA Plasmid Vaccine With and Without Adjuvants.

    PubMed

    Quirk, Erin K; Brown, Elizabeth L; Leavitt, Randi Y; Mogg, Robin; Mehrotra, Devan V; Evans, Robert K; DiNubile, Mark J; Robertson, Michael N

    2014-03-01

    The immunogenicity results from 3 phase I trials of the Merck DNA human immunodeficiency virus (HIV) vaccine have previously been reported. Because preventive DNA vaccine strategies continue to be leveraged for diverse infections, the safety and tolerability results from these studies can inform the field moving forward, particularly regarding adverse reactions and adjuvants. No serious vaccine-related adverse events were reported during the 3-dose priming phase. Pain at the injection site was more common with adjuvanted formulations than with the phosphate-buffered saline diluent alone. Febrile reactions were usually low grade. Although the AlPO4 or CRL1005 adjuvants used in these studies did not significantly enhance the immunogenicity of the DNA vaccine, adverse events were numerically more common with adjuvanted formulations than without adjuvants.

  5. Postmarketing cohort study to assess the safety profile of oral dexketoprofen trometamol for mild to moderate acute pain treatment in primary care.

    PubMed

    Carne, Xavier; Rios, Jose; Torres, Ferran

    2009-10-01

    Recently, new concerns on the safety profile of nonsteroidal anti-inflammatory drugs (NSAIDs) have been raised by the European Medicines Agency (EMEA) and other regulatory authorities. The safety profile of oral dexketoprofen trometamol for the treatment of acute mild to moderate pain of different causes in actual conditions of use in the primary care setting was assessed. A prospective cohort study was designed to evaluate the tolerability of dexketoprofen compared with other commonly prescribed analgesics. Medications were given according to specifications in the summary of product characteristics. The intensity of pain was assessed at baseline and at days 1 and 7 of drug treatment using a 100-mm visual analog scale (VAS). Adverse events (AEs) were recorded. A total of 7,337 patients (median age [IQR] = 46 [33-61] years) were included in the study comparing dexketoprofen (n = 5,429), diclofenac (n = 485), ibuprofen (n = 479), paracetamol (n = 459), metamizole (n = 207), aceclofenac (n = 103), naproxen (n = 74), piroxicam (n = 69) and dexibuprofen (n = 32). The reasons for use were: musculoskeletal disorders, headache, dysmenorrhea and odontalgia. Treatment compliance was very high. Metamizole-paracetamol and dexketoprofen showed the lowest prevalence of AEs (2.7% and 3.6%, respectively), while aceclofenac-diclofenac showed the highest prevalence (8.2%) (P < 0.0001). AEs most frequently observed during NSAID treatment were those related to the gastrointestinal tract (3.5% of subjects, 84% of all AEs), followed by AEs related to the nervous system (0.4%) and skin (0.1%). Most of the reported AEs (91.3%) were of mild to moderate intensity (303 of 332) and only 3.3% of them were considered severe (11 of 332). Risks for gastrointestinal AEs were adjusted for age, gender, history of previous NSAID intake, gastroprotective drugs and reason for prescription. Taking metamizole-paracetamol as the reference group, the odds ratios (OR, 95%) were: 1.30 (0.77-2.19) for

  6. Chronic Electromagnetic Exposure at Occupational Safety Level Does Not Affect the Metabolic Profile nor Cornea Healing after LASIK Surgery.

    PubMed

    Crouzier, David; Dabouis, Vincent; Gentilhomme, Edgar; Vignal, Rodolphe; Bourbon, Fréderic; Fauvelle, Florence; Debouzy, Jean-Claude

    2014-01-01

    LASIK eye surgery has become a very common practice for myopic people, especially those in the military. Sometimes undertaken by people who need to keep a specific medical aptitude, this surgery could be performed in secret from the hierarchy and from the institute medical staff. However, even though the eyes have been previously described as one of the most sensitive organs to electromagnetic fields in the human body, no data exist on the potential deleterious effects of electromagnetic fields on the healing eye. The consequences of chronic long-lasting radar exposures at power density, in accordance with the occupational safety standards (9.71 GHz, 50 W/m(2)), were investigated on cornea healing. The metabolic and clinical statuses after experimental LASIK keratotomy were assessed on the different eye segments in a New Zealand rabbit model. The analysis methods were performed after 5 months of exposure (1 hour/day, 3 times/week). Neither clinical or histological examinations, nor experimental data, such as light scattering, (1)H-NMR HRMAS metabolomics, (13)C-NMR spectra of lipidic extracts, and antioxidant status, evidenced significant modifications. It was concluded that withdrawing the medical aptitude of people working in electromagnetic field environments (i.e., radar operators in the navy) after eye surgery was not justified.

  7. Chronic Electromagnetic Exposure at Occupational Safety Level Does Not Affect the Metabolic Profile nor Cornea Healing after LASIK Surgery

    PubMed Central

    Dabouis, Vincent; Gentilhomme, Edgar; Vignal, Rodolphe; Bourbon, Fréderic; Fauvelle, Florence; Debouzy, Jean-Claude

    2014-01-01

    LASIK eye surgery has become a very common practice for myopic people, especially those in the military. Sometimes undertaken by people who need to keep a specific medical aptitude, this surgery could be performed in secret from the hierarchy and from the institute medical staff. However, even though the eyes have been previously described as one of the most sensitive organs to electromagnetic fields in the human body, no data exist on the potential deleterious effects of electromagnetic fields on the healing eye. The consequences of chronic long-lasting radar exposures at power density, in accordance with the occupational safety standards (9.71 GHz, 50 W/m2), were investigated on cornea healing. The metabolic and clinical statuses after experimental LASIK keratotomy were assessed on the different eye segments in a New Zealand rabbit model. The analysis methods were performed after 5 months of exposure (1 hour/day, 3 times/week). Neither clinical or histological examinations, nor experimental data, such as light scattering, 1H-NMR HRMAS metabolomics, 13C-NMR spectra of lipidic extracts, and antioxidant status, evidenced significant modifications. It was concluded that withdrawing the medical aptitude of people working in electromagnetic field environments (i.e., radar operators in the navy) after eye surgery was not justified. PMID:24757560

  8. Peptide receptor radionuclide therapy in the management of gastrointestinal neuroendocrine tumors: efficacy profile, safety, and quality of life

    PubMed Central

    Severi, Stefano; Grassi, Ilaria; Nicolini, Silvia; Sansovini, Maddalena; Bongiovanni, Alberto; Paganelli, Giovanni

    2017-01-01

    Peptide receptor radionuclide therapy (PRRT), developed over the last two decades, is carried out using radiopharmaceuticals such as 90Y-DOTA-Tyr3-octreotide and 177Lu-DOTA-Tyr3-octreotate (177Lu-Dotatate). These radiocompounds are obtained by labeling a synthetic somatostatin analog with a β-emitting radioisotope. The compounds differ from each other in terms of their energetic features (due to the radionuclide) and peptide receptor affinity (due to the analog) but share the common characteristic of binding specific membrane somatostatin receptors that are (generally) overexpressed in neuroendocrine neoplasms (NENs) and their metastases. NENs are tumors arising from diffuse neuroendocrine system cells that are classified according to grading based on Ki67 percentage values (Grades 1 and 2 are classed as neuroendocrine tumors [NETs]) and to the anatomical site of occurrence (in this paper, we only deal with gastroenteropancreatic [GEP]-NETs, which account for 60%–70% of all NENs). They are also characterized by specific symptoms such as diarrhea and flushing (30% of cases). Despite substantial experience gained in the area of PRRT and its demonstrable effects in terms of efficacy, safety, and improvement in quality of life, these compounds are still not registered (registration of 177Lu-Dotatate for the treatment of midgut NETs is expected soon). Thus, PRRT can only be used in experimental protocols. We provide an overview of the work of leading groups with wide-ranging experience and continuity in data publication in the area of GEP-NET PRRT and report our own personal experience of using different dosage schedules based on the presence of kidney and bone marrow risk factors. Our results on the retreatment of patients previously administered 90Y-DOTA-Tyr3-octreotide with a low dosage of 177Lu-Dotatate are also included. A comment on potential future developments of PRRT in GEP-NETs is provided. PMID:28203088

  9. Model-based prediction of the acute and long-term safety profile of naproxen in rats

    PubMed Central

    Sahota, Tarjinder; Sanderson, Ian; Danhof, Meindert; Della Pasqua, Oscar

    2015-01-01

    Background and Purpose Despite the increasing importance of biomarkers as predictors of drug effects, toxicology protocols continue to rely on the experimental evidence of adverse events (AEs) as a basis for establishing the link between indicators of safety and drug exposure. Furthermore, biomarkers may facilitate the translation of findings from animals to humans. Combined with a model-based approach, biomarker data have the potential to predict long-term effects arising from prolonged drug exposure. Here, we used naproxen as a paradigm to explore the feasibility of a biomarker-guided approach for the prediction of long-term AEs in humans. Experimental Approach An experimental toxicology protocol was set up for evaluating the effects of naproxen in rats, in which four active doses were tested (7.5, 15, 40 and 80 mg·kg−1). In addition to AE monitoring and histology, a few blood samples were also collected for the assessment of drug exposure, TXB2 and PGE2 levels. Non-linear mixed effects modelling was used to analyse the data and identify covariate factors on the incidence and severity of AEs. Key Results Modelling results showed that besides drug exposure, maximum PGE2 inhibition and treatment duration were also predictors of gastrointestinal ulceration. Although PGE2 levels were clearly linked to the incidence rates, it appeared that ulceration severity is better predicted by measures of drug exposure. Conclusions and Implications These results show that the use of a model-based approach provides the opportunity to integrate pharmacokinetics, pharmacodynamics and toxicity data, enabling optimization of the design, analysis and interpretation of toxicology experiments. PMID:25884765

  10. Profiling and Racial Profiling: An Interactive Exercise

    ERIC Educational Resources Information Center

    Semple, Philip

    2013-01-01

    Racial Profiling has been recognized as a serious problem that affects many segments of our society and is especially notable in law enforcement. Governments and police services have pronounced that racial profiling is not acceptable and will not be tolerated. They have gone to great lengths in trying to eradicate racial profiling through…

  11. Development of ultrasonic thermometry for high-temperature high-resolution temperature profiling applications in LMFBR safety research

    NASA Astrophysics Data System (ADS)

    Field, M. E.

    1986-05-01

    Ultrasonic thermometry was developed as a high temperature profiling diagnostic for use in the Liquid Metal Fast Breeder Reactor (LMFBR) Debris Coolability Program at Sandia National Laboratories. These instruments were used successfully in the DC series experiments and the D10 experiment. Temperatures approaching 3000 C with spatial resolution of 10 mm and indicated temperature gradients of 700 C/cm were measured. Instruments were operated in molten sodium, molten steel, and molten UO2 environments. Up to 14 measurement zones on a single instrument in molten sodium were used with 12 mm and 15 mm spatial resolution. Hermetically sealed units operating at elevated temperatures were used. Post-test examination revealed very little systematic calibration drifts (less than 10 C) with random drifts occuring with less than 40 C standard deviation in a 10 to 12 mm measured zone. The stability of the system varies from +/- 1 C to +/- 15 C depending on the sensor design constraints for a particular application. Doped tungsten sensors were developed to permit operation of total measurement zone length of 30 cm at temperatures above 2500 C.

  12. Stereotactic Radiosurgery for Melanoma Brain Metastases in Patients Receiving Ipilimumab: Safety Profile and Efficacy of Combined Treatment

    SciTech Connect

    Kiess, Ana P.; Wolchok, Jedd D.; Barker, Christopher A.; Postow, Michael A.; Tabar, Viviane; Huse, Jason T.; Chan, Timothy A.; Yamada, Yoshiya; Beal, Kathryn

    2015-06-01

    Purpose: Ipilimumab (Ipi), a monoclonal antibody against cytotoxic T-lymphocyte antigen-4, has been shown to improve survival in patients with metastatic melanoma. In this single-institution study, we investigated the safety and efficacy of stereotactic radiosurgery (SRS) for patients with melanoma brain metastases (BMs) who also received Ipi. Methods and Materials: From 2005 to 2011, 46 patients with melanoma received Ipi and underwent single-fraction SRS for BMs. A total of 113 BMs (91% intact, 9% postoperative) were treated with a median dose of 21 Gy (range, 15-24 Gy). Ipi was given at 3 mg/kg (54%) or 10 mg/kg (46%) for a median of 4 doses (range, 1-21). Adverse events were recorded with the use of the Common Terminology Criteria for Adverse Events 3.0. Kaplan-Meier methods were used to estimate survival, and Cox regression was used to investigate associations. Results: Fifteen patients received SRS during Ipi, 19 received SRS before Ipi, and 12 received SRS after Ipi. Overall survival (OS) was significantly associated with the timing of SRS/Ipi (P=.035) and melanoma-specific graded prognostic assessment (P=.013). Patients treated with SRS during or before Ipi had better OS and less regional recurrence than did those treated with SRS after Ipi (1-year OS 65% vs 56% vs 40%, P=.008; 1-year regional recurrence 69% vs 64% vs 92%, P=.003). SRS during Ipi also yielded a trend toward less local recurrence than did SRS before or after Ipi (1-year local recurrence 0% vs 13% vs 11%, P=.21). On magnetic resonance imaging, an increase in BM diameter to >150% was seen in 50% of patients treated during or before Ipi but in only 13% of patients treated after Ipi. Grade 3 to 4 toxicities were seen in 20% of patients. Conclusion: Overall, the combination of Ipi and SRS appears to be well tolerated. Concurrent delivery of Ipi and SRS is associated with favorable locoregional control and possibly longer survival. It may also cause a temporary increase in tumor size, possibly

  13. A quantitative multiplex nuclease protection assay reveals immunotoxicity gene expression profiles in the rabbit model for vaginal drug safety evaluation

    SciTech Connect

    Fichorova, Raina N.; Mendonca, Kevin; Yamamoto, Hidemi S.; Murray, Ryan; Chandra, Neelima; Doncel, Gustavo F.

    2015-06-15

    Any vaginal product that alters the mucosal environment and impairs the immune barrier increases the risk of sexually transmitted infections, especially HIV infection, which thrives on mucosal damage and inflammation. The FDA-recommended rabbit vaginal irritation (RVI) model serves as a first line selection tool for vaginal products; however, for decades it has been limited to histopathology scoring, insufficient to select safe anti-HIV microbicides. In this study we incorporate to the RVI model a novel quantitative nuclease protection assay (qNPA) to quantify mRNA levels of 25 genes representing leukocyte differentiation markers, toll-like receptors (TLR), cytokines, chemokines, epithelial repair, microbicidal and vascular markers, by designing two multiplex arrays. Tissue sections were obtained from 36 rabbits (6 per treatment arm) after 14 daily applications of a placebo gel, saline, 4% nonoxynol-9 (N-9), and three combinations of the anti-HIV microbicides tenofovir (TFV) and UC781 in escalating concentrations (highest: 10% TFV + 2.5%UC781). Results showed that increased expression levels of toll-like receptor (TLR)-4, interleukin (IL)-1β, CXCL8, epithelial membrane protein (EMP)-1 (P < 0.05), and decreased levels of TLR2 (P < 0.05), TLR3 and bactericidal permeability increasing protein (BPI) (P < 0.001) were associated with cervicovaginal mucosal alteration (histopathology). Seven markers showed a significant linear trend predicting epithelial damage (up with CD4, IL-1β, CXCL8, CCL2, CCL21, EMP1 and down with BPI). Despite the low tissue damage RVI scores, the high-dose microbicide combination gel caused activation of HIV host cells (SLC and CD4) while N-9 caused proinflammatory gene upregulation (IL-8 and TLR4) suggesting a potential for increasing risk of HIV via different mechanisms depending on the chemical nature of the test product. - Highlights: • A transcriptome nuclease protection assay assessed microbicides for vaginal safety. • Biomarkers were

  14. Safety and pharmacokinetic profiles of phosphorodiamidate morpholino oligomers with activity against ebola virus and marburg virus: results of two single-ascending-dose studies.

    PubMed

    Heald, Alison E; Iversen, Patrick L; Saoud, Jay B; Sazani, Peter; Charleston, Jay S; Axtelle, Tim; Wong, Michael; Smith, William B; Vutikullird, Apinya; Kaye, Edward

    2014-11-01

    Two identical single-ascending-dose studies evaluated the safety and pharmacokinetics (PK) of AVI-6002 and AVI-6003, two experimental combinations of phosphorodiamidate morpholino oligomers with positive charges (PMOplus) that target viral mRNA encoding Ebola virus and Marburg virus proteins, respectively. Both AVI-6002 and AVI-6003 were found to suppress disease in virus-infected nonhuman primates in previous studies. AVI-6002 (a combination of AVI-7537 and AVI-7539) or AVI-6003 (a combination of AVI-7287 and AVI-7288) were administered as sequential intravenous (i.v.) infusions of a 1:1 fixed dose ratio of the two subcomponents. In each study, 30 healthy male and female subjects between 18 and 50 years of age were enrolled in six-dose escalation cohorts of five subjects each and received a single i.v. infusion of active study drug (0.005, 0.05, 0.5, 1.5, 3, and 4.5 mg/kg per component) or placebo in a 4:1 ratio. Both AVI-6002 and AVI-6003 were safe and well tolerated at the doses studied. A maximum tolerated dose was not observed in either study. The four chemically similar PMOplus components exhibited generally similar PK profiles. The mean peak plasma concentration and area under the concentration-time curve values of the four components exhibited dose-proportional PK. The estimated plasma half-life of all four components was 2 to 5 h. The safety of the two combinations and the PK of the four components were similar, regardless of the target RNA sequence.

  15. The Dose-Effect Safety Profile of Skeletal Muscle Precursor Cell Therapy in a Dog Model of Intrinsic Urinary Sphincter Deficiency

    PubMed Central

    Eckman, Delrae; Dean, Ashley; Moradi, Mahmoudreza; Allickson, Julie; Cline, J. Mark; Yoo, James J.; Atala, Anthony

    2015-01-01

    Locally injected skeletal muscle precursor cells (skMPCs) integrate into and restore the muscle layers, innervation, vasculature, and function of the sphincter complex in animal models of intrinsic urinary sphincter deficiency (ISD). The goal of the present study was to test the dose-effect safety profile of skMPC therapy in a dog model of ISD. Sphincter deficiency was created in 20 adult female dogs by surgically removing the skeletal muscle layer of the urinary sphincter complex. skMPCs isolated from the hind leg were expanded in culture and injected 4 weeks later into the sphincter complex at a dose of 25 million cells (n = 5), 50 million cells (n = 5), or 100 million cells (n = 5) per milliliter in a 2-ml volume. Five dogs received no sphincter injection. The measures of maximal sphincter pressure, complete blood count, and blood chemistry were performed monthly until their sacrifice at 9 months. At that point, full necropsy was performed to assess the safety of the skMPC injections. Injection of different doses of cells had no effects on the body weight, blood cell count, or kidney or liver function test results (p > .05 among the skMPC doses). Some incidental pathologic features were found in the lower urinary tract in all groups and were most likely associated with repeat catheterization. The maximal urinary sphincter pressure was higher in the 50 million cells per milliliter treatment group than in the other experimental groups (p < .05). The findings of the present study have confirmed that urinary sphincter injection of skMPCs results in no significant local or systemic pathologic features within the dose range that improves sphincter pressures. PMID:25637189

  16. 76 FR 7853 - Patient Safety Organizations: Voluntary Delisting From Oregon Patient Safety Commission

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-11

    ... HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Delisting From Oregon Patient Safety Commission AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of delisting. SUMMARY: Oregon Patient Safety Commission: AHRQ has accepted...

  17. 76 FR 9350 - Patient Safety Organizations: Voluntary Delisting From Rocky Mountain Patient Safety Organization

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... Delisting From Rocky Mountain Patient Safety Organization AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. SUMMARY: Rocky Mountain Patient Safety Organization: AHRQ has accepted a notification of voluntary relinquishment from Rocky Mountain Patient Safety Organization,...

  18. Social Acceptance of Wind: A Brief Overview (Presentation)

    SciTech Connect

    Lantz, E.

    2015-01-01

    This presentation discusses concepts and trends in social acceptance of wind energy, profiles recent research findings, and discussions mitigation strategies intended to resolve wind power social acceptance challenges as informed by published research and the experiences of individuals participating in the International Energy Agencies Working Group on Social Acceptance of Wind Energy

  19. Effectiveness and tuberculosis-related safety profile of interleukin-1 blocking agents in the management of Behçet's disease.

    PubMed

    Cantarini, Luca; Lopalco, Giuseppe; Caso, Francesco; Costa, Luisa; Iannone, Florenzo; Lapadula, Giovanni; Anelli, Maria Grazia; Franceschini, Rossella; Menicacci, Cristina; Galeazzi, Mauro; Selmi, Carlo; Rigante, Donato

    2015-01-01

    Behçet's disease (BD) is a multi-systemic disorder of unknown etiology characterized by relapsing oral-genital ulcers, uveitis, and involvement of the articular, gastrointestinal, neurologic, and vascular systems. Although the primum movens of this condition remains unknown, a tangled plot combining autoimmune and autoinflammatory pathways has been hypothesized to explain its start and recurrence. In-depth analysis of BD pathogenetic mechanisms, involving dysfunction of multiple proinflammatory molecules, has opened new modalities of treatment: different agents targeting interleukin-1 have been studied in recent years to manage the most difficult and multi-resistant cases of BD. Growing experience with anakinra, canakinumab and gevokizumab is discussed in this review, highlighting the relative efficacy of each drug upon the protean BD clinical manifestations. Safety and tolerability of interleukin-1 antagonists in different doses have been confirmed by numerous observational studies on both large and small cohorts of patients with BD. In particular, the potential for Mycobacterium tuberculosis reactivation and tuberculosis development appears to be significantly lower with interleukin-1 blockers compared to tumor necrosis factor-α inhibitors, thus increasing the beneficial profile of this approach.

  20. Enhanced anti-tumor activity and safety profile of targeted nano-scaled HPMA copolymer-alendronate-TNP-470 conjugate in the treatment of bone malignances

    PubMed Central

    Segal, Ehud; Pan, Huaizhong; Benayoun, Liat; Kopečková, Pavla; Shaked, Yuval; Kopeček, Jindčrich; Satchi-Fainaro, Ronit

    2015-01-01

    Bone neoplasms, such as osteosarcoma, exhibit a propensity for systemic metastases resulting in adverse clinical outcome. Traditional treatment consisting of aggressive chemotherapy combined with surgical resection, has been the mainstay of these malignances. Therefore, bone-targeted non-toxic therapies are required. We previously conjugated the aminobisphosphonate alendronate (ALN), and the potent anti-angiogenic agent TNP-470 with N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer. HPMA copolymer-ALN-TNP-470 conjugate exhibited improved anti-angiogenic and anti-tumor activity compared with the combination of free ALN and TNP-470 when evaluated in a xenogeneic model of human osteosarcoma. The immune system has major effect on toxicology studies and on tumor progression. Therefore, in this manuscript we examined the safety and efficacy profiles of the conjugate using murine osteosarcoma syngeneic model. Toxicity and efficacy evaluation revealed superior anti-tumor activity and decreased organ-related toxicities of the conjugate compared with the combination of free ALN plus TNP-470. Finally, comparative anti-angiogenic activity and specificity studies, using surrogate biomarkers of circulating endothelial cells (CEC), highlighted the advantage of the conjugate over the free agents. The therapeutic platform described here may have clinical translational relevance for the treatment of bone-related angiogenesis-dependent malignances. PMID:21429572

  1. Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo

    PubMed Central

    Morozova, Svetlana Vyacheslavovna; Alekseeva, Natalia Stepanovna; Lilenko, Sergey Vasilyevich; Matsnev, Eduard Ivanovich; Melnikov, Oleg Anatol’evich

    2015-01-01

    Background We report here data from the >200 patients recruited in Russia to take part in OSVaLD, a 12-week, open-label, post-marketing surveillance study of the response to betahistine 48 mg/day in vertigo of peripheral vestibular origin carried out in a total of 13 countries. Methods The primary efficacy endpoint was change in the Dizziness Handicap Inventory (DHI; 100-point scale). Changes in Hospital Anxiety and Depression Scale (HADS) and Medical Outcomes Study Short-Form 36, version 2 (SF-36v2®) scores were a priori secondary Outcomes. Results Total DHI score improved by 43 points during betahistine treatment. This aggregate improvement was equally distributed across the three domains of the DHI (physical, emotional, and functional; P<0.0001 for main and subscore changes from baseline). Statistically significant improvements versus baseline were also observed in mean HADS scores for anxiety and depression (both P<0.0001), and in the Physical Component Summary and Mental Component Summary scores of the SF-36v2 (both P<0.0001 versus baseline). Only one suspected adverse drug reaction was recorded in the Russian safety population (n=204), indicating that betahistine was well tolerated in those patients. Conclusion Betahistine 48 mg/day was associated with clear improvements in well-configured and widely validated measures of health-related quality of life and an encouraging tolerability profile in patients in Russia who took part in OSVaLD. PMID:25653552

  2. Accepted Peer Practices in Adventure Programming.

    ERIC Educational Resources Information Center

    Johanson, Karl M., Comp.

    For the purpose of raising the level of safety, encouraging educational institutions and training programs to develop leaders, providing information for programs, establishing a base for communication with land use agencies, and providing information for school and agency custodians of potential students, the manual outlines "Accepted Peer…

  3. LIMS user acceptance testing.

    PubMed

    Klein, Corbett S

    2003-01-01

    Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

  4. On Maximum FODO Acceptance

    SciTech Connect

    Batygin, Yuri Konstantinovich

    2014-12-24

    This note illustrates maximum acceptance of FODO quadrupole focusing channel. Acceptance is the largest Floquet ellipse of a matched beam: A = $\\frac{a^2}{β}$$_{max}$ where a is the aperture of the channel and βmax is the largest value of beta-function in the channel. If aperture of the channel is restricted by a circle of radius a, the s-s acceptance is available for particles oscillating at median plane, y=0. Particles outside median plane will occupy smaller phase space area. In x-y plane, cross section of the accepted beam has a shape of ellipse with truncated boundaries.

  5. The Guinea pig as a preclinical model for demonstrating the efficacy and safety of statins.

    PubMed

    Madsen, Cort S; Janovitz, Evan; Zhang, Rongan; Nguyen-Tran, Van; Ryan, Carol S; Yin, Xiaohong; Monshizadegan, Hossain; Chang, Ming; D'Arienzo, Celia; Scheer, Susan; Setters, Robert; Search, Debra; Chen, Xing; Zhuang, Shaobin; Kunselman, Lori; Peters, Andrew; Harrity, Thomas; Apedo, Atsu; Huang, Christine; Cuff, Carolyn A; Kowala, Mark C; Blanar, Michael A; Sun, Chong-Qing; Robl, Jeffrey A; Stein, Philip D

    2008-02-01

    Statins, because of their excellent efficacy and manageable safety profile, represent a key component in the current armamentarium for the treatment of hypercholesterolemia. Nonetheless, myopathy remains a safety concern for this important drug class. Cerivastatin was withdrawn from the market for myotoxicity safety concerns. BMS-423526 [{(3R,5S)-7-[4-(4-fluorophenyl)-6,7-dihydro-2-(1-methylethyl)-5H-benzo[6,7]cyclohepta[1,2-b]pyridin-3-yl]-3,5-dihydroxy-heptenoic acid} sodium salt], similar to cerivastatin in potency and lipophilicity, was terminated in early clinical development due to an unacceptable myotoxicity profile. In this report, we describe the guinea pig as a model of statin-induced cholesterol lowering and myotoxicity and show that this model can distinguish statins with unacceptable myotoxicity profiles from statins with acceptable safety profiles. In our guinea pig model, both cerivastatin and BMS-423526 induced myotoxicity at doses near the ED(50) for total cholesterol (TC) lowering in plasma. In contrast, wide differences between myotoxic and TC-lowering doses were established for the currently marketed, more hydrophilic statins, pravastatin, rosuvastatin, and atorvastatin. This in vivo model compared favorably to an in vitro model, which used statin inhibition of cholesterol synthesis in rat hepatocytes and L6 myoblasts as surrogates of potential efficacy and toxicity, respectively. Our conclusion is that the guinea pig is a useful preclinical in vivo model for demonstrating whether a statin is likely to have an acceptable therapeutic safety margin.

  6. Safety: System Safety Engineering and Management

    DTIC Science & Technology

    2007-11-02

    Review system safety status and issues during each milestone decision review ( MDR ) of new or improved Army Acquisition Executive (AAE)-managed systems...under research, development, or modification. (3) Review system safety status and issues during each MDR of new or improved DISC4-managed systems. (4) Act...for acceptance in all MDR packages and forward to the appropriate decision level. Institute risk management procedures as described in appendix B and

  7. Preclinical safety profile of trastuzumab emtansine (T-DM1): Mechanism of action of its cytotoxic component retained with improved tolerability

    SciTech Connect

    Poon, Kirsten Achilles; Flagella, Kelly; Beyer, Joseph; Tibbitts, Jay; Kaur, Surinder; Saad, Ola; Yi, Joo-Hee; Girish, Sandhya; Dybdal, Noel; Reynolds, Theresa

    2013-12-01

    Trastuzumab emtansine (T-DM1) is the first antibody-drug conjugate (ADC) approved for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The therapeutic premise of ADCs is based on the hypothesis that targeted delivery of potent cytotoxic drugs to tumors will provide better tolerability and efficacy compared with non-targeted delivery, where poor tolerability can limit efficacious doses. Here, we present results from preclinical studies characterizing the toxicity profile of T-DM1, including limited assessment of unconjugated DM1. T-DM1 binds primate ErbB2 and human HER2 but not the rodent homolog c-neu. Therefore, antigen-dependent and non-antigen-dependent toxicity was evaluated in monkeys and rats, respectively, in both single- and repeat-dose studies; toxicity of DM1 was assessed in rats only. T-DM1 was well tolerated at doses up to 40 mg/kg (∼ 4400 μg DM1/m{sup 2}) and 30 mg/kg (∼ 6000 μg DM1/m{sup 2}) in rats and monkeys, respectively. In contrast, DM1 was only tolerated up to 0.2 mg/kg (1600 μg DM1/m{sup 2}). This suggests that at least two-fold higher doses of the cytotoxic agent are tolerated in T-DM1, supporting the premise of ADCs to improve the therapeutic index. In addition, T-DM1 and DM1 safety profiles were similar and consistent with the mechanism of action of DM1 (i.e., microtubule disruption). Findings included hepatic, bone marrow/hematologic (primarily platelet), lymphoid organ, and neuronal toxicities, and increased numbers of cells of epithelial and phagocytic origin in metaphase arrest. These adverse effects did not worsen with chronic dosing in monkeys and are consistent with those reported in T-DM1-treated patients to date. - Highlights: • T-DM1 was well tolerated in preclinical studies in rats and cynomolgus monkeys. • T-DM1 is associated with bone marrow/hematologic, hepatic, and neuronal toxicities. • T-DM1 toxicities are related to DM1 mechanisms of action and pharmacologic

  8. Safety profiles of anti-VEGF drugs: bevacizumab, ranibizumab, aflibercept and ziv-aflibercept on human retinal pigment epithelium cells in culture

    PubMed Central

    Malik, Deepika; Tarek, Mohamed; Caceres del Carpio, Javier; Ramirez, Claudio; Boyer, David; Kenney, M Cristina; Kuppermann, Baruch D

    2014-01-01

    Purpose To compare the safety profiles of antivascular endothelial growth factor (VEGF) drugs ranibizumab, bevacizumab, aflibercept and ziv-aflibercept on retinal pigment epithelium cells in culture. Methods Human retinal pigment epithelium cells (ARPE-19) were exposed for 24 h to four anti-VEGF drugs at 1/2×, 1×, 2× and 10× clinical concentrations. Cell viability and mitochondrial membrane potential assay were performed to evaluate early apoptotic changes and rate of overall cell death. Results Cell viability decreased at 10× concentrations in bevacizumab (82.38%, p=0.0001), aflibercept (82.68%, p=0.0002) and ziv-aflibercept (77.25%, p<0.0001), but not at lower concentrations. However, no changes were seen in cell viability in ranibizumab-treated cells at all concentrations including 10×. Mitochondrial membrane potential was slightly decreased in 10× ranibizumab-treated cells (89.61%, p=0.0006) and 2× and 10× aflibercept-treated cells (88.76%, 81.46%; p<0.01, respectively). A larger reduction in mitochondrial membrane potential was seen at 1×, 2× and 10× concentrations of bevacizumab (86.53%, 74.38%, 66.67%; p<0.01) and ziv-aflibercept (73.50%, 64.83% and 49.65% p<0.01) suggestive of early apoptosis at lower doses, including the clinical doses. Conclusions At clinical doses, neither ranibizumab nor aflibercept produced evidence of mitochondrial toxicity or cell death. However, bevacizumab and ziv-aflibercept showed mild mitochondrial toxicity at clinically relevant doses. PMID:24836865

  9. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  10. Safety management practices and safety behaviour: assessing the mediating role of safety knowledge and motivation.

    PubMed

    Vinodkumar, M N; Bhasi, M

    2010-11-01

    Safety management practices not only improve working conditions but also positively influence employees' attitudes and behaviours with regard to safety, thereby reducing accidents in workplace. This study measured employees' perceptions on six safety management practices and self-reported safety knowledge, safety motivation, safety compliance and safety participation by conducting a survey using questionnaire among 1566 employees belonging to eight major accident hazard process industrial units in Kerala, a state in southern part of India. The reliability and unidimesionality of all the scales were found acceptable. Path analysis using AMOS-4 software showed that some of the safety management practices have direct and indirect relations with the safety performance components, namely, safety compliance and safety participation. Safety knowledge and safety motivation were found to be the key mediators in explaining these relationships. Safety training was identified as the most important safety management practice that predicts safety knowledge, safety motivation, safety compliance and safety participation. These findings provide valuable guidance for researchers and practitioners for identifying the mechanisms by which they can improve safety of workplace.

  11. Newbery Medal Acceptance.

    ERIC Educational Resources Information Center

    Freedman, Russell

    1988-01-01

    Presents the Newbery Medal acceptance speech of Russell Freedman, writer of children's nonfiction. Discusses the place of nonfiction in the world of children's literature, the evolution of children's biographies, and the author's work on "Lincoln." (ARH)

  12. 14 CFR 415.35 - Acceptable flight risk.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Launch Range § 415.35 Acceptable flight risk. (a) Flight risk through orbital insertion or impact. Acceptable flight risk through orbital insertion for an orbital launch vehicle, and through impact for a... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval,...

  13. 14 CFR 415.35 - Acceptable flight risk.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Launch Range § 415.35 Acceptable flight risk. (a) Flight risk through orbital insertion or impact. Acceptable flight risk through orbital insertion for an orbital launch vehicle, and through impact for a... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval,...

  14. 14 CFR 415.35 - Acceptable flight risk.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Launch Range § 415.35 Acceptable flight risk. (a) Flight risk through orbital insertion or impact. Acceptable flight risk through orbital insertion for an orbital launch vehicle, and through impact for a... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval,...

  15. 14 CFR 415.35 - Acceptable flight risk.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Launch Range § 415.35 Acceptable flight risk. (a) Flight risk through orbital insertion or impact. Acceptable flight risk through orbital insertion for an orbital launch vehicle, and through impact for a... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval,...

  16. 14 CFR 415.35 - Acceptable flight risk.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Launch Range § 415.35 Acceptable flight risk. (a) Flight risk through orbital insertion or impact. Acceptable flight risk through orbital insertion for an orbital launch vehicle, and through impact for a... collective members of the public exposed to debris hazards from any one launch. To obtain safety approval,...

  17. 49 CFR 41.120 - Acceptable model codes.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Acceptable model codes. 41.120 Section 41.120 Transportation Office of the Secretary of Transportation SEISMIC SAFETY § 41.120 Acceptable model codes. (a) This... of this part. (b)(1) The following are model codes which have been found to provide a level...

  18. 78 FR 17212 - Patient Safety Organizations: Voluntary Relinquishment From Universal Safety Solution PSO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Relinquishment From Universal Safety Solution PSO AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.... AHRQ has accepted a notification of voluntary relinquishment from Universal Safety Solution PSO of its... the list of federally approved PSOs. AHRQ has accepted a notification from Universal Safety...

  19. 49 CFR 41.120 - Acceptable model codes.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Transportation Office of the Secretary of Transportation SEISMIC SAFETY § 41.120 Acceptable model codes. (a) This section describes the standards that must be used to meet the seismic design and construction requirements... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake...

  20. 49 CFR 41.120 - Acceptable model codes.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Transportation Office of the Secretary of Transportation SEISMIC SAFETY § 41.120 Acceptable model codes. (a) This section describes the standards that must be used to meet the seismic design and construction requirements... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake...

  1. 49 CFR 41.120 - Acceptable model codes.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Transportation Office of the Secretary of Transportation SEISMIC SAFETY § 41.120 Acceptable model codes. (a) This section describes the standards that must be used to meet the seismic design and construction requirements... seismic safety substantially equivalent to that provided by use of the 1988 National Earthquake...

  2. Accepting space radiation risks.

    PubMed

    Schimmerling, Walter

    2010-08-01

    The human exploration of space inevitably involves exposure to radiation. Associated with this exposure are multiple risks, i.e., probabilities that certain aspects of an astronaut's health or performance will be degraded. The management of these risks requires that such probabilities be accurately predicted, that the actual exposures be verified, and that comprehensive records be maintained. Implicit in these actions is the fact that, at some point, a decision has been made to accept a certain level of risk. This paper examines ethical and practical considerations involved in arriving at a determination that risks are acceptable, roles that the parties involved may play, and obligations arising out of reliance on the informed consent paradigm seen as the basis for ethical radiation risk acceptance in space.

  3. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    The Hermes space vehicle currently in project for the European Space Agency will open the road to European autonomous manned space missions at the beginning of the 21st century. The safety objectives are very ambitious and will require the implementation of a comprehensive safety assurance program, aimed at reducing the risks to an acceptable level. The risk acceptance is based on identification, ranking and minimization of Critical Items including all potential departures from the safety requirements. Prime contractors shall prepare a Critical Item List for their elements, and submit it to the Hermes Program Directorate for review; approval of the residual open critical items shall be obtained before launch. An independent committee (HESAC) has been set up by the ESA and the French National Space Center (CNES) Directors General to assess the adequacy of the Safety Control Program.

  4. Safety and acceptability of vaginal disinfection with benzalkonium chloride in HIV infected pregnant women in west Africa: ANRS 049b phase II randomized, double blinded placebo controlled trial. DITRAME Study Group

    PubMed Central

    Msellati, P.; Meda, N.; Leroy, V.; Likikouet, R.; Van de Perre, P.; Cartoux, M.; Bonard, D.; Ouangre, A.; Combe, P.; Gautier-Charpenti..., L.; Sylla-Koko, F.; Lassalle, R.; Dosso, M.; Welffens-Ekra, C.; Dabis, F.; Mandelbrot, L.

    1999-01-01

    OBJECTIVES: To study the tolerance and acceptability in Africa of a perinatal intervention to prevent vertical HIV transmission using benzalkonium chloride disinfection. DESIGN: A randomized, double blinded phase II trial. SETTING: Prenatal care units in Abidjan (Cote d'Ivoire) and Bobo-Dioulasso (Burkina Faso). PATIENTS: Women accepting testing and counselling who were seropositive for HIV-1 and under 37 weeks of pregnancy were eligible. A total of 108 women (54 in each group) enrolled from November 1996 to April 1997, with their informed consent. INTERVENTION: Women self administered daily a vaginal suppository of 1% benzalkonium chloride or matched placebo from 36 weeks of pregnancy, and a single intrapartum dose. The neonate was bathed with 1% benzalkonium chloride solution or placebo within 30 minutes after birth. MAIN OUTCOME MEASURES: Adverse events were recorded weekly, with a questionnaire and speculum examination in women through delivery, and examination of the neonate through day 30. The incidence of genital signs and symptoms in the women and cutaneous or ophthalmological events in newborns were compared between groups on an intent to treat basis. RESULTS: The median duration of prepartum treatment was 21 days (range 0-87 days). Compliance was 87% for prepartum and 69% for intrapartum treatment, and 88% for the neonatal bath, without differences between the two groups. In women, the most frequent event was leucorrhoea; the incidence of adverse events did not differ between treatment groups. In children, the incidence of dermatitis and conjunctivitis did not differ between the benzalkonium chloride and placebo groups (p = 0.16 and p = 0.29, respectively). CONCLUSION: Vaginal disinfection with benzalkonium chloride is a feasible and well tolerated intervention in west Africa. Its efficacy in preventing vertical HIV transmission remains to be demonstrated. 


 PMID:10754950

  5. Vaccine safety.

    PubMed

    Jacobson, Robert M

    2003-11-01

    Rates of reported adverse events are remarkably low. VAERS identifies an adverse event rate approximating 11.4 reports per 100,000 vaccine doses. Approximately 15% of these reports represent SAEs, but less than 2% involve death; in most cases, reviews have shown no causal relation between the events and the vaccine. Across the spectrum of vaccines in use (including those directed against influenza and hepatitis B virus), many claims of adverse events regarding vaccines represent typical reactions to vaccinations. These reactions can be thought of as foreign-body reactions and predominate among the inactivated vaccines. In controlled studies, the adverse event rates that occur with vaccination resemble those that occur with placebo injections. Typical reactions associated with live viral and bacterial vaccines, such as MMR and varicella vaccines, may resemble attenuated forms of the disease for which the vaccine is directed. Other claims against vaccines represent chance-coincidence or misunderstood data; further studies of claims have vindicated the overall safety of the vaccines in most cases. Two documented safety concerns with vaccines, however, have demonstrated that vaccines (like other biologics and pharmacologic) can result in harm (eg, rotavirus and OPV vaccines). The denouement with these vaccines indicates the broad postmarketing data collection and evaluation that extends efforts made with prelicensure study to balance the benefits from vaccination with the risk for harm. Overall, measures including prelicensure study and postlicensure surveillance, such as VAERS, the Vaccine Safety Datalink Project, and the Clinical Immunization Safety Assessment Centers, have resulted in an exceptional safety profile for the vaccines in use.

  6. Farm Safety

    PubMed Central

    Wilson, G. S.

    1966-01-01

    Accident and safety are related terms; the higher the accident rate in any industry, the greater is the need for safety measures designed to prevent accidents. This article discusses the accident and safety problems in agriculture, which includes horticulture and forestry. There is still a tendency among townspeople to think of the countryside as peaceful and tranquil, a place where nothing happens very quickly and far removed from violent death or crippling injury. This pleasant rustic picture has undergone a striking change in the last 30 years owing to considerable agricultural mechanization and the development of chemical pesticides, which have brought new dangers to those who live and work on the land. Although men have readily adapted themselves to new machines and methods, they have not proved as able to recognize new dangers and learn how to guard against them. In consequence, accidents have increased to such an extent that the whole industry has realized the need for positive preventive measures. In this country, it is generally accepted that an employer of labour has a responsibility to provide safe working conditions for those he employs. Farm safety legislation goes a little further and usually requires an employer to provide necessary safeguards, with the added requirement on a worker to make use of them. It is a feature of accident prevention work that it never reaches a stage when it can be regarded as complete. Even when a reduction in accidents has been achieved, the effort must be sustained or the trend will be quickly reversed. Images PMID:5904095

  7. Why was Relativity Accepted?

    NASA Astrophysics Data System (ADS)

    Brush, S. G.

    Historians of science have published many studies of the reception of Einstein's special and general theories of relativity. Based on a review of these studies, and my own research on the role of the light-bending prediction in the reception of general relativity, I discuss the role of three kinds of reasons for accepting relativity (1) empirical predictions and explanations; (2) social-psychological factors; and (3) aesthetic-mathematical factors. According to the historical studies, acceptance was a three-stage process. First, a few leading scientists adopted the special theory for aesthetic-mathematical reasons. In the second stage, their enthusiastic advocacy persuaded other scientists to work on the theory and apply it to problems currently of interest in atomic physics. The special theory was accepted by many German physicists by 1910 and had begun to attract some interest in other countries. In the third stage, the confirmation of Einstein's light-bending prediction attracted much public attention and forced all physicists to take the general theory of relativity seriously. In addition to light-bending, the explanation of the advance of Mercury's perihelion was considered strong evidence by theoretical physicists. The American astronomers who conducted successful tests of general relativity became defenders of the theory. There is little evidence that relativity was `socially constructed' but its initial acceptance was facilitated by the prestige and resources of its advocates.

  8. Approaches to acceptable risk

    SciTech Connect

    Whipple, C.

    1997-04-30

    Several alternative approaches to address the question {open_quotes}How safe is safe enough?{close_quotes} are reviewed and an attempt is made to apply the reasoning behind these approaches to the issue of acceptability of radiation exposures received in space. The approaches to the issue of the acceptability of technological risk described here are primarily analytical, and are drawn from examples in the management of environmental health risks. These include risk-based approaches, in which specific quantitative risk targets determine the acceptability of an activity, and cost-benefit and decision analysis, which generally focus on the estimation and evaluation of risks, benefits and costs, in a framework that balances these factors against each other. These analytical methods tend by their quantitative nature to emphasize the magnitude of risks, costs and alternatives, and to downplay other factors, especially those that are not easily expressed in quantitative terms, that affect acceptance or rejection of risk. Such other factors include the issues of risk perceptions and how and by whom risk decisions are made.

  9. Hanford Site solid waste acceptance criteria

    SciTech Connect

    Ellefson, M.D.

    1998-07-01

    Order 5820.2A requires that each treatment, storage, and/or disposal facility (referred to in this document as TSD unit) that manages low-level or transuranic waste (including mixed waste and TSCA PCB waste) maintain waste acceptance criteria. These criteria must address the various requirements to operate the TSD unit in compliance with applicable safety and environmental requirements. This document sets forth the baseline criteria for acceptance of radioactive waste at TSD units operated by WMH. The criteria for each TSD unit have been established to ensure that waste accepted can be managed in a manner that is within the operating requirements of the unit, including environmental regulations, DOE Orders, permits, technical safety requirements, waste analysis plans, performance assessments, and other applicable requirements. Acceptance criteria apply to the following TSD units: the Low-Level Burial Grounds (LLBG) including both the nonregulated portions of the LLBG and trenches 31 and 34 of the 218-W-5 Burial Ground for mixed waste disposal; Central Waste Complex (CWC); Waste Receiving and Processing Facility (WRAP); and T Plant Complex. Waste from all generators, both from the Hanford Site and from offsite facilities, must comply with these criteria. Exceptions can be granted as provided in Section 1.6. Specific waste streams could have additional requirements based on the 1901 identified TSD pathway. These requirements are communicated in the Waste Specification Records (WSRds). The Hanford Site manages nonradioactive waste through direct shipments to offsite contractors. The waste acceptance requirements of the offsite TSD facility must be met for these nonradioactive wastes. This document does not address the acceptance requirements of these offsite facilities.

  10. Acceptability of human risk.

    PubMed

    Kasperson, R E

    1983-10-01

    This paper has three objectives: to explore the nature of the problem implicit in the term "risk acceptability," to examine the possible contributions of scientific information to risk standard-setting, and to argue that societal response is best guided by considerations of process rather than formal methods of analysis. Most technological risks are not accepted but are imposed. There is also little reason to expect consensus among individuals on their tolerance of risk. Moreover, debates about risk levels are often at base debates over the adequacy of the institutions which manage the risks. Scientific information can contribute three broad types of analyses to risk-setting deliberations: contextual analysis, equity assessment, and public preference analysis. More effective risk-setting decisions will involve attention to the process used, particularly in regard to the requirements of procedural justice and democratic responsibility.

  11. Acceptability of human risk.

    PubMed Central

    Kasperson, R E

    1983-01-01

    This paper has three objectives: to explore the nature of the problem implicit in the term "risk acceptability," to examine the possible contributions of scientific information to risk standard-setting, and to argue that societal response is best guided by considerations of process rather than formal methods of analysis. Most technological risks are not accepted but are imposed. There is also little reason to expect consensus among individuals on their tolerance of risk. Moreover, debates about risk levels are often at base debates over the adequacy of the institutions which manage the risks. Scientific information can contribute three broad types of analyses to risk-setting deliberations: contextual analysis, equity assessment, and public preference analysis. More effective risk-setting decisions will involve attention to the process used, particularly in regard to the requirements of procedural justice and democratic responsibility. PMID:6418541

  12. Acceptance Test Plan.

    DTIC Science & Technology

    2014-09-26

    7 RD-Ai507 154 CCEPTANCE TEST PLN(U) WESTINGHOUSE DEFENSE ND i/i ELECTRO ICS CENTER BALTIMORE MD DEVELOPMENT AND OPERATIONS DIY D C KRRiJS 28 JUN...Ln ACCEPTANCE TEST PLAN FOR SPECIAL RELIABILITY TESTS FOR BROADBAND MICROWAVE AMPLIFIER PANEL David C. Kraus, Reliability Engineer WESTINGHOUSE ...ORGANIZATION b. OFFICE SYMBOL 7g& NAME OF MONITORING ORGANIZATION tIf appdeg ble) WESTINGHOUSE ELECTRIC CORP. - NAVAL RESEARCH LABORATORY e. AOORES$ (Ci7t

  13. Age and Acceptance of Euthanasia.

    ERIC Educational Resources Information Center

    Ward, Russell A.

    1980-01-01

    Study explores relationship between age (and sex and race) and acceptance of euthanasia. Women and non-Whites were less accepting because of religiosity. Among older people less acceptance was attributable to their lesser education and greater religiosity. Results suggest that quality of life in old age affects acceptability of euthanasia. (Author)

  14. Communicating for Safety's Sake

    ERIC Educational Resources Information Center

    Wiesner, Robert

    2005-01-01

    No community is safe until every member takes responsibility for the community's collective safety. College communities are no different from families, towns and businesses in that respect. Getting everyone to accept responsibility is a challenge and skilled communication is an important component of the solution. As part of the front line,…

  15. Optimization of the Current Ramp-up Phase in DIII-D via Physics-model-based Control of Plasma Safety Factor Profile Dynamics

    NASA Astrophysics Data System (ADS)

    Barton, J. E.; Wehner, W. P.; Schuster, E.; Luce, T. C.; Jackson, G. L.; Ferron, J. R.; Humphreys, D. A.; Hyatt, A. W.

    2014-10-01

    Simulations and experimental results in DIII-D are presented to demonstrate the potential of physics-model-based control of the q profile to improve the reproducibility of plasma startup conditions by achieving a specified target q profile at the end of the current ramp-up. Three different q profiles (qmin of 1.3, 1.65, 2.1 and q95 of 4.4, 5.0, 6.2, respectively) were specified as targets. A feedforward + feedback scheme is utilized to control the q profile and is constructed by embedding a nonlinear, physics-based model of the q profile dynamics into the control design process. A unique characteristic of the feedforward trajectories obtained by solving the optimization problem is the regulation of the plasma current ramp-up rate to achieve the target q profiles. The feedback controller is employed to add robustness to the control scheme and account for drifts due to external plasma disturbances. Supported by the US Department of Energy under DE-SC0001334, DE-SC0010661 and DE-FC02-04ER54698.

  16. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    PubMed

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma.

  17. 76 FR 41487 - Macy's, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... agrees that it will not seek or accept, directly or indirectly, indemnification, reimbursement,...

  18. 76 FR 55648 - Sunsations Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-08

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION Sunsations Inc., Provisional Acceptance of a Settlement Agreement and Order AGENCY: Consumer... settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register...

  19. M-M-R(®)II manufactured using recombinant human albumin (rHA) and M-M-R(®)II manufactured using human serum albumin (HSA) exhibit similar safety and immunogenicity profiles when administered as a 2-dose regimen to healthy children.

    PubMed

    Wiedmann, Richard T; Reisinger, Keith S; Hartzel, Jonathan; Malacaman, Edgardo; Senders, Shelly D; Giacoletti, Katherine E D; Shaw, Eric; Kuter, Barbara J; Schödel, Florian; Musey, Luwy K

    2015-04-27

    Prior to 2006, M-M-R(®)II (measles, mumps, and rubella virus vaccine live) was manufactured using human serum albumin (HSA) and each dose of the vaccine contained a relatively small amount (≤0.3mg) of HSA. Because of specific regulatory requirements and limited suppliers of HSA acceptable for human use, there was a need to replace HSA with recombinant human albumin (rHA) to mitigate any potential risk to the availability of M-M-R(®)II. Two different formulations of M-M-R(®)II manufactured using either rHA or HSA were clinically evaluated for safety and immunogenicity when administered as a 2-dose regimen to healthy children 12-18 months and 3-4 years of age. Adverse events, including those indicative of a possible hypersensitivity reaction, were collected for 42 days after each dose. Antibodies to measles, mumps, and rubella were measured before and approximately 6 weeks after dose 1. Antibodies to rHA were measured before and approximately 6 weeks after dose 1 and dose 2. Antibody seroconversion rates to measles, mumps, and rubella were 97.0%, 99.5%, and 99.7%, respectively, for recipients of M-M-R(®)II with rHA and 97.2%, 97.9%, and 99.6%, respectively, for recipients of M-M-R(®)II with HSA, and geometric mean titers to all 3 vaccine viral antigens were comparable between the 2 vaccination groups. The proportions of subjects who reported adverse events, including those suggestive of hypersensitivity reactions, after each dose of study vaccine were comparable between the 2 vaccination groups. No subject had detectable antibodies to rHA immediately prior to or following receipt of either the first or second dose of study vaccine. Given the comparable immunogenicity and safety profiles of both formulations, rHA is an acceptable replacement for HSA in the manufacture of M-M-R(®)II.

  20. Safety of magnetic fusion facilities: Requirements

    SciTech Connect

    1996-05-01

    This Standard identifies safety requirements for magnetic fusion facilities. Safety functions are used to define outcomes that must be achieved to ensure that exposures to radiation, hazardous materials, or other hazards are maintained within acceptable limits. Requirements applicable to magnetic fusion facilities have been derived from Federal law, policy, and other documents. In addition to specific safety requirements, broad direction is given in the form of safety principles that are to be implemented and within which safety can be achieved.

  1. High acceptance recoil polarimeter

    SciTech Connect

    The HARP Collaboration

    1992-12-05

    In order to detect neutrons and protons in the 50 to 600 MeV energy range and measure their polarization, an efficient, low-noise, self-calibrating device is being designed. This detector, known as the High Acceptance Recoil Polarimeter (HARP), is based on the recoil principle of proton detection from np[r arrow]n[prime]p[prime] or pp[r arrow]p[prime]p[prime] scattering (detected particles are underlined) which intrinsically yields polarization information on the incoming particle. HARP will be commissioned to carry out experiments in 1994.

  2. 49 CFR 232.505 - Pre-revenue service acceptance testing plan.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... acceptance tests; (3) Correct any safety deficiencies identified by FRA in the design of the equipment or in... measure or determine the success or failure of the tests. If acceptance is to be based on extrapolation of... 49 Transportation 4 2010-10-01 2010-10-01 false Pre-revenue service acceptance testing plan....

  3. 49 CFR 232.505 - Pre-revenue service acceptance testing plan.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... acceptance tests; (3) Correct any safety deficiencies identified by FRA in the design of the equipment or in... measure or determine the success or failure of the tests. If acceptance is to be based on extrapolation of... 49 Transportation 4 2011-10-01 2011-10-01 false Pre-revenue service acceptance testing plan....

  4. 16 CFR 1631.34 - Small carpets and rugs not meeting acceptance criterion.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... acceptance criterion. 1631.34 Section 1631.34 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION...) Rules and Regulations § 1631.34 Small carpets and rugs not meeting acceptance criterion. (a) If any... acceptance criterion of such standard, it shall, prior to its introduction into commerce, be legibly...

  5. Safety system status monitoring

    SciTech Connect

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.

  6. Maintaining plant safety margins

    SciTech Connect

    Bergeron, P.A.

    1989-01-01

    The Final Safety Analysis Report Forms the basis of demonstrating that the plant can operate safely and meet all applicable acceptance criteria. In order to assure that this continues through each operating cycle, the safety analysis is reexamined for each reload core. Operating limits are set for each reload core to assure that safety limits and applicable acceptance criteria are not exceeded for postulated events within the design basis. These operating limits form the basis for plant operation, providing barriers on various measurable parameters. The barriers are refereed to as limiting conditions for operation (LCO). The operating limits, being influenced by many factors, can change significantly from cycle to cycle. In order to be successful in demonstrating safe operation for each reload core (with adequate operating margin), it is necessary to continue to focus on ways to maintain/improve existing safety margins. Existing safety margins are a function of the plant type (boiling water reactor/pressurized water reactor (BWR/PWR)), nuclear system supply (NSSS) vendor, operating license date, core design features, plant design features, licensing history, and analytical methods used in the safety analysis. This paper summarizes the experience at Yankee Atomic Electric Company (YAEC) in its efforts to provide adequate operating margin for the plants that it supports.

  7. Effects of disciplinary cultures of researchers and research trainees on the acceptability of nanocarriers for drug delivery in different contexts of use: a mixed-methods study.

    PubMed

    Chenel, Vanessa; Boissy, Patrick; Cloarec, Jean-Pierre; Patenaude, Johane

    The acceptability of nanomedical applications, which have the potential to generate ethical and societal impacts, is a significant factor in the deployment of nanomedicine. A lack of fit between nanomedical applications and society's values may result from a partial consideration of such impacts. New approaches for technological evaluation focused on impact perception, acceptance, and acceptability are needed to go beyond traditional technology assessment approaches used with nanotechnology, which focus mainly on toxicological and safety criteria. Using a new evaluative approach based on perceived impacts of nanotechnology, the objective of this study was to assess perceptions among researchers and research trainees familiar with emergent technologies and from different disciplinary background the scope of acceptability judgments made towards the use of nanocarriers. This mixed-methods study was based on scenarios presenting two types of drug-delivery nanocarriers (carbon, synthetic DNA) in two contexts of use (lung cancer treatment, seasonal flu treatment). Researchers and research trainees in the natural sciences and engineering, and the social sciences and the humanities were invited by email to take part in this project. An online questionnaire followed by semi-directed interviews allowed characterization of disciplinary divergences regarding to impact perception, acceptance, and acceptability of the scenarios. The results suggest that impact perception is influenced by disciplinary culture. Also, trends can be seen between respondents' profiles and variables of acceptance and acceptability, and certain components of the acceptability judgement are specific to each disciplinary culture. The acknowledgment and consideration of these disciplinary divergences could allow, among others, for opening up interdisciplinary dialogue on matters related to the acceptability of nanomedical applications and their developments.

  8. Effects of disciplinary cultures of researchers and research trainees on the acceptability of nanocarriers for drug delivery in different contexts of use: a mixed-methods study

    NASA Astrophysics Data System (ADS)

    Chenel, Vanessa; Boissy, Patrick; Cloarec, Jean-Pierre; Patenaude, Johane

    2015-04-01

    The acceptability of nanomedical applications, which have the potential to generate ethical and societal impacts, is a significant factor in the deployment of nanomedicine. A lack of fit between nanomedical applications and society's values may result from a partial consideration of such impacts. New approaches for technological evaluation focused on impact perception, acceptance, and acceptability are needed to go beyond traditional technology assessment approaches used with nanotechnology, which focus mainly on toxicological and safety criteria. Using a new evaluative approach based on perceived impacts of nanotechnology, the objective of this study was to assess perceptions among researchers and research trainees familiar with emergent technologies and from different disciplinary background the scope of acceptability judgments made towards the use of nanocarriers. This mixed-methods study was based on scenarios presenting two types of drug-delivery nanocarriers (carbon, synthetic DNA) in two contexts of use (lung cancer treatment, seasonal flu treatment). Researchers and research trainees in the natural sciences and engineering, and the social sciences and the humanities were invited by email to take part in this project. An online questionnaire followed by semi-directed interviews allowed characterization of disciplinary divergences regarding to impact perception, acceptance, and acceptability of the scenarios. The results suggest that impact perception is influenced by disciplinary culture. Also, trends can be seen between respondents' profiles and variables of acceptance and acceptability, and certain components of the acceptability judgement are specific to each disciplinary culture. The acknowledgment and consideration of these disciplinary divergences could allow, among others, for opening up interdisciplinary dialogue on matters related to the acceptability of nanomedical applications and their developments.

  9. Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients

    PubMed Central

    Armstrong, Jon; Arrieta, Antonio; Bishai, Raafat; Das, Shampa; Delair, Shirley; Edeki, Timi; Holmes, William C.; Li, Jianguo; Moffett, Kathryn S.; Mukundan, Deepa; Perez, Norma; Romero, José R.; Speicher, David; Sullivan, Janice E.; Zhou, Diansong

    2016-01-01

    This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose of ceftazidime-avibactam in pediatric patients. A phase I, multicenter, open-label PK study was conducted in pediatric patients hospitalized with an infection and receiving systemic antibiotic therapy. Patients were enrolled into four age cohorts (cohort 1, ≥12 to <18 years; cohort 2, ≥6 to <12 years; cohort 3, ≥2 to <6 years; cohort 4, ≥3 months to <2 years). Patients received a single 2-h intravenous infusion of ceftazidime-avibactam (cohort 1, 2,000 to 500 mg; cohort 2, 2,000 to 500 mg [≥40 kg] or 50 to 12.5 mg/kg [<40 kg]; cohorts 3 and 4, 50 to 12.5 mg/kg). Blood samples were collected to describe individual PK characteristics for ceftazidime and avibactam. Population PK modeling was used to describe characteristics of ceftazidime and avibactam PK across all age groups. Safety and tolerability were assessed. Thirty-two patients received study drug. Mean plasma concentration-time curves, geometric mean maximum concentration (Cmax), and area under the concentration-time curve from time zero to infinity (AUC0–∞) were similar across all cohorts for both drugs. Six patients (18.8%) reported an adverse event, all mild or moderate in intensity. No deaths or serious adverse events occurred. The single-dose PK of ceftazidime and avibactam were comparable between each of the 4 age cohorts investigated and were broadly similar to those previously observed in adults. No new safety concerns were identified. (This study has been registered at ClinicalTrials.gov under registration no. NCT01893346.) PMID:27503642

  10. The correlation between CYP2D6 isoenzyme activity and haloperidol efficacy and safety profile in patients with alcohol addiction during the exacerbation of the addiction

    PubMed Central

    Sychev, Dmitry Alekseevich; Zastrozhin, Mikhail Sergeevich; Smirnov, Valery Valerieevich; Grishina, Elena Anatolievna; Savchenko, Ludmila Mikhailovna; Bryun, Evgeny Alekseevich

    2016-01-01

    Background Today, it is proved that isoenzymes CYP2D6 and CYP3A4 are involved in metabolism of haloperidol. In our previous investigation, we found a medium correlation between the efficacy and safety of haloperidol and the activity of CYP3A4 in patients with alcohol abuse. Objective The aim of this study was to evaluate the correlation between the activity of CYP2D6 and the efficacy and safety of haloperidol in patients with diagnosed alcohol abuse. Methods The study involved 70 men (average age: 40.83±9.92 years) with alcohol addiction. A series of psychometric scales were used in the research. The activity of CYP2D6 was evaluated by high-performance liquid chromatography with mass spectrometry using the ratio of 6-hydroxy-1,2,3,4-tetrahydro-beta-carboline to pinoline. Genotyping of CYP2D6 (1846G>A) was performed using real-time polymerase chain reaction. Results According to results of correlation analysis, statistically significant values of Spearman correlation coefficient (rs) between the activity of CYP2D6 and the difference of points in psychometric scale were obtained in patients receiving haloperidol in injection form (Sheehan Clinical Anxiety Rating Scale =−0.721 [P<0.001] and Udvald for Kliniske Undersogelser Side Effect Rating Scale =0.692 [P<0.001]) and in those receiving haloperidol in tablet form (Covi Anxiety Scale =−0.851 [P<0.001] and Udvald for Kliniske Undersogelser Side Effect Rating Scale =0.797 [P<0.001]). Conclusion This study demonstrated the correlations between the activity of CYP2D6 isozyme and the efficacy and safety of haloperidol in patients with alcohol addiction. PMID:27695358

  11. Physics-model-based Actuator Trajectory Optimization and Feedback Control of the Plasma Safety Factor Profile and Internal Energy Dynamics in DIII-D

    NASA Astrophysics Data System (ADS)

    Barton, J. E.; Schuster, E.; Walker, M. L.; Humphreys, D. A.

    2013-10-01

    Simulation and experimental results in DIII-D are presented to demonstrate the potential of integrated physics-model-based q profile and internal energy control algorithms for systematic attainment and repeatability of discharges. Both simulations and experiments demonstrate improved profile control accuracy relative to open loop (feedforward) control alone, by using a combined feedforward + feedback scheme. The scheme is constructed by embedding a nonlinear, first-principles-driven, physics-based model of the plasma dynamics into the control design process. Firstly, a tool to numerically design actuator trajectories that steer the plasma to a desired operating state (feedforward) is developed with the objective of supporting the traditional trial-and-error experimental process of advanced scenario planning. Secondly, an algorithm to track a desired q profile and internal energy evolution (feedback) is developed with the goal of adding robustness to the control scheme. Supported by the US Department of Energy under DE-FG02-09ER55064, DE-FG02-92ER54141 and DE-FC02-04ER54698.

  12. Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study

    PubMed Central

    Briggs, Paula; Serrani, Marco; Vogtländer, Kai; Parke, Susanne

    2016-01-01

    Background Oral contraceptives are still associated with high discontinuation rates, despite their efficacy. There is a wide choice of oral contraceptives available, and the aim of this study was to assess continuation rates, bleeding profile acceptability, and the satisfaction of women in the first year of using a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) versus a progestogen-only pill (POP) in a real-life setting after discontinuing an ethinylestradiol-containing pill. Methods and results In this prospective, noninterventional, observational study, 3,152 patients were included for the efficacy analyses (n=2,558 women in the E2V/DNG group and n=592 in the POP group (two patients fulfilled the criteria of the efficacy population, but the used product was not known). Women had been taking an ethinylestradiol-containing pill ≥3 months before deciding to switch to the E2V/DNG pill or a POP. Overall, 19.8% (n=506) of E2V/DNG users and 25.8% (n=153) of POP users discontinued their prescribed pill. The median time to discontinuation was 157.0 days and 127.5 days, respectively. Time to discontinuation due to bleeding (P<0.0001) or other reasons (P=0.022) was significantly longer in the E2V/DNG group versus the POP group. The E2V/DNG pill was also associated with shorter (48.7% vs 44.1%), lighter (54% vs 46.1%), and less painful bleeding (91.1% vs 73.7%) and greater user satisfaction (80.7% vs 64.6%) than POP use, within 3–5 months after switch. Conclusion The E2V/DNG pill was associated with higher rates of continuation, bleeding profile acceptability, and user satisfaction than POP use and may be an alternative option for women who are dissatisfied with their current pill. PMID:27695365

  13. 78 FR 38298 - Ross Stores, Inc. et al., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register...

  14. 75 FR 55777 - Pro-Pac Distributing Corp., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register...

  15. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  16. Vaccine Safety

    MedlinePlus

    ... FAQs about Vaccine Safety Research Publications HDM Reports ISO Scientific Agenda Ensuring Safety History Understanding Side Effects ... Datalink Publications Emergency Preparedness Vaccine Safety Partners About ISO File Formats Help: How do I view different ...

  17. Safety and Efficacy Profile of Echinacea purpurea to Prevent Common Cold Episodes: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Jawad, M.; Schoop, R.; Suter, A.; Klein, P.; Eccles, R.

    2012-01-01

    Objective. To investigate the safety (risk) and efficacy (benefit) of Echinacea purpurea extract in the prevention of common cold episodes in a large population over a 4-month period. Methods. 755 healthy subjects were allocated to receive either an alcohol extract from freshly harvested E. purpurea (95% herba and 5% root) or placebo. Participants were required to record adverse events and to rate cold-related issues in a diary throughout the investigation period. Nasal secretions were sampled at acute colds and screened for viruses. Results. A total of 293 adverse events occurred with Echinacea and 306 with placebo treatment. Nine and 10% of participants experienced adverse events, which were at least possibly related to the study drug (adverse drug reactions). Thus, the safety of Echinacea was noninferior to placebo. Echinacea reduced the total number of cold episodes, cumulated episode days within the group, and pain-killer medicated episodes. Echinacea inhibited virally confirmed colds and especially prevented enveloped virus infections (P < 0.05). Echinacea showed maximal effects on recurrent infections, and preventive effects increased with therapy compliance and adherence to the protocol. Conclusions. Compliant prophylactic intake of E. purpurea over a 4-month period appeared to provide a positive risk to benefit ratio. PMID:23024696

  18. Safety profile and gender specific differences of a methanol extract of Eriosema laurentii (Leguminosae) in acute and subchronic (28 days) oral toxicity studies in Wistar rats.

    PubMed

    Ateba, Sylvin Benjamin; Simo, Rudy Valdès; Mbanya, Jean Claude; Krenn, Liselotte; Njamen, Dieudonné

    2014-03-01

    Despite widespread use of Eriosema laurentii De Wild (Leguminosae) in West and Central Africa as herbal medicine and food additive the toxicity of this plant is unknown. Therefore, we performed the safety evaluation of a methanol extract (AEL). In acute toxicity, single oral administration of 2000mg/kg AEL caused neither toxicological symptoms nor mortality and the LD50 was estimated >5000mg/kg. In the subchronic oral toxicity, AEL induced no phenotypical signs of toxicity during and after treatment. Only a delayed decrease of relative spleen weight in males at the highest dose of 400mg/kg occurred. High density lipoprotein (HDL) increased significantly in females at 200 and 400mg/kg. Non-persistent increases in alanine aminotransferase activity within normal ranges were noted at 200mg/kg in males and at all doses in females. In males, AEL induced a decrease of white blood cell count at 400mg/kg, whereas lymphocytes increased at 200 and 400mg/kg and granulocytes at 400mg/kg. In females, no differences in haematological parameters occurred. Neither differences in bilirubin, creatinine and total protein levels were observed nor histological alterations in organs. The results indicate a broad safety margin for AEL.

  19. Sonic boom acceptability studies

    NASA Technical Reports Server (NTRS)

    Shepherd, Kevin P.; Sullivan, Brenda M.; Leatherwood, Jack D.; Mccurdy, David A.

    1992-01-01

    The determination of the magnitude of sonic boom exposure which would be acceptable to the general population requires, as a starting point, a method to assess and compare individual sonic booms. There is no consensus within the scientific and regulatory communities regarding an appropriate sonic boom assessment metric. Loudness, being a fundamental and well-understood attribute of human hearing was chosen as a means of comparing sonic booms of differing shapes and amplitudes. The figure illustrates the basic steps which yield a calculated value of loudness. Based upon the aircraft configuration and its operating conditions, the sonic boom pressure signature which reaches the ground is calculated. This pressure-time history is transformed to the frequency domain and converted into a one-third octave band spectrum. The essence of the loudness method is to account for the frequency response and integration characteristics of the auditory system. The result of the calculation procedure is a numerical description (perceived level, dB) which represents the loudness of the sonic boom waveform.

  20. Long-term safety concerns with proton pump inhibitors.

    PubMed

    Ali, Tauseef; Roberts, David Neil; Tierney, William M

    2009-10-01

    Proton pump inhibitors (PPIs) are among the most widely prescribed medications worldwide. Their use has resulted in dramatic improvements in treatment of peptic ulcer disease and gastroesophageal reflux disease. Despite an acceptable safety profile, mounting data demonstrate concerns about the long-term use of PPIs. To provide a comprehensive review regarding the concerns of long-term PPI use, a literature search was performed to identify pertinent original and review articles. Despite study shortcomings, the collective body of information overwhelmingly suggests an increased risk of infectious complications and nutritional deficiencies. Data regarding any increased risk in gastric or colon malignancy are less convincing. PPIs have revolutionized the management and complications of acid-related disorders with a high margin of safety; however, with the data available, efforts to reduce the dosing of or discontinue the use of PPIs must be reassessed frequently.

  1. Aviation Safety Simulation Model

    NASA Technical Reports Server (NTRS)

    Houser, Scott; Yackovetsky, Robert (Technical Monitor)

    2001-01-01

    The Aviation Safety Simulation Model is a software tool that enables users to configure a terrain, a flight path, and an aircraft and simulate the aircraft's flight along the path. The simulation monitors the aircraft's proximity to terrain obstructions, and reports when the aircraft violates accepted minimum distances from an obstruction. This model design facilitates future enhancements to address other flight safety issues, particularly air and runway traffic scenarios. This report shows the user how to build a simulation scenario and run it. It also explains the model's output.

  2. Safety evaluation of disposable baby diapers using principles of quantitative risk assessment.

    PubMed

    Rai, Prashant; Lee, Byung-Mu; Liu, Tsung-Yun; Yuhui, Qin; Krause, Edburga; Marsman, Daniel S; Felter, Susan

    2009-01-01

    Baby diapers are complex products consisting of multiple layers of materials, most of which are not in direct contact with the skin. The safety profile of a diaper is determined by the biological properties of individual components and the extent to which the baby is exposed to each component during use. Rigorous evaluation of the toxicological profile and realistic exposure conditions of each material is important to ensure the overall safety of the diaper under normal and foreseeable use conditions. Quantitative risk assessment (QRA) principles may be applied to the safety assessment of diapers and similar products. Exposure to component materials is determined by (1) considering the conditions of product use, (2) the degree to which individual layers of the product are in contact with the skin during use, and (3) the extent to which some components may be extracted by urine and delivered to skin. This assessment of potential exposure is then combined with data from standard safety assessments of components to determine the margin of safety (MOS). This study examined the application of QRA to the safety evaluation of baby diapers, including risk assessments for some diaper ingredient chemicals for which establishment of acceptable and safe exposure levels were demonstrated.

  3. Tank Farms Technical Safety Requirements [VOL 1 and 2

    SciTech Connect

    CASH, R.J.

    2000-12-28

    The Technical Safety Requirements (TSRs) define the acceptable conditions, safe boundaries, basis thereof, and controls to ensure safe operation during authorized activities, for facilities within the scope of the Tank Waste Remediation System (TWRS) Final Safety Analysis Report (FSAR).

  4. Running a hospital patient safety campaign: a qualitative study

    PubMed Central

    Ozieranski, Piotr; Robins, Victoria; Minion, Joel; Willars, Janet; Wright, John; Weaver, Simon; Martin, Graham P.; Woods, Mary Dixon

    2017-01-01

    Purpose Research on patient safety campaigns has mostly concentrated on large-scale multi-organisation efforts, yet locally led improvement is increasingly promoted. The purpose of this paper is to characterise the design and implementation of an internal patient safety campaign at a large acute National Health Service hospital trust with a view to understanding how to optimise such campaigns. Design/methodology/approach The authors conducted a qualitative study of a campaign that sought to achieve 12 patient safety goals. The authors interviewed 19 managers and 45 frontline staff, supplemented by 56 hours of non-participant observation. Data analysis was based on the constant comparative method. Findings The campaign was motivated by senior managers’ commitment to patient safety improvement, a series of serious untoward incidents, and a history of campaign-style initiatives at the trust. While the campaign succeeded in generating enthusiasm and focus among managers and some frontline staff, it encountered three challenges. First, though many staff at the sharp end were aware of the campaign, their knowledge, and acceptance of its content, rationale, and relevance for distinct clinical areas were variable. Second, the mechanisms of change, albeit effective in creating focus, may have been too limited. Third, many saw the tempo of the campaign as too rapid. Overall, the campaign enjoyed some success in raising the profile of patient safety. However, its ability to promote change was mixed, and progress was difficult to evidence because of lack of reliable measurement. Originality/value The study shows that single-organisation campaigns may help in raising the profile of patient safety. The authors offer important lessons for the successful running of such campaigns. PMID:25241600

  5. 33 CFR 175.130 - Visual distress signals accepted.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Visual distress signals accepted. 175.130 Section 175.130 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) BOATING SAFETY EQUIPMENT REQUIREMENTS Visual Distress Signals § 175.130 Visual distress...

  6. Determinants of debit cards acceptance: An empirical investigation

    NASA Astrophysics Data System (ADS)

    Ismail, Shafinar; Bakri, Mohamed Hariri; Zulkepli, Jafri; Adnan, Azimah; Azizi, Amsyar

    2014-12-01

    These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300 respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.

  7. Determinants of debit cards acceptance: An empirical investigation

    SciTech Connect

    Ismail, Shafinar; Adnan, Azimah; Azizi, Amsyar; Bakri, Mohamed Hariri; Zulkepli, Jafri

    2014-12-04

    These days, most of the Malaysians realize that the consumption of debit card will help them to reduce the household debt. Thus, it is important to analyse the acceptance of debit cards for further enhancement and expanding its market share in Malaysia. In addition, there is lacked of research being conducted on the determinants affecting the acceptance of debit cards among Malaysians. Thus, the study aimed to investigate the factors affecting the acceptance of debit cards. This study focuses on payment methods, consumer attitude, and safety of debit card in acceptance of debit cards. Questionnaires were distributed to the 300 respondents. The sampling procedure adopted was stratified random sampling. The data obtained were analysed using SPSS 20.0 which involves scale reliability, descriptive and regression analysis. The result indicates that payment methods, consumer attitude and safety are the determinants of debit cards acceptance. Safety is the best predictor as most of the customers are confidents to use debit cards because of the security being developed around these debit card transactions. The analyses presented in this study can be used by policymakers and managers as a guide to promote banking products and services. The findings achieved in this study will be of interest for practitioners and academics concerned with developments of the Malaysian banking industry.

  8. DOE standard: Firearms safety

    SciTech Connect

    1996-02-01

    Information in this document is applicable to all DOE facilities, elements, and contractors engaged in work that requires the use of firearms as provided by law or contract. The standard in this document provides principles and practices for implementing a safe and effective firearms safety program for protective forces and for non-security use of firearms. This document describes acceptable interpretations and methods for meeting Order requirements.

  9. Obviating much of the need for insulin therapy in type 2 diabetes mellitus: A re-assessment of insulin therapy's safety profile.

    PubMed

    Schwartz, Stanley S; Jellinger, Paul S; Herman, Mary E

    2016-08-01

    Current processes of care for diabetes mellitus (DM) were shaped during the era when insulin therapy was considered inexorable to the management of advanced stage type 2 (T2DM), though this no longer appears to be categorically true. There are also dashed hopes that insulin therapy can prevent or stall diabetes. While exogenous insulin remains a life-sparing tool for fully insulin-dependent DM, insulin therapy-induced hyperinsulinemia now appears to contribute to serious safety issues beyond hypoglycemia and weight gain. Iatrogenic and compensatory hyperinsulinemia are metabolic disruptors of β-cells, liver, muscle, kidney, brain, heart and vasculature, inflammation, and lipid homeostasis, among other systems. This may compromise β-cells, exacerbate insulin resistance (IR), and increase risk of cardiovascular (CV) disease. Striking associations between exogenous insulin and risks of CV events, cancer, and all-cause mortality in clinical trial and real-world cohorts caution that insulin may pose more harm than previously evidenced. At our disposal are numerous alternate tools that, alone or in combination, efficaciously manage hyperglycemia and glucolipotoxicity, and do so without inducing hypoglycemia, weight gain, or hyperinsulinemia. Moreover, these new tools support true precision therapy, as modern day drug classes can be aligned with the various mediating pathways of hyperglycemia at work in any given patient. Some also appear to promote β-cell survival, with intriguing data being presented for newer agents, such as incretins. As such, we encourage preferential use of non-insulin antidiabetic agents to injected insulin for the management of non-insulin-dependent patients with T2DM, including in advanced stage T2DM. The goal of this article is to augment existing literature to 1) correct misconceptions on the rationale and necessity for insulin therapy in T2DM, 2) discuss emerging negative safety data with insulin therapy, and, 3) offer a practical means to

  10. Safety in Outdoor Adventure Programs. S.O.A.P. Safety Policy.

    ERIC Educational Resources Information Center

    MacDonald, Wayne, Comp.; And Others

    Drafted in 1978 as a working document for Safety in Outdoor Adventure Programs (S.O.A.P.) by a council of outdoor adventure programmers, checklists outline standard accepted safety policy for Outdoor Adventure Programs and Wilderness Adventure Programs conducted through public or private agencies in California. Safety policy emphasizes: the…

  11. Acceptance of tinnitus: validation of the tinnitus acceptance questionnaire.

    PubMed

    Weise, Cornelia; Kleinstäuber, Maria; Hesser, Hugo; Westin, Vendela Zetterqvist; Andersson, Gerhard

    2013-01-01

    The concept of acceptance has recently received growing attention within tinnitus research due to the fact that tinnitus acceptance is one of the major targets of psychotherapeutic treatments. Accordingly, acceptance-based treatments will most likely be increasingly offered to tinnitus patients and assessments of acceptance-related behaviours will thus be needed. The current study investigated the factorial structure of the Tinnitus Acceptance Questionnaire (TAQ) and the role of tinnitus acceptance as mediating link between sound perception (i.e. subjective loudness of tinnitus) and tinnitus distress. In total, 424 patients with chronic tinnitus completed the TAQ and validated measures of tinnitus distress, anxiety, and depression online. Confirmatory factor analysis provided support to a good fit of the data to the hypothesised bifactor model (root-mean-square-error of approximation = .065; Comparative Fit Index = .974; Tucker-Lewis Index = .958; standardised root mean square residual = .032). In addition, mediation analysis, using a non-parametric joint coefficient approach, revealed that tinnitus-specific acceptance partially mediated the relation between subjective tinnitus loudness and tinnitus distress (path ab = 5.96; 95% CI: 4.49, 7.69). In a multiple mediator model, tinnitus acceptance had a significantly stronger indirect effect than anxiety. The results confirm the factorial structure of the TAQ and suggest the importance of a general acceptance factor that contributes important unique variance beyond that of the first-order factors activity engagement and tinnitus suppression. Tinnitus acceptance as measured with the TAQ is proposed to be a key construct in tinnitus research and should be further implemented into treatment concepts to reduce tinnitus distress.

  12. Safety Profiles and Antitumor Efficacy of Oncolytic Adenovirus Coated with Bioreducible Polymer in the Treatment of a CAR Negative Tumor Model

    PubMed Central

    2015-01-01

    Adenovirus (Ad) vectors show promise as cancer gene therapy delivery vehicles, but immunogenic safety concerns and coxsackie and adenovirus receptor (CAR)-dependency have limited their use. Alternately, biocompatible and bioreducible nonviral vectors, including arginine-grafted cationic polymers, have been shown to deliver nucleic acids through a cell penetration peptide (CPP) and protein transduction domain (PTD) effect. We utilized the advantages of both viral and nonviral vectors to develop a hybrid gene delivery vehicle by coating Ad with mPEG-PEI-g-Arg-S-S-Arg-g-PEI-mPEG (Ad/PPSA). Characterization of Ad/PPSA particle size and zeta potential showed an overall size and cationic charge increase in a polymer concentration-dependent manner. Ad/PPSA also showed a marked transduction efficiency increase in both CAR-negative and -positive cells compared to naked Ad. Competition assays demonstrated that Ad/PPSA produced higher transgene expression levels than naked Ad and achieved CAR-independent transduction. Oncolytic Ad (DWP418)/PPSA was able to overcome the nonspecificity of polymer-only therapies by demonstrating cancer-specific killing effects. Furthermore, the DWP418/PPSA nanocomplex elicited a 2.24-fold greater antitumor efficacy than naked Ad in vivo. This was supported by immunohistochemical confirmation of Ad E1As accumulation in MCF7 xenografted tumors. Lastly, intravenous injection of DWP418/PPSA elicited less innate immune response compared to naked Ad, evaluated by interleukin-6 cytokine release into the serum. The increased antitumor effect and improved vector targeting to both CAR-negative and -positive cells make DWP418/PPSA a promising tool for cancer gene therapy. PMID:25400213

  13. Safety profiles and antitumor efficacy of oncolytic adenovirus coated with bioreducible polymer in the treatment of a CAR negative tumor model.

    PubMed

    Jung, Soo-Jung; Kasala, Dayananda; Choi, Joung-Woo; Lee, Soo-Hwan; Hwang, June Kyu; Kim, Sung Wan; Yun, Chae-Ok

    2015-01-12

    Adenovirus (Ad) vectors show promise as cancer gene therapy delivery vehicles, but immunogenic safety concerns and coxsackie and adenovirus receptor (CAR)-dependency have limited their use. Alternately, biocompatible and bioreducible nonviral vectors, including arginine-grafted cationic polymers, have been shown to deliver nucleic acids through a cell penetration peptide (CPP) and protein transduction domain (PTD) effect. We utilized the advantages of both viral and nonviral vectors to develop a hybrid gene delivery vehicle by coating Ad with mPEG-PEI-g-Arg-S-S-Arg-g-PEI-mPEG (Ad/PPSA). Characterization of Ad/PPSA particle size and zeta potential showed an overall size and cationic charge increase in a polymer concentration-dependent manner. Ad/PPSA also showed a marked transduction efficiency increase in both CAR-negative and -positive cells compared to naked Ad. Competition assays demonstrated that Ad/PPSA produced higher transgene expression levels than naked Ad and achieved CAR-independent transduction. Oncolytic Ad (DWP418)/PPSA was able to overcome the nonspecificity of polymer-only therapies by demonstrating cancer-specific killing effects. Furthermore, the DWP418/PPSA nanocomplex elicited a 2.24-fold greater antitumor efficacy than naked Ad in vivo. This was supported by immunohistochemical confirmation of Ad E1As accumulation in MCF7 xenografted tumors. Lastly, intravenous injection of DWP418/PPSA elicited less innate immune response compared to naked Ad, evaluated by interleukin-6 cytokine release into the serum. The increased antitumor effect and improved vector targeting to both CAR-negative and -positive cells make DWP418/PPSA a promising tool for cancer gene therapy.

  14. Novel N-linked aminopiperidine inhibitors of bacterial topoisomerase type II with reduced pK(a): antibacterial agents with an improved safety profile.

    PubMed

    Reck, Folkert; Alm, Richard A; Brassil, Patrick; Newman, Joseph V; Ciaccio, Paul; McNulty, John; Barthlow, Herbert; Goteti, Kosalaram; Breen, John; Comita-Prevoir, Janelle; Cronin, Mark; Ehmann, David E; Geng, Bolin; Godfrey, Andrew Aydon; Fisher, Stewart L

    2012-08-09

    Novel non-fluoroquinolone inhibitors of bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) are of interest for the development of new antibacterial agents that are not impacted by target-mediated cross-resistance with fluoroquinolones. N-Linked amino piperidines, such as 7a, generally show potent antibacterial activity, including against quinolone-resistant isolates, but suffer from hERG inhibition (IC(50) = 44 μM for 7a) and QT prolongation in vivo. We now disclose the finding that new analogues of 7a with reduced pK(a) due to substitution with an electron-withdrawing substituent in the piperidine moiety, such as R,S-7c, retained the Gram-positive activity of 7a but showed significantly less hERG inhibition (IC(50) = 233 μM for R,S-7c). This compound exhibited moderate clearance in dog, promising efficacy against a MRSA strain in a mouse infection model, and an improved in vivo QT profile as measured in a guinea pig in vivo model. As a result of its promising activity, R,S-7c was advanced into phase I clinical studies.

  15. Cone penetrometer acceptance test report

    SciTech Connect

    Boechler, G.N.

    1996-09-19

    This Acceptance Test Report (ATR) documents the results of acceptance test procedure WHC-SD-WM-ATR-151. Included in this report is a summary of the tests, the results and issues, the signature and sign- off ATP pages, and a summarized table of the specification vs. ATP section that satisfied the specification.

  16. Risk-based Spacecraft Fire Safety Experiments

    NASA Technical Reports Server (NTRS)

    Apostolakis, G.; Catton, I.; Issacci, F.; Paulos, T.; Jones, S.; Paxton, K.; Paul, M.

    1992-01-01

    Viewgraphs on risk-based spacecraft fire safety experiments are presented. Spacecraft fire risk can never be reduced to a zero probability. Probabilistic risk assessment is a tool to reduce risk to an acceptable level.

  17. An update on safety and immunogenicity of vaccines containing emulsion-based adjuvants.

    PubMed

    Fox, Christopher B; Haensler, Jean

    2013-07-01

    With the exception of alum, emulsion-based vaccine adjuvants have been administered to far more people than any other adjuvant, especially since the 2009 H1N1 influenza pandemic. The number of clinical safety and immunogenicity evaluations of vaccines containing emulsion adjuvants has correspondingly mushroomed. In this review, the authors introduce emulsion adjuvant composition and history before detailing the most recent findings from clinical and postmarketing data regarding the effects of emulsion adjuvants on vaccine immunogenicity and safety, with emphasis on the most widely distributed emulsion adjuvants, MF59® and AS03. The authors also present a summary of other emulsion adjuvants in clinical development and indicate promising avenues for future emulsion-based adjuvant development. Overall, emulsion adjuvants have demonstrated potent adjuvant activity across a number of disease indications along with acceptable safety profiles.

  18. Comparison of the circulating metabolite profile of PF-04991532, a hepatoselective glucokinase activator, across preclinical species and humans: potential implications in metabolites in safety testing assessment.

    PubMed

    Sharma, Raman; Litchfield, John; Bergman, Arthur; Atkinson, Karen; Kazierad, David; Gustavson, Stephanie M; Di, Li; Pfefferkorn, Jeffrey A; Kalgutkar, Amit S

    2015-02-01

    A previous report from our laboratory disclosed the identification of PF-04991532 [(S)-6-(3-cyclopentyl-2-(4-trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid] as a hepatoselective glucokinase activator for the treatment of type 2 diabetes mellitus. Lack of in vitro metabolic turnover in microsomes and hepatocytes from preclinical species and humans suggested that metabolism would be inconsequential as a clearance mechanism of PF-04991532 in vivo. Qualitative examination of human circulating metabolites using plasma samples from a 14-day multiple ascending dose clinical study, however, revealed a glucuronide (M1) and monohydroxylation products (M2a and M2b/M2c) whose abundances (based on UV integration) were greater than 10% of the total drug-related material. Based on this preliminary observation, mass balance/excretion studies were triggered in animals, which revealed that the majority of circulating radioactivity following the oral administration of [¹⁴C]PF-04991532 was attributed to an unchanged parent (>70% in rats and dogs). In contrast with the human circulatory metabolite profile, the monohydroxylated metabolites were not detected in circulation in either rats or dogs. Available mass spectral evidence suggested that M2a and M2b/M2c were diastereomers derived from cyclopentyl ring oxidation in PF-04991532. Because cyclopentyl ring hydroxylation on the C-2 and C-3 positions can generate eight possible diastereomers, it was possible that additional diastereomers may have also formed and would need to be resolved from the M2a and M2b/M2c peaks observed in the current chromatography conditions. In conclusion, the human metabolite scouting study in tandem with the animal mass balance study allowed early identification of PF-04991532 oxidative metabolites, which were not predicted by in vitro methods and may require additional scrutiny in the development phase of PF-04991532.

  19. Survey of methods for improving operator acceptance of computerized aids

    SciTech Connect

    Frey, P. R.; Kisner, R. A.

    1982-04-01

    The success of current attempts to improve the operational performance and safety of nuclear power plants by installing computerized operational aids in the control rooms is dependent, in part, on the operator's attitude toward the aid. Utility experience with process computer systems indicates that problems may already exist with operator acceptance of computerized aids. The growth of the role that computers have in nuclear power plants makes user acceptance of computer technology an important issue for the nuclear industry. The purpose of this report is to draw from the literature factors related to user acceptance of computerized equipment that may also be applicable to the acceptance of computerized aids used in the nuclear power plant control room.

  20. Auto Safety

    MedlinePlus

    ... kids by following simple safety measures and by teaching some basic rules. Importance of Child Safety Seats ... your child correctly — a small child in a large seat may not be the best option. Models ...

  1. Water Safety

    MedlinePlus

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety A A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  2. Water Safety

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Water Safety KidsHealth > For Teens > Water Safety A A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  3. Food Safety

    MedlinePlus

    ... the safety of fish caught in your local lakes, rivers, and coastal areas. Advisories may recommend that ... Charts Picky Eating Physical Activity Food Safety Resources Kids Students Adults Families Professionals Multiple Languages MyPlate, MyWins ...

  4. Water Safety

    MedlinePlus

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety Print A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  5. Water Safety

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Water Safety KidsHealth > For Teens > Water Safety Print A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  6. Extending the Technology Acceptance Model: Policy Acceptance Model (PAM)

    NASA Astrophysics Data System (ADS)

    Pierce, Tamra

    There has been extensive research on how new ideas and technologies are accepted in society. This has resulted in the creation of many models that are used to discover and assess the contributing factors. The Technology Acceptance Model (TAM) is one that is a widely accepted model. This model examines people's acceptance of new technologies based on variables that directly correlate to how the end user views the product. This paper introduces the Policy Acceptance Model (PAM), an expansion of TAM, which is designed for the analysis and evaluation of acceptance of new policy implementation. PAM includes the traditional constructs of TAM and adds the variables of age, ethnicity, and family. The model is demonstrated using a survey of people's attitude toward the upcoming healthcare reform in the United States (US) from 72 survey respondents. The aim is that the theory behind this model can be used as a framework that will be applicable to studies looking at the introduction of any new or modified policies.

  7. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

    Safety policies, procedures, and related information are presented in this manual to assist school personnel in a continuing program of accident prevention. Chapter 1 discusses safety education and accident prevention in general. Chapter 2 covers traffic regulations relating to school safety patrols, school bus transportation, bicycles, and…

  8. The "Barnum Effect" and Acceptance of Negative Personal Evaluation

    ERIC Educational Resources Information Center

    Dmitruk, Victor M.; And Others

    1973-01-01

    Rokeach's value survey and Maxhover's Figure Drawing Tests were administered to two groups of college students. Subjects were then given bogus personality profiles. They were equally likely to accept positive and negative personal evaluations irrespective of whether the tests on which they were purportedly based were scored and interpreted'' by a…

  9. Biologic Safety in Psoriasis

    PubMed Central

    Mansouri, Yasaman

    2015-01-01

    The development of targeted biologic agents has revolutionized the treatment of psoriasis. In this review, the authors focus on the published long-term (≥ one year) safety data for the use of tumor necrosis factor-α antagonists etanercept, infliximab, and adalimumab, as well as the IL-12/IL-23 antagonist ustekinumab, in adult patients with moderate-to-severe psoriasis. The efficacy of these currently available biologic therapies has been demonstrated in several studies, and their safety profiles are also reassuring. PMID:25741401

  10. Market Acceptance of Smart Growth

    EPA Pesticide Factsheets

    This report finds that smart growth developments enjoy market acceptance because of stability in prices over time. Housing resales in smart growth developments often have greater appreciation than their conventional suburban counterparts.

  11. L-286 Acceptance Test Record

    SciTech Connect

    HARMON, B.C.

    2000-01-14

    This document provides a detailed account of how the acceptance testing was conducted for Project L-286, ''200E Area Sanitary Water Plant Effluent Stream Reduction''. The testing of the L-286 instrumentation system was conducted under the direct supervision

  12. 46 CFR 28.275 - Acceptance criteria for instructors and course curricula.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Acceptance criteria for instructors and course curricula... the Aleutian Trade § 28.275 Acceptance criteria for instructors and course curricula. (a) A Fishing Vessel Safety Instructor shall submit a detailed course curriculum that relates directly to...

  13. 14 CFR 435.35 - Acceptable reentry risk for reentry of a reentry vehicle.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Acceptable reentry risk for reentry of a reentry vehicle. To obtain safety approval for reentry, an applicant must demonstrate that risk for the proposed reentry, when assessed in combination with launch of the... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Acceptable reentry risk for reentry of...

  14. A Quantitative Assessment of the Factors that Influence Technology Acceptance in Emergency Response

    ERIC Educational Resources Information Center

    Seiter, Thomas C.

    2012-01-01

    Traditional models for studying user acceptance and adoption of technology focused on the factors that identify and tested the relationships forged between the user and the technology in question. In emergency response, implementing technology without user acceptance may affect the safety of the responders and citizenry. Integrating the factors…

  15. Acceptability and implementation of debriefings after trauma resuscitation.

    PubMed

    Berg, Gina M; Hervey, Ashley M; Basham-Saif, Angela; Parsons, Deanna; Acuna, David L; Lippoldt, Diana

    2014-01-01

    Postresuscitation debriefings allow team members to reflect on performance and discuss areas for improvement. Pre-/postsurveys of trauma team members (physicians, mid-level practitioners, technicians, pharmacists, and nurses) were administered to evaluate the acceptability of debriefings and self-perceptions after multidisciplinary trauma resuscitations. After a 3-month trial period, improvements were observed in perceptions of psychological and patient safety, role on team, team communication, and acceptability of the debriefing initiative. Regrouping for a debriefing requires organizational change, which may be more easily assimilated if team members recognize the potential for process improvement and feel confident about success.

  16. Probabilistic Requirements (Partial) Verification Methods Best Practices Improvement. Variables Acceptance Sampling Calculators: Empirical Testing. Volume 2

    NASA Technical Reports Server (NTRS)

    Johnson, Kenneth L.; White, K. Preston, Jr.

    2012-01-01

    The NASA Engineering and Safety Center was requested to improve on the Best Practices document produced for the NESC assessment, Verification of Probabilistic Requirements for the Constellation Program, by giving a recommended procedure for using acceptance sampling by variables techniques as an alternative to the potentially resource-intensive acceptance sampling by attributes method given in the document. In this paper, the results of empirical tests intended to assess the accuracy of acceptance sampling plan calculators implemented for six variable distributions are presented.

  17. Site acceptance test, W-030 MICON system

    SciTech Connect

    Hill, L.F., Westinghouse Hanford

    1996-06-10

    Monitoring and control of the W-030 ventilation upgrade is provided by a distributed control system (DCS) furnished by MICON Corporation. After shipment to the Hanford Site, the site acceptance test (SAT) for this system was conducted in a laboratory environment over a six month period, involving four distinct phases and numerous hardware and software modifications required to correct test exceptions. The final results is a system which is not fully compliant with procurement specifications but is determined to meet minimum Project W-030 safety and functional requirements. A negotiated settlement was reached with the supplier to establish a `path forward` for system implementation. This report documents the `as-run` status of the SAT. The SAT was completed in August of 1995. It was later followed by comprehensive acceptance testing of the W-030 control-logic configuration software; results are documented in WHC-SD-W030-ATR-011. Further testing is reported as part of process system startup operational testing, performed after the MICON installation.

  18. 2013 SYR Accepted Poster Abstracts.

    PubMed

    2013-01-01

    Promote Health and Well-being Among Middle School Educators. 20. A Systematic Review of Yoga-based Interventions for Objective and Subjective Balance Measures. 21. Disparities in Yoga Use: A Multivariate Analysis of 2007 National Health Interview Survey Data. 22. Implementing Yoga Therapy Adapted for Older Veterans Who Are Cancer Survivors. 23. Randomized, Controlled Trial of Yoga for Women With Major Depressive Disorder: Decreased Ruminations as Potential Mechanism for Effects on Depression? 24. Yoga Beyond the Metropolis: A Yoga Telehealth Program for Veterans. 25. Yoga Practice Frequency, Relationship Maintenance Behaviors, and the Potential Mediating Role of Relationally Interdependent Cognition. 26. Effects of Medical Yoga in Quality of Life, Blood Pressure, and Heart Rate in Patients With Paroxysmal Atrial Fibrillation. 27. Yoga During School May Promote Emotion Regulation Capacity in Adolescents: A Group Randomized, Controlled Study. 28. Integrated Yoga Therapy in a Single Session as a Stress Management Technique in Comparison With Other Techniques. 29. Effects of a Classroom-based Yoga Intervention on Stress and Attention in Second and Third Grade Students. 30. Improving Memory, Attention, and Executive Function in Older Adults with Yoga Therapy. 31. Reasons for Starting and Continuing Yoga. 32. Yoga and Stress Management May Buffer Against Sexual Risk-Taking Behavior Increases in College Freshmen. 33. Whole-systems Ayurveda and Yoga Therapy for Obesity: Outcomes of a Pilot Study. 34. Women�s Phenomenological Experiences of Exercise, Breathing, and the Body During Yoga for Smoking Cessation Treatment. 35. Mindfulness as a Tool for Trauma Recovery: Examination of a Gender-responsive Trauma-informed Integrative Mindfulness Program for Female Inmates. 36. Yoga After Stroke Leads to Multiple Physical Improvements. 37. Tele-Yoga in Patients With Chronic Obstructive Pulmonary Disease and Heart Failure: A Mixed-methods Study of Feasibility, Acceptability, and Safety

  19. Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

    SciTech Connect

    Ryan, Patricia C.; Sleeman, Matthew A.; Rebelatto, Marlon; Wang, Bing; Lu, Hong; Chen, Xiaomin; Wu, Chi-Yuan; Hinrichs, Mary Jane; Roskos, Lorin; Towers, Heidi; McKeever, Kathleen; Dixit, Rakesh

    2014-09-01

    Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters other than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys.

  20. Plasma Hazards and Acceptance for International Space Station Extravehicular Activities

    NASA Astrophysics Data System (ADS)

    Patton, Thomas

    2010-09-01

    Extravehicular activity(EVA) is accepted by NASA and other space faring agencies as a necessary risk in order to build and maintain a safe and efficient laboratory in space. EVAs are used for standard construction and as contingency operations to repair critical equipment for vehicle sustainability and safety of the entire crew in the habitable volume. There are many hazards that are assessed for even the most mundane EVA for astronauts, and the vast majority of these are adequately controlled per the rules of the International Space Station Program. The need for EVA repair and construction has driven acceptance of a possible catastrophic hazard to the EVA crewmember which cannot currently be controlled adequately. That hazard is electrical shock from the very environment in which they work. This paper describes the environment, causes and contributors to the shock of EVA crewmembers attributed to the ionospheric plasma environment in low Earth orbit. It will detail the hazard history, and acceptance process for the risk associated with these hazards that give assurance to a safe EVA. In addition to the hazard acceptance process this paper will explore other factors that go into the decision to accept a risk including criticality of task, hardware design and capability, and the probability of hazard occurrence. Also included will be the required interaction between organizations at NASA(EVA Office, Environments, Engineering, Mission Operations, Safety) in order to build and eventually gain adequate acceptance rationale for a hazard of this kind. During the course of the discussion, all current methods of mitigating the hazard will be identified. This paper will capture the history of the plasma hazard analysis and processes used by the International Space Station Program to formally assess and qualify the risk. The paper will discuss steps that have been taken to identify and perform required analysis of the floating potential shock hazard from the ISS environment

  1. 78 FR 3883 - The Bon-Ton Stores, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register...

  2. 76 FR 6453 - Raynor Marketing, Ltd., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... create an unreasonable risk of serious injury or death, and denies that it violated the...

  3. 75 FR 26939 - Target Corporation: Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in..., 2006, Target submitted a Full Report to CPSC containing information that it had commissioned...

  4. 76 FR 63906 - Henry Gordy International, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... their mouth, the dart can be inhaled into the throat and it can prevent the child from breathing....

  5. 77 FR 63801 - Aqua-Leisure Industries, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... filed a Supplemental Full Report in which it reported that the Firm had received at least 28...

  6. 77 FR 4023 - Hewlett-Packard Company, Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in.... Between March 2007 and April 2007, HP conducted a study, from which it obtained additional...

  7. 76 FR 49751 - Perfect Fitness, Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ... Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... death, and denies that it knowingly violated the reporting requirements of Section 15(b) of the CPSA,...

  8. 76 FR 49453 - CVS Pharmacy, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-10

    ... Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... knowingly violated the CPSA and asserts that at the time it sold the Jackets, CVS did not have...

  9. 78 FR 27190 - Williams-Sonoma, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in..., where it was hidden from view, there sometimes was no outward indication to consumers that the wood...

  10. How to pass a sensor acceptance test: using the gap between acceptance criteria and operational performance

    NASA Astrophysics Data System (ADS)

    Bijl, Piet

    2016-10-01

    When acquiring a new imaging system and operational task performance is a critical factor for success, it is necessary to specify minimum acceptance requirements that need to be met using a sensor performance model and/or performance tests. Currently, there exist a variety of models and test from different origin (defense, security, road safety, optometry) and they all do different predictions. This study reviews a number of frequently used methods and shows the effects that small changes in procedure or threshold criteria can have on the outcome of a test. For example, a system may meet the acceptance requirements but not satisfy the needs for the operational task, or the choice of test may determine the rank order of candidate sensors. The goal of the paper is to make people aware of the pitfalls associated with the acquisition process, by i) illustrating potential tricks to have a system accepted that is actually not suited for the operational task, and ii) providing tips to avoid this unwanted situation.

  11. Medication safety.

    PubMed

    Keohane, Carol A; Bates, David W

    2008-03-01

    Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

  12. From requirements to acceptance tests

    NASA Technical Reports Server (NTRS)

    Baize, Lionel; Pasquier, Helene

    1993-01-01

    From user requirements definition to accepted software system, the software project management wants to be sure that the system will meet the requirements. For the development of a telecommunication satellites Control Centre, C.N.E.S. has used new rules to make the use of tracing matrix easier. From Requirements to Acceptance Tests, each item of a document must have an identifier. A unique matrix traces the system and allows the tracking of the consequences of a change in the requirements. A tool has been developed, to import documents into a relational data base. Each record of the data base corresponds to an item of a document, the access key is the item identifier. Tracing matrix is also processed, providing automatically links between the different documents. It enables the reading on the same screen of traced items. For example one can read simultaneously the User Requirements items, the corresponding Software Requirements items and the Acceptance Tests.

  13. Defining acceptable conditions in wilderness

    NASA Astrophysics Data System (ADS)

    Roggenbuck, J. W.; Williams, D. R.; Watson, A. E.

    1993-03-01

    The limits of acceptable change (LAC) planning framework recognizes that forest managers must decide what indicators of wilderness conditions best represent resource naturalness and high-quality visitor experiences and how much change from the pristine is acceptable for each indicator. Visitor opinions on the aspects of the wilderness that have great impact on their experience can provide valuable input to selection of indicators. Cohutta, Georgia; Caney Creek, Arkansas; Upland Island, Texas; and Rattlesnake, Montana, wilderness visitors have high shared agreement that littering and damage to trees in campsites, noise, and seeing wildlife are very important influences on wilderness experiences. Camping within sight or sound of other people influences experience quality more than do encounters on the trails. Visitors’ standards of acceptable conditions within wilderness vary considerably, suggesting a potential need to manage different zones within wilderness for different clientele groups and experiences. Standards across wildernesses, however, are remarkably similar.

  14. States Respond to School Safety Concerns with 2013 Legislation. School Safety: 2013 Legislative Session

    ERIC Educational Resources Information Center

    Wixom, Micah Ann

    2014-01-01

    School safety policies are constantly evolving, often in response to fatal events. After several high-profile and tragic shootings over the past 15 years, school safety has become a major focus for parents, school officials, policymakers and the public nationwide. ECS [Education Commission of the States] conducted a scan of school safety-related…

  15. Metabolic profile and safety of piperlongumine

    PubMed Central

    de Lima Moreira, Fernanda; Habenschus, Maísa D.; Barth, Thiago; Marques, Lucas M. M.; Pilon, Alan Cesar; da Silva Bolzani, Vanderlan; Vessecchi, Ricardo; Lopes, Norberto P.; de Oliveira, Anderson R. M.

    2016-01-01

    Piperlongumine (PPL), a natural plant product, has been extensively studied in cancer treatment going up on clinical trials. Since the first report related to its use on cancer research (in 2011) around 80 papers have been published in less than 10 years, but a gap still remaining. There are no metabolism studies of PPL in human organism. For the lack of a better view, here, the CYP450 in vitro oxidation of PPL was described for the first time. In addition, the enzymatic kinetic data, the predicted in vivo parameters, the produced metabolites, the phenotyping study and possible piperlongumine-drug interactions in vivo is presented. PMID:27681015

  16. Solidifying Safety

    NASA Technical Reports Server (NTRS)

    Covault, Craig

    2003-01-01

    Contents include the following: 1. Solidifying Safety: NASA s new safety organization spools up, as the 1SS program grapples with long-term risk. 2. Earth to Orbit O'Keefe telling skeptical lawmakers Orbital Space Plan (OSP) will cover exploration vision. China's rapid pace.

  17. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  18. Lab Safety.

    ERIC Educational Resources Information Center

    West, Sandra S.

    1991-01-01

    In response to the Texas Hazardous Communication Act (THCA) of 1986 which raised many new health and liability issues regarding students in science laboratories, a laboratory safety survey was generated for use in evaluating laboratory safety. This article contains the easy-to-use survey. (ZWH)

  19. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

    Ned Miller does not take security lightly. As director of campus safety and emergency management at the Des Moines Area Community College (DMACC), any threat requires serious consideration. As community college administrators adopt a more proactive approach to campus safety, many institutions are experimenting with emerging technologies, including…

  20. [Validation and regulatory acceptance of alternative methods for toxicity evaluation].

    PubMed

    Ohno, Yasuo

    2004-01-01

    For regulatory acceptance of alternative methods (AMs) to animal toxicity tests, their reproducibility and relevance should be determined by intra- and inter-laboratory validation. Appropriate procedures of the validation and regulatory acceptance of AMs were recommended by OECD in 1996. According to those principles, several in vitro methods like skin corrosivity tests and phototoxicity tests were evaluated and accepted by ECVAM (European Center for the Validation of Alternative Methods), ICCVAM (The Interagency Coordinating Committee on the Validation of Alternative Methods), and OECD. Because of the difficulties in conducting inter-laboratory validation and relatively short period remained until EU's ban of animal experiments for safety evaluation of cosmetics, ECVAM and ICCVAM have recently started cooperation in validation and evaluation of AMs. It is also necessary to establish JaCVAM (Japanese Center for the Validation of AM) to contribute the issue and for the evaluation of new toxicity tests originated in Japan.

  1. Further Conceptualization of Treatment Acceptability

    ERIC Educational Resources Information Center

    Carter, Stacy L.

    2008-01-01

    A review and extension of previous conceptualizations of treatment acceptability is provided in light of progress within the area of behavior treatment development and implementation. Factors including legislation, advances in research, and service delivery models are examined as to their relationship with a comprehensive conceptualization of…

  2. Acceptance and Commitment Therapy: Introduction

    ERIC Educational Resources Information Center

    Twohig, Michael P.

    2012-01-01

    This is the introductory article to a special series in Cognitive and Behavioral Practice on Acceptance and Commitment Therapy (ACT). Instead of each article herein reviewing the basics of ACT, this article contains that review. This article provides a description of where ACT fits within the larger category of cognitive behavior therapy (CBT):…

  3. Nitrogen trailer acceptance test report

    SciTech Connect

    Kostelnik, A.J.

    1996-02-12

    This Acceptance Test Report documents compliance with the requirements of specification WHC-S-0249. The equipment was tested according to WHC-SD-WM-ATP-108 Rev.0. The equipment being tested is a portable contained nitrogen supply. The test was conducted at Norco`s facility.

  4. Imaginary Companions and Peer Acceptance

    ERIC Educational Resources Information Center

    Gleason, Tracy R.

    2004-01-01

    Early research on imaginary companions suggests that children who create them do so to compensate for poor social relationships. Consequently, the peer acceptance of children with imaginary companions was compared to that of their peers. Sociometrics were conducted on 88 preschool-aged children; 11 had invisible companions, 16 had personified…

  5. Euthanasia Acceptance: An Attitudinal Inquiry.

    ERIC Educational Resources Information Center

    Klopfer, Fredrick J.; Price, William F.

    The study presented was conducted to examine potential relationships between attitudes regarding the dying process, including acceptance of euthanasia, and other attitudinal or demographic attributes. The data of the survey was comprised of responses given by 331 respondents to a door-to-door interview. Results are discussed in terms of preferred…

  6. Helping Our Children Accept Themselves.

    ERIC Educational Resources Information Center

    Gamble, Mae

    1984-01-01

    Parents of a child with muscular dystrophy recount their reactions to learning of the diagnosis, their gradual acceptance, and their son's resistance, which was gradually lessened when he was provided with more information and treated more normally as a member of the family. (CL)

  7. Meal Replacement Mass Reduction and Integration Acceptability Study

    NASA Technical Reports Server (NTRS)

    Sirmons, T.; Cooper, M.; Douglas, G.; Barrett, A.; Richardson, M.; Arias, D.; Schneiderman, J.; Slack, K.; Ploutz-Snyder R.

    2016-01-01

    NASA, in planning for long duration missions, has an imperative to provide a food system with the necessary nutrition, acceptability, and safety to ensure sustainment of crew health and performance. The Orion Multi-Purpose Crew Vehicle (MPCV) and future exploration missions are mass constrained; therefore we are challenged to reduce the mass of the food system by 10% while maintaining safety, nutrition, and acceptability for exploration missions. Food bars have previously been used to supplement meals in the Skylab food system, indicating that regular consumption of bars will be acceptable. However, commercially available products do not meet the requirements for a full meal replacement in the spaceflight food system. The purpose of this task is to develop a variety of nutritionally balanced breakfast replacement bars, which meet spaceflight nutritional, microbiological, sensorial, and shelf-life requirements, while enabling a 10% food mass savings. To date, six nutrient-dense meal replacement bars have been developed, using both traditional methods of compression as well as novel ultrasonic compression technologies developed by Creative Resonance Inc. (Phoenix, AZ). All bars will be prioritized based on acceptability and the four top candidates will be evaluated in the Human Exploration Research Analog (HERA) to assess the frequency with which actual meal replacement options may be implemented. Specifically, overall impact to mood, satiety, dietary discomfort, and satisfaction with food will be analyzed to inform successful implementation strategies. In addition, these bars will be evaluated based on final product sensory acceptability, nutritional stability, qualitative stability of analytical measurements (i.e. water activity and texture), and microbiological compliance over two years of storage at room temperature and potential temperature abuse conditions to predict long-term acceptability. It is expected that this work will enable a successful meal

  8. NASA's Software Safety Standard

    NASA Technical Reports Server (NTRS)

    Ramsay, Christopher M.

    2007-01-01

    NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those

  9. Developing patient safety in dentistry.

    PubMed

    Pemberton, M N

    2014-10-01

    Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

  10. Nuclear power: Siting and safety

    SciTech Connect

    Openshaw, S.

    1986-01-01

    By 2030, half, or even two-thirds, of all electricity may be generated by nuclear power. Major reactor accidents are still expected to be rare occurrences, but nuclear safety is largely a matter of faith. Terrorist attacks, sabotage, and human error could cause a significant accident. Reactor siting can offer an additional, design-independent margin of safety. Remote geographical sites for new plants would minimize health risks, protect the industry from negative changes in public opinion concerning nuclear energy, and improve long-term public acceptance of nuclear power. U.K. siting practices usually do not consider the contribution to safety that could be obtained from remote sites. This book discusses the present trends of siting policies of nuclear power and their design-independent margin of safety.

  11. Systems safety including DOD standards

    NASA Astrophysics Data System (ADS)

    Layton, Donald M.

    The stated purpose of MIL STD 882B (1984), which is currently the basis of all U.S. DOD criteria in the field of systems safety design and analysis, is 'To provide uniform requirements for developing and implementing a system safety program of sufficient comprehensiveness to identify the hazards of a system, and to impose design requirements and management controls to prevent mishaps by eliminating hazards or reducing the associated risk to a level acceptable to the managing activity.' Attention is presently given to safety-related issues in material acquisition activities, as well as over the course of a system's life cycle, together with accounts of current hazard-analysis techniques, risk management and system-safety control methods, human factors, and the role of interfaces.

  12. Software safety

    NASA Technical Reports Server (NTRS)

    Leveson, Nancy

    1987-01-01

    Software safety and its relationship to other qualities are discussed. It is shown that standard reliability and fault tolerance techniques will not solve the safety problem for the present. A new attitude requires: looking at what you do NOT want software to do along with what you want it to do; and assuming things will go wrong. New procedures and changes to entire software development process are necessary: special software safety analysis techniques are needed; and design techniques, especially eliminating complexity, can be very helpful.

  13. Acceptability of reactors in space

    SciTech Connect

    Buden, D.

    1981-01-01

    Reactors are the key to our future expansion into space. However, there has been some confusion in the public as to whether they are a safe and acceptable technology for use in space. The answer to these questions is explored. The US position is that when reactors are the preferred technical choice, that they can be used safely. In fact, it does not appear that reactors add measurably to the risk associated with the Space Transportation System.

  14. Acceptability of reactors in space

    SciTech Connect

    Buden, D.

    1981-04-01

    Reactors are the key to our future expansion into space. However, there has been some confusion in the public as to whether they are a safe and acceptable technology for use in space. The answer to these questions is explored. The US position is that when reactors are the preferred technical choice, that they can be used safely. In fact, it dies not appear that reactors add measurably to the risk associated with the Space Transportation System.

  15. Solid waste burial grounds interim safety analysis

    SciTech Connect

    Saito, G.H.

    1994-10-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment.

  16. Sun Safety

    MedlinePlus

    ... Links Buttons and Badges Stay Informed Cancer Home Sun Safety Language: English Español (Spanish) Recommend on Facebook Tweet Share Compartir The sun’s ultraviolet (UV) rays can damage your skin in ...

  17. Consumer studies on sensory acceptability of boar taint: a review.

    PubMed

    Font-i-Furnols, Maria

    2012-12-01

    Boar taint can be found in meat from boars and affects consumer acceptability of pork. The aim of this review is: (1) to describe different aspects of the existing methodologies used in consumer studies when evaluating boar taint from a sensory point of view, (2) to draw conclusions on different studies regarding the acceptability of meat from entire males, and (3) to discuss a possible harmonization of the different aspects to be considered when performing consumer studies on boar taint. This paper focuses on different aspects of studies previously carried out such as the country of assessment, the location of the test, the cooking procedure, the type of meat samples evaluated, the attributes and scales used, consumer profile, the results obtained, and the effect of androstenone sensitivity of the consumers on boar meat acceptability. A discussion on the possibility of a harmonization of the different aspects is also performed and final remarks and considerations have been drawn.

  18. Space Station crew safety alternatives study. Volume 5: Space Station safety plan

    NASA Technical Reports Server (NTRS)

    Mead, G. H.; Peercy, R. L., Jr.; Raasch, R. F.

    1985-01-01

    The Space Station Safety Plan has been prepared as an adjunct to the subject contract final report, suggesting the tasks and implementation procedures to ensure that threats are addressed and resolution strategy options identified and incorporated into the space station program. The safety program's approach is to realize minimum risk exposure without levying undue design and operational constraints. Safety objectives and risk acceptances are discussed.

  19. Acceptance sampling using judgmental and randomly selected samples

    SciTech Connect

    Sego, Landon H.; Shulman, Stanley A.; Anderson, Kevin K.; Wilson, John E.; Pulsipher, Brent A.; Sieber, W. Karl

    2010-09-01

    We present a Bayesian model for acceptance sampling where the population consists of two groups, each with different levels of risk of containing unacceptable items. Expert opinion, or judgment, may be required to distinguish between the high and low-risk groups. Hence, high-risk items are likely to be identifed (and sampled) using expert judgment, while the remaining low-risk items are sampled randomly. We focus on the situation where all observed samples must be acceptable. Consequently, the objective of the statistical inference is to quantify the probability that a large percentage of the unsampled items in the population are also acceptable. We demonstrate that traditional (frequentist) acceptance sampling and simpler Bayesian formulations of the problem are essentially special cases of the proposed model. We explore the properties of the model in detail, and discuss the conditions necessary to ensure that required samples sizes are non-decreasing function of the population size. The method is applicable to a variety of acceptance sampling problems, and, in particular, to environmental sampling where the objective is to demonstrate the safety of reoccupying a remediated facility that has been contaminated with a lethal agent.

  20. Food safety: revising the statute.

    PubMed

    Kessler, D A

    1984-03-09

    There is increasing recognition that federal food safety laws and policies need to be revised. Congressional debate on proposed amendments to the Food, Drug, and Cosmetic Act has generated several different perspectives on how the food safety laws should be changed. Before a consensus can be reached, scientists, regulators, the food industry, and consumers will have to review such complex and controversial issues as the level of acceptable risk, the value of risk-benefit analysis, the proper role of independent scientific review, and the reliability of quantitative risk assessment.

  1. Monitoring product safety in the postmarketing environment.

    PubMed

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  2. Biological safety cabinetry.

    PubMed Central

    Kruse, R H; Puckett, W H; Richardson, J H

    1991-01-01

    The biological safety cabinet is the one piece of laboratory and pharmacy equipment that provides protection for personnel, the product, and the environment. Through the history of laboratory-acquired infections from the earliest published case to the emergence of hepatitis B and AIDS, the need for health care worker protection is described. A brief description with design, construction, function, and production capabilities is provided for class I and class III safety cabinets. The development of the high-efficiency particulate air filter provided the impetus for clean room technology, from which evolved the class II laminar flow biological safety cabinet. The clean room concept was advanced when the horizontal airflow clean bench was manufactured; it became popular in pharmacies for preparing intravenous solutions because the product was protected. However, as with infectious microorganisms and laboratory workers, individual sensitization to antibiotics and the advent of hazardous antineoplastic agents changed the thinking of pharmacists and nurses, and they began to use the class II safety cabinet to prevent adverse personnel reactions to the drugs. How the class II safety cabinet became the mainstay in laboratories and pharmacies is described, and insight is provided into the formulation of National Sanitation Foundation standard number 49 and its revisions. The working operations of a class II cabinet are described, as are the variations of the four types with regard to design, function, air velocity profiles, and the use of toxins. The main certification procedures are explained, with examples of improper or incorrect certifications. The required levels of containment for microorganisms are given. Instructions for decontaminating the class II biological safety cabinet of infectious agents are provided; unfortunately, there is no method for decontaminating the cabinet of antineoplastic agents. Images PMID:2070345

  3. Practical Differential Profiling

    SciTech Connect

    Schulz, M; De Supinski, B R

    2007-02-04

    Comparing performance profiles from two runs is an essential performance analysis step that users routinely perform. In this work we present eGprof, a tool that facilitates these comparisons through differential profiling inside gprof. We chose this approach, rather than designing a new tool, since gprof is one of the few performance analysis tools accepted and used by a large community of users. eGprof allows users to 'subtract' two performance profiles directly. It also includes callgraph visualization to highlight the differences in graphical form. Along with the design of this tool, we present several case studies that show how eGprof can be used to find and to study the differences of two application executions quickly and hence can aid the user in this most common step in performance analysis. We do this without requiring major changes on the side of the user, the most important factor in guaranteeing the adoption of our tool by code teams.

  4. Model of aircraft passenger acceptance

    NASA Technical Reports Server (NTRS)

    Jacobson, I. D.

    1978-01-01

    A technique developed to evaluate the passenger response to a transportation system environment is described. Reactions to motion, noise, temperature, seating, ventilation, sudden jolts and descents are modeled. Statistics are presented for the age, sex, occupation, and income distributions of the candidates analyzed. Values are noted for the relative importance of system variables such as time savings, on-time arrival, convenience, comfort, safety, the ability to read and write, and onboard services.

  5. Safety Profile of Pertuzumab With Trastuzumab and Docetaxel in Patients From Asia With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Results From the Phase III Trial CLEOPATRA

    PubMed Central

    Im, Young-Hyuck; Im, Seock-Ah; Chan, Valorie; Miles, David; Knott, Adam; Clark, Emma; Ross, Graham; Baselga, José

    2014-01-01

    Introduction. We report detailed safety analyses by geographic region from the phase III study CLEOPATRA with pertuzumab, trastuzumab, and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive first-line metastatic breast cancer. Patients and Methods. Patients received pertuzumab/placebo at 840 mg in cycle 1 and 420 mg in subsequent cycles, and trastuzumab at 8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycles; docetaxel was initiated at 75 mg/m2. All study drugs were given intravenously, 3 times weekly. Results. Docetaxel dose reductions below 75 mg/m2 were more common in patients from Asia (47.0%) than other regions (13.4%); docetaxel dose escalations to 100 mg/m2 were less frequent in Asia (2.4%) than other regions (18.7%). Rates of edema (26.1% and 5.4% for Asia and other regions, respectively), myalgia (42.3%, 14.7%), nail disorder (39.9%, 15.1%), febrile neutropenia (18.6%, 7.1%), upper respiratory tract infection (25.7%, 10.2%), decreased appetite (47.0%, 19.1%), and rash (44.3%, 22.0%) were at least twice as high in Asia as in other regions. Adverse events did not result in a reduction in the median number of study treatment cycles administered in patients from Asia. Efficacy analyses per region showed hazard ratios similar to those of the whole intention-to-treat (ITT) population for progression-free survival (ITT: 0.63; Asia: 0.68; other regions: 0.61) and overall survival (ITT: 0.66; Asia: 0.64; other regions: 0.66). Conclusion. Despite a higher proportion of docetaxel dose reductions in patients from Asia, survival benefits were comparable between regions. The benefit-risk profile of pertuzumab, trastuzumab, and docetaxel supports this regimen as the first-line therapy for patients with HER2-positive metastatic breast cancer from all geographic regions. PMID:24869931

  6. Nanodrugs: pharmacokinetics and safety

    PubMed Central

    Onoue, Satomi; Yamada, Shizuo; Chan, Hak-Kim

    2014-01-01

    To date, various nanodrug systems have been developed for different routes of administration, which include dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles. Nanodrug systems have been employed to improve the efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profile of pharmaceutical substances. In particular, functionalized nanodrug systems can offer enhanced bioavailability of orally taken drugs, prolonged half-life of injected drugs (by reducing immunogenicity), and targeted delivery to specific tissues. Thus, nanodrug systems might lower the frequency of administration while providing maximized pharmacological effects and minimized systemic side effects, possibly leading to better therapeutic compliance and clinical outcomes. In spite of these attractive pharmacokinetic advantages, recent attention has been drawn to the toxic potential of nanodrugs since they often exhibit in vitro and in vivo cytotoxicity, oxidative stress, inflammation, and genotoxicity. A better understanding of the pharmacokinetic and safety characteristics of nanodrugs and the limitations of each delivery option is necessary for the further development of efficacious nanodrugs with high therapeutic potential and a wide safety margin. This review highlights the recent progress in nanodrug system development, with a focus on the pharmacokinetic advantages and safety challenges. PMID:24591825

  7. System safety education focused on flight safety

    NASA Technical Reports Server (NTRS)

    Holt, E.

    1971-01-01

    The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

  8. Fire safety. Explosion safety - Handbook

    NASA Astrophysics Data System (ADS)

    Baratov, Anatolii Nikolaevich

    The physicochemical principles underlying combustion and explosion processes are examined, and the main fire and explosion safety characteristics of materials are reviewed with particular reference to the ignition limits of combustible mixtures, the minimal oxygen content that constitutes an explosion hazard, and the flash point and ignition temperatures. Fire-fighting and explosion suppression methods and equipment are described. The discussion also covers the efficiency of fire prevention measures and safety engineering in fire fighting.

  9. Heat exchanger, head and shell acceptance criteria

    SciTech Connect

    Lam, P.S.; Sindelar, R.L.

    1992-09-01

    Instability of postulated flaws in the head component of the heat exchanger could not produce a large break, equivalent to a DEGB in the PWS piping, due to the configuration of the head and restraint provided by the staybolts. Rather, leakage from throughwall flaws in the head would increase with flaw length with finite leakage areas that are bounded by a post-instability flaw configuration. Postulated flaws at instability in the shell of the heat exchanger or in the cooling water nozzles could produce a large break in the Cooling Water System (CWS) pressure boundary. An initial analysis of flaw stability for postulated flaws in the heat exchanger head was performed in January 1992. This present report updates that analysis and, additionally, provides acceptable flaw configurations to maintain defined structural or safety margins against flaw instability of the external pressure boundary components of the heat exchanger, namely the head, shell, and cooling water nozzles. Structural and flaw stability analyses of the heat exchanger tubes, the internal pressure boundary of the heat exchangers or interface boundary between the PWS and CWS, were previously completed in February 1992 as part of the heat exchanger restart evaluation and are not covered in this report.

  10. Predicting nurses' acceptance of radiofrequency identification technology.

    PubMed

    Norten, Adam

    2012-10-01

    The technology of radiofrequency identification allows for the scanning of radiofrequency identification-tagged objects and individuals without line-of-sight requirements. Healthcare organizations use radiofrequency identification to ensure the health and safety of patients and medical personnel and to uncover inefficiencies. Although the successful implementation of a system incorporating radiofrequency identification technologies requires acceptance and use of the technology, some nurses using radiofrequency identification in hospitals feel like "Big Brother" is watching them. This predictive study used a theoretical model assessing the effect of five independent variables: privacy concerns, attitudes, subjective norms, controllability, and self-efficacy, on a dependent variable, nurses' behavioral intention to use radiofrequency identification. A Web-based questionnaire containing previously validated questions was answered by 106 US RNs. Multiple linear regression showed that all constructs together accounted for 60% of the variance in nurses' intention to use radiofrequency identification. Of the predictors in the model, attitudes provided the largest unique contribution when the other predictors in the model were held constant; subjective norms also provided a unique contribution. Privacy concerns, controllability, and self-efficacy did not provide a significant contribution to nurses' behavioral intention to use radiofrequency identification.

  11. Axelrod model: accepting or discussing

    NASA Astrophysics Data System (ADS)

    Dybiec, Bartlomiej; Mitarai, Namiko; Sneppen, Kim

    2012-10-01

    Agents building social systems are characterized by complex states, and interactions among individuals can align their opinions. The Axelrod model describes how local interactions can result in emergence of cultural domains. We propose two variants of the Axelrod model where local consensus is reached either by listening and accepting one of neighbors' opinion or two agents discuss their opinion and achieve an agreement with mixed opinions. We show that the local agreement rule affects the character of the transition between the single culture and the multiculture regimes.

  12. [Somnology and occupational safety].

    PubMed

    Dorokhov, V B

    2013-01-01

    Somnology has saved up enough great volume of objective knowledge of negative effects of a lack of the sleep, the raised drowsiness and sleep pathologies for health of people and occupational safety to formulate this knowledge in the accessible form for a society and acceptance by the state of acts and the organizational actions preventing these negative effects. The necessity of the salvation of these problems has led to occurrence of a new area of occupational sleep medicine, which problem is the analysis of influence of physiological mechanisms ofa sleep and functioning circadian systems on efficiency of professional activity and health of people. For a designation of the various items causing infringements of professional work use the term fatique. It is believed that fatigue development is connected with three major factors: deficiency of a sleep - defined by duration of previous wakefulness and a sleep, time-of-day and at last, task-related factors. Within the limits of approaches developed the occupational sleep medicine had been formulated the Fatigue Risk Management System. In the Russian literature there is a lack of the information on influence of mechanisms of a sleep on occupational safety, therefore the review will be interesting to a wide range of the experts dealing with the analysis of the human factor, health and an occupational safety

  13. First Aid and Safety

    MedlinePlus

    ... First-Aid Kit Food Safety for Your Family Gun Safety Halloween Candy Hints Household Safety Checklists Household ... Climbing, and Grabbing Household Safety: Preventing Injuries From Firearms Household Safety: Preventing Injuries in the Crib Household ...

  14. Learning Style Profile: Examiner's Manual.

    ERIC Educational Resources Information Center

    Keefe, James W.; Monk, John S.

    This examiner's manual accompanies the Learning Style Profile (LSP), which measures cognitive skills as well as affective and environmental preferences. Charles Letteri's General Operations Model was accepted as the prototype for relating learning styles to cognitive information processing. The LSP was developed from 1983 to 1986; several versions…

  15. BWR AXIAL PROFILE

    SciTech Connect

    J. Huffer

    2004-09-28

    The purpose of this calculation is to develop axial profiles for estimating the axial variation in burnup of a boiling water reactor (BWR) assembly spent nuclear fuel (SNF) given the average burnup of an assembly. A discharged fuel assembly typically exhibits higher burnup in the center and lower burnup at the ends of the assembly. Criticality safety analyses taking credit for SNF burnup must account for axially varying burnup relative to calculations based on uniformly distributed assembly average burnup due to the under-burned tips. Thus, accounting for axially varying burnup in criticality analyses is also referred to as accounting for the ''end effect'' reactivity. The magnitude of the reactivity change due to ''end effect'' is dependent on the initial assembly enrichment, the assembly average burnup, and the particular axial profile characterizing the burnup distribution. The set of bounding axial profiles should incorporate multiple BWR core designs and provide statistical confidence (95 percent confidence that 95 percent of the population is bound by the profile) that end nodes are conservatively represented. The profiles should also conserve the overall burnup of the fuel assembly. More background on BWR axial profiles is provided in Attachment I.

  16. State Profiles.

    ERIC Educational Resources Information Center

    State-Federal Information Clearinghouse for Exceptional Children, Reston, VA.

    State-by-state public policy profiles are provided by the Council for Exceptional Children's State-Federal Information Clearinghouse. These profiles summarize the present legal base for the delivery of educational services to handicapped children in the United States. Included in each profile is information from various avenues used to establish…

  17. Mining Behavior Based Safety Data to Predict Safety Performance

    SciTech Connect

    Jeffrey C. Joe

    2010-06-01

    The Idaho National Laboratory (INL) operates a behavior based safety program called Safety Observations Achieve Results (SOAR). This peer-to-peer observation program encourages employees to perform in-field observations of each other's work practices and habits (i.e., behaviors). The underlying premise of conducting these observations is that more serious accidents are prevented from occurring because lower level “at risk” behaviors are identified and corrected before they can propagate into culturally accepted “unsafe” behaviors that result in injuries or fatalities. Although the approach increases employee involvement in safety, the premise of the program has not been subject to sufficient empirical evaluation. The INL now has a significant amount of SOAR data on these lower level “at risk” behaviors. This paper describes the use of data mining techniques to analyze these data to determine whether they can predict if and when a more serious accident will occur.

  18. Accepting managed aquifer recharge of urban storm water reuse: The role of policy-related factors

    NASA Astrophysics Data System (ADS)

    Mankad, Aditi; Walton, Andrea

    2015-12-01

    A between-groups experimental design examined public acceptance for managed aquifer recharge of storm water for indirect potable and nonpotable reuse; acceptance was based on five policy-related variables (fairness, effectiveness, trust, importance of safety assurances, and importance of communication activities). Results showed that public acceptance (N = 408) for managed aquifer recharge of storm water was higher for nonpotable applications, as was the importance of safety assurances. Analyses of variance also showed that perceptions of fairness and effectiveness were higher for a nonpotable scheme, but not trust. A three-step hierarchical regression (Step 1: age, gender, education, and income; Step 2: type of use; Step 3: fairness, effectiveness, trust, safety assurance, and communication activities) demonstrated that type of storm water use and the policy-related factors accounted for 73% of the variance in acceptance of storm water (R2 = 0.74, adjusted R2 = 0.74, F (10, 397) = 113.919, p < 0.001). Age, type of use, and three of the five policy-related factors were also significant individual predictors of acceptance. The most important predictors were perceptions of trust in water authorities, perceptions of effectiveness, and perceptions of fairness. Interestingly, while safety assurance was important in attitudinal acceptance of managed aquifer recharge based on type of use, safety assurance was not found to be significant predictor of acceptance. This research suggests that policy-makers should look to address matters of greater public importance and drive such as fairness, trust, and effectiveness of storm water programs and advocate these at the forefront of their policies, rather than solely on education campaigns.

  19. Safety First!

    ERIC Educational Resources Information Center

    Longfield, Judith

    2006-01-01

    In this article, the author relates how a hands-on chemistry investigation provided her the inspiration to develop an effective safety lesson for her third grade chemistry class. She began the lesson by demonstrating the use of pH indicator paper to show that ordinary household (white) vinegar was an acid. With the students, she wondered aloud…

  20. Art Safety.

    ERIC Educational Resources Information Center

    BCATA Journal for Art Teachers, 1991

    1991-01-01

    Advocating that Canadian art programs should use and model environmentally safe practices, the articles in this journal focus on issues of safe practices in art education. Articles are: (1) "What is WHMIS?"; (2) "Safety Precautions for Specific Art Processes"; (3) "Toxic Substances"; (4) "Using Clay, Glazes, and…

  1. Home Safety

    MedlinePlus

    ... in Pune (October 2015) Preventing accidental injuries to children in India. Video Changing the News with Neal McDonough: Fire Safety Together, we can change the news by learning simple, effective ways to prevent injuries to children due to fire. Infographic Escuche el Bip Donde ...

  2. Safety Resources.

    ERIC Educational Resources Information Center

    Hoot, James L.; Bartkowiak, Elaine T.

    1994-01-01

    Lists 72 organizations and programs that deal with child safety, grouped by the following categories: (1) general; (2) general violence; (3) gun violence; (4) media violence; (5) drugs and alcohol; (6) child abuse and at-risk children; (7) parenting programs; (8) community service programs; (9) leadership programs; (10) peer counseling; (11)…

  3. Studying Student Teachers' Acceptance of Role Responsibility.

    ERIC Educational Resources Information Center

    Davis, Michael D.; Davis, Concetta M.

    1980-01-01

    There is variance in the way in which student teachers accept responsibility for the teaching act. This study explains why some variables may affect student teachers' acceptance of role responsibilities. (CM)

  4. [Subjective well-being and self acceptance].

    PubMed

    Makino, Y; Tagami, F

    1998-06-01

    The purpose of the present study was to examine the relationship between subjective well-being and self acceptance, and to design a happiness self-writing program to increase self acceptance and subjective well-being of adolescents. In study 1, we examined the relationship between social interaction and self acceptance. In study 2, we created a happiness self-writing program in cognitive behavioral approach, and examined whether the program promoted self acceptance and subjective well-being. Results indicated that acceptance of self-openness, an aspect of self acceptance, was related to subjective well-being. The happiness self-writing program increased subjective well-being, but it was not found to have increased self acceptance. It was discussed why the program could promote subjective well-being, but not self acceptance.

  5. Alternative food safety intervention technologies: flash pasteurization of finfish

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Alternative nonthermal and thermal food safety interventions are gaining acceptance by the food processing industry and consumers. These technologies include high pressure processing, ultraviolet and pulsed light, ionizing radiation, pulsed and radiofrequency electric fields, cold atmospheric plasm...

  6. Project W-030 safety class upgrade summary report

    SciTech Connect

    Kriskovich, J.R.

    1998-02-13

    This document presents a summary of safety class criteria for the 241-AY/AZ Tank Farm primary ventilation system upgrade under Project W-030, and recommends acceptance of the system as constructed, based on a review of supporting documentation.

  7. Formulation factors affecting acceptability of oral medicines in children.

    PubMed

    Liu, Fang; Ranmal, Sejal; Batchelor, Hannah K; Orlu-Gul, Mine; Ernest, Terry B; Thomas, Iwan W; Flanagan, Talia; Kendall, Richard; Tuleu, Catherine

    2015-08-15

    Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required to demonstrate acceptability of new paediatric formulations in target age groups as an integrated part of the development of these products (Kozarewicz, 2014). Two questions arise when trying to tackle this task: "which dosage form to choose for each target age group?" and "how to formulate it once the dosage form is decided?". Inevitably, both the regulator and the developer turn to scientific evidence for answers. Research has emerged in recent years to demonstrate age-appropriateness and patient acceptability of different dosage forms; however, such information is still fragmented and far from satisfactory to define efficient formulation development strategies for a diverse patient subset (Ranmal and Tuleu, 2013). This paper highlights how formulation factors affect the acceptability of different oral medicines in children (Table 1), and it is based on a more extensive review article by Liu et al. (Liu et al., 2014). Gaps in knowledge are highlighted in order to stimulate further research. In some areas, findings from studies conducted in adult populations may provide useful guidance for paediatric development and this is also discussed.

  8. Vehicle Battery Safety Roadmap Guidance

    SciTech Connect

    Doughty, D. H.

    2012-10-01

    The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

  9. Public Acceptance for Geological CO2-Storage

    NASA Astrophysics Data System (ADS)

    Schilling, F.; Ossing, F.; Würdemann, H.; Co2SINK Team

    2009-04-01

    Public acceptance is one of the fundamental prerequisites for geological CO2 storage. In highly populated areas like central Europe, especially in the vicinity of metropolitan areas like Berlin, underground operations are in the focus of the people living next to the site, the media, and politics. To gain acceptance, all these groups - the people in the neighbourhood, journalists, and authorities - need to be confident of the security of the planned storage operation as well as the long term security of storage. A very important point is to show that the technical risks of CO2 storage can be managed with the help of a proper short and long term monitoring concept, as well as appropriate mitigation technologies e.g adequate abandonment procedures for leaking wells. To better explain the possible risks examples for leakage scenarios help the public to assess and to accept the technical risks of CO2 storage. At Ketzin we tried the following approach that can be summed up on the basis: Always tell the truth! This might be self-evident but it has to be stressed that credibility is of vital importance. Suspiciousness and distrust are best friends of fear. Undefined fear seems to be the major risk in public acceptance of geological CO2-storage. Misinformation and missing communication further enhance the denial of geological CO2 storage. When we started to plan and establish the Ketzin storage site, we ensured a forward directed communication. Offensive information activities, an information centre on site, active media politics and open information about the activities taking place are basics. Some of the measures were: - information of the competent authorities through meetings (mayor, governmental authorities) - information of the local public, e.g. hearings (while also inviting local, regional and nation wide media) - we always treated the local people and press first! - organizing of bigger events to inform the public on site, e.g. start of drilling activities (open

  10. The Heart of Change: Acceptance and Intimacy Mediate Treatment Response in a Brief Couples Intervention

    PubMed Central

    Hawrilenko, Matt; Gray, Tatiana D.; Cordova, James V.

    2015-01-01

    This study examined mediators of a brief couples intervention. Intimate safety, acceptance, and activation were examined in two roles: their contribution to marital satisfaction gains in the first two weeks after treatment (contemporaneous effects), and how early changes in the mediators influenced longer-term changes in marital satisfaction over two years of follow-up (lagged effects). Married couples (N = 215) were randomized to intervention or wait-list control and followed for two years. Latent change score models were used to examine contemporaneous and time-lagged mediation. A booster intervention in the second year was used for a replication study. Changes in intimate safety and acceptance were uniquely associated with contemporaneous treatment effects on relationship satisfaction in year one, but only acceptance was uniquely associated with contemporaneous effects in year two. With respect to lagged effects, early changes in acceptance partially mediated later changes in marital satisfaction in year one, whereas the same effect for intimate safety was marginally significant. These lagged paths were moderate in size and indirect effects were small. No lagged effects were significant in year two. Changes in activation were not significant as either a contemporaneous or lagged predictor of changes in relationship satisfaction. This study found moderate support for acceptance and more limited support for intimate safety as mediators of short and long-term treatment response, suggesting that these processes play an important role in sustaining marital health. PMID:26524618

  11. Safety climate in OHSAS 18001-certified organisations: antecedents and consequences of safety behaviour.

    PubMed

    Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

    2012-03-01

    The occupational health and safety standard OHSAS 18001 has gained considerable acceptance worldwide, and firms from diverse sectors and of varying sizes have implemented it. Despite this, very few studies have analysed safety management or the safety climate in OHSAS 18001-certified organisations. The current work aims to analyse the safety climate in these organisations, identify its dimensions, and propose and test a structural equation model that will help determine the antecedents and consequences of employees' safety behaviour. For this purpose, the authors carry out an empirical study using a sample of 131 OHSAS 18001-certified organisations located in Spain. The results show that management's commitment, and particularly communication, have an effect on safety behaviour and on safety performance, employee satisfaction, and firm competitiveness. These findings are particularly important for management since they provide evidence about the factors that should be encouraged to reduce risks and improve performance in this type of organisation.

  12. Death Attitudes Across the Life-Span: The Development and Validation of the Death Attitude Profile (DAP).

    ERIC Educational Resources Information Center

    Gesser, Gina; And Others

    1988-01-01

    The Death Attitude Profile was developed and four orthogonal factors were identified: Fear of Death/Dying, Approach-Oriented Death Acceptance, Escape-Oriented Death Acceptance, and Neutral Death Acceptance. An elderly sample (N=50) showed less fear of death and more acceptance (all three kinds of acceptance) than did middle aged (N=50) and young…

  13. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  14. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  15. Older Adults' Acceptance of Information Technology

    ERIC Educational Resources Information Center

    Wang, Lin; Rau, Pei-Luen Patrick; Salvendy, Gavriel

    2011-01-01

    This study investigated variables contributing to older adults' information technology acceptance through a survey, which was used to find factors explaining and predicting older adults' information technology acceptance behaviors. Four factors, including needs satisfaction, perceived usability, support availability, and public acceptance, were…

  16. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 1 2011-10-01 2011-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  17. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 1 2014-10-01 2014-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  18. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 1 2013-10-01 2013-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  19. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 1 2012-10-01 2012-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  20. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  1. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... offered have either achieved commercial market acceptance or been satisfactorily supplied to an agency... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance....

  2. 21 CFR 820.86 - Acceptance status.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Acceptance status. 820.86 Section 820.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Acceptance Activities § 820.86 Acceptance status. Each manufacturer...

  3. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  4. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) 41 U.S...) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an agency under current...

  5. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Market acceptance. 2911.103... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  6. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  7. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  8. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  9. The relation between remembered parental acceptance in childhood and self-acceptance among young Turkish adults.

    PubMed

    Kuyumcu, Behire; Rohner, Ronald P

    2016-05-11

    This study examined the relation between young adults' age and remembrances of parental acceptance in childhood, and their current self-acceptance. The study was based on a sample of 236 young adults in Turkey (139 women and 97 men). The adult version of the Parental Acceptance-Rejection/Control Questionnaire for mothers and fathers along with the Self-Acceptance subscale of the Psychological Well-Being Scale, and the Personal Information Form were used as measures. Results showed that both men and women tended to remember having been accepted in childhood by both their mothers and fathers. Women, however, reported more maternal and paternal acceptance in childhood than did men. Similarly, the level of self-acceptance was high among both men and women. However, women's self-acceptance was higher than men's. Correlational analyses showed that self-acceptance was positively related to remembrances of maternal and paternal acceptance among both women and men. Results indicated that age and remembered paternal acceptance significantly predicted women's self-acceptance. Age and remembered maternal acceptance made significant and independent contributions to men's self-acceptance. Men's remembrances of paternal acceptance in childhood did not make significant contribution to their self-acceptance. Finally, the relation between women's age and self-acceptance was significantly moderated by remembrances of paternal acceptance in childhood.

  10. Effectiveness and relevance of MR acceptance testing: results of an 8 year audit.

    PubMed

    McRobbie, D W; Quest, R A

    2002-06-01

    The effectiveness and relevance of independent acceptance testing was assessed by means of an audit of acceptance procedures for 17 MRI systems, with field strengths in the range 0.5-1.5 T, acquired over 8 years. Signal-to-noise ratio and geometric linearity were found to be the image quality parameters most likely to fall below acceptable or expected standards. These received confirmed successful corrective action in 69% of instances. Non-uniformity, ghosting and poor fat suppression were the next most common non-compliant parameters, but yielded less satisfactory outcomes. Spatial resolution was not found to be a sensitive parameter in determining acceptability. 49% of all non-compliant parameters received verifiable corrective attention. A schedule of actual acceptance criteria is presented and shown to be reasonable. Parameter failure rates were shown not to have improved with time. A safety audit of 11 of the installations revealed the most common failings to be inadequate suite layout and poor use of signs. The mean number of safety issues per installation identified as requiring attention was 5, from a questionnaire of 100 points. A number of anecdotal errors and omissions are reported. The data support the importance of an appropriate acceptance procedure for new clinical MRI equipment and for the involvement of a suitably qualified safety adviser on the project team from the outset.

  11. Meal Replacement Mass Reduction and Integration Acceptability Study

    NASA Technical Reports Server (NTRS)

    Sirmons, T.; Barrett, A.; Richardson, M.; Arias, D.; Schneiderman, J.; Slack, K.; Williams, T.; Douglas, G.

    2017-01-01

    NASA, in planning for long-duration missions, has an imperative to provide a food system with the necessary nutrition, acceptability, and safety to ensure sustainment of crew health and performance. The Orion Multi-Purpose Crew Vehicle (MPCV) and future exploration missions are mass constrained; therefore the team is challenged to reduce the mass of the food system by 10% while maintaining product safety, nutrition, and acceptability. Commercially available products do not meet the nutritional requirements for a full meal replacement in the spaceflight food system, and it is currently unknown if daily meal replacements will impact crew food intake and psychosocial health over time. The purpose of this study was to develop a variety of nutritionally balanced breakfast replacement bars that meet spaceflight nutritional, microbiological, sensorial, and shelf-life requirements, while enabling a 10% savings in food mass. To date, six nutrient-dense meal replacement bars (approximately 700 calories per bar) have been developed, using traditional methods of compression as well as novel ultrasonic compression technologies developed by Creative Resonance Inc. (Phoenix, AZ). The four highest rated bars were evaluated in the Human Exploration Research Analog (HERA) to assess the frequency with which actual meal replacement options may be implemented. Specifically, overall impact of bars on mood, satiety, digestive discomfort, and satisfaction with food. These factors are currently being analyzed to inform successful implementation strategies where crew maintain adequate food intake. In addition, these bars are currently undergoing shelf-life testing to determine long-term sensory acceptability, nutritional stability, qualitative stability of analytical measurements (i.e. water activity and texture), and microbiological compliance over two years of storage at room temperature and potential temperature abuse conditions to predict long-term acceptability. It is expected that

  12. World Market Development and Consumer Acceptance of Irradiation Technology

    PubMed Central

    Maherani, Behnoush; Hossain, Farah; Criado, Paula; Ben-Fadhel, Yosra; Salmieri, Stephane; Lacroix, Monique

    2016-01-01

    Food irradiation is an efficient technology that can be used to ensure food safety by eliminating insects and pathogens to prolong the shelf life. The process could be applied to fresh or frozen products without affecting the nutritional value. Presently more than 60 countries have adopted the technology. However, the technology adaptation differs from one country to another and, in some cases, consumers’ misunderstanding and lack of acceptance may hinder the technology adaptation process. This review summarizes the development of irradiation treatment worldwide and consumer attitudes towards the introduction of this technology. Also, the wholesomeness, beneficial effects, and regulation of irradiation are assessed. PMID:28231173

  13. Surface moisture measurement system hardware acceptance test report

    SciTech Connect

    Ritter, G.A., Westinghouse Hanford

    1996-05-28

    This document summarizes the results of the hardware acceptance test for the Surface Moisture Measurement System (SMMS). This test verified that the mechanical and electrical features of the SMMS functioned as designed and that the unit is ready for field service. The bulk of hardware testing was performed at the 306E Facility in the 300 Area and the Fuels and Materials Examination Facility in the 400 Area. The SMMS was developed primarily in support of Tank Waste Remediation System (TWRS) Safety Programs for moisture measurement in organic and ferrocyanide watch list tanks.

  14. World Market Development and Consumer Acceptance of Irradiation Technology.

    PubMed

    Maherani, Behnoush; Hossain, Farah; Criado, Paula; Ben-Fadhel, Yosra; Salmieri, Stephane; Lacroix, Monique

    2016-11-24

    Food irradiation is an efficient technology that can be used to ensure food safety by eliminating insects and pathogens to prolong the shelf life. The process could be applied to fresh or frozen products without affecting the nutritional value. Presently more than 60 countries have adopted the technology. However, the technology adaptation differs from one country to another and, in some cases, consumers' misunderstanding and lack of acceptance may hinder the technology adaptation process. This review summarizes the development of irradiation treatment worldwide and consumer attitudes towards the introduction of this technology. Also, the wholesomeness, beneficial effects, and regulation of irradiation are assessed.

  15. 76 FR 48808 - Black & Decker (U.S.) Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ...: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in... defects in its Grasshog XP spool cover in December 2005. It modified the defective spool...

  16. Safety harness

    SciTech Connect

    Gunter, L.W.

    1991-04-08

    A safety harness to be worn by a worker, especially a worker wearing a plastic suit thereunder for protection in a radioactive or chemically hostile environment. The safety harness comprises a torso surrounding portion with at least one horizontal strap for adjustably securing the harness about the torso, two vertical shoulder straps with rings just forward of the of the peak of the shoulders for attaching a life-line and a pair of adjustable leg supporting straps releasibly attachable to the torso surrounding portion. In the event of a fall, the weight of the worker, when his fall is broken and he is suspended from the rings with his body angled slightly back and chest up, will be borne by the portion of the leg straps behind his buttocks rather than between his legs. Furthermore, the supporting straps do not restrict the air supplied through hoses into his suit when so suspended.

  17. Safety harness

    DOEpatents

    Gunter, Larry W.

    1993-01-01

    A safety harness to be worn by a worker, especially a worker wearing a plastic suit thereunder for protection in a radioactive or chemically hostile environment, which safety harness comprises a torso surrounding portion with at least one horizontal strap for adjustably securing the harness about the torso, two vertical shoulder straps with rings just forward of the of the peak of the shoulders for attaching a life-line and a pair of adjustable leg supporting straps releasibly attachable to the torso surrounding portion. In the event of a fall, the weight of the worker, when his fall is broken and he is suspended from the rings with his body angled slightly back and chest up, will be borne by the portion of the leg straps behind his buttocks rather than between his legs. Furthermore, the supporting straps do not restrict the air supplied through hoses into his suit when so suspended.

  18. Multi-discipline Waste Acceptance Process at the Nevada National Security Site - 13573

    SciTech Connect

    Carilli, Jhon T.; Krenzien, Susan K.

    2013-07-01

    The Nevada National Security Site low-level radioactive waste disposal facility acceptance process requires multiple disciplines to ensure the protection of workers, the public, and the environment. These disciplines, which include waste acceptance, nuclear criticality, safety, permitting, operations, and performance assessment, combine into the overall waste acceptance process to assess low-level radioactive waste streams for disposal at the Area 5 Radioactive Waste Management Site. Four waste streams recently highlighted the integration of these disciplines: the Oak Ridge Radioisotope Thermoelectric Generators and Consolidated Edison Uranium Solidification Project material, West Valley Melter, and classified waste. (authors)

  19. Safety Checklists

    DTIC Science & Technology

    1987-01-01

    all rags, waste, etc., soiled by combustible or flaxmable materials kept In tightly rnosed metal containers for daily disposal? 3. Are fire plans ...To prevent cold weather injuries, does the cowmander ensure that: (TBMad 81, pars, 5) a. Safety is included in planning ? b. Suitable cold weather gear...pages 2-2 thru 2-6) 2. Are prior planning and coordination of sling load operations always accomplished between the ground crews and aviation crews

  20. Safety valve

    DOEpatents

    Bergman, Ulf C.

    1984-01-01

    The safety valve contains a resilient gland to be held between a valve seat and a valve member and is secured to the valve member by a sleeve surrounding the end of the valve member adjacent to the valve seat. The sleeve is movable relative to the valve member through a limited axial distance and a gap exists between said valve member and said sleeve.

  1. Acceptability of GM foods among Pakistani consumers.

    PubMed

    Ali, Akhter; Rahut, Dil Bahadur; Imtiaz, Muhammad

    2016-04-02

    In Pakistan majority of the consumers do not have information about genetically modified (GM) foods. In developing countries particularly in Pakistan few studies have focused on consumers' acceptability about GM foods. Using comprehensive primary dataset collected from 320 consumers in 2013 from Pakistan, this study analyzes the determinants of consumers' acceptability of GM foods. The data was analyzed by employing the bivariate probit model and censored least absolute deviation (CLAD) models. The empirical results indicated that urban consumers are more aware of GM foods compared to rural consumers. The acceptance of GM foods was more among females' consumers as compared to male consumers. In addition, the older consumers were more willing to accept GM food compared to young consumers. The acceptability of GM foods was also higher among wealthier households. Low price is the key factor leading to the acceptability of GM foods. The acceptability of the GM foods also reduces the risks among Pakistani consumers.

  2. Consumer Acceptability of Intramuscular Fat

    PubMed Central

    Frank, Damian; Joo, Seon-Tea

    2016-01-01

    Fat in meat greatly improves eating quality, yet many consumers avoid visible fat, mainly because of health concerns. Generations of consumers, especially in the English-speaking world, have been convinced by health authorities that animal fat, particularly saturated or solid fat, should be reduced or avoided to maintain a healthy diet. Decades of negative messages regarding animal fats has resulted in general avoidance of fatty cuts of meat. Paradoxically, low fat or lean meat tends to have poor eating quality and flavor and low consumer acceptability. The failure of low-fat high-carbohydrate diets to curb “globesity” has prompted many experts to re-evaluate of the place of fat in human diets, including animal fat. Attitudes towards fat vary dramatically between and within cultures. Previous generations of humans sought out fatty cuts of meat for their superior sensory properties. Many consumers in East and Southeast Asia have traditionally valued more fatty meat cuts. As nutritional messages around dietary fat change, there is evidence that attitudes towards animal fat are changing and many consumers are rediscovering and embracing fattier cuts of meat, including marbled beef. The present work provides a short overview of the unique sensory characteristics of marbled beef and changing consumer preferences for fat in meat in general. PMID:28115880

  3. Primary battery design and safety guidelines handbook

    NASA Technical Reports Server (NTRS)

    Bragg, Bobby J.; Casey, John E.; Trout, J. Barry

    1994-01-01

    This handbook provides engineers and safety personnel with guidelines for the safe design or selection and use of primary batteries in spaceflight programs. Types of primary batteries described are silver oxide zinc alkaline, carbon-zinc, zinc-air alkaline, manganese dioxide-zionc alkaline, mercuric oxide-zinc alkaline, and lithium anode cells. Along with typical applications, the discussions of the individual battery types include electrochemistry, construction, capacities and configurations, and appropriate safety measures. A chapter on general battery safety covers hazard sources and controls applicable to all battery types. Guidelines are given for qualification and acceptance testing that should precede space applications. Permissible failure levels for NASA applications are discussed.

  4. Department of Energy Construction Safety Reference Guide

    SciTech Connect

    Not Available

    1993-09-01

    DOE has adopted the Occupational Safety and Health Administration (OSHA) regulations Title 29 Code of Federal Regulations (CFR) 1926 ``Safety and Health Regulations for Construction,`` and related parts of 29 CFR 1910, ``Occupational Safety and Health Standards.`` This nonmandatory reference guide is based on these OSHA regulations and, where appropriate, incorporates additional standards, codes, directives, and work practices that are recognized and accepted by DOE and the construction industry. It covers excavation, scaffolding, electricity, fire, signs/barricades, cranes/hoists/conveyors, hand and power tools, concrete/masonry, stairways/ladders, welding/cutting, motor vehicles/mechanical equipment, demolition, materials, blasting, steel erection, etc.

  5. Primary battery design and safety guidelines handbook

    NASA Astrophysics Data System (ADS)

    Bragg, Bobby J.; Casey, John E.; Trout, J. Barry

    1994-12-01

    This handbook provides engineers and safety personnel with guidelines for the safe design or selection and use of primary batteries in spaceflight programs. Types of primary batteries described are silver oxide zinc alkaline, carbon-zinc, zinc-air alkaline, manganese dioxide-zionc alkaline, mercuric oxide-zinc alkaline, and lithium anode cells. Along with typical applications, the discussions of the individual battery types include electrochemistry, construction, capacities and configurations, and appropriate safety measures. A chapter on general battery safety covers hazard sources and controls applicable to all battery types. Guidelines are given for qualification and acceptance testing that should precede space applications. Permissible failure levels for NASA applications are discussed.

  6. Acceptance in Romantic Relationships: The Frequency and Acceptability of Partner Behavior Inventory

    ERIC Educational Resources Information Center

    Doss, Brian D.; Christensen, Andrew

    2006-01-01

    Despite the recent emphasis on acceptance in romantic relationships, no validated measure of relationship acceptance presently exists. To fill this gap, the 20-item Frequency and Acceptability of Partner Behavior Inventory (FAPBI; A. Christensen & N. S. Jacobson, 1997) was created to assess separately the acceptability and frequency of both…

  7. 24 CFR 203.202 - Plan acceptability and acceptance renewal criteria-general.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUD acceptance of such change or modification, except that changes mandated by other applicable laws... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Plan acceptability and acceptance... Underwriting Procedures Insured Ten-Year Protection Plans (plan) § 203.202 Plan acceptability and...

  8. Efficacy and safety of deferasirox in myelodysplastic syndromes.

    PubMed

    Breccia, Massimo; Alimena, Giuliana

    2013-07-01

    Transfusion dependence in myelodysplastic syndrome (MDS) patients may lead to organ damage due to accumulation of non-transferrin-bound iron with consequent increased oxidative stress. Iron chelation has been reported in retrospective studies to improve overall survival in low-risk MDS patients, but this information needs to be validated in prospective trials. The oral iron chelator, deferasirox, has been shown to reduce serum ferritin levels in chelation naïve and pre-treated patients and to reduce labile plasma iron, independently from the efficacy on iron overload. Deferasirox is a potent NF-kB inhibitor, tested in vivo and on acute myeloid leukemia and MDS cell lines, and this effect may explain in part the phenomenon of hematological improvements reported in case reports and in different clinical trials. The drug has an acceptable safety profile, with the most common side effects reported being non-progressive change in serum creatinine level, gastrointestinal disturbances, and skin rash. In this review, we report the results of different studies testing safety and efficacy of deferasirox in MDS patients, side effects associated with the drug, and suggested management of iron overload.

  9. Payload safety requirements

    NASA Technical Reports Server (NTRS)

    Scheller, J.

    1979-01-01

    Space Shuttle payload safety requirements are summarized. Consideration is given to NASA objectives on STS payloads, payload safety documents, STS payload safety management, safety implementation possibilities, the hazard control procedure, and significant technical requirements.

  10. Safety and Liability.

    ERIC Educational Resources Information Center

    Berthelot, Ronald J.; And Others

    1982-01-01

    This series of five articles highlights Pensacola Junior College's occupational safety course, involving simulated emergencies, Florida's standards for teacher liability, electrical safety in the classroom and laboratory, color coding for machine safety, and Florida industrial arts safety instructional materials. (SK)

  11. An Essay: The Culture of Safety.

    ERIC Educational Resources Information Center

    Watters, Ron

    Any outdoor educator knows about rules. Outdoor educators spend a considerable amount of time at conferences talking about them: risk management plans, accepted safety practices, and first aid protocols. You name it, they've got a rule. When a Buddhist friend asked if rules really made programs safer, the author's first response was yes. His…

  12. 77 FR 48506 - CPSC Safety Academy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... Fast-Track process. These discussions will be held in a panel format, with a brief question and answer... 6b''; or ``Fast-Track Process--Compliance.'' An official of the General Administration of Quality... speak. If the invitation is accepted, the schedule will be adjusted accordingly. The CPSC Safety...

  13. Plutonium Finishing Plant safety evaluation report

    SciTech Connect

    Not Available

    1995-01-01

    The Plutonium Finishing Plant (PFP) previously known as the Plutonium Process and Storage Facility, or Z-Plant, was built and put into operation in 1949. Since 1949 PFP has been used for various processing missions, including plutonium purification, oxide production, metal production, parts fabrication, plutonium recovery, and the recovery of americium (Am-241). The PFP has also been used for receipt and large scale storage of plutonium scrap and product materials. The PFP Final Safety Analysis Report (FSAR) was prepared by WHC to document the hazards associated with the facility, present safety analyses of potential accident scenarios, and demonstrate the adequacy of safety class structures, systems, and components (SSCs) and operational safety requirements (OSRs) necessary to eliminate, control, or mitigate the identified hazards. Documented in this Safety Evaluation Report (SER) is DOE`s independent review and evaluation of the PFP FSAR and the basis for approval of the PFP FSAR. The evaluation is presented in a format that parallels the format of the PFP FSAR. As an aid to the reactor, a list of acronyms has been included at the beginning of this report. The DOE review concluded that the risks associated with conducting plutonium handling, processing, and storage operations within PFP facilities, as described in the PFP FSAR, are acceptable, since the accident safety analyses associated with these activities meet the WHC risk acceptance guidelines and DOE safety goals in SEN-35-91.

  14. Oakland County Science Safety Series: Reference Guide for Biology.

    ERIC Educational Resources Information Center

    Bury, Dan; And Others

    This reference guide is designed to organize and suggest acceptable practices and procedures for dealing with safety in the area of biology instruction. It is intended as a reference for teachers, administrators, and other school staff in planning for science activities and in making daily safety decisions. Discussions deal with responsibility for…

  15. Oakland County Science Safety Series: Reference Guide for Elementary Science.

    ERIC Educational Resources Information Center

    Crowder, Betty Pogue; And Others

    This reference guide is designed to organize and suggest acceptable practices and procedures for dealing with safety in elementary science instruction. It is intended as a reference for teachers, administrators, and other school staff in planning for science activities and in making daily safety decisions. Topics covered in the guide include: (1)…

  16. Application of food and feed safety assessment principles to evaluate transgenic approaches to gene modulation in crops.

    PubMed

    Parrott, Wayne; Chassy, Bruce; Ligon, Jim; Meyer, Linda; Petrick, Jay; Zhou, Junguo; Herman, Rod; Delaney, Bryan; Levine, Marci

    2010-07-01

    New crop varieties containing traits such as enhanced nutritional profiles, increased yield, and tolerance to drought are being developed. In some cases, these new traits are dependent on small RNAs or regulatory proteins such as transcription factors (TF) that modify the expression of endogenous plant genes. To date, the food and feed safety of genetically modified (GM) crops has been assessed by the application of a set of internationally accepted procedures for evaluating the safety of GM crops. The goal of this paper is to review the main aspects of the current safety assessment paradigm and to recommend scientifically sound principles for conducting a safety assessment for GM crops that are developed by technologies that modify endogenous plant gene expression. Key considerations for such a safety assessment include the following: (1) RNA and TF are generally recognized as safe (GRAS); (2) Genes encoding RNAi and regulatory proteins such as TFs are an important component of the plantgenome; (3) Crops engineered using RNAi modifications are not expected to produce heterologous proteins; (4) The modulation of TFs may result in quantitative differences in endogenous plant components,which can be assessed through agronomic performance and compositional analysis on a caseby-case basis.

  17. Chemical process safety at fuel cycle facilities

    SciTech Connect

    Ayres, D.A.

    1997-08-01

    This NUREG provides broad guidance on chemical safety issues relevant to fuel cycle facilities. It describes an approach acceptable to the NRC staff, with examples that are not exhaustive, for addressing chemical process safety in the safe storage, handling, and processing of licensed nuclear material. It expounds to license holders and applicants a general philosophy of the role of chemical process safety with respect to NRC-licensed materials; sets forth the basic information needed to properly evaluate chemical process safety; and describes plausible methods of identifying and evaluating chemical hazards and assessing the adequacy of the chemical safety of the proposed equipment and facilities. Examples of equipment and methods commonly used to prevent and/or mitigate the consequences of chemical incidents are discussed in this document.

  18. Safety Grooving

    NASA Technical Reports Server (NTRS)

    1985-01-01

    Safety grooving, the cutting of grooves in concrete to increase traction and prevent injury, was first developed to reduce aircraft accidents on wet runways. Represented by the International Grooving and Grinding Association (IG&GA), the industry expanded into highway and pedestrian applications. The technique originated at Langley, which assisted in testing the grooving at airports and on highways. Skidding was reduced, stopping distance decreased, and a vehicle's cornering ability on curves was increased. The process has been extended to animal holding pens, steps, parking lots and other potentially slippery surfaces.

  19. Environmental Restoration Disposal Facility (Project W-296) Safety Assessment

    SciTech Connect

    Armstrong, D.L.

    1994-08-01

    This Safety Assessment is based on information derived from the Conceptual Design Report for the Environmental Restoration Disposal Facility (DOE/RL 1994) and ancillary documentation developed during the conceptual design phase of Project W-296. The Safety Assessment has been prepared to support the Solid Waste Burial Ground Interim Safety Basis document. The purpose of the Safety Assessment is to provide an evaluation of the design to determine if the process, as proposed, will comply with US Department of Energy (DOE) Limits for radioactive and hazardous material exposures and be acceptable from an overall health and safety standpoint. The evaluation considered affects on the worker, onsite personnel, the public, and the environment.

  20. 49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 3 2014-10-01 2014-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance...

  1. 49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance...

  2. 49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance...

  3. 49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance...

  4. 30 CFR 18.16 - Withdrawal of approval, certification, or acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Withdrawal of approval, certification, or acceptance. 18.16 Section 18.16 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND...

  5. 49 CFR 195.228 - Welds and welding inspection: Standards of acceptability.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Welds and welding inspection: Standards of... SAFETY TRANSPORTATION OF HAZARDOUS LIQUIDS BY PIPELINE Construction § 195.228 Welds and welding inspection: Standards of acceptability. (a) Each weld and welding must be inspected to insure compliance...

  6. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  7. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  8. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  9. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  10. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  11. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  12. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  13. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  14. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND ORDERS; FRUITS, VEGETABLES, NUTS), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  15. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND ORDERS; FRUITS, VEGETABLES, NUTS), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  16. Acceptance Criteria for Aerospace Structural Adhesives.

    DTIC Science & Technology

    ADHESIVES, *AIRFRAMES, PRIMERS, STRUCTURAL ENGINEERING, CHEMICAL COMPOSITION, MECHANICAL PROPERTIES, INDUSTRIAL PRODUCTION , DATA ACQUISITION , PARTICLE SIZE, ACCEPTANCE TESTS, ELASTOMERS, BONDING, QUALITY CONTROL, .

  17. Safety analysis report for the Waste Storage Facility. Revision 2

    SciTech Connect

    Bengston, S.J.

    1994-05-01

    This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

  18. Formal Foundations for Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2015-01-01

    Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

  19. In acceptance we trust? Conceptualising acceptance as a viable approach to NGO security management.

    PubMed

    Fast, Larissa A; Freeman, C Faith; O'Neill, Michael; Rowley, Elizabeth

    2013-04-01

    This paper documents current understanding of acceptance as a security management approach and explores issues and challenges non-governmental organisations (NGOs) confront when implementing an acceptance approach to security management. It argues that the failure of organisations to systematise and clearly articulate acceptance as a distinct security management approach and a lack of organisational policies and procedures concerning acceptance hinder its efficacy as a security management approach. The paper identifies key and cross-cutting components of acceptance that are critical to its effective implementation in order to advance a comprehensive and systematic concept of acceptance. The key components of acceptance illustrate how organisational and staff functions affect positively or negatively an organisation's acceptance, and include: an organisation's principles and mission, communications, negotiation, programming, relationships and networks, stakeholder and context analysis, staffing, and image. The paper contends that acceptance is linked not only to good programming, but also to overall organisational management and structures.

  20. Estimating provisional acceptable residues for extralabel drug use in livestock.

    PubMed

    Baynes, R E; Martín-Jiménez, T; Craigmill, A L; Riviere, J E

    1999-06-01

    In 1996, the United States Congress passed legislation (Animal Medicinal Drug Use Clarification Act, AMDUCA), which allows some veterinary or human drugs to be used off label in food-producing animals. In order to implement this Act and protect the U.S. consumer, tolerances or safe concentrations are required before a withdrawal time can be estimated for extralabel drug use. Use of foreign MRLs to satisfy these data needs may not be applicable because of differences in safety standards between the U.S. and other countries. This paper presents strategies that can be used to derive equivalent safe concentrations, referred to as provisional acceptable residues (PARs), that may then be used to estimate drug withdrawal times. Health-based methods are proposed for calculating a PAR for a tissue. Procedure A partitions 50% of the acceptable daily intake (ADI) to edible tissues and reserves the remainder for milk. Procedure B equally partitions the ADI into all edible tissues. Procedure C partitions 50% of the ADI to milk and equally partitions the remaining 50% ADI into edible tissues. Simulations were performed for florfenicol, tetracycline, dexamethasone, azaperone, ivermectin, eprinomectin, and doramectin. In general, these simulations resulted in derivation of conservative PARs, which did not result in daily intakes of residues greater than the health-based ADI. These simulations demonstrated that provided the safe concentrations or equivalent PARs are based on rigorous toxicology safety data (e.g., NOELs, ADIs), the safety of food animal products will not be compromised. It is proposed that these PARs can be used for estimating withdrawal times after extralabel drug use or inadvertent exposure to an environmental contaminant where no approved withdrawal time exists. Finally, implementing similar transparent methods could have a positive impact on international harmonization and trade.

  1. Automating the Generation of Heterogeneous Aviation Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

    2012-01-01

    A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

  2. Leadership Profiles.

    ERIC Educational Resources Information Center

    Teach, Beverly; And Others

    1994-01-01

    Presents profiles of two leaders in the field of educational media and technology: Carolyn Guss and Mendel Sherman, both retired professors from Indiana University's program in Information Systems Technology. (KRN)

  3. Leadership Profiles.

    ERIC Educational Resources Information Center

    Morgan, Robert M.; And Others

    1992-01-01

    Presents profiles of three leaders in the field of educational media and technology: Robert Mills Gagne, Florida State University; Robert Heinich, Indiana University; and Charles Francis Schuller, University of Georgia. (SLW)

  4. Biophysical Profile

    MedlinePlus

    ... is Rh positive Worrisome results from other prenatal tests Your health care provider might also recommend a biophysical profile if ... the test and at regular intervals during the test. Your health care provider or a member of your health care ...

  5. Defining "Acceptable Risk" for Earthquakes Worldwide

    NASA Astrophysics Data System (ADS)

    Tucker, B.

    2001-05-01

    The greatest and most rapidly growing earthquake risk for mortality is in developing countries. Further, earthquake risk management actions of the last 50 years have reduced the average lethality of earthquakes in earthquake-threatened industrialized countries. (This is separate from the trend of the increasing fiscal cost of earthquakes there.) Despite these clear trends, every new earthquake in developing countries is described in the media as a "wake up" call, announcing the risk these countries face. GeoHazards International (GHI) works at both the community and the policy levels to try to reduce earthquake risk. GHI reduces death and injury by helping vulnerable communities recognize their risk and the methods to manage it, by raising awareness of its risk, building local institutions to manage that risk, and strengthening schools to protect and train the community's future generations. At the policy level, GHI, in collaboration with research partners, is examining whether "acceptance" of these large risks by people in these countries and by international aid and development organizations explains the lack of activity in reducing these risks. The goal of this pilot project - The Global Earthquake Safety Initiative (GESI) - is to develop and evaluate a means of measuring the risk and the effectiveness of risk mitigation actions in the world's largest, most vulnerable cities: in short, to develop an earthquake risk index. One application of this index is to compare the risk and the risk mitigation effort of "comparable" cities. By this means, Lima, for example, can compare the risk of its citizens dying due to earthquakes with the risk of citizens in Santiago and Guayaquil. The authorities of Delhi and Islamabad can compare the relative risk from earthquakes of their school children. This index can be used to measure the effectiveness of alternate mitigation projects, to set goals for mitigation projects, and to plot progress meeting those goals. The preliminary

  6. Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake

    PubMed Central

    Edwards, James A.

    2016-01-01

    Zeaxanthin is a nutritional carotenoid with a considerable amount of safety data based on regulatory studies, which form the basis of its safety evaluation. Subchronic OECD guideline studies with mice and rats receiving beadlet formulations of high purity synthetic zeaxanthin in the diet at dosages up to 1000 mg/kg body weight (bw)/day, and in dogs at over 400 mg/kg bw/day, produced no adverse effects or histopathological changes. In developmental toxicity studies, there was no evidence of fetal toxicity or teratogenicity in rats or rabbits at dosages up to 1000 or 400 mg/kg bw/day, respectively. Formulated zeaxanthin was not mutagenic or clastogenic in a series of in vitro and in vivo tests for genotoxicity. A 52-week chronic oral study in Cynomolgus monkeys at doses of 0.2 and 20 mg/kg bw/day, mainly designed to assess accumulation and effects in primate eyes, showed no adverse effects. In a rat two-generation study, the NOAEL was 150 mg/kg bw/day. In 2012, this dosage was used by EFSA (NDA Panel), in association with a 200-fold safety factor, to propose an Acceptable Daily Intake equivalent to 53 mg/day for a 70 kg adult. The requested use level of 2 mg/day was ratified by the EU Commission. PMID:26885380

  7. Investigations of the environmental acceptability of fluorocarbon alternatives to chlorofluorocarbons.

    PubMed

    McFarland, M

    1992-02-01

    Chlorofluorocarbons (CFCs) are currently used in systems for preservation of perishable foods and medical supplies, increasing worker productivity and consumer comfort, conserving energy and increasing product reliability. As use of CFCs is phased out due to concerns of ozone depletion, a variety of new chemicals and technologies will be needed to serve these needs. In choosing alternatives, industry must balance concerns over safety and environmental acceptability and still meet the preformance characteristics of the current technology, the only viable alternatives meeting the safety, performance, and environmental requirements for the remaining 40% of demand are fluorocarbons, hydrochlorofluorocarbons (HCFs), and hydrofluorocarbons (HFCs). HCFCs and HFCs possess many of the desirable properties of the CFCs, but because of the, hydrogen, they results in shorter atmospheric lifetimes compared to CFCs and reduces their potential to contribute to stratospheric ozone depletion or global warming; HFCs do not contain chlorine and have no potential to destroy ozone. This paper provides an overview of challenges faced by industry, regulators, and society in general in continuing to meet societal needs and consumer demands while reducing risk to the enviroment without compromising consumer or worker safety.

  8. Safety of rosuvastatin.

    PubMed

    Shepherd, James; Hunninghake, Donald B; Stein, Evan A; Kastelein, John J P; Harris, Susan; Pears, John; Hutchinson, Howard G

    2004-10-01

    The safety and tolerability of rosuvastatin were assessed (as of August 2003) using data from 12,400 patients who received 5 to 40 mg of rosuvastatin in a multinational phase II/III program, which represented 12,212 patient-years of continuous exposure to rosuvastatin. An integrated database was used to examine adverse events and laboratory data. In placebo-controlled trials, adverse events, irrespective of causality assessment, occurred in 57.4% of patients who received 5 to 40 mg of rosuvastatin (n = 744) and 56.8% of patients who received placebo (n = 382). In fixed-dose trials with comparator statins, 5 to 40 mg of rosuvastatin showed an adverse event profile similar to those for 10 to 80 mg of atorvastatin, 10 to 80 mg of simvastatin, and 10 to 40 mg of pravastatin. Clinically significant elevations in alanine aminotransferase (>3 times the upper limit of normal) and creatine kinase (>10 times the upper limit of normal) were uncommon (10 times the upper limit of normal with muscle symptoms) that was possibly related to treatment occurred in safety profile was similar to those of the comparator statins investigated in this extensive clinical program.

  9. Heavy Metal, Religiosity, and Suicide Acceptability.

    ERIC Educational Resources Information Center

    Stack, Steven

    1998-01-01

    Reports on data taken from the General Social Survey that found a link between "heavy metal" rock fanship and suicide acceptability. Finds that relationship becomes nonsignificant once level of religiosity is controlled. Heavy metal fans are low in religiosity, which contributes to greater suicide acceptability. (Author/JDM)

  10. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  11. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  12. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  13. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  14. Nevada Test Site Waste Acceptance Criteria (NTSWAC)

    SciTech Connect

    NNSA /NSO Waste Management Project

    2008-06-01

    This document establishes the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, Nevada Test Site Waste Acceptance Criteria (NTSWAC). The NTSWAC provides the requirements, terms, and conditions under which the Nevada Test Site will accept low-level radioactive (LLW) and LLW Mixed Waste (MW) for disposal.

  15. Consumer acceptance of ginseng food products.

    PubMed

    Chung, Hee Sook; Lee, Young-Chul; Rhee, Young Kyung; Lee, Soo-Yeun

    2011-01-01

    Ginseng has been utilized less in food products than in dietary supplements in the United States. Sensory acceptance of ginseng food products by U.S. consumers has not been reported. The objectives of this study were to: (1) determine the sensory acceptance of commercial ginseng food products and (2) assess influence of the addition of sweeteners to ginseng tea and ginseng extract to chocolate on consumer acceptance. Total of 126 consumers participated in 3 sessions for (1) 7 commercial red ginseng food products, (2) 10 ginseng teas varying in levels of sugar or honey, and (3) 10 ginseng milk or dark chocolates varying in levels of ginseng extract. Ginseng candy with vitamin C and ginseng crunchy white chocolate were the most highly accepted, while sliced ginseng root product was the least accepted among the seven commercial products. Sensory acceptance increased in proportion to the content of sugar and honey in ginseng tea, whereas acceptance decreased with increasing content of ginseng extract in milk and dark chocolates. Findings demonstrate that ginseng food product types with which consumers have been already familiar, such as candy and chocolate, will have potential for success in the U.S. market. Chocolate could be suggested as a food matrix into which ginseng can be incorporated, as containing more bioactive compounds than ginseng tea at a similar acceptance level. Future research may include a descriptive analysis with ginseng-based products to identify the key drivers of liking and disliking for successful new product development.

  16. Genres Across Cultures: Types of Acceptability Variation

    ERIC Educational Resources Information Center

    Shaw, Philip; Gillaerts, Paul; Jacobs, Everett; Palermo, Ofelia; Shinohara, Midori; Verckens, J. Piet

    2004-01-01

    One can ask four questions about genre validity across cultures. Does a certain form or configuration occur in the culture in question? Is it acceptable? If acceptable, is it in practice preferred? Is it recommended by prescriptive authorities? This paper reports the results of an attempt to answer these questions empirically by testing the…

  17. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... may, under appropriate circumstances, require offerors to demonstrate that the items offered— (1)...

  18. 48 CFR 2811.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Market acceptance. 2811.103... Planning DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 2811.103 Market acceptance... offerors to demonstrate that the items offered meet the criteria set forth in FAR 11.103(a)....

  19. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance. The TSP record keeper will reject a loan application if: (a) The participant is not qualified to apply...

  20. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance. The TSP record keeper will reject a loan application if: (a) The participant is not qualified to apply...

  1. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance. The TSP record keeper will reject a loan application if: (a) The participant is not qualified to apply...

  2. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  3. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  4. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  5. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND SECURITY... Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf of the head...

  6. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  7. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  8. Understanding diversity: the importance of social acceptance.

    PubMed

    Chen, Jacqueline M; Hamilton, David L

    2015-04-01

    Two studies investigated how people define and perceive diversity in the historically majority-group dominated contexts of business and academia. We hypothesized that individuals construe diversity as both the numeric representation of racial minorities and the social acceptance of racial minorities within a group. In Study 1, undergraduates' (especially minorities') perceptions of campus diversity were predicted by perceived social acceptance on a college campus, above and beyond perceived minority representation. Study 2 showed that increases in a company's representation and social acceptance independently led to increases in perceived diversity of the company among Whites. Among non-Whites, representation and social acceptance only increased perceived diversity of the company when both qualities were high. Together these findings demonstrate the importance of both representation and social acceptance to the achievement of diversity in groups and that perceiver race influences the relative importance of these two components of diversity.

  9. Heavy metal, religiosity, and suicide acceptability.

    PubMed

    Stack, S

    1998-01-01

    There has been little work at the national level on the subject of musical subcultures and suicide acceptability. The present work explores the link between "heavy metal" rock fanship and suicide acceptability. Metal fanship is thought to elevate suicide acceptability through such means as exposure to a culture of personal and societal chaos marked by hopelessness, and through its associations with demographic risk factors such as gender, socioeconomic status, and education. Data are taken from the General Social Survey. A link between heavy metal fanship and suicide acceptability is found. However, this relationship becomes nonsignificant once level of religiosity is controlled. Metal fans are low in religiosity, which contributes, in turn, to greater suicide acceptability.

  10. Monte Carlo determination of Phoswich Array acceptance

    SciTech Connect

    Costales, J.B.; E859 Collaboration

    1992-07-01

    The purpose of this memo is to describe the means by which the acceptance of the E859 Phoswich Array is determined. By acceptance, two things are meant: first, the geometrical acceptance (the angular size of the modules); second, the detection acceptance (the probability that a particle of a given 4-momentum initially in the detector line-of-sight is detected as such). In particular, this memo will concentrate on those particles for which the energy of the particle can be sufficiently measured; that is to say, protons, deuterons and tritons. In principle, the phoswich array can measure the low end of the pion energy spectrum, but with a poor resolution. The detection acceptance of pions and baryon clusters heavier than tritons will be neglected in this memo.

  11. Modeling of the charge acceptance of lead-acid batteries

    NASA Astrophysics Data System (ADS)

    Thele, M.; Schiffer, J.; Karden, E.; Surewaard, E.; Sauer, D. U.

    This paper presents a model for flooded and VRLA batteries that is parameterized by impedance spectroscopy and includes the overcharging effects to allow charge-acceptance simulations (e.g. for regenerative-braking drive-cycle profiles). The full dynamic behavior and the short-term charge/discharge history is taken into account. This is achieved by a detailed modeling of the sulfate crystal growth and modeling of the internal gas recombination cycle. The model is applicable in the full realistic temperature and current range of automotive applications. For model validation, several load profiles (covering the dynamics and the current range appearing in electrically assisted or hybrid cars) are examined and the charge-acceptance limiting effects are elaborately discussed. The validation measurements have been performed for different types of lead-acid batteries (flooded and VRLA). The model is therefore an important tool for the development of automotive power nets, but it also allows to analyze different charging strategies and energy gains which can be achieved during regenerative-braking.

  12. REFOS study: efficacy and safety of lanthanum carbonate in clinical practice in Spain.

    PubMed

    Torregrosa, José-Vicente; González-Parra, Emilio; González, M Teresa; Cannata-Andía, Jorge

    2014-05-21

    Lanthanum carbonate is a powerful phosphate binder that has shown efficacy and safety in clinical trials for hyperphosphataemia management, although there are few data in regular clinical practice. The study's objective was to evaluate, in regular clinical practice, its efficacy and safety in patients on dialysis. We retrospectively collected data from 15 months of monitoring, corresponding to 3 months prior to the start of treatment with lanthanum carbonate until 12 months after the start. Results included values of serum calcium, phosphorus, alkaline phosphatase, iPTH, hepatic enzymes and haemogram, as well as the daily-prescribed dose of lanthanum carbonate, the concomitant medication, treatment compliance and adverse events. 647 patients were included of which 522 completed the study. Abandonment, for the most part, was due to gastrointestinal disorders (26%) and hypophosphatemia (19%). Serum phosphorus decreased from 6.4±1.7 mg/dl (start) to 4.9±1.4 mg/dl (12 months) (P<.001). At the end of the monitoring period, 47% were within the desired phosphorus range (3.5-5mg/dl). There were no significant variations in the remaining parameters. Initial dose of lanthanum carbonate: 1900 mg/day; and end dose: 2300 mg/day. The variables independently associated with phosphataemia were baseline serum phosphorus and treatment compliance. In relation to safety, we observed 238 slight or moderate adverse effects in 117 patients, with 88% linked to gastrointestinal abnormalities. In conclusion, lanthanum carbonate reduces the serum phosphorus values in patients on dialysis with a good safety profile and acceptable adherence to that profile, with gastrointestinal disorders being the most frequent adverse effect.

  13. Safety analysis

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1995-01-01

    We are engaged in a research program in safety-critical computing that is based on two case studies. We use these case studies to provide application-specific details of the various research issues, and as targets for evaluation of research ideas. The first case study is the Magnetic Stereotaxis System (MSS), an investigational device for performing human neurosurgery being developed in a joint effort between the Department of Physics at the University of Virginia and the Department of Neurosurgery at the University of Iowa. The system operates by manipulating a small permanent magnet (known as a 'seed') within the brain using an externally applied magnetic field. By varying the magnitude and gradient of the external magnetic field, the seed can be moved along a non-linear path and positioned at a site requiring therapy, e.g., a tumor. The magnetic field required for movement through brain tissue is extremely high, and is generated by a set of six superconducting magnets located in a housing surrounding the patient's head. The system uses two X-ray cameras positioned at right angles to detect in real time the locations of the seed and of X-ray opaque markers affixed to the patient's skull. the X-ray images are used to locate the objects of interest in a canonical frame of reference. the second case study is the University of Virginia Research Nuclear Reactor (UVAR). It is a 2 MW thermal, concrete-walled pool reactor. The system operates using 20 to 25 plate-type fuel assemblies placed on a rectangular grid plate. There are three scramable safety rods, and one non-scramable regulating rod that can be put in automatic mode. It was originally constructed in 1959 as a 1 MW system, and it was upgraded to 2 MW in 1973. Though only a research reactor rather than a power reactor, the issues raised are significant and can be related to the problems faced by full-scale reactor systems.

  14. Rebuilding a safety culture

    NASA Astrophysics Data System (ADS)

    Rodney, George A.

    1991-11-01

    The development of a culture of safety and NASA since the Challenger accident is reviewed. The technical elements of the strengthened NASA safety program are described, including problem reporting, risk/assessment/risk management, operational safety, and safety assurance are addressed. Future directions in the development of safety are considered.

  15. Transportation Safety Excellence in Operations Through Improved Transportation Safety Document

    SciTech Connect

    Dr. Michael A. Lehto; MAL

    2007-05-01

    A recent accomplishment of the Idaho National Laboratory (INL) Materials and Fuels Complex (MFC) Nuclear Safety analysis group was to obtain DOE-ID approval for the inter-facility transfer of greater-than-Hazard-Category-3 quantity radioactive/fissionable waste in Department of Transportation (DOT) Type A drums at MFC. This accomplishment supported excellence in operations through safety analysis by better integrating nuclear safety requirements with waste requirements in the Transportation Safety Document (TSD); reducing container and transport costs; and making facility operations more efficient. The MFC TSD governs and controls the inter-facility transfer of greater-than-Hazard-Category-3 radioactive and/or fissionable materials in non-DOT approved containers. Previously, the TSD did not include the capability to transfer payloads of greater-than-Hazard-Category-3 radioactive and/or fissionable materials using DOT Type A drums. Previous practice was to package the waste materials to less-than-Hazard-Category-3 quantities when loading DOT Type A drums for transfer out of facilities to reduce facility waste accumulations. This practice allowed operations to proceed, but resulted in drums being loaded to less than the Waste Isolation Pilot Plant (WIPP) waste acceptance criteria (WAC) waste limits, which was not cost effective or operations friendly. An improved and revised safety analysis was used to gain DOE-ID approval for adding this container configuration to the MFC TSD safety basis. In the process of obtaining approval of the revised safety basis, safety analysis practices were used effectively to directly support excellence in operations. Several factors contributed to the success of MFC’s effort to obtain approval for the use of DOT Type A drums, including two practices that could help in future safety basis changes at other facilities. 1) The process of incorporating the DOT Type A drums into the TSD at MFC helped to better integrate nuclear safety

  16. Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

    PubMed Central

    Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

    2016-01-01

    Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials

  17. A Positive View of Peer Acceptance in Aggressive Youth: Risk for Future Peer Acceptance.

    ERIC Educational Resources Information Center

    Hughes, Jan N.; Cavell, Timothy A.; Prasad-Gaur, Archna

    2001-01-01

    Uses longitudinal data to determine whether a positive view of perceived peer acceptance is a risk factor for continued aggression and social rejection for aggressive children. Results indicate that perceived peer acceptance did not predict aggression. However, children who reported higher levels of perceived peer acceptance received lower actual…

  18. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis

    PubMed Central

    Calkwood, Jonathan; Vollmer, Timothy; Fox, Robert J.; Zhang, Ray; Novas, Mark; Sheikh, Sarah I.

    2016-01-01

    Background: Delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) is indicated for relapsing multiple sclerosis (MS). The objective of this study was to explore the safety and tolerability of DMF when administered with interferon beta (IFNβ) or glatiramer acetate (GA). Methods: Patients with relapsing-remitting MS receiving established therapy with the same dose of IFNβ or GA for at least 12 months continued their prescribed therapy for 2 months (monotherapy period) and then received DMF 240 mg three times daily in addition to their prescribed MS therapy for 6 months (add-on therapy period). Safety and magnetic resonance imaging outcomes were monitored monthly. Results: During the add-on therapy period, in the DMF+IFNβ (n = 57) and DMF+GA (n = 47) groups, the overall incidence of adverse events was 95% and 100%, respectively; the most common adverse events were flushing, diarrhea, and abdominal pain. In both groups, mean lymphocyte counts decreased but remained within normal limits, and hepatic transaminase levels increased transiently; no case met Hy's law criteria. There was no overall increased risk of infection. In both groups, gadolinium-enhancing lesion activity and new/enlarging T2 lesions decreased compared with the monotherapy period (exploratory endpoints). Conclusions: The safety profile of DMF taken with IFNβ or GA was acceptable and consistent with the known safety profile of DMF monotherapy. PMID:27252601

  19. The Evolution of System Safety at NASA

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Everett, Chris; Groen, Frank

    2014-01-01

    The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

  20. Consumer Acceptance of Dry Dog Food Variations

    PubMed Central

    Donfrancesco, Brizio Di; Koppel, Kadri; Swaney-Stueve, Marianne; Chambers, Edgar

    2014-01-01

    Simple Summary The objectives of this study were to compare the acceptance of different dry dog food products by consumers, determine consumer clusters for acceptance, and identify the characteristics of dog food that drive consumer acceptance. Pet owners evaluated dry dog food samples available in the US market. The results indicated that appearance of the sample, especially the color, influenced pet owner’s overall liking more than the aroma of the product. Abstract The objectives of this study were to compare the acceptance of different dry dog food products by consumers, determine consumer clusters for acceptance, and identify the characteristics of dog food that drive consumer acceptance. Eight dry dog food samples available in the US market were evaluated by pet owners. In this study, consumers evaluated overall liking, aroma, and appearance liking of the products. Consumers were also asked to predict their purchase intent, their dog’s liking, and cost of the samples. The results indicated that appearance of the sample, especially the color, influenced pet owner’s overall liking more than the aroma of the product. Overall liking clusters were not related to income, age, gender, or education, indicating that general consumer demographics do not appear to play a main role in individual consumer acceptance of dog food products. PMID:26480043